Davita Independence County Dialysis

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 37145 Based on observation and interview, the facility failed to ensure one of one Water Room doors were secured to prevent entry of unauthorized person(s). This failed practice failed to ensure the integrity of the treated water and mixed bicarbonate for patient use was protected. The failed practice had the likelihood to affect all 39 patients on census. The findings were: A. Observation on 10/09/24 at 12:30 PM, showed the double doors to the water room were standing wide open and accessible to unauthorized person(s). B. During an interview on 10/09/24 at 12:30 PM, Certified Clinical Hemodialysis Technician (CCHT) #1 confirmed the doors should be shut and locked.”

“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: 37145 Based on observation and interview, the facility failed to ensure that the integrity of all physical surfaces were intact, clean, and free from damage. The failed practice promoted the spread of infection and had the likelihood to affect all 39 in-center hemodialysis patients on census. The findings were: A. On 10/07/24 from 1:00 PM through 1:45 PM, the following observations were made on tour of the facility: 1) The water room showed: a) There was a buildup of dirt and grime on the floor drain close to the booster pump and M 130 monitoring system. b) The acid tank had a buildup of white residue on the plastic base. A white residue was on the hoses and pipes near the acid tank. c) The sink by the bicarb tank and the drainpipe underneath the sink had a buildup of white residue. d) By bicarb tank 1 there was a purple stain and a buildup of white residue on the floor. 2) The Storage room showed: a) There was a box of biohazard trash bags and hospital towels stored on the floor. b) The painted wooden shelves holding supplies had multiple areas of peeling paint. 3) The door to the biomed office had multiple paint scrapes and stains and a window shelf had chipping paint and a green stain. 4) The treatment room showed: a) Ddirty sink 1 had dirt and grime buildup and a white residue on the fixtures. b) Clean sink 2 had a buildup of white residue. c) The pack cart had a buildup of white residue. B. During an interview on 10/07/24 at 1:45 PM, the findings in A were verified with the Facility Administrator.”

“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: 37145 Based on observation, policy review and interview, the facility failed to ensure blood pressure (BP) cuffs were maintained in that there was a build-up of threads in the hook portion of the Velcro which did not allow for effective cleaning and disinfection and failed to ensure an open vial of Tubersol was discarded within Manufacturer recommended guidelines after opened. The failed practice promoted the spread of infection from cross contamination. The failed practice had the likelihood to affect all 39 in-center hemodialysis patients on census and staff. The findings were: A. Review of the facility policy titled, “Infection Control for Dialysis Facilities,” revised April/2023 showed, “At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (control panel, top, front and sides of dialysis machine, touchscreens and countertops).” B. Review of the Tubersol package insert showed, “Storage, A vial of Tubersol which has been entered and in use for 30 days should be discarded.” C. On 10/07/24 at 1:20 PM, a vial of Tubersol dated 08/13/24 was observed in the medication refrigerator. The Administrator stated, “It needs to be tossed.” D. On 10/09/24 from 9:00 AM to 11:00 AM shift change observations showed multiple fibers in the blood pressure cuffs at stations 1, 3, 4, and 12. E. During an interview on 10/09/24 at 9:15 AM, the facility Administrator confirmed the findings in B-D.”

“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: 37145 Based on clinical review, and interview, it was determined a Registered Nurse (RN) failed to assess or intervene for one (#2) of five (#1-#5) patients reviewed with a pulse rate outside of parameters. The failed practice did not ensure the physician was aware of the patient’s health status to determine the course of treatment and had the likelihood to affect all 39 in center hemodialysis patients on census. Findings follow: A. Review of the facility Pre-Intra-Post treatment data collection, monitoring and nursing assessment with revision date of April 2024, showed, “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to abnormal findings section in this policy). The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or NPP if applicable) as needed in the patient status. Heart Rate Pre/Intra/Post: Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heartbeat.” B. Patient 2: 1) Review of six TFS (treatment flow sheets) dated 09/09/24 -10/04/24, showed no evidence the RN assessed the patient’s pulse rate, provided treatment, and/or notified Physician of findings. Heart Rate examples: a) 09/16/24-Predialytic - 57, Intradialytic - 44, 45, 48, 49, 50, 51, 52, Post-dialytic - 52 b) 09/20/24- Predialytic - 51, Intradialytic - 44, 45, 50, 52, 53 c) 10/02/24- Intradialytic - 54, 56 d) 10/04/24- Predialytic - 70, Intradialytic - 38, 41, 43, 45, 111, Post-dialytic - 55 2) There was no evidence that an RN assessment had been completed or physician notification of the out of heart rates. 3) In an interview with the Facility Administrator on 10/09/24 at 1:15 PM, the findings in A-B were confirmed.”

“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: 37145 Based on clinical record review, policy review, and interview, it was determined the Registered Nurse (RN) failed to assess, treat, and/or notify Physician of the blood pressure (BP) for five of five (Patient 1-#5) in center hemodialysis patients reviewed. The failed practice placed patients at risk for complications related to un-managed blood pressure. The failed practice had the likelihood to affect all 39 in-center hemodialysis patients. The findings were: A. Review of the facility Pre-Intra-Post treatment data collection, monitoring and nursing assessment with revision date of April 2024, showed, “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to abnormal findings section in this policy). The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or NPP if applicable) as needed in the patient status. Blood Pressure: Pre-dialysis: systolic greater than 180 mm/Hg (millimeters of mercury) or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. Blood pressure-Interdialytic: systolic greater than 180 mm/Hg (millimeters of mercury) or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. Signs/symptoms of hypotension, restlessness, nausea, vomiting, diaphoretic, excessive yawning. Blood Pressure Post Treatment: Standing systolic BP (blood pressure) greater than 140 mm/Hg or less than 90 mm/Hg. Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. Sitting BP for patients that cannot stand: Standing systolic BP (blood pressure) greater than 140 mm/Hg or less than 90 mm/Hg. Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg.” B. Patient #1 1) Review of five TFS (treatment flow sheets), five of six treatments, dated 09/27/24 - 10/7/24. a) 09/27/24 - Intradialytic BP 161/68 b) 09/30/24 - Intradialytic BP 145/62 and Post treatment 164/70. c) 10/02/24 - Intradialytic BP 146/56 and Post treatment 151/55. d) 10/04/24 - Intradialytic BP 161/67, 176/71, and Posttreatment 151/55 e) 10/07/24 - Intradialytic BP 183/98 and post treatment 183/98 2) There was no evidence that an RN assessment had been completed or physician notification of the out of range blood pressures. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in B. C. Patient #2 1) Review of six TFS, six of six treatments, dated 09/10/24 - 10/03/24. BP Examples: a) 09/09/24 - Intradialytic 96/57, 97/46 b) 09/11/24 - Pretreatment - 150/86, Intradialytic - 81/49, 95/54, 98/55, 96/56, 89/56, Post treatment 112/69. c) 09/16/24 - Pretreatment - 96/51, Intradialytic - 87/43,93/49,93/51,87/45,90/51 Posttreatment 102/53. d) 09/30/24 - Pretreatment - 100/43, Intradialytic - 93/52, 93/35, 87/41, 96/46, Post treatment 134/61. e) 10/02/24 - Pretreatment - 93/49, Intradialytic - 88/41, 87/41, 93/47, 86/50, 96/58, 95/50, Post treatment 138/50. f) 10/04/24 - Pretreatment - 80/56, Intradialytic - 68/37, 82/42, 86/43, 76/57, 85/46, Posttreatment 108/66. 2) There was no evidence that an RN assessment had been completed or physician notification of the out of range blood pressures. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in C. D. Patient # 3 1) Review of six TFS, five of six treatments, dated 09/10/24 - 10/03/24. BP Examples: a) 09/10/24 - Pretreatment 146/49, Intradialytic 150/67, 96/64 Post treatment 149/72. b) 09/12/24 - Pretreatment 148/60, Intradialytic 102/55, 173/71 Post treatment 142/68 c) 09/17/24 - Pretreatment 155/74, Intradialytic 85/45, 98/35 Post treatment 129/62 d) 09/24/24 - Pretreatment 170/72, Intradialytic 102/54, Post treatment 142/68 e) 10/01/24 - Pretreatment 132/56, Intradialytic 140/64,104/54 Post treatment 125/59 f) 10/03/24 - Pretreatment 188/68, Intradialytic 192/81,118/56 Post Treatment 160/67 2) There was no evidence that an RN assessment had been completed or physician notification of the out-of-range blood pressures. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in D. E. Patient # 4 1) Review of six TFS, six of six treatments, dated 09/23/24 - 10/04/24. BP Examples: a) 09/23/24 - Pretreatment 164/63, Intradialytic 130/59, 168/60 Post treatment 173/73. b) 09/25/24 - Pretreatment 154/58, Intradialytic 141/53, Post treatment 148/55 c) 09/27/24 - Pretreatment 176/68, Intradialytic 171/67, 163/61, Post treatment 148/62 d) 09/30/24 - Pretreatment 148/48, Intradialytic 121/47, Post treatment 145/54. e) 10/02/24 - Pretreatment 186/56, Intradialytic 174/63, Post treatment 185/73 f) 10/04/24 - Pretreatment 138/58, Intradialytic 110/46, 116/46, Post treatment 143/59. 2) There was no evidence that an RN assessment had been completed or physician notification of the out-of-range blood pressures. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in E. F. Patient # 5 1) Review of six TFS, six of six treatments, dated 09/23/24 - 10/04/24. BP Examples: a) 09/23/24 - Pretreatment 124/51, Intradialytic 98/40, 103/44, Post treatment 121/55. b) 09/25/24 - Pretreatment 113/52, Intradialytic 64/36, 98/48, 81/56 Post treatment 132/64. c) 09/27/24 - Pretreatment 113/52, Intradialytic 85/50, 57/17, 111/54 Post treatment 136/72. d) 09/30/24 - Intradialytic 128/60, Intradialytic 105/67, 106/34, 114/44 Post treatment 140/74. e) 10/02/24 - Pretreatment 160/67, Intradialytic 91/30, 102/33, 186/52 Post treatment 136/55. f) 10/04/24 - Pretreatment 147/59, Intradialytic 86/51, 87/32, 97/48, 94/54 Post treatment 105/46. 2) There was no evidence that an RN assessment had been completed or physician notification of the out of range blood pressures. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in F.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 37145 Based on clinical record review, policy review, and interview, it was determined the Interdisciplinary Team (IDT) failed to modify the patient’s plan of care (POC) for five of five (Patient #1-#5) in center hemodialysis patients when the patients’ blood pressure was outside established parameters. The failed practice placed patients at risk for complications related to un-managed blood pressure and fluid volume. The failed practice had the likelihood to affect all 39 in center hemodialysis. The findings were: A. Review of the facility Pre-Intra-Post treatment data collection, monitoring and nursing assessment with revision date of April 2024, showed, “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to abnormal findings section in this policy). The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary. The licensed nurse notifies the physician (or NPP if applicable) as needed in the patient status. Blood Pressure: Pre-dialysis: systolic greater than 180 mm/Hg (millimeters of mercury) or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. Blood pressure-Interdialytic: systolic greater than 180 mm/Hg (millimeters of mercury) or less than 90 mm/Hg. Diastolic greater than or equal to 100 mm/Hg or less than 50 mm/Hg. Signs/symptoms of hypotension, restlessness, nausea, vomiting, diaphoretic, excessive yawning. Blood Pressure Post Treatment: Standing systolic BP (blood pressure) greater than 140 mm/Hg or less than 90 mm/Hg. Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg. Sitting BP for patients that cannot stand: Standing systolic BP (blood pressure) greater than 140 mm/Hg or less than 90 mm/Hg. Standing diastolic BP greater than 90 mm/Hg or less than 50 mm/Hg.” B. Patient #1 1) Review of five TFS (treatment flow sheets), five of six treatments, dated 09/27/24 - 10/7/24. a) 09/27/24 - Intradialytic BP 161/68 b) 09/30/24 - Intradialytic BP 145/62 and Post treatment 164/70. c) 10/02/24 - Intradialytic BP 146/56 and Post treatment 151/55. d) 10/04/24 - Intradialytic BP 161/67, 176/71, and Posttreatment 151/55 e) 10/07/24 - Intradialytic BP 183/98 and post treatment 183/98 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in B. C. Patient #2 1) Review of six TFS, six of six treatments, dated 09/10/24 - 10/03/24. BP Examples: a) 09/09/24 - Intradialytic 96/57, 97/46 b) 09/11/24 - Pretreatment - 150/86, Intradialytic - 81/49, 95/54, 98/55, 96/56, 89/56, Post treatment 112/69. c) 09/16/24 - Pretreatment - 96/51, Intradialytic - 87/43,93/49,93/51,87/45,90/51 Posttreatment 102/53. d) 09/30/24 - Pretreatment - 100/43, Intradialytic - 93/52, 93/35, 87/41, 96/46, Post treatment 134/61. e) 10/02/24 - Pretreatment - 93/49, Intradialytic - 88/41, 87/41, 93/47, 86/50, 96/58, 95/50, Post treatment 138/50. f) 10/04/24 - Pretreatment - 80/56, Intradialytic - 68/37, 82/42, 86/43, 76/57, 85/46, Posttreatment 108/66. 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in C. D. Patient # 3 1) Review of six TFS, five of six treatments, dated 09/10/24 - 10/03/24. BP Examples: a) 09/10/24 - Pretreatment 146/49, Intradialytic 150/67, 96/64 Post treatment 149/72. b) 09/12/24 - Pretreatment 148/60, Intradialytic 102/55, 173/71 Post treatment 142/68 c) 09/17/24 - Pretreatment 155/74, Intradialytic 85/45, 98/35 Post treatment 129/62 d) 09/24/24 - Pretreatment 170/72, Intradialytic 102/54, Post treatment 142/68 e) 10/01/24 - Pretreatment 132/56, Intradialytic 140/64,104/54 Post treatment 125/59 f) 10/03/24 - Pretreatment 188/68, Intradialytic 192/81,118/56 Post Treatment 160/67 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in D. E. Patient # 4 1) Review of six TFS, six of six treatments, dated 09/23/24 - 10/04/24. BP Examples: a) 09/23/24 - Pretreatment 164/63, Intradialytic 130/59, 168/60 Post treatment 173/73. b) 09/25/24 - Pretreatment 154/58, Intradialytic 141/53, Post treatment 148/55 c) 09/27/24 - Pretreatment 176/68, Intradialytic 171/67, 163/61, Post treatment 148/62 d) 09/30/24 - Pretreatment 148/48, Intradialytic 121/47, Post treatment 145/54. e) 10/02/24 - Pretreatment 186/56, Intradialytic 174/63, Post treatment 185/73 f) 10/04/24 - Pretreatment 138/58, Intradialytic 110/46, 116/46, Post treatment 143/59. 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in E. F. Patient # 5 1) Review of six TFS, six of six treatments, dated 09/23/24 - 10/04/24. BP Examples: a) 09/23/24 - Pretreatment 124/51, Intradialytic 98/40, 103/44, Post treatment 121/55. b) 09/25/24 - Pretreatment 113/52, Intradialytic 64/36, 98/48, 81/56 Post treatment 132/64. c) 09/27/24 - Pretreatment 113/52, Intradialytic 85/50, 57/17, 111/54 Post treatment 136/72. d) 09/30/24 - Intradialytic 128/60, Intradialytic 105/67, 106/34, 114/44 Post treatment 140/74. e) 10/02/24 - Pretreatment 160/67, Intradialytic 91/30, 102/33, 186/52 Post treatment 136/55. f) 10/04/24 - Pretreatment 147/59, Intradialytic 86/51, 87/32, 97/48, 94/54 Post treatment 105/46. 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) During the interview on 10/09/24 at 1:20 PM, the Facility Administrator confirmed the findings in F.”