Usrc Bryant Irvin

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 29191 Based on observation, record review, and staff interview, the facility staff failed A. to ensure a clean and sanitary environment was monitored and maintained in the in-center treatment area. Also, the facility staff failed to follow the facility policies, “Disinfection and Cleaning of Dialysis machine Equipment” and “Facility Space/design and Safety Requirements”. (Cross Refer to V0111) B. to allow the disinfectant on the access site to dry in the allotted timeframe on 1 (#12) of 1 patient. (Cross Refer to V0113) C. 1. store vaccines in the refrigerator as recommended by the Centers for Disease Control (CDC). 2. ensure medications maintained in the facility are properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to comply with the facility’s policy titled, “Guideline for Administration of Medication.” 3. ensure that medication vials are labeled when opened and initialed by the staff member. (Cross Refer to V0117) D. to monitor and provide a safe environment to store outside infectious waste. (Cross Refer to V0121) E. to disinfect 1 (#7) of 19 patient dialysis machines every 7 days. Also, the facility staff failed to follow their policy “Machine Disinfection - Fresenius Requirements.” (Cross Refer to V0122) F. to ensure 2 (Staff # 9 and # 17 ) of 2 Licensed Nurses provided CVC (central venous catheter; a catheter that is inserted into a central vein that leads directly to the heart) care following the facility’s policy and procedure for CVC care. The facility failed to follow the facility’s policy “ Dialysis Catheter Dressing Change “. (Cross Refer to V0147)”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interviews, the facility’s A. biomedical staff failed to ensure the regenerable softener tank was labeled with an identifier that described its function, how performance was verified, and what actions to take in the event performance was not within an acceptable range. (Cross Refer to Tag V0187) B. biomedical staff failed to disinfect the water loop at least monthly. Also, the facility’s biomedical staff failed to follow the policy, “Monthly Water Treatment Monitoring”. (Cross Refer to Tag V0219) C. biomedical staff failed to identify and promptly correct 3 acid leaks present in the facility’s water treatment room. (Cross Refer to Tag V0222) D. staff failed to ensure that the acid pick-up tubes (wands) were fitting securely to the acid jugs being used to dialyze the patients to prevent bacterial contamination and evaporation during a dialysis treatment. Also, the facility staff to follow the facility policy for disinfecting the pick-up tubes (wands). (Cross Refer to Tag V0243) E. biomedical staff failed to identify and promptly correct acid leaks on and around the acid outlet in 17 of 17 wall boxes. Also, the facility staff failed to ensure the wall boxes were cleaned and maintained. (Cross Refer to Tag V0245) F. biomedical staff failed to identify and promptly correct bicarbonate leaks on and around the bicarbonate outlet in 17 of 17 wall boxes. (Cross Refer To Tag V0246) F. staff failed to identify and promptly correct expired CalRite and ProbeRite (quality control) solutions on the tri-station located in the facility’s water room. Also, the facility’s direct care staff failed to identify and correct out-of-parameter dialysate conductivity results prior to initiating dialysis treatment on 2 (# 4 and # 6) of 2 patients. (Cross Refer To Tag V0250)”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s A. Registered Nurse failed to complete pre-treatment and post-treatment nursing assessments within one hour of treatment start and end on 7 (# 1, # 3, # 4, # 5, # 6, # 7, # 8) of 7 patient medical records reviewed. The facility failed to follow the facility policy “Pre-Treatment Assessment of Patient”. (Cross Refer to Tag V0502) B. direct care staff failed to ensure the patient received the correct dialysate prescription that the physician had ordered on 1 (# 1) of 1 patient. Also, the facility staff failed to follow the policy, “Initiation of Dialysis”. C. direct care staff failed to follow the physician’s prescribed orders for blood flow rate (BFR) and dialysate flow rate (DFR) in 5 (# 1, # 3, # 5, # 7, # 8) of 8 medical records reviewed. The facility staff failed to verify the ordered prescription matched the prescription the patient was receiving prior to initiation and during treatment. Also, the facility staff failed to follow the facility policy titled, “Initiation of Dialysis Treatment”. (Cross Refer to Tag V0503) D. staff failed to ensure direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 5 (# 3, # 4, # 5, # 6, # 8) of 8 patient charts reviewed. Also, the nursing staff failed to notify the physician/non-physician practitioner of abnormal findings on 5 (# 3, # 4, # 5, # 6, # 8) of 8 patient charts reviewed. The facility staff failed to follow the facility policy “Intradialytic Monitoring of Patient”. (Cross Refer to Tag V0504)”

“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: 29191 Based on observation, record review, and staff interview, the facility staff failed to ensure a clean and sanitary environment was monitored and maintained in the in-center treatment area. Also, the facility staff failed to follow the facility policies, “Disinfection and Cleaning of Dialysis machine Equipment” and “Facility Space/design and Safety Requirements”. This deficient practice had the likelihood to result in the transmission of infectious agents within the unit and between patients, staff members, and members of the public. The CDC defines a “sanitary environment” as an environment that meets the “Standard Precautions” for an inpatient hospital setting plus the more stringent precautions which are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. During a tour of the facility on 05/06/2024 at 12:30 AM the following infection control issues were observed: Isolation Room: The isolation room located in the in-center treatment area had not been used in the last year according to staff interviews. There were 3 cans of “Bed Bug” spray, a urinal, an IV bag containing Normal Saline solution (expired 6/2022), trash bags, and a dialyzer all in the same drawer of the isolation room. * The wall box in the isolation was dirty and had a build-up of old, dried acid on the inside. * There were Povidone prep pads a box of 100 that expired 2/2023 in the drawer of the isolation room. * A trash can was found stored on the wall chase behind the dialysis chair in the isolation room. * Observed a white clamp was lying in a cracked clear plastic container on the shelf in the isolation room, unknown if the clamp was clean or dirty. * In the cabinet of the isolation room was an open bottle of hydrogen peroxide and sitting beside it was a can of “Bed Bug” spray. * There was a sink in the isolation room, when the cabinet door was opened a brown-colored liquid was leaking and there was a dead roach observed beside the liquid. * The computer stand was covered in dust and white splatter. * The electrical cord of the centrifuge in the isolation was running across the sink which had the likelihood of causing an electrical shock. * Observed the back of the dialysis machine was covered in dust and debris in the isolation room. * The hand sanitizer dispenser in the isolation room was open and empty. In-Center Treatment Area * There were used white gowns and face shields hanging at the exit door. The face shields were covered in thick dust. * The large white refrigerator that was storing sample medication had black splatter on the bottom shelf. * Dialysis Machines were designated as “clean” and observed to have debris, hair, and dust particles on the bottom and backside of the dialysis machines. * Observed one Infusion pump labeled clean, but the legs of the Infusion pump were covered with a dried brown splattered substance. * The plaster on the wall by station #12 was loose and flaking off to the floor. * Observed on the wall where oxygen concentrators were stored was dried brown splatter running down the wall. The oxygen concentrators were designated as clean, but white splatter and thick dust were observed. * The floor by station #16 had a dried white substance running down the chase wall and underneath the back of the chase wall. This observation was viewed on 05/06/2024 and 05/07/2024 after housekeeping had cleaned the unit. * The small red metal biohazard bins were dirty with dust, trash particles, spillage, and rusted bolts. The bins had a very un-clean appearance. * The large black metal Bio-hazard bins were covered in dirt, dust, and trash particles. The bins had a very un-clean appearance. * In Pod #4 area observed a drawer labeled “Please Do not Use”. There was a white splatter running done the drawer to the floor. In an interview with Staff #1 surveyor asked what was wrong with the drawer. Staff #1 stated, “The drawer has been broken for a while.” * The chairside computer on wheels had dust and white splatter over the bottom of the stand and the wheels in the 16 stations. * The code cart was covered with a plastic covering. The plastic cover had a build-up of dust on it. When the surveyor removed the plastic cover, there was dust and debris noted on the code cart and the suction canister located on top of it. The wheels of the code cart were also covered in dust and dirt build-up. There was an open Ambu bag lying on the top of the code cart. * Beside the code cart were oxygen E cylinders. There were parts of the wheelchair legs lying on the oxygen tank holders. Observed spider webs and dead bugs underneath the oxygen E cylinders. Medication Area: During a tour of the medication area on 05/06/2024 at 1:00 PM with Staff # 1, the surveyor observed: * There were 2 boxes of syringes stored under the sink and observed green circles where the sink had been leaking. * Observed underneath the eye wash station sink was a brown spot and debris particles. There were circles of what appeared to be water leakage. * In a drawer of the medication area found 25 infusion administration sets that had expired on 03/31/2023. * Four bottles of Hydrogen peroxide were opened and not dated as to when or by whom. Corrugated cardboard boxes were stored with sterile patient supplies. The corrugated boxes were stored over top of clean and sterile patient supplies. Cardboard boxes harbor parasites, insects, and microorganisms. “External shipping containers have been exposed to unknown and potentially high microbial contamination. Also, shipping cartons, especially those made of corrugated material; serve as generators of and reservoirs for dust.” (AAM1 ST46-Section 5.2 Receiving items). A review of the facility’s policy titled, “Disinfection and Cleaning of Dialysis Machine Equipment” dated 7/2023 revealed the following: “Purpose: To provide guidance on proper disinfection of the dialysis station, machine, equipment and surrounding surfaces with the appropriate method prevents the transmission of disease/infection to the dialysis population. 14. Clean chairside computer keyboards, computer on wheels (COW), external surfaces of computer stations, and wall boxes with individual 1:100 bleach wipes at the end of the day. To prevent any cross-contamination, change gloves and perform hand hygiene any time the wall box is touched. Examples: When connecting/disconnecting dialysate lines and after disinfecting the wall box. 15. Disinfect non-disposable medical equipment (e.g., scissors, hemostats in open position and clamps), between uses by fully submerging items and soaking in a 1:100 bleach solution for at least 5 minutes. a. If an item is visibly soiled, clean with a wet 1:100 bleach cloth prior to submerging in bleach solution. b. After at least a 5-minute contact time, remove items, place in a clean container or on a clean pad, and allow to air dry. 16. Place all non-disposable medical equipment in a designated clean area for storage.” A review of the facility’s policy titled, “Facility Space/design and Safety Requirements” dated 4/2023 revealed the following: “PURPOSE: Facilities will provide a physical environment that protects the health and safety of patients, staff and the public. The surrounding areas that are used by patients (e.g., stairwells, corridors, passageways) will meet local building and fire safety codes relating to design and space requirements for safe access, ingress, egress, and patient privacy. Floors will be kept free of liquids and debris: a. Inform staff and patients of wet floor; b. Place wet floor sign near or on the affected area; c. Clean wet floor immediately; d. Evaluate source of wet floor(s); e. Report to supervisor. 15. Storage areas will be kept clean and orderly at all times. Supplies will not be stored directly on the floor but on pallets or shelves. Doorways will not be blocked by supplies. 16. Ensure all supplies, medications and testing strips are checked at least monthly for expiration. If medication/supply only gives the month and year for expiration date, item is good until the end of the month (e.g. 04/2023). Expired items will be discarded appropriately prior to or day of expiration.” An interview with Staff #1 on 05/ at 4:00 PM confirmed the facility had infection control issues and did not follow the facility’s infection control policies. Staff #1 acknowledged the treatment floor and isolation room had been left unclean.”

“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: 29191 Based on observation, record review, and interview, the staff failed to allow the disinfectant on the access site to dry in the allotted timeframe on 1 (#12) of 1 patient. Findings: On 05/06/2024 the following was observed in the In-center hemodialysis treatment area: Patient #12: At 3:15 PM, the surveyor observed Patient #12 dialyzing at station #1. Staff #9 was observed with gloved hands after cleaning the access site fanning the site to speed up the drying time. Staff #9 preceding in accessing the graft with the hemodialysis needles. A review of the policy titled, “Initiation of Dialysis Treatment” dated 08/20/2020 revealved the following: “POLICY: To provide guidance to prevent complications related to initiation of the hemodialysis procedure. PROCEDURE: 1. Don PPE, perform hand hygiene and don clean gloves. 2. Clean and disinfect the patient’s access per policy and procedure according to the type of vascular access (e.g., AVF, AVG or catheter). 3. Follow policy and procedure for accessing the patients’ blood. 4. Obtain needed blood samples for lab work, if indicated. 5. If heparin is not on hold or not contraindicated, administer heparin bolus as ordered by physician.” An interview with staff #1 on 05/06/2024 at 3:30 PM was asked if the Patient Care technicians were allowed to fan the access site to speed up the drying time of the disinfectant. Staff #1 reported that the staff should allow the disinfectant to dry in the allotted timeframe and fanning was not allowed.”

“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: 29191 Based on observation and staff interviews, the facility staff failed to A. store vaccines in the refrigerator as recommended by the Centers for Disease Control (CDC). These deficient practices had the likelihood to cause harm to all patients and staff receiving vaccines in the facility by not maintaining the medication at the correct temperature. B. ensure medications maintained in the facility are properly safeguarded and not accessible to unauthorized persons. Also, the facility staff failed to comply with the facility’s policy titled, “Guideline for Administration of Medication.” This deficient practice had the likelihood to cause harm by medication left unsecured and accessible to unauthorized staff. C. ensure that medication vials are labeled when opened and initialed by the staff member. This deficient practice had the likelihood to cause harm to patients by receiving expired medication. Findings include: A. On 05/06/2024 at 1:00 PM while on tour on the treatment floor observed vaccines were being stored against the wall of the refrigerator versus the center of the refrigerator as recommended by the Center for Disease Control (CDC). Review of CDC instruction for the storage of immunizations: https://www.cdc.gov/vaccines/hcp/admin/storage/index.html “Store between 35 and 46 degrees. Place the vaccine in bins with open airflow or leave the top off. Make sure the door is shut. Remove crisper bins and place water bottles labeled “Do Not Drink in the bottom. Leave 2-3 inches between all vaccine containers and refrigerator walls. Post do not unplug on the refrigerator. Don’t use the dormitory-style refrigerator. Don’t store vaccines on the top shelf Don’t put food and beverages in the refrigerator. Don’t put vaccines or diluents in the door or floor of the refrigerator. Don’t drink or remove water bottles.” An interview with Staff #1 on 05/06/2024 at 2:00 PM confirmed the vaccines were sitting against the wall of the refrigerator. B. During a tour of the treatment floor observed medications to be unsecured. Medication refrigerators at the nurse’s station and on the treatment floor X 2 refrigerators were unlocked and all contained medication. The nursing staff were observed talking at another bay area which left no nurse where the medication was left unattended. C. During a tour of the medication area at the medication nurse’s station observed that a vial of Epogen 20,000 unit of medication was not labeled as to when the vial had been opened or by whom. Epogen multidose vials must be discarded 21 days after opening or accessed. Also, the nursing staff were mixing nutritional supplements with the medication. On the treatment floor, the floor refrigerator observed that the tuberculosis vial was opened and was not labeled as to when the vial had been opened or by whom. Medications containing a preservative must be discarded in 28 days. Also, observed 4 boxes of sample medications (Veltassa) in the large white refrigerator that was unlocked and available to staff, patients, and family visitors. A review of the facility’s policy titled, “Guideline for Administration of medication” with a revision date of 4/2024 revealed the following: “Policy: To maintain the safety and comfort of the patient with regard to the administration of a medication and to administer medications in accordance with a physician’s order and protocol where applicable, per state and federal regulations and according to the following procedure. Procedure: The charge nurse is responsible for the security of medications. During the charge nurse absence from the treatment floor, the security of the medications will only be delegated to a nurse until charge nurse returns. a. Medication(s) will be secured in a locked cabinet except for the emergency medication supply which is kept in an emergency medication box or the facility emergency cart and will be secured with a locking tag to ensure the safety of these medications. b. An inventory of medications with expiration dates will be kept for timely replacement. c. Check inventory of emergency medications monthly for expiration. 17. Multi-dose vials (MDV): a. Multi-dose vials will be discarded within 28 days of opening unless otherwise specified by manufacturer instructions. Unopened vials will be discarded according to the manufacturer’s expiration date. Exception: Epogen and Retacrit expire in 21 days. b. Open only one vial of any specific multi-dose medication at a time. Date and initial vials when opened as a point of reference for staff utilizing the medications. c. Use aseptic techniques when entering a vial. d. Only use new sterile syringe and needle for each entry into a vial. Example: Patient has a heparin order for 5000 units: nurse withdraws remaining 3000 units from the open heparin bottle into a syringe; a new syringe is used to withdraw 2000 units from a newly opened heparin bottle. 18. Discard unused medications removed from original container. This avoids contamination and the risk of the medication being returned to the wrong container. 19. Medications labeled or marked “sample” will only be administered if the governing body has approved the specific “sample” medication(s), policies specifying guidelines and protocol(s) for administration. No other medication(s) labeled “sample” will be stored or administered in the facility. 20.The charge nurse will be notified immediately by any person involved in a medication error and an occurrence/incident report will be completed within 24 hours of occurrence and reviewed at the monthly QAPI.” An interview with Staff #1 on 05/06/2024 at 3:00 PM confirmed the facility had not properly secured medications and/or the refrigerators that contained medication. Also, the staff had failed to label the vials of injectable medications that had been opened or accessed per the facility policy. Also, the vaccines were not stored according to the CDC guidelines.”

“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: 48653 Based on observation and staff interviews, the facility failed to monitor and provide a safe environment to store outside infectious waste. This deficient practice had the likelihood to cause harm by increasing the risk of infectious waste being made available to the public outside of the facility. The facility had one dumpster on-site that was unsecured without physical confinement secured around it. The unsecured dumpster allowed the public and rodents to pilfer through the hazardous trash. In an interview with Staff # 1 on 05/07/2024 at 4:00 PM, Staff # 1 confirmed the dumpsters were unsecured.”

“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: 29191 Based on the machine disinfection log review, policy review, and staff interview, the facility staff failed to disinfect 1 (#7) of 19 patient dialysis machines every 7 days. Also, the facility staff failed to follow their policy “Machine Disinfection - Fresenius Requirements.” This deficient practice had the likelihood of placing all patients being dialyzing on these machines at risk for potential harm due to the machines using bicarbonate during the dialysis process having a high potential for bacterial growth. Findings included: A review of machine disinfection logs for the month of April 2024 revealed staff documented that dialysis machine #7 was out of service and weekly disinfect was not performed on 4/25/2024. Machine #7 was placed back on the treatment floor for patient use on 05/06/2024. An interview with Staff #6 on 05/07/2024 at 11:00 AM confirmed that Dialysis machine #7 was not out of service and should have been bleached by the staff member performing the weekly disinfection on 4/25/2024 and 05/02/2024 before the machine got placed back on the floor for patient use. A review of the facility policy titled, “Machine Disinfection - Fresenius Requirements” dated 2/2023 revealed the following: “Purpose: To ensure machine disinfection is completed per manufacturer recommendations. Responsibility: Medical Director, Facility Administrator, Technical Manager, Biomedical Technician, Patient Care Technician Policy: 1. All machines that utilized bicarbonate that day must be run through a vinegar rinse followed by heat disinfection. If bicarbonate was not used heat disinfection is all that is required. This includes backup machines. * Citric Acid is also and approved alternative to Vinegar 2. All machines including backup machines must go through weekly bleach disinfection. All machines that utilized bicarbonate that day must be run through a vinegar rinse prior to bleach disinfection. The designated patient care staff member must check for negative residual using test strips post bleach disinfection. An additional negative residual test is to be completed before setting up the machine for the next treatment. The negative residual results must be documented on the “Dialysis Machine Disinfection Log.” In an interview with Staff #5 and #6 (biomedical technicians) on 05/07/2024 acknowledged the deficient practices and failure to follow their policy regarding disinfection of the dialysis machine.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview, the facility staff failed to ensure 2 (Staff # 9 and # 17 ) of 2 Licensed Nurses provided CVC (central venous catheter; a catheter that is inserted into a central vein that leads directly to the heart) care following the facility’s policy and procedure for CVC care. The facility failed to follow the facility’s policy “ Dialysis Catheter Dressing Change “. This deficient practice had the likelihood to put all patients with a CVC at increased risk for infection. Failure to provide a clean field, perform hand hygiene, and change gloves at the appropriate intervals during procedures with the central venous catheter can lead to cross-contamination (infection) of the catheter. Findings Include: During an observation on 05/06/2024 at 3:00 PM on the treatment floor with the following deficient practices were observed: Patient # 11 Observed a central venous catheter (CVC) access and dressing change being performed by Staff #18 at dialysis station #7. During the dressing change of the CVC, observed Staff #9 with a clean gloved hand while performing CVC care move the patient’s hair from the CVC site and did not change her gloves. Staff #18 continued with CVC care without changing gloves. Patient # 13 Observed a central venous catheter (CVC) access and dressing change being performed by Staff # 17 at dialysis station #4. During the dressing change of the CVC site, observed Staff #17 clean the CVC site from an outward motion to the center catheter site and then outward. This type of motion with the sterile swab contaminated the catheter site. The site should be cleaned with the sterile swab starting at the CVC site and cleaning outward. A review of the facility’s policy, “Dialysis Catheter Dressing Change” dated, January 2020 revealed the following: “Dressing changes on catheters utilized for dialysis will be changed by personnel trained and deemed competent, if unable to perform catheter dressing change before initiation of treatment, don clean gloves, to lift the dressing to assess the site and condition of the catheter, and then re-cover until dressing is changed. The care of catheters will include an accurate assessment of the insertion site for signs/symptoms of infection. Dressing changes will occur as follows: o Replace sterile gauze dressings every treatment. o Replace sterile transparent dressings if insertion site is visible, no more than every 7 days, The catheter dressing will be changed if at any time the dressing integrity is compromised by drainage, dampness, blood, or non-adherence to the skin. 1. Place mask on patient. 2. Don PPE (gown/mask/face shield or goggles/mask), perform hand hygiene, and don clean gloves. Secure clothing away from dressing/exit site. If any staff entering the station during this procedure they will don full PPE including a mask. 3. Perform hand hygiene and don clean gloves. 4. Remove and discard old exit site dressing. Remove gloves, perform hand hygiene, and don clean gloves. 5. Observe the catheter exit site for redness, swelling, tenderness or drainage. (If any abnormal findings, ask the patient if he/she has been experiencing any increase in temperature, chills or pain at exit site). Notify the nurse in charge of findings. Nurse in charge will notify the physician as indicated. 6. If indicated and per physician order, culture exit site drainage prior to cleaning the site. 7. Using an aseptic technique, cleanse the skin surrounding the exit site with the appropriate skin antiseptic. Choice of agents is patient dependent upon known allergies, catheter tolerance to a cleansing agent, and availability of cleansing agent. Acceptable cleansing agents include: a. Chloraprep {chlorhexidine 2% with 70% alcohol) is the preferred solution for cleansing long-term catheter exit sites. o Apply Chloraprep swab or solution using gentle, back and forth strokes, progressing from the catheter exit site outwards for 30 seconds; allow to dry for 30 seconds IRRITATION MAY OCCUR WITH INADEQUATE DRY TIME. o If using alcohol or Povidone iodine solution, use the “bullseye” technique, applying in a circular motion around the insertion site and progressing outward (alcohol=1 minute; Povidone iodine=2-3 minutes) allow solution to dry (alcohol=immediate; Povidone=2 minutes) before applying dressing. o If using ExSept, apply in a concentric motion for 2-3 minutes. Allow to dry for 2 minutes.” An interview with Staff #17 and #18 on 05/06/2024 at 3:30 PM confirmed the deficient practices when accessing and changing the dressing of the CVC patients.”

“ENVIRONMENT-SCHEMATIC DIAGRAMS/LABELS CFR(s): 494.40(a) 8 Environment: schematic diagrams/labels Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range. This Standard is not met as evidenced by: 48653 Based on observation and staff interviews, the facility’s biomedical staff failed to ensure the regenerable softener tank was labeled with an identifier that described its function, how performance was verified, and what actions to take in the event performance was not within an acceptable range. During a tour of the facility’s water room on 05/06/2024 at 12:50 PM with Staff # 5, the surveyor observed the black regenerable softener tank with no label affixed to it. There was nothing affixed to the tank that identified its contents, function, how performance was verified, and what actions to take in the event the performance was not within an acceptable range. During an interview with Staff # 5 on 05/06/2024 at 12:50 PM, Staff # 5 acknowledged the regenerable softener tank was not clearly labeled.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 48653 Based on record review and staff interviews, the facility’s biomedical staff failed to disinfect the water loop at least monthly. Also, the facility’s biomedical staff failed to follow the policy, “Monthly Water Treatment Monitoring”. This deficient practice had the likelihood to result in the proliferation of microorganisms in hemodialysis systems such as the hemodialysis water loop and hemodialysis machines. Failure to disinfect the water loop at least monthly could result in an increased risk of microorganism contamination to the patients undergoing treatment at the facility. A review of “Monthly Water System Posting” revealed the following, December 2023 - January 2024 The water loop was disinfected on December 10, 2023, at 4:49 PM. The water loop was disinfected on January 28th, 2024, at 2:36 PM. The water loop went 49 days between disinfection in December 2023 and January 2024. March 2024 - April 2024 The water loop was disinfected on March 10th, 2024, at 9:40 AM. The water loop was disinfected on April 21st, 2024, at 10:41 AM. The water loop went 42 days between disinfection in March and April of 2024. A review of the facility’s policy, “Monthly Water Treatment Monitoring” with a revision date of 08/2020 revealed the following, “PURPOSE: To ensure the dialysis water dystem operates safely and realiably through monthly observations and/or testing of specific component performance parameters. This policy includes testing and comparison of observed/measured parameters to those recorded in ELF (Electronic Log Filing System) on the ‘Daily Water Log’. RESPONSIBILITY: Medical Director, Facility Administrator, Technical Manager, Biomedical Technician. POLICY: 1. All observations and test results must be recorded in ELF (Electronic Log Filing System) on the “Monthly Water Log”. 2. Only Biomedical Technicians trained to perform the observations and testing required to complete the “Monthly Water Log” will be permitted to observe, test and document their findings. 3. All observations and testing are done while the Reverse Osmosis (RO) machine has stabilized and has been actively supplying water for a minimum of 15 minutes. 4. After completing the “Monthly Water Log” compare results to those most recently recorded on the “Daily Water Log”. If there are discrepancies in the results notify the Facility Administrator/designee and provide training/in-service as necessary. All training is to be documented on an in-service log. 5. The “Monthly Water Log” is to be completed by the Biomedical Technician who performed and documented the observations and test results.” During an interview with Staff # 5 and # 6 on 05/07/2024 at 10:30 AM, both Staff # 5 and # 6 acknowledged the water loop had not been disinfected at least monthly 2 different times in the last 6 months.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interviews, the facility’s biomedical staff failed to identify and promptly correct 3 acid leaks present in the facility’s water treatment room. During a tour of the facility’s water treatment room on 05/06/2024 at 12:50 PM with Staff # 5, the surveyor observed a large build-up of dried white crystals on the piping located under the acid mixer and around the bottom of the acid storage tank. A review of the facility policy titled, “Responsibilities of the Biomed Department” with a revision date of October 2021 revealed, “PURPOSE: To provide guidance for the responsibilities of the DaVita Biomed department. POLICY: 1. The responsibilities of the Biomed Department include: Repair and maintain, with support documentation, all dialysis delivery machines, RO water treatment systems, ancillary equipment, and related equipment used in the provision of care to patients as recommended by the equipment manufacturer’s specifications and DaVita policies and procedures ....” During an interview with Staff # 1 on 05/06/2024 at 4:00 PM, Staff # 1 acknowledged the acid leak coming from under the acid mixer and at the bottom of the acid storage tank.”

“BICARB JUGS RINSED DAILY/STORED DRY CFR(s): 494.40(a) 6.5 Concentrate distribution: bicarb jugs rinsed daily/stored dry Bicarbonate concentrate jugs should be rinsed with treated water and stored inverted at the end of each treatment day. Pick-up tubes should also be rinsed with treated water and allowed to air dry at the end of each treatment day. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that the acid pick-up tubes (wands) were fitting securely to the acid jugs being used to dialyze the patients to prevent bacterial contamination and evaporation during a dialysis treatment. Also, the facility staff to follow the facility policy for disinfecting the pick-up tubes (wands). This deficient practice allowed for cross-contamination and acid spills from the acid jug. While the acid concentrate is not susceptible to bacterial contamination, every effort should be made to keep the system closed to prevent nonbacterial contamination and evaporation per the ANSI/AAMI standards. During a tour of the facility on 05/6/2024 at 1:00 PM, observed patient #1 on machine #10 at station #14 receiving dialysis treatment. The pick-up tube (wand) was observed to be hanging out of the acid jug. There was no secure connection from the pick-up tube to the opening of the acid jug. Also, the staff failed to disinfect the pick-up tube (wand) per the facility policy. An interview with Staff #18 on 05/06/2024 at 1:05 PM acknowledged the pickup tube (wand) was not secured to the acid jug. The staff members were using 3-gallon jugs of acid for the 3k 2.5 CA for patients on different dialysates that what runs through the loop which was 2k 2.5 Ca. Surveyor observed that 6 of the 3-gallon jugs were sitting on a cart in the storage area full of solution. The wands were still connected to the jugs, the wands had an open area and not a closed circuit to keep the system closed to prevent nonbacterial contamination and evaporation per the ANSI/AAMI standards. The pickup wand had an unclean appearance with a white dried substance around the top of the wand. A review of the policy titled, “Disinfection Protocols for Bicarbonate Mixers and Containers” dated 4/2021 revealed the following: “Weekly Disinfection of Bicarb Jugs and Pickup Wands 1. Bicarb containers & pickup wands shall be rinsed with RO water on a daily basis and disinfected weekly using a 1 % bleach solution. Bicarb jugs and pickup wands must dwell in I% bleach for a minimum of 30 minutes. 2. Citric or acetic acid can be used to remove un-dissolved bicarbonate in bicarb containers & pickup wands if needed. 3. Damaged bicarb containers and pickup wands should not be used. 4. Following disinfection, the jugs and pickup wands must be checked for residual bleach, drained, and inverted to dry. 5. Document results in ELF (Electronic Log Filing System) on the “Weekly Central Bicarb Disinfection Log’.” An interview with Staff #5 on 05/8/2024 at 10:35 AM confirmed the pickup wands were unsecured and were hanging from the acid jugs. Also, the facility staff were not disinfecting the wands per the facility’s policy.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 48653 Based on observation and staff interviews, the facility’s biomedical staff failed to identify and promptly correct acid leaks on and around the acid outlet in 17 of 17 wall boxes. Also, the facility staff failed to ensure the wall boxes were cleaned and maintained. During a tour of the facility’s in-center treatment area on 05/06/2024 at 12:00 PM with Staff # 1, the surveyor observed a thick build-up of white crystals on and around the acid outlet in all 17 wall boxes present on the treatment floor. The wall boxes had not been cleaned and had a build-up of white substance inside them. During an interview with Staff # 1 and # 5 on 05/06/2024, Staff # 1 and # 5 acknowledged the acid leaks present on the outlet acid valves.”

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 48653 Based on observation and staff interviews, the facility’s biomedical staff failed to identify and promptly correct bicarbonate leaks on and around the bicarbonate outlet in 17 of 17 wall boxes. During a tour of the facility’s in-center treatment area on 05/06/2024 at 12:00 PM with Staff # 1, the surveyor observed a build-up of white substance on the bicarbonate outlets in all 17 wall boxes present on the treatment floor. During an interview with Staff # 1 and # 5 on 05/06/2024, Staff # 1 and # 5 acknowledged the bicarbonate leaks present on the bicarbonate valves.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s staff failed to A. identify and promptly correct expired CalRite and ProbeRite (quality control) solutions on the tri-station located in the facility’s water room. B.identify and correct out-of-parameter dialysate conductivity results prior to initiating dialysis treatment on 3 (# 3, # 4, # 6) of 8 patients medical records reviewed. The facility failed to follow the facility policy “Initiation of Dialysis Treatment”. A. Findings include: During a tour of the facility’s water room on 05/06/2024 at 12:50 PM with Staff # 5, the surveyor observed 2 expired quality control solutions on the tri-station. The following were observed as expired: One (1) bottle of CalRite QC Standard Solutions 10.00pH with an expiration date of 05/01/2024. One (1) bottle of ProbeRite Sensor Cleaning Solution with an expiration date of 05/01/2024. A review of the facility’s policy, “Phoenix-Phoenix XL Meter Cleaning and Calibration” with a revision date of 08/202 revealed, “Tri Station Maintenance: Daily: *Rinse and refill RO and Bleach bottles with fresh solutions. *Label bottles with initials, date, and times solutions were changed. *Verify expiration dates on all calibration and cleaning solutions. *Discard any solution bottle that has visible microbial growth.” During an interview with Staff # 1 on 05/07/2024 at 4:00 PM, Staff # 4 acknowledged the facility staff failed to identify and correct expired quality control solutions. 48749 B. Findings Include: Patient # 3 A review of 1 of 6 treatment sheets revealed facility staff did not follow the policy “Initiation of Dialysis Treatment” on treatment dates 04/15/2024. On 04/15/2024: Machine Conductivity: 13.5 mS Meter Conductivity: 14.1 mS The conductivity was out of acceptable parameters at 0.6 mS. There was no documentation by facility staff to support any corrective action that was taken to correct the conductivity. Patient # 4 A review of 3 of 6 treatment sheets revealed facility staff did not follow the policy “Initiation of Dialysis Treatment” on treatment dates 04/23/2024, 04/30/2024, and 05/04/2024. On 04/23/2024: Machine Conductivity: 13.2 mS Meter Conductivity: 14.0 mS The conductivity was out of acceptable parameters at 0.8 mS. On 04/30/2024: Machine Conductivity: 13.5 mS Meter Conductivity: 14.1 mS The conductivity was out of acceptable parameters at 0.6 mS. On 05/04/2024: Machine Conductivity: 13.5 mS Meter Conductivity: 14.1 mS The conductivity was out of acceptable parameters at 0.6 mS. There was no documentation by facility staff to support any corrective action that was taken to correct the conductivity. Patient # 6 A review of 4 of 6 treatment sheets revealed facility staff did not follow the policy “Initiation of Dialysis Treatment” on treatment dates 04/16/2024, 04/27/2024, 04/30/2024, and 05/02/2024. On 04/16/2024: Machine Conductivity: 13.5 mS Meter Conductivity: 14.0 mS The conductivity was out of acceptable parameters at 0.5 mS. On 04/27/2024: Machine Conductivity: 13.5 mS Meter Conductivity: 14.1 mS The conductivity was out of acceptable parameters at 0.6 mS. On 04/30/2024: Machine Conductivity: 13.7 mS Meter Conductivity: 14.2 mS The conductivity is out of acceptable parameters at 0.5 mS. On 05/02/2024: Machine Conductivity: 13.5 mS Meter Conductivity: 14.0 mS The conductivity was out of acceptable parameters at 0.5 mS. There was no documentation by facility staff to support any corrective action that was taken to correct the conductivity. A review of facility policy, dated, “Initiation of Dialysis Treatment” 08/ 2020 revealed, “POLICY: 1. Ensure conductivity alarms are set +/- 0.5 mS of TCD (theoretical conductivity). 2. Perform independent conductivity and pH test. 3. Verify that both the actual conductivity value on the machine and the pHoenix meter value is +/- 0.4 mS of TCD value. 4. Assess patient through subjective and objective assessment skills as described in “Pre-dialysis Assessment of Patient”. This includes, but is not limited to, verifying the patient has not fallen since the last treatment as this may affect current heparin orders. 5. Compare findings with previous treatments. 6. Determine the current treatment plan. 7. Two staff members must verify and document on the flow sheet indicating the following items are correct prior to initiation of treatment: a. Correct patient; b. All machine alarm and pressure holding tests passed and documented; c. Conductivity and pH are documented and within acceptable parameters; d. Correct prescription (dialyzer, concentrate, DFR, etc.). 14. Prior to walking away from the patient’s dialysis machine, verify all prescribed orders are followed. If unable to follow any part of the patient’s prescription after troubleshooting, notify the charge nurse and document notification. The charge nurse will notify the physician if indicated and document any follow-up or new orders.” An interview with Staff # 1 on 05/07/2024 at 3:30 PM confirmed the facility staff did not follow the parameters per facility policy “Initiation of Dialysis Treatment” or document any corrective action taken.”

“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: 29191 Based on record review, observation, and interview, the facility failed to: A. ensure that 4 (#13, #14, #15, and #16) of 17 patient dialysis treatment chairs were maintained in a clean and comfortable manner for patients. B. ensure quality control solutions (a liquid made up of water, glucose, and buffers used to test the function of the meter and test strips) and test strips (a band, piece, or strip of material used for biological testing) for the glucometers(a small device that measures how much sugar is in a blood sample) were dated when opened. Also, the facility staff did not perform quality control testing on 1 (# 833413) of 2 glucometers. The facility staff failed to follow the policy, “Blood Glucose Testing”. Findings: A. These findings had the likelihood to cause harm by increasing the risk of infection to all patients receiving care at the facility by allowing equipment to be used that had been exposed to microbial contamination and unclean surfaces. During observation in the patient treatment area on 05/06/2024 at 12:19 PM the following was observed: * Treatment chairs at stations #13, #14, #15, and #16 had torn vinyl arm cushions. The foam cushions were cracked and exposed. There was no way to clean the cracked vinyl. An interview with Staff #6 on 05/06/2024 at 4:00 PM reported that chair parts were on backorder for over 4 months. An interview with Staff #1 on 05/08/2024 at 10:30 AM, confirmed that the dialysis chairs have had cracked vinyl for several months and have been reported to upper management. 48749 Findings: B. Glucometer # 833413 A review of the glucometer control test record revealed there was no documentation to support quality control testing that was performed in March and April of 2024. A review of the glucometer control test record for May 2024 revealed there was no quality control testing performed from May 1st, 2024, through May 6th, 2024. There were two sets of opened control solutions and test strips that were not labeled with an opening date. A review of the facility’s policy, “Blood Glucose Testing” dated 02/2023 revealed, “1. Refer to the manufacturer’s instructions provided with a glucometer to perform control solution testing. 2. Follow the manufacturer’s guidance for proper storage, expiration, and use by dates of the control solution and test strips. a. Document the date new control solution bottles and test strips are opened on each bottle or test strip container. NOTE: DO NOT use control solution or test strips past the manufacturer’s expiration date or after use by date. 3. Utilize the Control solution to perform control solution testing when: a. Using the glucometer for the first time. b. Opening a new bottle of test strips. c. The test strips bottle has been left open. d. The glucometer has been dropped. e. It is suspected the glucometer or test strips may not be functioning properly. f. Test results appear to be inconsistent with clinical symptoms. g. Verifying technique procedure. 4. Document glucometer control solution testing on C-FORMS-0371.” An interview was conducted on 05/06/2024 at 3:30 PM with Staff #17 When questioned if staff are using both glucometers, Staff #17 stated “Yes, we use both glucometers.” Staff #17 was asked if daily control testing was performed on both meters, Staff #17 stated “We should be testing, and they should be listed.” Staff #17 was asked if staff were dating test strips and control solutions after opening, Staff #17 stated “We should be writing it on the bottles.” Staff #17 confirmed that the test strips and control solution bottles were not dated. Also, Staff #17 confirmed the glucometer testing log was not completed.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 48749 Based on record review and interview, the Registered Nurse failed to complete pre-treatment and post-treatment nursing assessments within one hour on 7 (# 1, # 3, # 4, # 5, # 6, # 7, # 8) of 7 patient medical records reviewed. The facility failed to follow the facility policy “Pre-Treatment Assessment of Patient”. Findings Include: A review of the facility policy titled, “Pre-Treatment Assessment of Patient” dated 01/2020 revealed, “POLICY: The patient will receive hemodialysis treatment and nursing care based on data collected and the pre-dialysis nursing assessment. Pre-dialysis nursing assessment will occur within the first hour of patient contact or per stricter state regulations. ASSESSMENT: 1. PRE-DIALYSIS DATA COLLECTION: Some data may be collected by qualified Patient Care Technicians (PCT) during the pre-treatment and initiation process but this data does NOT replace the nursing assessment. The following may be collected by the PCT: a. Temperature; b. Blood pressure (sitting completed on i:311 patients followed by a standing, if able); c. Pulse rate; d. Pre weight; e. Vascular access patency (bruit, thrill), signs of infection such as redness, drainage, warm to touch, bruising, bleeding, or swelling; f. State of well-being: Any falls or hospitalizations since last treatment; g. Any data outside of the acceptable facility/patient parameters will be reported to the CN prior to treatment initiation. 2. PRE-DIALYSIS NURSING ASSESSMENT/EVALUATION OF DATA COLLECTED: Pre-dialysis assessments are performed by qualified nursing staff (RN/LPN/LVN) based on state-specific ESRD regulations and the Nurse Practice Act: a. Blood pressure above or below acceptable facility/patient specific parameters; b. Rhythm and quality of pulse rate; c. Auscultation of lungs and evaluation of volume status (weight gain/loss, presence/absence of edema and/or neck vein distension, hyper/hypotension, headache, or ringing in the ears); d. Any patient complaint such as fever, chills, chest pain, acute pain, or any symptom of distress. Pain is evaluated on a scale of 0-10 to determine the degree of pain; e. General sense of well-being or any problems since the last dialysis treatment including but not limited to: GI (nausea, vomiting, diarrhea, constipation, or loss of appetite), insomnia, restless legs, nervousness/anxiousness, weakness, dizziness or falls. Report any significant finding(s) to the physician. INTERVENTION: 1. Compare data to previous findings. 2. Notify the patient’s physician of any significant changes or problems. 3. Implement/adjust treatment plan based on assessment data, within prescribed parameters: This may include but not limited to: a. Ultrafiltration; b. Volume replacement; c. Anticoagulation; d. Medication(s). 4. Refer to other members of the health care team as needed.” Patient # 1 A review of 4 of 6 treatment sheets for Patient # 1 revealed that pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment. A review of the treatment sheet dated 04/26/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 04/26/24 at 4:35 PM) within 1 hour of the initiation of treatment. Treatment started on 04/26/24 at 9:59 AM. Staff # 17 did not complete the post-treatment nursing assessment (documented on 04/26/24 at 4:37 PM) within 1 hour of the termination of treatment. Treatment ended on 04/26/24 at 1:11 PM. A review of the treatment sheet dated 05/01/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 05/01/24 at 12:09 PM) within 1 hour of the initiation of treatment. Treatment started on 05/01/24 at 10:05 AM. Staff # 17 did not complete the post-treatment nursing assessment (documented on 05/01/24 at 4:44 PM) within 1 hour of the termination of treatment. Treatment ended on 05/01/24 at 1:05 PM. A review of the treatment sheet dated 05/03/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 05/03/24 at 11:48 AM) within 1 hour of the initiation of treatment. Treatment started on 05/03/24 at 9:53 AM. Staff # 17 did not complete the post-treatment nursing assessment (documented on 05/03/24 at 6:00 PM) within 1 hour of the termination of treatment. Treatment ended on 05/03/24 at 1:22 PM. A review of the treatment sheet dated 05/06/24 revealed Staff # 17 did not complete the post-treatment nursing assessment (documented on 05/06/24 at 5:27 PM) within 1 hour of the termination of treatment. Treatment ended on 05/06/24 at 1:45 PM. Patient # 3 A review of 3 of 6 treatment sheets for Patient # 3 revealed that pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment. A review of the treatment sheet dated 04/17/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 04/17/24 at 7:33 PM) within 1 hour of the initiation of treatment. Treatment started on 04/17/24 at 2:33 PM. A review of the treatment sheet dated 04/25/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 04/25/24 at 6:36 PM) within 1 hour of the initiation of treatment. Treatment started on 04/25/24 at 1:27 PM. Staff # 17 did not complete the post-treatment nursing assessment (documented on 04/25/24 at 6:39 PM) within 1 hour of the termination of treatment. Treatment ended on 04/25/24 at 5:18 PM. A review of the treatment sheet dated 05/06/24 revealed Staff # 17 did not complete the post-treatment nursing assessment (documented on 05/06/24 at 8:06 PM) within 1 hour of the termination of treatment. Treatment ended on 05/06/24 at 6:54 PM. Patient # 4 A review of 3 of 6 treatment sheets for Patient # 4 revealed that pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment. A review of the treatment sheet dated 04/25/24 revealed Staff # 17 did not complete the post-treatment nursing assessment (documented on 04/25/24 at 6:14 PM) within 1 hour of the termination of treatment. Treatment ended on 04/25/24 at 10:11 AM. A review of the treatment sheet dated 04/27/24 revealed Staff # 12 did not complete the post-treatment nursing assessment (documented on 04/27/24 at 11:36 AM) within 1 hour of the termination of treatment. Treatment ended on 04/27/24 at 10:19 AM. A review of the treatment sheet dated 04/30/24 revealed Staff # 12 did not complete the pre-treatment nursing assessment (documented on 04/30/24 at 8:20 AM) within 1 hour of the initiation of treatment. Treatment started on 04/30/24 at 6:32 AM. Patient # 5 A review of 1 of 6 treatment sheets for Patient # 5 revealed that a pre-treatment nursing assessment was not completed within 1 hour of the patient’s treatment. A review of the treatment sheet dated 04/26/2024 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 04/26/2024 at 4:14 PM) within 1 hour of the treatment initiation. Treatment started on 04/26/2024 at 2:55 PM. Patient # 6 A review of 3 of 6 treatment sheets for Patient # 6 revealed that pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment. A review of the treatment sheet dated 04/25/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 04/25/24 at 6:52 AM) within 1 hour of the initiation of treatment. Treatment started on 04/25/24 at 5:38 AM. Staff # 17 did not complete the post-treatment nursing assessment (documented on 04/25/24 at 5:44 PM) within 1 hour of the termination of treatment. Treatment ended on 04/25/24 at 9:26 AM. A review of the treatment sheet dated 04/27/24 revealed Staff # 12 did not complete the post-treatment nursing assessment (documented on 04/27/24 at 11:34 AM) within 1 hour of the termination of treatment. Treatment ended on 04/27/24 at 9:34 AM. A review of the treatment sheet dated 05/02/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 05/02/24 at 9:42 AM) within 1 hour of the initiation of treatment. Treatment started on 05/02/24 at 5:43 AM. Staff # 17 did not complete the post-treatment nursing assessment (documented on 05/02/24 at 9:44 AM) within 1 hour of the termination of treatment. Treatment ended on 05/02/24 at 7:01 AM. Patient # 7 A review of 4 of 6 treatment sheets for Patient # 7 revealed pre-treatment and post-treatment nursing assessments were not completed within 1 hour of the patient’s treatment. A review of the treatment sheet dated 04/18/24 revealed Staff # 17 did not complete the pre-treatment nursing assessment (documented on 04/18/24 at 12:36 PM) within 1 hour of treatment initiation. Treatment started on 04/18/24 at 11:18 AM. A review of the treatment sheet dated 04/22/24 revealed Staff # 17 did not complete the post-treatment nursing assessment (documented on 04/22/24 at 7:43 PM) within 1 hour of the termination of treatment. Treatment ended on 04/22/24 at 6:39 PM. A review of the treatment sheet dated 04/23/24 revealed Staff # 12 did not complete the pre-treatment nursing assessment (documented on 04/23/24 at 12:41 PM) within 1 hour of treatment initiation. Treatment started on 04/23/24 at 11:28 AM. A review of the treatment sheet dated 05/02/24 revealed Staff # 17 did not complete the post-treatment nursing assessment (documented on 05/02/24 at 5:26 PM) within 1 hour of the termination of treatment. Treatment ended on 05/02/24 at 3:04 PM. Patient # 8 A review of 1 of 6 treatment sheets for Patient # 8 revealed that a post-treatment nursing assessment was not completed within 1 hour of the patient’s treatment. A review of the treatment sheet dated 05/02/24 revealed Staff # 17 did not complete the post-treatment nursing assessment (documented on 05/02/24 at 6:14 PM) within 1 hour of the termination of treatment. Treatment ended on 05/02/24 at 2:52 PM. An interview with Staff # 1 on 05/07/2024 at 3:30 PM confirmed the facility staff had not been consistently documenting pre-nursing and post-nursing assessment times within the required time frame among all patient’s records reviewed.”

“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: 48653 Based on observation, record review, and staff interview, the facility’s direct care staff failed to A. ensure the patient received the correct dialysate prescription the physician ordered on 1 (# 1) of 1 patient. Also, the facility staff failed to follow the policy, “Initiation of Dialysis”. B. follow the physician’s prescribed orders for blood flow rate (BFR) and dialysate flow rate (DFR) in 5 (# 1, # 3, # 5, # 7, # 8) of 8 medical records reviewed. The facility staff failed to verify the ordered prescription matched the prescription the patient was receiving prior to initiation and during treatment. Also, the facility staff failed to follow the facility policy titled, “Initiation of Dialysis Treatment”. Findings Include: A. This deficient practice had the likelihood to result in serious injury, serious harm, serious impairment, and/or death due to the patient’s increased risk of electrolyte imbalances such as hyperkalemia (high potassium) and/or hypokalemia (low potassium). Both hyperkalemia and hypokalemia can result in cardiac arrhythmias, shortness of breath, and cardiac arrest. During a tour of the facility’s in-center treatment area on 05/06/2024 at 12:00 PM, the surveyor observed Patient # 1 receiving dialysis treatment on machine # 10. The patient was receiving an acid concentration of 2.0 K (potassium)/ 3.0 Ca (calcium). The surveyor requested to see the physician’s order for Patient # 1 and observed the order to read, “2.0K/2.5 Ca”. In an interview with Staff # 18 on 05/06/2024 at 12:05 PM, Staff # 18 was questioned as to why the prescription was different than what the patient was receiving. Staff # 18 stated, “The patient is receiving the wrong prescription. The patient should be receiving 2.0K/2.5 Ca.” A review of the facility’s policy titled, “Initiation of Dialysis Treatment” with a revision date of 08/2020 revealed, “PURPOSE: To provide guidance to prevent complications related to initiation of the hemodialysis procedure ... POLICY: 1. Ensure conductivity alarms are set +/- 0.5 mS of TCD (theoretical conductivity). 2. Perform independent conductivity and pH test. 3. Verify that both the actual conductivity value on the machine and the phoenix meter value are +/- 0.4 mS of TCD value. 4. Assess patient through subjective and objective assessment skills as described in “Pre-dialysis Assessment of Patient”. This includes but is not limited to, verifying the patient has not fallen since the last treatment as this may affect current heparin. orders. 5. Compare findings with previous treatments. 6. Determine current treatment plan. 7. Two staff members must verify and document on the flow sheet indicating the following items are correct prior to initiation of treatment: a. Correct patient; b. All machine alarm and pressure holding tests passed and documented; c. Conductivity and pH are documented and within acceptable parameters; d. Correct prescription (dialyzer, concentrate, DFR, etc.) ...” During an interview with Staff # 1 on 05/06/2024 at 4:00 PM, Staff # 1 was informed of the findings of an immediate jeopardy and acknowledged the patient was receiving an in-correct prescription. 48749 B. This deficient practice had the likelihood to harm patients by not following the physician’s dialysis orders which could negatively impact the effectiveness and adequacy of the dialysis treatment for all 74 in-center hemodialysis patients receiving care at this facility. Findings Include: A review of facility policy, dated, “Initiation of Dialysis Treatment” 08/ 2020 revealed, “POLICY: 1. Ensure conductivity alarms are set +/- 0.5 mS of TCD (theoretical conductivity). 2. Perform independent conductivity and pH test. 3. Verify that both the actual conductivity value on the machine and the pHoenix meter value is +/- 0.4 mS of TCD value. 4. Assess patient through subjective and objective assessment skills as described in “Pre-dialysis Assessment of Patient”. This includes, but is not limited to, verifying the patient has not fallen since the last treatment as this may affect current heparin orders. 5. Compare findings with previous treatments. 6. Determine the current treatment plan. 7. Two staff members must verify and document on the flow sheet indicating the following items are correct prior to initiation of treatment: a. Correct patient; b. All machine alarm and pressure holding tests passed and documented; c. Conductivity and pH are documented and within acceptable parameters; d. Correct prescription (dialyzer, concentrate, DFR, etc.). 14. Prior to walking away from the patient’s dialysis machine, verify all prescribed orders are followed. If unable to follow any part of the patient’s prescription after troubleshooting, notify the charge nurse and document notification. The charge nurse will notify the physician if indicated and document any follow-up or new orders. Prescription orders and safety measures include, but are not limited to the following: a. Blood flow is at prescribed rate; b. Heparin pump (if used) is turned on and delivering the correct dose; c. Correct dialysate flow rate; d. Dialysis machine temperature; e. Bloodlines are secured; f. Access, bloodline connections, and face are visible; g. Fluid removal goal is programmed correctly. NOTE: UFR must be =/>300 to prevent back filtration. If UFR is <300, calculate normal saline replacement to prevent volume depletion. Administer boluses in increments of 100 ml hourly or per physician order.” Patient # 1 A review of 3 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR and DFR on treatment dates 04/24/2024, 04/29/2024, and 05/06/2024. A review of the treatment sheet dated 04/24/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 600.00 ml/min” Staff # 17 and # 22 documented the following BFR and DFR throughout the patient’s treatment, “ 9:16 AM: BFR- 400 DFR- 500 10:01 AM: BFR- 400 DFR- 500 10:31 AM: BFR- 400 DFR- 500 11:01 AM-12:13 PM: BFR- 400 DFR- 500” Staff # 17 documented the following on 04/24/2024 at 9:50 AM: “Goal, Bath, and Prescription verified. Charge Nurse Rounds completed.” There was no documented order from the physician to adjust the BFR or DFR for this treatment date. A review of the treatment sheet dated 04/29/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 600.00 ml/min” Staff # 22 and # 17 documented the following BFR during the patient’s treatment, “12:31 PM: BFR- 350” Staff # 17 documented the following on 04/29/2024 at 10:31 AM: “Goal, Bath, and Prescription verified. Charge Nurse Rounds completed.” There was no documented order from the physician to adjust the BFR for this treatment date. A review of the treatment sheet dated 05/06/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 600.00 ml/min” Staff # 17 and # 18 documented the following BFR during the patient’s treatment, “11:00 AM: BFR- 350 11:30 AM: BFR- 350 12:00 PM: BFR- 350” Staff # 17 documented the following on 05/06/2024 at 10:30 AM: “Goal, Bath, and Prescription verified. Charge Nurse Rounds completed.” There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 3 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR on treatment dates 04/17/2024. A review of the treatment sheet dated 04/17/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 425ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 18 documented the following BFR throughout the patient’s treatment, “4:01 PM: BFR- 350 5:31 PM: BFR- 350 6:01 PM: BFR- 350 6:31 PM: BFR- 350” Staff # 18 documented the following on 04/17/2024 at 6:37 PM: “BFR adjusted due to arterial pressure. Asymptomatic. Charge Nurse notified.” There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 5 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR on treatment date 04/26/2024. A review of the treatment sheet dated 04/26/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350ml/min (milliliters per minute) Dialysate Flow Rate: 800.00 ml/min” Staff # 22 documented the following BFR throughout the patient’s treatment, “4:02 PM: BFR- 300 4:32 PM: BFR- 305 5:02 PM: BFR- 305 5:38 PM: BFR- 300 6:02 PM: BFR- 300 6:32 PM: BFR- 300 6:39 PM: BFR- 300” Staff # 17 documented the following verification of the prescription on 04/26/2024 at 3:32 PM: “Goal, Bath, and Prescription verified. Charge Nurse Rounds completed.” There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 7 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for BFR on treatment date 04/23/2024. A review of the treatment sheet dated 04/23/2024 revealed the following, “Dialysis Prescription: Blood Flow Rate: 400ml/min (milliliters per minute) Dialysate Flow Rate: 500.00 ml/min” Staff # 9 and #11 documented the following BFR throughout the patient’s treatment, “11:31 AM: BFR- 350 12:01 PM: BFR- 350 12:31 PM: BFR- 350 1:01 PM: BFR- 350 1:32 PM: BFR- 350 1:34 PM: BFR- 350 2:01 PM: BFR- 350 2:32 PM: BFR- 350” Staff # 12 documented the following on 04/23/2024 at 1:42 PM: “Pt complaining of cramping. UF turned off and 200 ml bolus given.” Staff # 12 documented the following on 04/23/2024 at 3:36 PM: “UF turned back on.” There was no documented order from the physician to adjust the BFR for this treatment date. Patient # 8 A review of 1 of 6 treatment sheets revealed facility staff did not follow the physician’s prescribed orders for DFR on treatment dates 05/04/2024. A review of the treatment sheet dated 05/04/2023 revealed the following, “Dialysis Prescription: Blood Flow Rate: 350ml/min (milliliters per minute) Dialysate Flow Rate: 500.00 ml/min” Staff # 10 documented the following DFR throughout the patient’s treatment, “10:14 AM: DFR- 350 10:32 AM: DFR- 350 11:02 AM: DFR- 350 11:32 AM: DFR- 350 12:02 PM: DFR- 350 12:32 PM: DFR- 350 1:02 PM: DFR- 350 1:32 PM: DFR- 350” Staff # 12 documented the following on 05/04/2024 at 10:13 AM: “Goal, Bath, and Prescription verified. Charge Nurse Rounds completed.” There was no documented order from the physician to adjust the DFR for this treatment date. An interview conducted with Staff # 1 on 05/07/2024 at 3:30 PM confirmed the facility staff were not consistently verifying prescriptions prior to initiation of treatment and did not follow the physician’s prescription on the patient’s treatments.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 48749 Based on record review and interview, the facility staff failed to ensure direct care staff were reporting patient vital signs that fell outside of the facility’s set parameters to the CN (charge nurse) for further assessment and intervention on 5 (# 3, # 4, # 5, # 6, # 8) of 8 patient charts reviewed. Also, the nursing staff failed to notify the physician/non-physician practitioner of abnormal findings on 5 (# 3, # 4, # 5, # 6, # 8) of 8 patient charts reviewed. The facility staff failed to follow the facility policy “ Intradialytic Monitoring of Patient.” This deficient practice had the likelihood to cause harm and delay in care to all 74 in-center hemodialysis patients receiving care at the facility. Findings Include: A review of facility policy, “Intradialytic Monitoring of Patient” dated 09/2020 revealed, “MONITORING: Direct patient care staff will monitor the following parameters during each dialysis treatment: PATIENT: 1. Must be in direct view of a staff member at all times; if leaving the treatment area for any reason, report off to another staff member and ensure observation of the assigned patients. 2. Vital signs: Obtained and documented at least every 30 minutes and reported to the charge nurse if outside of standing orders and/or reportable parameters, refer to C-FORMS-0081 Reportable Parameters to CN. 3. Volume status: Indicated by changes in BP and HR parameters, lung sounds and presence or reduction of edema. 4. Vascular access: Site clean and dry; venous and arterial pressure monitoring; signs and symptoms of recirculation; signs and symptoms of infiltration. 5. ENSURE PATIENT’S ACCESS, BLOODLINES AND FACE ARE VISIBLE AT ALL TIMES: a. During every 30-minute monitoring, the access and visualization of the face must be observed. b. If the patient refuses to keep access or face uncovered at all times (including eye shades or hats/caps), the charge nurse will be notified. c. Document patient refusal and charge nurse notifications in the flow sheet. Continued non-adherence will require additional intervention from the interdisciplinary team. 6. Anticoagulation effectiveness. 7. Well-being; level of consciousness. 8. Delivery of dialysis prescription. 9. Response to treatment. 10. Comment regarding patient status and staff observation at least every 30 minutes. DELIVERY SYSTEM: 1. Integrity of extracorporeal circuit: Pressure monitor readings (check arterial and venous drip chambers are filled with blood but are not backed up into the transducer filter protector, if applicable). NOTE: If the transducer filter becomes wet, replace it immediately. Inspect the side of the protector that faces the machine. If the fluid is visible, the Biomed technician will be notified and the machine taken out of service after dialysis treatment is completed. 2. Anticoagulant delivery 3. Blood flow rate 4. Dialysate flow rate 5. Alarm limits and/or conditions INTERVENTION: 1. Administer medications and/or parental fluids as ordered. 2. Modify the treatment plan based on the patient’s response, which must be documented by the charge nurse.” The parameters provided by the facility revealed; Pre-Dialysis: Blood Pressure (BP)- Systolic >180 or < 90 or Diastolic >110 or < 50 Heart Rate (HR)- >100 beats per minute (BPM) or < 50 BPM Intra-Dialysis: BP- Systolic >180 or < 90 or Diastolic >110 or < 50 HR- >100 BPM or < 50 BPM Post-Dialysis: BP- Systolic >160 or < 90 or Diastolic >110 or < 50 HR- >100 BPM or < 50 BPM Patient # 3 A review of 2 of 6 treatment sheets revealed nursing staff did not report out-of-parameter vital signs to the Charge Nurse and the Charge Nurse did not report abnormal findings to the physician for further evaluation and instruction. A review of the treatment sheet dated 04/17/2024 revealed Staff # 18 documented the following vital signs: “6:31 PM: BP- 184/93” There was no documentation from Staff # 18 to support that the Charge Nurse was made aware of these abnormal findings. A review of the treatment sheet dated 04/25/2024 revealed Staff # 10 and # 11 documented the following vital signs: “4:01 PM: BP- 181/99 4:31 PM: BP- 189/96 5:01 PM: BP- 188/99 5:18 PM: BP- 180/99 (Post-Treatment)” There was no documentation from Staff # 10, or # 11 to support the Charge Nurse being made aware of the abnormal findings during treatment. Staff # 17 completed a post-treatment assessment and documented at 5:18 PM a BP of “180/99.” There was no documentation from Staff # 17 to support the Physician being made aware of the abnormal findings. The patient was discharged home with a blood pressure of “180/99” by Staff # 17. Patient # 4 A review of 2 of 6 treatment sheets revealed nursing staff did not report out-of-parameter vital signs to the Charge Nurse and the Charge Nurse did not report abnormal findings to the physician for further evaluation and instruction. A review of the treatment sheet dated 04/25/2024 revealed Staff # 10 and Staff # 15 charted the following vital signs: “7:31 AM: BP- 181/100 8:04 AM: BP- 198/102 8:31 AM: BP- 196/84 9:01 AM: BP- 187/91 9:31 AM: BP- 190/92 10:01 AM: BP- 193/93 10:11 AM: BP- 182/102 10:38 AM: BP-191/103 (Post-Treatment)” There was no documentation from Staff # 15 to support the Charge Nurse being made aware of the abnormal findings. Staff # 17 completed a post-treatment assessment and documented at 10:12 AM a BP of “191/103.” There was no documentation from Staff # 17 to support the Physician being made aware of the abnormal findings. The patient was discharged home with a blood pressure of “191/103” by Staff # 17. A review of the treatment sheet dated 05/04/2024 revealed Staff # 9 charted the following vital signs: “7:32 AM: BP- 181/99 8:02 AM: BP- 183/96” There was no documentation from Staff # 9 to support that the Charge Nurse was made aware of these abnormal findings. Patient # 5 A review of 1 of 6 treatment sheets revealed facility staff did not report abnormal vital signs to the Charge Nurse and the Charge Nurse did not report abnormal findings to the physician for further evaluation and instruction. A review of the treatment sheet dated 04/26/2024 revealed Staff # 22 charted the following vital signs: “4:32 PM: BP- 184/102 6:02 PM: BP- 184/100” There was no documentation from Staff # 22 to support that the Charge Nurse was made aware of these abnormal findings. Patient # 6 A review of 5 of 6 treatment sheets revealed facility staff did not report abnormal vital signs to the Charge Nurse and the Charge Nurse did not report abnormal findings to the physician for further evaluation and instruction. A review of the treatment sheet dated 04/16/2024 revealed Staff # 12, Staff # 16 and # 18 charted the following vital signs: “5:39 AM: BP-199/100 (Pre-Treatment) 5:40 AM: BP-205/100 6:05 AM: BP-183/98 6:31 AM: BP-194/98 7:01 AM: BP-186/90 9:31 AM: BP-181/94 9:45 AM: BP- 181/85 (Post-Treatment)” The Charge Nurse was made aware of the patient’s elevated blood pressure at 7:01 AM. However, there was no documentation from the Charge Nurse to support the physician being made aware of the patient’s elevated blood pressure. A review of the treatment sheet dated 04/23/2024 revealed Staff # 11 and # 15 charted the following vital signs: “3:00 PM: BP-191/93 (Pre-Treatment) 3:09 PM: BP-181/92 3:11 PM: BP-198/93 3:32 PM: BP-185/92 4:02 PM: BP-199/100 6:21 PM: BP-139/79 heart rate (HR)- 102 (Post-Treatment)” The Charge Nurse was made aware of the patient’s elevated blood pressure at 3:32 PM. However, there was no documentation from the Charge Nurse to support the physician being made aware of the patient’s elevated blood pressure. A review of the treatment sheet dated 04/25/2024 revealed Staff # 15 charted the following vital signs: “5:32 AM: BP-195/90 (Pre-Treatment) 6:01 AM: BP-190/102 6:32 AM: BP-194/89 8:31 AM: BP-193/103 9:01 AM: BP-180/98 9:45 AM: BP-181/103 (Post-Treatment)” There was no documentation from facility staff to support notifying the Charge nurse of abnormal vital signs. However, the charge nurse did notify the Physician of an elevated BP during Pre-Treatment. The patient was discharged home with a BP of 181/103. There is no documentation from the Charge Nurse to support the Physician being made aware of the patient’s elevated blood pressure post-treatment. A review of the treatment sheet dated 04/27/2024 revealed Staff # 15 and Staff # 16 charted the following vital signs: “5:39 AM: BP-151/85- HR- 103 (Pre-Treatment) 6:01 AM: BP-188/100 6:31 AM: BP-195/95 7:01 AM: BP-186/90 8:32 AM: BP-184/93 9:31 AM: BP-181/82 9:34 AM: BP- 192/93 (Post-Treatment) There was no documentation from Staff # 15 and Staff # 16 to support that the Charge Nurse was made aware of these abnormal findings. A review of the treatment sheet dated 05/02/2024 revealed Staff # 17 charted the following vital signs: “7:20 AM: BP-151/88- HR- 102” Staff # 15 charted at 7:01 that the patient’s access site infiltrated, charge nurse was aware of the infiltration and authorized termination of treatment. There is no documentation from the charge nurse to support that the Physician was notified of the access infiltration, termination of treatment, and the elevated HR. Patient # 8 A review of 3 of 6 treatment sheets revealed facility staff did not report abnormal vital signs to the Charge Nurse and the Charge Nurse did not report abnormal findings to the physician for further evaluation and instruction. A review of the treatment sheet dated 04/23/2024 revealed Staff # 11 charted the following vital signs: “2:02 PM: BP- 106/48” There was no documentation from Staff # 11 to support that the Charge Nurse was made aware of these abnormal findings. A review of the treatment sheet dated 04/25/2024 revealed Staff # 10 charted the following vital signs: “1:32 PM: BP- 181/73 2:02 PM: BP- 184/61” There was no documentation from Staff # 10 to support that the Charge Nurse was made aware of these abnormal findings. A review of the treatment sheet dated 04/30/2024 revealed Staff # 1, Staff #11, and # 16 charted the following vital signs: “10:54 AM: BP- 100/46 (Pre-Treatment) CN 1:32 PM: BP- 118/41 3:06 PM: BP- 111/47 3:08 PM: BP- 107/40 (Post-Treatment)” There was no documentation from Staff # 11 and # 16 to support the Charge Nurse being made aware of these abnormal findings. An interview with Staff # 1 on 05/07/2024 at 3:30 PM confirmed the facility staff did not consistently report out-of-parameter vital signs to the Charge Nurse and the Charge Nurse did not consistently notify the Physician of abnormal findings. Staff # 1 confirmed the facility staff should be reporting abnormal vital signs and were not follow the facility parameters.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 29191 Based on observation, record review, and interview, the governing body failed to ensure an adequate number of staff were present in the treatment area to observe every patient citing 12 of 12 patients during dialysis treatment to deliver routine care, promptly respond to an emergency, and address patient care needs. This deficient practice placed all patients in the dialysis facility at risk for harm and unsafe patient care. Findings: During a tour of the treatment floor on 05/06/2024 at 2:00 PM observed that the registered nurse and the licensed vocational nurse took a lunch break at the same time. There was no licensed nurse on the floor. The surveyor observed at one time for 5 minutes there was only one Patient Care Technician on the floor for 10 patients. A review of the policy titled, “U.S. RENAL CARE Intradialytic Monitoring of Patient” dated 09/2020 included “PURPOSE: The patient will receive a safe, effective and comfortable treatment. Policy: 1. Must be in direct view of a staff member at all times; if leaving the treatment area for any reason, report off to another staff member and ensure observation of the assigned patients.” An interview with Staff #1 on 05/06/2024 at 3:00 PM acknowledged the licensed nurses had left the treatment for a break leaving only the Patient Care Technician to attend to the needs of 10 patients.”