Master All Common Checklist

1 MasterAll Common ChecklistCAP Accreditation ProgramCollege of American Pathologists325 Waukegan RoadNorthfield, IL of 53 All Common 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 website. Thechecklists undergo regular revision and a new edition may be published after the inspection materialsare 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 Programshave been created by the CAP and are copyrighted works of the CAP. The CAP has authorized copyingand use of the checklists by CAP inspectors in conducting laboratory inspections for the Commissionon Laboratory Accreditation and by laboratories that are preparing for such inspections. Except aspermitted by section 107 of the Copyright Act, 17 sec. 107, any other use of the Checklistsconstitutes infringement of the CAP's copyrights in the Checklists. The CAP will take appropriate legalaction to protect these Checklists are 2017.

3 College of American Pathologists. All rights of 53 All Common Common ChecklistTABLE OF CONTENTSSUMMARY OF THE CAP ACCREDITATION Checklist 6 DEFINITION OF 6 ALL Common 10 PROFICIENCY 10 QUALITY 17 GENERAL 17 SPECIMEN COLLECTION AND 21 PROCEDURE 23 RESULTS 28 INSTRUMENTS AND and Equipment Maintenance/Function 35 Temperature-Dependent Instruments, Equipment, and 36 TEST METHOD VALIDATION AND PERFORMANCE SPECIFICATIONS - NONWAIVED 39 REFERENCE QUALITY CONTROL PLAN (IQCP)..484 of 53 All Common Checklist AVAILABILITYP articipants of the CAP accreditation programs may download the checklists from the CAP website( ) by logging into e-LAB Solutions.

4 They are available in different Checklist types and formattingoptions, including: Master contains ALL of the requirements and instructions available in PDF, Word/XML or Excelformats Custom customized based on the laboratory's activity (test) menu; available in PDF, Word/XML orExcel formats 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. Requirements that havebeen moved or merged appear in a table at the end of the OF Checklist EDITION CHANGESAll Common Checklist08/21/2017 EditionThe information below includes a listing of Checklist requirements with significant changes in the current editionand previous edition of this Checklist .

5 The list is separated into three : Modifications that may require a change in policy, procedure, or process for continuedcompliance; 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: The listing of requirements below is from the Master version of the Checklist . The customized checklistversion created for on-site inspections and self-evaluations may not list all of these Checklist RequirementsRequirementEffective Checklist RequirementsRequirementEffective of 53 All Common Checklist RequirementsNone6 of 53 All Common 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 (EOC)

6 Is intended to: Suggest specific examples of acceptable records; 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 Complianceif such statement adds clarity. All policies or procedures covered in the CAP checklists must be a writtendocument. A separate policy or procedure may not be needed for items in EOC if it is already addressed by anoverarching 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 howcompliance will be All Common Checklist (COM) contains a core set of requirements that apply to all areas performinglaboratory tests and procedures.

7 In some instances, the same requirement exists in both the COM Checklist andin a discipline-specific Checklist , but with more specificity in the discipline-specific Checklist . In these situations,the discipline-specific requirement takes COM Checklist is provided for inspection of each laboratory section or department. If more than oneinspector is assigned to inspect a section, each inspector must be familiar with the COM requirements andensure that all testing is in requirements are different for waived versus nonwaived tests. Refer to the Checklist headings andexplanatory text to determine applicability based on test complexity.

8 The current list of tests waived under CLIAmay be found at for non-US laboratories: Checklist requirements apply to all laboratories unless a specific disclaimer ofexclusion is stated in the OF TERMSA ddendum - Information appended to a final report with no changes to the original test result(s); original reportis intact and unchanged, the addendum is added as an attachment or supplement to the original assessment - A system for determining the reliability of laboratory examinations for which nocommercial proficiency testing products are available, are not appropriate for the method or patient populationserved by the laboratory, or participation is not required by the accrediting - Any change in a previously issued anatomic pathology or cytopathology reportintended to correct an inaccuracy, including changes in the diagnosis, narrative text, clinical history.

9 Pre- andpost-operative diagnoses, patient identification, or other of 53 All Common validation - The process used to confirm with objective evidence that a laboratory-developed ormodified FDA-cleared/approved test method or instrument system delivers reliable results for the verification - The process by which a laboratory determines that an unmodified FDA-cleared/approved test performs according to the specifications set forth by the manufacturer when used as - Every 12 calendar monthsBiennial - Every 24 calendar monthsAuthority - The power to give orders or make decisions: the power or right to direct someone or control aprocessCalibrator, historical - The set of archived results of a single-point calibrator that demonstrates stability of theassay over timeCheck - Examination to determine the accuracy, quality or presence of any attribute of a test systemClinical validation - The determination of the ability of a test to diagnose or predict risk of a particular healthcondition or predisposition, measured by sensitivity, specificity.

10 And predictive valuesCommutable - The property of a reference material that yields the same numeric result as would a patient'sspecimen containing the same quantity of analyte in the analytic method under discussion ( matrix effects areabsent).Confirmation - Substantiation of the correctness of a value or processCorrected/correction - A change in a previously issued clinical pathology test report intended to correct aninaccuracy, including changes in test results, patient identification, reference intervals, interpretation, or Action - Action taken to eliminate the cause of a detected nonconformity or other undesirablesituationCorrelation - Establishment of agreement between two or more measured valuesCredentialing - The process of obtaining, verifying.