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Hospital officials respond

Nov 11, 2016 By Kelli Ameling, Staff Writer

Officials at SageWest Health Care responded to several questions regarding recent complaints that led to two visits from the Wyoming Department of Health this year.

The complaints from surgical staff, involving blood and "bone-like fragments" found on equipment that had been prepared for use, date back to 2012 and have put the hospital's Medicare/Medicaid provider agreement at risk.

Based on two of the complaints, the WDH visited the hospital in June 2015 and in October 2016, along with the Centers for Medicare and Medicaid Services. The WDH is now asking for a plan of correction.

Response

The Lander Journal reached out to SageWest Health Care with a number of questions about the reoccurrence of the problems listed in the WHD survey.

Officials were asked how many patients have been affected since 2012 and what steps the hospital is taking to make sure these problems do not persist, in addition to questions about staffing.

Betty Brown, interim chief operating officer for SageWest, responded, saying:

"Our top priority at SageWest Health Care is to provide high quality, safe care to our patients. We took immediate action and are addressing each item outlined in the complaint you have referenced. At SageWest, we take matters like this very seriously and are committed to ensuring our corrective action plan is credible and sustained. We have been working closely with WDH-CMS and other agencies to ensure that our practices are meeting the highest standards, and are confident in our improved equipment processes and procedures. We are not aware of any individual being adversely affected by this situation, but take this very seriously and regret any concern this has caused the community."

SageWest had told the Lander Journal that the hospital had been closed to all elective surgeries due to "equipment issues." Spokeswoman Lindsey Anderson said SageWest is resuming selected elective surgeries this week.

"We consider it a privilege to serve the needs of the Fremont County communities and thank the community or their patience as we've addressed this issue," Anderson said.

Equipment issues

The WDH sent a letter to SageWest on Oct. 31 regarding the department's latest site visit, which was performed Oct. 19.

The October visit was a follow up to a May 5 survey that evaluated the hospital's participation in the Medicare/Medicaid program.

The WDH found that the hospital still was not in substantial compliance with five issues outlined in May and noted two new issues from the October visit.

One of the re-occurring problems from the May to October visit involved the hospital's reported failure to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases.

"The facility failed to ensure acceptable standards of infection control practices were used for cleaning, inspecting and sterilizing surgical instruments and administering intravenous medications," the survey states.

The second issue highlighted in the survey piggybacks off of the first, stating SageWest did not meet the standard for having an infection control program.

"The failure to follow acceptable standards of infection control practices resulted in potential harm for four of four sample patients," the WDH wrote.

According to the report, two patients were exposed to unclean instruments during surgery, and one patient was in the operating room when unclean instruments were removed prior to use. Another patient was anesthetized for 34 minutes while staff replaced a contaminated instrument tray.

"In addition ... the hospital failed to ensure staff used safe injection practices for two of two sample patients ... observed during intravenous medication administration," the WDH reported.

A chief nursing officer confirmed unclean surgical equipment was found in the operating room during a surgical procedure in June and prior to surgery in July and September. She also noted education and testing was given to the employees, but on Oct. 19 those efforts had not resolved the recurring problem.

The survey found that, with one patient, a surgeon placed an instrument used for suctioning in the surgery area; the instrument did not function properly "due to clogged dried blood" in the small lumens.

"A replacement instrument was checked prior to use, and dried blood was found in this instrument too," the document recorded. "Review of the root cause analysis revealed the instruments were not properly cleaned and inspected."

A third instrument was used on the patient, who was tested for hepatitis and HIV. The results were negative.

Also, during an orthopedic surgery, an instrument called an acetabulum reamer needed to be used. It was brought to the OR as "available for use," but there were "bone-like fragments" on it.

The chief nursing officer told the WDH she was aware of the incident.

"She further stated the unclean instrument did not have contact with the patient, therefore this incident had not been reviewed or investigated to determine what steps had been omitted in the sterilization process," the survey stated.

A microlarygeal suction was placed down the throat of one patient and was withdrawn due to a malfunction; the report states dried, bloody materials were found on the instrument. Investigation showed the instrument had been washed, cleaned, inspected and stored in a room on Friday before the Tuesday surgery, but on Monday, the instruments were packaged and sterilized without an additional inspection or cleaning.

The patient involved was tested for hepatitis and HIV, and the results were negative.

Another patient was to undergo arthroscopy and was put under anesthesia when the surgeon found instruments to be contaminated with "bone-like fragments" that were "whitish and reddened in color." When that surgeon asked for the backup set of instruments, he was told the second pack had not yet been sterilized, so he had to use an immediate sterilizing process which caused a 34-minute delay in the procedure - all while the patient was anesthetized.

"The surgeon further stated the hospital had only one full-time employee in the sterile processing department at the Lander location, and one employee responsible for sterile processing was inadequate," the document stated.

The chief nursing officer told the WDH she was not sure of the cause of the problem, but she confirmed the incident and said she planned to hire another employee for in sterile processing.

During another procedure, an anesthesiologist was observed withdrawing and administering intravenous medications to a patient at the Lander location. It was revealed the anesthesiologist did not consistently disinfect the septum on the medication vial, nor did she disinfect the intravenous ports prior to administering each medication.

"Further observation revealed she withdrew and administered medications using the same syringe and needle two times," the survey stated.

Another anesthesiologist at the Riverton location administered intravenous medications before and during surgery for patient numbered nine without disinfecting the septum on the medication vial prior to withdrawing the medication into the syringe.

"Further observation revealed he removed and covered the intravenous port with the same intravenous cap after each injection," the survey stated.

Governance

Another issue in the survey stated SageWest did not meet the condition of having an effective governing body legally responsible for the conduct of the hospital. The WDH showed in the report the hospital "failed to ensure the quality assessment and performance improvement program effectively addressed uncorrected system failures, and failed to ensure sustaining measures were implemented to address ongoing breaches in infection control practices, as well as out of acceptable range humidity levels in the operation room, sub-sterile room and endoscopy rooms."

The document stated the interim CEO "acknowledged the facility had not completely resolved all of the problems that were identified during the May 5, 2016 validation survey." However, the interim CEO noted the hospital was improving on the issue.

The survey shows a fourth area for improvement, stating SageWest was not compliant in developing, implementing and maintaining an "effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program." This was one of two new issues identified in the Oct. 19 visit. The WDH noted the problem was not resolved due to the findings listed earlier.

The WDH stated in the survey the hospital failed to identify and implement measures to address ongoing breaches in infection control practices. Through an interview in the survey process with the chief nursing officer, it was revealed unclean surgical instruments were found in the operating room during a surgical procedure in June 2016, and prior to a surgery in September 2016.

To help fix the problem, the chief nursing officer stated staffing received education and testing.

"She acknowledged the problem continued to occur even though the above measures had been implemented," the survey stated. "In addition ... ongoing unsafe injection practices were observed."

Another violation involved the hospital's failure to maintain humidity levels within acceptable ranges in the operating room. Since the May visit, improvements had been made, but not in all areas.

Another standard not met by SageWest Health Care was ventilation, lighting and temperature controls in pharmaceutical, food preparation and other areas.

To help correct this problem, in May the hospital had security check the temperatures and humidity while documenting the findings at the beginning and end of each shift.

A review showed the humidity was to remain between 30 and 60 percent.

However, the WDH in a review of the July log found one OR to be less than 30 percent on four days, with four days in another OR, six days in substerile room and three days in the endoscopic procedure room.

The review of the August, September and October logs at both the Lander and Riverton locations showed more days where the rooms were not kept between the required humidity levels.

"(An) interview with the director of plant operations ... confirmed the facility had issues with humidity levels at both locations," the survey stated, noting the facility planned to contract with an outside entity to fix the problem.

Another regulation violation regarded operating room policies, highlighting and giving the examples outlined in the other problem areas.

"The facility failed to ensure resources related to adequate number of sterile processing personnel and surgical instrument availability for scheduled surgeries were consistently provided to meet surgical service needs," the survey stated. "The failure affected four of four sample patients."

Plan of correction

According to the letter from the WDH to SageWest Health Care, the hospital has until Nov. 10 to develop a plan of correction for these issues.

"We are recommending to the Centers for Medicare and Medicaid Services Regional Office that your Medicare agreement termination date be extended to Dec. 30," the letter also stated.

WDH spokeswoman Kim Deti said if the hospital does not come into compliance with the rules, it will jeopardize its Medicare/Medicaid certification.

"The department's goal is for the facility to come into compliance and provide safe, quality care," she said. "A follow-up survey will be done to determine if the hospital meets the requirements."

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