HospitalInspections.org

Based on interview and record review, it was determined the hospital's governing body (GB)failed to ensure the infection control program was integrated to include all three campuses listed under their provider number and that their infection control program was functioning.

The GB also failed to ensure that all campuses of the hospital were moniored and overseen as part of the overall hospital operations.

Findings include:

1. The hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital also failed to develop and maintain an active program for the prevention, control, and investigation of infections and communicable diseases. (Refer to tag A-747)

2. On 8/5/19 at 9:15 AM, an interview was conducted with the director of plant operations (DPO). The surveyor asked the DPO if he worked with the plant managers from the other campuses to coordinate the Legionella plan. The DPO stated that he worked with the plant manager of the west campus but did not work with the plant manager from the Mountain Point campus. The DPO stated that Mountain Point campus worked as an independent facility. The Mountain Point campus had different leadership from the main facility and the west campus. The DPO stated the DPO at the Mountain Point campus was not willing to participate but would rather "do their own thing".

On 8/5/19 at 3:15 PM, an interview was conducted with the Infection preventionist (IP). The IP stated that she tracked infections for the main and west campuses. She did not track infections for Mountain Point. The IP stated there was someone at Mountain Point that did infection control. The IP stated that the person who tracked infections was also over other departments of the hospital. The IP stated that she did not have the authority to look at some of the infection documentation at Mountain Point. The Mountain Point infection control person would send infection information over on a spread sheet, but the IP has taken it upon herself to do some of the surveillance to ensure it was done. The IP stated that the person doing infection control at Mountain Point was not certified nor had they had training. The IP stated that she had given the person APIC (Association for Professionals in Infection Control and Epidemiology) and NHSN (National Healthcare Safety Network) training information but the person has not done any training yet.

The Mountain Point Campus is Medicare certified as a campus of Jordan Valley Hospital, and not an independent hospital.

Based on observation, interview, and record review, it was determined that the hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital also failed to develop and maintain an active program for the prevention, control, and investigation of infections and communicable diseases.

On 7/31/19 a finding of Immediate Jeopardy (IJ) was identified in the area of Infection Control. The hospital was notified of this finding on 7/31/19 at approximately 5:30 PM. The Hospital submitted an IJ removal/abatement plan on 8/1/19 at 8:31 AM, alleging removal as of 8/1/19 at 6:55 AM. The plan was accepted and the hospital was notified at 8:52 AM on 8/1/19. Surveyors were on site and reviewed for IJ removal. It was determined that IJ had been removed on 8/1/19 at 6:55 AM, as indicated in the removal plan - the hospital was notified of this at 4:40 PM on 8/1/19.

Findings include:

1. On 7/31/19 at 9:59 AM, an interview was conducted with the central processing (CP) manager. The CP manager stated each day a chemical indicator was placed in each washer to ensure the washer was properly cleaning the surgical instruments. The CP manager stated there had been an issue with the washers about a month ago because they ran out of salt for the water softener. The CP manager stated at that time CP staff began hand washing surgical instruments and sending them to the hospital's "west" campus for sterilizing. The CP manager stated that she would run a Bowie Dick test (tests which evaluate the performance of prevacuum sterilizers by confirming adequate air removal from the sterilizer chamber) on the facility's steam sterilizers every morning prior to running the first load of instruments to be sterilized. The CP manager stated she would normally run the test with the Bowie Dick test kit only. The CP manager stated that there were times that an instrument pack would be needed for the first surgery of the day so she would sterilize the instrument pack while performing the Bowie Dick test. The CP manager further stated she did not know when the hospital's steam sterilizers had last been cleaned. The CP manager stated the steam sterilizers were supposed to be cleaned by the manufacturer once a year and that she had requested cleanings on both of their steam sterilizers but it had not yet been scheduled.

On 7/31/19, a review of the steam sterilizer logs for 7/1/19 through 7/31/19 was completed. On the following dates an instrument pack was sterilized at the same time as the Bowie Dick test:

a. 7/1/19 - sterilizer 3 (sterilizer in the outpatient surgical center)
b. 7/8/19 - sterilizer 2
c. 7/29/19 - sterilizer 1
d. 7/30/19 - sterilizer 1
e. 7/30/19 - sterilizer 2

A review of the Bowie Dick test instructions was conducted. The instruction manual indicated that the Bowie Dick test was to be completed in an empty chamber.

On 7/31/19 at 2:00 PM, an interview was conducted with the director of surgery for the West campus. The director stated that no instruments were to be sterilized when a Bowie Dick test was performed.

On 7/31/19 at 1:25 PM, a follow-up interview was conducted with the CP manager. The CP manager stated her and her staff completed a descaling on each washer once a week but that was the only maintenance her staff had been completing on the washers. The CP manager further stated CP staff did not complete any type of maintenance on their steam or chemical sterilizers.

On 7/31/19, the survey team reviewed the "Washer Test" forms which revealed whether or not the washers used to clean surgical instruments were functioning appropriately. Washer tests were reviewed from 6/27/19 through 7/31/19. On the following days the tests came back as failed:

a. On 7/30/19 washer 1
b. On 7/24/19 washer 2
c. On 7/19/19 washers 1 and 2
d. On 7/9/19 washers 1 and 2

The "Washer Test" forms were reviewed against the hospital surgery list for July 2019. There was no "Washer Test" forms verifying the test had been completed for the following dates in July when surgery had been conducted: 1, 2, 3, 5, 6, 8, 11, 13, 14, 17, 18, and 21.

On 7/31/19 at 12:34 PM, an interview was conducted with the biomedical manager. The biomedical manager stated that he did not do any maintenance on the sterilizers or washers. He stated he did not know what the CP staff did for regular maintenance and cleaning on the machines. The biomedical manager stated he thought that the service representative for the machines came out once a year to service the machines.

On 7/31/19 at 3:07 PM, an interview was conducted with CP technician 1. CP technician 1 stated each day a chemical indicator was placed in each washer to ensure the washer was properly cleaning the surgical instruments. CP technician 1 stated if the test failed CP staff were to run another test. CP technician 1 stated if the second test passed no other remediation was necessary, however if the second test failed that the manufacturer of the washer, Steris, was to be notified and no other surgical instruments were to be put through the washer. CP technician 1 stated he had not been the one completing the washer tests, but that the CP manager had been completing the tests.

On 7/31/19 at 4:17 PM, a telephone interview was conducted with the CP manager. The CP manager confirmed she was the one who had been completing the washer tests. The CP manager stated the test completed in washer 1 on 7/30/19 had failed, but that "I was told if it fails that is fine," because it was most likely just that the clamps that the chemical indicators were placed in were too "stiff". The CP manger stated she marked that the chemical indicator came out as failed because she could see pink coloration left on the indicator and, "you are not supposed to see the pink" after the cycle was over. The CP manager confirmed she had marked several chemical indicator tests over the last month as failed after being run through the washers, and had not completed a second test or any other remediation. The CP manager confirmed that even if an indicator test failed surgical tools continued to be ran through the washers and then sterilizers. The CP manager stated she had talked with CP technician 1 after he had spoken with the survey team, and that she was now aware of the retesting process if an indicator failed. The CP manager further stated she had never been trained on performing washer tests and when she had started, about two months ago, she did not even know washer tests were supposed to be done. The CP manager then stated, "I am learning as I go". The CP manager stated she found expired chemical indicator tests for the washers, and that was how she determined washer tests were supposed to be conducted. The CP manger stated she ordered new indicators and began testing, but did not begin testing the washers daily until she had eventually found out what the process was supposed to be. The CP manager stated she had no documentation to indicate the washers had been tested prior to her start date, and confirmed the washer tests had been being conducted only sporadically until recently. The CP manager stated the only training she had received since starting at the hospital was, "they print out a piece of paper and say here read this or figure it out on your own." The CP manager stated there had been no formal education or training to any member of the hospital's CP staff since she had been hired.

On 8/6/19, a review of the operation manuals for both the steam sterilizer and the washer was completed. Both manuals indicated that preventative regular maintenance was required and each manual contained a routine maintenance guide with detailed instructions to follow.

On 8/1/19 at 9:18 AM, an interview was conducted with the CP manager and two representatives from the manufacturer of the hospital's surgical instrument washers and sterilizers. One representative stated he completed annual preventative maintenance on the equipment but the hospital should be doing the weekly, monthly, and quarterly maintenance that the manufacturer recommends. The representative stated the pictures of the hospital's sterilizers were concerning due to evidence of "black specks" on the inside of the sterilizers. The representative stated CP staff should be climbing inside the sterilizer's to clean and inspect them once a month. The second representative then added that the sterilizer screens should be cleaned once a day. The CP manager stated neither of those things had been been done because the sterilizers were "always" at 240 degrees Fahrenheit and staff would get burned. The second representative stated CP staff should have oven mitts to check the screens and that the sterilizers should be turned off for at least eight hours prior to staff climbing into them to clean. The CP manager stated she did not know that should have been conducted.

On 7/31/19, an interview was conducted with a central processing technician (CPT). The surveyor noted a large metal panel sitting on the floor next to one of the Autoclaves. There was a large opening that revealed plumbing for the autoclave that was covered in dust. The CPT stated the panel was used to cover the mechanical parts of the autoclave and it had been sitting on the floor since the time she had started working there, which was approximately 2 months.

On 8/1/19 at approximately 10:00 AM, surveyors observed several dark, burnt looking spots on the inside of the autoclave. At that time an interview was conducted with a central processing technician. She stated the dark spots are "normal wear and tear" on the autoclave.

2. An incident report was reviewed and revealed the following information; "On Sunday 6.23.19 at 10:18 a.m., the CPD (central processing department) tech (technician) noted there was a residual film on the instruments while processing. The CPD tech notified the CPD Manager of her findings. The CPOD (sic) manager advised the CPD Tech to enter a work order for Plant Operations. The CPD Manager notified the OR (operating room) director the morning of 6.24.19. The OR director spoke with plant ops (operations) and emailed administration with her concerns for the integrity of the instruments. The biological/chemical indicators were ok. Bacterial vs. (versus) chemical like residue found on the instruments as well as water staining. Plant Operations feels this may be due to salt imbalance in the water system as we traditionally would add salt to soften the water, the process to balance out the chemicals added in this particular region. The Salt Bine (sic) is empty. The salt has not been resupplied for approx.. (approximately) 2-3 weeks due to bills not being paid at the corporate level ...The salt will be delivered to JV (Jordan Valley) on 6/25/19 and we can see what happens when added back to system. There is also an issue at the Ambulatory Surgery CPD site with spotting on the instruments. May be a drying issues there? West Valley Campus- no reported issue thus far. We have canceled cases here and have cases scheduled for 6/25. Per our Corporate IASIS policy and AORN, we need to reprocess and resterilize all instruments borrowed from our sister facilities. Corporate call scheduled for 6/24 @ (at) 1730 (5:30 PM) hrs Outcome of corporate call was as follows:

1. (Vendor who assisted hospital in water managment) to arrive onsite to conduct a water analysis on the main campus and the Surgery Center on 6/25 @ 1730 hrs

2. All dirty instruments will be decontaminated at JVMC prior to being transported in red biohazard puncture resistant container to JWVC. All instruments will be processed and sterilized at JWVC until a root cause is identified. JVMC CPD staff will maintain custody of instruments during transportation and processing/sterilizing to and from JVMC and JWVC. Scheduled OR cases will proceed on 6/25/19 with the sterilization occurring at JWVC.

3. Sterilizer Vendor...will arrive onsite 6/25 a.m. to conduct an assessment on the sterilizers on the Main Campus and provide a report of findings.

4.1 pallet of salt to arrive at JVMC on 6/25 a.m.

5. All patients potentially impacted by this incident are logged with CQO/Risk Director

6. Root Cause Analysis to be performed once analysis from outside parties has been completed."

2a. On 7/31/19 at 11:27 AM, an interview was conducted with the director of plant operations (DPO). The DPO stated he was notified on 6/23/19, at about 2:00 PM, by the CP manager that the surgical instruments had spots and film on them. The DPO stated he would come in and look at it, but that the CP manager told him they were done for the day so he stated he would be back on Monday morning to look at it. The DPO stated once he began looking into the issue he found that the hospital's water softener system had been out of salt for "about four to five weeks due to payment issues." The DPO stated he had previously notified administration and corporate that the salt vendor had threatened to cut off the hospital salt deliveries due to non payment, "but it went ignored until this happened." The DPO also stated the hospital had since installed a deionization (DI) system to help reduce issues with the water in central processing.

On 8/5/19, review of documentation concerning the lack of salt for the water softener and chemicals was completed.

An email was sent from the West campus on 5/22/19 which indicated, "Just an FYI (for your information) ...we are on credit hold with (name of vendor) and we are completely out of bulk salt at (West campus). (name of employee) is going to bypass the water softener so it doesn't keep cycling without salt. He mentioned he is also going to turn up the chemicals to the boilers to accommodate for hard water."

An email dated 5/22/19, was sent to administration with concerns over the lack of salt for the water softener at the main campus. The email indicated, "With this vendor placing us on credit hold and not supplying salt for the softeners, this will greatly impact our quality of water inside Hospital (sic) along with equipment (corrosion, then leaking pipes). Patient Care will be effected (sic). Our list of credit holds by vendors is getting out of control. We will soon be in a position of not being able to acquire critical services. This will be detrimental to Patient Care, Safety, Quality, and Sustainability of Hospital Functions".

An email was sent to administration with concerns over the lack of salt for the water softener at the main campus on 6/11/19 indicating "We are in critical need to get chemicals and salt into our systems before we have major equipment failures. We need accounts for (name of vendor) and (name of vendor) brought current asap (as soon as possible). (Name of vendor) supplies us with enzymes that we mechanical feed down drains in the grease traps and blood collection ports in the ORs (operating rooms) We are out of chemical in the OR (surgery) this causing waste (blood infected) to back up into the drains and onto the floors in Soiled Utility. This chemical keeps pipes clear and flowing. In the kitchen it keeps the grease from building up in the floor drains. If it backs up, we will contaminate the entire kitchen (health issue). We had one back up today. More will follow in the coming days.
Salt is used to soften the water we use. Without soft water systems, we will damage plumbing pipes, boiler tubes, steam lines and water supply system ....."

On 8/2/2019, the patient in room 170 on the Telemetry floor was interviewed. She had concerns with the drain in her sink not draining very well. The surveyor was asked by the patient to turn on the sink faucet and watch the drain. The surveyor did and it took at least a minute for the sink to empty. The patient also stated that she has been a patient at this hospital multiple times in the recent past and has noticed the slow drain issue throughout the hospital including the shower drains in the patient rooms. She was concerned with this issue because she is a cancer patient receiving chemotherapy and is immnocompromised.

An email sent from one of the vendors dated 6/20/19 indicated; "Is there anything I can do to assist your billing department. I would love to fill the two orders I have waiting." On the printed copy of the email was a hand written note indicating, "tried to order 6/5 - unable to process".

Documentation from the vendor that monitors and assists with water management at the facility was reviewed. The vendor sent a report to the facility dated 6/7/19, indicating; "Salt for the softeners will be out after the weekend. No time frame is in sight to fill the tanks due to issues between Steward Corporate and the salt vendor. Boilers will start to scale up and chemical usage will increase. (Vendor) cannot be held responsible for the system scale or failure from hard water passing into the boilers due to lack of salt for the softeners ..."

A report from the water management vendor dated 6/24/19, indicated; "Brine tank is out of salt. Hard water is going into the boilers. This can cause scale and corrosion issues. City water conductivity more than doubled on the main hospital side since my last visit. The surgery center city water water (sic) almost tripled since my last visit. (Vendor) cannot be responsible for the damage caused to the boiler systems because of the lack of salt in the brine tank. All boilers need to be calibrated Surgery center was the worst."

The delivery invoices for January 2019 through August 2019 were reviewed. Salt was to be delivered once a week to the hospital. No salt was delivered to the hospital between 5/14/19 and 6/25/19. The hospital went without a salt delivery for five weeks, according to documentation.

2b. On 8/1/19 at 5:07 PM, an interview was conducted with the chief quality officer (CQO). The CQO stated this incident had not been taken through the hospital's quality assurance program yet because there had been a lot of the team on vacation and surveys which "prevented" the hospital from having their scheduled meeting. The CQO stated surgeries were canceled on 6/24/19, but that some surgeries had already been completed so those patients were being tracked by the hospital's infection preventionist, but they had not been notified, "as we did not identify an infection risk." The CQO further stated the hospital had notified the physician's about the incident and they were informed to notify the hospital's infection preventionist if their patient returned to their office with an infection.

The survey team reviewed the surgery list from 6/24/19 and found that 13 surgeries were conducted.

On 8/5/19 at 4:32 PM, a follow up interview was conducted with the CQO. The CQO confirmed there was a delay in the timeliness of canceling surgeries on 6/24/19 because the OR director and herself were not notified until 6/24/19. The CQO stated she should have been notified "immediately".

On 7/31/19 at 10:20 AM, an interview was conducted with the surgery coordinator. He stated that sometime in June or July 2019 staff was noticing a "film" and brownish colored staining on surgical instruments after they came out of the autoclave. He stated the staining resembled rust. He stated they did not use the discolored instruments for surgical procedures because they did not know why this was happening or if the instruments were sterile. He stated it took the hospital "about a week" to figure out why this was happening to the instruments. He stated during that time the staff would visualize the instruments after opening them in the OR and if they did not see any staining then they would use the instruments. If they did see staining then they would get a different set of instruments. (Note: Instrument sets are opened on a sterile field by a sterile technician just prior to a surgical procedure being performed). He also stated during that time they were transporting some instruments to be sterilized at the west campus approximately 10 miles away. He stated this practice went on for about a week. When asked how they ensured the instruments remained sterile during transport he stated they would look at the wraps and if they looked intact then the instruments should still be sterile. (Note: Sterile instruments must be maintained at a specific temperature and humidity range to ensure continued sterility). He stated it would take approximately 4 to 6 hours from the time the instruments left to the time they would return. When asked about urgently needed instruments he stated staff would use their personal vehicles to transport the instruments back and forth.

On 7/31/19 at 12:34 PM, an interview was conducted with the biomedical manager (BM). The BM stated he was notified of a second incident regarding the hospital's water and a red staining on surgical instruments on 7/11/19. The BM stated the hospital had installed a new DI system to improve the water quality and that one of the tanks "ran out" and a new tank was not placed. The BM stated he believed the staining had occurred in part becasue the DI tank was not replaced when needed. The BM further stated he immediately contacted the manufacturer of the washers and sterilizers who came out on 7/12/19. The BM further stated the washers and sterilizers were on an alternative equipment maintenance (AEM) plan and were serviced once a year by the vendor. The BM stated if the equipment was not on an AEM plan the vendor would be out once a quarter. The BM stated he was unsure the last time the steam sterilizers were cleaned by the vendor because they had switched systems for tracking. The BM also stated the cleaning of the sterilizers was separate from the yearly preventative maintenance completed by the vendor. The BM stated any other routine maintenance required for the washers or sterilizers was supposed to be completed by the CP staff.

On 7/31/19 at 2:02 PM, an interview was conducted with the risk manager (RM). The RM stated there was a "new" incident in July when CP staff noticed a "redish discoloration" on the surgical instruments. The RM stated the hospital again sent all surgical equipment to be processed at their west campus "around the 11th or 12th" of July. The RM stated several tests were done to help determine the cause, but that the only issue identified was with the water. The RM stated the issue with the water was fixed and the discoloration went away. The RM stated the incident was not on the incident log because he had been on vacation recently, but that it should have been. The RM stated he would see what other information he had on this incident.

On 7/31/19 at 2:13 PM, an interview was conducted with the infection preventionist(IP). The IP stated they did not have an official policy on the transportation of surgical instruments between campuses but that they followed APIC (association for professionals in infection control and epidemiology) recommendations which applied to transportation of instruments. The IP also stated they called UDOT(Utah Department of Transportation) and confirmed it was appropriate to transport the instruments. The IP stated herself, administration, and corporate had determined the instruments needed to be transported in a rigid container and with CP staff at all times. The IP further stated "as far as I know they did not monitor the temperature or humidity" of the vans used to transport the surgical equipment. The IP stated CP staff was "talked" to about the process but there was no "formalized training". The IP stated all equipment was transported via hospital vans and courier service.

On 7/31/19 at 2:29 PM, an interview was conducted with the director of surgery (DS) at the West campus. The DS stated she believed the Main campus surgical instruments were processed at the West campus from July 8th through July 19th but would look into it. The DS provided a log with the list of instruments that were processed and sterilized at the West campus. The survey team could not determine what instruments were for the Main Campus as there was no documentation next to each entry.

On 7/31/19 at 4:28 PM, a follow up interview was conducted with the RM. The RM stated according to the documentation he had, the red discoloration on surgical instruments, "came up on the 11th" of July. The RM stated the CP technician reported that she observed "red stuff, maybe rust" on the instruments. The RM stated they investigated the issue and found that the water was discoloring and staining the instruments so new filters were installed and they were no longer having the issue. The RM stated he was unsure if the issue had occurred prior to July 11th because he was not aware of it until July 11th.

An email provided to the survey team by the RM dated 7/11/19, at 5:37 PM, from the DPO to several hospital staff members, including the IP, RM, CQO, BM, and hospital president. The email read as follows, "As a follow-up to our conversation today around 1130 MST (mountain standard time). We discussed (and you approved) to move forward with installing a permanent DI System (2 tank units) in CSP ... Shortly after our conversation, (DON) called me to her office around 2:25 pm. We meet (sic) with (names of the CQO, DON, OR manager, RM, and IP) and two CSP techs. The techs reported a finding of a substance in color similar to rust being found on instruments, notable more today this (sic) early this week. After discussion with local teams, we are not fully sure of causes however we know that the temp (temporary) DI tanks were depleted sometime in the last few days. I had a vendor deliver late this afternoon two more tanks. We are also working with Biomed and (name of vendor) to see if machine chemical cycles are correct. We may need to send sample instruments in for cultures to determine findings of rust, chemical residue, or something outside of water quality. We conducted two independent water test this week (Tues and Wed) and found that although Conductivity is still high (around 870) and sulfite is still little low (20) we have two test showing water quality is within acceptable ranges and softener is working correctly. More to follow as I don't believe we have fully conquered this project."

Note: The survey team was provided with conflicting information and was unable to determine when surgical instruments began being processed at the West campus and when exactly the red discoloration was noted on surgical instruments.

3. On 8/5/19 at 10:40 AM, an observation was made of endoscopy technician (ET) 1 while he cleaned two endoscopes. As ET 1 was manually cleaning the scopes, he attached a 60 milliliter (mL) syringe, and proceeded to flush both devices. After ET 1 flushed each scope he then slightly shook each scope as he held them up from the sink to get any residual water out. ET 1 then placed each scope in an automated endoscope reprocessor (AER). ET 1 stated that the AER rinsed and disinfected the scopes.

After surveyors observed ET 1 process the endoscopes, they reviewed the manufacturers instructions for all scopes used by the hospital. Each scope's manufacturers instructions indicated that as part of the manual cleaning process a rinse with clean water was necessary to ensure all chemicals used during the cleaning processes were appropriately flushed out of the scopes. All manufacturers instructions also indicated that an AER may be used to perform high-level disinfection of the scopes, but that all endoscopes "must" be pre-cleaned and manually cleaned according to the instructions. The manufacturer's instructions for the duodenoscope indicated flushing should be done with a 30 mL syringe (This is important in order to provide an adequate amount of pressure while flushing). Note: manually cleaning included a rinse with clean water per manufacturers instructions prior to high level disinfection.

On 8/5/19 at 1:07 and 1:31 PM, follow up interviews were conducted with ET 1. ET 1 stated he performed the exact steps observed by the surveyors for each scope he cleaned no matter what type. ET 1 stated it was his understanding that the AER rinsed the scopes so that he did not have to perform that step. ET 1 also stated he uses 60 mL syringes when cleaning all scopes and did not know a 30 mL syringe should be used on Duodenoscopes.


30334


4. On 8/5/19, the facility Legionella plan was reviewed. No documentation could be located to indicate that the facility had a list of team members who participated in the Legionella plan. No documentation could be located that indicated the roles and responsibilities of the team members.

Further review of the Legionella plan revealed no documented evidence that the facility had developed a schematic/flow diagram of the facility's water system.

On 8/5/19 at 10:37 AM, an interview was conducted with the director of plant operations (DPO). The DPO stated the facility would discuss the Legionella plan and surveillance quarterly in the environment of care meeting. The DPO stated that he would have to look for a list of the Legionella plan team members. The DPO stated that he was not aware that they needed to develop a schematic/flow diagram of the facility's water system. The DPO provided a list of titles of positions. The DPO stated that these were the people who were a part of the Legionella plan team. A review of the list revealed it was a list of recommended people that could potentially sit on the team. The list was provided by the water management vendor who assisted in the management of the plan.

The DPO stated that every quarter a preventative maintenance order would be generated to do Legionella water sampling. The facility would do random testing throughout the hospital then send the samples to the state lab for processing. The results would come back in approximately two weeks. He would review the results. If there were issues he would run the hot water and cold water for 2 hours each, collect a second water sample and send to the state lab. If the test came back negative they would do nothing further for that area. If the test came back positive they would call the vendor that assisted them with their Legionella plan and request a chlorine flush of the pipes. At that time the DPO was asked if they collected biofilm samples to be sent for testing. The DPO stated they did not, he felt there was no need to do so.

The DPO stated if an area had tested positive for Legionella in the past, he would add the room to the low use room scheduled maintenance order. Each week the housekeepers would run the hot and cold water for one minute each and flush toilets if applicable in each of the areas. A review of the work order revealed no identification of the location of the "low use rooms". There were specific areas that were identified such as the chapel. The DPO stated that housekeeping would determine which rooms were considered low use, but they did not specifically document the room numbers.

A review of the Legionella testing results revealed the facility chapel sink had tested positive in January 2019. The facility flushed the line with hot and cold water and retested the water. The second test came back negative. No further remediation was documented.

The chapel sink was again documented to test positive for Legionella on 6/26/19. The DPO stated that the facility had flushed both the hot and cold water facets for 2 hours each and sent a second sample for testing after the flush. On 7/10/19, the results of the second sample were again positive. No documentation could be located to indicate that further remediation had occurred. Also on 6/26/19, a sample taken from the plant operations sink tested positive for Legionella. No documentation could be located to indicate that the facility had completed any remediation at that location. The DPO stated at that time, that they had not held a meeting in July due to conflicting schedules and that they were to discuss these issues in the August meeting. The DPO stated they had not done any remediation for the positive Legionella cultures because it was from the low use areas of the hospital.

A follow up interview was conducted with the DPO on 8/6/19 at 11:00 AM. The DPO stated that the facility reviewed the Legionella plan once a year. The DPO stated that the facility did not review the plan when the water source changed twice every year, or when they changed equipment or did service on any piece of equipment that utilized water. The DPO stated they only reviewed the plan and made changes if they had issues with the plumbing or during a major construction project.

Communication sent 1/23/19

Based on observation, interview, and record review, it was determined the hospital and its infection control officer did not develop a sufficient system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel.

Findings include:

1. On 8/1/19, the hospital's incident log was reviewed. It revealed an incident dated 6/20/19 involving patient 6. It was documented on the incident log, "A surgical instrument was found after the case was over to have bio-Burden on it from another patient." (Note: bio-burden refers to some sort of human tissue that was adhered to the instrument). Upon review of the incident report it was documented;
"1. The instrument was removed from the sterile field however the contamination was already there and the case was nearing an end so they continued on. I was told about the incident the next morning.
2. The instrument was not used in the surgery but was part of a set that was. The set itself was contaminated and not discovered until mid-case. So yes the patient was exposed."
It was further documented;
"1. This particular instrument was not used during the case or the prior case. It was found to be dirty. If an instrument was not used it does not get hand washed and it was on the bottom part that was not looked at.
2. To prevent future occurrences. Staff Education: All staff working with instruments will review policy and sign. Implement instrument cleaning in our rotating monthly education.
Process change All trays will need to be disassembled for inspection and washed in a separate tray if needed. This is different from our current process, that allowed some unused instruments to be washed in the tray that stores them."

a. On 8/1/19 at 1:53 PM, an interview was conducted with the quality director. She stated they had determined the instrument had not been used on patient 6 or patient 12 (the previous case) because the surgeries had been performed back to back and the surgeon stated he had not used the instrument on either patient. Surveyors asked if the patients had been notified about the exposure. The quality director stated she was not sure if the patients had been notified and since the instrument had gone through the washer and sterilizer the risk was low anyway.

The quality director further stated it was the expectation for central processing (CP) staff to manually hand scrub and visually inspect each instrument prior to them going into the washers regardless if they were used during surgery or not. She stated that staff had not been manually hand scrubbing or visually inspecting the instruments that were not used during a procedure. Instead staff was separating the un-used instruments and leaving them in the bottom of the tray to go straight into the washers. She stated staff had been instructed and retrained on the expectations after the instrument with bioburden had been found.

b. On 8/1/19 at 5:09 PM, an interview was conducted with the chief quality officer. She stated the incident involving the bioburden on the surgical instrument should have been reported to the quality committee but it was not. She stated it must have been an "oversight". She further stated that the severity rating of incidents that occur are decided by the risk manager, risk director, and the corporate office; they collaborate to decide the potential risk for harm of incidents. (Note: The incident involving the bioburden on the surgical instrument was determined to be a risk level 1, the lowest risk for harm.)

c. On 8/1/19, patient 6's medical record was reviewed. In a document titled Operative Report dictated by the physician, there was no mention of the instrument with bioburden or the potential exposure to the patient. On 8/1/19 at 5:59 PM, the risk manager (RM) stated that detail should have been included in the operative report.

d. On 8/1/19 at 5:24 PM, an interview was conducted with the hospital's infection preventionist (IP). She stated when a patient is identified for a possible infection from an exposure, she would put them on a list and track the patient for infections. She stated the tracking consisted of running a report "a couple times a week" that would identify if the patient has had blood cultures drawn. She stated the report can only identify if the patient's blood cultures were drawn at one of three hospitals; this hospital and it's two sister hospitals. She stated she would also check the patient's medical record "a couple of times a month" to see if the patient had been treated in one of the three hospital's emergency departments. Surveyors asked if she notified patients when she was tracking them for infections. She stated she does not notify the patients when they are being tracked and has the assumption that the physician does. She stated if there was evidence a patient had been exposed, the patient should be notified. She further stated she does not feel it is her responsibility to notify patients and expects the physician to do it and to do any needed follow up.

The IP further stated that since the instrument with bioburden was not used on either patient 6 or patient 12, that it was only a potential exposure therefore they never considered notifying the patients.

e. On 8/1/19 at 5:35 PM, an interview was conducted with the RM. The RM stated due to the bioburden incident, they had re-educated the "whole team" about the appropriate sterilization process. He stated the way they are monitoring if the staff is doing the process correctly is through the hospital's incident logs. He stated if bioburden was to be found again, then they would know CP staff was not doing the process appropriately.

f. On 8/5/19 at approximately 5:30 PM, surveyors were provided with a document meant for tracking patient 6's potential for infection after the exposure to the contaminated instruments. It was documented on the form; "#7 reamer was n (sic) a basin of NS w/ other reamers which were used when #7 was removed for use it was found to have dried bioburden and was not used."

g. On 8/6/19 at approximately 11:00 AM, surveyors were provided with a document detailing training that had been conducted for CP staff on the decontamination and cleaning for a surgical instrument called a broach. At that time the RM stated a broach was the instrument that had been found with the bioburden on it therefore they had conducted training specific to cleaning the broach. Surveyors asked why patient 6's tracking form named the instrument as a reamer. Hospital administration was unable to clarify which instrument was actually contaminated with the bioburden.

h. On 8/6/19, surveyors reviewed the hospital's policy titled Sterilization of Instruments and Supplies. It was documented in the policy; "1. Articles to be steam sterilized must be decontaminated, cleaned and inspected before wrapping. 2. All items used within a sterile field must be rendered sterile."

i. On 8/6/19, surveyors reviewed a document titled Competency Criteria & Validation Form. (A document used to assess the competency of CP staff during training.) It was documented on the form; "7. ...All instruments opened in the procedure or operating room should be decontaminated whether or not they have been used."

j. On 8/5/19 at 11:02 AM and 11:37 AM, two surgical technicians were interviewed. Both technicians stated after a surgical procedure is completed, they put all un-used instruments on the bottom of the tray, cover them with a towel, and put the used instruments on top of the towel, then send them to CP.

k. On 8/5/19 at 1:09 PM, an interview was conducted with a CP technician. She stated when they receive the surgical instruments from the OR, the un-used instruments are in the bottom of the tray covered by a towel and the used instruments are on top of the towel. She stated they put the used instruments in a sink to soak and leave the un-used instruments in the tray. She stated they then hand scrub and visually inspect the used instruments but do not scrub or inspect the un-used instruments. She stated since the instruments had not been used during surgery they did not need to be hand scrubbed and visually inspected.

l. On 8/6/19 at approximately 5:30 PM, an interview was conducted with the risk manager, medical director, director of nursing, and hospital president. Surveyors informed the administrative staff of the interviews with the OR and CP staff. Surveyors stated they were confused and inquired as to why the OR and CP staff was reporting that they were still leaving un-used instruments in the bottom of the trays and not hand washing them since previous interviews with administrative staff had assured surveyors the whole team had been re-trained on the appropriate sterilization process. Surveyors received the response, "we see why that would be confusing."

m. Patient 12 was admitted on 6/20/19, and underwent surgery to repair a broken left hip. In an incident report dated 6/20/19, it was documented that in the tray of sterile instruments being used during patient 12's surgery, staff found a "dirty" instrument that had bioburden from another patient. (Note: Bioburden refers to some sort of human tissue that was adhered to the instrument). The bioburden had the potential to expose patient 12 to infectious disease.

Upon review of patient 12's medical record it was documented that he developed an infection within two days of surgery and had the infection for approximately three weeks. Throughout his medical record it was documented that his white blood cell (WBC) count was elevated; as high as 38. The normal WBC count is 4-10.4. It was also documented that patient 12 had blood and urine cultures drawn on 6/29/19. (Cultures are a specific way to test for infection).

n. On 8/1/19 at 5:24 PM, the hospital's IP provided a form titled Infection Control Data Collection; a document she used to track patient infections. The document had areas for tracking WBC values, if/when blood cultures were obtained and the results, and other details pertinent to infections. The document had patient 12's name, date of birth, and date of surgery documented. It also had patient 12's admit date as 6/20/19 and discharge date as 6/25/19. (Note: Patient 12 remained in the hospital until 7/23/19.) There was no documentation about the elevated WBC's or blood cultures/results on the form as of 8/1/19, approximately 6 weeks after patient 12 was first diagnosed with an infection.

o. On 8/6/19 at 11:13 AM, a follow up interview was conducted with the IP. She stated she does not document the dates or times when she conducts tracking of patients with infections nor does she document when she conducts the medical record reviews on patients who have potential infections because "it's just my job" and "I just do it".

2. On 7/31/19 at approximately 10:40 AM, a tour of two OR's was conducted. In OR #3 surveyors observed an arm table with multiple tears throughout the vinyl. Some of the tears were observed to have a plastic tape covering them. Surveyors also observed multiple tears on the slider board (a board used to transfer a patient from one bed to the next). In the other OR called the "spine room" surveyors observed multiple tears in the vinyl on the bed pads where patients are positioned during surgery. One of the bed pads was severely torn and was covered in clear tape. An interview was conducted with the surgery coordinator at that time. He stated they knew the tears in the vinyl made the items unsanitizable but it was difficult to get replacements in a timely manner.

Based on observation, interview and record review, it was determined that the chief executive officer, the medical officer, and the director of nursing, failed to ensure that the hospital-wide quality assessment and performance improvement (QAPI) program addressed infection control problems and failed to be responsible for the implementation of successful corrective actions in the problem areas.

Findings include:

1. The hospital failed to provide a sanitary environment to avoid sources and transmission of infections and communicable diseases. The hospital also failed to develop and maintain an active program for the prevention, control, and investigation of infections and communicable diseases. (Refer to tag A-0747)

2. The hospital and its infection control officer failed to develop a sufficient system for identifying, reporting, investigating, and controlling infections and communicable diseases of patients and personnel. (Refer to tag A-749)