The state of Michigan and Detroit Medical Center agreed Friday to have a third party to monitor the hospital system’s cleaning of surgical instruments.
Under the agreement, an infection control and sterilization consultant will “validate” that DMC’s surgical instruments are clean and file reports with the state Department of Licensing and Regulatory Affairs (LARA) every 10 days on the system’s progress in correcting violations discovered during recent inspections. The DMC will pay for the consultant.
The action comes two weeks after state inspectors found the hospital in violation of the state health code because of lax training. The state’s investigation was prompted by a Detroit News series that documented 11 years of complaints about dirty, broken and missing instruments. The issues complicated operations including brain surgeries, heart repairs and spinal fusions, kept patients under anesthesia unnecessarily and led to cancellations of dozens of operations.
The DMC did not comment beyond a statement posted on its website. One observer said the agreement shows the state is serious about rectifying the issues.
“They need a neutral party, one who is not attached to politics or bickering, to make sure the problems are solved,” said Jahan Azizi, a retired clinical engineer for risk management at the University of Michigan and an expert on cleaning medical instruments.
“The state can’t send someone to watch every step, all the time, but they are saying to the DMC that ‘The clock starts now to fix these problems.’ They want the DMC to get its act together.”
As part of the deal, the state and DMC agreed to keep the consultant’s findings secret.
“Any findings, reports, documents, prepared or reported by the consultant, whether orally or in writing, including electronically, shall be held by the parties as confidential ... and not disclosed to anyone,” it reads.
Jason Moon, communications director for LARA, called hiring of a consultant an “additional action to ensure corrective steps are taken.” He said the company won’t be affiliated with the DMC and will be “decided by and under the direction of LARA.”
“The agreement is designed to assure the general public receiving surgical services at the downtown DMC facilities that steps are being taken to correct any deficient practices that were cited,” Moon wrote in an email.
The agreement was signed by LARA Director Shelly Edgerton. It reads in part that the deal “builds on the long-standing relationship between the Hospital and the Department in the pursuit of quality patient care.”
It wasn’t clear Friday when the consultant would come on board. The agreement calls for the consultant to remain until the DMC corrects eight health code violations cited by the state. The DMC has until mid-November to do so or face possible penalties, including fines or license suspensions.
“We will continue to aggressively monitor the DMC’s progress to ensure all violations of the public health code are addressed,” Moon said.
The announcement was cheered by Erica Mobley, director of communications for the Leapfrog Group, a national nonprofit that provides hospital quality data for consumers.
“It appears that DMC is actively working to remedy the significant problems with their sterilization unit that have posed serious risk to patients,” Mobley wrote in an email. “The hospital should demonstrate full transparency in communicating (its) corrective action plan to the public in an expedient fashion and this agreement seems to be a positive step forward in doing so.”
While the state cited primarily training concerns, state investigators also conducted an investigation into sterilization issues on behalf of the federal Centers for Medicare and Medicaid Services, a part of the U.S. Department of Health and Human Services. The DMC on Sept. 15 received the results of that probe, which focuses on clinical operations and infections.
Under federal rules, the Centers for Medicare and Medicaid Services can’t release the report until the DMC responds with a plan to correct any problems found. DMC could voluntarily make the report public, but has declined a request from The News to release it.
The parallel investigations focus on a Central Sterile Processing Department in the basement of Detroit Receiving Hospital, whose workers clean, sort and package thousands of instruments per day into sets for surgery at Receiving, Children’s, Harper University, Hutzel Women’s and DMC Heart hospitals.
In June, the DMC hired another company, Unity HealthTrust of Alabama, to manage the system’s sterilization workers. But state regulators faulted the company for failing to assess the competence of the DMC’s sterilization technicians or ensure they attend training.
Just last week, a doctor told The News he discovered a dirty instrument marked as clean during a routine surgery.
State Sen. Mike Shirkey, R-Clarklake, who chairs the Senate Health Policy Committee, said fixing the issues will require attentiveness.
“The most critical element is for full transparency in the entire organization including staff, and if anybody notices a breach in the process (that) they make management aware of it right away,” Shirkey said Friday. “It requires constant diligence to monitor it and I have every confidence that will be done at the DMC.”
The DMC has maintained that the appearance and even use of instruments that contained blood, bone or sutures from previous surgeries did not harm patients. Its leaders have declined interviews with The News since the series appeared in late August.
Last week, DMC CEO Josephy Mullany told WJR-760 that the DMC’s owner, Tenet Healthcare of Dallas, Texas, has flown in consultants to help fix sterilization issues.
He claimed that the more than 200 emails and internal records obtained by The News were sent following a DMC program that encouraged employees to file complaints about problems.
Mullany said he “applauds them for looking out for kids” but it’s “unfair it’s portrayed this way.”