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TJUHBB

Records and Disposition

Standard Operating Procedure (SOP 01.007)

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PURPOSE

To define the management of controlled records generated from Biorepository activities. The system of record keeping includes creation, correction, review, retention, storage, and retrieval. The Biorepository shall retain documents, records and specimens according to the guidelines published by the College of American Pathologists unless applicable state or federal regulations or other accrediting agencies supersede these guidelines.

SCOPE

This standard operating procedure (SOP) describes which documents must be held by the Biorepository, for how long these records must be kept on hand, as well as how to regulate documents.

REFERENCE TO OTHER TJUHBB SOPS OR POLICIES

  • TJUHBB POL 03.004 Personnel Training and Records
  • TJUHBB POL 03.001 Delegation of Duties by Laboratory Director
  • TJUHBB POL 03.002 Director Responsibilities and Qualifications
  • TJUHBB POL 01.001 Quality Management Plan

ROLES AND RESPONSIBILITIES

This SOP applies to all qualified tumor biobank personnel and clinical staff at the collection centers that are involved in recruiting patients and the acquisition of informed and voluntary consent. This may include the following personnel:

Tumor Biobank PersonnelResponsibility
DirectorVerifies that procedures for record maintenance are accurate based on the scope of the activities
Biorepository ManagerResponsible for maintaining records for the appropriate amount of time

MATERIALS, EQUIPMENT AND FORMS

The materials, equipment and forms listed in the following list are recommendations only and may be substituted by alternative/equivalent products more suitable for the site-specific task or procedure.

Materials & EquipmentQuantity
Markers, ink and pens
Binders
Computer for accessioning
Paper

DEFINITIONS

See the TJUHBB Glossary.

PROCEDURES

  • Temperature Logs
    • Temperature readings for both freezers and the room are logged electronically. Monthly reports are saved and stored locally for at least two years.
  • Shipping Invoices
    • Shipping invoices are stored locally for at least two years.
  • Chemical Inventory
    • Inventory of chemical supplies is taken monthly. Storage conditions are noted and expiration dates are checked and logged. Lot numbers for chemical reagents are recorded. Chemical inventories are kept for at least two years.
  • Specimen Inventory
    • Specimen location is tracked by OpenSpecimen
    • Specimen transfers or termination of collection are noted in OpenSpecimen
    • Depletion of biospecimen aliquot must be documented by closing the aliquot in OpenSpecimen
    • Upon participant request for discontinuation, all associated samples are disposed via biohazard waste procedures.
    • Physical biospecimen quality is evaluated by pathologist for fixation or processing deficiencies as well as hemolysis and necrosis. Pathology QC is documented in OpenSpecimen under the slide entry.
    • Weekly checks are performed to verify the accuracy of specimen location. Missing samples are noted and OpenSpecimen is updated.
  • Discontinued Policies
    • When a procedure is discontinued or replaced, an electronic copy is maintained for 2 years
    • Records must indicate initial date of use as well as retirement date

APPLICABLE REFERENCES, REGULATIONS AND GUIDELINES

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