HospitalInspections.org

Based on documentation review, and based on interviews with facility staff members, it was determined that the hospital failed to develop a system for mitigating health-care associated infections and communicable diseases, as required by this regulation.

Findings include:

A document titled: "Medivator Disinfection Cycle Occurrence Report" was received, and was found to contain the following information:

"Tuesday September 28, Cycle of DSD 91E (a specific automated high-level disinfection machine) was programmed for regular flush, disinfection, rinse 1, rinse 2, alcohol and air. At around 1500 (hours) (name), Medivator (brand name of high-level disinfection machine) rep (representative) came to (name of facility unit) for service call. At that time (s/he) reprogrammed both medivators. The tape from that day clearly shows the change in programming that occurred. After 1600 (hours) the medivator no longer showed a disinfection cycle in the programming. This was not noticed by the techs.

Wednesday Sept (September) 29 DSD 91E used to process 6 scopes without disinfection cycle in the programming.

Thursday Sept 30 DSD 91E used to process 6 scopes without disinfection cycle in the programming. In the late afternoon, the tech (technician) detected a very small amount of golden fluid at the bottom of the DSD machine. Thinking that this might be an oil leak from the motor, (s/he) shut the entire system down.

Friday October 1 through Wednesday October 6: DSD 91E was taken out of service for presumed "oil leak."

Wednesday October 6 In the afternoon, (representative's name) from (name of Medivator company) came to service the DSD. The "oil leak" turned out to be a very small pool of Rapicide from a hairline crack in the system. After this was evaluated, (name of representative) ran a test and noticed the disinfection cycle had not gone. (S/he) then reprogrammed the DSD to include the disinfection cycle once again.

Thursday October 7 (Name of facility staff person) brought the issue of the medivator to my attention. I contacted (two representatives of the Medivator company). Both were sent copies of the Medivator strips documenting the disinfection cycle. (Unit manager) was notified of the incident."

In a meeting with I1, I2, I3, I4, and I5 at 0840 hours in the "board room," I2 confirmed that on September 28, 2010, at approximately 1500 hours, a representative of the company who serviced the high-level disinfection machines used by the facility inadvertently "programmed out" the disinfection cycle, one of six cycles which were normally run to disinfect each colonoscope used in the facility. Within 48 hours, the machine was taken out of service for a presumed oil leak, which was diagnosed by the service technician as a separate issue on October 6, 2010. At that time, on October 6, 2010, the service technician ran a disinfection cycle of the machine, and noted that the disinfection cycle had been programmed out. The technician reprogrammed the machine to include the disinfection cycle. On October 7, 2010, the charge nurse of the unit was made aware of the fact that the machine in question had been reprogrammed to exclude the disinfection cycle on September 28, 2010, and on October 6, 2010, the disinfection cycle had been reprogrammed back into the automated high-level disinfection cycle for that specific machine. This series of events was confirmed by I3, who also stated that a number of system changes had been instituted since the incident was discovered, and described that series of changes in the following way:

A meeting was called on the afternoon of October 7, 2010, which included the unit manager, the unit director, the head of the hospital's infection control program, the clinical risk manager, and the Medical Director of the hospital.

? The machine in question was taken out of service.
? Each patient who received a colonoscopy using a colonoscope which had been disinfected in the machine in question had been determined. Each patient's record had been reviewed to determine special health risks.
? In the following days, each patient was contacted via a written letter, as well as with a follow up phone call. Testing for communicable disease was offered and arranged by the hospital for each patient who agreed to the testing.


Also at the time of the October 7, 2010 meeting, the hospital's system for quality assurance was activated, and the following changes were instituted:

At the commencement of each high-level disinfection cycle run by the Medivator colonoscope disinfection, a "tape" containing the following information was automatically generated. The tape contained the following information:
Date, time, event
Flush (time cycle completed)
Disinfect " " "
Rinse 1 " " "
Rinse 2 " " "
Alcohol " " "
Air " " "
End

The hospital policy was amended to include that the employee responsible for sanitization of the colonoscope must circle the word "disinfection" and initial the tape by hand, to indicate that the employee had specifically noted that the disinfection step had taken place.

This change in protocol was reflected in a review of the facility policy titled: "RECORD KEEPING PROCESS."

Hospital logs which contained the original printed Medivator "tapes" for the Dates November 1, 2010, through March 8, 2011, were reviewed. Each tape contained the word "Disinfect," which had been hand-circled and initialed in pen.

Hospital policy was amended to included that each time a high-level disinfection machine was serviced, a cleaning cycle would be required at the end of the service call, which would be verified by two signatures--the signature of the service technician as well as the signature of a staff member--and that these signatures would indicate that the test was accurate and that all cycles of the machine were included in the electronic program of the machine.

This change in protocol was reflected in a review of the hospital protocol titled: "Endoscope Reprocessing Protocol."

The log which recorded which colonoscope had been used by which patient was updated to include the Medivator confirmation tape attached to specific information about the patient, which, per I2, assisted the staff members in the task of tracing which instruments were used on a specific patient.

On 03/09/11, between 0920 hours and 1000 hours, an observation of the entire process that the hospital unit utilized to disinfect a colonoscope was observed. All steps, from the manual disinfection in the procedure room, to the manual disinfection in the utility room, to the automated high-level disinfection process, to the documentation step, were observed and were noted to have followed the written protocol, without exception.

Meeting minutes titled : "Cleaning of Scopes, October 26, 2010" were reviewed. Each employee of the unit was listed as an attendee. The minutes reflected notification of all employees of the unit regarding the incident, as well as notification of process changes made concerning high-level disinfection of colonoscopes.

The hospital failed to notice that the disinfection step of the automated high-level disinfection process had been inadvertently "programmed out" by a service technician, placing eighteen patients who received colonoscopies with improperly disinfected colonoscopes at risk.

Of special note, the hospital's systems for tracking potential infections and for addressing issues related to quality of care were evaluated at the time of this survey, and were determined to be highly effective.