Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey,...

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

Transcript of Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey,...

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

Michigan Regional Laboratory System

Reorganization

Frances Pouch Downes, Dr.P.H.

Jeffrey P. Massey, Dr.P.H.

MDCH Bureau of Laboratories

Page 2: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 3: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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)

Page 4: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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)

Page 5: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 6: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.
Page 7: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

Why reorganize?

• Shrinking state workforce

• Fewer non-waived tests used throughout system

• Inequitable charges for shared support structure

Page 8: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 9: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 10: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 11: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 12: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

Options

• No participation in MRLS

• Technical support (Basic Membership)

• Enhanced services

Page 13: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

Non-Participation in MRLS

• Independently responsible for ensuring CLIA compliance

• No access to technical consultation

Page 14: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 15: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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)

Page 16: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 17: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 18: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 19: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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

Page 20: Michigan Regional Laboratory System Reorganization Frances Pouch Downes, Dr.P.H. Jeffrey P. Massey, Dr.P.H. MDCH Bureau of Laboratories.

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