Fresenius Medical Care Denbigh

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 34452 Based on observation, interview and document review, it was determined that the facility failed to maintain a locked emergency cart when not use per facility policy for one (1) of one (1) emergency carts in the treatment area of the in-center hemodialysis (ICHD) unit. The findings include: On February 13, 2024 at 10:30 a.m., during the initial tour of the ICHD unit, the emergency cart was observed to be unlocked. On February 14, 2024, a review of the facility policy titled “Emergency Medications, Equipment and Supplies” reads in part “the emergency cart must be: locked when not in use.” On February 14, 2024 at 9:30 a.m., an interview with Staff Member (SM) # 2 revealed “the cart is locked now.” On February 14, 2024 at 2:00 p.m., the findings were discussed with SM # 2, # 3 and # 4 during the exit interview.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 34452 Based on document review and interview, it was determined that the facility failed to ensure Patient education and documentation of Emergency Preparedness (EP) training was completed for two (2) of ten (10) In-center Hemodialysis (ICHD) Patients (P), P # 1 and # 6. The findings include: On February 14, 2024 between 9:30 a.m. and 1:00 p.m., clinical record reviews revealed there was no documented EP education and training for P # 1 and # 6. On February 14, 2024 at 1:00 p.m., an interview with SM # 1 revealed “I could not find any EP education and training for [Patient Names].” On February 14, 2024 at 1:15 p.m., a review of the facility policy titled “Guidelines for Emergency Preparedness” reads in part “Quarterly, all [Name of facility] patients must receive fire drill and emergency evacuation training. Training must be documented.” On February 14, 2024 at 2:00 p.m., the findings were discussed with SM # 2, # 3 and # 4 during the exit interview.”

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 34452 Based on observation, interview and document review, it was determined that the facility failed to ensure a sanitary environment to minimize the transmission of infectious agents in treatment area by having stained ceiling tiles for one (1) of twenty six (26) Stations, Station # 19. The findings include: On February 13, 2024 at 10:30 a.m. during the initial tour of the in-center hemodialysis (ICHD) unit, the ceiling tiles above Station # 19 were observed to be stained. There were several rings of stain ranging from 3 to 6 inches in diameter, causing what appeared to be overlapping stains. (A stained ceiling tile is typically the result of a water damage from a leak. This can cause mold or mildew growth to form on the ceiling tile which can present an infection risk to patients.) On February 14, 2024, a review of the facility policy titled “General Cleanliness and Infection Control Guidelines” reads in part “the purpose of this policy is to provide guidance for [Name of Facility] staff on preventing the spread of infectious disease and maintain a clean, safe aesthetically pleasant environment for patients, staffs and visitors. All areas must be kept clean and organized including but not limited to the treatment area...” On February 14, 2024 at 2:00 p.m., the findings were discussed with Staff Members # 2, # 3 and # 4 during the exit interview.”

“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: 34452 Based on document review and interview, it was determined that the facility staff failed to evaluate and ensure the appropriate dialysis prescription was obtained for three (3) of ten (10) in-center hemodialysis (ICHD) Patients (P), P # 2, # 4 and # 5. The findings include: On February 14, 2024 between 9:30 a.m. and 1:00 p.m., during clinical record reviews the following was revealed: P # 2- The flowsheet dated February 12, 2024 revealed the Physician’s prescription ordered a blood flow rate (BFR) of 400. The treatment was initiated at 12:40 p.m. and ended at 4:23 p.m. The BFR from 2:03 p.m. until the end of the treatment was documented at 375. There was no documentation of why the BFR was decreased or that the RN or Physician was notified of the decreased BFR. P # 4- The flowsheet dated February 9, 2024 revealed the Physician’s prescription ordered a BFR of 350. The treatment was initiated at 12:49 p.m. and ended at 4:31 p.m. The BFR from 2:33 p.m. until the end of the treatment was documented at 300. There was no documentation of why the BFR was decreased or that the RN or Physician was notified of the decrease BFR. P # 5- The flowsheet dated February 6, 2024 revealed the Physician’s prescription ordered a BFR of 400. The treatment was initiated at 6:02 a.m. and ended at 10:06 a.m. The BFR from 6:02 a.m. until 9:33 a.m. was documented at 350. There was no documentation of why the BFR was decreased or that the RN or Physician was notified of the decrease BFR. There was no documentation by the RN of treatment verification within one hour of the initiation of the treatment. The flowsheet for P # 5 dated February 8, 2024 revealed the Physician’s prescription ordered a BFR of 400. The treatment was initiated at 6:05 a.m. and ended at 10:10 a.m. The BFR from 6:05 a.m. until 8:04 a.m. was documented at 250. The BFR from 8:34 a.m. until the end of the treatment was documented at 200. There was no documentation of why the BFR was decreased or that the RN or Physician was notified of the decrease BFR. The documentation by the RN of treatment verification at 6:30 a.m. revealed “verified machine setting” yet the BFR was below the Physician ordered prescription with no explanation documented. The flowsheet for P # 5 dated February 10, 2024 revealed the Physician’s prescription ordered a BFR of 400. The treatment was initiated at 6:15 a.m. and ended at 10:27 a.m. The BFR from 6:27 a.m. until 7:48 a.m. was documented at 250. The BFR from 8:08 a.m. until the end of the treatment was documented at 300. There was no documentation of why the BFR was decreased or that the RN or Physician was notified of the decrease BFR. The documentation by the RN of treatment verification at 6:41 a.m. revealed the “verified machine setting” yet the BFR was below the Physician ordered prescription with no explanation documented. The flowsheet for P # 5 dated February 13, 2024 revealed the Physician’s prescription ordered a BFR of 400. The treatment was initiated at 6:16 a.m. and ended at 10:20 a.m. The BFR from 6:27 a.m. until the end of treatment was documented at 350. There was no documentation of why the BFR was decreased or that the RN or Physician was notified of the decrease BFR. The documentation by the RN of treatment verification at 6:52 a.m. revealed the “verified machine setting” yet the BFR was below the Physician ordered prescription with no explanation documented. On February 14, 2023 at 1:00 p.m., a review of the facility’s policy titled “Pre-intra-post treatment data collection, monitoring and nursing assessment” reads in part “Document machine parameters and safety checks every 30 or more often as needed but not to exceed 45 minutes. Check machine settings and measurements: Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.” The Nursing Supervision and Delegation policy reads in part: “...The registered nurse must evaluate the patient preferably within an hour or according to state requirements to... Review patient treatment prescription and equipment parameter to verify correct settings, and if dialysis prescription is being followed ...”. On February 14, 2024 at 2:00 p.m., the findings were discussed with Staff Members # 2, # 3 and # 4 during the exit interview.”

“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: 34452 Based on document review and interview, it was determined that the facility failed to obtain and document standing blood pressures (BP) for two (2) of ten (10) In-Center Hemodialysis (ICHD) Patients (P), P # 1 and # 3; and assess and document at least every 45 minutes treatment data to include blood pressures for three (3) of ten (10) ICHD Patients, P # 2 and # 3 , and # 4. The findings include: On February 14, 2024 between 9:30 a.m. and 1:00 p.m., during clinical record reviews the following was revealed: P # 1- The flowsheet dated February 6, 2024 revealed Pre treatment standing BP as “cannot assess”. The post treatment standing BP was documented as 161/72. The nursing evaluation at 7:56 a.m. revealed ambulation status “ambulates without assistance”. The flowsheet dated February 10, 2024 revealed Pre treatment standing BP as “cannot assess”. The post treatment standing BP was documented as 164/71. The nursing evaluation at 8:03 a.m. revealed ambulation status “ambulates without assistance”. The flowsheet dated February 13, 2024, revealed Pre treatment standing BP as “cannot assess”. The post treatment standing BP was documented as 138/70. The nursing evaluation at 7:32 a.m. revealed ambulation status “ambulates without assistance”. P # 2- The flowsheet dated February 2, 2024 revealed there was no documentation of treatment data to include BP between 2:32 p.m. and 3:30 p.m. (more than 45 minutes). The flowsheet dated February 5, 2024 revealed there was no documentation of treatment data to include BP between 1:02 p.m. and 2:09 p.m. (more than 45 minutes). P # 3- The flowsheet dated February 3, 2024 revealed Pre treatment standing BP 231/81. The post treatment standing BP was documented as “cannot assess”. The flowsheet dated February 7, 2024 revealed there was no documentation of treatment data to include BP between 6:33 a.m. and 7:30 a.m. (more than 45 minutes). P # 4- The flowsheet dated February 9, 2024 revealed there was no documentation of treatment data to include BP between 1:34 p.m. and 2:33 p.m. (more than 45 minutes). On February 14, 2023 at 1:00 p.m., a review of the facility’s policy titled “Pre-intra-post treatment data collection, monitoring and nursing assessment” reads in part “ Standing BP is obtained pre and post dialysis by the licensed nurse or PCT (Patient Care Technician). Obtain blood pressure and pulse rate every 30 minutes or more as needed but not to exceed 45 minutes.” On February 14, 2024 at 2:00 p.m., the findings were discussed with Staff Members # 2, # 3 and # 4 during the exit interview.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 34452 Based on document review and interview, it was determined that the facility failed to ensure the Plan of Care was completed and signed by the interdisciplinary team (IDT) including the Patient for one (1) of ten (10) Patients (P), P # 2. The findings include: On February 14, 2024 between 9:30 a.m. and 1:00 p.m., clinical record reviews revealed the following: Patient # 2- The Patient’s plan of care meeting was documented as January 29, 2024. There was no Physician, Registered Nurse (RN), and Registered Dietitian (RD) signature (attended in person) to reflect participation in the plan of care meeting. On February 14, 2024 at 1:00 p.m., a review of the facility policy titled “Comprehensive Interdisciplinary Assessment an Plan of Care” reads in part “The Comprehensive Interdisciplinary Assessment and Plan of Care must be developed and implemented by an interdisciplinary team (IDT) consisting of at a minimum, the Patient or Patient’s designee ... The Plan of Care must be signed at the time of the interdisciplinary team meeting for those attending in person. If unable to sign at the time of the meeting or if attending remotely, the care plan must be signed by the IDT member within 30 days of the interdisciplinary team meeting.” On February 14, 2024 at 2:00 p.m., the findings were discussed with Staff Members (SM) # 2, # 3 and # 4 during the exit interview. SM # 2 stated “we identified an issue with care plans in November 2023 and have an action plan in place.””