Davita Faribault Dialysis Unit

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 22198 Based on observation, interviews, document review and policy review, the facility failed to meet the requirements of the Conditions for Coverage (CfC) for the Physical Environment, when it failed to: 1) ensure that the dialysis supplies area, the Acid and Bicarbonate mixing room, the water room and the dialysis patient treatment floor was monitored, cleaned and maintained to ensure the spaces were free from debris and potential hazards, correctly repaired and properly functioning, and unauthorized entry; 2) failed to ensure that the glucometer equipment used to test patients’ blood sugar was quality control (QC) tested per manufacturers (MFR) director for use (DFU) and re-tested or removed from service or sent for repaid when the high/low QC test failed. This deficient practice has the potential to cause harm or have a negative impact on all 24-in-center dialysis patients, visitors, and staff. Refer to V401 and V403 Findings Include: 1. The facility failed to ensure that the dialysis supplies area, the Acid and Bicarbonate mixing room, the water room and the dialysis patient treatment floor were monitored, cleaned, and maintained to ensure the spaces were free from debris and potential hazards, correctly repaired and properly functioning, and unauthorized entry. (Refer to V401) 2. The facility failed to ensure that the glucometer equipment used to test patients’ blood sugar was quality control (QC) tested per manufacturers (MFR) director for use (DFU) and re-tested or removed from service or sent for repaid when the high/low QC test failed. (Refer to Tag V403)”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. This Standard is not met as evidenced by: 22198 Based on review of employee files & Emergency Management Plan, Emergency Plan Training, and interviews, the facility failed to ensure that emergency training on the facility’s Emergency Management Plan was completed for four of 11 staff (Biomedical Technician (BMT) Master’s Social Work (MSW), Registered Dietitian (RD) and Patient Care Technician (PCT 2). The failure to ensure that all staff were educated on Emergency Preparedness and the facility’s specific Emergency Management Plan places all 24 dialysis patients at this facility at risk during an emergency. Findings include: Review of BMT’s employee file revealed that for the calendar year 2024/2025, there was no evidence in BMT’s electronic learning had all-encompassing emergency preparedness. The Paper log for the last annual Emergency Preparedness Training titled, “Facility Emergency Preparedness Training Form,” dated 04/24/24, did not include BMT as an attendee. Additional staff missing from the Emergency Preparedness Training form were MSW, RD and PCT2. During an interview on 01/29/25 at 9:00 AM, the Facility Administrator confirmed that BMT, MSW, RD, and PCT2 had not received the facility specific Emergency Preparedness Training within the past 12 months, and currently did not have a system in place for staff to review the current Facility Emergency Preparedness Training if they were unable to attend the training in-person. Review of the facility’s Emergency Preparedness document titled “Facility Emergency Management Plan (ICHD, Home)” [for in-center and home program] dated 10/24 revealed, “Training and Education: ... The FA [Facility Administrator], or designee, is responsible for providing training of EMP [employee]: a. Teammates: i. Annually 1. Policy and Facility Emergency Management Plan 2. Appropriate hazards policies, per HVA 3. Clinical emergency policies 4. Facility specific emergency repose procedures ...v. Document training in teammate file 1. Training/In-service Documentation Form””

“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 two observations days, the Biomedical Technician (BMT) and one of two access holding patients (P5) performed hand hygiene after gloves were removed. This failure puts all 24 in-center patients at risk for cross contamination. Findings include: 1. During an observation of the dialysis discontinuation and needle removal for P5 on 01/27/25 at 9:13 AM revealed P5 was holding his/her access site to help stop the bleeding with one hand gloved. Once hemostasis was achieved P5 removed his/her glove and Patient Care Technician (PCT2 placed on a cleaning dressing and discharged P5. PCT failed to remind P5 to perform hand hygiene or offer hand sanitizer before P5 left the facility. During an interview while observing P5 leave the facility without performing hand hygiene on 01/27/25 at 9:20 AM, PCT2 confirmed P5 should be reminded to perform hand hygiene after holding their access site and removing their glove. 2. During an observation on 01/27/25 at 2:07 PM the BMT was observed on the dialysis floor trouble shooting Dialysis Machine #3 at Station #7. BMT removed the glove from his/her left hand after working on the machine troubleshooting the alarm and put his/her left hand into his/her jean pocket without performing hand hygiene. BMT then shut the machine keyboard, removed the right glove, and walked off the dialysis treatment floor removing his/her face mask and gown without performing hand hygiene. During an interview with PCT1 on 01/27/25 2:07 PM as BMT was leaving the dialysis floor, PCT1 confirmed that BMT did not perform hand hygiene after removing his/her gloves and should have. During an interview BMT on 01/27/25 at 2:45 PM stated he/she was hardly on the floor and did not know he/she was required to perform hand hygiene after removing gloves. BMT stated that he/she unusually worked in the back on the machines. BMT stated he/she did not remember getting infection control training. 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-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 22198 Based on observation, interview and policy review, the facility failed to keep common items that were not dedicated, or disposable and could not be disinfected into the dialysis station to prevent cross contamination for two of two observation days. This deficient practice has the potential for cross contamination that could affect all 24 in-center dialysis patients and all staff. Findings include: During an observation of the dialysis treatment floor on 01/29/25 from 10:10 AM until 12:00 PM, a box of gloves and a box of tissues were sitting on the countertop between Stations #1 through #3, Stations #4 and #7, and Stations #8 and #9. Also observed were patient’s personal items/bags on the countertops behind these dialysis stations. During an interview on 01/27/25 at 10:00 AM during the flash tour the Facility Administrator and the Acting Manager of Clinical Services (A-MCS), they confirmed that because of the size of this facility patient’s items can be stored on the back countertops at the dialysis station and staff are to be cleaning the countertop as a part of the dialysis station. When the boxes of gloves and tissue also on the countertops behind the dialysis stations were pointed out, the Facility Administrator and A-MCS stated the tissue boxes and gloves should not be stored there. During an observation on 01/27/2025 at 9:13 AM Patient Care Technician (PCT) 2 brought the sharp’s container from the corner between Stations #7 and #8 to Station #8 to use for the needles removed. There were three visible spots of red substance on the top of the sharp’s container. After the procedure was completed PCT2 put the sharps container back into the corner without cleaning it. During an observation on 01/27/25 at 3:16 PM PCT1 brought the same sharp’s container from the corner between Stations #7 and #8 to Station #8 to use for the needles removed. The three visible spots of red substance were still on the lid of the sharp’s container. After the procedure was completed PCT1 put the sharps container back into the corner without cleaning it. During an interview on 01/27/25 at 3:20 PM PCT1 confirmed it was the facility’s practice to use one sharps container for every two stations. PCT1 confirmed he/she had not cleaned the sharps container either before or after using it in Station #8, before putting it back in the corner between Stations #7 and #8. PCT 1 confirmed there was drops of “blood” on the top of the sharp’s container lid, which had not been wiped off. During an observation of the remaining four sharps containers on 01/27/25 at 3:30 PM revealed red dried substance on the lids of the sharp’s container between Stations #1 and #2, Stations #3 and #4, Stations #5 and #6, and the one sharps contained between stations #9 and #10 was up against a pillar section of a wall with red spots on the lid of the sharps container and on the wall behind where the sharps contained was located. During an interview on 01/27/25 at 3:30 PM, the Registered Nurse Manager (RN-M) stated the spots looked like blood and confirmed that the facility does not clean those sharps buckets shared between station. 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. ... Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient. ...Unused supplies (syringes, alcohol swabs, tape, etc.) or medications (including multiple dose vials containing diluents) taken into the station should be used only for that patient and should not be returned to a common clean area or used on other patients. 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.””

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 22198 Based on observations, interviews and policy review, the facility failed to ensure that 10 of 10 stations (1-10) they used medical waste containers with closed tight-fitting lids to prevent leakage of potentially hazardous bodily fluids and minimizing the risk of exposure to bloodborne pathogens. The failure to use medical waste containers with closed, tight-fitting lids to prevent leakage of potentially hazardous bodily fluids has the potential to affect all 24 current dialysis patients, all staff, and visitors. Findings include: During observation of the treatment floor from 01/27/25 from 10:00 AM until 12:00 PM, each station had a small red bucket without a lid with a biohazardous liner at the bottom of each dialysis machine leaving them open to air. The biohazardous buckets were used for the disposal of blood lines and dialyzer after treatment was completed. The blood lines and dialyzer were removed as soon as the treatment was completed before the patient left the Station and were either left open to the environment at the bottom of the dialysis machine or on the floor next to the patient chair while technicians continued to take care of patients prior to their discharge as follows: 1. During observation on 01/27/25 at 9:13 AM at Station #8, the blood lines and dialyzer were removed from the dialysis machine by Patient Care Technician (PCT) 2 and the biohazardous lidless bucket remained on the bottom of the dialysis machine. While PCT2 continued to enter data on the dialysis machine, PCT2’s gown brushed against the biohazard lidless biohazardous bucket with the bloodlines and dialyzer. 2. During observation on 01/27/25 at 3:16 PM at Station #8, the blood lines and dialyzer were removed from the dialysis machine by PCT1, and the biohazardous lidless bucket was placed on the floor between the dialysis machine and chair. While PCT1 continued to enter perform tasks to discharge the patient and ready the station for cleaning, PCT1’s gown brushed against the biohazard lidless biohazardous bucket with the bloodlines and dialyzer. During an interview on 01/27/25 at 3:16 PM PCT1 stated that this was the facility practice since he/she could remember. PCT1 confirmed that they do not have a lidded biohazardous container at the dialysis station, they will tie up the bag and dispose of it in a larger biohazard bin after each treatment. During an interview on 01/27/25 at 3:30 PM PCT2 stated he/she has worked here for almost a year, and this is the way they were taught (regarding the lidless biohazardous waste containers). PCT2 confirmed that they do not have a lidded biohazardous contained at the dialysis station, they will tie up the bag and dispose of it in a larger biohazard bin after each treatment. During an interview on 01/28/25 at 9:15 AM, the Facility Administrator and the Manager of Clinical Services (MCS), and review of the potential cross contamination that occurs, confirmed that the medical waste containers on each dialysis station did not have lids to ensure they were closed to avoid exposure. Review of facility’s policy titled, “Segregation of Medical Waste,” revised 10/23, revealed, “2. Medical waste containers are defined as: ...b. A labeled medical waste transfer container with a wheeled base tray and foot mechanism to open the lid. c. A labeled plastic container with no foot mechanism to open the lid. 3. When using option c above, the following infection control practices need to be followed: Lid should be tight fitting.””

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 22198 Based on observation, interviews and policy review, the facility failed to ensure that one of two water room locations (Acid and Bicarbonate Mixing and Storage) were secured and not accessible to unauthorized users. The failure to ensure the dialysis water system and storage is protected from unauthorized users puts all 24 in-center dialysis patients at risk for potentially contaminated the two water mixing systems. Findings include: During the flash tour on 01/27/25 at 10:10 AM with the Facility Administrator and the Acting Manager of Clinical Services (A-MCS) the room to the acid mixing and storage and the bicarbonate mixing and storage systems door was propped open. The door had a doorknob that did not have a locking mechanism. On 01/27/25 at 10:10 AM during an interview the Facility Administrator (also present A-MCS) confirmed that the door remains open all the time. The Facility Administrator and the A-MCS confirmed that the door did not have a locking mechanism and was accessible to anyone walking in their facility. During an interview on 01/27/25 at 10:15 AM the Biomedical Technician (BMT) confirmed that the door does not have the ability to lock, and it does remain open accessible to anyone walking in that hallway. BMT stated there was a lock on the main water room system but was not aware that the Acid and Bicarbonate mixing and storage was considered a part of the dialysis water system. Review of the facility’s policy titled, “Water Treatment Systems Minimum Component Requirement,” dated 10/21 revealed, “New and renovated water purification and distribution systems should be located in a secure area that is readily accessible to authorized teammates. ... Access to the water treatment system should be restricted to those personnel/trained teammates responsible for monitoring, maintenance of the system and supply ordering.””

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 22198 Based on observation, interviews and policy review, the facility failed to ensure that the filter in the pre- reverse osmosis (RO) treatment section of the water room system was maintained and functioning properly. Failure to ensure that the pre-treatment section of the dialysis water system is maintained and functioning properly has the potential to affect all 24 in-center dialysis patients by potential exposure to hazardous contaminants that will not get filtered out of the water. Findings include: During the flash tour on 01/27/25 at 10:10 AM with the Facility Administrator and the Acting Manager of Clinical Services (A-MCS) in the main water room identified a blue filter that was steadily leaking as evidenced by water underneath running towards the drain, and crystallization around the section where the blue filter is attached into the pre-RO water housing system. Interview during the observation on 01/27/25 at 10:10 AM the Facility Administrator (also present A-MCS) confirmed that the floor was wet under the filter and draining to the floor drain and that the crystallization was around the filter connection area. The Facility Administrator and the A-MCS stated they could not say how long the filter had been leaking or the last time it was changed, and referred to the Biomedical Technician (BMT). On 01/27/25 at 10:15 AM during an interview with the BMT, he/she stated he/she is not at this facility every week and could not say how long the filter had been leaking. BMT stated the facility staff should notify him/her of any maintenance issues in the water room and possibly a work order should be entered. BMT stated he/she had last changed the filter at the beginning of the month and did not know if the filter had been leaking since it was last changed. Review of the documentation of the last pre-RO filter change titled, “DaVita Ticket Summary,” revealed “Work Performed: Replaced R.O prefilter. Per Manufacture and Davita policy” was dated completed “01/07/25.” During an interview on 01/29/25 at 10:30 AM the. BMT when asked about the crystallization around the filter’s pre-RO water housing system, stated “it takes about two months” for that amount of crystallization, and confirmed on his/her visits to this facility he did not notice the crystallization or leaking around the pre-RO housing of the filter. BMT confirmed that there were no outstanding work orders or notice of maintenance issues at this facility. 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, ...dialysis delivery systems and the water treatment systems are maintained and operated in accordance with the manufacturer’s recommendations.””

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 22198 Based on observation, interviews, policy, water training log, and manufacturers review the facility failed to ensure that one of one staff (Patient Care Technician (PCT) 1) completed chlorine tests per manufacturer’s recommendation to ensure the results were accurate. Failure for staff to perform the chlorine tests by manufacturer’s (MFR) directions for us (DFU) could lead to high levels of chlorine by causing destruction of red blood cells (hemolytic anemia) and places all 24 in-center dialysis patients for negative outcomes. Findings include: During an observation on 01/27/25 at 4:44 PM PCT1 completed a chlorine and chloramine test in the water room, swishing the chlorine test strip in the water for the designated amount of time, removed the test strip and without shaking off the excess water read the strip. During an interview at the time of the chlorine and chloramine testing on 01/27/25 at 4:44 PM, PCT1 stated he/she was not aware that the water needed to be shook off prior to reading the test strip. PCT1 confirmed he/she was not aware of shaking off the excess water was necessary and had not been taught that way. Review of the MFR DFU for “Serim Guardian” chlorine and chloramine test strips not dated with a reference #5167, revealed, “. . .3. Remove strip and shake off excess water. ...” During an interview on 01/29/25 at 10:30 AM, the Biomedical Technician (BMT) confirmed that DaVita per policy uses four different manufacture’s Chlorine test strips, so that can cause confusion if the MFR DFU requirements are different. BMT confirmed he/she was responsible for the training and oversight of the staff who are allowed to perform water room functions like the Chlorine testing. BMT stated that he/she was only at this facility sometimes “once a week, sometimes once every three weeks.” BMT stated he/she had oversight to six dialysis clinics. Review of the facility’s policy titled, “Daily Water System Total Chlorine Monitoring” dated 10/24, revealed, “The following test kits/strips are approved for Total Chlorine testing of water used for dialysis in DaVita facilities: RPC Ultra Low Total Chlorine Test Strips- Sterichek Total Chlorine Test Kit -E-Z Check Chloramine Test Ships o Serim HiSense Ultra 0.1 TM Test Strips Using one of the approved methods listed above, samples for Total Chlorine are tested immediately to avoid errors due to the instability of chlorine/chloramines in water.””

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 22198 Based on observations, interviews and facility documents and policy review the facility failed to ensure the facility was constructed to secure all prescription medications, a water system that was cleaned, maintained and monitored to ensure it was maintained and functioning and provide dialysis patients, staff, and the public a safe, functional, treatment environment to prevent contamination. This failure places all 24 in-center dialysis patients, staff, and visitors at risk for a negative outcome. Findings include: Observation of the facility on 01/27/25 revealed the following: 1. Upon entrance to the facility on 01/27/25 at 8:00 AM the door between the waiting room and the dialysis treatment floor was opened and three patients were visible at Station #3, #4, and #5. The door had a coded lock system but was propped open. After observing for 10 minutes, and having a patient walk past and enter the dialysis floor, a staff approached to ask if I needed help. During an interview on 01/27/27 at 8:10 AM Patient Care Technician (PCT) 1 introduced him/herself and confirmed the door leading directly to the dialysis treatment floor should not be propped open and immediately released the door to close it. During an interview on 01/27/25 at 8:15 AM Registered Nurse Manager (RN-M) when asked about the door leading to the dialysis treatment floor being propped open stated, the Biomedical Technician (BMT) “just came in and failed to close it”” During an interview on 01/27/25 at 8:25 AM, the BMT confirmed that the door was propped open when he/she got to the facility and BMT just walked through back to the water treatment area. There were boxes of gloves and tissues on the countertops behind the dialysis stations along with patient’s personal items/bags. During the entrance conference on 01/27/25 at 9:29 AM and interview, the Facility Administrator, and the Acting Manager of Clinical Services (A-MCS) confirmed that the dialysis treatment floor should not be propped open for the staff and patient’s safety. 2. During the Flash Tour of the facility on 01/27/25 at 9:55 AM the following was observed: a. leaving the treatment floor area the door to the storage and water room was open and accessible to any patient, visitor, or vendor. b. The Storage room was dusty, with debris and stained on the floors. The door outside the storage room (leading directly into the mall commons areas) was opened to check security and two palates of dialysis supplies were in the hallway not secured. c. In the main water room the following was observed: i. Three ceiling tiles were displaced and two had cracks or intension breakage. ii. The floor seal was broken around the floor drain exposing the porous cement approximately 3x6 inches with a stream of standing water draining towards the floor drain. iii. The floor in front of the reverse osmosis (RO) system had six divots out of the seal on the floor exposing the porous cement. vi. The blue filter on the RO system has crystallization formed around the housing attachment and was leaking and there was dust, white stains and paper and test strip debris on the floor. v. The brine tank cover was dusty and was partially hanging off the brine tank. The signage on the brine tank indicated, “Factors Affecting Operation: ...The brine tank should be kept closed to eliminate debris from coming in contact with the salt ...” vi. Between the back flow preventor, the booster pump, the water heater, and the Brine tank there was a dry dark-colored substance covering the wall, and all the equipment in that area, including an open box of gloves. The back flow preventor housing had rust on the exterior and the floor was discolored underneath. vii. The back flow preventer drain funnel was rusted, three fourths of the funnel was covered in black duct tape and there were back zip ties holding up the funnel to some of the water system pipes. Just above the back flow prevent was plumbing that had a metal hexagon housing made of metal that had a reddish/brown colored. The plumbing section of the housing was discolored with greenish blue and white and had rusted bolts. d. The second water room where the mixing and storage of acid and bicarbonate was observed: i. There was dirt and debris on the floor. ii. Rust and white powdery substance on the mixing tank, and underneath the acid mixing tank the floor was discolored and debris. iii. Above the two storage tanks in the mixing room were holes poked into the ceiling where it appears to have been punctured by the red and yellow hoses that went through it. There were dead legs of tubing zip tied above the tanks that were attached to the plumbing. The debris from the broken ceiling tiles was still on the floor. iv. The acid testing hydrometer stored in its box to prevent breakage had white crystals on it and inside the box. v. The pump motors for the two storage tanks were sitting directly on the floor. During an interview on 01/27/25 at 9:55 AM at the time of the observations on the Flash t our the Facility Administrator and the A-MCS confirmed the findings, and the facility does not do cleaning that a contracted service comes in but does not touch dialysis equipment. The Facility Administrator confirmed that the facility does not have an internal cleaning system. The Facility Administrator provided a copy of the DaVita audit completed April 17, 2024, by the BMT, the MCS, and the Divisional Vice President (DVP) and stated two “safety” audits are done annually the last one was done November 18, 2024, but most of these items identified were not identified in these audits. The Facility Administrator confirmed that the facility’s dialysis supply deliveries should not be left unattended in the mall area. During an interview on 01/27/25 at 10:10 AM the BMT confirmed all findings in the water room areas and stated he/she was not aware of the issues identified on the Flash Tour. BMT confirmed the last time the acid was mixed was 01/17/25, and that the MFR requires cleaning after use. BMT stated he/she did the hosing repairs identified with the punched-out holes for the hosing in 2024, and confirmed the broken-out ceiling pieces were still on the floor. During an interview of 10/29/25 at 10:30 AM, the BMT stated that the Facility Administrator should be delegated environmental tour because BMT was only there once a week maybe once every three weeks, stating, he/she had oversight to six clinics. BMT confirmed that when he/she is onsite he/she does not look for dirt and garbage, and staff should not be throwing test strips on the floor and should notify BMT if there is a problem in the water room like the leaking filter. When asked about the rusty funnel by the booster tank with the black duct tape and zip ties, that “I didn’t do it.” The BMT was asked how long it took to build up the amount of crystallization found around the blue pre-RO filter housing, stated it “takes about 2 months” to build up to that amount. BMT confirmed there are no outstanding maintenance or work orders at this facility. Observation of the facility on 01/28/25 revealed the following: 1. Upon entrance to the patient’s waiting area on 01/28/25 at 8:30 AM a square hole was noted in the baseboard in front of the scale. During an interview on 01/28/25 at 8:30 AM, the Administrative Assistant (AA) confirmed that the scale had been replaced in 2024, but the hole put in the wall to reach the electricity to make the floor scale work was never fixed and the scale itself never had the seal on the floor scale removed and now it is just peeling away. 2. On 01/28/25 between 8:30 AM and 10:15 AM, the Facility Administrator and Manager of Clinical Services (MCS) the following was observed on the dialysis treatment floor: a. The tissues remained on the back countertop. (Observation noted on 01/27/25 example 1.) b. At Stations #3, #5, #6, and #10 the Dia Safe filter covers were off the Dia Safe filter connected to the dialysis machines and laying on the counter tops behind the stations. c. At Stations #1 and #3 the hand cranks used to manually return blood in an emergency or power outage at these two stations were on the counter behind the dialysis machine and not attached to the machine in case of an emergency. d. At Station #6 was a translucent plastic container with dust and debris covering the entire bottom of the open container and along its sides and rim. e. The wall boxes at Stations #2, #4, #5, #9, and #10 had visible stains and crystals. f. Stations #2 wall box had a rusty washer and hook up connector on the 2K (potassium) spout. The wall box at Station #4 had a rusted washer on the 3K (potassium) spout and crystallization on the connector. g. At Station #1 there was crystallization behind & under the chair. There were holes in the wall exposing the porous drywall. h. The floor under the cabinets between Stations #1, #2, and #3 had a paper cup, a white stick, dust debris, rust colored stain, and crystallization under the wall boxes. i. One pull out drawer behind the nurse’s station did not have a lock and contained the facility’s supply of Heparin. One glass vial of the 30,000 per 30 milliliters (ml) lot LJ3062 was opened with visible puncture marks in the vial’s septum, however staff failed to time or date when the Heparin was opened. j. A cupboard at the other end of the counter behind the nurses station did not have a lock on it and contained prescription medications, and examples of some of the medication in this cupboard, Venofer (an Iron supplement), Cefazolin (an antibiotic), Ondansetron (to prevent nausea and vomiting), Korsuva (to treat moderate-to-severe itching associated with chronic kidney disease), and Diphenhydramine (relieves allergy symptoms). k. The blue medication refrigerator had a locking mechanism but was not locked and contained tuberculin testing agent, influenza and COVID vaccinations, and prescription Micera (to treat anemia). l. Paper signage was identified on the hand sanitizer stand at the dialysis treatment entrance/exit. During an interview at the time of each observation identified on the dialysis unit on 01/28/25 between 8:30 AM and 10:15 AM, the Facility Administrator and MCS confirmed the observation. The Facility Administrator and MCS confirmed that the Heparin was not labeled and should have been with the date, time, and initials of who opened it. The Facility Administrator and MCS indicated they did not think the prescription medication in the drawer and the cupboard needed to be locked and confirmed that the blue refrigerator should have been locked. The Facility Administrator confirmed this facility is open Monday, Wednesday, and Friday, so the contracted cleaning staff, and contracted maintenance personnel come into the dialysis facility on the days the facility is closed (Tuesday, Thursday, or Saturday) to do their work unaccompanied by facility staff. The Facility Administrator confirmed the facility does not currently have a system in place to audit and identify environmental issues. The facility Administrator and the MCS confirmed the paper signs should not be on the floor, there was no excuse for the environmental issues identified. Review of the audit titled, “Treatment Detail Report,” completed 11/22/24 revealed “Question 20 - Water and Dialysate: Water room: Water room is locked and secure; equipment in observable good repair” is marked “Yes.” Review of the facility document for the work completed on the patient’s floor scale titled “Contract’ the start date was “09/22/23’ and the work completion date was “02/01/24’ for the patient floor scale. During an interview on 01/29/25 at 10:00 AM, the Administrative Assistant (AA) stated that the facility had known about the hole in the wall and the film on the scale not being removed and now it is peeling off. AA stated “It should have been done at that time (02/01/24)” AA confirmed that there was not work order to have these items taken care of. During an interview on 01/29/25 at 10:30 AM, BMT confirmed there are no outstanding maintenance or work orders at this facility. During an interview on 01/29/25 at 12:50 PM the Registered Nurse Manager (RN-M) when asked about the blue medication refrigerator stated, “I forgot to lock it.” RN-M confirmed that the drawer with the Heparin and the cupboard with the prescription medication never had locks on them. RN-M confirmed the facility is closed Tuesday/Thursday/Saturday and that is when the cleaning person, and maintenance are typically there. 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 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. ... Systems to assure patient safety will be in place, ... Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only. Access limitation does not preclude visitors or tours by individual(s) authorized and supervised by facility personnel. The dialysis facility will store supplies in a manner that is consistent with fire safety and other appropriate regulations. Supplies will not obstruct any fire exits or hallways. Refer to: Monthly OSHA and Safety Checklist for further guidance or as required by local jurisdiction requirements. Supplies are stored as to minimize deterioration, contamination or breakage. ... Incoming supplies are visually inspected prior to acceptance by the facility to verify: Supplies are in original container during storage. ... Containers and boxes are undamaged. There is no evidence of leaks or spillage.” Review of the facility policy titled, “Medication Policy,” dated 10/23, revealed “All refrigerated medications, for example erythropoietin stimulating agents (ESA) and vaccines are to be locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate or per state regulations. ... If multi-dose vials are used to prepare saline flush syringes, they must be dated upon opening and discarded within 28 days unless the manufacturer specifies a different date for that vial. The beyond-use date should never exceed the manufacturer’s expiration date.””

“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 observation, interviews, and review of the glucometer quality control (QC) testing log, the policies and manufacturer’s (MFR) direction for use (DFU), the facility failed to re-test one of one glucometer that was tested for the QC hi/low testing parameters to ensure the blood sugar tests were providing accurate results for four of six months reviewed (September 2024, October 2024, November 2024, December 2024, and January 2025). The failure to follow the MFR/DFU and the facilities policies has the potential to negatively affect the blood sugar test results giving an inaccurate reading. Findings include: During an observation and record review on 01/28/25 at 10:15 AM the Facility Administrator and the Manager of Clinical Services (MCS) identified one glucometer (MFR: EmbracePRO TM) in a drawer with the test strips, and the high/low solution was stored in the refrigerator. Review of the Glucometer QC testing logs titled “Incenter Hemodialysis Policies & Procedures DaVita HealthCare Partners Inc Procedure 1-08-06A” revealed as follows: The low parameters were defined as “87 to 117” the high parameters were defined as “282 to 380” the following out of range QC tests were identified in the testing logs: 1. For the month of September 2024, the test strips identified that the expiration date was 09/26/25 for the entire month defining a date greater than four months after opening per MFR/DFU and the facility policy. On 09/11/24 the low was 83 and the high was 262. No re-test was completed per MFR/DFU. No intervention was documented. On 09/20/24 the high was 381. No re-test was completed per MFR/DFU. No intervention was documented. On 09/23/24 the low was 119. No re-test was completed per MFR/DFU. No intervention was documented. 2. For the month of October 2024, the test strips identified that the expiration date was 09/26/25 for the entire month defining a date greater than four months after opening per MFR/DFU and the facility policy. On 10/11/24 the low was 79. No re-test was completed per MFR/DFU. No intervention was documented. On 10/14/24 the high/low parameters were changed to low between 89-119 and high 281 to 379 and the test strip expiration date changed to 09/21/25, which is greater than the four months defined after opening per MFR/DFU and the facility policy. On 01/14/24 the high was 382. No re-test was completed per MFR/DFU. No intervention was documented. On 10/18/24 the low was 87 and the high was 271. No re-test was completed per MFR/DFU. No intervention was documented. On 10/23/24 the low was 128. No re-test was completed per MFR/DFU. No intervention was documented. On 10/28/24 the low was 84. No re-test was completed per MFR/DFU. No intervention was documented. 3. For the month of November 2024, the test strips identified that the expiration date as 07/11/24 (would have been expired at the time of use) and additional expiration dates documented for this month were 09/21/25, 04/16/26 during this month defining a date greater than four months after opening per MFR/DFU and the facility policy. The hi/low solution was changed to an expiration date of 03/14/25, that is past the 90 days after opening per MFR/DFU and the facility policy. The low ranged defined as 89 to 119 and the high range 281 to 379. On 11/01/24 the low was 122. No re-test was completed per MFR/DFU. No intervention was documented. On 11/06/24 the low was 86. No re-test was completed per MFR/DFU. No intervention was documented. On 11/11/24 the hi/low testing range changed to low between 90-120 and high between 283-381. On 11/15/24 the high was 554. No re-test was completed per MFR/DFU. No intervention was documented. On 11/18/24 the low was 84 and the high was 275. No re-test was completed per MFR/DFU. No intervention was documented. On 11/29/24 the low was 80 and the high was 259. No re-test was completed per MFR/DFU. No intervention was documented. 4. For the month of December 2024, the test strips identified that the expiration date as 03/11/24 that would have been expired at the time of use. The high/low solution defined the expiration date as 02/11/24, that would have been expired at the time of use. The low ranged defined as 90 to 120 and the high range 283 to 381. On 12/02/24 the low was 89 and the high was 274. No re-test was completed per MFR/DFU. No intervention was documented. On 12/06/24 the low was 85. No re-test was completed per MFR/DFU. No intervention was documented. On 12/13/24 the high was 250. No re-test was completed per MFR/DFU. No intervention was documented. On 12/18/24 the hi/low ranges changed to low between 91-121 and high between 284-384. On 12/18/24 the high was 265. No re-test was completed per MFR/DFU. No intervention was documented. On 12/20/24 the high was 265. No re-test was completed per MFR/DFU. No intervention was documented. On 12/23/24 the low was 89. No re-test was completed per MFR/DFU. No intervention was documented. On 12/26/24 the low was 90 and the high was 277. No re-test was completed per MFR/DFU. No intervention was documented. 4. For the month of January 2025, the test strips identified that the expiration date as 06/13/26, which would have exceeded the four months after opening per the MFR/DFU and the facility’s policy. The high/low range was defined as 91 to 121 and the high range 284 to 384. On 01/01/25 the low was 85. No re-test was completed per MFR/DFU. No intervention was documented. On 01/06/25 the low was 87 and the high was 282. No re-test was completed per MFR/DFU. No intervention was documented. On 01/08/25 the low was 80 and the high was 257. No re-test was completed per MFR/DFU. No intervention was documented. On 01/10/25 the high was 269. No re-test was completed per MFR/DFU. No intervention was documented. On 01/13/25 the low was 89. No re-test was completed per MFR/DFU. No intervention was documented. On 01/15/25 the low was 80 and the high was 259. No re-test was completed per MFR/DFU. No intervention was documented. On 01/17/25 the low was 85 and the high was 281. No re-test was completed per MFR/DFU. No intervention was documented. On 01/27/25 the low was 189 and the high was 392. No re-test was completed per MFR/DFU. No intervention was documented. During an interview on 01/28/25 at 10:15 AM the Facility Administrator and the Manager of Clinical Services (MCS) after identifying the glucometer QC checks out of range, confirmed the staff did not follow the MFR/DFU for re-testing or the facility’s policy to determine the cause of the glucometer testing failure, and did not document any interventions if any were done. The MCS stated that staff might have entered the wrong date for those expiration dates that were clearly expired but could not confirm that. Review of the MFR DFU found in the booklet titled “Embrace PRO TM” dated 10/13 revealed, “If test results fall outside of the range printed on the test strip vial, repeat the test. Out-of-range results may be caused by one or more of the following: - Expired or contaminated control solution. - Expired or damaged test strips. - Error in performing test. - The code number “71” and “72” on the system is just classification number for the ‘Embrace PRO TM Test Strip.’ - Meter, test strips or control solution are kept too warm or too cold. - Meter malfunction. ... Discard control solutions 90 days after opening or on the expiration date printed on the bottle. ... Discard test strips four (4) months after opening or on the expiration date printed on the bottle.” Review of the facility’s policy titled “EmbracePRO TM Blood Glucose Monitor: Quality Control (QC)” dated 09/20, revealed, “Glucose control checks should be performed: Before using the meter for the very first time. Whenever there is a reason to question blood glucose results. Any time the test strips have been exposed to extremes in temperature. A new box of test strips is opened. ... Check high and low control solutions expiration date. Do not use control solutions past expiration date. Discard control solutions 90 days after opening or on the expiration date printed on the bottle, whichever comes first. 90-day expiration is per the manufacturer’s directions for use (DFU). Do not use test strip past expiration date. Discard test strips four (4) months after opening or on the expiration date printed on the bottle, whichever comes first. The four (4) month expiration is per the manufacturer’s DFU. ... If control results fall outside the acceptable range, the test must be repeated. If the monitor does not read control solution values accurately, it may not read patient blood glucose values accurately and is not safe to use. Following the manufacturer’s DFU, the meter must be assessed for the cause of the malfunction. Date and document any needed interventions for monitor problems on the reverse side of the QC Log sheet.””

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 22198 Based on interviews, medical record review, and policy review, the facility failed to ensure three of five in-center sampled patients (P1, P2, and P3) low blood pressure (BP) were assessed per policy. The failure to assess and address blood pressure during dialysis has the potential for worsening patient conditions without a timely intervention that could affect 24 in-center patients. Findings include: Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” dated 04/24 revealed, “This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge. ... Patient data will be obtained and documented by the patient care technician (PCT) or a licensed nurse. ... ii. Measurement of Blood Pressure (BP) ...Abnormal Findings: Blood Pressure-Intradialytic: Systolic greater than 180 [Millimeters of mercury] mm/Hg or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg.” 1. Review of P1’s medical record revealed for three of six of the current “Treatment Details Report” the following: a. On 01/15/25 at 9:30 AM, P1’s BP was recorded as 185/84 (mm/Hg). There was no documentation the Patient Care Technician (PCT) notified the Registered Nurse (RN) of the BP that was out of range. b. On 01/17/25 at 8:30 AM, P1’s BP was recorded by the PCT as 194/81 mm/Hg. At 9:30 AM, the BP was recorded by the PCT as 204/82 mm/Hg. At 9:48 AM, the BP was recorded by the PCT as 198/91 mm/Hg. For these three events on 01/17/25, the PCT did not document notifying the RN of the out-of-range BP. c. On 01/20/25 at 8:00 AM, P1’s BP was recorded as 196/87 mm/Hg. At 8:30 AM the BP was recorded as 199/90 mm/Hg. The PCT did not document notifying the RN of the out-of-range BPs for P1. 2. Review of the medical record for P2 revealed the following for three of six of the most current “Treatment Details Report”: a. On 01/15/25 at 7:32 AM, the BP was recorded as 114/38 mm/Hg. The PCT did not document notifying the RN. At 8:31 AM, the BP was recorded as 111/43 mm/Hg. The PCT did not document notifying the RN. b. On 01/20/25 at 8:04 AM, the BP was recorded as 118/45 mm/Hg. The PCT did not document notifying the RN. c. On 01/24/25 at 6:31 AM, P2’s BP was recorded as 149/101 mm/Hg. At 8:31 AM, the BP was recorded as 98/47. The PCT did not document notifying the RN of the out-of-range BPs for P2. 2. Review of the medical record for P3 revealed the following for five of six of the most current “Treatment Details Report” indicated P3 has a special order that varied for the BP parameters defined in the facility’s policy under the header titled, “Treatment Parameter Orders” that indicated “Do Not Initiate Tx (treatment) And Notify Nurse For Pre Assessment If” BP Systolic (SBP) above 180 mm/Hg SBP below 90 mm/Hg BP Diastolic (DBP) DBP above 110 mm/Hg DBP below 60 mm/Hg ... Notify The For Post Assessment If SBP above 180 mm/Hg SBP below 90 mm/Hg DBP above 110 or DBP below 60 mm/Hg.” a. On 01/15/25 the Pre-Treatment Vital Signs were documented a Standing BP: 185/94 mm/Hg and a Sitting BP: 193/105 mm/Hg. P3’s dialysis was initiated at 9:50 AM by the PCT who recorded BP of 188/98 mm/Hg. The RN pre-assessment was not completed until 9:55 AM, after P3 was started on dialysis. b. On 01/17/25 the Pre-Treatment Vital Signs were documented a Standing BP of 188/102 mm/Hg and a sitting BP of 195/103 mm/Hg. P3’s dialysis was initiated at 6:27 AM by the PCT who recorded the BP of 194/98 mm/Hg. The RN pre-assessment was not completed until 6:32 AM, after P3 was started on dialysis. c. On 01/20/25 the Pre-Treatment Vital Signs were documented a Standing BP of 201/113 mm/Hg and a sitting BP of 214/121 mm/Hg. P3’s dialysis was initiated at 5:57 AM by the PCT who recorded the BP of 208/114 mm/Hg. The RN pre-assessment was not completed until 6:18 AM, after P3 was started on dialysis. d. On 01/22/25 the Pre-Treatment Vital Signs were documented a Standing BP of 206/114 mm/Hg and a sitting BP of 212/119 mm/Hg. P3’s dialysis was initiated at 10:07 AM by the PCT who recorded the BP of 216/113 mm/Hg. The RN pre-assessment was not completed until 10:17 AM, after P3 was started on dialysis. e. On 01/24/25 at the Pre-Treatment Vital Signs were documented a Standing BP of 202/108 mm/Hg and a sitting BP of 197/107 mm/Hg. P3’s dialysis was initiated at 10:03 AM by the PCT who recorded the BP of 204/113 mm/Hg. The RN pre-assessment was not completed until 10:24 AM, after P3 was started on dialysis. During an interview on 01/28/25 at 8:00 AM the Manager of Clinical Services (MCS) confirmed that the PCTs should notify the RN for parameters outside those defined in the policy for P1 and P2. The RNs were responsible to document interventions and/or outcomes and then the MCS pointed out two sections in the “Treatment Details Report” where the RN could document dialysis concerns. The MCS confirmed that for P3 the PCT’s should have documented notification of the RN, and the RN should have had a completed assessment on P3 prior to initiation of dialysis per the physician’s special order. MCS confirmed that the facility did identify this as a problem area in the 11/24 facility assessment, but obviously “we still have some work to do.””

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 22198 Based on observation, interviews, and policy review, the facility failed to ensure that Patient Care Technician (PCT) 2 did not touch the cleaned skin, without repeating skin antisepsis process for one of the two patients (Patient (P) 6) observed for arteriovenous fistula (AVF) initiation (cleaning the skin in order to insert the dialysis needles). The failure to not maintain the skin antisepsis has the potential to contaminate the site and allow for the introduction of bacteria during cannulation. Findings include: During an observation on 01/27/25 at 8:55 AM PCT2 was observed cleaning P6’s AVF skin to destroy or inhibit micro-organisms growth. Just prior to inserting the lower needle, PCT2 palpated over the insertion site but did not re-clean the skin before inserting the lower needle. PCT2 continued with the upper needle insertion site, and just prior to inserting the upper needle palpated over the insertion site but did not re-clean the skin before inserting the lower needle. Interview with PCT 2 on 01/27/25 at 9:00 AM confirmed he/she had palpated over the insertion site after PCT2 performed skin asepsis on P6 without recleaning the skin. PCT2 confirmed he/she was unsure if their policy allowed them to palpate the skin after it had been cleaned prior to insertion without re-cleaning it first. During the entrance conference on 01/27/25 at 9:29 AM, the above observation was discussed with the Facility Administrator and the Acting Manager of Clinical Service (A-MCS), A-MCS confirmed that staff should reclean their skin if they palpate over an aseptically cleaned needled insertion site. Review of the facility’s policy titled, “AV [arteriovenous] Fistula Or Graft Cannulation With Nipro Or Medisystems Safety Fistula Needles (SFN) And Administration Of Heparin Loading Dose” dated 10/22, revealed, “Do not palpate insertion site once area has been prepped. Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.””