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Biopsy Specimen Send Outs: Risk Management Recommendations to Avoid Delays in Diagnosis

Delay in cancer diagnosis is one of the leading causes for professional liability claims associated with biopsy specimens. Mislabeling of specimens, failure to track receipt of the results and follow-up on the results with the patient when they are received by the practice are contributing factors in these claims.

Recommendations to enhance office practice systems:

  • Establish a standardized specimen collection process.
  • Utilize two patient specific identifiers when performing biopsies in the practice setting.
    • Request the patient state their full name and date of birth when they arrive at the practice.
    • Confirm the same two patient identifiers to assure the correct medical record is obtained for the patient who is to receive the biopsy. The practice may wish to establish an individual patient identifier, e.g., unique patient number, bar-code or biometric tag.
    • Prepare labels with the patient specific information and use to identify all specimens and patient forms specific to the biopsy. Printed labels would be preferred.
  • Prepare for biopsy.
    • Prepare all equipment/supplies needed for the procedure.
    • Take only the biopsy tray(s) necessary for the patient biopsy into the treatment room.
    • Label specimen containers and forms in front of the patient in the treatment room. Do not pre-label specimen containers and forms.
  • Implement a double check system which includes a "time out" for biopsies performed in the office practice setting. In the treatment room:
    • Ask the patient to review the labels to assure the information on the labels is correct.
    • Prepare the lab requisitions and specimen containers and attach the labels.
    • Ask the provider to review the labeled requisitions and specimen containers to assure the labels match the patient's profile and patient's medical record. The specimen container is documented correctly including specific origin of the specimen, and laterality.
    • Place the specimen containers and the requisition slips in the transport packaging provided by the pathology lab, document appropriate information on the specimen pick-up log, and place the specimen in the pick-up area for transport to the pathology lab.
  • Track the specimen.
    • Establish a manual log or electronic system that tracks when pathology specimens are sent out and when they are received. Establish a timeframe for anticipated receipt of the specimen result report. Reconcile results not received within this timeframe. A reasonable timeframe is typically not longer than 7 days.
    • Require providers to review, initial and date reports of test results upon receipt.
    • Instruct staff to assure the provider has documented review of report prior to filing in the paper record.
    • Establish a process to assure results of electronic and scanned reports are directed to the provider for approval.
    • Assure a process is in place for the provider to address STAT results.
    • Assure a process is in place to assure results are reviewed by a qualified covering provider if the ordering provider is unavailable.
  • Follow-up with the patient.
    • Notify the patient of the pathology results including normal and abnormal findings.
    • Document patient notification and any discussion/recommendations in the patient's medical record.
    • Schedule patient follow-up appointments for treatment or further testing if needed, and document in the patient's medical record.
    • Assure patient completes any necessary follow-up. For more information please see Appointments: Referral Not Completed, Missed (No Show) & Canceled Appointments.
  • Monitor for patient safety improvement opportunities.
    • Track all specimen labeling errors.
      • Identify opportunities for improvement.
      • Implement system changes as necessary.

Resources

  1. WHO Collaborating Center for Patient Safety, May 2007.
  2. Joint Commission Two Patient Identifiers April 2016.
  3. Who are my patients and what am I doing to them?, www.wapatientsafety.org