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Children’s Hospital of Michigan failed a late January inspection conducted by the federal Centers for Medicare and Medicaid Services as part of a broad investigation into dirty surgical instruments at Detroit Medical Center hospitals.

An inspections sweep of three DMC hospitals and the Karmanos Cancer Center on Jan. 30 and 31 also found Karmanos was not in compliance with federal certification requirements. The cancer center, which is on the Midtown campus, is not part of DMC, but many of its patients are operated on at DMC’s Harper University Hospital.

Children’s and Karmanos have been given until May 23 to show they are in compliance with federal standards, or risk losing federal Medicaid or Medicare funding.

It was the second CMS investigation of DMC hospitals in six months. CMS and the Michigan Department of Licensing and Regulatory Affairs (LARA) launched investigations in early September in response to a six-month Detroit News investigation that revealed the system’s five Midtown hospitals had struggled for nearly a decade with dirty, broken and missing surgical instruments.

The health system failed the inspections at that time, but state and federal agencies closed their books on the case in December after the health system passed a surprise inspection.

A new investigation was launched by CMS in January after The Detroit News reported that a filthy surgical tool had interrupted an operation one day after the favorable inspection that ended its initial probe. That incident occurred at Children’s Hospital, which inspectors did not visit during their initial investigation despite numerous complaints reported by the News’ in August.

The 22-page report of the Children’s inspection in January details problems with dirty surgical tools that, together with a shortage of instruments and staffing issues, resulted in “delays in surgical procedures, patients being exposed to anesthesia for longer than necessary, increased flash sterilization and the increased potential for infection and negative patient outcomes for all surgical patients serviced by the facility.”

One employee told an inspector: “Within the last month there were several cases where no instruments were available to do the surgeries.

“There were several occasions when the heart team opened sets, sometimes as many as three in one day, where either rust or bioburden (bodily material) was found on the instruments,” the employee said.

“During a neuro-shunt placement case last weekend I found a straight hemostat with a piece of material that fell out when I opened the clamp,” the employee told investigators. “The material tested positive for blood.

“Also, last weekend we didn’t have supplies. There were no drapes, towels or saline solution. We ended up getting these supplies from Harper Hospital so we could do our cases.”

Dr. Joseph Lelli, the surgeon-in-chief at Children’s Hospital, in a public statement released Monday said: “While recent findings have shown areas for additional improvement in our CSP (central sterile processing) department, I have seen a consistent effort on the part of our DMC team members to ensure that our surgical services continue to be safely delivered with the highest quality of care.

“I’m encouraged by the changes made thus far and look forward to being a part of the positive efforts moving forward to create a world-class CSP department,” Lelli continued. “We remain steadfast in our commitment to resolve these issues and to build upon our legacy of providing quality care to this community.”

In response to the citations against Children’s Hospital, DMC officials filed a plan of corrective action vowing to implement a common instrument classification system that allows surgeons to communicate their instrumentation priorities to the sterile processing department. That plan has been accepted by CMS.

In its response, DMC also indicated it had already implemented improvements such as increased training for sterile processing workers, and authorized purchase of $107,000 to purchase surgical instruments, and operating room directors provided lists of additional instrument sets that are needed. The report also noted the health system had spent $500,000 on instruments in 2016.

Two other DMC hospitals, Harper Universityand Detroit Receiving, also were cited with violations during the January inspections but were found to be “in substantial compliance” with federal certification requirements and are not at risk of losing federal funding. Children’s, Harper, and Receiving continue to be accredited by Joint Commission, according to the DMC.

CMS said it has accepted plans of correction from all four Detroit hospitals. Children’s and Karmanos have to pass unannounced inspections by May 23 or they could lose federal funding.

“Should (Children’s Hospital) not come back in compliance with CMS Conditions of Participation, they would be terminated from the program and not receive funding from Medicaid,” said Jennifer Eisner, spokeswoman for the state Department of Health and Human Services, which administers Michigan’s Medicaid program.

At Karmanos, inspectors in January faulted Karmanos’ handling of bio-hazards like bodily fluids in a five-page inspection report. In one instance, an inspector noted there were no gowns or masks available for staff in a room used for pre-cleaning and transport of dirty surgical equipment. There was no secure red biohazard bin or plastic biohazard bags to transport contaminated equipment.

“Staff 1 was asked were (sic) the biohazard bags were located for staff to put the dirty equipment into. He stated ‘let me find out,’ ” the inspector wrote. “He returned with a plastic patient belonging bag that was not puncture resistant or labeled as a biohazard.”

In their plan of corrective action, Karmanos said it has provided extra training to employees and updated its cleaning and disinfection policy to state “instrument must be transported in a rigid, sealable, bio-hazard labeled container.”

Karmanos said it has implemented improvements, such as post-operative phone call interview with patients to check for possible signs and symptoms of infection.

“Those that are flagged as possible infection trigger a notification to the infection control practitioner for follow-up,” according to the Karmanos plan of corrective actions.

Patricia Ellis, director of media relations for Karmanos, said the cancer center, which was inspected as part of the ongoing investigation of the central sterile processing department at DMC, has maintained its accreditation by the Joint Commission, which also has recommended the center be allowed to continue participating in the federal Medicare program. CMS relies on the Joint Commission to verify that hospitals meet quality standards.

“We did submit an action plan within the time period we were supposed to, and the corrective action was accepted,” Ellis said. “The Joint Commission has given us accreditation status, and we’ve met all the conditions of participation.”

kbouffard@detroitnews.com

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