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Biopsy Specimen

Failure to follow-up and delay in diagnosis are leading causes of claims filed in the ambulatory setting1. Errors associated with biopsy specimens can be found within those professional liability claims, especially with cancer diagnoses.

Some common factors contributing to these are:

  • Mislabeling of the specimen(s).
  • Loss of the specimen(s).
  • Failure to track receipt of the results.
  • Failure to notify the patient of the biopsy results.
  • Delay in notifying the patient of their biopsy results.
  • Failure to provide treatment planning options, including appropriate specialty referral.
  • Failure to follow up on outstanding referrals.
  • Failure to document the biopsy results and treatment plan in the patient's medical record.

Here are some steps you can take to improve biopsy specimen management in ambulatory settings to reduce your medicolegal risk:

  • Establish a written policy and procedure for the specimen collection process. At a minimum, ensure the following processes are addressed.
    • Use at least two patient identifiers when performing and collecting biopsy specimens2. Identifiers that are appropriate to use should be listed within a positive patient identification (PPID) policy.
    • Prepare labels with all applicable patient and specimen information. Document and label the specimens collected in the presence of the patient. Do not pre-label specimen containers and forms. The use of lab-specific printed labels would be preferable to reduce the risk of missing information from the label.
    • Take only the biopsy tray(s) and supplies necessary for the patient's biopsy into the treatment room.
    • Follow Universal Protocol standards, which apply to all nonsurgical invasive procedures3. Implement a pre-procedure verification process, conduct site marking as applicable, and conduct a "time out" for biopsies to ensure a standard process to confirm the correct patient, correct site, correct procedure (to collect the specimens), correct placement of the specimen into the correct collection vessel, and correct labeling.
    • Develop a standard process and location for specimen transportation to the lab. Ensure the process includes any requisition slips needed, documenting appropriate information on the specimen pick-up log, and placement of the specimen in the pick-up area for transport to the pathology lab.
  • Establish a written policy and procedure for the results management process1.
    • Establish an electronic system (or manual process if you do not have an electronic medical record) that tracks when pathology specimens are sent out and when the results are received. Standardize 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 seven (7) days.
    • Require providers to electronically review and sign (or initial and date for manual logging) reports of biopsy results upon receipt. Establish a process to ensure the provider has documented the review of electronic and scanned biopsy reports.
    • Ensure a process is in place for the provider to address critical biopsy results.
    • Ensure a process is in place for biopsy results to be reviewed and acted upon by a qualified covering provider if the ordering provider is unavailable.
    • For more details on results management, please see our practice tip Results Management: Tracking Diagnostic Tests and Referrals.
  • Develop standard processes to ensure follow-up with the patient occurs.
    • Notify the patient of the biopsy 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 the patient's medical record.
    • Ensure the patient completes any necessary follow-up or document an explanation regarding why the recommended follow-up/treatment was not completed.
    • For more information on patient follow-up and appointment management, please see our practice tip on Appointment Management: Missed and canceled appointments, referrals not completed.
  • Monitor for patient safety improvement opportunities.
    • Track all specimen labeling errors.
    • Routinely audit the steps within specimen and results management to identify opportunities for improvement.
    • When opportunities for improvement are identified, utilize a structured method, such as Plan-Do-Study-Act (PDSA) to implement and monitor system/process changes.


  1. American Society for Health Care Risk Management. (2016). Physician Office Risk Management Playbook.ASHRM
  2. The Joint Commission. (2024, January). National Patient Safety Goals Effective January 2024 for the Ambulatory Health Care Program.Goal 1- Improve the accuracy of patient identification.
  3. The Joint Commission. (2024, January). National Patient Safety Goals Effective January 2024 for the Ambulatory Health Care Program.Universal Protocol UP.01.01.01, UP01.02.01, UP.01.03.01.

Last updated: 2/20/24