Dirty instruments cause second DMC hospital to fail federal inspection

Karen Bouffard
The Detroit News
Detroit Receiving Hospital is under inspection Wednesday after it failed a federal review in October when investigators found multiple cases involving contaminated instruments and other infection control violations, according to an inspection report released by the federal government Wednesday.

Detroit Receiving hospital stopped surveillance of most surgical site infections due to staff cuts in 2018, including for patients exposed to dirty surgical instruments, according to a report released Wednesday that details why the hospital failed federal inspections.

The federal Centers for Medicare and Medicaid Services ordered inspections Oct. 18 of Detroit Receiving Hospital and Harper University Hospital in October in response to physician complaints about quality of care issues at the Detroit Medical Center hospitals. Harper University Hospital also failed its inspection over problems with infection control that included flying insects found in the Intensive Care Unit there.

At Receiving, inspectors found that, with few exceptions, surgical site infections were monitored for a select group of surgeries where mandatory reporting of surgical site infections is required by the federal Centers for Disease Control and Prevention. Surveillance includes infection detection, data collection and analysis, monitoring, and evaluation of preventive interventions, according to the federal government. 

"There was no SSI (surgical site infection) surveillance documented for surgeries where contaminated instruments were entered on Adverse Event Reports," the report said. 

The federal agency has informed both DMC hospitals that they are now subject to unannounced inspections by the Michigan Department of Licensing and Regulatory Affairs. The DMC confirmed the state inspection at Detroit Receiving was already underway Wednesday morning. 

CMS has informed the DMC that federal funding for Harper and Detroit Receiving hospitals will be ended if the problems aren't fixed.

The two hospitals welcome the surveyors, who will "evaluate compliance with health and safety requirements," DMC said in a Wednesday statement.

"CMS specified in the letter that the hospital was not required to submit an action plan. Yet, to demonstrate its commitment to swift action, the hospital immediately implemented a comprehensive action plan and elected to share it with CMS and LARA in advance of the survey," the DMC statement continued.

The hospitals will continue to treat patients throughout the survey process, the DMC said, indicating surveyors have not yet arrived at Harper University Hospital.

"DMC remains committed to providing residents of Detroit with safe, accessible, quality care. This commitment is central to our mission and everything we stand for."

Continuing instrument issues

It's the second time in more than two years that the DMC has been threatened with loss of Medicare and Medicaid dollars over problems with dirty surgical instruments. 

A six-month Detroit News investigation published in August 2016 found the DMC had an 11-year history of problems with dirty surgical instruments at its five Midtown hospitals, endangering patients and causing surgeries to be canceled or delayed. The coverage spurred federal and state investigations that forced the health system to reconfigure their sterile processes.

A review of Receiving's infection control reports revealed that no infection rates were calculated for neuro-surgeries after Jan. 10, 2018.  The CDC requires that hospitals report infections related to a sampling of surgeries to the National Healthcare Safety Network, but neuro-surgeries aren't on that list.

Asked why infections weren't being tracked for neuro-surgeries, an employee told inspectors there were "structural changes in the hospital network resulting in staff layoffs, so administration instructed the Infection Control (IC) Department to only do surveillance for the healthcare acquired infections (HAI) that the hospital was required to report to NHSN (mandatory reporting requirement)," inspectors wrote in their report.

Read: DMC hospital may lose federal aid after discovery of infection-control issues 

The only infections reviewed or discussed at meetings of the hospital's Infection Control Program Committee were those with mandatory federal reporting requirements, inspectors were told. 

Minutes for one meeting noted that officials were considering changes in surveillance methods to reduce the facility's high rates of Catheter Associated Bloodstream Infections and Catheter Associated Urinary Tract Infections, both of which hospitals are required to report. "Looking at central surveillance definitions to make sure we are reporting appropriately," they said, adding that the math could be skewed by errors.

One administrator "denied that Administration was attempting to revise the definition of HAI (healthcare associated infection) in an attempt to lower infection," the inspectors wrote, adding there was no documentation of the hospital's actual surgical site infection rate, and no explanation of the possible math errors involved.

Inspectors reviewed the hospital's monthly Hospital Acquired Infection Reports from January through August 2018 and found that a rate of zero infections was recorded for some months, even though infections were cited in daily surveillance logs.

In February, the report noted a surgical site infection associated with one hysterectomy, a surgery with a mandatory reporting requirement. Infections in two patients who'd had lumbar-spinal surgery weren't mentioned in the report. In March, the notation said "SSI: None to report." But four surgical site infections were revealed in the daily logs. 

One staff member told inspectors "she did not realize that it was a national standard for Infection Control programs to identify high risk/high volume surgeries and do tracking and trending of SSI for these surgeries. Staff GGG was unable to explain why SSI surveillance was not periodically audited for surgeries with the types of instrument sets most frequently identified as having sterile (processing) problems."

Dirty instruments

In October, inspectors reviewed six cases of contaminated instrument events that occurred between Sept. 15 and Oct. 15 and concluded Detroit Receiving "failed to ensure that breaches in sterile processing of surgical instruments were documented, investigated and corrective measures implemented in coordination with the Infection Control Department" for two of the cases reviewed.

According to CMS regulations: "In order to prevent, control and investigate infections and communicable diseases, the hospital’s program must include an active surveillance component that covers both hospital patients and personnel working in the hospital." 

The DMC submitted a detailed Plan of Correction, saying it changed Receiving hospital’s Infection Control 2018 Strategic Plan and surveillance policies to follow nationally recognized guidelines from the CDC and other groups.

DMC officials streamlined communication about infections between doctors, departments and quality control personnel, and required monthly meetings of the Infection Control Committee, according to the health system.  

Receiving hospital countered the allegation that its officials have not been surveilling all surgical site infections.

"Identification, analysis and remediation activities related to SSIs was occurring; however, the information was not communicated through the Quality structure to the appropriate committees for review and action" according to the hospital's Plan of Correction. Beginning December, "Detroit Receiving Hospital Infection Control Committee will meet monthly to address results of surveillance, analysis of data, and review of actions.”

Among corrective actions already taken: “The Senior Director Quality Management educated the Infection Control Manager on the importance of minutes as an accurate reflection of decisions and the identification and tracking of action items; and that address conclusions, recommendation, actions and follow-up.”

Dirty, missing instruments plague DMC surgeries

At Harper in October, inspectors observed flying insects, improperly stored surgical instruments, filthy floors and other problems, and they determined that hospital staff and management were not following infection control protocols developed just over two years ago in response to revelations about dirty surgical instruments at the DMC's five Detroit hospitals.

"We have determined that the deficiencies cited are significant and limit your hospital’s capacity to render adequate care and to ensure the health and safety of your patients," the Centers for Medicare and Medicaid Services informed the hospital in a letter sent Nov. 7 and obtained by The Detroit News late Monday. 

The letter stated: "... Your hospital is no longer deemed to meet the Medicare Conditions of Participation."

The hospital inspections were conducted by LARA on behalf of the federal agency.

The reviews were triggered by reports in The News and other media that three cardiologists and the top doctor at DMC Heart Hospital were forced to resign after complaining about quality-of-care issues. Heart Hospital adjoins Harper and shares many of its facilities.

DMC's Children's Hospital of Michigan was also inspected in October in response to an unrelated complaint. Children's passed the inspection and was deemed compliant with federal regulations.

The report on Detroit Receiving Hospital:


The report on Harper University Hospital:


Twitter: @kbouffardDN