Patient Suffers Septic Shock Following Laboratory Clerical Error

Case Overview

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.

Questions to the Chemistry expert and their responses

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

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.

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

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. 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 ensure the result is accurately delivered in a timely fashion.

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

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.

About the expert

This expert has four decades of experience in the field. He earned his BS in Biology from Manhattan College, his first MS in biology from Seton Hall University, and his second MS in microbiology and immunology at New York Medical College. He then went on to complete his MBA from the Westchester University of Pennsylvania. He is a member of prestigious societies and has presented multiple national and international lectures. He is a former adjunct instructor in science from Rockland Community College, laboratory manager, and microbiologist at Coatesville Veterans Affairs Medical Center Laboratory Services. He has also served as both the chair of the department of pathology quality management team and as the chief medical technologist at Irwin Army Community Hospital. Most recently this expert was the interim laboratory operations manager at B.E. Smith. Currently, he is the owner and chief consultant of a laboratory medicine consultancy in New York and is working towards completing his Ph.D. in health care administration, with a dissertation on improving provider utilization of laboratory results.

E-034857

Specialties:

Chemistry

Victoria Negron has extensive experience in journalism and thought leadership in the legal space, with a background crafting content, whitepapers, webinars, and current event articles pertaining to the role of expert witnesses in complex litigation matters. She is a skilled professional specializing in B2B product marketing and content marketing. Currently, she serves as an Enterprise Product Marketing Manager at Postman, and previously held the position of Technical Product Marketing Manager at Palantir Technologies, where she developed her skills in launch strategies, go-to-market strategy, and competitive analysis.

Her expertise in content marketing was further refined during her tenure at the Expert Institute, where she progressed from a Marketing Writer to Senior Content Marketing Manager, and eventually to Associate Director of Content & Product Marketing. In these roles, she honed her abilities in digital marketing, SEO, content strategy, and thought leadership.

Educationally, Victoria holds a Master of Business Administration from the University of Florida - Warrington College of Business and a Bachelor of Arts in Literature, Art, and Hispanic Studies from Hamilton College. Her diverse educational background and professional experience have equipped her with a robust skill set in product marketing, content development, and strategic marketing initiatives.