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Inspectors sent in on a complaint against Roper Hospital found issues with infection control and sterilization of surgical instruments. File/Grace Beahm Alford/Staff

Inspectors sent in on a complaint against Roper Hospital found issues with infection control and sterilization of surgical instruments. File/Grace Beahm Alford/Staff

Inspectors watched as a worker at Roper Hospital in Charleston dunked only half of a dirty surgical tray into a cleaning solution in a sink, then pulled it out and piled surgical instruments back onto it.

When the inspectors asked when the other half would be cleaned, the employee replied, “I’ll go back and get to that.”

The incident from a complaint survey in March found the hospital was not complying with federal standards for infection control and sterilization of surgical instruments and how the hospital monitors compliance with both, according to documents obtained by The Post and Courier.

The visit resulted in a statement of deficiencies from the Centers for Medicare and Medicaid Services a month later.

The matter did not fall into a category of the most serious kind possible and should not threaten the hospital's continued accreditation with the federal agency, Roper St. Francis Healthcare CEO Jeffrey P. DiLisi said in a June 29 memo to employees.

The hospital has "gone above and beyond to resolve" the problems cited in the survey, he said in the memo.

The unannounced inspection was conducted by the S.C. Department of Health and Environmental Control on behalf of CMS. It began on March 15, just four days after a joint commission accreditation survey of Roper turned up a condition that “poses a threat to patients and other individuals served,” according to a document on the accrediting body’s web site.

The commission survey was on March 11 and the unannounced complaint survey began March 15.

Because accreditation by the commission is voluntary, “there are some aspects and details that we do not disclose to the public,” spokeswoman Maureen Lyons said. She would not address whether the two surveys were connected but noted that Roper has now received its full three-year accreditation.

DiLisi said the issues identified by the commission were "immediately resolved" but that days later the inspectors showed up to look at "issues that mirrored the ones previously identified." 

DHEC spokesman Derrek Asberry said the "survey is still in progress" so the agency would not be able to release additional details.

"Once the survey is completed, a public report with any citations will be made available," he said, adding that the survey should be done in the next month.

The CMS Regional Office in Atlanta did not return calls this week seeking comment.

The complaint survey appeared to be narrowly focused on infection control in the hospital and sterilization in surgical departments. It found Roper was “not in compliance” with four Medicare standards related to surgery, infection control, patient rights and governance.

The hospital’s problems in the inspection report can be illustrated by what the inspectors saw in the hospital’s Sterile Processing Department on the second floor. The inspectors found a technician washing surgical equipment in a sink. The temperature probe in the sink showed the water was 69.2 degrees. A sign on the wall above the sink said the water needed to be at least 80 degrees and that the equipment must soak for at least five minutes.

When inspectors asked the technician how long the equipment had been in the sink, they got a shoulder shrug and “no verbal response,” according to the report.

Days later, inspectors were in the sterile processing decontamination and pre-clean area. This kind of cleaning is essential before sterilization, according to the Centers for Disease Control and Prevention “because inorganic and organic materials that remain on surfaces of instruments interfere with the effectiveness” of the sterilization.

That’s where inspectors saw the tech bring in the dirty tray, put half of it in the sink filed with cleanser and other soiled surgical instruments, and then load it up again.

In the case of the blood glucose meter, the inspectors saw a nurse and two patient care technicians — on different floors of the hospital on the same day — failing to clean the devices properly between patients. Those devices are supposed to be wet with disinfectant for two minutes to ensure any “blood borne pathogens” are killed, according to the manufacturer’s instructions.

But a nurse in the cardiac care unit cleaned the device with a disinfecting cloth for 17 seconds and it was dry after 45 seconds, according to the report.

On the third floor an hour later, after using one of the meters on a patient, a technician cleaned it for 15 seconds with a wipe and returned it to the nurses’ station for another use where it was dry a minute later, the inspectors found.

That afternoon, another technician on the fourth floor used the device on a patient and then wiped it for 18 seconds and then waited. The technician knew about the two-minute timeframe but “was unsure how to accomplish this,” according to the report. It was dry less than two minutes later, the inspectors found.

In the memo to employees, DiLisi said the hospital has taken extensive measures to address some of the issues cited in the inspection, including "strengthening education around disinfecting surfaces and medical devices, for example using sanitation wipes so that areas stay wet for the recommended two minutes."

The inspection report noted the hospital routinely did not follow its own policies and procedures for infection control, sterilization and oversight. The inspection found the sterile processing department did not use the correct type of sterilization with the four surgical instruments checked according to what the manufacturers recommended.

In the case of one “flash” sterilization meant to ready an instrument for immediate use, the item was actually left in the sterilizer for nearly an hour, which a Roper official admitted is problematic due to the potential for contamination as it sits there.

Roper has since made changes to its cleaning and sterilization procedures, including limiting the immediate use sterilization cited in the report to only "emergency situations identified by surgeons," DiLisi said.

The inspectors also found problem with logs meant to document precisely how the sterilization was done. Roper has an “infection prevention plan” for staff to follow standardized practices for “appropriate cleaning, disinfecting and sterilizing of medical equipment, devices and supplies,” the report noted.

But a review of the minutes of the hospital’s Infection Control Committee meetings as far as a year back found nothing to document the committee was monitoring the proper cleaning of devices like the blood glucose meters or the sterilizing of surgical equipment, the inspectors found.

Roper has since hired outside consultants to come in and "validate our practices, create action plans and simplify our processes" for employees by, for instance, providing visual aids, DiLisi said.

None of the issues cited by the inspectors resulted in a bad outcome for a patient, DiLisi said in the memo to employees.

Inspections and deficiency reports of this kind are common for hospitals, even those cited as among the nation's best, DiLisi said.

Reach Tom Corwin at 843-214-6584. Follow him on Twitter at @AUG_SciMed.

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