RALEIGH, NC (WTVD) -- A federal investigation into a Raleigh surgery center reports a "systematic failure" in protocols at Raleigh surgery center that resulted in a brief termination of its Medicare contract.
The investigation, conducted by the North Carolina Department of Health and Human Services on behalf of the Centers for Medicare and Medicaid, was a response to complaints directed against Blue Ridge Surgery Center located at 2308 Wesvill Court in Raleigh. Health officials conducted an on-site inspection from Jan. 30 to Feb.2.
"Our first priority is to protect the health and welfare of the patients," April Washington, a CMS spokeswoman, tells the ABC11 I-Team. "CMS and the North Carolina State Survey Agency are working together to ensure the safety of all patients in this facility."
According to the 36-page report, the investigation "resulted in the identification of an immediate jeopardy to the safety of patients as evidenced by a systematic failure to ensure thorough, accurate pre-procedure verification processes" that opened the door for the wrong surgeries to be performed. That includes the lack of site marks or review of relevant labeling of materials.
Specifically, the report cites three cases as evidence for CMS' conclusions:
- Medical records reviews found the "wrong procedure was checked" on a 9-year-old needing mouth surgery and there was a "wrong site surgery" performed. Interviews with inspectors revealed a surgeon technician recognized the problem from the start but she did not feel comfortable speaking up yet as a new employee. The doctor told investigators this was the first "wrong site surgery in 33 years of being a surgeon" and that "there was a perfect storm of distractions."
- While performing an eye procedure on a patient, a doctor injected an expired lens into the patient's eye. According to the report, staff in the room "failed to look at the expiration date because the patient was moving around and they were focused on the patient." Additionally, officials concluded staff "did not pay attention to detail." The report also notes there was no written policies or procedures for verifying expiration dates.
- A 19-year-old patient entered the Operating Room needing surgery on her left knee, but there was confusion in the way the room was set up, resulting in the wrong surgical incision. Though the "Safe Surgical Checklist" was checked and initialed, the post and tourniquet were placed on the right side. The O-R team then prepped and draped the right knee. Interviews with inspectors revealed that "speed seemed to be a priority" because it was "a very busy day" at Blue Ridge.
In its assessment, health officials concluded that the following federal Conditions for Coverage were not met:
42 CFR 416.41 Governing Body and Management
42 CFR 416.42 Surgical Services
42 CFR 416.43 Quality Assessment and Performance Improvement
After the report was submitted on February 2nd, CMS gave Blue Ridge managers until March 10th to submit a plan of action to improve procedures and protocols in order to rescind the "Immediate Jeopardy" classification.
The CMS website shows a notice posted March 15th that in fact rescinds that original order.
According to Washington, Blue Ridge submitted a "plan of correction" that was approved. Health inspectors must return for follow-up compliance check within 23 days of the IJ's retraction, which is April 2nd.
"Our top priority is the health, care and safety of our patients, said Kathy Leibl, Blue Ridge Surgery Center's Administrator, in a statement to the I-Team. "We work hard to ensure that all aspects of our operations are in compliance with all applicable laws and regulations. We are a certified provider of services under the Medicare program and are accredited by The Joint Commission, which accredits and certifies nearly 21,000 health care organizations and programs in the United States."