cap accreditation 2012 and beyond · anniversary celebration in september 2011 at cap ‘11 and...

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CAP Accreditation 2012 and Beyond

Danette L. Godfrey, MS, MT (ASCP)Senior Product Manager, Accreditation Programs

College of American Pathologists

AGENDA

• 50 Years of Accreditation

• 2011 Checklist Release

• CAP Accreditation Readiness Assessment

• Biorepository Accreditation Program

• Soft Tech

• DigitalScope

• …and Beyond

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College of American Pathologists

CAP Accreditation 50th Anniversary• The CAP kicked off its Laboratory Accreditation Program’s 50th

Anniversary celebration in September 2011 at CAP ‘11 and will close celebration in September 2012 at CAP ‘12.

• Events being planned for:o Accreditation customers and partnerso Accreditation leadershipo CAP memberso CAP staff

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College of American Pathologists

CAP Accreditation 50th Anniversary

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• Banner events include:o CAP ‘11 Kickoff Receptiono Receptions at various Accreditation

meetingso CAP-sponsored events at AMP 2011,

USCAP 2012, CLMA 2012, and AACC 2012

o Lab Week 2012o CAP ‘12 Event

College of American Pathologists

CAP Accreditation 50th Anniversary

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• Web site launched, includes:• Accreditation Story• History Timeline• History Snapshot• Articles• Videos

College of American Pathologists

2011 Edition if the CAP Accreditation Checklists include enhancements to improve & promote quality

1. Less redundancy and removal of obsolete requirements

2. Introduction of the All Common Checklist

3. Completed implementation of the ROAD Inspection Process

4. A customized Laboratory General Checklist

5. A new Clinical Biochemical Genetics Checklist

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College of American Pathologists

• Rationale: To eliminate and remove requirements that no longer provide valueo Outdated technologieso Unclear or vague in purposeo Sole purpose of representing a best practice o Impossible to determine compliance during an on-site

inspectiono Rarely cited (non-regulatory)

• No loss of determination of whether the laboratory is in compliance with the Standards

2011 brings fewer requirements, less redundancy leading to greater

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College of American Pathologists

• A true deletion (75)o No longer relevant or was duplicative

• A merged or incorporated requirement (353)o Merged or combined with another similar requiremento Incorporated into a more general requirement (e.g. A

requirement about centrifuges incorporated into a requirement about equipment maintenance)

Checklist “diet” project resulted in a reduction of requirements

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College of American Pathologists

The All Common Checklist

• A consolidated listing of requirements that are similar or identical across most disciplines

• Synchronize checklist requirements that apply across disciplines

• To streamline the inspection process and reduce redundancy• Items moved to COM:195

The All Common Checklist

Proficiency Testing

Test Method

ValidationProcedure Manuals

Critical Results

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College of American Pathologists

The All Common Checklist: One to One

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College of American Pathologists

The All Common Checklist: One to many

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College of American Pathologists

R.O.A.D. Instructions now appear in every CAP Checklist

READ/review a sampling of laboratory documents

OBSERVE laboratory practices

ASK open-ended, probing questions

DISCOVER to "drill down" on areas of concern

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College of American Pathologists

• Each laboratory will update its Laboratory General activities and scope of services

• Following the 2011 checklist release the CAP sent an email to all laboratories; complete and return a form

• The next set of checklists (the lab receives) will include a shorter, streamlined and customized Laboratory General Checklist

Laboratory General now customizable

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College of American Pathologists

The CAP publishes a new checklist

• CBG = Clinical Biochemical Genetics

• For the diagnosis and management of patients with inborn errors of metabolism

• This testing differs from clinical chemistry in the extent of interpretation necessary to make its results meaningful to the clinician

• CAP Checklists are comprehensible, flexible and continue to evolve with 21st

century laboratory medicine

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College of American Pathologists

Checklist enhancements & technical content available behind e-Lab Solutions™

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College of American Pathologists

• Email:o Format and enhancements: checklistcomments@cap.orgo Changes to requirements: accred@cap.org

• Phone:o Ambiguities and special cases: 800-323-4040, option 1

• Share your expertise to improve quality:o CAP Checklist Committee welcomes experts to review

proposed changes, particularly for the specialty disciplines

We want to hear from you

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College of American Pathologists

• CAP now allows an inspection team leader to communicate directly with the laboratory director prior to setting an inspection date as long as they don’t discuss dates for the unannounced inspection.

• Benefits:• Improves “rightness” of team size• Ensures appropriate team composition• Enables inspection team to arrive at correct

location on day of inspection• Eliminates unnecessary surprises for team and

laboratory

NEW for 2011!Improved inspector/inspectee communication

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College of American Pathologists

Most Common Deficiencies Cited in 2010Checklist ID Requirement Corresponding CLIA

Regulation(s)Number of

laboratories cited in 2010

GEN.11226 Ungraded PT Challenges 493.1236 (a)(2) 262GEN.20375 Document Control 493.1105(a)(2) 673

GEN.41042 Refrigerator/Freezer Temperatures

493.1252 (b)(2) 300

GEN.54400 Personnel Records 493.1423; 493.1489 330

GEN.55500 Competency Assessment 493.1235 756

GEN.70250 Annual Fire Drill 493.1101(d) 520

GEN.70450 Chemical Hygiene Plan 493.1101(d) 269

GEN.72500 Emergency Eyewash 493.1101(d) 313

CHM.10300 PT Evaluation 493.803 376

CHM.11100 Procedure Manual Annual Review

No equivalent CLIA Standard 327

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cap.org

CAP Accreditation Readiness AssessmentLess stress. More control. Zero risk.

NEW SERVICE

College of American Pathologists

How Ready Are You?

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The CAP Accreditation Readiness Assessment is the easy way to find out how prepared you are for the CAP’s accreditation process.

College of American Pathologists

Accreditation Readiness Assessment Overview

• Evaluation by the experts

• Customized on-site visit

• Actionable feedbacko Identifies areas where performance

meets or exceeds standardso Determines variances in applicable standards;

opportunities for improvemento Provides useful tools for action planning

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NEW SERVICE

College of American Pathologists

Challenges Facing Biorepositories

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High-quality biospecimens are of vital importance.

Lack of standard and uniform operating procedures for:

• Collection

• Processing

• Annotation

• Storage and transport

This results in a shortage of quality biospecimens.

College of American Pathologists

The CAP’s Qualifications

• 50+ year history of leadership in accreditation

• Accredits more than 7,000 laboratories, including many that handle biospecimens

• Regarded by the industry as the Gold Standard in accreditation

• Proven peer-inspection model

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College of American Pathologists

• Assembles an advisory group of industry experts

• Enables continuous oversight of practices

• Ensures compliance with standardized criteria

• Promotes widespread adoption of universal standards

• More than 17 participating in limited launch

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CAP Accreditation for Biorepositories

cap.org

…And Beyond

College of American Pathologists

Automated Compliance and Quality Management- CAP Audit Manager

• Document Management Software that supports compliance for accreditation programs, and quality excellence

• The CAP, in partnership with SoftTech Health, will be piloting a new program

− Q1 2012 − In Michigan, Ohio and Texas

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NEW PRODUCT

College of American Pathologists28

Automated Compliance and Quality Management CAP Audit Manager

o Incorporates each laboratory’s customized CAP Checklisto Allows annotation of Checklists to laboratory’s documentso Organizes supporting evidence

o Streamlines communication and collaboration

o Updates new or modified CAP Checklist requirements

College of American Pathologists

• DigitalScope is a storage and viewing system for whole slide images (WSI) developed by Proficiency Testing Services (PTS) that the CAP has an exclusive license agreement to use.

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DigitalScope – What is it?Coming Soon!

College of American Pathologists

1. Photomicrograph o (Kodachromes, 35mm Slides)

2. Photopages

3. Static Digital Images (jpeg)

4. Whole Slide Images (WSI)o www.cap.org/digitalscope

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Technical Transformation of Images in CAP PT

College of American Pathologists

• Hematologyo VPBS (Peripheral Blood and the new honors challenges)o BMD (Bone Marrow) o VBF (Body Fluid)

• Microbiologyo VS2 (Vaginosis Gram Stain)o VGS (Gram stain and honor challenges)

• Anatomic Pathologyo VBP (Biopsies)o PIPW (Surgical Pathology)o DPATH (Dermatopathology)

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What CAP programs will include WSI’s in 2012?

College of American Pathologists

• The National Marrow Donor Program (NMDP) recognizes the CAP Laboratory Accreditation Program (Fall 2011)o Applies to laboratories that need to meet the human

leukocyte antigen (HLA) typing accreditation requirement included in the NMDP’s Donor Center Participation Criteria

• NMDP also accepts accreditation for HLA typing from:o The American Society for Histocompatibility and

Immunogenetics (ASHI)o The European Federation for Immunogenetics (EFI)

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New Recognition of CAP Accreditation

College of American Pathologists

In 2006, the United Network for Organ Sharing (UNOS) recognized the CAP as an approved accrediting bodyo Applies to laboratories in UNOS’ Organ Procurement and

Transplantation Networko UNOS recognizes ASHI, too.

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New Recognition of CAP Accreditation

College of American Pathologists34

CAP Applies to CA for Deemed Status

CAP applies to the State of California for approval as an accrediting organization.

•Allows CAP-accredited laboratories to be deemed by the California DPH to meet state licensure or registration requirements

•Allows CAP-accredited laboratories to be inspected and overseen by the CAP in conjunction with DPH.

College of American Pathologists

US-centricElimination of Embedded References

Online Reference Document

Team Leader Checklist

EOC to assess Laboratory Director

Single ChecklistConcept

One checklist per section unit

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And beyond