Michigan regulators are reviewing whether to reopen an investigation of the Detroit Medical Center after a filthy surgical tool interrupted an operation just one day after the state ended its probe of dirty instruments at the system, The Detroit News has learned.
Officials with the Department of Licensing and Regulatory Affairs notified the DMC on Dec. 22 it was no longer in violation of eight health codes, concluding a three-month investigation prompted by a series of articles in The News exposing a decade of complaints about dirty instruments at the five hospitals of the DMC’s Midtown Detroit campus.
The next day, a laparoscopic grasper caked with old blood and brown ooze was marked as sterile and delivered to a Children’s Hospital of Michigan operating room for pediatric surgeon Dr. Scott Langenburg. The instrument was intercepted and replaced before it could be used during gall bladder surgery on an 18-year-old Armada woman.
The state is reviewing the incident, said Jason Moon, communications director of LARA, the state department that includes the Bureau of Community and Health Systems that conducted the DMC investigation.
“Once the bureau’s thorough review of the information is complete it will determine the next course of action,” wrote Moon — who did not answer follow-up questions — in an email to The News.
The revelation coincides with the abrupt departure of Joe Mullany as CEO of the eight-hospital system. The DMC’s for-profit owner, Tenet Healthcare, announced Tuesday he was out and had been replaced by Dr. Anthony J. Tedeschi, who had served as CEO of the corporation’s four-hospital Chicago Market and as top executive of Weiss Memorial Hospital.
There’s no indication Wednesday the filthy instrument, which the state learned of last Friday, had anything to do with Mullany’s exit. DMC and Tenet officials did not respond to requests for comment beyond a written statement saying Mullany “left the organization to pursue other opportunities.”
The discovery of the soiled instrument has prompted questions about the DMC’s efforts to fix a decade-in-the-making problem in a few months.
Amy Hicks, the mother of the 18-year-old whose gall bladder was removed after the instruments were exchanged, said she was outraged.
“It wasn’t used on her, but that didn’t make me feel any safer that the instrument that was used came off of the same tray,” Hicks said of her daughter, Melissa. “I was kind of dumbfounded. It’s just amazing that they said they had the inspection the day before, but yet the following day of my daughter’s surgery — it just, it didn’t make sense.”
Hicks said Langenburg, the surgeon, gave her photos of the dirty instrument, which she shared with The News. Langenburg wouldn’t talk specifically about the patient or the procedure, citing privacy concerns, but said he reported what happened during the surgery to hospital officials.
DMC “self-reported” the incident to LARA 21 days later, Moon said.
The DMC acknowledged it notified the state because Hicks posted a comment complaining about the dirty instrument on a detroitnews.com story about the conclusion of the state’s investigation.
It issued a statement saying "as part of our ongoing performance improvement efforts, we are reviewing the circumstances surrounding the event."
Donna Swenson, president and CEO of Sterile Processing Quality Services Inc., an Illinois-based company that consults hospitals about instrument cleaning, said the discovery of the dirty instrument is a major red flag, indicating that other tools at the hospital also could be contaminated and that staffers may be cutting corners because they’re under pressure to quickly clean and assemble tools into surgical sets.
“It’s obvious that the changes have not become ‘the way things are done’ at the DMC,” said Swenson, who examined a photo of the instrument at the request of The News.
“An instrument that is grossly dirty like this should never happen.”
Criticism of investigation
The News investigation focused on a sterilization department in the basement of Detroit Receiving Hospital that cleans and assembles into surgical sets thousands of instruments per day for the hospitals of the DMC’s Midtown campus, which includes Children’s, Receiving, Harper University, Hutzel Women’s and DMC Heart hospitals.
LARA regulators conducted an investigation into dirty instruments at the hospitals on behalf of the U.S. Centers for Medicare and Medicaid Services. That agency, which oversees the approximately $700 million in federal funds that go to the DMC per year, threatened the DMC with loss of funding before deeming it back in compliance with federal standards in November.
The same state regulators in 2015 found no evidence of problems with tools during an inspection of the DMC’s Midtown campus, even as doctors complained to administrators about unsterile instruments. The leader of both state and federal probes — Larry Horvath director of the Bureau of Community and Health Systems — acknowledged in an email that his staff’s “expertise is limited” in investigating dirty instruments, The News reported in November.
As of Wednesday, a nonprofit organization, the Joint Commission, which provides the accreditation of hospitals had not provided details, requested by the News in November, about its review of specific instrument-related incidents at the DMC. The commission is not subject to state or federal Freedom of Information laws because it is not a government agency.
The short duration of the DMC investigations dismayed Marjorie Mitchell, executive director of the Michigan Universal Health Care Access Network, a coalition of Metro Detroit health advocacy groups. She said she thinks more oversight is needed.
“I was extremely disappointed that (state and federal regulators) would just close it out,” Mitchell said. “That kind of situation required supervision over a very long period of time.
“There has to be at least a substantial period of time where there is no problem reported by surgeons, their families or the inspectors, in order to know that problem is fixed.”
‘An issue at every hospital’
Hicks said she wasn’t aware of the DMC’s issues with instruments before her daughter’s surgery.
“Mistakes like dirty instruments shouldn’t happen — mistakes like this that could result in death,” she said.
Langenburg voluntarily informed Hicks about the blood-stained instrument. Michigan is not among the 28 states with laws requiring doctors to notify patients if something goes wrong during surgeries.
“Whenever I operate on a patient, just as I expect them to be very transparent with me about what their issues are ... I am transparent with them about anything that comes up in my operations,” Langenburg told The News.
He credited the vigilance of operating room staff for flagging the dirty instrument before it could reach the patient. He said surgeons and technicians must double check to make ensure instruments are cleaned properly, no matter where they work.
“This was something that the institution’s continue to try to work on,” he said. “I have privileges at lots of other hospitals, and it’s an issue at every hospital that we work at. It’s just that it’s not talked about.
“All the instruments are checked before we use them, and if they’re not satisfactory they’re removed and you start over. Fortunately people are vigilant, and were vigilant, about checking these things before we even started.”
Since this fall, the DMC has implemented numerous changes to its sterilization procedures. Among other things, it’s formed committees to reform instrument cleaning, revamped policies, hired more sterilization technicians and outsourced management of the sterilization department.
The DMC also hired a monitor, Clean Start Surgical of Plymouth Township, that reviewed its operations and reported to the state. The consultant was on site for four days, most recently Nov. 17, and is no longer monitoring the DMC.
Clean Start’s final, nine-page report to the state noted the DMC had several problems including outdated sterilization washers, equipment shortages and delays in delivering soiled instrument trays from operating rooms that can make cleaning more difficult.
But it concluded the DMC was making progress to fix the issues.
Ryan Jankovic, CEO of Clean Start, told The News the company was hired to observe the DMC and provide a “very basic overview of sterilization.” It made no recommendations on whether the DMC was complying with public health codes.
“We were not asked to do an extensive review or audit of those operations,” he said, adding the company told state officials “if you’d like to do a deeper dive with our expertise, we could do it.”
Donna Stern, unit chairwoman of Local 140 of the American Federation of State, County and Municipal Employees, one of four locals that represent sterilization employees, said many of the changes put in place at the hospital are cosmetic.
New sterilization technician hires are temporary workers, she said, adding that promises to invest in new equipment at the hospitals to address an instrument shortage haven’t materialized.
“They still have an inadequate number of instruments, broken case carts and disposable supplies,” Stern said.
“They (union members) feel like being put between a rock and a hard place. On the one hand, they can’t take too much time assembling each (surgical) tray but they don’t have enough instruments, so they’re (threatened with disciplined) if the carts are missing instruments. It’s damned if you do, damned if you don’t.”
The hospital system has maintained no patients have been harmed or infected because of dirty instruments and has declined to release confidential records to prove the contention.
Twitter: @kbouffardDN, @joeltkurth