Usrc North Richland Hills

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 30377 Based on review of hemodialysis flow sheets and staff interview the registered nurse failed to follow the physician’s standing orders for treatment of hypertension. Based on review of medical records, policy and procedures, and staff interview the facility failed to address out of range potassium and bicarbonate blood levels in a timely manner. Based on review of medical records, policy and procedures and staff interview the social worker failed to evaluate and follow up on identified psychosocial issues for 1 of 1 patient (Patient #6). This deficient practice placed this patient on census at risk of unmet psychosocial needed. (Cross Refer to Tag V0504, V0505, and V0510)”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 30377 Based on review of hemodialysis flow sheets and staff interview the registered nurse failed to follow the physician’s standing orders for treatment of hypertension. Based on review of medical records, policy and procedures, and staff interview the Medical Director failed to ensure the facility addressed out of range potassium and bicarbonate blood levels in a timely manner. Based on review of medical records, policy and procedures and staff interview the Medical Director failed to ensure that the social worker evaluated and followed up on identified psychosocial issues for 1 of 1 patient (Patient #6). This deficient practice placed this patient on census at risk of unmet psychosocial needed. (Cross Refer to Tag V0504, V0505, and V0510)”

“IC: HBV: TEST ALL,REV RESULTS/STATUS B4 ADMIT CFR(s): 494.30(a)(1)(i) Routine Testing for Hepatitis B The HBV serological status (i.e. HBsAg, total anti-HBc and anti-HBs) of all patients should be known before admission to the hemodialysis unit. Routinely test all patients [as required by the referenced schedule for routine testing for Hepatitis B Virus]. Promptly review results, and ensure that patients are managed appropriately based on their testing results. This Standard is not met as evidenced by: 30377 Based on facility policies and procedures, medical record review, and staff interview the facility failed to identify the patients’ HBV serological status monthly on patients that were susceptible to Hepatitis B virus. This deficient practice has potential to cause harm to all patients and staff who have negative anti-HBs. Findings included: A review of facility policy titled “Patient Hepatitis B Testing/ Vaccination/Seroconversion” stated in part the facility is to Obtain HBsAg monthly for all HBV-susceptible patients. Susceptible patients include any patient: a. In a vaccine series; b. Anti-HBs <10 mlU/mL c. Non-responders to the vaccine after 2 series; and/or d. Anti-HBs <10mIU/mL and refusing the vaccine. Review of the facility’s Hepatitis Management Report date range from January 2025 to current revealed the following patients with nonreactive Hepatitis Surface AB (anti-HBs) results were missing monthly Hepatitis B antigens (HBsAg). Patient #1 Hepatitis Surface AB with nonreactive result on 04/16/2025 were missing monthly Hepatitis B Antigens for May 2025, and as of 06/18/2025 there was no monthly Hepatitis B Antigen draw. Patient # 2 Hepatitis Surface AB with nonreactive result on 02/19/2025 was missing monthly Hepatitis B Antigen for March 2025. Patient #3 Hepatitis Surface AB with nonreactive result on 04/08/2025 was missing monthly Hepatitis B Antigen for May 2025. Patient # 4 Hepatitis Surface AB with nonreactive result on 02/06/2025 was missing monthly Hepatitis B Antigen for March 2025. Patient #5 Hepatitis Surface AB with nonreactive result on 03/04/2025 were missing monthly Hepatitis B Antigens for April 2025 and May 2025. An interview conducted with (Staff Member #1) on 06/18/2025 at 12:55 p.m. following her own review of the findings revealed she was aware of the missing antigens for the month of March 2025. Staff Member #1 stated that an internal audit completed March 25, 2025, observe that the facility had missing antigens in the month of March. At the time of the interview no evidence of compliance was presented where noncompliance was found.”

“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: 30377 Based on review of hemodialysis flow sheets and staff interview the registered nurse failed to follow the physician’s standing orders for treatment of hypertension. The findings included: Review of hemodialysis flow sheets in the facility conference room revealed an example of the following discrepancies: Patient # 7 Flow Sheet Dated: 6/09/25. Initiation of treatment: 04:53 AM Termination of treatment: 08:20 AM. Pre-Vitals: 211/80 heart rate 67. Post Vitals: 230/74 heart rate 57. Pre-Dialysis Assessment completed 06:21 AM by the Registered Nurse stated “No signs and symptoms of covid infection, pre-assessed patient blood pressure high patient asymptomatic. MD notified okay to run treatment will give Clonidine if no blood pressure drops ....” The following vitals were recorded: 04:53 AM Blood Pressure 211/80 with heart rate of 66 04:55 AM Blood Pressure 233/92 with heart rate of 63 04:56 AM Blood Pressure 240/97 with heart rate of 64 04:57 AM Blood Pressure 215/92 with heart rate of 64 05:06 AM Blood Pressure 217/83 with heart rate of 62 05:06 AM Catapres 0.1mg PO administered by the registered nurse. 05:36 AM Blood Pressure 216/79 with heart rate of 61 06:06 AM Blood Pressure 208/80 with heart rate of 59 06:06 AM Catapres 0.1mg PO administered by the registered nurse. 06:36 AM Blood Pressure 148/78 with heart rate of 65 07:06 AM Blood Pressure 221/79 with heart rate of 60 07:06 AM Catapres 0.1mg PO administered by the registered nurse. 07:36 AM Blood Pressure 216/76 with heart rate of 58 08:06 AM Blood Pressure 223/72 with heart rate of 57 08:06 AM Catapres 0.1mg PO administered by the registered nurse. 08:19 AM Blood Pressure 215/68 with heart rate of 56 08:48 AM Blood Pressure 201/72 with heart rate of 57 08:57 AM Blood Pressure 230/74 with heart rate of 57 08:57 AM Blood Pressure 194/92 with heart rate of 56 Physician’s Standing Order in part stated “ #9 Hypertension give Clonidine 0.1mg PO x 1 PRN for Systolic >180. Repeat Blood Pressure every 15 minutes for one hour after giving medication. Notify the MD if post setting systolic Blood Pressure > 180 mmHg.” Post Dialysis Assessment completed at 10:51AM by the Registered Nurse stated “ Blood Pressure high. PRN medication given. Patient refused to recheck blood pressure again. Patient Kg is below estimated dry weight. No distress noted. MD aware.” At time of review there was no evidence provided that the registered nurse followed the Physician Standing Orders for treatment of Hypertension to include monitoring blood pressure readings every 15 minutes after administration of Clonidine and notifying the physician that the Clonidine was not effective. There was no evidence provided that the registered nurse obtained additional orders from the physician to administer an additional three doses of Clonidine. Flow Sheet Dated: 6/11/25. Initiation of treatment: 04:48 AM Termination of treatment: 08:13 AM. Pre-Vitals: 208/81 heart rate 73. Post Vitals: 206/70 heart rate 57. Pre-Dialysis Assessment completed 04:48 AM by the Registered Nurse stated “No signs and symptoms of covid infection, pre-assessed patient blood pressure high patient asymptomatic. MD notified okay to run treatment will give Clonidine if no blood pressure drops ....” The following vitals were recorded: 04:51 AM Blood Pressure 230/92 with heart rate of 68 04:59 AM Blood Pressure 206/80 with heart rate of 65 04:59 AM Catapres 0.1mg PO administered by the registered nurse 05:14 AM Blood Pressure 215/80 with heart rate of 63 04:57 AM Blood Pressure 215/92 with heart rate of 64 05:28 AM Blood Pressure 207/77 with heart rate of 61 05:43 AM Blood Pressure 201/71 with heart rate of 61 05:58 AM Blood Pressure 207/72 with heart rate of 59 06:13 AM Blood Pressure 208/73 with heart rate of 59 06:13 AM Catapres 0.1mg PO administered by the registered nurse 06:28 AM Blood Pressure 186/75 with heart rate of 57 06:43 AM Blood Pressure 205/71 with heart rate of 58 06:58 AM Blood Pressure 210/70 with heart rate of 57 07:13 AM Blood Pressure 200/70 with heart rate of 58 07:28 AM Blood Pressure 206/72 with heart rate of 58 07:58 AM Blood Pressure 215/73 with heart rate of 58 07:58 AM Catapres 0.1mg PO administered by the registered nurse 08:13 AM Blood Pressure 218/72 with heart rate of 55 08:13 AM Catapres 0.1mg PO administered by the registered nurse 08:31 AM Blood Pressure 206/70 with heart rate of 57 Post Dialysis Assessment completed at 09:16 AM by the Registered Nurse stated “Blood Pressure high. Patient asymptomatic, Patient refused to take more Clonidine due to risk of sudden blood pressure drop while going back home ... ... ... ... .... MD notified.” At time of review there was no evidence provided that the registered nurse obtained additional orders from the physician to administer an additional three doses of Clonidine. To note the documentation was not clear when the registered nurse documented MD notified and or MD aware what the physician was being notified of. An interview conducted with the facility administrator on 6/19/25 following her own review of the findings revealed she was unaware of the discrepancies found in the flow sheets. The facility administrator confirmed the above findings.”

“PA-ASSESS LAB PROFILE CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: (3) Laboratory profile, This Standard is not met as evidenced by: 30377 Based on review of medical records, policy and procedures, and staff interview the facility failed to address out of range potassium and bicarbonate blood levels in a timely manner. The findings included: Review of facility labs dated from 03/01/25 to 06/17/25 on 06/17/25 at 12:30 PM in the facility conference room revealed the following out of range blood levels. Patient #9 06/04/25 Potassium blood level was 7.3 mEq/L 06/06/25 Potassium blood level was 6.6 mEq/L Potassium Protocol in part stated “ ....If potassium greater than 6 mEq/L call MD .....” Nursing Note dated 06/06/2025 at 7:59 AM stated: “Received critical lab report. 7.3 mEq/L MD aware. Ordered to recheck potassium today ....” To note as of 06/17/2025 the repeated potassium level of 6.6 mEq/L has not been addressed. At time of review there was no evidence provided that the nursing service and or the attending physician addressed the repeated potassium level of 6.6 mEq/L dated 06/06/25. Patient # 11 06/05/25 Potassium level was 6.3 mEq/L Potassium Protocol in part stated “ ....If potassium greater than 6 mEq/L call MD .....” Registered Dietitian Note recorded at 01:22 PM on 06/10/25 did not acknowledge or address the elevated potassium. At time of review there was no evidence provided that the registered nurse or the attending physician acknowledged and or addressed the elevated potassium drawn 06/05/25. Patient # 12 05/07/25 Potassium level was 6.7 mEq/L 06/04/25 Potassium level was 5.7 mEq/L 06/05/25 Potassium level was 6.4 mEq/L Potassium Protocol in part stated “ ....If potassium greater than 6 mEq/L call MD .....” At time of review there was evidence provided that the registered nurse or the attending physician addressed the elevated potassium lab drawn 05/07/25. The potassium blood level of 6.7 mEq/L drawn on 05/07/25 was not repeated until the next monthly lab draw dated 06/04/25. Patient # 10 03/06/25 Patient’s bicarbonate blood level was 13 with a prescribed bicarbonate machine setting of 27 ordered on 02/27/25. Bicarb Protocol stated in part “Bicarbonate Level Q2WK Target 20-26. If Bicarb less than 20 adjust (dialysis machine setting) plus 4 to max 36 ... ...MD may want to start Bicarb PO if Bicarb 36 and CO2 is less than 20. At time of review there was no evidence provided that the registered nurse or the attending physician addressed the low bicarbonate level, repeated the lab at minimum every two weeks, and or adjusted the dialysis prescription per the facility Bicarb Protocol. An interview conducted with staff #1 on 06/18/25 following her own review of the findings revealed she was unaware of the discrepancies found. Staff #3 confirmed the above findings.”

“PA-MSW-PSYCHOSOCIAL NEEDS CFR(s): 494.80(a)(7) The patient’s comprehensive assessment must include, but is not limited to, the following: (7) Evaluation of psychosocial needs by a social worker. This Standard is not met as evidenced by: 30377 Based on review of medical records, policy and procedures and staff interview the social worker failed to evaluate and follow up on identified psychosocial issues for 1 of 1 patient (Patient #6). This deficient practice placed this patient on census at risk of unmet psychosocial needs. Findings were: Facility policy entitled “Comprehensive Interdisciplinary Patient Assessment/Plan of Care “ stated in part “Psychosocial Status: Evaluate family/support systems, Intervention individualized to meet the patient’s adjustment to kidney failure and treatment, and survey physical and mental functioning by standardized tool. Patient # 6 Review of Care Plan dated 05/13/2025 revealed the following: Registered Nurse General Comments: “Patient is a wheelchair bound and blind. Always comes in late for her treatment. Continue to encourage treatment compliance to prevent hospital readmissions .....Patient had absences of more than 30 days last month due to patient refusing to come to dialysis and due to patient’s hospitalization ....” Registered Dietician General Comments: “Patient is now seen for stable initial assessment related to missed treatments due to feeling depressed and not wanting to attend dialysis and states she want to “die.” Patient’s family urges her to come to treatment ....” Review of Psychosocial area of care plan revealed the following documentation: Depression Information: Blank PHO-2 Depression Screening: Blank Depression Screening Scoring: Last Screening 02/04/2025. Depression Screen Scoring: PHQ-2 Score: (0) Negative screen and no follow up needed. In an interview with the Regional Social Worker Staff # 2 on 06/18/25 at 1:50 PM after her own review confirmed that the social worker should have completed a Depression Screening and documented those findings. At the time of the interview no evidence of compliance was presented where noncompliance was found.”

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s staff failed to: A. monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center. Also, the facility staff failed to follow the facility policy, “Infection Control and Precautions for All Patients”. (Cross Refer to Tag V0111) B. ensure staff did not have personal drinks and belongings while in the patient treatment area. The facility failed to follow the facility policy on “ Infection Control and Precautions for All Patients.” (Cross Refer to Tag V0115) C. ensure residual bleach testing was performed on 7 of 19 dialysis machines before initiation of patient dialysis treatments in March and April of 2024. Also, the facility staff failed to follow, “Machine Disinfection - Fresenius”. The deficient practices were identified under the following Condition of Coverage and were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death. (Cross Refer to Tag V0122)”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s biomedical staff failed to: A . identify and correct a water leak from the RO (reverse osmosis) tank in the facility’s water room. The facility staff failed to follow the policy, “Monthly Water Treatment Monitoring”. (Cross Refer to Tag V0208) B. ensure the water system R/O (reverse osmosis) was disinfected at least monthly. (Cross Refer to Tag V0219) C. 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) D. program hemodialysis machines to the prescribed dialysate concentrate ratio, utilized on patients for 15 of 15 hemodialysis machines. (Cross Refer to Tag V0248)”

“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: 48653 Based on observation, record review, and staff interview, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center. Also, the facility staff failed to follow the facility policy, “Infection Control and Precautions for All Patients”. This deficient practice had the likelihood to cause harm to patients, staff members, and the public by increasing the risk of transmission of infectious agents within the facility. During a tour of the facility on 04/10/2024 at 10:00 AM, the surveyor observed the following infection control issues in the supply room and in-center treatment area. Supply Room * Cardboard boxes were observed mixed in with sterile supplies. There were cardboard boxes stored on top of sterile patient supplies. The sterile supplies were stored in clear plastic bins. The clear plastic bins did not have lids on them. “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). * The bins with sterile patient supplies stored in them had a build-up of dirt and dust inside of them. Several of the bins had dead bugs inside of them. * The floor of the supply area was dirty with dust, dirt and dead bugs. * There was an extension cord plugged into the wall that had a thick build-up of dust and dirt on it posing a fire risk . * Full biohazard bins were being stored in the hallway of the supply room. The used and contaminated bins were not properly stored in the designated biohazard room. In-center Treatment Area * The tri-station had a build-up of dust, dirt, and other unknown debris. The Phoenix meter station had a large build-up of dust in the bottom of it. * The drawer located below the tri-station had a build-up of dust, dirt, and other unknown brown substances in the bottom of it. The glucometer and other patient supplies were stored in the drawer. * The cabinet below the tri-station had white and blue clamps inside of it. It was unknown if the clamps had been cleaned and sanitized. There were no labels on the clamps. The white clamps were not in a bag or container. * The cabinet below the tri-station had damage to the laminate on the bottom shelf. Damaged laminate cannot be thoroughly cleaned and disinfected. * 3 cardboard boxes were being stored on the in-center treatment area floor. The cardboard boxes had patient supplies in them. * There was dust and dirt on many of the hard surfaces in the in-center treatment area. The hand sanitizer machine located in front of the eye-wash station had a thick build-up of dust on it. * The area designated as “clean” in the in-center treatment area had equipment stored in it. The IV (intravenous) pump designated as “clean” was found the have splatters of brown and orange substances on it. * The cabinet located below the locked medication safes had damage to the cabinet door. The laminate was damaged, and the cabinet door could not be adequately cleaned and disinfected. * Dialysis machine # 12 had three pieces of sticky tape and residue on the side of it. The dialysis machine could not be adequately cleaned and disinfected due to the sticky tape. * Dialysis machine # 12 had a thick build-up of dust and dirt on the back of the machine. The dialysate filter on the back of the machine had a brown and black substance inside of it. There was a thick build-up of dust and dirt inside of it. A review of the facility policy, “Infection Control and Precautions for All Patients” with a revision date of 07/2023 revealed, “PURPOSE: To educate staff on general guidelines in the prevention of infection within the dialysis facility. PROCEDURE: 1. Take steps to ensure all patients with respiratory symptoms (e.g., fever, cough) adhere to strict respiratory hygiene, cough etiquette, hand hygiene and triage procedures throughout the entire time within the facility. 2. Patients and staff must use designated lavatories. 3. Clean areas will be clearly designated and separated from contaminated areas and unused supplies and equipment. 4. Discard used needles and sharps in appropriate containers. 5. Keep hands and all articles away from mouth. Do not place pen, pen caps, pencils or needle caps in mouth. 6. Lab specimens will only be kept in the refrigerator with a biohazard sign. Medications will only be kept in the medication refrigerator. 7. Only vascular access dressings may be changed in the dialysis facility. 8. Staff performing dialysis access care will not wear artificial nails and will maintain nails no longer than ¼ inch beyond the fingertip. 9. Use external transducer protectors (CombiSet® only) to prevent blood contamination of the dialysis machines’ pressure monitors. Change protector’s if wetted 10. Hand Hygiene: Refer to policy C-IC-0060 Hand Hygiene. a. Patient and visitors must perform hand hygiene before and after entering patient treatment area and after removal of PPE, if applicable. If patient is unable to perform independently, staff will assist patient. b. Staff will perform hand hygiene: i. Using soap and water or antibacterial hand sanitizer before/after all patient contact and before donning and after doffing PPE, including gloves. ii. After contact with integrated keyboard or chairside computer, regardless of whether contact occurred through gloved or ungloved hands. 11. Personal Protective Equipment (PPE): refer to policy C-IC-0025 for comprehensive guidance on PPE requirements for staff, patients, visitors and transportation personnel. a. Staff MUST remove gloves and perform hand hygiene between each patient or station. 12. Medications/Medication area/room: a. Will be clearly designated as a clean area and separated from contaminated areas for the preparation, handling and storage of medications. b. Remove PPE prior to entering the medication area/room. c. Multiple dose medication vials (MDV’s), including vials containing diluents or supplies (e.g., syringes, alcohol swabs): i. Prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. ii. If taken to the patient’s station will be used only for that patient and will not be returned to a common clean area or used on other patients. iii. DO NOT carry in pockets, from station to station or 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. 13. Supplies: Items taken into the dialysis station will 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. a. Non-disposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) will be dedicated for use only on a single patient. b. Preparation of tape will be as follows: tear a long piece of tape and place on a clean barrier. DO NOT place directly on the chair or chair side table. Place torn tape for access taping on top of the barrier tape. At no time will tape hang directly from the chair or chair side table. 14. Food/Drink/Other: follow policy C-IC-0050 Eating and Drinking in the Treatment Area in addition to the below guidance. a. Eating, drinking, chewing gum, smoking, applying cosmetics or lip balm and handling contact lenses are prohibited by staff in work areas where there is a reasonable likelihood of occupational exposure. b. Food and drink will not be kept in medication and laboratory refrigerators, freezers, shelves, cabinets or on countertops. where the risk of contamination from blood or other potentially infectious materials is possible. c. Eating and drinking by patients is strongly discouraged in the facility. Encourage patients to eat or drink prior to or after dialysis. If a patient chooses to eat during treatment, food will remain at the station assigned to the patient. d. Do not accept food from patients. 15. Cleaning and disinfection: a. Clean and disinfect the dialysis station (e.g., chairs, beds, tables, integrated keyboards, dialysis machines, ancillary equipment) after patient has vacated the station. i. Give special attention to cleaning control panels on the dialysis machines and other surfaces that are frequently touched and potentially contaminated with patients’ blood. ii. If the station has a privacy curtain and it becomes visibly soiled, the curtain will need to be cleaned and disinfected with 1:100 bleach wipe, laundered or replaced. iii. Discard all fluid and clean and disinfect all surfaces and containers associated with the prime waste (including buckets attached to the machines). b. The following areas will undergo routine cleaning and disinfection at the end of the day or more frequently as needed: i. Nursing stations and common biomed desk/work areas. ii. High-touch areas (e.g., screening iPads, door or scale handles, keyboards, wheelchair arms). c. Any blood spills must be cleaned/disinfected immediately and thoroughly. d. Refer to policy C-IC-0080 Disinfection and Cleaning of Dialysis Machine Equipment, for bleach instructions.” In an interview with Staff # 1 on 04/11/2024 at 2:30 PM, Staff # 1 acknowledged the facility had issues with maintaining a clean and sanitary environment to minimize and limit the transmission of infections among patients and staff in the facility.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 29191 Based on observation, policy review, and staff interview, the facility failed to ensure staff did not have personal drinks and belongings while in the patient treatment area. The facility failed to follow the facility policy on “ Infection Control and Precautions for All Patients.” Findings include: During the observation tour of the patient treatment area on 04/10/2024 at 1:52 PM observed a staff member’s drink and belongings stored in a black metal cabinet that stored sterile supplies. The drink was located directly next to the sterile IV fluid. The cell phone and notebook were next to tape rolls and gauze. A review of the facility policy titled, “Infection Control and Precautions for All Patients” with a revision date of 07/2023 revealed, “PURPOSE: To educate staff on general guidelines in the prevention of infection within the dialysis facility. 14. Food/Drink/Other: follow policy C-IC-0050 Eating and Drinking in the Treatment Area in addition to the below guidance. a. Eating, drinking, chewing gum, smoking, applying cosmetics or lip balm and handling contact lenses are prohibited by staff in work areas where there is a reasonable likelihood of occupational exposure. b. Food and drink will not be kept in medication and laboratory refrigerators, freezers, shelves, cabinets or on countertops. where the risk of contamination from blood or other potentially infectious materials is possible. c. Eating and drinking by patients is strongly discouraged in the facility. Encourage patients to eat or drink prior to or after dialysis. If a patient chooses to eat during treatment, food will remain at the station assigned to the patient. d. Do not accept food from patients.” In an interview with Staff # 1 on 04/11/2024 at 2:30 PM, Staff # 1 acknowledged drinks and personal belongings should not be on the treatment floor stored in the patient supply cart.”

“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: 48653 Based on record review and staff interview, the facility’s staff failed to ensure residual bleach testing was performed on 7 of 19 dialysis machines before initiation of patient dialysis treatments in March and April of 2024. Also, the facility staff failed to follow, “Machine Disinfection - Fresenius”. The deficient practices were identified under the following Condition of Coverage and were determined to pose Immediate Jeopardy to patient health and safety and placed all patients at risk for the likelihood of harm, serious injury, and possibly subsequent death. According to the National Institutes of Health (NIH), “Gross hemolysis resulting from accidental hypochlorite (bleach) infusion has led to cardiac arrest because of hyperkalemia (high potassium)”. A review of the facility document, “Machine Disinfection Log-Fresenius March 2024” with a date of 03/29/2024 revealed the following, Machine # 4 Machine # 4 underwent bleach disinfection on 3/28/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 3/29/2024 at 4:43 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 03/29/2024. Machine # 5 Machine # 5 underwent bleach disinfection on 3/28/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 3/29/2024 at 4:43 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 03/29/2024. Machine # 8 Machine # 8 underwent bleach disinfection on 3/28/2024 at 6:00 PM. Staff #17 documented a bleach residual test on 3/29/2024 at 4:28 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 03/29/2024. Machine # 9 Machine # 9 underwent bleach disinfection on 3/28/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 3/29/2024 at 4:43 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 03/29/2024. Machine # 11 Machine # 11 underwent bleach disinfection on 3/28/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 3/29/2024 at 4:44 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 03/29/2024. Machine # 14 Machine # 14 underwent bleach disinfection on 3/28/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 3/29/2024 at 4:44 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 03/29/2024. Machine # 18 Machine # 18 underwent bleach disinfection on 3/28/2024 at 6:00 PM. Staff #18 documented a bleach residual test on 3/29/2024 at 3:20 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 03/29/2024. A review of the facility document, “Machine Disinfection Log-Fresenius April 2024” with a date of 04/05/2024 revealed the following, Machine # 2 Machine # 2 underwent bleach disinfection on 04/04/2024 at 6:00 PM. Staff #17 documented a bleach residual test on 04/05/2024 at 4:23 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 04/05/2024. Machine # 7 Machine # 7 underwent bleach disinfection on 04/04/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 04/05/2024 at 7:10 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 04/05/2024. Machine # 11 Machine # 11 underwent bleach disinfection on 04/04/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 04/05/2024 at 7:10 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 04/05/2024. Machine # 12 Machine # 12 underwent bleach disinfection on 04/04/2024 at 6:00 PM. Staff #17 documented a bleach residual test on 04/05/2024 at 4:23 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 04/05/2024. Machine # 14 Machine # 14 underwent bleach disinfection on 04/04/2024 at 6:00 PM. Staff #15 documented a bleach residual test on 04/05/2024 at 7:10 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 04/05/2024. Machine # 17 Machine # 17 underwent bleach disinfection on 04/04/2024 at 6:00 PM. Staff #17 documented a bleach residual test on 04/05/2024 at 4:23 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 04/05/2024. Machine # 18 Machine # 18 underwent bleach disinfection on 04/04/2024 at 6:00 PM. Staff #17 documented a bleach residual test on 04/05/2024 at 3:56 PM. The machine was not tested for bleach residuals before a patient was treated on the machine on 04/05/2024. During an interview with Staff # 15 and # 17 on 04/10/2024 at 3:20 PM in the biomedical staff office, Staff # 15 and # 17 reported they were not completing a residual bleach test on all 19 dialysis machines before initiating patient treatment. Staff # 17 stated, “We only check bleach residuals on the machines in our bay. Some of the float staff do not have access to document the bleach residual test and we have to document a residual was completed prior to closing out at the end of the day.” A review of the facility policy titled, “Machine Disinfection- Fresenius” with a revision date of 02/2023 revealed, “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 ... 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 # 4 (biomedical staff) on 04/10/2024 at 3:30 PM in the biomedical staff office, Staff # 4 acknowledged the facility was unable to determine if a residual bleach test had been performed on the dialysis machines before patient treatments had been initiated.”

“H20 STORAGE & DISTRIBUTION-DESIGN CFR(s): 494.40(a) 5.3 Water storage and distribution 5.3.1 General: Design A water storage and distribution system should be designed specifically to facilitate bacterial control, including measures to prevent bacterial colonization and to allow for easy and frequent disinfection. This Standard is not met as evidenced by: 48653 Based on observation, record review, and staff interview, the facility’s biomedical staff failed to identify and correct a water leak from the RO (reverse osmosis) tank in the facility’s water room. The facility staff failed to follow the policy, “Monthly Water Treatment Monitoring”. During a tour of the facility’s water room on 04/10/2024 at 9:52 AM with Staff # 4, the surveyor observed a large accumulation of water on the floor in the water room. The water was on the floor located under the RO system and dripping down the side of the RO water tank. Staff # 4 acknowledged the water leak during the tour. A review of the facility’s “Daily Water Log” revealed Staff # 17 documented “Yes, Water Room Free of Leaks” on 04/10/2024 at 3:29 AM, the same day the surveyors observed the water leak in the water room. A review of the facility policy, “Monthly Water Treatment Monitoring” with a revision date of 08/2020 revealed, “Purpose: To ensure the dialysis water system operates safely and reliably 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.” An interview with Staff # 4 on 04/10/2024 at 9:50 AM confirmed the facility had a water leak coming from the RO tank in the water room. Staff # 4 stated, “Yes, I can see the water is coming from the gasket on top of the tank”.”

“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: 29191 Based on record review, policy review, and interview, the facility failed to ensure the water system R/O (reverse osmosis) was disinfected at least monthly. This deficient practice had the likelihood of causing contaminated water to be distributed to 75 in-center hemodialysis patients receiving treatments at the facility. Findings include: A review of the water system disinfection logs from January -April 2024 revealed the facility did not disinfect the water system for 5 weeks. The system was disinfected on 02/11/2024 and not disinfected again until 03/17/2024. An interview with the Bio-Med on 04/11/2024 at 9:30 AM confirmed the facility went over 30 days for the disinfection of the water system. An interview with the Area Bio-Med on 04/11/2024 at 9:30 AM confirmed the facility went over 30 days for the disinfection of the water system. A review of the facility policy titled, “ Monthly Water Treatment Monitoring” revealed the following: Purpose: To ensure the dialysis water system operates safely and reliably 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 Waterlog”. 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 Waterlog”. 2. Only Biomedical Technicians trained to perform the observations and testing required to complete the “Monthly Waterlog” 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 Waterlog” compare results to those most recently recorded on the “Daily Waterlog”. 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 Waterlog” is to be completed by the Biomedical Technician who performed and documented the observations and test results.””

“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 04/10/2024 at 10:05 AM, observed patient #7 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. The surveyor requested Staff #17 to perform the procedure of disinfecting the wands. Staff #17 placed the wand in the bleach solution container that holds the clamps. The wand was too long and was not completely submerged in the bleach solution. Then Staff #17 rinsed the wand with tap water from the faucet. Then, the wand was taken to the plastic container that held clean clamps. This container was too small, and the wand was outside of the clean plastic container. The standard for pick-up wands was for the pick-up wands to be rinsed with treated R/O water and allowed to air dry at the end of each treatment day in a vertical position. Patient #7 was the only patient receiving a special dialysate bath, so the wand should have been disinfected per the policy. An interview with Staff #17 on 04/10/2024 at 10:05 AM acknowledged the pickup tube (wand) was not secured to the acid jug. A review of the policy titled, “Disinfection Protocols for Bicarbonate Mixers and Containers” 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 #4 on 04/10/2024 at 10:35 AM confirmed the wands were unsecured and were hanging from the acid jugs. Also, the facility staff were not disinfecting the wands per the facility’s policy.”

“DIALYS PROPORT-MATCH RATIO-ALL CONC/MACHINE CFR(s): 494.40(a) 5.6 Dialysate proportioning: match ratio all conc/machine The acid and bicarbonate concentrates [must] be matched with respect to the proportioning ratio and with the model and setup configuration of the dialysis machine. Several types of three-stream concentrates are available, with different ratios of acid concentrate to bicarbonate concentrate to water (see Table 3). The different proportioning types are not compatible with one another. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s Bio-medical staff failed to program hemodialysis machines to the prescribed dialysate concentrate ratio, utilized on patients for 15 of 15 hemodialysis machines. Findings include: Patient #7 On 04/10/2024 at 10:05 a.m. Patient #7 was observed on the treatment floor of the facility at station #1 hemodialysis machine 2008K2 serial number 6KOS-934P. The Patient was utilizing dialysate concentrate of 2 K, 2.0 calcium from the jug observed connected to the machine. At the request of the Surveyor the Patient Care Technician (#17) opened the panel on the hemodialysis machine which displayed the dialysate concentrate setting. It was programmed to mix the dialysate concentrate of 2.5 K potassium 2.5 calcium. A review of the Patient’s clinical record, located in the chairside computer revealed a physician’s order dated May 2023 for dialysate concentrate of 2.0 potassium and 2.0 calcium. The Surveyor immediately notified the Facility’s Charge Nurse #7 who also observed the setting on the hemodialysis machine. During an interview on 04/10/2024 at 10:08 AM with Registered Nurse #7 who was assigned to patient #7. The Surveyor notified Staff #7 that the setting for dialysate composition on the patients’ hemodialysis machines was incorrect. Staff RN #7 stated, “I set the machine for the setting that the bio-medical technician told me to use for the special bath of 2.0 potassium and 2.0 calcium.” The surveyor asked do you see the setting that the machine was set incorrectly. Staff #7 stated, “I see it is wrong it is set at 2.5 potassium and 2.5 calcium which is incorrect.” Surveyor and Biomedical technician #4 observed every machine in the facility which consisted of 19 machines. All the machine concentrates were set with the settings of: 2251G 45X 3251G 45X 1251A 45X 2201N 45X This setting was set at 2.5K#, Ca#2.5, MG#2.5.0, Acetate 3.0, chloride, and Dextrose 200MG 2201N 45X--- The setting of concentrate should have been set at 2.0K#, Ca#2.0, MG#1.0, Acetate 4.0, chloride, and Dextrose 100 mg according to the manual for a patient to receive 2.0 potassium and 2.0 calcium special dialysate bath. The nephrologist had ordered 2.0 potassium and 2.0 calcium for the patient from May of 2023 to present. Review of the Manufacture’s Direction for Use Manual directs uses as follows: “It is mandatory that acid and bicarb types be matched. These set-ups included machine calibration, special adapters for concentrate type, correct settings of concentrate option, and labeling.” An interview with bio-medical technician #4 on 04/10/2024 at 11:00 AM acknowledged that he had made the mistake of setting the concentration wrong on all 19 dialysis machines located in the facility.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 48653 Based on observation and staff interviews, the facility staff failed to ensure the emergency pull cord (a call light strategically placed throughout the facility to provide a user with a convenient means of summoning help in an emergency) was accessible for a patient in the event of an emergency. The emergency pull cord should be within 6 inches of the floor, hanging freely, and accessible to patients. Upon entering the facility’s lobby on 04/10/2024 at 8:45 AM, the surveyor observed the emergency pull cord inaccessible and blocked by chairs. During a tour of the facility’s in-center treatment area on 04/10/2024 at 10:00 AM, the surveyor observed the emergency call cord in the patient bathroom wrapped around the toilet paper dispenser. The emergency call cord was not hanging freely and accessible to patients. In an interview with Staff #1 on 04/11/2024 at 2:00 PM. Staff # 1 acknowledged the pull cord was blocked and inaccessible to patients in the event of an emergency.”

“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. change the ultra-filter (Diasafe) every 90 days according to the manufacturer’s recommendations for 19 of 19 machines located in the facility. This deficient practice had the likelihood of causing harm to the patients being dialyzed if the preventive maintenance on the machines was not completed as required by the manufacturer guidelines. Findings included: The ultra-filter on the dialysis machine was last changed 10/2023 which was 6 months ago. Patients were currently being dialyzed on the machines. A review of the Operators instructions for the 2008H and 2008K with “Diasafe” filters revealed the following guidelines: “Replace the DIASAFE filter at least every 90 days (3 months). After replacing the DIASAFE filter, perform either the automated test function or a manual pressure holding test AND then perform the DIASAFE filter integrity test.” An interview with Staff #4 on 04/10/2024 at 11:00 AM confirmed the diasafe filters had not been changed since 10/2023. 48653 B. record the temperature of 2 refrigerators located on the in-center treatment floor (medication, and laboratory refrigerators) twice a day as required by the facility policy, “Medication and Laboratory Refrigerator Temperature Log”. Also, the facility staff did not take the appropriate action to ensure the refrigerator temperature was adjusted when the temperatures fell outside of the set parameters. Findings include: Medication Refrigerator A review of the “Medication and Laboratory Refrigerator Temperature Log” for March of 2024 revealed the following, “Monitoring Frequency: Medication refrigerator: twice daily. Reference Range: 36 degrees Fahrenheit- 46 degrees Fahrenheit The facility administrator or designee will review the log monthly. Action steps: if alarming or outside of reference range: Notify the supervisor and biomed immediately. Document findings and any actions taken ...” The medication refrigerator had the following temperatures recorded without follow-up action from staff. 03/02/2024: AM Temp: 50 degrees F (Fahrenheit); PM Temp: 54 degrees F 03/07/2024: AM Temp: 52 degrees F; PM Temp: 56 degrees F 03/14/2024: AM Temp: 50 degrees F; PM Temp: 55 degrees F 03/15/2024: AM Temp: 52 degrees F; PM Temp: No temperature documented. 03/21/2024: AM Temp: 50 degrees F; PM Temp: 52 degrees F 03/28/2024: AM Temp: 48 degrees F; PM Temp: 50 degrees F Laboratory Refrigerator A review of the “Medication and Laboratory Refrigerator Temperature Log” revealed the following, “Monitoring Frequency: Medication refrigerator: twice daily. Reference Range: 36 degrees Fahrenheit- 46 degrees Fahrenheit The facility administrator or designee will review the log monthly. Action steps: if alarming or outside of reference range: Notify the supervisor and biomed immediately. Document findings and any actions taken ...” A review of the “Medication and Laboratory Refrigerator Temperature Log” for the Laboratory refrigerator revealed there were no temperatures recorded in February and March of 2024. In an interview with Staff # 1 on 04/11/2024 at 1:30 PM, Staff # 1 acknowledged the facility staff were not documenting and taking appropriate action when the temperatures of the refrigerators fell outside of the facility’s set parameters. C. clean and disinfect oxygen concentrator filters weekly as required by the facility policy, “Oxygen Concentrator Filter Cleaning”. Findings include: A review of the facility’s “Oxygen Concentrator Filter Cleaning Log” revealed the following, Concentrator Serial # CBB0121460604 In March of 2024, the concentrator filter was only cleaned 2 times on 03/11/2024 and 03/20/2024. There was no other cleaning documented for March of 2024. Concentrator Serial # CBB0121460695 In March of 2024, the concentrator filter was only cleaned 2 times on 03/11/2024 and 03/20/2024. There was no other cleaning documented for March of 2024. Concentrator Serial # BVB00116300077 In March of 2024, the concentrator filter was only cleaned 2 times on 03/11/2024 and 03/20/2024. There was no other cleaning documented for March of 2024. Concentrator Serial # BVB0116300079 In March of 2024, the concentrator filter was only cleaned 2 times on 03/11/2024 and 03/20/2024. There was no other cleaning documented for March of 2024. Concentrator Serial # BVB0116300082 In March of 2024, the concentrator filter was only cleaned 2 times on 03/11/2024 and 03/20/2024. There was no other cleaning documented for March of 2024. A review of the facility policy titled, “Oxygen Concentrator Filter Cleaning” with a revision date of 01/2020 revealed the following, “PURPOSE: To maintain the oxygen concentrator at maximum operating efficiency and to provide clean oxygen to the patient, the air intake gross particle filter will be cleaned weekly. PROCEDURE: 1. Ensure the device is disconnected from the power source. 2. Remove the filter and wash in a warm solution of soap and water. 3. Rinse the filter thoroughly and remove excess water with a paper towel. 4. Replace the filter. 5. Document the cleaning on the maintenance log.” An interview with Staff # 5 on 04/10/2024 at 10:50 AM confirmed the facility staff were not cleaning the oxygen concentrator filters weekly as required by the facility’s policy. D. identify and document the correct high and low control solution parameters for glucometer control solution testing as required by the facility policy, “Blood Glucose Testing”. Findings include: A review of the facility’s “Glucose Meter Control Test Record” for March 16, 2024 revealed the following, “Control Solutions High Range: 167-227 Test Strips Lot #: 16823062008” During a tour of the facility’s in-center treatment area on 04/10/2024 at 10:46 AM, the surveyor observed the glucometer test strips on the treatment floor had a lot # of “16823062008”. The high control solutions parameter on the test strip bottle was “162-215”. The facility staff were not documenting the correct control solutions parameters to ensure accurate testing of the glucometer machine. A review of the facility’s policy, “Blood Glucose Testing” with a revision date of 02/2023 revealed the following, “PURPOSE: To provide guidance on proper utilization of blood glucose monitoring devices (glucometers) to obtain blood samples for glucose measurement. POLICY: 1. Glucometers are intended for the quantitative measurement of glucose in fresh capillary whole blood samples obtained from the fingertips or palms. 2. Refer to the user guide for the glucose monitoring device for complete instructions. PROCEDURE: Checking Glucometer Performance SUPPLIES: * Glucometer * Glucometer test strips * Control solutions 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 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. 5. For troubleshooting see glucometer reference guide ...” An interview with Staff # 5 on 04/10/2024 at 10:50 AM acknowledged the facility staff did not document the correct control solution parameter. Staff # 5 stated, “There are no other test strips on the treatment floor, so the staff had to have written the wrong parameters from the test strip bottle”.”

“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: 50181 Based on record review and interview, the facility staff failed to ensure direct patient care (DPC) 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 4 of 8 patient charts reviewed. This deficient practice had the likelihood to cause harm and delay in care to all in-center hemodialysis patients receiving care at the facility. Findings Include: A review of C-FORMS-0081, “Reportable Parameters to the Charge Nurse” revealed, “PRE-DIALYSIS Weight: No weight gain or gain >4.5kg B/P Systolic: >180 or <90 Pulse: <60 or >100 beats per minute INTRA-DIALYSIS B/P Systolic: >180 or <90 Diastolic: >100 Pulse: <60 or >100 beats per minute POST DIALYSIS B/P Systolic: >180 or <90 Diastolic: >110 Pulse: <60 or >100” Patient #7 A review of the treatment sheet dated 04/05/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:00: Pulse 51 11:00: Pulse 59 A review of the treatment sheet dated 03/15/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 13:02: Pulse 43 13:26: Pulse 49 A review of the treatment sheet dated 03/13/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:03: BP 215/108 10:05: BP 197/108 10:33: BP 197/99 12:03: BP 127/103 A review of the treatment sheet dated 03/11/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:00: BP 183/103 10:32: BP 180/105 11:32: BP 146/104 A review of the treatment sheet dated 03/08/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:02: BP 172/102 11:31: BP 140/101 A review of the treatment sheet dated 03/06/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:01: BP 171/105 10:31: BP 184/110 Patient #9 A review of the treatment sheet dated 04/08/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 13:30: BP 201/84 14:00: BP 204/83 14:05: BP 219/89 A review of the treatment sheet dated 04/05/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:05: BP 190/76 10:30: BP 182/76 12:32: BP 193/82 13:29: BP 214/87 A review of the treatment sheet dated 04/01/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:30: BP 184/75 A review of the treatment sheet dated 03/20/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 10:08: BP 225/95 12:32: BP 197/80 13:32: BP 202/84 13:35: BP 207/84 Patient #12 A review of the treatment sheet dated 04/09/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 12:03: BP 209/92 12:32: BP 190/80 12:47: BP 196/77 13:02: BP 205/79 13:17: BP 199/79 13:32: BP 189/76 A review of the treatment sheet dated 04/06/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 12:02: BP 184/77 12:32: BP 191/78 A review of the treatment sheet dated 04/04/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 12:28: BP 196/84 13:29: BP 182/80 13:58: BP 185/89 14:44: BP 199/91 14:59: BP 184/81 A review of the treatment sheet dated 04/02/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 14:01: BP 186/87 16:01: BP 188/81 16:32: BP 196/81 16:51: BP 200/80 A review of the treatment sheet dated 03/28/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 11:11: BP 182/75 Patient #15 A review of the treatment sheet dated 04/01/2024 revealed the following vital signs documented by the DPC staff during treatment without documentation to support the CN was notified of the out of parameter findings. 15:01: BP 190/118 15:31: BP 184/116 16:02: BP 166/101 16:30: BP 173/103 17:01: BP 167/110 An interview with Staff # 1 on 04/12/2024 confirmed the facility staff did not consistently report out-of-parameter vital signs to the Charge Nurse. Staff #1 confirmed the facility staff did not follow the facility’s reportable parameters to the Charge Nurse.”

“GOV-ID GOV BODY W/FULL AUTHORITY/RESPONS CFR(s): 494.180 The ESRD facility is under the control of an identifiable governing body, or designated person(s) with full legal authority and responsibility for the governance and operation of the facility. The governing body adopts and enforces rules and regulations relative to its own governance and to the health care and safety of patients, to the protection of the patients ’ personal and property rights, and to the general operation of the facility. This Standard is not met as evidenced by: 30377 Based on observation, record review, and staff interview, the facility failed to follow its policy for the storage and handling of sample medication. Findings: During a tour of the facility on 04/10/2024 at 3:00 PM, the surveyor observed a rolling cabinet behind the nurse’s station in-center treatment area with several boxes of “sample” prescription medications. The cabinet was not locked. Review of policy C-MA-0010 dated 2/2024, page 1 of 4 States “8a 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. Review of policy C-MA-0010 dated 2/2024, page 3 of 4 States “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. Findings: “Sample” Medications found in the facility: Auryxia 210 milligrams tablets (62 bottles containing 25 tablets each, 25 of the 62 bottles expired on 03/2024) Fosrenal 1000 mg (9 bottles containing 10 tablets each) Sevelamer Carbonate 0.8g Powder (90 packets) An interview with Staff #8 (Registered Nurse) on 04/10/2024 at 3:15 p.m. confirmed that the facility stored and distributed sample medications to patients. The Registered Nurse stated that several physicians provided samples of prescription medications to the facility to give to their patients when the patient had difficulty obtaining the medication. The Registered Nurse stated that with the direction of the attending physician, the nurse would give samples to the patient. The Registered Nurse confirmed the sample medications were stored in an unlocked cart behind the nurse’s station. An interview with Staff #1 on 04/11/2024 at 12:45 p.m. confirmed that the facility failed to follow its policy for the Guidelines for Administration of Medication. Staff #1 confirmed that no governing body meeting was held to approve “sample” medications, no specific guidelines and protocols for administration were produced, and no log and or process to ensure out-of-date medications were disposed of were produced.”