Free blood tests, patient backtracking in line for SageWest Lander after investigationMar 9, 2017 By Kelli Ameling, Staff Writer
SageWest Health Care at Lander will offer free blood tests at the request of the Wyoming Department of Health, which determined after investigation that unsterile and poorly-cleaned equipment was used on patients.
WDH's Infectious Disease Epidemiology Unit made three recommendations resulting from its investigation: SageWest should prioritize proper staffing in the CSP unit, educate the staff involved with instrument cleaning and surgical procedures, properly document and monitor each sterilization cycle using biological and chemical indicators with parametric monitoring and issue notifications to all surgical patients who underwent surgery between Dec. 1, 2013 and Oct. 27, 2016.
WDH said the notification should explain to patients that "they were potentially exposed to contaminated surgical equipment, and that although the risk was low, patients might have been placed at risk for blood-borne pathogens (HIV, hepatitis B and hepatitis C) and surgical site infections."
The investigation notes patients who only received endoscopy procedures do not need to be notified.
SageWest spokeswoman Katina Anderson said the facility is evaluating how to best address patient concern "without causing undue alarm, since there is no evidence that infectious diseases were transmitted to SageWest Lander's patients.
"Even though the Wyoming Department of Health agrees that the risk of potential infection is low, SageWest will be offering testing free of charge to patients who underwent surgery in SageWest Lander's operating suite between December 2013 and October 2016," Anderson said.
As plans develop, Anderson said SageWest will communicate with patients about how to obtain testing.
WDH began its investigation after its Office of Health Care Licensing and Surveys received a letter from a surgeon (identified as Surgeon X in the department's report) who "described a series of detailed complaints" against the Lander facility related to unclean surgical equipment, which has been a documented recurring problem "dating back several years."
The WDH initiated a site visit on Oct. 19 to follow up after a complaint was made in 2015 regarding sterile conditions at SageWest.
A first on-site visit occurred in May 2016, then after receiving another complaint, a second on-site visit was conducted in October.
The site visit outlined seven areas - five of which were reoccurring issues, two were new issues - the hospital needed to improve on. The issues stemmed from equipment not being clean before and during surgeries, rooms not being kept at the required humidity, sterilization of needles and more.
The investigation through the Infectious Disease Epidemiology Unit only focused on the fact there were poorly cleaned and unsterile surgery equipment used on patients to try to determine if the was any sort of health risk for patients.
The unit reviewed health care licensing surveys dating back to Aug. 12, 2010, requested a list of all patients exposed to contaminated medical devices and if those patients were notified, reviewed hospital responses, visited the facility, conducted interviews with the infection control preventionist, chief nursing officer and director of perioperative services and had an epidemiologic review.
The US Center for Disease Control also assisted in the investigation.
The investigation showed at least 16 instances where unclean instruments were used during surgery or found prior to surgery, however, it noted patients still could have harmful exposure even if the poorly-cleaned instruments were in the room but not used as it contaminates the operating room.
SageWest confirmed a number of instruments had dents and rust, which the unit said confirmed equipment was not being cleaned properly resulting in damaged equipment.
"It was found that items were being left to sit out for one or more days after surgery without being cleaned; the hospital's response was simply to claim that this does not happen," the investigation stated.
The investigation determined although "the risk of infection is low, the risk is not zero."
The office of Health Care Licensing and Surveys revealed in 2015 that SageWest was found to have an insufficient system for patient follow-up to determine if the patients were impacted by the contamination.
"SageWest Heath Care's response to this point does not address what they would do to improve follow up with patients," the documents stated.
"If patients were potentially being exposed to contaminated equipment without SageWest Heath Care doing its due diligence to understand their risks and exposures, this represents a risk to public health. Patients were potentially put at risk for unidentified transmission of blood-borne pathogens and SSIs."
Investigators wanted to determine where there were any changes in the incidence of hepatitis B, hepatitis C and HIV in Fremont County during the time period of the investigation, along with surgical-site infection rates.
However, because of poor record keeping, surgical-site infection rates could not be properly represented in the investigation.
SageWest provided data for the Lander facility in 2012 and 2013. In September 2014, when the company merged the Riverton and Lander facilities, the data did not reflect which rates came from which hospital at which time. In 2015 the data represented data for both hospitals, and in 2016 data was only provided for the Lander facility from January to September.
The Infectious Disease Epidemiology Unit reviewed all of the documentation Surgeon X provided, and compared it to documentation provided by SageWest Health Care, along with how the facility handled the possible contaminations.
"There is discordant documentation of contamination events between Surgeon X's list, the list provided by the hospital, the allegation timeline and the surveys," the investigation stated.
In some of the documented instances SageWest Health Care did not believe there was any harm to the patient during exposers to poorly-cleaned equipment, However, Surgeon X said that was "untrue" as "dried blood pieces had in face entered the patient's wound."
SageWest Health Care also began visibly inspecting surgical equipment before surgery, but did not keep track of how many instruments were inspected or how many were discarded and replaced due to defects.
"In 2014, it was found that the facility failed to maintain complete records of sterilization," the reports stated. "This is significant because without complete records, we cannot be certain that sterilization was always successful and that instruments were not contaminated."
"The CDC described the events that occurred at SageWest Health Care as a category B breaches of infection control," WDH stated in its investigation report. "Category B breaches are events where the likelihood of blood exposure resulting from the breach is uncertain, examples include incorrect disinfectant solutions and using sterilized instruments that have retained tissue. Investigators and CDC discussed that patients could have been exposed to instruments with retained tissue and bioburden from previous patients."
Anderson said the quality of care and patient safety is the hospital's "highest priorities."
"In November 2016, SageWest published an Open Letter to the community addressing certain patient care process issues. In this letter, we confirmed a report from the Centers for Medicare and Medicaid Services regarding the sterilization process for surgical instruments at SageWest Lander," Anderson said. "We also shared updates on our in-depth investigation, our voluntary decision to postpone elective surgeries, and some of the quality improvements that we made to address the issues outlined in the report.
"Importantly, there is no evidence of any patient harm or infectious disease transmission to any surgical patient at SageWest Lander due to these issues. We have shared this data with the Wyoming Department of Health as we continue to try to work together to improve the quality of care provided by SageWest."