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The family of Kalaya Hull-Mason was stunned to learn that her open-heart surgery was interrupted when blood from a previous patient was found in an instrument.

Reports, emails show years-long problem putting patients at risk

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Detroit  — The Midtown hospitals of the Detroit Medical Center have struggled for years to properly clean surgical instruments, stoking doctors’ fears about patient safety, a Detroit News investigation has found.

The News has obtained more than 200 pages of internal emails and reports indicating that surgeons and staffers have complained for at least 11 years about improperly cleaned, broken and missing instruments. The complaints have continued under the tenure of the for-profit Tenet Healthcare of Dallas, Texas, which acquired the DMC in 2013, the documents show.

The records show improperly sterilized tools complicated operations from appendectomies and brain surgeries to cleft palate repair and spinal fusions. Patients were kept under anesthesia for up to an hour as staffers replaced instruments. Dozens of operations were canceled at the last minute, some after anesthesia was administered.

At least twice a child’s chest or skull was open for surgery when doctors discovered dirty instruments. In January 2015, open-heart surgery for a 7-month-old girl was interrupted at Children’s Hospital of Michigan because a tube leading to a bypass machine was clogged with blood from a previous operation.

“We are putting patients at risk frequently and now canceling up to 10 cases this week ... promises just aren’t cutting it,” Joseph Lelli, chief surgeon at Children’s Hospital, wrote in an email to top administrators on June 29, 2015, at least his third warning in six months.

Doctors are concerned because old blood and bone, even when sterilized, are biohazards that can trigger infection, septic shock and even death if they come into contact with patients. In one recent 17-month period, Children’s Hospital logged 186 complaints about dirty, missing or incomplete instrument sets.

The emails offer a rare glimpse into an issue that experts such as Chicago-based surgical instrument designer Jim Schneiter say is growing at hospitals nationwide as the number and complexity of surgical tools have increased.

And while the issue of improperly cleaned instruments at some hospitals has garnered recent publicity, four DMC surgeons and four former administrators told The News the duration and severity of problems at the system is unusual.

The DMC’s chief administration officer, Conrad Mallett, acknowledged challenges sterilizing equipment have frustrated doctors and canceled surgeries.

“This is something that has to be fixed,” he said.

Mallett said the situation stems from a Central Sterile Processing Department in the basement of Receiving Hospital. The department cleans instruments for all five hospitals at the DMC center campus — Children’s, Detroit Receiving, Harper University, Hutzel Women’s and DMC Heart hospitals.

Mallett said the issues have equally affected all five hospitals, which perform more than 37,000 operations per year.

In late May, the DMC signed a contract with Unity HealthTrust of Birmingham, Alabama, to take over management of sterile processing. The agreement came one day after The News first inquired about the situation.

The deal began June 1, did not involve job losses and allows the company to recommend and implement changes.

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Conrad Mallett, Detroit Medical Center's chief administration officer, admits surgical equipment has needed to be re-cleaned on occasion, but says the main problem has been a failure to recruit high-quality managers for Central Sterile Processing. David Guralnick, The Detroit News

“What we are not is uncaring. What we are not is negligent. What we are is concerned,” Mallett said.

This week, the DMC reiterated Mallett’s assertions, adding the system is “working to enhance standardization and efficiency of our sterilization process” and maintaining that “no safety issues or surgical site infections” have been reported due to unsterile instruments.

Infant faced ‘significant risk’

Kalaya Hull-Mason was 7 months old when a soiled instrument complicated surgery to fix life-threatening heart defects.

She came to Children’s on Jan. 22, 2015, for an operation to partially repair a condition known as tetralogy of Fallot, a combination of four heart abnormalities that prevents adequate circulation of oxygen-rich blood.

As her relatives worried in the waiting room, she was put under anesthesia and her breastbone was cut open. A team led by chief cardiologist Dr. Henry Walters III tried to connect her to a bypass machine to keep blood flowing during the operation.

The operation stopped, though, when a suction tube needed to draw blood from Kalaya appeared to be clogged.

When a technician moved the instrument away from Kalaya’s exposed heart and inserted a wire into the tube’s narrow opening, “copious amounts of a dark black substance … came out of the instrument,” according to hospital records.

It was blood from a previous patient. It had remained in the tube following sterilization, records show.

The early-morning surgery — which was supposed to last three hours — stretched into the afternoon.

It was successfully completed after Walters and staffers covered Kalaya’s heart, dismantled the bypass machine and surgical drapes, then rebuilt the sterile field. After the operation, an X-ray of Kalaya was taken to ensure no instruments, sponges or needles were lost.

The incident posed “significant risk” to the girl, according to a hospital report.

“We were led to believe everything was OK,” said her father, Laron Mason, 21, who lives in northwest Detroit.

“It’s scary to think what could have happened.”

Hospital records obtained by The News indicate Walters “informed the infant’s parent” of the complication.

The records don’t indicate what he said or to whom. Kalaya’s parents — Mason and Keonna Hull of Flint — told The News they were never told someone else’s blood came out of the tube. Both said they were unaware of any surgery problems until The News contacted them.

There is no Michigan law about what doctors have to report to patients. In general, ethics guidelines encourage doctors to tell patients about mishaps “whether or not there is an injury,” said Dr. Ed Goldman, a professor of medicine and law at the University of Michigan.

Reached on his cell phone, Walters said he couldn’t discuss the operation. He didn’t specify a reason and did not return other messages. Medical ethics and federal law bar doctors from discussing patients’ care without their consent.

As Kalaya recovered, administrators quickly identified the sterilization technician who signed off on the tube as clean.

She was disciplined, but the action was overturned after questions were raised about the evidence during a grievance hearing, records show. Sterile workers are represented by four unions at the DMC.

Mallett did not answer questions about the incident. Speaking broadly, he acknowledged some patients have been inconvenienced and the DMC is “not perhaps delivering the service with the kind of satisfaction our physician cadre is depending.”

“Have there been occasions where the operation has not run as smoothly as we’d like? I’d say the answer is yes,” Mallett said.

“But we have been very, very diligent about making sure no one is in danger.”

Mallett would not back up the assertion by releasing data on infection rates, which can spike because of improperly sterilized instruments. Under state and federal rules, hospitals aren’t required to publicly disclose the information.

‘It’s a surgeon’s nightmare’

Four surgeons at the DMC said they encounter improperly cleaned, missing or incomplete sets of instruments about once a month or more. At other hospitals, the problems are less common, occurring less than once a year, said the doctors, who spoke on the condition of anonymity, fearing job reprisals.

“Instruments are getting lost. Instruments are getting dirty. Instruments are not available. It’s a surgeon’s nightmare,” one doctor told The News.

“It’s not the way it should work. I cannot do surgeries with my bare hands. ... We are running out of tricks to work around this. You can only improvise so much.”

One longtime surgeon said he’s discovered old tissue and blood on surgical equipment that he regularly uses, and has used duct tape on occasion to repair broken instruments during surgeries.

He said he quit filing complaints more than a year ago because the situation has not improved. Without such documentation, the situations are not addressed and the employees involved cannot be disciplined.

“Sometimes, I’ve operated and thought, ‘Maybe I shouldn’t have done that,’ ” the doctor said.

“There’s not a week that goes by when I don’t have a missing or incomplete (surgery set). Not a week goes by when I couldn’t file a (formal complaint). But why bang your head against the wall?”

A third doctor said he’s canceled 30-40 operations in the past two years because of instrument problems.

Two doctors told The News they have not noticed any improvements since the management of sterile processing at the DMC was privatized.

Cases of quick action

In many cases, hospitals nationwide have moved quickly to correct problems with dirty instruments or have been forced to by public health officials.

Last fall, the Veterans Administration Ann Arbor Healthcare System voluntarily shut its operating room, brought in national experts and transferred heart surgeries to the University of Michigan Health System after finding particles on instrument trays.

The contamination arose after repairs to a nearby water main. VA officials voluntarily disclosed the issue to the public.

Last year, Seattle Children’s Hospital announced as many as 12,000 children treated at its Bellevue Clinic and Surgery Center since 2010 may have come in contact with improperly cleaned instruments. Those instruments were sterilized, but some may have been contaminated with tiny bits of blood and bone due to improper washing. The hospital publicly acknowledged the problem and offered free blood testing for diseases including HIV and Hepatitis C. About 5,000 children were tested at a cost of $2 million.

At the DMC, the system’s “huge challenges” have persisted for years — and there’s been no “prolonged effort” to fix them, contended Laura Cortner, a former director the DMC’s Central Sterilization Department.

The department’s 71 technicians make about $18 an hour and are responsible for cleaning several thousand instruments per day to exacting specifications, assembling them into sterile “case carts” and delivering them to operating rooms in a few hours.

“Consultants, experts and all manner of leadership have traveled in and out, with no sustainable improvement to show for the effort,” said Cortner, who left the DMC in November 2014 and now works for a private sterilization company.

“It is a perfect storm. High volume, high patient acuity, entry level-low paid staff who are not self governing and no sustained support from admin,” she wrote in an email. “All with (unions) fighting amongst themselves.”

Cortner wrote the DMC’s approach to problems was to “fire someone ... replace ... run them in to the ground, blame them, repeat.”

Mallett said managers are to blame and the DMC has made numerous efforts at reform.

In 2010, then-DMC CEO Mike Duggan, now mayor of Detroit, consolidated three sterile processing departments at DMC hospitals in an effort to “improve the process,” Mallett said.

Duggan declined comment. Since his resignation in 2012 to campaign for mayor, the DMC has gone through at least five sterile processing managers and two executives who oversaw sterilization operations.

Mallett said top executives, including departed DMC chief operating officer Andrei Soran, have spent years trying to fix the problem. Soran resigned in April to become president of Verity Health System in Redwood, California.

In an interview with The News, Soran said Detroit’s sterile processing department is one of the largest in the Midwest and meets national standards.

He could not cite the standards but said he is confident DMC meets them.

“Everyone is entitled to their own opinion. Are there things we have to improve? Definitely, but I think there are actions being taken to improve,” Soran told The News.

Hospital sterilization accuracy rates aren’t public. DMC emails indicate 95 percent of instruments were delivered without problems in the month of June 2014. That was touted as an improvement in the emails.

That works out to a rate of 50,000 errors per million instruments.

Most sterile processing managers strive for no more than 3.4 errors per million, according to the ECRI Institute, a Philadelphia-area nonprofit that researches best practices in medical procedures and devices.

That would be nearly 15,000 times better than the DMC rate reported in the email.

Regulation a mixed bag

A patchwork of government groups and accreditation agencies regulate hospitals’ sterilization facilities, but reports are private and discipline for infractions is rare, experts say.

The federal Centers for Disease Control and Prevention collects data on hospital quality but has no regulatory authority over hospitals. The Food and Drug Administration tracks problems involving specific types of surgical instruments — but not which hospitals are reporting the incidents.

Internal hospital records about mishaps are exempt from discovery in lawsuits, said Norm Tucker, a longtime malpractice attorney from Southfield. And proving a link to dirty instruments is difficult because infections can originate from many different sources.

“They should tell patients if something goes wrong, but they usually don’t,” Tucker said.

“Very few malpractice cases stem from unsterile instruments because infections seldom become life-threatening. They go away in 14 days and everyone moves on. Proof is always a problem.”

Hospitals are regulated by the Centers for Medicare and Medicaid Services — and the federal agency relies largely on nonprofit accrediting agencies to catch problems.

Accreditation — a seal of approval — is required to receive Medicare funding, and hospitals are inspected every three years by three major agencies: the Joint Commission, the Healthcare Facilities Accreditation Program or Det Norske Veritas Healthcare.

The groups can revoke accreditation if problems arise — but have no power to close hospitals. And hospitals without accreditation can still operate.

“If you are getting audited every three years, that’s a huge hole,” said Jonathan Wilder, managing director of Quality Processing Resource Group, a Virginia-based surgical sterilization consulting firm.

“With sterile processing, you can have quick personnel turnover, so things can get bad really quickly and won’t get caught in an audit.”

Until the past few years, sterilization facilities were given “short shrift” during audits, he said, adding that regulators typically only became aware of cleaning issues if infections spiked or large numbers of doctors refused to perform surgeries.

Elizabeth Zhani, a spokeswoman for the Joint Commission, said the group inspects all hospital areas where high-level disinfection occurs. Like the other agencies, its inspection findings aren’t public.

In Michigan, state law requires inspections every three years — but that requirement is waived for hospitals that are accredited, said Michael Loepp, spokesman for the state Department of Regulatory Affairs.

Typically, about 10 of the state’s 150 hospitals are inspected each year, Loepp said. The inspections ensure equipment reaches proper temperature to sterilize instruments, he said.

The state can issue fines but has not. Hospitals voluntarily fix problems before that is necessary, Loepp said.

Pleading for a solution

The records obtained by The News indicate that problems at the DMC came in waves.

In two months alone in 2013, for instance, staffers reported: hairs in instruments; bone in a rongeur, a tool used in neurosurgery; dried blood in a sterilized drill; blood-covered instruments on a sterilized tray; a scope broken due to improper cleaning that cost $2,000 to replace; and a child whose lip was burned after an improper cauterizing tool was used during surgery.

“The surgeons at Children’s have lost confidence, long ago I am told, in (the DMC’s) ability to deliver sterile, complete sets/packs in a sustainable fashion,” Larry Gold, who resigned in April as CEO of Children’s, wrote in a June 13, 2014, email to Soran.

Gold did not respond to requests for comment.

Lelli, the chief surgeon at Children’s, pleaded for a solution after old blood was found on surgical instruments and a doctor complained in an email that it’s “hard to convince suburban patients to come to CHM after episodes like this.”

“Who has the will to solve this problem that has not been solved in the 11 years I have been at CHM?” Lelli wrote in an email on June 8, 2013, referring to Children’s Hospital. The email was sent to Rodney Huebbers, then chief operating officer of the DMC.

One day later, Joseph Mullany, who became CEO of the DMC that year, was informed of problems by Herman B. Gray, then-president of Children’s, emails show. The records obtained by The News don’t indicate whether Mullany responded.

Lelli has not returned messages or responded to interview requests from The News, and DMC staffers did not respond to three requests to interview him. Gray, who is now CEO of United Way of Southeastern Michigan, declined comment.

Emails indicate problems reached a “crisis level” in mid-May 2014, prompting another shakeup.

On the morning of Sept. 10, 2014, a now-former DMC administrator in charge of efficiency, Victor Bell, praised staffers in an email for “great work” to “improve the delivery of instruments and supplies.”

Hours later, drama was unfolding in a Children’s Hospital operating room.

Deborah Niedbala, the hospital’s director of quality safety, wrote that cables needed to pace, or regulate the patient’s heartbeats, during open-heart surgery were missing — and surgeons were told they wouldn’t be delivered for more than an hour.

“THE PT IS ON THE TABLE HAVING OPEN HEART SURGERY AND WE CAN NOT PACE THE PT,” she wrote in capital letters.

Disciplinary efforts blunted

Doctors and documents indicate some of the problems stem from friction between unions and management.

Cortner, a former sterilization manager, wrote to administrators in 2013 that unions are so powerful she was reluctant to discipline workers for dirty or missing equipment unless physicians took photos of the problems.

“We have stopped formally disciplining staff, when we are lacking the substantiating items listed above, because it ends up getting reversed at third steps (or grievance hearings),” Cortner wrote in an email.

“Our valuable time is spent in completing the requisite paperwork, and it ends up with us being at fault.”

One of her successors, Lukeysih Hall, wrote a long memo on April 2, 2015, to a Tenet human resources official expressing similar frustrations.

The month before, internal reports show that eye surgeries on infants were canceled because of missing and dirty equipment; broken scopes were found during operations and an internal audit found that 100 percent of durable medical equipment — intravenous machines and feeding pumps — at Children’s were incorrectly labeled as clean.

Hall wrote that her efforts at discipline were not supported by upper management. In one case, a search of lockers used by sterile technicians found 400 missing brushes as well as an “immeasurable amount of supplies and instrumentation that were missing from instrument sets.”

Those workers were allowed to keep their jobs after grievance hearings, according to the memo.

Mallett said unions aren’t to blame. So did Marge Robinson, president of SEIU Healthcare Michigan, which represents 14,000 workers including those at the DMC who clean surgical tools.

She said the union tries to enforce the contract but has no interest in keeping on bad employees. Workers want to improve the situation, she said.

“There is a problem with dirty instruments at the DMC,” Robinson said. “To me, it’s a management problem.”

Family fears for others

Kalaya, who underwent heart surgery last year, turned 2 in June. She celebrated with two birthdays — a party in Flint with her mother and a bounce house and cotton candy with her father in Detroit.

Known as Lay-Lay, she’s as energetic as any other toddler, bossing around her twin brother, King. The heart defect doesn’t impair her daily life, but she’ll need another operation around age 11 to fully repair it.

Her family is thankful she’s healthy and surgery eventually was completed — but doesn’t want another family to go through a similar experience at the DMC.

“They just have to do better,” said her paternal grandmother, Dana Tumpkin of Detroit.

If you fear exposure

  • Doctors and hospitals aren’t required to tell patients if they were exposed to improperly cleaned instruments. If you fear a loved one may have been at risk:
  •  Ask the doctor who performed the procedure.
  •  If you suspect an exposure led to serious illness or death, you can have the hospital administration review it as a “sentinel event,” a preventable occurrence that resulted in serious harm.
  •  Call your hospital’s medical records office and ask to review your case file. For the Midtown campuses of the Detroit Medical Center hospitals — Children’s, Harper University, Hutzel Women’s, Heart and Detroit Receiving Hospital — call 1-888-362-3370.
  •  File a complaint with Tenet Healthcare, owner of the Detroit Medical Center, by calling 1-800-8ETHICS.

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 three dozen interviews with doctors, patients, administrators and experts.

Coming tomorrow

kbouffard@detroitnews.com

jkurth@detroitnews.com

Twitter: @kbouffardDN, @joeltkurth

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