CLIA Challenges in Laboratory Consolidation

Transcription

1 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

2 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

3 Cleveland Clinic 51,000 employees

4 Scope of Laboratory Tests per year: 21,000,000 Pathologists: 105 Employees: 1600 Number of CLIA Certificates: 208 Number of Lab Directors: 155 POC Personnel: Waived 12,000, Nonwaived 800, PPMP 500

5 Challenges in Laboratory Integration Local test menu (onsite vs. core lab) Logistics Standardization of ordering, preanalytics Standardize lab management Quality oversight; accountability

6 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

7 Accreditation Challenges in System Integration Each hospital independently accredited and must independently meet CMS Conditions of Participation (CoP) Each CLIA certified 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

8 CMS Medicare Medicaid Reimbursement Hospital Conditions & Standards CoPs CLIA Laboratory Conditions & Standards Joint Commission Deemed Status For Accreditation CAP COLA, AABB, ASHI, etc.

9 Differences Between CAP and CMS Inspections CAP Inspectors Peers and Professional Professional State Dept of Health or CMS Regional office Inspection Biannual: usually 1-2 days on site Validation within 90 days of AO extended ; copy materials and review remotely CMS 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 consultation 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

10 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

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

14 Main Areas of Disparities Personnel records Test validation Proficiency Testing Competency Assessment Laboratory Director Responsibility

15 Types of CMS Deficiencies Standard-Level Condition-Level Immediate Jeopardy

16 CMS Deficiencies Standard-Level: noncompliance with a particular requirement - Example: Lab not performing gram stain QC weekly: 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 Condition: Laboratories performing moderate complexity testing; laboratory director

17 CMS Deficiencies

18 CMS Deficiencies

19 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

20 Possible Sanctions

21 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)

22 Examples and Lessons from Deficiencies Proficiency Testing Competency Assessment Personnel Qualifications; 209 Form

23 Proficiency Testing CFR 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

24 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

25 Competency Assessment Assessor had not been assessed Individual observing competency not certified by LD for role as TS or GS (high complexity) or TC (moderate complexity) No direct observation Didn t include problem solving or quizzes not graded Pathologists as TP: Competency for FS, grossing

26 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

27 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

28 Personnel Lessons Review/LD approve qualifications during hiring diploma and transcript (post-hire audit) 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

29 CMS 209 Form Accuracy

30 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

31 Hospital vs. System Focus SOP header PLMI CMS wanted all SOP s to be MMH only System policies were based on main hospital policy - PT policy included PT catalog numbers for main campus, not just MMH

32 Site Corrective Action POC Submitted Testing discontinuation To other CLIA s (CCL, POC, Blood Gas, Mobile stroke) CLIA consultant Re-wrote SOP s Rehired staff, Retrained, Re-competency IJ Removed November 2015 Testing reintroduced over next 8 months

33 Effect of Lab Integration Central oversight challenge Subject matter experts - central Local management new, covering several sites Standardized platforms and IT with local QMS Uncovered pre-existing practices CLIA Lab Directors focused on AP

34 What did we do? System-wide Risk Mitigation CLIA Audits CLIA Training Standardization of PT, Competency, Personnel Qualification review Quality and Compliance Structure ISO 15189

35 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)

36 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

37 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

38 Approach to Quality Structure Development 8 Case Studies & Industry Best Practices PLMI Consensus Building Operating Model & Culture that is: Global Scalable Standardized Accountable 3 Key Industry Opinion Leaders PLMI Internal Assessment

39 System-wide risk Mitigation Established new QA structure - Laboratory Quality Specialists (LQS) - Center for Accreditation and Compliance - CLIA Lab Director Meetings Target ISO accreditation

40 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 (process) CAP (procedures) CLIA (regulations) ISO = pinnacle of lab quality ¹Data from National Jewish Health ISO Implementation

41 ISO and CAP Root Cause ISO Defects Processes CAP Improvement Improved Quality Nonconformances Standard work Teamwork

42 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

43 Compliance Insurance Compliance is a Moving Target 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)

44 Compliance: Team Sport! Say what you do Do what you say Document it (if you don t document it, it didn t happen)

45 Labs Oversees IVD manufacturers Lab Reagents Instruments Administers CLIA Oversight Lab Services Accreditation Compliance

46 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

47 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 - Make sure that the DOERS Do and the REVIEWERS don t miss something

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