Patient Suffers Septic Shock Following Laboratory Clerical Error

This case involves an elderly woman with a history of poor circulation who was treated at a wound care clinic for lower extremity lymphedema and several leg wounds. She developed clear signs of infection along those wounds, including foul-smelling bandages and greenish-blue wounds. Cultures were obtained and the preliminary results were negative. The woman was discharged and told the clinic would follow up as soon as possible regarding the final report. However, the wound clinic never followed up with the patient due to an alleged clerical error. Several days later, the patient went into septic shock in her home and passed away. It was later discovered that the final culture report was positive for pseudomonas pseudocaligenes bacteria.

Question(s) For Expert Witness

1. What is your experience managing a clinical laboratory that handles wound cultures?

2. What safeguards should be in place to ensure that a referring physician and/or patient receives timely reporting of the laboratory results?

3. Can you speak to the standard practices for reporting laboratory results and cultures?

Expert Witness Response E-034857

I am a clinical microbiologist and a College of American Pathologists (CAP) accreditation inspector with 20 years of experience. I hold a master's degree in microbiology and immunology in the area of clinical microbiology and have been a laboratory manager for a federal healthcare services agency for a similar timeframe. I have both the training and experience to speak to the professional standard of care with respect to general laboratory tests and specifically with respect to microbial cultures. All of the laboratories I have managed have robust microbiology sections, which routinely handle wound cultures from a variety of anatomic sites and conditions. These include both aerobic and anaerobic bacterial cultures as well as fungal cultures. Since these are dependent upon the growth of microorganisms and their identification via various biochemical tests, there is obviously a delay in reporting microbiological studies. This does not in any fashion lessen the duty of both the provider and the laboratory to seek the identification and susceptibility in a timely fashion and with the highest possible accuracy and quality. It does add a complicating factor in that due to the potential delay in reporting, laboratories must use tools (manual or electronic case logs or culture reports) to maintain visibility on all cultures in their care.

Results reporting is one of the accreditation standards of the College of American Pathologists (CAP) as well as The Joint Commission (TJC) laboratory accreditation programs. There are several different methods of reporting results -- a shared electronic medical record (EMR) or laboratory information system (LIS), a separate interface between the laboratory and provider(s), faxed results, emailed results, mailed results or courier distribution. Under the clinical laboratory improvement amendments (CLIA), the laboratory director is responsible for ensuring that results are made available in a clinically relevant timeframe (turn-around time). Measuring the turn-around time is a standard quality metric for laboratories and mandated by both CAP and TJC. Safeguards would include periodic quality reviews of lab result turn-around time using the electronic EMR or LIS, the mandatory provider satisfaction survey, and discussion between the laboratory and the client providing the results. Specifically, if there is a critical (panic) value, the laboratory is also required to separately notify and document contact with the provider on that result. Based upon this summary of the case, it appears to me that identifing pseudomonad in a wound meets these criteria. However, I would need to review their critical value SOP and test list. Finally, the referring provider has a duty to the patient to follow up on ordered testing, either by themselves or by use of a proxy (other provider, nurse, etc). In this way, both parties have a shared responsibility to insure the result is accurately delivered in a timely fashion.