Category: Reliable Diagnoses

Risk: Failure to Diagnose

Inadequate management of a patient-detected breast lump

Diagnostic Process of Care in Ambulatory Diagnosis Cases*

Inadequate patient assessment is a contributing factor in 35% of CRICO (31% of Candello) ambulatory cases alleging a missed or delayed diagnosis.

Percent of Cases**

1. Patient notes problem and seeks care 1% 1%
2. History and physical 10% 8%
3. Patient assessment/evaluation of symptoms 35% 31%
4. Diagnostic processing 43% 35%
5. Order of diagnostic/lab test 40% 31%
6. Performance of tests 5% 3%
7. Interpretation of tests 37% 23%
8. Receipt/transmittal of test results to provider 4% 5%
9. Physician follow up with patient 21% 18%
10. Referral management 13% 21%
11. Provider-to-provider communication 12% 12%
12. Patient compliance with follow-up plan 14% 17%

* Cases with claim made date 1/1/11–8/31/16
** A case will often have multiple factors identified
† Candello is CRICO’s Comparative Benchmarking System

Closed Malpractice Case

During an appointment for a self-detected breast lump, a 34-year-old’s physical exam was noted as normal. The gynecologist ordered a mammogram, but did not indicate the patient’s breast complaint on the order. Four months later, a screening mammogram was done and reported as “normal,” with a note of “very dense stromal pattern,” which reduces sensitivity for cancer detection. The radiologist did not recommend an ultrasound; the gynecologist received the report with no recommendation for further testing.

Nine months later, the patient returned to her gynecologist complaining of the same breast lump. The physician palpated the lump on exam and ordered a diagnostic mammogram and a surgical consult. Subsequent work up revealed breast cancer. The patient underwent a radical mastectomy and axillary node dissection, and was found to have metastases to the spine. The patient’s positive family history of breast cancer was not recorded until after her diagnosis.

Patient Safety Vulnerabilities

  1. Failure or delay in ordering (appropriate) diagnostic tests, consults, or referrals can lead to missed or delayed diagnosis.

    Safer Care: Prioritize efforts to decrease diagnosis-related harm through use of decision support tools such as the CRICO Breast Care Management Algorithm.
  2. Failure to regularly update pertinent family history can lead to missed identification of patients for increased risk related to that history.

    Safer Care: Consider using a checklist or templates for details that are often overlooked (i.e., family history) but can be relevant for improving diagnostic reasoning.

Practice Assessment

  1. Has this type of event happen at our practice?
    Recommended practice: Analyze similar events (including near misses) for patient safety improvement opportunities
  2. Does our clinical team use disease-specific recommended guidelines, and are they readily available?
    Recommended practice: Identify relevant clinical guidelines (e.g., CRICO Breast Care Management Algorithm) for all practice providers
  3. How do we incorporate recommended guidelines into our provider education and practice?
    Recommended practice: Educate staff regarding implementation of practice guidelines and periodically audit compliance.

    Recommended practice: Establish a systems-based process to identify that patients undergo recommended tests per guidelines

Additional Resources

Disclaimer: The CRICO Are You Safe? case studies offer suggestions for assessing and addressing patient safety and should not be construed as a standard of care.

CRICO’s mission is to provide a superior medical malpractice insurance program to our members, and to assist them in delivering the safest health care in the world. CRICO, a recognized leader in evidence-based risk management, is a group of companies owned by and serving the Harvard medical community.

How to Earn Category 2 Risk Management Credits

This Are You Safe? case study is suitable for 0.25 AMA PRA Category 2 Credit™. This activity has been designed to be suitable for .25 hours of Risk Management Study in Massachusetts. Risk Management Study is self-claimed; print and keep this page for your record keeping.

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