정도관리공통(CAP All Common Checklist )

[Adams]

    Laboratory Medicine분야에서 World Class Quality 의 질을 향상시키기위해서 

CAP Accreditation Prpogram에 적극적으로 참여하고 있은 기관들이 증가하고 있다.

미국병리학회 검사실인증점검표 중   정도관리공통 점검표는 아래와 같다.

    진단검사의학분야에서 모든 부서는 정도관리 점검표<CAP All Common Checklist>에서 요구하는 사항에 맞도록 검증하고 자료를 준비해야 한다.

CAP All Common Checklist;

Every patient deserves the GOLD STANDARD ...		Master
		All Common Checklist
		CAP Accreditation Program
College of American Pathologists 325 Waukegan Road Northfield, IL 60093-2750 www.cap.org		07.29.2013

Disclaimer and Copyright Notice

If you are enrolled in the CAP's Laboratory Accreditation Program and are preparing for an inspection, you must use the Checklists that were mailed in your application or reapplication packet, not those posted on the Web site.  The Checklists undergo regular revision and Checklists may be revised after you receive your packet.

If a Checklist has been updated since receiving your packet, you will be inspected based upon the Checklists that were mailed.  If you have any questions about the use of Checklists in the inspection process, please e-mail the CAP (accred@cap.org), or call (800) 323-4040, ext. 6065. 

The checklists used in connection with the inspection of laboratories by the Laboratory Accreditation Program of the College of American Pathologists have been created by the College and are copyrighted works of the College.  The College has authorized copying and use of the checklists by College inspectors in conducting laboratory inspections for the CLA and by laboratories that are preparing for such inspections.  Except as permitted by section 107 of the Copyright Act, 17 U.S.C. sec. 107, any other use of the checklists constitutes infringement of the College’s copyrights in the checklists.  The College will take appropriate legal action to protect these copyrights.

All Checklists are ©2013. College of American Pathologists. All rights reserved.

All Common Checklist

TABLE OF CONTENTS

SUMMARY OF CHANGES........................................................................................................................ 5

UNDERSTANDING THE CAP ACCREDITATION CHECKLIST COMPONENTS............................................... 7

HOW TO INSPECT USING R.O.A.D INSPECTION TECHNIQUES................................................................. 8

INTRODUCTION........................................................................................................................................ 9

DEFINITION OF TERMS............................................................................................................................ 9

ALL COMMON CHECKLIST..................................................................................................................... 12

PROFICIENCY TESTING...................................................................................................................... 12

QUALITY MANAGEMENT..................................................................................................................... 17

GENERAL ISSUES........................................................................................................................... 17

PROCEDURE MANUAL.................................................................................................................... 20

RESULTS REPORTING..................................................................................................................... 23

REAGENTS..................................................................................................................................... 25

TEST METHOD VALIDATION/VERIFICATION........................................................................................ 28

METHOD PERFORMANCE SPECIFICATIONS................................................................................... 29

REFERENCE INTERVALS................................................................................................................ 35

SUMMARY OF CHECKLIST EDITION CHANGES

All Common Checklist

07/29/2013 Edition

The following lists of requirements provide information on what has changed in this edition of the checklist, or in the previous edition. This information is provided in three categories:

1. New — requirements that have been added

2. Revised — requirements listed in this section fall into two categories:

• A major change to a requirement or a note that would necessitate a change in procedure for the laboratory

• A change to the Phase

1. Deleted/Moved/Merged — requirements listed in this section fall into three categories:

• Deleted — requirements that have been removed

• Moved — requirements that have been relocated from this checklist into another checklist, or have been moved within this checklist and given a new checklist requirement number (resequenced)

• Merged — requirements that have been combined with a similar requirement in the checklist

If this checklist was created for an on-site inspection or self-eval‎uation, it has been customized based on the laboratory's activity menu. The listing below is comprehensive; therefore, some of the requirements included may not appear in the customized checklist. Such requirements are not applicable to the testing performed by the laboratory.

Note: For the detail of the changes, refer to the "Changes Only" document which may be found on the CAP website through e-LAB Solutions (Laboratory Accreditation Program Master and Custom Checklists). To access this document select "Changes Only" from the Checklist Type drop-down menu.

The "Changes Only" document contains the text of new and deleted checklist requirements, major and minor requirement revisions, and changes to explanatory text. These changes are presented, in order, as they appear in the checklist. Major requirement revisions will display a "Revised" flag. Minor revisions will not display a "Revised" flag and are defined as those editorial changes that are not likely to affect your laboratory operations, but are worded to better convey the intent of the requirement. Changes appear in redline/strikeout format that compares the previous checklist edition to this edition. Requirements that have been moved or merged will appear at the end of that file.

NEW Checklist Requirements

Requirement	Effective Date
COM.04000	07/31/2012
COM.04050	07/31/2012
COM.04100	07/31/2012
COM.04150	07/31/2012
COM.04200	07/31/2012
COM.29950	07/29/2013
COM.30300	07/31/2012
COM.30350	07/31/2012
COM.30500	07/31/2012
COM.40450	07/29/2013
COM.40620	07/29/2013
COM.40630	07/29/2013
COM.40640	07/29/2013

REVISED Checklist Requirements

Requirement	Effective Date
COM.01300	07/31/2012
COM.01500	07/29/2013
COM.01700	07/29/2013
COM.01900	07/29/2013
COM.10100	07/29/2013
COM.10200	07/29/2013
COM.10250	07/29/2013
COM.10400	07/29/2013
COM.30000	07/31/2012
COM.30250	07/29/2013
COM.30400	07/29/2013
COM.30450	07/29/2013
COM.40000	07/29/2013
COM.40100	07/31/2012
COM.40500	07/29/2013
COM.50000	07/29/2013

DELETED/MOVED/MERGED Checklist Requirements

None

UNDERSTANDING THE CAP ACCREDITATION

CHECKLIST COMPONENTS

To provide laboratories with a better means to engage in and meet their accreditation requirements, the CAP has enhanced the checklist content and updated its design. New components containing additional information for both the laboratory and inspectors include Subject Headers, Declarative Statements and Evidence of Compliance. See below for a definition of each new feature as an example of how they appear in the checklists.

Using Evidence of Compliance (EOC)

This component, which appears with several checklist requirements, is intended to:

1. Assist a laboratory in preparing for an inspection and managing ongoing compliance

2. Drive consistent understanding of requirements between the laboratory and the inspector

3. Provide specific examples of acceptable documentation (policies, procedures, records, reports, charts, etc.)

Evidence of Compliance suggests ways to document compliance with checklist requirements.  Other types of documentation may be acceptable.  Whenever a policy/procedure/process is referenced within a requirement, it is only repeated in the Evidence of Compliance if such statement adds clarity.  All policies/procedures/processes covered in the CAP checklists must be documented.  A separate policy is not needed for each item listed in EOC as it may be referenced in an overarching policy.

HOW TO INSPECT USING R.O.A.D INSPECTION TECHNIQUES

(Read, Observe, Ask, Discover)

CAP has streamlined the inspection approach used during onsite inspections and is now offering guidance to inspectors by providing assessment techniques to facilitate a more efficient, consistent, and effective inspection process. Specific inspector instructions are listed at the beginning of a grouping of related requirements.

Rather than reviewing each individual requirement, CAP inspectors are encouraged to focus on the Inspector Instructions for a grouping of related requirements. Once an area of concern has been identified through "Read," "Observe," "Ask," "Discover," or a combination thereof, inspectors are encouraged to "drill down" to more specific requirements, when necessary and review more details outlined in the Evidence of Compliance statements. If a requirement is non-compliant, circle the requirement number to later list on the Inspector Summation Report. Inspectors may also make notes in the margins of the checklist document.

Inspector Instructions and Icons used to eval‎uate a laboratory's performance now appear in several areas throughout the Inspector Checklists. Please note that all four R.O.A.D elements are not always applicable for each grouping, or sections of related requirements.

Inspector Instructions:

	READ/review a sampling of laboratory documents. Information obtained from this review will be useful as you observe processes and engage in dialogue with the laboratory staff. (Example of the complimentary inspector instructions for Quality Management/Quality Control General Issues section appearing across checklists): ●      Sampling of QM/QC policies and procedures ●      Incident/error log and corrective action
	OBSERVE laboratory practices by looking at what the laboratory personnel are actually doing and note if practice deviates from the documented policies/procedures. (Example) ●      Observe the settings/QC range limits established in the laboratory LIS/HIS to ensure that the laboratory's stated ranges are accurately reflected
	ASK open-ended, probing questions that start with phrases such as "tell me about..." or "what would you do if..." This approach can be a means to corroborate inspection findings that were examined by other techniques, such as Read & Observe. Ask follow-up questions for clarification. Include a variety of staff levels in your communication process. (Example) ●      As a staff member, what is your involvement with quality management? ●      How do you detect and correct laboratory errors?
	DISCOVER is a technique that can be used to "drill down" or further eval‎uate areas of concern uncovered by the inspector. "Follow the specimen" and "teach me" are two examples of Discovery. Utilizing this technique will allow for the discovery of pre-analytic, analytic, and post-analytic processes while reviewing multiple requirements simultaneously. (Example) ●      Select several occurrences in which QC is out of range and follow documentation to determine if the steps taken follow the laboratory policy for corrective action

INTRODUCTION

The purpose of the All Common Checklist (COM) is to group together those requirements that were redundant in Laboratory General and the discipline-specific checklists. Therefore, the CAP centralized all requirements regarding: proficiency testing, procedure manuals, test method validation, and critical results into one checklist, the COM checklist. Please note that due to variations in different laboratory disciplines, there are some situations where the same requirement continues to exist in both the COM Checklist and in a discipline-specific checklist, but with a different checklist note that has a more specific requirement. In these situations, the discipline-specific requirement takes precedence over the COM requirement.

The Laboratory General Checklist applies to all sections of the laboratory. An inspection of a laboratory section, or department will include the discipline-specific checklist(s) (e.g. Anatomic Pathology), the Laboratory General Checklist, and the All Common Checklist.

If a section unit should require more than one inspector, each inspector must ensure that each area within the section unit is in compliance with the requirements in COM.

DEFINITION OF TERMS

Annual - Every 12 calendar months

Biennial - Every 24 calendar months

Calibrator, historical - The set of archived results of a single-point calibrator that demonstrates stability of the assay over time

Check - Examination to determine the accuracy, quality or presence of any attribute of a test system

Confirmation - Establishment of the correctness of a value or process

Correlation - Establishment of agreement between two or more measured values

Credentialing - The process of obtaining, verifying, and assessing the qualifications of a practitioner to provide care in a health care organization

Digital image analysis - The computer-assisted detection or quantification of specific features in an image following enhancement and processing of that image, including immunohistochemistry, DNA analysis, morphometric analysis, and in situ hybridization

Equipment - Single apparatus or set of devices or apparatuses needed to perform a specific task

Examination - In the context of checklist requirements, examination refers to the process of inspection of tissues and samples prior to analysis. An examination is not an analytical test.

FDA - In the context of checklist requirements, FDA should be taken to mean the national, state, or provincial authority having jurisdiction over in vitro diagnostic test systems.

Function Check - Operational check performed to confirm‎ that instruments and equipment (electrical, mechanical systems) are working according to manufacturer's specifications on a daily basis or before use. Examples may include base line calibration, balancing/zero adjustment, component operational checks (electronics, lamps, tubing), operational readiness (thermometer calibration, reagent delivery), and electronic function and peak performance.

High complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on their risks to public health. Tests in this category are seen to have the highest risks to public health.

Instrument - An analytical unit that uses samples to perform chemical or physical assays (e.g. chemistry analyzer, hematology analyzer)

Laboratory Director - The individual who is responsible for the overall operation and administration of the laboratory, including provision of timely, reliable and clinically relevant test results and compliance with applicable regulations and accreditation requirements. This individual is listed on the laboratory's CAP and CLIA certificate (as applicable).

Maintenance - Those activities that prolong the life of an instrument or minimize breakdowns or mechanical malfunctions. Examples include cleaning or changing parts, fluids, tubing, lubrication, electronic checks, etc.

Moderate complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on their risks to public health

Modification of manufacturer's instructions - Any change to the manufacturer's supplied ingredients or modifications to the assay as set forth in the manufacturer's labeling and instructions, including specimen type, instrumentation or procedure that could affect its performance specifications for sensitivity, specificity, accuracy, or precision or any change to the stated purpose of the test, its approved test population, or any claims related to interpretation of the results

Nonwaived - Tests categorized as either moderately complex (including provider-performed microscopy) or highly complex by the US Food and Drug Administration (FDA), according to a scoring system used by the FDA

Reagent - Any substance in a test system other than a solvent or support material that is required for the target analyte to be detected and its value measured in a sample.

Report errors - A report element (see GEN.41096) that is either incorrect or incomplete

Section Director - The individual who is responsible for the medical, technical and/or scientific oversight of a specialty or section of the laboratory.

Semiannual - Every 6 calendar months

Subject to U.S. Regulations - Laboratories located within the United States and laboratories located outside of the US that have obtained or applied for a CLIA certificate to perform laboratory testing on specimens collected in the US for the assessment of the health of human beings.

Telepathology - The practice in which the pathologist views digitized or analog video or still image(s), and renders an interpretation that is included in a formal diagnostic report or document in the patient record.

Test system - The process that includes pre-analytic, analytic, and post-analytic steps used to produce a test result or set of results. A test system may be manual, automated, multi-channel or single-use and can include reagents components, equipment or instruments required to produce results. A test system may encompass multiple identical analyzers or devices. Different test systems may be used for the same analyte.

Validation - A defined process by which a laboratory confirm‎s that a laboratory developed or modified FDA-cleared/approved test performs as intended or claimed.

Verification - The process by which a laboratory determines that an FDA-cleared/approved test performs according to the specifications set forth by the manufacturer.

Waived - A category of tests defined as "simple laboratory examinations and procedures which have an insignificant risk of an erroneous result." Laboratories performing waived tests are subject to minimal regulatory requirements.

ALL COMMON CHECKLIST

PROFICIENCY TESTING

Definitions:

Proficiency testing (PT) is defined as determination of laboratory testing performance by means of interlaboratory comparisons, in which a PT program periodically sends multiple specimens to members of a group of laboratories for analysis and/or identification; the program then compares each laboratory's results with those of other laboratories in the group and/or with an assigned value…(adapted from Clinical Laboratory Standards Institute Harmonized Terminology Database; available at http://www.clsi.org/).

Alternative assessment is defined as determination of laboratory testing performance by means other than PT--for example, split-sample testing, testing by a different method, etc.

Inspector Instructions:

	●      Sampling of proficiency testing policies and procedures ●      Sampling of eval‎uations of unacceptable proficiency testing results ●      Sampling of proficiency testing records including worksheets, instrument read-outs, reporting forms, attestation statement and director review ●      Records of semi-annual alternative assessment testing, if applicable ●      Eval‎uations of ungraded proficiency testing results, if applicable
	●      How do you ensure proficiency testing samples are rotated among all testing personnel? ●      In what situations would you repeat a proficiency testing sample? ●      What do you consider unacceptable proficiency testing performance and how do you determine corrective action? ●      How do you eval‎uate ungraded proficiency testing?
	●      Select a representative sample of unacceptable proficiency testing results and follow documentation from original testing to final determination of root cause.  Determine if the procedures and processes produce a thorough investigation with appropriate corrective action taken

COM.01000	PT Procedure	Phase II
	The laboratory has written procedures for proficiency testing sufficient for the extent and complexity of testing done in the laboratory. NOTE: The laboratory must have written procedures for the proper handling, analysis, review and reporting of proficiency testing materials. There must be written procedure(s) for investigation and correction of problems that are identified by unacceptable proficiency testing results. The laboratory should also have procedure(s) for investigation of results that, although acceptable show bias or trends suggesting a problem. CAP-accredited laboratories must participate in proficiency testing (PT) (when available through CAP or a CAP-accepted alternate provider) for all patient tests designated by CAP. The current list of analytes for which CAP requires PT is available on the CAP website [http://www.cap.org/] or by phoning 800-323-4040 (or 847-832-7000), option 1. The CAP office audits PT participation to assure that accredited laboratories participate in PT as appropriate.

COM.01100

Ungraded PT Challenges

Phase II

The laboratory has a procedure for assessing its performance on PT challenges that were intended to be graded, but were not.

NOTE: This requirement addresses PT challenges that were intended to be graded, but were not, for reasons such as: 1) the laboratory submitted its results after the cut-off date, 2) the laboratory did not submit results, 3) the laboratory did not complete the result form correctly (for example, submitting the wrong method code or recording the result in the wrong place). Also, if possible, the laboratory should assess its performance on PT challenges that were not graded because of lack of consensus. For guidance on the approach to these situations, refer to appendix I in the CAP Laboratory Accreditation Manual for listing of PT exception codes and actions.

Evidence of Compliance:

✓      Records of review and eval‎uation of ungraded PT challenges

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3705 [42CFR493.1236(a)(2)]

COM.01200

Activity Menu

Phase I

The laboratory's current CAP Activity Menu accurately reflects the testing performed.

NOTE: The Activity Menu should at all times reflect the laboratory’s current testing. The accuracy of the Activity Menu can be assessed by inquiry of responsible individuals, and by examination of the laboratory's test requisition(s), computer order screens, procedure manuals, or patient reports.  All tests performed by the laboratory should be listed on the Activity Menu, and vice versa.

Please note that unusual or esoteric tests performed in the laboratory section may not be specifically listed on the laboratory's activity menu but may be identified on the activity menu as a miscellaneous code.  Further information may be found with the laboratory's instrumentation list.  Some activities are also included on the Master Activity Menu using more generic groupings or panels instead of listing the individual tests.  The Master Activity Menu represents only those analytes that are directly measured.  Calculations are not included.

If any tests omitted from the laboratory’s Activity Menu are not covered by the checklists provided for the inspection, the inspector should contact the CAP (800-323-4040) for instructions.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2004(Oct 1): 985 [42CFR493.51]

**REVISED**       07/31/2012

COM.01300

PT Participation

Phase II

The laboratory participates in the appropriate required proficiency testing (PT)/external quality assessment (EQA) program accepted by CAP for the patient testing performed.

NOTE 1:  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.  A laboratory's participation in proficiency testing must include all analytes on this list for which it performs patient testing.

NOTE 2: For laboratories subject to US regulations, participation in proficiency testing may be through CAP PT Programs or another proficiency testing provider accepted by CAP.  Laboratories will not be penalized if they are unable to participate in an oversubscribed program.  If unable to participate, however, the laboratory must implement an alternative assessment procedure for the affected analytes.  For regulated analytes, if the CAP and CAP-accepted PT programs are oversubscribed, CMS requires the laboratory to attempt to enroll in another CMS-approved PT program.

NOTE 3: For laboratories not subject to US regulations, participation in proficiency testing must be through CAP PT Programs. Laboratories may use acceptable alternatives when the CAP is unable to deliver PT due to oversubscribed programs, stability issues or customs denial, contingent on CAP approval. (This goes into effect as of the 2014 Proficiency Testing Program year.) If unable to participate, however, the laboratory must implement an alternative assessment procedure for the affected analytes.

NOTE 4: Proficiency testing for HER2 is method specific. If the laboratory performs HER2 testing by multiple methods, the laboratory must participate in PT for each method.

A.  HER2 interpretation by immunohistochemistry (IHC): If the laboratory interprets its HER2 test results from IHC stains prepared at another facility, the laboratory must:

●      Enroll in an appropriate PT Program

●      Send PT materials to the staining facility for preparation, and

●      Interpret the resulting stains using the same procedures that are used for patient specimens

B.  HER2 interpretation by FISH (or ISH): If the laboratory sends its FISH (or ISH) slides for hybridization to another facility, the laboratory must perform an alternative assessment of the test twice annually and may not participate in formal (external) PT.

NOTE 5: For purposes of photograph/image identification in CAP PT Programs, it is strongly recommended that the current CAP Surveys Hematology Glossary be readily available to the bench technologist in the hematology and urinalysis sections.

Evidence of Compliance:

✓      Records such as CAP order form or purchase order indicating that the laboratory is enrolled in CAP PT Programs for all analytes that CAP requires PT OR record of completed/submitted result forms for all analytes on the activity menu

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 [42CFR493.801]
2)	Tholen DW. Reference values and participant means as targets in proficiency testing. Arch Pathol Lab Med. 1993;117:885-889
3)	Borsotti M. External quality assessment scheme in Tuscany, Italy. Ann 1st Super Sanita. 1995;31:175-186
4)	Westgard JO, et al. Laboratory precision performance. State of the art versus operating specifications that assure the analytical quality required by clinical laboratory improvement amendments proficiency testing. Arch Pathol Lab Med. 1996;120:621-625
5)	Ross JW, et al. The accuracy of laboratory measurements in clinical chemistry. A study of 11 routine chemistry analytes in the College of American Pathologists chemistry survey with fresh frozen serum, definitive methods, and reference materials. Arch Pathol Lab Med. 1998;122:587-608
6)	College of American Pathologists, Commission on Laboratory Accreditation. Standards for laboratory accreditation; standard III. Northfield, IL: CAP, 1998
7)	Dale JC, Hamrick HJ. Neonatal bilirubin testing practices. Reports from 312 laboratories enrolled in the College of American Pathologists Excel proficiency testing program. Arch Pathol Lab Med. 2000;124:1425-1428
8)	Plebani M, et al. External quality assessment for serum proteins: state of the art. Clin Chem. 2001;47(suppl):A35
9)	Panteghini M, et al. External quality assessment scheme for biochemical markers of cardiac damage. Clin Chem. 2001;47(suppl):A195
10)	Wilson JF, et al. Primary standardization of assays for anticonvulsant drugs: comparison of accuracy and precision. Clin Chem. 2002;48:1963-1969
11)	Taylor A, et al. Comparison of procedures for eval‎uating laboratory performance in external quality assessment schemes for lead in blood and aluminum in serum demonstrates the need for common quality specifications. Clin Chem. 2002;48:2000-2007
12)	Wolff AC, Hammond ME, Schwartz JN, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer. Arch Pathol Lab Med 2007;131:18-43
13)	Nakhleh RE, Grimm EE, Idowu MO, et al. Laboratory compliance with the American Society of Clinical Oncology/College of American Pathologists (ASC/CAP) guidelines for human epidermal growth factor 2 (HER2) testing: a College of American Pathologists survey of 757 laboratories. Arch Pathol Lab Med 134:728034, 2010

COM.01400

Attestation Page

Phase II

The proficiency testing attestation statement is signed by the laboratory director or designee and the individual performing the testing.

Evidence of Compliance:

✓      Appropriately signed attestation statement from submitted PT result forms

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 [42CFR493.801(b)(1)]

**REVISED**       07/29/2013

COM.01500

Alternative Performance Assessment

Phase II

For tests for which CAP does not require PT, the laboratory at least semi-annually exercises an alternative performance assessment system for determining the reliability of analytic testing.

NOTE 1:  Appropriate alternative performance assessment procedures include participation in an external PT program not required by CAP; participation in an ungraded/educational PT program; split sample analysis with reference or other laboratories, split samples with an established in-house method, assayed materials, clinical validation by chart review, or other suitable and documented means.  It is the responsibility of the laboratory director to define such alternative assessment procedures and the criteria for successful performance in accordance with good clinical and scientific laboratory practice.

NOTE 2: For FISH testing, alternative assessment may be performed by method and specimen type, rather than for each tested abnormality (i.e. one program for all FISH cytogenetics tests performed on cell suspensions). Additionally, for sequencing based testing such as Sanger, pyrosequencing and next generation, alternative assessment may be performed by method and specimen type. For tests such as allergen testing, alternative assessment may be performed in batches of analogous tests.

NOTE 3: Semi-annual alternative performance assessment must be performed on tests for which external PT is not available.

NOTE 4: This checklist requirement applies to both waived and nonwaived tests.

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.

Evidence of Compliance:

✓      List of tests defined by the laboratory as requiring alternative assessments AND

✓      Records of those assessments

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7184 [42CFR493.1236(c)(1)]
2)	Shahangian S, et al. A system to monitor a portion of the total testing process in medical clinics and laboratories. Feasibility of a split-specimen design. Arch Pathol Lab Med. 1998;122:503-511
3)	Shahangian S, Cohn RD. Variability of laboratory test results. Am J Clin Pathol. 2000;113:521-527
4)	CLSI. Assessment of Laboratory Tests When Proficiency Testing is not Available; Approved Guideline-Second Edition. CLSI Document GP29-A2. [ISBN 1-56238-673-5]. CLSI, 940 West Valley Road, Suite 1400, Wayne, PA 19087-1898 USA, 2008
5)	Marks V. False-positive immunoassay results: a multicenter survey of erroneous immunoassay results from assays of 74 analytes in 10 donors from 66 laboratories in seven countries. Clin Chem. 2002;48:2008-2016

COM.01600

PT Integration Routine Workload

Phase II

The laboratory integrates all proficiency testing samples within the routine laboratory workload, and those samples are analyzed by personnel who routinely test patient/client samples, using the same primary method systems as for patient/client/donor samples.

NOTE:  Duplicate analysis of any proficiency sample is acceptable only if patient/client specimens are routinely analyzed in the same manner.  With respect to morphologic examinations (identification of cell types and microorganisms; review of electrophoretic patterns, etc.), group review and consensus identifications are permitted only for unknown samples that would ordinarily be reviewed by more than one person in an actual patient sample.

If the laboratory uses multiple methods for an analyte, proficiency samples should be analyzed by the primary method.  The educational purposes of proficiency testing are best served by a rotation that allows all technologists to be involved in the proficiency testing program.  Proficiency testing records must be retained and can be an important part of the competency and continuing education documentation in the personnel files of the individuals.  When external proficiency testing materials are not available, the semi-annual alternative performance assessment process should also be integrated within the routine workload, if practical.

Evidence of Compliance:

✓      Written policy describing proper handling of PT specimens AND

✓      Instrument printout and/or work records AND

✓      Completed attestation pages from submitted PT result forms

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 [42CFR493.801(b)]
2)	Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43
3)	Parsons PJ. Eval‎uation of blood lead proficiency testing: comparison of open and blind paradigms. Clin Chem. 2001;47:322-330

**REVISED**       07/29/2013

COM.01700

PT Eval‎uation

Phase II

There is ongoing eval‎uation of PT and alternative assessment results, with prompt corrective action taken for unacceptable results.

NOTE: 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.

For laboratories outside the US, PT failures relating to problems with shipping and specimen stability should include working with local customs and health regulators to ensure appropriate transit of proficiency testing specimens.

Evidence of Compliance:

✓      Records of ongoing, timely review of all PT reports and alternative assessment results by the laboratory director or designee AND

✓      Records of investigation of "unacceptable" PT and alternative assessment results including records of corrective action that is appropriate to the nature and magnitude of the problem

REFERENCES

1)	Ehrmeyer SS, et al. Use of alternative rules (other than the 1-2s) for eval‎uating interlaboratory performance data. Clin Chem. 1988:34:250-256
2)	Klee GG, Forsman RW. A user's classification of problems identified by proficiency testing surveys. Arch Pathol Lab Med. 1988;112:371-373
3)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(4)(iv)]
4)	Steindel SJ, et al. Reasons for proficiency testing failures in clinical chemistry and blood gas analysis. A College of American Pathologists Q-Probes study in 655 laboratories. Arch Pathol Lab Med. 1996;120:1094-1101
5)	Clinical and Laboratory Standards Institute (CLSI). Using Proficiency Testing to Improve the Clinical Laboratory; Approved Guideline—Second Edition. CLSI document GP27-A2 (ISBN 1-56238-632-8). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2007
6)	Shahangian S, et al. Toward optimal PT use. Med Lab Observ. 2000;32(4):32-43
7)	Zaki Z, et al. Self-improvement by participant interpretation of proficiency testing data from events with 2 to 5 samples. Clin Chem. 2000;46:A70

COM.01800

PT Interlaboratory Communication

Phase II

There is a policy that prohibits interlaboratory communication about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider.

NOTE: There is a strict prohibition against interlaboratory communications about proficiency testing samples until after the deadline for submission of data to the proficiency testing provider. The laboratory director is responsible for enforcing this prohibition.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7146 [42CFR493.801(b)(3)]
2)	Bierig JR. Comparing PT results can put a lab's CLIA license on the line. Northfield, IL: College of American Pathologists CAP Today. 2002;16(2):84-87

**REVISED**       07/29/2013

COM.01900

PT Referral

Phase II

There is a policy that prohibits referral of proficiency testing specimens to another laboratory or acceptance from another laboratory.

NOTE:  This prohibition takes precedence over the requirement that proficiency testing specimens be handled in the same manner as patient specimens. For example, a laboratory's routine procedure for review of abnormal blood smears might be referral of the smear to a pathologist located at another site. For proficiency testing specimens, the referring laboratory must NOT follow its routine procedure in this situation. Rather, the laboratory must submit a PT result of "test not performed" since the review does not occur within the referring laboratory.

For laboratories subject to US regulations, this applies even if the second laboratory is in the same health care system. It is the responsibility of the laboratory director to ensure that this prohibition is enforced.

Refer to 'Tips for Avoiding Proficiency Testing Referral' on the CAP website (e-LAB Solutions, Laboratory Accreditation, LAP Resources for Laboratories) for further information.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28): [42CFR493.801(b)(4)]

QUALITY MANAGEMENT

GENERAL ISSUES

Inspector Instructions:

	●      Sampling of QM policies and procedures ●      QM/QC program, including pre-analytic, analytic and post-analytic monitor records and corrective action when indicators do not meet threshold ●      Incident/error log and corrective action ●      Records of high school graduate high complexity test review by supervisor
	●      How do you eval‎uate data on the incident/error log?  How do you determine appropriate corrective action? ●      As a staff member, what is your involvement with quality management? ●      How do you detect and correct laboratory errors?
	●      Follow an incident identified on the incident/error log and follow actions including notification and resolution ●      Select several problems identified by the QM plan and follow tracking and corrective action. Determine if the methods used led to discovery and effective correction of the problem.

**NEW**       07/31/2012

COM.04000

Documented QM/QC Plan

Phase II

The laboratory has a written quality management/quality control (QM/QC) program.

NOTE: The program must ensure quality throughout the pre-analytic, analytic, and post-analytic (reporting) phases of testing, including patient identification and preparation; specimen collection, identification, preservation, transportation, and processing; and accurate, timely result reporting. The program must be capable of detecting problems in the laboratory's systems, and identifying opportunities for system improvement. The laboratory must be able to develop plans of corrective/preventive action based on data from its QM system.

All QM requirements in the Laboratory General Checklist pertain to the laboratory.

Evidence of Compliance:

✓      Records reflecting conformance with the program as designed AND

✓      Results of quality surveillance

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7176 [42CFR493.1445(e)(5)
2)	Clinical and Laboratory Standards Institute (CLSI). Quality Management System: A Model for Laboratory Services; Approved Guideline—Fourth Edition. CLSI document GP26-A4 (ISBN 1-56238-761-8 [Print]; ISBN 1-56238-762-6 [Electronic]). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2011.

**NEW**       07/31/2012

COM.04050

Unusual Laboratory Results

Phase II

There is a documented system in operation to detect and correct significant clerical and analytical errors, and unusual laboratory results, in a timely manner.

NOTE: One common method is review of results by a qualified person (technologist, supervisor, pathologist) before release from the laboratory, but there is no requirement for supervisory review of all reported data for single analyte tests that do not include interpretation.  In computerized laboratories, there should be automatic "traps" for improbable results. The system for detecting clerical errors, significant analytical errors, and unusual laboratory results must provide for timely correction of errors, i.e. before results become available for clinical decision making. For confirmed errors detected after reporting, corrections must be promptly made and reported to the ordering physician or referring laboratory, as applicable.

Each procedure must include a listing of common situations that may cause analytically inaccurate results, together with a defined protocol for dealing with such analytic errors or interferences. This may require alternate testing methods; in some situations, it may not be possible to report results for some or all of the tests requested.

The intent of this requirement is NOT to require verification of all results outside the reference (normal) range.

Evidence of Compliance:

✓      Records of review of results OR records of consistent implementation of the error detection system(s) defined in the procedure AND

✓      Records of timely corrective action of identified errors

REFERENCES

1)	Dufour D, et al. The clinical significance of delta checks. Am J Clin Pathol. 1998;110:531

**NEW**       07/31/2012

COM.04100

Supervisory Result Review

Phase II

In the absence of on-site supervisors, results of tests performed by personnel are reviewed by the laboratory director or supervisor/general supervisor within 24 hours.

NOTE: The CAP does NOT require supervisory review of all test results before or after reporting to patient records. Rather, this requirement is intended to address only that situation for "high complexity testing" performed by trained high school graduates when a qualified supervisor/general supervisor is not present.

Evidence of Compliance:

✓      Written policy defining the review process and personnel whose results require review AND

✓      Records of result review for specified personnel

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7182 [42CFR493.1463(a)(3) and 42CFR493.1463(c)]: 7183 [42CFR493.1489(b)(1)] and [42CFR493.1489(b)(5)]

**NEW**       07/31/2012

COM.04150

Specimen Collection Manual

Phase II

There is a documented procedure describing methods for patient identification, patient preparation, specimen collection and labeling, specimen preservation, and conditions for transportation, and storage before testing, consistent with good laboratory practice.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Oct 1):1034 [42CFR493.1242(a)]

**NEW**       07/31/2012

COM.04200	Instrument Maintenance Eval‎uation	Phase II
	There is documentation of monthly eval‎uation of instrument maintenance and function, including temperatures of refrigerators/freezers in which reagents or patient specimens are kept. NOTE: There must be documentation of ongoing monitoring of instrument function and maintenance records on all devices. Monitoring of device operation must be in accordance with manufacturers' instructions. If the manufacturer does not provide monitoring recommendations, the laboratory must document the specific monitoring procedures used. Limits of acceptable variation must be defined in laboratory procedures. For cytopathology, a sample of slides from slide preparation instruments, including those using liquid-based technology and cytocentrifuge or filtration methods, should be routinely reviewed microscopically for technical acceptability.

PROCEDURE MANUAL

The procedure manual should be used by personnel at the workbench and must include the following elements, when applicable to the test procedure:

1. Principle and clinical significance

2. Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection

3. Microscopic examination, including the detection of inadequately prepared slides

4. Step-by-step performance of the procedure, including test calculations and interpretation of results

5. Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing

6. Calibration and calibration verification procedures

7. The analytic measurement range for test results for the test system, if applicable*

8. Control procedures

9. Corrective action to take when calibration or control results fail to meet the laboratory's criteria for acceptability

10. Limitations in the test methodology, including interfering substances

11. Reference intervals (normal values)

12. Imminently life-threatening (critical) test results

13. Pertinent literature references

14. The laboratory's system for entering results in the patient record and reporting patient results including, when appropriate, the protocol for reporting imminently life-threatening (critical) results

15. Description of the course of action to take if a test system becomes inoperable

(*The analytic measurement range may not apply to qualitative or semi-quantitative tests.)

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.

Inspector Instructions:

	●      Representative sample of procedures for completeness and laboratory director review. Current practice must match contents of procedures/policies. ●      Validation study of modified FDA-cleared/approved test, if applicable
	●      How do you access procedures? ●      What procedure has most recently been implemented or modified? ●      How do you ensure all copies of procedures are up to date? ●      How are changes in procedures documented and communicated to staff? ●      How are discontinued policies and procedures removed from general access?
	●      Identify a newly-implemented procedure in the prior two years and follow the steps through authoring, director review and staff training

COM.10000

Procedure Manual

Phase II

A complete procedure manual is available at the workbench or in the work area.

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 complete manual is available for reference

■      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 biennial 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.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1251(a) (b) (1-14)(c)(d)(e)]
2)	van Leeuwen AM. 6 Steps to building an efficiency tool. Advance/Laboratory. 1999:8(6):88-91
3)	Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs Maryland health care system. Mod. Pathol. 2001;14:1-5
4)	Clinical and Laboratory Standards Institute (CLSI). Quality Management System: Development and Management of Laboratory Documents; Approved Guideline - Sixth Edition. CLSI document QMS02-A6 (ISBN 1-56238-869-X). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087 USA, 2013.

**REVISED**       07/29/2013

COM.10100

Procedure Manual Review

Phase II

There is documentation of review of all technical policies and procedures by the current laboratory director or designee at least every two years.

NOTE:  The director must ensure that the collection of testing 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 1/24 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.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7173 [42CFR493.1407(e)(13)]
2)	Borkowski A, et al. Intranet-based quality improvement documentation at the Veterans Affairs Maryland health care system. Mod. Pathol. 2001;14:1-5

**REVISED**       07/29/2013

COM.10200

New Procedure Review

Phase II

The laboratory director reviews and approves all new technical policies and procedures, as well as substantial changes to existing documents, before implementation.

NOTE: This review may not be delegated to designees in laboratories subject to the CLIA regulations.

Evidence of Compliance:

✓      Policy on procedure review AND

✓      Records of policy/procedure approval

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1251(d)]

**NEW/REVISED**       07/29/2013

COM.10250	New Procedure Review	Phase II
	For laboratories not subject to US regulations, the laboratory director or designee reviews and approves all new technical policies and procedures, as well as substantial changes to existing documents before implementation. Evidence of Compliance: ✓      Policy on procedure review AND ✓      Records of policy/procedure approval

COM.10300	Knowledge of Procedures	Phase II
	The laboratory has a system documenting that all personnel are knowledgeable about the contents of procedure manuals (including changes) relevant to the scope of their testing activities. NOTE:  The form of this system is at the discretion of the laboratory director.  Annual procedure sign-off by testing personnel is not specifically required. Evidence of Compliance: ✓      Records indicating that the testing personnel have read the procedures, new and revised, OR records of another documented method approved by the laboratory director

**REVISED**       07/29/2013

COM.10400

New Director Procedure Review

Phase II

If there is a change in laboratory directorship, the new laboratory director reviews and approves (over a reasonable period of time) that laboratory procedures are current.

NOTE: This should be completed within three months of the change of directorship for most laboratories.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1251(d)]

COM.10500

Discontinued Procedure

Phase II

When a procedure is discontinued, a paper or electronic copy is maintained for at least 2 years, recording initial date of use, and retirement date.

NOTE 1: In transfusion medicine, procedures related to donor collection, transfusion, and administration of tissues and progenitor cells, procedures (paper or electronic) must be maintained for 5 years.

NOTE 2: For genetic testing, in order to meet the requirements of some states relating to the testing of minors (under the age of 21), it is recommended that laboratories retain procedures (paper or electronic) for at least 23 years (to cover the interval from fetal period to age 21).

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1105(a)(2)]

RESULTS REPORTING

Inspector Instructions:

	●      Sampling of critical patient results/log
	●      How do you document critical results? Who do you contact?
	●      Follow a critical result from testing, reporting and recording of notification

**NEW**       07/29/2013

COM.29950

Reference Intervals

Phase II

All patient/client results are reported with reference (normal) intervals or interpretations as appropriate.

NOTE: The laboratory must report reference (normal) intervals or interpretations with patient/client results, where such exist. This is important to allow proper interpretation of patient/client data. Age- and/or sex-specific reference ranges (normal values) or interpretive ranges must be reported with patient test results, as applicable. In addition, the use of high and low flags (generally available with a computerized laboratory information system) is recommended. It is not necessary to include reference intervals when test results are reported as part of a treatment protocol that includes clinical actions, which are based on the test result.

Under some circumstances it may be appropriate to distribute lists or tables of reference intervals to all users and sites where reports are received. This system is usually fraught with difficulties, but if in place and rigidly controlled, it is acceptable.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7162 [42CFR493.1291(d)]

**REVISED**       07/31/2012

COM.30000

Critical Result Notification

Phase II

The laboratory has procedures for immediate notification of a physician (or other clinical personnel responsible for the patient's care) when results of designated tests exceed established "alert" or "critical" values that are important for prompt patient management decisions.

NOTE:  Alert or critical results are those results that may require rapid clinical attention to avert significant patient morbidity or mortality.  The laboratory may establish different critical results for specific patient subpopulations (for example, dialysis clinic patients).  Critical results should be defined by the laboratory director, in consultation with the clinicians served.

Allowing clinicians to "opt out" of receiving critical results is strongly discouraged.

Records must be maintained showing prompt notification of the appropriate clinical individual after obtaining results in the critical range. These records should include: date, time, responsible laboratory individual, person notified (the person's first name alone is not adequate documentation), and test results. Any problem encountered in accomplishing this task should be investigated to prevent recurrence.

Reference laboratories may report critical results directly to clinical personnel, or to the referring laboratory.  The reference laboratory should have a written agreement with the referring laboratory that indicates to whom the reference laboratory reports critical results.

In the point-of-care setting, the identity of the testing individual and person notified need not be documented when the individual performing the test is the same person who treats the patient. In this circumstance, however, there must be documentation of the critical result, date, and time in the test report or elsewhere in the medical record.

REFERENCES

1)	Kost GJ. Critical limits for urgent clinician notification at US medical centers. JAMA. 1990;263:704-707
2)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24): [42CFR493.1291(g)]
3)	Steindel SJ, Heard NV. Critical values: data analysis and critique. Q-Probes 92-04. Northfield, IL: College of American Pathologists, 1992
4)	Kost GJ. Using critical limits to improve patient outcome. Med Lab Observ. 1993;25(3):22-27
5)	Tate KE, Gardner RM. Computers, quality, and the clinical laboratory: a look at critical values. Proc Annu Symp Comput Appl Med Care. 1993;193-197
6)	Kaufman HW, Collins C. Notifying clients of life-threatening results. Med Lab Observ. 1994;26(8):44-45
7)	Emancipator K. Critical values. ASCP practice parameter. Am J Clin Pathol. 1997:108:247-253

COM.30100	Critical Result Read-Back	Phase I
	When critical results are communicated verbally or by phone, there is a policy that laboratory personnel ask for a verification “read-back” of the results. NOTE:  Laboratory personnel should document the read-back. Transmission of critical results by electronic means (FAX or computer) is acceptable.  If critical results are transmitted electronically, the laboratory should confirm‎ receipt of the result by the intended recipient (e.g. by a phone call); however, no read-back is necessary. Evidence of Compliance: ✓      Records of critical result notification with documented read-back

REAGENTS

Inspector Instructions:

	●      Sampling of test procedures for reagent handling ●      Sampling of new reagent/shipment confirmation of acceptability records ●      Sampling of ambient temperature logs (if reagents stored at ambient temperature)
	●      Sampling of reagents (expiration date, labeling, storage)
	●      How do you store the reagents and controls used in test procedures? ●      How do you confirm‎ the acceptability of new reagent lots? ●      What are your laboratory's criteria for mixing components from one lot number of reagent kit with components from another lot number of kit? ●      How does your laboratory manage and control reagent inventory?

**NEW/REVISED**       07/29/2013

COM.30250	Reagent Handling/Storage - Waived Tests	Phase II
	For waived tests, the laboratory follows manufacturer instructions for handling and storing reagents, cartridges, test cards, etc. NOTE: 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. If the manufacturer defines a required storage temperature range, the temperature of storage areas must be monitored and recorded daily. The two acceptable ways of recording temperatures are: 1) recording the numerical temperature, or 2) placing a mark on a graph that corresponds to a numerical temperature (either manually, or using a graphical recording device). The identity of the individual recording the temperature(s) must be documented (recording the initials of the individual is adequate). The use of automated (including remote) temperature monitoring systems is acceptable, providing that laboratory personnel have ongoing immediate access to the temperature data, so that appropriate corrective action can be taken if a temperature is out of the acceptable range. The functionality of the system must be documented daily. Evidence of Compliance: ✓      Written procedure consistent with manufacturer's instructions for each waived test

The remaining checklist requirements in the REAGENTS section do not apply to waived tests.

**NEW**       07/31/2012

COM.30300

Reagent Labeling

Phase II

Reagents, calibrators, controls, and solutions are 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.

Evidence of Compliance:

✓      Written policy defining elements required for reagent labeling

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(c)]

**NEW**       07/31/2012

COM.30350

Reagent Storage

Phase II

All reagents and media are stored as recommended by the manufacturer.

NOTE: Reagents and media must be stored as recommended by the manufacturer to prevent environmentally-induced alterations that could affect test performance. If ambient storage temperature is indicated, there must be documentation that the defined ambient temperature is maintained and corrective action taken when tolerance limits are exceeded.

A frost-free freezer may not be used to store reagents and controls unless either of the following conditions are met: 1) Reagent/control materials are kept in thermal containers and the laboratory can demonstrate that the function of these materials is not compromised; or 2) Freezer temperature is monitored by a continuous monitoring system, or a maximum/minimum thermometer.

Patient samples may be stored in a frost-free freezer only if the temperature is monitored in accordance with (2), above.

The use of automated (including remote) temperature monitoring systems is acceptable, providing that laboratory personnel have ongoing immediate access to the temperature data, so that appropriate corrective action can be taken if a temperature is out of the acceptable range. The functionality of the system must be documented daily.

Evidence of Compliance:

✓      Records of reagent and media storage consistent with manufacturer's instructions, including refrigerator, freezer and room temperature monitoring, as applicable

REFERENCES

1)	Gonzales Y, Kampa IS. The effect of various storage environments on reagent strips. Lab Med. 1997;28:135-137

**NEW/REVISED**       07/29/2013

COM.30400

Reagent Expiration Date

Phase II

All reagents and media are used within their indicated expiration date.

NOTE: The laboratory must assign an expiration date to any reagents and media 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.

For laboratories not subject to US regulations and military laboratories in overseas locations, expired reagents may be used only under the following circumstances: 1) The reagents are unique, rare or difficult to obtain; or 2) Delivery of new shipments of reagents is delayed through causes not under control of the laboratory. The laboratory must document verification of the performance of expired reagents in accordance with written laboratory policy.

Laboratories subject to US regulations must not use expired reagents.

Evidence of Compliance:

✓      Written policy for eval‎uating reagents and media lacking manufacturer's expiration date

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1252(d)]

**NEW/REVISED**       07/29/2013

COM.30450

New Reagent Lot Confirmation of Acceptability

Phase II

New reagent lots and/or shipments are checked against old reagent lots or with suitable reference material before or concurrently with being placed in service.

NOTE: The purpose of this check is to confirm‎ that the use of the new reagent lot or shipment does not affect patient results. Matrix interferences between different lots of reagents may impact the calibration status of instruments and consistency of patient results. Improper storage conditions during shipping of reagents may have a negative impact on their ability to perform or exhibit the same levels of reactivity as intended.

Qualitative: For qualitative nonwaived tests, minimum cross-checking includes retesting at least one positive and negative sample with known reactivity against the new reagent lot. A weakly positive sample should also be used in systems where patient results are reported in that fashion.

Examples of suitable reference materials for qualitative tests include:

1.     Positive and negative patient samples tested on a previous lot;

2.     Previously tested proficiency testing materials;

3.     External QC materials tested on the previous lot;

4.     Control strains of organisms or previously identified organisms for microbiology reagents used to detect or eval‎uate cultured microorganisms.

For flow cytometry reagents, this may be accomplished by comparing the results of the old and new reagent tested in parallel on the same fresh control (patient or normal) or testing just the new reagent on a standardized control with defined mean and reference range. This does not imply the need to compare the new reagent lot to a negative control.

Quantitative: For quantitative nonwaived tests, patient specimens should be used to compare a new lot against the old lot, when possible. Manufactured materials, such as proficiency testing (PT) or QC materials may be affected by matrix interference between different reagent lots, even if results show no change following a reagent lot change. The use of patient samples confirm‎s the absence of matrix interference. Other than patient samples, the following materials may also be used:

1.     Reference materials or QC products provided by the method manufacturer with method specific and reagent lot specific target values;

2.     Proficiency testing materials with peer group established means;

3.     QC materials with peer group established means based on interlaboratory comparison that is method specific and includes data from at least 10 laboratories;

4.     Third party general purpose reference materials if the material is documented in the package insert or by the method manufacturer to be commutable with patient specimens for the method. Commutability between reference materials and patient samples can be demonstrated using the protocol in CLSI EP14-A2.

5.     QC material used to test the current lot is adequate alone to check a new shipment of the same reagent lot, as there should be no change in potential matrix interactions between the QC material and different shipments of the same lot number of reagents.

Evidence of Compliance:

✓      Written procedure for the confirmation of acceptability of new lots and shipments prior to use AND

✓      Records of acceptability study of new reagents/shipments

REFERENCES

1)	Clinical and Laboratory Standards Institute. Eval‎uation of Matrix Effects; Approved Guideline Second Edition. Clinical and Laboratory Standards Institute document EP14-A2 (ISBN 1-56238-561-5). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005
2)	Clinical and Laboratory Standards Institute. Verification of comparability of patient results within one healthcare system: Approved Guideline (Interim Revision). CLSI document C54-A-IR (ISBN 1-56238-671-9).Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2012.
3)	Miller WG, Myers GL, Rej R. Why commutability matters. Clin Chem. 2006;52:553-554

**NEW**       07/31/2012

COM.30500	Reagent Kit Components	Phase II
	If there are multiple components of a reagent kit, the laboratory uses components of reagent kits only within the kit lot unless otherwise specified by the manufacturer. Evidence of Compliance: ✓      Written documentation defining allowable exceptions for mixing kit components from different lots

TEST METHOD VALIDATION/VERIFICATION

Inspector Instructions:

●      Policies and procedures for the introduction of new tests/methods/instruments ●      Sampling of assay validation/verification studies, including signed summary statements and data, for tests with emphasis on tests introduced in the past two years ●      Sampling of assay validation studies for laboratory-developed tests (LDTs), including tests that are not FDA-cleared/approved and FDA-cleared/approved tests modified by the laboratory, introduced since the last on-site inspection ●      Sampling of patient reports for laboratory-developed assays

●      Which laboratory tests or instruments have been implemented in the past two years, particularly those that are not FDA-cleared/approved? ●      How does your laboratory validate/verify assay performance prior to test implementation? ●      How has your laboratory verified/established the reportable range (AMR) for the test? ●      How does your laboratory establish or verify reference intervals? ●      How do you ensure that a modified FDA-cleared/approved test exhibits equal or superior performance? ●      How does your laboratory validate clinical claims made by the laboratory about LDTs?

**REVISED**       07/29/2013

COM.40000

Method Validation/Verification Approval

Phase I

There is a summary statement, signed by the laboratory director (or designee who meets CAP director qualifications) prior to reporting patient results, documenting review of validation/verification studies and approval of each test for clinical use.

NOTE:  This checklist item is applicable only to tests implemented after June 15, 2009.

An example of such a statement is: "This validation study has been reviewed and the performance of the method is considered acceptable for patient testing."

See the Method Performance Specifications section for details concerning validation/verification.

Evidence of Compliance:

✓      Summary of validation/verification studies with review and approval

REFERENCES

1)	Lawrence Jennings, Vivianna M. Van Deerlin, Margaret L. Gulley (2009) Recommended Principles and Practices for Validating Clinical Molecular Pathology Tests. Archives of Pathology & Laboratory Medicine: Vol. 133, No. 5, pp. 743-755

METHOD PERFORMANCE SPECIFICATIONS

NOTE:  The subsection on METHOD PERFORMANCE SPECIFICATIONS does not apply to waived tests.

Sound laboratory practice requires full characterization of each test/method/instrument system before its use in patient testing, without regard to when the test was first introduced by a given laboratory.  For each test performed on blood, the laboratory must have data on accuracy, precision, analytic sensitivity, interferences and reportable range (i.e. analytic measurement range (AMR) as applicable).

The method performance specifications must be performed in the location in which patient testing will be performed. If an instrument is moved, the laboratory must verify the method performance specifications (i.e. accuracy, precision, reportable range) after the move to ensure that the test system was not affected by the relocation process or any changes due to the new environment (e.g. temperature, humidity, reagent storage conditions, etc.). The laboratory must follow manufacturer's instructions for instrument set up, maintenance, and system verification. Each instrument is considered a separate test system, including instruments of the same make and model. The laboratory must verify the performance specifications of each instrument.

Laboratories subject to US regulations:  For unmodified FDA-cleared or approved tests, the laboratory may use data from manufacturers' information or published reports, but the laboratory must verify outside data on accuracy, precision and reportable range.  For tests that are not FDA-cleared or approved (including tests developed in-house), or for FDA-cleared/approved tests modified by the laboratory, the laboratory must establish accuracy, precision, analytic sensitivity, interferences and reportable range, as applicable; data on interferences may be obtained from manufacturers or published literature, as applicable.

Laboratories not subject to US regulations:  The laboratory must verify or establish analytic accuracy, precision, analytic sensitivity, analytic specificity (interfering substances) and reportable range for each test.  Laboratories may use information from manufacturers, published literature, or studies performed in other laboratories, but should verify such outside information, whenever practical.

Not all method performance specifications apply to qualitative tests.  For qualitative tests, the laboratory must establish/verify the method performance specifications that are applicable and clinically relevant.

The laboratory must retain records of method performance specifications while the method is in use and for at least two years after discontinuation of a method.

A laboratory-developed test (LDT) is defined as follows: A test used in patient management that has all of the following characteristics:

• The test is performed by the clinical laboratory in which the test was developed

• The test is neither FDA-cleared nor FDA-approved, or the laboratory has made a modification to manufacturer's instructions for an FDA-cleared/approved test

• The test was first used for clinical testing after April 23, 2003

A laboratory is considered to have developed a test if the test procedure was created by the laboratory performing the testing, irrespective of whether fundamental research underlying the test was developed elsewhere or reagents (including ASRs) equipment, or technology integral to the test were purchased, adopted, or licensed from another entity.

**REVISED**       07/31/2012

COM.40100	Intermittent Testing	Phase II
	When a test is put back into production, the following requirements must be met: 1.     PT or alternative assessment performed within 30 days prior to restarting patient testing 2.     Method performance specifications verified, as applicable, within 30 days prior to restarting patient testing 3.     Competency assessed for analysts within 12 months prior to restarting patient testing NOTE: This requirement applies to tests that are taken out of production for a time (for example, seasonal testing for influenza). A test is considered to be taken out of production when (1) patient testing is not offered AND (2) PT or alternative assessment, as applicable, is suspended. The laboratory should have written procedures for putting intermittent tests into production. For tests for which PT is required by CAP, if a PT challenge is not offered during the 30-day period prior to restarting patient testing, the laboratory may perform an alternative assessment of the test. In such a case, the laboratory must participate in the next scheduled PT event.

COM.40200	Laboratory-Developed Tests	Phase I
	The laboratory documents the list of tests it has developed and implemented during the previous 2 years. NOTE: This list will help the inspector review the analytic validation data for these tests. This includes tests developed in-house, and for laboratories subject to US regulations, tests using ASRs, and FDA-cleared/approved tests that have been modified by the laboratory.

COM.40250	Manufacturer Instructions	Phase II
	The laboratory follows manufacturer instructions or provides documentation of validation study(ies) if the test has been modified. NOTE: Following manufacturer instructions includes performing quality control, calibration, calibration verification, and related functions as applicable to the scope of testing. If the laboratory modifies manufacturer instructions, the test is categorized as a non-FDA cleared/approved test, and the modification must be validated by the laboratory. Changes in the specimen type or collection device are examples of common modifications. Additional requirements for validation/verification may be found in the discipline-specific checklists. For waived tests, if manufacturer instructions are modified, the test is no longer considered waived, and requirements for high complexity testing apply. Evidence of Compliance: ✓      Documentation of validation of established performance specifications (accuracy, precision, analytic sensitivity, analytic specificity, interferences, reference range, and reportable range) of any test that has been modified.

COM.40300

Analytic Accuracy/Precision

Phase II

The laboratory verifies or establishes analytic accuracy and precision for each test.

NOTE:  Where current technology permits, accuracy is established by comparing results to a definitive or reference method, or may be verified by comparing results to an established comparative method.  Use of reference materials or other materials with known concentrations or activities is suggested in establishing or verifying accuracy.  Precision is established by repeat measurement of samples at varying concentrations or activities within-run and between-run over a period of time.

Evidence of Compliance:

✓      Written procedure for determining method performance characteristics, including accuracy/precision AND

✓      Records of verification or establishment of analytic accuracy and precision for each test

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7164 [42CFR493.1253]
2)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):62607-62608 [42CFR493.1253]
3)	Clinical and Laboratory Standards Institute (CLSI). Method Comparison and Bias Estimation Using Patient Samples; Approved Guideline—Second Edition (Interim Revision). CLSI document EP09-A2-IR (ISBN 1-56238-731-6). CLSI, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2010
4)	Voss EM, et al. Determining acceptability of blood glucose meters. Statistical methods for determining error. Lab Med. 1996;27:601-606
5)	Clinical and Laboratory Standards Institute (CLSI). Statistical Quality Control for Quantitative Measurement Procedures: Principles and Definitions; Approved Guideline—Third Edition. CLSI document C24-A3 (ISBN 1-56238-613-1). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2006
6)	Clinical and Laboratory Standards Institute (CLSI). Preliminary Eval‎uation of Quantitative Clinical  Laboratory Methods – Approved Guideline- Third Edition. CLSI Document EP10-A3 (ISBN 1-56238-622-0). Clinical and Laboratory Standards Institute, 940 West Valley Road, Wayne, PA, 19087-1898, USA, 2006.
7)	Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3707 [42CFR493.1253]

COM.40400

Analytic Sensitivity

Phase II

The laboratory verifies or establishes the analytic sensitivity (lower detection limit) of each assay, as applicable.

NOTE:  For laboratories subject to US regulations, documentation for FDA-cleared/approved tests may consist of data from manufacturers or the published literature.

Evidence of Compliance:

✓      Written procedure for determining method performance characteristics, including analytic sensitivity AND

✓      Records of verification or establishment of analytic sensitivity for each assay

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7164 [42CFR493.1213]
2)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):62607-62608 [42CFR493.1253]
3)	Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3707 [42CFR493.1253]

**NEW**       07/29/2013

COM.40450	Analytical Specificity/Interfering Substances	Phase II
	For modified FDA-cleared/approved tests or LDT's, the results of each validation study include a sufficient number of samples to establish the test's analytical specificity. NOTE: The analytical specificity refers to the ability of a test or procedure to correctly identify or quantify an entity in the presence of interfering or cross-reactive substances that might be expected to be present. Laboratories are encouraged to review the cited references for guidance and provided confidence intervals to estimated performance characteristics. Evidence of Compliance: ✓      Records of validation studies to establish analytical specificity

**REVISED**       07/29/2013

COM.40500

Analytic Interferences

Phase II

The laboratory understands the analytic interferences for each test, and has an appropriate plan of action when they are present.

NOTE:  Interfering substances may pose a significant problem to the clinical laboratory and healthcare providers who may be misled by laboratory results that do not reflect patient clinical status.  The laboratory must be aware of common interferences by performing studies (during LDT validation) or referencing studies performed elsewhere (such as by the instrument-reagent manufacturer).

Evidence of Compliance:

✓      Written procedure for determining method performance characteristics, including analytic interferences AND

✓      Document listing known interferences for each test and plan of action when they are present

REFERENCES

1)	Clinical and Laboratory Standards Institute (CLSI). Interference Testing in Clinical Chemistry; Approved Guideline—Second Edition. CLSI document EP7-A2 (ISBN 1-56238-584-4). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2005
2)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7162 [42CFR493.1253(b)(2)(iv)]
3)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1994(Dec 6):62607-62608 [42CFR493.1449]
4)	Ho C-H. The hemostatic effect of packed red cell transfusion in patients with anemia. Transfusion. 1998;38:1011-1014
5)	Department of Health and Human Services, Centers for Medicare & Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):3707 [42CFR493.1253]

COM.40600

Reportable Range

Phase II

The reportable range (analytic measurement range) is verified/established for each analytic procedure before implementation.

NOTE:  The analytic measurement range (AMR) is the range of analyte values that a method can directly measure on the specimen without any dilution or concentration.

Expanded definitions and details of the AMR are provided in some of the section-specific checklists (e.g. Chemistry).  Verification of the AMR may not apply to certain assays (for example, in immunology and coagulation).

The limits of the AMR are based on meeting accuracy and precision requirements such as the minimal limit of quantification or sensitivity, when applicable.  In some cases, clinically relevant limits may be narrower than the potential analytical range, and the clinically relevant limit would be used as the limit of the reportable range.

Evidence of Compliance:

✓      Written policy for determining method performance characteristics, including reportable range AND

✓      Records of verification or establishment of reportable ranges for each test

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7164 [42CFR493.1213]

**NEW**       07/29/2013

COM.40620

Body Fluid Validation

Phase II

Testing of body fluid specimens using methods intended for other specimen types (e.g. blood or other fluid) have been validated by the laboratory for accuracy, precision, analytic sensitivity, analytic interferences, and reportable range.

NOTE: This requirement applies directly to body fluid testing that the laboratory offers as a routine, orderable test. If the test is routinely performed on the fluid, there must be a written procedure. The laboratory director determines the extent of the method performance specifications relevant for clinical purposes. Method performance specifications for blood specimens may be used for body fluids if the laboratory can exclude the existence of matrix interferences affecting the latter. The laboratory may eval‎uate the specimen type for interferences due to matrix effects by performing an appropriate study (e.g. a dilution study using admixtures of samples, spiking samples, further dilution). The reference range must be defined and reported with results, unless the value is reported in comparison to its concentration in blood. Reference range citations from the manufacturer's insert or published literature citations may be used to determine the range (COM.50000). Alternate performance assessment is required (COM.01500) and may be performed using clinical assessment by chart review.

For clinically unique samples where specimens are submitted with a unique request based on an unusual clinical concern in a specific patient or situation (e.g. pathologic states where the analyte is not normally found in the fluid type), it may not be possible to establish test performance characteristics. Protein and lipid content can vary considerably from specimen to specimen. "Normal" fluid samples may not be obtainable. In such cases, the result must be accompanied by a comment such as, "The reference range and other method performance specifications have not been established for this body fluid. The test result must be integrated into the clinical context for interpretation."

REFERENCES

1)	Clinical and Laboratory Standards Institute (CLSI). Body Fluids in Clinical Chemistry; Approved Guideline. CLSI document C49-A (ISBN 1-56238-638-7). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2007

**NEW**       07/29/2013

COM.40630

LDT Reporting

Phase I

Reports for laboratory-developed tests (LDT) contain a description of the method, a statement that the assay was developed by the laboratory, and appropriate performance characteristics.

NOTE: General guidelines for reports are given in the Results Reporting sections of the checklists. Laboratories subject to US regulations often include an LDT disclaimer as follows: "This test was developed and its performance characteristics determined by <insert laboratory/company name>. It has not been cleared or approved by the FDA. The laboratory is regulated under CLIA as qualified to perform high-complexity testing. This test is used for clinical purposes. It should not be regarded as investigational or for research."

REFERENCES

1)	CLSI. Establishing Molecular Testing in Clinical Laboratory Environments: CLSI document MM19-A (ISBN 1-56238-773-1). Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, Pennsylvania 19087-1898 USA, 2011

**NEW**       07/29/2013

COM.40640	LDT Clinical Claims Validation	Phase II
	All clinical claims made by the laboratory about a laboratory-developed test are validated. NOTE: Clinical claims may include statements about a test's diagnostic sensitivity and specificity, ability to predict the risk of a disease or condition, clinical usefulness, or cost-effectiveness. Clinical claims may be found on the test report or in other information distributed by the laboratory (websites, test catalogues, newsletters, memoranda, advertisements, etc.). Laboratories are not required to make clinical claims about a test, but any claims made by the laboratory must be validated. In general, the laboratory should validate claims through a clinical study, but for rare conditions or well-accepted uses of a test, reference to published peer-reviewed literature is acceptable. Evidence of Compliance: ✓      Records of clinical studies performed by the laboratory OR peer-reviewed literature that reasonably substantiate all claims made by the laboratory about a test

COM.40700

Method Performance Specifications Availability

Phase II

The laboratory's current test methods, including performance specifications and supporting validation/verification data (analytic accuracy, precision, analytic sensitivity, interferences, reference range, and reportable range, as acceptable), are available to clients of the laboratory and to the inspection team upon request.

NOTE: The laboratory must also provide data on clinical performance claims to clients upon request if clinical performance claims are made. The laboratory may at its option require clients to agree to treat such data as confidential and not to share such data with any other party except as required by law.

The CAP inspection team is instructed to use the data solely for accreditation purposes.

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7163 [42CFR493.1291(e)]

COM.40800

Analytic Methodology Changes

Phase II

If the laboratory changes its analytic methodology so that test results or their interpretations may be SIGNIFICANTLY different, the change is explained to clients.

NOTE:  This requirement can be accomplished in any of several different ways, depending on local circumstances.  Some methods include directed mailings, laboratory newsletters or part of the test report itself.

Evidence of Compliance:

✓      Records such as directed mailings, laboratory newsletters or comment on the patient report advising of the change

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 2003(Jan 24):7163 [42CFR493.1291(e)]

REFERENCE INTERVALS

**REVISED**       07/29/2013

COM.50000

Reference Intervals Established/Verified

Phase II

The laboratory establishes or verifies its reference intervals (normal values).

NOTE:  Reference intervals are important to allow a clinician to assess patient results against an appropriate population.  The reference range must be established or verified for each analyte and specimen source (e.g. blood, urine, cerebrospinal fluid), when appropriate.  For example, a reference interval can be verified by testing samples from 20 healthy representative individuals; if no more than 2 results fall outside the proposed reference interval, that interval can be considered verified for the population studied (refer to CLSI guideline C28-A3c, reference below).

If a formal reference interval study is not possible or practical, then the laboratory should carefully eval‎uate the use of published data for its own reference ranges, and retain documentation of this eval‎uation. For many analytes (e.g. therapeutic drugs and CSF total protein), literature references or a manufacturer's package insert information may be appropriate.

Evidence of Compliance:

✓      Record of reference range study OR records of verification of manufacturer's stated range when reference range study is not practical (e.g. unavailable normal population) OR other methods approved by the laboratory/section director

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7164 [42CFR493.1253]
2)	Van der Meulen EA, et al. Use of small-sample-based reference limits on a group basis. Clin Chem. 1994;40:1698-1702
3)	Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Approved Guideline- Third Edition - CLSI Document C28-A3c. (ISBN 1-56238-682-4) Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898, USA, 2010.

COM.50100

Reference Interval Eval‎uation

Phase II

The laboratory eval‎uates the appropriateness of its reference intervals and takes corrective action if necessary.

NOTE:  Criteria for eval‎uation of reference intervals include:

1.     Introduction of a new analyte to the test repertoire

2.     Change of analytic methodology

3.     Change in patient population

If it is determined that the range is no longer appropriate for the patient population, corrective action must be taken.

Evidence of Compliance:

✓      Records of eval‎uation and corrective action, if indicated

REFERENCES

1)	Department of Health and Human Services, Centers for Medicare and Medicaid Services. Clinical laboratory improvement amendments of 1988; final rule. Fed Register. 1992(Feb 28):7164 [42CFR493.1253]
2)	Van der Meulen EA, et al. Use of small-sample-based reference limits on a group basis. Clin Chem. 1994;40:1698-1702
3)	Clinical and Laboratory Standards Institute (CLSI). Defining, Establishing, and Verifying Reference Intervals in the Clinical Laboratory - Approved Guideline- Third Edition - CLSI Document C28-A3c. (ISBN 1-56238-682-4) Clinical and Laboratory Standards Institute, 940 West Valley Road, Suite 1400, Wayne, PA, 19087-1898, USA, 2010.