Executive Summary
The following blog was contributed by an ambulatory surgery center specializing in gastrointestinal procedures. They have offered this case study as an example for benchmarking and infection control and quality improvement activities for ambulatory surgery centers. This study was conducted as part of their Quality Management program and their process for analyzing and reviewing the data and incorporating the appropriate improvement process is an excellent example of the type of Quality Improvement/Infection Control review Medicare and Accrediting bodies would expect to find in an excellent surgery center.
Case Study
On the initial testing date, five scopes were randomly cultured to ensure that the equipment was properly disinfected. The endoscopes were swabbed in the biopsy channel
and on the tip using sterile dual swabs. These swabs were then put back into the tubes and pushed down into the growth medium.
Results
The center received the results with three out of the five showing a moderate growth of bacillus species. The scopes that were tested are as follows:
- Colonoscope #2-no growth
- Colonsocsope #4-no growth
- Endoscope #C-moderate growth bacillus species
- Colonoscope #8-moderate growth bacillus species
- Endoscope #B-moderate growth bacillus species
The results were received too late to request an identification of the bacillus species. The G.I. techs were interviewed to determine possible causes for the positive test results. Out of this, it was determined that the scopes had been swabbed with alcohol with one of the non-sterile swabs that are used in the ORs to transfer tissue samples into the formalin. This was done with the same swab. It was then determined that the tests were inaccurate.
The G.I. techs were re-educated about sampling techniques to ensure accuracy of future testing. The staff was given an in service on reprocessing the scopes with a module that was produced by SGNA and a reprocessing chart was placed in the scope washing area.
To date, there have been no reported post procedure infections; however, it was felt that the center needed to assess the risk to the patients. Research into bacillus spores revealed that there are many species of bacillus and that the spores can only be inactivated using sterilization. The scopes can not withstand any type of sterilization.
An assessment was made of the following areas:
- Single use items are not being reused
- Testing of the OPA with every load and documented properly
- Hand Hygiene
- The scopes are hung in the scope cabinet immediately after reprocessing
- All steps followed in the SGNA guidelines for scope reprocessing
- All of these measures were found to be accurately performed
On a later testing date, all of the scopes were swabbed for culture to ensure that the previous test results were inaccurate. The results concluded seven of twelve scopes tested positive for bacillus spores. The results of the second swab cultures are as follows:
- Colonsocope #2-bacillis species(not anthracis)
- Colonoscope #1-bacillis species (not anthracis)
- Colonoscope #4-bacillis species (not anthracis)
- Colonoscope #5-no growth
- Colonoscope #3-no growth
- Colonoscope #7-no growth
- Endoscope #E-no growth
- Colonoscope #C-bacillus species
- Colonoscope #8-bacillus species
- Endoscope # B-no growth
- Endoscope #D-gram positive rods (oxidase-negative)
- Colonoscope #6-gram positive rods (oxidase-negative)
(None of these were ID’d by the lab.)
A cross reference of the positive scopes and the AER unit revealed no relevant information. These results were concerning and the investigation became much more aggressive, including the following checks and measures:
- All enzymatic cleaner were assessed for proper concentration and use.
- The fan in the scope cabinet was checked and found to be functioning properly.
- Verification that the filters are being changed per manufactures guidelines.
- Verification that the AER manufacturing instructions were being followed.
- Verification of the proper amount of alcohol is being used.
(These measures were and are being done accurately)
Other steps and measures that were taken:
- All valves were thoroughly disinfected and all containers that house the valves were also disinfected.
- The sinks were disinfected in between scopes.
- The scope cabinet was thoroughly cleaned and disinfected.
(These measures have been adopted and will be used in the center)
Further investigation on infection control from the National Center for Continuing Education revealed high level disinfection is all that is required for semi critical equipment-endoscopes. The module states the high level disinfection destroys all forms of microbial life except high numbers of bacterial spores.
In addition, the center contacted their managing firm, the manufactures of the AER, the scope manufactures, and other center directors for assistance.
It was suggested that the center use another technique to test the scopes. On September 20th the scopes were retested using 20 cc of sterile water thru the lumen of the endoscopes at the biopsy port and collected in a sterile specimen container at the tip.
On September 24th Quest Diagnostics called the center director with the results from the sterile water tests through the scopes. The samples from scopes 7 and 8 had leaked out of the container and the remaining ten samples showed no growth. This has lead to the conclusion that the lumens of the scopes are being disinfected properly.
The Johnson and Johnson Field Service technician tested the AER and found it to be functioning properly and the settings for wash times and soak times per manufactures recommendations. A test was conducted on a scope immediately after it was removed from the AER and it was found to have excess water. The psi on the AER was increased to improve water removal from the scopes.
Water samples were taken to determine the effectiveness of the filters on the AER. These were taken at the Inlet and Outlet valves, the basin, and the drain outlet. A sample of the tap water was also taken as a control.
The water testing revealed several clues as to the possible source of the positive spore tests.
- Tap water- heavy growth of gram positive rods
- Unit #1
o Water inlet-heavy growth positive rods
o Filter outlet-heavy growth gram positive rods
o Basin Fill- light growth gram positive rods
o Drain- no growth
- Unit #2
o Water inlet-heavy growth positive rods
o Filter outlet-heavy growth gram positive rods
o Basin Fill- light growth gram positive rods
o Drain- no growth
The filters appear to be removing most contamination from the water. Manufacturers directions for the filters state that the device does not treat the water and the filter should be sanitized on a regular basis.
The Fujinon representative observed the steps in reprocessing for breaks in technique. No breaks were noted, however, he did offer several tips. Another in service on reprocessing was done for the staff.
Conclusion
According to the standards of practice by SGNA, ASGE, Advanced Sterilization, and Fujinon, the scopes that are being used are being disinfected adequately. The center will continue to monitor every patient for post operative infections and retest the endoscopes at intervals to be determined by the QM committee.
It was determined that the bacillis spores most likely came from the tap water and the AER is doing its job. The center will also be sterilizing the filters and AER’s between the monthly filter changes with the manufacturers recommended product.
As an extra measure for the improvement in infection control, the scopes will be wiped with alcohol immediately prior to being taken into the O.R.