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

2. 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

3. 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 1960s.

4. 4/25/2017
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.
© 2009 College of American Pathologists. All rights reserved.

5. 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

6. 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.

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

8. 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.

9. 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 non-waived 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.

10. 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:
Complimentary webinar held in August
IQCP flowchart
Additional training tools for laboratories and inspectors
Watch for CAP eAlerts and CAP website for information.
© 2015 College of American Pathologists. All rights reserved.

11. 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:
Tests that employ an internal QC system (electronic/procedural, built-in)
Exceptions exist for Microbiology
Tests are performed in disciplines other than Anatomic Pathology and Cytopathology (CMS requirement)
© 2015 College of American Pathologists. All rights reserved.

12. IQCP continued
Laboratories may develop their own model for an IQCP or use CLSI Guideline EP23-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:
Risk assessment (RA), including all five required elements
Written QC plan
Medical director written approval, prior to implementation
Ongoing assessment of QC failures, including need to reassess IQCP
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.

13. IQCP continued
The five required components of RA include evaluation of possible sources of error related to:
Specimen
Test system
Reagents
Environment
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.

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

15. 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.
Intraprocedural guidance of biopsy or tissue excision
Surgical (intraoperative) guidance
Primary evaluation and/or diagnosis
Screening
Intra- or extra-institutional consultation
Post-procedural evaluation and/or diagnosis
© 2015 College of American Pathologists. All rights reserved.

16. In Vivo Microscopy continued
Examples of IVM technologies include: 
Confocal microscopy
Optical coherence tomography (OCT)
Multiphoton microscopy
Optical spectroscopy and spectroscopic imaging
Not applicable to:
Informal reviews without formal reporting
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.

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

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

19. 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

20. Most commonly cited deficiencies: 2014
GEN — competency records %
GEN — document control %
GEN — personnel files %
POC — personnel competency in POCT 6.9%
POC — reference intervals in POTC   %
© 2015 College of American Pathologists. All rights reserved.

21. Most commonly cited deficiencies: 2014 continued
COM — accurate Activity Menu       %
(various) — semiannual instrument correlation 5.4%
ANP — cryostat decontamination       %
TRM.32000
— instrument preventive maintenance %
MIC.14583
— controls for direct antigen testing %
© 2015 College of American Pathologists. All rights reserved.

22. 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

23. 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.

24. Tips for a successful inspection
Make sure to stay current with resources available through eLAB Solutions Suite on cap.org.
© 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 Manual as part of eLAB Solutions Suite.
© 2015 College of American Pathologists. All rights reserved.

26. 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.

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

28. 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.

29. 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.

30. Tips for a successful inspection
Leverage Accreditation education available on cap.org.
© 2015 College of American Pathologists. All rights reserved.

31. 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

32. 21 Checklists 1,165 pages 2,919 requirements 246 new 482 changed
289 moved/merged
© 2015 College of American Pathologists. All rights reserved.

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

34. Personnel 22.3% 9.2% citation rate
The competency of each person performing patient testing to perform their assigned duties is assessed. (GEN.55500)
22.3%
Personnel files are maintained on all current technical personnel and personnel records include... (GEN.54400)
9.2%
Most common oversight by CAP inspectors discovered by CMS during its validation inspections.
© 2015 College of American Pathologists. All rights reserved.

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

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

37. 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.

38. 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.

39. 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.

40. 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 applies to any individual who performs patient testing.
© 2015 College of American Pathologists. All rights reserved.

41. 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.
© 2015 College of American Pathologists. All rights reserved.

42. 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.
© 2015 College of American Pathologists. All rights reserved.

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

44. 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.

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

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

47. 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.

48. 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:
Dates when placed in service
Schedule of review
Responsible reviewers
Dates when discontinued or superseded
• NCCLS's GP2-A stands out as the first consensus document to define a set of CAP Checklist requirements (ca. 1980)
• Now QMS02-A6, it remains a key resource for accredited laboratories
© 2015 College of American Pathologists. All rights reserved. 48

49. Questions?
© 2015 College of American Pathologists. All rights reserved.