Van Buren/Cass District Health Department
Appendix 2 to the Biological Disease Annex:
Laboratory Response Capacity
Table of Contents
Record of Change 3
Record of Distribution 3
Purpose 4
Concept of Operations 4
State of Michigan Laboratory System 4
Laboratory Response Network (LRN) 4
Michigan Regional Laboratories 5
Divisions and Contact Information 5
Laboratory Capacity and Capabilities 6
Michigan Department of Community Health Laboratory 6
Divisions and Contact Information 6
Specimen Collection 7
Guidelines for Collection 7
Specimens for the Centers for Disease Control and Prevention 8
MDHHS Specimen Rejection Policy 9
Shipping 10
Data Management 12
Attachments: Error! Bookmark not defined.
Record of Change
Change / Date / Person ResponsibleCreation of document / 3/2013 / Jennifer Zordan
Document reformatting / 2/2014 / Jennifer Zordan
Annual Updates / 7/2015 / Jennifer Zordan
Updates to MDHHS website/chain of custody / 9/2015 / Jennifer Zordan
Record of Distribution
Sue Bailey, Director of NursingRick Johansen, Medical Director
Employee Intranet
Purpose
The purpose of the Van Buren/Cass DHD Laboratory Annex is to provide an overview of laboratory capabilities in Van Buren and Cass County and throughout the state of Michigan. This annex includes details on shipping requirements, contact information, testing capabilities, result communication, and evidence management.
Concept of Operations
A. (n4ii)All actions related to the laboratory annex of the Van Buren/Cass District Health Department Emergency Operations Plan occur under the authority of the Administrative Health Officer or his/her designee.
B. (n4i)Employees who may have specific roles under this plan include, but are not limited to the Administrative Health Officer, Medical Director, Nursing Director, Environmental Health Director, & Emergency Preparedness Coordinator. These roles may include but not limited to specimen collection, packaging, shipping/receiving, data management, & communications.
C. (n4ii/n4iii))Specimens that are related to an emergency response will have higher priority for testing and shipping than normal samples, depending on the agent and incident. Tests and/or shipping will occur as soon as possible.
D. (n4v)Emergency response actions will be documented on an ICS 214 form and sent to the Emergency Preparedness Coordinator for inclusion into the after action report and improvement plan. Test and result records are also included in MDSS for reportable diseases.
State of Michigan Laboratory System
All current laboratory guidance including specimen collection, testing, shipping, and contact information can be found at the Michigan Department of Health & Human Services website at: http://www.michigan.gov/mdch/0,4612,7-132-2945_5103---,00.html
Laboratory Response Network (LRN)
The Laboratory Response Network (LRN) is a national network of over 150 federal, state, and local public health, veterinary, food testing, and environmental testing laboratories that have the capacity to respond to public health emergencies, including chemical and biological terrorism. Laboratories that participate in biological testing are designated as LRN-B laboratories and chemical testing laboratories are designated as LRN-C.
Within LRN-B there are three levels of laboratories: national, reference and sentinel.
National laboratories are responsible for specialized strain characterizations, bio-forensics, select agent activity, and handling highly infectious biological agents. These labs are operated by CDC, U.S. Army Medical Research Institute for Infectious Diseases (USAMRIID), and the Naval Medical Research Center (NMRC).
Reference laboratories are responsible for the investigation and/or referral of specimens. These labs include state and local level public health laboratories.
Sentinel laboratories provide routine diagnostic services, rule-out, and referral steps in the identification process. While these laboratories may not be equipped to perform the same tests as LRN reference laboratories, they can test samples.
Michigan Regional Laboratories
The Michigan Regional Laboratory system currently has three regional labs located in the local health departments of Kalamazoo, Kent, and Saginaw counties and two associate laboratories located in Oakland and Genesee county health departments.
The Regional Laboratory is responsible for assessing services that may be required for samples or specimens submitted for testing or to be referred to other laboratories for testing. These responsibilities include:
1. Mobilize 24/7 emergency surge testing capacity for essential testing.
2. Advise and provide procedures for safe appropriate sample collection, handling, transport and storage.
3. Provide proper chain of custody policy and forms when obtaining, transporting, and transferring samples.
4. Ensure accurate and timely testing and reporting of clinical and environmental samples.
5. Notify appropriate entities through chain of command of results of all laboratory findings related to the incident.
6. Provide interpretation of laboratory findings and make any necessary recommendations.
7. Coordinate and collaborate with other agencies and testing sites, such as MDHHS- BOL, MDEQ, MDA, CDC, FBI, or members of the Laboratory Response Network for laboratory findings and any needed testing or referral of samples to ensure timely testing and communication in the event of a regional, state or federal emergency event.
8. Maintain Standard Operating Procedures (SOP) for all emergency laboratory-testing methods.
Divisions and Contact Information
(n1iv) Seventy-seven of the eighty-three Michigan counties have joined the Regional Lab System divided into three regional divisions. See Attachment 1 for the map of the Regional Laboratory System. The contacts for each division and associate labs are as follows:
REGIONAL DIVISIONS
Region 1: Grand Rapids
Technical Consultant: Erin Lammers
Phone:
Region 2: Saginaw
Technical Consultant: Tammy Theisen, MT(ASCP)
Phone: 989-758-3680
Region 3: Kalamazoo
Technical Consultant: Aaron Hoogenboom
Phone: 269-373-5077
Associate Members
Oakland County Health Division Laboratory
Laboratory Supervisor: Barbara Weberman
Phone:
Genesee County Health Department
Laboratory Officer: Gary Johnson, M.D, MPH.
Phone:
Laboratory Capacity and Capabilities
The regional labs are considered to be LRN-B laboratories except for Genesee County. They have the capability to perform routine diagnostic services, rule-out for specific select agents, and refer samples to MDHHS for further testing. In terms of select agent rule out testing, these labs only perform procedures on clinical samples. Environmental samples are sent directly to MDHHS Bureau of Laboratories for testing. These labs do not participate in the LRN-C. Attachment 2 summarizes the capabilities of the laboratories. (n1iv)
Michigan Department of Community Health Laboratory
The MDHHS Laboratory is a LRN-B and LRN-C lab. The MDHHS Laboratory will perform procedures for isolation and identification for Bacillus anthracis, Yersinia pestis, Francisella tularensis, Brucella spp. (genus level), Burkholderia spp. (species level), Clostridium botulinum and toxin testing, rule out and/or confirm Variola virus, and Coxiella burnetii. The MDHHS laboratory has the capacity to test for cyanide, nerve agent metabolites, nitrogen mustard, abrine, ricinine, and sulfur mustard metabolites. The capabilities of the Lansing State Laboratory can be found at http://www.michigan.gov/mdch/0,4612,7-132-2945_5103---,00.html.
Divisions and Contact Information
Michigan Department of Community Health
Bureau of Laboratories
3350 North Martin Luther King Jr. Blvd.
Building 44 Room 155
Lansing, Michigan 48906
Main Lab Telephone Number: 517.335.8063
Main Lab Fax Number: 517.335.8051
24/7 Emergency Number: 517.335.9030
MDHHS Bureau of Laboratory Director
Sandip Shah, Ph.D., HCLD(ABB) Director's Office - (517) 335-8063
Specimen Collection
Any Michigan local health department, licensed physician's office, licensed laboratory or licensed health care facility may submitspecimens for testing. Animal heads may be submitted for rabies testing by veterinarians, animal control officers, law enforcement agencies, and etc. MDHHS guidelines for euthanizing bats are in Attachment 4.
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 (MDHHS) Bureau of Laboratories. The Laboratory Support Unit at MDHHS 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, Attachment 5 and for other specialized tests including Variola see Attachment 6) to the MDHHS Bureau of Laboratories.
Orders may be submitted by:
Mail - 927 Terminal Drive, Lansing, MI 48906
Fax - (517)335-9039,
Phone - (517) 335-9040)
or E-mail:
Guidelines for Collection
a. Use containers (mailing units) provided by the MDHHS Bureau of Laboratories for the collection and transport of specimens.
b. 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.
c. 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.
d. Submit specimens in the appropriate transport containers. Do not submit cultures in petri plates as they are easily broken.
Specimens for the Centers for Disease Control and Prevention
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 the state 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), Attachment 8) and routed through the state laboratory, unless otherwise advised. MDHHS will assign a number for tracking purposes. History forms are available from the Data and Specimen Handling Unit at MDHHS [(517) 335-8059].
If specimens or etiologic agents submitted to the state 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
MDHHS Specimen Rejection Policy
A. If the submitter of any specimen has not completed the test requisition form, the form will be returned via mail or fax. The testing will not be performed until the completed test requisition 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.
B. Specimens of any type will be subject to rejection if they:
· Are of insufficient quantity.
· Are of insufficient quality.
· Are of excessive age for the type of examination requested.
· Are received with either specimen container unlabeled or test request form incomplete or mismatched.
· Are submitted in an inappropriate manner, i.e., are not shipped according to Federal Postal regulations.
· 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.
· Are sent in expired media.
C. Serum specimens will be rejected if they are in glass tubes.
D. Specimens for culture will be rejected if:
· They are submitted in an improper transport medium (i.e., transport medium that could compromise results).
· They are not received within a time frame optimal for the organisms for which isolation is being attempted.
· 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.
E. 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.
F. The reporting of cultures submitted for identification but which are not pure isolates will be delayed and may not be attempted.
Packaging/Shipping (n1i), (n1ii)
A. General
1. Ship specimens to MDHHS at the following address:
Michigan Department of Community Health
Bureau of Laboratories
3350 North Martin Luther King Jr. Blvd.
Building 44 Room 155
P.O. Box 30035
Lansing, Michigan 48909
2. 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 by MDHHS. Do not use wet ice, as it melts and may leak in transit, thus endangering the integrity of the specimen.
3. Refer to the instructions accompanying the collection units for the proper way to prepare specimens for shipping.
4. 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.
5. 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.
6. 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 specialty laboratory is strongly encouraged.
7. All packages containingbiological specimens and/orinfectious agents must conform to regulations for the transporting of specimens of this type.These regulations are subject to change.
a. VBCDHD utilizes Quest Diagnostics and FedEx as their main couriers for specimens; however other shipping companies may be used as needed.