Muddled records lead to Saint Vs kidney mistake

Courtesy Saint Vincent Hospital in Worcester said it is addressing deficiencies that state and federal officials say led to a kidney being removed from the wrong patient in July.

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By Susan Shalhoub

(From the print edition) While denying that it was at fault in what led to the removal of an organ from the wrong patient over the summer, Saint Vincent Hospital in Worcester could see Medicaid and Medicare payments terminated in December if patient safety deficiencies remain, according to state officials.

According to reports from the state Department of Public Health (DPH) and federal Centers for Medicare and Medicaid Services (CMS), the fallout stems from a July 20 surgery, where an error resulted in a kidney being removed from the wrong person at Saint Vincent. The surgeon — who had been working from a CT scan image of a tumorous kidney — was told from pathology results that the kidney was, in fact, healthy.

What led to this error was, in some ways, a perfect storm in terms of coincidence, and a cautionary tale for the Central Massachusetts healthcare industry, about how the potential for such errors exists. It highlights the importance of locked-down patient safety procedures and accountability.

Logistics at play

The patient who had the kidney removed and the patient who should have had a kidney removed had the same name, and the same month and day of birth. Additionally, the DPH and CMS report says that the two patients had imaging procedures done on the same date.

The first patient’s CT scan was missing from his or her medical record, but the wrong one was there instead, according to the DPH and CMS.

According to the state and federal investigators’ official report, the fact that the CT scan was missing was not unusual. A pre-admission testing unit nurse at Saint Vincent’s said that staff have had difficulty getting reports and documents from doctors’ offices. The report quotes this person as saying the issue had been ongoing “for a while, years.”

A Saint Vincent associate medical director was documented in the report saying that the patient’s outside physician was responsible for providing the CT scan. In addition, a previous internal report cited in the investigation said that certain CT scans weren’t properly displaying patients’ birthdates on the operating-room monitor at Saint Vincent — a problem which the report says was fixed just recently.

The hospital was told by the DPH Division of Health Care Facility Licensure that Medicaid and Medicare agreements will end on Dec. 12 if deficiencies are not corrected.

Saint Vincent Hospital spokeswoman Erica Noonan said the hospital was unable to give details on the incident but denied that the error occurred inside the hospital. Noonan cited HIPAA privacy rules and was unable to offer a status update on the affected patient.

“The misidentification and scans … happened outside the hospital,” Noonan said. “The hospital will meet all CMS guidelines and deadlines, and its Medicaid program is not in jeopardy.”

According to the report by the DPH and CMS showing both a summary of deficiencies and Saint Vincent’s intended fixes, the hospital’s compliance plan “is not an admission by the facility that it agrees that the citations are correct or that it violated the law,” but an effort to right the wrong as required by federal standards, Noonan said in an email.

The Saint Vincent compliance plan outlined in the report includes educational meetings with staff on patient identification practices, ensuring all pertinent image reports are present before surgery, and re-communicating certain roles and responsibilities. The plan makes clear all responsible parties for oversight and accountability in each area.

Safety standards

The term “never event,” referring to an event that should never occur in a heathcare facility because it’s wholly preventable, was introduced by Dr. Ken Kizer of the National Quality Forum in 2001. Wrong-patient surgery is on the list. Since then, hospitals have made great strides in reducing errors with things like electronic health records and financial incentives via CMS, for example.

In 2011, CMS published a final rule requiring that states implement non-payment policies for provider-preventable conditions — one of which is wrong-patient surgery.

Initiatives such as the Hospital Engagement Network (HEN), a CMS-backed program meant to reduce patient harm and hospital readmissions, have been instrumental in reducing the numbers of patient safety incidents statewide as well, says Pat Noga, vice president of clinical affairs at the Massachusetts Health & Hospital Association. More than 34,000 “harms” have been prevented as a result of HEN and other efforts in 2015 and 2016, said Noga in an email.

Though she couldn’t comment on the Saint Vincent incident specifically, she said MHA-member hospitals aspire to “completely eliminate patient harm … When caring for any patient falls short in terms of proving harm-free care, the entire caregiving team and those who support them take the incident extremely seriously.”

Area hospitals react

So how could this kind of error happen, with an industry-wide focus on patient safety in place?

Dr. Adel Bozorgzadeh, professor of surgery and chief of organ transplant services at UMass Memorial Medical Center in Worcester, says the transplant surgery community is hypervigilant with patient identification, allowing no room for human error.

The UMass Memorial process involves two health professionals identifying each patient by two criteria, such as medical number and date of birth. The surgeon reviews it and signs it in the pre-op area. X-rays are checked and the surgery site is marked in washable marker, he said. The anesthesiologist also checks, and the patient is asked “What is the plan for today?” so he or she can tell medical staff in their own words.

“We check and double check. On multiple levels,” he said. “Surgeons communicate with the organ bank. We check compatibility with the organ and recipient, at each one of those check points we document that this event has taken place,” he said.

Bozorgzadeh said policies cannot be reactionary in response to something that goes on at another hospital. ts.

“To make it a zero event, the institution has to engage. It’s a leadership issue, a cultural issue across the board,” he said, noting that Saint Vincent’s has talented, skilled surgeons on its staff.

Kathleen Davis, vice president of quality and patient safety at Harrington HealthCare in Southbridge, said Harrington is always paying attention to “anything noteworthy” in regard to medical errors in the industry, such as the Saint Vincent incident.

Diligence is key in matters of patient identification, she said. “You can’t skip a step. If something doesn’t make sense, ask for clarification before anything is done.”

The Harrington process also involves multiple layers and a patient verification form that has to be signed.

And the staff errs on the side of being overcautious. “Patients do get annoyed,” said Davis. “They will say things like, ‘You’re the fifth person who’s asked me this!’”

Hospital survey

Ironically, the incident came shortly before a national healthcare survey organization — The Leapfrog Group — gave Saint Vincent an “A” in hospital safety.

According to the Leapfrog website, Saint Vincent Hospital declined to rank itself on the “Never-Event Management” question — which does not specifically include wrong-patient surgery, but is the closest category.

An information tab about the non-response reads: “… disappointingly, hospital leadership chose to withhold some critical information on quality and safety from its patients.”

Survey rules allow participants to skip a certain number of questions and still get a rating. And the survey is not meant to be the end-all, be-all method of analyzing hospital safety, says Leapfrog.

“At this time, there is not a measure included in the Leapfrog Hospital Safety Grade that would directly correlate with this type of incident,” said Erica Mobley, director of communications and development at Leapfrog, in an email.

Mobley said that patients are advised to talk to their doctors about what they will do to protect their safety. The Hospital Safety Grade also factors in CMS data, Leapfrog noted.

“If it turns out this was not an exception but a pattern for this hospital, they will receive a lower Safety Grade in the future,” wrote Mobley.