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CAP Accreditation Withdraws ANP.10039 from 2021 Checklist Edition

Communication Date:  November 24, 2021

NOTE: The information below was current at the time of communication. Subsequent CAP changes, if applicable, are not reflected in this eAlert.

The CAP has decided to temporarily withdraw ANP.10039 (Total Fixation Time) from the 2021 Checklist Edition, effective immediately. With the withdrawal of ANP.10039, we have made additional revisions to the following 2021 Laboratory General Checklist requirements:

  • GEN.40115 (Specimen Collection Manual Elements – Surgical Pathology and Cytopathology Specimens)
    • We revised the note to remove specific content referring to ANP.10039.
  • GEN.40125 (Handling of Referred Specimens)
    • We revised the note to remove specific content referring to ANP.10039.
    • We revised the note to reinstate previously published content from the 2020 Checklist Edition regarding breast tissue pathology specimens for lesions clinically suspicious for malignancy.

Why is the CAP making these changes?

  • The intent of adding ANP.10039 as a new requirement in the 2021 Checklist edition was for laboratories to control fixation time as an important preanalytic variable that could potentially impact future molecular testing and other ancillary testing used for precision medicine.
  • We reevaluated the requirement and supporting evidence due to CAP-accredited laboratories' and CAP members' concerns about the scientific validity of the supporting evidence for a total fixation time at room temperature of no less than six hours and no greater than 36 hours for most tissues, as well as for the potential impact on laboratory practice.
  • The CAP conducted an in-depth review of the scientific peer-reviewed literature and, while controlling fixation time is important and is a good laboratory practice, we determined that it was premature to incorporate ANP.10039 as a requirement based on available data. This content will be carefully reconsidered for a future checklist edition.

How will these changes affect my laboratory?

Effective immediately, ANP.10039 will:

  • No longer appear in a laboratory’s customized checklist.
  • Not be enforced for laboratories inspected with the 2021 Checklist Edition.
  • Be removed during the post-inspection review process if a deficiency is cited in error using the content withdrawn from the 2021 Checklist Edition.

Updated versions of the 2021 Anatomic Pathology and Laboratory General Checklists are available for download on cap.org (log-in required). If this impacts your laboratory’s operations, a copy of this eAlert should be retained in your files to present to inspectors as needed.

If you have any questions, please call an accreditation representative at 800-323-4040, +001-847-832-7000 option 1, or email accred@cap.org.