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Based on observation, staff interview, and review of facility policies, autoclave records, and manufacturer's instructions, the hospital failed to properly reprocess LMAs prior to reusing the devices. In addition, the facility failed to monitor staff practices for compliance with infection control standards and, further, failed to ensure dust and debris were contained in a construction area. The cumulative impact of these deficiencies was a determination the hospital failed to meet the requirements for the condition of participation in infection control.

Refer to A940 for details of the hospital's failure to properly reprocess LMAs prior to reuse. Refer to A749 for details regarding noncompliance with infection control standards of practice.

Based on observation, staff interview, and review of hospital policies and manufacturer's instructions, the hospital failed to ensure staff followed manufacturer's instructions and established policies for reprocessing 36 of 36 LMAs between patient uses. Also, the hospital failed to implement safeguards to contain construction dust and debris from 1 of 1 remodeling projects within the sterile processing area. In addition, the hospital failed to ensure staff understood and applied the correct contact time for a chemical disinfectant, and failed to remove 2 of 12 expired bottles of disinfectant from use. The findings were:

1. Periodic observations throughout the day on 11/8/11 revealed the following concerns with reprocessing LMAs between patient uses:
a. Hospital staff failed to properly reprocess LMA devices as required by the device manufacturer prior to reusing these airways in subsequent surgical cases. Review of the manufacturer's instructions for reprocessing LMAs on 11/8/11 at 9:40 AM revealed a requirement to sterilize the airways prior to reusing them. Review of sterilization records and LMA reuse logs on 11/8/11 at 10:10 AM showed 36 LMAs were reused 108 times in the last 60 days, but there was no evidence to show these devices had been sterilized prior to reuse. Interviews with the sterile processing supervisor on 11/8/11 at 9:45 AM and with the OR nurse manager on 11/8/11 at 2:30 PM confirmed the facility did not sterilize LMAs between uses, although both stated they were familiar with the manufacturer's requirement to sterilize airways prior to reuse.
b. The infection control nurse stated in interview on 11/8/11 at 2:40 PM the facility's policy for cleaning and reusing anesthesia supplies, such as LMAs, required staff to follow the manufacturer's instructions. The infection control nurse further stated it was her expectation that the manufacturer's instructions be followed without deviation.

2. Observation in the decontamination room of the sterile processing area on 11/8/11 at 8:40 AM showed the following concerns:
a. The floor and horizontal surfaces in the room were covered with a layer of dust. Two holes in the room's walls were observed, each exposing plumbing lines. The sterile processing supervisor, CST (central sterile technician) #2, stated a contractor was remodeling the sterile processing area and had removed a sink and flush hopper from the walls. The supervisor stated the contractor should have put a plastic barrier over the work site to contain the dust.
b. Between 8:45 AM and 9:10 AM surgical personnel were observed entering and exiting the decontamination room, walking through the dust on the floor and returning to the OR suites. There were no precautions in place to contain the construction dust or minimize the transfer of construction dust from the decontamination room, through the surgical corridor, and into the OR suites while the suites were being prepared for the next surgical case.
c. Interview with the infection control nurse on 11/9/11 at 9:35 AM revealed the original remodeling project in the sterile processing area had not included relocating the sink and flush hopper described by CST #2. The infection control nurse further said the infection control risk assessment did not address dust abatement in the decontamination room and, therefore, the unscheduled work was not coordinated through the infection control program.

3. Periodic observations of cleaning the surgical suites between cases on 11/8/11 showed the following concerns:
a. Observation on 11/8/11 at 9:20 AM showed surgical technician #2 entered the decontamination room and removed items from a stainless steel cart; the items were from previous surgical cases and were waiting to be washed, wrapped, and sterilized for reuse. The technician sprayed the table top and shelf with a chemical disinfectant and immediately wiped the surfaces with a cloth towel. As noted above, the room was undergoing an unscheduled renovation project and the floor and horizontal surfaces were covered with dust. The table was pushed into OR #1 and supplies for the next surgical case were placed on the top shelf of the cart.
b. Review of the product label information for the disinfectant used by surgical technician #2, RE-JUV-NAL 16, showed the product required a minimum of 10 minutes wet exposure time to disinfect environmental surfaces. Surgical technician #2 stated in interview on 11/8/11 at 9:50 AM that she was not aware the product required 10 minutes exposure to disinfect and acknowledged she just "...sprayed and wiped..." to avoid delays in preparing for subsequent surgical cases.
c. Observation of the room turnover (cleaning between cases) of surgical suite #2 on 11/8/11 at 11:10 AM showed surgical technician #1 also used RE-JUV-NAL 16 disinfectant to wipe down the tables, trays, bed, foot rests, arm rests, and for overall cleaning of the room. Observation showed the disinfectant was sprayed on or wiped on with a cloth. In none of these observations was the wet exposure time a minimum of ten minutes as required. Interview with surgical technician #1 at 11:10 AM revealed she usually just sprayed and wiped and thought the disinfect should remain wet on the item for ten seconds. She said she really did not know for sure because she had not read the label directions.

3. Observation in the anterooms adjacent to the four OR suites on 11/8/11 at 10:15 AM showed 2 of 12 spray bottles of chemical disinfectant were expired, one was labeled with an expiration date of 10/25/11 and the other showed an expiration date of 4/25/11. Both spray bottles were available for use.

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Based on observation, staff interview, and review of facility policies, sterilization records, and manufacturer's instructions, the hospital failed to properly reprocess 36 LMA devices as required by the device manufacturer. The hospital further failed to accurately account for reusable LMA devices, and failed to follow policies and procedures for reprocessing anesthesia supplies. The cumulative effects of these failures resulted in an immediate jeopardy situation due to the increased risk to patient health and safety. The findings were:

Observation of the surgical area on 11/8/11 beginning at 8:30 AM revealed LMAs were utilized during general anesthesia. The following concerns were identified:
a. On 11/8/11 at 9:15 AM, an LMA was observed in the decontamination room of the sterile processing area. CST (central sterile technician) #2 cleaned the airway in an enzyme-enhanced detergent, rinsed it with tap water, and loaded it into an automated washer. After washing and drying, the LMA was sealed in an instrument wrapper by CST #1. The packaged LMA was placed on a stainless steel cart. When asked by a surveyor, CST#1 replied on 11/8/11 at 9:25 AM that LMAs were autoclaved (sterilized) "...when we have time, but we don't always have time to autoclave them..." A follow-up interview with CST#2, the sterile processing supervisor, confirmed LMAs were not routinely sterilized between uses and she stated the devices had not been sterilized "...for a couple of months..."
b. The manufacturer's instructions for reusing LMAs were reviewed with CST #2 on 11/8/11 at 9:50 AM. The manufacturer required that LMAs be washed, visually inspected, and sterilized before reusing the airways on other patients. A telephone interview with a manufacturer's technical representative on 11/8/11 at 1:10 PM confirmed that LMAs must be sterilized before being reused. The technical representative stated the airways were only reusable if reprocessed as specified in the instructions; she further stated the manufacturer did not recognize or endorse any reuse protocols that did not include terminal sterilization. The CST confirmed the facility was not complying with the manufacturer's requirement to sterilize airways between uses.
c. On 11/8/11 at 9:40 AM the LMA tracking logs for the last 2 months were reviewed. These documents consisted of 75 records identifying each LMA in the hospital by serial number, size, unique color coding, and the number of times each airway had been used; 5 additional records were folded and filed in a separate document protector. From the 75 LMA tracking records, it was discovered that 36 LMAs were reused a total of 108 times between 9/7/11 and 11/7/11. Autoclave records for the same period were reviewed on 11/8/11 at 10:05 AM; according to these documents none of the 36 LMAs used in the past 2 months had been sterilized. CST #2 stated in interview on 11/8/11 at 10:15 AM that the autoclave logs for the last 2 months did not include any LMAs and reiterated that LMAs were not sterilized between uses. The CST stated the 75 records in the LMA binder were actively tracked for reuse, the 5 records filed in a separate document protector were LMAs that had not cycled through the sterile processing room in the last 12 months; she was not sure if the devices were still in service or had been retired from use.
d. Interview with the OR nurse manager on 11/8/11 at 1:50 AM confirmed the hospital did not sterilize LMAs before reusing the airways on other patients. He further stated the facility had not contacted the manufacturer to determine if the lack of sterilization between uses was an acceptable practice for the reusable airways.
e. On 11/8/11 at 2:40 PM, the infection control nurse provided a copy of facility policy SS-3600, "Cleaning of Anesthesia Supplies", dated 01/29/2009. The policy required hospital staff to process "...LMA airways per manufacturer's recommendation..." and further required each item be washed and visually inspected to ensure the airway was acceptable for reuse. The infection control nurse stated at this time that she was not aware LMAs were no longer being sterilized and, further, stated her expectation that the manufacturer's instructions for reprocessing be followed without exception. She added that hospital policies required any changes potentially impacting infection risks to patients be reviewed by the infection control committee prior to implementation.
f. Quarterly meeting minutes for the surgical department and the infection control committees were reviewed on 11/8/11 at 3:15 PM; these minutes summarized committee activities for 2010 and to date in 2011. These documents failed to show any evidence that policies and procedures for reprocessing LMAs were addressed, discussed, or modified. The medical staff coordinator assisted with the review and confirmed there was no evidence to show LMAs, reprocessing techniques for surgical devices, or modifications to existing policies for cleaning and reusing anesthesia supplies was discussed at medical staff meetings or the surgery and infection control subcommittees.

Failure of the facility to adhere to the manufacturer's requirements for reusing LMAs, failure to follow established policies and procedures, and failure to verify modifications to the reprocessing protocol with the manufacturer resulted in a determination of immediate jeopardy on 11/8/11 at 2:38 PM. The hospital's action plan was accepted on 11/8/11 at 4:50 PM and the immediate jeopardy situation was abated at 5:10 PM. The abatement was based on the fact the staff were educated in the proper care and handling of LMAs according to manufacture's instructions, and hospital staff collected LMAs in the facility and reprocessed the devices as specified by the manufacturer. The reprocessing of LMAs was observed in progress on 11/8/11 at 4:10 PM and autoclave records were reviewed on 11/8/11 at 5:25 PM. The OR nurse manager stated in interview on 11/9/11 at 9:30 AM that a total of 53 LMAs were retrieved and sterilized, he stated these were all the LMAs in the hospital. When asked by a surveyor why sterile processing had been tracking 75 individual LMAs, he attributed the discrepancy to outdated or inaccurate records.

Based on staff interview and review of hospital documents, the hospital failed to have in place an organizational chart for delineating lines of authority and delegation of responsibility within the department of surgery. The findings were:

Interview with the surgical services manager on 11/9/11 at 10:01 AM revealed the only organizational chart available was for the entire hospital and showed only that the surgical services manager reported to the chief nursing officer. It did not delineate lines of authority and delegation of responsibility within the department of surgery specifically. Review of the hospital wide organizational chart provided by the surgical services manager confirmed this statement.

Based on staff interview and review of hospital documents, the hospital failed to ensure an operating register of surgical procedures was maintained. The findings were:

Interview with the surgical services manager on 11/9/11 at 10:01 AM revealed the surgery department did not maintain a register of surgical procedures including the patient's name, the patient's hospital identification number, the date of the operation, the inclusive or total time of the operation, the name of the surgeon and any assistants, the name of nursing personnel, the type of anesthesia used and name or person administering it, the operation performed, the pre and postoperative diagnoses, and the age of the patient. Interview with the Director of Quality Improvement on 11/9/11 at 10:30 AM confirmed there was no surgery log maintained.