Davita Humboldt Ridge Dialysis

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 22198 Based on observations, interviews, and policy review, the facility failed to meet the Condition for Coverage (CfC) for V110 Infection Control when it failed to: 1. provide and monitor a sanitary environment to minimize the transmission of infectious agents for three of three dialysis spaces (dialysis unit, clean supply room and the water treatment room), 2. Failed to ensure that for two of three observation days staff and patients performed hand hygiene to prevent cross contamination, 3. Failed to ensure that there was a separation of clean and dirty spaces for two of three observation days, and 4. Failed to clean dialysis station per policy for two of two observations. Findings include: 1. The facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents for three of three dialysis spaces (dialysis unit, clean supply room and the water treatment room) Cross Reference V111. 2. The facility failed to ensure that for two of three observation days, two of two staff (Patient Care Technician (PCT) (PCT2 and PCT4) performed hand hygiene between glove changes and between tasks, and one of two patients (Patient (P) 9) performed hand hygiene after holding his/her fistula site to achieve hemostasis (stop the bleeding) to prevent cross contamination. Cross Reference V113. 3. The facility failed to ensure that for three of three observation days the designated clean areas were separated from contaminated areas, and not adjacent areas where a hand washing sink and dialysis station were located where there was potential for splash or cross contamination. Cross Reference V117. 4. The facility failed to ensure the dialysis stations were cleaned per policy that for two of two dialysis cleaning observations (Stations 6, and 18) and for two of two observation days that the wall boxes in 20 of 20 dialysis stations were cleaned. Cross Reference V122.”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 22198 Based on observations, interviews, and review of policy and manufacturer’s directions for use (DFU) review, the facility failed to meet the Condition for Coverage (CfC) for V400 Physical Environment for three of three dialysis locations when it failed to: 1. Ensure the dialysis treatment floor, the clean storage area and the water room was maintained to prevent contamination and to ensure the safety of the patients, the staff, and 2. failed to follow manufacturer’s instructions for use of ExSept (wound cleanser), two of two Glucometers, and expired patient supplies. This systemic failure prevented the facility to maintain a functional safe environment for all 65 patients and staff at this facility. Findings include: 1. The facility failed to maintain a safe, functional, and comfortable treatment environment for its patients and staff when: a. In the water room, there was standing water between the bicarbonate tank that ran under storage, rust was identified on the water room pump and pump stand, the floor by the bicarbonate mixer and tanks was not sealed, the bicarbonate system was leaking, behind the pump was a polyvinyl chloride (PVC) drain pipe coming out of the floor three-inches but the hoses leading to the three-inch drain did not reach the drain and allowed for water to splash out of the drain causing standing water on the floor, inside the PVC drain had a black film, and the two drains observed had standing water with black substance around the drain. b. The dialysis treatment floor: the dry wall in POD 6 near dialysis Station 20 had a patched area not sealed, near the patients’ bathroom there was two holes in the wall above an electrical panel, 13 of 20 dialysis chairs were torn, the counter top for soaking dirty equipment was pitted preventing it from having a solid surface for cleaning, behind the dialysis stations there were three of four PODs that had sections cut into the wall behind the dialysis station that resembles a door allowing access to the pipe without securing the pipes, the raw wood edges were not sealed, and the sections were held shut with hinges on one side the other three sides were sealed with painters tape, there were two of two splash guards observed that did not extend to the end of the counter with potential for sink splash and patient blood splash, one of three refrigerators (laboratory) was not monitored to ensure the temperature was accurate to ensure the patient’s blood samples were viable for testing and accurate results, and the two glucometers were not tested and logged to ensure they provided accurate readings . c. The clean supply area had two types of shelving; one area had rusting shelves; the other was a pressed board that contained cleaning supplies, and the clean supply room did not have a cleaning schedule. Cross Reference V402. 2. The facility failed to follow the manufacturer’s recommendations for patient supplies that are required for labeling after opening and discarding if they pass their expiration date. Cross Reference: V403.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 22198 Based on observations, interviews, and policy review, the facility failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents for three of three dialysis spaces (dialysis unit, clean supply room and the water treatment room). In addition, three of three (Patient Care Technician (PCT)4, Registered Nurse (RN)1 and Administrator) facility staff were observed with artificial nails even though the facility policy indicated direct care staff were not to wear artificial nails. This failure in infection control has the potential to affect all 65 incenter dialysis patients related to potential contamination of clean supplies and cross contamination on the dialysis unit. Findings include: 1. During the flash tour observations on 10/21/24 at 9:50 AM the following was identified: a. Walking through the dialysis unit to get to the storage area, discarded packaging and gauze pads were laying on the floor in the dialysis unit in PODS 4, 5, and 6. The IV poles and computer stand poles had white, brown substance on them. The garbage bins and biohazardous waste bins were on wheeled stands and were covered in white and brown stains. b. The clean storage area door was open and unsecured and had three rusty metal racks with dialysis supplies on them along with a pressure hose. A wall of additional clean and sterile storage shelves made of a sealed solid compressed board were stained and covered in dust and debris. c. The entire inside on a raised drainpipe in the water treatment room was made of PVC (polyvinyl chloride) and had a thick moist coat of black gelatinous substance down as far as possible to see. During an interview on 10/21/24 at 9:50AM the Manager of Clinical Services (MCS) confirmed that the dialysis pole type stands on the unit, and the waste and biohazardous bins were not clean and should be. MCS confirmed the dialysis supply room door was propped open and should be closed. MCS confirmed that the metal shelves in the supply room were rusted and should be discarded. When asked about the cleaning schedule for the clean and sterile supply shelves, MCS confirmed that the shelves were stained and had dust and debris but was not aware of the cleaning schedule. During an interview on 10/21/24 at 9:51AM the Facility Administrator confirmed that the facility did not have a cleaning schedule for the clean and sterile storage room. During an interview and observations on 10/21/24 at 3:00 PM, of the water room, PCT 4 and the Biomedical Technician (BMT) were shown the black gelatinous substance in the PCV drainpipe. BMT confirmed he/she did not know the last time it had been cleaned and confirmed that the drainpipe needed to be cleaned. 2. During observations on 10/21/24 from 10:00 AM until 12:00 PM, PCT4, RN1 and the Facility Administrator had artificial nails. PCT4 and RN1 were observed performing care. During an interview of 10/21/24 at 3:45 PM, the Manager of Clinical Services (MCS) confirmed the facility policy does not allow direct care staff to have artificial nails. During an interview on 10/23/24 at 10:00 AM, the Facility Administrator confirmed that he/she does mix bicarb and perform patient care when needed. Review of the facility’s policy titled, “Infection Control For Dialysis Facilities” dated 03/23 revealed, “It is a requirement for all DaVita teammates whose primary location is working in a facility to have only natural nails and fingernail length should not extend more than ¼ inch. Traditional nail polish that is not chipped may be worn.” 3. During an observation on 10/21/24 at 2:30 PM, 20 of 20 wall boxes in the 20 dialysis stations had black stains around the wall box drain and crystal formation around the acid connector ports. During an interview on 10/21/24 at 2:30 the BMT confirmed that all 20 of the 20 wall boxes did have black stain around the drain and crystal formation around the acid connection port. The BMT stated that the PCTs are supposed to be wiping the wall box as a part of the dialysis station cleaning between patients and at the end of the day. 3. During an observation on 10/22/24 at 9:00 AM the designated medication preparation area for drawing up Heparin was across from a patient station 14 and did not have the splash guard extended to prevent splashes or spray from the dialysis station. 4. During an observation on 10/22/24 at 9:05 AM, the designated laboratory area in the dialysis station had a splash guard that did not extend to the end of the counter to protect the counter space for clean supplies with daily tubes set up for patients on the counter across from a patient station and a clean hand washing sink to prevent splashes or spray. During an interview on 10/23/24 at 9:25 AM the Manager of Clinical Services (MCS) confirmed that not having the splash guard extended on the medication preparation counter and the laboratory counter had the potential for splashes or sprays. 5. Observation on 10/22/24 at 10:40 AM, blue painters’ tape on wall sections cut into the wall behind dialysis stations in POD 2, POD 4, and POD 6. The countertop where the bucket for dirty wands used in the dialysis station was pitted and discolored. During an interview on 10/23/24 at 9:25 AM, the MCS confirmed that the painter’s tape was not a washable surface and countertop for soaking the dirty wands needed to be replaced. 6. Thirteen of the 20 dialysis station chairs had tears in the chair seat and arms at Stations 1, 2, 3, 4, 5, 7, 8, 9, 10,13, 15, 19, and 20. During an interview on 10/23/24 at 9:25 AM, the MCS confirmed that 13 of the 20 dialysis chairs needed repair and the tears prevent the chair from being cleaned per facility policy. Review of the facility’s policy titled “Physical Environment” dated 04/18 revealed, “The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.” Review of the facility’s policy titled, “Infection Control For Dialysis Facilities” dated 03/23 revealed, “DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. ... Use an appropriate disinfectant such as l:100 (one to one hundred) bleach solution for routine disinfection of environmental surfaces. ... At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to all surfaces in contact with the patient or their belongings. ...The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system.””

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 22198 Based on observations, interviews and policy review, the facility failed to ensure that for one of three observations days, two of two staff (patient care technicians (PCT) 2 and PCT4) and one of one patient (P)9) failed to perform hand hygiene between tasks and glove changes. This failure puts all 65 incenter patients at risk for cross contamination. Findings include: During an observation on 10/21/24 at 10:30 AM of the central venous catheter (CVC) exit site care and initiation of CVC catheter dialysis, PCT4 was observed removing the old dressing and discarding it. Without changing his/her gloves PCT4 opened the cleaning swabs and started the cleaning of the CVC site, cleansed and redressed the CVC site, before PCT4 changed gloves and performed hand hygiene. During an interview on 10/21/24 at 10:45 AM, PCT4 confirmed gloves should be changed between clean and dirty tasks and hand hygiene performed between glove changes. During an observation on 10/21/24 at 11:10 AM of the CVC exit site care and initiation of CVC catheter dialysis, PCT2 was observed removing the old dressing and discarding it. Without changing his/her gloves PCT2 opened the cleaning swabs and started the cleaning of the CVC site, found debris left near the CVC site and removed gloves without hand hygiene and went to the clean supply cart to obtain another cleaning swab. PCT2 donned new gloves without performing hand hygiene recleaned the CVC site and redressed the CVC site. PCT2 removed gloves and failed to perform hand hygiene before donning new gloves and moving into dialysis initiation for P12. During an interview on 10/21/24 at 11:30 AM, PCT2 confirmed gloves should be changed between clean and dirty tasks and hand hygiene performed between glove changes. During an observation on 10/21/24 at 1:50 PM, during a discontinuation on dialysis, P9 was observed with a gloved hand holding his/her fistula site to achieve hemostasis (stop the bleeding) after the needles were removed. After hemostasis was achieved, Registered Nurse (RN) 1 removed P9’s glove, then assisted P9 to the common scale for a weight, then P9 left the dialysis unit without being offered hand sanitizer or a reminder to wash his/her hands. During an interview 10/21/24 at 1:50 PM, RN1 confirmed P9 should have been offered or reminded to perform hand hygiene, but “I forgot.” During a review of the facility’s policy titled “Infection Control For Dialysis Facilities” dated 04/23, revealed the purpose of the policy was “To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... All teammates, ... will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves, ... d. after patient and dialysis delivery system contact, ... f. between patients even if the contact is casual, g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse. ... Patients ... will be encouraged to ... after treatment before leaving treatment area.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 22198 Based on observations, interviews and policy review, the facility failed to ensure that for two of three observation days the designated clean areas were separated from contaminated areas, and the clean spaces for medication preparation and clean laboratory supplies adjacent to potential splash zones (a hand washing sink and dialysis station) were protected from potential splash or spray. This had the potential to negatively affect all 65 incenter dialysis patients if there was cross contamination. Findings include: During an observation on 10/21/24 from 9:50 AM to 12:00 PM, the mobile red Biohazardous sharps container was observed butted up against the dialysis chair at Stations 5 while there was a patient receiving treatment. During an interview on 10/21/24 at 9:58 AM the Manager of Clinical Services (MCS) confirmed that the biohazardous sharps container should not be next to the patient’s chair. During an observation of the laboratory area on 10/21/24 at 11:45 AM, clean laboratory supplies prepped for upcoming patient lab draws, were observed on the laboratory space countertop across from the clean hand washing sink and a patient’s dialysis chair, without the protection of the splash guard. During an observation on 10/22/24 at 9:40 AM of the preparation of medication a splash guard on the counter across from a dialysis station in POD 6 revealed that the splash guard did not extend to cover the clean medication preparation area for Heparin. During an observation on 10/22/24 at 8:45 AM, a prison guard accompanying a patient was allowed to sit between the mobile biohazardous bin (used for the disposal of blood lines) and the dialysis clean supply cart, without their gown closed properly. During an interview on 10/22/24 at 9:00 AM, MCS confirmed that the prison guard should not be sitting that close to the biohazardous bin, and the bin was then moved. MCS confirmed that the splash guard by the nurse’s medication preparation was not extended to include the Patient Care Technician’s Heparin preparation area and had the potential for splash of spray from the dialysis unit directly across the countertop. MCS confirmed that the clean supplies on the laboratory counter were not protected from splash or spray of the handwashing sink or the dialysis station over the counter because the splash guard did not extend to the end of the countertop. During an observation on 10/22/24 at 9:05 AM in the middle of the interview with MCS, as we turned to view POD 6, the mobile biohazardous sharp container was pushed up against the clean supply cart that contained clean supplies without cover. During an interview on 10/22/24 at 9:05 AM, MCS confirmed that space is an issue in the facility, however, the biohazardous bins should not be sitting up against the clean supply cart. Review of the facility’s policy titled “Infection Control For Dialysis Facilities” dated 04/23 revealed, “The purpose of the policy is To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ... Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies. ... If a common supply cart is used to store clean supplies in the patient treatment area, this cart is to remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood.””

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 22198 Based on observations, interviews, and policy review. the facility failed to ensure that two of two dialysis stations were cleaned per facility policy (Stations 6 and 18) when two of two staff (Patient Care Technician (PCT) 1 and PCT3) failed to clean the wall boxes and oxygen concentrators when cleaning the dialysis station. This failure to clean the station per policy has the potential to negatively impact all 65 incenter patients related to potential cross contamination or bacteria growth on the dialysis equipment. Findings include: During an observation of dialysis station cleaning on 10/21/24 at 1:05 PM, PCT3 did not clean the dialysate wall box, the countertop directly behind the dialysis station, pick up the garbage from the floor, or remove the full garbage bin right next to the dialysis chair that had just been wiped down. During an interview on 10/21/24 at 1:05 PM, PCT3 confirmed that he/she had finished cleaning the dialysis station and walked away. During an observation on a walk-through of the entire dialysis unit, the wall boxes for Stations 1 through 20 had black substance around the drain and crystallization formed around the dialysate connectors. During an interview on 10/21/24 at 2:00 PM, the Biomedical Technician (BMT) confirmed that the wall drains in Station 1 through 20 were not being cleaned per policy and stated that the wall box cleaning problem was reported to management when he/she identified the problem. BMT stated he/she was aware the facility policy that required the wall boxes to be cleaned as a part of the dialysis station, cleaning between patient use and at the end of the day. During an observation of dialysis station cleaning on 10/22/24 at 9:00 AM, PCT1 did not clean the dialysate wall box, the countertop directly behind the dialysis station, or the oxygen concentrator used during the dialysis treatment. During an interview on 10/22/24 at 9:00 AM, PCT1 confirmed that he/she had finished cleaning the dialysis station and when asked about cleaning the countertop, oxygen concentrator and the dialysate wall box confirmed that he/she did not clean them and should have. Review of the facility’s policy titled “Infection Control For Dialysis Facilities” dated 04/23 revealed, The purpose of the facility’s policy was “To minimize the spread of infections or bloodborne pathogens in the dialysis facility environment. ...Disinfection. 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e., used or brought into the station) and prior to returning to clean/designated area or removal from treatment area. ... At the end of each treatment, the dialysis station will be cleaned and disinfected. a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings ... i. The Wall box, Drain and Water supply lines are considered part of the dialysis delivery system ...””

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 22198 Based on observation, interviews and policy review, the facility failed to ensure that the layout of the water purification system provided easy access to the primary carbon tank timer used as a part of the daily water room monitoring system. The failure to ensure that the carbon tank components were assembled correctly puts all 65 incenter dialysis patients at risk for negative outcomes. Findings include: During an observation on 10/21/24 at 3:00 PM in the water room, the primary carbon tank “Timer Head” was turned around backwards facing the wall and did not face the center of the room so it could be read as a part of the daily water room monitoring. During an interview on 10/21/24 at 3:00 PM, the Biomedical Technician (BMT) confirmed that the “Timer Head” for the primary carbon tank was on backwards and faced the wall after the Primary Carbon Tank was re-bedded. On 09/27/24 the company reinstalled it with the “Timer Head” turned to face the wall not the center of the water room. The BMT confirmed he/she could not get back between the two tanks or between the tank and the wall to read the Timer Head. The BMT stated that when the company returns to re-bed the secondary carbon tank in November they would correct the placement of the Timer Head on the primary carbon tank. During an observation on 09/22/24 at 12:30 PM, the Manager of Clinical Services (MCS) squeezed between the primary carbon tank and the water softener, then attempted to get behind the primary carbon tank and the water room wall to visualize the reading of the Time Head but was unable to complete the task. Review of the facility’s water room treatment logs titled “DaVita Daily Water Treatment Log” dated 09/28/24 through present 10/21/24 revealed on line 5, “All Pretreatment Timers are Set for the Correct time of day? (Y/N), indicating that the staff document Y = yes and N = no. Line 5 for the dates 09/28/24 through present (10/21/24) were marked “Y”. During a telephone interview on 10/22/24 at 12:25 PM, the BMT confirmed that the primary carbon tank “Timer Head” should be read and documented as a part of the water room openers responsibility and documented on the daily water room log before the opener starts the CM130 (Chlorine Monitoring) pre-treatment. The BMT confirmed that the Timer Heads times should match because they need to be periodically backwashed. The BMT stated that both the Primary and Secondary carbon tank readings should match. The BMT confirmed that the staff were not able to read the primary carbon tank Time Head. Review of the facility’s policy titled “Physical Environment” dated 04/18 revealed, “The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.””

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 22198 Based on observations, interviews and policy review, the facility failed to ensure the facility was maintained and safe for three of three dialysis areas (the treatment floor, the clean supply room, and the water treatment room). The failure to ensure the dialysis facility was functioning correctly and maintained placed all 65 incenter hemodialysis patients and their staff at risk for negative outcome. Findings include: 1. During observations of the dialysis treatment floor from 10/21/24 through 10/23/24: a. Plaster and drywall covered the holes identified in the wall by POD 6 where the tv station had been mounted, however the space in the dialysis unit was not sealed and could not be cleaned per facility policy. b. In the alcove area by patients’ bathroom above an electrical panel was a large hole behind and above the electrical panel with the conduit and wires exposed. Looking straight up on the wall near the ceiling above that same electrical panel was another hole with wires visible. c. In POD 2, POD 4, and POD 6, someone had cut into the wall behind Stations 5,7, and 11, 18 and 0 a rectangular section of the wall where door hinges were placed on the left side of the three rectangular sections, had raw unsealed wood and were taped closed with painters’ tape and the pipes behind the wall were not secured. d. In five of five PODs (1, 2, 4, 5, and 6) the garbage bins, Intravenous (IV) poles, computer stands, the Hoyer lift and oxygen concentrators were not cleaned and maintained with evidence of stains of white and dark debris. e. One of three patient dedicated refrigerators (laboratory refrigerator) was not monitored to ensure the patient’s lab specimens obtained were stable and would provide accurate testing results. In the laboratory refrigerator were five lab tubes with blood. During an interview on 10/21/24 at 9:30 AM, the Manager of Clinical Services (MCS) confirmed that the wall in POD 6 where the tv station had been mounted was not plastered and the drywall had not been sealed to make it a washable surface. MCS confirmed that in the five of five PODs (1, 2, 4, 5, and 6) the garbage bins and their rolling stands, IV poles, computer stands, Hoyer lift and oxygen concentrators had evidence of stains of white and dark debris. During an interview on 10/21/24 at 2:00 PM the Biomedical Technician (BMT) confirmed that the wall behind the dialysis station in POD 2, 4 and 6 had been cut, hinged, and taped but was unaware of when it happened. The BMT stated that the intent was to do all five PODs to ensure he/she and plumbers could access the pipes. The BMT stated he/she was not aware that the three PODs that had been cut and were not secure only taped shut. During an interview on 10/23/24 at 9:25 AM, MCS and the Facility Administrator provided the facility laboratory refrigerator policy and confirmed that laboratory refrigerator has not been monitored, for the temperature to ensure labs were stable to accurate test results. 2. During observations of the Water room from 10/21/24 through 10/23/24: a. The floor in the water room from the bicarb mixer and tanks to the drain was not sealed. b. The bicarb mixing tank was leaking with water on the floor leading all the way to the drain. c. Behind the water pump was a PVC (polyvinyl chloride) pipe drain, the inside of the pipe was black down as far as could be seen, and the hoses did not reach the pipe that allowed for water to spray around the pipe and onto the floor. The drain near the PVC water on the floor was wet with dark stains. d. There was rust on the water pump and the pump stand. e. The two Acid tanks had signage labeled “Concentrate Storage” indicating the tank would hold 250 gallons. On both Acid concentrate holding tanks was handwritten information “200 ----- Do Not * Let Tank* Level Drop Below Line”. Both Acid Concentrate tanks were below the 150-gallon line mark. During a second tour and interview of the water room on 10/21/24 at 3:00 PM, the BMT confirmed the above-mentioned water room findings, and stated the facility was aware that the above findings in the water room needed repair but could not identify what on the bicarbonate mixer and tanks was leaking. BMT stated he/she was aware that the water hoses did not reach far enough to the drain to prevent splash and spray onto the floor but confirmed he/she was not aware that the drain had a black gelatinous substance covering the entire inside of the PVC drain. The BMT and Patient Care Technician (PCT) 4 confirmed that the fill line was there to protect the system. During an interview 10/21/24 at 3:30 PM, PCT4 confirmed that over the weekend there was pool staff working and might not have understood the necessity of keeping the Acid Concentrate tanks at the fill line of “200”. PCT4 confirmed that if the Acid Concentrate tanks went below the 200-gallon fill line it had the potential to “air lock” the dialysis loop system, and that could cause a disruption in the patient’s dialysis treatment. 3. During observations of the Clean Supply room from 10/21/24 through 10/23/24: a. Three wire racks were observed rusty and pitting, with debris, dust, and dirt on the floor. b. An entire long wall contained solid pressed board shelving units that were stained and had dust and debris built up on the solid shelves. c. The clean supply room door was not locked or secured and left open to the nursing station and dialysis treatment floor for three of three observation days. During an interview on 10/21/24 at 9:30 AM, the MCS confirmed the clean supply door should be closed and stated it might just be a fluke that the clean supply room door was opened. MCS stated that the three rusted wire racks were ear marked for disposal but confirmed that they were still in the clean supply area with supplies on them and there was debris, dust, and dirt on the floor. MCS also confirmed that the long wall of solid shelving units contained clean and sterile supplies and were stained and had dust and debris built up on them. MCS was asked what the cleaning schedule for the clean supply room was. The MCS replied “I don’t know. You will have to ask the Facility Administrator.” During an interview on 10/21/24 at 9:45 AM the facility Administrator confirmed that the door was propped open, and the clean supply room did not have a cleaning schedule. Review of the facility’s policy titled, “Laboratory Specimens Requiring Refrigeration” dated 03/16 revealed, “The laboratory refrigerator is checked daily during normal operating hours for cleanliness and to verify the temperature remains between 36 F (Fahrenheit) and 46 F. The laboratory refrigerator temperature is to be checked by a licensed nurse or designee daily. The temperature will be documented on the Laboratory Refrigerator Temperature Log.” Review of the facility’s policy titled “Physical Environment” dated 04/18 revealed “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public a safe, functional, and comfortable treatment environment. The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public. The dialysis facility will implement and maintain a program to verify that all equipment, including emergency equipment, dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations... The space for treating each patient will be sufficient to provide needed care and services, prevent cross contamination, and to accommodate medical emergency equipment and teammates... Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only... The dialysis facility will store supplies in a manner that is consistent with fire safety and other appropriate regulations...” Review of the facility’s policy titled “Infection Control For Dialysis Facilities” dated 04/23 revealed, “ ... Supplies will be stored in a manner that maintains their integrity. a. Patient and visitors should not access the supplies... Facility Hygiene 16. Clean areas should be clearly designated for the preparation, handling, and storage of medications and unused supplies and equipment, Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled... Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 22198 Based on observations, interviews, policy review, and manufacturers’ direction for use (DFU), the facility failed to ensure that staff followed their policy and the MFR DFU to ensure that equipment and patient supplies and products were maintained, stable and not expired for two of three observation days. Failure to ensure that all facility equipment and products used were stable and not expired has the potential to negatively affect all 65 incenter patients. Findings include: 1. During an observation on 10/21/24 at 11:35 AM, in POD 2’s clean supply cart there was a bottle of ExSept (a wound cleansing agent) that was opened and partially used, without the date it was opened or the initials of the staff who opened it. During an interview on 10/21/24 at 11:35 AM, Patient Care Technician (PCT) 3 confirmed that the ExSept wound cleanser had not been labeled with the date it was opened or who opened it. When asked to read the MFR DFU label, PCT4 stated, “Oh I didn’t know it expired six months after being opened.” During observation on 10/21/24 from 11:40 AM, in POD 4’s clean supply cart there was a bottle of ExSept (a wound cleansing agent) that was opened and partially used, without the date it was opened or the initials of the staff who opened it. During an interview on 10/21/24 at 11:40 AM, PCT2 confirmed that the ExSept wound cleanser had not been labeled with the date it was opened or who opened it. When asked to read MFR DFU label on the bottle of ExSept, PCT2 confirmed that the ExSept expired six months after being opened. During observation on 10/21/24 from 11:45 AM, in POD 6’s clean supply cart there was a bottle of ExSept (a wound cleansing agent) that was opened and partially used, without the date it was opened or the initials of the staff who opened it. During an interview on 10/21/24 at 11:45 AM, PCT1 confirmed that the ExSept wound cleanser had not been labeled with the date it was opened or who opened it. When asked to read MFR DFU label, PCT1 confirmed that the ExSept expired six months after being opened. During observation on 10/21/24 from 11:50 AM in POD 5’s clean supply cart there was a bottle of ExSept (a wound cleansing agent) that was opened and partially used, without the date it was opened or the initials of the staff who opened it. During an interview on 10/21/24 at 11:40 AM, PCT4 confirmed that the ExSept wound cleanser had not been labeled with the date it was opened or who opened it. When asked to read the MFR DFU label, PCT4 confirmed that the ExSept expired six months after being opened. Review of the “ExSept manufacturer DFU” label and instructions for use revealed, “expires 6 months after being opened.” During an interview on 10/21/24 at 11:55 AM, the Manager of Clinical Services (MCS) confirmed that the facility did not have a policy or procedure for labeling supplies that expired sooner than the original expiration date, once opened. The MCS confirmed that staff are trained if there is no policy and procedure they are to follow the MFR DFU. The MCS confirmed that the bottles of ExSept wound cleanser should have been labeled with the date opened and the initials of who opened it. 2. During an observation on 10/21/24 at 2:30 PM, one fully sealed yellow (100 count) top blood vials specimen collection tubes and an open container with 38 blood collection yellow top tubes expired 09/30/24 but were in the cabinet for immediate use. Per set up patient bags with the color specific lab tubes contained one yellow top tube that expired 09/30/24. During an interview on 10/21/24 at 2:30 PM, PCT4 confirmed that the yellow top tubes identified above including the one in the patient bag labeled to be used had expired 09/30/24. 3. Two “Embrace Pro” glucometers were identified in a drawer in the designated laboratory area. The first glucometer serial #EE208801658 and the second glucometer serial # EE19HA02149. During a review of the glucose testing logs titled “Incenter Hemodialysis Policies and Procedures” dated 09/20 revealed, glucose meter # EE19HA0Z149 was last tested 02/29/24. There was no glucose testing log for glucose meter #EE208801658. The Glucometer “Embrace Pro” test strips used to verify that the glucometers are reading correctly had a label on the bottle indicating it was “opened 05/21/24” the MFR DFU revealed “Use all strips within 4 months after the first opening.” The Hi/Low (ensure the glucometers are calibrated correctly to ensure the glucometers are calibrated and giving correct blood sugar results) testing solution found in the draw had been opened and was not dated with the date it was opened The MFR for glucose test strips and hi-low solution DFU revealed, “The control solutions can be used for up to three months after opening the vial.” During an interview on 10/22/24 at 12:57 PM, the MCS confirmed that glucometers and glucometer testing supplies had not been checked or maintained per MFR DFU and the facility’s policy. Review of the facility policy titled “Blood Glucose Testing” dated 12/19 revealed, “Quality control testing is completed prior to the first use of the day when the DaVita approved blood glucose monitor is used for patient blood glucose testing (or more often as required by state regulations).” During an interview of 10/23/24 at 9:25 AM, the Facility Administrator confirmed that they had one patient in the facility whose blood glucose was checked using the glucometer every Monday, Wednesday, and Friday as a part of the dialysis order. 4. During an observation on 10/22/24 at 10:30 AM two vials of Hepatitis B vaccination had expired on 08/24/24 and were in the medication refrigerator available for immediate use. During an interview on 10/22/24 10:30 AM the MCS confirmed that the two vials of Hepatitis vaccine had expired 08/24/24 and should not be available in the medication refrigerator for immediate use. The MCS confirmed the facility did not have a policy for expired supplies and that the facility follows the MFR DFU.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 26190 Based on record review, interview, and policy review, the facility’s staff failed to ensure the dialysis machine settings were following the patient’s dialysis prescription for one of eight patients (P)5) dialysis treatments reviewed. This oversight had the possibility of negatively impacting all 65 patients receiving dialysis treatments at the facility. Findings include: Review of P5’s “face sheet” located in the medical record, indicated P5 was admitted to the facility on 10/09/23 with the diagnosis of End Stage Renal Disease. P5’s dialysis treatment prescription was to run the Dialysis Flow Rate (DFR) at 600 (milliliters per minute (mL/min). Review of P5’s “dialysis flow sheets”, located in the medical record, for four dialysis treatments were reviewed with two of the sheets indicated the DFR was run at on the following dates: DFR 700 mL/min on 10/10/24 (from 9:37 AM through 1:38 PM) and DFR 500 mL/min on 10/19/24 (from 10:08 AM through 1:32 PM). The dialysis flow sheet dated 10/10/24 indicated at 11:14 AM, Registered Nurse (RN)1 verified, “the patient’s prescription matches what is currently being delivered during the dialysis treatment.” The “dialysis flow sheet” dated 10/19/24 indicated at 11:20 AM. RN1 verified, “the patient’s prescription matches what is currently being delivered during the dialysis treatment.” The “nursing and PCT (Patient Care Technician) notes” within the dialysis flow sheet did not indicate a reason why the DFR prescription was not being followed. During an interview on 10/23/24 10:15 AM, the Facility Administrator (FA) reviewed P5’s dialysis flow sheets. He/she stated he/she could not determine a reason why P5’s prescription was not being followed. The FA said there was a possibility that the dialysis machine changed to a “default setting” on its own. During an interview on 10/23/24 at 11:30 AM, Patient Care Technician (PCT)3, who was involved with treating P5 on 10/10/24, stated the process he/she followed once a patient had been connected to the dialysis machine was to check the DFR reading to ensure it was set at the appropriate setting. PCT3 said if a patient was having a medical issue that may warrant adjusting the DFR and he/she would contact the nurse to assess the situation and make any adjustments to the DFR. Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” revised April 2024 stated, “ ...Purpose: To obtain and document baseline and ongoing information about the patient before, during and after the dialysis treatment through data collection and nursing assessment ...Policy:2. The Nursing assessment will be performed and documented by a licensed nurse ...a. The assessment includes the following components ...iii. Verification of prescription ...3. Patient identity, prescription and machine setting are verified by teammate prior to initiation of treatment ...The prescription components are confirmed by a licensed nurse within one hour of treatment initiation ...Prescription components include ...g. Dialysate flow rate ...7. If there are no abnormal findings or concerns identified during the pretreatment data collection, the treatment may be initiated ...Intradialytic Data Collection/Assessment ...9. Intradialytic treatment monitoring and data collection which may be performed by the PCT, or licensed nurse includes ...b. At a minimum, obtain and document the following ...iii. Blood and dialysate flows ...10. If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed flow rate) the reason will be documented, and the licensed nurse informed ...””

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 26190 Based on document review and interview, the facility failed to conduct infection control (IC) audits of staff members on a monthly basis as part of their Quality Assessment Performance Improvement (QAPI) program. During the past year, the facility did not complete IC audits during seven of 12 of the previous months. This failure had the possibility to negatively impact all 65 patients currently dialyzing at the facility. Findings include: Review of the “infection control audits” of staff members for the past year (October 2023 - September 2024) indicated the audits were not completed on a routine basis. The following months were not included in the IC audits: October, November and December of 2023 and January, February, March and August of 2024. During an interview on 10/23/24 at 9:00 AM, the Manager of Clinical Services (MCS) confirmed that the IC audits on staff members should be completed on a monthly basis and that some of the audits for the past year were missing. When the MCS was questioned why the IC audits had not been completed, he/she stated he/she did not specifically know why, but there were times when staffing was an issue, and all staff members were providing direct patient care to ensure all patients received their dialysis treatments.”