Joe Mullany, CEO of DMC, said the issues identified by LARA and CMS are correctable. "None involve direct patient safety. None of our patients were in immediate jeopardy," he said.
The LARA inspection was prompted by a six-month investigation and Aug. 26 report by The Detroit News that found various problems in the sterile processing department over an 11-year period that led to dozens of surgeries being postponed.
Mullany said DMC did not experience a drop in surgery volume in August or September at its hospitals. He said only five people questioned whether to go forward with their surgeries, and only one decided against, for reasons other than news articles outlining problems.
One deficiency, on Aug. 29 at 11:35 a.m. during an interview with surgical staff, noted the following concern of dirty instruments, a key infraction noted by inspectors: "During setting up of surgical instruments on the sterile back table before surgery (a surgical staffer said): 'I always check inside (holding up hollow instrument). I've had it come up dirty before. The drill guide needs to be taken apart and cleaned inside. I always check it. Blood that's been through the autoclave (sterilizer) is easy to see because it's black.'"
Another broad deficiency, noted by LARA, was described this way: "The hospital must provide a sanitary environment to avoid sources and transmission of infections and communicable diseases."
The CMS report said "this condition is not met as evidenced by ... observation, interview, and document review." Infection control officers on duty in various surgical areas "failed to implement aseptic cleaning procedures between surgeries" and "failed to ensure staff received education and were deemed competent in infection control policies and procedures."
As a result, DMC staff created a "potential for unsatisfactory patient outcomes for all surgical patients served by the facility."
Suzanne White, M.D., DMC's chief medical officer, said a review of surgery cases found that patient care and safety were not jeopardized because of the deficiencies.
"(CMS) said 'potential for.' They did not see any immediate jeopardy of the patients," White said.
Larry Horvath, director of LARA's bureau of community and health systems, said state inspectors did not view an immediate patient danger at the time of the inspection. If they had, Horvath said steps could have been taken to protect the public.
"We would not have left that site until that risk is removed," Horvath said.
Another deficient practice in the perioperative department was lack of precleaning surgical instruments in the operating rooms before they were taken to sterile processing.
"After surgery, instruments contain blood and tissue. In the best of worlds, precleaning those instruments in the OR helps the process," said Terri Dyke, LARA's state health facilities licensing director. "If you don't do it right way, (the blood) tends to dry (on the instrument)."
Dyke said DMC was inconsistently using precleaning processes in the ORs.
According to the deficiency report, "On 8/29/16 at 10:30 a.m., during a tour of (DMC's downtown) central sterile processing department, a tray of dirty instruments was observed with dried blood on the instruments in the decontamination side of the department. In an interview with Staff Q, he stated that the new CSP management is in the process of revising the policy."
White said a precleaning policy in the operating room is nearly in place.
"We will do more precleaning in the OR after the operations," Mullany said.
LARA's inspection Aug. 29-30 of DMC's downtown sterile processing department also found various state health code violations. DMC expects to submit the separate corrective action plan on those issues to LARA later this week, said Mullany, noting that most improvements have already been made.
The state inspection report, released Sept. 15, covered employee and management training problems and lack of required documentation.
DMC also has promised to meet every other week with LARA officials to discuss progress the hospital system is making in improving sterile processing and taking corrective actions.
In June, DMC hired Unity Health Trust, an Alabama-based management company, to manage its sterile processing department at all of DMC's hospitals, not just the downtown Detroit hospitals cited by LARA and CMS.
Despite the infractions, lack of management oversight and training, Mullany said no one has been fired related to the problems.
"We have always continued to invest in our CSO and perioperative departments," Mullany said. "We hired eight people to fill those positions (to add to the unit's 82-member workforce) ... and are buying new instruments to replace what's broken. Each year we clean 10 (million) to 15 million instruments."
In addition, a consultant hired by DMC and overseen also by LARA is expected to start work next week to oversee improvements in sterile processing department, which serves Detroit Receiving, Harper University, Hutzel Women's and Children's hospitals.
"(CMS) reflected a lot of technical points in areas we need to do additional training and competency assessments," Mullany said. "The findings related to direct observations as well as documents. We are working on a robust action plan. We completed (most of the corrections). We have a few remaining elements to complete before the (follow-up) survey."
White said the corrective action plan is a very complex process that involves improvement in precleaning, training, auditing and education.
Mullany said the Joint Commission, which accredits DMC and more than 3,500 other hospitals, recently completed its audit and found no problems.
At the time of the inspections Aug. 29-30, LARA reported that inpatient census at Detroit Receiving Hospital was 230 patients. There were eight surgical suites and three procedure rooms being used for 35 surgeries on Aug. 29 and 22 on Aug. 30.
