This manual was developed to assist the users of the Bureau of Laboratories in the proper collection and submission of specimens for testing and in the interpretation of results. The format was chosen for ease of use and for ease of updating. As tests are modified, deleted or added, information is updated. This guide is intended to be used by all submitters of specimens including, but not limited to, Michigan physicians, licensed laboratories, health care facilities, local health departments, veterinarians, animal control officers and law enforcement officers.
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I. Specimen Submission Guidelines
Any Michigan local health department, licensed physician's office, licensed laboratory or licensed health care facility may submit specimens for testing. Animal heads may be submitted for rabies testing by veterinarians, animal control officers, law enforcement agencies, etc.
The accuracy and clinical usefulness of all laboratory analyses are limited by the quality and appropriateness of the specimen. However, the quality of the specimen is not under the control of the laboratory. The techniques used for the collection and submission of the specimens can influence the outcome of testing results.
Appropriate specimens are to be submitted using collection units supplied by the Michigan Department of Community Health (MDCH) Bureau of Laboratories. The Laboratory Support Unit at MDCH is responsible for assembling the various units that are distributed to the numerous health departments, licensed physician's offices and licensed health care facilities. Order units by submitting the Requisition for Clinical Specimen Containers - DCH 0568 form (see Appendix) to the MDCH Bureau of Laboratories. Orders may be submitted by mail (927 Terminal Drive, Lansing, MI 48906), fax (517/335-9039), phone (517/335-9867), or E-mail: DietzR@michigan.gov
Guidelines for Collection
*Please read instructions pertaining to individual test units for more specific instructions.*
1. Use containers (mailing units) provided by the MDCH Bureau of Laboratories for the collection and transport of specimens.
2. The specimen must be properly identified. The patient's name, hospital number or other unique identifier must be clearly written on the specimen container. The appropriate test request form, complete with the patient's name or a unique identifier must accompany the specimen. The patient identification on the specimen must match exactly the identifier on the test request form. Unlabeled or mislabeled specimens will not be tested.
3. If the patient (or a family member) is to collect the specimen, it may be necessary to write the patient's name on the container prior to dispensing the container. Please instruct the patient on the proper specimen collection method.
4. Please submit specimens in the appropriate transport containers. Do not submit cultures in petri plates as they are easily broken.
Please refer to the Appendix for a complete listing of testing units and their components.
Guidelines for Shipping
1. The specimen must be properly packaged while in transit to the laboratory. To ensure the quality of the laboratory test results, sometimes it is critical that specimens are frozen, kept cool, or placed in a fixative prior to their arrival at the laboratory. If indicated, use the ice substitute provided. Do not use wet ice, as it melts and may leak in transit, thus endangering the integrity of the specimen.
2 Refer to the instructions accompanying the collection units for the proper way to prepare specimens for shipping.
3. The specimen must be delivered to the laboratory in a timely manner. Delays in transit may render the specimen unsuitable for testing. Mail or ship specimens as early as possible in the week to avoid weekend or holiday delays.
4. The specimen must not arrive at the laboratory in a condition which poses a hazard to the laboratory staff or others who handle the specimen. Leaking specimens will not be tested.
5. When an unusually large number of specimens are to be submitted, such as to support an outbreak investigation in a school, group or day care setting, prior consultation with the speciality laboratory is strongly encouraged.
6. Remember all packages containing clinical specimens and/or etiologic agents must conform to postal regulations for the transporting of specimens of this type.
These regulations are subject to change!
Federal Postal Regulations
United Parcel Service
Federal Express
Specimens for the Centers for Disease Control and Prevention (CDC)
Additional tests for diseases of public health importance are offered by the U.S. Public Health Service, Centers for Disease Control and Prevention. CDC accepts specimens and cultures under the following circumstances:
1. From an outbreak
2. From an uncommon or exotic disease
3. An isolate which cannot be identified, is atypical, shows multiple antibiotic resistance, or from a normally sterile site.
4. From a disease for which reliable diagnostic reagents or expertise are unavailable at this laboratory.
All specimens to be sent to the CDC must be accompanied by CDC history form (CDC 50.34 Rev. 11-90 (Formerly 3.203)) and routed through this laboratory, unless otherwise advised. MDCH will assign a number for tracking purposes. History forms are available from the Data and Specimen Handling Unit at MDCH [(517) 335-8059].
If specimens or etiologic agents submitted to this laboratory require further studies at the CDC for any of the above listed reasons, a request will be sent to the submitter asking that a CDC history form be completed. Please respond in a timely fashion because the specimen or etiologic agent cannot be forwarded to CDC without a completed history form.
A list of tests performed at the CDC at the request of state health department laboratories is included in this manual (Please refer to page 32 of the CDC Reference Guide in the Appendix). There is no charge for testing performed at CDC.
For a copy of the CDC Reference Guide from the Data and Specimen Handling Unit at CDC:
phone: (404) 639-3931
fax: (404) 639-4982
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II. Specimen Rejection Policy
1. If the submitter of any specimen has not completed the test requestion form, the form will be returned via mail or fax. The testing will not be performed until the completed test requestion form is received. If delay in testing will compromise the test results, the submitter will be contacted by telephone or fax to clarify the test request.
2. Specimens of any type will be subject to rejection if they:
a. Are of insufficient quantity.
b. Are of insufficient quality.
c. Are of excessive age for the type of examination requested.
d. Are received with either specimen container unlabeled or test request form incomplete or mismatched.
e. Are submitted in an inappropriate manner, i.e., are not shipped according to Federal Postal regulations.
f. Are leaking and can easily be replaced by recollection. Every attempt will be made to salvage leaking or improperly submitted samples of cerebrospinal fluid, biopsy tissues, aspirates and other specimens attained through surgical means providing that the safety of the laboratory worker is not compromised.
g. Are sent in expired media.
3. Serum specimens will be rejected if they are in glass tubes.
4. Specimens for culture will be rejected if:
a. They are submitted in an improper transport medium (i.e., transport medium that could compromise results).
b. They are not received within a time frame optimal for the organisms for which isolation is being attempted.
c. They are submitted in petri plates. If culture is from a priority specimen or is a suspect bioterrorism agent, please call for consult and guidance. (517) 335-8063.
5. If the submitter of any specimen has not completed the test requisition, the form will be returned. Testing will not be performed until the completed test requisition is received.
6. The reporting of cultures submitted for identification but which are not pure isolates will be delayed and may not be attempted.
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III. Reporting Results
The various specialty areas of the MDCH Bureau of Laboratories make every effort to process and test specimens as quickly as possible. Turnaround time is an important indicator of our Quality Assurance program. The respective turnaround times (analytic time) are listed for each procedure in the Laboratory Services Guide.
To improve the turnaround time in reporting results, the Bureau of Laboratories offers the option of receiving laboratory reports by fax transmission. Fax reporting will provide a 24-72 hour improvement in turnaround time by avoiding the mail carrier service. If you are interested in converting your agency to an automatic fax transmission agency, please contact Debra Groh (517-335-8059), GrohD@michigan.govor Sam Davis (517-335-8074), DavisSam@michigan.gov.
If you have any questions concerning turnaround time or reporting in general, call the Data and Specimen Handling Unit (517-335-8059). Before you call for results, please take into account transit time for the specimen and turnaround time for testing. Transport by the U.S. Postal Service will add two or three days to the total turnaround time. Some test procedures are batched and run periodically during the week. Please refer to the appropriate section (Quick Reference Guide) within the Laboratory Services Guide to determine if this is the case before contacting the laboratories.
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IV. Bureau Administration
Michigan Department of Community Health
Bureau of Laboratories
3350 North Martin Luther King Jr. Blvd.
Building 44 Room 155
Lansing, Michigan 48906
Laboratory Director
Frances Pouch Downes, Dr. P.H. (517) 335-8063, email: DownesF@michigan.gov
Interim Safety Officer
Judy Smith (517) 335-8859, email: SmithJK@michigan.gov
Quality Assurance Section
Samuel Davis - Manager (517) 335-8074, email: DavisSam@michigan.gov
Data and Specimen Handling Unit (517) 335-8059, fax (517) 335-9871
Debra Groh - Supervisor (517) 335-8059, email: GrohD@michigan.gov
Laboratory Support Unit (Shipping Container Orders) (517) 335-9867, fax (517) 335-9039
Quality Control Unit (517) 335-8859, fax (517) 335-9631
LABORATORIES
Division of Clinical Chemistry and Toxicology
Kevin Cavanagh, Ph.D. - Director (517) 335-9490
Analytical Chemistry Section
Bonita Taffe, Ph.D.- Manager (517) 335-8344
Trace Metals Section
Jeff Dupler- Manager (517) 335-8244
Newborn Screening Section
Harry Hawkins - Manager (517) 335-8095
Metabolic Unit
Eleanor Stanley - Manager (517) 335-9599
Endocrine Unit
Marilyn Boucher - Manager (517) 335-9795
Division of Infectious Disease
Patricia A. Somsel, Dr.P.H. - Director (517) 335-8067
Bioterrorism Coordinator
Valerie Reed (517) 335-9653
Microbiology Section
James T. Rudrik, Ph.D. - Manager (517) 335-9641
Enterics/STD/Chromatography (ESC) Unit
William Schneider - Manager (517) 335-9343
Mycobacterial and Mycology Unit
Dale Berry - Manager (517) 335-9637
Reference Bacteriology Unit
Sandip Shah - Manager (517) 335-9638
Virology Section
Anthony Muyombwe, Ph.D., - Manager
(517) 335-8099
Bacterial and Parasitic Serology Unit
William Crafts - Manager (517) 335-8100
HIV Unit
Deborah Stephens - Manager (517) 335-8098
Viral Isolation and Viral Serology Unit
Patricia A Clark, M.P.H. - Manager (517) 335-8102
Upper Peninsula Laboratory
Jeffrey P. Massey, Dr.P.H. - Section Manager (906) 487-3011
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V. Suggestions
For any suggestions concerning MDCH's Laboratory Service Guide, please e-mail SmithJK@michigan.gov
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VI
. Specimen Collection and Shipping Containers
This section of the Lab Services Guide includes a listing of specimen collection and shipping container components for Clinical Specimen Container Units.
Clinical Specimen Container Unit Order Form
Mailing Regulations:
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Rev. 1/25/2008