Half a million dollar verdict raises concerns about surgical infections
Are you doing all you can to avoid infection control breaches?
By Joy Daughtery Dickinson, Executive Editor
After a case that lasted years, a California surgery center recently was found guilty of negligence in a civil trial resulting from a post-surgical infection and was ordered to pay more than half a million dollars to the former patient, according to media reports.1 The patient developed a bacterial infection following arthroscopic knee surgery in 2010.
Three days after surgery, the patient reported severe pain and a fever to his doctor. He went to a hospital emergency department, where he underwent antibiotic therapy and additional surgery. The patient had a knee replacement in 2012. His lawyer says he is unable to walk more than four blocks. The jury awarded the patient more than $543,000 for pain and suffering, as well as past and future monetary loss.
After the initial patient's infection, the surgery center staff learned that three other patients also had been infected with what was determined to be Pseudomonas aeruginosa bacteria. The center didn't know if any common instruments had been used on the patients because the facility didn't have quality control records indicating which instruments were used on which patients, the media report said.1 The surgeon testified that he trusted that the instruments he used were fully sterilized.
The facility hasn't had any similar infections reported since 2010. A spokesperson for the surgery center blamed the manufacturer of an enzymatic detergent sponge and said the center immediately discontinued using the product.1 The center provided necessary care and follow up to the patient, and the verdict is being appealed, the spokesperson said.
How to avoid being sued
This case provides a valuable lesson, says Lisa Waldowski, MS, APRN, CIC, infection control specialist in the Standards Interpretation Group, Division of Healthcare Improvement, at The Joint Commission.
"Ensure you have documentation in the event of a recall or, as in this example, you need to trace [the equipment or device] back to the patient," Waldowski says. Don't take this step only for selective high-risk cases, she emphasizes: "That's [for] all cases," Waldowski says.
Place lot control numbers on the patient chart with the name of the item written next to the label, says Natalie Lind, educational director at the International at the Association of Healthcare Central Service Materiel Management. Also, manually document instruments processes with information including the item, serial number, and the name of the person who cleaned or disinfected the item, Lind says. "Some computer tracking systems allow instruments to be scanned to a patient," she says.
You can use the tray label for the patient record, Lind advises. However, she notes, "there is no system available as of yet that allows for complete documentation."
One problem with documentation is that while the contents of the surgical instrument pack are fairly standardized, the actual instruments taken from inventory and placed into those packs may vary from day to day, says Jack Egnatinsky, MD, medical director for the Accreditation Association for Ambulatory Health Care (AAAHC). "The list of instruments to be placed in each pack is known, but the actual instrument content is usually not documented," Egnatinsky says.
The sterilized packs are normally numbered. This information is kept in a log and should be able to be tracked to the case for which it was used, "but the actual instruments within that pack may not be known, especially if there are multiple packs used which may be cleaned and/or assembled at the end of a group of cases or the end of the day," he says.
Radio-frequency identification (RFID) technology might help. For example, RFID would identify each specific instrument with a unique RFID tag and in some cases, if required, a tray might be tagged as well with the individual instruments nested to that tray identity, says Dan Galarde, chief solutions architect at American RFID Solutions, an Arlington Heights, IL-company that offers RFID. RFID technology also "could easily identify which instrument or sets of instruments were present in the operating arena with a given patient," Galarde says. However, there are technical limitations, Galarde says. "There is no inobtrusive method of tracking if a given instrument was actually used or not used during a specific surgical procedure or just sat in a tray as a standby .," he says. "The reality of the situation is RFID could provide documentation to prove the instruments were indeed sterilized in accordance with the facility's best practices between operations and identify the patients that were present in the operating arena with a given instrument or set of instruments over time."
The Joint Commission finds issues
Identifying the instruments used wasn't the only issue in the case mentioned above. There also was a bacterial infection. Although healthcare providers are well aware of how important it is to clean, disinfect, and sterilize medical equipment, devices, and supplies, The Joint Commission has observed several significant missteps in these processes in recent years, the American College of Surgeons (ACS) has reported.2
The ACS cited "issues related to the proper use of steam sterilization as well as the unprecedented pace at which new devices and resistant pathogens have emerged and generated concern." In response, The Joint Commission has revised a standard and two elements of performance related to reducing these risks in ambulatory care facilities, office-based surgery centers, hospitals, critical access hospitals, and long-term care facilities, the ACS reports.
To address such issues, the ACS recommends a published description of the program at Virginia Mason Medical Center in Seattle, where quality improvement interventions in the surgical instrument sterilization process were based on adoption of a specific set of Lean production improvement methods called the Virginia Mason Production System (VMPS). An article in The Joint Commission Journal on Quality and Patient Safety describes how the center used VMPS to improve surgical sterile instrument processing in its 24 operating rooms, where about 18,000 operative procedures are performed annually.3 As a result of the project, the instrument sterilization error rate decreased 50%, going from 3.0 per 100 surgical procedures at baseline to 1.5 in the final sustainability period.
The 37-month project at Virginia Mason relied on a quality monitoring approach to identify and categorize errors in sterile instrument processing through use of a "daily defect sheet." The organization used Lean methods to reduce risks in sterile processing of surgical instruments. It created separate steps of defined work related to assembling and packaging the instruments. It also rearranged the physically confined sterile processing workspace to accommodate the new work processes. The center developed a brief checklist and other processes to mistake-proof sterilization, created an instrument sterilization certification training program for staff, and sought continuous feedback on the sterilization processes, the ACS reported.
Improvements were observed in multiple categories of error types, particularly assembly errors in packaging and foreign objects such as pens and paper clips. Although process reviewers at Virginia Mason were unable to directly measure and attribute specific clinical outcomes to the surgical instrument processing interventions, reviewers anticipate the improved processes will contribute to lower infection rates, fewer surgical errors, and reduced costs, the ACS said.
To reduce infection rates in your own facility, consider this final advice from Lind: "Careful monitoring of the entire sterilization process — cleaning, inspection, packaging, sterilization, cooling and storage and transport — is critical, as is ensuring that every step is carried out correctly." (For more information on this topic, see these stories in the November 2013 Same-Day Surgery: "Initiative reduces SSIs from 7% to 2.6%," p. 125, and "Pathway to reduce SSIs focused on 12 areas," p. 126.)
- Fountain M. A local surgical institute pays big in a negligence case. New Times. Dec. 18, 2013. Accessed at http://bit.ly/18VcFqb.
- American College of Surgeons. Using Lean methodology to improve sterilization of surgical instruments Bulletin of the ACS. June 1, 2013. Accessed at http://bulletin.facs.org/2013/06/using-lean-method.
- Blackmore CC, Bishop R, Luker S, et al. Applying Lean Methods to improve quality and safety in surgical sterile instrument processing. Jt Comm J Qual Patient Saf 2013; 39(3):99.