10/19/2012 They’re Here!!! Are you ready for a CAP Inspection? Marty Finger, MHSM, HTL(ASCP) E-mail: fingermarquazetteg@uams.edu University of Arkansas for Medical Sciences Little Rock, Arkansas Learning Objectives Present and explain the latest format of the CAP checklist. Provide helpful information on how to construct the “Evidence of Compliance” component necessary for a successful CAP inspection from the eyes of an inspector. Discuss some of the most frequent deficiencies sited in the Lab General Checklist ; Problematic Anatomic Pathology Checklist Statements; New 2012 Anatomic Pathology Checklist Statements. The Mission of CAP Laboratory Accreditation Program Improve Patient Safety by advancing the quality of Pathology and Laboratory Services through: Education Quality Improvement and Standard Setting Regulatory Compliance 1 10/19/2012 Brief History of CAP Laboratory Accreditation Program 1962 ‐ LAP established 1965 ‐ First checklist published 1967 – Profiency Testing required for participation 1969 ‐ CAP judged equivalent to CLIA 67 Brief History of CAP (Cont.) Laboratory Accreditation Program 1978 ‐ JCAHO grants deemed authority 1995 ‐ CLIA grants deemed authority 2004 ‐ CAP required posting of CAP Hotline 2006 ‐ Unannounced Routine Inspections 2010 ‐ Enhancement to the CAP Checklist Types of Inspections of CAP Laboratory Accreditation Program Every two years on‐site inspection Intervening years, self inspection Complaint inspection, may include CMS or other agencies (rare) Verifying CMS inspection (rare) Verifying CAP inspection (rare) 2 10/19/2012 CAP Checklist New Look Subject Header ‐ a phrase to provide the key concept of the requirement. Declarative statements to better convey the regulatory nature of requirements. Evidence of Compliance which appears with several checklist requirements (A very helpful element). Evidence of Compliance Assist laboratory in preparing for an unannounced inspection and managing on‐going compliance. Promote consistency in the understanding of the requirements between the laboratory and the inspector. Evidence of Compliance Provide specific examples of acceptable documentation (policies, procedures, records, reports, charts, etc.). All policies/procedures/processes covered in the CAP checklist must be properly documented. 3 10/19/2012 The All Common Checklist New CAP checklist which is common to all section. Includes Proficiency Testing, previously part of Lab General. Quality Management and Quality Control of Procedure Manual, Result Reporting, Test Method Validation, Reference Intervals. From the eyes of an Inspector When preparing for your inspection, be familiar with your Checklist Statements. When preparing for your inspections, be familiar with your Evidence of Compliance component. Conduct a very thorough mid‐cycle inspection. Utilize the CAP Inspector R.O.A.D. Technique: Read, Observe, Ask, Discover. The CAP R.O.A.D. Inspection Technique R‐ READ/Review a sampling of laboratory documents: Sampling of QM/QC policies and procedures, incident/error and corrective action. 4 10/19/2012 The CAP R.O.A.D. Self Inspection Technique O‐ OBSERVE your laboratory practices by observing laboratory personnel practices. Note if their practices deviate from the written policies and procedures. The CAP R.O.A.D. Inspection Technique A‐ ASK open‐ended, probing questions that start with phrases such as “Tell me about….” or “What would you do if….”. The CAP R.O.A.D. Inspection Technique D‐ DISCOVER a technique that can be used to “drill down” or further evaluate areas of concern uncovered during your self ‐ inspection. 5 10/19/2012 Deficiencies VS Recommendations Deficiencies must be corrected with documentation to CAP before accreditation can be approved. Deficiencies VS Recommendations Recommendations are improvements suggested by Inspectors BUT not required for accreditation. Phase I vs Phase II Deficiencies All Phase I and II deficiencies must be addressed. For Phase I deficiencies: a statement as to the corrective action being taken is sufficient. Recurring Phase I deficiencies will be reviewed critically as to the effectiveness of proposed actions. 6 10/19/2012 Phase I VS Phase II Deficiencies For Phase II deficiencies corrective actions must be accompanied by appropriate documentation, such as: policies or procedures. supporting records such as patient reports, log sheets, purchase orders, photographs, memos or minutes from meetings. These records must demonstrate compliance with the policy or procedure. Failure to provide this documentation will delay your accreditation. Lab General Checklist Items Common to All Sections Quality Management Specimen collection, Data Handling & Reporting Direct‐To‐Consumer Testing Lab General Checklist Items Common to All Sections Quality of Water and Glassware Washing Laboratory Computer Services. Personnel Laboratory Safety 7 10/19/2012 Lab General Checklist New Item: Biorepository Accreditation Program Biorepository: Define as an entity that receives, stores, processes, and/or disseminates biospecimens, their derivatives and relevant data, as needed. It encompasses the physical location as well as the full range of activities associated with its operation. Lab General Checklist Most Common Deficiencies Sited GEN.75400 ‐ Annual Fire Drill: Fire drills are conducted at least annually. GEN.75800 ‐ Fire Extinguishers: Personnel are instructed in the use of portable fire extinguishers. Resource: Lab General Checklist 01.04.2012 Lab General Checklist Most Common Deficiencies Sited GEN.20330 CAP Sign: The laboratory posts the official CAP sign regarding reporting of quality concerns. Gen.20375 Document Control: The laboratory has a document control system. Resource: Lab General Checklist 01.04.2012 8 10/19/2012 Lab General Checklist Most Common Deficiencies Sited GEN.41042 Refrigerator/Freezer Temperatures: Refrigerator/freezer Temperatures are checked and recorded daily. GEN.73300 Safety Policies: Safety policies and procedures are posted or readily available to all personnel. Resource: Lab General Checklist 01.04.2012 Lab General Checklist Most Common Deficiencies Sited GEN.55500 Competency Assessment: The competency of each person to perform his/her assigned duties is assessed. GEN.55400 Visual Color Discrimination: Technical personnel are tested for visual color discrimination. Resource: Lab General Checklist 01.04.2012 Lab General Checklist Most Common Deficiencies Sited GEN.76000 Chemical Hygiene Plan: The laboratory has a Chemical Hygiene Plan (CHP) that defines the safety procedures for all chemicals used in the laboratory. Resource: Lab General Checklist 01.04.2012 9 10/19/2012 Lab General Checklist Most Common Deficiencies Sited GEN.76700 Acid/Base Storage: Supplies of concentrated acids and bases are stored safely. GEN.73900 Evacuation Plan: There is a comprehensive, documented and workable evacuation plan for the laboratory, including specific plans for any persons with disabilities. Resource: Lab General Checklist 01.04.2012 Anatomic Pathology Checklist What’s New on AP Checklist ANP.11716 Paraffin Microtomy: There is a written procedure that indicated the sectioning thickness of paraffin embedded tissue for various tissue types and procedures. ANP.12170: Report Review: All reports are reviewed and signed by the pathologist. ANP.22985 Predictive Marker Testing‐ Decalcified Tissue. If the laboratory performs FISH and/or immunohistochemistry for ER,PgR, and /or HER2 on decalcified tissues, the results Resource: Lab General Checklist 01.04.2012 Anatomic Pathology Checklist What’s New on AP Checklist (continues) ANP.22985 Predictive Marker Testing‐ Decalcified Tissue. If the laboratory performs FISH and/or immunohistochemistry for ER,PgR, and /or HER2 on decalcified tissues, the results includes a disclaimer noting that these assays have not been validated on decalcified specimens. ANP.23120 Tissue Processor: Tissue processing schedules are validated. Resource: Lab General Checklist 01.04.2012 10 10/19/2012 The Inspectors have left the Building!! QUESTIONS ? Marty Finger, MHSM, HT, HTL (ASCP) QIHC, RMA(AMT) fingermarquazetteg@uams.edu 501‐526‐4464 11