6/28/2016. Questions? Workshop 6 CAP Inspection Preparation Thursday, June 23, 2016

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1 Workshop 6 CAP Inspection Preparation Thursday, June 23, 2016 Allan W. Fraser Jr., CG(ASCP)CM, CCS, CQA(ASQ) Quality Assurance Manager, Quest Diagnostics at Nichols Institute Questions? Have you been inspected by CAP? How many have been inspected and interacted with inspectors directly? How was your experience? Did you survive? How many have been an inspector for CAP? The Good? The Bad? 2 Agenda Informal Conversation CAP and LAP and CLIA Why is your laboratory inspected by CAP? CAP & LAP History CAP & LAP Inspection Process CAP as Resource Pre-Inspection Activities Closer to the Inspection (in the window) Day of the Inspection Common Findings Commercial Products 3 1

2 What is the College of American Pathologists? Non-profit medical specialty society. Inspecting Laboratories since the early 60s. 18,100 members of board-certified pathologists. CAP is considered the leader in laboratory quality assurance. Interactions with 20,000 Laboratories around the world Laboratory Accreditation Program (LAP) 4 CAP Mission - The College of American Pathologists (CAP), the leading organization of board-certified pathologists, serves patients, pathologists, and the public by fostering and advocating excellence in the practice of pathology and laboratory medicine worldwide. Vision - People are healthier because of excellence in the practice of pathology and laboratory medicine. 5 CAP Centers for Medicare & Medicaid Services (CMS) granted the CAP Laboratory Accreditation Program deeming authority, which allows CAP inspection in lieu of a CMS inspection. CAP accreditation is recognized by The Joint Commission CAP accreditation can be used to meet many state certification requirements. 6 2

3 What is CLIA? Clinical Laboratory Improvement Amendments Are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States CFR Part 493, Subpart Q - Inspection The Clinical Laboratory Improvement Amendments mandate in Subpart Q that all test sites performing non-waived testing must undergo an inspection every two years. This presentation is designed to review what can be done to prepare for a CAP inspection to make it successful and stress-free Condition: Inspection requirements applicable to all CLIA-certified and CLIA-exempt laboratories Standard: Basic inspection requirements for all laboratories issued a CLIA certificate and CLIA-exempt laboratories. 8 Why is your laboratory inspected by CAP? CLIA mandates that virtually all laboratories, including physician office laboratories, meet applicable Federal requirements and have a CLIA certificate to operate. CLIA requires the U.S. Department of Health & Human Services (HHS) to certify laboratories performing non-research testing. The CMS administers the CLIA certification program. The CAP inspects and accredits medical laboratories under deemed authority of the CMS. 9 3

4 CAP History LAP Established Proficiency Testing required for participation CAP Hotline posting required CAP Checklist evolve CAP's plans to introduce IQCP checklist requirements. NYS Licensed Laboratories have a choice in Proficiency Testing Providers First checklist published CLIA grants deemed authority Unannounced Routine Inspections CAP Competency Assessment Program Available NYS designated CAP PT as equivalent Laboratory Accreditation Program (LAP) Accredits laboratory test disciplines with CMS approved customized checklist requirements. The CAP's peer-based inspector model is both regulatory and educationally collaborative. Peer Based inspection Inspectors are trained 2 Year Cycle 11 LAP -2 Year Cycle 12 4

5 LAPs Standards for Laboratory Accreditation I Director and Personnel Lists the qualifications and responsibilities of the laboratory director and defines the role of the consulting pathologist II Physical Resources Provides for a safe workplace for: Laboratory Employees / Hospital Employees / Patients III Quality Management Performance improvement Quality control Instrument maintenance Proficiency testing Clinical relevance IV Administrative Requirements Inspections 13 CAP & LAP Inspection Process Consultative and Collaborative. Objective of Continuous Improvement of the quality of clinical laboratory services through: Voluntary Participation. Peer Review. Education. Compliance with recognized performance standards. 14 CAP & LAP Inspection Process Inspections need to take place while the site s CLIA certificate is still valid. Receive the Inspection Checklists 3-6 months prior to the Inspection. CAP inspections are unannounced (1 hour) Inspectors have participated successfully in Team Member Training. 15 5

6 CAP & LAP Inspection Process Team Leader Inspection Planner Team Member Planner Team Meeting Review Specifics (Inspection Packet) for Laboratory being inspected. Inspection Packets Previous Finding PT Failures Personnel Equipment Facility Layout Section and Checklists 16 Inspector s View of Things Utilize the CAP Inspector R.O.A.D. Technique: Read Review a sampling of laboratorydocuments: Sampling of QM/QC policies and Procedures Nonconformance and corrective action. Observe Observe laboratory practices by observing laboratory personnel practices. (Note if their practices deviate from the written policies and procedures.) Ask Ask open ended, probing questions that start with phrases such as Tell me about. or What would you do if.. Discover A technique that can be used to drill down or further evaluate areas of concern uncovered during your self inspection. 17 CAP Learning Resources Inspection Team Member Training Credit Type: CE, CME, SAM Duration: 4 hours Inspection Team Leader Training Credit Type: CE, CME, SAM Duration: 4 hours 45 minutes Quality Management Biorepository Inspector Training Reproductive Forensic Drug Testing Cytogenetics Flow Cytometry 18 6

7 CAP Learning Resources Checklists Read them. Have your staff read them. Assign review of checklists sections to individuals. Assign accountability for checklist questions. Insure consistency Checklist interpretations. Competency Program 19 e- LAB SOLUTIONS SUITE 20 CAP Inspection Considerations Being Ready. Can t guarantee a stress-free inspection Should make you look good/professional in the eyes of the inspector Should lead to a better audit outcome First impressions do count! 21 7

8 CAP Inspection Considerations Different Challenges for Different Labs Size Complexity Number of Checklist Unique Laboratories (Cytogenetics, Flow Cytometry Specialist Auditors) How many days? How many inspectors? 22 Pre-Inspection Activities Meeting(s) with Personnel, Director, Management, and Personnel CAP LAP CLIA Review Checklists New Checklists Question Review Team Leader Review The inspection process Assign responsibilities Assign tasks What is expected? Book of Evidence (BOE) 23 Pre-Inspection Activities Inspector Documents Laboratory organization Charts Test menu LDT lists Instrumentation on a (section-by-section basis) Floor plan Test Activity Menu Personnel Lists 24 8

9 Pre-Inspection Activities Personnel Records: CVs CEUs Licensure Diplomas Transcripts Foreign Credential Evaluations (readily available) Experience 25 Pre-Inspection Activities Review Internal Inspections PT Issues Nonconformance & CAPA Quality Improvement Plans /QMS Safety 26 Pre-Inspection Activities Checklist answers General Lab Specific Checklists (Cytogenetics) Evidence of correction from previous inspection Pull together the Evidence of Compliance Provide specific examples of acceptable documentation (policies, procedures, records, reports, charts, etc.). Promote consistency in the understanding of the requirements between the laboratory and the inspector. (Interpretation) 27 9

10 Closer to the Inspection (in the window) Review with Staff: Blackout Days Identify Contact People Schedule Considerations for the Inspectors Location and Times for the Inspectors Meetings 28 Closer to the Inspection (in the window) Review: Complete Books of Evidence Checklists Previous inspections Spot Checks: Temperature Monitoring Reagent Expiration Previous findings PPE / Safety 29 Day of the Inspection Contact Security Reserve Meeting room for Inspection Team Opening Meeting Announced Opening Meeting Contact should introduce themselves to their corresponding inspector Brief tour Ask inspectors to inform staff being inspected of any findings with details at days end. Shadow Problem Sections Fix on site if possible Determine when closing will be and announce 30 10

11 Day of the Inspection list of individuals and management Lunch (special requirements) Opening meeting (Schedule, Room, Announce, all involved) Summation Special Issues (lab coats) 31 Action Items and Information The Mock Inspection Delegate Inspection Preparation Tasks Everyone in your laboratory has a stake Give your employees a quick reference for how your lab meets checklist requirements. Limit communications with Inspectors 32 Common Inspection Topics Laboratory Information Systems (LIS) Laboratory Reports and Test Requisitions Method Validation Studies Quality Management Program Quality Control Program Document Control Program Proficiency Testing Program/External Quality Assessment (EQA) Laboratory Safety Program Personnel Training and Competency Programs Transfusion and Donor Service Practices 33 11

12 Specific Inspection Disciplines Specialty Disciplines: Embryology Andrology Cytogenetics Histocompatibility Molecular Pathology Next Generation Sequencing Clinical Biochemical Genetics 34 TOP Inspection Deficiencies 1. Instrument Maintenance 2. Procedure Manual 3. QC/ Reagent Management/Validation 4. Competency 5. Temperature 6. Reagent Labeling 7. Safety 8. Document Control 9. Training 10. QC Statistical Reviews & Tolerance Limits 35 Known Issues Personnel records Test validation Proficiency testing Competency 36 12

13 Commercial Product 37 Commercial Product 38 Summary Know the inspection process Communicate Plan Assign Review 39 13

14 Relax You ve got your plan and you have prepared. 40 They re here!!! Let the disruption begin. Why do I have such a headache? Let me call my wife, she has to pick up the kids. 41 Conclusion Look at the findings as opportunities to improve. It s about improving the quality of care for your patients

15 Thank you! 43 15