Danette L. Godfrey, MS, MT (ASCP) Senior Product Manager, Accreditation Programs cap.org
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1 CAP Accreditation 2012 and Beyond Danette L. Godfrey, MS, MT (ASCP) Senior Product Manager, Accreditation Programs cap.org
2 AGENDA 50 Years of Accreditation 2011 Checklist Release CAP Accreditation Readiness Assessment Biorepository Accreditation Program Soft Tech DigitalScope and Beyond 2
3 CAP Accreditation 50 th Anniversary The CAP kicked off its Laboratory Accreditation Program s 50 th 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 partners o Accreditation leadership o CAP members o CAP staff 3
4 CAP Accreditation 50 th Anniversary Banner events include: o CAP 11 Kickoff Reception o Receptions at various Accreditation meetings o CAP-sponsored events at AMP 2011, USCAP 2012, CLMA 2012, and AACC 2012 o Lab Week 2012 o CAP 12 Event 4
5 CAP Accreditation 50 th Anniversary Web site launched, includes: Accreditation Story History Timeline History Snapshot Articles Videos 5
6 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
7 2011 brings fewer requirements, less redundancy leading to greater Rationale: To eliminate and remove requirements that no longer provide value o Outdated technologies o Unclear or vague in purpose o Sole purpose of representing a best practice o Impossible to determine compliance during an on-site inspection o Rarely cited (non-regulatory) No loss of determination of whether the laboratory is in compliance with the Standards 7
8 Checklist diet project resulted in a reduction of requirements A true deletion (75) o No longer relevant or was duplicative A merged or incorporated requirement (353) o Merged or combined with another similar requirement o Incorporated into a more general requirement (e.g. A requirement about centrifuges incorporated into a requirement about equipment maintenance) 8
9 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 Test Method Validation Procedure Manuals Proficiency Testing The All Common Checklist Critical Results 9
10 The All Common Checklist: One to One 10
11 The All Common Checklist: One to many 11
12 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
13 Laboratory General now customizable Each laboratory will update its Laboratory General activities and scope of services Following the 2011 checklist release the CAP sent an 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 13
14 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 21 st century laboratory medicine 14
15 Checklist enhancements & technical content available behind e-lab Solutions 15
16 We want to hear from you o Format and enhancements: checklistcomments@cap.org o Changes to requirements: accred@cap.org Phone: o Ambiguities and special cases: , option 1 Share your expertise to improve quality: o CAP Checklist Committee welcomes experts to review proposed changes, particularly for the specialty disciplines 16
17 NEW for 2011! Improved inspector/inspectee communication 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 17
18 Most Common Deficiencies Cited in 2010 Checklist ID Requirement Corresponding CLIA Regulation(s) Number of laboratories cited in 2010 GEN Ungraded PT Challenges (a)(2) 262 GEN Document Control (a)(2) 673 GEN Refrigerator/Freezer (b)(2) 300 Temperatures GEN Personnel Records ; GEN Competency Assessment GEN Annual Fire Drill (d) 520 GEN Chemical Hygiene Plan (d) 269 GEN Emergency Eyewash (d) 313 CHM PT Evaluation CHM Procedure Manual Annual Review No equivalent CLIA Standard
19 NEW SERVICE CAP Accreditation Readiness Assessment Less stress. More control. Zero risk. cap.org
20 How Ready Are You? The CAP Accreditation Readiness Assessment is the easy way to find out how prepared you are for the CAP s accreditation process. 20
21 Accreditation Readiness Assessment Overview Evaluation by the experts Customized on-site visit Actionable feedback o Identifies areas where performance meets or exceeds standards o Determines variances in applicable standards; opportunities for improvement o Provides useful tools for action planning 21
22 NEW SERVICE 22
23 Challenges Facing Biorepositories 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. 23
24 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
25 CAP Accreditation for Biorepositories 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
26 And Beyond cap.org
27 Automated Compliance and Quality Management- CAP Audit Manager NEW PRODUCT 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 Q In Michigan, Ohio and Texas 27
28 Automated Compliance and Quality Management CAP Audit Manager o Incorporates each laboratory s customized CAP Checklist o Allows annotation of Checklists to laboratory s documents o Organizes supporting evidence o Streamlines communication and collaboration o Updates new or modified CAP Checklist requirements 28
29 DigitalScope What is it? Coming Soon! 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
30 Technical Transformation of Images in CAP PT 1. Photomicrograph o (Kodachromes, 35mm Slides) 2. Photopages 3. Static Digital Images (jpeg) 4. Whole Slide Images (WSI) o 30
31 What CAP programs will include WSI s in 2012? Hematology o VPBS (Peripheral Blood and the new honors challenges) o BMD (Bone Marrow) o VBF (Body Fluid) Microbiology o VS2 (Vaginosis Gram Stain) o VGS (Gram stain and honor challenges) Anatomic Pathology o VBP (Biopsies) o PIPW (Surgical Pathology) o DPATH (Dermatopathology) 31
32 New Recognition of CAP Accreditation 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
33 New Recognition of CAP Accreditation In 2006, the United Network for Organ Sharing (UNOS) recognized the CAP as an approved accrediting body o Applies to laboratories in UNOS Organ Procurement and Transplantation Network o UNOS recognizes ASHI, too. 33
34 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. 34
35 And beyond US-centric Elimination of Embedded References Online Reference Document Team Leader Checklist EOC to assess Laboratory Director Single Checklist Concept One checklist per section unit 35
36
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