The federal Centers for Medicare and Medicaid Services, or CMS, terminated its agreement with ESEC Surgery Center on Aug. 18, citing three state inspections that found multiple disqualifying deficiencies.
In a court filing on Aug. 16, ESEC management said the loss of Medicare and Medicaid payments would be “devastating” to the center’s employees and patients. The facility gets more than 60 percent of its revenue from the federal funding, according to court records.
“The public interest is in no way served by an unwarranted shutdown of a facility that provides care to numerous low-income, disadvantaged and disabled patients,”the lawsuit complaint stated.
The complaint continued: “Indeed, there are 35 patients scheduled for surgery next week that will have to reschedule their surgeries and delay the care they need if ESEC’s provider agreement is terminated,”
The lawsuit asked a federal judge to keep its CMS agreement in place while ESEC appeals the decision to terminate it, but the judge dismissed the suit on Aug. 22, citing lack of jurisdiction over the matter. The judge also noted ESEC provided no evidence that showed the cancelation would cause irreparable harm to the facility or patients.
How the termination has affected the facility is unclear. A spokeswoman for the ESEC Surgery Center told The Frontier on Thursday the facility was “in the process of repairing and fixing” the problems and said she had no interest in talking to reporters.
An attorney representing ESEC did not return The Frontier’s requests for comment.
CMS spokesman Bob Moos told The Frontier ESEC has reapplied for the federal program, but that process could take up to 60 days. The facility must first correct the problems that resulted in the termination.
An Oklahoma State Department of Health spokesman on Thursday said the agency has not yet verified ESEC has corrected the problems.
In CMS’s agreement termination notice, the federal agency stated the ESEC Surgery Center failed to “meet the minimum health and safety standards required” for program participation. The notice cited three Oklahoma State Department of Health Medicare surveys that found repeated instances of noncompliance from 2015 to 2018.
State and federal regulators maintain the surgery center is required to ensure two machines used to sterilize surgical instruments should be vented to exhaust by-products of the cleaning process. Additionally, surveyors stated the facility’s electrical system must be separated into two panels.
In court filings, ESEC said the problems cited for the agreement termination notice have “no threat to patient safety,” and in the 13 years the center has been open, there have been no incidents involving the issues.
Additionally, ESEC management stated, the problems that CMS and Oklahoma’s health department cited were never flagged in previous visits, and the health department approved building plans years ago, before regulations were put in place.
After a survey in July 2015, the state health department alerted ESEC management that inspectors found several deficiencies that would make the facility ineligible for Medicare and Medicaid unless they were corrected.
Surveyors reported the center failed to properly sterilize and disinfect surgical instruments. ESEC staff reportedly said they used a hand-washing sink for final steps in the disinfection process.
“At the time of the survey, a large syringe and a nylon instrument brush were found on the sink,” the survey stated. “This practice likely exposed clean instruments to contaminants found in and around hand washing sinks.”
At the same time, inspectors reported the only useable work counter in the sterile processing room was “cluttered with books, manuals, papers, and various other items that are not considered clean and should not have been” close to sterile instruments and supplies.
“In addition, there was evidence this counter was not regularly cleaned,” the 50-page survey stated. “Dust, lint, and debris was found in and around this counter.”
Health department employees also reported the medication carts in operating rooms were dirty and “soiled with liquid stains, dust and debris.” They found rusted equipment in the rooms that could not be disinfected, according to the survey.
The survey also noted operating rooms did not have exhaust systems for smoke in operating rooms.
Surveyors called a surgery holding room “soiled” and stated it was used to store bags of trash and biohazard waste from the surgery suite. The room also contained a dirty garden hose.
“One trash bag was leaking clear fluid onto the floor,” the survey stated.
Because the surgery center had only one large sterilizer, staff used “flash” sterilizers routinely. The health department surveyor stated the machines were not suited for routine sterilization. And a large sterilizer was placed in a room that was too small, as the machine produced too much humidity.
ESEC management submitted its required plan to correct the deficiencies in September 2015, however the health department did not accept a plan until ESEC submitted a second plan that addressed all the inadequacies and how they would be fixed.
ESEC’s plan stated the state approved the plans for the two flash sterilizers at an earlier date and argued the cited deficiencies came from standards created after the center’s construction. Facility managers also stated they cleaned up areas found to be messy and they would install exhaust fans for each sterilizer to help with the humidity.
But in December 2015 an attorney representing ESEC mailed a letter to the health department that argued deficiencies cited with the sterilizers and lack ventilation were not cited in previous inspections.
As a compromise, the attorney proposed the facility buy a portable ventilation system for surgery room and noted the sterilizers did not need ventilation. The attorney also requested the time for ESEC to be in compliance be extended past Jan. 27, 2016.
In turn, the health department extended the deadline to December 2016, but noted the facility’s Medicaid and Medicare agreement would be terminated if all deficiencies were not corrected. The agency later extended the deadline to March 2017.
When the health department conducted a follow-up survey in November 2017 and another in June 2018, surveyors reported the same problems. CMS sent ESEC an agreement termination notice on Aug. 3.
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