CLIACLIA

CLIA ExperienceLaboratory Director’s

Responsibilities

CLIACLIA

CLIA ExperienceLaboratory Director’s

Responsibilities

Judith Yost, M.A., M.T. (ASCP)DirectorDivision of Laboratory Services

CLIACLIA

CLIA Experience• Topics for Discussion:

– CLIA philosophy Lab Director position– Impetus for re-emphasis– Overview of Lab Director responsibilities– Delegations– CMS “Brochure”—Handout– CMS survey findings– What if the educational approach fails?– Thoughts for the road

CLIACLIA

CLIA Experience

• CLIA Philosophy– Lab Director has overall responsibility for

ensuring quality testing; can fill all or any positions.

– This means active, ongoing participation in lab’s operation & accessibility.

– CLIA quality requirements correspond to these responsibilities.

– If there are serious issues in the lab, then the lab director is often cited, too.

CLIACLIA

CLIA Experience

• Impetus for Re-emphasis– Concerns about significant quality problems in

hospitals; e.g., MGH.– Other oversight agencies were not as focused.– Without top down support & good leadership,

the lab can’t succeed.– CLIA qualification requirements for testing &

supervisory personnel are minimal.

CLIACLIA

CLIA Experience• MGH Experience

– No collaboration or coordination between administrative & clinical directors.

– No active participation by director of record in daily operations.

– Serious QC, QA, personnel issues.– Intimidation of staff, rather than support.– Recipe for disaster of great proportions.

CLIACLIA

CLIA Experience

• MGH Experience– CMS believes this situation was an aberration,

not the routine.– But it doesn’t preclude the possibility of add’l.

occurrences, so it’s not an all clear signal.– There have been a few other close calls.– Therefore, it’s a wake up call for us all to

prevent future problems before they happen.– YOU have the power now!!

CLIACLIA

CLIA Experience• Lab Director’s Responsibilities Under CLIA

– Test systems provide quality services in all phases of testing process & appropriate for patient population. Includes:• Enrollment & successful PT participation.• QC/remedial actions/method verification,

etc.• QA.• Records & specimen integrity.• Personnel training & competency.

CLIACLIA

CLIA Experience• Lab Director’s Responsibilities Under CLIA

– New test procedures are reviewed, appropriate & included in procedure manual.

– Gen. Supervisor is available (HC only) for day-to-day oversight.

– Sufficient numbers of qualified personnel with duties specified in writing.

– Physical plant is adequate & safe.– Remember: CLIA is a minimum!!

CLIACLIA

CLIA Experience

• Delegations– To Clinical Consultant:

• Appropriateness of report interpretations.

CLIACLIA

CLIA Experience

• Delegations– To Technical Supervisor:

• Appropriate test method selection;• Adequate method verifications;• Acceptable analytical test performance;• PT enrollment & performance;• QC & QA programs;• Remedial actions;• Personnel training & competency;• Procedure manual.

CLIACLIA

CLIA Experience

• Delegations– To General Supervisor:

• Remedial actions if test performance deviates from performance specifications;

• Patient results not reported until corrective actions completed;

• Personnel orientation & annual evaluations.

CLIACLIA

CLIA Experience

• CMS Lab Director’s Responsibilities Brochure– Lists them in simple terms, along with CLIA

required positions.– Clarifies delegations.– Provides suggestions to ensure they are met.

• Develop a plan & monitor ongoing.

• CLIA Brochure states sources of further information.

CLIACLIA

CLIA Experience

CMS 2002 Survey Findings:DEFICIENCIES IN LABORATORY

DIRECTOR CONDITIONLabs Cited

Labs Surveyed

% Citations

Mod Complex 228 2789 8%

16%High Complex 111 691

CLIACLIA

CLIA Experience

CMS 2004 Survey Findings:

DEFICIENCIES IN LABORATORY

DIRECTOR CONDITION

Labs Cited

Labs

Surveyed

% Citation

s

Mod Complex

224

2789

8%

13%

High Complex

89 691

CLIACLIA

CLIA Experience

Most Frequently Cited Director Standards 2004Mod Complexity High Complexity

PT Reviews 11% Quality Control 19%Training 11% Quality Assurance 14%Correct PT 11% Training 10%Quality Assurance 10% Assign Duties 9%Quality Control 10% Correct PT 7%

CLIACLIA

CLIA ExperienceCMS SURVEY FINDINGS: MOD COMPLEXITY

0%

2%

4%

6%

8%

10%

12%

14%

16%

PT Review Training QC QA PT CorrAction

2002 2004

CLIACLIA

CLIA ExperienceCMS SURVEY FINDINGS: HIGH COMPLEXITY

0%

5%

10%

15%

20%

25%

QC QA Training PT CorrAction

Competency

2002 2004

CLIACLIA

CLIA Experience

• What is CMS doing to help?– Working with Partners in Lab Oversight.– Re-training surveyors.– Publishing brochure.– Updating surveyor guideline document.– Supporting educational conferences.– Augmenting CMS CLIA website.

CLIACLIA

CLIA Experience• What if education fails?

– CMS has an armamentarium of “incentives”.– The more serious, pervasive & repetitive the

problem, the greater & faster they are imposed. • Fines, directed corrective plans, on-site

visits;• Certificate & Medicare payment revocation.• Director can’t direct for 2 yrs. if revoked.

NOTE: Labs losing accreditation default to CMS & may have further actions imposed if not in compliance..

CLIACLIA

CLIA Experience• Thoughts for the Road

– Communicate!– Be actively involved in all aspects of the lab’s

operations, but allow experts to participate.– Hire good staff; where necessary, more

qualified than CLIA minimums.– Medical director must collaborate w/

administrative director to maximize success.– Utilize a Quality Systems approach.– Be creative & keep an open mind.

CLIACLIA

CLIA Experience

Where to get Information– CMS Central Office

• 410-786-3531– CMS CLIA Website

• www.cms.hhs.gov/clia/– Judy Yost’s email

• Judith.yost@cms.hhs.gov

http://www.cms.hhs.gov/clia/

CLIACLIA

CLIA Experience

THANK YOU!!!

QUESTIONS????

CLIA Experience�Laboratory Director’s ResponsibilitiesCLIA Experience�Laboratory Director’s Responsibilities�CLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA ExperienceCLIA Experience