Greenfield Hs - Northwest Detroit

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 37411 Based on observation, record review, and interview, the facility failed to ensure items taken into the dialysis station were cleaned or disinfected before being taken into a common area or used on another patient, resulting in the potential to spread infectious diseases to all 67 patients receiving in-center hemodialysis at this facility at the time of observations. Findings include: **Policy titled “Infection Prevention and Control Policy” (revised 10/2022) states “IV Patient Care: B. Infection Control Precautions for all patients: 1. Items taken to a patient’s dialysis station, including those placed on top of dialysis machines, should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being returned to a common clean area or used on other patients.” During dialysis floor observation on 2/11/25 and 2/12/25, the following was noted: On 2/11/25 at 1130, the staff were observed using the Hoyer lift (mechanical lift used for people who are unable to stand) on the patient at station C-5. Afterwards, Staff H (Dialysis Assistance) was observed rolling the Hoyer lift back to the storage area without disinfecting it first. On 2/12/25 at 0940, the staff were observed using the Hoyer lift on the patient at station C-1. Afterwards, Staff H was observed rolling the Hoyer lift back to the storage area without disinfecting it first. These findings were reviewed and acknowledged by the Nurse Manger (Staff A) and Quality Compliance Coordinator (Staff C) during interview on 2/13/25 at 1045.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 38304 Based on record review and interview, the facility failed to ensure patients were informed of all aspects of care failed for 2 (P-7 and P-14) of 15 in-center records reviewed, out of a total sample of 15 records reviewed, resulting in the potential for patients to be unaware of the consequences of early termination of treatment. Findings include: P-14: This 53-year-old male was admitted to the dialysis Facility on 2/24/21, with diagnoses which included hypertensive CKD (chronic kidney disease), anemia, and hypertension. P-14 was receiving treatments 3 times per week (Mon-Wed-Fri) for an ordered duration of 210 minutes each treatment. Record review of P-14’s 6 most recent treatments (1/22/25 through 2/10/25) revealed the treatment on 2/6/25 ended after 108 minutes. Further review of P-14’s medical record revealed a lack of an Against Medical Advice (AMA) form completed for 2/6/25. Additionally, there was no documented physician notification or education to the patient to explain the cumulative harm of shortening dialysis treatments. The findings above were reviewed and acknowledged by the Facility Administrator (Staff B) and Quality Compliance Coordinator (Staff C) on 2/13/25 at 1228. At this time Staff B noted that this did not meet facility expectations, or its policy referenced below. Facility Policy “Against Medical Advice (AMA)” (revised 02/2023) stated, “Refusing medical treatment includes but is not limited to voluntarily cutting treatment time more than ten minutes shorter than prescribed... Once the patient’s decision to leave AMA is final, the physician/APP/nurse will complete the following documentation: The patient will be asked to sign and date on the AMA form. If the patient refuses to sign, document on the form that the patient refused to sign ...” 46476 P-7: This 68-year-old was admitted to the facility on 12/4/23 with end stage kidney disease and high blood pressure. Review of P-7’s medical record revealed physician orders for hemodialysis included a treatment duration time of 180 minutes (3 hours). Record review of P-7’s 6 most recent treatment sheets, dated between 1/30/25 and 2/11/25, revealed on 2/8/25 the duration of treatment was 113 minutes (1 hour 53 minutes). There was no documentation indicating a reason for the shortened treatment time. This finding was reviewed on 2/13/25 at 1410 during interview with the Nurse Manager (Staff A) and the Quality Compliance Coordinator (Staff C). Staff A acknowledged the finding and was unable to provide a patient signed Against Medical Advice form for the date requested.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 46476 . Based on record review and interview, the facility failed to ensure medications were administered per physician order for 1 (P-11) of 15 records reviewed resulting in the potential for poor patient outcomes. Findings include: P-11: This 40-year-old was admitted to the facility on 10/26/24 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25 and included 6 hemodialysis flowsheets dated between 1/28/25 and 2/8/25. Active hemodialysis physician orders for the period of review included hemodialysis to be done 3 times per week and also included the following medications: Zemplar 6 micrograms to be given 3 times per week (used in the treatment of high parathyroid hormone levels), and Epogen 11,000 Units to be given 3 times per week (used in the treatment of low red blood cell counts). During review of the hemodialysis flowsheet dated 2/8/25, it was noted that both medications Zemplar and Epogen were not given. It was also noted that there was documentation in the section of the flowsheet titled “Hemodialysis 2/8/2025 Undone Meds/Labs” which listed each of those medications and had a “Reason/Justification” documented as “Staff Oversight”. On 2/13/25 at 1410 the above finding was reviewed during an interview with the Nurse Manager (Staff A) and the Quality Compliance Coordinator (Staff C). Staff C was asked if these medications were given as ordered on 2/8/25. Staff C stated that “Staff Oversight” meant that these medications were overlooked and acknowledged that these medications were not given according to physician orders.”

“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: 46476 Based on interview and record review, the facility failed to ensure evaluation for the appropriateness of the dialysis prescription for 1 (P-13) of 15 sample records reviewed potentially resulting in inability to meet the dialysis needs of the patient. Findings include: P-13: This 49-year-old was admitted to the facility on 4/30/10 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25. During review of the physician orders for hemodialysis dated 12/17/24, the number of days for dialysis treatment each week was ordered as 4 days (scheduled on Mondays, Wednesdays, Thursdays, and Fridays). The ordered dialysis treatment duration was 180 minutes, which is 3 hours. Additionally, there were “Unique Orders” with a “Start Date” of 3/18/24 which included the following, “on Monday and Wednesday patient will do 3 hrs treatment ... on Wednesday and Thursday patient will do 2 hrs and 45 min”. It was unclear from the orders when staff would choose to follow the unique orders (which had been added 11 months earlier) and if so, what the treatment time would be on Wednesdays because Wednesday was mentioned twice with different durations. Hemodialysis treatment duration times for Wednesdays between 1/29/25 and 2/12/25 were reviewed. During review the following were noted: On 1/29/25, (Wednesday), total treatment duration was 151 minutes (2 hours 31 minutes) On 2/5/25 (Wednesday), total treatment duration was 170 minutes (2 hours and 50 minutes) On 2/12/25, (Wednesday), total treatment duration was 166 minutes (2 hours and 46 minutes) During interview on 2/13/25 at 1410 with the Nurse Manger (Staff A), the Clinical Educator (Staff D) and the Quality Compliance Coordinator (Staff C), the question was asked, when staff would choose to use unique orders and what the treatment run time would be for Wednesdays. Staff A commented that the unique orders were helpful for P-13 because she does not usually want to stay for a 3-hour treatment and that staff could reduce the time by 15 minutes at least 2 of the 4 days each week to encourage her to comply. Staff D agreed that based on the unique orders, it was unclear how staff would choose a duration for Wednesdays. Staff D acknowledged that the physician orders were unclear in how many days the physician wanted the patient to be treated 3 hours and how many days were fine to treat for only 2 hours and 45 minutes.”

“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: 46476 Based on interview and record review the facility failed to ensure a comprehensive reassessment and revision of the plan of care (POC) was completed monthly for 1 (P-3) of 3 unstable in-center hemodialysis patient records reviewed potentially resulting in unmet patient needs and less than optimal patient outcomes. Findings include: P-3: This 54-year-old was admitted to the facility on 9/10/16 with end stage kidney disease and type 2 Diabetes. The medical record was reviewed on 2/12/25. During record review, it was noted on 12/14/24, the patient was determined by the facility to be unstable due to hospitalizations and an unstable POC was developed. There were no additional POC reassessments after that date provided for review. This finding was reviewed during interview on 2/13/25 at 1410 with the Nurse Manager (Staff A), the Quality Compliance Coordinator (Staff C), and the Registered Dietician (Staff L). Staff L stated that she sets up care plan meetings and the patient was in the hospital a lot so it was hard to find a time when everyone could get together with her. Staff L was asked if the patient had attended any hemodialysis treatments since becoming unstable. Staff L stated yes but that she (Staff L) liked to have the whole team together when they do a care plan meeting because the patient listens better that way. Staff L was asked if an unstable care plan was completed for this patient in January 2025. Staff L stated no. Staff L stated that “we” (meaning the interdisciplinary team) just opened one up yesterday (60 days since last completed unstable POC). Staff L was asked if the unstable POC started “yesterday” was complete, and Staff L stated “no” and acknowledged that an unstable POC had not been completed for this patient since becoming unstable on 12/14/24. Facility policy titled “Patient Assessment and Plan of Care”, revised 07-12-2024, was reviewed on 2/14/25. On page 2., it stated “A comprehensive IDT reassessment of each patient and a revision of the plan of care will be conducted ... (2) At least monthly for unstable patients ... If the patient or significant other is unable or unwilling to participate in the plan of care, this information will be documented in the plan of care.””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 37411 Based on record review and interview, the facility failed to deliver the dialysis prescription as ordered for 7 (P-2, P-3, P-7, P-8, P-11, P-12, and P-13) of 15 in-center patient records reviewed, out of a total sample of 15 records reviewed, resulting in failure to achieve optimal effectiveness of dialysis treatments provided and poor patient care outcomes. Findings include: **Policy titled “Patient Monitoring Guidelines” (revised 05-18-2023) states, “Monitoring During Dialysis: 7. Changes in treatment status and/or adverse side effects are continually monitored/assessed, communicated and documented in a timely fashion. Interventions and responses are recorded as necessary...” P-8: This 57-year-old male was admitted to the facility on 4/28/14, with diagnoses which included end stage renal disease and hypertension. On 2/13/25, record review of P-8’s six most recent in-center dialysis treatments (12/11/24 through 2/5/25) noted the following concern: The treatment flow sheet dated 2/5/25 documented the physician ordered dialysis prescription as BFR (Blood Flow Rate) to be delivered at 400 milliliters/minute (mL/min) with a unique order stating, “Blood flow rate 350-400 d/t (due to) cardiac problem as per order.” However, the 2/5/25 treatment sheet documented that the BFR was ran at 450 with no documented reason for the higher rate. This finding was reviewed and acknowledged by the Nurse Manger (Staff A) and Quality Compliance Coordinator (Staff C) during interview on 2/13/25 at 1045. 38304 P-2: This 67-year-old patient was admitted to this Facility on 11/24/2020, with diagnoses which included end stage renal disease, hypertension, diabetes-type 2, and anemia. On 2/12/25, record review of P-2’s six most recent in-center dialysis treatments (1/28/25 through 2/11/25) noted the following concern: The treatment flow sheet dated 2/6/25, documented the physician ordered (effective 1/3/25) a dialysis prescription for the BFR (Blood Flow Rate) to be delivered at 450 milliliters/minute (mL/min). Further review noted the BFR was delivered at 400 mL/min. from 1139 through 1200 by RN/Staff J. Then at 1231 through 1447 (end of treatment), 11 of 11 subsequent BFR recordings found it was further lowered to 350 mL/min. by certified technician/Staff K. No explanation or physician notification of changing the ordered BFR was found in the medical record. These findings were reviewed and acknowledged by the Facility Administrator (Staff B) and Quality Compliance Coordinator (Staff C) during interview on 2/13/25 at 1210. 46476 P-3: This 54-year-old was admitted to the facility on 9/10/16 with end stage kidney disease and type 2 Diabetes. The medical record was reviewed on 2/12/25 and included 6 hemodialysis flowsheets dated between 1/30/25 and 2/11/25. Active physician orders for hemodialysis during the time of review included a blood flow rate (BFR) of 500 milliliters/minute (mL/min), and a dialysate flow rate (DFR) of 800 mL/min each treatment. During record review, on the hemodialysis flowsheet dated 2/1/25, it was noted that the treatment duration was 185 minutes (3 hours and 5 minutes). It was also noted that the BFR was run at 250 mL/min (250 mL/min less than prescribed) from 0723 to 0818 (55 minutes). There was no documented explanation for the BFR being run lower than prescribed during this treatment. P-7: This 68-year-old was admitted to the facility on 12/4/23 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25 and included 6 hemodialysis flowsheets dated between 1/30/25 and 2/11/25. Active physician orders for hemodialysis during the time of review included a BFR of 450 mL/min and DFR of 800 mL/min each treatment. “Unique Orders” stated “BFR range From; 200 To; 500 DFR 2X BFR to 800 MAX” [sic], but it did not give an indication for why to deviate from the original order. During flowsheet review, the following were noted: On 1/30/25, the BFR was run at 400 mL/min (50 mL/min less than ordered) for the entire treatment (149 minutes) with no documented explanation. On 2/1/25, the BFR was run at 400 mL/min for the entire treatment (168 minutes) with no documented explanation. On 2/4/25, the BFR was run at 400 mL/min for the entire treatment (164 minutes) with no documented explanation. On 2/6/25, the BFR was run at 400 mL/min for the entire treatment (179 minutes) with no documented explanation. On 2/8/25, the BFR was run at 350 mL/min (100 mL/min less than ordered) for all but 25 minutes of the total treatment (113 minutes) and the DFR was run at 500 mL/min (300 mL/min less than ordered) for the entire treatment. There was no documented explanation for why the BFR and DFR were both run at a lower rate than prescribed. P-11: This 40-year-old was admitted to the facility on 10/26/24 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25 and included 6 hemodialysis flowsheets dated between 1/28/25 and 2/8/25. Active physician orders for hemodialysis during the time of review included a BFR of 350 mL/min and DFR of 700 mL/min each treatment. There were no unique orders noted. During flowsheet review, the following were noted: On the flowsheet dated 1/28/25, the BFR was run at 400 mL/min (50 mL/min more than ordered), and the DFR was run at 800 mL/min (100 mL/min more than ordered) for the entire treatment (197 minutes) with no documented reason. On 1/30/25, the BFR was run at 400 mL/min, and the DFR was run at 800 mL/min for the entire treatment (210 minutes) with no documented explanation. On 2/1/25, the DFR was run at 800 mL/min for the entire treatment (210 minutes) with no documented explanation. On 2/4/25, the DFR was run at 800 mL/min for the entire treatment (210 minutes) with no documented explanation. On 2/6/25, the BFR was run at 400 mL/min for the entire treatment (206 minutes). The DFR was run at 800 mL/min for 126 minutes, and then was turned down to 500 mL/min for the remainder of the treatment (80 minutes). There was no documented explanation for any of the changes. On 2/8/25, the DFR was run at 800 mL/min for the entire treatment (206 minutes) with no documented explanation. P-12: This 79-year-old was admitted to the facility on 1/19/24 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25 and included 6 hemodialysis flowsheets dated between 1/29/25 and 2/10/25. Active physician orders for dialysis during the time of review included a BFR of 500 mL/min and a DFR of 800 mL/min each treatment. “Unique Orders” stated that the DFR should be 2 times the BFR range of 400-500, and not to exceed 800 mL/min. It was unclear why the unique order would be written since the DFR would always be 800 mL/min. During flowsheet review, the following were noted: On 1/31/25, the DFR was run at 500 mL/min (300 mL/min less than ordered) for the entire treatment (212 minutes) with no documented explanation. On 2/5/25, the DFR was run at 500 mL/min for the entire treatment (196 minutes) with no documented explanation. On 2/7/25, the DFR was run at 500 mL/min for the entire treatment (213 minutes) with no documented explanation. P-13: This 49-year-old was admitted to the facility on 4/30/10 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25 and included 6 hemodialysis flowsheets dated between 1/31/25 and 2/10/25. Active physician orders for hemodialysis during the time of review included a BFR of 350 mL/min and a DFR of 800 mL/min each treatment. During flowsheet review, it was noted that on 2/3/25, the BFR was run at 300 mL/min (50 mL/min less than ordered), and the DFR was run at 500 mL/min (300 mL/min less than ordered) for 130 minutes of a 147-minute treatment. There was no documented explanation. On 2/12/25 at 1530, interview was conducted with the facility Medical Director (Staff E). Staff E was questioned regarding when staff were to use unique orders to change BFR or DFR. Staff E stated that the unique orders could be used for dialysis access site issues or symptom management but that ideally staff would challenge the patient beginning with the regular physician dialysis order and not the unique orders. Staff E was asked if staff should be documenting reasons for using the unique order versus the regular order and Staff E stated yes. These findings were reviewed and acknowledged by the Nurse Manger (Staff A) and Quality Compliance Coordinator (Staff C) during interview on 2/13/25 at 1410.”

“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: 46476 Based on interview and record review, the Medical Director failed to ensure an initial patient evaluation was completed by a registered nurse prior to the first hemodialysis treatment in accordance with facility policy in 1 (P-11) of 15 sample records reviewed potentially resulting in failure to identify immediate needs of the patient. Findings include: Facility Policy titled “Patient Assessment and Care Planning”, revised 07-12-2024, was reviewed on 2/13/25. On page 1., it stated “Prior to First Treatment A nursing evaluation/assessment must be completed before the first treatment is started and will be entered into the medical record ... This nursing evaluation is separate ... from the medical review and is an assessment the day the patient comes to first treatment which should be completed before the first treatment is started.” P-11: This 40-year-old was admitted to the facility on 10/26/24 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25. During record review, the initial nursing assessment was requested. On 2/13/25 at 1410 during interview, the Quality Compliance Coordinator (Staff C) stated that no initial nursing assessment could be found in the medical record prior to the first hemodialysis treatment. On 2/12/25 at 1530, interview was conducted with the facility Medical Director (Staff E). During interview, Staff E stated that he expected all staff to follow policies and procedures of the facility.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 37411 Based on record review and interview, the facility failed to ensure accurate records in 4 (P-3, P-8, P-9, and P-13) of 15 records reviewed, resulting in the potential for poor patient outcomes. Findings include: **Policy titled “Patient Monitoring Guidelines” (revised 05-18-2023) states, “III. Monitoring During Dialysis: 1. The blood pressure, pulse, hemodialysis machine parameters, and patient response to treatment are assessed, documented at least ... hourly (outpatient setting) on the hemodialysis flowsheet.” P-8: This 57-year-old male was admitted to the Facility on 4/28/14, with diagnoses which included end stage renal disease and hypertension. During record review on 2/13/25, it was noted the treatment dated 12/11/24 contained no “Hemodialysis Session Data” which notes BFR (Blood Flow Rate), VP (Venous Pressure), -AP (Arterial Pressure), TMP (Temperature), UFR (Ultrafiltration Rate), and DFR (Dialysate Flow Rate). Additionally, the treatment dated 2/5/25 documented a blood pressure at 1403 and the next at 1603. P-9: This 57-year-old male was admitted to the Facility on 5/15/20, with diagnoses which included end stage renal disease, hypertension and diabetes myelitis type 2. During record review on 2/13/25, it was noted that the treatment dated 1/31/25 contained no “Hemodialysis Session Data” between 0702 and 0903. Additionally, it was noted that the treatment dated 2/5/25 contained no “Hemodialysis Session Data” between 0657 and 0902. These findings were reviewed and acknowledged by the Nurse Manger (Staff A) and Quality Compliance Coordinator (Staff C) during interview on 2/13/25 at 1100. 46476 P-13: This 49-year-old was admitted to the facility on 4/30/10 with end stage kidney disease and high blood pressure. The medical record was reviewed on 2/13/25 and included 6 hemodialysis flowsheets dated between 1/31/25 and 2/10/25. Active physician orders during the time of review included a hemodialysis treatment duration of 180 minutes (3 hours) each treatment, and Heparin (a medication to prevent blood clotting), 1000 Units per hour for maintenance to be stopped 60 minutes prior to the end of treatment (for a total dose of 2000 Units each treatment if the treatment is 180 minutes). During flowsheet review, the following were noted: On 1/31/25, the treatment duration was 126 minutes (from 0941 to 1147). The flowsheet included an amount of Heparin administration in the section “HEP” and indicated that by 1106, the patient had received “13”. It was also noted at 0957, Staff M, a Certified Clinical Hemodialysis Technician (CCHT), signed out a 2000 Unit maintenance dose of Heparin. An interview was conducted on 2/13/25 at 1410 with the Nurse Manager (Staff A) and the Quality Compliance Coordinator (Staff C). Staff C stated that the section on the flowsheet titled “HEP” indicated the cumulative dose of Heparin given at time intervals during a treatment in Units of 100. Staff C stated that a reading of 13 would indicate the Heparin administration was 1300 at 1106. Staff C agreed that Staff M should have only signed out the amount which was given (1300 Units), and not the regular dose amount (2000 Units), and acknowledged that this was a documentation accuracy error. P-3: This 54-year-old was admitted to the facility on 9/10/16 with end stage kidney disease and type 2 Diabetes. The medical record was reviewed on 2/12/25 and included 6 hemodialysis flowsheets dated between 1/30/25 and 2/11/25. Active physician orders during the time of review included a hemodialysis treatment duration of 210 minutes (3.5 hours), and Heparin 500 Units per hour for maintenance to be stopped 60 minutes prior to the end of treatment (for a total dose of 1250 Units each treatment if the treatment is 210 minutes). During flowsheet review, it was noted that all 6 flowsheets reviewed had a cumulative Heparin dose reading during the treatment of “0” in the section of the flowsheet titled “HEP”. Additionally, it was noted that each flowsheet had a Heparin maintenance dose of 1300 Units signed out (with only one sign out time) indicating that this maintenance dose was given each treatment. It was unclear how the Heparin was cumulatively dosed (for maintenance) and if it had been stopped 60 minutes prior to the end of each treatment as ordered. Interview was conducted on 2/13/25 at 1410 with Staff A and Staff C. During interview, query was made to why this patient had a maintenance dose signed out with no documentation of cumulative dosing, and why there was no recording of the cumulative Heparin dosing on the flowsheets. After investigating, Staff C stated that this patient sets up her own dialysis machine each visit and had not been recording the Heparin dosing. Staff C acknowledged that this patient and staff need to be educated to document the proper administration time/dose of Heparin each treatment.”

“CFC-RESPONSIBILITIES OF THE MEDICAL DIRECTOR CFR(s): 494.150 This Condition is not met as evidenced by: 45246 Based on observation, interview and record review, the facility’s medical director failed to ensure staff adhered to policy and procedure regarding 1) blood flow rates and/or dialysate flow rates running as prescribed by the physician for 7 (P-8, 10, 11, 12, 13, 14 and 15) of 15 in-center patients reviewed and 2) post-treatment assessments are performed and documented after dialysis treatment for 5 (P-8, 12, 13, 14 and 15) of 15 in-center patients reviewed, resulting in the potential for adverse patient outcomes. Findings include: See Specific Tags: V-715 Failure to adhere to policy and procedure”

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 47415 Based on observation, interview and record, the facility failed to maintain an emergency preparedness program that included checking the emergency crash cart on the treatment floor daily, resulting in the potential for the inability to provide safe patient care in the event of any actual medical emergency for all 190 patients that were being served by the facility. Findings include: On 1/30/24 at 1120 during the initial tour of the facility, it was revealed that the facility failed to check the emergency crash cart daily. A review of the daily check log for the emergency crash cart (January 2024) indicated daily checks were not performed on 1/5, 1/6, 1/15, 1/22 ,1/23, and 1/24. Registered Nurse (RN) Staff E was queried about the missing daily checks on the emergency crash cart on the treatment floor. Staff F stated that daily checks on the crash carts are assigned to someone daily, by the charge nurse. On 1/30/24 at approximately 1330 and interview with Nurse Manager A revealed that the crash cart checks are assigned daily (except Sundays, facility is not open for treatment). A document review of the policy titled “Emergency Code Cart and Evacuation Box”, dated, 06/2021 states: “The Emergency Code Cart contents are checked daily during business hours and/or after it is opened for any ...The Lifepak 20 and suction machine are tested daily when unit is open, plugged and unplugged ...Records are kept of inspections on the top of the code cart”.”

“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: 47415 Based on observation, interview, and record review the medical director failed to ensure staff adhered to policy and procedure regarding 1) blood flow rates and/or dialysate flow rates running as prescribed by the physician for 7 (P-8, 10, 11, 12, 13, 14 and 15) of 15 in-center patients reviewed, and 2) post-treatment assessments are performed and documented after dialysis treatment for 5 (P-8, 12, 13, 14 and 15) of 15 in-center patients reviewed, resulting in the potential for adverse patient outcomes. Findings include: On 1/30/24 at 1400, review of the medical record revealed that P-10 had a prescribed blood flow rate (BFR) order of 200 to 500 with dialysate flow rate (DFR) of 2 x BFR to 800 Max, and 4 of 6 treatment sheets dated (1/18/24, 1/23/24, 1/27/24, 1/30/24) revealed: Treatment sheet dated 1/18/24: DFR was not documented in the hemodialysis session data section of the flowsheet for the entire treatment session from 1202 -1538 (216 minutes). Treatment sheet 1/23/24 BFR and DFR was not documented in the hemodialysis session data section of the flow sheet for the entire treatment session from 1224 - 1500 (156 minutes). Treatment sheet 1/27/24 DFR was not documented in the hemodialysis session data section of the flow sheet for the entire treatment session from 1203 -1504 (181 minutes). Treatment sheet dated 1/30/24 DFR was not documented in the hemodialysis session data section of the flow sheet for the entire treatment session from 1216 - 1512 (176 minutes). No documentation found on any of the above listed treatment sheets as to why the prescription documentation was not present. On 1/30/24 at 1430, review of the medical record revealed that P-11 had a prescribed Blood flow rate (BFR) order of 200 to 500 with Dialysate flow rate (DFR) of 2 x BFR to 800 Max, and for 4 of 6 treatment sheet dated (1/13/24, 1/23/24, 1/27/24, 1/30/24) revealed: Treatment sheet dated 1/13/24: BFR documented as running at 400 with DFR at 500 during entire treatment session from 0639-0958 (199 minutes) Treatment sheet 1/23/24: BFR documented as running at 400 with DFR at 500 during entire treatment session from 0734-1055 (201 minutes). Treatment sheet 1/27/24: BFR documented as running at 400 with DFR at 500 during entire treatment session from 0623 -0942 (199 minutes). Treatment sheet dated 1/30/24 BFR documented as running at 450 from 0720- 1002 at 1027 entry BFR is documented at 0 with DFR at 500 from 0720 - 1027, during treatment session from 0714-1030 (196 minutes). No documentation found on any of the above listed treatment sheets as to why the prescription was not run at that prescribed rate. On 1/31/24 at approximately 0900, Manager Staff A was queried in her office as to if there was a reason the DFR and BFR was not run or not documented as prescribed. She stated prescription should be followed and called in Floor Staff D to her office to clarify. Floor Staff D queried on why DFR was documented as 0 on the treatment records for P-10 and she stated it should have been manually entered at prescribed rate, the machine may not have been transferring data. Staff D also queried on variance in DFR rates from prescription and stated it should be clarified with the physician and documented. Policy titled, “Patient Monitoring Guidelines”, dated 5/18/2023, states under section Monitoring During Dialysis: “The blood pressure, pulse, hemodialysis machine parameters, and patient response to treatment are assessed, documented at least every half hour (inpatient setting) and hourly (outpatient setting) on the hemodialysis flowsheet. If the patient condition warrants, vital signs will be monitored and documented more frequently ...For permanent access (i.e., graft or fistula) target blood flow will be 400 to 500 ml/min. if attainable within the pre-pump arterial pressure limits of the maximum of -250 mm Hg. For catheters, the target blood flow will be 300 ml/min or greater. An inability to consistently maintain a specified blood flow rate may require access intervention and documentation ...Changes in treatment status and/or adverse side effects are continually monitored/assessed, communicated, and documented in a timely fashion. Interventions and responses are recorded as necessary. Interventions may include but are not limited to adjustment of blood flow based on arterial and venous pressures, ultrafiltration rate, adjustment of needle placement, and initiation of sodium modeling/variation when applicable. The appropriateness of the intervention will directly affect the patient’s outcome and is based on a thorough assessment, which assures that the main goals of patient safety and adequacy of dialysis are achieved ...The attending physician or designee is notified of any unusual problems in a timely manner”. On 2/01/24 at 1025 phone interview with Medical Director (Staff J) revealed that it was his expectation that staff follow policy and procedure, and that between the mid-level providers and himself, someone was always available to be called. 45246 Nursing care observation, treatment orders review in real time and Interview with Staff E, Registered nurse, was conducted on 1/30/24 at 14:40. Staff E showed orders P-15 and compared them to dialysis machine settings. P-15 had orders for BFR (blood flow rate) at 450 and DFR (dialysate flow rate) at 0 (zero). Dialysis machine for P-15 was set for BFR 400 and DFR at 800. When asked how Staff E knows what DFR rate to set for treatment if provider’s order indicated 0 (zero), nurse responded that it is usually set to 800 or twice the rate of BFR. On 01/31/24 during review of records for 5 patients of 15 sampled revealed the following documentation. P-8’s treatment orders dated 01/12/24 indicated: duration- 220 min, BFR (blood flow rate)- 500, DFR (dialysate flow rate)- 800. Unique orders dated -1/30/24 (after entrance conference on site) revealed the following: BFR range from 200 to 500, DFR 2 x (twice) BFR to 800 max. P-8’s treatment dated 01/19/24 started at 0916 and was done at 1215. At 0916 BFR was recorded 400, DFR was 800. At 0942 DFR was changed to 500 and stayed at this rate till 1215. No nursing progress/treatment note was found with explanation of DFR change and provider’s notification. On 1/22/24 treatment flowsheet for P-8 indicated dialysis began at 1201 and was done at 1441. BFR was documented as 400, DFR as 300. No nursing progress/treatment note was found with explanation of the reason why DFR was changed to 300 and no provider’s notification was found in the record. P-12’s treatment orders dated 01/09/24 indicated: duration- 220 min, BFR- 500, DFR- 800. Unique orders dated -1/30/24 (after entrance conference on site) revealed the following: BFR range from 200 to 800, DFR 2 x (twice) BFR to 800 max. Review of P-12’s treatment flowsheets revealed the following documentation. Treatment dated 01/10/24: treatment order- BFR 500, DFR -800. Treatment was initiated at 1033 and completed at 1357. During treatment BFR was set to 350 and DFR was at 700. No nursing notes were found regarding clarification with provider of changing BFR setting to 350 instead of 500 as per order. There were no unique orders with flow range at that treatment date. Treatment dated 01/12/24: treatment order- BFR 500, DFR -800. Treatment was initiated at 1029 and completed at 1410. During treatment BFR was set to 350 and DFR was at 800. No nursing notes were found regarding clarification with provider of changing BFR setting to 350 instead of 500 as per order. There were no unique orders with flow range for that treatment date. Treatment dated 01/17/24: treatment order- BFR 500, DFR -800. Treatment was initiated at 1200 and completed at 1447. During treatment BFR was set to 350 and DFR was at 800. No nursing notes were found regarding clarification with provider of changing BFR setting to 350 instead of 500 as per order. There were no unique orders with flow range for that treatment date. P-13’s treatment orders dated 12/27/23 indicated: duration- 210 min, BFR- 400, DFR- 800. Unique orders dated -1/30/24 (after entrance conference on site) revealed the following: BFR range from 200 to 500, DFR 2 x (twice) BFR to 800 max. Review of P-13’s treatment flowsheets revealed the following documentation. Treatment dated 01/16/24: treatment order- BFR 400, DFR -800. Treatment was initiated at 0557 and completed at 0933. During treatment BFR was recorded in range from 400 to 450 and DFR was documented as 0 (zero) from 0557 till 0659 (for over an hour) and set at 800 for the rest of the dialysis treatment. No nursing notes were found regarding clarification with provider of changing DFR setting to 0 instead of 800 as per order. There were no unique orders with flow range for that treatment date. Treatment dated 01/18/24: treatment order- BFR 400, DFR -800. Treatment was initiated at 0607 and completed at 0928. During treatment BFR was recorded as 300 and DFR was documented as 0 (zero) from 0607 till 0812 (for over two hours) and set at 800 for the rest of the dialysis treatment. No nursing notes were found regarding clarification with provider of changing DFR setting to 0 instead of 800 as per order. There were no unique orders with flow range for that treatment date. Treatment dated 01/20/24: treatment order- BFR 400, DFR -800. Treatment was initiated at 0604 and completed at 0942. During treatment BFR was recorded as 400 and DFR was documented as 0 (zero) from 0604 till 0702 (for 58 minutes) and set at 800 for the rest of the dialysis treatment. No nursing notes were found regarding clarification with provider of changing DFR setting to 0 instead of 800 as per order. There were no unique orders with flow range for that treatment date. P-14’s treatment orders dated 1/20/24 indicated: duration- 180 min, BFR- 500, DFR- 800. Unique orders dated -1/30/24 (after entrance conference on site) revealed the following: BFR range from 200 to 500, DFR 2 x (twice) BFR to 800 max. Review of P-14’s treatment flowsheets revealed the following documentation. Treatment dated 01/26/24: treatment order- BFR 500, DFR -800. Treatment was initiated at 0920 and completed at 1217. During treatment BFR was set to 400 and DFR was at 500. No nursing notes were found regarding clarification with provider of changing BFR setting to 400 instead of 500 and DFR to 500 instead of 800 as per order. There were no unique orders with flow range for that treatment date. P-15’s treatment orders dated 1/31/24 (after entrance conference on site) indicated: duration- 210 min, BFR- 450, DFR- 800. Unique orders dated -1/30/24 (after entrance conference on site) revealed the following: BFR range from 200 to 500, DFR 2 x (twice) BFR to 800 max. Review of P-15’s treatment flowsheets revealed the following documentation. Treatment dated 01/18/24: treatment order- BFR 450, DFR -0. Treatment was initiated at 1128 and completed at 1501. During treatment BFR was in range from 400 to 450 and DFR was at 800. No nursing notes were found with clarification with provider regarding DFR settings. Treatment dated 01/20/24: treatment order- BFR 450, DFR -0. Treatment was initiated at 1228 and completed at 1531. During treatment BFR was 350 and DFR was at 800. No nursing notes were found with clarification with provider regarding BFR and DFR settings. Treatment dated 01/23/24: treatment order- BFR 450, DFR -0. Treatment was initiated at 1132 and completed at 1428. During treatment BFR was 450 and DFR was at 700. No nursing notes were found with clarification with provider regarding DFR settings. Treatment dated 01/27/24: treatment order- BFR 450, DFR -0. Treatment was initiated at 1213 and completed at 1517. During treatment BFR was 450 and DFR was at 500. No nursing notes were found with clarification with provider regarding DFR settings at 500 for the whole duration of the treatment. On 02/01/24 at 0925 during interview with Staff A, she stated that BFR and DFR for patients’ dialysis treatments are ordered by provider and if need adjustments or changes due to patient’s condition communication should be initiated between nurses and prescribing physician. Further review of patients’ records was conducted on 2/01/24. Review of P-8’s treatment flowsheets revealed the following documentation. On 1/23/24 dialysis treatment was initiated at 1127 and completed at 1500. Nursing post-treatment assessment was documented at 1449 (prior to treatment completion). On 1/25/24 dialysis treatment was initiated at 1142 and completed at 1527. Nursing post-treatment assessment was documented at 1424 (one hour and 3 minutes prior to treatment completion). Review of P-12’s treatment flowsheets revealed the following documentation. On 1/08/24 dialysis treatment was initiated at 1032 and completed at 1350. Nursing post-treatment assessment was documented at 1345 (prior to treatment completion). On 1/12/24 dialysis treatment was initiated at 1029 and completed at 1410. Nursing post-treatment assessment was documented at 1409 (prior to treatment completion). Review of P-13’s treatment flowsheets revealed the following documentation. On 1/18/24 dialysis treatment was initiated at 0607 and completed at 0928. Nursing post-treatment assessment was documented at 0926 (prior to treatment completion). On 1/20/24 dialysis treatment was initiated at 0604 and completed at 0942. Nursing post-treatment assessment was documented at 0938 (prior to treatment completion). On 1/23/24 dialysis treatment was initiated at 0532 and completed at 0913. Nursing post-treatment assessment was documented at 0838 (35 minutes prior to treatment completion). Review of P-14’s treatment flowsheets revealed the following documentation. On 1/24/24 dialysis treatment was initiated at 0947 and completed at 1247. Nursing post-treatment assessment was documented at 1222 (prior to treatment completion). On 1/26/24 dialysis treatment was initiated at 0920 and completed at 1217. Nursing post-treatment assessment was documented at 1214 (prior to treatment completion). On 1/29/24 dialysis treatment was initiated at 0900 and completed at 1145. Nursing post-treatment assessment was documented at 1135 (prior to treatment completion). Review of P-15’s treatment flowsheets revealed the following documentation. On 1/18/24 dialysis treatment was initiated at 1128 and completed at 1501. Nursing post-treatment assessment was documented at 1500 (prior to treatment completion). On 1/27/24 dialysis treatment was initiated at 1213 and completed at 1517. Nursing post-treatment assessment was documented at 1455 (prior to treatment completion). On 2/01/24 at 1025 during interview with Medical Director of the facility Staff J he was asked if the expectations are for nursing staff to assess and document post-treatment assessment after the dialysis treatment was completed Staff J stated “yes, that’s why it is called post-treatment assessment”. Facility’s Policy for Patient monitoring was requested and reviewed on 2/01/24. Patient Monitoring Guidelines approved 12/08 and revised 05/18/23 indicated: Changes in treatment status and/or adverse side effects are continually monitored/assessed, communicated and documented in a timely fashion. Interventions and responses are recorded as necessary. Interventions may include but are not limited to adjustment of blood flow based on arterial and venous pressures, ultrafiltration rate, adjustment of needle placement, and initiation of sodium modeling/variation when applicable. The appropriateness of the intervention will directly affect the patient’s outcome and is based on a thorough assessment, which assures that the main goals of patient safety and adequacy of dialysis are achieved. The attending physician or designee is notified of any unusual problems in a timely manner. Post-dialysis monitoring is conducted to evaluate the patient’s response to therapy and effectiveness in achieving planned goals. The data is documented in the post-dialysis note areas of the hemodialysis flowsheet. A patient assessment is performed post-treatment based on collected data, patient complaints, and/or observations. Facility’s Policy for Responsibilities of Medical Directors was requested and reviewed on 2/01/24. Policy approved 09/01 and revised 05/21 indicated the following. The Medical Directors of the ESRD Programs are responsible for ensuring the following: Assuring complete and intensive training of staff in dialysis therapy procedures, techniques and theory. Assuring and maintaining safe and effective monitoring of the patient and dialysis process. Assuring that 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 non-physician providers.”