HospitalInspections.org

Based on observation, staff interviews, and hospital documentation review, the hospital failed to provide a safe environment and maintain an active infection control program (IC).


Findings:


1. On 10/27/15, between 9:15 a.m. and 10:20 a.m., surveyors toured the hospital.


Observations:

Surgery Department:

~Door separating central processing and package receiving area was open.

~Equipment room in semi-sterile corridor contained corrugated boxes.

~Equipment room in semi-restricted area had non-washable ceiling tile (AAMI 2010 - The floor, walls, ceiling, and work surfaces should be constructed of non-porous materials that will withstand frequent cleaning and wet conditions.)

~Sterile Processing manager's office with desk, covered with papers, was within the semi-restricted area near wrapping area.

~No hand washing sink in endoscopic decontamination room (AAMI 2010 The decontamination area should also include space for...hand hygiene facilities.)


2. On the tour, surveyors interviewed an endoscopic technician (endo tech) regarding the cleaning and disinfecting of endoscopes.

~The endo tech stated that the use of the Air Water (AW) cleaning adapter was not part of the bedside pre-cleaning process.

~Surveyors reviewed manufacturer's reprocessing manual for endoscope (PCF-H 190L/I). The manual stated in the pre-cleaning instructions, "Detach the air/water (AW) value from the endoscope and place it in the detergent. Attach the AW channel cleaning adapter ..."

~Surveyors reviewed a policy titled, "Cleaning and Processing Flexible Endoscopes & Accessories", revised 3/27/15, which stated, "Flexible endoscopes should be cleaned and stored in accordance with the manufacturer's written instructions...Pre-cleaning of flexible endoscope...includes wiping the external surfaces of the endoscope...and cleaning the channels..."

~The hospital policy and the pre-cleaning process described the endo tech did not follow manufacture's instruction.


The hospital did not follow the manufacturer's cleaning guidelines for the endoscopic retrograde cholangiopancreatography (ERCP) endoscope.

~The manufacturer of the ERCP scope (TJF 160 VF) had issued an instruction update which included the cleaning addition of a designate type of cleaning brush.

~The endo manager stated she was unaware the manufacturer had issued a revised version of the manual (dated 09/15/2015). The manual specifies a required cleaning brush (MAJ-1534).

~On 10/27/15, both endo nurse manager and endo tech stated that the ERCP pre-cleaning process did not include using a specific brush.

~Review of a hospital document titled, "Safety Matters Alert Flexible Endoscope Reprocessing", dated 02/25/2015, stated, "...Follow closely all manufacturer instructions for cleaning and reprocessing ... "

~ Review of another document titled, "Flexible Duodenoscope Reprocessing" stated, "...following strict adherence to the manufacturer's written reprocessing".


The hospital did not follow their policy regarding the reprocessing of stored endoscopes.

~Surveyors reviewed a policy titled, "Cleaning and Processing Flexible Endoscopes & Accessories", revised 3/27/15, which stated, "...Flexible endoscopes should be reprocessed before use if unused for more than five days ..."

~On 10/25/2015, surveyors requested and reviewed the reprocessing logs for automatic endoscopic reprocessors (AER) from 08/1/2015 through 10/22/2015.

~The logs revealed that a specified endoscope was reprocessed on 08/28/2015, and was not reprocessed again until 09/25/2015.


3. The filters of the two automatic endoscopic reprocessors (AER) designated as "A and B" were not changed per manufacturer's guidelines. The manufacturer requires the filters to be changed every 3 months.

~Review of the "Automatic Endoscopic Reprocessor Filter Log Sheet" documented filter change of both machine A and B were performed on 03/13/2015, and 04/08/2015. The filters were not changed again until 10/05/2015.


4. On the afternoon of 10/28/15, the infection preventionist provided surveyors with the AER cycle error logs from 03/2015, and 04/2015.

~Surveyor identified eleven errors in the cycle logs.

~The endo manager stated there was no policy regarding management of error cycles.

~Each AER machines had 2 chamber that independently reprocesses one endoscope per cycle.

~The endo manager stated that she was unable to identify by the logs which chamber had the cycle error.


5. Staff used the autoclaves located in the sub-sterile area between the operating rooms to routinely sterilize full instruments sets, in addition to any emergency use. (The purpose of the autoclaves in the sub-sterile is to have the availability to flash/provide immediate use steam sterilization of an instrument needed in emergency situations so as not to have to leave the operating suite space.) This finding was confirmed by autoclave tape review for October 2015, and interview with Staff T on 10/28/2015, between 10:50 a.m. and 11:35 a.m.

~Examples included, but not limited to:

On 10/06/2015, Sterilizer #4 - 6 sets of eye instruments at 4/10 (4 minutes sterilization and 10 minutes drying time);

On 10/14/2015, Sterilizer #3 - 2 loads (load #3 and #4) of 2 laparoscopy (lap) cholecystectomy (chole) sets at 4/10;

On 10/20/2015, Sterilizer #4 - 7 loads of various instruments at 4/10 and 4/20; and

On 10/22/2015, Sterilizer #5 - 3 loads of lap chole instruments.

6. On 10/28/2015 at 11:30 a.m. Staff T stated most instruments, including eye instrument sets, were manufactured by V. Mueller.


The V. Mueller Products and Services General Surgical instrument sterilization Guide:
Parameters for Wrapped Instrument in Steam Sterilization documented, "...Prevacuum Sterilization 270ºF 4 minutes, 30 minute drying time..."


~On 10/28/2015, at 11:30 a.m., Staff T stated the unit had 3 eye sets and performed 5-7 cases each scheduled day.

a. Staff T stated the sterilization settings for eye sets were being done in the sub-sterile autoclave with the temperature of 270° (degrees) F (Farenheit) for 4 minutes sterilization and 10 minutes drying time throughout the day.


b. Staff T told the surveyor that at the end of day, the all the sets were taken to the central processing autoclave and autoclaved at 270° F for 4 minutes sterilization time and 40 minutes drying time.


c. CMS Ref: S&C: 14-44-Hospital/CAH/ASC 8/29/15, "...Therefore use of IUSS (immediate use steam sterilization), even when all steps are performed properly, should be limited to situations in which there is an urgent need and insufficient time to process an instrument by using terminal sterilization... "



7. On 10/27/2015, the surveyors were told the hospital sent "some" single-use items to an outside vendor for reprocessing.

~The facility did not maintain documentation that the company who processed the single-use items had been approved by the FDA to reprocess.

~The documentation provided on 10/28/2015 did not specify what instruments sent to the outside source had been approved by the FDA for reprocessing.


8. On arrival on the morning of 10/27/2015, the surveyors requested infection control plan for 2015 and meeting minutes, all monitoring/surveillance performed. The data identified as Infection Control was not provided until 10/28/2015.

a. Infection Control Surveillance:

~The data provided only showed hand washing and laboratory culture data. The hand washing surveillance did not demonstrate all areas of the Edmond Campus were monitored and did not show surveillance of hand hygiene related to gloving (putting on and taking off gloves) or all the required times for hand hygiene per CDC (Centers for Disease Control) or WHO (World Health Organization) guidelines.

~Environmental surveillance was not provided, including monitoring of disinfectant application.

~The Infection Control Risk Assessment only contained the summary sheet with numerical totals and no description of how those numbers were determined.

~ Surveillance tools for required NHSN (National Healthcare Safety Network) data were being completed by electronic record review off-site.


b. On 10/28/2015, between 12:45 p.m. and 1:00 p.m., the surveyor interviewed the persons identified as responsible for infection control, Staff J, L, and S, with Staff L designated as the main staff assigned to the Edmond Campus.

~Staff L stated she only visited the campus 4 times a month. She stated she visited the intensive care units, medical/surgical units and the emergency department. She stated she also "spot checked" patients with Foleys/urine catheters.

~Staff J and L stated they had not performed documented surveillance on any part of the surgical area - emphasis on processes. Staff S did not comment.

~Staff J and L stated they had not performed surveillance on disinfectant application. Staff S did not comment.

~Staff J stated she completed electronic chart review and surveillance for infections and went on environmental rounds.


c. Infection Control Meeting Minutes:

a. On 10/28/2015, two different meeting minutes were provided to the surveyors for review. Staff J identified the meeting minutes as the infection control minutes:

~"Healthcare Associated Infections Team" - Recorded that the NHSN data was reviewed; however, no analysis or strategies for improvement were provided to the surveyors.

~"Hospital Acquired Conditions PI Leadership Committee" - The meeting minutes contained NHSN data and vague discussions of pilots with no specific analysis or improvement strategies.


b. On 10/27/2015, at 9:45, Staff P had provided the "Patient Care Committee Meeting Minutes".

~The minutes contained hospital acquired infection data and documented there was discussion, but did not show analysis or strategies for improvement.

~The minutes did not contain evidence all areas, where patient care occurs, were included in infection control activities - such as respiratory or physical therapy.

~The 07/04/2015 meeting minutes documented Clostridium difficile as one patient in April and two patient in May. On 10/28/2015, the surveyors requested the total number of cases of Clostridium difficile specifically for the Edmond Campus. The document provided contained five patients (date rage 06/04/2015 to 09/02/2015).

Based on review of hospital documents and staff interview, the hospital failed to ensure the appropriate types and numbers of qualified personnel for surgical services.


Finding:


On 10/28/15, at 10:00 a.m., Staff B stated during endoscopic procedures performed at the bedside, in the Emergency Room (ER) and the intensive care unit (ICU), two staff assisted the endoscopist. Staff B stated the two staff consisted of a registered nurse (RN) and an endo technician.


The RN administered moderate sedation and monitored the patient. Staff B stated no staff functioned in the role of circulating nurse.


On 10/28/15, surveyors reviewed a policy titled, "Sedation and Analgesia by Non-Anesthesiologist" effective 3/2012, which stated, " ...The registered nurse...responsible for monitoring the patient, and documentation thereof, shall have no other responsibilities that would require the compromise of continuous monitoring or leaving the patient unattended... "


Oklahoma Board of Nursing guideline titled, "Moderate (Conscious) Sedation Guidelines for Registered Nurse Managing and Monitoring Patients", revised 5/20/2015, documented, "...The Registered Nurse administering, managing and/or monitoring moderate (conscious) sedation shall have no other responsibilities during the procedure that would leave the patient unattended or compromise continuous monitoring..."