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Michigan regulators on Thursday cited the Detroit Medical Center for violating the state’s Public Health Code because of difficulties sterilizing surgical instruments, a probe that was sparked by a Detroit News investigation.

The investigation by the state Department of Licensing and Regulatory Affairs concluded that technicians in the Central Sterile Processing Department that services five Midtown hospitals aren’t properly trained and don’t work well with operating room personnel. The DMC has 60 days to submit a plan of correction.

State investigators took no immediate steps to ensure instruments are currently being cleaned properly. The state plans to meet soon with the DMC to “discuss remedies to address these findings,” said Jason Moon, communications director for LARA. Noncompliance could result in a host of penalties, from fines to license suspensions.

“The findings do show systemic problems with proper processing of instruments, but not to the nature that poses an immediate risk to ongoing surgeries,” Moon wrote in an email.

In a statement released late Thursday, DMC said: “We will take all actions necessary to correct the findings and based on the results of the survey, we believe the community should continue to have confidence in the care they receive at DMC.

“We also will work diligently to ensure that our actions are sustained. Nothing is more important to us than the safety and quality of the services we provide.”

The inspections that led to Thursday’s report were conducted in conjunction with an investigation on behalf of the federal Centers for Medicare and Medicaid Services. That agency’s report, which will focus more on clinical issues related to sterilization, is not yet complete. Its officials didn’t respond to a request for comment Thursday.

The probe followed a Detroit News series in late August 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.

The articles were based on 200 pages of internal emails and incident reports that showed doctors feared for patients’ safety because of unsterile, broken or incomplete instrument sets. As recently as last summer, Children’s Hospital of Michigan chief surgeon Joseph Lelli wrote in an email that “we are putting patients at risk frequently.”

The problems stem from the sterile processing facility in the basement of Detroit Receiving Hospital that processes thousands of instruments per day for Receiving, Children’s, Harper University, Hutzel Women’s and DMC Heart hospitals. A team of state inspectors toured the facilities over two days in late August and found eight violations.

“The CSP Department does not have a robust, consistent, repeatable, comprehensively documented, and well maintained training system for new and existing employees and management,” the LARA report read.

The report also found that “there appeared to be a lack of collaborative sharing, communication and process consistency between the operating rooms and the CSP Department.”

The state found that employees routinely are absent from training sessions. At one, 74 employees were supposed to attend but 28 did not show up. At another session, only half of the 80 employees attended.

On June 1, the DMC contracted with a private company, Unity HealthTrust of Alabama, to manage the department. State investigators interviewed two Unity officials who acknowledged they had yet to evaluate the staff and procedures or looked at employee files. Nor did they have a timetable for implementing changes or plan an assessment of employee capabilities, according to the report.

What’s more, the president of Unity, Roger Pugh, told investigators he spent 80 percent of his time at the DMC’s Sinai-Grace Hospital — 11 miles away from the facilities he was supposed to fix.

Disappointing findings

Surgeons, staffers and patients had been awaiting the LARA findings. Some said they were disappointed it focused mostly on training.

“I just want to see the problem corrected. That is the bottom line,” said one longtime doctor, who requested anonymity in fear of job reprisals.

Jim Schneiter, a Chicago-based instrument designer and expert on sterile processing of surgical instruments, said a two-day inspection isn’t enough evaluate the depth of problems at the DMC.

“That’s not an inspection, that’s a visit,” Schneiter said, adding there are a range of actions LARA could have taken, such as suspending surgeries.

The Rev. Horace Sheffield III called the findings a “slap on the wrist.”

“That this went on for so long indicates institutional neglect,” said Sheffield, chief executive officer of the Detroit Association of Black Organizations Inc., whose father once served as board chairman of Detroit Receiving.

More training needed

The News’ series featured the story of Kalaya Hull-Mason, who was 7 months old last year when her open heart surgery at Children’s Hospital was complicated because of a clogged tube. When a technician removed it from Kalaya and inserted a wire brush, “copious amounts” of blood from a previous patient gushed out.

The mishap caused significant delays in the surgery, requiring staffers to take down and rebuild the sterile field. Had the blood come into contact with Kalaya, it could have caused an infection or worse. A sterile technician had signed off on the instrument as clean.

The girl’s father, Laron Mason, expressed outrage after learning of the state’s findings Thursday from The News.

“How are they able to still do surgery after that?” said Mason, 21.

Union leader Donna Stern, who went public this week about longstanding worker complaints about training and staffing, said she wished the report went further. The sterilization department has about 70 employees who process thousands of instruments and is beset by high turnover because it is “extremely hard labor,” Stern said.

“We agree training is needed, but it’s just not sufficient. We have to hire more staff,” said Stern, unit chair of the American Federation of State, County and Municipal Employees Local 140, which represents 250 workers at Children’s Hospital including a quarter of the Midtown campus’ 70 sterilization technicians.

Leah Binder, president and CEO of Leapfrog Group, which publishes national safety ratings for hospitals, said the DMC must “become safe and they have to do it now.”

Michigan House Speaker Kevin Cotter, R-Mount Pleasant, is “going to keep a close eye on the results of these investigations and on the DMC’s response,” his spokesman, Gideon D’Assandro, said in a statement released late Thursday.

JKurth@detroitnews.com

Twitter: @joeltkurth

kbouffard@detroitnews.com

Twitter: @kbouffardDN

Major findings

■The CSP Department does not have a consistent and well-maintained training system for new and existing employees and management.

■Training sessions weren’t well attended and seldom was subject matter available for review.

■Competency or training levels were not factored into staff performance evaluations.

■ Collaboration and communication between the CSP department and the operating room staff was lacking.

Read more LARA findings inside, 7A.

Among the findings

■ The CSP Department does not have a robust, consistent, repeatable, comprehensively documented, and well-maintained training system for new and existing employees and management. Any evidence of training of employees and competencies on general and specific processes were listed on sign-in sheets printed and placed in either binders or folders for the corresponding year. ... The majority of the training subject matter was unavailable, unable to be located, or not in the control of DMC or the CSP Department.

■ DMC and the CSP Department did not have a system or process in place to offer training to employees that did not appear to sign in and attend the initial training, nor did the CSP Department outline a system of training for new employees. Follow-up training was also not offered at a later date.

■ CSP staff received training or held in-services 18 times in 2016 on subjects related to instrument inspection, cleaning, and processing. Only two of the 18 training seminars had the associated subject matter attached or available for review. Evidence of the pertinent training subject matter was either unavailable, not on the DMC premises, or remained in the control of medical equipment suppliers and unavailable at the time of the investigation.

■ There appeared to be no consistent process or procedure for employees across the board, nor was there proof of employees with the same job title receiving the same level of CSP training. Furthermore, employee Job Performance Evaluation Worksheets either lacked statements pertaining to the employees’ competency or training level ... (or) there was no evidence of the process, training for the process, or whether or not that process was consistently repeated with similarly skilled and classified employees.

■ There appeared to be a lack of collaborative sharing, communication, and process consistency between the operating rooms and the CSP Department. Christina Gravalese, the interim administrative director of perioperative services at DMC stated, “CSP handles their own training.”

Full DMC response

LARA completed a two-day survey of surgical instrument processing at DMC’s Midtown campus on August 30. Today, we received the results of the survey, which include some findings requiring corrective action by the hospital. We have already taken many actions to address the findings, including leadership and structural standardization, improved education, training and competency documentation, improved auditing and event monitoring. This will be documented in a comprehensive plan of correction we will submit to LARA. Once the authorities have had an opportunity to review and approve our corrective actions, we will make these plans public on our dedicated webpage. We look forward to collaborating with LARA to address all findings raised during the survey.

We will take all actions necessary to correct the findings and based on the results of the survey, we believe the community should continue to have confidence in the care they receive at DMC. We also will work diligently to ensure that our actions are sustained. Nothing is more important to us than the safety and quality of the services we provide.

Detroit Medical Center

About this series

The Detroit News spent six months investigating complaints about instrument sterilization at the Detroit Medical Center. The project involved more than 200 pages of confidential emails and hospital reports, as well as interviews with five dozen doctors, patients, administrators and experts.

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