Davita Maple Grove Dialysis Unit

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 38687 Based on observation, interview, and document review, the facility failed to follow appropriate infection control (IC) technique and wear appropriate personal protective equipment (PPE) (gown and gloves) during observations of 2 of 4 staff (patient care dialysis tech (PCDT)-D and registered nurse (RN)-A) observed during numerous observations. Furthermore, the facility failed to ensure 4 bleaching solution tubs were dated as to when they were created and/or were to be discarded. This had the potential to affect all 47 patients scheduled to receive treatment during the survey by putting them at high risk for serious infection from potential cross-contamination of blood and bodily fluids. The condition at § 494.30 Condition: Infection control was NOT MET. The Immediate Jeopardy began on 3/11/24 at 8:05 a.m., when staff failed to perform hand hygiene and donn (put on) and remove gloves between tasks, did not ensure dialysis stations were vacated before setting up another patient’s sterile supplies, and failed to ensure disinfecting bleach solutions were mixed and discarded within 24 hours. The facility administrator and consultant were notified of the Immediate Jeopardy on 3/11/24 at 1:56 p.m.. Findings include: During an observation on 3/11/24 at 7:56 a.m., of the treatment room identified 12 patients were dialyzing. On each side of the treatment area were 2 bins at each of the 2 nursing work stations containing a bleach solution for a total of 4 bins. 1 bleach solution had a date of 1/20/24. The remaining 3 bins had made on or no use-by dates of expiration. There was no indication the solutions had been prepared within 24 hours or replaced after that time. Review of the World Health Organization, How To Use and Dilute Bleach information, located https://www.who.int/docs/default-source/wpro---documents/wpro---pdf-infographics/covid-19/bleach-dilution-and-guidance-for-visitors-20200622.pdf?sfvrsn=4fcf7133_2, identified : 1) There were 2 different concentrations for the usage of bleach. 0.5% was to be used for blood/bodily fluids, and 0.1% was to be used for disinfecting other surfaces. 2) Staff were to prepare new bleach daily in a container that was clean and dry. 4) Label the container with concentration of the solution, date and time it was made, and cover with a lid. 5) Instructions not to use mixed solutions for more than 24 hours as they were no longer effective. Observations on 3/11/24 identified during continuous observation from 8:05 a.m. through 8:41 a.m. identified at:: 1) 8:05 a.m., PCDT-D reached up with her non-gloved hands and grabbed an item off P5’s IV pole and placed it on his chair-side table. PCDT-D then returned to the multi-patient portable computer on wheels (COW) that was stationed within 6 feet of the P5 and proceeded to input information into the computer. Without performing hand hygiene or donning gloves, PCDT-D returned to P5’s chair-side table and began setting up strips of tape to be used upon discontinuation of dialysis treatment (used to secure gauze over the patients access site). PCDT-D then left P5’s station and proceeded to the work station on one end of the treatment room. Without performing hand hygiene or donning gloves, PCDT-D opened the drawer, grabbed a needle and syringe, and began drawing up 3 syringes of a liquid solution from a multi-dose vial. After drawing up the solution, she labeled each syringe of solution. 2) 8:13 a.m., PCDT-D then took those 3 syringes without performing hand hygiene or donning gloves to chair #7 to get that station ready for the next dialysis patient. She then proceeded to her computer and entered information touching the computer keyboard with her non-gloved hands. PCDT-D then donned gloved without first performing hand hygiene. She returned to P5 to draw blood samples from P5’s blood-line. P5’s machine began alarming. PCDT-D then went to the machine while holding the laboratory supplies, touched the machine to silence alarm and returned to draw P5’s labs without first removing her soiled gloves, performing hand hygiene, and donning new gloves before beginning a new task. After drawing P5’s blood, PCDT-D then transported the blood samples across the room to the laboratory area, and returned to P5 to administer his IV syringe solution while wearing the same gloves and before beginning a new task. With the same gloves, PCDT-D then touched P5’s machine, touched then touched his contaminated dialysis blood-line tubing, then returned to the COW and touched the keyboard without first removing her contaminated gloves, performing hand hygiene, and donning new gloves. 3) 8:17 a.m., PCDT-D then then went back and touched P5’s blood line dialysis tubing with the same gloved hands. PCDT-D then acquired a stool to sit on, touching the stool with her gloved hand. PCDT-D then applied sterile dressings to P5’s access site with her contaminated gloves and clamps to his left arm. 4) 8:21 a.m., PCDT-D proceeded back to P5’s machine with removing her gloves. performing hand hygiene, and donning new gloves and gathered P5’s contaminated blood-line dialysis tubing. PCDT-D then removed her contaminated gloves,but failed to perform hand hygiene. PCDT-D then used her bare hand to push a walker out of her way, and went back to her COW and performed hand hygiene. 5) 8:23 a.m., with her bare hands, PCDT-D used a thermometer to check P5’s temperature. PCDT-D then retrieved unused dressings that were at P5’s contaminated dialysis chair station to the nurses work station and set them on the counter beside the undated bleach mixture. PCDT-D then touched her personal clothing with her bare hands, returned to P5’s station, grabbed gloves and proceeded to put them on without first performing hand hygiene. PCDT-D then went back to the nurses work station, dipped them into the bleach mixture, and proceeded to terminally clean and disinfect P5’s dialysis machine without ensuring P5 had vacated the station. Without removing her gloves and performing hand hygiene, PCDT-D retrieved P6’s personal supply tub and sterile blood-line tubing and IV solution bag and set the tubing on top of the dialysis machine where P5 was still located. PCDT-D then proceeded to hang the IV bag from the IV pole and open the sterile dialysis blood-line tubing with her same gloved hands, set P6’s sterile blood-line tubing directly on top of P5’s contaminated personal supply bin. PCDT-D began connecting that tubing to the machine and opened P6’s dialysis filter and attached that to the machine. P5 still remained at his chair less than 1 foot away. PCDT-D then removed her gloves but failed to perform hand hygiene and returned to type on the keyboard of the COW that was still next to P5’s station within 3 feet of his chair. PCDT-D then responded to an alarm at P8’s station machine (3 chairs away from P5) without performing hand hygiene or applying gloves and proceed to touch P8’s machine and silenced P8’s alarm and returned to the COW beside P5’s machine and touched the keyboard. 6) 8:32 a.m., with her bare hands, PCDT-D was observed to touch her face and head scarf. 7) 8:33 a.m., RN-A was observed in the treatment area within 5 feet of P4’s machine, looking at readings on the machine without wearing a gown (required within the treatment area due to potential blood spatter). 8) 8:35 a.m., PCDT-D went back to P5, donned gloves and removed his clamps from his dialysis access arm. P6’s supplies remained connected to P5’s machine while P5 had not vacated the station. PCDT-D then assisted P5 in lowering his foot rest. With her same gloves, PCDT-D then touched P5’s machine that she had set up and connected P6’s blood-line tubing, grabbed his contaminated clamps that were used to hold pressure to the dialysis site on P5’s arm, and take them to the undated bleach solution for disinfection. Without removing her contaminated gloves and performing hand hygiene, PCDT-D retrieved P5’s personal supplies and placed his personal items inside his bin that laid on his chair-side table and closed the lid. PCDT-D touched P5’s machine 2 more times with her same gloved hands. 9) 8:41 a.m., PCDT-D was observed checking P5’s blood pressure (BP) with his personal BP cuff she retrieved from inside his bin. After completing this task, PCDT-D failed to disinfect P5’s BP cuff prior to placing it inside his bin. P5 exited his station. PCDT-D took P5’s personal item bin and placed it on the shelf on top of an unidentified patient’s bin without first ensuring it had been disinfected from potential blood spatter or contamination. With the same gloves, PCDT-D proceeded to P11’s station to silence an alarm on his machine. PCDT-D then returned to P5’s station, and grabbed the red trash bag used for hazardous waste. PCDT-D then retrieved clean gauze cloths from the nurses work station counter, dipped them into the undated bleach solution and went back to P5’s station to begin terminal cleaning of P5’s chair and chair-side table. Once finished, PCDT-D placed another smaller garbage bag into the red bag. PCDT-D then removed her gloves, but failed to perform hand hygiene. During an interview on 3/11/24 at 8:50 a.m., RN-A identified she should be wearing a gown while on the treatment floor per facility policy, but had personal health issues that made her skin temperature feel hot while wearing a gown, so she would not wear one during those times. In regard to the IC breeches above by PCDT-D, RN-A stated hand hygiene and glove changes were to occur between tasks. No other patient’s equipment was supposed to be placed into a treatment area or attached to a machine without first having the previous patient vacate the station. That was a serious concern, especially as P6 had a central venous catheter (CVC) access (catheter inserted into the chest directly into the , subjecting that patient who already has a higher risk of infection. RN-A could not identify when the bleach solution had last been created, or if it had been changed since January 2024. During an interview on 3/11/24 at 8:51 a.m., PCDT-D identified she agreed she should be performing appropriate hand hygiene and glove use between tasks. She set up P6’s dialysis equipment without first having P5 vacate the station and terminally clean and disinfect all surfaces within because P6 would “want to get on right away”. PCDT-D was unaware of the serious risks of cross-contamination of potential blood or infectious disease that were observed earlier. During an interview on 3/11/24 at 8:59 a.m., and again at 9:23 a.m., with the facility administrator (FA) and facility consultant (FC)-A identified they were aware of IC concerns due to staff failures of performing hand hygiene beginning in December 2023 after a safety meeting audit. The FA did re-education in January to all staff, but stated he failed to audit any further after his December 2023 findings to ensure staff education had been effective. Both were unaware the bleaching solution had not been dated on 3 of the containers and the 4th container had a January 2024 date on it. Both agreed new solution needed to be mixed right away and all staff educated on appropriate IC practices. The FA was out on the treatment floor often, but made no environmental rounds or audits of basic care provided to dialysis patients by staff. During an interview on 3/11/24 at 12:27 p.m., with the medical director identified she was aware of the IC concerns from the December 2023 Safety meeting audits. She understood the FA had been auditing for compliance and had ensured all IC practices were being followed. She agreed the above mentioned observations were a serious risk to patient health and safety as it carried high risk for cross-contamination and potential infection to other patients. She noted the facility needed to immediately address the concerns. She has a medical director meeting scheduled for 3/18/24 and will discuss this with leadership at that time. There are a lot of new staff related to a high turn over rate and identified lately she has had to be very involved in the day to day operations at the facility and has never had to provide this much oversight as a medical director before. Review of the January 2024 IC education identified December 2023 top CMS citations related to immediate jeopardy situations were discussed. Upon findings discussed were the need to wear gloves and wash hands per CDC, items taken to dialysis stations were not designated for use or had been disinfected, and that a condition level deficiency had been identified 8 times in dialysis. There was no mention of the Safety meeting audit of the facility staff’s failures at performing hand hygiene and use of PPE discussed or evidence staff had been re-educated to those specific concerns identified by the FA in December 2023. Review of the 1/5/01 Infection Control for Dialysis Facilities policy identified all staff were to: 1) Perform hand hygiene: a) Upon entering and exiting the treatment area, b) Prior to gloving and after the removal of gloves. c) After contamination with blood or other infectious materials. d) After patient or dialysis system contact. e) Between patients (even if the encounter is casual) f) Before touching clean areas such as supplies, the supply cart and chair-side keyboards and mouse [COWS]. 2) PPE was to be worn whenever there was a potential for contact with bodily fluids, hazardous chemicals, contaminated equipment and environmental surfaces. PPE was to be worn prior to entering the treatment area and removed prior to leaving. Gloves were to be changed when moving to a “dirty” area or task to a “clean” area or task, and after touching one patient or their dialysis delivery system and before arriving to care for another patient or touch their dialysis delivery care system. 3) At the end of each treatment, the dialysis station was to be cleaned and disinfected using the appropriate bleach solution. Those surfaces to be disinfected were all surfaces to come in contact with the patient and/or their belongings. The dialysis station was to be completely vacated by the previous patient before staff could begin to bring disinfection supplies to the station in order to clean and disinfect for the next patient. Dialysis delivery systems with computers. Keyboards were considered “dirty” equipment. The immediate jeopardy was removed on 3/12/24 at 9:30 a.m., when it could be verified by observations, staff interviews, and documentation staff had been re-educated to appropriate IC practices and PPE use during patient dialysis care. Bleach solutions were labeled with appropriate made on dates/expiration dates to ensure solution was changed daily and staff were audited to ensure competency with performing IC practices by facility leadership.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 38687 Based on interview and document review, the facility failed to follow their process for grievances, include a description of how the patient or the patient’s designated representative was to be informed of steps taken to resolve the grievance, or identify a temporary solution to a grievance that impacted patient care while the grievance was being reviewed for 1 of 5 sampled grievances. Findings include: Review of the facility grievance logs from 9/6/23 through 3/8/24 identified P2 had voiced complaints on 2/29/24 and 3/6/24. P2’s Risk Event Management (REM) identified on 3/6/24, P2 had a complaint. Contributing factors were agitation and lack of compliance/adherence. The notes stated that day, PCDT-B was working (on the side of the room (MOD)) where P2 was expected to be treated. At approximately 6:20 a.m., P2 showed up for dialysis treatment. She would not allow PCDT-B to cannulate her dialysis access for treatment. PCDT-B was noted to have successfully cannulated P2 previously. The nurse explained to P2 in order to get treatment, she needed to allow PCDT-B to cannulate her access. P2 refused to allow PCDT-B to perform the cannulation. P2 stated only the FA was allowed to cannulate her that day. “Eventually” P2 left without treatment. RN-B called the patient and offered treatment at 3:00 p.m. Pt replied “I need to talk to someone”. There was no indication P2 was offered to be cannulated by RN-B, nor was there any process followed to identify what could be done to ensure P2 could receive future treatments that would be acceptable to P2 and work for the facility. There was also no indication there was any follow up with P2 about her complaint, or any type of resolution offered. Interview on 3/12/24 at 8:10 a.m., with the licensed social worker (LSW) identified it was her role as the LSW to hear patient’s concerns or complaints. Whether or not the grievance was acted upon depended on “how formalized the patient wants to make the grievance”. When asked about the complaints P2 was noted to have on her log, she stated she wrote a note to the facility administrator (FA) on 3/6/24. P2 reportedly sat in the waiting room “for hours” and then finally left. The LSW contacted P2’s MD about her concern about not getting treatment. At the time of the incident on 3/6/24, there were 3 patient care dialysis techs (PCDT) on duty and 1 registered nurse (RN)-B. The LSW reported P2 does have some mental health concerns with anxiety and depression and was told in January this dialysis access (fistula) was her last access. P2’s anxiety has been increasing since January when she was told of her final option. P2 is a younger patient and is very scared. “For her this is life or death”. P2 feels confident with the FA starting her dialysis treatment. She stated she thought PCDT-B had cannulated P2’s dialysis access several times with no concerns, but now P2 doesn’t want any technicians to perform this. The LSW noted “We cannot possibly accommodate that.” The LSW admitted to having a high staff turn over. P2 had reportedly advised her insurance group about fear of retaliation from facility staff. She had not scheduled a care conference as “her anxiety is so unchecked”. P2 is afraid of having a technician cannulize her except for the FA who used to be a tech. The LSW agreed she had knowledge of P2’s fears and escalating refusals of staff but this past incident on 3/6/24 “only happened last week”. She sees patients quarterly for established patients. P2 has been coming to this facility for 10 years. The LSW stated P2 had no other behaviors of not wanting a technician prior to January. The LSW does not see patients more often than their required quarterly visits for established patients for psychosocial issues because she has a large workload of over 100 patients to see. The LSW did report these concerns to the FA. The FA then takes over the grievance process. Interview on 3/12/24 at 8:30 a.m., with the FA and facility consultants (FC)- A and FC-B identified the facility stored their complaints and details of a complainant in the REM reporting tracker. The FA placed the information into the form on 3/6/24, but had not followed up any farther. Interview on 3/12/24 at 9:10 a.m., with RN-B identified he was working 3/6/24 when P2 had come in for treatment and subsequently did not receive it. P2 came in while he was on break. P2 looked at the staff on duty (the PCDT’s) and did not want them to cannulize her. P2 was fearful of complications from staff who may not be able to cannulize her correctly. RN-B was told she wanted him to cannulize her. That is against the facility policy where the PCDT’s must attempt once each with 2 PCDT’s. If they fail, then the nurse may cannulize them RN-B reiterated the policy to P2 and advised her she can come back for treatment. P2 “chose” to leave. P2 was not offered to be cannulize by RN-B to initiate her treatment in order to decrease her fears and anxiety and in the meantime until a potential resolution could be found. RN-B made the medical director (MD)-A aware of the situation. MD-A stated to follow the policy. He was not aware if he made MD-A aware of the fears and anxiety being the reason behind P2’s increased behavior and refusal to let PCDT’s cannulate her. Interview on 3/12/24 at 10:14 a.m., with FA-A and FA-B identified the plan to work on P2’s concerns was to meet with P2 after this weeks treatments after discussion with the interdisciplinary meeting. They agreed they had not followed their formal process outlined in the policy below, nor had they identified an intermittent solution in the mean time. Review of the 3/1/6, Patient Grievance policy identified all patients had the right to have their grievances handled promptly and courteously. The facility staff should report the grievance to the charge nurse. If the solution is not reached through this discussion, the charge nurse was to report the FA and the regional operations director (ROD) within 1 business day for follow up. the FA was to discuss the grievance with the patient, and investigate and take appropriate action. If it could not be resolved, by the FA, the ROD and MD-A were to be notified and a formal grievance conference was to be coordinated. if the grievance could not be resolved by the ROD and MD-A, the divisional vice president (DVP) was to be notified. The DVP was to discuss the grievance with the patient and take appropriate actions if possible. The DVP and general counsel would take necessary steps to review and if necessary, investigate the grievance. The DVP was to issue a final decision to the patient within 10 days. There was no mention of prioritizing grievances that impacted care to ensure patients received dialysis while the grievance was being investigated by facility administration in attempt to find a temporary resolution.”