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)

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

Application for CLIA Certificate Overview 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

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

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

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

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.

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

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

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

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

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)

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

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)

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

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

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

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)

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

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

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

Special Recognition Good 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)

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)

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

Feedback and Discussion