CAP Accreditation and Checklists Update California Clinical Laboratory

CAP Accreditation and Checklists Update California Clinical Laboratory Association Amy Daniels, MT(ASCP) CAP Senior Manager, Investigations, Laboratory Accreditation November 5, 2015

Agenda • Centers for Medicare & Medicaid Services (CMS) Reapproval of the CAP as an accreditor • Accreditation Checklists and highlights of changes in 2015 edition • Most commonly cited deficiencies: 2014 • Tips for a successful inspection • Key Accreditation Checklists overview • Questions 2

CMS reapproval • The CMS determined that the CAP met or exceeded the applicable Clinical Laboratory Improvement Amendments of 1988 (CLIA) requirements in its reapproval application. • The CAP currently accredits more than 7, 700 clinical laboratories as part of its Laboratory Accreditation Program, launched in the early 1960 s. 3

CMS reapproval CAP Accreditation sets high standards for clinical, anatomic, and specialty laboratories that address quality, efficiency, and safety: • Exceeds US Federal Government (CMS) regulatory requirements • Provides a solid foundation for quality practices • Leads in developing requirements for molecular oncology, cytogenetics, and reproductive medicine • Reaches globally…the CAP accredits laboratories in 50 countries © 2015 College of American Pathologists. All rights reserved. 4

Agenda • Centers for Medicare & Medicaid Services (CMS) Reapproval of the CAP as an accreditor • Accreditation Checklists and highlights of changes in 2015 edition • Most commonly cited deficiencies: 2014 • Tips for a successful inspection • Key Accreditation Checklists overview • Questions 5

Accreditation Checklists The CAP program is based on rigorous accreditation standards that are translated into detailed checklist requirements. • CAP inspection teams use the checklists, a quality practice blueprint for laboratories, as a guide to assess the laboratory’s overall management and operation. • The CAP releases a new edition annually. © 2015 College of American Pathologists. All rights reserved. 6

Accreditation Checklists • Laboratory General • All Common • Hematology and Coagulation • Anatomic Pathology • Histocompatibility • Team Leader Assessment • Immunology of Director and Quality • Limited Service Laboratory • Chemistry and Toxicology • Microbiology • Clinical Biochemical • Molecular Pathology Genetics • Point-of-Care Testing • Cytogenetics • Transfusion Medicine • Cytopathology • Urinalysis • Flow Cytometry © 2015 College of American Pathologists. All rights reserved. 7

Highlights of changes in 2015 Checklist edition New Checklists were released in July Changes/additions include: • Individual Quality Control Plans (IQCP) (CMS reviewed and approved the CAP’s plan) • Specimen labeling for primary and secondary specimens • Use of third party verification (credential verification organization) for personnel records for educational qualifications • In vivo microscopy • Laboratory developed tests (LDTs) © 2015 College of American Pathologists. All rights reserved. 8

Individualized Quality Control Plan (IQCP) CLIA regulations require a laboratory to have quality control (QC) procedures to monitor the accuracy and precision of the complete testing process. Effective January 1, 2016, CMS will no longer accept equivalent QC (EQC) as an option for meeting daily QC requirements. CMS will allow either of the following QC options for nonwaived testing: • Follow CLIA QC regulatory requirements as written; two levels of external QC each day of patient testing (for each instrument/device/cartridge)* or • Implement IQCP *exceptions remain for coagulation and blood gas QC requirements © 2015 College of American Pathologists. All rights reserved. 9

IQCP continued CAP IQCP requirements are found in the 2015 edition of the All Common Checklist • Requirements will be effective January 1, 2016, for all laboratories performing non-waived testing, as required by CMS, regardless of checklist edition in use by a laboratory on that date • Informational and educational materials: o Complimentary webinar held in August o IQCP flowchart o Additional training tools for laboratories and inspectors • Watch for CAP e. Alerts and CAP website for information. © 2015 College of American Pathologists. All rights reserved. 10

IQCP continued The CAP Individualized QC Plan (CAP IQCP) meets or exceeds the CLIA and CMS requirements for non-waived QC performance. • Eligibility for use of CAP IQCP is limited to non-waived testing meeting both of the following criteria: o Tests that employ an internal QC system (electronic/procedural, built-in) § Exceptions exist for Microbiology o Tests are performed in disciplines other than Anatomic Pathology and Cytopathology (CMS requirement) © 2015 College of American Pathologists. All rights reserved. 11

IQCP continued • Laboratories may develop their own model for an IQCP or use CLSI Guideline EP 23 -A, a manufacturer protocol, or other commercially available products. CDC/CMS has created Developing an IQCP: a step by step guide • Required elements of an IQCP include: o Risk assessment (RA), including all five required elements o Written QC plan o Medical director written approval, prior to implementation o Ongoing assessment of QC failures, including need to reassess IQCP o Annual review of each IQCP • An IQCP cannot allow QC to be performed less frequently than indicated in manufacturer’s instructions. © 2015 College of American Pathologists. All rights reserved. 12

IQCP continued • The five required components of RA include evaluation of possible sources of error related to: o Specimen o Test system o Reagents o Environment o Testing personnel • Each laboratory with a separate CAP/CLIA number must have a separate RA. System laboratories/affiliated laboratories may use the same format, but the data collected must be specific to each laboratory. © 2015 College of American Pathologists. All rights reserved. 13

Specimen Labeling Moved to All Common Checklist in 2015 • Primary specimen container labeling o Two patient-specific identifiers required o More specific description of primary container o Limited exceptions o Includes slides prepared in patient setting ( FNA, bone marrow preps) • Secondary specimen container labeling o Single, traceable, unique identifier acceptable o Slides prepared from specimens in the laboratory are considered secondary specimens 14 © 2015 College of American Pathologists. All rights reserved.

In Vivo Microscopy • New section to Anatomic Pathology (ANP) checklist for 2015 • Physician views digitized or analog video or still image(s) or other data (IVM dataset) and renders an interpretation that is included in a formal diagnostic report or in the patient record. o Intraprocedural guidance of biopsy or tissue excision o Surgical (intraoperative) guidance o Primary evaluation and/or diagnosis o Screening o Intra- or extra-institutional consultation o Post-procedural evaluation and/or diagnosis © 2015 College of American Pathologists. All rights reserved. 15

In Vivo Microscopy continued • Examples of IVM technologies include: o Confocal microscopy o Optical coherence tomography (OCT) o Multiphoton microscopy o Optical spectroscopy and spectroscopic imaging • Not applicable to: o Informal reviews without formal reporting o Educational or research only use of these systems • IVM services may be located entirely within a clinical department, the pathology department (laboratory), or may represent collaboration between a clinical department and the laboratory. The responsibility for checklist requirements rests with the IVM service. © 2015 College of American Pathologists. All rights reserved. 16

In Vivo Microscopy continued • IVM section in ANP checklist o Definition of terms o 15 new requirements for: § Quality management § Validation § IVM analysis § IVM reports © 2015 College of American Pathologists. All rights reserved. 17

Laboratory-developed Tests (LDTs) • New and revised requirements in 2015; no requirements deleted • New requirements to provide clearer compliance with existing CLIA requirements o Analytic Validation of FDA-cleared/approved modified tests (LDTs) o Analytic accuracy: LDTs o Calibration/QC procedures © 2015 College of American Pathologists. All rights reserved. 18

Agenda • Centers for Medicare & Medicaid Services (CMS) Reapproval of the CAP as an accreditor • Accreditation Checklists and highlights of changes in 2015 edition • Most commonly cited deficiencies: 2014 • Tips for a successful inspection • Key Accreditation Checklists Overview • Questions 19

Most commonly cited deficiencies: 2014 • GEN. 55500 — competency records 23. 5% • GEN. 20375 — document control 13. 9% • GEN. 54400 — personnel files 7. 9% • POC. 06910 — personnel competency in POCT 6. 9% • POC. 04500 — reference intervals in POTC 6. 7% © 2015 College of American Pathologists. All rights reserved. 20

Most commonly cited deficiencies: 2014 continued • COM. 01200 — accurate Activity Menu 6. 2% • (various) — semiannual instrument correlation 5. 4% • ANP. 23410 — cryostat decontamination 4. 8% • TRM. 32000 — instrument preventive maintenance 4. 3% • MIC. 14583 — controls for direct antigen testing 4. 0% © 2015 College of American Pathologists. All rights reserved. 21

Agenda • Centers for Medicare & Medicaid Services (CMS) Reapproval of the CAP as an accreditor • Accreditation Checklists and highlights of changes in 2015 edition • Most commonly cited deficiencies: 2014 • Tips for a successful inspection • Key Accreditation Checklists Overview • Questions 22

Tips for a successful inspection CAP Laboratory Accreditation Program: The Value of Peer-Based Inspections Laboratory professional (pathologist, technologist, etc. ) • Gains insight through interacting with peer professionals • First-hand knowledge to offer constructive feedback • • Promotes continuous education & continuous improvement Inspectors with specialty expertise Working professionals exposed to new technologies Staff Inspectors • Ancillary sites and large groups of limited service labs • Participate in all for-cause inspections • Cover domestic and international inspections © 2015 College of American Pathologists. All rights reserved. 23

Tips for a successful inspection • Make sure to stay current with resources available

Tips for a successful inspection • Familiarize yourself and your team with the CAP’s Laboratory Accreditation Manual as part of e. LAB Solutions Suite. © 2015 College of American Pathologists. All rights reserved. 25

Tips for a successful inspection • Familiarize yourself and your team with the CAP’s Laboratory Accreditation Program Checklists, ie, the edition being used for your inspection. © 2015 College of American Pathologists. All rights reserved. 26

Tips for a successful inspection • Use the Excel spreadsheet from e. LAB Solutions Suite to identify documents needed to demonstrate compliance. © 2015 College of American Pathologists. All rights reserved. 27

Tips for a successful inspection • From the Laboratory Accreditation Manual (p. 131), use the required, off-year self-inspection as a “mock inspection” to identify possible gaps in compliance. © 2015 College of American Pathologists. All rights reserved. 28

Tips for a successful inspection • Perform a mock inspection immediately prior to the inspection “window” to assess readiness of personnel and accessibility of records/documents. • Involve as many personnel as possible in a mock inspection to conduct and participate. • Use personnel from another facility or department as inspectors to provide fresh eyes. © 2015 College of American Pathologists. All rights reserved. 29

Tips for a successful inspection • Leverage Accreditation education available on cap. org. ©

Agenda • Centers for Medicare & Medicaid Services (CMS) Reapproval of the CAP as an accreditor • Accreditation Checklists and highlights of changes in 2015 edition • Most commonly cited deficiencies: 2014 • Tips for a successful inspection • Key Accreditation Checklists Overview • Questions 31

21 Checklists 1, 165 pages 2, 919 requirements 246 new 482 changed 289 moved/merged

Objective 1: Key Accreditation Requirements • Personnel o High risk • The “All Common” Checklist o It's everywhere • LDTs o Applies to more than you might think • Document Control o Easy to miss © 2015 College of American Pathologists. All rights reserved. 33

Personnel The competency of each person performing patient testing to perform their assigned duties is assessed. citation rate 22. 3% (GEN. 55500) Personnel files are maintained on all current technical personnel and personnel records include. . . 9. 2% (GEN. 54400) Most common oversight by CAP inspectors discovered by CMS during its validation inspections. © 2015 College of American Pathologists. All rights reserved. 34

Personnel Competency (GEN. 55500) • Assessment o Initially, and at 6 and 12 months, then annually; all 6 elements required (non-waived) o Initially and annually; elements may be selected (waived) • Record keeping o Section director or general supervisor (high-cx) o Technical consultant (mod-cx) © 2015 College of American Pathologists. All rights reserved. 35

Personnel Records (GEN. 54400) • Appropriate documentation of qualifications varies by laboratory locale. • Description of current duties and responsibilities as specified by the laboratory director: o Procedures the individual is authorized to perform o Whether supervision is required for specimen processing, test performance, or result reporting o Whether supervisory or section director review is required to report patient test results © 2015 College of American Pathologists. All rights reserved. 36

Personnel. . . but wait. There's more. • Qualifications of testing personnel • Consultants • Performance assessment of the assessors • Professional competency • Director's responsibility for personnel © 2015 College of American Pathologists. All rights reserved. 37

Qualifications of Testing Personnel (GEN. 54750) All testing personnel meet the following requirements: • High complexity: associates degree • Moderate complexity: high school diploma Key points: • Standardized across the Checklists wherever possible • Exceptions: cytopathology, cytogenetics, and molecular testing © 2015 College of American Pathologists. All rights reserved. 38

Consultants • Technical consultants meet defined qualifications and fulfill expected responsibilities. (GEN. 53625) • Clinical consultants meet defined qualifications and fulfill expected responsibilities. (GEN. 53650) Key points: • Applies to laboratories performing moderately complex testing • Qualifications and responsibilities must be in accord with CLIA regulations. • Must be available for consultation © 2015 College of American Pathologists. All rights reserved. 39

Performance Assessment (GEN. 55525) • The performance of section directors/technical supervisors, general supervisors, and technical consultants is assessed and satisfactory. Key points: • Refers to role in management of patient testing • Unsatisfactory performance must be addressed in a plan of corrective action. • COM. 55500 applies to any individual who performs patient testing. © 2015 College of American Pathologists. All rights reserved. 40

Professional Competency (ANP. 10255) • The laboratory director ensures the professional competency of pathologists who provide interpretive services to the anatomic pathology laboratory. Key points: • Written policy for assessing professional competency, criteria for the assessment, and records of the assessment • Documentation may be by participation in peer-educational programs, metrics developed from quality management reports, or individual assessment by the director according to defined criteria. 41 © 2015 College of American Pathologists. All rights reserved.

Director's Responsibility for Personnel (TLC. 11300) The laboratory director ensures sufficient numbers of personnel with appropriate educational qualifications, documented training and experience, and adequate competency to meet the needs of the laboratory. Key points: • Staffing should be considered insufficient only if there is clear evidence from quality monitoring records, data derived from complaints or concerns, turnaround time, and error statistics, etc. • This responsibility may not be delegated. 42 © 2015 College of American Pathologists. All rights reserved.

All-Common Checklist (COM) requirements © 2015 College of American Pathologists. All rights reserved. pages

All-Common Checklist (COM) • Definition of terms • Proficiency testing • Quality management • Policies & procedures • Reagents • Instruments & equipment • Test method validation/verification © 2015 College of American Pathologists. All rights reserved. 44

Laboratory Developed Tests • What is an LDT? The definition is uncertain. o Developed entirely or partly in the laboratory? o Risk-based classification? o Modified, commercial IVDs? o What about “traditional” methods? • LDTs must be validated by the laboratory before use. © 2015 College of American Pathologists. All rights reserved. 45

Laboratory Developed Tests • Maintain a list of all LDTs implemented during the previous two years (or more) • Include commercial tests modified by the laboratory o Reagents, incubation times, QC etc. o Target population • Validate o Analytical accuracy, precision, sensitivity, specificity, reportable range o Clinical claims (if any) © 2015 College of American Pathologists. All rights reserved. 46

Laboratory Developed Tests (COM. 40000) There is a summary statement, signed by the laboratory director or designee prior to use in patient testing, that includes the evaluation of validation studies and approval of each test for clinical use. Key points: • Written assessment of the data • Approval for clinical use • Include clinical claims (if any) © 2015 College of American Pathologists. All rights reserved. 47

Document Control “The laboratory has a document control system to manage policies, procedures, and forms. ” (GEN. 20375) Key points: • Only the current policies, procedures, and forms are in use. • A control log is recommended and includes: o Dates when placed in service o Schedule of review o Responsible reviewers o Dates when discontinued or superseded 48 © 2015 College of American Pathologists. All rights reserved.