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Saint Luke's operates on patients with 'rusty' and 'damaged' equipment, according to complaint

'It's extremely dangerous'
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Posted at 3:50 PM, Oct 17, 2023
and last updated 2023-10-20 06:30:38-04

KANSAS CITY, Mo. — A complaint filed Sunday with health care oversight agencies claims one of Kansas City's largest hospitals uses damaged, rusty and broken equipment on surgery patients.

Through her attorney, Elizabeth Bell, the former Sterile Processing Manager at Saint Luke's Hospital - Kansas City, provided the KSHB 41 News I-Team with photos and videos of what she said are unsanitary conditions.

When it comes to patients, Bell said, "They have no idea" what happens to the equipment that's used on them during surgery.

"It's extremely dangerous," Bell said.

Photos, videos and stunning accusations

Bell, who provided the I-Team with proof of employment, said Saint Luke's hired her as its first-ever sterile processing manager.

It's a career Bell said she's done for the past 15 years in other facilities.

"We have the ability to keep people safe," Bell said. "Life or death is truly our responsibility and we have to be able to stop the line when things are wrong."

But, calling out bad practices cost Bell her job, she says.

"Saint Luke's is unlike any other place I've ever been," Bell said. "It was shocking."

Almost immediately upon her hiring, Bell said she identified issues that are not in compliance with standards with the Healthcare Sterile Processing Agency.

“People’s families, their children, they have a right to safe surgery,” Bell said.

Bell provided the I-Team with photos of equipment showing rust and apparent damage to equipment.

A Saint Luke's spokesperson said they could not comment on all of Bell's claims and could not authenticate any images and videos shared by Bell and her attorneys with KSHB 41.

"We can share that quality, patient safety and clinical excellence are, and have always been, top priorities of Saint Luke’s Hospital," Saint Luke's spokesperson Laurel Gifford told KSHB 41. "We are proud of our rigorous sterilizing process and the experts who collaborate closely every day to ensure our patients are safe."

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Bell said the equipment is used on surgery patients.

"Pitting and rust. Cracks and chipped instruments. Those cannot be properly cleaned," Bell said. "Those should be replaced."

Saint Luke's Hospital told the I-Team surgeons serve as a last line of defense and would remove any instrument that puts patients at risk.

Bell said she complained numerous times about the hazards she claims to have identified, as she was hired to do, but was overruled by staff in the operating room.

The damaged equipment does not allow for proper sanitization, which can lead to infection, Bell said.

Bell provided the I-Team with copies of complaints she filed on Sunday, Oct. 15, with The Joint Commission, Missouri Department for Health and Senior Services and Occupational Safety and Health Administration.

"I was told by Saint Luke’s leadership that (operating room) surgeons did not want to use anything else and didn’t like the newer versions of the instruments," Bell wrote in the complaint. "As a result, patients undergoing surgery at Saint Luke’s are treated with chipped, rusty, cracked, dull, broken, obsolete, and bent instruments."

There's also a concern by Bell that patients can be physically harmed during surgery.

According to Bell, some tools need to be sharpened after each surgery or the equipment will become dull.

"When it's used on the next patient it will tear the tissue not cut it, which harms the patient," Bell said. "There were many instances of that occurring where it would tear the tissue and not cut it."

Bell said she also encouraged surgeons to discontinue use of "custom-made instruments."

"It's not FDA cleared, therefore we did not know if the instrument could be properly cleaned or sterilized," Bell told the I-Team.

Bell warned of similar issues in her complaint.

"Because these instruments have no manufacturer instructions for use (IFU), there are no validated cleaning and sterilization instructions to ensure the instruments can be properly reprocessed for use on patients," she wrote.

Bell also said the hospital is supposed to have a system that tracks what pieces of equipment are used for each patient, in cases where a sanitation breach occurs.

"Saint Luke’s OR leadership and staff refuse to track instrument use to the patient level for adequate reporting of breaches in sterilization practices; they say they do not have time to scan these items into the tracking system," Bell noted in the complaint. "Saint Luke’s also refuses to notify patients once breaches in sterilization are identified."

Saint Luke's denies the claim by Bell, adding the hospital does have as system to track breaches in sterilization.

Bell said there are also concerns about general sanitation outside of equipment.

She provided the I-Team with a video that shows a cockroach crawling outside of a door that Bell said is to the hospital's operating room.

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Footage of a cockroach outside of a Saint Luke's Operating Room.

Another video shows an insect in what Bell said is the hospitals sterile storage room.

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In her complaint, Bell writes, "Saint Luke’s OR fails to provide a clean, safe, and sanitary environment due to broken and damaged OR equipment and a well-known pest problem. Broken and malfunctioning lithotripsy equipment, booms, camera towers, lighting, water leaks, and air handler issues were everyday occurrences. One pest control technician confirmed the existence of a cockroach problem at Saint Luke’s for years. I have documented roaches in the OR, OR hallways, patient hallways, sterile supply area, linens, SPD, instrument trays, elevators, pre-op rooms, and surgical waiting rooms."

On Tuesday, the hospital told the I-Team it's not aware of any pest control issues.

Gold seal of approval

Saint Luke's is the Kansas City area's largest health care provider.

The Joint Commission has given the hospital as a whole a gold seal of approval, along with various other gold seal accreditations.

The last Commission survey conducted on the hospital was in October 2022.

The Joint Commission lists a number of goals for Saint Luke's, which includes reducing site infections during surgery.

However, the reports that are publicly available are vague.

The I-Team asked Saint Luke's for a copy of the survey and deficiencies noted but were not provided the documents.

Saint Luke's invites I-Team into sterilization room

Saint Luke's denies all of Bell's accusations, saying her claims are not in line with the hospital's rigorous sterilization processes.

Laurel Gifford, spokeswoman for Saint Luke's, invited the I-Team inside the hospital's new $8 million sterilization department. After Tuesday's tour, Dr. Michael Main, spoke with reporters. Dr. Main is a practicing cardiologist and is CEO of Saint Luke's Physician Group.

Dr. Michael Main weighs in on complaint

"Anytime a claim is brought forward, of course we’re concerned. We take it very seriously. And we should," Dr. Main told reporters. "I am completely satisfied with the processes that we have in place and that’s what we are doing today because we wanted to demonstrate you what actually occurs here on an every day basis."

Saint Luke's showcased a process that takes several hours and has multiple safeguards, that includes high temperatures washing and inspections.

Gifford said the hospital follows standards with Association of Operating Room Nurses, Association for the Advancement of Medical Instruments and Healthcare Sterile Processing Association.

"What we have here is a culture of safety, a culture of transparency, and I think you saw the transparency today, evidenced by the fact that we invited all of you in here, you got infinite access to our sterile processing procedures and you saw nothing of the sort. That’s how we operate every single day," Dr. Main said.

In addition, the hospital provided KSHB 41 with a fact sheet for its sterile processing department.

You can view the link below:

LINK: Saint Luke's Sterile Processing Department Fact Sheet

Lisa McCormick, KSHB investigative producer, showed a doctor Bell's pictures of a dead fly on what Bell said is a sterilized cart with other equipment.

Saint Luke's said it could not confirm if the image was taken inside its hospital.

"This just doesn't make sense and it's not consistent with anything you saw today certainly, or anything I've experienced in 25 years here," Dr. Main said.

The hospital released the following statement, which reads in full:

"Since this is a personnel matter, we cannot comment on this situation. We can share that quality, patient safety and clinical excellence are, and have always been, top priorities of Saint Luke’s Hospital. We are proud of our rigorous sterilizing process and the experts who collaborate closely every day to ensure our patients are safe.

Our organization’s core values include transparency and a culture of advocating on behalf of patients and patient safety. At Saint Luke’s, we encourage everyone — regardless of their role — to speak up if there is an issue that needs to be addressed, as we want to take action to resolve any issue as quickly as possible. This is deeply rooted in our organizational DNA.

In January 2023, we opened a new $8 million state-of-the-art sterile processing department. Since 2021, Saint Luke’s has invested approximately $7.5 million in instrument replacement and continues to replace or add instruments, as needed. We also follow a rigorous 14-step process for sterilizing, which is based on national best practices.

In addition to our rigorous processes and protocols, we have multiple quality and safety checkpoints, including daily safety huddles and a multi-disciplinary team in the OR setting who inspect the instruments, with our surgeons as the final safety net in that process.

Saint Luke’s is fully accredited by the Joint Commission, has a 5-star rating from Centers for Medicare and Medicaid Services (CMS), and received an “A” grade in safety from the Leapfrog Group for spring 2023.

Saint Luke’s is in compliance with regulations and guidance of The Joint Commission (TJC), Centers for Medicare and Medicaid Services (CMS), Centers for Disease Control and Prevention (CDC), Association for the Advancement of Medical Instrumentation (AAMI), and the Association of periOperative Registered Nurses (AORN)."


Surgeon's email

Bell said her concerns over sterilization policies often led to frustrations, that surgeons refused to comply with her recommendations.

Through Bell's attorney, Ryan McClelland, of McClelland Law Firm, the I-Team obtained an email McClelland said is between a surgeon and another Saint Luke's employee.

"I had an almost two hour turnover between my robotic cases on Thursday," the surgeon wrote in an e-mail dated May 16, 2023. "I believe this is largely because of the burden of cleaning instruments that has been placed on the surgical tech staff."

The surgeon goes on to say, "I have inquired as to whether this practice is required from OR directors at other institutions. They have indicated to me that the standard is to rinse lumens of instruments and spray them down so they stay damp to sterile processing. We cannot have our techs spending 20-30 minutes pre-cleaning instruments. It leads to inefficiency, patient and staff dissatisfaction and ultimately decreased revenue. We need to have a tenable solution to this problem."

The surgeon finishes by saying, "Obviously this is a multi-factorial problem, but I think we are all committed to giving our staff and patients the best environment to give and receive care."

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In a different email provided to the I-Team another surgeon emails the director of surgical services and writes, "Longer turnovers have been the frustration of several surgeons as of late (myself included-Except for yesterday my room was fantastic).

The surgeon goes on to say, " We're the only facility that cleans the instruments in the room."

The director of surgical services responds, "Cleaning instruments in the room at point of use has been a regulatory requirement for at least 10 years and unfortunately not fully adopted and implemented at Saint Luke's Hospitals."

Fired for complaining, according to Bell

Ten months into the job, Bell claims she was fired for complaining about what she describes as mistreatment of staff.

Bell also claims women were treated less favorably than men.

Bell said she also regularly voiced her concerns about her claims of unsanitary conditions, which drew the ire of operating room staff.

"This is just a classic example of retaliation," Bell's attorney told the I-Team. "Firing an employee for reporting patient safety concerns is a violation of federal and state law."

Though Bell has only filed a complaint with The Joint Commission, Missouri Department of Health and Senior Services (MDHSS) and OSHA about her claims of unsanitary conditions, she plans to sue Saint Luke's for discrimination and retaliation.

"Their reputation in the community, they're supposed to be the best place to give and receive care and they pride themselves on having a culture of kindness," Bell said. "I did not experience a culture of kindness."

Bell said she's worried about patients.

"It can be hard to sleep at night when you've seen the things I've seen and you've gone through the things I've gone through," Bell said. "It changes you. It's very discouraging."

The I-Team contacted MDHSS about Bell's claims. Lisa Cox, spokesperson for MDHSS confirms Bells complaint against the hospital is under review.

Maureen Lyons, spokeswoman for TJC acknowledges the commission also received Bell's complaint.

Read Lyon's response below:

I contacted The Joint Commission’s Office of Quality and Patient Safety (OQPS) about the event you shared about HCO 8351, Saint Luke’s Hospital, Kansas City.  OQPS responded that an event matching the description you provided was reported to The Joint Commission, and OQPS subsequently opened an incident report based on the allegation provided and followed its usual processes for these types of events. 

The Joint Commission assesses all reports of concerns relating to patient safety and quality and carefully evaluates whether or not a report describes unsafe conditions or incidents which have reached a patient. Based on an analysis of the risk of harm inherent in the report, action may be taken, including:

  • If the situation raises concerns about a continuing threat to patient safety, then The Joint Commission may conduct a for-cause evaluation of the organization.
  • The organization may be requested to provide a response to the concern.
  • If the health care organization is scheduled for its routine accreditation survey or certification review in the near future, then the concern may be reviewed at that time.
  • The details of the concern are incorporated into a database used to monitor patient safety and quality issues and track trends at Joint Commission-accredited or certified health care organizations.
  • Failure to address the concern may potentially adversely affect a health care organization’s accreditation status.

Joint Commission’s Office of Quality and Patient Safety receives notification of patient safety concerns from a variety of sources including organization self-reports, federal and state agencies, media coverage or reporter inquiries. The sources of information reported to The Joint Commission are confidential in order to encourage candor in reporting.

Please understand that Joint Commission accreditation is voluntary – our organization is not a regulator and cannot mandate hospitals and other health care organizations. Because Joint Commission accreditation is voluntary, there is some information we keep confidential about health care organizations.