cap accreditation and checklists update amy daniels, mt(ascp) cap senior manager, investigations,...

CAP Accreditation and Checklists Update

Amy Daniels, MT(ASCP)

CAP Senior Manager, Investigations,

Laboratory Accreditation

November 5, 2015

California Clinical Laboratory Association

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

1960s.

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

4© 2015 College of American Pathologists. All rights reserved.

Agenda




in 2015 edition



• Key Accreditation Checklists overview

• Questions

5

6

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.

Accreditation Checklists

© 2015 College of American Pathologists. All rights reserved.

7

• 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

Accreditation Checklists


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)


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. 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 eAlerts and CAP website for information.


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)


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:o Risk assessment (RA), including all five required

elementso Written QC plano Medical director written approval, prior to implementationo Ongoing assessment of QC failures, including need to

reassess IQCPo Annual review of each IQCP

• An IQCP cannot allow QC to be performed less frequently than indicated in manufacturer’s instructions.


IQCP continued

• The five required components of RA include evaluation of

possible sources of error related to:o Specimeno Test systemo Reagentso Environmento 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.


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

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


In Vivo Microscopy continued

• Examples of IVM technologies include:

o Confocal microscopy

o Optical coherence tomography (OCT)

o Multiphoton microscopyo 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

oDefinition of terms

o 15 new requirements for:

Quality management

Validation

IVM analysis

IVM reports


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


Agenda




in 2015 edition



• Key Accreditation Checklists Overview

• Questions

19

• 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%


Most commonly cited deficiencies: 2014

• 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%


Most commonly cited deficiencies: 2014 continued

Agenda




in 2015 edition




• Questions

22

23

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


Tips for a successful inspection


• Make sure to stay current with resources

available through eLAB Solutions Suite on

cap.org.



• Familiarize yourself

and your team with

the CAP’s Laboratory

Accreditation Manual

as part of eLAB

Solutions Suite.



• Familiarize yourself and your team with the CAP’s Laboratory Accreditation

Program Checklists, ie, the edition being used for your inspection.



• Use the Excel

spreadsheet

from eLAB

Solutions

Suite to

identify

documents

needed to

demonstrate

compliance.



• From the Laboratory

Accreditation Manual

(p. 131), use the

required, off-year self-

inspection as a “mock

inspection” to identify

possible gaps in

compliance.



• 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.



• Leverage Accreditation education available on

cap.org.


Agenda




in 2015 edition




• Questions

31

21 Checklists1,165 pages

2,919 requirements246 new

482 changed289 moved/merged


Objective 1:Key Accreditation Requirements

• Personnelo High risk

• The “All Common” Checklisto It's everywhere

• LDTso Applies to more than you might think

• Document Controlo Easy to miss


The competency of each person performing patient testing to perform their assigned duties is assessed. (GEN.55500)

Personnel files are maintained on all current technical personnel and personnel records include... (GEN.54400)

9.2%

22.3%

citation rate

Most common oversight by CAP inspectors discovered by CMS during its validation inspections.

Personnel


Personnel Competency (GEN.55500)

• Assessmento 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 keepingo Section director or general supervisor (high-cx)

o Technical consultant (mod-cx)


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


Personnel ...but wait. There's more.

• Qualifications of testing personnel

• Consultants

• Performance assessment of the assessors

• Professional competency

• Director's responsibility for personnel


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


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 consultation39© 2015 College of American Pathologists. All rights reserved.

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.


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.


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


All-Common Checklist (COM)

requirements pages


• Definition of terms

• Proficiency testing

• Quality management

• Policies & procedures

• Reagents

• Instruments & equipment

• Test method validation/verification

All-Common Checklist (COM)


• 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.

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)

Laboratory Developed Tests


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)

Laboratory Developed Tests (COM.40000)


“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

Document Control


Questions?


cap accreditation and checklists update amy daniels, mt(ascp) cap senior manager, investigations,...

Documents

clinical laboratories

checklists updateamy

cap inspection teams

highlights of changes

quality control qc procedures

specialty laboratories

quality practice blueprint

developing requirements