CLIA Challenges in Laboratory Consolidation 5/1/18 Kandice Kottke-Marchant, MD, PhD Pathology & Laboratory Medicine Institute Eileen Pomiecko, HACP, CJCP Senior Director Regulatory Affairs

Cleveland Clinic System Integration One Cleveland Clinic

• Goal – unified health care across enterprise • Laboratory

- One institute, employed pathologists - One LIS - Standardized instrumentation - Standardized test menu, reference ranges,

critical values

Cleveland Clinic 51,000 employees

14 CCHS Hospitals

18 Family Health Centers & ASC

Scope of Laboratory

• Tests per year: 21,000,000 • Pathologists: 105 • Employees: 1600 • Number of CLIA Licenses: 208 • Number of Lab Directors: 155 • POC Personnel: Waived 12,000,

Nonwaived 800, PPMP 500

Challenges in Laboratory Integration

• Local test menu (onsite vs. core lab) • Logistics • Standardization of ordering, preanalytics • Standardize lab management • Quality oversight; accountability

Complexity of Lab Quality • >1000 CLIA Regulations • >1500 unique Lab Tests • 155 CLIA Lab Directors • 16,000 policies and procedures • 3500 CAP requirements • Competency assessment; QC;

Proficiency Testing; equipment maintenance; SOP review - training

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Accreditation Challenges in System Integration

• Each hospital independently accredited and must independently meet CMS Conditions of Participation (CoP)

• Each CLIA licensed lab must independently meet CLIA regs

• Standardization is the key to create “systemness” and a highly reliable organization

• Policies and Procedures • Central oversight, local accountability

CMS

CLIA

Medicare Medicaid Reimbursement

Laboratory Conditions & Standards

CAP Deemed Status For Accreditation Joint Commission

CoPs Hospital Conditions & Standards

COLA, AABB,

ASHI, etc.

Differences Between CAP and CMS Inspections

CAP CMS Inspectors Peers and Professional Professional – State Dept of Health or CMS Inspection Biannual: usually 1-2 days on site Validation – within 90 days of AO extended ;

copy materials and review remotely Basis CAP Checklist CLIA regulations Correction On site corrections allowed Not allowed for CLIA

System Understanding of lab as part of a system

All SOP’s and materials must originate from CLIA specific site

Response Submitted in writing, some discussion Submitted in writing; no feedback or discussion

Personnel Becoming more strict Extremely strict interpretation Competency 6 elements Delegation strict; assessment of assessor;

grading Point of Care testing locations

Optional review (if time allows) Every location inspected

CMS Validation Survey • Occurs after about 3-5% of Accrediting Organization

(AO) inspections • Performed concurrently or within 90 days of AO

inspection • Goal: To validate the accreditation agency’s survey

process • Review lab compliance with CLIA standards • Focuses on quality assurance and quality control

programs, documentation, personnel (qualifications and competency), proficiency testing, equipment & more

Reasons for Disparities

• CLIA’88 vs. CAP Checklist • Professional vs. Peer inspectors • Deep dive vs. Spot check • Citation for single instance vs. pattern/trend

Main Areas of Disparities

• Personnel records • Test validation • Proficiency Testing • Competency Assessment • Laboratory Director Responsibility

Types of CMS Deficiencies

• Standard-Level • Condition-Level • Immediate Jeopardy

CMS Deficiencies • Standard-Level: noncompliance with a

particular requirement - Example: Lab not performing gram stain QC weekly: - §493.1261 Standard: Bacteriology. (a)(2) Each week of use for gram

stains.

• Condition-Level: significant or serious issue that affects or could affect the accuracy and reliability of patient results - Example: Laboratory doesn’t have a qualified medical director - §493.140 Condition: Laboratories performing moderate complexity

testing; laboratory director

CMS Deficiencies

• Immediate Jeopardy (IJ) - Noncompliance has caused or is likely to cause serious

injury or harm, or death - 3 components:

• Seriousness • Immediacy • Harm

CMS Deficiencies • Immediate Jeopardy (IJ)

- 2 day notice to CMS Regional Office and provider - 23 day termination track - Submit “credible allegation of compliance” - Revisit to ensure IJ removed

• If IJ cleared, 90 day termination track (67 extra days) • Submit “Plan of Correction” (PoC) for remaining

findings • Second revisit

Plan of Correction • Submit in 10 calendar days:

- Description of how the deficient practice(s) will be or have been corrected

- Audit performed on past test results to determine impact on patient care

- The method(s) to maintain and monitor compliance

- A realistic date of correction

Possible Sanctions - Suspend, limit, or revoke CLIA certificate - Directed Plan of Correction - Specific corrective action

• Notice to clients/patients - Suspension of all or part of lab Medicare

/Medicaid payments - State onsite monitoring - Civil money penalty - Public notice

Case Study: CMS Validation Survey • Marymount Hospital: CAP Accredited • CAP Inspection December 2014: 3 deficiencies • CMS Validation Survey March 2015: • 3 inspectors, 5 days, 1500 pages copied • May 2015 many deficiencies; Immediate Jeopardy

(Personnel qualifications, PT, Hematology, Blood Bank)

Examples and Lessons from Deficiencies

• Proficiency Testing • Competency Assessment • Personnel Qualifications; 209 Form

Proficiency Testing

• CFR 493.801 Enrollment and Testing of Samples - Not treating PT in same manner as patient - Not tested with regular workload by persons

who normally do testing • ACT, activity logs

- TP consulted pathologist during PT of microscopic samples

Proficiency Testing Lessons

• Schedule personnel to do PT to ensure rotation

• Accession PT in LIS; safeguard to prevent other hospitals from viewing

• Part time individuals working at more than one hospital

• Duplicate testing – make sure SOP is explicit

Competency Assessment

• Assessor had not been assessed • Individual observing competency not

certified by LD for role as TS or GS • No direct observation • Didn’t include problem solving – or quizzes

not graded • Pathologists as TP: Competency

Competency Assessment Lessons

• Define test systems and TP by test system • Do assessment of assessors at start of

year • Moderate complexity –TC can assess • High complexity – TS and GS can assess • Pathologist competency – FS, grossing,

microscopic evaluation

Personnel Qualifications and Delegations

• Degree in biological, chemical or physical science (issue of RN)

• Bachelor’s degree not stating field - Requires transcript and calculation of credit

hours for chemistry/biology - Stringent requirements for TC, TS, GS

• Foreign degree - Requires translation and equivalency

Personnel Lessons

• Review/LD approve qualifications during hiring – diploma and transcript

• Keep detailed personnel files on all employees – readily available

• Understand whether TP would qualify for GS, TC, TS positions

• Experience – may require letter from former employer

209 Form Accuracy

What Surprised Us? • Discrepancy between CAP and CMS

findings • Deep Dive of CMS inspection • Intensive interviews • Detailed personnel qualification scrutiny • Lack of guidance by CMS for corrective

action • Stand-alone hospital / CLIA focus

Hospital vs. System Focus

• SOP header – PLMI • CMS wanted all SOP’s to be MMH only • PT policy included PT catalog numbers for

main campus, not just MMH

Site Corrective Action

• POC Submitted • Testing discontinuation • CLIA consultant • re-wrote SOP’s • Rehired staff, Retrained • IJ Removed November 2015 • Testing reintroduced over next 8 months

Effect of Lab Integration • Central oversight – challenge • Subject matter experts - central • Local management – new, covering several

sites • Uncovered pre-existing practices • Audits without local accountability for

correction • CLIA Lab Directors – focused on AP

What did we do? System-wide Risk Mitigation

• Audits • Training • Standardization • Quality and Compliance Structure • ISO 15189

System-wide Risk Mitigation AUDITS

• Engaged external consultant • Performed mock CLIA audits –

enterprise laboratories • Prioritized corrective action • Expanded and empowered

internal audit group (Center for Accreditation and Compliance)

System-wide Risk Mitigation TRAINING

• CLIA holder accountability – fewer, more focused CLIA holders

• Retrained all CLIA Lab Directors • Developed CLIA holder council • Required CLIA holder monthly meetings • CLIA training for testing personnel

System-wide Risk Mitigation STANDARDIZATION

• Adopt standardized quality management system

• Metrics – central reporting/oversight • Develop systemic document control

process and oversight • Standardized competency process • Vice Chair for Integration - Accountability

for implementation

Approach to Quality Structure Development 8 Case

Studies & Industry Best

Practices

3 Key

Industry Opinion Leaders

PLMI Internal

Assessment

PLMI

Consensus Building

Operating Model & Culture

that is: Global

Scalable Standardized Accountable

System-wide risk Mitigation

• Established new QA structure - Laboratory Quality Specialists - Center for Accreditation and

Compliance - CLIA Lab Director Meetings

• Target ISO 15189 accreditation

Why ISO 15189? • Fastest growing lab standard.

- Internationally based best practices • Supplements CAP accreditation

- Roadmap to implement QMS - Insures quality management

process. - Uses professional assessors

• Significantly decreases risk of errors (up to 45%¹) as well as costs of poor quality (related to errors).

• Supports CC and PLMI growth: - International laboratory standard for

CC

ISO = pinnacle of lab quality

ISO (process)

CAP (procedures)

CLIA (regulations)

¹Data from National Jewish Health ISO Implementation

ISO

ISO and CAP

CAP

“Defects” Nonconformances

Pro

cess

es

Root Cause

Standard work Teamwork

Improvem

ent Improved Quality

Laboratory Quality is everyone’s responsibility

Those Who

Do • Medical

Technologists • Lead Techs • Lab Supervisors

Those Who Review

• LQS • Lab Managers • Lab/Medical

Directors

Those Who Audit

• LQS • Center for

Accreditation and Compliance

Compliance “Insurance”

• DOERS (remember all of the CLIA and CAP things to do)

• REVIEWERS (make sure that the Doers “did”)

• AUDITORS (make sure that the Reviewers didn’t miss something)

“Compliance is a Moving Target”

Compliance: Team Sport! • Say what you do • Do what you say • Document it • (if you don’t

document it, it didn’t happen)

Oversees IVD manufacturers

• Lab Reagents • Instruments

Administers CLIA

Oversight • Lab Services

Labs

Why Now? Between Scylla and Charybdis

Accreditation Compliance

What Could We Have Done Better?

• Be better prepared for CMS validation inspections

• Focus on CLIA regulations in addition to CAP regulations

• Standardized quality, competency, personnel at time of original integration

What Did We Do Well? • Complete revamp of the index

laboratory (Model Laboratory) • Transferred Lessons to whole system • Put preventive measures in place • Improved accountability and

oversight

CLIA Challenges in Laboratory ConsolidationCleveland Clinic System Integration�One Cleveland ClinicSlide Number 3Scope of Laboratory Challenges in Laboratory IntegrationComplexity of Lab QualityAccreditation Challenges in System IntegrationSlide Number 8Differences Between CAP and CMS InspectionsCMS Validation SurveySlide Number 11Slide Number 12Reasons for DisparitiesMain Areas of DisparitiesTypes of CMS DeficienciesCMS DeficienciesSlide Number 17Slide Number 18Plan of CorrectionSlide Number 20Case Study: CMS Validation SurveyExamples and Lessons from DeficienciesProficiency TestingProficiency Testing LessonsCompetency AssessmentCompetency Assessment LessonsPersonnel Qualifications and DelegationsPersonnel Lessons209 Form AccuracyWhat Surprised Us?Hospital vs. System FocusSite Corrective ActionEffect of Lab IntegrationWhat did we do?�System-wide Risk MitigationSystem-wide Risk Mitigation�AUDITSSystem-wide Risk Mitigation�TRAININGSystem-wide Risk Mitigation�STANDARDIZATIONApproach to Quality Structure Development System-wide risk Mitigation�Why ISO 15189?ISO and CAPLaboratory Quality�is everyone’s responsibilityCompliance “Insurance”Compliance: Team Sport!Slide Number 45What Could We Have Done Better?What Did We Do Well?Slide Number 48