State regulators who last week cited the Detroit Medical Center for lax training failed to find problems with dirty surgical instruments during an inspection last year — even as surgeons were complaining to hospital officials about them, records show.
The Detroit News has obtained inspection reports — and internal hospital records — showing that issues with the delivery and cleaning of surgical instruments were occurring amid the Feb. 18 and Feb. 19, 2015, state inspection of sterilization facilities that serve five Midtown hospitals.
On the second day of the inspection, an entire set of instruments wasn’t delivered for surgery. Earlier that week, Children’s Hospital of Michigan surgeons reported to hospital administrators they found unclean clamps, scissors and needle holders, missing parts to a high-speed drill and rust on surgical tools used for heart surgery, according to internal DMC reports.
State inspectors never checked to see if instruments were properly sterilized during the routine inspection, though, because they received no complaints indicating there was a problem, said Larry Horvath, director of the state’s Bureau of Community and Health Systems.
“There’s always a limitation on what we can find because of duration of inspections,” Horvath said. “We are talking about a large institution with thousands of employees. It is a snapshot in time. We try to do as much as possible.”
The revelation comes as some industry and community leaders question the breadth of the state’s investigation into the DMC following a Detroit News series documenting 11 years of internal complaints about dirty instruments that complicated operations from brain surgeries to spinal fusions, kept patients under anesthesia unnecessarily and led to cancellations of dozens of operations.
After a two-day inspection in late August, the state Department of Licensing and Regulatory Affairs (LARA) on Thursday cited the DMC for violating the Public Health Code by failing to ensure adequate training for sterilization workers. The state issued eight violations and gave the DMC 60 days to fix them or face possible discipline including license suspension.
The DMC is allowed to continue surgeries during that time. It issued a statement on Thursday saying it plans to “take all actions necessary” to fix the issues.
Jason Moon, communications director for LARA, said regulators found no evidence patients are at immediate risk. He said the investigation included an inspection of surgical tools and complaint logs.
The state also conducted an investigation on behalf of the federal Centers for Medicare and Medicaid Services. That agency’s report, which focuses on clinical issues related to sterilization, is not yet public.
The investigation on Friday became an issue in the race for the state House’s 1st District, which covers part of Detroit, Harper Woods, Grosse Pointe Woods and Grosse Pointe Shores.
Republican challenger William Broman criticized the state’s lack of immediate action, citing photos that accompanied The Detroit News stories of instruments covered in bone fragments that were delivered to operating rooms and marked as sterile.
“I would not feel comfortable having any member of my family in an operating room with the possibility that an instrument like that gets used,” Broman said in a statement, adding “Detroit’s children and parents deserve better than mediocrity.”
Incumbent state Rep. Brian Banks, D-Harper Woods, said he’s met with hospital officials about the “serious” problem and “has all faith and confidence the DMC will address the issue comprehensively and correctly.”
The latest investigation came about 11/2 years after regulators paid a visit to DMC sterilization facilities.
That inspection was part of a survey of Harper Hospital, which is amid an ongoing $25 million expansion of operating rooms. That hospital is served by a Central Sterile Processing Department in the basement of Detroit Receiving Hospital that also cleans tools and assembles them into sets for Children’s, DMC Heart and Hutzel Women’s hospitals.
Unlike complaint-driven inspections, the survey was broad in nature and concluded Harper was “well maintained.” It did find fault with sterilization facilities, though, finding seven deficiencies, according to the March 16, 2015, inspection report obtained by The Detroit News through the Freedom of Information Act.
The facility was too humid. Staffers entered the room without protective gear to ensure equipment stayed sterilized. A wall was removed as part of the construction project that separated clean and soiled equipment. A sink in a decontamination room lacked caulk. A ceiling was water damaged. The floor was chipped. And staffers used panic bars to open doors because it took too long to open with the air-door lock.
Separately, none is a huge issue. Together, they point to big problems, said Chicago-based surgical instrument designer Jim Schneiter.
Humidity increases the risk of waterborne pathogens remaining on equipment. Workers in street clothes could bring germs. A sink and broken floor are “breeding grounds for mold and spores,” he said.
“The totality of all those little pieces is indicative of a lack of managerial concern for sterile processing at the hospital,” he said.
“Too many things should have been corrected and should not have been present in the hospital in those areas.”
Schneiter faulted state inspectors for failing to inspect surgical instruments but acknowledged “odds of opening trays and finding contaminated instruments are pretty thin.”
Horvath said inspectors typically don’t open surgical kits unless there is a complaint.
One DMC surgeon told The Detroit News doctors have had issues with tools for years, but never complained to the state because they feared job reprisals from the DMC. The state accepts anonymous complaints, but those don’t provide an opportunity for follow-up, Horvath said.
The DMC was given time to fix the issues cited in the report, according to the report. All were fixed except the floor, which the report noted was also an issue in a 2014 inspection. There are plans to replace it, the report showed.
Less than a week after the state inspectors visited the DMC, doctors were again sending photos to hospital officials of dirty equipment delivered to operating rooms and marked as sterile, according to the internal records.
State Sen. Curtis Hertel Jr., who has been critical of funding levels for state inspections, said the DMC’s recurring issues “point to a problem with the state of regulations” in Michigan.
“When you don’t have the proper number of staff, it’s difficult to do due diligence that’s required,” said Hertel, D-East Lansing, minority vice chairman of the Senate Health Policy Committee.
State regulators typically respond to complaints within two working days if there is “possible immediate harm to residents/patients,” Michael Loepp, a spokesman for LARA wrote in an email to The Detroit News. Otherwise, the state responds within 45 days, he said.
Loepp said the state has about 25 inspectors trained to inspect hospitals.
He said he couldn’t provide exact numbers showing how that has changed in the past six years.