Wrong Box Pulled from Shelf Sparked U.S. Probe of Hospital Implant Flub

It could happen to anyone—grabbing the wrong box off the shelf.

But when it happened at Sharp Coronado Hospital in April 2012, it forced surgeons to redo a knee replacement a day later and triggered a federal investigation only now made public. See the report here.

According to a new database of 8,000 serious federal safety rule violations nationwide since January 2011, an unnamed patient got a new right knee last April 25 in Coronado.

But in a report after the operation, a surgeon wrote: “I was notified by the [company representative] that yesterday I implanted a TC3 (tibial) insert—not the stabilized plus (tibial) insert that I had asked for.”

The unidentified man—working for the vendor and not the hospital—later told investigators that he went to the operating room’s supply room and “grabbed a TC3 tibial insert instead of a Posterior Stabilized Plus tibial insert.”

As summarized in the database created by the Association of Health Care Journalists, the vendor rep “returned to the OR suite and announced to the surgeon that he had a Posterior Stabilized Plus tibial insert, and handed it to the circulating nurse. It was not until the next day that the [rep] realized that he had picked out the wrong tibial insert.”

The TC3 tibial insert is 4 millimeters [about an eighth of an inch] higher than the Posterior Stabilized Plus model and not compatible with the femoral implant undertaken, the report said.

“Therefore, the TC3 tibial insert was removed the next day and replaced with Posterior Stabilized Plus model,” it said.

The surgeon involved said he was across the room and couldn’t read the description on the box. So he approved the tibial insert and the vendor rep opened the box and handed the sterile packaged tibial insert to the circulation nurse to give to the scrub technician.

The handoff apparently violated standard practices of the Association of periOperative Register Nurses, or AORN.

The federal report noted AORN’s guidance statement on the role of vendor reps (called health care industry representatives): “Each facility should develop a system that clearly delineates limits on the health care industry’s activities in the room where the surgical or other invasive procedure is performed.”

How did a vendor rep have a role in surgery? And what is Sharp Coronado doing to prevent a recurrence of the wrong-box mistake?

Hospital spokesman Tom Hanscom said Monday that he was making inquiries and would respond to Patch questions.

In this case, no lawsuit was filed, according to San Diego Superior Court records. And no serious harm was listed as having been done the patient.

According to a recent Coronado Eagle & Times report: Sharp Coronado in 2012 “performed 1,650 perform hips, knees, shoulders and ankle joint replacements.”

The case came to light only after documents of federally authorized complaint investigations called 2567s were released over the weekend by the Centers for Medicare & Medicaid Services—a federal agency.

According to a report Monday by former San Diego Union-Tribune health writer Cheryl Clark, the documents were released “after a longstanding request from and collaboration with the Association of Health Care Journalists.”

The group then created a searchable website—hospitalinspections.org.

“AHCJ president Charles Ornstein, a senior reporter at ProPublica in New York, made the announcement about the database during a news conference Saturday at the organization’s annual meeting in Boston,” wrote Clark, now senior quality editor for HealthLeaders Media.

She quoted Ornstein as saying the documents “show deception, fraud, falsification, and medical errors that are inexcusable.”

“No members of the public can find out not only which hospitals in their cities or regions had incidents serious enough to prompt such investigations, but how often errors of a particular type occurred in any facility to receive such a federal investigation report in the last 26 months,” Clark wrote.

Before the federal release, she said, such documents were available only after members of the public or news media filed Freedom of Information Act or state public records requests.

“It was a time-consuming process, and there would be no way to compare (various hospitals or regions of the country) except by spending a lot of time and spending many hours creating spreadsheets, and creating data tools to do that,” Ornstein was quoted as saying. “What we wanted to do was make this easy for the public to access these reports.”

The database will be updated quarterly, Ornstein told the group.

A spokeswoman for the American Hospital Association told Clark:

Despite our hope that these data would help inform the public, the public has not found the data as useful as we anticipated… It is hard even for a seasoned healthcare policymaker to understand the CMS documents or thoughtfully apply them to making informed decisions.

Even with the release of documents, Clark said a key deficiency in the online database is that “hospitals’ plans of correction—required if a hospital is to continue to receive reimbursement for care of Medicaid and Medicare patients—were not included because of technical difficulties.”

Members of the public or news media have to make a federal or state public records act request, she said.