Regional Laboratory System
- Summary of 2011B Proficiency Testing Results - 2/27/2012
- Technical Consultant Assignments- Document that identifies assignment of technical consultants to each participating agency in the MRLS - added 10/10/2011
- 2012 Proficiency Testing Options- Document summarizing pricing information for PT providers of waived testing - added 9/23/2011
- September 1 & 8, 2011 - PowerPoint presentation for webinar of 9/1/11 & 9/8/11
- Resources for Waived Testing- Link to the CDC.gov site
- List of Waived Tests- Link to the CMS.gov site
- Summary of Good Laboratory Practices
- Good Laboratory Practices for Waived Testing Sites- Link to the CDC MMWR document
- Webinar #2 - July 20, 2011- PowerPoint presentation for webinar of 7/20/2011
- CME Courses for Moderate Complexity Lab Directors - Link to the CMS.gov site
- CLIA Certificate Decision Tree - Flow chart for determining the appropriate CLIA certificate for your agency
- How to Apply for a CLIA Certificate - Link to the CMS.gov site
- Webinar #1 - July 6, 2011- PowerPoint presentation for webinar of 7/6/2011
The mission of the Michigan Regional Laboratory System is to provide for the delivery of analytical data which is accurate, timely and relevant to public health, clinical and epidemiological program needs. To continuously strive to improve testing quality and service delivery. To strengthen public health programs throughout Michigan through the voluntary affiliation of public health professionals in the Regional Laboratory System.
The goals of the Michigan Regional Laboratory System are:
- To develop and implement standardized testing procedures which meet CMS criteria for public health with emphasis on local public health jurisdictions.
- To provide a mechanism for local health departments to meet federal laboratory testing standards as set by the Clinical Laboratory Improvement Amendment of 1988(CLIA).
- To continuously monitor and evaluate the quality of testing performance, so that appropriate intervention can be taken when testing quality falls below acceptable levels of performance.
- To serve as an expert testing, training and consultative resource for local public health.
- Assist local health department laboratories in obtaining compliance with the laboratory accreditation process.
Region 1: Grand Rapids
Technical Consultant: Allyson Chirio
Region 2: Saginaw
Technical Consultant: Tammy Theisen, MT(ASCP)
Region 3: Kalamazoo
Technical Consultant: Aaron Hoogenboom
Oakland County Health Division Laboratory
Laboratory Supervisor: Barbara Weberman
Genesee County Health Department
Laboratory Officer: Gary Johnson, M.D, MPH.
The Regional Laboratory System was developed in response to a specific need expressed by local health departments in Michigan. In 1967, the federal Clinical Laboratory Improvement Act (CLIA' 67) was enacted to require hospitals and large clinical laboratories to adhere to strict quality control, test performance and personnel standards. Each testing facility had to have a certificate and was subject to a compliance inspection every other year. In 1988 the Clinical Laboratory Improvement Amendment (CLIA' 88) expanded the standards and extended them to include any facility performing a clinical test. This meant that each local health department had to develop an entire laboratory program which complied with CLIA'88 to continue many of its programs(e.g. health screening, WIC, ESPDT, Family Planning). Local health departments were not equipped to comply with the federal legislation. In 1990, MDCH Bureau of Laboratories developed the Regional Laboratory System in response to provide experienced Laboratory Directors (MDCH managerial staff) and Technical Consultants (the laboratory managers from Kent, Kalamazoo and Saginaw County Health Departments) to comply with the CLIA' 88 legislation. Seventy seven counties have joined the Regional Laboratory System. The regional laboratory system as initially established consisted of 6 administrative regions, each with its own Laboratory Director and CLIA'88 certificate. Three jurisdictions (Oakland County, Genesee County, and the City of Detroit) participate as associate members in the Regional Laboratory System. The associate members provide their own laboratory directors and oversight of laboratory operations, but collaborate with MDHHS on the implementation of laboratory quality assessment activities.
MDHHS laboratory managers, the Technical Consultants and additional MDHHS staff make up the Regional Laboratory Committee which meets on a quarterly basis. The primary responsibility of the Regional Laboratory Committee has been to develop standardized testing methods and uniform quality assurance practices which comply with the CLIA'88 requirements.
The Michigan Regional Laboratory System reorganized on October 1, 2011. The existing regional laboratory umbrella certificates were dissolved and each agency is responsible for obtaining their own CLIA certificate commensurate with the level of testing they perform. Each agency is also responsible for designating a laboratory director to oversee testing activities. Technical support is available to agencies upon request.
CONTROLS FOR WET MOUNTS
The Quality Control Unit within the Michigan Department of Health and Human Services Bureau of Laboratories provides the Regional Laboratories with deactivated yeast and bacterial suspensions to be used as a control for Wet Mount preparations. For more information on these see the Internal Proficiency Specimens for Wet Mount Microscopy page.