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Notification to CAP-Accredited Biorepositories: Personnel Update

To the College of American Pathologists (CAP) Biorepository Accreditation Program (BAP) facilities:

The 2017 edition of the BAP and BAP General (GEN) checklists are now available. To help our BAP-accredited facilities achieve compliance, the CAP is providing the following updates regarding Personnel checklist requirements:

GEN.83510 (Biorepository Personnel Evaluation Roster) is a new requirement for 2017. It has been created to:

  • Document personnel qualification verification
  • Ensure that personnel records are complete

New – 08/21/2017

GEN.83510Biorepository Personnel Evaluation RosterPhase II
The Biorepository Personnel Evaluation Roster is current and accurate and is audited by the
biorepository director or designee at least annually.

Evidence of Compliance:
✔ Records of completed rosters accurately reflecting personnel and
✔ Records of annual audits performed by the biorepository director or designee

The biorepository director is responsible for ensuring that biorepository personnel have the appropriate qualifications based on their assigned duties and responsibilities. Facilities will be assessed for compliance with GEN.83510 beginning with on-site and interim self-inspections using the 2017 checklist edition.

The Biorepository Personnel Roster form (Excel, 35 KB) is provided with application materials and is available on the biorepository page.

GEN.82000 (Director Qualifications) has been revised to clarify the required training and experience for biorepository directors. Facilities must retain these records to provide to an inspector upon request.

Revised – 08/21/2017

GEN.82000Director QualificationsPhase II
The qualifications of director of the biorepository are appropriate for the
scope of activities.

NOTE: The director must have had four or more years of full-time general
laboratory training and experience of which at least two years were spent
acquiring proficiency in biorepository operations and management. The director
must be qualified to assume professional, scientific, organizational, administrative,
and educational responsibilities for the services provided. The director’s experience
and qualifications must also meet the institutional policy for the degree of responsibility
acceptable to operate and manage the scope of the biorepository.

The CAP offers compliance alerts to help your laboratory maintain continuous compliance. If this impacts your biorepository’s operations, a copy of this notification should be retained in your files to present to inspectors as needed.

Questions? Contact us at 800-323-4040 or accred@cap.org.