Fmcna - Stuttgart Dialysis

“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 51 patients on census and all staff. The findings were: A. On 04/15/24 from 9:55 AM through 10:30 AM, the following observations were made on tour of the facility: 1) The lab area and medication area showed: a) Two sinks had scattered white buildup on the countertops surrounding the sinks and on the faucets, and both sinks had rust colored buildup in the drains. b) There were two exposed brown colored screws exposed to the left of the sink in the lab area, the counter appeared to be missing a piece of the cabinet leaving the screws exposed and out in the open. c) The cabinets below both sinks had a buildup of dirt and grime. 2) The stock and storage room observations showed: a) Several boxes of patient supplies were stored directly on the floor. b) The floors had cracked tile and various colored stain buildup. 3) The Treatment area observation showed: a) Throughout the treatment area, there was a buildup of dust and rust colored residue. b) Throughout the treatment area, the floors had cracked tile and various colored stain buildup. c) Throughout the treatment room the supply and trash carts had a buildup of white residue. d) Between stations 4 through 6 the countertops behind the chairs were missing pieces of Formica. e) There was a 4 inch circular hole in the wall between station 14 and 15. f) Station 7 treatment chair had a crack and was frayed on the left armrest. g) Station 11, 12, and 14 treatment chairs had various areas of rips and frayed upholstery which did not allow for disinfection. 4) The Water/Storage room showed: a) There was a rust-colored substance on the floor around the RO (Reverse Osmosis) area. b) There was dirt and grime buildup scattered across the floor and on the water system pipes throughout the water room. c) The water heater pan had a buildup of brown and white colored flakes. d) The floor adjacent to the water treatment system had a large area of flooring missing leaving exposed floor showing that was not sealed. B. During an interview on 04/18/24 at 11:05 AM, the findings in A were verified with the Clinic Manager.”

“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 and procedure review and interview, it was determined 15 of 15 (Stations #1-#15) blood pressure (BP) cuffs were not 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. The failed practice promoted the spread of infection from cross contamination. The failed practice had the likelihood to affect all 51 in-center hemodialysis patients on census and staff. The findings included: A. Review of policy titled, “Cleaning and Disinfecting the Dialysis Station,” published 09/05/2023, showed, “The purpose of this policy is to provide guidelines to prevent the spread of infectious disease in accordance with appropriate regulations, and to maintain a clean, safe, and aesthetically pleasant environment for patients, staff and visitors. . General cleaning: After use, any non disposable equipment and supplies brought into the dialysis station must be disinfected with 1:100 bleach before being removed from the dialysis station.” B. Observation of shift change on 4/17/24 from 9:30 AM to 12:15 PM showed BP cuffs at Station #1-#15 had a build-up of threads in the hook portion of the Velcro which did not allow for effective cleaning and disinfection between patients. C. During an interview on 11/01/23 at 1:45 PM, the Clinic Manager confirmed the findings in A.”

“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 three (#2, #4 and #5) of seven (#1-#7) in-center hemodialysis patients. The failed practice placed patients at risk for complications related to un-managed blood pressure. The failed practice had the likelihood to affect all 51 in-center hemodialysis patients. The findings were: A. Review of the facility Blood Pressure Algorithm showed: 1. Pretreatment: The following orders are to be implemented if the patient’s admission blood pressure is greater than 180/100 wait one hour before medicating patient. After one hour of treatment, if the patient’s blood pressure is still greater than 180/100 follow intradialytic dosing of BP. If patient’s admission blood pressure is equal to or greater than 240/120, administer Clonidine 0.2 mg(milligrams) and monitor closely. Continue to follow intradialytic dosing of BP. 2. Intradialytic: After one hour of treatment, give Clonidine 0.2 mg for systolic BP > (greater than) 180 or diastolic BP is > 100. Check BP in one hour. If systolic BP is still > 180 or diastolic is > 100, administer Clonidine 0.1 mg. Check BP in one hour after second dose of Clonidine, if no improvement, notify MD (Medical Doctor). 3. Post Treatment: If a patient’s post treatment systolic BP is > 160-180 or diastolic BP > 100, repeat Clonidine 0.1 mg. After one hour, if systolic BP is 160-180 or diastolic BP is > 100, repeat Clonidine 0.1 mg. If still no improvement in one hour after second dose of Clonidine, notify MD. 4.” If patient has Clonidine ordered as a home medication, they are to take their Clonidine before coming to treatment. Patient’s are never to hold Clonidine unless attending physician states otherwise.” 5. FMC’s (Fresenius Medical Care) goal for blood pressure is 140/90. If patient leaves the facility with a blood pressure of 160/90 or greater three or more times in a month, call Physician. B. Review of MAT (Measures Assessment Tool) showed the Euvolemic, and pre-treatment BP was to be <140/90 and post-treatment was to be BP < 130/80. C. During an interview on 04/16/24 at 3:50 PM, the Director of Operations (DO) confirmed findings in A and B. D. During interview with the Clinic Manager on 04/17/24 at 3:45 PM, she stated, “We follow the standing orders and algorithm for BP management. Every Patient has the algorithm’s signed by their Physician in their record. It gives us a little room to make treatment changes.” E. Patient #2 1) Review of six TFS (treatment flow sheets), six of six treatments, 04/01/24 - 04/15/24, showed no evidence the RN assessed the patient’s pretreatment, intradialytic, and/or post treatment BP, provided treatment, and/or notified Physician of findings. BP Examples: a) 04/01/24 - Pretreatment 157/93, Intradialytic 193/103, Post treatment 183/94. RN # 1 documented “Post BP elevated. She stated she would take BP meds at home.” b) 04/03/24 - Pretreatment 203/108, Intradialytic, 205/117 and Post treatment 187/96. RN # 1 documented “UF (ultrafiltration) goal not met due to patient c/o (complained of) feeling lightheaded. Post BP elevated. She stated she would take BP meds at home.” c) 04/05/24 - Pretreatment 193/118, Intradialytic 218/119, and Post treatment 160/95. d) 04/08/24-Pretreatment 180/97, Intradialytic 185/99, and Post treatment 154/94 e) 04/12/24-Pretreatment 176/96, Intradialytic 196/109, and Post treatment 138/82 f) 04/15/24 -Pretreatment 165/96, Intradialytic 184/108, and Post treatment 157/90. g) There was no evidence of an RN assessment for HTN (hypertension). h) Review of the six TFA and Physician orders had no evidence that blood pressure medications had been ordered for home use or given to patient # 2 in center. 2) During the interview on 04/18/24 at 10:00 AM, the Clinic Manager confirmed the findings in E. F. Patient #4 1) Review of six TFS, six of six treatments, 02/26/24 - 04/15/24, showed no evidence the RN assessed the patient’s pretreatment, intradialytic, and/or post treatment BP, provided treatment, and/or notified Physician of findings. BP Examples: a) 02/26/24 - Pretreatment 150/111, Intradialytic 239/117, and Post treatment 207/100 b) 03/01/24 - Pretreatment 252/145, Intradialytic 220/124, and Post treatment 194/103. RN # 2 documented, “BP elevated at start of tx (treatment). Patient states he took his BP med this AM as prescribed declined Clonidine.” c) 03/04/24 - Pretreatment 243/127, Intradialytic 210/106, and Post treatment 222/117. RN # 1 documented goal not met. Patient c/o severe cramping.” d) 04/10/24 - Intradialytic 82/37, and Post treatment 121/72. The TFS showed UF goal not met due to low BP during tx. RN # 2 documented at 9:37 AM, UF off BP 88/47. CCHT (Certified Clinical Hemodialysis Technician) documented at 10:04 UF off BP low RN notified, UF documented off until 11:22 AM. RN # 2 documented at 1:40 PM, machine temp (temperature) adjusted with legs elevated. Patient stated he took his BP meds prior to tx. Instructed to hold AM BP med on Friday prior to tx. e) 04/12/24 - Pretreatment 168/85, Intradialytic 160/84 f) 04/15/24-Pretreatment 151/77, Intradialytic 98/56, Post treatment 189/102. The TFS showed UF goal not met due to low BP during tx. At 9:37 AM, CCHT (Certified Clinical Hemodialysis Technician) # 1 documented UF off BP 88/47. At 11:05 AM CCHT # 1 documented BP low RN notified, UF documented off from 11:47 AM to 12:05 PM. RN # 2 documented at 12:00 PM, UF off with legs elevated and machine temp adjusted. 200 mls (milliliters) given. BP improved. 2) There was no evidence of an RN assessment for HTN. 3) During the interview on 04/18/24 at 10:00 AM, the Clinic Manager confirmed the findings in F. G. Patient #5 1) Review of six TFS, three of six treatments, 04/02/24 - 04/13/24, showed no evidence the RN assessed the patient’s pretreatment, Intradialytic, and/or Post treatment BP. BP Examples: a) 04/02/24 - Pretreatment 181/91, Intradialytic 178/94, Post treatment 175/91 b) 04/04/24 - Pretreatment 183/60, Intradialytic 161/97, Post treatment 179/93 c) 04/06/24 - Pretreatment 193/96, Intradialytic 193/96, Post treatment 176/88 d) 04/09/24 - Pretreatment 171/89, Intradialytic 176/94, Post treatment 171/85 e) 04/11/24 - Pretreatment 199/98, Intradialytic 178/95 f) 04/13/24 - Pretreatment 181/90, Intradialytic 175/93, Post treatment 170/96 2) There was no evidence of an RN assessment for HTN. 3) During the interview on 04/18/24 at 10:00 AM, the Clinic Manager confirmed the findings in G.”

“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 three (#2, #4 and #5) of seven (#1-#7) 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 51 in-center hemodialysis. The findings were: A. Review of the facility Blood Pressure Algorithm showed: 1. Pretreatment: The following orders are to be implemented if the patient’s admission blood pressure is greater than 180/100 wait one hour before medicating patient. After one hour of treatment, if the patient’s blood pressure is still greater than 180/100 follow intradialytic dosing of BP. If patient’s admission blood pressure is equal to or greater than 240/120, administer Clonidine 0.2 mg (milligrams) and monitor closely. Continue to follow intradialytic dosing of BP. 2. Intradialytic: (After one hour of treatment) After one hour of treatment, give Clonidine 0.2 mg for systolic BP > (greater than) 180 or diastolic BP is > 100. Check BP in one hour. If systolic BP is still > 180 or diastolic is > 100, administer Clonidine 0.1 mg. Check BP in one hour after second dose of Clonidine, if no improvement, notify MD (Medical Doctor). 3. Post Treatment: If a patient’s post treatment systolic BP is > 160-180 or diastolic BP > 100, repeat Clonidine 0.1 mg. After one hour, if systolic BP is 160-180 or diastolic BP is > 100, repeat Clonidine 0.1 mg. If still not improvement in one hour after second dose of Clonidine, notify MD. 4. If a patient has Clonidine ordered as a home medication, they are to take their Clonidine before coming to treatment. Patient’s are never to hold Clonidine unless attending physician states otherwise. 5. FMC’s (Fresenius Medical Care) goal for blood pressure is 140/90. If patient leaves the facility with a blood pressure of 160/90 or greater three or more times in a month, call Physician. B. Review of MAT (Measures Assessment Tool) showed the Euvolemic, and pre-treatment BP was to be <140/90 and post-treatment was to be BP < 130/80. C. During an interview on 04/16/24 at 3:50 PM, the Director of Operations (DO) confirmed findings in A and B. D. During interview with the Clinic Manager on 04/17/24 at 3:45 PM, she stated, “We follow the standing orders and algorithm for BP management. Every Patient has the algorithm’s signed by their Physician in their record. It gives us a little room to make treatment changes.” E. Patient #2 1) Review of six TFS (treatment flow sheets), six of six treatments, 04/01/24 - 04/15/24, showed the following: BP Examples: a) 04/01/24 - Pretreatment 157/93, Intradialytic 193/103, Post treatment 183/94. RN # 1 documented “Post BP elevated. She stated she would take BP meds at home.” b) 04/03/24 - Pretreatment 203/108, Intradialytic, 205/117 and Post treatment 187/96. RN # 1 documented “UF (ultrafiltration) goal not met. due to patient c/o (complained of) feeling lightheaded. Post BP elevated. She stated she would take BP meds at home.” c) 04/05/24 - Pretreatment 193/118, Intradialytic 218/119, and Post treatment 160/95. d) 04/08/24 - Pretreatment 180/97, Intradialytic 185/99, and Post treatment 154/94 e) 04/12/24 - Pretreatment 176/96, Intradialytic 196/109, and Post treatment 138/82 f) 04/15/24 - Pretreatment 165/96, Intradialytic 184/108, and Post treatment 157/90. 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) Review of the six TFS and Physician orders showed no evidence that blood pressure medications had been ordered for home use or given to patient # 2 in-center. 4) During the interview, on 04/18/24 at 10:00 AM, the Clinic Manager confirmed the findings in E. F. Patient #4 1) Review of six TFS, six of six treatments, 02/26/24 - 04/15/24, showed the following: BP Examples: a) 02/26/24 - Pretreatment 150/111, Intradialytic 239/117, and Post treatment 207/100 b) 03/01/24 - Pretreatment 252/145, Intradialytic 220/124, and Post treatment 194/103. RN # 2 documented, “BP elevated at start of tx (treatment). Patient states he took his BP med this AM as prescribed declined Clonidine.” c) 03/04/24 - Pretreatment 243/127, Intradialytic 210/106, and Post treatment 222/117. RN # 1 documented goal not met. Patient c/o severe cramping.” d) 04/10/24 - Intradialytic 82/37, and Post treatment 121/72. The TFS showed UF goal not met due to low BP during tx. RN # 2 documented at 09:37 AM, UF off BP 88/47. CCHT (Certified Clinical Hemodialysis Technician) documented. At 10:04 UF off BP low RN notified, UF documented off until 11:22 AM. RN # 2 documented at 13:40 PM, machine temp (temperature) adjusted with legs elevated. Patient stated he took his BP meds prior to tx. Instructed to hold AM BP med on Friday prior to tx. e) 04/12/24 - Pretreatment 168/85, Intradialytic 160/84 f) 04/15/24 - Pretreatment 151/77, Intradialytic 98/56, Post treatment 189/102. The TFS showed UF goal not met due to low BP during tx. At 09:37 AM, CCHT (Certified Clinical Hemodialysis Technician) # 1 documented UF off BP 88/47. At 11:05 AM CCHT # 1 documented BP low RN notified, UF documented off from 11:47 AM to 12:05 PM. RN # 2 documented at 12:00 PM, UF off with legs elevated and machine temp adjusted, 200 mls (milliliters) given. BP improved. 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 04/18/24 at 10:00 AM, the Clinic Manager confirmed the findings in F. G. Patient #5 1) Review of six TFS, three of six treatments, 04/02/24 - 04/13/24, showed the following: BP Examples: a) 04/02/24 - Pretreatment 181/91, Intradialytic 178/94, Post treatment 175/91 b) 04/04/24 - Pretreatment 183/60, Intradialytic 161/97, Post treatment 179/93 c) 04/06/24 - Pretreatment 193/96, Intradialytic 193/96, Post treatment 176/88 d) 04/09/24 - Pretreatment 171/89, Intradialytic 176/94, Post treatment 171/85 e) 04/11/24 - Pretreatment 199/98, Intradialytic 178/95 f) 04/13/24 - Pretreatment 181/90, Intradialytic 175/93, Post treatment 170/96 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 04/18/24 at 10:00 AM, the Clinic Manager confirmed the findings in G.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 37145 Based on review of Quality Assurance (QA) Meeting Minutes, review of QA data and interview, it was determined in six of six (October 2023-March 2024) meeting minutes there was no evidence the Interdisciplinary Team (IDT) evaluated the established root cause analysis when target goals were not achieved, developed improvement plans with actions that resulted in improved outcomes, and evaluated the success of the improvement plan with revisions as indicated for blood pressure and fluid management and vascular access. The failed practice did not ensure outcomes were improved with sustainability of the outcomes. The failed practice had the likelihood to affect all 51 patients on census. The findings were: A. Fluid Management Review of Quality Assurance Meeting Minutes and data for fluid management from October 2023 to March 2024 showed the goal/quality indicator was not met as follows: 1) October 2023 minutes showed 44.7 % of the patients did not meet fluid management/UFR (ultrafiltration rate) goals. Review of the Action Plan showed the identified root causes were CMAB (Chronic Maintenance and Administration of Blood) recommended volume and management algorithm and not used-ICHD (In clinic hemodialysis), lack of effective root cause analysis-ICHD and noncompliance with fluid regimen, noncompliance with treatment. The Action Plan was to educate all staff on fluid volume algorithm and quick reference guide, utilization of root cause analysis tools- 5 why’s and select top 1-2 root causes to utilize intervention tool and reeducate each patient according to finding of root cause analysis tool. The action plan will be delegated to the IDT that will implement, monitor, and evaluate weekly seeking a goal of 5 %. The action plan will be reassessed if no measurable improvement is made within the next 3 months. There was no evidence the QA Committee had re-evaluated the root cause for the fluid management outcomes not met. 2) November 2023 minutes showed 56.3 % of the patients did not meet fluid management/UFR goals. 3) December 2023 minutes showed 51 % of the patients met fluid management/UFR goals. 4) January 2024 minutes showed 51 % of the patients did not meet fluid management/UFR goals. 5) February 2024 minutes showed 45.8% of the patients did not meet fluid management/UFR goals. 6) March 2024 minutes showed 45.7 % of the patients did not meet fluid management/UFR goals. 7) There was no evidence the QA Committee had reevaluated the action plan or made any changes in interventions to improve outcomes from November 2023 through March 2024. B. The findings of A were verfied in an interview with the Clinic Manager on 04/18/2024 at 11:00 AM. C. Vascular Access Review of Quality Assurance Meeting Minutes and data for vascular access from October 2023 to March 2024 showed the goal/quality indicator was not met as follows: October 2023 through March 2024 showed the goal was to enter 5 % improvement. as follows: 1) October 2023 minutes showed 41.7 % of patients had a CVC (Central Venous Catheter). Review of the action plan was to reeducate and revisit getting access monthly. Continue to set up and educate all new admissions different access and the benefits and risks of each access. Notify access manager of all new admissions for timely appointments of access assessment. Have Nephrologist meet with patient to discuss fears and risk of CVC. 2) November 2023 minutes showed 41.7 % of patients had a CVC. 3) December 2023 minutes showed 52.1 % of the patients had a CVC. 4) January 2024 minutes showed 52.1 % of the patients had a CVC. 5) February 2024 minutes showed 50.0% of the patients had a CVC. 6) March 2024 minutes showed 47.8 % of the patients had a CVC. 7) There was no evidence the QA Committee had reevaluated the action plan or made any changes in interventions to improve outcomes from November 2023 through March 2024. D. The findings of C were verfied in an interview with the Clinic Manager on 04/18/2024 at 11:00 AM.”