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College of American Pathologists
Laboratory Accreditation Program
Avoiding the Most Common Deficiencies
April 16, 2008
Copyright © 2008 College of American Pathologists (CAP). All rights are reserved. Participants are permitted to duplicate the materials for educational use only within their own institution. These materials may not be used for commercial purposes or altered in any way.
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Paul Bachner, MD, FCAP• Regional Commissioner (TN, KY, IL)• Council on Accreditation, Council on
Education• Past Board of Governors, Past President• Chairman, Department of Pathology &
Laboratory Medicine & Director of Laboratories, University of Kentucky
• First CAP Inspection in 1969, many since
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Learning Objectives
• Identify the most frequently cited deficiencies that are common to all checklists
• Develop strategies to efficiently and effectively demonstrate continuous compliance with these checklist requirements
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LAP Inspection: Key Goals are Patient Safety & Quality Testing
Quality Improvement
and Standards
Education
Regulatory Compliance
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On-Site Inspection
• Lab: Demonstrates that practices comply with the intent of the checklist questions and CLIA requirements
• Inspector: Verifies compliance, identifies deficiencies and highlights areas for improvement (recommendations)
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Deficiencies• Deficiencies should be clearly
communicated to sections and at Summation Conference
• Deficiency citation should be specific and not a repeat of the question
• Deficiency should identify a lack of compliance, not a practice different from inspector’s laboratory!
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Deficiencies and Recommendations
• Deficiencies must be corrected with documentation to CAP before accreditation can be approved
• Recommendation is an improvement suggested by inspector BUT not a requirement for accreditation
• CAP may convert a “recommendation” into a deficiency requiring correction and documentation
• 48% of team leaders and 31% of team members uncertain whether to cite deficiency or recommendation “some of the time”
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Deficiencies Corrected On-Site
• Will remain on record as a deficiency for that inspection cycle & available to next team
• Lab does not need to submit documentation if deficiency is corrected on-site (but CAP may request)
• Limit to simple deficiencies not requiring:– Major process change– Staff retraining– Elaborate documentation
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The Triad of Compliance
1. Policy/Procedure (P/P) address the checklist item
2. Actual practices match the written P/P3. Documentation of the practices
Say what you do, do what you say, document it!Processes should meet the intent of the question
and should contribute to testing quality!
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Items Common to All Sections*
• Proficiency testing• Quality control• Procedure manuals• Reagents• Instruments/equipment
* Labs Accredited November 06 - 07
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Please See Attachments
• Attachment A: Common Deficiencies Self-Assessment Tool
• Attachment B: Summary of Waived testing requirements (not to be discussed)
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#12
• Does the laboratory have a documented system to ensure consistency of morphologic observations among all personnel performing…? – MIC.21565: 3.8% – URN.30800: 1.9%
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#11
• Are all reagents used within their indicated expiration date?– LSV.36840: 5.5%– MIC.14550: 2.5%
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#10
• If the laboratory uses more than one instrument to test for a given analyte, are the instruments checked against each other at least twice a year for correlation of patient/client results?– POC.07568: 4.8%– CHM.13800: 3.9%
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#9• Is validation of the analytical
measurement range (AMR) performed with matrix-appropriate materials, which include the low, mid and high range of the AMR, and is the process documented?– LSV.40610: 5.9% – CHM.13600: 4.5%
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#8
• Are new reagent lots and/or shipments validated before or concurrent with use for patient testing?– CHM.1290: 2.7%– IMM.33150: 3.5%– URN.24220: 1.3%
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#7
• Is a complete procedure manual available at the workbench or in the work area?– POC.03900: 4.0%– MIC.12050: 3.1%– IMM.31000: 1.1%
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#6
• Are quality control data reviewed and assessed at least monthly by the laboratory director or designee? – LSV.00900 4.1%– MIC.11020 3.2% – IMM.34362 1.8%– URN.25750 1.1%
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#5• Is there evidence of ongoing evaluation
of records of controls, instrument maintenance and function, temperature, etc., for all procedures as required? – LSV.00700: 4.5%– TRM.30000: 3.7%– CHM.10700: 3.7% – URN.26550: 1.6%
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#4• For tests for which CAP does not require PT,
does the laboratory at least semiannually 1) participate in external PT, or 2) exercise an alternative performance assessment system for determining the reliability of analytic testing?– HEM.10160: 4.1%– LSV.00425: 3.9% – MIC.00130: 3.2 %– URN.10525: 2.0% – IMM.10050: 1.5%
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#3• Is there ongoing evaluation of PT and
alternative assessment results, with prompt corrective action taken for unacceptable results? – LSV.00350: 6.9%– CHM.10300: 5.6%– MIC.00425: 4.8% – HEM.10185: 3.5%– URN.10575: 2.4%– IMM.10150: 1.0%
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#2• Are reagents and solutions properly
labeled, as applicable and appropriate, with the following elements?– Content and quantity, concentration or titer– Storage requirements– Date prepared or reconstituted by
laboratory– Expiration date
• 6 checklists
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Reagents Improperly Labeled
– LSV.36820: 10.7%– POC.04800: 8.6%– HEM.24000: 4.8%– CHM.12400: 3.7%– MIC.143500: 2.3%– URN.24000: 2.1%
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#1
• Is there documentation of at least annual review of all policies and procedures by the current laboratory director or designee?
• 8 checklists
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Annual Review of Procedure Manuals
LSV.01800: 9.9%CHM.11100: 7.6% TRM.31150: 6.3%MIC.12110: 4.8%POC.04100: 4.6% HEM.21070: 4.3% URN.21200: 2.6% IMM.31100: 2.6%
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Checklist (Discipline) Specific
Frequently Cited Deficiencies
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Lab General
• GEN.55500 Has competency been assessed? – 9.7 %***
• GEN.20375 Does lab have a document control system? – 7.6%***
• GEN.70250 Are fire drills conducted?– 7.1%
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Transfusion Medicine• TRM. 30866 Agreement between transfusion
service and clinical areas to ensure provision of blood/components/tissues– 4.4%
• TRM.41850 Potential hemolytic transfusion reaction immediate investigation – 3.7%
• TRM.30550 Program to ensure risks of mistransfusion are monitored/continual process improvement– 2.8%
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POCT
• POC.06900 Is there a documented program to ensure competence?– 6.5 %
• POC. 04500 Are patient results reported with reference ranges?– 5.6%
• POC.07300 Are controls run daily?– 4.9%
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Anatomic Pathology• ANP.12087 Is there a policy for the routine
decontamination of cryostat?– 4.9%
• ANP.08216 Are vapor concentrations maintained below maximal limits?– 3.3%
• ANP.11713 Is there documented evidence of daily review of technical quality of histo preps?– 2.4%
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Cytopathology• CYP.08500 Is there a documented workload
policy?– 3.0%
• CYP.05285 Is there documented procedure for handling workload if instrument failure?– 1.9%
• CYP.02800 Have a system documenting that personnel are knowledgeable about procedure manuals?– 1.6%
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Prevention is Better Than Cure!
• Review list of common deficiencies to determine if you have maintained compliance
• Procedure, Performance, Documentation• Be proactive and check CAP Web site for
new checklist versions• Perform an effective self-inspection
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Best Practices for Self-Inspections
• Involve multiple staff members in the self-inspection
• Formalize the event• Document and fix!• Look upon your lab with “fresh eyes”
– Other lab personnel– Residents if available
• Introduce a surprise element (Unannounced)
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Thank you for joining us today.
Questions?
