cap accreditation 2012 and beyond · anniversary celebration in september 2011 at cap ‘11 and...
TRANSCRIPT
cap.org
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
2
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
3
College of American Pathologists
CAP Accreditation 50th Anniversary
4
• 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
5
• 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
6
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• Rationale: To eliminate and remove requirements that no longer provide valueo Outdated technologieso Unclear or vague in purposeo Sole purpose of representing a best practice o Impossible to determine compliance during an on-site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
7
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
8
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
9
College of American Pathologists
The All Common Checklist: One to One
10
College of American Pathologists
The All Common Checklist: One to many
11
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
12
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
13
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
14
College of American Pathologists
Checklist enhancements & technical content available behind e-Lab Solutions™
15
College of American Pathologists
• Email:o Format and enhancements: [email protected] Changes to requirements: [email protected]
• 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
16
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
17
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
18
cap.org
CAP Accreditation Readiness AssessmentLess stress. More control. Zero risk.
NEW SERVICE
College of American Pathologists
How Ready Are You?
20
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
21
22
NEW SERVICE
College of American Pathologists
Challenges Facing Biorepositories
23
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
24
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
25
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
27
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.
29
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
30
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)
31
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)
32
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.
33
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
35
And beyond