Vamana, Inc.

“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/Supply Storage Room and one of one Bicarbonate Room doors were secured to prevent entry of unauthorized person(s). This failed practice failed to ensure the integrity of the treated water, patient supplies and mixed bicarbonate for patient use was protected. The failed practice had the likelihood to affect all 26 patients on census. This was a recurring deficiency from the last standard survey. The findings were: A. Observation on 02/26/24 at 1:55 PM, showed the door entering the Bicarbonate Room was not locked and accessible to unauthorized person(s). B. Observation on 02/26/24 at 1:55 PM, showed in the Bicarbonate Room, the door entering the Water/Supply Storage Room was closed but not locked which allowed access by unauthorized person(s). C. Observation on 02/26/24 at 1:55 PM, showed the red outside door exit from the Bicarbonate Room was unlocked which allowed access by unauthorized person(s) to enter the Bicarbonate Room or the Water/Supply Storage Room. D. During an interview on 02/26/24 at 1:55 PM, the Facility Administrator confirmed all three doors should be 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; expired equipment wasn’t available for patient use; and, access to medication, water treatment, and storage areas were restricted to authorized personnel only. The failed practice promoted the spread of infection and did not limit access to medications to authorized personnel. This failed practice had the likelihood to affect all 26 patients on census and all staff. The findings were:: A.On 02/26/24 from 1:15 PM through 2:30 PM, the following observations were made on tour of the facility: 1) The lab area and leading to water/RO (reverse osmosis room) showed: a) The dirty and clean sinks had rust colored buildup in the drains. b) There were four syringes that contained a liquid substance and were not labeled as to content of the syringe. c) The cabinet doors had a buildup of tape residue, dirt, and grime. d) The medication refrigerator shelves, and door had a buildup of dirt and grime on the inside where the medications were stored. e) The right lower cabinet contained five boxes of fistula needles that expired 12/31/22. f) The stainless steel three compartment sink had a build of white residue. The extension of the sink had a buildup of white residue and areas of reddish discoloration around the legs at the base of the sink. The baseboard at the bottom of the sink area was missing with visible yellow brown colored dried adhesive was visible. 2) 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 a heavy white residue buildup. c) Behind Station #4, #6, and #7, the drain had a moderate size gap between the wall and pipe. d) There were tiles throughout the Treatment Room that were cracked and/or had pieces of tile missing which did not allow for effective cleaning and disinfection. e) The nurse’s office had the door propped open and was not locked when not in direct line of sight of staff. Inside an unlocked file cabinet drawer were three paper cups with unpackaged pills inside that were marked with patient names and a white medication capsule was loose on the floor of the medication room. 3) Observation of the Patient entrance and waiting area on showed: a) Two chairs in the waiting area had two inch tears in the upholstery. b) The ceiling in the waiting room had brown discolored areas and gaps / holes in the ceiling tile. c) The exit sign by the entrance door was sagging with approximate 2 inch space between the ceiling tile and runner in the middle of the exit sign. d) The entry door had multiple areas of chipped paint. 4) The Water/Storage room showed. a) There was a rust colored substance oin the floor around the booster pump. b) There was dirt and grime buildup scattered across the floor. c) The water heater pan had a buildup of brown and white colored flakes. d) The floor around the storage tank had a large amount of water in the floor. e) The bottom of a lattice panel wall between the water area and storage area had a black and green discoloration on the bottom frame of the wall. f) The entry door had multiple areas with scratches and missing varnish. g) The floor behind the storage tank had multiple test strips lying on the floor. B. During the observation of the lab area Registered Nurse (RN) # 1 confirmed the expired fistula needles were being used for patient care. When asked what was in the syringes with clear liquid she stated, “Heparin” and disposed of the syringes. C. During the medication room and storage observation RN # 2 stated, “The pills in the paper cups belonged to patients who didn’t show up for treatment.” She was asked if it was appropriate to prepare medications in advance of administration. RN #2 stated, “Their names are on the cup.” D. During an interview on 02/26/24 at 4:20 PM, the findings in A through C were discussed with the 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, procedure review, manufacturers operation manual review and interview, the facility failed to ensure 1. The recommended monthly Dialysate meter calibration checks of conductivity/TDS were completed and 2. Blood pressure (BP) cuffs were maintained in that there was a build-up of threads in the hook portion of the Velcro. The failed practice did not ensure the dialysate meter measured the conductivity/TDS within established parameter and did not allow for effective disinfection of the blood pressure cuffs. The failed practice had the likelihood to affect all 26 patients on census and staff. The findings were: A. Review of the Myron L Dialysate meter operations manual showed, “Suggested Calibration intervals, Checking water quality conductivity recommended frequency Monthly, TDS recommended frequency Monthly. “ B. Review of the preventative maintenance log for the Myron L meter showed the conductivity and TDS reading had not been completed since 11/20/2023. C. During an interview on 02/28/2022 at 1:30 PM, RN # 1 confirmed the findings in A and B. D. Observation of shift change on 02/28/24, from 7:45 AM to 9:30 AM showed BP cuffs at Station #1-#11 had a build-up of threads in the hook portion of the Velcro which did not allow for effective cleaning and disinfection between patients. E. During interview on 02/28/24 at 9:30 AM, Dialysis Technician (DT) #1 confirmed the findings in D. F. On 02/27/24 at 2:03 PM, the facility Biomedical Technician was interviewed by phone and asked to describe the preventative maintenance that had been completed since 11/2023. She stated, “The previous full time biomedical technician was doing the preventative maintenance on all the equipment. That Biomedical technician left them in a bind. I have been doing preventative maintenance on the dialysis machines and disinfects only.””

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 37145 Based on observation and interview, the facility failed to ensure one of one (# 4) patient’s face and vascular access was visible to direct patient care staff. The failed practice did not allow the direct patient care staff to ensure Patient # 4’s safety during the dialysis treatment. The failed practice had the likelihood to affect all 26 patients on the census. The findings were: A. Review of facility policy titled “Patient Safety During Dialysis” revised 02/09/2023, showed, “Ensure the bloodlines are visible at all times, and ensure the head/face of patients are visible at all times.” B. During observation with Registered Nurse (RN) # 1 on 02/28/24 at 8:00 AM, Patient #4’s face was not visible to the staff as the patient had his hooded jacket over his vascular access, head, and face. He remained with his head, face, and access covered until 9:00 AM. Staff did not ask him to uncover his face and access during this time. C. During interview on 02/28/24 at 11:15 AM, RN # 1 confirmed the findings in A-B.”

“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 the blood pressure (BP) for three (#1,#3, and #4) of five (#1-#5) in-center hemodialysis patients. The failed practice placed patients at risk for complications related to unmanaged BP. The failed practice had the likelihood to affect all 26 in-center hemodialysis patients. The findings were: A. Review of facility hemodialysis Admission and Annual Standing Orders showed “Record vital signs pre/post dialysis and every 30 minutes during treatment. If systolic BP (blood pressure) falls more than 40 mm (millimeters)HG (mercury) from the last BP reading and/or symptomatic, give 100-300 ml (milliliters) normal saline in increments of 100 ml and reduce UF (ultrafiltration) to minimum until a BP increase is observed. If systolic BP > (greater than) 180 mmHg or diastolic > 110 after one (1) hour on dialysis, give Catapress 0.2 mg (milligrams) po (by mouth), may repeat hourly x 3 unless contraindicated, and if so must be documented in record.” 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 02/28/24 at 3:50 PM, Registered Nurse (RN) # 1 confirmed findings in A and B. D. During interview with the Administrator on 02/07/23 at 3:00 PM, she stated, “We follow the standing orders and any written orders for BP management. Dry weight changes are made as needed on regular order sheets and updated in base orders monthly, so no specific policy/procedure for fluid management besides monthly assessments during IDT meetings.” E. Patient #1 1) Review of five TFS (treatment flow sheets), three of five treatments, 02/14/24 - 02/23/24, showed no evidence the RN assessed the patient’s pretreatment, intradialytic, and/or post treatment systolic BP. BP Examples: a) 02/16/24 - Pretreatment 160/85, Intradialytic 193/98, Post treatment 226/102 b) 02/19/24 - Pretreatment 166/86 intradialytic, 180/84 and post treatment 191/90 c) 02/21/24 - Pretreatment 170/89, intradialytic 184/107, and post treatment 211/104 2) There was no evidence of an RN assessment for HTN (hypertension). 3) During the interview, on 02/28/24 at 10:45 AM, RN # 1 confirmed the findings in E. F. Patient #3 1) Review of five TFS, five of five treatments, 01/03/24 - 02/23/24, showed no evidence the RN assessed the patient’s pretreatment, intradialytic, and/or post treatment BP. BP Examples: a) 01/03/24 - Pretreatment 230/80 b) 01/05/24 - Pretreatment 190/99, intradialytic 158/85, and Post treatment 155/81 c) 01/08/24 - Pretreatment 166/80, intradialytic 163/73, and Post treatment 163/82 d) 01/26/24 - Pretreatment 181/97, intradialytic 181/98, and Post treatment 186/99 e) 02/23/24 - Pretreatment 169/84, intradialytic 174/87, and Post treatment 171/91 2) There was no evidence of an RN assessment for HTN. 3) During interview, on 02/28/24 at 11:05 AM, RN # 1 confirmed the findings in F. G. Patient #4 1) Review of six TFS, three of six treatments, 02/12/24 - 02/23/24, showed no evidence the RN assessed the patient’s pretreatment, intradialytic, and/or post treatment BP. BP Examples: a) 02/12/24 - Pretreatment 146/88, intradialytic 135/99 b) 02/14/24 - Pretreatment 145/93 c) 02/21/24 - Pretreatment 148/92. 2) There was no evidence of an RN assessment for HTN. 3) During interview on 02/28/24 at 11:15 AM, RN # 1 confirmed the findings in G.”

“PA-ASSESS ANEMIA CFR(s): 494.80(a)(4) The patient’s comprehensive assessment must include, but is not limited to, the following: (4) Evaluation of factors associated with anemia, such as hematocrit, hemoglobin, iron stores, and potential treatment plans for anemia, including administration of erythropoiesis-stimulating agent(s). This Standard is not met as evidenced by: 37145 Based on policy review, clinical record review and interview, it was determined two (#2 and #4) of five (#1-#5) patients selected for anemia management review showed the IDT (Interdisciplinary Team) had not assessed hemoglobin (Hgb) less than (<) 10 grams/deciliter (g/dL) and Hgbs that significantly dropped for causative factors or barriers to revise the plan of care (POC) and implement a revision to the plan of care. The failed practice placed the patients at risk of complications related to low hemoglobin levels. The failed practice had the likelihood to affect all 26 in-center hemodialysis patients. The findings were: A. Review of the “Anemia Management Policy and Procedure” revised 03/29/2018, showed: 1) “Purpose: To monitor hemoglobin and hematocrit levels at least monthly so that ESA (Erythropoietin stimulating agents) medications can be adjusted, or causative problems be determined.” 2) “It is the policy for the Medical Director to assign all dialysis patients with their individual ESA therapy.” 3) “The Medical Director will monitor each dialysis patient’s lab results at least monthly.” 4) “The Medical Director will assign Epoetin dosage according to their Hgb(hemoglobin) & HCT (hematocrit) results.” B. Patient #2: 1) Review of Hgb laboratory data from 11/08/2023 to 02/07/2024 showed: a) 11/08/2023-10.0 g/dL. b) 12/06/2023-8.0 g/dL c) 12/13/2023-8.1 g/dL d) 12/18/2023-9.0 g/dL e) 01/31/2024-8.2 g/dL f)02/07/2024- 7.0 g/dL 2) Review of base Physician orders and treatment flow sheets dated 02/12/2024 through 02/23/2024 showed, Venofer 50 mg (milligrams) weekly on Mondays and Epogen 2.2 k (2200 Units) was given with treatments on Monday and Fridays. 3) Review of the progress and Physician notes with Registered Nurse (RN) # 1, showed there was no evidence the Physician assessed for causative factors or barriers to the decreased Hgb < 10 g/dL. 4) Review of the annual CIPA (Comprehensive Interdisciplinary Patient Assessment-assessment and POC) dated 03/08/2023, showed, “Anemia, Hgb 9.1, ANEMIA Issues potential blood loss, Anemia plan of care continue ESA dose, patient teaching on anemia ongoing.” There was no evidence the IDT had assessed or referred the patient for assessment for potential blood loss. 5) During an interview on 02/28/2024 at 11:00 AM, RN #1 confirmed the findings in B1-4. C. Patient #4: 1) Review of Hgb laboratory data from 12/06/2023 to 02/12/2024 showed: a) 12/06/2023-9.1 g/dL. b) 12/18/2023-9.3 g/dL c) 01/08/2024-7.0 g/dL d) 02/07/2024-7.7 g/dL e) 02/12/2024-8.3 g/dL 2) Review of base Physician orders and treatment flow sheets dated 02/12/2024 through 02/23/2024 showed, Venofer 50 mg weekly on Mondays and Epogen 2.2 k was given with treatments on Monday and Fridays. 3) Review of the progress and Physician notes with RN # 1, showed there was no evidence the Physician assessed for causative factors or barriers to the decreased Hgb < 10 g/dL. 4) Review of the annual CIPA Notes dated 10/16/23 showed, “Anemia, Hgb 12.0 , ANEMIA Issues potential blood loss, Anemia plan of care hold ESA dose, patient teaching on anemia ongoing. There was no evidence the IDT had had referred for assessment for potential blood loss.There was no evidence the IDT had assessed or referred the patient for assessment for potential blood loss. 5) During an interview on 02/28/2024 at 11:00 AM, RN #1 confirmed the findings in B1-4.”

“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 (#1, #3, and #5) of five (#1-#5) 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 26 in-center hemodialysis. The findings were: A. Review of facility hemodialysis Admission and Annual Standing Orders showed “Record vital signs pre/post dialysis and every 30 minutes during treatment. If systolic BP (blood pressure) falls more than 40 mm (millimeters) Hg (mercury) from the last BP reading and/or symptomatic, give 100-300 ml (millileters) normal saline in increments of 100 ml and reduce UF (ultrafiltration) to minimum until a BP increase is observed. If systolic BP > (greater than) 180 mmHg or diastolic > 110 after one (1) hour on dialysis, give Catapress 0.2 mg (milligrams) po (by mouth), may repeat hourly x 3 unless contraindicated, and if so must be documented in record.” B. Review of MAT (Measures Assessment Tool) shows the Euvolemic, and pre- BP was to be <140/90 and post BP < 130/80 . C. During an interview on 02/29/24 at 3:50 PM, Registered Nurse (RN) # 1 confirmed findings in A and B. D. Patient #1 1) Review of five TFS (treatment flow sheets), three of five treatments, 02/14/24 - 02/23/24, showed the following: a) 02/16/24 - Pretreatment 160/85, intradialytic193/98, post treatment 226/102 b) 02/19/24 - Pretreatment 166/86 intradialytic, 180/84 and post treatment 191/90 c) 02/21/24 - Pretreatment 170/89, intradialytic 184/107, and post treatment 211/104 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 02/28/24 at 10:45 AM, RN # 1 confirmed the findings in D. E. Patient #3 1) Review of five TFS, five of five treatments, 01/03/24 - 02/23/24, showed the following: a) 01/03/24 - Pretreatment 230/80 b) 01/05/24 - Pretreatment 190/99, intradialytic 158/85, and Post treatment 155/81 c) 01/08/24 - Pretreatment 166/80, intradialytic 163/73, and Post treatment 163/82 d) 01/26/24 - Pretreatment 181/97, intradialytic 181/98, and Post treatment 186/99 e) 02/23/24 - Pretreatment 169/84, intradialytic 174/87, and Post treatment 171/91 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) During interview, on 02/28/24 at 11:05 AM, RN # 1 confirmed the findings in E. F. Patient #4 1) Review of six TFS, three of six treatments, 02/12/24 - 02/23/24, showed the following: a) 02/12/24 - Pretreatment 146/88, intradialytic 135/99 b) 02/14/24 - Pretreatment 145/93 c) 02/21/24 - Pretreatment 148/92. 2) There was no evidence the IDT modified the POC related to the patient’s BPs outside of established parameters. 3) During interview on 02/28/24 at 11:15 AM, RN # 1 confirmed the findings in F.”

“POC-MANAGE MINERAL METABOLISM CFR(s): 494.90(a)(3) Provide the necessary care to manage mineral metabolism and prevent or treat renal bone disease. This Standard is not met as evidenced by: 37145 Based on clinical record review and interview, it was determined the Interdisciplinary Team (IDT) failed to achieve and sustain Phosphorous levels in that patients were not reassessed and POC (Plan of Care) was not reviewed/revised when the patient’s Phosphorous levels increased or remained greater than (>) 5.5 grams/deciliter (g/dL) for two (#2 and #3) patients of five (#1-#5) selected for mineral metabolism review. The failed practices did not assure the IDT had assessed patients for contributing factors or barriers to improve Mineral metabolism outcomes. The failed practice had the likelihood to affect all 26 patients on census. The findings were: A. Review of the “Mineral/Bone Disease Management Policy and Procedure” revised 12/17/2021, showed: 1) “Purpose: To monitor calcium and phosphorous levels monthly and intact PTH levels at least quarterly so that medication can be adjusted, or causative problems be determined.” 2) “It is the policy for the Medical Director to assign all dialysis patients with their individual mineral/bone disease management therapy.” 3) “The Medical Director will monitor each dialysis patient’s lab results at least monthly.” 4) “The Medical Director will assign phosphate binders, drugs for calcium disorders, and drugs for parathyroid disorders accordingly.” B. Patient #2: 1) Review of Phosphorus laboratory data from 11/08/2023 to 02/07/2024 showed: a) 02/12/2024 - 6.1g/dL. b) 02/16/2024 - 7.3 g/dL. c) 02/23/2024 - 7.1 g/dL. 2) Review of base Physician orders and treatment flow sheets dated 02/12/2024 through 02/23/2024 showed no evidence of any medications prescribed to lower phosphorus levels. 3) Review of the progress and Physician notes with Registered Nurse (RN) # 1, showed there was no evidence the Physician assessed for causative factors or barriers to the increased Phosphorous > 5.5 g/dL. 4) Review of the annual CIPA (Comprehensive Interdisciplinary Patient Assessment-assessment and POC) dated 03/08/2023, showed, “Phosphorous 4.5, Phosphorous goal met. Compliant with diet and fluids.” 5) There was no evidence the Lab values were reported to Physician or any medications prescribed to lower phosphorous levels, or on consequences of elevated Phosphorous level.. 6) During an interview on 02/28/2024 at 11:00 AM, RN #1 confirmed the findings in B. C. Patient # 3 ) Review of Phosphorus laboratory data from 11/27/2023 to 01/26/2024 showed: a) 11/27/2023 - 9.1 g/dL. b) 01/03/2024 - 8.8 g/dL. c) 01/08/2024 - 5.8 g/dL. d) 01/26/2024 -14.0 g/dL. 2) Review of base Physician orders and treatment flow sheets dated 02/12/2024 through 02/23/2024 showed no evidence of any medications prescribed to lower phosphorus levels. 3) Review of the progress and Physician notes with RN # 1, there was no evidence the Physician assessed for causative factors or barriers to the increased Phosphorous > 5.5 g/dL. 4) Review of the Unstable CIPA dated 12/17/2023, showed, “Phosphorous goal 3.4-5.5, comments Non-compliant.” 5)There was no evidence the Lab values were reported to Physician or any orders for medications prescribed to lower phosphorous levels or education on consequences of elevated Phosphorous level. 6) During an interview on 02/28/2024 at 11:05 AM, RN #1 confirmed the findings in C.”

“POC-MANAGE ANEMIA/H/H MEASURED Q MO CFR(s): 494.90(a)(4) The interdisciplinary team must provide the necessary care and services to achieve and sustain the clinically appropriate hemoglobin/hematocrit level. The patient’s hemoglobin/hematocrit must be measured at least monthly. The dialysis facility must conduct an evaluation of the patient’s anemia management needs. 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 achieve and sustain hemoglobin (Hgb) levels in that patients POC (Plan of Care) was not reviewed/revised when the patient’s hemoglobin (Hgb) dropped or remained less than (<) 10 grams/deciliter (g/dL) for two (#2 and #4) of five (#1-#5 ) patients selected for hemoglobin review. The failed practices did not ensure the IDT had assessed patients for contributing factors or barriers to improve the Hgb outcomes. The failed practice had the likelihood to affect all 26 patients on census. The findings were: A. Review of the “Anemia Management Policy and Procedure” revised 03/29/2018, showed: 1) “Purpose: To monitor hemoglobin and hematocrit levels at least monthly so that ESA (Erythropoetin stimulating agent) medications can be adjusted, or causative problems be determined.” 2) “It is the policy for the Medical Director to assign all dialysis patients with their individual ESA therapy.” 3) “The Medical Director will monitor each dialysis patient’s lab results at least monthly.” 4) “The Medical Director will assign Epoetin dosage according to their Hgb & HCT (Hematocrit) results.” B. Patient #2: 1) Review of Hgb laboratory data from 11/08/2023 to 02/07/2024 showed: a) 11/08/2023 - 10.0 g/dL. b) 12/06/2023 - 8.0 g/dL. c) 12/13/2023 - 8.1 g/dL. d) 12/18/2023 - 9.0 g/dL e) 01/31/2024 - 8.2 g/dL f) 02/07/2024 - 7.0 g/dL 2) Review of base Physician orders and treatment flow sheets dated 02/12/2024 through 02/23/2024 showed, Venofer 50 mg (milligrams) weekly on Mondays and Epogen 2.2 k (2,200 units) was given with treatments on Monday and Fridays. 3) Review of the progress and Physician notes from 12/06/23 to 02/07/24, with Registered Nurse (RN ) # 1, showed there was no evidence the Physician assessed for causative factors or barriers to the decreased Hgb < 10 g/dL. 4) Review of the annual CIPA (Comprehensive Interdisciplinary Patient Assessment-Assessment and POC) dated 03/08/2023, showed, “Anemia, Hgb 9.1, ANEMIA Issues potential blood loss, Anemia plan of care continue ESA dose, patient teaching on anemia ongoing.” 5) There was no evidence the IDT had revised the POC to address the Hgb levels < 10 gm/dL. 6) During an interview on 02/28/2024 at 11:00 AM, RN #1 confirmed the findings in B. C. Patient #4: 1) Review of Hgb laboratory data from 12/06/2023 to 02/12/2024 showed: a) 12/06/2023 - 9.1 g/dL. b) 12/18/2023 - 9.3 g/dL c) 01/08/2024 - 7.0 g/dL d) 02/07/2024 - 7.7 g/dL e) 02/12/2024 - 8.3 g/dL 2) Review of base Physician orders and treatment flow sheets dated 02/12/2024 through 02/23/2024 showed, Venofer 50 mg weekly on Mondays and Epogen 2.2 k (2200) units was given with treatments on Monday and Fridays. 3) Review of the progress and Physician notes from 12/06/23 to 02/12/24, with RN # 1 showed there was no evidence the Physician assessed to evaluate for causative factors or barriers to the Hgb < 10 g/dL. 4) Review of the CIPA Notes dated 10/16/23 showed, “Anemia, Hgb 12.0, ANEMIA Issues potential blood loss, Anemia plan of care hold ESA dose, patient teaching on anemia ongoing.” 5) There was no evidence the IDT assessed for potential blood loss causative factors or barriers to the Hgb less than < 10 g/dL. potential blood loss and showed no evidencethe IDT assessed for causative factors or barriers to the Hgb less than < 10 g/dL. or barriers to the decreased Hgb less than < 10 g/dL. 6) During interview on 02/28/24 at 11:15 AM, RN # 1 confirmed the findings in C.”

“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 five of five (August 2023-December 2023) 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 anemia management and vascular access. The failed practice The failed practice did not ensure outcomes were improved with sustainability of the outcomes. The failed practice had the likelihood to affect all 26 patients on census. The findings were: A. Anemia Management Review of Quality Assurance Meeting Minutes and data for anemia management from August 2023 to December 2023 showed the goal/quality indicator was not met for <= (less than or equal to) 10% of patients would have a Hgb (hemoglobin) < 10 g/dL (grams/deciliter) as follows: 1) August 2023 minutes showed 19% of the patients had a Hgb < 10 g/dL. Review of the Action Plan showed the identified root causes were blood loss, infection, EPO (Epogen-Erythropoietin Stimulating Agent) therapy. The Action Plan in July 2023 was to continue to monitor and adjust medication per patient needs. There was no evidence the QA Committee had re-evaluated the root cause for the Hgb outcomes not met. There was no evidence the QA Committee evaluated July 2023’s Action Plan to determine the effectiveness of the plan. The July 2023’s Action Step was adjust EPO per patient needs. 2) September 2023 minutes showed 25% of the patients had a Hgb < 10 g/dL. The Action Plan in August 2023 was to Ensure blood was being returned completely in lines. There was no evidence the QA Committee had re-evaluated the root cause for the Hgb outcomes not met. There was no evidence the QA Committee had evaluated August 2023’s Action plan to determine the effectiveness of the plan. re-evaluated the root cause for the Hgb outcomes not met. August 2023’s Action Plan to determine the effectiveness of the plan. September 2023’s Action Step was to monitor patients during tx (treatment) to ensure there was no blood lost during tx. 3) October 2023 minutes showed 25% of the patients had a Hgb < 10 g/dL. The Action Plan in September 2023 was to monitor patients during tx (treatment) to ensure there is no blood lost during tx. There was no evidence the QA Committee re-evaluated the root cause for the Hgb outcomes not met. There was no evidence the QA Committee evaluated September 2023’s Action Plan to determine the effectiveness of the plan. October 2023’s Action Step was FeSO4 (Ferrous sulfate) will be administered to each patient per treatment. 4) November 2023 minutes showed 19% of the patients had a Hgb < 10 g/dL. The Action Plan in October 2023 was FeSO4 (Ferrous sulfate) will be administered to each patient per treatment. There was no evidence the QA Committee re-evaluated the root cause for the Hgb outcomes not met. There was no evidence the QA Committee evaluated October 2023’s Action Plan to determine the effectiveness of the plan. November 2023’s Action Step was to monitor patients post tx to ensure patients are applying pressure and not losing blood. 5) December 2023 minutes showed 29% of the patients had a Hgb < 10 g/dL. The Action Plan in November 2023 was to monitor pt post tx to ensure patients are applying pressure and not losing blood. There was no evidence the QA Committee re-evaluated the root cause for the Hgb outcomes not met. There was no evidence the QA Committee evaluated November 2023’s Action Plan to determine the effectiveness of the plan. December 2023’s Action Step was to continue to adjust Epo per patient needs. B. Vascular Access Review of Quality Assurance Meeting Minutes and data for vascular access from August 2023 to December 2023 showed the goal/quality indicator was to increase prevalent AVF(Arteriovenous Fistula) use in selected subset of patients by 25 %. as follows: 1) August 2023 minutes data showed: a) Over fifty percent (50%) of patients had a CVC (Central Venous Catheter). b) Fourteen patients had a CVC with eight refusing to get any other type of access. c) July 2023’s root causes were patient refusal/resistance. The July 2023 Action Step was to educate patients on the importance of getting and using permanent access. d) There was no evidence the QA Committee determined barriers for why the eight patients were refusing another type of access. e) There was no evidence the QA Committee evaluated July 2023’s Action Step to determine the effectiveness of the plan and determine if the root causes remained the same. f) August 2023’s Action Step was to schedule all catheter patients for access placement. 2) September 2023 minutes showed: a) Thirteen patients had a CVC. Eight of the 13 are refusing to get any other type of access. b) The Action Plan showed the goal was to increase prevalent AVF use in selected subset of patients by 10% with a root cause of patient refusal/resistance and timely placement of permanent vascular access. c) There was no evidence the QA Committee determined barriers for why the eight patients were refusing another type of vascular access. f) There was no evidence QA Committee addressed barriers for the two patients needing to see surgeon for ultrasound before cannulating access. g) There was no evidence the QA Committee addressed barriers for making appointments and keeping appointments for vein mapping. h) There was no evidence the QA Committee evaluated August 2023’s Action Step to determine the effectiveness of the plan and determine if the root causes remained the same. i) September 2023’s Action Step was to educate patients on the risk of not having permanent access. 3) October 2023 minutes showed: a) Forty-six percent (46%) of the patients had a CVC. b) Twelve patients had a CVC. One of the twelve patients are not a candidate for permanent access. Five of the twelve are refusing to get any other type of access. c) There was no evidence the QA committee determined barriers for why the five patients were refusing another type of access. Action Plan showing the goal was to increase prevalent AVF use in selected subset of patients by 10% with a root cause of patient refusal/resistance and timely placement of permanent vascular access. d) There was no evidence the QA Committee had determined barriers for why the five patients were refusing another type of vascular access. e) There was no evidence of Septembers 2023’s or October 2023’s Action Step. f) Findings and follow up for October Access action plan continues. 4) November 2023 minutes showed: a) Thirteen had CVC with five refusing to get any other type of access, and one patient was not a candidate for permanent access. b) The Action Plan showed the goal was to increase prevalent AVF use in selected subset of patients by 25% with a root cause of patient refusal/resistance and timely placement of permanent vascular access. c) There was no evidence the QA Committee determined barriers for why the five patients were refusing another type of vascular access. d) There was no evidence of Septembers 2023’s, October 2023’s, or November 2023” s Action Step. e) Findings and follow up for November action plan continues. 5) December 2023 minutes for December 2023’s data showed: a) Twelve patients had a CVC. One of the twelve patients are not a candidate for a permanent access. Five of the twelve are refusing to get any other type of access . b) The Action Plan showed the goal was to increase prevalent AVF (arteriovenous fistula) use in selected subset of patients by 25% with a root cause of patient refusal/resistance and timely placement of permanent vascular access. c) There was no evidence the QA Committee determined barriers for why the five patients were refusing another type of access. d) Findings and follow up for December Access action plan continues. C. The findings of A and B were confirmed in an interview with Registered Nurse # 1 on 02/28/24 at 2:00 PM.”