Davita New Haven Dialysis

“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: 32738 44675 Based on observation, clinical record review, interview and review of facility policy, the facility failed to clean and disinfect the hemodialysis station after hemodialysis treatment per facility policy. The finding included: a. Observation conducted on 6/17/24 at 9:52 AM identified Staff Person #1 cleaning and disinfecting Station #6 Machine #23 after a hemodialysis treatment. Staff Person #1 failed to clean and disinfect the top of the IV pole attached to the hemodialysis machine. b. Observation conducted on 6/17/24 at 10:53 AM identified Staff Person #2 cleaning and disinfecting Station #7 and Machine #9 after a hemodialysis treatment. Staff Person #2 disinfected the wallbox, discarded the cleaning and rag and proceeded to clean the chair without the benefit of discarding her gloves, completing hand hygiene and donning a new pair of clean gloves after contact with the wallbox. c.Observation on 6/18/24 at station #1 at 11:00 AM identified that the staff person disinfecting the hemodialysis station after treatment, the staff person wrapped the electrical cord around the oxygen concentrator and placed it against the wall for storage without disinfecting the unit. Review of the infection control for dialysis facilities policy identified surfaces to disinfect include but are not limited to all surfaces in contact with the patient or their belongings and frequently contacted by healthcare personnel. It further identified non-disposable items are to be disinfected after each patient use.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 47640 The facility failed to ensure that the facility was designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. 1. On 06/14/24 at 9:20 AM the surveyor, while accompanied by the Bio Med Technician, observed that the flooring throughout the treatment floor was not being maintained to a degree in which it was able to be cleaned and sanitized properly, the seams of the floor were peeling off and some of the flooring was missing throughout the treatment floor 2. On 06/14/24 at 9:25 AM the surveyor, while accompanied by the Bio Med Technician, observed that the carts within the treatment area had rust build-up on the caster. 3. On 06/14/24 at 9:30 AM the surveyor, while accompanied by the Bio Med Technician, observed that the clean sink across from Station # 26 had wall damage and marring above it, the caulking appeared to be ripped off and pulled with some of the wall material with it.”

“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: 47640 Based on a documentation review on 06/14/24 at 11:00 AM, the facility failed to maintain a building that was constructed and maintained to ensure the safety of the patients for the staff and the public. The findings include the following: 1. During a documentation review, the surveyor was not provided with documentation from the Bio Medical Technician or the Facility Administrator (FA). The following are violations: a. The facility failed to provide documentation to indicate that the partial dry trip test was conducted on their dry sprinkler system within the past year as required by section 13.4.4.2.2 of the 2011 Edition of NFPA 25. b. The facility failed to provide documentation to indicate that the 3-year full dry trip test was completed on their dry sprinkler system within the past 3 years as required by section 13.4.4.2.2.2* of NFPA 25, 2011 edition. c. The facility failed to provide documentation to indicate that the 3-year air leakage test was completed on their dry sprinkler system within the past 3 years as required by section 13.4.4.2.9 of NFPA 25, 2011 edition. d. The facility failed to provide documentation to indicate that the FDC was hydrostatically tested within the past 5 years, as required by table 5.1.1.2 of NFPA 25, 2011 edition.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 32738 Based on a review of clinical records, interview, and policy review for two (2) of fifteen (15) hemodialysis patients reviewed for prescription, (Patient #1 and #7), the facility failed to ensure that adequacy was calculated in accordance with facility policy and the patient’s hemodialysis treatment was in accordance with the physician orders. The findings include the following: 1. Patient #1 had a diagnosis of end stage renal disease and required hemodialysis three (3) times weekly with a blood flow rate was 120. Review of the Kt/V (measures the effectiveness of dialysis treatment) identified that the patient had a Kt/V of 1.09 on 2/19 and 1.05 on 2/16/24 and on 2/9/24 on 1.21 (normal Kt/v is 1.2). There were no further Kt/V’s noted for March, and April or May 2024. The Kt/v for March and April were unable to be calculated because the patients post Blood Urea Nitrogen (BUN) was below three (3). In May 2024 the manual entry of the fluid volume removed was not entered into the system by the staff and therefor, could not be calculated. Interview with the Manager of Clinical Services on 6/18/24 at 12:30 PM identified that Kt/V is calculated monthly. There is a different calculation for Kt/V for pediatric patients. The Kt/V’s were calculated in February because the post hemodialysis treatment BUN was above 3 and the fluid volume removed was entered enabling the calculation to occur. The Kt/V could not be calculated in March and April because the Post BUN was below 3. In May the post BUN was 25, however, the facility failed to enter the fluid volume removed from the patient, and the Kt/V calculation could not be calculated. Review of the pediatric Kt/V procedure identified that the Kt/V should be 1.2. If the blood flow rate is below 150 the nurse is required to manually enter the volume of fluid removed for that treatment in order for the laboratory to calculate an accurate Kt/V. 2. Patient #7 had diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three times weekly for four (4) hours and thirty (30) minutes with a dialysate flow rate (DFR) of 800 and blood flow rate (BFR) of 450. A sample review of Patient #7’s treatment flowsheets identified the following: On 5/23/24, 6/1/24, 6/6/24, 6/11/24, and 6/15/24 Patient #7’s DFR during treatment was 700 with no rationale as to why the prescribed DFR of 800 was not met. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment identified if the dialysis prescription is not being met (including dialysis flow rate) the reason will be documented and the licensed nurse informed. 44675”

“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: 32738 Based on a review of clinical records, interview, and policy review for two (2) of fifteen (15) hemodialysis patients reviewed for blood pressure, (Patient #3 and #6), the facility failed to ensure that an as needed medication given to treat low blood pressure was administered in accordance with physician orders and for one patient who was ambulatory had a standing blood pressure and pulse pre and post hemodialysis treatment. The findings include the following: 1. Patient #3 had a diagnosis of end stage renal disease and required hemodialysis three (3) times weekly. Physician’s orders dated 5/1/24 directed to administer midodrine (given to treat low blood pressure) 10 milligrams one tablet at the start of treatment and repeat up to three (3) times for systolic blood pressures 110 and under. Review of treatment sheets 5/28/24 through 6/5/24 failed to identify that midodrine was administered at the start of the hemodialysis treatment as ordered. Further, on 5/30, 6/1, 6/4, 6/6, 6/8 and 6/15/24 the systolic blood pressures ranged between 85 and 107 during treatment and midodrine was not administered. Interview with the Facility administrator on 6/18/24 at 2:00 PM identified that the midodrine should be administered in accordance with physician orders. 2. Patient #6 had diagnoses that included end stage renal disease. Patient #6’s physician orders included hemodialysis treatment three (3) times a week for three (3) hours and thirty (30) minutes, 2.0 K 2.5 Ca dialysate and an estimated dry weight (EDW) of 83 kg. Review of Patient #6’s hemodialysis flowsheets identified the following: On 5/28/24, 5/30/24, 6/1/24, 6/4/24, 6/8/24, 6/11/24, 6/13/24, and 6/15/24 Patient #6 ambulated with a walker to treatment and did not have a pre and post standing blood pressure and/or the reason why a standing blood pressure was not obtained documented. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed that 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 policy directed an abnormal blood pressure finding would be a systolic less than 90mm/HG. It further directed if a patient is not able to stand, document the reason and sitting BP. 44675”

“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: 44675 Based on a review of clinical records, interview, and policy review for one (1) of three (3) hemodialysis patients reviewed for anemia, (Patient #7), the facility failed to review hemoglobin results with the physician and/or implement facility protocol for anemia. The findings include the following: 1. Patient #9 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours. Review of Patient #7’s physician orders directed to follow the protocol for Mircera (helps the body produce red blood cells) the protocol was initiated on 1/22/24 and discontinued on 3/24/24. A physician’s order dated 2/13/2 through 3/24/24 directed Mircera 30 mcg every two weeks. Review of the Patient #7’s hospitalization log identified Patient #7 was hospitalized from 2/26/24 through 3/26/24 due to a stroke, Patient #7’s anemia was stable during the hospitalization. Nephrology recommended not resuming Mircera given the risk of stroke and it should be discussed further in the outpatient setting. Hemoglobin levels dated 3/27/24 identified Patient #7’s hemoglobin was 10.5 and on 4/3/24 was 9.6 (Hemoglobin range for patients with chronic kidney disease is 10 - 12). An anemia manager note dated 4/5/24 identified Patient #7’s hemoglobin level was trending down. The Mircera protocol was discontinued on 3/24/24. The writer asked to please review with the provider. A hemoglobin level dated 4/17/24 was 9.5. An anemia manager note dated 4/19/24 identified Patient #7’s hemoglobin was 9.5. Patient #7 was on Mircera protocol 30 mcg every two weeks but was discontinued while in the hospital from 2/26/24 - 3/26/24. The writer asked to review with the provider. The care plan dated 4/29/24 identified Patient #7 was unstable. Patient #7’s anemia goal was to use the lowest Mircera dose to reduce the risk of transfusion with an intervention to evaluate the patient with the physician for anemia related medication and supplements. A hemoglobin level dated 5/8/24 was 8.6. An anemia manager note dated 5/10/24 identified Patient #7’s hemoglobin was 8.6. Patient #7 was currently not on Mircera, the writer asked to review with the provider if protocol would be appropriate. Review of Patient #7’s protocols identified the Mircera protocol was started on 5/10/24. A physician’s order dated 5/14/24 directed Mircera 50 mcg every four weeks. A hemoglobin level dated 5/15/24 was 8.3 and on 5/22/24 was 7.7. Review of Patient #7’s medical record failed to identify the physician was notified that Patient #7 was not on the Mircera protocol for one month and twenty one days and/or did not have a Mircera order with decreasing hemoglobin values until 5/14/24. Interview with the Clinical Coordinator on 6/18/24 at 9:26 AM identified Patient #7 was hospitalized from 2/26/24 - 3/26/24 and Patient #7’s labs were drawn on 3/27/24 and resulted on 4/3/24. She identified the labs following the hospitalization would be used to determine needs for orders. However, the Mircera protocol was not put into place until 5/14/24 and she was unable to speak as to why. Interview with the Clinical Specialist on 6/18/24 at 10:45 AM identified Patient #7’s Mircera protocol was discontinued after Patient #7’s extended hospitalization which resulted in Patient #7 becoming inactive. She identified Patient #7’s protocol was not put back into place until 5/14/24 in error. Review of the Mircera protocol is discontinued the patient will be re-started when the hemoglobin level drops below 12.”

“PA-RD-NUTRITIONAL STATUS CFR(s): 494.80(a)(6) The patient’s comprehensive assessment must include, but is not limited to, the following: (6) Evaluation of nutritional status by a dietitian This Standard is not met as evidenced by: 44675 Based on a review of clinical records, interview, and policy review for 1 of 3 hemodialysis patients reviewed for dietary documentation (Patient #6), the facility to ensure the patient had a documented monthly registered dietician note per facility policy. The findings include the following: Patient #6 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes. A Registered Dietitian note dated 3/20/24 - 4/29/24 identified Patient #6’s parathyroid hormone (PTH) rose to 1178 (expected value for chronic kidney patient’s is 150-300), Cinacalcet ( reduces calcium in the blood) maintained at 90 milligrams per treatment up until 3/29/24, then the medication was unavailable due to a medication shortage and resumed 4/18/24. It further identified the dietician was awaiting May results. Review of hospital discharge summary dated 5/23/24 - 5/26/24 identified Patient #6 diagnoses included hyperkalemia ( increased levels of potassium in teh blood) in the setting of missed hemodialysis treatments. Review of Patient #6’s progress notes failed to identify Patient #6 had a monthly dietician progress note for the month of May and further failed to identify if potassium was reviewed after the hospital of 5/23/24 - 5/26/24 for hyperkalemia. There further was no dietitian note subsequent to April 2024 monthly note. Interview with the Clinical Manager on 6/18/24 at 12:00 PM identified the facility currently has a covering dietician. She further identified the expectation is for the dietitian to complete a monthly progress note.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 47491 Based on review of clinical records, interviews, and facility policy for one (1) of five patients reviewed for Peritoneal Dialysis, (Patient #15), the facility failed to ensure an assessment was completed to identify stability for a patient had not met adequacy over a period of four (4) months. The findings included: Resident #15 had diagnoses which included end stage renal disease, had an abdominal peritoneal dialysis catheter, and required daily peritoneal dialysis treatments. A physician’s order dated 1/25/24 directed a nine (9) hour and thirty (30) minute daily dialysis treatment which consisted of five (5) exchanges at a 2300 milliliter fill volume of varied dialysate, with a day exchange of 1000 milliliters. Review of Patient #15’s Care Plan dated 2/7/24 indicated the patient was assessed as stable. Review of Resident #15’s clinical record identified an adequacy result of 1.51 on 2/21/24, 1.51 on 3/1/24, 1.6 on 4/22/24, and 1.54 on 5/15/24 (adequacy for PD patients is 1.7). Interview with RN #2 on 6/18/24 at 11:41 AM identified an adequacy result of 1.7 or greater deemed a peritoneal dialysis patient adequate, Resident #11 has been inadequate since 2/21/24, and should have had an assessment to assess for stability. Interview with SW #1 on 6/18/24 at 1:10 PM identified the patient should have been deemed unstable due to consistently not reaching adequacy since 2/21/24. SW #1 further indicated two or more consecutive adequacy results of less than 1.7 for a PD patient would deem the patient unstable for care planning purposes and would have required that the patient’s plan of care was reviewed monthly. Although requested, the facility was unable to provide an unstable care plan policy.”

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 32738 Based on observation, clinical record review, interview and review of facility policy, for one (1) of three (3) Patients (Patient #21), reviewed during hemodialysis treatment, the facility failed to create and implement a plan of care to address behavioral concerns. The finding included: Observations conducted on 6/17/24 between 9:45 AM -12:00 PM identified Patient #21 sitting at Station #14 Machine #8 playing loud music with inappropriate and foul language. During the observations from 9:45 AM - 12:00 PM there was no observation that a staff member attempted to ask Patient #21 to lower his/her music or use headphones. At 10:52 AM Patient #22 entered the treatment floor and was directed to Station #14 for treatment. Patient #22 stated he/she did not want to sit at that station because of the loud music. Another station was not available and Patient #22 sat at Station #14 so he/she would not be late for treatment. Interview with Patient #22 on 6/17/24 at 2:16 PM identified he/she has complained to staff about Patient #21’s loud music previously, however, nothing was done. Review of Patient #21’s medical record identified Patient #21 was admitted to the facility with diagnoses that included end stage renal disease. Patient #21’s standards of conduct was last signed on 5/8/19. A SW #1 note dated 10/30/23 at 10:55 AM identified the FA asked SW #1 to speak with Patient #21 about last treatment event (upset over music) but Patient #21 refused to look at SW#1. Patient #21 would not speak with or listen to SW #1. SW #1 left the area and informed the FA of the exchange. A subsequent SW note dated 10/30/23 at 1:19 PM identified the Social Worker spoke with Patient #21 about his/her loud music on the treatment floor as other patient’s were disturbed by the volume of the music. Other patient’s refused to sit beside Patient #21 due to the loud music. Patient #21 became verbally aggressive and stated “don’t come the f*** over here because I don’t want to hear any s*** you say”. After the Social Worker asked Patient #21 several times to put on his/her headphones and reiterated the Code of Conduct, Patient #21 stated “this is how low my music is going” still refusing the lower the volume. Interview with SW #1 on 6/18/24 at 9:45 AM Patient #21’s behaviors will trend up and down. She identified patient’s have complained before, the behavior would improve for a few days and then Patient #21 would resume normal loud music again. She identified the team has discussed a behavioral contract previously but nothing formal was put into place. Interview with multiple staff members on 6/18/24 at 10:00 AM identified Patient #21 has a history of playing loud music. It was identified that patient’s have complained about the loud music before and not wanting to sit next to Patient #21. It was further identified that patient’s who did not want to sit next to Patient #21 were moved to a different station if the schedule allowed. Interview with the Clinical Coordinator on 6/18/24 at 12:30 PM identified Patient #21’s behaviors goes up and down. She identified if you challenge him/her (example. ask him/her to lower his/her music down, he/she will turn the music up) Patient #21 will act out. She further identified other Patient’s have complained before and they will move their station to another location. Review of the Code of conduct, in part, directed patients will treat other patients and staff with mutual respect. Patients will not use profanity and patients will follow the directions of the charge nurse will in the facility. It directed the patient will be expected to conform to the above standards of behavior. It a patient behaves in a manner not consistent with the standards of the facility, the administrator, physician, regional director, as applicable will discuss the non-conformance with the patient.”

“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: 47491 Based on review of clinical records, interviews and facility policy for one of five patients reviewed for peritoneal dialysis treatments, the facility failed to administer a medication in accordance with physician’s orders. The findings included: Patient #11 had diagnoses that included end stage renal disease, placement of an abdominal peritoneal dialysis catheter, and a physician’s order for daily peritoneal dialysis treatments which consisted of a 10 hour and 20 minute automated peritoneal dialysis treatment of 5 exchanges at a 2000 milliliter fill volume of dialysate of varied strengths, instilled intraperioneally. A physician’s order dated 2/9/24 directed 75 micrograms Mircera (a medication which stimulates red blood cell production) be administered every (2) two weeks. Review of February 2024 service and clinic visit documentation failed to identify Resident #11 had been administered Mircera 75mcg. Interview with RN#1 on 6/18/24 at 10:00 AM identified Resident #11 had issues with attendance to appointments due to transportation, and did have a history of systolic blood pressures greater than 180 (indicating the administration of Mircera would not be appropraite). RN #1 could not identify that the Mircera was administered for the month of February 2024, and if appointments were missed the Mircera should have been rescheduled during the month of February 2024. Review of the Mircera protocol identified that if a dose is missed it should be re-scheduled during the next possible treatment (appointment).”

“H-FAC RECEIVE/REVIEW PT RECORDS Q 2 MONTHS CFR(s): 494.100(b)(2),(3) The dialysis facility must - (2) Retrieve and review complete self-monitoring data and other information from self-care patients or their designated caregiver(s) at least every 2 months; and (3) Maintain this information in the patient ’ s medical record. This Standard is not met as evidenced by: 32738 Based on review of clinical records, interviews and facility policy for three (3) of five (5) patients reviewed for peritoneal dialysis treatments, ( Patient #11, 12 and 13), the facility failed to indicate patient peritoneal treatments were completed in accordance with the physician’s order. The findings included: 1. Patient #11 had diagnoses that included end stage renal disease, an abdominal peritoneal dialysis catheter, and a physician’s order for daily peritoneal dialysis treatments which consisted of a (ten) 10 hour and twenty (20) minute automated peritoneal dialysis treatment of five (5) exchanges at a 2000 milliliter fill volume of dialysate of varied strengths, instilled intraperioneally. Review of Patient #11’s April 2024 treatment sheets identified missing pre-weights and dialysate concentrations used for 19 treatments. Review of Patient #11’s May 2024 treatment sheets identified missing pre-weights and dialysate concentrations used for 5 treatments. Review of Patient #11’s Personal Fluid Balance Chart identified dialysate concentrations of 1.5%, 2.5%, and 4.25% (which varied in strength to meet the patient’s fluid removal needs during treatment) to be used with treatment was based on the patient’s daily pre-dialysis weight. Interview with RN #1 on 6/18/24 at 10:44 AM indicated he/she communicated with Patient #11 on which dialysate concentration to use for treatment, however, failed to identify nurse’s notes confirming the communication had taken place or that he/she was able to validate the patient was performing his/her treatments according to physician’s orders. 2. Patient #12 had diagnoses that included end stage renal disease, placement of an abdominal peritoneal dialysis catheter, and a physician’s order for daily peritoneal dialysis treatments which consisted of an eleven (11) hour automated peritoneal dialysis treatment of six (6) exchanges at a 2100 milliliter fill volume of dialysate of varied strengths, instilled intraperitoneally. Review of Patient #12’s April 2024 treatment sheets identified missing pre-weights and dialysate concentrations used for 24 of 30 treatments. Review of Patient #12’s May 2024 treatment sheets identified missing pre-weight and dialysate concentrations used for 18 of 31 treatments. Review of Patient #12’s Personal Fluid Balance Chart identified dialysate concentrations of 1.5%, 2.5%, and 4.25% (which varied in strength to meet the patient’s fluid removal needs during treatment) to be used with treatment was based on the patient’s daily pre-dialysis weight. Interview with RN #1 on 6/18/24 at 10:17 AM identified Patient #12 was currently residing at a nursing home and staff at the nursing home were trained on how to enter and document the patient’s vitals, weight and dialysate used with treatments. RN #1 further identified he/she hasn’t provided any further verbal guidance to the nursing home staff regarding proper documentation of Patient #12’s treatments since their initial training on 3/21/24 and that without documenting the patient’s weight, he/she was unable to validate if the physician’s order was being followed. 3. Patient #13 had diagnoses which included end stage renal disease, placement of an abdominal peritoneal dialysis catheter, and a physician’s order for daily peritoneal dialysis treatments which consisted of a nine (9) hour automated peritoneal dialysis treatment of four exchanges at a 2200 milliliter fill volume of dialysate of varied strengths, instilled intraperitoneally. Review of Patient #13’s April 2024 treatment sheets identified missing dialysate concentrations used for 15 of 30 treatments. Review of Patient #13’s March 2024 treatment sheets identified missing dialysate concentrations used for 26 of 31 treatments. Interview with RN #1 on 6/18/24 at 10:44 AM identified he/she had conversations with Patient #13 about the missing dialysate entries, but hasn’t reinforced the need to document this since his/her last home visit in February 2024. RN #1 further indicated he/she was unable to validate Patient #13 was completing his/her treatment according to the physician’s order. Review of the Peritoneal Dialysis Home Training Agreement identified the requirement of completing and maintaining all necessary documentation as required by state and federal regulations which included vital signs and documentation. The Peritoneal Dialysis Home Training Agreement further requires the patient to document all treatments accurately and completely. 4. Patient #11 had diagnoses that included end stage renal disease, placement of an abdominal peritoneal dialysis catheter, and a physician’s order for daily peritoneal dialysis treatments which consisted of a ten (10) hour and twenty (20) minute automated peritoneal dialysis treatment of five (5) exchanges at a 2000 milliliter fill volume of dialysate of varied strengths, instilled intraperioneally with a target weight of 88 kg. Review of Patient #11’s Personal Fluid Balance Chart identified dialysate concentrations of 1.5%, 2.5%, and 4.25% (which varied in strength to meet the patient’s fluid removal needs during treatment) to be used with treatment was based on the patient’s daily pre-dialysis weight, however the fluid guidelines charted for Patient #11 were based on a target weight of 92.5 kilograms however patient’s target weight was currently ordered at 88 kilograms. Interview with RN #1 on 6/18/24 at 10:11 AM identified the Fluid Balance Chart which informs Patient #11 on which dialysate(s) to use with treatments was old. RN #1 failed to locate the current Fluid Balance Chart Patient #11 was utilizing to determine his/her current dialysate use with treatments and indicated Patient #11 did not have a copy to refer to as RN #1 would communicate which dialysate the patient should use with his/her daily treatments. RN #1 was unable to provide documentation entailing the instructions given daily for daily dialysate use. Review of Patient #11’s treatment documentation for March 2024 failed to identify treatments were completed on 3/21/24, 3/23/24, 3/27/24, and 3/29/24. Review of Patient #11’s treatment documentation for April 2024 failed to identify treatments were completed on 4/13/24 and 4/23/24. Review of Patient #11’s treatment documentation for May 2024 failed to identify treatments were completed on 5/8/24, 5/10/24, 5/12/24, 5/14/24, 5/16/24, 5/22/24, 5/24/24, and 5/27/24. Interview with RN #1 on 6/18/24 identified facility practice was to contact the patient to verify if treatments were completed and the patient’s responsibility to follow the physician’s order. RN #1 indicated, at times, Patient #11 was having modem issues which prevented treatment data from being sent to the server and captured, and that Patient #11 would perform manual exchanges during the day instead of connecting to the cycler for his/her night treatments due to abdominal discomfort related to previous gastric bypass surgery. RN #1 further indicated Patient #11 failed to consistently communicate with him/her when manual exchanges were done. Further, RN #1 was unable to provide a physician’s order for Patient #11’s manual exchanges. RN #1 identified it was his/her responsibility to verify treatment completion, and although the patient had stated the treatments were done, failed to provide data/documentation confirming this communication. Review of requirements in the Peritoneal Dialysis Home Training Agreement and Training Release directed adherence to prescribed treatment was necessary to receive the benefits of dialysis and the expectation to dialyze as prescribed by the physician. Furthermore, the patient agrees to not make any changes to their treatment without authorization from the physician and/or home training team.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 32738 Based on clinical record review, facility documentation, and interviews, for one (1) of fifteen (15) patients reviewed for pain management, (Patient #4), the facility failed to ensure that medications were administered in accordance with physician’s orders, that expired medications were discarded, and properly stored in the medication room, The findings included: 1. Patient #4 had a diagnosis of end stage renal disease and required hemodialysis three times weekly. A physician’s order dated 5/1/24 directed to administer Acetaminophen 650 milligrams (mg) every four hours as needed for pain. Review of the treatment records dated 5/27/24, 5/29/24, and 6/14/24 the patient was administered 975 mg of acetaminophen for complaints of pain (325 mg more than the physician’s order directed). Interview with the Facility Administrator on 6/18/24 at 2:30 PM identified that the patient should only receive 650 mg of Acetominophen as ordered by the physician The medication administration policy identified that all medications will be administered in accordance with physician’s orders. 2. Observations on 6/14/24 at 9:15 AM identified: a. One (1) 60 milliliter (ml) edgeless syringe with an expiration date of 2/29/24, twenty-eight (28) 1 ml edgeless syringe with an expiration date of 4/7/21, two (2) full boxes of three (3) ml needleless syringes with expiration dates of 7/31/23, one (1) box of one (1) ml Safety Lok syringes with an expiration date of 4/2021, one (1) box of one (1) ml twenty-nine (29) gauge needles with an expiration date of 5/31/24, and ten (10) twenty-three (23) gauge butterfly needles with an expiration date of 3/31/24. b. Three (3) tubes of Gentamicin Cream 0.1 % (an antibiotic cream) two (2) with an expiration date of 3/24 (of which one (1) was opened and labeled for use for a patient and one had not yet been opened) and one (1) with an expiration date of 6/25. c. Two and a half boxes of Naloxone (an opioid reversal agent), 0.4 ml vials with an expiration date of 3/24. Interview with the interim facility administrator on 6/14/24 at 9:45 AM identified expired supplies and medications should be discarded and medications were to be stored in the med room. Review of the medication policy directed medications and needle/syringe storage are done in accordance with state regulations and disposal of expired medications were to remove from the treatment and inventory areas and disposed of per state/local regulations. 44675 Based on a review of clinical records, interview, and policy review for 1 of 3 hemodialysis patients reviewed for treatment compliance (Patient #6), the facility failed to complete against medical advice (AMA) forms in accordance with facility policy and for 1 of 3 hemodialysis patients reviewed for target weight (Patient #7), the facility failed to address and implement interventions for a patient whose post weight was 1 kg or more above the prescribed target weight post treatment per facility policy. The findings include the following: 1. Patient #6 was admitted to the clinic with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three times weekly for three hours and thirty minutes. A sample review of Patient #6’s hemodialysis flowsheets identified the following: a. On 6/11/24 Patient #6 had 3 hours and 12 minutes of treatment (18 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met. b. On 6/13/24 Patient #6 had 2 hours and 17 minutes of treatment (1 hour and 13 minutes short) with no documentation as to why Patient #6’s prescribed treatment time was not met and if the physician was notified. c. On 6/15/ 24 Patient #6 had 2 hours and 31 minutes of treatment (59 minutes short) due to requested sign off and if the physician was notified. Review of Resident #6’s medical record failed to identify AMA forms for 6/11/24, 6/13/24 and 6/15/24. Review of the against medical advice policy directed that the AMA form will be used for patients who refuse to complete the prescribed treatment. It further directed the charge nurse will review and have the patient sign the AMA form. It directed if shortened/early termination of treatment time exceeds 30 minutes or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention (if any). The AMA form will be maintained in the patients medical records. 2. Patient #7 was admitted to the facility with diagnoses that included end stage renal disease. Review of the physician’s orders directed hemodialysis three times weekly for four hours and thirty minutes with a target weight of 100.5 kg. A sample review of Patient #7’s treatment flowsheets identified the following: a. On 6/6/24 Patient #7’s post weight was 102.2 kg (1.7 kg above prescribed EDW). The treatment flowsheet and nursing notes failed to identify if the physician was notified and/or interventions that were implemented. b. On 6/11/24 Patient #7’s Patient #7’s post weight was 105.3 kg (4.8 kg above prescribed EDW). The treatment flowsheet and nursing notes failed to identify if the physician was notified and/or interventions that were implemented. c. On 6/13/24 Patient #7’s post weight was 102.1 kg (1.6 kg above prescribed EDW). The treatment flowsheet and nursing notes failed to identify if the physician was notified and/or interventions that were implemented. Review of the pre-intra-post treatment data collection, monitoring and nursing assessment policy directed the PCT or licensed nurse will obtain and document basic data on each patient post dialysis and if an abnormal finding is identified post treatment, this needs to be reported to the licensed nurse and the licensed nurse will assess the patient prior to discharge. The licensed nurse will use their clinical judgment based on individual patient needs to determine notification of the physician. It further identified if a patient is above or below 1 kg from their targe weight, it would be an abnormal finding.”