Call-In Information

1. Call-In Information • Web meeting address: https://www.webmeeting.att.com • Meeting number 8773361828 • Access Code: 1666469 • Join the audio portion at: • 877-336-1828 • Access code 1666469 (yes, they are the same) (the audio will not be able to be streamed through the computer)

2. Michigan Regional Laboratory System Reorganization Jeffrey P. Massey, Dr.P.H. Pamela Diebolt, MT(ASCP) – CLIA Program Webinar #2 – July 20, 2011 MDCH Bureau of Laboratories

3. Outline • Choose your certificate type • Choose your laboratory director • Choose your laboratory staff • Submit your CLIA application (CMS-116) • Ensure CLIA compliance • Prepare for accreditation

4. Certificate Types • Certificate of Waiver: Waived tests only • Certificate of Provider Performed Microscopy: Wet mount performed by physician or mid-level practitioner & waived tests • Certificate of Compliance: moderate or high complexity tests (including wet mounts) performed by med tech or nurse, etc. & waived tests

6. Lab Director Qualifications:CLIA Certificate of Waiver • CLIA does not have specific requirements – any staff member can assume these responsibilities

7. Lab Director Responsibilities:CLIA Certificate of Waiver • Ensure CLIA certificate is active (pay fees) • Ensure all testing is performed according to the manufacturer’s package insert • Ensure that only CLIA-waived testing is performed • Notify the CLIA Program of changes in ownership (tax id), name, address, and laboratory director within 30 days AND of certificate changes before any non-waived testing is performed • Ensure adherence to principles of Good Laboratory Practices

8. Testing Staff Qualifications:CLIA Certificate of Waiver • CLIA does not have specific requirements – any staff member can assume these responsibilities

9. Testing Staff Responsibilities:CLIA Certificate of Waiver • Lab staff must be capable of and trained to perform CLIA-waived testing in accordance with manufacturer’s instructions

10. Laboratory Director Qualifications:Certificate of Provider Performed Microscopy • MUST be either a physician or mid-level practitioner (NP, PA, or nurse mid-wife) that is licensed to practice in the State of Michigan

11. Laboratory Director Responsibilities:Certificate of Provider Performed Microscopy • Must accept responsibility for all CLIA testing performed under the certificate • Ensure CLIA certificate is active (pay fees) • Ensure that only CLIA-waived testing and PPMP testing is performed • Notify the CLIA Program of changes in ownership (tax id), name, address, and laboratory director within 30 days AND of certificate changes before non-waived or non-PPMP testing is performed • Ensure adherence to principles of Good Laboratory Practices • Comply with all CLIA requirements for moderately complex non-waived testing

12. Testing Staff Qualifications:Certificate of Provider Performed Microscopy • MUST be either a physician or mid-level practitioner (NP, PA, or nurse mid-wife) • CLIA-waived testing performed under this certificate may be performed by any trained staff member

13. Testing Staff Responsibilities:Certificate of Provider Performed Microscopy • Comply with all CLIA requirements for non-waived, moderate complexity testing at 42 CFR 493 • Daily QC • Training / Competency • 2x year verification of test accuracy (Proficiency Testing) • Documentation of QA activities

14. Laboratory Director Qualifications:Certificate of Compliance (Moderate Complexity) • Bachelors Degree in chemical, physical, biological, clinical laboratory science or medical technology AND 2 years non- waived laboratory training and experience AND 2 years non- waived supervisory experience • Masters Degree in chemical, physical, biological, clinical laboratory science or medical technology AND 1 years non-waived laboratory training and experience AND 1 years non-waived supervisory experience • PhD in chemical, physical, biological or clinical laboratory science AND either certified by an approved Board OR can demonstrate 1 year directing or supervising non-waived, clinical laboratory testing (not research) • Physician licensed to practice medicine in the State of Michigan that is a board certified pathologist OR can demonstrate 1 year directing or supervising non-waived testing OR has obtained 20 CMEs in laboratory practice

15. Laboratory Director Training • The courses listed below are designed to meet the CLIA requirement at 42 CFR 493.1405(b)(2)(ii)(B). • Universityof Iowa – On-line computer assisted laboratory director course. ($425) • Universityof Wisconsinand COLA – Physician's Office Laboratory (POL) Symposium: Three day meeting with national speakers and exhibits containing POL equipment. ($625) • Universityof Wisconsin and COLA – Lab University: On-line laboratory director course. ($382.50)

16. Laboratory Director Responsibilities:Certificate of Compliance(Moderate Complexity) • Found at 42 CFR 493.1407 • Include responsibility for ensuring quality laboratory systems, ensuring a safe environment, ensuring PT testing is performed as required, ensuring that QC and QA systems are in place, ensuring that staff are competent to perform testing, etc. • Duties in this section can be delegated in writing to another individual, but the director remains responsible for ensuring duties are performed • 493.1251(d) requires that all procedures be approved, signed and dated by the current laboratory director. This duty can not be delegated to another individual.

17. Laboratory Director Responsibilities:Certificate of Compliance • NOTE: An individual may direct no more than 5 non-waived laboratories at one time. This includes PPMP labs, Certificate of Compliance labs and Certificate of Accreditation labs. • A multiple-site certificate counts as one laboratory

18. Testing Staff Qualifications:Certificate of Compliance(Moderate Complexity) • Minimum educational requirements: • Moderate complexity testing requires at least a high school diploma (or equivalent) • Laboratory training requirements: • Must maintain documentation of appropriate training prior to testing

19. Testing Staff Responsibilities:Certificate of Compliance(Moderate Complexity) • Found at 42 CFR 493.1425 • May only perform testing authorized by the laboratory director to perform • Must follow the laboratory procedures and policies • Must maintain documentation for PT, QC, instrument calibrations, and instrument maintenance • Must be capable of identifying problems in the laboratory systems • Must document any corrective actions taken

20. Application for CLIA CertificateOverview • Complete CMS-116 http://www.cms.gov/cmsforms/downloads/cms116.pdf • Submit to State CLIA program • Applications usually processed in 2-3 business days • Bill mailed by CMS • Mail payment to CMS • Certificate mailed by CMS The process typically takes at least 3-4 weeks

21. CMS-116 CLIA Application • Section 1 – General information • Section 2 – Type of Certificate Requested • Section 3 – Type of Laboratory • Section 4 – Hours of Testing • Section 5 – Multiple Sites*** • Section 6 – Waived Testing • Section 7 – PPM Testing • Section 8 – Non-Waived Testing • Section 9 – Type of Control • Section 10 – Director Affiliation other labs

22. Requirements for Multiple Site Certificate • Multiple site exception #2: A not-for-profit or government lab engaged in limited testing and filing for a single certificate for multiple sites • Testing can be no more complex than moderate complexity • No more than 15 different moderate complexity and/or waived tests per certificate • Identify the location of all testing sites • One tax ID per CLIA certificate

23. Submitting a CMS-116 Application • Must be signed and dated by the laboratory director • When submitting an application for a certificate of compliance, submit documentation of the laboratory director qualifications (State license, board certification, laboratory CMEs completed, college transcript, etc.) • Submit to State CLIA program at: • Fax to: 517-241-3354 • E-mail to: DCH-BHS-Lab@michigan.gov • Mail to: MDLARA Bureau of Health Systems/Division of Licensing and Certification Laboratory Improvement Section PO Box 30664 Lansing, Michigan 48909

24. Submitting a CMS-116 Application • The CLIA state agency will send an acknowledgement letter after the CLIA application is processed. • A second letter requesting a Clinical Laboratory Licensure Application will be enclosed. • Laboratory licensure is a separate State requirement. • All CLIA certified laboratories must submit an application for laboratory licensure. • No Clinical Laboratory licenses are being issued at this time.

25. CLIA Contacts and Information Contact the Laboratory Improvement Section (CLIA State Agency) at 517-241-2648 regarding CLIA questions • Direct line to Pam is 517-241-0821 or DCH-BHS-Lab@michigan.gov • The CLIA regulations are found at: http://wwwn.cdc.gov/clia/regs/toc.aspx • A list of CLIA-waived tests is found at: http://www.cms.gov/CLIA/downloads/waivetbl.pdf • Good Laboratory Practices document found at: http://www.cms.gov/CLIA/downloads/wgoodlab.pdf

26. Options for Participation in the MRLS • Non-participation: no technical support • Technical support (Basic Membership) • Enhanced services

27. Costs of Participation • CLIA Certificate – variable (based on certificate type) • Basic Membership - $250 • 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 • Proficiency Testing

28. Proficiency Testing Costs:WSLH • Hemoglobin (hemocue): $122 • Urine chemistry/pregnancy: $104 • Cholestech: $150 • Group A strep: $92 • Whole Blood Glucose: $134 • Shipping: $30 per site

29. How Much Will it Cost?Example #1 • Lab does waived testing only • Request Basic membership, no enhanced services • No PT • Certificate Required • Certificate of Waiver • Breakdown of costs – TOTAL COST $400 • CLIA Certificate fee: $150 (every 2 yrs) • Basic MRLS membership fee: $250 (annually)

30. How Much Will it Cost?Example #2 • Lab has NP performing wet mount & nurses performing waived tests • Request basic membership with enhanced services (site visit & quarterly document review) • Certificate Required • Certificate of Provider-Performed Microscopy

31. How Much Will it Cost?Example #2 • Breakdown of costs • CLIA Certificate fee: $200 (paid every 2 yrs) • Basic MRLS membership fee: $250 (annually) • Enhanced services • Document review: 4 x 2 hrs = 8hr x $50/hr = $400 • 210 mile x $0.51/mile = $107.1 • 3 hr travel time x $50/hr = $150 • 3 hr onsite time x $50/hr = $150 • TOTAL COST = $1257.10 (first year)

32. How Much Will it Cost?Example #3 • Agency has med techs and nurses performing 1500 wet mounts per year. • Physician with no lab experience will be lab director. • The agency performs hemoglobin, urine chemistry, urine pregnancy and cholestech at 2 sites. • PT will be performed for all waived tests. • Agency decides basic membership with no enhanced services

33. How Much Will it Cost?Example #3 • Regulatory Requirements • Certificate of Compliance • Lab Director must document 20 CME laboratory training • On site survey required

34. How Much Will it Cost?Example #3 • Breakdown of Costs • CLIA fees • Certificate of Registration: $100 • Compliance Fee: $300 • Certificate Fee: $150 • Basic MRLS Membership Fee: $250 • Lab Director Training: $382.50 • PT (subscription with WSLH): • Hemoglobin: $122 x 2 = $244 • Urine Pregnancy/Urine Chemistry: $104 x 2 = $208 • Cholestech: $150 x 2 = $300 • Shipping: $30 x 2 = $60 • TOTAL COST $1994.50

35. 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)

36. Accreditation Requirements: Certificate of Waiver • Hold valid Certificate of Waiver • Perform testing in accordance with manufacturer requirements (refer to slide #7)

37. Accreditation Requirements: Certificate of Provider Performed Microscopy • Physician/Mid-level Practitioner serves as lab director • Only Physician/Mid-level Practitioner performs testing • Meet all QA requirements for non-waived testing • Meet criteria for waived testing

38. Accreditation Requirements: Certificate of Compliance Requirements • Hold valid CLIA Certificate of Compliance • Qualified Lab Director • Surveyed by CMS & determined to be compliant • Meet criteria for waived testing

39. Special RecognitionGood Laboratory Practice(Waived tests) • Training/Competency • Proficiency Testing • QC – performance & review • Corrective and Preventive Action • Written QA plan – evidence of QA activities • Written procedures for all testing • (i.e., keep doing everything you’re currently doing now)

40. 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 (date TBD) • Apply for CLIA certificate (no later than 9/1/11)

41. Implementation Timeline • August/Sept: Site Coordinator training • By Sept. 1: submit CLIA application (CMS-116) • By Sept 1: notify MDCH with decision of MRLS participation (none, basic only, basic with enhanced) • By October 1: MDCH to dissolve current umbrella certificates • October 1: Target launch date

42. Feedback and Discussion