Category: Closing the Loop

Risk: Mismanaged specimen

Patient suffers unnecessarily due to improper management of lab specimen obtained during a physician office visit.

Diagnostic Process of Care in Ambulatory Diagnosis Cases*

Test performance is a contributing factor in 5% of CRICO (3% of Candello) ambulatory cases alleging a missed or delayed diagnosis.

Step 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

A 27-year-old female was seen in office for complaints of frequency and burning on urination. A urine culture and sensitivity (C&S) was ordered. The patient was prescribed Bactrim and instructed to follow up with any ongoing issues. The urine specimen was never sent to the lab. Two weeks later, the patient called the office with complaints of excruciating back pain, and was referred to the emergency department. In the ED, urinalysis confirmed 3+ bacteria. Urine C&S was sent, the patient’s Bactrim prescription was renewed, and she was discharged.

Two days later, the patient was admitted to the hospital through the ED with fever, nausea, and vomiting. The urine C&S obtained in the ED confirmed E-coli (not sensitive to Bactrim), and a new antibiotic was ordered. After a four-day inpatient admission, the patient was discharged home with a peripherally inserted central catheter line for prolonged antibiotic treatment.

A disclosure and apology to the patient revealed that her urine C&S had never been sent from the initial office visit.

Patient Safety Vulnerabilities

  1. A lack of reliable systems for specimen handling can lead to missed opportunities for earlier treatment.

    Safer Care
    : Maintain a chain of custody to track specimens from collection to final disposition. Implement a quality monitoring system (e.g., specimen log). Investigate discrepancies to close potential gaps in test result processing and communication. Incorporate patient huddles and include specimens in a patient care checklist.

  2. Imaging, diagnostic, or lab results that fail to reach you or your patients—or if the information is not integrated into the care plan—exposes patients to unnecessary risk.

    Safer Care
    : Implement systems that assist in reconciliation of all results, including confirmation of provider receipt, review, and transmission of results and recommendations to the patient. When possible use electronic health record (EHR) reminders in this effort.

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 practice have a process to track that collected specimens are sent to the lab?
    Recommended practice: A standard process for appropriate specimen collection and management
  3. Do we have a standardized process for specimen handling that ALL team members follow? How do we ensure the process is being followed?
    Recommended practice: A responsible person is identified as accountable for specimen processing

    Recommended practice: Specimen handling is included during staff orientation and annual competencies review
  4. What other processes, similar to specimen handling, pose major risks to our patients?
    Recommended practice: Analyze similar events (including near misses) for patient safety improvement opportunities


Additional Resources


Disclaimer: The CRICO Are You Safe? cases 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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