The Health Department has reprimanded Miriam Hospital, after identifying a confluence of missteps that led a surgical team to operate on the wrong knee of a patient undergoing elective surgery last month.

The staff failed to look for the surgeon’s mark on the patient’s skin, the “yes” that indicated which side needed surgery. But there were other problems as well, including marking surgical sites with ink that sometimes rubs off and failing to verify the surgical site against the original source of information.

Dr. David R. Gifford, state health director, said that the underlying issue was the hospital’s “culture,” what he described as a tendency to regard critical patient-safety measures as rote administrative tasks. For example, on a pre-surgical checklist, a nurse drew a vertical line through all the boxes rather than checking off each individually.

In a consent agreement signed Thursday, Miriam Hospital pledged to make several changes in policy and procedure and to hire a patient-safety consultant who will evaluate and monitor the hospital for 12 months.

“We need to do the technical fixes,” Gifford said. “I’m [also] trying to get at the underlying culture.”

“It’s not that Miriam doesn’t have a culture of safety,” said Dr. Kathleen C. Hittner, hospital president. “Of course we have a culture of safety.” The nurse who drew the line through the boxes may have diligently performed each listed task, but just filled out the form quickly, she said.

The culture change that’s needed, Hittner said, involves making sure that “people speak up and tell us what is going on.” For example, no one informed the hospital administration that the pens used to mark surgical sites sometimes blurred or washed off during preparation for surgery.

After learning of the Health Department’s findings, the U.S. Centers for Medicare and Medicaid Services this week notified Miriam that it is “not in compliance” with requirements to participate in the federal program and that the deficiencies are “of such a serious nature as to substantially limit your hospital’s capacity to render adequate care.”

CMS, which has lately taken a hard line against medical errors, hired the Health Department to conduct a top-to-bottom survey of the hospital. Gifford said that the on-site portion of that survey was being completed yesterday, and that there was no reason to think that Miriam would lose its right to accept Medicare patients.

The Miriam incident was the eighth wrong-site surgery to occur around the state in recent years. Three of them involved neurosurgery at Rhode Island Hospital –– which, like Miriam, is owned by the Lifespan hospital group. Like hospitals around the country, Miriam and Rhode Island have implemented procedures to prevent such errors. But, as in the rest of the country, the mistakes keep happening.

The Joint Commission, the agency that accredits hospitals, receives reports of 8 to 10 wrong-site surgeries per month, despite a nationwide push to prevent them.

The incident occurred on Sept. 19, when a 60-year-old woman came to the Miriam’s outpatient surgical center for arthroscopic surgery to repair a tear in her left meniscus, the cushion of cartilage where the bones of the legs meet.

Shortly before surgery, the surgeon met with the patient, discussed the surgery, and correctly marked her left knee with the word “yes.” Then, a nurse failed to look for the mark and mistakenly prepped the wrong knee for surgery.

In the operating room, the staff performed the required “time-out” in which they reviewed a checklist to make sure they were doing the right procedure on the correct part of the right patient. A white board in the operating room listed site verification as one of the tasks to perform during pre-surgical time-out. But it didn’t specify what site verification should entail, and the staff did not check for the surgeon’s mark nor did they check the MRIs.

(The white board has already been changed. It now says: “Site verification: Can everyone see the mark?”)

The first person to notice the error was the patient when she awakened about an hour later.

At the patient’s request, the operation was then performed on the left knee. Hittner said yesterday that the patient was “doing fine.”

One issue that emerged from the investigation was the fact that pens used to mark surgical sites have ink that is hard to see on dark skin and that sometimes washes off when the surgical site is prepared. This was well known among the staff –– but came as a total surprise to the administration. (The hospital is now testing new pens.)

“No one said anything about it,” Gifford said. “Each time that ink washed off, that’s a ‘near miss’ ” — the term for medical errors that almost happen.

As part of the consent order, Miriam must institute “a robust ‘near-miss’ reporting program.”

Hittner said that for three days after the incident, either she or a member of the hospital’s Board of Trustees attended the beginning of every surgery to witness the “time out” process.

She has also been meeting with doctors, nurses and others to review the policies and explain their importance. “Nothing is as powerful as telling the story [of the recent error],” she said, “…and to stress that it could happen to anyone.”

The hospital will also be inviting patients to address its board every quarter for two years.

The Board of Medical Licensure and Discipline and the Board of Nursing are investigating whether to take disciplinary action against any of the professionals involved.

“There is nothing to suggest that we need to suspend or revoke anyone’s license,” Gifford said. “But I do think there is some culpability.”

The Health Department’s statement of deficiencies faults the surgeon for “failing to take a leadership role” in site verification. The hospital has declined to name the surgeon, but his name will be made public if the medical board finds evidence of unprofessional conduct.

ffreyer@projo.com