All Common Checklist

1 MasterEvery patientdeserves theGOLD STANDARD ..All Common ChecklistCAP Accreditation ProgramCollege of American Pathologists325 Waukegan RoadNorthfield, IL and Copyright NoticeOn-site inspections are performed with the edition of the Checklists mailed to a facility at the completionof the application or reapplication process, not necessarily those currently posted on the Web site. Thechecklists undergo regular revision and a new edition may be published after the inspection materials questions about the use of the Checklists or Checklist interpretation, email or call800-323-4040 or 847-832-7000 (international customers, use country code 001).

2 The Checklists used for inspection by the College of American Pathologists' Accreditation Programs havebeen created by the CAP and are copyrighted works of the CAP. The CAP has authorized copying anduse of the checklists by CAP inspectors in conducting laboratory inspections for the Commission onLaboratory Accreditation and by laboratories that are preparing for such inspections. Except as permittedby section 107 of the Copyright Act, 17 sec. 107, any other use of the Checklists constitutesinfringement of the CAP's copyrights in the Checklists. The CAP will take appropriate legal action to protectthese Checklists are 2014.

3 College of American Pathologists. All rights of Common ChecklistAll Common ChecklistTABLE OF CONTENTSSUMMARY OF THE CAP ACCREDITATION Checklist OF Common AND and Equipment Maintenance/Function Instruments, Equipment, and METHOD PERFORMANCE of Common ChecklistON-LINE Checklist AVAILABILITYP articipants of the CAP accreditation programs may download the checklists from the CAP Web site ( )by logging into e-LAB Solutions. They are available in different Checklist types and formatting options, including: Master contains ALL of the requirements and instructions available in PDF, Word/XML or Excel formats Custom customized based on the laboratory's activity (test) menu; available in PDF, Word/XML or Excelformats Changes Only contains only those requirements with significant changes since the previous checklistedition in a track changes format to show the differences; in PDF version only.

4 Requirements that havebeen moved or merged appear in a table at the end of the OF Checklist EDITION CHANGESAll Common Checklist04/21/2014 EditionThe information below includes a listing of Checklist requirements with significant changes in the current editionand previous edition of this list is separated into three : Modifications that may require a change in policy, procedure, or process for continued compliance;or A change to the : Deleted Moved Relocation of a requirement into a different Checklist (requirements that have beenresequenced within the same Checklist are not listed) Merged The combining of similar requirementsNOTE.

5 The listing of requirements below is from the Master version of the customized checklistversion created for on-site inspections and self-evaluations may not list all of these Checklist RequirementsEffective DateRequirement04/21 of Common ChecklistREVISED Checklist RequirementsEffective DateRequirement04/21 Checklist RequirementsEffective DateRequirement04/20 of Common ChecklistUNDERSTANDING THE CAP ACCREDITATIONCHECKLIST COMPONENTSAll Checklist requirements contain a requirement number, subject header, phase, and a declarative requirements also contain a NOTE and/or Evidence of NOTE portion of a Checklist requirement provides additional detail to assist in interpreting the of Compliance is intended to: Suggest specific examples of acceptable documentation; some elements are required Assist in inspection preparation and for managing ongoing compliance Drive consistent understanding of requirementsIf a policy or procedure is referenced within a requirement, it is only repeated in the Evidence of Compliance ifsuch statement adds clarity.

6 All policies or procedures covered in the CAP checklists must be documented. Aseparate policy or procedure may not be needed for items in EOC if it is already addressed by an Master version of the Checklist also contains references and the inspector instructions (Read,Observe, Ask, Discover), which can provide valuable insight for the basis of requirements and on how compliancewill be All Common Checklist (COM) contains a core set of requirements that apply to all areas performing laboratorytests and procedures. In some instances, the same requirement exists in both the COM Checklist and in adiscipline-specific Checklist , but with a different Checklist note that has a more specific requirement.

7 In thesesituations, the discipline-specific requirement takes precedence over the COM COM Checklist is provided for inspection of each laboratory section or department. If more than one inspectoris assigned to inspect a section, each inspector must be familiar with the COM requirements and ensure that alltesting is in requirements are different for waived versus nonwaived tests. Refer to the Checklist headings and explanatorytext to determine applicability based on test complexity. The current list of tests waived under CLIA may be foundat for non-US laboratories: Checklist requirements apply to all laboratories unless a specific disclaimer ofexclusion is stated in the OF TERMSA nnual - Every 12 calendar monthsBiennial - Every 24 calendar monthsCalibrator, historical - The set of archived results of a single-point calibrator that demonstrates stability of theassay over timeCheck - Examination to determine the accuracy.

8 Quality or presence of any attribute of a test systemConfirmation - Substantiation of the correctness of a value or process6 of Common ChecklistCorrelation - Establishment of agreement between two or more measured valuesCredentialing - The process of obtaining, verifying, and assessing the qualifications of a practitioner to providecare in a health care organizationDigital image analysis - The computer-assisted detection or quantification of specific features in an image followingenhancement and processing of that image, including immunohistochemistry, DNA analysis, morphometric analysis,and in situ hybridizationEquipment - Single apparatus or set of devices or apparatuses needed to perform a specific taskExamination - In the context of Checklist requirements, examination refers to the process of inspection of tissuesand samples prior to analysis.

9 An examination is not an analytical - In the context of Checklist requirements, FDA should be taken to mean the national, state, or provincialauthority having jurisdiction over in vitro diagnostic test Check - Confirmation that an instrument or item of equipment operates according to manufacturer'sspecifications before routine use, at prescribed intervals, or after minor adjustment ( base line calibration ,balancing/zero adjustment, thermometer calibration , reagent delivery).High complexity - Rating given by the FDA to commercially marketed in vitro diagnostic tests based on their risksto public in this category are seen to have the highest risks to public - An analytical unit that uses samples to perform chemical or physical assays ( chemistry analyzer,hematology analyzer)

10 Instrument platform - Any of a series of similar or identical analytical methods intended by their manufacturer togive identical patient results across all modelsLaboratory 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 regulationsand 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 mechanicalmalfunctions.