1. Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories

2. Terms Level of Testing –Waived –Non-waived (moderate and high complexity) CLIA certificate –Certificate of Waiver –Certificate of Microscopy –Certificate of Compliance Affiliate laboratory Technical consultant

3. Certificate of Waiver Performance of waived tests only Waived tests: so simple that there is little risk of error. –These tests are exempted from most CLIA requirements –no routine inspections Examples: urine pregnancy, hemoglobin (hemocue), urine dipstick, cholesterol (cholestech), rapid strep Requirements: follow manufacturer package insert with no modification Cost of certificate: $150 (good for 2 years)

4. Certificate of Microscopy Provider performed microscopy procedure: must be performed by physician or mid-level practitioner (e.g., NP or PA) Lab Director: Physician or mid-level practitioner Test: Wet mount (moderately complex) CLIA: must comply with all requirements for non-waived testing. No routine survey Waived tests: may be performed Cost of certificate: $200 (good for 2 years)

5. Certificate of Compliance Non-waived testing (either high or moderate complexity) Waived testing may also be performed Lab Director: lab training or experience required Wet Mount: COC required if testing performed by Med Tech or nurse CLIA: must comply with all requirements for non-waived testing. Lab survey performed every two years Variable cost based on test volume

7. Why reorganize? Shrinking state workforce Fewer non-waived tests used throughout system Inequitable charges for shared support structure

8. Process Initial proposals unacceptable Utilize Lean Process tools and trained facilitators Focus Group 3 day Workshop Resulted in a model with consensus of all participants

9. Retained from current organization Consultation available from technical consultants –Phone, e mail –Site visits –QC review –Assistance with “occurrence management” –New test implementation Website Maintain collection of current documents

10. What changes Each jurisdiction obtains and maintains its own CLIA certificate Enhanced site coordinator role (like food program on-site trainer) Basic service package LHDs can get and pay only for the enhanced services they want Subscribe directly to proficiency testing service (if accreditation with “Special Recognition” desired) Accreditation tool revised Training and competency evaluations to be available at conferences and regionally

11. Proposal Advantages Responsive to current testing environment More local control Maintain access to most requested services Cost at or below current level usually More equitable fees Paying fees to regional lab providing service Less regulation- –opt for lower level certificates –less paperwork/documentation Improved training options Redirect state resources to other priorities Maintain networking

12. Options No participation in MRLS Technical support (Basic Membership) Enhanced services

13. Non-Participation in MRLS Independently responsible for ensuring CLIA compliance No access to technical consultation

14. Basic Membership Package Phone and email consultation Annual technical consultant meeting Access to website List serve updates Initial QA system training for site coordinators Discount for training Annual cost: $250

15. Changes to Accreditation Tool Compliance with current, valid CLIA certificate –On site review not required for all sites Option for “Special Recognition” if perform waived testing following CDC Good Laboratory Practice (GLP) (Webinar #2 to discuss details of revised tool)

16. Enhances Services A la carte menu- pay for what you want/need Site visits Competency evaluation/training at annual public heath conferences Review of QA documents (quarterly or monthly) Corrective action assistance Pre-inspection audits Procedure and form development New test introduction assistance

17. Costs of Enhanced Services $50 per hour (travel time, on site time, document review time, etc.) IRS rate for travel (currently $0.51 per mile) Actual costs for postage, copying, other supplies

18. Implementation Timeline April/May: finalized plan (establish fees, assignments) June: revised accreditation tool Webinar #1: July 6 10:00 – 12:00 Webinar #2: July 20 10:00-12:00 August/Sept: Site Coordinator training Sept: submit CLIA application (CMS- 116) October 1: Target launch date

19. Next steps Determine what kind of certificate you need –What tests performed and by whom Identify lab director Is lab director training needed Determine MRLS participation level: basic membership, enhanced services, or opt out Identify site coordinator Attend site coordinator training Apply for CLIA certificate

20. Feedback and Discussion