College of American Pathologists...COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES AVOIDING THE MOST COMMON DEFICIENCIES – CREATED AND

COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES A VOIDING THE MOS T COMMON DEFICIENCIES – CREATED AND PRESENTED BY PAUL BACHNER, MD, FCAP

©2 0 0 8 COLLEGE OF AMERICAN PATHOLOGISTS

April 16, 2008

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Laboratory Accreditation Program

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College of American Pathologists


Avoiding the Most Common Deficiencies

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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Assistance

http://www.cap.orgEmail: [email protected], ext. 6065

[email protected]



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Thank you for joining us today.

Questions?

Common Deficiencies 2006-2007 Attachment A

Self-assessment tool

© 2008 College of American Pathologists. All rights reserved. Avoiding the Most Common Deficiencies Audioconference, April 16, 2008

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Question text Deficiency #12: Does the laboratory have a documented system to ensure consistency of morphologic observations among all personnel performing …(U/A, Micro, Hem)

NOTE (sample) Suggested methods to accomplish this include:

1. Circulation of blood films with defined leukocyte differential distributions and specific qualitative abnormalities of each class of cells (WBC, RBC, PLT), and/or

2. Multi-headed microscopy, and/or 3. Use of blood or marrow photomicrographs with referee and consensus

identifications (e.g., former CAP surveys photomicrographs) The procedure manual should include definitions of semiquantitative measurements such as 1+, 2+, 3+, etc. In the case of comparative blood film WBC differentials, the method of Rümke is recommended to define statistical agreement between observers (Rümke CL. The statistically expected variability in differential leukocyte counts. In: Differential Leukocyte Counting, CAP Conference/Aspen. Northfield, IL: CAP, 1977:39-45.

Ways to comply

Current practice

Compliant with intent □ YES □ NO

Corrective action/improvement




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Question text Deficiency #11:

Are all reagents used within their indicated expiration date?

NOTE The laboratory must assign an expiration date to any reagents that do not have a manufacturer-provided expiration date. The assigned expiration date should be based on known stability, frequency of use, storage conditions, and risk of deterioration.

Ways to comply

Current practice






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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?

NOTE This question applies to quantitative tests performed on the same or different instrument makes/models. This comparison must include all instruments. The use of fresh human samples (whole blood, serum, plasma, urine, etc.), rather than stabilized commercial controls, is important to directly address the issue of whether a patient/client sample yields the same results on all of the laboratory's instruments. Statistical agreement of commercial control materials across instruments does not guarantee comparability of patient/client specimen results because of potential matrix effects. In cases when pre-analytical stability of patient/client specimens is a limiting factor, alternative protocols based on QC or reference materials may be necessary but the materials used should be validated to have the same response as fresh human samples for the instruments/methods involved. This checklist requirement applies only to instruments/methods accredited under a single CAP number.

Ways to comply

Current practice






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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?

NOTE Calibration, calibration verification, and validation of the analytical measurement range (AMR) are required to substantiate the continued accuracy of a test method. The CLIA-88 regulations use the term "calibration verification" to refer to both verification of correct method calibration and validation of the analytical measurement range. This Checklist uses separate terms to identify two distinct processes that are both required for good laboratory practice. The AMR is the range of analyte values that a method can directly measure on the specimen without any dilution, concentration, or other pretreatment that is not part of the usual assay process. Validation of the AMR is the process of confirming that the assay system will correctly recover the concentration or activity of the analyte over the AMR. The materials used for validation must be known to have matrix characteristics appropriate for the method. The test specimens must have analyte values that as a minimum are near the low, midpoint, and high values of the AMR. Guidelines for analyte levels near the low and high range of the AMR should be determined by the laboratory director. Factors to consider are the expected analytic imprecision near the limits, the clinical impact of errors near the limits, and the availability of test specimens near the limits. It may be difficult to obtain specimens with values near the limits for some analytes (e.g., T-uptake, free thyroxine, free phenytoin, prolactin, FSH, troponin, pO2). In such cases, reasonable procedures should be adopted based on available specimen materials. The method manufacturer’s instructions for validating the AMR should be followed, when available. Specimen target values can be established by comparison with peer group values for reference materials, by assignment of reference or comparison method values, and by dilution ratios of one or more specimens with known values. Each laboratory must define limits for accepting or rejecting validation tests of the AMR. The AMR must be revalidated at least every 6 months, and following changes in major system components or lots of analytically critical reagents (unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected).

Ways to comply




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(Deficiency #9, continued)

Current practice






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Are new reagent lots and/or shipments validated before or concurrent with use for patient testing?

NOTE NOTE: New reagent lots and/or shipments must be tested in parallel with old lots before or concurrently with being placed in service to ensure that the calibration of the new lot of reagent has maintained consistent results for patient specimens. Good clinical laboratory science includes patient-based comparisons when possible, since it is patient specimens that are tested. For quantitative tests, reagent validation is most reliably performed by assaying the same patient specimens with both the old and new lots to ensure consistent results. For qualitative tests, minimum cross-checking includes retesting at least one known positive and one known negative patient sample from the old reagent lot against the new reagent lot, ensuring that the same results are obtained with the new lot. A weakly positive sample should also be used in systems where patient results are reported in that fashion. Some method manufacturers provide reference materials or QC products specifically intended to validate successful calibration of their methods; these should be used when available. Such materials have method-specific, and, where appropriate, reagent-lot-specific, target values. Thus, these materials should be used only with the intended methods. Proficiency testing materials with peer group established mean values are acceptable for validation of new reagent lots. Third party general purpose reference materials may be suitable for validation of calibration following reagent lot changes if the material is documented in the package insert or by the method manufacturer to be commutable with patient specimens for the method. A commutable reference material is one that gives the same numeric result as would a patient specimen containing the same quantity of analyte in the analytic method under discussion; e.g., matrix effects are absent. Commutability between a reference material and patient specimens can be demonstrated using the protocol in NCCLS EP14-A2. QC material may be an acceptable alternative for validating calibration following reagent lot changes. However, the laboratory should be aware that QC material may be affected by matrix interference between different reagent lots. Thus, even if QC results show no change following a reagent lot change, a calibration inconsistency for patient specimens could exist nonetheless, masked by matrix interference affecting the QC material (a “false negative” validation). The use of patient samples to confirm the absence of matrix interference may be helpful. It is acceptable to use QC material alone to check a new shipment of a reagent lot currently in use, as there should be no change in potential matrix interactions between QC material and different shipments of the same lot number of reagent.




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Ways to comply

Current practice






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Is a complete procedure manual available at the workbench or in the work area?

NOTE The procedure manual should be used by personnel at the workbench and should include: test principle, clinical significance, specimen type, required reagents, test calibration, quality control, procedural steps, calculations, reference intervals, and interpretation of results. The manual should address relevant pre-analytic and post-analytic considerations, as well as the analytic activities of the laboratory. The specific style and format of procedure manuals are at the discretion of the laboratory director.

NOTE 1: The use of inserts provided by manufacturers is not acceptable in place of a procedure manual. However, such inserts may be used as part of a procedure description, if the insert accurately and precisely describes the procedure as performed in the laboratory. Any variation from this printed or electronic procedure must be detailed in the procedure manual. In all cases, appropriate reviews must occur.

NOTE 2: A manufacturer's procedure manual for an instrument/reagent system may be acceptable as a component of the overall departmental procedures. Any modification to or deviation from the procedure manual must be clearly documented. NOTE 3: Card files or similar systems that summarize key information are acceptable for use as quick reference at the workbench provided that:

a. A complete manual is available for reference b. The card file or similar system corresponds to the complete manual

and is subject to document control

NOTE 4: Electronic (computerized) manuals are fully acceptable. There is no requirement for paper copies to be available for the routine operation of the laboratory, so long as the electronic versions are readily available to all personnel. However, procedures must be available to laboratory personnel when the electronic versions are inaccessible (e.g., during laboratory information system or network downtime); thus, the laboratory must maintain either paper copies or electronic copies on CD or other media that can be accessed via designated computers. All procedures, in either electronic or paper form, must be readily available for review by the inspector at the time of the CAP inspection.

Electronic versions of procedures must be subjected to proper document control (i.e., only authorized persons may make changes, changes are dated/signed (manual or electronic), and there is documentation of annual review). Documentation of review of electronic procedures may be accomplished by including statements such as “reviewed by [name of reviewer] on [date of review]” in the electronic record. Alternatively, paper review sheets may be used to document review of electronic procedures. Documentation of review by a secure electronic signature is NOT required.




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Ways to comply

Current practice






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Are quality control data reviewed and assessed at least monthly by the laboratory director or designee?

NOTE Results of controls must be recorded or plotted to readily detect a malfunction in the instrument or in the analytic system. These control records must be readily available to the person performing the test.

Ways to comply

Current practice






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Is there evidence of ongoing evaluation of records of controls, instrument maintenance and function, temperature, etc., for all procedures as required?

NOTE None

Ways to comply

Current practice






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Question text Deficiency #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?

NOTE Appropriate alternative performance assessment procedures may include: split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed material, regional pools, clinical validation by chart review, or other suitable and documented means. It is the responsibility of the laboratory director to define such alternative performance assessment procedures, as applicable, in accordance with good clinical and scientific laboratory practice. Participation in ungraded/educational proficiency testing programs also satisfies this checklist question. Semiannual alternative assessment must be performed on tests for which PT is not available. The list of analytes for which CAP requires proficiency testing is available on the CAP website [http://www.cap.org/] or by phoning 800-323-4040 (or 847-832-7000), option 1.

Ways to comply

Current practice



http://www.cap.org/




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Question text Deficiency #3: Is there ongoing evaluation of PT and alternative assessment results, with prompt corrective action taken for unacceptable results?

NOTE Compliance with this item can be examined by selecting a sample of PT evaluation results and alternative assessment records. Special attention should be devoted to unacceptable results. Compliance requires that all of the following are true:

1. There is documented evidence of ongoing review of all PT reports and alternative assessment results by the laboratory director or the director’s designee. Reviews should be completed within one month of the date reports and results become available to the laboratory.

2. All “unacceptable” PT results and alternative assessment test result have been investigated.

3. Corrective action has been initiated for all unacceptable PT and alternative assessment results. Corrective action is appropriate to the nature and magnitude of the problem; it might consist of staff education, instrument recalibration, change in procedures, institution of new clerical checks, discontinuation of patient testing for the analyte or discipline in question, or other appropriate measures.

4. Primary records related to PT and alternative assessment testing are retained for two years (unless a longer retention period is required elsewhere in this checklist for specific analytes or disciplines). These include all instrument tapes, work cards, computer printouts, evaluation reports, evidence of review, and documentation of follow-up/corrective action.

Ways to comply

Current practice






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Are reagents and solutions properly labeled, as applicable and appropriate, with the following elements?

1. Content and quantity, concentration or titer 2. Storage requirements 3. Date prepared or reconstituted by laboratory 4. Expiration date

NOTE The above elements may be recorded in a log (paper or electronic), rather than on the containers themselves, providing that all containers are identified so as to be traceable to the appropriate data in the log. While useful for inventory management, labeling with "date received" is not routinely required. There is no requirement to routinely label individual containers with "date opened"; however, a new expiration date must be recorded if opening the container changes the expiration date, storage requirement, etc.

Ways to comply

Current practice






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Is there documentation of at least annual review of all policies and procedures by the current laboratory director or designee?

NOTE The director must ensure that the collection of policies and technical protocols is complete, current, and has been thoroughly reviewed by a knowledgeable person. Technical approaches must be scientifically valid and clinically relevant. To minimize the burden on the laboratory and reviewer(s), it is suggested that a schedule be developed whereby roughly 1/12 of all procedures are reviewed monthly. Paper/electronic signature review must be at the level of each procedure, or as multiple signatures on a listing of named procedures. A single signature on a Title Page or Index of all procedures is not sufficient documentation that each procedure has been carefully reviewed. Signature or initials on each page of a procedure is not required.

Ways to comply

Current practice



Attachment B


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College of American Pathologists Laboratory Accreditation Program

Summary of Waived Testing Requirements (Inspection Checklist Edition 10/31/06*)

√ Reagents 1. Lot-to-lot reagent validation not required 2. Follow manufacturer instructions for handling and validating √ Competency – same as for non-waived testing 1. During the first year that an individual is performing patient testing, competency must be assessed every six

months. 2. Competency must be reassessed at least annually. √ Correlation 1. Initial correlation between waived instruments (e.g., glucose meters) not required 2. Correlation between waived instruments and main lab instrument not required 3. Multi-instrument comparison not required √ QC 1. Follow manufacturer instructions. 2. QC results must be judged acceptable and recorded prior to release of patient results.

If control results exceed tolerance limits, corrective action must be documented. - Internal control results need not be documented for instruments using such controls, if (and only if) an unacceptable instrument control automatically locks the instrument and prevents release of patient results.

3. Frequency of QC is defined by the manufacturer. 4. External controls run as required by manufacturer. √ Calibration and Calibration Verification 1. Follow manufacturer instructions. Calibration verification every 6 months not necessary unless required by manufacturer √ Analytical Measurement Range (AMR) 1. Follow manufacturer instructions. Initial AMR Validation and 6-month interval validation not necessary

unless required by manufacturer √ Method Performance Specifications Verification not required EXCEPT for reference range. Other checklist requirements-in areas of proficiency testing, instrument maintenance, procedure manuals, personnel, specimen handling, results reporting and safety-remain the same for waived and non-waived testing. *Waived testing is covered in the following Checklists: Point of Care, Chemistry, Hematology, Immunology, Microbiology, Urinalysis and Limited Service.

College of American Pathologists • 325 Waukegan Road • Northfield, IL (800) 323-4040 • www.cap.org

Documents

College of American Pathologists...COLLEGE OF AMERICAN PATHOLOGISTS ~ LABORATORY ACCREDITATION PROGRAM ~ AUDIOCONFERENCE SERIES AVOIDING THE MOST COMMON DEFICIENCIES – CREATED AND