Georgia Public Health Laboratory service manual

SECTION I ADMINISTRATION

DHR

Gary B. Redding, Acting Commissioner Kathleen E. Toomey, M.D., M.P.H., Division Director
Elizabeth A. Franko, Dr.P.H., Laboratory Director

Georgia Department of Human Resources $ 2 Peachtree Street, NW $ Atlanta, Georgia 30303-3142 Division of Public Health $ 2 Peachtree Street, NW $ Suite 15-470 $ Atlanta, Georgia 30303-3142 $ (404)
657-2700 Laboratory $ 1749 Clairmont Road $ Decatur, Georgia 30033-4050 $ (404) 327-7900

July, 2001
Dear Public Health Laboratory Customer:
We are pleased to provide you with the July, 2001 revision of the "Laboratory Service Manual" for the Georgia Public Health Laboratory (GPHL). We have retained the ring-binder format and have added a considerable amount of new information about the Central Laboratory Facility in Decatur. We have also included material about additions to our services and changes in the way we provide services. For anyone not aware of it, the Macon Regional Laboratory closed in June, 1999 and those activities have been absorbed by the three GPHL facilities. For those of you who have Internet access, the Laboratory Service Manual is available on the Division of Public Health Web Site at http://www.health.state.ga.us/ under Publications/Manuals & Guidelines/Laboratory Service Manual.
If you ever have any questions about or problems with the services provided by the Public Health Laboratory, please do not hesitate to contact me at 404/327-7900 or to call one of the Supervisors and Mangers listed in the following pages. As always, we solicit your comments and suggestions. Thank you for your continued, enthusiastic support of the Georgia Public Health Laboratory.
Sincerely,
Elizabeth A. Franko, Dr.P.H. Director Public Health Laboratory
AN EQUAL OPPORTUNITY EMPLOYER

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Administrative Office
PH Laboratory Director Elizabeth A. Franko, Dr.P.H. Administrative Operations Manager - George E. Rains PH Laboratory Service Manager Microbiology/Immunology Mahin M. Park, Ph.D. Project Manager Karl E. Hoenes, M.S. PH Laboratory Service Manager Chemistry/Hematology M. Ramachandran, Ph.D.
Program Assistants Kay Felder Audrey Curry
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GEORGIA PUBLIC HEALTH LABORATORY BRANCHES

Decatur Laboratory:

Georgia Public Health Laboratory CLIA #11D0671793 (Specific Laboratory Unit) 1749 Clairmont Road Decatur, GA 30033-4050

Individual Units and Telephone Numbers:

Unit

Telephone

Administrative

(404) 327-7900

Office

FAX (404) 327-7919

Bacteriology

(404) 327-7990

Central Accessioning

(404) 321-2281

Laboratory Supply

(404) 327-7920

LIS Office

(404) 327-7931

Microbial Immunology

(404) 327-7970

Mycobacteriology

(404) 327-7940

Mycology

(404) 321-2260

Newborn Screening

(404) 327-7950

Parasitology

(404) 327-7960

Reports and Records

(404) 321-2240

Virology

(404) 327-7980

Regional Public Health Laboratories: Albany Regional Laboratory CLIA #11D0671770 1109 N. Jackson Street Albany, GA. 31701-2022 (229) 430-4122 FAX (229) 430-5143
Waycross Regional Laboratory CLIA #11D0671837 1101 Church Street Waycross, GA. 31501-3525 (912) 285-6000 FAX (912) 285-6032

Specimen Collection outfits: Order outfits from the Laboratory Branch, which will perform the test (see below). Mailing labels are pre-addressed to the branch providing the outfits.

Georgia Public Health Laboratory Laboratory Supply 1749 Clairmont Road Decatur, GA 30033-4050 (404) 327-7920

Albany Regional Laboratory 1109 N. Jackson Street Albany, GA 31701-2022 (229) 430-4122

Waycross Regional Laboratory 1101 Church Street Waycross, Ga. 31501-3525 (912) 285-6000

Procedure for Payment of Tests: Tests are paid for by a pre-paid stamp system. Stamps may be purchased, in the amounts of $1.00, $4.00, and $8.00 from the Georgia Public Health Laboratory, 1749 Clairmont Road, Decatur, GA. 30033-4050, (404) 327-7900. See Fee Code column of the List of Services, Section VII, for charges for specific tests.

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SECTION II OPERATIONS

TRANSPORTATION
There have been recent changes in the United States Postal Service (USPS) guidelines for shipping hazardous materials through the mail. The Georgia Public Health Laboratory is in the process of revising our shipping outfits for infectious substances (etiological agents) so they will be in compliance with these new regulations. We have been advised by our local postal representative to use the current outfits specified in each of the technical sections of this manual until we are in a position to provide new ones. We will be informing our clients of the availability of these new outfits in the near future. Packages delivered by courier or other carriers are subject to the guidelines of the specific company.
The information below defines the difference between infectious substances and clinical specimens. Also provided below is a summary of the shipping guidelines for each of these categories, which have been taken from Publication 52, July 1999, Hazardous, Restricted, and Perishable Mail, and the Federal Register 49 CFR Part 72. In general, the USPS has adopted the regulations specified by the International Air Transport Association (IATA). Appendix A of this manual gives further detailed USPS guidelines on the transport of infectious substances/etiological agents and diagnostic specimens, as well as Federal Express guidelines and the IATA standards.
Infectious substances (etiological agents) are substances known to contain, or reasonably expected to contain, a pathogen(s), i.e. a viable microorganism, or its toxin, that causes or may cause disease in human beings or animals. Infectious substances are synonymous with "etiologic agents." Table 1 lists the bacterial, fungal, viral and rickettsial agents that are "etiologic agents," according to 42 CFR Part 72.3. Clinical specimens (diagnostic specimens) mean any human or animal material including, but not limited to, excreta, secreta, blood, blood components, tissue, and tissue fluids that have been collected and are being mailed to a medical or forensic laboratory for the purpose of diagnosis. These substances are not known, or not reasonably believed to contain, an infectious substance.
Packages containing infectious substances that are to be transported by the USPS are subject to the following standards:
Each mailpiece should contain no more than 50 ml of infectious substance(s). Infectious substances must be packaged in a sealed, waterproof, primary receptacle
(test tube, vial, etc.) that is enclosed in another securely sealed, watertight, and durable secondary packaging. Several primary receptacles may be enclosed in a single secondary packaging if there is adequate shock-absorbent material between them to prevent breakage during ordinary handling, and if the total liquid volume of all enclosed primary receptacles does not exceed 50 ml. The space between the primary receptable(s) and secondary packaging at the top, bottom, and sides must contain enough material to absorb the entire content of the primary receptacle(s) in case of breakage or leakage. The primary-receptacle(s) and secondary packaging must be placed in a sealed outer packaging constructed of fibreboard or other equivalent material.
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A return address must be included on the outside of the package. Each outer packaging that contains infectious substances must bear: the "Etiologic
Agent/Biohazard Material" label, the DOT Class 6 label for infectious substances, the proper shipping name and UN number ("Infectious Substances Affecting Animals," UN2900, or "Infectious Substances Affecting Humans," UN2814), and orientation markings that properly indicate the upright position of the primary receptacle(s). A shipper's declaration for dangerous goods is required. The package must be sent by Express Mail, Priority Mail, or First-Class Mail. Specific infectious substances must be sent registered mail (see Table 2). When dry ice is used as a refrigerant, it must be placed outside the secondary container, and never be placed in a sealed container. If it is placed between the secondary container and the outer shipping container, enough shock-absorbent material must be added so that the secondary container does not become loose as the dry ice sublimates. A class 9 label should be applied to the outside container.
The packaging of clinical or diagnostic specimens that are to be transported by USPS must meet the following guidelines:
A clinical specimen consisting of 50 ml or less per mailpiece must be packaged in a securely sealed primary receptacle. Sufficient shock-resistant, absorbent material must surround the primary receptacle, or be otherwise configured to take up the content in case of leakage. The primary receptacle and the absorbent cushioning must be enclosed in a secondary packaging having a leakproof barrier. The secondary packaging may serve as the outer packaging or may be placed in an outer container.
Clinical specimens that exceed 50 ml per mailpiece must meet the above guidelines, but the secondary packaging must be placed in an outer fibreboard box or equivalent container. Each primary receptacle must not contain more than 1,000 ml of specimen, and the combined volume must not exceed 4,000 per mailpiece.
Each mailpiece must be marked "Clinical Specimen, Blood Sample," "Clinical Specimen, Urine Sample," etc., as appropriate, and must bear the universal biohazard symbol.
A complete return address and delivery address must be used. When dry ice is used as a refrigerant, it must be placed outside the secondary
container, and never be placed in a sealed container. If it is placed between the secondary container and the outer shipping container, enough shock-absorbent material must be added so that the secondary container does not become loose as the dry ice sublimates. A class 9 label should be applied to the outside container.

NOTE:

Blood specimens collected on filter paper (Form #3491) for the Newborn

Screening laboratory should continue to be mailed in the envelopes provided.

In the event of damaged packages, the carrier shall promptly, upon discovery of evidence of leakage or any other damage to packages bearing the Etiologic Agents label, isolate the package and notify the Director, Centers for Disease Control and Prevention, 1600 Clifton Road, N.E., Atlanta Ga. 30333, by telephone (404) 633-5313. The carrier shall also notify the sender.

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Table 1. List of "Etiologic Agents," from 42 CFR Part 72.3

Acinetobacter calcoaceticus- all members Actinobacillus all members

Bacterial Agents Leptospira interrogans all serovars Listeria all species

Actinomycetaceae all members Aeromonas hydrophilia Arachnia propionica

Mima polymorpha Moraxella all species Mycobacterium all species

Arizona hinshawii all serotypes Bacillus anthracis Bacteroides spp.

Mycoplasma all species Neisseria gonorrhoeae, N. meningitidis Nocardia asteroides

Bartonella all species Bordetella all species Borrelia recurrentis, B. vincenti

Pasteurella all species Plesiomonas shigelloides Proteus all species

Brucella all species Campylobacter fetus, C. jejuni Chlamydia psittaci, C. trachomatis

Pseudomonas mallei Pseudomonas pseudomallei Salmonella all species and all serotypes

Clostridium botulinum, C. chauvoei, C. haemolyticum, C. histolyticum, C. novyi, C. septicum, C. tetani

Shigella all species and all serotypes Sphaerophorus necrophorus Staphylococcus aureus

Corynebacterium diptheriae, C. equi, C. haemolyticum, C. pseudotuberculosis, C. pyogenes, C. renale

Streptobacillus moniliformis Streptococcus pneumoniae Streptotoccus pyogenes

Edwarsiella tarda Erysipelothrix insidiosa Escherichia coli, all enteropathogenic serotypes

Treponema careteum, T. pallidum, and T. pertenue Vibrio cholerae, V. parahaemolyticus

Francisella tularensis Haemophilus ducreyi, H. influenzae Klebsiella all species and all serotypes

Yersinia (Pasteurella) pestis, Y. enterocolitica

Legionella all species and all Legionella-like organisms

Blastomyces dermatitidis Coccidioides immitis Cryptococcus neoformans

Fungal Agents Histoplasma capsulatum Paracoccidioides brasiliensis

Viral and Rickettsial Agents

Adenoviruses human all types

Infectious bronchitis-like virus

Arboviruses all types

Influenza viruses all types

Coxiella burnetii

Kuru agent

Coxsackie A and B viruses all types

Lassa virus

Creutzfeldt-Jacob agent

Lymphocytic choriomeningitis virus

Cytomegaloviruses

Marburg virus

Dengue viruses all types

Measles virus

Ebola viruses

Mumps virus

Echoviruses all types

Parainfluenza viruses all types

Encephalomyocarditis virus

Polioviruses

Hemorrhagic fever agents including, but not limited to,

Rabies virus all strains

Crimean hemorrhagic fever(Congo), Junin, Machupo viruses, Reoviruses all types

And Korean hemorrhagic fever viruses

Respiratory syncytial virus

Hepatitis associated materials (Hepatitis A,

Rhinoviruses all types

Hepatitis B, Hepatitis nonA-nonB)

Rickettsia all types

Herpesvirus all members

Rochalimaeae quintana

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Table 1 (continued) List of "Etiologic Agents," from 42 CFR Part 72.3

Viruses and Rickettsial Agents (continued)

Rotaviruses all types

Vaccinia virus

Rubella virus

Varicella virus

Simian virus 40

Variola major and Variola minor viruses

Tick-borne encephalitis virus comples,

Vesicular stomatis viruses all types

including Russian spring-summer encephalitis, Kyasanur forest disease,

White pox viruses Yellow fever virus1

Omsk hemorrhagic fever, and Central

European encephalitis viruses

1This list may be revised from time to time by Notice published in the Federal Register to identify additional agents which must be packaged in accordance with the requirements contained in this part.

Table 2. List of Infectious Substances Requiring Registered Mail/Receipt Notification during Transport (42 CFR Part 72.3)
Coccidioides immitis Ebola virus Francisella ( Pasteurella) tularensis Hemorrhagic fever agents including, but not limited to, Crimean hemorrhagic fever (Congo), Junin, Machupo viruses, and Korean hemorrhagic fever viruses Herpesvirus simiae (B virus) Histoplasma capsulatum Lassa virus Marburg virus Pseudomonas mallei Pseudomonas pseudomallei Tick-borne encephalitis virus complex including, but not limited to, Russian spring-summer encephalitis, Kyasanur Forest disease, Omsk hemorrhagic fever, and Central European encephalitis viruses Variola major, Variola minor, and whitepox viruses Yersinia (Pasteurella) pestis

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SUPPORT SERVICES
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LABORATORY SUPPORT SERVICES INTRODUCTION
All non-technical laboratory responsibilities are performed by several specialized units which comprise the Laboratory Support Services Unit. This Unit is supervised and administratively represented by the Administrative Operations Manager.
Well organized, support services have always been a vital part of any efficiently functioning operation. Electronic data processing, has expanded the role of Support Services in the Laboratory Branch. The Central Accessioning area was added in 1999. Also in 1999, the Office of Laboratory Information Systems was removed from the Support Service Unit.
Components of the Georgia Public Health Laboratory Support Services Unit and a brief statement of responsibilities are listed below:
(a) Central Accessioning All specimens sent to the Public Health Laboratory for testing are processed through the Central Accessioning area. Here the specimens are opened, numbered and entered, electronically, into the Laboratory Information System (LIS).
(b) Reports and Records Office This office processes laboratory result reports Electronically, by U.S. Mail and Courier Services. Copies of reports are kept on file for reference, and record retention schedules are coordinated with DHR through this office.
(c) Service and Supply Unit This unit provides all technical and non-technical purchasing services for the Laboratory. All equipment Maintenance Contracts and in-house maintenance service are provided from this unit. The Procurement and Services Officer for this unit participates in and monitors the budget process for regular operating expenses.
(d) Scientific Services Unit This Unit handles the preparation of specialized media as requested from any of the technical areas. This unit also handles sterilization and biohazardous waste disposal.
(e) Laboratory Fee System This unit handles the sale of Laboratory fee stamps and processes the proceeds from the sale.
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The Support Service Unit clients consist of the general public and co-workers within the Laboratory Branch. It is our goal to provide the best services possible so that working together, we can provide efficient Clinical Laboratory services to the citizens of Georgia. George Rains, Administrative Operations Manager
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Services & Supply Unit

Unit Personnel

Receiving Area

Specimen Outfit Area

Program Assistant - Maxine Simpson
Procurement & Services Officer Regenia McCord

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LABORATORY SERVICES AND SUPPLY UNIT The Laboratory Services and Supply Unit operates with a staff of eight. This unit provides support services, in the areas listed below, to the Decatur, Albany and Waycross Public Health Laboratories. Additionally, employees in this Unit assemble and distribute specimen submission outfits to clients of the Decatur Laboratory (see page II-13). PURCHASING: The Procurement and Services Officer, who manages this unit is responsible for purchasing all laboratory testing materials and reagents used in the three Public Health Laboratories. These purchases are accomplished with appropriated funds and by adhering to strict purchasing guidelines imposed by the Department of Human Resources and the Department of Administrative Services. It is also the responsibility of this unit to administer grant funds covering regular operating expense for special projects in which the laboratory participates. EQUIPMENT MAINTENANCE: Approximately twenty-five equipment maintenance contracts are negotiated annually to ensure rapid and competent service for technical lab equipment. These contracts and other building maintenance needs are handled by a Maintenance Coordinator who is a member of the Service & Supply staff. MAIL HANDLING: All incoming and outgoing mail is processed through the Service & Supply Unit. US Mail is sorted and delivered to the appropriate areas. SHIPPING AND RECEIVING: All deliveries for the Decatur Laboratory are received and signed for in the Service and Supply area. Outgoing shipments are also processed through this area. COURIER SERVICE: Courier service is provided for the Decatur facility through the Service and Supply unit.
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SPECIMEN COLLECTION OUTFIT ODERING INFORMATION

Specimen collection and transportation supplies are provided COST-FREE by the GA Public Health Laboratories in Decatur, Albany, and Waycross. Supplies are provided only for specimens submitted to Georgia Public Health Laboratories. Supplies are not provided for submitting specimens to other testing laboratories.

Supplies are to be ordered from the laboratory location where the specimen will be sent for testing. Refer to section VII, pages 1-34 in the List of Services Section to determine the laboratory location where a particular test is available, the correct outfit name, and the item number to order. Specimens submitted incorrectly must be forwarded to the appropriate test site, and this delays the turnaround time.

TO ORDER SUPPLIES: Complete a Specimen Collection Outfit Order Form for the appropriate laboratory location (see Appendix B, pages 3-8 for specific examples). Each laboratory's order form lists only the supplies available at that location. Order only the supplies needed, as collection outfits have expiration dates. Supplies are available as:
(1) Outfits, which include the submission form, instructions for collecting and transporting specimens, the collection container, specimen bags, and a pre-addressed mailing container;
(2) Individual items, if only single items are needed; and (3) Forms, if only individual submission forms are needed. Order quantities by "the each;" do not order by the box unless noted on the order form. See Appendix C for the specific components of each type outfit. Provide the full street address as orders are shipped by UPS. If only the P.O. Box is given, the order cannot be shipped. Include the name and telephone number of the person ordering.

For those clients with Internet access, many of the GPHL submission forms are also available on the Division of Public Health Web Site at http://www.gdph.state.ga.us under Publications/Manuals & Guidelines/Laboratory Service Manual/Forms. As new forms are updated, these will be added.

For additional ordering information, please contact:

Decatur

Regenia McCord (404) 327-7921

Albany

Ann Blalock

(229) 430-4122

Waycross Frances Bowen

(912) 285-6000

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Central Accessioning/Data Processing Unit
Central Accessioning Personnel
Data Processing Personnel
Associate - Jenuryl Fluellen Technician - Greg Simpson Data Transcriber Supervisor Juanita Johnson
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CENTRAL ACCESSIONING / DATA ENTRY UNIT

The Accessioning Unit is the entry point for all specimens submitted for testing to the Central Public Health Laboratory in Decatur or one of the branch laboratories in Albany or Waycross.

The Decatur Unit is divided into two areas. The first area is where the specimens are opened, sorted and assigned a number. All specimens are processed on the day received and delivered to the testing laboratory. All specimens must have a submission form indicating the test requested. Central Accessioning ensures that a name or unique identifier is on the specimen and that the name and unique identifier matches the name and unique identifier on the submission form. If either of these conditions are not met, the specimen is not delivered to the testing laboratory, and a report of "unsatisfactory" is sent to the Client.

The second area, Data Entry is where the submission information for each specimen is electronically entered into the Laboratory Information System (LIS). The data entry area ensures that patient demographics and test requested are entered in an accurate and timely manner.

The two branch laboratories have the accessioning area arranged to meet their specific needs.

For information concerning the receipt of specimens or accessioning information, contact:

Jenuryl Fluellen Ann Blalock Frances Bowen

Decatur Lab Albany Lab Waycross Lab

404/321-2281 229/430-4122 912/285-6000

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Reports & Records Unit
Unit Personnel
Office Manager Shirley Simmons-Walton Program Assistant Lavette Usher
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REPORTS AND RECORDS UNIT

Reports and Records Units in the Public Health Laboratories in Decatur, Albany and Waycross perform three (3) essential functions:

1. Report laboratory findings. 2. Maintain records and statistical data. 3. Serve as a liaison/communication network with clinicians, public health officials and the
general public.

The Reports and Records Units in the Albany and Waycross Regional Laboratories report laboratory findings for the tests performed at the respective locations.

The Reports and Records Unit in the Decatur Laboratory reports laboratory findings for the majority of the tests performed at this location, with a few exceptions noted below. To make telephone inquiries about the status of a particular specimen, contact Reports and Records (404) 321-2240 or the appropriate section. Please note: Information can only be provided to the treating clinician, not to the patient.

Bacteriology

Reports and Records reports all testing. Contact Reports and Records for report status.

Microbial Immunology

Reports and Records reports all testing. Contact Reports and Records for report status.

Mycobacteriology/ Mycology Newborn Screening
Parasitology
Virology

Reports and Records reports all testing. Contact Reports and Records for report status.
Reporting is provided by Reports and Records. Contact Newborn Screening for report status and duplicate reports
at (404) 327-7950.
Reports and Records reports all testing. Contact Reports and Records for report status.
Reports and Records reports most testing. Exception: Rabies, contact the Laboratory at (404) 327-7980.

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Reports are provided only to the submitting clinician (the doctor submitting the specimen for testing). Currently, these reports are provided in one of three formats:
A. A machine copy of the submission form onto which laboratory findings are recorded.
B. Submission form on which laboratory findings are recorded in selected cases.
C. A computer-generated report form containing the laboratory findings and pertinent information provided on the submission form.

Laboratory test records are retained by Reports and Records for a year after reporting. Records are then forwarded to the State Records Center where they are retained for an additional year before destruction. Duplicate copies of laboratory test reports, can be provided upon request from the original submitting clinician. Proper identification is essential. All requests for more than five reports must be submitted in writing.
For additional information on Reports and Records, please contact:

Decatur Shirley Simmons-Walton

Albany

Ann Blalock

Waycross Frances Bowen

404-321-2241 229-430-4122 912-285-6000

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Scientific Services Unit

Unit Personnel

Media Preparation

Sterilization and Waste Disposal

Fluoride Testing
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SCIENTIFIC SERVICES UNIT The Scientific Services area prepares microbiological culture media for the Decatur Laboratory and two diagnostic regional laboratories located in Albany, Georgia and Waycross, Georgia. Media is also prepared for the Newborn Screening area of the Decatur facility. All newborns in the state of Georgia are screened for 8 metabolic disorders using media prepared in this area. Sterilization and biohazardous waste disposal for the entire Decatur facility are handled through the Scientific Services area. Glassware is also cleaned, sterilized and delivered to the labs. January 1, 2000, the Scientific Services Unit began fluoride proficiency testing for the DHR, Office of Oral Health. Each water system, in Georgia, that adjusts the fluoride level in drinking water is asked to participate in this proficiency testing. This work had previously been handled by the Environmental Protection Division of the Georgia Department of Natural Resources. If you have questions or wish further information on Scientific Services/Media Preparation you may call one of the people listed below:
George Sweeney, Scientific Services Manager, phone 404/327-7967 Michael Colbert, Laboratory Technologist, phone 404/327-7966
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Laboratory Information System
Laboratory Information Coordinator - Shane Crockett LAN Engineer - Marv Coleman
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LABORATORY INFORMATION SYSTEMS UNIT
The Laboratory Information Systems Unit provides a support function for all of the information and data system needs of the GPHL. The Laboratory Information Systems (LIS) are key elements of the laboratory for maintenance of precise records on all specimens that are handled by the laboratory. Not only are data captured identifying the specimen, requestor, and tests to be performed, but many items that assist the Public Health programs in the delivery, assessment and management of their services. The Unit is staffed to cover the two major areas of responsibility. The first is the support, development and maintenance of the LIS. This responsibility involves the integration of the technical aspects of the laboratory operation with the computer-based software systems that collect, display and report the tests performed on specimens. The data analysis and information transfer requirements of the laboratory are met in this responsibility. Responsibility is staffed with personnel of the laboratory. The second responsibility concerns the installation, maintenance and enhancement of the physical computer assets that are required to support the operation of the LIS. The LIS employ the latest technologies in the LANs, servers and interfaces to the automated specimen testing systems. Support is provided for a LIS that operates in three separate locations that must operate concurrently yet function separately in certain emergency situations. This responsibility is staffed by personnel from the IT Unit of the Department of Human Resources.
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Laboratory Training Area
Training Classroom
Training Laboratory Library/Conference Room
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LABORATORY TRAINING The GPHL in Decatur houses a training facility consisting of a laboratory, classroom, and satellite downlink equipment for the purpose of providing training opportunities for public health staff in Georgia. The classroom can seat 24 in a classroom configuration and more than 40 for lectures. The training laboratory is a sixteen place BioSafety Level 2 (BSL2) space with two attached BSL3 suites. Each BSL3 suite contains an incubator and two biosafety cabinets. There is a fume hood in the specimen preparation area. The GPHL is a member of the National Laboratory Training Network (NTLN) and participates in a number of training program offered by the NTLN. The GPHL hosts training programs organized and administered by the NTLN in a variety of public health subject areas. The GPHL satellite downlink equipment connects the Laboratory with the wide range of training programs offered by the CDC through the Public Health Training Network as well as the health departments of other states.
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SECTION III BIOTERRORISM

BIOTERRORISM
They say it's not a question of "if" but rather "when" we will have a bioterrorism attack. We may find it hard to believe that a biological attack could occur here, but it is well documented by agencies with expertise in weapons of mass destruction (WMD), that the United States is vulnerable to the deliberate use of biological agents. Homeland defense is no longer the responsibility of only the military and law enforcement infrastructure. Clinical laboratories have an important role to play.
Background: In order to address the threat of bioterrorism (BT), CDC and the Association of Public Health Laboratories (APHL) have established the "Laboratory Response Network" (LRN). The LRN includes all state public health laboratories as well as CDC, the FBI Laboratory and the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) as well as other clinical labs. The concept of the LRN is based on strengthening existing state, local and federal public health laboratories and improving linkage with the network of private and hospital laboratories that submit specimens for routine and referral testing to the public health system. The Georgia Public Health Laboratory (GPHL) is an active member of the LRN, participating in development of consensus protocols for testing for BT agents, training, and infrastructure improvement. Because bioterrorism events are low probability, high consequence events, the capabilities for bioterrorism have functionality beyond emergency response, and are applied to surveillance and identification of the causes of infectious disease outbreaks.
To ensure capacity and responsiveness, a four-tier LRN model has been defined. This model describes a laboratory network that can detect, identify and communicate timely information concerning the occurrence of an infectious disease or bioterrorism event to aid in effective interventions to treat cases and prevent the spread of disease. The LRN consist of:
v Level A: Any clinical laboratory that can rule out specific/critical agents and forward specimens to a higher level laboratory. By rule-out or referral, these laboratories provide early detection. They should assess for risk from aerosols and work at a minimum of biosafety level 2 (BSL-2) capacity.
v Level B: Any state and/or county public health laboratory that can rule-in specific/critical agents, forward specimens to higher level laboratories, process environmental samples, perform confirmatory testing and antibiotic susceptibility testing. These laboratories are usually BSL-2 working with BSL-3 practices (recommended).
v Level C: State public health laboratories with advanced capacity, nucleic acid amplification assays, antigen detection assays, molecular typing, and ability for surge capacity. These laboratories work at BSL-3.
v Level D: These laboratories include the CDC and USAMRIID facilities. They are able to perform all A to C tests, validate new assays, detect genetic recombinants, provide
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specialized reagents, bank/archive isolates, perform molecular typing and test for smallpox. They can perform work to the highest, BSL-4, capacity.
Bioterrorism attacks are expected to be either overt (announced) or covert, perhaps affecting a large number of people at a public gathering. In covert attacks, as victims seek medical intervention, illness may be reported in random locations for some time after the initial exposure. Primary health care facilities such as hospitals, primary care physicians, and county health departments may be the first to deal with the consequences of a covert attack. Health care providers should be able to:
v Recognize the possibility of a bioterrorist attack. v Be prepared to act quickly v Have contact name and telephone numbers readily available. v Develop a bioterrorism preparedness plan. v Presumptively identify bioterrorism organisms. v Send suspected organisms to the nearest public health laboratory for confirmation. v Report notifiable diseases to State Office of Epidemiology.
By improving communications within the health care system, a more efficient, effective means of detecting and responding to biological emergencies can be achieved. Improving the public health infrastructure not only helps with timely response to a bioterrorist event, but also enhances the existing mechanisms for the early detection of an emerging infectious disease. Basic laboratory information for Level A Laboratories is available for public access at www.bt.cdc.gov.
GPHL Capacity: The GPHL Central Facility in Decatur has biosafety level 3 (BSL-3) capability for the isolation and identification of bioagents in the event of bioterrorist attack. The laboratory has the capacity to identify the organisms believed most likely to be used in a bioterrorist attack. Currently, these include Bacillus anthracis (Anthrax), Francisella tularensis (Tularemia), Yersinia pestis (Plague), and Brucella species (Brucellosis). Specimens for Variola major (Smallpox) and Clostridium botulinum toxin are sent to CDC for testing. Additional infectious organisms and toxins will be added to the BT profile of agents in the future, as consensus protocols are developed.
Submission of Specimens: The GPHL will accept specimens from the two possible types of events. Environmental (overt) specimens (threat letters, notes, papers, envelopes, powder, etc.) should be double bagged and handed over to law enforcement (FBI) for delivery to the GPHL. Because a terrorist attack, or even the threat of such an action, is a federal offense, it is critical that appropriate chain of custody be established to preserve the integrity of potential evidence.
Reference specimens (possible covert event) should be submitted to the GPHL from any hospital or other clinical laboratory in the state. If bioterrorism is suspected, it is important to contact law enforcement (FBI). A "Culture Referral/Isolation for ID" (form #3410) should accompany the specimen. Please refer to the Bacteriology or Virology sections of this manual for other specific information.
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Important Telephone Contacts: Local Police : ____________________________________________ Local Fire Department : ___________________________________ Local EMS: _____________________________________________ Federal Bureau of Investigation (FBI): 404-679-9000 (Atlanta)
Local FBI office: _______________________________ Georgia Poison Control Center (24/7 coverage):
404-616-9000 (metro Atlanta) 1-800-282-5846 (throughout Georgia) 404-616-9287 (for hearing impaired only Teletype TTY) Georgia Public Health Laboratory (business hours): 404-327-7900 (Main phone) 404-327-7990 (Bacteriology Unit) 404-327-7980 (Virology Unit)
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SECTION IV
CENTRAL FACILITY (DECATUR)

CHEMISTRY/HEMATOLOGY/METABOLIC SCREENING SERVICES INTRODUCTION
Newborn screening is offered free of charge to Georgia residents as mandated by Georgia Law. All newborns are screened for possible incidence of phenylketonuria (PKU), tyrosinemia, homocystinuria, maple syrup urine disease (MSUD), galactosemia, hypothyroidism, congenital adrenal hyperplasia and Sickle Cell Disease. This manual describes the overall policies and procedures of laboratory testing by the State Public Health Laboratories that includes Newborn Screening. Specific instructions for specimen collection, preparation of appropriate requisition forms and guidelines for proper packaging and transport of specimens are outlined under relevant headings. Details regarding procurement of collection outfits, specimen acceptance policies, turn-around time for different tests, reporting results and interpretation are also given. Testing procedures and other exclusive services (like the blood lead) performed at each of the Regional Laboratories and at the laboratory in Atlanta are described independently. It is hoped that this manual will serve as a resource guide for submitters for all the information that they may need in looking for a particular test and getting it done by any of the State Public Health Laboratories. The relevant contact persons and their telephone numbers are provided. The submitters are encouraged to use them freely before they initiate a test request. M. Ramachandran, Ph.D. Laboratory Clinical Program Director Chemistry/Hematology/Metabolic Screening Services
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Newborn Screening Unit

Unit Personnel

Associate - Henry Carson, B.S. Manager - Sandra Hollman, B.S.

Data Transcriber II - Emma Martin Data Transcriber Supervisor - Michelle Dukes Program Assistant - Sondra Rates
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NEWBORN SCREENING UNIT 404-327-6800

INTRODUCTION

The Newborn Screening Unit fulfills a Georgia mandate that requires that all infants born in the state are tested, before the first month of life, for certain inherited metabolic disorders that may cause mental retardation or death if not detected within this time frame. The Genetics Division of the Department of Pediatrics at Emory University School of Medicine provides all the followup work on positive infants (confirmation, counseling, treatment, etc.) with metabolic disorders. Universal Screening for Sickle Cell Disease was introduced by the State in October 1998 and is performed at the Laboratory in Atlanta. All testing is done on blood specimens collected on filter paper. Present protocol includes testing for specific compounds/metabolites in blood as indicated.

PHENYLKETONURIA (PKU): Phenylalanine is measured

HOMOCYSTINURIA:

Methionine is measured

MAPLE SYRUP URINE DISEASE (MSUD):

Leucine is measured

TYROSINEMIA:

Tyrosine is measured

GALACTOSEMIA:

Uridyl transferase qualitatively assayed on all specimens. Galactose and galactose-1-phosphate, quantitatively measured on all positives and inconclusives.

HYPOTHYROIDISM:

Thyroxine (T4) is measured on all specimens. Thyroid stimulating hormone (TSH) is measured on a selective lowest percentile of T4 values.

CONGENITAL ADRENAL HYPERPLASIA (CAH):

17-OH-Progesterone is measured.

SICKLE CELL DISEASE:

Screening is done by Isoelectric focussing. Presumptive positives are confirmed by HPLC and Citrate agar electrophoresis.

SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Excerpts from "BLOOD COLLECTION ON FILTER PAPER FOR NEONATAL SCREENING PROGRAMS", NCCLS Document LA4-A, Vol. 8 No. 9
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A. MATERIALS NEEDED 1. Form 3491 is the combination collection outfit and patient information instrument. A pre-addressed envelope is also available. Order these from: Laboratory Services and Supply, 1749 Clairmont Road, Decatur, GA 30033, (phone: 404-327-7921). Ask for form #3491 for Metabolic screens and #3603 for the pre-addressed envelope. Order sufficient amounts that can be used within six months. Store in a cool dry area. When submitting metabolic screens to our laboratory, use only the material we supply. These filter paper collection outfits are to be used prior to the expiration date, which is approximately two years from the printing date. The expiration date is on the filter paper portion. Destroy all outfits after the expiration date. The forms currently in use include a protective wrap-around cover for the filter paper, and do not require an individual envelope for each specimen card. 2. 75% isopropanol 3. Sterile lancets with a point of 2.5 mm in length. A LONGER POINT MIGHT PIERCE THE HEEL BONE. Sterile prepackaged lancets designed for pediatric use are available through private vendors. 4. Sterile gauze 5. Gloves
B. Recommendations for Blood Collection 1. Normal Infants - The infants should preferably be on a protein diet 24 hours prior to collecting the blood sample. The sample should be collected between 48 hours and 7 days of birth. 2. Early Discharge of a Normal Infant - If the infant is discharged earlier than 48 hours after birth, or before a 24 hour period of protein feeding, a specimen should still be collected. Write on the report form the infant's age at the time the blood was collected. The parents are to be informed in writing that the child must be retested by one week of age. 3. Sick Babies - Collect a blood sample on the fourth day of life. Note on the report form if the infant is being given specific therapy,i.e. antibiotics, hyperalimentation, etc. The blood sample should again be collected by one week of age. 4. Premature Infants - Infants less than 36 weeks gestation or 5 1/2 pounds or less in weight at birth should be retested when the child is about four weeks of age. Collect the first specimen 24 hours after protein feeding or 48 hours after birth. 5. How Much Blood To Collect - Six(6) spots of blood should be submitted in order to provide sufficient blood if retesting is required. If the infant is not bleeding freely, for initial screening purposes, three spots completely filled are better than five spots incompletely filled. 6. Interference: Antibiotics and Transfusions - Some antibiotics interfere with the testing for PKU, MSUD, homocystinuria, and tyrosinemia. When this occurs the results will be reported as "Unsatisfactory-Bioassay Inhibited". If the infant is to be transfused, collect a specimen before the transfusion regardless of the age. If the child is less than 48 hours old, collect a second sample one week after the last transfusion and a third sample two months after the last transfusion.
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C. Collection Procedure 1. HEEL STICK ABSORPTION (METHOD OF CHOICE) a. The blood collector should wear gloves and take universal precautions for handling blood. b. Collect the blood from the infant's heel, using the most medial or lateral portion of the plantar surface of the heel, where "medial" is defined as that close to the midline of the body, and "plantar surface" as the walking surface of the foot. DO NOT use previous puncture sites or the curvature of the heel. DO NOT perform skin punctures for obtaining blood specimens on the central area of a newborn's or infant's foot (area of the arch). This may result in injury to the nerves, tendons and cartilage. DO NOT perform skin punctures on the fingers of newborns or infants. c. Warming the skin-puncture site can increase blood flow through the site. A warm, moist towel or diaper at a temperature no higher than 42o C may be used to cover the site for three minutes. d. Clean the skin with an alcohol swab (75%). Wipe off the excess alcohol with dry sterile gauze, and allow the skin to air-dry. Alcohol residue remaining on the skin may dilute the specimen and adversely affect test results. e. To obtain sufficient flow of blood, forcefully puncture the infant's heel with a sterile lancet with tip 2.5 mm long or less or with an automated lancet device. Wipe away the first drop of blood with sterile gauze. f. Hold the infant's heel loosely so not to impede the flow of blood. If bleeding does not immediately occur, massage the lower portion of the leg in a downward direction. Avoid squeezing the area since this dilutes the blood with tissue fluid. g. When a large drop of blood appears, fold back the protective wrap-around cover, and gently touch the filter paper to the drop of blood. Allow a sufficient quantity of blood to soak through to completely fill a preprinted circle on the filter paper. Apply blood only to one side of the filter paper. Examine the opposite side to be sure that blood has penetrated through to make a circle which is approximately the same size as the printed circle. The success lies in allowing the blood drop to grow to its full size and touching with the filter paper when it is about to fall. Repeat this process until all circles are filled. If there is a problem getting a blood flow to fill five circles, get at least three correctly filled circles. Keep the cover folded away from the wet blood while it is being air-dried.
CAUTION: 1. Milking or squeezing the puncture may cause hemolysis of the
specimen and/or a mixture of tissue fluids with the specimen. This type specimen will be called "unsatisfactory, contaminated". 2. Do not layer successive drops of blood in the printed circle. If blood flow diminishes so that circles are not completely filled,
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repeat the sampling technique in a new circle. EACH CIRCLE SHOULD BE FILLED WITH ONLY ONE APPLICATION OF FREE FLOWING BLOOD. If not, the specimen will be called "unsatisfactory, unevenly soaked". h. After blood has been collected from the heel of the newborn, the foot should be elevated above the body, and a sterile gauze, pad or cotton swab pressed against the puncture site until the bleeding stops. i. After the blood has been collected, keep the cover folded away from the wet blood. Allow the blood to dry at room temperature for a minimum of three hours by placing the form horizontally on a table top with the wet blood spots over the edge to allow air drying from both sides. Do not place the form inside an envelope until completely dry. Do not put near a heat source, in direct sunlight, or on an absorbent surface. DO NOT TOUCH THE FILTER PAPER WITH YOUR HAND AT ANY TIME. j. Give all the information requested on form 3491. USE BLOCK PRINT. The date of birth, date of collection, time of collection and birth weight are needed to interpret the results. Do not touch the blood spots when completing this step. 2. CAPILLARY COLLECTION -- Although not the preferred method, application of blood collected in sterile heparinized capillary tubes into the preprinted circles of the filter paper is an acceptable alternative to direct application from the heel puncture site, provided the capillary does not touch the filter paper. a. Touch the tip of the heparinized capillary tube to the blood drop formed at the heel puncture site. Blood will flow into the tube by capillary action. Collect approximately 100 ul of blood into the heparinized capillary tube. Use a fresh capillary tube for each blood spot that will be collected on the filter paper. b. After collection of each capillary tube immediately apply the blood to the filter paper in one smooth continuous step without dabbing or other action that might scratch, compress, or indent the paper. Waiting too long before application will allow cells and plasma to separate. c. Apply the blood to each preprinted circle to only one side of the filter paper. Do not try multiple applications. Specimens that exhibit caking or heterogeneous spreading will be called unsatisfactory. d. Observe above mentioned guidelines for preparing infant's heel before and after collection and for specimen handling.
D. Requisition Form The requisition outfit is combined with the collection outfit (form 3491). All of the information requested on the form are important for some of the test result interpretation. The information on the infant's name, birthday, hospital of birth and the physician of record and the telephone number to report abnormal test results are mandatory.
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Specimen cards without this information will be classified as "Specimen Unsatisfactory Insufficient Information." BLOCK PRINT all information that is requested. To aid in researching missing reports, keep the submitter's copy of the requisition. This can be useful in identifying missing reports that can be linked to data entry interpretation errors and forms that are incorrectly filled out.
SHIPMENT OF SPECIMENS
Due to the life threatening nature of several of these diseases, the law requires that the specimen collection, testing, retrieval of suspected cases and specific diagnosis all be done before the infant is three weeks old. For this reason the blood specimen must be collected when the infant is no less than forty-eight hours old but not later than one week of age. In order to expedite the testing of the blood sample, and to insure the integrity of the sample, all specimens must be sent to an approved laboratory on the day of collection. Specimens must be completely dry before covering and inserting in the mailing envelope (form 3603). The dried blood spot specimens MUST NOT be packaged in airtight, leak-proof bags. The lack of air exchange in the inner environment of a sealed plastic bag may cause heat buildup, moisture accumulation and/or chemical leaks from the plastic that can damage the specimen integrity. Once collected, specimens can either be mailed to the testing laboratory using the pre-addressed enveloped that is part of the collection outfit or they may be sent by courier. Precaution should be taken that mailed specimens are not put in mail boxes that do not have a daily pickup. The specimen must reach the laboratory within seven days of the collection date or it will be called "unsatisfactory, delayed".
REPORTING AND INTERPRETATION OF RESULTS
Normal results for all tests other than hemoglobins will be reported as WITHIN NORMAL LIMITS. All abnormal results will be reported as POSITIVE or INCONCLUSIVE (galactose), ABOVE NORMAL LIMITS (phenylalanine, tyrosine, methionine, leucine, TSH, or 17-0HProgesterone) or BELOW NORMAL LIMITS (thyroxine), all with a quantitation. Specimens that were previously positive or are Known Cases will always be reported with a quantitative value whether normal or abnormal. Normal hemoglobins will be reported as FA Normal. All heterozygote results (abnormal hemoglobin plus A) will be reported as traits. Any homozygote abnormal (absence of Hgb A) will be reported as a disease. Traits that are not identifiable by the methods used within this lab are reported as: "FA-Variant. Variant Trait Carrier. Confirm Test Required." All tests are performed within the third day of receipt in the lab. Results are available two days after day of testing. All abnormal results are electronically generated and mailed to the hospital of birth and the physician of record on the date of test completion. A letter of interpretation and instructions will accompany the report. All abnormal reports will also be sent to the Genetics Department at Emory University who is responsible for the necessary tracking, confirmation and counseling of positive cases. All normal reports will be mailed after testing is completed for all disease conditions and when the demographic entry is completed which usually takes about three working days. Results of all testing are sent to the Genetics Program Office. The report of any sickle cell disease that is identified will also be faxed to the Program office who, inturn, will relay the information to the follow up centers at Medical
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College of Georgia, Augusta and at the Grady Hospital, Atlanta. These centers are responsible for follow-up, confirmation of screening results, treatment of diagnosed cases and for counseling.

NORMAL RANGES:

Phenylalanine Methionine Leucine Tyrosine Galactose TSH T4 17a-0H Progesterone

<4 mg/dl <2 mg/dl <4 mg/dl <12 mg/dl <11 mg/dl <25 uU/ml *See below *See below

*Normal range is dependent upon age and birth weight of infant and may shift due to population being tested. Abnormal T4 levels must be confirmed by elevated TSH levels to be indicative of hypothyroidism. Presently the following levels are recognized.

AGE/BIRTH WEIGHT

NORMAL RANGES

Normal birth weight, < 1 week of age
Normal birth weight, >1 week of age Premature/low birth weight

T4 >7.5 ug/dl
>5.4 ug/dl >4.5 ug/dl

CAH (Age >48 hrs) <45 ng/ml (Age <48 hrs) <80 ng/ml
<45 ng/ml <80 ng/ml

UNACCEPTABLE SPECIMENS
Specimens will be called unsatisfactory to test for the following reasons: 1. Inadequate blood collection (QNS) - A specimen will be considered QNS if at least two
filled and evenly soaked circles are not submitted, or if the blood spot card has an inadequate quantity of blood, either front or back, for the automatic punch assembly to fit within. 2. Oversaturated - Too much blood was allowed to soak onto the filter paper, causing the paper to bend, fold and crumple. May also results in clots on the surface of the paper. 3. Delayed - There is a seven day or more lapsed from date of collection and date received in the laboratory. 4. Contamination - Disinfectant, alcohol, water, tissue fluid or other foreign substance showing to be diluting the specimen. 5. Unevenly Soaked - Multiple applications of blood causing a layering of blood on paper. 6. Capillary - Recognizable as unevenly soaked blood in a circular pattern with roughed up filter paper tracks caused by dragging the tip of the capillary across the surface of the filter paper.

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7. Crumpled - oversaturation or multiple applications of blood causing the surface of the filter paper to buckle.
8. Obsolete or wrong outfit - Any outfit that is not using the same lot # of filter paper that is presently in use within the lab. This also applies to unfamiliar forms with no lot # given.
9. Roughed Up - Collection of specimen on damaged filter paper so that fibers from paper are standing on end.
10. No Blood - No collection was made. 11. No Information - Specimens without a name (infant or mother) will be reported as
unsatisfactory. When other information is missing but the actual collection is acceptable, certain assumptions will be made, the specimen will be tested, and whereever possible, the results will be released. **A training videotape titled "How to Collect Acceptable Filter Paper Specimens" is available from the Genetics Program upon request. Call (404) 651-7551 for details.
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MICROBIOLOGY/IMMUNOLOGY SERVICES INTRODUCTION
The Microbiology/Immunology Service offers a listing of services we provide to our clients in the areas of bacteriology, immunology, parasitology, mycobacteriology, mycology, and virology. The mission of this unit is to give assistance to public and private health-care providers in their investigation and control of diseases. It is believed that this mission can be best accomplished by the accurate analysis of clinical and reference specimens submitted by the county health departments, hospitals, other clinical laboratories, and physicians in private practice.
In addition to providing this manual, our laboratory services support several statewide investigations. When deemed necessary, both environmental and non-human specimens are tested to help investigate outbreaks of diseases. We also assist the Centers for Disease Control and Prevention (CDC) by participating in surveillance studies and by providing them with the results of our laboratory findings for a number of communicable diseases.
Our Bacteriology Unit uses gas liquid chromatography for analysis of the fatty acid contents of bacterial cell walls as an adjunct to the conventional biochemical tests for bacterial identification. We use the pulsed-field gel electrophoresis (PFGE) technology for the molecular subtyping of a number of different bacteria. Our laboratory has provided valuable information on molecular typing of a number of isolates and has identified strains that have been implicated in a number of foodborne outbreaks. Also, to assist the Food and Drug Administration (FDA) in their AFood Safety Initiatives," our food and enteric section has expanded its services to include detection of Shiga-like toxins (SLT I and II) for enterohemorrhagic Escherichia coli (EHEC), enterotoxin for Staphylococcus aureus, and Clostridium perfringens. The Bacteriology Unit also determines antibiograms for various Salmonella serotypes and all Shigella isolates throughout the state. The Bacteriology Unit, in conjunction with the Albany and Waycross Regional Laboratories, has expanded testing for Chlamydia trachomatis and Neisseria gonorrhoeae (GC) by DNA probes to all Family Planning and STD Clinics throughout the state. We continue to expand our Chlamydia and Gonorrhea testing to include DNA amplification procedures (PCR) for selected sites in the state. To enable us to detect agents of bioterrorism more rapidly, we are in the process of evaluating PCR protocols for these agents. In addition, we are developing PCR protocols for the detection of enterotoxigenic E. coli and Bordetella pertussis.
The Microbial Immunology Unit implemented an enzyme immunoassay procedure in 1997 to confirm the presence of specific syphilis antibodies in RPR-reactive specimens. We continue to offer testing for four hepatitis B virus markers (i.e., surface antigen, surface antibody, core antibody, and e antigen). In addition, a hepatitis B surface antibody quantitative procedure is available to evaluate the level of a vaccine response. In 1998, we implemented testing for hepatitis A instead of referring these specimens to CDC. In 1999, we started parvovirus B-19 testing to expand our viral exanthems testing panel. In 2001, we started offering antibody tests for arboviruses using a panel which includes West Nile Virus.
Our Mycobacteriology Unit continually strives to improve our services by incorporating the latest, appropriate technological advances into our diagnostic assays. To accomplish this, the
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laboratory now uses quicker and more specific tests in the diagnosis of mycobacteria (e.g., Gen Probe, Bactec MGIT 960, and HPLC), and is capable of identifying most species of mycobacteria. Our skilled mycobacteriologists are committed to reducing our turnaround time for reporting diagnostic and sensitivity results for Mycobacterium tuberculosis; this ensures that reports of acid-fast examinations are available within 24 hours after specimens are received in our laboratory. Additionally, M. tuberculosis is identified in 17 days, on the average, and results of susceptibility tests are provided within 7-14 days after identification of M. tuberculosis. Currently, we are testing four primary drugs (isonazid, rifampin, ehtambutol, and streptomycin) for susceptibility testing.
The Mycology Unit was integrated with Mycobacteriology Unit in 2000 and serves as the state reference laboratory. Our technologists are capable of identifying most, if not all, fungi. This is especially important because, as the number of immunocompromised patients in our population increases, many fungi, which have been considered saprophytes, may become opportunistic pathogens in these patients. The identification of these fungi, as well as the primary pathogens, provides valuable epidemiological information for control of nosocomial and communityacquired infections.
Our Parasitology Unit provides a full range of diagnostic services to all County Health Departments. In addition, our laboratory serves as a reference laboratory to all health care providers. All routine specimens are reported within 12-24 hour turn-around-time of specimen receipt. In addition to testing for intestinal parasites, we examine specimens for blood, tissue, and intestinal parasites, and we identify arthropods of public health importance (e.g., ticks, fly larvae, mites, and lice). The Parasitology Unit routinely examines all fecal specimens for the presence of Cryptosporidium and Cyclospora spp. We also examine blood for all species of malaria and microfilaria. Upon request, urine can be examined for Schistosoma haematobium. We hope to add Microsporidia to our routine diagnostic work in the near future.
The Virology Unit provides testing for HIV antibody by EIA and Western blot. In January 2001, we received funding to perform Viral Load Test (VLT). The latter is a PCR-based procedure that determines the number of copies of HIV-1 RNA in infected patient's blood. Offering VLT expanded our HIV testing by providing the amount of HIV in patient's blood, which will assist clinicians in proper drug selection for treating their patients. The Virology Unit identifies other viruses such as influenza and herpes by culture and specific detection procedures. In addition, all potentially rabid domestic and wild animals are tested for rabies when there is a suspected human or domestic animal exposure. Every year during flu season, our laboratory participates in a statewide surveillance to determine the predominant type of flu virus in circulation, throughout the state. We use electron microscopy for preliminary identification of Norwalk-like viruses, enteroviruses, rotaviruses, and adenoviruses. We participate in the Viropharma/ Epidemiology Surveillance for enteroviruses.
Our ability to expand the aforementioned services and offer more to the community has been made possible, in part, through financial support from federally funded programs dedicated and delivered to our laboratory by the Emerging Infection Program, and the STD, the TB, and the
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Immunization programs. We participate in the Viropharma /Epidemiology surveillance for enteroviruses. To ensure that our laboratories continue producing high-quality results, we have expanded our current quality assurance (QA) program to include the tracking of agencies and individuals that submit "unsatisfactory" specimens. This will better enable us to communicate with these submitters as to how they can improve the quality of the specimens they submit to us. Other aspects of our QA program include our continued participation in proficiency testing, which is offered through the College of American Pathologists and the American Association of Bioanalysts for all our laboratory units. In addition, our HIV and Microbial Immunology Units participate in proficiency testing offered by CDC. The Virology Unit participates in the Rabies Proficiency Testing offered by the Wisconsin State Laboratory of Hygiene, and Mycobacteriology Unit participates in the Sensitivity Assay Proficiency Testing offered by the CDC. In summary, we are constantly endeavoring to provide the most accurate and the most reliable laboratory services possible for the purpose of maintaining and improving the overall health of our state, our community, and its individual members.
Mahin M. Park, Ph.D., HCLD Clinical Laboratory Service Director Immunology/ Microbiology Services E-mail: mpark@gdph.state.ga.us Telephone No: (404) 327-7905
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Bacteriology Unit
Unit Personnel
Program Assistant - Deborah Wilson Associate - Leith Cobb, M.S. Manager - Marsha Ray, M.S.
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BORDETELLA PERTUSSIS 404-327-7990
INTRODUCTION
The Bacteriology Unit accepts cultures for the isolation of both Bordetella pertussis and B. parapertussis, nasopharyngeal swabs in charcoal-blood transport medium for both agents, and slides for direct fluorescent antibody (FA) testing for B. pertussis only. Specimens may be sent from public and private health care providers. Pulsed-field gel electrophoresis (PFGE) will be performed on all B. pertussis isolates to evaluate similarities between strains, and antibiotic susceptibility to erythromycin will be performed on all isolates as well. We are in the process of developing and evaluating a PCR protocol for the detection of B. pertussis.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Nasopharyngeal swabs are the specimens of choice, and they should be collected as soon as possible after onset of illness, preferably before antibiotic treatment. Calcium alginate swabs are superior to other types of swabs and should be used to collect specimens as follows: pass swab very gently through the nostril until it reaches the posterior nares and leave in place for 15 to 30 seconds (this may induce a cough and in practice only a few seconds may be possible). Collect a second swab from the contralateral nostril in the same manner.
A. Specimen for Culture: Inoculate the culture plate first to avoid contamination if both a smear and culture are being submitted. Select one of the following procedures immediately after collection (the choice dependent upon delay in transport - see Shipment of Specimens Section): (1) Inoculate specimen directly at bedside onto a Regan-Lowe plate.* Rotate swab over the first quadrant, and streak the remaining plate for isolated colonies using a sterile loop; (2) Place swab in a fatty acid-free solution of 1.0% Casamino Acids, available commercially. (3) Place swab in a charcoal-blood transport medium.* Label plate or transport tube with the patient=s name or other unique identifier and date of specimen collection.
*Regan-Lowe plates and tubes of charcoal-blood transport media may be obtained from the Bacteriology Laboratory. To obtain these items, special arrangements must be made in advance of specimen collection. They are also available commercially. Plates and transport medium should be stored refrigerated and warmed to room temperature before use.
B. Specimen for Slides: Prepare 2 dime-sized smears on each of 2 microscope slides (one slide per nostril). Use frosted-end slides with prestamped circles if possible (frosted side up). Label slide holder
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with the patient=s name or other unique identifier and date of specimen collection (avoid using wax pencil or gummed labels on slides).
C. Culture (B. pertussis isolated at submitting laboratory): 1. Inoculate a pure culture onto a plate of charcoal agar with horse blood, such as Regan-Lowe medium, and incubate at 35o C under high humidity. Schedule subculture so that time between optimal growth and transport of culture is <24 hours. 2. Examine medium beginning after 2 days incubation until confluent growth appears in the first quadrant of the plate. 3. Using a Dacron swab, aseptically harvest all growth from the first quadrant of the plate by sweeping the swab head through the area of confluent growth while rotating the swab shaft. Immerse swab containing harvested growth 2mm deep into the agar of a charcoal-blood transport tube, warmed to room temperature. 4. Aseptically cut the swab shaft flush with the top of the transport tube and replace cap. 5. Label transport tube with patient identifier information. 6. Maintain additional subculture(s) on plates at submitting laboratory until viability of referred culture is confirmed by the Bacteriology Unit.
Requisition Form If both culture and direct FA are requested, complete form #3410 and include the following information: (1) Unique patient identifier (name or number). (2) Date of specimen collection. (3) Test requested, such as culture for B. pertussis and B. parapertussis and direct FA for B.
pertussis. (4) Submitter=s name and address. (5) Name and telephone number of clinician to contact. (6) Source of specimen, such as nasopharyngeal. (7) Patient=s race, sex, age, and address, if available. (8) Brief clinical history, if available.
If only direct FA is requested, use form #3415 and include the above information. If an isolate is submitted, complete form #3410.
The patient identifier (name, number, or both) indicated on the requisition form should match that written on the slide holder, transport tube, or culture. Unlabeled specimens will not be tested.
SHIPMENT OF SPECIMENS AND CULTURES (See pages II-1 - II-4 of this manual for recent changes in federal shipping guidelines)
A. Slides: Place slides securely in the plastic slide holders provided (outfit #0525, available from Laboratory Services and Supply, 404-327-7920). Place plastic holder in a plastic biohazard bag. Insert requisition form in the pouch in the front of the bag. Place the bag
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with form affixed in the orange-labeled cardboard mailing container (Decatur address). Seal the lid of the outside container with tape. Send by first class mail, common carrier, or courier. If there is any delay in shipment, slides may be held at room temperature.
B. Nasopharyngeal Specimens for Culture: The method of shipment is dependent upon the selection of transport media used and the length of time required to arrive at the Bacteriology Unit. (1) Inoculated plates must be incubated at 35o C with increased humidity or transported (room temperature) to the Bacteriology Unit immediately by courier. (2) Specimens in tubes of charcoal-blood transport media should be transported (room temperature) to the Bacteriology Unit immediately by courier, or if there is any delay in shipment, they should be stored and sent refrigerated (with ice packs) by first class mail, common carrier, or courier. (3) Specimens in Casamino Acids must arrive within 2 hours after specimen collection. Under these conditions, they may be sent at room temperature.
C. Isolates inoculated into charcoal-blood transport media may be shipped at room temperature via Federal Express using pre-printed labels (available from the Bacteriology Unit).
REPORTING AND INTERPRETATION OF RESULTS
Results of direct FA testing are completed the day of receipt if received by 1:00 pm, Monday through Thursday, or by 2:00 pm on Friday. Results of both negative and positive reports are telephoned to the submitter the day of testing. Nasopharyngeal smears are reported positive for Bordetella pertussis if there are > 5 organisms present with typical cellular morphology and intense fluorescence. Due to shortage of quality reagent, B. parapertussis FA testing is confined to confirmation of positive cultures for this organism.
Cultures are held 7 days from the date of inoculation and are read daily. Nasopharyngeal swabs received in transport medium tubes are inoculated immediately onto Regan-Lowe plates when received, placed back into the transport medium and incubated an additional 48 hours, and then again inoculated onto Regan-Lowe plates. Each plate is held 7 days, so the total turnaround time for reporting swabs received in transport medium is 9 days. After the final day of incubation, if there are no colonies typical of B. pertussis or B.parapertussis present, the culture is reported negative for these organisms. A positive culture report is based upon typical cellular and colonial morphology and is confirmed by fluorescent antibody testing. Positive cultures or cultures overgrown with mold or normal flora are reported immediately upon detection, and results are telephoned to the submitter.
Both culture and direct FA procedures are recommended for diagnosis of B. pertussis whenever possible. AFalse negative@ FA results may occur from low numbers of organisms present in nasopharyngeal secretions. The FA test is most valuable during the early phase of illness and before antibiotic treatment when the largest number of organisms are being shed. Positive FA results should be considered presumptive. As with any subjective test, Afalse positive@ FA results
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are possible. Only highly experienced staff in the Bacteriology Unit reads slides and reports results to minimize false positives. AFalse negative@ culture results may follow from any procedures that render the organisms nonviable, such as improper handling of plates and transport medium after collection or prolonged antibiotic treatment. The FA test will detect nonviable organisms. A positive culture result is the most reliable. UNACCEPTABLE SLIDES AND CULTURES 1. Smears that are too thick or too thin for accurate interpretation (these slides will be read
but reported as unsatisfactory and the reason will be noted on the report). 2. Slides broken in transit. 3. Cultures overgrown with mold or normal flora. 4. Cultures or transport medium improperly submitted (see above for the recommended
procedure). 5. No patient identifier on specimen or culture.
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CHLAMYDIA/GONORRHEA DNA PROBES 404-327-7990
INTRODUCTION
Chlamydia (C.) trachomatis is the most common treatable sexually transmitted infection affecting females of reproductive age in the United States today, with an estimated four million new cases each year. Up to 80% of infected females have few or no symptoms, and asymptomatic infection in females can persist for up to 15 months. Complications of untreated chlamydial infection in females include: acute pelvic inflammatory disease; ectopic pregnancy; chronic pelvic pain; and infertility.
Gonorrhea affects males and females from symptoms of purulent discharge in males, a few days after exposure, to very mild symptoms in females. Symptoms may pass unnoticed with a consequence that asymptomatic carriers contribute significantly to the public health problem of gonorrhea.
The Bacteriology Unit uses Gen-Probe Pace 2 reagents and DNA Probe methodology for chlamydia and gonorrhea screening, and when indicated, uses the Probe Competitive Assay (PCA) by Gen-Probe for confirmation.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Pap smears should be collected after specimens for DNA probes. Female endocervix and male urethra are the only specimens FDA approved for the Gen-Probe Pace 2 test. Throat, rectum, and vaginal specimens should not be submitted for DNA probes.
Use the Gen-Probe Pace 2 specimen collection kits supplied by the District or County services and supply representative, or contact Teresa Edwards at (404) 657-3100 to place an order. The kits are color-coded B pink for females, and blue for males.
CLIENT TESTING CRITERIA:
Family Planning Clinics: All females age 29 years or younger who receive a pelvic exam during a visit (initial, annual or comprehensive medical only) will be screened for chlamydia. A female will only be screened once per calendar year for chlamydia unless she has clinical signs or symptoms of chlamydia (cervicitis/MPC, friable cervix, cervical ectopy, abdominal pain, abnormal bleeding, dyspareunia or dysuria) or a new sex partner or multiple sex partners in the past 60 days. All females 30 years and older who meet these criteria will also be screened for chlamydia.
STD/General Clinics: All females age 10-29, who receive a pelvic exam during a visit, will be screened for chlamydia. This includes rescreening females who are returning for medical problems, receiving more than one pelvic exam a year and/or are currently on antibiotics. All females 30 years and older who present with clinical
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signs or symptoms of chlamydia (cervicitis/MPC, friable cervix, cervical ectopy, abdominal pain, abnormal bleeding, dyspareunia or dysuria) or have a new sex partner or multiple sex partners in the past 60 days will also be screened for chlamydia. Male clients presenting for services should also be screened for chlamydia.
Teen Clinics : All females who receive a pelvic exam will be screened for chlamydia. This includes rescreening females who are returning for medical problems, receiving more than one pelvic exam a year and/or are currently on antibiotics. Males should also be screened.
All female/male clients screened for chlamydia will also be screened for gonorrhea.
Females with cervical stenosis should be included in the chlamydia/gonorrhea screening.
If the client does not have a cervix, she will not be included in the chlamydia screening.
SPECIMEN COLLECTION
Endocervical females 1. Moisten the speculum with warm water (do not use any other lubricant), insert the
speculum, and visualize the cervix. 2. Remove excess mucus from the cervical os and surrounding mucosa by gently wiping
with one of the swabs provided in the kit. 3. Discard cleaning swab. 4. Insert other swab from collection kit one to one and one-half centimeters into the
endocervical canal. 5. Rotate the swab slowly 180 degrees (at least 10 seconds) in the endocervical canal to
ensure adequate sampling. Withdraw swab carefully; avoid any contact with vaginal mucosa. 6. Insert this second swab (collection swab only) into the GEN-PROBE transport tube. Snap off shaft at score line or cut shaft to fit tube. Cap tube tightly. Legibly label tube with client=s name, patient ID# and date of collection. UNLABELED SPECIMENS WILL NOT BE TESTED.
Urethra males 1. Patient should not have urinated for at least one hour. 2. Insert swab from collection kit two to four centimeters into urethra. 3. Once inserted, rotate swab gently at least one full rotation using sufficient pressure to
ensure swab comes into contact with all urethra surfaces. Allow swab to remain inserted for two to three seconds. 4. Withdraw swab.
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5. Insert collection swab into the GEN-PROBE transport tube. Snap off shaft at score line or cut shaft to fit tube. Cap tube tightly. Legibly label tube with client=s name, patient ID# and date of collection. UNLABELED SPECIMENS WILL NOT BE TESTED.
Requisition Form 1. Use the Chlamydia and Gonorrhea requisition form #3568 (Rev. 8-00). 2. Fill out the form completely by printing or typing legibly. Only legible information can
be entered correctly into the laboratory database. Incomplete or illegible information may delay your results. Do not use computer-generated labels for patient information. 3. Information required is as follows: a. Submitter information (submitter code, submitter address, and phone number). b. Patient information (name, patient ID number, county of residence, zip code,
State, race, ethnicity, gender, date of birth). c. Specimen information (test requested, reason for test, date collected, source of
specimen, specimen status). 4. Tear off the top section of form (white copy) and mail to the laboratory with the
specimen, making sure the names on the specimen and form are EXACT matches. Retain the other two copies of the form (pink and yellow) for clinic and program use. 5. Chlamydia and Gonorrhea Laboratory Submission forms should be ordered as indicated by the STD Program Office.
SHIPMENT OF SPECIMENS
For best results, specimens should be transported to the laboratory on the date of collection; however, if this is impossible, specimens may be kept at room temperature and shipped as soon as possible. Specimens over seven days old at the time of arrival in the laboratory will be reported unsatisfactory.
1. Chlamydia/Gonorrhea Probe specimens may be transported at room temperature. Use the specimen transport cans and Decatur address labels (available from the laboratory).
2. Be sure the caps on the transport tubes are secure, and wrap each specimen in absorbent packing material. Place the wrapped specimen inside the aluminum can, and close the can securely.
3. Wrap the completed requisition form around the aluminum can and secure it with a rubber band.
4. Place the aluminum can inside the labeled (Decatur address) fiberboard can, close, and secure the lid with tape.
5. An alternate shipping method may be utilized by substituting the BIOHAZARD BAG for the inner aluminum container. If this method is chosen, the matching requisition forms should be placed in the pouch located in the front of each bag.
6. Specimens may be mailed or shipped by the method most convenient and expedient.
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REPORTING AND INTERPRETATION OF RESULTS
The goal of the Bacteriology Unit is to test and report all Chlamydia/Gonorrhea Probe specimens within a 48-hour turnaround period, unless confirmation testing is required (these specimens are reported the following business day). An electronic copy of all positive Chlamydia and Gonorrhea reports is transmitted to the State Sexually Transmitted Disease (STD) Program. A hard copy of all positives is also mailed to the State STD Surveillance Office.
Results are reported as follows:
POSITIVE B Nucleic acid for C. trachomatis and/or N. gonorrhoeae was detected in the specimen, and as indicated, confirmed by Probe Competitive Assay.
NEGATIVE B No evidence of nucleic acid of C. trachomatis and/or N. gonorrhoeae was found in the specimen.
INDETERMINATE B Results of repeat testing are equivocal. Submit another specimen.
UNSATISFACTORY B Specimen compromised in some manner making it unsatisfactory for testing. The reason for each Unsatisfactory result will be listed on the report form.
UNACCEPTABLE SPECIMENS
Specimens will be reported UNSATISFACTORY for the following reasons: 1. No patient identifier on the specimen, or discrepancy between identifier on the specimen
and requisition form. 2. Source other than cervix or male urethra. 3. Two swabs received in the collection outfit. 4. No solution in the collection outfit. 5. No swab, or improper swab (not from Gen-Probe kit) in the collection outfit. 6. Specimen greater than seven days old from date of collection when received. 7. Grossly bloody specimen. 8. Collection kit expired. 9. No specimen received. 10. Medical/legal specimens (DNA probes are not approved for medical/legal cases).
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ENTERIC BACTERIOLOGY 404-327-7990
INTRODUCTION
The Bacteriology Unit examines feces and other specimens for the presence of enteric pathogens, namely Salmonella serotypes, Shigella, Campylobacter, Aeromonas species, Yersinia enterocolitica, and E.coli O157:H7, on a routine basis. Testing for Shiga-like toxin (SLT) will be done on all bloody stools and on all stools when E.coli O157 is requested. Stool specimens for other foodborne etiologic agents, such as Staphylococcus aureus, Vibrio spp., and Clostridium perfringens, will be tested if the patient=s clinical history and the epidemiological data warrant (see section on Foodborne Illness). Environmental samples may be accepted for enteric culture, but only when implicated in cases of human illness or by prior consultation.
All isolates of Salmonella, Shigella, Campylobacter, E.coli O157:H7, Yersinia enterocolitica, and Vibrio. recovered from specimens by other clinical laboratories in Georgia should be referred to the Bacteriology Unit, either directly or through the Emerging Infections Program (EIP) site. Referred isolates will be further characterized by various methods, such as biochemical reactions, serogrouping/serotyping, cell wall fatty acid analysis, Pulsed-field gel electrophoresis (PFGE), and/or antibiotic susceptibility testing, depending upon the organism. Tests for SLT will be performed on all cultures when E.coli O157 is requested. A multiplex PCR assay is available for enterotoxigenic E. coli by special arrangement. These services are used in conjunction with epidemiological investigations and surveillance, and are offered at no charge. Tests for occult blood and fecal WBC counts are not performed at the GPHL.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
A. Feces Specimens for Salmonella, Shigella, Campylobacter, Aeromonas, Yersinia, E.coli O157, Listeria, Staphylococcus aureus, and Vibrio: 1. Feces specimens for the above agents should be collected in the Para-Pak C&S outfit, salmon-colored top (do not use the Parasitology O&P kit, blue and whitecolored top, because it contains formalin that kills bacteria). Collect freshly passed feces as soon as possible after onset of illness and before antimicrobial therapy has been initiated (stools for S. aureus must be collected within 24 hours after onset). Select portions containing blood or mucous, if present. Use the Aspoon@ in the lid of the collection vial to facilitate placing a portion of the feces into the vial, add specimen only to the red line on the vial, tighten the cap securely, and invert several times. The solution in the vial should be salmon colored before the specimen is added. Two to three specimens collected on different days may be necessary for diagnosis. 2. Rectal swabs containing detectable feces may be collected and placed in a culturette with Stuarts, Cairy-Blair, or other commercially available transport medium (not provided by the GPHL), if a feces specimen cannot be obtained. Pathogens are less likely to recovered from rectal swabs than from feces. 3. Store and ship at room temperature.
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B. Feces specimens for Clostridium perfringens, C. botulinum, and Bacillus cereus: 1. For these agents, collect fresh stool specimens and place in a leak-proof, noncrushable, clean container (not provided by GPHL). Do not use the enteric ParaPak C&S stool culture outfit. 2. For C. perfringens and B.cereus, stool specimens must be collected within 48 hours from the time symptoms begin. 3. Store and ship refrigerated.
C Each stool specimen must be clearly labeled with the patient=s name and accompanied by a properly completed isolation form #3416 (Feces Culutre for Bacterial Enteric Pathogens). The form must include the following information: 1. Patient identifier (name or number). 2. Date of specimen collection. 3. Agent suspected, if applicable. 4. Submitter=s name and address. 5. Symptoms.
D. Referred Cultures (for identification) Submit an overnight, pure culture of the isolated bacteria on carbohydrate-free media (TSA and TSI are acceptable). Label tube with the patient=s name and complete the Isolation for Identification form #3410. The form must include the following information: 1. Patient identifier (name or number). 2. Date of collection. 3. Source of specimen. 4. Agent suspected. 5. Submitter=s name and address. If possible, please include any clinical data, cultural characteristics, biochemical reactions, or serology.
The patient identifier (name, number, or both) indicated on the requisition form should match that written on the specimen or culture. Unlabeled specimens or cultures will not be tested.
SHIPMENT OF SPECIMENS AND REFERRED CULTURES (See pages II-1 - II-4 of this manual for recent changes in federal shipping guidelines).
Mailing containers for submitting fecal specimens and referred enteric cultures are available from Laboratory Services and Supply (404) 327-7920. For stool specimens order #0555, Astool culture,@ and for cultures order #0505, Aculture referral for identification.@
To facilitate handling, the following should be observed:
1. Wrap kyfax absorbent around the specimen/culture and place in the biohazard bag provided. Put the correct requisition form (stools for isolation, #3416, or cultures for serotyping or identification, #3410) in the pouch located in front of the bag.
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2. Place the biohazard bag in the cardboard mailing container with the Decatur address label (orange). Seal the lid of the outside can with tape.
3. Ship specimens as soon as possible after collection. If there is a delay in transport, keep the specimen at room temperature; do not refrigerate (except as noted above for stool specimens for C.perfringens, C.botulinum, and B.cereus).
4. Specimens and referred cultures should be mailed first class, shipped by common carrier, or delivered to the Laboratory by courier.
5. When large numbers of specimens are expected (such as in an outbreak), please alert the Bacteriology Unit by telephone (404) 327-7990 before mailing so adequate amounts of media will be available for processing.

REPORTING AND INTERPRETATION OF RESULTS

Negative stool specimen results are reported within 2 to 4 working days. Preliminary positive specimen results are also reported within 1 to 4 working days and are telephoned to the submitter; final results are reported within 4 to 6 working days.

Serotyping and confirmation or identification results are usually reported within 3 to 5 working days for Salmonella, Shigella, Aeromonas, Vibrio, and Yersinia spp., within 4 to 6 working days for E.coli O157:H7, and up to 10 working days for Campylobacter.

A negative stool culture report reflects the organisms for which the stool specimen was routinely examined: ANo Salmonella, Shigella, Campylobacter, Aeromonas, Yersinia enterocolitica, or E.coli O157:H7 found.@ Other organisms will be reported, as appropriate, per request. The
results of SLT testing will be reported when performed.

The following enteric pathogens, whether isolated from stool specimens or submitted as referred

cultures are identified/confirmed to the species or serotype level:

Salmonella sp. or serotype

Aeromonas sp.

Shigella sp. and serotype

Vibrio sp.

Campylobacter sp.

Yersinia enterocolitica and serotype

E.coli O157 positive/negative, H7 positive/negative, and/or SLT positive/negative

UNACCEPTABLE SPECIMENS

1. Specimens submitted in wrong preservative, e.g., PVA or 10% formalin. 2. Refrigerated specimen for Shigella. 3. Multiple specimens collected on the same day (only one specimen will be tested). 4. No patient identifier on specimen or culture. 5. Specimens received more than 7 days after collection (they will be tested, but a
disclaimer will be added to the report indicating that negative results are questionable). 6. Swab submitted in Para-Pak C&S outfit.

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FOODBORNE OUTBREAKS 404-327-7990
INTRODUCTION
The Bacteriology Unit assists physicians and county health department officials in the diagnosis and epidemiological investigation of outbreaks of suspected foodborne illness. The laboratory examines food, feces, and other epidemiologically implicated specimens for the presence of disease-producing bacteria or toxins. Food samples from single cases of suspected foodborne illness will not be examined with the exception of suspected botulism cases. The Georgia Environmental Health and Injury Control Branch (404-657-6534) must be notified by the County Health Department in which the suspected outbreak has occurred, unless botulism is suspected, in which case the Georgia Epidemiology and Prevention Branch (404-657-2588) should be notified. The Bacteriology Laboratory must be advised by either the Environmental Health and Injury Control Branch or the County Health Department of the forthcoming samples, the method of shipment, and the expected time of arrival. This will facilitate the necessary preparations that must be made for processing and examining the samples. Suspect food samples from commercial or retail stores should be referred to the Georgia Department of Agriculture (404656-3621).
When submitting food samples, clinical signs and symptoms, incubation periods, duration of illness, the type of food being submitted, and other pertinent clinical or epidemiological data, must be indicated. This information should also be appropriate for the suspected organism before testing will be initiated. Feces and other epidemiologically implicated specimens, as deemed appropriate by the investigating environmental health specialist, may also be tested.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
All food items must be clearly labeled as to contents and type of food. Fecal or other specimens should be clearly labeled with the patient's name or other unique identifier and indicated as being associated with the outbreak under investigation. Unlabeled specimens will not be tested.
A. Food All food specimens (25 grams minimal, preferably 100 grams ) should be collected under sterile conditions, placed in sterile plastic bags (whirlpacks) or other suitable leakproof containers, and refrigerated. It is the responsibility of the environmental health specialist who collects the specimens to ensure that each food item is accompanied by a completed Food Report (form #3450). The following minimum information must be included: source of sample; type of sample; date collected; incubation period; clinical symptoms; organism suspected; and submitter's name and address.
B. Fecal Specimen 1. Enteric Pathogens and Staphylococcus aureus: Refer to the Enteric Bacteriology section of this manual for instructions pertaining to collecting and shipping specimens in the ParaPakTM stool culture outfit. Do
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not refrigerate these stool specimens . Ensure that each specimen is properly collected and labeled and submitted with form #3416. Indicate the enteric pathogens suspected on this form. 2. Clostridium perfringens and Bacillus cereus: Collect a stool specimen within 48 hours from the time symptoms begin, place in a leak-proof, non-crushable container and refrigerate immediately. Label the specimen with the patient's name or other unique identifier. Do not use the enteric ParaPakTM stool culture outfit, as this will result in erroneous spore count results. Form #3416 must be filled out and C. perfringens or B. cereus, depending upon the request, written on the form as the agent suspected.
C. Food Handlers 1. S. aureus: Swab the infected area and/or anterior nasal membranes. Place the swab in a culturette with Stuarts, Cairy-Blair, or other commercially available transport medium. Label specimen with the patient's name or other unique identifier and complete form 3410 (Isolation for Identification). 2. Enteric Pathogens: Follow procedure in section B.1, above.
D. Environmental Swab the suspected area(s) and submit as in C. above.
E. Botulism (testing performed at CDC) - Also see Section C, AShipment of Specimens@ 1. Contact the Bacteriology Unit (404-327-7990) for the initial coordination of specimen collection. 2. The submitter must also contact the Ga. Epidemiology and Prevention Branch, (404-657-2588), who will assess, through epidemiological and patient clinical history, if testing for botulism is warranted. 3. If approval is given, Epidemiology will notify both the Bacteriology Unit and CDC that specimens will be coming. 4. Feces, food, and bowel contents (at autopsy) may be examined directly for C.botulinum specific neurotoxins A through G. These specimens may also be cultured for C. botulinum, and if an isolate is recovered, it may subsequently be tested for the specific neurotoxins present. 5. For infant botulism, the above procedures may be followed, but the most rapid method is by detection of neurotoxin in feces. 6. Collect feces and food samples in leak-proof, non-crushable containers, refrigerate immediately, and keep refrigerated after collection.. 7. Complete a CDC form #50.34 (available from the Bacteriology Unit) for each specimen or food sample submitted.
SHIPMENT OF SPECIMENS
A. Food: Keep food samples refrigerated. Do not freeze or use dry ice. However, if a food is received frozen, keep it frozen and ship with dry ice. Using a sturdy, waterproof shipping container, place samples and refrigerant in the shipper. Place form(s) 3450 and
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other epidemiological and clinical information in an envelope attached to the outside of the shipper, or put the form(s) in a separate waterproof plastic bag inside the shipper with the food. Deliver sample(s) to the Bacteriology Unit by courier or ship by the most rapid method. Always notify the Bacteriology Unit of the expected time of arrival.
B. Feces and Other Types of Clinical Specimens (except those for botulism) Feces for enteric pathogens and Staphylococcus aureus should be shipped according to the instructions in the Enteric Bacteriology section of this manual. They should not be sent refrigerated. Specimens for Clostridium perfringens and Bacillus cereus should be sent refrigerated and may be delivered to the Bacteriology Unit by courier or shipped separately by the usual transportation or mailing systems available.
C. Botulism 1. Specimens may be sent to the Bacteriology Unit for referral to CDC or sent directly to CDC, as deemed necessary. 2. All specimens for botulism must be shipped with refrigeration.
REPORTING AND INTERPRETATION OF RESULTS
Examination of food samples and fecal specimens may require up to seven working days depending upon the suspected etiologic agent. Positive reports will reflect the etiological agent(s) which have been detected and/or enumerated and may include one or more of the following: Salmonella sp. or serotype, Shigella sp. serotype, Campylobacter sp., E. coli 0157:H7, Clostridium perfringens, Staphylococcus aureus, Bacillus cereus, Vibrio sp., or other possible pathogens. Negative reports will be issued in those cases where the suspected organism was not found. "Test Not Performed" will be indicated when the foodborne organism requested for isolation and Gram stain does not fit the epidemiological and clinical data indicated. Gram stains are performed and reported when requested, and also if the interpretation of these results can assist in the assessment of samples for the suspected organism(s). Toxin studies may be performed in appropriate cases: enterotoxin for S. aureus, enterotoxin for C. perfringens, and SLT for E. coli, and may take an additional two to three working days. Swab results from food handlers are usually reported within three days. Pulse-field gel electrophoresis will be done on E. coli O157:H7, Listeria monocytogenes, Salmonella, and Staphylococcus aureus isolates, and may require an additional two to three days for completion.
Confirmation that a certain food sample is involved in an outbreak is made by detecting the same pathogen (or toxin) in patient specimens and also in suspect food(s). See Table, AGuidelines for Confirmation of Foodborne-Disease Outbreaks of Bacterial Origin,@ on pages IV-35 through IV39.
UNACCEPTABLE SPECIMENS
Unacceptable food specimens will be assessed on an individual basis in conjunction with the Environmental Health and Injury Control Branch.
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Guidelines for Confirmation of Foodborne-Disease Outbreaks of Bacterial Origin

Etiological Agent
Bacillus cereus Emetic toxin (heat stable)

Incubation Period
1 6 h

Bacillus cereus Diarrheal toxin (heat labile)

6 24h

Campylobacter

2 10d; usually 2 5d

Clostridium perfringens 6 24h, median 12h

Clinical Syndrome

Required Collection Submis- How to

Specimen Vial

sion Form Ship

Criteria for Outbreak Association

Nausea & vomiting, sometimes diarrhea. Fever rare. Duration of < 1 day.

Stool w/in 48 h after onset
Food

Clean container
Zip-lock bags; clean container

#3416 #3450

Refrigerated

Isolation of organism from > 2 people.

Refrigerated

Isolation of > 105 organisms/g from implicated food, provided specimen properly handled.

Watery diarrhea, abdominal cramps; sometimes nausea & vomiting; fever rare. Duration of < 1 days.

Same as for emetic toxin

Same as for emetic toxin

Same as for emetic toxin

Same as for emetic toxin

Same as for emetic toxin

Diarrhea (oftern bloody), fever, abdominal pain. Duration 1 - 5 days.

Stool Food

Para-Pak #0555
Zip-lock bags; clean container

#3416 #3450

Diarrhea, abdominal cramps; vomiting, fever, & chills rare. Short duration of < 1 day.

Stool w/in Clean 48h after container onset

#3416

Food

Zip-lock bags; clean container

#3450

Ambient Temp.
Refrigerated

Isolation of organism from > 2 people.
Isolation of organism from implicated food.

Refrigerated
Refrigerated

Isolation of > 105 organisms/g from > 2 people; Demonstration of enterotoxin from > 2 people.
Isolation of > 105 organisms/g from implicated food; isolation of enterotoxin-producing strain of C. perfringens

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Etiological Agent

Incubation Period

Clinical Syndrome

Required Collection Submis- How to

Specimen Vial

sion Form Ship

Criteria for Outbreak Association

Clostridium botulinum Preapproval by Georgia Epidemiology & Prevention Branch and Prearrangement with CDC required.

2h - 8d; usually 12 - 48h

Illness of variable severity; nausea, vomiting, abdominal pain, & diarrhea may appear early. Headache, diplopia, blurred vision, & bulbar weakness common; paralysis, which is usually descending & bilateral may progress rapidly.

Serum Stool* Gastric Contents Food

Clean vials and/or container

CDC Form #50.34 one per specimen

Refrigerated

Detection of botulinal toxin in serum, stool, gastric contents, or implicated food; Isolation of organism from stool or intestine. Isolation of C. botulinum, but not the toxin, in a food consumed by a patient with suspected botulism is generally inadequate for confirming the illness.

Enterohemorrhagic E. coli (O157:H7 and others)

1 10d; usually 3 4d

Diarrhea (often bloody), abdominal cramps (often severe), little or no fever.

Stool** Food

Para-Pak #3416 #0555

Zip-lock bags; clean container

#3450

Ambient Temp.
Refrigerated

Isolation of SLT-producing E. coli (O157:H7 or others) from > 2 people, same subtype (PFGE).
Isolation of SLT-producing E. coli (O157:H7 or others) from implicated food, same serotype/subtype as that found from stool specimens.

*Best for infant botulism. **Tests for detection of SLT from an overnight broth culture, or directly from a fresh stool, will be performed. The presence or absence of the SLT will be reported. These results must be interpreted according to the total clinical picture.

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Etiological Agent

Incubation Period

Listeria monocytogenes Invasive disease 2-6 wks

Clinical Syndrome
Meningitis, neonatal sepsis, fever

Diarreal disease Unknown

Diarrhea, abdominal cramps, fever

Salmonella

6h - 10d, usually 6 - 48h

Diarrhea, abdominal cramps, fever, chills, vomiting, headache, anorexia, malaise. Duration of several days.

Required Collection Submissio How to

Specimen Vial

n Form Ship

Criteria for Outbreak Association

CSF, bld., placenta, amniotic fld, fetal tissue

Sterile vial and/or Container

#3410

Pure Culture

Culture Referral Outfit #0505

#3410

Stool

Para-Pak #3416 #0555

Food
Stool Food

Zip-lock bags;clea n container
Para-Pak #0555
Zip-lock bags;clea n container

#3450
#3416 #3450

Refrigerated arrive w/in 48 hr.
Ambient Temp.

Isolation of organism from normally sterile site, same serotype/subtype as implicated food.
Confirmation of identification of organism & of same serotype/subtype as implicated food.

Ambient Temp.
Refrigerated
Ambient Temp. Refrigerated

Isolation of organism, same serotype /subtype: (a) from > 2 people exposed to implicated food, or (b) as isolate recovered from implicated food.
Isolation of organism from implicated food, same serotype/subtype as isolates from > 2 people.
Isolation of organism, same serotype/subtype, > 2 people.
Isolation of organism from implicated food, same serotype/subtype as that found from stool specimens.

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Etiological Agent Staphylococcus aureus

Incubation Period
30 min 8h, usually 2 4h

Shigella

12h - 6d; usually 2-4d

Vibrio cholerae O:1 and O:139

1 5d

Clinical Syndrome

Required Collection Submis- How to

Specimen Vial

sion Form Ship

Vomiting, diarrhea.

Stool w/in Para-Pak

Short duration of not 24h after #0555

more than a day or two. onset

#3416

Nasal or Wound Swab food handler

Commercial swab outfit (not supplied)

#3415

Food

Zip-lock bags;clea n container

#3450

Ambient Temp.
Ambient Temp.
Refrigerated

Diarrhea (often bloody), fever, abdominal cramps. Duration of several days.

Stool Food

Sudden onset, profuse watery diarrhea, often w/ mucus, abdominal pain, rapid dehydration.

Stool Food

Para-Pak #3416 #0555

Zip-lock bags;clea n container

#3450

Para-Pak #3416 #0555

Zip-lock bags;clea n container

#3450

Ambient Temp.
Refrigerated
Ambient Temp.
Refrigerated

Criteria for Outbreak Association
Isolation of organism of same subtype (PFGE) from > 2 people.
Isolation of organism of same subtype (PFGE) as stool and/or food isolates.
Detection of enterotoxin in implicated food; isolation of enterotoxin-producing strain of S. aureus; isolation of > 105 organisms/g from implicated food, provided specimen properly handled.
Isolation of organism, same serotype/subtype, from > 2 people.
Isolation of organism from implicated food, same serotype /subtype as stool isolates.
Isolation of toxigenic organism from > 2 people.
Isolation of toxigenic organism from implicated food.

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Etiological Agent
Vibrio parahaemolyticus

Incubation Period
4 30 h

Clinical Syndrome Diarrhea

Yersinia enterocolitica

1 10d, usually 4 6d

Diarrhea, abdominal pain (often severe) may mimic appendicitis

Required Collection Submis- How to

Specimen Vial

sion Form Ship

Criteria for Outbreak Association

Stool Food
Stool Food

Para-Pak #0555
Zip-lock bags;clea n container
Para-Pak #0555
Zip-lock bags;clea n container

#3416 #3450
#3416 #3450

Ambient Temp.
Refrigerated

Isolation of Kanagawa-positive organism from > 2 people.
Isolation of > 105 Kanagawa-positive organisms/g from implicated food.

Ambient Temp.
Refrigerated

Isolation of pathogenic strain or serotype from > 2 people.
Isolation of pathogenic strain or serotype from implicated food.

References:

1.

Centers for Disease Control and Prevention. CDC Surveillance Summaries, March 17, 2000. MMWR 2000; 49(No. SS-1).

2.

Bryan, F.L. 1982. Diseases Transmitted by Foods. A Classification and Summary, 2nd ed. Centers for Disease Control, Atlanta.

3.

Bryan, F.L. 1995. Outbreaks of Food-Borne Disease, p. 209-226. In P. Murray et al. (ed.), Manual of Clinical Microbiology, 6th ed. ASM Press,

Washington D.C.

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GENITOURINARY SLIDES 404-327-7990
INTRODUCTION
The Bacteriology Unit examines smears of suspected material for the presumptive diagnosis of trichomonads, yeast, Haemophilus ducreyi, or Neisseria gonorrhoeae. This method of diagnosing N. gonorrhoeae is satisfactory for male smears; however, in females and young children, where organisms may be scarce or atypical, microscopic methods are not acceptable
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Trichomonads/Yeast
Use a cotton tipped applicator to collect vaginal discharge. Roll a thin smear onto a glass slide and air dry.
Haemophilus ducreyi
1. Ulcer Cleanse ulcer thoroughly with saline. Obtain serous material from the border on a swab. Roll swab (in one direction) onto a glass slide. Air dry.
2. Lymph node (bubo) aspirate After local preparation, aspirate material from bubo and prepare a thin smear on a glass slide. Air dry.
Neisseria gonorrhoeae:
Male urethra: Obtain discharge on cotton swab, or if discharge cannot be expressed, use a calcium alginate swab inserted 2-3 cm. into interior urethra, rotating gently as swab is withdrawn. Roll a thin smear onto a slide and air dry.
Note: Use FROSTED END slides and properly label with patient identifier and collection date. A separate slide must be submitted for each direct examination, e.g., trichomonads/yeast, Haemophilus ducreyi, and Neisseria gonorrhoeae.
Requisition Form
Complete lab form #3415 and include the following: 1. Unique patient identifier (name or number). 2. Date of specimen collection. 3. Test requested (trichomonads/yeast, H. ducreyi, or N. gonorrhoeae). 4. Submitter's name and address. 5. Type of specimen collected. 6. Patient's race, sex, age, and address, if available.
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The patient identifier (name, number, or both) indicated on the requisition form must match that written on the slide. Unlabeled slides will not be tested.
SHIPMENT OF SPECIMENS
1. Place slide securely in the plastic slide holder provided (outfit #0545, available from Laboratory Services and Supply, 404-327-7920).
2. Place the plastic holder and requisition form in the cardboard mailing container with the Decautr address label (orange).
3. Seal the lid of the outside container with tape. 4. Send by first-class mail, common carrier, or courier. 5. It is best to send slides to the laboratory on the day of collection, but if there is any delay
in shipment, hold specimens at ambient temperature.
REPORTING AND INTERPRETATION OF RESULTS
Results of microscopic examinations will be completed the day of receipt, if slides are received by 12:00 p.m.; otherwise, they will be ready the next day. Results will be reported as follows:
1. Trichomonads/yeast (female): a. Trichomonads Present b. Yeast-like Cells Present c. No Trichomonads Seen, No Yeast-like Cells Seen
2. Haemophilus ducreyi: a. Negative Presumptive: No organisms resembling Haemophilus ducreyi seen on direct smear. b. Positive Presumptive: Organisms resembling Haemophilus ducreyi seen on smear.
3. Gonorrhea smears: a. Positive: Gram-negative intracellular diplococci resembling gonococci present. b Suggestive: Extracellular Gram-negative diplococci present suggestive but not typical of gonococci. c. Negative: No Gram-negative intracellular diplococci resembling gonococci seen. If material is scarce, the report will read: Due to scarcity of material negative results may be of no value. Please resubmit. d. Unsatisfactory: See section below on unacceptable specimens.
NOTE: When there are many to numerous pus cells present in the absence of bacteria, the Laboratory will make the following comment to the report: 1. Smears with >10 WBC/field: "Numerous pus cells present - Suggestive of non-
gonococcal urethritis." 2. Smears with 5-9 WBC/field: "Many pus cells present - Suspicious of non- gonococcal
urethritis."
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UNACCEPTABLE SPECIMENS 1. Smear is too thick/too thin for accurate interpretation. 2. Slides broken in transit. 3. No patient identifier on specimen. 4. Patient identifier on specimen does not exactly match that on form. 5. Smear is fixed for a PAP smear examination.
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GROUP A STREPTOCOCCUS 404-327-7990
INTRODUCTION
The Bacteriology Unit accepts specimens from public health care providers for the detection of Group A Streptococcus and other beta-hemolytic streptococci. Reference cultures will be accepted from public and private health care providers for identification and/or serogrouping of beta-hemolytic streptococci. Culture is the method used for isolation of the organism, and latex agglutination is used for serogrouping isolates. In cases of systemic infections or necrotizing fascitis, or if acute rheumatic fever or glomerulonephritis are suspected, referred cultures of Group A Streptococcus will be forwarded to CDC for molecular typing. (See Special Bacteriology Section).
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Throat, nasal, skin, and wounds are suitable specimens for the isolation of Group A Streptococcus. The sterile swab supplied in outfit #0560 should be used for throats, skin, and wound swabs. Outfits are available from Laboratory Services and Supply, 404-327-7920. For nasal swabs, a sterile cotton-tip flexible wire, available commercially, is recommended.
1. Throat: After adequately exposing and illuminating the pharynx, rub tonsils and pharynx with the swab provided. Be careful to obtain any exudate present and avoid the tongue and uvula tissues.
2. Skin: Remove the crusts of the pustule or vesicle cap and rub swab firmly into the lesion. 3. Wound: Follow the same procedure as described for skin. If the area is dry, moisten the
swab first. 4. Nasal: Moisten the flexible wire swab and introduce it gently along the floor of the nasal
cavity, under the middle turbinate, until the pharyngeal wall is reached.
Place swab in the silica gel envelope, according to instructions supplied with the outfit. Place the silica gel package in the polyfoil kraft envelope, and clearly write the patient's name or other unique identifier in the space provided.
Use requisition form #3418 and supply the following information: (1) Patient identifier (name or number). (2) Date of specimen collection. (3) Name and telephone number of clinician to contact. (4) Submitter's name and address. (5) Patient's race, sex, age, and address, if available.
The patient identifier on the form should match that on the specimen. Unlabeled specimens will not be tested.
The Group A Streptococcus outfit may be used for the isolation of any beta-hemolytic Streptococcus from throat, nasal, skin, or wound infections. Specimen of "throat swab" and
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examine for "Group A Streptococcus" will already be indicated on form #3418, which is supplied in the outfits. If a different type of specimen is submitted, or if an organism besides Group A Streptococcus is suspected, this information MUST be indicated on the requisition form. SHIPMENT OF SPECIMENS Place the polyfoil envelope and requisition form in the brown mailing envelope provided. Specimens may be sent to the Laboratory by first-class mail, common carrier, or courier. If there is any delay in shipment, hold specimens at room temperature. REPORTING AND INTERPRETATION OF RESULTS Culture results of beta-hemolytic Streptococcus will be completed 18-24 hours after receipt of the specimen. Any Group A Streptococcus detected will be reported. Other groups of betahemolytic Streptococci will be reported if they are the predominate organism present. The report will read "No Group A Streptococcus Found by Culture" for negatives; if no growth is detected this also will be noted. For positives, the report will read, "Group A Streptococcus Found by Culture," or Group B, C, F, G Streptococcus Found by Culture, Predominate Organism Present." Reports of positive specimens will be telephoned to submitters the day testing is completed. UNACCEPTABLE SPECIMENS 1. Specimens not submitted in the silica gel outfit (or other suitable transport outfit
approved by the Bacteriology Unit). 2. Silica gel envelope not sealed.* 3. Specimens received >4 weeks after collection.* 4. No patient identifier on specimen. *Specimens will be tested, but a disclaimer will be added to the report indicating that negative results are questionable.
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SPECIAL BACTERIOLOGY 404-327-7990
INTRODUCTION
The Bacteriology Unit accepts reference cultures from public and private health care providers for the identification, confirmation, and/or serotyping of bacterial isolates. This includes a wide variety of aerobic, anaerobic, and facultative organisms from clinical sources. Isolates should be submitted as pure cultures. Techniques used in the identification process include a combination of some or all of the following: cellular and colonial morphology, conventional biochemical tests, gas-liquid chromatography (GLC) for metabolic end-product determination, GLC for cell wall fatty acid analysis, and DNA probes. All isolates of Neisseria meningitides, Haemophilus influenzae, Group A Streptococci, Group B Streptococci, Listeria monocytogenes, and Streptococcus pneumoniae recovered from sterile sources should be forwarded to the Bacteriology Unit, either directly or through the Emerging Infections Program (EIP) site. The following services are provided by the GPHL in conjunction with epidemiological investigations and surveillance, and are offered at no charge: N. meningitidis grouping, H. influenzae typing, and Pulsed-field gel electrophoresis (PFGE) for L. monocytogenes. Group A Streptococci, Group B Streptococci, and S. pneumoniae isolates from sterile sources will be forwarded to the Centers for Disease Control and Prevention (CDC) for typing and/or molecular characterization. With the exception of Neisseria gonorrhoeae, antimicrobial susceptibilities are not performed except as an aid to identification. Such requests can be forwarded to the CDC through the Bacteriology Unit by special arrangement. Any unidentified organisms isolated from sterile sources will also be sent to the CDC for further studies, upon request.
Clinical material for the primary isolation of bacteria may also be submitted, although specimens other than feces and throats are usually handled at local laboratories. The organism(s) recovered are then sent for identification as noted above for reference cultures.
The Bacteriology Unit will accept specimens or cultures from environmental sources under the following conditions: (1) when these are associated with human illness; (2) for infection control purposes; (3) during an epidemiological investigation; or (4) by special arrangement. Specimens or cultures from animals will be accepted by special arrangement only.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
A. Specimens and Cultures for Anaerobic Isolation and Identification:
Aspirates collected with a sterile syringe or tissue specimens are recommended for anaerobic culture. Acceptable clinical specimens include: aspirated pus, transtracheal and lung aspirates, body fluids, tissue (biopsy, surgical, and autopsy), suprapubic aspirate of bladder urine, and sulfur granules from suspected cases of actinomycosis. Pure culture isolates from these sources may be submitted and are preferred over specimens.
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Unacceptable specimens include: throat, nasopharyngeal, and gingival swabs, sputum, bronchial washings (except those obtained via a protected double lumen catheter or properly done bronchoalveolar lavage), gastric and small bowel contents, feces (except for foodborne illnesses and infant botulism), voided or catheterized urine, and rectal, skin, vaginal, and cervical swabs. Referred cultures from these sources will be accepted only if accompanied by information establishing clinical significance.
Collect specimens with care to avoid contamination with indigenous flora and place under anaerobic conditions immediately. Clearly label both specimens and/or referred cultures with the patient's name or other unique identifier.
B. Specimens and Cultures for Aerobic Isolation & Identification:
Collect all specimens, such as autopsy material, tissues, urine, respiratory and urogenital tract secretions, wounds, abscesses, spinal fluid, and blood, aseptically using techniques appropriate for the particular type of specimen. The Bacteriology Laboratory may be contacted for further information on specific collection methods, if needed. Clearly label both specimens and/or referred cultures with the patient's name or other unique identifier.
See Table 1 for aerobic and anaerobic organisms requiring special handling. In all of the cases noted in Table 1, notify the Bacteriology Unit prior to shipping.
Requisition Form
Complete form #3415 when submitting specimens for aerobic or anaerobic isolation and identification. Use form #3410 when sending referred cultures for aerobic or anaerobic identification, confirmation, and/or serotyping. Include the following information:
1. Unique patient identifier (name or number). 2. Agent suspected or test requested. 3. Submitter's name and address. 4. Name and telephone number of contact person. 5. Date of specimen collection. 6. Source of specimen. 7. Date of transplant (if applicable). 8. Brief clinical history. 9. Patient's race, sex, age, and occupation, if available.
The patient identifier (name or number) indicated on the requisition form should match that written on the specimen or culture. Unlabeled specimens or cultures will not be tested.
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SHIPMENT OF SPECIMENS AND REFERRED CULTURES (See pages II-1 II-4 of this manual for recent changes in federal shipping guidelines).
Because of problems of maintaining viability and possible overgrowth of normal flora during transit, the mailing of clinical specimens for primary isolation is discouraged. Exceptions include stools for enteric pathogens, throats for Group A Streptococcus, nasopharyngeal swabs for Bordetella pertussis, slides for Neisseria gonorrhoeae and Haemophilus ducreyi, and other specimens in certain unusual circumstances. If specimens for anaerobic isolation are submitted, they should be sent in an anaerobic environmental system available commercially.
Submit referred cultures as pure cultures in the appropriate medium. For anaerobic identification, chopped meat broth, thioglycollate broth, motility test medium (inoculate near the bottom of the tube), or anaerobic blood culture bottles are suitable choices. For aerobic identification, slants of solid medium appropriate for growth of the organism in question are recommended. Use screw-capped tubes and tighten securely. Place a strip of parafilm around the cap of the tube to help prevent loosening of the cap in transit. In all cases, submit young, actively growing subcultures to ensure viability. Various types of agar slants and chopped meat broth are available in limited supply from the Bacteriology Unit.
Wrap the sides and bottom of culture tubes in kyfax packing material or paper towels to prevent breakage. Use outfit #0505, "Culture Referral Isolation for Identification," available from Laboratory Services and Supply, 404-327-7920, and follow these instructions: 1. Place culture wrapped in packing material in the biohazard bag provided. 2. Put the requisition form in the pouch in the front of the bag. 3. Place the biohazard bag in the orange-labeled cardboard mailing container (Decatur
address) and secure the lid with tape. 4. Place the return address on the outside of the container. 5. Send by first class mail, common carrier, or courier. 6. Avoid submitting cultures in petri dishes, but if necessary, cushion them with absorbent
material and securely package in leak-proof containers. Seal culture plates for anaerobic identification in an anaerobic "bag" system before packaging.
See Table 1 for instructions on shipment of organisms requiring special handling.
REPORTING AND INTERPRETATION OF RESULTS
Organisms are identified to the genus and species level when there is agreement with all appropriate data, such as cultural, morphologic, biochemical, gas-liquid chromatography, and cell wall fatty acid analysis. Occasionally an organism can be identified accurately only to the genus level. Genus and species designations are consistent with designations in the Manual of Clinical Microbiology and are updated according to publications in the International Journal of Systematic Bacteriology. The identification of the organism only will be reported; results of specific tests, such as biochemical reactions, must be requested on the requisition form when the culture is submitted. When serotyping is requested and available, the appropriate serotype or serogroup will be reported. Unidentified organisms isolated from sterile sources may be
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forwarded to CDC, but those isolated from nonsterile sites must be accompanied by a detailed clinical history to justify sending to CDC. Culture results for the identification of aerobic, facultative, and anaerobic bacteria are usually completed within seven working days, but may require up to fifteen working days, depending upon the organism. Mixed cultures, fastidious, slow-growing, or nutritionally-deficient bacteria may occasionally require additional time beyond the fifteen working days for a complete identification. Results of serotyping are usually completed as follows: Neisseria meningitidis (13 working days); Haemophilus influenzae (2-3 working days); and beta hemolytic Streptococcus (3-4 working days). Cultures referred to the CDC may require up to six months for a final identification. If results are urgent, this should be specified on the requisition form and a preliminary and/or final report will be telephoned to the submitter. If the identification is inconsistent with the organism suspected, the submitter will also be notified by telephone. UNACCEPTABLE SPECIMENS 1. Cultures broken in transit. 2. Non-viable cultures: all cultures received will be subcultured upon receipt. Every
attempt will be made to obtain viable growth. If no growth occurs, the submitter will be notified by telephone and a report will be issued immediately. Another subculture will be requested, if available. 3. Cultures grossly overgrown with contaminants. 4. No patient identifier on the specimen or culture. 5. Specimens improperly collected or submitted (see section on specimen collection and shipment).
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Organism Bacillus anthracis
Brucella species
Clostridium botulinum
Clostridium perfringens
Corynebacterium diphtheriae
Francisella tularensis

Table 1. Organisms Requiring Special Handling
Special Instructions and Requirements
Aspectically collect specimens from lesion, contaminated hair products, or sputum. Send specimens refrigerated in sterile containers (container not provided). Subculture isolates to blood or nutrient agar slants. Send suspected isolates in culture referral outfit (#0505) at ambient temperature. USE BIOLOGICAL SAFETY HOOD. Do not create aerosols.
Aseptically collect multiple blood samples, infected tissues, abscess material, bone marrow, or liver biopsies. Refrigerate clinical specimen if delay in inoculation of primary plating medium or delay in shipment is anticipated. Send specimens refrigerated in sterile containers (container not provided). Subculture isolates to blood, chocolate, or nutrient agar slants. Send suspected isolates in culture referral outfit (#0505) at ambient temperature. USE BIOLOGICAL SAFETY HOOD.
See section on Foodborne Illness for further details on food intoxication and infant botulism. For wound infections, submit material from wound, refrigerated with cold pack, in an anaerobic environment system. Send suspected isolate in chopped meat broth or motility test medium (inoculate near bottom of tube) in culture referral outfit (#0505) at ambient temperature. Specimens and isolates will be forwarded to CDC for isolation, confirmation, and/or toxin testing.
See Foodborne Outbreaks Section for further details on food intoxication. Submit material from site of infection, refrigerated with cold pack, in an anaerobic environment system; or send suspected isolate in chopped meat broth or motility test medium (inoculate near bottom of tube) in culture referral outfit (#0505) at ambient temperature.
Collect throat or skin lesion swabs (use Strep outfit #0560 or place on Loeffler's agar slant). Subculture suspected isolates to Loeffler or cystine blood agar slants. Toxigenicity testing will be performed at CDC. Send suspected isolates in culture referral outfit (#0505).
Aseptically collect material from lesions, lymph nodes, gastric and nasopharyngeal washings, sputum, pleural fluid, and bronchial secretions (pulmonary tularemia), and conjunctival scrapings (ocularglandular tularemia). Ship specimens in sterile containers (not provided) on dry ice. Subculture isolates to chocolate agar slants with IsoVitaleX. Send suspected isolates in culture referral outfits (#0505) at ambient temperature. USE BIOLOGICAL SAFETY HOOD AND EXTREME CAUTION. Send by courier or receipted mail.
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Table 1. (Continued) Organisms Requiring Special Handling

Organism

Special Instructions and Requirements

Haemophilus ducreyi

Collect specimens from lesions or inguinal bubo. Inoculate onto enriched chocolate agar with vancomycin. Incubate 33-35o C in 5-10%
CO2 in water-saturated atmosphere. Except for slides, referred cultures only will be accepted. (See separate section for submission of
genitourinary slides).

Haemophilus influenzae

For serotyping and/or culture confirmation, submit 18-24 hr. subculture on chocolate slant (slants may be obtained from the GPHL). Submit through the EIP site, by mail, or by courier.

Leptospira

Collect blood or spinal fluid during first 10 days of illness, and urine (3 consecutive samples) from second to fourth week of illness. Obtain Ellinghausen medium and instructions for inoculation from the Bacteriology Unit prior to specimen collection. Immediately inoculate tubes and submit at room temperature to the Bacteriology Unit. Inoculated cultures will be read for up to six weeks before reporting as negative. Positive cultures will be reported as soon as detected and confirmed.

Neisseria gonorrhoeae

For culture confirmation, submit 18-24 hr. subculture on chocolate slant or emulsify fresh growth in trypticase soy broth with 20% glycerol and freeze. Submit preferably by overnight mail (slant) or frozen on dry ice (broth). See separate section for GC culture screening.

Neisseria meningitidis

For serogrouping and/or culture confirmation, submit 18-24 hr. subculture on chocolate slant (slants can be obtained from the GPHL). Submit through the EIP site, by overnight mail, or by courier.

Pertussis

See separate section on Bordetella pertussis

Pseudomonas mallei & P. pseudomallei

Aseptically collect blood, sputum, or pus. Send refrigerated in sterile containers (not provided). Subculture isolates to nutrient or infusion agar slant. Send suspected isolates in culture referral outfits (#0505) at ambient temperature. Send by courier or receipted mail.

Staphylococcus aureus

Submit coagulase positive isolates from outbreaks or multiple isolates from different sources in same patient. Submit on nutrient or heart infusion agar slants. Documentation must accompany specimens. Isolates will be typed by pulsed-field gel electrophoresis.

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Organism
Yersinia pestis

Table 1. (Continued) Organisms Requiring Special Handling
Special Instructions and Requirements
Aspirate fluids from lymph nodes (bubonic plague); collect sputum or tracheal aspirates (pneumonic plague); collect blood samples for culture bottles. Submit specimens in sterile containers (not provided), refrigerated with ice packs. Subculture isolates to blood or infusion agar slants. Send suspected isolates in culture referral outfit (#0505) at ambient temperature. USE BIOLOGICAL SAFETY HOOD AND EXTREME CAUTION. Do not create aerosols. Send by courier or receipted mail.

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Microbial Immunology Unit
Unit Personnel
Manager - Sandra Watkins, M.S.A. Program Assistant - Selina Price Associate - Kim Kilgour, B.S.
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MICROBIAL IMMUNOLOGY UNIT INFECTIOUS DISEASE SEROLOGY
404-327-7970
INTRODUCTION
The Microbial Immunology Unit performs many infectious disease serology. Serology for HIV (Human Immunodeficiency Virus), is performed in the Virology Unit. Various serologic procedures are performed for a variety of bacterial, parasitic, and viral agents. Hepatitis B serology is performed for county health departments, and Georgia Department of Human Resources (GDHR) agencies, only. Tests not performed in the Public Health Laboratory are forwarded to CDC, if they provide the requested testing.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Collection: Using Universal Precautions, and standard venipuncture technique, collect approximately six milliliters of whole blood (for serum) in a red top tube (no additive), labeled with patient's identifier (name, first and last, or number), date, and name of the submitter. Use a marker that will not fade, smear, or run during transportation. Use proper size needle (large enough to prevent hemolysis of the red blood cells) for the vein location and age of the patient. Allow blood specimen to clot, at least 30 minutes undisturbed, at room temperature, and transport, or place in the refrigerator for transporting. Collect blood specimens in, or transfer them to non-breakable, leak resistant tubes. Specimens should be transported as soon as possible, do not hold over 7 days. Specimens over 14 days old are unacceptable. Many of the procedures we perform are not approved for use with plasma. Therefore, please submit only serum or whole blood without anticoagulants, not plasma.
Collect cerebrospinal fluids (CSF) according to proper hospital procedure. CSF contaminated with blood or grossly contaminated with bacteria is unacceptable.
Labeling: All specimens must be labeled with patient identification (name or number), in acceptable testing condition, and accompanied by a completed requisition form. If the form is not specific for one test or a set of tests, the specific testing requested must be hand-written in the proper area, e.g., "viral serology" is not acceptable, the specific agent, e.g., "CMV", must be clearly requested. Failure to provide proper patient information may result in testing delays.
Requisition Form: Use Form #3432 for all tests performed by the Microbial Immunology Unit. There is a single requisition form for all serological tests performed, including the RPR and EIA tests for syphilis, Premarital serology (including rubella on females), Hepatitis B (GDHR facilities and county health departments only), and Other Serology. Completely fill out the form and include the following information:
1. Unique patient identifier (name or number). 2. TEST(S) REQUESTED (Please check only the corresponding box for test(s)
requested).
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3. Date specimen collected. 4. Submitter's name, address, and code number, where applicable. 5. For hepatitis the reason for testing, e.g., routine, or prenatal. 6. Any information the submitter needs for patient identification, e.g., chart number,
address. 7. The date of onset of illness, if applicable. 8. Race, sex, and age, where applicable, e.g., hepatitis testing.
SHIPMENT OF SPECIMENS
Use outfit #0500, available from Laboratory Services and Supply, 404-327-7920, and follow the specific instructions below. Specimens may be mailed or delivered to the laboratory by courier.
Shipping Instructions for USPS. and Couriers: Place the tubes of blood in protective, leak resistant, double-walled containers, e.g., aluminum and cardboard box, for transport. Wrap the requisition form around the inner (aluminum) can, secure with a rubber band and place in the outer container. If a screw-cap outer container is used, the screw-cap must be secured with tape or the Postal Service will return it for taping. Up to 50 milliliters of blood may be transported in one package (U.S. postal regulations). Therefore, an individual tube of blood may be placed in the metal can, with the requisition form secured to the outside by a rubber band, and several aluminum cans placed in one cardboard box for transporting.
Shipping Instructions for Courier Services Only: Tubes of blood may be placed in leak proof biohazard bags. Wrap brown absorbent material around the tube, then secure with a rubber band. Place the requisition form in the sleeve located on the outside of the bag.
REPORTING AND INTERPRETATION OF RESULTS
Table 1 (pages IV-61 through IV-63) summarizes the interpretation of results for all serological tests performed in the Microbial Immunology Unit. Table 2 (page IV-64) gives the turnaround times for all of the same serological tests. Turn-around-time after the receipt of the specimen depends on the testing methodology and the frequency of testing. The frequency of testing depends on the demand for a specific test. Several tests are performed daily, while others are performed weekly. The turnaround time for specimens referred to CDC depends on CDC's schedule, which varies from laboratory to laboratory.
UNACCEPTABLE SPECIMENS
1. Spinal fluid obviously contaminated with bacteria or blood; 2. All specimens:
a) Not approved for testing by the indicated method, e.g., plasma for RPR. b) Grossly hemolyzed, lipemic, turbid, or contaminated. c) Over 14 days old.
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d) Broken in transit. e) Insufficient quantity for testing. f) No identification on specimen. g) Name on tube and form does not match. The submitter will be notified of all rejected specimens. Most serologic services are available to both the public and private sectors. However, hepatitis B testing is limited to the public health care providers, and not available to the private providers.
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Table 1. Testing Results

Agent
California EncephaLitis
Cytomegalovirus (CMV)

I g G1 IgM1
IgG IgM

Method IFA1
EIA1

Eastern

IgG

IFA

Equine

IgM

Encephalitis

VCA1 IgG

Epstein-

VCA

EIA

Barr Virus

IgM

(EBV)

EBNA 1

IgG

HBs 1

Hepatitis B

Hbe1

Virus (HBV)6

EIA AntiHBs 1

AntiHBc1

Herpes Simplex Virus (HSV)

Type 1

EIA

Type 2

Lyphogranuloma

IFA

Venereum (LGV)

Test Result Interpretation1

Negative

Positive2

Diagnostic

IgG <1:16 IgM <1:16

IgG >1:16 Four-fold rise in titer IgM > 1:16 between paired sera4

No IgG Detected No IgM Detected
IgG <1:16 IgM <1:16

IgG Detected IgM Detected
IgG >1:16 IgM > 1:16

IgM detected and/or significant rise in titer between paired sera 4,5
Four-fold rise in titer between paired sera4

Presumptive3 > 1:16
IgM Equivocal
> 1:16

No IgM Detected
No IgM Detected
No IgG Detected
Negative
Negative
Negative

IgG Detected
IgM Detected
IgG Detected
Positive
Positive
Positive

Current Infection: Positive VCA IgG and IgM, and EBNA IgG Negative

Positive VCA IgM Only

Recurrent Infection: Positive VCA IgG, IgM and EBNA IgG
Positive HBs

None

Negative

Positive

No IgG Detected

IgG Detected

Significant difference between paired sera4,5

None

<1:10

> 1:10

Four-fold rise in titer between paired sera4

> 1:10

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Agent Mumps

Murine typhus

Mycoplasma Pneumonia

Parvo-

IgG

Virus

IgM

Q-Fever

Method EIA IFA EIA EIA
IFA

Rocky Mountain

IFA

Spotted Fever (RMSF)

Rubeola

IgG

(Measles

EIA

IgM

Rubella (German Measles)
St. Louis Encephalitis
Syphilis

IgG

IgM

EIA

Premarital

IgG

IFA

IgM

RPR1

Agg1.

Confir-

matory

EIA

EIA

FTA

IFA

Test Result Interpretation1

Negative

Positive2

Diagnostic

No IgG Detected

IgG Detected

Significant difference between paired sera4,5

<1:16

> 1:16

Four-fold rise in titer between paired sera4

No IgG Detected
No IgG Detected;
No IgM Detected
Phase I <1:16 Phase II <1:16

IgG Detected
IgG Detected
IgM Detected
Phase I >1:16 Phase II >1:16

Significant difference between paired sera4,5
IgM detected and/or significant increase between paired sera4,5
Four-fold rise in titer between paired sera4

< 1:16

> 1:16

Four-fold rise in titer between paired sera4

No IgG Detected
No IgM Detected

IgG Detected
IgM Detected

IgM detected and/or
significant increase
between paired sera 4,5

No IgG Detected
No IgM Detected

IgG Detected
IgM Detected

IgM detected and/or
significant increase
between paired sera 4,5

NonImmune

Immune

Not Applicable

IgG <1:16 IgM <1:16

IgG >1:16 Four-fold rise in titer IgM > 1:16 between paired sera4

NonReactive
NonReactive

Reactive > 1:1
Reactive

RPR and EIA Reactive

NonReactive

Reactive

RPR, EIA, FTA

Presumptive3 None
> 1:128 None None
Phase I > 1:128 PhaseII > 1:128
> 1:128
IgM Equivocal
Not Applicable
Not Applicable > 1:16
Reactive RPR and Equivocal EIA
Equivocal EIA

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Agent Syphilis
Toxoplasmosis
Varicella Zoster West Nile Virus

VDRL (CSF1) IgG
IgM
IgG IgM

Method Agg1 EIA
EIA EIA

Western

IgG

IFA

Equine

IgM

Encephalitis

Test Result Interpretation1

Negative

Positive2

Nonreactive Reactive

Diagnostic VDRL Reactive

No IgG Detected
No IgM Detected
No IgG Detected
No IgG Detected No IgM Detected
IgG <1:16 IgM <1:16

IgG Detected
IgM Detected
IgG Detected
IgG Detected IgM Detected
IgG >1:16 IgM > 1:16

IgM detected and/or significant increase between paired sera 4,5
Significant increase between paired sera4,5
IgM detected and/or significant increase between paired sera4,5
Four-fold rise in titer between paired sera4

Presumptive3 Reactive VDRL IgM Equivocal
None
IgM Equivocal
> 1:16

Abbreviations (in alphabetical order)1

Agg. CSF EBV VCA EBV EBNA EIA FTA HBs HBe

Agglutination Cerebrospinal Fluid Epstein-Barr Virus capsid antigen Epstein-Barr nuclear antigen Enzyme Immunoassay Fluorescent treponemal antibody Hepatitis B surface antigen Hepatitis B E antigen

Anti-HBs Anti-HBc IFA IgG IgM RPR VDRL

Hepatitis B surface antibody Hepatitis B core antibody Indirect Fluorescent Antibody Immunoglobulin G Immunoglobulin M Rapid Plasma Reagin Veneral Disease Research Laboratory

2A positive result indicates natural or acquired immunity, especially for vaccine-preventable diseases

3Presumptive results identify a significant result for a single (not paired) serum, and need confirmation by clinical symptoms, recollection of specimen for retesting, or if applicable, submission of a convalescent specimen.

4Paired sera (acute and convalescent) dates of collection and date of onset of illness are needed for proper interpretation of results.
5A significant difference is determined by instructions given in individual enzymeimmunoassay procedures, and may differ between manufacturers.

6Performed for county health departments and DHR facilities only.

FOR ADDITIONAL INFORMATION REGARDING TEST INTERPRETATION CALL THE MICROBIAL IMMUNOLOGY LABORATORY AT (404) 327-7970

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Table 2. Turnaround Times

Agent

California Encephalitis IgG2/IgM2

Cytomegalovirus IgG/ IgM

Eastern Equine Encephalitis IgG/ IgM

Epstein-Barr virus VCA2IgG/IgM EBNA2IgG

Hepatitis A

Hepatitis B Diagnosis

Surface antigen

Total antibody

core antibody

e-antigen (performed on surface antigen-

positive specimens only)

Herpes simplex 1&2

Lymphogranuloma Venereum

Mumps

Murine typhus

Mycoplasma

Parvovirus IgG/IgM

Q Fever IgG

Rocky MountainSpotted Fever

Rubella Immune Status (EIA)2

IgG/ IgM

Rubeola IgG/IgM

St. Louis Encephalitis IgG/ IgM

Syphilis RPR2Non-Reactive

RPR Reactive

.

Confirmatory Non-Reactive

Confirmatory Reactive FTA2 Non-Reactive

FTA Reactive

Toxoplasmosis IgG /IgM

West Nile Virus IgG/ IgM

Western Equine Encephalitis IgG/ IgM

Varicella zoster VDRL2 (CSF2 only)

Turnaround Time (Working Days)1 10-12 days 5-7 days 10-12 days
5-7 days 5-7 days 10-12 days
3 days 3 days 3 days 7 days
5-7 days 10-12 days 5-7 days 5-7 days 5-7 days 7-10 days 5-7 days 5-7 days
1-3 days 5-7 days 5-7 days 10-12 days
1-2 days 2-3 days 2-3 days 2-3 days 5-7 days 5-7 days 5-7 days 10-12 days 10-12 days 5-7 days 5-7 days

1Special arrangements may be made in the case of an emergency. 2Abbreviations: IgG, Immunoglobulin; G; IgM, Immunoglobulin M; VCA, Epstein-Barr viral capsid antigen; EBNA, Epstein-Barr nuclear antigen; EIA, Enzyme Immunoassay; RPR, Rapid Plasma Reagin; FTA, Fluorescent treponemal antibody; VDRL, Veneral Disease Research Laboratory; CSF, Cerebrospinal Fluid.
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Mycobacteriology/Mycology Unit
Unit Personnel
Associate - Jane Bush, B.S. Manager - Elizabeth Dennis, M.S.
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ISOLATION AND IDENTIFICATION OF MYCOBACTERIA 404-327-7940
INTRODUCTION
The Mycobacteriology section accepts specimens for isolation and identification of Mycobacterium tuberculosis and other mycobacteria which may cause disease under certain circumstances. The services of this laboratory are available to both public and private health care providers.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Although the most common specimen received is expectorated sputum, the GPHL accepts specimens of various other types: sputum collected by aerosol induction, laryngeal swab, or gastric lavage, urine (voided early morning, catheterized from bladder, or cystoscopic from kidney), pus (aspirated or on swab), tissue (biopsied lymph node or biopsied portions of organs, usually lung), and body fluids (cerebrospinal, pleural, pericardial, or joint).
If a case has not been diagnosed as tuberculosis, a series of three to six single, early morning sputum specimens should be collected on successive days and transported to the laboratory as soon as possible. Specimen collection outfits are available at no charge from the Laboratory Supply Office. Each outfit consists of a rigid mailing container that holds a specimen tube (50 mL plastic screw-cap) and a plastic bag with two pouches. All caps and the zip-lock pouch should be closed tightly to prevent leakage. Collection instructions are enclosed with each shipment of mailing containers, and the information provided there should be communicated to the patients to help ensure that the Mycobacteriology Unit receives adequate specimens. Even the highest quality laboratory work can not produce good results on a poor specimen.
The plastic centrifuge tube must be labeled with the patient=s name. Tuberculosis Form 3412 should be filled out completely, giving the following information: patient=s name (be sure it is legible and evident which is the first and which is the last name), address including county of residence, race, sex, date of birth, type of specimen, date collected, and name and address of submitter. All information requested on the form should be provided on all request forms, since the laboratory information system creates a unique medical record for each patient based on these demographics. There is a nominal charge of $8.00 per specimen for private health care providers. Fee stamps are available from the laboratory administrative office and should be attached to the requisition form as payment for each specimen.
SHIPMENT OF SPECIMENS
The specimen should be collected in the plastic centrifuge tube and the cap tightened securely. The tube must be labeled legibly with the patient=s name. The specimen is placed in the zip-lock portion of the plastic bag and a Tuberculosis Form 3412, marked for "Routine for clinical specimen," in the front pouch. The bag is placed in the mailing container and the lid screwed on tightly. The screw-cap of the outer mailing container should be secured with tape to meet Postal
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Service requirements. The specimen should be mailed or delivered to the laboratory as soon as possible after collection to avoid overgrowth of bacteria other than M. tuberculosis. If mailing is delayed overnight, the specimen should be refrigerated.
Shipment of Specimens for Identification (See pages II-1 II-4 of this manual for recent changes in federal shipping guidelines.)
Cultures for identification and/or drug susceptibility testing should be submitted on solid media after good growth appears. A Tuberculosis Form 3412, appropriately marked for either "Culture for identification" or "Culture for susceptibility tests," should be filled out completely and legibly and submitted with each isolate. If an isolate submitted for identification is M. tuberculosis, susceptibilities will be performed. Glass tubes must be wrapped with cushioning material before being placed into the zip-lock pouch of the plastic bag. Seal the pouch securely. The Form 3412 should be placed in the front pouch of the bag, which is then placed inside the outer shipping container. All caps should be tightened securely.
MGIT tubes showing growth of acid-fast bacilli may be submitted for identification and drug susceptibility testing. A MGIT tube must be sent in accordance with postal/shipping regulations governing infectious substances. They may be centrifuged and the supernatant decanted, leaving the organisms retained in the sediment pellet in the original tube, which should then be placed inside one of the 50 mL centrifuge tubes, capped, and packaged as instructed for specimens. Uncentrifuged MGIT tubes containing broth must be placed inside a 50 mL centrifuge tube, capped securely, and packaged as instructed for specimens. In case of breakage of the MGIT tube, the broth will still be contained inside the 50 mL conical tube, provided all caps have been securely tightened.
REPORTING AND INTERPRETATION OF RESULTS
Results for all mycobacterial testing are reported to the submitter as soon as they are available. In addition copies of reports for positive specimens (i.e. positive AFB smears, positive TB identification, and susceptibilities) are sent to TB Control. If the submitter is a private health care provider, copies of positive reports are sent to the health department in the county of residence of the patient, if such information was supplied on the submission form. No results can be provided to a private health care provider unless the specimen was submitted by the provider.
Microscopic Examination Mycobacteria contain unique mycolic acids and lipids in their cell walls. Primary stains bind tightly to these compounds and are not removed by exposure to strong mineral acids or acidalcohol; therefore, mycobacteria are called Aacid-fast bacilli@ (AFB). Fluorochrome stained slides are prepared from all specimens the day they are received in the laboratory, and results are reported within 24 hours. The slides are examined using a fluorescent microscope for the
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presence of bacilli showing a yellow-green fluorescence. Results are reported as "no AFB found"; "+/-" (1-3 AFB/slide); "1+" (4-36 AFB/100 fields); "2+" (4-36 AFB/10 fields); "3+" (436 AFB/field); or "4+" (>36 AFB/field). Submitters are notified by telephone of a positive smear on a new patient.
Culture A tube of solid medium (Lowenstein-Jensen agar) and a tube of liquid medium (Bactec MGIT broth) are inoculated from each specimen. These cultures are incubated for six weeks before a report of ANo Growth@ is issued. If growth in either medium occurs at any time during the six weeks, identification procedures begin. Use of the new Bactec MGIT system facilitates more rapid detection of mycobacterial growth and has decreased turn around time on specimens from patients who are not on antituberculosis drugs by two to three days. As mycobacteria grow in the MGIT broth tubes, they deplete the oxygen and a substrate in the tube begins to fluoresce. The Bactec 960 instrument reads the tubes every hour and signals a positive reaction when it detects fluorescence.
Identification As soon as growth has been detected, a culture is stained for acid-fast organisms. Sometimes the growth is made up of other bacteria which are not acid-fast, and the specimen is reported as AContaminated.@ Cultures showing acid-fast organisms are subjected to nucleic acid probe testing. Four gene probe tests are available and confirm the identification of M. tuberculosis complex, M. avium complex, M. gordonae, and M. kansasii; an appropriate report based on the gene probe identification is issued immediately. If the organism does not react with the gene probes, it is subcultured to solid medium and, after growth has been obtained, identification is performed utilizing HPLC (High Performance Liquid Chromatography) and/or special biochemical studies. The special biochemical studies usually require four to eight weeks for identification of the organism, whereas HPLC provides rapid identification.
Organisms which test positive with the M. tuberculosis complex gene probe are reported as AM. tuberculosis complex@. This complex consists of the following species: M. tuberculosis, M. bovis, M. bovis BCG, M. africanum and M. microti. Gene probe testing cannot distinguish between these organisms because they contain closely related nucleic acids. Although M. bovis and M. africanum can cause human tuberculosis, the probability that an isolate of M. tuberculosis complex is a species other than M. tuberculosis is extremely small. M. microti is pathogenic in certain animals, but not in humans. Organisms which test positive with the M. avium complex gene probe are reported as AM. avium complex.@ This complex consists of two distinct species, M. avium and M. intracellulare, and includes 28 different serovars.
Drug Susceptibility Testing Drug susceptibility testing is performed only on M. tuberculosis complex organisms. Each new isolate is automatically tested at the time of identification, and the test is repeated every three months if the organism is still being isolated. Results are usually available within 7-10 days after identification of the organism. Susceptibility testing is performed using the Bactec system with a panel of three drugs (isoniazid, rifampin, and ethambutol) initially. If any of the drugs tests as resistant, the test is repeated, and streptomycin is added to the panel. If the results of the two
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tests are the same, the drug is reported as resistant; currently isolates which are resistant to one or more drugs are sent to the Centers for Disease Control and Prevention for testing with additional drugs. This usually requires approximately 4-6 weeks. Reports on isolates showing drug resistance for the first time are called to submitters as soon as results are available. UNACCEPTABLE SPECIMENS 1. No patient identifier on specimen or culture. 2. No specimen received (empty collection tubes). 3. Specimen leaked, was damaged or crushed in transit. 4. Wrong type of specimen submitted. 5. Patient identifier on specimen does not match that on form.
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ISOLATION AND IDENTIFICATION OF FUNGI 404-321-2260/404-327-7940
INTRODUCTION
The Mycology section functions primarily as a reference lab, providing identification of fungal isolates. Instead of submitting clinical specimens, primary cultures from normally sterile or nonsterile sites are preferred. Time in transit adversely affects the quality of such specimens and the opportunity to isolate fungi. Clinical specimens for examination for dermatophytes (hair, skin and nails) are affected very little by time in transit and may be submitted for isolation and identification.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
A. SPECIMENS: HAIR 1. No cleaning of the scalp is usually necessary. However, if hair and scalp are grossly dirty, contaminants may overgrow any pathogens which may be present. 2. With forceps, gently epilate at least 10-12 hairs and collect skin scales from the scalp. This material may be folded inside a piece of clean, hard-finish paper (not tissue), or placed between two glass slides which are then wrapped with hardfinish paper (fold paper over both sides and both ends of slides, so that the specimen is completely enclosed). Do not tape slides together.
SKIN 1. Wipe lesions well with an alcohol gauze sponge. (If alcohol is not advisable, use
sterile water or broth.) 2. Scrape the entire periphery of lesions with a sterile scalpel. Place scrapings in a
hard-finish paper packet or between slides, as described for HAIR.
INTERSPACES 1. Clean interspaces with a gauze sponge moistened with alcohol or sterile water.
Remove all dried exudate. 2. Using a scalpel, gently scrape both sides and base of the interspace. (If fissuring is
present, scrape only the sides.) Note: The fourth interspace of each foot should be included when seeking a laboratory diagnosis of tinea pedis. A dermatophyte may be present in this area in patients with asymptomatic infections or with an id reaction. Submit as described for HAIR.
NAILS 1. Clean nails with a moistened gauze sponge. 2. Remove and discard the first layer of debris under the nail. Collect the remaining
debris for examination. 3. Scrape the undersurface of the nail if it appears diseased. If the dorsal plate
appears diseased, scrape the outer surface and discard, then collect scrapings from
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the diseased area. Submit scrapings in folded paper or between slides wrapped in paper, as described for HAIR.
Requisition Form: Enclose a Mycology form 3410 (Rev. 4-01) with the following: 1. Patient's identifier (name or number). 2. Date of collection. 3. Source of specimen. 4. Agent suspected. 5. Submitter's name and address.
B. CULTURES: Ideal cultures are pure, young subcultures taken from the primary isolation medium. In cases where the submitting lab is not licensed to subculture fungi, primary cultures may be sent (while young, before overgrowth by contaminants). Cultures should be sent on appropriate medium (preferably Sabouraud dextrose agar) in screw-capped tubes. Culture plates should not be transported unless sealed, carefully packaged, and handdelivered by courier.
Requisition Form: Use the Mycology Form 3410 (Rev. 4-01) with the following information: 1. Patient's identifier (name or number). 2. Date of collection. 3. Source of specimen (be specific). 4. Agent suspected. 5. Submitter's name and address. 6. Any available clinical data and/or lab results.
SHIPMENT OF SPECIMENS AND CULTURES (See pages II-1 II-4 of this manual for recent changes in federal shipping guidelines.)
A. SPECIMENS: 1. Dermatological specimens should be transported in a dry container. A hard-finish paper packet containing the specimen can be sent in a regular envelope; specimen between glass slides (wrapped in paper) can be sent in a slide mailer. 2. Primary cultures of fresh specimens may be submitted if the submitting lab is not licensed for mycology. If possible, use the "Culture Referral Outfit" described below under "Cultures".
B. CULTURES: Cultures in tubes should be sent in double-walled mailing containers. "Culture Referral Outfits" (#0505) are available from the Laboratory Services and Supplies Unit, 404-3277920. Tubes should be wrapped carefully to protect against breakage, and placed in the zip-lock portion of the plastic bag and the submission form in the front pouch. The bag is placed in the mailing container and the lid screwed on tightly. The lid of the outside container should be secured with tape.
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Specimens/cultures can be mailed first class or delivered by courier. REPORTING AND INTERPRETATION OF RESULTS Cultures of dermatological specimens are held for three weeks before being reported as negative. Identification of dermatophytes isolated from specimens is usually accomplished in one to three weeks after growth appears. Contaminants are common in dermatological specimens, and are not identified routinely. The time required for identification of referred isolates varies greatly. When appropriate, preliminary reports will be issued, and submitters may check on the status of submissions at any time, by phone 404-321-2260 or 404-327-7940. Whenever possible, complete identification of isolates will be given. In some cases, the extent of identification will depend on clinical information given and the probable significance of the isolate. It is not possible to "rule out pathogenic fungi" when studying mixed cultures, as fungi may be present in varying numbers, and growth rates differ. Proper collection and handling of specimens and appropriate primary culturing are most important in determining the presence of fungi. Determination of significance is case-by-case, as many fungi which have been considered saprophytes may become opportunistic pathogens, especially in immunocompromised patients. UNACCEPTABLE SPECIMENS AND CULTURES 1. No patient identifier on specimen or culture. 2 Specimen damaged or crushed in transit. 3 Patient identifier on specimen does not match that on form.
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Parasitology Unit
Unit Personnel
Manager - Lexie Kreckman, B.A.
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INTESTINAL PARASITES 404-327-7960/61
INTRODUCTION
The Parasitology Unit accepts fecal specimens to be examined for human parasites from all county health departments. Reference specimens for confirmation of parasite identity or further identification are accepted from all laboratories and health care providers.
Diagnosis of most intestinal parasitic infections is dependent upon finding the eggs or larvae of helminthes and trophozoites or cysts of protozoa in feces. The proper collection and/or handling of fecal specimens is essential to ensure that the parasites will be found and identified when they reach our laboratory. Specimens that are inadequate in amount, old, or have been poorly preserved are of limited value and may lead to inaccurate diagnosis. The ingestion of antidiarrheal compounds, antacids, bismuth, and mineral oils may also interfere with the diagnosis of parasites. If particular infections are suspected, please alert our laboratory to your suspicions. We have the capability of capturing images of parasites with our digital camera set up and transmitting them by Internet access to our submitters. This is used for reference and training purposes.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
All specimen containers should be properly labeled with the patient's name and date collected. It will be marked unsatisfactory and discarded if the patient's name is not on this container. The submission/report form should be filled out completely. DO NOT write in the Laboratory Findings section of the form. This is where we let you know the test performed and the test results. When outfits are picked up or shipped in bulk the instruction sheets and submission/report form may be placed in the box with the specimen containers.
A. IP (5% formalin)/LV-PVA outfit: Each Para-Pak Parasitology Transport System Kit contains unbreakable plastic vials each having color-coded caps and labels, a clearly marked "fill to here" line, a clearly marked expiration date, and a built-in collection spoon in the screw-cap top. The kit systems are packaged in ziplock bags with illustrated, multilingual patient instructions to assist in safe and sanitary specimen collection by personnel and/or patients. Remove IP/LV-PVA vials from ziplock bags and discard the bag. Collect fecal specimens according to instructions. Do not contaminate specimen with dirt, urine, or paper; place enough feces in container to bring the liquid up to the red line; mix thoroughly. This will give you a ratio of 1 part feces to 3 parts formalin. Secure cap to avoid leakage. Stack vials (IP/LV-PVA), one on top of the other and place in the biohazard transport bag; seal and complete 2 Forms: #3414 (Rev. 8-87) per patient (1 for IP and 1 for PVA); fold completed forms in half and place in OUTSIDE POUCH of the biohazard bag. Place biohazard transport bag in the fiberboard mailing container, secure lid and mail. Three kits (per patient), collected on consecutive days that you have a bowel movement, should be sent for testing (e.g., one collected on Monday, one collected on Tuesday, and one collected on Thursday). We ask you to send in both
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the IP (5% formalin) and the LV-PVA because we see different organisms when these preservatives are used. If both containers are sent, we can diagnose Giardia lamblia, Entamoeba histolytica, Dientamoeba fragilis, Cryptosporidium sp., Cyclospora, Microsporidium, and all the helminth eggs and larvae. The LV-PVA container is a must for Dientamoeba fragilis and Entamoeba histolytica. Please make sure the patient=s race/nationality and foreign travel is marked on the submission form. Please write the patient=s last name then the first name on the submission form to avoid confusing the two names for data entry and reports and records.
IP/LV-PVA collection instructions included in each outfit Written in 10 languages
B. Pinworm Outfits: Because the female Enterobius vermicularis (Pinworm) leaves the intestinal tract to lay her eggs around the anal opening, we have a special collection outfit to collect these eggs. The specimen needs to be immediately collected upon the patient's awakening in the morning since the eggs may be lost later during the day as a result of scratching, bowel movement or bathing. Collect the specimen following the printed instructions for Pinworm Slide Outfit (Form 3451) included in the outfit. DO NOT let
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feces get on the tape or slide. Place slide inside the cardboard mailing container and close the top. Make sure patient's name is written on the cardboard mailing container label. Place container with slide inside the mailing envelope. Complete Form 3414(8-87).
C. Whole Worms or Proglottids : At times individuals will pass whole worms or small white segments (Proglottids) with feces, these should be separated from the feces and preserved in 70% alcohol. If the worm/Proglottids cannot be separated, please note on the submission form that worms or white segments were seen upon collection. If worms/proglottides were passed without feces, they should be preserved in 70% alcohol. Place in a plastic or glass container to mail. Make sure the patient's name is on the container. Complete Form 3414(Rev.8-87).
D. Entamoeba histolytica Outfit: See Miscellaneous Parasites, Specimen Collection, Section F
SHIPMENT OF SPECIMENS
Specimens may be delivered to the laboratory by courier, shipped by common carrier, or mailed. Be sure specimens are placed in the correct mailing container, otherwise they may get lost in shipment or be delayed in delivery. The double-walled mailing containers for submitting fecal specimens are available from Laboratory Services and Supply (404-327-7920). The round fiberboard mailing container is not necessary for specimens delivered by courier. Place several biohazard transport bags containing specimens in a box or a large envelope for courier delivery. Parasitologic specimens sent through the mail have to conform to postal regulations. If a screwcap outer container is used to mail the specimen, the screw cap must be secured with tape or the Postal Service will return it for taping. It is the responsibility of the sender to make sure any biological material preserved, or viable, conforms to the most recent postal regulations.
When unusually large numbers of specimens are anticipated (such as outbreak situations), the Parasitology Unit should be alerted so that preparations may be made (404-327-7960/61/63).
REPORTING AND INTERPRETATION OF RESULTS
Specimens are reported as quickly as possible. We strive for a 12-24 hour turn around time. The specimen results may be reported the same day that they are received. When you have large clinics, it may take us more than 24 hours because of the number of specimens. If there is an emergency situation, the specimen will be considered stat and immediately processed, and reported. Please notify us when you have an emergency.
Intestinal worms shed eggs intermittently and in varying numbers, and certain protozoan cyst are shed in "showers"; therefore, we request three consecutive day specimens on each patient. An individual's report may be positive one day and negative the next day due to this shedding. If you only return 1 kit (IP/LV-PVA), we only have a 30% chance of recovering the organism, 90% chance if 3 kits are returned.
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The Laboratory Findings section of the report form contains the results of our examination. The extent of testing informs the submitter the actual test that we performed. If the report indicates the presence of pathogenic parasites, the patient needs to be treated. Non-pathogenic parasites are also reported, but their presence indicates hand to mouth fecal contamination. Unsatisfactory results indicate the specimen was compromised in a way that might render the test results invalid. Below, is the list of unsatisfactory specimen submissions. UNACCEPTABLE SPECIMENS 1. No patient identifier on specimen container. 2. No specimen (submission form only) received. 3. No feces (container only) received. 4. No preservative in container. 5. Severely leaked in transit and are considered a hazard to open. 6. Urine submitted instead of feces. 7. Multiple specimens collected on the same day (one specimen will be tested). 8. Insufficient material to examine. 9. Specimens submitted in Para-Pak C&S Outfit (for enteric bacteria). 10. Inappropriate specimen/collection outfit for test requested. 11. Refractile material interfering with diagnosis. 12. PVA solution jelled. 13. Frosted tape. 14. Pinworm tape stuck to applicator paddle. 15. Feces or powder on pinworm slide or tape. 16. Slide broken in transit.
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INTRODUCTION

BLOOD AND TISSUE PARASITES 404-327-7960/7961

The Parasitology Unit also examines specimens for blood and tissue parasites. Due to the ease of foreign travel and the influx of immigrants and refugees, it is very important to fill out patient history on the form. Some "exotic" parasites enter this country by travelers who visit or those who come from a foreign country. We need to know any recent health problems, symptomatology, travel history, place of residence, typical and unusual food preferences and environmental exposure. Many parasites have well-defined geographical ranges and unless an individual has traveled or resided within an endemic or enzootic zone, infection with the parasite is unlikely. There are other situations individuals may become infected with blood parasites. Ones to consider are - blood transfusions, use of hypodermic needles contaminated by prior use, possibly congenital infection and transmission in the United States by indigenous mosquitoes that acquired the parasites from imported infections. Food fads have introduced new parasites into the human population. Some of the blood and tissue parasites that we examine are malaria, microfilaria, Trypanosoma, Isospora, and Babesia. Parasites in human tissue are also examined in our lab, but are often sent to a reference lab for confirmation.

SPECIMEN COLLECTION/LABELING/REQUISITION FORM

Presently, the microscopic examination of blood parasites in stained blood smears offers the most accurate and reliable method of laboratory diagnosis of malaria and other blood parasites.
The morphologic features of protozoan parasites such as malarias, trypanosomas, and babesias are demonstrated in these smears. In order to diagnose the malaria parasites, thick and thin
blood smears are required. The most favorable time for collecting blood for making the smears would be halfway between the chill/fever. Prepare three thick and three thin smears immediately from capillary blood (fingerstick) or within one hour from venous blood, using EDTA as an
anticoagulant. If possible the smear should be stained with Giemsa stain. If you do not have the capability of staining, send it as soon as possible. Morphological changes can occur within one
hour of taking the blood. These changes make it very difficult to diagnose the species. An EDTA tube of blood (2 ml.) should be sent with smears.

Blood Parasites:

Thick smear preparation: 1. Cleanse the finger-tip with alcohol and allow to dry thoroughly. 2. Puncture the skin deeply enough to allow the blood to well up in a large drop. Do not squeeze the finger, this will dilute the blood with tissue fluid. 3. Touch the clean slide to the crest of the drop of blood, or place a drop of venous blood using a Pasteur pipet, in the center of the slide. 4. With a wooden applicator stick, using a circular motion, spread the blood to the size of a dime. The thick smear should just be thick enough so that newspaper print can

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barely be read through it. Do not place a large a drop of blood on the slide. Too much blood will cause it to flake off the slide after drying.. 5. Allow the smear to air dry in a flat, horizontal position so that the blood will be evenly distributed. Protect from dust and insects (roaches enjoy eating the blood on the slide). Do not fix with alcohol. 6. Write patient identifier number or name, and the date the smear was made on the frosted-end portion of the slide. Place in the cardboard mailing container with completed Form 3415. Thin Smear Preparation: 1. Cleanse the finger-tip with alcohol and allow to dry thoroughly. 2. Puncture the skin deeply enough to allow the blood to well up in a large drop. Do not squeeze the finger, this will dilute the blood with tissue fluid. 3. Touch the clean slide to the crest of the drop of blood, or place a drop of venous blood using a Pasteur pipet, at the frosted end of the slide. 4. Hold a second Aspreader@ slide at a 40- 45 degree angle and touch edge of blood, allow blood to spread by capillary action to edge of slide. 5. Rapidly and smoothly push the Aspreader@ slide to the opposite end of the slide while pulling the blood behind it. The smear should have a feathered edge. 6. Air dry at room temperature. Protect from dust and insects. Remember - roaches will eat the blood on the slides. 7. Write patient identifier number or name, and the date the smear was made on the frosted-end portion of the slide. Place in the cardboard mailing container with completed Form 3415.
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Tissue parasites:
Histology preparations from biopsy material are prepared in the hospital or private laboratories and mailed to our lab for review, consultation, or confirmation. Most of these smears are H&E or Giemsa stained. Place patient identifier number or name, and the date the smear was made on the frosted-end portion of the slide. Place in a cardboard mailing container with completed Form 3415.
SHIPMENT OF SPECIMENS
Specimens may be delivered to the laboratory by courier, shipped by common carrier, or mailed. Be sure specimens are placed in the correct mailing container, otherwise they may get lost in shipment or be delayed in delivery. The mailing containers for submitting blood and tissue specimens are available from Laboratory Services and Supply (404-327-7920). The round fiberboard mailing container is not necessary for specimens delivered by courier. Place several biohazard transport bags containing specimens in a box or large envelope for courier delivery. Prepared slides can be packed in boxes, cardboard slide holders, or any other suitable container that will prevent damage or breakage. Specimens for Parasitology sent through the mail have to conform to postal regulations. If a screw-cap outer container is used to mail the specimen, the screw cap must be secured with tape or the Postal Service will return it. It is the responsibility of the sender to make sure any biological material preserved, or viable, conforms to the most recent postal regulations.
REPORTING AND INTERPRETATION OF RESULTS
Specimens are reported as quickly as possible. The specimen results may be reported the same day that they are received. We strive for a 12-24 hour turn around time. If there is an emergency situation, the specimen will be considered stat and immediately processed, and reported. Please notify us when you have an emergency. We speciate malaria specimens when possible otherwise we report as Plasmodium sp. The four species reported are Plasmodium malariae, Plasmodium ovale, Plasmodium vivax and Plasmodium falciparum. At times, a species diagnosis can not be determined from smears and we refer the specimen to CDC for PCR testing. PCR results in some areas of parasitology are considered experimental and are provided for information only.
At times, we report a specimen unsatisfactory. Unsatisfactory results indicate the specimen was compromised in a way that might render the test results invalid. Below is the list of unsatisfactory specimen submissions
UNACCEPTABLE SPECIMENS
1. No patient identifier on specimen container. 2. No specimen received. 3. Smear is too thin or too small. 4. Smear damaged by flies or roaches
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5. Smear is improperly dried 6. Thick smear is too thick (portion flaked off) 7. Thin smear not feathered at the end 8. Grease on slide 9. Smear improperly fixed. 10. Blood coagulated or dried up
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MISCELLANEOUS PARASITES 404-327-7960/61
INTRODUCTION
The Parasitology Unit examines specimens collected from the environment as well as from humans for identification. There are many arthropods of medical importance that transmit diseases to man and other animals. Transmission may be mechanical or biological. Acanthocephala (e.g. thorny-headed worms) and Pentastomida (e.g.. tongue worms) occasionally parasitize humans. We identify nymphs, larvae, eggs, and adults of many parasites. Some of the common one that are sent in are flies, midges, lice, bedbugs, ticks, mites, chiggers, spiders and many more. Some specimens sent in for identification are pseudoparasites and artifacts. These need to be distinguished from the true parasite because of the physical and mental relief it has upon individuals. Parasites such as Entamoeba histolytica, Giardia lamblia, Cryptosporidium parvum, Cyclospora cayetanensis and Microsporidia spp. can cause waterborne and foodborne illness.
SPECIMEN COLLECTION/LABELING/SUBMISSION FORM
All specimen containers/slides should be properly labeled with the patient's name, date collected, and time of collection. It will be marked unsatisfactory and discarded if the patient's name is not on the container/slide. The submission/report form should be filled out completely. DO NOT write in the Laboratory Findings section of the form. When outfits are picked up or shipped in bulk, the instruction sheet and submission/report form may be placed in the box with the specimen containers.
A. Skin scrapings Gently scrape the skin with a scalpel. Collect the scrapping on a piece of paper and transfer into a bottle containing 70% alcohol. Complete Form 3415.
B. Impression Smears Smears from the aspirated material/tissue can be made and examined for parasites. To prepare the smear, press the material/tissue to the slide, air dry, and fix if needed.
C. Arthropods Place in 70% alcohol or on a pad of tissue or loose cotton to avoid damaging fragile body structures. Do not place on cellophane tape. Place in plastic or glass container and mail. Complete Form 3415.
D. Water Samples for Giardia/Cryptosporidium Water samples thought to be the source of human giardiasis or cryptosporidosis will be accepted by special arrangement. Please contact your local County Health Department's environmental specialist to collect the water and notify the laboratory before submitting the water sample. Three and one-half gallons of water need to be collected in sterile
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containers and sent to the lab. Before the water is accepted for testing, a test for fecal (not total) coliform bacteria must be positive from the water sample, and Giardia/Cryptosporidium infection must be confirmed in stool specimens of people who have used the water. Complete Form 3415.
E. Worms for Identification When worms are found in diapers, on bed linens, in the toilet bowel, etc., they should be retrieved as carefully as possible and placed in a bottle containing 70% alcohol. Some of the worms have delicate structures used for identification and should be collected carefully. Make sure the patient's name is on the container. Complete Form 3415.
F. Feces for Entamoeba histolytica Place enough feces in the container to bring the liquid preservative up to the 6 ml line of the container label; mix thoroughly. This will give you a ratio of one-part feces to onepart diluent. Secure cap to avoid leakage. Place in biohazard bag; seal and complete Form 3414 (Rev.8-87); fold completed form and place in OUTSIDE POUCH of biohazard bag. Place biohazard transport bag in the fiberboard mailing container, secure lid and mail.
SHIPMENT OF SPECIMENS
Specimens may be delivered to the GPHL by courier, shipped by common carrier, or mailed. Be sure specimens are placed in the correct mailing container, otherwise they may get lost in shipment or be delayed in delivery. The double-walled mailing containers for submitting fecal specimens are available from Laboratory Services and Supply (404-327-7920). The round fiberboard mailing container is not necessary for specimens delivered by courier. Place several biohazard transport bags containing specimens in a box or large envelope for courier delivery. Parasitic specimens sent through the mail have to conform to postal regulations. If a screw-cap outer container is used to mail the specimen, the screw cap must be secured with tape or the Postal Service will return it. It is the responsibility of the sender to make sure any biological material preserved, or viable, conforms to the most recent postal regulations. When unusually large numbers of specimens are anticipated (as an outbreak) the lab should be alerted so that preparations may be made (404-327-7960/61/63).
REPORTING AND INTERPRETATION OF RESULTS
Specimens are reported as quickly as possible. The specimen results may be reported the same day that they are received. We strive for a 12-24 hour turn around time. If there is an emergency situation, the specimen will be considered stat and immediately processed, and reported. Please notify us when you have an emergency. If we have to send it to a reference lab, it may take two weeks to get the results. PCR results in some areas of parasitology are considered experimental and are provided for information only.
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At times, we report a specimen unsatisfactory. Unsatisfactory results indicate the specimen was compromised in a way that might render the test results invalid. Below is a list why the report may have been marked unsatisfactory. UNACCEPTABLE SPECIMENS 1. No patient identifier on specimen container/slide. 2. No specimen received. 3. Smear is to thin or to small. 4. Smear damaged by flies or roaches. 5. Smear is improperly dried. 7. Smear is too thick. 8. Sample amount insufficient for accurate diagnosis. 9. Identifying structure/s missing. 10. No preservative in container 11. Severely leaked in transit and considered a hazard to open. 12. Container/slide broken in transit.
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Virology Unit
Unit Personnel
Manager - Rom Morales, M.S. Program Assistant - Rachelle Snell Associate - Cynthia Mc Ewen, B.S.
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HUMAN IMMUNODEFICIENCY VIRUS SEROLOGY 404-327-7980
INTRODUCTION
Serologic assays are available for the detection of antibodies to the human immunodeficiency virus (HIV-1). An enzyme immunoassay (EIA) is used as a screening test for antibodies to HIV. All reactive EIAs are repeated in duplicate to verify the initially reactive test result. All repeatably reactive EIA tests (two or more reactive EIAs) are confirmed by the Western Blot (WB) Assay.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Using Universal Precautions, and standard venipuncture technique collect approximately five milliliters of whole blood (or serum) in a red top tube (no additive), labeled with patient's identifier, date, and name of the submitter, use a marker that will not fade, smear, or run during transportation. Use proper size needle (large enough to prevent hemolysis of the red blood cells) for the vein location and age of the patient. Wrap the specimen in the absorbent packing paper provided to absorb any fluid from leaking or broken specimens (do not use rubber bands or tape). Place the wrapped specimen inside a biohazard bag. Place the completed HIV submission form (Form 3605, Rev. 6-99) in the pouch of the biohazard bag. Allow blood specimen to clot and transport, or place in the refrigerator for transporting. Do not hold over seven days before transporting.
Requisition Form
Complete the appropriate laboratory form providing:
1. Unique patient identifier (number not name). 2. Test(s) requested. 3. Date specimen collected. 4. Submitter's name, address, and code. 5. Any information submitter needs for patient identification, e.g., chart number, address,
physician name, contact person and phone number. 6. Race, sex and age/DOB.
SHIPMENT OF SPECIMENS
Specimens may be mailed, shipped by common carrier, or delivered to the laboratory by courier. Place the biohazard bag with its contents inside the cardboard outer can. Place only one or two specimens in the cardboard can so that they can be removed without mishap. If a screw-cap mailer is shipped by the Postal Service, the cap must be secured by tape, or the Postal Service will return them for taping. Be sure to use the proper mailing label for the final specimen destination. Virology HIV outfits can be obtained from Laboratory Services and Supply, telephone number is (404) 327-7920.
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REPORTING AND INTERPRETATION OF RESULTS

The following chart provides information regarding turn-around times (the time the specimen is received to the time the test is completed) and interpretations.

DESCRIPTION
HIV Antibody Screening
HIV Antibody Confirmation

TEST PROCEDURE
EIA
Western Blot

TURNAROUND TIME
2 working days
5 working days

When EIA results are negative, the test results will be reported as "Negative" and no further testing will be required.
The Georgia Public Health Laboratory uses the APHL/CDC criteria shown below for the interpretation of the Western Blot.

Interpretation

Criteria

Negative

The absence of any and all bands-not just viral bands.

Indeterminate

The presence of any viral or non-viral band or bands that fail to meet

the positive criteria.

Positive

The presence of any two of the following bands:

P24

Gp41

Gp120/gp160

Reference: Centers for Disease Control. Interpretation and Use of the Western Blot Assay for

Serodiagnosis of Human Immunodeficiency Virus Type 1 Infections. MMWR 1989;38:1-7.

The following recommendations are made regarding follow-up specimens: 1. If the result of a Western Blot is indeterminate, submit another specimen fo r testing
within a month. If the second specimen is also indeterminate, the patient should be tested again at three and six months. 2. When a patient receives his/her first positive test result and has not identified a high risk behavior, collect a verification specimen at the time the patient is given the results of the first test.

UNACCEPTABLE SPECIMENS

1. ID on form and specimen do not match (ID mismatch). 2. No ID on form. 3. Name on form or tube. 4. No ID on specimen. 5. Over 14 days old.

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6. Broken in transit. 7. Insufficient quantity for testing (QNS). 8. No sample received with form.
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HIV-1 VIRAL LOAD TESTING 404-327-7981
INTRODUCTION
This blood test is performed on confirmed HIV-1 positive patients to determine the level of infection and is not a diagnostic test for HIV infection. Currently, this test is offered to the patients in the Ryan White Program. Evaluation of HIV-1 RNA levels is valuable in the clinical assessment of disease progression prior to initiation of therapy, in monitoring the progression of infection and in assessing a response to anti-retroviral therapy. The Amplicor HIV-1 Monitor Test uses Polymerase Chain Reaction (PCR) technology to achieve the quantitative detection of HIV-1 RNA. The results received in the Amplicor HIV-1 Monitor test procedure are reported as HIV-1 RNA copies/ml. The standard test has a linear range of 400 copies/ml to 750,000 copies/ml. The Ultrasensitive method has a linear range of 50 copies/ml to 75,000 copies/ml.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
a) Follow all safety precautions when drawing blood from patients. b) No special patient preparation is necessary before collection. Use proper size needle
(large enough to prevent hemolysis of the red blood cells) for the vein location and age of the patient. c) Please collect all specimens in a sterile collection tube with EDTA as the anticoagulant or in the Prepared Plasma Tube (PPT) provided by the Georgia Public Health Lab (GPHL). d) Collect one PPT tube using standard venipuncture techniques. After collection of the whole blood in the PPT tube, gently invert the PPT tube 8-10 times.
Specimen Labeling Label the specimen with the patient's identification number, submitter code and the date.
Specimen Handling and Storage a) Centrifuge the whole blood specimen for a minimum of 10 minutes at 1,100xg at room
temperature within two hours of collection. b) Avoid prolonged contact of plasma with the red blood cells. Immediately transfer plasma
into a properly identified, sterile, polypropylene test tube after centrifugation provided by GPHL. If the PPT tube is used, do not need to transfer to a polypropylene test tube. c) Place the specimen in a biohazard bag and store in a freezer at 20o C.
Requisition Form: Complete the HIV Form#3605(Rev.6-99) providing:
1. Unique patient identifier number. 2. Date specimen collected. 3. Submitter's name, address, and code, if applicable. 4. Check the other box and write "Viral load PCR standard" or "Ultra-sensitive." 5. Any information submitter needs for patient identification, e.g., chart number, or
address.
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6. The date of onset of illness, if applicable. 7. Race, ethnicity, sex and age.
Place the HIV form in the pouch of the biohazard bag along with the specimen so that it is ready for courier pickup.
SHIPMENT OF SPECIMENS
Specimens will be delivered to the laboratory by courier according to a schedule provided for your facility.
REPORTING AND INTERPRETATION OF RESULTS
Reporting Format For the Standard Procedure, test results higher than 750,000 HIV-1 RNA Copies/ml is reported as ">750,000 HIV-1 RNA Copies/ml". Test results less than 400 is reported as "<400 copies/mL".
For the Ultrasensitive Procedure, test results higher than 75,000 HIV-1 RNA Copies/ml is reported as "Greater than 75,000 HIV-1 RNA Copies/ml". Test results less than 50 is reported as "<50 copies/ml".
Expected Values
A result of 10,000 to 20,000 copies/ml and below is considered low, while 50,000 copies/ml and above is considered high.
Viral load tests are being used to help doctors determine which treatments are best for HIV positive individuals. This testing is also used to determine whether the chosen treatment is working effectively.
If viral load drops more than three-fold during the treatment, the therapy is considered to be working. If the viral load decreases less than three-fold, or increases during treatment, the doctor and the HIV positive individual may decide to switch to a different treatment.
Critical Interpretation Results of viral load tests may be interpreted differently by different health care providers. The National Institute of Health (NIH) in the US has developed guidelines on when to initiate or alter antiviral therapy.
The following are the guidelines for interpreting viral load tests: "Undetectable" (<400 or <50) viral load does not mean the virus has been eliminated, but
that the level of the virus in the blood is below the sensitivity of the viral test being used. The virus may be harbored in the lymph tissue or the brain. A change in viral load less than three-fold is not considered to be significant. If viral load is less than 20,000 copies/ml, the doctor may start treatment. According to the guidelines the decision to start treatment is up to the HIV individual and his or her doctor. If viral load is more than 20,000 copies/ml, the doctor should start a treatment program.
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Doctors and HIV positive individuals should consider changing therapy if: 1. Viral load fails to drop at least three-fold. 2. Viral load does not fall below detectable levels (<500 copies/mL) within four to six months or to <50 copies/mL within six to eight months. 3. Viral load rises, or drops to undetectable levels and then rises, suggesting resistance to anti-HIV therapies. 4. CD4 count fails to rise. 5. Clinical deterioration exists.
The aim of treatment is to reduce viral load to undetectable levels (<50 copies/mL) for as long as possible.
UNACCEPTABLE SPECIMENS 1. No ID of form. 2. Name on form or tube. 3. No ID on specimen. 4. ID on specimen and form do not match. 5. Not approved for testing by the indicated method, e.g., blood for VDRL. 6. Serum instead of plasma. 7. Grossly hemolyzed, lipemic, turbid, or contaminated. 8. Broken in transit. 9. With an insufficient quantity for testing (QNS).
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RABIES 404-327-7980
INTRODUCTION
The goal of the Virology Unit is to report an accurate and reliable diagnosis so that rabies treatment can be initiated or terminated as necessary. The current methodology for rabies detection is the Fluorescent Antibody (FA) test, which is the most accurate microscopic test available for the diagnosis of rabies. The key factor in obtaining quality results is the condition of the specimen received. Due to the importance of rabies diagnosis, the specimen must not be compromised.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM:
1. Only specimens received in good condition with at least two identifiable principal brain parts are approved for reporting test results. Brain parts must include the cerebellum and the brain stem.
2. In all cases, there must have been exposure of human or domestic animals to the suspected rabid animal.
3. The Virology Unit is not equipped to handle whole carcasses; therefore, only the HEAD is accepted, except bats or small rodents. Bats or small rodents such as mice should be submitted whole. Carcasses of any other animal will be sent back to the submitter for proper collection.
These guidelines are recommended for the removal of animal heads: (Whenever possible, this procedure should be performed by a person who has received pre-exposure prophylaxis).
a. Rubber gloves and protective clothing as well as face and eye protection should be worn while the head is being removed and packaged.
b. Sever neck so as not to damage the skull. Local veterinarians can assist in this removal - never advise clients to remove animal heads!
c. Allow fluids and blood to drain from the head. Keep heads as clean as possible. Place head in a double plastic bag for transportation to the laboratory.
d. If fleas or ticks are evident, spray insecticide into the plastic bag containing the head before closing.
e. Gloves should be cleaned and disinfected or discarded following use, and cutting surfaces should be carefully cleaned and disinfected.
4. Only brain material (not the entire head) of very large animals (e.g. cows/horses) will be accepted, as the laboratory is not equipped to handle these large heads due to limited hood and sterilizer space. Veterinarians should be requested to perform the necropsy. Heads will be sent back to the submitter for proper collection.
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5. Rodents and rabbits are not accepted for laboratory examination- unless the animal makes an unprovoked attack on a person. Bites from animals such as hamsters, guinea pigs, gerbils and white mice that are obtained directly from pet shops and have never been exposed to carnivorous animals or bats, constitute no risk from rabies. Heads of these types of animals will not be accepted for rabies testing.
6. Reporting will be delayed on specimens that are received frozen because the brain tissue needs to be thawed out before testing. If specimens cannot be delivered to the laboratory immediately, refrigerate, but DO NOT freeze.
Requisition Form
1. One Rabies History/Report Form #3062 should accompany each specimen submitted for rabies examination. This form provides the laboratory with the needed information for accurate records.
2. Fill out the form completely and legibly. Include accurate addresses and phone numbers for reporting.
3. A copy of the rabies report is forwarded to the GDHR Office of Epidemiology for review and data collection, then filed for a period of three years.
SHIPMENT OF SPECIMENS
1. Properly package the specimen by placing the severed animal head in a double plastic bag and secure the bag by twisting and knotting. For bats or small rodents, do not remove heads, but submit the whole animal.
2. Place the bag containing the specimen into a shipper with ice or cold packs. DO NOT USE DRY ICE! Seal the shipper. Place the completed history form in the brown envelope, and tape to the lid of the sealed shipper. Place the shipper in a cardboard box, tape and address for shipment.
3. The package should be shipped, prepaid, to the GPHL. Use the method of shipment that will assure prompt service.
4. Any bite case in which the case history reveals a strong probability of rabies, particularly in a case of human exposure , should be handled with utmost speed. Hand deliver such specimens to the laboratory after calling ahead to advise the laboratory of probable time of arrival.
5. Do not ship specimens on the weekends unless prior approval has been obtained from the laboratory manager.
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6. Rabies outfits can be obtained from the Virology Unit; the telephone number is (404) 327-7980. The Virology Unit does not furnish cold packs.

REPORTING AND INTERPRETATION OF RESULTS/CONSULTATION:

1. Rabies testing is available Monday through Friday. Due to the required period for tissue fixation, reports will be issued the next business day following the receipt of the specimen, if the specimen is received by 10:00 a.m. Reporting will be delayed on specimens that are received frozen.

NOTE:

Specimens involved in emergency situations (i.e., severe human head and neck exposures or human exposure for which emergency testing has been approved by Epidemiology) will be tested and reported the same day as received, if received by 10:00 a.m. Monday - Friday. Otherwise, reporting will be issued the next working day.

2. If the brain material found inside the skull is decomposed or damaged to the point of uncertainty about its being brain tissue, no slides will be prepared unless human exposure to the suspected rabid animal is involved.

UNKNOWN EXPOSURE
EXPOSURE

Reported "UNSATISFACTORY" and comment is made "Test requires at least two identifiable brain parts".
Routine testing is performed. If the test results are POSITIVE, a report can be issued as such. If the test results are NEGATIVE, a report of "UNSATISFACTORY" is made and the comment "test requires at least two identifiable brain parts" is added.

3. All Rabies positive and unsatisfactory reports are telephoned immediately to the submitter listed on the history/report form. For human exposures, the health district office is also, called. Copies of each report are mailed to the submitter (animal control, county health department or the county Environmentalist), and to the GA Public Health Epidemiology Office.
4. If you have any more specific questions, please refer to the Rabies Control Manual. If you need a copy of the Rabies Control Manual, please contact Epidemiology at (404) 6572610. If you need consultation for a rabies exposure call Poison Control statewide 1800/282-5846, Atlanta (404) 589-4400, or if you have difficult or emergency cases, contact the Epidemiologist-On-Call, (404) 657-2588.

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UNACCEPTABLE SPECIMENS: The Central Laboratory specimen acceptance policy requires that all specimens be received in good condition with at least two (2) identifiable brain parts and there must have been exposure of humans or domestic animals to the suspected rabid animal. Specimens will be reported "No Test - Unsatisfactory for Testing" for the following reasons: 1. No known exposure of humans or domestic animals. 2. Brain tissue is damaged or decomposed beyond recognition of at least two (2) identifiable
brain parts. 3. Tissue in preservative such as formalin.
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VIRUS ISOLATION AND IDENTIFICATION 404-327-7981
INTRODUCTION
Virus culture provides a mechanism for the detection and identification of many human viruses which cause a wide variety of common illnesses. Viruses are isolated in cell culture and confirmed by enzyme immunoassay tests, indirect fluorescence antibody tests, and neutralization tests. Respiratory viruses and herpes zoster virus can be detected by a direct fluorescent antibody test. Gastrointestinal Viral Outbreaks can be detected by Electron Microscopy.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Refrigerate promptly after collection at 2-6o C for no more than 3 days prior to transporting. Specimens that must be held for longer intervals before transporting should be promptly frozen to 70o C or below. Avoid freezing to 20o C because infectivity of viruses is rapidly lost at this temperature and they can not be recovered by culture. Any container used for viral culture specimens should be sterile.
Swab Collection Procedures: 1. DO NOT USE CALCIUM ALGINATE SWABS TO COLLECT SPECIMEN AS IT
INACTIVATES SOME VIRUSES. 2. USE ONLY TRANSPORT MEDIA SUPPLIED WITH OUTFIT OR APPROVED
BY THE VIROLOGY LABORATORY. 3. AFTER COLLECTION, PLACE SWAB IN TUBE OF TRANSPORT MEDIUM,
BREAK OFF STEM WHERE HANDLED AND DISCARD, AND CAP TUBE.
Nasal/Pharyngeal: Swab each nostril leaving the swab in nose for a few seconds to absorb secretions. Rub the walls of the posterior pharynx with either dry swab or swab wetted with transport media.
Oral: Swab oral lesions.
Eye: Use sterile swab to remove any exudate or pus present in eye and discard. Moisten second swab with transport medium/saline rubbing affected conjunctiva. An Ophthalmologist or trained physician should collect corneal specimens using a spatula.
Cervical: Use sterile swab to remove mucus from cervix and discard. Inserts second swab about 1 cm into cervical canal, rotate, swabbing lesions and remove.
Rectal: Swab rectum in a manner to collect feces.
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Vesicle Fluids/Skin Scrapings: DO NOT PREPARE SITE WITH DISINFECTANTS SUCH AS ALCOHOL OR BETADINE AS THESE MAY INACTIVATE VIRUS; USE ONLY AFTER COLLECTION. In the case of primary infections with herpes simplex, virus may be recovered up to 7-10 days after onset. Collect from base of lesions. Aspirate vesicle fluid with 26/27-gauge tuberculin syringe or capillary pipette. Promptly rinse fluids collected into small volume of transport medium to prevent clotting. Swab open lesions to obtain both fluid and cells from the lesion base.
Other Collection Procedures:
Throat Washings: Adults-Gargle with smallest convenient volume (10 to 20 ml) of cell culture medium or general-purpose bacteriological broth expectorates into paper cup. Pour contents of the cup into screw-cap vial. Pediatrics to be collected in similar manner, however, throat swabs is sufficient.
Stools: Collect stool in a sterile container, transfer small portion (1 to 4 grams) into empty screw cap vial.
Urine: Collect urine in a sterile container; refrigerate immediately at 2 to 6 degrees Celsius.
CSF: Adults-obtain at least 2 ml, infants-1 ml, place in sterile screw cap vial. Do not dilute, refrigerate immediately.
Serum/Blood: Although serum is rarely used to recover viruses it is a suitable specimen for isolation of enterovirus from infected infants.
Autopsy/Biopsy: Aseptically collect specimens as soon as possible after death. Use separate sterile instrument for each collection site. Collect fresh tissue (1-2 grams) from affected site/lesion. Place each specimen in separate sterile container containing small amount of transport medium or saline, clearly label, and refrigerate. Specimen should not be fixed or placed in any sort of preservative solution.
Requisition Form
Complete form #3595R (Virology Request) and include the following: 1. Physician or contact person's name and phone number. 2. Patient's name, age and sex.
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3. Date of illness onset, symptoms. 4. Submitter name/address ("send report to") box. 5. Type of specimen collected, date collected. 6. Test requested.
SHIPMENT OF SPECIMENS (See pages II-1 II-4 of this manual for recent changes in federal shipping guidelines.)
Wrap packing material around specimen container, secure cap to prevent leakage; place the wrapped specimen inside a biohazard bag and seal tightly. Place the completed requisition form #3595R (Virology Request) in the pouch of the biohazard bag. Place the biohazard bag with specimen in a Styrofoam shipper with adequate ice/cold packs to keep cold until the specimen is received. Dry ice is not recommended. Mail, ship common carrier or deliver by courier to the Virology Unit, 1749 Clairmont Road; Attn: Virology Unit; Decatur, GA 30033. Deliveries to be made between 8:00am-4:30pm Monday-Friday. Viral culture outfits are available from the Laboratory Services and Supply, 1749 Clairmont Road; Decatur, GA 30033-4050, telephone number is 404-327-7920.
REPORTING AND INTERPRETATION OF RESULTS
Turn-around time (time specimen is received to the time the test is completed) for cultures varies from two to five weeks. See Table 1., page IV-106, for summary. Cultures yielding virus isolates may require more or less time for identification of the virus, depending upon the isolate involved. Failure to isolate a virus may be the result of a number of factors, including improperly collected specimens, specimens collected at a period in the disease when the patient is not shedding virus, improperly transported specimens, or a lack of test sensitivity. Failure to isolate a virus should not rule out the virus as a cause of the illness. Conversely, since people may asymptomatically carry a variety of viruses, viruses may be isolated which are unrelated to the current clinical illness.
UNACCEPTABLE SPECIMENS
1. Improperly identified specimens (name on tube/form do not match). 2. No identification on form or tube. 3. Specimens with insufficient quantity for testing (QNS). 4. Improper specimen type sent.
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AGENT Adenovirus
Coxsackievirus Cytomegalovirus

Table 1. Viral Isolation and Identification

METHOD

SPECIMEN TYPE

TURN-AROUND TIME

Cell Culture/ Fluorescent Antibody(FA)
Cell Culture/ Neutralization Cell Culture/ FA

Throat washing (TW) or throat swab (TS), NasoPharyngeal (NP) washing or swab, conjunctival swab, urine, feces TS, feces, CSF, pericardial fluid Urine, TS, buffy coat,

4 weeks for cell culture 1-2 days for direct FA
4 weeks for cell culture 5 weeks for cell culture

Echovirus
Enterovirus
Herpes simplex virus
Influenza Virus
Mumps Virus
Norwalk Virus/ Norwalk-like Virus Parainfluenza Virus Poliovirus

Cell Culture/FA
Cell Culture/FA
Cell Culture/Enzyme ImmunoAssay CellCulture/FA/He maglutination(HA)/ Hemaglutination Inhibition (HI) Cell Culture/FA/HA/HI Electron Microscopy (EM)

TS, feces, CSF, pericardial fluid TS, feces, CSF, pericardial fluid vesicle scraping Vesicle scraping (lesion), brain biopsy
TW or TS, NP washing or swab
TS, Urine, CSF
Feces/stool

4 weeks for cell culture 4 weeks for cell culture
2 weeks for cell culture
4 weeks for cell culture 1-2 days for direct FA
4 weeks for cell culture 1-2 days for direct FA 2 days

Cell Culture/FA/HA/HI Cell Culture/FA

TW or TS, NP washing TS, Urine, CSF

4 weeks for cell culture 1-2 days for direct FA 4 weeks for cell culture

Respiratory Syncytial Virus Respiratory Panel
Rotavirus

Cell Culture/FA
Cell Culture/FA/HA/HI EM, EIA

NP washing or swab, TS
TW or TS, NP washing or swab Feces/stool

4 weeks for cell culture 1-2 days for direct FA 4 weeks for cell culture 1-2 days for direct FA 1-2 days

Varicella (Herpes) Zoster Virus Viral Culture Confirmation and Identification

Cell Culture/FA
Cell Culture/EIA/FA/ HA/HI

Vesicle Scraping
Frozen isolate or infected cell culture

3 weeks for cell culture 1-2 days for direct FA 4 weeks for cell culture 1-2 days for direct FA

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SECTION V
ALBANY REGIONAL LABORATORY

ALBANY REGIONAL LABORATORY 229-430-4122
INTRODUCTION The Albany Regional Laboratory is a multi-function clinical laboratory which operates under the Public Health Division of the Georgia Department of Human Resources. The laboratory which is licensed by the State of Georgia and the Federal Government (CLIA), is located in the District Health Building at 1109 North Jackson Street in Albany, Georgia, with Dr. E.A. Franko serving as Director. The laboratory performs testing mandated by State Law as well as testing required by various Health and Environmental Programs. Services are available on a limited basis to private sector customers, but some may be subject to a nominal fee. The goal of the Albany Regional Laboratory is to provide timely, accurate, and reliable test results. This goal can only be accomplished by following proper specimen collection and handling procedures. The following pages are a composite of the testing performed in the Albany Regional Laboratory, with specific requirements for specimen collection and submission for each type of test. Also included are guidelines for reporting, interpretation, specimen acceptance policies, and information on expected turn-around times. A list of services for all the laboratories in the State Public Health System is also included in this manual. The Albany Regional Laboratory provides specimen collection outfits only for the services it provides. Outfits for tests performed in other State Laboratories must be ordered from the laboratory that performs that particular test. For additional information contact: Albany Regional Laboratory 1109 North Jackson Street Albany, GA 31701-2022 Telephone: (229) 430-4122
V-1

V-2

Albany Regional Laboratory

Laboratory Personnel

Manager - Ann Blalock, B.S. Associate - Rheyshene King, B.S.

Data Transcriber I - Betty Robinson Program Assistant - Rushie Kennedy

V-3

V-4

CHEMISTRY FOR LEAD PROGRAM
V-5

V-6

CHEMISTRY FOR THE LEAD PROGRAM 229-430-4122
INTRODUCTION
The Albany Regional Laboratory performs blood lead testing on children from birth to six years of age for the Georgia Childhood lead Poisoning Prevention Program (GCLPPP). Currently Atomic Absorption Spectrometry (Perkin Elmer) is the method of testing in the Albany Regional Laboratory, and blood lead levels above 10 micrograms/deciliter are targeted for follow-up and treatment if necessary.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
I. MICRO OR FINGERSTICK: A. Procedure for Finger Preparation 1. Select examination gloves and rinse to remove powder from the gloves and rinse to remove powder from the gloves if present. This will help avoid contamination of the specimen. 2. Thoroughly wash the patient's hands with soap and water, then dry, using appropriate toweling (low-lint). If water is not available, foam type soap is acceptable. Again, this step is necessary to avoid contamination. 3. The finger to be used must not be allowed to come into contact with any surface, including the patient's other fingers. 4. The finger to be punctured (often the middle finger) must be free of any visible infection or wound. 5. Grasp the finger that has been selected for puncture between your thumb and index finger with the palm of the patient's hand facing up. 6. If not done during washing, massage the fleshy portion of the finger gently. 7. Clean the ball or pad of the finger to be punctured with an alcohol swab. Dry the fingertip using a sterile gauze. 8. Puncturing the fingers of infants less than one year of age if not recommended. Puncturing the heel is more suitable for these children(NCCLS, 1986). The GDHR Child Health Manual (Section B10, #1) states that from age birth to one year use the big toe or exterior lower lateral side of the heel, and over age one year use the middle or ring finger.
B. Puncturing of the Finger and Forming Drops of Blood: 1. Grasp the finger and quickly puncture it with a sterile lancet in a position slightly lateral of the center of the fingertip. 2. Wipe off the first droplet of blood with the sterile gauze. (This drop contains tissue fluids that will produce inaccurate results).
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3. If blood flow is inadequate, gently massage the proximal portion of the finger and then press firmly on the digital joint of the finger. A wellbeaded drop of blood should form at the puncture site.
4. Do not let the blood run down the finger or onto the fingernail. (This blood is unsuitable).
C. Filling the Collection Container 1. Make sure that the microcontainer you are using contains EDTAnticoagulant only. These tubes have purple or lavender tops. 2. Continue to grasp the finger, touch the tip of the collection container to the beaded drop of blood. 3. Draw the blood into the container maintaining a continuous flow of blood. 4. Fill the microcontainer at least one-half full, or to the middle line. Put Cap on the microcontainer. 5. Holding the tube with your thumb and forefinger, immediately invert the tube several times to mix the blood and anticoagulant thoroughly and to avoid the formation of clots. The specimen will be reported unsatisfactory if any clots are noted, or if the quantity of blood is insufficient for testing. 6. When you have finished filling and mixing the microcontainer, put a gauze pad on the finger and have the patient or mother hold until the bleeding has stopped. If bleeding continues after 3-5 minutes of applying pressure, consult a physician. 7. Properly label the microcontainer with patient's first and last name. Use a label and marker that will be legible when the specimen reaches the name listed on the requisition form.
II. VENOUS SPECIMENS A. Select examination gloves and rinse to remove any powder from the gloves. This will avoid contamination of the specimen. B. Clean the puncture site with an alcohol swab or sponge, apply tourniquet, and perform venipuncture using butterfly needles appropriate for size.Make sure the vacutainer tube you are using contains only EDTA anticoagulant(purple or lavender top). C. Fill the tube at least one-half and preferable three-fourths full. Immediately invert several times to insure proper mixing of the blood and anticoagulant, and prevent clotting. D. Properly label the tube with the patient's first and last name exactly as it appears on the requisition form. Use a marker that will be legible when the specimen reaches the laboratory.
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Requisition Form 1. Use form #3593 (03-99) 2. Fill out the form completely. Important elements to be filled in on the form for the
collection of data by the GCLPPP are: a. Submitter name, address, and phone number b. Patient name c. County of residence d. Birthdate e. Race, Ethnicity, Gender f. Date collected g. Method of collection h. Test reason 3. Make sure the name on the form exactly matches the name on the specimen.
SHIPMENT OF SPECIMENS
For best results, specimens should be transported to the laboratory on the date of collection; however, if this is impossible, specimens may be refrigerated at 2 to 8 degrees C, and mailed as soon as possible.
1. Lead specimens may be transported at room temperature. 2. Be sure the caps on the tubes are secure, and wrap each specimen in absorbent packing
material (kyfax). Place the wrapped specimen inside the aluminum can and close the can securely. 3. Wrap the requisition form around the aluminum can and secure it with a rubber band. 4. Place the aluminum can inside the labeled (Albany Address) fibreboard and, close, and secure the lid with tape. 5. An alternate shipping method may be utilized by substituting the biohazard bag for the inner container. If this method is chosen, the requisition form should be placed in the pouch located on the side of each bag. 6. Specimens may be mailed or shopped by the method most convenient and expedient. 7. The laboratory mail is picked up and refrigerated on Saturday, therefore, it is permissible to mail specimens on Friday.
REPORTING AND INTERPRETATION OF RESULTS
The laboratory strives to test each lead specimen on the day it arrives, and the reports are mailed on the same day. Lead levels above 10 micrograms/deciliter are considered abnormal, and case managers should refer to the guidelines supplied by the GCLPPP for recommendations on follow-up screening and treatment. All lead levels above 45 micrograms/deciliter as well as venous specimen levels greater than 10mg/dl are immediately telephoned to the submitter for prompt action.
All laboratory data is transmitted quarterly to the GCLPPP for statistical collection and review.
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UNACCEPTABLE SPECIMENS Specimens will be reported "no test unsatisfactory" for the following reasons: 1. No patient identification on specimen (first and last names must be legible); 2. Discrepancy between patient identification on specimen and requisition form; 3. Insufficient quantity for testing; 4. Specimen broken or leaked in transit; 5. Specimen age exceeds 14 days; 6. Specimen clotted; and 7. Wrong anticoagulant (only EDTA is acceptable).
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RABIES
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RABIES 229-430-4122
INTRODUCTION
The goal of the Albany Regional Laboratory is to confidently report an accurate and reliable diagnosis so that rabies treatment can be initiated if necessary. The Laboratory currently uses the Fluorescent Antibody (FA) methodology which is the most accurate microscopic test available for the diagnosis of rabies. One key factor in obtaining accurate results is the quality or condition of the specimen received. Due to the importance of rabies diagnosis, the specimen must not be compromised.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
1. Only specimens received in good condition with at least two identifiable principal brain parts are approved for reporting.
2. In all cases, there must have been exposure of human or domestic animals to the suspected rabid animal.
3. The Albany Regional Laboratory is no equipped to handle whole carcasses; therefore, only the heads of animals are accepted, except bats or small rodents. Bats or rodents should be submitted whole.
Environmentalists should follow these instructions for the removal of animal heads: A. Rubber gloves and protective clothing as well as face and eye protection should be worn while the head is being removed and packaged. B. Sever neck so as not to damage the skull. Local veterinarians can assist in this removal. Never advise clients to remove animal heads! C. Allow fluids and blood to drain from the head, and keep head as clean as possible. Place head in a double plastic bag for transportation to the laboratory. D. If fleas or ticks are in evidence, spray insecticide into the plastic bag containing the head before closing. E. Gloves should be cleaned and disinfected or discarded following use, and cutting surfaces should be carefully cleaned and disinfected.
4. Only brain material (not the entire head) of very large animals (cows/horses) will be accepted, as the laboratory is not equipped to handle these large heads due to limited hood and sterilizer space. Veterinarians should be requested to perform this necropsy procedure.
5. Rodents or rabbits are not accepted for laboratory examination unless the animal attacks a person unprovoked. Bites from animals that constitute no risk from rabies are hamster, guinea pigs, gerbils and white mice that are obtained directly from pet shops and have never been exposed to carnivorous animals or bats.
6. Reporting will be delayed on specimens that are received frozen. If specimens cannot be delivered to the laboratory immediately, refrigerate, but do not freeze.
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Requisition Form
1. Rabies History/Report Form #3062 should accompany each specimen submitted for rabies examination. This form provides the laboratory with the needed information for accurate results.
2. Fill out the form completely and legibly, being careful to include accurate addresses and telephone numbers for reporting.
3. A copy of each rabies report is forwarded to the State Office of Epidemiology for review and data collection.
SHIPMENT OF SPECIMENS
1. Properly package the specimen by placing the severed animal head in a double plastic bag and secure the bag by twisting and knotting. For bats or rodents, do not remove heads, but submit the whole animal.
2. Place the bag containing the specimen into a shipper with wet ice. Do not use dry ice! Seal the shipper. Place the completed history form in a separate plastic bag, and tape to the lid of the sealed shipper. Place the shipper in a cardboard box, tape, and address for shipment.
3. The package should be shipped prepaid to the laboratory. Use the method of shipment that will assure prompt service.
4. Any bite case in which the history reveals a strong probability of rabies should be handled with utmost speed. Hand deliver such specimens to the laboratory after calling ahead to inform the laboratory staff of estimated time of arrival.
5. Do not ship specimens on the weekends unless prior approval has been obtained from the laboratory manager.
REPORTING AND INTERPRETATION OF RESULTS/CONSULTATION
1. Rabies testing is available Monday through Friday. Due to the required period of tissue fixation, reports will be issued the day following the receipt of the specimen. Reporting will be delayed on specimens that are received frozen.
NOTE: Specimens involved in emergency situations, and Monday am and Friday am specimens will receive only four hours of fixation; and reports will be issued the same day if received by 10:00. Otherwise, reporting will be next day or following the weekend.
2. If the brain material found inside the skull is decomposed or damaged to the point of uncertainty about its being brain tissue, no slides will be prepared unless human exposure to the suspected rabid animal is involved.
a. NO EXPOSURE Reported "UNSATISFACTORY" and comment is made "Test requires at least two identifiable brain parts."
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b. EXPOSURE Routine testing is performed. If the test results are POSITIVE, a report can be issued as such. If the results are NEGATIVE, a report of "UNSATISFACTORY" is made and the comment "Test requires at least two identifiable brain parts" is added.
1. All Rabies reports are telephoned immediately to the submitter listed on the history form. Copies of each report are mailed to the submitter, County Environmentalist (County of animal), and to the State Epidemiology Office.
2. Test results may be given to concerned individuals, such as owners of animals, persons bitten, etc.
UNACCEPTABLE SPECIMENS Rabies specimens will be reported as "UNSATISFACTORY" for the following reasons: 1. There is no known exposure to humans or domestic animals. 2. Brain tissue is damaged or decomposed beyond recognition of at least two principal parts. 3. Tissue in preservative, such as formalin.
NOTE: See #2 under Reporting/Interpretation Section above.
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SEXUALLY-TRANSMITTED DISEASES
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CHLAMYDIA/GONORRHEA DNA PROBES 229-430-4122
INTRODUCTION
Chlamydia (C.) trachomatis is the most common treatable sexually transmitted infection affecting females of reproductive age in the United States today, with an estimated four million new cases each year. Up to 80% of infected females have few or no symptoms, and asymptomatic infection in females can persist for up to 15 months. Complications of untreated chlamydial infection in females include: acute pelvic inflammatory disease; ectopic pregnancy; chronic pelvic pain; and infertility.
Gonorrhea affects males and females from symptoms of purulent discharge in males, a few days after exposure, to very mild symptoms in females. Symptoms may pass unnoticed with a consequence that aymptomatic carriers contribute significantly to the public health problem of gonorrhea.
The Albany Regional Laboratory uses Gen-Probe Pace 2 reagents and DNA Probe methodology for chlamydia and gonnorrhea screening, and the Gen Probe Competitive Assay for confirmation.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Pap smears should be collected after specimens for DNA probes. Female endocervix and male urethra are the only specimens FDA approved for the Gen-Probe Pace 2 test. Throat, rectum, and vaginal specimens should not be submitted for DNA probes.
Use the GEN-PROBE Pace 2 specimen collection kits supplied by the District or County services and supply representative, or contact Teresa Edwards at (404) 657-3100 to place an order. The kits are color coded pink for females, and blue for males.
CLIENT TESTING CRITERIA:
Family Planning Clinics: All females age 29 years or younger who receive a pelvic exam during a visit (initial, annual or comprehensive medical only) will be screened for chlamydia. A female will only be screened once per calendar year for chalmydia unless she has clinical signs or symptoms of chlamydia (cervicitis/MPC, friable cervix, cervical ectopy, abdominal pain, abnormal bleeding, dyspareunia or dysuria) or a new sex partner or multiple sex partners in the past 60 days. All females 30 years and older who meet these criteria will also be screened for chlamydia.
STD/General Clinics: All females age 10-29, who receive a pelvic exam during a visit, will be screened for chlamydia. This includes rescreening females who are returning for medical problems, receiving more than one pelvic exam a year and/or are currently on antibiotics. All females 30 years and older who present with clinical
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signs or symptoms of chlamydia (cervicitis/MPC, friable cervix, cervical ectopy, abdominal pain, abnormal bleeding, dyspareunia or dysuria) or have a new sex partner or multiple sex partners in the past 60 days will also be screened for chlamydia. Male clients presenting for services should also be screened for chlamydia.
Teen Clinics : All females who receive a pelvic exam will be screened for chlamydia. This includes rescreening females who are returning for medical problems, receiving more than one pelvic exam a year and/or are currently on antibiotics. Males should also be screened.
All female/male clients screened for chlamydia will also be screened for gonorrhea.
Females with cervical stenosis should be included in the chlamydia/gonorrhea screening.
If the client does not have a cervix, she will not be included in the chlamydia screening.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Endocervical - females 1. Moisten the speculum with warm water (do not use any other lubricant), insert the
speculum, and visualize the cervix. 2. Remove excess mucus from the cervical os and surrounding mucosa by gently wiping
with one of the swabs provided in the kit. 3. Discard cleaning swab. 4. Insert other swab from collection kit one to one and one-half centimeters into the
endocervical canal. 5. Rotate the swab slowly 180 degrees (at least 10 seconds) in the endocervical canal to
ensure adequate sampling. Withdraw swab carefully; avoid any contact with vaginal mucosa. 6. Insert this second swab (collection swab only) into the GEN-PROBE transport tube. Snap off shaft at score line or cut shaft to fit tube. Cap tube tightly. Legibly label tube with client's name, patient ID# and date of collection. UNLABELED SPECIMENS WILL NOT BE TESTED.
Urethra - males 1. Patient should not have urinated for at least one hour. 2. Insert swab from collection kit two to four centimeters into urethra. 3. Once inserted, rotate swab gently at least one full rotation using sufficient pressure to
ensure swab comes into contact with all urethra surfaces. Allow swab to remain inserted for two to three seconds. 4. Withdraw swab.
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5. Insert collection swab into the GEN-PROBE transport tube. Snap off shaft at score line or cut shaft to fit tube. Cap tube tightly. Legibly label tube with client's name, patient ID# and date of collection. UNLABELED SPECIMENS WILL NOT BE TESTED.
Requisition Form 1. The Chlamydia and Gonorrhea requisition form #3568 (Rev. 8-00). 2. Fill out the form completely by printing or typing legibly. Only legible information can
be entered correctly into the laboratory database. Incomplete or illegible information may delay your results. Do not use computer generated labels for patient information. 3. Information required is as follows: a. Submitter information (submitter code, submitter address, and phone number) b. Patient information (name, patient ID number, county of residence, zip code,
State, race, ethnicity, gender, date of birth) c. Specimen information (test requested, reason for test, date collected, source of
specimen, specimen status) 4. Tear off the top section of form (white copy) and mail to the laboratory with the
specimen, making sure the names on the specimen and form are EXACT matches. Retain the other two copies of the form (pink and yellow) for clinic and program use. 5. Chlamydia and Gonorrhea Laboratory Submission forms should be ordered from the Albany Regional Laboratory by using the specific yellow order form provided by the laboratory.
SHIPMENT OF SPECIMENS
For best results, specimens should be transported to the laboratory on the date of collection; however, if this is impossible, specimens may be kept at room temperature and shipped as soon as possible. Specimens over seven days old at the time of arrival in the laboratory will be reported unsatisfactory.
1. Chlamydia/Gonorrhea Probe specimens may be transported at room temperature. Use the specimen transport cans provided by the laboratory, or cardboard boxes and Albany address labels (also available from the laboratory).
2. Be sure the caps on the transport tubes are secure, and wrap each specimen in absorbent packing material (kyfax). Place the wrapped specimen inside the aluminum can, and close the can securely.
3. Wrap the completed requisition form around the aluminum can and secure it with a rubber band.
4. Place the aluminum can inside the labeled (Albany address) fibreboard can, close, and secure the lid with tape.
5. An alternate shipping method may be utilized by substituting the BIOHAZARD BAG for the inner aluminum container. If this method is chosen, the matching requisition forms should be placed in the pouch located on the side of each bag.
6. Specimens may be mailed or shipped by the method most convenient and expedient. 7. The Albany Regional Laboratory mail is delivered on Saturday, therefore, it is
permissible to mail specimens on Friday.
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REPORTING AND INTERPRETATION OF RESULTS
The goal of the Albany Regional Laboratory is to test and report all Chlamydia/Gonorrhea Probe specimens on the same day they arrive in the laboratory, unless confirmation testing is required (these specimens are reported the following business day). Copies of all reports are transmitted to the State Sexually Transmitted Disease Program for statistical review and data collection.
Results are reported as follows:
POSITIVE Nucleic acid for C. trachomatis or N. gonorrhoeae was detected in the specimen, and as indicated, confirmed by Probe Competitive Assay.
NEGATIVE No evidence of nucleic acid of C. trachomatis or N. gonorrhoeae was found in the specimen.
INDETERMINATE Results of repeat testing are equivocal. Submit another specimen.
UNSATISFACTORY Specimen compromised in some manner making it unsatisfactory for testing. The reason for each Unsatisfactory result will be listed on the report form.
UNACCEPTABLE SPECIMENS
Specimens will be reported UNSATISFACTORY for the following reasons:
1. No patient identifier on the specimen, or discrepancy between identifier on the specimen and requisition form;
2. No source of specimen identified; 3. Two swabs received in the collection outfit; 4. No solution in the collection outfit; 5. No swab, or improper swab (not from Gen-Probe kit) in the collection outfit; 6. Specimen greater than seven days old when received; 7. Grossly bloody specimen; 8. Collection kit expired; 9. No specimen received; or 10. Medical/legal specimens (DNA probes are not approved for medical/legal cases).
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GENITOURINARY SLIDES 229-430-4122
INTRODUCTION
Smears of suspected material may be submitted for the diagnosis of trichomonads, yeast, Haemophilus ducreyi, or Neisseria gonorrhoeae. A microscopic examination is simple, rapid, and inexpensive. This method of diagnosing N. gonorrhoeae is satisfactory for male smears; however, in females and young children, where organisms may be scarce of atypical, culture methods are for more effective and are recommended.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Trichomonads/Yeast
Use a cotton tipped applicator to collect vaginal discharge. Roll a thin smear onto a glass slide and air dry.
Haemophilus ducreyi
1. Ulcer Cleanse ulcer thoroughly with saline. Obtain serous material from the border on a swab. Roll swab (in one direction) onto a glass slide. Air dry.
2. Lymph node (bubo) aspirate After local preparation, aspirate material from bubo and prepare a thin smear on a glass slide. Air dry.
Neisseria gonorrhoeae
Male urethra Obtain discharge on cotton swab, or if discharge cannot be expressed, use a calcium alginate swab inserted two to three cm into anterior urethra, rotating gently as swab is withdrawn. Roll a thin smear onto a glass swab and air dry.
NOTE: Use frosted end glass slides and properly label with patient identifier and collection date. A separate slide must be submitted for each direct examination, e.g. H. ducreyi, N. gonorrhoeae or trichomonads/yeast.
Requisition Form
Legibly complete the entire laboratory form GDHR #3415 in full providing:
1. Unique patient identifier (first and last name); 2. Collection date; 3. Test submitted; 4. Source of specimen; 5. Complete and accurate mailing address of submitter; and 6. Patient's race, sex, age, and address.
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SHIPMENT OF SPECIMENS
In order to expedite examination of smears, and to insure the integrity of the sample, all specimens should be sent to the Albany Regional Laboratory on the day of collection. 1. Place slide securely in plastic slide box. 2. Place plastic slide box and laboratory requisition form in a specimen transport can with
an Albany (gold) label. 3. Transport specimen promptly to the laboratory. If transport is delayed, store at ambient
temperature. 4. Transport by U.S. mail or courier
REPORTING AND INTERPRETATION OF RESULTS
Turnaround time for microscopic examinations is the same day if received before noon; otherwise examination and reporting will be the next business day. Results will be reported as follows:
1. Female trichomonads/yeast a. Trichomonads present; b. Yeast-like cells present; c. No trichomonads seen, no yeast-like cells seen.
2. Haemophilus ducreyi a. Organisms resembling Haemophilus ducreyi seen; b. No organisms resembling Haemophilus ducreyi seen.
3. Male smears GC a. Gram-negative intracellular diplococci resembling gonococci present; b. No Gram-negative intracellular diplococci resembling gonococci seen.
NOTE: When there are many to numerous pus cells present in the absence of bacteria, the Laboratory will make the following comment to the report: a. Smears which have >10 WBC/field: "Numerous pus cells present Suggestive of
non-gonococcal urethritis." b. Smears which have five to nine WBC/field: "Many pus cells present- Suspicious
of non-gonococcal urethritis."
4. Unsatisfactory: Specimen was compromised in a way that might render the test results invalid. The reason for the unsatisfactory report is indicated on each requisition form.
UNACCEPTABLE SPECIMENS
The Albany Regional Laboratory specimen acceptance policy requires that all specimens be properly labeled with patient identifier matching the identifier on the laboratory requisition form,
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in acceptable testing condition, and accompanied by completed requisition form. Failure to provide proper patient information may result in testing/reporting delays. Specimens will be reported "No Test Unsatisfactory" for the following reasons: 1. Smear is too thick/too thin for accurate interpretation or covered with a PAP fixative; 2. Slide broken in transit; 3. No patient identifier on specimen; and 4. Discrepancy between patient identifier on slide and on requisition form.
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SYPHILIS AND RUBELLA 229-430-4122
INTRODUCTION
All serologic services provided by the Albany Regional Laboratory are available to both public and private sector customers. Currently the Rapid Plasma Reagin (RPR) 18 mm Circle Card Test (a non-treponemal test) is the screening procedure for the diagnosis of syphilis. All reactive RPR tests will be confirmed by the Syphilis IgG Enzyme Immunoassay (EIA) or the Fluorescent Treponemal Antibody-Absorption Double Staining (FTA-ABS DS) test* unless the requisition form is marked no confirmatory test needed.
The current methodology for determining the immune status of an individual with regard to resistance or susceptibility to primary rubella infection is latex agglutination.
*FTA is performed on all specimens when the EIA results are equivocal, or the RPR results are greater than 1:16 with a negative EIA.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
For routine testing, whole blood from a venipuncture or serum transferred to a clean, leak resistant, nonbreakable tube may be used.
NOTE: Plasma is not approved for use.
1. No special preparation of the patient is required prior to specimen collection. 2. Using universal precautions and standard venipuncture technique, collect
approximately five (5) ml of blood in a plain (no additive) red-top vacuum blood collection tube. Use appropriate size needle (large enough to prevent hemolysis of the red blood cells) for the vein location and age of the patient. 3. Properly label with patient identifier (name, first and last), collection date, and name of submitter. Use a waterproof marker that will not fade, smear, or run during transportation and handling. 4. Allow blood specimen to clot undisturbed at room temperature for 20-30 minutes before transporting or storing.
Requisition Form Legibly complete laboratory requisition form GDHR #3432 (Rev. 4-00) in full providing:
1. Submitter information a. Submitter code (6 digits) b. Name and address of submitter c. Submitter phone number
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2. Patient information a. Patient name b. Patient ID# (e.g. chart #) c. Birthdate/age d. Race, ethnicity, gender e. Treatment status
3. Specimen information a. Reason for test b. Date specimen collected c. Specimen type d. Special test request
NOTE: Affix pink stickers to the right edge of the laboratory requisition forms of those specimens requiring premarital testing for marriage license.
SHIPMENT OF SPECIMENS
In order to expedite the testing of all of the blood samples, and to insure the integrity of the sample, all specimens should be sent to the Albany Regional Laboratory on the day of collection:
1. Transport specimens using the doubled-walled mailing containers (aluminum and cardboard mailer provided by the Albany Regional Laboratory) or package in a cardboard box complying with federal regulations pertaining to the transportation of clinical specimens and etiological agents.
2. Wrap each specimen with absorbent material to cushion it from breakage or in case of leakage.
3. Place wrapped specimen in aluminum container and close lid. 4. Wrap the requisition form around the aluminum container, secure with a rubber band and
place in: a. The outer fibreboard mailer with the Albany Regional Laboratory address, (secure
the lid with tape); or b. A cardboard box sealed with plastic tape with an Albany Regional Laboratory
address label. Labels are available from Albany Regional Laboratory. 5. An alternate shipping method may be utilized by substituting the Biohazard Bag for the
inner aluminum container. If this method is chosen, the accompanying requisition form should be placed in the pouch located on the side of each bag.
NOTE: U.S. postal regulations allow up to 50 ml of blood to be transported in one package.
6. Transport specimen promptly to the laboratory. When mailing must be delayed, refrigerate at 2-8o C pending transport.
7. Transport by U.S. mail or courier. 8. While refrigeration during transport is not necessary, avoid exposure to extreme
temperatures.
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REPORTING AND INTERPRETATION OF RESULTS
Turnaround time for a RPR/Premarital specimen is the same day if received in early morning, otherwise testing and reporting will be next business day. Arrangements may be made however, for "special request specimens", e.g. blood sample for premarital test, that are received after early morning for same-day testing and reporting. Results will be reported as follows:
RPR
Nonreactive - negative RPR test Reactive - positive RPR test Titer - Endpoint (highest dilution giving a reaction
NOTE: All reactive RPR specimens will be confirmed by the EIA or FTA-ABS DS test unless the requisition form is marked no confirmatory test needed. RPR test is performed on all specimens submitted for EIA or FTA.
EIA
Nonreactive negative EIA (tested by FTA if RPR is greater than 1:16) Equivocal - +/- EIA (If specimen is repeatedly equivocal, it will be tested by FTA-ABS DS) Reactive Positive EIA
FTA-ABS DS
Nonreactive negative FTA-ABS DS Minimal Reactive weakly positive FTA-ABS DS (1+ fluorescence) Reactive Positive FTA-ABS DS (2+ - 4+ fluorescence)
RUBELLA
Immune Presence of Rubella antibodies at a 1:10 dilution of serum Not Immune No Rubella antibodies detected at a 1:10 dilution of serum Unsatisfactory Specimen was compromised in a way that might render the test results
invalid. The reason for the unsatisfactory report will be indicated on each report.
UNACCEPTABLE SPECIMENS
In order to expedite testing and to insure the integrity of the sample, all specimens should be sent to the Albany Regional Laboratory on the day of collection. If kept refrigerated at 2-8O C until ready for transport, specimens can be tested satisfactorily for 14 days before the red blood cells lyse to the extent that tests cannot be accurately interpreted.
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The Albany Regional Laboratory specimen acceptance policy requires that all specimens must be properly labeled with unique patient identifier (name) with matching identifier on requisition form, in acceptable testing condition, and accompanied by a completed requisition form. Failure to provide proper patient information may result in testing/reporting delays. Plasma is not approved for any procedure; therefore, submit only venous blood without anticoagulants or serum. Specimens will be reported "No Test Unsatisfactory" for the following reasons: 1. No patient identifier on specimen (first and last names must be legible); 2. Discrepancy between patient identifier on specimen and requisition form; 3. Insufficient quantity for testing; 4. Specimen broken or leaked in transit; 5. Specimen grossly hemolyzed; and 6. Plasma submitted instead of serum.
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WELL WATER TESTING
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WELL WATER TESTING PROGRAM 229-430-4122
INTRODUCTION
The Albany Regional Laboratory offers analysis for coliform bacteria/Escherichia coli (E.coli) in water from privately-owned wells. Coliform bacteria and E. coli serve as indicators of the bacterial contamination of water. Therefore, their presence or absence are often used to measure the safety of water supplies.
The Albany Regional Laboratory is certified for microbiological analysis in drinking water by the Georgia Environmental Protection Division. The Albany Regional Laboratory uses the Colilert reagent which provides a qualitative, presence-absence test for the simultaneous detection of total coliform bacteria and E. coli in water samples. Samples which contain too much sulfur and/or iron can not be tested for total coliform/E.coli using the Colilert reagent. In these cases, the Albany Regional Laboratory uses an alternate method, the Presence/Absence Broth procedure.
Unless prior arrangements are made with the laboratory manager, the Albany Regional Laboratory will not accept specimens from public water systems*. These specimens should be referred to the Georgia Department of Natural Resources, Water Quality/BacT Lab (404-2065269).
*any water supplier with a piped water system that has at least 15 service connections or regularly serves an average of 25 individuals daily for at least 60 days out of the year
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
1. Samples are collected from privately-owned wells by county health department environmentalists or by environmental health specialists.
2. The laboratory will provide sterile sample bottles containing the appropriate amount of sodium thiosulfate for dechlorination. Do not discard the powder (thiosulfate) out of the sample bottle. The laboratory will also provide the sample labels for the collection bottles, and the forms for the bacteriological analysis of water.
3. Samples should be collected from a tap free of aerators, strainer, hose attachments, water purifiers or other devices.
4. Samples should be aseptically collected after maintaining a steady flow, without splashing, from sampling tap for two to three minutes.
5. The bottle should be filled up to the fill line of 100ml. Do not overfill: ample air space (about one inch) should remain in the bottle.
6. All specimens must be accompanied by the bacteriological analysis of water form (requisition/report form). The upper portion of the form should be completed by the submitter. The bottle containing the specimen should also be labeled with matching
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information, including date and time of collection, and initials of the person responsible for the collection. Use indelible ink to complete the sample information. 7. Specimens should be delivered to the laboratory preferable by 1:00 pm on the day of collection, Monday through Thursday. Do not deliver after 3:00 pm, unless prior approval has been obtained from the laboratory manager. Samples will not be accepted by the laboratory on Friday. 8. To comply with State and Federal Regulations, the time from sample collection to initiation of analysis may not exceed 30 hours. Any specimen exceeding 30 hours at the time of delivery to the laboratory will be reported as UNSATISFACTORY.
SHIPMENT OF SPECIMENS
According to State and Federal Regulations, submitters of water samples for coliform analysis are encouraged but not required to hold samples below 10 decrees C during transit to the laboratory. For hand delivered samples, an iced cooler can be used for this purpose. No refrigeration will be required for mailed samples. When arranging for a mail delivery, remember that the time from sample collection to initiation of analysis cannot exceed 30 hours.
HAND DELIVERY
1. Place the water container and the bacteriological analysis of water form inside the polyfoam box provided by the laboratory.
2. Place the polyfoam box inside an iced cooler. This would assure that the temperature of the specimen is below 10o C during transit to the laboratory.
3. Transport specimen promptly to the laboratory. Keep in mind that the maximum time allowed between sample collection and initiation of analysis is 30 hours.
4. Deliver the specimens to the laboratory on the day of collection preferable before 1:00 pm and not later than 3:00 pm.
5. Do not deliver specimens on Friday.
MAIL/COURIER DELIVERY
1. No cooling of the specimen is required when using mail/courier delivery. 2. Place the water container and the bacteriological analysis of water form inside the
polyfoam box provided by the laboratory. 3. Place the polyfoam box in the cardboard mailing sleeve provided by the laboratory, tape,
and address for shipment. 4. Mail specimens Monday through Wednesday only. Delivery to the laboratory must be
done not later than 3:00 pm (Monday-Thursday) within 30 hours from the time of collection. No specimens will be accepted by the laboratory on Friday.
REPORTING AND INTERPRETATION OF RESULTS
Water analysis is available Monday through Thursday. If possible, the analysis will be initiated the day of receipt.. The Colilert test requires at least 24 hours (maximum 28 hours) for the
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availability of results. Results for the Presence/Absence Broth procedure take longer (2-5 days). Results will be mailed to the submitter within one to four days after receipt in the laboratory. If the Presence/Absence Broth procedure is used, results will be mailed within two to six days after receipt.

Results for the Colilert Presence/Absence test will be reported as follows:

Total Coliform ABSENT: Indicated no evidence for the presence of total coliforms.

Total Coliform PRESENT: Indicates evidence for the presence of total coliforms. All positive samples for total coliform are checked for E. coli.

E. coli ABSENT:

Indicated that the positive total coliform specimen was negative for the presence of E.coli.

E.coli PRESENT:

Indicates that the positive total coliform specimen was also positive for the presence of E. coli.

For the Presence/Absence Broth procedure, total coliform and E. coli results are reported in the same manner as for the Colilert Presence/Absence method.

UNACCEPTABLE SPECIMENS

1. Specimens received without a completed bacteriological analysis of water form and/or without a sample label on the bottle containing the specimen.
2. Specimens for which the information on the bacteriological analysis of water form does not match the information on the sample label (bottle).
3. Samples collected more than 30 hours before they are received by the laboratory. 4. Samples in collection bottles other than the sterile bottles provided by the laboratory. 5. Samples delivered to the laboratory with a volume of less than 100ml. 6. Samples delivered to the laboratory in cracked, broken or improperly sealed bottles. 7. Samples received by the laboratory on Friday. 8. Specimens which are not submitted by county health department environmentalists or
environmental health specialists. 9. Samples containing too much chlorine. This situation may occur after disinfection of the
well using bleach. The presence of elevated levels of chlorine suggests the need for longer time between chlorine disinfection and collection of the sample. 10. Samples containing too much sulfur and/or iron. In this case, the analysis time should be prearranged with the laboratory so that the Presence/Absence Broth procedure may be performed.

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SECTION VI
WAYCROSS REGIONAL LABORATORY

WAYCROSS REGIONAL LABORATORY 912-285-6000
INTRODUCTION The Waycross Regional Laboratory is a multi-functional clinical public health laboratory which operates under the Public Health Division of the Georgia Department of Human Resources. The laboratory is located in the District Health Building at 1101 Church Street in Waycross, Georgia with Dr. E. A. Franko serving as the Laboratory Director. It is licensed by the State of Georgia and the Federal Government under the Clinical Laboratory Improvement Act of 1988 (CLIA). The laboratory performs tests mandated by state laws as well as those examinations required to support the State of Georgia's public health programs. These services are available free of charge to county health departments and units of the Department of Human Resources. Services are also available on a limited basis to the private sector customers and may be subject to a nominal fee. The following pages describe the examinations available at the Waycross Regional Laboratory with specific requirements for specimen collection and handling for each test category. Included also, are expected turn-around times for reports, specimen acceptance policies, and guidelines for interpretation of reported results. Specimen collection outfits are provided free of charge for those services performed in the Waycross Regional Laboratory and may be ordered using the Specimen Collection Outfit order form. For additional information contact: Waycross Regional Laboratory 1101 Church Street Waycross, Georgia 31501-3525 Telephone: 912-285-6000
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Waycross Regional Laboratory

Laboratory Personnel

Laboratory Associate - Alice Jeffers, M.S. Program Assistant - Pat Roundtree

Manager - Frances Bowen, B.S.

Program Assistant - Sandra Capps

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PARASITOLOGY
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INTESTINAL PARASITES 912-285-6000
INTRODUCTION
Stool specimens may be submitted for examination for intestinal parasites by county health departments and for confirmation purposes by the private sector. There is no charge for this service or for the collection outfit. The current tests performed at the Waycross Regional Laboratory to detect intestinal parasites include a Formalin ethyl acetate concentration, a Kinyoun acid-fast stain and a Trichrome stained PVA permanent slide on each specimen.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Each collection outfit kit contains two unbreakable plastic vials, each having a color-coded cap and label, a clearly marked "fill to here" line, a clearly marked expiration date, and a built-in collection spoon in the screw cap top. The kit systems are packaged in ziplock bags with illustrated, multilingual patient instructions to assist in safe and sanitary specimen collection by personnel and/or patients. A biohazard bag for secure transportation to the laboratory completes the outfit.
Health Department Instructions 1. Collection instructions should be reviewed with the patient. 2. It should be stressed to the patient that each specimen must be properly identified with
the patient's name. Unidentified or misidentified specimens will not be tested. 3. It should be made clear to the patient that multiple specimens collected on the same day
will be considered unsatisfactory.
Patient Instructions 1. Remove IP/PVA vials from ziplock bags and collect fecal specimens as directed by
instructions included in outfit. 2. Carefully label each vial with the patient's name. 3. Replace only the vials in original ziplock bag. 4. Place ziplock bag inside biohazard bag and seal.
Requisition Form Health Department Instructions: 1. Fill in submitter return address in proper area on form #3414. 2. Instruct patient in the correct manner to complete remainder of form.
Patient Instructions: 1. Complete Form #3414 as directed. 2. Fold form in half and place in outside pouch of biohazard bag. 3. Return the outfit to the Health Department for transportation to the Waycross Regional
Laboratory.
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SHIPMENT OF SPECIMENS
The specimen vials correctly placed and sealed within the provided ziplock bag within the biohazard bag may be carried by courier or mailed in a sturdy fiber board box which meets U.S. postal regulations to:
Waycross Regional Laboratory 1101 Church Street Waycross, Georgia 31501-3525
REPORTING AND INTERPRETATION OF RESULTS
Submitters may expect to have test results reported within two to three working days after receipt in the laboratory.
The following results are reported: 1. No parasites found; 2. A specific parasite found
Note: Reported parasites are classed as pathogenic or nonpathogenic.
3. Unsatisfactory results indicate that the specimen was compromised in a way that might render the test results invalid. The reason for the unsatisfactory report is indicated on each form.
UNACCEPTABLE SPECIMENS
Specimens will be reported unsatisfactory for the following reasons. 1. Overfilled; 2. Quantity not sufficient; 3. No preservative in bottle; 4. Leaked or broken in transit; 5. Expired outfit; 6. More than one specimen collected on same day; 7. No specimen received; 8. Non-fecal material received; 9. No specimen in bottle; 10. Specimen unidentified.
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PINWORMS 912-285-6000
INTRODUCTION
The female Enterobius(Pinworm) leaves the intestinal tract to lay her eggs in the area surrounding the anus. For this reason, Enterobius(Pinworm) ova are not often present in detectable numbers within fecal specimens. The outfit best suited for the detection of pinworm infections consists of a clear, plastic tape and glass slide outfit. This outfit is designed for the direct collection of the eggs from around the anal area upon the awakening of the patient and the transportation of the specimen to the laboratory for examination. Please note that this examination is satisfactory only for detection of Enterobius (Pinworms) and no other intestinal parasites.
SPECIMEN COLLECTION/LABELING/ REQUISITION FOR
Each collection outfit kit contains collection instructions, a glass slide with clear plastic tape, a tongue blade, a labeled cardboard slide holder, and requisition form # 3414.
Health Department Instructions: 1. Collection instructions should be carefully reviewed with the collector. 2. It should be stressed to the collector that each specimen must be properly identified with
the patient's name. Unidentified or misidentified specimens will not be tested. 3. It should be made clear to the collector that multiple specimens collected on the same day
will be considered unsatisfactory.
Collection Instructions: 1. Collect the specimen immediately upon patient's awakening in the morning since the
eggs maybe lost later during the day as a result of scratching, bowel movements or bathing. 2. Place the round end of tongue blade at middle of the slide. Holding the slide near center with one hand, grasp the blade and white tab on end of tape with the other hand. 3. Rotate slide while lifting up on blade and tape. 4. Continue to rotate slide until one half of tape is stripped from it. 5. Turn the slide back over tongue blade and grasp other tab with thumb. 6. Strip tape completely off slide. 7. Spread the buttocks apart to expose the anus and press the tape firmly against each side at the level of the zone between the moist anal canal and dry skin surrounding it. 8. Replace tape and tongue blade on slide. 9. Smooth tape down with tongue blade. 10. Place slide in holder and discard tongue blade. 11. Label cardboard slide holder with patient's name.
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Requisition Form
Health Department Instructions 1. Fill in submitter return address in proper area on form #3414. 2. Instruct patient in the correct manner to complete remainder of form. 3. Indicate type of specimen submitted( for example, Pinworm slide)
Patient Instructions 1. Complete Form #3414 as directed. 2. Fold form in half and wrap around the slide holder securing with rubber band before
placing in mailing envelope.
SHIPMENT OF SPECIMEN
The specimen may be returned to the health department or after attaching proper amount of postage mailed to:
Waycross Regional Laboratory 1101 Church Street Waycross, Georgia 31501
REPORTING AND INTERPRETATION OF RESULTS
Submitters may expect to have test results reported within 1 to 2 working days after receipt in the laboratory.
The following results are reported:
1. No parasites found; 2. Enterobius(Pinworm); 3. Unsatisfactory results indicate that the specimen was compromised in a way that might
render the test results invalid. The reason for the unsatisfactory report is indicated on each form.
UNACCEPTABLE SPECIMENS
Specimens will be reported unsatisfactory for the following reasons: 1. No specimen on tape; 2. Crushed in transit; 3. Cream or powder on tape; 4. More than one specimen collected on the same day; 5. No specimen received; 6. Feces on tape; 7. Specimen unidentified or misidentified; 8. Frosted tape used instead of clear plastic tape.
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NON-NEONATAL HEMOGLOBINOPATHY
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NON-NEONATAL HEMOGLOBINOPATHY 912-285-6000
INTRODUCTION
This testing program employs a screening technique to detect the presence of abnormal hemoglobin or hemoglobinopathies. Testing is provided to both the public and private sectors. Patients must be greater than one month of age for non-neonatal hemoglobinopathy screening. Testing is indicated in patients who have not been previously tested at birth or in patients requiring retesting. The current methodology for hemoglobinopathy screening is isoelectric focusing electrophoresis.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
For routine testing, whole blood from a venipuncture or capillary blood from a finger stick or a heel prick may be used. Puncturing the fingers of infants less than one year of age is not recommended (NCCLS, 1986).
A. Venous Sampling Technique
Using standard venipuncture technique, collect approximately 5 ml of blood in an EDTA (lavender stopper) vacuum blood-collection tube.
B. Finger-Stick Sampling Technique
1. Cleanse the puncture area with 70% isopropyl alcohol. 2. Wipe off the excess alcohol with dry sterile gauze and allow the skin to air dry or
wipe dry with sterile gauze. (Alcohol residue remaining on the skin may dilute the specimen and adversely affect test results). 3. Grasp the finger and forcefully puncture it with a sterile lancet in a position slightly lateral of the center of the fingertip. 4. Wipe off the first droplet of blood with a sterile gauze or cotton ball. (Initial drop contains tissue fluids which may dilute sample). 5. Holding the EDTA Capiject collection vial in an upright position, funnel the blood into the vial. Maintain a continuous flow of blood by applying intermittently gentle pressure with thumb as drops form. 6. Fill the blood collection vial to between first (250ul) and second line (500ul) from bottom of vial. Replace the lavender cap and immediately after collection, invert the tube 8-10 times to insure mixing and prevent clotting. 7. After the needed blood has been obtained, hold a sterile gauze pad/cotton ball applying slight pressure on the finger puncture site until the bleeding has stopped. If bleeding continues after 3-5 minutes, consult a physician. 8. Using a marker that will not smear, fade, or run, label the specimen with patient's name exactly as it appears on the requisition form; use the small, white press-on labels that are supplied with capillary blood collection vials.
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C. Heel-Prick Sampling Technique

1. Collect the blood from the infant's heel, using the most medial or lateral portion of the plantar surface of the heel, where "medial" is defined as the midline of the body, and "plantar surface" as the walking surface of the foot.

NOTE:

DO NOT use any previous puncture sites or the curvature of the heel. DO NOT perform skin punctures for obtaining blood specimens on the central area of a newborn's or infant's foot (area of the arch). This may result in injury to the nerves, tendons and cartilage.

2. Warming the skin-puncture site can increase blood flow through the site. A warm, moist towel at a temperature no higher than 42o C may be used to cover the site for three minutes.
3. Clean the skin with a 70% isopropyl alcohol swab. 4. Wipe off the excess alcohol with dry sterile gauze, and allow the skin to air dry or
wipe dry with sterile gauze. Alcohol residue remaining on the skin may dilute the specimen and adversely affect test results. 5. In order to obtain a sufficient flow of blood, forcefully puncture the infant's heel with a sterile lancet with tips 2.5 mm. Hold the infant's heel loosely so not to impede the flow of blood. If bleeding does not immediately occur, massage the lower portion of the leg in a downward direction. 6. Wipe off the first droplet of blood with a sterile gauze or cottonball. (Initial drop contains tissue fluids which may dilute sample). 7. Wait for spontaneous free flow of blood. Funnel the blood into the EDTA Capiject blood collection vial.

NOTE:

Milking or squeezing the puncture may cause hemolysis of the specimen and/or mixture of tissue fluids with the specimen.

8. Fill the blood collection vial to between first (250ul) and second (500ul) line from bottom of vial. Replace the lavender cap and immediately after collection, invert the vial 8-10 times to insure mixing and prevent clotting.
9. After the needed blood has been collected from the heel of the newborn, the foot should be elevated above the body, and a sterile gauze, pad or cotton swab pressed against the puncture site until the bleeding stops. If bleeding continues after 3-5 minutes, consult a physician.
10. Using a marker that will not smear, fade, or run, label the specimen with the patient's name exactly as it appears on the requisition form; use the labels that are supplied with capillary blood collection vials.

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Legibly complete the entire laboratory requisition form GDHR #3563 (Rev. 5-88). Important elements are the following:

1. Unique patient identifier (Name); 2. Birthdate, sex, race; 3. Collection date; 4. County of residence; 5. Mother's name, address and telephone number; and 6. Complete and accurate mailing address and telephone number of clinician.
SHIPMENT OF SPECIMENS

In order to expedite the testing of all of the blood samples, and to insure the integrity of the sample, all specimens should be sent to the Waycross Regional Laboratory on the day of collection.

1. Transport specimens using the doubled-walled mailing containers (aluminum can or biohazard bag in outer cardboard mailer provided by the Waycross Regional Laboratory). Package in a cardboard box meeting U.S. postal regulations.
2. Wrap each specimen with absorbent material to cushion it from breakage or in case of breakage, to absorb the leakage.
3. Place wrapped specimen in aluminum container or biohazard bag. 4. Wrap the requisition form around the aluminum container or place in pouch of biohazard
bag; secure with a rubber band and place in either of the following: A. The outer cardboard mailer with the Waycross Regional Laboratory address.
Postal regulations require that the outer metal screw-on lid be secured with tape. If not, the specimen will be rejected by the Postal Service and returned to the submitter. (Acceptance of hazardous, restricted or perishable matter. USPS Publication 52, April, 1990). B. A cardboard box with a Waycross Regional Laboratory address label. Labels may be ordered from Waycross Regional Laboratory. U.S. postal regulations allow up to 50 ml of blood to be transported in one package. 5. Transport specimen promptly to the laboratory. When mailing is delayed, refrigerate at 2-8o C pending transport. 6. Transport by U.S. mail, or courier.

NOTE:

If U.S. mail is used, precautions should be taken that specimens are put in mail boxes that have a daily pick-up. While refrigeration during transport is not necessary, avoid exposure to extreme temperatures.

REPORTING AND INTERPRETATION OF RESULTS

Normal hemoglobin will be reported as AA normal. The AA pattern is the designation for normal adult hemoglobin and indicates that NO hemoglobinopathy was detected. All heterozygote results (abnormal hemoglobin plus Hb A) will be reported as traits. All

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homozygote abnormals (absence of Hb A) will be reported as a disease. Traits and diseases that are not identifiable by the methods used will be reported as: Unknown Variant present. A letter of interpretation and instructions for reference testing, if indicated, will accompany the report. Testing is performed weekly with all reports being electronically generated and mailed to the submitter within 7 working days after receipt. UNACCEPTABLE SPECIMENS The Waycross Regional Laboratory specimen acceptance policy requires that all specimens be properly labeled with patient's name matching the name on the laboratory requisition form, in acceptable testing condition, and accompanied by a completed requisition form. In order to expedite testing and to insure the integrity of the sample, all specimens should be sent on the day of collection to: Waycross Regional Laboratory 1101 Church Street Waycross, Georgia 31501-3525 If kept refrigerated at 2-8o C until ready for transport, specimens can be tested satisfactorily for 28 days before the red blood cells lyse to the extent that tests cannot be accurately interpreted. The submitter will be notified of all specimens unacceptable for testing. When possible, the unacceptable specimens will be held in the refrigerator for 14 days. At the end of the 14 days, the specimen will be discarded without further notification. Specimens will be reported "Unsatisfactory" for the following reasons: 1. No patient identifier on specimen (first and last name must be legible); 2. Discrepancy between patient identifier on specimen and on requisition form; 3. Insufficient quantity for testing; 4. Specimen broken or leaked in transit; 5. Specimen age exceeds 28 days; and 6. Specimen clotted or hemolyzed.
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RABIES
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RABIES 912-285-6000
INTRODUCTION
The goal of the Waycross Regional Laboratory is to confidently report an accurate and reliable diagnosis so that rabies treatment can be initiated if necessary. The Laboratory currently uses Fluorescent Antibody (FA) methodology, the most accurate microscopic test available for the diagnosis of rabies. One vitally important factor in obtaining accurate results is the quality of the specimen received. The importance of rabies diagnosis makes it imperative that the condition or identity of the specimen not be compromised.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
1. Only specimens received in good condition with at least two identifiable principal brain parts are approved for reporting.
2. In all cases, there must have been exposure of human or domestic animals to the suspected rabid animal.
4. The Waycross Regional Laboratory is not equipped to handle whole carcasses; therefore, only the HEADS of animals are accepted except for bats or small rodents. Bats or small rodents should be submitted whole.
Environmentalists should follow these instructions for the removal of animal heads:
a. Rubber gloves and protective clothing as well as face and eye protection should be worn while the head is being removed and packaged.
b. Sever neck so as to not to damage the skull. Local veterinarians can assist in this removal. Never advise clients to remove animal heads!
c. Allow fluids and blood to drain from the head, and keep head as clean as possible. Place head in a double plastic bag for transportation to the laboratory.
d. If fleas or ticks are in evidence, spray insecticide into the plastic bag containing the head before closing.
e. Gloves should be cleaned and disinfected or discarded following use and cutting surfaces should be carefully cleaned and disinfected.
4. Only brain material (not the entire head) of very large animals (cows or horses) will be accepted, as the laboratory is not equipped to handle these large heads due to limited hood and sterilizer space. Veterinarians should be requested to perform this necropsy procedure.
5. Rodents or rabbits are not accepted for laboratory examination-unless the animal attacks a person unprovokedly. Bites from animals that constitute no risk from rabies are
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hamster, guinea pigs, gerbils and white mice that are obtained directly from pet shops and have never been exposed to carnivorous animals or bats.

6. Reporting will be delayed on specimens that are received frozen. If specimens cannot be delivered to the laboratory immediately, refrigerate, but do not freeze.

Requisition Form

One Rabies History/Report Form #3062 should accompany each specimen for rabies examination. This form provides the laboratory with the needed information for accurate results.

SHIPMENT OF SPECIMENS

Notify the Waycross Regional Laboratory of the shipment or expected arrival of all rabies specimens so that tracking can be initiated immediately on those which become misdirected.

1. Properly package the specimen by placing the severed animal head in a double plastic bag and secure the bag by twisting and knotting. For bats and rodents, do not remove heads, but submit the whole animal.

2. Place the bag containing the specimen into a shipper with wet ice. DO NOT USE DRY ICE! Seal the shipper. Place the completed history form in a separate plastic bag, and tape to the lid of the sealed shipper. Place the shipper in a cardboard box, tape, and address for shipment.

3. The package should be shipped prepaid to the laboratory. Use the method of shipment that will assure prompt service.

4. Any bite case in which the history reveals a strong probability of rabies should be handled with utmost speed. Hand deliver such specimens to the laboratory after calling ahead to inform the laboratory staff of the emergency situation and the estimated time of arrival.

5. Do not ship specimens on the weekends unless prior approval has been obtained from the lab manager.

REPORTING AND INTERPRETATION OF RESULTS

1. Rabies testing is available Monday through Friday excluding official state holidays. Due to the required period of tissue fixation, reports will be issued the day following the receipt of the specimen. Reporting will be delayed on specimens that are received frozen.

NOTE:

Specimens involved in emergency situations, and Monday am and Friday am specimens will receive only four hours of fixation; and reports will be issued the

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same day if received by 10:00. Otherwise, reporting will be next day or following the weekend.

2. If the brain material found inside the skull is decomposed or damaged to the point of uncertainty about its being brain tissue, no slides will be prepared unless human exposure to the suspected rabid animal is involved.

a. NO EXPOSURE Reported UNSATISFACTORY" and comment is made "Test requires at least two identifiable brain parts."

b. EXPOSURE - Routine testing is performed. If the test is result is POSITIVE, a report is issued as such. If the test result is NEGATIVE, a report of UNSATISFACTORY is made and the comment "Test requires at least two identifiable brain parts " is added.

3. All Rabies reports are telephoned immediately to the submitter listed on the history form. Copies of all reports are mailed to the submitter, County Environmentalist (county of the animal) and to the State Epidemiology Office.

4. Test results may be given to concerned individuals, such as owners of animals, persons bitten, etc.

UNACCEPTABLE SPECIMENS

Rabies specimens will be reported as UNSATISFACTORY for the following reasons:

1. There is no documented exposure to humans or domestic animals.

2.

Brain tissue is damaged or decomposed beyond recognition of at least two principal

parts.

3. Tissue in preservative, such as formalin.

NOTE: See #2 under Reporting/Interpretation Section above.

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SEXUALLY-TRANSMITTED DISEASES
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CHLAMYDIA/GONORRHEA DNA PROBES 912-285-6000
INTRODUCTION
Chlamydia (C.) trachomatis is the most common treatable sexually transmitted infection affecting females of reproductive age in the United States today, with an estimated four million new cases each year. Up to 80% of infected females have few or no symptoms, and asymptomatic infection in females can persist for up to 15 months. Complications of untreated chlamydial infection in females include: acute pelvic inflammatory disease; ectopic pregnancy; chronic pelvic pain; and infertility.
Gonorrhea affects males and females from symptoms of purulent discharge in males, a few days after exposure, to very mild symptoms in females. Symptoms may pass unnoticed with a consequence that asymptomatic carriers contribute significantly to the public health problem of gonorrhea.
The Waycross Regional Laboratory uses Gen-Probe Pace 2 reagents and DNA Probe methodology for chlamydia and gonnorrhea screening, and the Gen Probe Competitive Assay for confirmation.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Pap smears should be collected after specimens for DNA probes. Female endocervix and male urethra are the only specimens FDA approved for the Gen-Probe Pace 2 test. Throat, rectum, and vaginal specimens should not be submitted for DNA probes.
Use the GEN-PROBE Pace 2 specimen collection kits supplied by the District or County services and supply representative, or contact Teresa Edwards at (404) 657-3100 to place an order. The kits are color coded pink for females, and blue for males. CLIENT TESTING CRITERIA:
Family Planning Clinics: All females age 29 years or younger who receive a pelvic exam during a visit (initial, annual or comprehensive medical only) will be screened for chlamydia. A female will only be screened once per calendar year for chalmydia unless she has clinical signs or symptoms of chlamydia (cervicitis/MPC, friable cervix, cervical ectopy, abdominal pain, abnormal bleeding, dyspareunia or dysuria) or a new sex partner or multiple sex partners in the past 60 days. All females 30 years and older who meet these criteria will also be screened for chlamydia.
STD/General Clinics: All females age 10-29, who receive a pelvic exam during a visit, will be screened for chlamydia. This includes rescreening females who are returning for medical problems, receiving more than one pelvic exam a year and/or are currently on antibiotics. All females 30 years and older who present with clinical signs or symptoms of chlamydia (cervicitis/MPC, friable cervix, cervical ectopy,
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abdominal pain, abnormal bleeding, dyspareunia or dysuria) or have a new sex partner or multiple sex partners in the past 60 days will also be screened for chlamydia. Male clients presenting for services should also be screened for chlamydia.
Teen Clinics : All females who receive a pelvic exam will be screened for chlamydia. This includes rescreening females who are returning for medical problems, receiving more than one pelvic exam a year and/or are currently on antibiotics. Males should also be screened.
All female/male clients screened for chlamydia will also be screened for gonorrhea.
Females with cervical stenosis should be included in the chlamydia/gonorrhea screening.
If the client does not have a cervix, she will not be included in the chlamydia screening.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Endocervical - females 1. Moisten the speculum with warm water (do not use any other lubricant), insert the
speculum, and visualize the cervix. 2. Remove excess mucus from the cervical os and surrounding mucosa by gently wiping
with one of the swabs provided in the kit. 3. Discard cleaning swab. 4. Insert other swab from collection kit one to one and one-half centimeters into the
endocervical canal. 5. Rotate the swab slowly 180 degrees (at least 10 seconds) in the endocervical canal to
ensure adequate sampling. Withdraw swab carefully; avoid any contact with vaginal mucosa. 6. Insert this second swab (collection swab only) into the GEN-PROBE transport tube. Snap off shaft at score line or cut shaft to fit tube. Cap tube tightly. Legibly label tube with client's name, patient ID# and date of collection. UNLABELED SPECIMENS WILL NOT BE TESTED.
Urethra - males 1. Patient should not have urinated for at least one hour. 2. Insert swab from collection kit two to four centimeters into urethra. 3. Once inserted, rotate swab gently at least one full rotation using sufficient pressure to
ensure swab comes into contact with all urethra surfaces. Allow swab to remain inserted for two to three seconds. 4. Withdraw swab.
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5. Insert collection swab into the GEN-PROBE transport tube. Snap off shaft at score line or cut shaft to fit tube. Cap tube tightly. Legibly label tube with client's name, patient ID# and date of collection. UNLABELED SPECIMENS WILL NOT BE TESTED.
Requisition Form 1. The Chlamydia and Gonorrhea requisition form #3568 (Rev. 8-00). 2. Fill out the form completely by printing or typing legibly. Only legible information can
be entered correctly into the laboratory database. Incomplete or illegible information may delay your results. Do not use computer generated labels for patient information. 3. Information required is as follows: a. Submitter information (submitter code, submitter address, and phone number) b. Patient information (name, patient ID number, county of residence, zip code,
State, race, ethnicity, gender, date of birth) c. Specimen information (test requested, reason for test, date collected, source of
specimen, specimen status) 4. Tear off the top section of form (white copy) and mail to the laboratory with the
specimen, making sure the names on the specimen and form are EXACT matches. Retain the other two copies of the form (pink and yellow) for clinic and program use. 5. Chlamydia and Gonorrhea Laboratory Submission forms should be ordered from the Waycross Regional Laboratory by using the specific pink order form provided by the laboratory.
SHIPMENT OF SPECIMENS
For best results, specimens should be transported to the laboratory on the date of collection; however, if this is impossible, specimens may be kept at room temperature and shipped as soon as possible. Specimens over seven days old at the time of arrival in the laboratory will be reported unsatisfactory.
1. Chlamydia/Gonorrhea Probe specimens may be transported at room temperature. Use the specimen transport cans provided by the laboratory, or cardboard boxes and Waycross address labels (also available from the laboratory).
2. Be sure the caps on the transport tubes are secure, and wrap each specimen in absorbent packing material (kyfax). Place the wrapped specimen inside the aluminum can, and close the can securely.
3. Wrap the completed requisition form around the aluminum can and secure it with a rubber band.
4. Place the aluminum can inside the labeled (Waycross address) fiberboard can, close, and secure the lid with tape.
5. An alternate shipping method may be utilized by substituting the BIOHAZARD BAG for the inner aluminum container. If this method is chosen, the matching requisition forms should be placed in the pouch located on the side of each bag.
6. Specimens may be mailed or shipped by the method most convenient and expedient. 7. The Waycross Regional Laboratory mail is delivered on Saturday, therefore, it is
permissible to mail specimens on Friday.
VI-27

REPORTING AND INTERPRETATION OF RESULTS
The goal of the Waycross Regional Laboratory is to test and report all Chlamydia/Gonorrhea Probe specimens on the same day they arrive in the laboratory, unless confirmation testing is required (these specimens are reported the following business day). Copies of all reports are transmitted to the State Sexually Transmitted Disease Program for statistical review and data collection.
Results are reported as follows:
POSITIVE Nucleic acid for Chlamydia trachomatis or Neisseria gonorrhoeae was detected in the specimen, and as indicated, confirmed by Probe Competitive Assay.
NEGATIVE No evidence of nucleic acid of Chlamydia trachomatis or Neisseria gonorrhoeae was found in the specimen.
INDETERMINATE Results of repeat testing are equivocal. Submit another specimen.
UNSATISFACTORY Specimen was compromised in some manner making it unsatisfactory for testing. The reason for each Unsatisfactory result will be listed on the report form.
UNACCEPTABLE SPECIMENS
Specimens will be reported UNSATISFACTORY for the following reasons:
1. No patient identifier on the specimen, or discrepancy between identifier on the specimen and requisition form;
2. Two swabs received in the collection outfit; 3. No solution in the collection outfit; 4. No swab, or improper swab (not from Gen-Probe kit) in the collection outfit; 5. Specimen greater than seven days old when received; 6. Grossly bloody specimen; 7. Collection kit expired; 8. No specimen received; 9. Medical/legal specimens (DNA probes are not approved for medical/legal cases); or 10. Incorrect source.
VI-28

GENITOURINARY SLIDES 912-285-6000
INTRODUCTION
Smears of suspected material may be submitted for the diagnosis of trichomonads, yeast or Neisseria gonorrhoeae. A microscopic examination is simple, rapid, and inexpensive. This method of diagnosing Neisseria gonorrhoeae is satisfactory for male smears; however, in females and young children, where organisms may be scarce or atypical, culture methods are far more effective and are recommended.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
Neisseria gonorrhoeae
Male Urethra: Obtain discharge on cotton swab, or if discharge is not present, use a calcium alginate swab inserted 2-3 cm into the anterior urethra, rotating gently as swab is withdrawn. Onto a frosted-end slide properly labeled with patient's identifier and collection date, roll a thin smear and allow to air dry.
Yeast and trichomonads
Use a cotton tipped applicator to collect vaginal discharge. Roll a thin smear onto a glass slide and air dry.
NOTE: Use frosted end glass slides and properly label with patient identifier and collection date. A separate slide must be submitted for N.gonorrhoeae and trichomonads/yeast.
Requisition Form
Legibly complete the entire laboratory form GDHR #3415, being sure to provide the following: 1. Unique patient identifier(Name); 2. Collection date; 3. Test requested; 4. Complete and accurate mailing address of submitter; 5. Type of specimen collected; and 6. Patient's age, race, sex and address.
SHIPMENT OF SPECIMENS
On the day of collection, send specimen to the Waycross Regional Laboratory in the following manner: 1. Place slide securely in plastic slide box. 2. Place plastic slide box and laboratory requisition form in a specimen transport can with a
Waycross label.
VI-29

3. Transport specimen promptly to the laboratory. When mailing is delayed, hold specimen at ambient temperature (23-29o C).
4. Transport by U.S. mail or courier.
REPORTING AND INTERPRETATION OF RESULTS
Turn around time for this microscopic examination is one to two days depending on time of receipt.
Results will be reported as follows:
1. Female trichomonads/yeast a. Trichomonads present; b. Yeast-like cells present; c. No trichomonads seen; No yeast cells seen.
2. Male smears for GC a. Gram-negative intracellular diplococci resembling gonococci present. b. No Gram-negative intracellular diplococci resembling gonococci seen. c. Gram-negative extracellular diplococci suggestive but not typical of gonococci present.
Note: When there are many to numerous pus cells present in the absence of bacteria, the Laboratory will make the following comment to the report: a. Smears which have >10 WBC/field: "Numerous pus cells present Suggestive of non-gonococcal urethritis." b. Smears which have 5-9 WBC/field: "Many pus cells present - Suspicious of non-gonococcal urethritis."
UNACCEPTABLE SPECIMENS
The Waycross Regional Laboratory specimen acceptance policy requires that all specimens be: 1. Properly labeled with patient identifier matching the identifier on the laboratory
requisition form; 2. In acceptable testing condition; and 3. Accompanied by a complete requisition form.
Specimens will be reported "UNSATISFACTORY NO TEST" for the following reasons:
1. Smear is too thick or too thin for accurate interpretation; 2. Slide crushed in transit; 3. No patient identifier on specimen; 4. Patient identifier on specimen does not exactly match that on form; and 5. Smear is fixed for a PAP smear examination.
VI-30

SYPHILIS AND RUBELLA 912-285-6000
INTRODUCTION
All serologic services provided by the Waycross Regional Laboratory are available to both the public and private sector customers.
Currently the Rapid Plasma Reagin (RPR) 18mm Circle Card Test (a nontreponemal test) is the screening procedure for the diagnosis of syphilis. All reactive RPR tests will be confirmed by the Enzyme Immunoassay (EIA) unless the requisition form is marked "No Confirmatory Test Needed." The fluorescent Treponemal Antibody-Absorption Double Staining (FTS-ABS DS) test will be performed only on specimens when the EIA results are equivocal, or the RPR results are reactive1:16 or greater with a negative EIA.
The current methodology for determining the immune status of an individual with regard to resistance or susceptibility to primary rubella infection is a latex agglutination screening procedure.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
For routine testing, whole blood from a venipuncture or serum transferred to a clean, leak resistant, non-breakable tube may be used.
NOTE: Plasma is not approved for use.
1. No special preparation for the patient is required prior to specimen collection. 2. Using Universal Precautions and standard venipuncture technique collect approximately
five (5) milliliters of blood in a plain (no additive) redtop vacuum blood collection tube. Use appropriate size needle (large enough to prevent hemolysis of the red blood cells) for the vein location and age of the patient. 3. Properly label with patient identifier (name, first and last, or number), collection date, and name of submitter. Use a waterproof marker that will not fade, smear, or run during transportation. 4. Allow blood specimen to clot undisturbed at room temperature for 20-30 minutes before transporting or storing.
Requisition Form
Legibly complete laboratory requisition form GDHR #3432 (Rev. 4/2000) in full providing:
1. Unique patient identifier (name); 2. Tests requested; 3. Race, sex, and date of birth; 4. Collection date;
VI-31

5. Complete and accurate mailing address of submitter; and 6. Any information the submitter needs for patient identification, e.g.,chart number, address.
NOTE: For those specimens requiring premarital testing for marriage license, affix pink stickers to the lower right corner of the laboratory requisition form GDHR #3432 (Rev. 4/2000); and for EIA regardless of RPR result, mark confirmatory testing required section of GDHR #3432 (Rev. 4/2000).
SHIPMENT OF SPECIMENS
In order to expedite the testing of all of the blood samples, and to insure the integrity of the sample, all specimens should be sent to the Waycross Regional Laboratory on the day of collection.
1. Transport specimens using the doubled-walled mailing containers (aluminum can or biohazard bag and cardboard mailer provided by the Waycross Regional Laboratory) or package in a cardboard box using U. S. postal regulations.
2. Wrap each specimen with absorbent material to cushion it from breakage or in case of breakage, to absorb the leakage.
3. Place wrapped specimen in aluminum container or biohazard bag. 4. Wrap the requisition form around the aluminum container or place in pocket of
biohazard bag and place in either of the following: a. The outer cardboard mailer with the Waycross Regional Laboratory address.
Reinforce the metal cover of the can with tape around the circumferential seam. To aid the laboratory in removing the tape, please do not use reinforced tape. b. A cardboard box sealed with plastic tape with a Waycross Regional Laboratory label. Labels are available from Waycross Regional Laboratory (912) 285-6000. U.S. postal regulations allow up to 50 ml of blood to be transported in one package. 5. Transport specimen promptly to the laboratory. When mailing is delayed, refrigerate at 2-8o C pending transport. 6. Transport by U.S. mail, or courier.
NOTE: If U.S. mail is used, precautions should be taken that specimens are put in mail boxes that have a daily pick-up.
7. While refrigeration dur ing transport is not necessary, avoid exposure to extreme temperatures and avoid mailing over long weekends and holidays.
INTERPRETATION AND REPORTING OF RESULTS
Turn-around-time for a RPR/Premarital specimen is same day if received by 9:00 am, otherwise testing and reporting will be next business day. Arrangements may be made however, for "special request specimens," e.g. blood sample for premarital test, that are received after 9:00 am for same-day testing and reporting.
VI-32

Results will be reported as follows:

RPR

Nonreactive Reactive Titer Unsatisfactory

negative RPR test positive RPR test Endpoint (highest dilution giving a reactive result) Specimen was compromised in a way that might render the test results invalid. The reason for the unsatisfactory report will be indicated on each requisition form.

NOTE: All reactive RPR specimens will be confirmed by the EIA or FTA-ABS DS test unless the requisition form is marked "NO CONFIRMATORY TEST NEEDED." RPR test is performed on all specimens submitted for EIA and/or FTA.

CONFIRMATORY EIA

Nonreactive Equivocal
Reactive Unsatisfactory

Negative EIA (tested by FTA-ABS DS if greater than 1:16) +/- EIA (IF specimen if repeatedly equivocal, it will be tested by FTA-ABS DS) Positive EIA Specimen was compromised in a way that might render the test results invalid. The reason for the unsatisfactory report will be indicated on each requisition form.

FTA-ABS DS

Nonreactive Minimal Reactive Reactive Unsatisfactory

Negative FTA-ABS DS Weakly positive FTA-ABS DS (1+ fluorescence) Positive FTA-ABS DS (2+ - 4+ fluorescence) Specimen was compromised in a way that might render the test results invalid. The reason for the unsatisfactory report will be indicated on each requisition form.

NOTE: The FTA-ABS DS will be performed on all specimens when the EIA test results are equivocal, or the RPR results are reactive 1:16 or greater with a negative EIA.

RUBELLA

Immune Not Immune Unsatisfactory

Presence of Rubella antibodies at a 1:10 dilution of serum No Rubella antibodies detected at a 1:10 dilution of serum Specimen was compromised in a way that might render the test results invalid. The reason for the unsatisfactory report will be indicated on each requisition form.

VI-33

UNACCEPTABLE SPECIMENS The Waycross Regional Laboratory specimen acceptance policy requires that all specimens must be properly labeled with unique patient identifier (name) with matching identifier on requisition form, in acceptable testing condition, and accompanied by a completed requisition form. Failure to provide proper patient information may result in testing/reporting delays. Plasma is not approved for many procedures. Therefore, submit only venous blood without anticoagulants or serum. In order to expedite testing and to insure the integrity of the sample, all specimens should be sent to the Waycross Regional Laboratory on the day of collection. If kept refrigerated at 2-8o C until ready for transport, specimens can be tested satisfactorily for 14 days before the red blood cells lyse to the extent that tests cannot be accurately interpreted. The submitter will be notified of all specimens unacceptable for testing with the reason for the unsatisfactory report indicated on the requisition form. When possible, the unacceptable specimen will be held in the refrigerator for 14 days. At the end of 14 days the specimen will be discarded without further notification. Specimens will be reported "No Test Unsatisfactory for Testing" for the following reasons: 1. No patient identifier on specimen (first and last name must be legible); 2. Discrepancy between identifier on specimen and identifier on requisition form; 3. Insufficient quantity for testing; 4. Specimen broken or leaked in transit; 5. Specimen grossly hemolyzed, lipemic, turbid or contaminated; and 6. Plasma samples.
VI-34

WELL WATER TESTING
VI-35

VI-36

WELL WATER TESTING PROGRAM 912-285-6000
INTRODUCTION
The Waycross Regional Laboratory offers analysis for coliform bacteria/Escherichia coli (E. coli) in water from privately-owned wells. Coliform bacteria and E. coli serve as indicators of the bacterial contamination of water. Therefore, their presence or absence is often used to measure the safety of water supplies.
The Waycross Regional Laboratory is certified for microbiological analysis in drinking water by the Georgia Environmental Protection Division. The Waycross Regional Laboratory uses the Colilert reagent which provides a qualitative, presence-absence test for the simultaneous detection of total Coliform bacteria and E. coli in water samples. For samples that cannot be tested for total coliform/E. coli using the Colilert reagent, the Waycross Regional Laboratory uses an alternate method, the Presence/Absence Broth procedure.
SPECIMEN COLLECTION/LABELING/REQUISITION FORM
1. Samples are collected from privately-owned wells by the county health department environmentalists or by environmental health specialists.
2. The Laboratory will provide sterile sample bottles containing the appropriate amount of sodium thiosulfate for dechlorination. Do not discard the powder (thiosulfate) out of the sample bottle. The laboratory will provide the sample labels for the collection bottles, and the forms for the bacteriological analysis of water.
3. Samples should be collected from a tap free of aerators, strainers, hose attachments, water purifiers or other devices.
4. Samples should be aseptically collected after maintaining a steady flow, without splashing, from sampling tap for two to three minutes.
5. The bottle should be filled up to the fill line of 100-mL. Do not overfill: ample airspace (about one inch) should remain in the bottle.
6. All specimens must be accompanied by the bacteriological analysis of water form (requisition/report form). The upper portion of the form should be completed by the submitter. The bottle containing the specimen should also be labeled with matching information, including date and time of collection, and name of the person responsible for the collection. Use indelible ink to complete the sample information.
7. Specimen should be delivered to the laboratory preferably by 1:00 p.m. on the day of collection, Monday through Thursday. Do not deliver after 3:00 p.m., unless prior
VI-37

approval has been obtained from the laboratory manager. Samples will not be accepted by the laboratory on Friday.
8. To comply with State and Federal Regulations, the time from sample collection to initiation of analysis may not exceed 30 hours. Any specimen exceeding 30 hours at the time of delivery to the laboratory will be reported as UNSATISFACTORY.
SHIPMENT OF SPECIMENS
According to State and Federal Regulations, submitters of water samples for coliform analysis are encouraged but not required to hold samples below 10o C during transit to the laboratory. For hand delivered samples, an iced cooler can be used for this purpose. No refrigeration will be required for mailed samples. When arranging for a mail delivery, remember that the time from sample collection to initiation of analysis can not exceed 30 hours.
Hand Delivery
1. Place the water container inside the polyfoam box provided by the laboratory, and wrap the bacteriological analysis of water form around the outside.
2. Place the polyfoam box inside an iced cooler. This would assure that the temperature of the specimen is below 10o C during transit to the laboratory.
3. Transport specimen promptly to the laboratory. Keep in mind that the maximum time allowed between sample collection and initiation of analysis is 30 hours.
4. Deliver the specimens to the laboratory on the day of collection preferably before 1:00 p.m. and not later than 3:00 p.m.
5. Do not deliver specimens on Friday.
Mail/courier Delivery
1. No cooling of the specimen is required when using mail/courier delivery.
2. Place the water container inside the polyfoam box provided by the laboratory, and wrap the bacteriological analysis of water form around the outside.
3. Place the polyfoam box in the cardboard mailing sleeve provided by the laboratory, tape, and address for shipment.
4. Mail specimens Monday through Wednesday only. Delivery to the laboratory must be done not later than 3:00 p.m. (Monday Thursday) within 30 hours from the time of collection. No specimens will be accepted by the laboratory on Friday.
VI-38

REPORTING AND INTERPRETATION OF RESULTS

Water analysis is available Monday through Thursday. If possible, the analysis will be initiated the day of receipt. The Colilert test requires at least 24 hours (maximum 28 hours) for the availability of results. Results for the Presence/Absence Broth Procedure take longer (2-5 days). Results will be mailed to the submitter within one to four days after receipt in the laboratory. If the Presence/Absence Broth Procedure is used, results will be mailed within two to six days after receipt.

Results for the Colilert Presence/Absence test will be reported as follows:

Total Coliform ABSENT: Indicates no evidence of the presence of total coliforms.

Total Coliform PRESENT: Indicates evidence of the presence of total coliforms. All positive samples for total coliforms are checked for E. coli.

E. coli ABSENT:

Indicates that the positive total coliform specimen was Negative for the presence of E. coli.

E. coli PRESENT:

Indicates that the positive total coliform specimen was also Positive for the presence of E. coli.

For the Presence/Absence Broth procedure, total coliform and E. coli results are reported in the same manner as for the Colilert Presence/Absence method.

UNACCEPTABLE SPECIMENS

1. Specimens received without a completed bacteriological analysis of water form and/or without a sample label on the bottle containing the specimen.
2. Specimens for which the information on the bacteriological analysis of water form does not match the information on the sample label (bottle).
3. Samples collected more than 30 hours before they are received by the laboratory. 4. Samples in collection bottles other than the sterile bottles provided by the laboratory. 5. Samples delivered to the laboratory with a volume of less than 100-mL. 6. Samples delivered to the laboratory in cracked, broken or improperly sealed bottles. 7. Samples received by the laboratory on Friday. 8. Specimens which are not submitted by country health department environmentalists or
environmental health specialists. 9. Samples containing too much chlorine. This situation may occur after disinfection of the
well using bleach. The presence of elevated levels of chlorine suggests the need for longer time between chlorine disinfection and collection of the sample. 10. Samples containing too much sulfur and/or iron. In this case, the analysis time should be prearranged with the laboratory so that the Presence/Absence Broth procedure may be performed.

VI-39

VI-40

SECTION VII LIST OF SERVICES

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Abnormal Hemoglobin see Hemoglobin screen, Hemoglobin screen - newborns

Acanthamoeba

IV 85-87

Vitreous fluid

O

sterile vial/not provided/ Parasitology

X

CDC Form 50.34

Actinomycosis culture

IV 71-74

Pure culture

C

culture referral/0505/

Form 3410

Mycobacteriol- X ogy/Mycology

Actinomyces, thermophilic IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

serology (Farmer=s Lung)

CDC Form 50.34

Acute Respiratory Disease (ARD) See Respiratory Virus

Adenovirus serology

IV 55-64

Serum/blood6

E

serology/0500/

Immunology

X

CDC Form 50.34

Adenovirus culture

IV 103-106

Eye swab, throat C swab

viral culture/0575/ Form 3595R

Virology

X

Feces, urine

sterile container/not provided/Form 3595R

African trypanosomiasis IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

serology

CDC Form 50.34

African trypanosomiasis slide

IV 81-84

Thick blood

C

blood smear/0542/

smear

Form 3415

Parasitology

X

AIDS - see HIV

1See Explanation of Footnotes on page VII-36

VII- 1

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Amebiasis, intestinal

IV 77-80 (Dec.) Or VI 7-8 (W)

Feces

C,E

IP & PVA/0521/&

E.histolytica diluent

Form 3414

Amebiasis, extraintestinal, IV 55-64 serology

Serum/blood6

O

serology/0500/ CDC Form 50.34

Parasitology;

X

Regional Lab

Manager

Immunology

Anaerobic bacteria culture IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Anaerobic bacteria specimen
Anthrax7

IV 47-53 IV 47-53

Aspirates, tissues

C

sterile syringe or container Bacteriology

X

with an anaerobic

environment/not provided/

Form 3415

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Antimicrobial susceptibility, bacterial
Anti-streptococcal antibody, serology
Anti-streptococcal hyaluronidase (AHT) serology
Arbovirus serology

IV 47-53 IV 55-64 IV 55-64
IV 55-64

Pure culture

E

Serum/blood6

E

Serum/blood6

E

Serum/blood6

C

culture referral/0505/ CDC Form 50.34
serology/0500/ CDC Form 50.34
serology/0500/ CDC Form 50.34
serology/0500/ Form 3432

Bacteriology Immunology Immunology
Immunology

1See Explanation of Footnotes on page VII-36

VII- 2

W X
X X X X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Aseptic Meningitis - See Meningitis, viral

Aspergillosis serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Aspergillosis culture

IV 71-74

Culture

C

culture referral/0505/

Form 3410

Mycobacteriol- X ogy/Mycology

Atypical pneumonia - see Pneumonia, viral

Babesiosis

IV 81-84

Thin blood smear

C

blood smear/0542/

Form 3415

Parasitology

X

Bacterial culture for identification
Bacillus cereus

IV 47-53 IV 27-30 IV 47-53 IV 31-40

Pure culture

C

Feces

E

Pure culture

C

Food (outbreaks only)

E

culture referral /0505/ Form 3410
stool culture/0555/ Form 3416 culture referral/0505/ Form 3410 no outfit provided/ Form 3450

Bacteriology

X

Bacteriology

X

Bartonella (cat scratch

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

disease) serology

CDC form 50.34

Bartonella (cat scratch disease) culture
Bioterrorism Agents7

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

1See Explanation of Footnotes on page VII-36

VII- 3

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Blastocystis hominis

IV 77-80 (Dec) Or VII 7-8 (W)

Feces

C,E

IP & PVA/0520/

Form 3414

Blastomycosis serology

IV 55-64

Serum/blood6

O

Serology/0500/ CDC Form 50.34

Blastomycosis culture

IV 71-74

Culture

C

Culture referral/0505/

Form 3410

Blood Parasites

IV 81-84

Thick & thin

C

blood smears

blood smear/0542/ Form 3415

Blood Lead - See Lead Testing

Bordetella (B. pertussis, whopping cough) - See Pertussis

Borrelliosis (Borrelia spp.) IV 55-64

Serum/blood6

O

Botulism serology (Clostridium botulinum) Call Epidemiology, 404-6572588 in advance

IV 55-64

Serum/blood6

E

Serology/0500/ CDC Form 50.34
Serology/0500/ CDC Form 50.34

Parasitology

X

W

Immunology

X

Mycobacteriol- X ogy/Mycology

Parasitology

X

Immunology

X

Immunology

X

1See Explanation of Footnotes on page VII-36

VII- 4

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Botulism culture/toxin6

IV 47-53

Pure culture

C

Culture referral/0505/

Bacteriology

X

(Clostridium botulinum)

Form 3410

Call Epidemiology 404-657-

2588 in advance

IV 27-30

Feces-refrigerate E

sterile container/not

X

provided/CDC Form 50.34

IV 31-40

Food

E

no outfit provided/CDC

X

Form 50.34

Break-bone Fever - See Dengue Fever

Brucellosis culture (Brucella)7

IV 47-53

Pure culture

C

Culture referral/0505/

Form 3410

Bacteriology

X

C Disease - See Hemoglobin screen

California encephalitis serology

IV 55-64

Serum/blood6

C

Serology/0500/ Form 3432

Immunology

X

Campylobacter culture

IV 27-30

Pure culture

C

Culture referral/0505/

Form 3410

Bacteriology

X

IV 27-30

Feces

C

stool culture/0555/

Form 3416

IV 31-40

Food (outbreak E only)

no outfit provided/ Form 3450

Candidiasis serology

IV 55-64

Serum/blood6

O

Serology/0500

Immunology

X

(Candida albicans)

CDC Form 50.34

1See Explanation of Footnotes on page VII-36

VII- 5

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Candidiasis culture (Candida spp.)

IV 71-74

Cat scratch fever - See Bartonella

Chagas= disease serology (Trypanosoma cruzi)

IV 55-64

Chagas= disease slide

IV 81-84

Chancroid

IV 41-44 (Dec.) Or V 23-26 (A)

Chickenpox - See Varicella zoster

Chlamydia (LGV) serology IV 55-64

Pure culture
Serum/blood6 Thick and thin blood smears Smear
Serum/blood6

Chlamydia trachomatis DNA probe

IV 23-26 (Dec) or V 19-22 (A)

Swab: cervix, male urethra, conjunctiva

or VI 25-28 (W)

Cholera - See Vibrio cholerae

Clonorchiasis

IV 77-80 (Dec) Or VI 7-8 (W)

1See Explanation of Footnotes on page VII-36

Feces

C

Culture referral/0505/

Form 3410

O

Serology/0500/

CDC Form 50.34

C

blood smear/0542/

Form 3415

HD

slide/0545/Form 3415

C

Serology/0500/

Form 3432

O, D outfit available through STD Program/Form 3568

C

IP & PVA/0520/

Form 3414

VII- 6

Mycobacteriol- X ogy/Mycology

Immunology

Parasitology

X

Bacteriology;

X

Regional Lab

Manager

Immunology

X

Bacteriology;

X

Regional Lab

Manager

Parasitology;

X

Regional Lab

Manager

X A A,W W

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Clostridium botulinum - See Botulism

Clostridium perfringens

IV 47-53

Pure culture

C

Culture referral/0505

Form 3410

Bacteriology

X

IV 27-30

Feces

E

stool culture/0555

Form 3416

IV 31-40

Food (outbreak E only)

no outfit provided/ Form 3450

CMV - See Cytomegalovirus

Coccidioidomycosis

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

serology

CDC Form 50.34

Coccidioidomycosis culture

IV 71-74

Culture

C

culture referral/0505/

Form 3410

Mycobacteriol- X ogy/Mycology

Congenital adrenal hyperplasia (CAH) - See Metabolic diseases

Conjunctivitis, bacterial

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

IV 47-53

Eye swab

culturette/not provided/ Form 3415

Conjunctivitis, viral

IV 103-106

Eye swab

C

viral culture/0575/

Form 3595R

Virology

X

1See Explanation of Footnotes on page VII-36

VII- 7

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Coxsackievirus

IV 103-106

Throat swab, rectal swab
CSF8 feces

Cryptococcosis - See Fungus Infections

Cryptosporidium

IV 77-80 (Dec) or VI 7-8 (W)

Feces

C

viral culture/9575/

Form 3595R

sterile container/not provided/Form 3595R

C,E

IP & PVA/0520/

Form 3414

IV 85-87 (Dec) Water

Cyclospora cayetanensis

IV 77-80 (Dec) or Feces VI 7-8 (W)

E

Sterile container/not

provided/Form 3415

C,E

IP & PVA/0520/

Form 3414

Cysticercosis serology (Cysticercus cellulosae)

IV 55-64

Serum/blood6

O

Cytomegalic inclusion disease (CID) See Cytomegalovirus

Cytomegalovirus (CMV) serology

IV 55-64

Serum/blood6

C

Serology/0500/ CDC Form 50.34
serology/0500/ Form 3432

Virology

X

Parasitology;

X

Regional Lab

Manager

Parasitology

Parasitology;

X

Regional Lab

Manager

Immunology

W
W X

Immunology

X

1See Explanation of Footnotes on page VII-36

VII- 8

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Cytomegalovirus (CMV) IV 103-106

Urine, buffy

C

sterile container/not

Virology

X

coat,

provided/Form 3595R

bronchoalveolar

Lavage (BAL)

D disease - See Hemoglobin screen

Dengue fever serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Diarrhea, bacterial (Salmonella, Shigella, Campylobacter, Aeromonas, E. coli O157:H7, Vibrio, & Yersinia enterocolitica)

IV 27-30

Culture Feces

C - no charge for HD or Epi investi -gation

culture referral/0505/ Form 3410
stool culture/0555/ Form 3416

Bacteriology

X

Diarrhea, unknown etiology

IV 27-30 and IV 77-80 and IV 103-106

Feces

C - no charge for HD or Epi investi -gation

stool culture/0555 Form 3416 and IP & PVA/0520/ Form 3414 and sterile container/not provided/Form 3595R

Bacteriology

X

Parasitology

X

Virology

X

Diphtheria culture

IV 47-53 IV 47-53

Pure culture

C

Throat or nasopharyngeal swab

culture referral/0505/

Bacteriology

X

Form 3410

Loeffler=s slant or strep

outfit/0560/Form 3415

1See Explanation of Footnotes on page VII-36

VII- 9

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Dirofilariasis serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Dirofilariasis slide

IV 81-84

Thick and thin C blood smears

blood smear/0542/ Form 3415

Parasitology

X

Dysentery, amoebic - See Amebiasis, intestinal

E disease - See Hemoglobin screen

Eastern Equine encephalitis serology

IV 55-64

Serum/blood6

C

serology/0500/ Form 3432

Immunology

X

Echinococcosis serology IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

(Echinococcus granulosus)

CDC Form 50.34

Echovirus culture (serology not available)

IV 103-106

Throat swab,

C

rectal swab

viral culture/0575/ Form3595R

Virology

X

CSF8 feces

sterile container/not provided/Form 3595R

Ectoparasites

IV 85-87

Lice, mites, ticks, C fly larvae, etc.

in 70% alcohol/not provided/Form 3415

Parasitology

X

Ehrlichiosis serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Electrophoresis - See Sickle cell anemia

1See Explanation of Footnotes on page VII-36

VII- 10

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Encephalitis, viral culture IV 103-106

Encephalomyocarditis culture

IV 103-106

Endocarditis, bacterial culture
Entamoeba histolytica serology (amebiasis)

IV 47-53 IV 55-64

Throat swab,

C

rectal swab

CSF8 feces, CNS tissue

Throat swab,

C

rectal swab

CSF8 feces

Pure culture

C

Serum/blood6

O

viral culture/0575/ Form 3595R
sterile container/not provided/Form 3595R
viral culture/0575/ Form 3595R
sterile container/not provided/Form 3595R
culture referral/0505/ Form 3410
serology/0500/ CDC Form 50.34

Entamoeba histolytica (amebiasis)
Enterovirus culture

IV 77-80 (Dec) Or VI 7-8 (W)
IV 103-106

Feces
Throat swab, rectal swab CSF8 feces

C,E

IP & PVA/0521/

E.histolytica diluent

Form 3414

C

viral culture/0575/

Form 3595R

sterile container/not provided/Form 3595R

Virology

X

Virology

X

Bacteriology

X

Immunology

X

Parasitology;

X

W

Regional Lab

Manager

Virology

X

1See Explanation of Footnotes on page VII-36

VII- 11

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Epstein-Barr virus (EBV) Serology

IV 55-64

Erysipelothrix rhusiopathiae Culture
Escherichia coli (enterohemorrhagic) typing and shiga-like toxin (SLT) (O157:H7)

IV 47-53 IV 27-30 IV 27-30

Serum/blood5 Pure culture Pure culture Feces

C (x2) C

serology/0500/ Form 3432
culture referral/0505/ Form 3410

C

culture referral/0505/

Form 3410

C

Stool culture/0555/

Form 3416

Escherichia coli (Enterotoxigenic)

IV 31-40 IV 27-30

Food (outbreaks E only)

Feces

E

Culture

Farmer=s lung - See Actinomyces, thermophilic

No outfit provided/ Form 3450
Stool culture/0555/ Form 3416
culture referral/0505/ Form 3410

Immunology

X

Bacteriology

X

Bacteriology

X

Bacteriology

X

Fascioliasis (Fasciola spp.)

IV 77-80 (Dec) Or VI 7-8 (W)

Filariasis (Wucheereria bancrofti)

IV 81-84

1See Explanation of Footnotes on page VII-36

Feces
Thick blood smear

C,E

IP & PVA/0520/

Form 3414

C

blood smear/0542/

Form 3415

VII- 12

Parasitology;

X

W

Regional Lab

Manager

Parasitology

X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Fluorescent treponemal antibody (FTA-ABS) - See Syphilis, confirmation

Foodborne illness outbreak, bacterial: Bacillus cereus, Campylobacter, Clostridium botulinum, C. perfringens, E. coli O157:H7, Salmonella, Shigella, Staphylococcus aureus, S. aureus enterotoxin, & Vibrio spp.): Contact Environ- mental Health (404)657-6534 or Epidemiology (404)6572588.
Foodborne illness outbreak- parasitic: (Cryptosporidium, Cyclospora, Giardia, Entamoeba histolytica) contact Environmental Health (404)657-6534 or Epidemiology (404)6572588

IV 31-40 IV 27-30
IV 77-80

Food

E

Feces

Food (tested

E

only if organism

found in feces)

Feces

Foodborne illness outbreak IV 103-106

Feces

E

- viral

Francisella tularensis - See tularemia

no outfit provided/ Form 3450 stool culture/0555/ Form 3416
no outfit provided/ Form 3415
IP & PVA/0521/& E.histolytica diluten Form 3414
sterile container/not provided/Form 3595R

1See Explanation of Footnotes on page VII-36

VII- 13

Bacteriology

X

Parasitology

X

Virology

X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Fungus serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Fungi for identification/ confirmation (cultures)

IV 71-74

Culture

C

culture referral/0505/

Form 3410

Mycobacteriol- X ogy/Mycology

Fungus infections, culture IV 71-74

Culture

C

culture referral/0505/

Form 3410

Mycobacteriol- X ogy/Mycology

Fungus, superficial and cutaneous mycoses, culture

IV 71-74

Hair, skin, nail C scrapings

no outfit provided; fold in Mycobacteriol- X

paper/Form 3415

ogy/Mycology

Fungus sensitivity test (cultures)

IV 71-74

Culture

E

culture referral/0505/

Form 3410

Galactosemia - See Metabolic diseases

Gardnerella culture

IV 47-53

Giardiasis

IV 77-80 or VI 7-8 (W)
IV 85-87

Pure culture Feces Water

1See Explanation of Footnotes on page VII-36

C

culture referral/0505/

Form 3410

C,E

IP & PVA/0520/

Form 3414

E

Sterile container/not

provided/Form 3415

VII- 14

Mycobacteriology/Mycology

X (Ref. to Univ. of Texas)

Bacteriology

X

Parasitology;

X

W

Regional Lab

Manager

Parasitology

X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Gonorrhea culture

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Gonorrhea, antibiotic sensitivities

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Gonorrhea DNA Probe
Gonorrhea smear, male only

IV 23-26 (Dec) Swab: cervix,

O, D outfit available through

Bacteriology;

X

or

male urethral,

STD program, Form 3568 Regional Lab

V 19-22 (A)

conjunctiva

Manager

or

VI 25-28 (W)

IV 41-44 (Dec) Exudate smear O,D slide/0545/Form 3415 or V 23-26 (A) or VI 29-30 (W)

Bacteriology;

X

Regional Lab

Manager

Haemophilus ducreyi - See chancroid

Haemophilus influenzae, typing (types a-f)

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Hemoglobinopathy - See Hemoglobin screen

Hemoglobin screen, nonneonatal

VI 11-16

Heparinized

O

abnormal hemoglobin,

Regional Lab

blood

adult - sickle cell 1/0701/ Manager

Form 3563

Hemoglobin screen, newborns (Universal screening for hemoglobinopathies)

IV 3-11

Dried blood spot O

sickle cell disease

Newborn

X

test/0535/Form 3491

Screening

1See Explanation of Footnotes on page VII-36

VII- 15

A,W A, W
W

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Hepatitis A serology

IV 55-64

Serum/blood6

O

serology/0500/ Form 3432

Immunology

X

Hepatitis B serology

IV 55-64

Serum/blood6

HD

serology/0500/

Form 3432

Immunology

X

Hepatitis, delta, serology IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 53.2

Herpes simplex serology IV 55-64

Serum/blood6

C

serology/0500/ Form 3432

Immunology

X

Herpes simplex culture

IV 103-106

Lesion swab

C

viral culture/0575/ Form 3595R

Virology

X

Herpes zoster (shingles) - See Varicella zoster

Histoplasmosis serology - See Fungus serology

Histoplasmosis serology IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Histoplasmosis culture

IV 71-74

Culture

C

culture referral/0505/

Form 3410

Mycobacteriol- X ogy/Mycology

Homocystinuria - See Metabolic diseases

Human Immunodeficiency IV 91-94 Virus (HIV) serology

Serum/blood6

C

HIV/0515/Form 3605

Virology

X

(Use code #s, no names)

HIV 2 serology

IV 91-94

Serum/blood6

O

HIV/0515/

Virology

X

CDC Form 50.34

1See Explanation of Footnotes on page VII-36

VII- 16

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

HTLV I/II serology

IV 91-94

Serum/blood6

O

HIV/0515/ CDC Form 50.34

Virology

HIV-1 Viral Load (PCR)

IV 95-98

Plasma

O

HIV/0505Form 3605

Virology

X

(Use code #s, no names)

Hypothyroidism - See Metabolic diseases

Influenza serology

IV 55-64

Serum/blood6

E

serology/0500/ CDC Form 50.34

Immunology

Influenza culture

IV 103-106

Throat swab

C

viral culture/0575/ Form 3595R

Virology

X

Intestinal parasites available to public health departments, or for confirmation only from other health care providers

IV 77-80 (Dec) Or VI 7-8 (W)

Feces

C,E

IP & PVA/0520/

Form 3414

Parasitology;

X

Regional Lab

Manager

Lead testing

V 5-10

Legionnaires disease serology

IV 55-64

Whole blood (EDTA)
Serum/blood6

HD & outfit components special provided/Lead/Form 3593 cases

O

serology/0500/

CDC Form 50.34

Regional Lab Manager
Immunology

Legionnaires disease culture

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

X
X W A
X

1See Explanation of Footnotes on page VII-36

VII- 17

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Legionnaires disease,

IV 47-53

E

environmental sample

Bacteriology

X

Leishmaniasis, cutaneous IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

or visceral, serology

CDC Form 50.34

Leishmaniasis, cutaneous IV 81-84 or visceral

Tissue smear

C

blood smear/0542/ Form 3415

Parasitology

X

Leptospira serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Leptospira culture

IV 47-53

Ellenhausen=s

C

media inoculated

with blood/urine

Ellenhausen=s

Bacteriology

X

medium/available from

testing lab/Form 3410

Listeria monocytogenes

IV 47-53

typing/subtyping by PFGE

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Lyme disease serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

(Borrelia burgdorferi)

CDC Form 50.34

Lymphocytic chorio-

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

meningitis (LCM) serology

CDC Form 50.34

Lymphogranuloma venereum (LGV) serology

IV 55-64

Serum/blood6

C

serology/0500/ Form 3432

Immunology

X

Malaria serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

1See Explanation of Footnotes on page VII-36

VII- 18

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Malaria slide

IV 81-84

Thick and thin C blood smears

blood smear/0542/ Form 3415

Parasitology

X

Maple syrup urine disease (MSUD) See Metabolic diseases

Measles serology

IV 55-64

Serum/blood6

C

serology/0500/Form 3432 Immunology

X

Melioidosis serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

(Burkholderia

CDC Form 50.34

pseudomallei)

Melioidosis culture (B. pseudomallei)

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Meningitis, bacterial, culture

IV 47-53

Meningitis, viral, serology IV 55-64

Pure culture

C

CSF8 blood

Serum/blood6

C

culture referral/0505/ Form 3410 sterile container/not provided/Form 3415

Bacteriology

X

serology/0500/Form 3432 Immunology

X

Meningitis, viral, culture IV 103-106

Throat swab,

C

rectal swab

viral culture/0575 Form 3595R

Virology

X

CSF8 feces

sterile container/not provided/Form 3595R

Meningoencephalitis,

IV 55-64

CSF8

O

serology/0500/

Immunology

X

amoebic, serology

CDC Form 50.34

1See Explanation of Footnotes on page VII-36

VII- 19

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Metabolic diseases, newborn genetic screening (Congenital adrenal hyperplasia, galactosemia,homocystinur ia, hypothyroidism, maple syrup urine disease, phenylketonuria, tyrosinemia)

IV 3-11

Microsporidia spp.

IV 77-80

Microfilaria

IV 81-84

Mites

IV 85-87

Mumps serology Mumps culture

IV 55-64 IV 103-106

Murine typhus serology IV 55-64

Dried blood spot O

metabolic disease

Newborn

X

test/0535/Form 3491

Screening

Feces

O

IP & PVA/0520/

Form 3414

Parasitology

X

Thick blood

C

blood smear/0542/

smear

Form 3415

Parasitology

X

Mite

C,E

70% alcohol/not

Parasitology

X

provided/Form 3415

Serum/blood6

C

serology/0500/Form 3432 Immunology

X

Throat swab

C

Serum/blood6

C

viral culture/0575/ Form 3595R

Virology

X

serology/0500/Form 3432 Immunology

X

1See Explanation of Footnotes on page VII-36

VII- 20

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Mycobacteria cultures for identification (Drugsensitivity testing will be done automatically when M.tuberculosis is isolated for the first time.)
Mycobacteria cultures for drug susceptibility test

IV 67-70 IV 67-70

Mycobacterial diseases [Mycobacterium spp. (tuberculosis & others)]. Drug-sensitivity testing done on first isolate from a patient.

IV 67-70

Mycoplasma pneumonia serology
Myocarditis, viral culture

IV 55-64 IV 103-106

Neisseria meningitidis grouping

IV 47-53

1See Explanation of Footnotes on page VII-36

Pure culture or C AFB positive MGIT tubes

TB culture identification/0585/ Form 3412 (rev. 7/99)

Mycobacteriol- X ogy/Mycology

Pure culture

C

Sputum, gastric C washings, urine, body fluids, exudates, bronchial washings, tissue samples

Serum/blood6

C

Throat swab,

C

rectal swab

Feces, tissue

Pure culture

O

TB culture identifi-

Mycobacteriol- X

cation/0585/Form 3412 (rev. ogy/Mycology

7/99)

sputum/0550/Form 3412 (rev. 7/99)

Mycobacteriol- X ogy/Mycology

serology/0500/ Form 3432
viral culture/0575/ Form 3595R
sterile container/not provided/Form 3595R
culture referral/0505/ Form 3410

Immunology

X

Virology

X

Bacteriology

X

VII- 21

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Nocardiosis culture (Nocardia spp.)

IV 71-74

Norwalk, Norwalk-like virus IV 103-106

Culture Feces

Newborn metabolic disease screen - See Metabolic diseases

Paragonimiasis serology (Paragonimus spp.)

IV 55-64

Serum/blood6

Paragonimiasis (Paragonimus westermani)
Parainfluenza serology

IV 77-80 (Dec) Or VI 7-8 (W)
IV 55-64

Feces Serum/blood6

Parainfluenza culture Parasites, serology

IV 103-106 IV 55-64

Throat swab Serum/blood6

C

culture referral/0505/

Form 3410

C - no charge for HD or Epi investigation

sterile container/not provided/Form 3595R

O

serology/0500/

CDC Form 50.34

C,E

IP & PVA/0520/

Form 3414

E

serology/0500/

CDC Form 50.34

C

viral culture/0575/

Form 3595R

O

serology/0500/

CDC Form 50.34

Mycobacteriol- X ogy/Mycology

Virology

X

Immunology

Parasitology;

X

Regional Lab

Manager

Immunology

Virology

X

Immunology

X W
X
X

1See Explanation of Footnotes on page VII-36

VII- 22

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Parasites, intestinal (helminths & protozoa)

IV 77-80 (Dec) Or VI 7-8 (W)

Feces

C,E

IP & PVA/0520/

Form 3414

Parasitology;

X

W

Regional Lab

Manager

Parvovirus B-19

IV 55-64

Serum/blood6

C

serology/0500/ Form 3432

Immunology

X

Pertussis, smears for FA (Bordetella pertussis & B. parapertussis)

IV 19-22

Nasopharyngeal C (NP) smear

pertussis slide/0525/ Form 3415

Bacteriology

X

Pertussis culture(B.pertussis & B.parapertussis), ID, antibiotic susceptibility, and typing (PFGE)

IV 19-22

Culture

C - no RL transport medium or RL Bacteriology

X

charge plates available from

NP swab in

for HD testing lab/Form 3410

Regan-Lowe

or Epi

(RL) transport in-

medium

vesti-

gation

Phenylketonuria (PKU) - See Metabolic diseases

Pinworm

IV 77-80 (Dec) Or VI 9-10 (W)

Tape slide

C,E

pinworm/0520/Form 3414 Parasitology;

X

W

Regional Lab

Manager

Pneumocystis carinii

IV 81-84

Tissue smear,

C

bronchoalveolar

lavage (BAL)

blood smear/0542/ Form 3415

Parasitology

X

1See Explanation of Footnotes on page VII-36

VII- 23

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Penumonia, bacterial, culture

IV 47-53

Pneumonia, viral culture

IV 103-106

Poliomyelitis (Polio) culture IV 103-106

Pure culture

C

Pleural or bronchial fluid, sputum, bronchial washing

Throat swab

C

Tissue

Throat swab,

C

rectal swab

CSF8 feces

culture referral/0505/ Form 3410

Bacteriology

X

sterile vial/not provided/ Form 3415

viral culture/0575/ Form 3595R

Virology

X

sterile container/not provided/Form 3595R

viral culture/0575/ Form 3595R

Virology

X

sterile container/not provided/Form 3595R

Premarital serology (include rubella for females)
Psittacosis serology

IV 55-64 (Dec) Serum/blood6

O

or V 27-30 (A)

or VI 31-34 (W)

IV 55-64

Serum/blood6

E

syphilis/rubella/0500/ Form 3432
serology/0500/ CDC Form 50.34

Immunology

X

A,W

Immunology

X

1See Explanation of Footnotes on page VII-36

VII- 24

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

PVA-preserved fecal specimens
Q fever serology Quality Control Cultures, Bacterial or Fungal
Rabies

IV 77-80 (Dec) Or VI 7-8 (W)
IV 55-64
IV 47-53 Or IV 71-74
IV 99-102 or V 11-15 or VI 17-21

Feces

C

Serum/blood6

C

C

Animal heal or

O

brain, whole bat

Rapid plasma reagin (RPR) See Syphilis serology

Rat-bite fever culture (Spirillum minor, Streptoacillus moniliformis)

IV 47-53

Pure culture

C

Respiratory syncytial virus IV 55-64 (RSV) serology

Serum/blood6

E

Respiratory syncytial virus (RSV) antigen detection
Respiratory virus serology

IV 103-106 IV 55-64

Nasopharyngeal C

swab

Serum/blood6

C

IP & PVA/0520/ Form 3414

Parasitology;

X

Regional Lab

Manager

serology/0500/Form 3432 Immunology

X

Bacteriology,

X

Mycobacteriol-

ogy/Mycology

rabies/Form 3062

Virology/

X

Regional Lab

Manager/

Epidemiology

culture referral/0505/ Form 3410
serology/0500/ CDC Form 50.34
viral culture/0575/ Form 3595R serology/0500/ CDC Form 50.34

Bacteriology

X

Immunology

Virology

X

Immunology

1See Explanation of Footnotes on page VII-36

VII- 25

W A,W
X X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Respiratory virus culture IV 103-106

Rocky Mountain spotted fever serology (Rickettsialpox)

IV 55-64

Throat swab

C

Nasopharyngeal washing

Serum/blood6

C

viral culture/0575 Form 3595R
sterile container/not provided/Form 3595R
serology/0500/ Form 3432

Rotavirus detection

IV 103-106

Feces

RPR (Rapid plasma reagin) - See Syphilis serology

Rubella, premarital - see Premarital serology

Rubella, diagnostic

IV 55-64

Serum/blood6

Rubeola - See Measles

S disease - See Hemoglobin screen

Saint Louis encephalitis serology

IV 55-64

1See Explanation of Footnotes on page VII-36

Serum/blood6

C - no charge for HD or Epi investi -gation

sterile container/not provided/Form 3595R

C

serology/0500/

Form 3432

C

serology/0500/

Form 3432

VII- 26

Virology

X

Immunology

X

Virology

X

Immunology

X

Immunology

X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Salmonella serotyping and IV 27-30 subtyping (PFGE)

Salmonellosis culture (Salmonella)

IV 27-30

IV 31-40

Schistosomiasis serology (Schistosoma spp.)

IV 55-64

Pure culture

O

Feces

C

Food (outbreak E only)

Serum/blood6

O

culture referral/505/ Form 3410
stool culture/0505/ Form 3416
no outfit provided/ Form 3450
serology/0500/ CDC Form 50.34

Schistosomiasis (Schistosoma haematobium, manson, japonicum, mekongi)
Septicemia culture

IV 77-80 (Dec) Or VI 7-8 (W)

Feces

IV 47-53

Pure culture

Shigella serotyping and subtyping (PFGE)

IV 27-30

Pure culture

C,E

IP & PVA/0520/

Form 3414

C

culture referral/0505/

Form 3410

C

culture referral/0505/

Form 3410

Shigellosis culture (Shigella)

IV 27-30 IV 31-40

1See Explanation of Footnotes on page VII-36

Feces

C

Food (outbreak E only)

stool culture/0555/ Form 3416
no outfit provided/ Form 3450

VII- 27

Bacteriology

X

Bacteriology

X

Immunology

X

Parasitology;

X

W

Regional Lab

Manager

Bacteriology

X

Bacteriology

X

Bacteriology

X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Shingles - See Varicella zoster

Sickle cell anemia, adult - See Hemoglobin Screen, non-neonatal

Sickle cell anemia, newborn - See Hemoglobin Screen, newborn

Spirillum minor - See Rat-bite Fever

Sporotrichosis - See sporotrichosis FA examination and serology, and Fungus infections culture

Sporotrichosis serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

Sporotrichosis FA

IV 71-74

Tissue sections O

Sterile container/not

Mycobacteriol-

X

examination (Sporothrix

provided/CDC Form 50.34 ogy/Mycology

schenckii)

Slides

slide/0545/CDC Form 50.34

Staphylococcus aureus

IV 47-53

Pure culture

C

Culture referral/0505/

Form 3410

Bacteriology

X

IV 47-53

Swab from

C

infected area

culturette/not provided/ Form 3415

IV 27-30

Feces

E

stool culture/0555/

Form 3416

IV 31-40

Food (outbreak D only)

no outfit provided/ Form 3450

1See Explanation of Footnotes on page VII-36

VII- 28

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Staphylococcus aureus enterotoxin

IV 31-40

Food

E

no outfit provided/

Form 3450

Bacteriology

X

Staphylococcus aureus typing/MRSA (PFGE)

IV 47-53

Pure culture

E

culture referral/0505/

Form 3410

Bacteriology

X

Streptobacillus moniliformis See Rat-bite fever

Streptococcus Group A

IV 47-53

Pure culture

C

IV 45-46

Throat swab, ear

swab

B

culture referral/0505/

Bacteriology

X

Form 3410

Streptococcus

culture/0560/Form 3418

Streptococcus, Group B

IV 47-53

Vaginal/ano-

E

rectal swab(s)

CDC, MMWR

1996; 45, (No.RR-

7)

Streptococcus

Bacteriology

X

culture/0560/Form 3418

Streptococcus grouping, beta

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

Streptococcus typing, beta IV 47-53

Pure culture

E

culture referral/0505/

Bacteriology

X

(Groups A & B)

CDC Form 50.34

Streptococcus pneumoniae IV 47-53

Pure culture

E

culture referral/0505/

Bacteriology

X

typing

CDC Form 50.34

Strongyloides serology

IV 55-64

Serum/blood6

O

serology/0500/

Immunology

X

CDC Form 50.34

1See Explanation of Footnotes on page VII-36

VII- 29

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Strongyloides
Subacute sclerosing panencephalitis (SSPE) serology (Measles complication) Syphilis serology screening
Syphilis serology confirmation
Syphilis serology confirmation for IgM (infants only) and CSF

IV 77-80 (Dec) Or VI 7-8 (W)

Feces

C,E

IP & PVA/0520/

Form 3414

IV 55-64

Both serum or O blood6and CSF8

serology/0500/ CDC Form 50.34

IV 55-64 (Dec) Serum/blood6

A

or V 27-30 (A)

or VI 31-34 (W)

IV 55-64 (Dec) Serum/blood6

B

or V 27-30 (A)

or VI 31-34 (W)

IV 55-64

Serum (IgM) or O CSF8

syphilis/rubella/0500/ Form 3432
syphilis/rubella/0500/ Form 3432
serology/0500/ CDC Form 50.34

Parasitology;

X

Regional Lab

Manager

Immunology

Immunology;

X

Regional Lab

Managers

Immunology;

X

Regional Lab

Managers

Immunology

T4, newborn
Thyroid stimulating hormone (TSH)

IV 3-11 IV 3-11

Dried blood spot O

metabolic screening/0535/ Newborn

X

Form 3491

Screening

Dried blood spot O

metabolic screening/0535/ Newborn

X

Form 3491

Screening

W X
A,W A,W
X

1See Explanation of Footnotes on page VII-36

VII- 30

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

ToRCH serology (toxo-plasmosis, rubella, cyto-megalovirus, herpes simplex virus)
Toxocariasis serology (Toxocara spp.)

IV 55-64 IV 55-64

Serum/blood6

C

Serum/blood6

O

Toxocariasis (Toxocara

IV 77-80 (Dec) Feces

C

spp.)

Or

VI 7-8 (W)

Toxoplasmosis serology (Toxoplasma gondii)

IV 55-64

Serum/blood6

C

serology/0500/ Form 3432
serology/0500/ CDC Form 50.34 IP & PVA/0520/ Form 3414
serology/0500/ Form 3432

Immunology

X

Immunology

Parasitology;

X

Regional Lab

Manager

Immunology

X

X W

Trichomonads

IV 41-44 (Dec) Or V 23-25 (A)

Slide

HD

slide/0545/

Form 3415

Trypanosomiasis (Chagas= disease)

IV 55-64

Serum/blood6

O

serology/0500/ CDC Form 50.34

TSH - See thyroid stimulating hormone

Tuberculosis and other Mycobacterial diseases See Mycobacterial diseases

Tularemia culture7 (Francisella tularensis)

IV 47-53

Pure culture

C

culture referral/0505/ Form 3410

1See Explanation of Footnotes on page VII-36

VII- 31

Bacteriology;

X

Regional Lab

Manager

Immunology

A,W X

Bacteriology

X

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Tularemia FA7 (Francisella tularensis)
Typhoid Fever culture (Salmonella ser. Typhi)

IV 47-53 IV 27-30

Tissue

O

Pure culture

O

Feces

O

Blood

O

Typhus - See Murine typhus

Tyrosinemia - See Metabolic diseases

Undulant fever - See Brucellosis

Upper respiratory infection (URI) See Respiratory virus

Vancomycin-Resistant Enterococci (VRE),

IV 47-53

Pure culture

E

Confirmation & typing (PFGE)

Varicella zoster serology (Chickenpox)

IV 55-64

Serum/blood6

C

sterile container/not

Bacteriology

X

provided/CDC Form 50.34

culture referral/0505/ Form 3410

Bacteriology

X

stool culture/0555/ Form 3416

sterile tube/not provided/ Form 3415

culture referral/0505/ Form 3410

Bacteriology

X

serology/0500/ Form 3432

Immunology

X

1See Explanation of Footnotes on page VII-36

VII- 32

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Varicella zoster (Chickenpox) culture

IV 103-106

Lesion swab

C

viral culture/0575/ Form 3595R

Virology

X

Vesicle fluid

sterile container or syringe/not provided/ Form 3595R

VDRL serology

IV 55-64

CSF8only (must A be clear)

sterile tube/not provided/ Immunology

X

Form 3432

Venezuelan encephalitis

IV 55-64

Serum/blood6

O

Serology/0500/

Immunology

X

serology

CDC Form 50.34

Vibrio spp.

IV 27-30 IV 27-30 IV 31-40

Vibrio cholerae confirmation and typing

IV 27-30

Vibrio parahaemolyticus confirmation and typing

IV 27-30

Viral Meningitis See Meningitis, viral

Viral pneumonia See Pneumonia, viral

Pure culture

C

Feces

C

Food (outbreaks E only)

Pure culture

C

Pure culture

C

culture referral/0505/ Form 3410 stool culture/0555/ Form 3416 no outfit provided/ Form 3450
culture referral/0505/ Form 3410
culture referral/0505/ Form 3410

Bacteriology

X

Bacteriology

X

Bacteriology

X

1See Explanation of Footnotes on page VII-36

VII- 33

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Viral serology (specific virus must be indicated): cytomegalovirus, herpes virus, mumps, parvovirus, rubeola, rubella, varicella zoster

IV 55-64

Viral culture (must specify IV 103-106 virus suspected)

Visceral larva migrans serology Well Water testing
Western Equine encephalitis serology West Nile Virus serology

IV 55-64
V 31-35 (A) or VI 35-39 (W) IV 55-64
IV 55-64

Whooping cough see Pertussis

Serum/blood6
Throat swab, lesion swab, rectal swab CSF8 urine, blood, feces, tissue Serum/blood6
Well water
Serum/blood6
Serum/blood6 CSF8

C for 4 serology/0500/ tests Form 3432

C

viral culture/0575/

Form 3595R

sterile container/not provided/Form 3595R

O

serology/0500/

CDC Form 50.34

HD

outfit 3W

C

serology/0500/

Form 3432

C

serology/0500/

Form 3432

Immunology

X

Virology

X

Immunology

Regional Lab Managers

Immunology

X

Immunology

X

X A,W

1See Explanation of Footnotes on page VII-36

VII- 34

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Worm identification

IV 85-87 (Dec) Or VI 7-8 (W)

Worms or segments

C,E

bottle containing 70%

Parasitology;

X

W

alcohol/not provided/

Regional Lab

Form 3414

Manager

Wound infection

IV 47-53

Wound infection (surface)

Wound infection (deep)

Pure culture

C

culture referral/0505/

Bacteriology

X

Form 3410

Swab

culturette (aerobic)/not

provided/Form 3415

Aspirate

sterile syringe (anaerobic

environment)/not

provided/Form 3415

1See Explanation of Footnotes on page VII-36

VII- 35

Disease/agent Suspected or Test Required1

Related Techni-
cal Section(s) of Manual2,3

Specimen Needed

Fee Code4

Submission Outfit Name/ Order Number/ Form Number

Laboratory Unit to Contact

Lab Performing Test

Decatu Reg.3 r

CDC5

Yersinia serology

IV 55-64

Serum/blood6

E

seology/0500/

Immunology

X

CDC Form 50.34

Yersinia enterocolitica culture &/or typing (O:3, O:5, O:8, O:9)

IV 27-30

Pure culture

C

culture referral/0505/

Form 3410

Feces

stool culture/0555/

Form 3416

Bacteriology

X

Yersinia pestis culture7

IV 47-53

Pure culture

C

culture referral/0505/

Form 3410

Bacteriology

X

1See technical section of respective laboratory or units for further information on each disease or agent listed. 2If the testing is performed in more than one of the Public Health Laboratories, refer to the related section under the laboratory you use. 3Regional Laboratories (Lab performing the test): A = Albany; W = Waycross. 4Codes: A - $1.00; B - $4.00; C - $8.00; D - Selected users only; telephone lab unit indicated; E - Pre-arrangements required, telephone lab unit indicated; HD test available through local health department only, no charge; O No fee charged by GPHL 5All specimens designated for testing at CDC must first come through the GPHL (Decatur, Albany, or Waycross Lab). 62-5ml blood or 1ml serum (minimum). 7If a bioterrorist threat is suspected, see Section III on ABioterrorism@ for protocol to follow. 8Cerebrospinal Fluid
VII- 36

APPENDICES

APPENDIX A GUIDELINES FOR TRANSPORT OF SPECIMENS
UNITED STATES POSTAL SERVICE FEDERAL EXPRESS
INTERNATIONAL AIR TRANSPORT ASSOCIATION
A-1

A-2

USPS Packaging Instruction 6B
Infectious Substances (Etiologic Agents)
Infectious substances (etiologic agents) in Division 6.2 that are known or reasonably believed to contain an etiologic agent are mailable only when all applicable requirements in 346 and DMM C023.8.0 are met.
Proper Shipping Name and ID Number
_ Infectious Substances Affecting Animals, UN2900 _ Infectious Substances Affecting Humans, UN2814
Mailability
_ International Mail: Only as permitted in 622.2 and IMM 135 when written approval has been granted prior to mailing. _ Domestic Mail: Only via Express Mail, Priority Mail, or First-Class Mail service. Etiologic agents listed in 42 CFR 72.3(f) must be sent registered mail service.
Required Packaging
Separate conditions apply to domestic mail and international mail as noted. For Domestic Mail: Primary Receptacle _ The primary receptacle must be a securely sealed and watertight container (i.e., test tube, vial). _ The primary receptacle (or the secondary packaging) must be capable of withstanding, without leakage, an internal pressure that produces a pressure differential of not less than 14 psi (95 kPa) and a temperature in the range of 40 _ F to 131 _ F (40 _ C to 55 _ C) as required by 49 CFR 173.196. _ Multiple primary receptacles are permitted provided the total liquid volume of the infectious substance in all enclosed primary receptacles does not exceed 50 ml (1.66 ounces) per mailpiece. Cushioning and Absorbent Material _ Enough cushioning material must surround the primary receptacle to absorb shocks and prevent breakage. _ The space between the primary receptacle(s) and the secondary packaging at the top, bottom, and sides must contain enough material to absorb the entire contents of the primary receptacle(s) in case of breakage or leakage. Secondary Packaging _ The secondary packaging must be constructed of a durable and watertight material and have a secure sealing method.
A-3

_ The secondary packaging must be capable of withstanding, without leakage, an internal pressure that produces a differential of not less than 14 psi (95 kPa) and a temperature in the range of 40 _ F to 131 _ F (40 _ C to 55 _ C), as required by 49 CFR 173.196. Outer Packaging _ Proper UN specification packaging must be used. _ The primary receptacle(s) and the secondary packaging must be enclosed in a strong outer packaging constructed of fiberboard or other equivalent material. _ No external surface of the outer packaging may be less than 3.9 inches wide (100 mm) as required by 49 CFR 173.196. _ Each mailpiece must be designed and constructed so that, if it were subject to the environmental and test conditions in 49 CFR 178.609, there would be no release of the contents to the environment and no significant reduction in the effectiveness of the packaging. Marking _ The address side of the mailpiece must bear the "Etiologic Agents/Biohazard Material" label required by 42 CFR 73.2(d) (see Exhibit 346.42a). _ Each mailpiece must bear a DOT Hazard Class 6 warning label for infectious substances (see Exhibit 325b.) _ Each mailpiece must be clearly marked on the address side with the proper shipping name and UN number, which is "Infectious Substances Affecting Animals, UN2900" or "Infectious Substances Affecting Humans, UN2814," as applicable. _ Orientation markings (see Exhibit 226) that properly indicate the upright position of the primary receptacle(s) must be displayed on two opposite outer side walls of the mailpiece. _ Each mailpiece must bear a complete return address and delivery address. Documentation _ Each mailable material must have a properly completed shipper's declaration for dangerous goods that is prepared in triplicate and affixed to the outside of the mailpiece. For International Mail: _ The requirements specified in 622.2 and IMM 135 apply in addition to the packaging instructions for domestic mail. Note: Articles that include dry ice as a refrigerant for the infectious substance must meet the requirements of 42 CFR 72.3(c) and 49 CFR 173.196(e)(2)(ii). Additionally, the dry ice must be placed outside the secondary container -- it must never be placed inside a sealed container. When dry ice is placed between the secondary container and the outer shipping container, the shock-absorbent material must be placed in such a way that the secondary container does not become loose inside the outer container as the dry ice dissipates.
A-4

USPS Packaging Instruction 6C
Clinical (Diagnostic) Specimens and Biological Products
A clinical specimen (e.g., a urine or blood specimen used in drug-testing programs or for insurance purposes) or a biological product (e.g., polio vaccine) that is not known or not reasonably believed to contain an infectious substance (etiologic agent) is mailable, provided all applicable requirements in 346 and DMM C023.8.0 are met.
Proper Shipping Name and ID Number
_ Not applicable (not regulated under 49 CFR as a hazardous material in domestic commerce).
Mailability
_ International Mail: Only as permitted in 622.2 and IMM 135 when written approval has been granted prior to mailing. Prepare using Packaging Instruction 6B. _ Domestic Mail: Permitted only via Express Mail, Priority Mail, or First-Class Mail service.
Required Packaging
As noted, separate conditions apply based on the quantity. For Specimens Not Exceeding 50 ml (1.66 ounces) per Mailpiece: Primary Receptacle _ The specimen material must be packaged in a durable and securely sealed primary receptacle. Absorbent and Cushioning Material _ Absorbent material must surround the primary receptacle or be otherwise configured to take up all of the liquid content in the primary receptacle in case of leakage. _ Sufficient cushioning material to withstand shock and pressure changes must surround the primary receptacle. Secondary Packaging _ The primary receptacle and the absorbent cushioning must be enclosed in a secondary packaging that has a leakproof barrier capable of preventing the failure of the secondary packaging should there be leakage from the primary receptacle. _ The secondary packaging may serve as the outer packaging. Marking _ The address side of the mailpiece must be clearly marked "Clinical Specimen, Blood Sample," "Clinical Specimen, Urine Sample," "Clinical Specimen, Saliva Sample," "Biological Product," etc., as applicable.
A-5

_ The universal biohazard symbol may appear on the address side of the mailpiece (see Exhibit 346.42c). _ A complete return address and delivery address must be used. For Specimens Exceeding 50 ml (1.66 ounces) per Mailpiece: Primary Receptacle _ The specimen material must be packaged in a durable and securely sealed primary receptacle. _ A single primary receptacle must not contain more than 1,000 ml of a specimen. Multiple primary receptacles are permitted provided a single mailpiece does not contain more than 4,000 ml. Absorbent and Cushioning Material _ Absorbent material must surround the primary receptacle or be otherwise configured to take up all of the liquid content in the primary receptacle in case of leakage. _ Sufficient cushioning material to withstand shock and pressure changes must surround the primary receptacle. Secondary Packaging _ The secondary packaging must have a leakproof barrier capable of preventing the failure of the secondary packaging should there be leakage from the primary receptacle. _ The primary receptacle(s) and the absorbent cushioning must be enclosed in the secondary packaging. _ The secondary packaging cannot serve as the outer packaging. Outer Packaging _ The outer packaging must be a fiberboard box or a container of equivalent strength. _ The primary receptacle(s), the absorbent cushioning, and the secondary packaging must be enclosed in the outer packaging. _ A single outer packaging must not contain more than 4,000 ml of the specimen material. Marking _ The address side of the mailpiece must be clearly marked "Clinical Specimen, Blood Sample," "Clinical Specimen, Urine Sample," "Clinical Specimen, Saliva Sample," "Biological Product," etc., as applicable. _ The universal biohazard symbol may appear on the address side of the mailpiece (see Exhibit 346.42c). _ A complete return address and delivery address must be used. Note: A shipper's declaration for dangerous goods is not required for clinical specimens and biological products that do not contain infectious substances. A clinical specimen or biological product known or reasonably believed to contain an infectious substance (etiologic agent) must be packaged as an infectious substance using Packaging Instruction 6B.
A-6

Service Information

FEDERAL EXPRESS

Dangerous Goods All packages containing Dangerous Goods must be limited to the materials and quantities authorized for air transportation according to the current edition of the International Air Transport Association ("IATA") Dangerous Goods Regulations, except as noted in paragraph (D) below. You must comply with these regulations regardless of the routing or the mode by which the package is transported within our integrated system. Each shipment must be accompanied by a minimum of two copies of a properly executed Shipper's Declaration for Dangerous Goods, when required in accordance with the regulations.

Shipper must provide all required information and complete all boxes pertaining to Dangerous Goods on the FedEx airbill. Dangerous Goods packages that cannot accommodate all of the required FedEx and regulatory documentation as well as all required regulatory markings and labeling on the top or sides of the outer package will not be accepted for carriage. Required documentation, marking and labeling will not be permitted on the bottom of the package. Exception: Package specification markings are acceptable on the bottom of the package. Dangerous Goods cannot be shipped on an Express Manifest.

Accessible Dangerous Goods shipments may only be shipped using FedEx Priority Overnight or FedEx 1Day Freight. Inaccessible Dangerous Goods shipments may be shipped using FedEx Priority Overnight, FedEx Standard Overnight, FedEx 2Day, FedEx Express Saver, FedEx 1Day Freight, FedEx 2Day Freight and FedEx 3Day Freight. The shipper should contact Customer Service at 1800GoFedEx (800-463-3339) if they need assistance in determining whether their Dangerous Goods are accessible or inaccessible.

Dangerous Goods Service is not available for FedEx SameDay or when using FedEx Stamps. Except for dry ice, Dangerous Goods other than dry ice are not acceptable for transportation via FedEx First Overnight.

Dangerous goods may not be shipped in any FedEx packaging.

Dangerous goods shipments are not accepted at every FedEx location. For specific locations, call Customer Service at 1800GoFedEx (800-463-3339) or see the FedEx Worldwide Directory. Dangerous goods shipments are not accepted at FedEx Drop Boxes or unstaffed FedEx locations.

All Dangerous Goods shipments must be prepared in accordance with IATA regulations. FedEx Express does not offer a ground service and we do not accept Dangerous Goods shipments prepared for ground shipment.

The following Dangerous Goods may be shipped in accordance with the current edition of Title 49
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Code of Federal Regulations prepared for AIR transport: Toxics in exemption packaging ORM-D (with a shipper's declaration) Small quantities under section 49 CFR 173.4 Some Department of Transportation (DOT) exemptions that have been approved for air transportation FedEx Express does not offer a ground service and we do not accept dangerous goods shipments prepared for ground shipment.
Toxic shipments will be accepted on any of our operating days. Shippers of Division 6.1, Packing Group III must indicate "PG III" adjacent to the hazard label on the outer package. Packages containing toxic materials in packaging groups I or II are acceptable only when packaged in U.S. Department of Transportation Exemption packaging. Primary Classes of Division 6.1 and Class 8 will not be accepted for carriage when packed in the same overpack or all packed in one outer package. Poison Inhalation Hazard, Zone "A" or any Class 2 substance with a toxic primary or subsidiary risk label will not be accepted for carriage.
Dry ice shipments prepared in accordance with IATA regulations do not require a Shipper's Declaration, and there is no special handling fee for transporting dry ice at this time. However, the dry ice box must be checked and the dry ice information must be entered under the special handling section on the airbill. Where dry ice is tendered as a refrigerant with Dangerous Goods that require a declaration, the "Dangerous Goods" block and the dry ice block on the airbill must be checked, and the dry ice information must be entered under the special handling section on the airbill. All dry ice shipments require package marking and labeling. FedEx is not required to add dry ice to packages in its system. Prior to shipment, call 1800GoFedEx (800-463-3339)) and press "81" to connect to the Dangerous Goods Hotline for assistance.
Common Fireworks (Division 1.4 explosives) will be accepted only with prior written approval from FedEx. A preapproved shipper is responsible for ensuring the recipient complies with all applicable federal, state and local laws, regulations, ordinances and rules. A preapproved shipper is also responsible for complying with all packing requirements and appropriate marking and labeling of the package as well as compliance with applicable federal, state and local laws, regulations, ordinances and rules.
Division 1.3 explosives are acceptable on an airport-to-airport basis to and from designated airports only. Call 1800GoFedEx (800-463-3339) and press "81" to connect to the Dangerous Goods Hotline prior to shipment for current information on approved airport locations.
Blood, urine, fluids and other liquid diagnostic specimens containing infectious substances are considered Dangerous Goods. NOTE: Regulated Infectious Substances must not be shipped in Diagnostic Specimen Envelopes. (See Packaging and Marking.) IATA regulations apply. Noninfectious blood, urine and diagnostic specimens must be packaged to specific FedEx standards. For additional information on FedEx standards for diagnostic specimens, see our Web site at
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www.fedex.com or request a brochure for blood, urine and diagnostic samples. Shippers must also comply with all applicable local, state and federal laws governing packing, marking and labeling of shipments of blood and blood products regardless of whether they are infectious. Blood, urine and diagnostic specimen shipments may not be deposited in a FedEx Drop Box. For additional information or assistance concerning these shipments, call 1800GoFedEx (800-463-3339) and press "81" to connect to the Dangerous Goods Hotline, see our Web site at www.fedex.com or request our brochure.
Any concentration of solid or liquid Polychlorinated Biphenyls (PCBs), or environmental samples suspected of containing PCBs, will be accepted by FedEx only if prepared in accordance with the current applicable IATA packing instructions. Additionally, PCB shipments must utilize combination packaging consisting of inner metal containers (IP3 or IP3A) inside an outer metal (1A2) drum. Absorbent material must be sufficient to fill all available space.
Hazardous Waste will not be accepted for carriage.
The following Class 8, Division 5.1, and Division 6.2 materials will not be accepted for carriage: UN 2031 Nitric acid, over 40% concentration UN 1796 Nitrating acid mixtures, over 40% concentration UN 1826 Nitrating acid mixtures, spent over 40% in original solution UN 1873 Perchloric acid, over 50% concentration Division 6.2, Risk Group 4 Infectious Substances
Highway Route Controlled Quantity or Fissile Class III radioactive materials will not be accepted for carriage without advance arrangements. For additional information or approval for these shipments, call 1800GoFedEx (800-463-3339) and press "81" to connect to the Dangerous Goods Hotline.
Labeled (White I, Yellow II, III) Plutonium will not be accepted for carriage.
If a shipment containing Dangerous Goods is refused by the recipient, leaks or is damaged, the shipment will be returned to the shipper if possible. If the shipper refuses to accept the returned shipment or it cannot be returned because of leakage, or damage due to faulty packaging, the shipper is responsible for and will reimburse FedEx for all costs and fees of any type connected with the disposal of the shipment, and all costs and fees of any type connected with cleanup of any spill or leakage.
Any package/shipment with an odor or any package that is wet or leaking will not be accepted for carriage. If a Dangerous Goods shipment damages or contaminates any property, the shipper is responsible for and will reimburse FedEx for any and all costs, fees and expenses incurred in connection with such damage or contamination.
Chemical oxygen generators will only be accepted for carriage when the required competent authority approval documents accompany the shipment.
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Not all FedEx locations accept Dangerous Goods, and we reserve the right to refuse Dangerous Goods at any location where they cannot be accepted in accordance with applicable law.
The United States Department of Transportation (DOT) regulates the movement of Dangerous Goods by all modes of transportation. The Federal Aviation Administration (FAA) is a branch of the DOT that oversees Dangerous Goods shipments by air. When FedEx and other air carriers encounter improperly declared or undeclared shipment of Dangerous Goods, we are required by law to report improperly declared or undeclared shipments of Dangerous Goods to the U.S. Department of Transportation. Penalties for such shipments can range up to $500,000 and five years in jail.
The DOT/FAA also requires every shipper to have job-specific Dangerous Goods training prior to offering a Dangerous Goods shipment to FedEx or another air carrier.
Dry Shippers/Dry Dewars meeting the note in IATA regulations Packing Instruction 202 must have an indication on the outer package that the shipment is not restricted or non-hazardous.
U.S. domestic shippers who omit the technical name under the provisions of USG-14 must indicate on the Shipper's Declaration that their material falls under the provisions of USG-14 for "n.o.s." or generic proper shipping names.
Packaging and Marking:
All packages must be prepared and packed by the sender for safe transportation with ordinary care in handling. Recipient address labels should be placed on both sides of each package with an additional label enclosed inside. Any articles susceptible to damage as a result of conditions which may be encountered in air transportation, such as changes in temperature or atmospheric pressure, must be adequately protected by proper packaging. (See Restrictions for additional packaging instructions on particular commodities.) Each shipment must be legibly and durably marked with the name, address and ZIP Code of both the shipper and recipient. The ZIP Code is crucial to the efficient movement of the package through our system.
Blood, urine and other non-infectious liquid diagnostic specimens will be accepted only when shipped in a sturdy outer container* containing a sealed watertight primary receptacle placed inside of a sealed watertight secondary receptacle. Absorbent material must also be placed inside of the secondary watertight receptacle. NOTE: Regulated Infectious Substances must not be shipped in Diagnostic Specimen Envelopes provided by FedEx. The FedEx Diagnostic Specimen Envelope is for noninfectious substances only. (See Blood, Urine, Fluids and Other Liquid Diagnostic Specimens.)
If multiple primary receptacles are placed into a single secondary packaging, it should be wrapped individually to ensure that contact is prevented. The absorbent material, such as gauze or cotton wadding, must be sufficient to absorb the entire contents of all primary receptacles. It is the
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responsibility of the shipper to ensure that proper packaging is used.
* Sturdy outer packaging constructed of cardboard/corrugated fiberboard, wood, metal or rigid plastic is required. The sturdy outer packaging must be larger than 7" in length, 4" in width, and 2" in depth.
Unacceptable packaging includes, but is not limited to, StyrofoamTM, plastic bags, paper envelopes, FedEx Envelope, FedEx Packet, FedEx Pak, FedEx Box, FedEx Tube, and FedEx 10kg and FedEx 25kg boxes. We will refuse to accept packages not meeting these or any federal requirements. These shipments will not be accepted at FedEx Drop Boxes or unstaffed FedEx locations. For additional information or assistance concerning required packaging materials, FedEx Express customers may call the Packaging Design and Development Department at (800)633-7019.
Expanded polystyrene foam coolers (StyrofoamTM) must be shipped inside of a sturdy outer container unless evaluated by the FedEx Packaging Design and Development Department, (800)633-7019. Expanded polystyrene foam coolers (StyrofoamTM) containing blood, urine and other non-infectious liquid diagnostic specimens must be shipped inside of a sturdy outer packaging. No exceptions are permitted.
Shipping and Handling:
Dangerous-Goods Declarations
Coming this summer: As of June 1, 2001, FedEx Express will accept Shipper's Declarations for Dangerous Goods only in typed or computer-generated formats. Handwritten declarations will not be accepted. Call the Dangerous Goods Hotline at 1800GoFedEx 800.463.3339, and press "81" for more information.
See the Dangerous Goods Service section for additional information.
Undeliverable Shipments
Don't forget that FedEx Express no longer returns undeliverable shipments if the return is not related to a service failure. If a package is undeliverable through no fault of FedEx Express, we will try to contact the shipper for instructions on returning the shipment. If the shipment remains undeliverable, it will be returned to the shipper via FedEx Express Saver at the shipper's expense.To minimize the number of undeliverable shipments returned, ask about Signature Release.
fedex.com Terms of Use | Contact Us! This site is protected by copyright and trademark laws under U.S. and International law. Review our privacy policy. All rights reserved. 1995-2001 FedEx FedEx Ground Tarif (pdf)
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APPENDIX B ORDER FORMS FOR SPECIMEN COLLECTION OUTFITS
DECATUR LABORATORY ALBANY REGIONAL LABORATORY WAYCROSS REGIONAL LABORATORY
B - 1

B - 2

SPECIMEN COLLECTION OUTFIT ORDER FORM DECATUR PUBLIC HEALTH LABORATORY

DATE: ________________________
NAME OF COMPANY _________________________________ ADDRESS: ___________________________________________ _____________________________________________________ _____________________________________________________
ORDERS ARE SHIPPED U.P.S. PLEASE INDICATE STREET ADDRESS.

ORDER FORM:

GA Public Health Laboratory Laboratory Services & Supply 1749 Clairmont Road Decatur, GA 30033-4050 (404) 327-7920

NO FAXED ORDERS/PLEASE MAIL

ITEM 0500
0501

QT/EA

SEROLOGY OUTFITS
DESCRIPTION
MICROBIAL IMMUNOLOGY W/BLOOD TUBE #3432
MICROBIAL IMMUNOLOGY W/O BLOOD TUBE #3432

PERSON ORDERING: _____________________________ PHONE #: _______________________________________
BACTERIOLOGY AND MYCOLOGY OUTFITS

ITEM

QT/EA

DESCRIPTION

0505

CULTURE REFERRAL/ISOLATION FOR I.D. #3410

0525

PERTUSSIS SLIDE

#3415

0515

VIROLOGY OUTFITS
HIV (AIDS) #3605

0545 0555
0560

SLIDE STOOL CULTURE (PARA-PAK) #3416 STREPTOCOCUS #3418

0575 *0565

VIRAL CULTURE #3595R VIRAL LOAD #3605

0550

MYCOBACTERIOLOGY OUTFITS
TB SPUTUM #3412

PARASITOLOGY OUTFITS

0585

TB CULTURE/FOR I.D. #3412

*0520 *0521

INTESTINAL PARASITES/PVA #3414 (2)
AMEBIASIS/E. HISTOLYTICA #3414

*0530

PINWORM SLIDE #3414

0542

BLOOD SMEAR SLIDE #3415

*AVAILABLE TO COUNTY HEALTH DEPARTMENTS ONLY

FOR LAB USE ONLY
DATE FILLED:____________________# BOXES:_________ BY:_______________________________

MAILING CANS/LIDS AND INDIVIDUAL COMPONENTS

ITEM

QT/EA

DESCRIPTION

0800

SPECIMEN BAGS

0801

OUTSIDE CANS/LIDS

0802

LIDS ONLY

0803

KYFAX WRAPPING PAPER

0507

6 ML RED TOP BLOOD TUBE

NOTE: All outfits include cans. If a complete outfit is not needed, please order individual components.

B - 3

DECATUR PUBLIC HEALTH LABORATORY
FORMS ONLY

DATE: ________________________
NAME OF COMPANY _________________________________ ADDRESS: ___________________________________________ _____________________________________________________ _____________________________________________________ _____________________________________________________
ORDERS ARE SHIPPED U.P.S. PLEASE INDICATE STREET ADDRESS.
NO FAXED ORDERS/PLEASE MAIL

ORDER FORM: GA Public Health Laboratory Laboratory Services & Supply 1749 Clairmont Road Decatur, GA 30033-4050 (404) 327-7920
PERSON ORDERING: __________________________ PHONE #: ____________________________________

QT/EA ______ ______ ______ ______ ______ ______ ______ ______
______ ______ ______ ______ ______ ______ ______

ITEM 0598 0810 3410 3411 3412 3414(2) 3415 3416
3418 3423 3432 3595( R) 3605 3491 3603

DESCRIPTION Premarital Stickers 80/sheet Biohazard Labels Isolation for Identification Marriage License Tuberculosis Submission Form Intestinal Parasites Parasitology Miscellaneous (Pertussis Slide) Feces Culture for Bacterial Enteric Pathogens Salmonella, Shigella, and Campylobacter (Stool Culture) Miscellaneous (Streptococcus) Miscellaneous Long Form Microbial Immunology Submission Form (Rev. 4/2000) Virology Request Form (Viral Culture) HIV Submission Form Newborn Screening Form Newborn Screening Mailing Envelope

DATE FILLED: _________________

FOR LAB USE ONLY #BOXES:___________ BY:__________________

For those clients with Internet access, many of the GPHL submission forms are also available on the Division of Public Health Web Site at http://health.state.ga.us/programs/lab. These forms can be completed online, then printed and submitted. As new forms are updated, these will be added to the web site.

B - 4

SUBMITTER CODE: CLINIC NAME: ADDRESS:

ALBANY REGIONAL PUBLIC HEALTH LABORATORY 1109 N JACKSON ST, ALBANY, GA 31701-2022 PHONE:229-430-4122
ORDER FROM: ALBANY REGIONAL LABORATORY 1109 N. JACKSON ST. ALBANY, GA 31701-2022

PERSON ORDERING:

ORDERS ARE SHIPPED UPS, INDICATE STREET ADDRESS, NOT PO BOX NUMBER
PHONE:

SEROLOGY SUPPLIES

GC SUPPLIES

ITEM

QT.EA DESCRIPTION

ITEM

QT EA

DESCRIPTION

0507

6 ML VACUTAINER TUBES,

0526

GC SLIDE HOLDERS

100/BX

3432

SYPHILIS/RUBELLA/EIA FORMS 3514

MISCELLEANOUS FORMS

3411

PREMARITAL LICENSE

CERTIFICATE

0591

PINK PREMARITAL STICKERS,

80/SHEET

LEAD SCREENING SUPPLIES

WATER SUPPLIES

0605

CAPILLARY BLOOD TUBE,

A200

COLLECTION BOTTLES

EDTA, PURPLE TOP

0604

5 ML VACUTAINER TUBE,

A201

STYROFOAM SHIPPERS FOR

EDTA, PURPLE TOP

WATER BOTTLES

3593

LEAD SCREENING FORM

A202

MAILING SLEEVES FOR

STYROFOAM SHIPPERS

A203

WATER FORMS

FOR LAB USE ONLY: DATE RECEIVED:

3596 0801 0800 0203 DATE FILLED: FILLED BY: NUMBER OF BOXES:

GENERAL SHIPPING SUPPLIES
GOLD MAILING LABELS/ALBANY ADDRESS TALL CARDBOARD CANS/ALBANY ADDRESS BIOHAZARD BAGS
KYFAX WRAPPING PAPER

For those clients with Internet access, many of the GPHL submission forms are also available on the Division of Public Health Web Site at http://health.state.ga.us/programs/lab. These forms can be completed online, then printed and submitted. As new forms are updated, these will be added to the web site.

B - 5

B - 6

SPECIMEN COLLECTION OUTFIT ORDER FORM WAYCROSS REGIONAL PUBLIC HEALTH LABORATORY

SUBMITTER CODE____________________________________ FACILITY______________________________________________________ ADDRESS_______________________________________________________ ________________________________________________________________

ORDER FROM: WAYCROSS REGIONAL LABORATORY 1101 CHURCH ST. WAYCROSS, GA 31501-3525 (912) 285-6000 FAX (912) 285-6032
ORDERS ARE USUALLY SHIPPED U.P.S. STREET ADDRESS IS REQUIRED , NOT P.O. BOX

PERSON ORDERING__________________________________________________PHONE ______________________ EXT.______

SEROLOGY OUTFITS AND INDIVIDUAL COMPONENTS

GONORRHEA SLIDE OUTFITS

ITEM 0500

AMOUNT NEEDED

0501

507

UNIT

DESCRIPTION

EACH EACH EACH

OUTFIT: SYPHILIS / RUBELLA / PREMARITAL / FTA #3432
AS ABOVE WITHOUT 6 ML BLOOD TUBE
6 ML RED TOP BLOOD TUBE

3411 0598

EACH

PREMARITAL CERTIFICATES

SHEETS

PREMARITAL STICKERS 80/SH

ITEM

Amount needed

UNIT

DESCRIPTION

0526

EACH

SLIDE OUTFIT: MALE (GC) #3415

0527

EACH

SLIDE OUTFIT: FEMALE (TRIC) #3415

PARASITOLOGY OUTFITS
AVAILABLE ONLY TO COUNTY HEALTH DEPARTMENTS

0520

BOX

INTESTINAL PARASITE OUTFIT
IP/PVA (10 /BOX)

3432
0900 3062

EACH

MICROBIAL IMMUNOLOGY FORM FOR SYPHILIS / RUBELLA /EIA

RABIES INDIVIDUAL COMPONENTS

EACH

SHIPPING CONTAINER

EACH

RABIES HISTORY FORM

MAILING CANS/LIDS AND INDIVIDUAL COMPONENTS

3597

EACH

PINK MAILING LABEL

0800 081

EACH EACH

INSIDE CONTAINER (BIOHAZARD BAG)
TALL DOUBLE SHIPPING CONTAINER

0803

EACH

KYFAX WRAPPING

530

EACH

PINWORM OUTFIT

WATER TESTING COMPONENTS

20714

EACH

STERILE WATER COLLECTION BOTTLES

1W

EACH

STYROFOAM SHIPPING

CONTAINERS FOR WATER

SAMPLES

2W

EACH

WATER TESTING REQUEST

FORM

3W

EACH

COMPLETE OUTFIT

( INCLUDES BOTTLE, FORM, & SHIPPING CONTAINER)

NON-NEONATAL HEMOGLOBINOPATHY SCREENING OUTFITS AND COMPONENTS

1 NN HGB

EACH

COMPLETE OUTFIT ( CONTAINS CAPIJECT, FORM,
KYFAX, SHIPPING CONTAINER & LABEL)

3563

EACH

NON-NEONATAL REQUEST FORM

0810

EACH

BIOHAZARD LABELS

1 CAP

EACH CAPIJECT COLLECTION TUBE

FOR LAB USE ONLY DATED FILLED_______________ # OF BOXES SENT________________ BY _______________ MODE OF TRANSPORT MAIL UPS PICKUP

B - 7

For those clients with Internet access, many of the GPHL submission forms are also available on the Division of Public Health Web Site at http://health.state.ga.us/programs/lab. These forms can be completed online, then printed and submitted. As new forms are updated, these will be added to the web site.
B - 8

APPENDIX C COMPOSITION OF SPECIMEN COLLECTION OUTFITS
DECATUR LABORATORY WAYCROSS REGIONAL LABORATORY
C- 1

C- 2

Composition of Specimen Collection Outfits Decatur Laboratory

ITEM NO.

TYPE TESTS

BACTERIOLOGY/MYCOLOGY OUTFITS

0505

Culture Referral

0555

Stool Culture

0525

Pertussis

0545

Slide

0560

Streptococcus

MICROBIAL IMMUNOLOGY OUTFITS

0500

Microbial Immunology

w/Blood Tubes

0501

Same As Above

OUTFIT COMPONENTS
1 medium mailing can/lid w/orange label #3570
1 biohazard transport bag 1 absorbent packing paper 1 requision form #3410
1 short mailing can/lid w/orange label #3570
1 biohazard transport bag 1 vial preservative (Para-Pak) 1 requisition form #3416
1 short mailing can/lid w/orange label #3570
1 biohazard transport bag 1 slide holder w/2 glass-etched ring slides 1 requisition form #3415
1 short mailing can/lid w/orange label #3570
1 biohazard transport bag 1 slide holder w/1 glass slide 1 requisition from #3415
1 preaddressed #10 envelope #3547 1 pack preservative (Dripaz) 1 Self-seal HS Envelope 1 cotton tip applicator 1 requisition from #3418
1 medium mailing can/lid w/orange label #3570
1 biohazard transport bag 1 absorbent packing paper 1 5ml plastic blood collection tube 1 requisition from #3432
Same as #0500 without 5ml blood tube

C- 3

ITEM NO.

TYPE TESTS

MYCOBACTERIOLOGY (TB) OUTFITS

0550

Sputum

0585

Identification

NEWBORN SCREENING OUTFITS

3491

Metabolic Disease

3603

Mailing Envelope

PARASITOLOGY OUTFITS

0520

Intestinal Parasites/PVA

0521

Amebiasis/E. Histolytica

0530

Pinworms

0542

Blood Smears

OUTFIT COMPONENTS
1 medium mailing can/lid w/orange label #3580
1 biohazard transport bag 1 absorbent packing paper 1 50ml conical tube 1 requisition from #3412
1 medium mailing can/lid w/orange label #3570
1 biohazard transport bag 1 absorbent packing paper 1 requisition form #3452
1 4 part snap-out form #3491 w/filter paper attached
1 preaddressed envelope
1 tall mailing can/lid w/orange label #3570
1 biohazard transport bag 1 prepackaged kit (2 vials preservative) 2 requisition forms #3414
1 medium mailing can/lid w/orange label #3570
1 biohazard transport bag 1 E.h. Diluent 1 requisition from #3414
1 preaddressed kraft envelope #3602 1 slide holder w/1 glass slide w/tape
attached 1 wooden depressor 1 requisition from #3414
1 small mailing can/lid 1 double slide holder w/2 glass slides 1 requisition form #3415

C- 4

ITEM NO.

TYPE TESTS

OUTFIT COMPONENTS

VIROLOGY OUTFITS

0515

HIV (AIDS)

1 medium mailing can/lid w/orange label #3570
1 biohazard transport bag 1 absorbent packing paper 1 5ml plastic blood collection tube 1 requisition from #3605

0575

Viral Culture**

1 tall aluminum can/lid 1 vial w/preservative 2 6" cotton swabs 1 requisition from #3595R

0565

Viral Load

1 medium mailing can/lid w/orange label #3570
1 biohazard transport bag 1 absorbent packing paper 1 Vacutainer PPT Tube 1 12 x 75mm tube

**Shipping containers are NOT provided. Address to Virology Laboratory.

INSTRUCTIONS FOR THE COLLECTION, STORAGE AND TRANSPORTAION OF SPECIMENS ARE INCLUDED WITH EACH OUTFIT.

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Composition of Specimen Collection Outfits Waycross Regional Laboratory

ITEM NUMBER

TYPE TEST

ABNORMAL HEMOGLOBIN OUTFITS

1NN HGB

Non-neonatal (>30 days of age)

GONORRHEA OUTFITS 0526/27

Slide Male/Female

PARASITOLOGY OUTFITS 0520

Intestinal Parasites/PVA

0530

Pinworm

SEROLOGY OUTFITS 0500

Syphilis/Rubella/Premarital

WATER COLLECTION OUTFITS

3W

Bacteriological Examination

Of Water

VIROLOGY OUTFITS 0900

Rabies

C -7

OUTFIT COMPONENTS
1 - tall mailing can/lid W/pink Waycross mailing label
1 - biohazard transport bag 1 - absorbent packing paper 1 - capillary blood tube w/label 1 - requisition form # 3563 Instructions for specimen collection & transportation
1 - tall mailing can/lid W/pink Waycross mailing label
1 - biohazard transport bag 1 - slide holder w/1 glass slide 1 - requisition form # 3415 Instructions for specimen collection & transportation
1 - pink Waycross mailing label 1 - prepacked kit(2 vials preservative) 1 - biohazard transport bag 1 - requisition form # 3414 Instructions for specimen collection & transportation
1 - preaddressed kraft envelope #3469 1 - slide holder w/1 glass slide
w/clear tape attached 1 - wooden depressor 1 - requisition form #3414 Instructions for specimen collection & transportation
1 - tall mailing can/lid W/pink Waycross mailing label
1 - biohazard transport bag 1 - absorbent packing paper 1 - 6 ml plastic blood collection tube 1 - requisition form # 3432 Instructions for specimen collection & transportation
1 - Styrofoam shipper w/sleeve 1 - sterile labeled collection bottle 1 - requisition form Instructions for specimen collection & transportation
1 - shipping container with 2 - plastic bags 1 - brown envelope 1 - brown tape
1 - Rabies history form #3062 Instructions for specimen collection & transportation

C -8