The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

ST JOHN MEDICAL CENTER 29000 CENTER RIDGE ROAD WESTLAKE, OH 44145 May 26, 2016
VIOLATION: INFECTION CONTROL Tag No: A0747
Based on interview and document review, the facility failed to have a program that would detect and discourage routine use of immediate use steam sterilization in the operating theater, and to provide oversight in the quality control of disinfecting solutions and test strips in place in the endoscopic, radiology, and cardiology areas. This has the potential to affect all patients receiving services in these areas. (A749) The census was 117 patients.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on interview and document review, the facility failed to have a system in place that detected and identified the improper use of immediate use steam sterilization as well as the improper quality controls in place for disinfecting solutions and test strips in endoscopy, radiology, and cardiology.

Findings include:

A review of the facility's documentation of its rate of immediate use steam sterilization use revealed between April 2015 and April 2016 immediate use steam sterilization was used 20.9 percent of the time, with the highest rate being 24.9 percent in November 2015.

A review of the facility's 2015 infection prevention and control plan annual assessment completed on 05/25/16 did not reveal a discussion of this high rate of use of immediate use steam sterilization.

A review of the facility's Infection Control and Prevention meeting minutes from 04/14/15 to 03/01/16 completed on 05/25/16 did not reveal any discussion of the rate of use of immediate use steam sterilization.

A review of the facility's minutes to the 02/18/16 operating room committee meeting revealed a discussion of the volume of supplies and the rate of immediate use steam sterilization.

On 05/24/16 at 9:00 AM in an interview, Staff N stated the use of immediate use steam sterilization was high because of a low amount of instruments. Staff N said this was discovered a few months ago while preparing for an accreditation survey.

A review of the facility's flash (immediate use steam sterilization) sterilization policy, last reviewed 03/16, was completed on 05/26/16. The review revealed the only items to be flash sterilized are "instruments that we only have one of a kind," borrowed instruments, or "any instrument that may have been dropped or contaminated. "

Despite a review of the flash sterilization policy in March of 2016, the immediate use steam sterilization rate remained high and for April 2016 it was 15.7 percent.

On 05/25/16 at 2:23 PM in an interview, Staff U said she had started working in the surgical department for about seven weeks and had worked as a surgical technician elsewhere. Staff U said she was concerned because whole trays of instruments were getting flash sterilized and she had never seen that before. She said when she spoke to other staff about it, they said there were not enough instruments. (This validated Staff N's interview of 05/24/16 at 9:00 AM.)

A review of the facility's infection control and prevention meeting minutes was completed on 05/26/16. The review revealed the last meeting was held on 03/01/16 and there was no discussion of the rate of immediate use steam sterilization and a meeting hasn't been held since.

A review of the facility's immediate use steam sterilization policy as revised in May, 2016, revealed, instruments to be immediately sterilized include those that are one of a kind and are needed in an emergency or those that may have been dropped or contaminated, are needed emergently, and there is only one of.

On 05/24/16 at 12:45 PM in an interview, Staff V stated if he is in a procedure the staff will go ahead and flash sterilize an instrument just in case rather than ask him if it is one of a kind that he will need.