Delay in cancer diagnosis is one of the leading causes for professional liability claims associated with mismanagement of biopsy specimens in the office practice setting. Factors contributing to these claims are:
- Mislabeling of the specimen(s).
- Failure to track receipt of the results.
- Failure to notify the patient of the biopsy results.
- Failure to notify the patient in a timely manner of the biopsy results.
- Failure to provide treatment planning options, including appropriate specialty referral.
- Failure to document the biopsy results management and treatment plan in the patient's medical record.
Recommendations for improving biopsy specimen management in the office practice setting:
- Establish a written, standardized specimen collection process.
- Utilize two patient-specific identifiers when performing biopsies.
- Request the patient state their full name and date of birth when they arrive at the practice.
- Use the same two patient identifiers to confirm 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 them 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's 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 that includes a "time out" for biopsies. 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 medical record.
- Ask the provider to confirm the specimen information is documented correctly, including the 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 the results 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 seven (7) days.
- Require providers to review, initial, and date reports of biopsy results upon receipt.
- Instruct staff to assure the provider has documented review of the biopsy report prior to filing in the paper record.
- Establish a process to assure the provider has documented review of electronic and scanned biopsy reports.
- Assure a process is in place for the provider to address STAT biopsy results.
- Assure a process is in place to require biopsy results are reviewed and acted upon if appropriate by a qualified covering provider if the ordering provider is unavailable.
- Follow-up with the patient.
- 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 document in the patient's medical record.
- Assure the patient completes any necessary follow-up or document an explanation regarding why recommended follow-up/treatment was not completed. For more information, please see Appointment Management: Missed and canceled appointments, referrals not completed.
- Monitor for patient safety improvement opportunities.
- Track all specimen labeling errors.
- Identify opportunities for improvement.
- Implement system changes as necessary.
- Track all specimen labeling errors.
WHO Collaborating Center for Patient Safety, May 2007.
Joint Commission Two Patient Identifiers March 2021.
Who are my patients and what am I doing to them?, www.wapatientsafety.org
Medical Mutual Insurance Company of Maine's "Practice Tips" are offered as reference information only and are not intended to establish practice standards or serve as legal advice. MMIC recommends you obtain a legal opinion from a qualified attorney for any specific application to your practice.