Fmc Dialysis Center of Newington

“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: 44675 Based on observation, interview and review of facility policy, the facility failed to ensure the facility hemodialysis stations were maintained in a sanitary, clean manner with impermeable surfaces in accordance with facility policy. The findings included: Observations conducted on 6/16/25 at 9:10 AM of the facility treatment floor identified the following: a. Observations of Stations #2, #4, #5, #6, #7, #8, #9 and #10 had a small, ripped piece of blue painters tape (porous material that cannot be disinfected) below the wallbox. b. Observations of Station #11 had medical tape (porous material that cannot be disinfected) on the wallbox in a “x” shape stating do not use. Interview and observation with Staff Member #6 on 6/16/25 at 9:30 AM identified at Station #11, the acid was pouring out when the valve was turned on. She identified the biomed clamped the value and was told to use an acid jug for treatments. Interview and observation with the Biomedical Manager on 6/17/25 at 3:00 PM identified at the Station #11, the acid valve is broken and will be replaced once the patient’s are off the station as it can not be repaired when patient’s are treating. c. Observations of Stations #11, #12, #13, #14, #15 and #16 had large pieces of blue painters tape below the wallbox, with some tape peeling up. Interview and observation with the Regional Operations Manager on 6/27/25 at 3:30 PM identified he was not aware of the tape below each wallbox, subsequent to surveyor inquiry the tape was removed from the stations. Interview and observation with the Biomedical Technician on 6/17/25 at 3:30 PM identified he was unaware why there was tape below each wallbox on the treatment floor and identified place the tape on the wall boxes. Review of the cleaning and disinfecting the dialysis station policy directed that in order to prevent cross contamination, a dialysis station must be cleaned and disinfected between dialysis patients. It directed to use a cloth wetted with 1:100 bleach solution to clean and disinfect the dialysis station. It further directed to surface disinfect the dialysis wall box and the area/wall around the wall box at the end of each treatment day or immediately if splattered with blood.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 47491 Based on observations, review of facility policy, and interviews, the facility failed to ensure the water room was only accessible to facility staff, and that a service contractor was supervised in the water room (a secured room where the focus is on maintaining water quality to ensure patient safety during hemodialysis) while performing repairs resulting in a finding of Immediate Jeopardy. The finding includes the following: On 6/13/25 at 9:15 AM, a service contractor (not employed by the facility) was observed to enter the passcode to the water room door, then proceeded to enter the water room unsupervised by staff. Further observation on 6/13/25 a 9:50 AM identified the service contractor was still working in the water room unsupervised (a total of thirty-five (35) minutes after entering at 9:15 AM). Interview with the Area Technical Operations Manager (ATOM) on 6/13/25 at 12:37 PM identified he had given the service contractor the code to enter the water room as the contractor indicated he/she would be at the facility around 5:00 AM on 6/13/25 to perform a repair to the water heater, located in the water room. The Manager was aware that a staff member would not have been available to let the service contractor into the water room and supervise the work being done at 5:00 AM. The Manager further identified that the code to the water room should not have been given to a non-staff member and that the repair was not an emergency and could have been scheduled at a time when appropriate staff was able to provide oversight in the water room. Interview with the Service Contractor (SC) on 6/13/25 at 11:32 AM identified he/she was at the facility to fix an issue with the water heater which was located in the water room. The SC knew the codes to the doors of the facility and would let him/herself in to perform the work needed as long as the facility was notified he/she would be there. The SC further identified that it has been his/her experience to perform the work at the facility unsupervised in the water room. Interview with the Facility Administrator on 6/13/25 at 9:44 AM identified that when a service contractor needs to come to the building to perform maintenance or repairs in the water room they enter through the front of the building and a staff member will escort the service contractor to the water room and and supervise the contractor while the repair(s) were being made. The Facility Administrator further identified that contractors should not have the codes to the building doors and that staff should always supervise the service contractor while work was being done in the water room. Review of the Physical Security and Facility Access policy directed Non-Fresenius Kidney Care employees or third party personnel must be under direct observation/supervision of a Fresenius Kidney Care employee while working in or outside a facility, the facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic, Non Fresenius Kidney Care employees and third party personnel who repair/maintain water treatment equipment or deliver supplies in the water treatment area must be monitored at all times by a Fresenius Kidney Care employee while in the area, and technical staff will supervise any work being performed in the water treatment area of a technical nature; this may not be delegated to non-technical staff.”

“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: 38422 Based om observation and interviews the facility failed to ensure that the sprinkler heads were free of dust and debris, smoke detectors were tested, door were not porpped open and fire drills were completed. The findings include: a. On 06/13/2025 at approximately 9:30 AM, the surveyor observed sprinkler heads on the treatment floor had dust and debris in them negating their ability to operate as designed as required by Sections 4.8 and 5.2.1.1.1 of NFPA 25 “Standard for the Inspection, Testing, and Maintenance of Water Based Fire Protection Systems”. The loaded sprinkler heads were noted on prior sprinkler reports. b. On 06/13/2025 at approximately 11:00 AM, Documentation review of the facility fire alarm testing records indicated that smoke detectors were not tested for sensitivity as required by Section 9.6.1.3 of NFPA 101 “Life Safety Code” and Section 14.4.5.3.2 of NFPA 72 “National Fire Alarm Code” c. On 06/13/2025 at approximately 9:30 AM, the surveyor observed the fire door separating the Supply Room and the corridor was propped open with an unapproved device not allowing the door to close upon alarm activation as required. d. On 06/13/2025 at approximately 11:00 AM, Documentation provided indicated that the facility did not complete the required fire drills for the fourth quarter of 2024.”

“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: 47491 Based on review of clinical records, interview, and review of facility policy and documentation for one (1) of five (5) patients (Patient #4) reviewed for treatments, the facility failed to administer the patient’s dialysis treatment in accordance with physician’s orders. The findings included: Patient #4 had diagnoses that included end stage renal disease. Physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and thirty (30) minutes per treatment, using a 2.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 450, and dialysate flow rate (DFR) of 800 while using a central venous catheter (CVC). Review of Patient #4’s treatment records identified the following: a. On 5/7/25, Patient #4’s treatment was administered at a DFR of 400 from 12:32 PM to 1:11 PM, 700 from 1:11 PM to 3:34 PM without documentation identifying the reason the ordered DFR of 800 was not achieved. b. On 5/19/25, Patient #4’s treatment was administered at a DFR of 700 the entire treatment without documentation identifying the reason the ordered DFR of 800 was not achieved. c. On 5/23/25, Patient #4’s treatment was administered at a BFR of 400 and DFR of 700 the entire treatment without documentation identifying the reason the ordered BFR of 450 and DFR of 800 were not achieved. d. On 5/26/25, Patient #4’s treatment was administered at a BFR of 400 and DFR of 600 the entire treatment without documentation identifying the reason the ordered BFR of 450 and DFR of 800 were not achieved. e. On 5/30/25, Patient #4’s treatment was administered at a BFR of 400 and DFR of 600 the entire treatment without documentation identifying the reason the ordered BFR of 450 and DFR of 800 were not achieved. f. On 6/2/25, Patient #4’s treatment was administered at a BFR of 400 from 12:26 PM to 2:06 PM, 300 from 2:06 PM to 3:21 PM and DFR of 600 from 2:06 PM to 3:21 PM without documentation identifying the reason the ordered BFR of 450 and DFR of 800 were not achieved. g. On 6/4/25, Patient #4’s treatment was administered at a DFR of 500 from 12:44 PM to 1:13 PM and 700 from 1:13 PM to 3:37 PM without documentation identifying the reason the ordered DFR of 800 was not achieved. h. On 6/6/25, Patient #4’s treatment was administered at a DFR of 700 the entire treatment without documentation identifying the reason the ordered DFR of 800 was not achieved. i. On 6/9/25, Patient #4’s treatment was administered at a BFR of 475 from the entire treatment without documentation identifying the reason the ordered BFR of 450 was exceeded. Interview with the Facility Administrator 6/17/25 at 3:16 PM identified staff should be documenting reason the prescribed BFR and DFR could not be attained in the electronic medical record, and that the both the charge nurse and physician should be informed. Review of the Patient Assessment and Monitoring policy directed to check that the prescribed blood flow rate is being achieved or to document, in the medical record, if unable to meet the prescribed blood flow rate and to check the dialysate flow rate setting was correct and that the prescribed flow was being delivered.”

“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: 47491 Based on review of clinical records, interviews, review of facility documentation and policy for two (3) of five (5) five patients (Patient #1 #2, #4) reviewed for vital signs during hemodialysis treatment, the facility failed to ensure vital signs were performed in accordance with facility policy. The findings included: 1. Patient #1 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three times weekly for four (4) hours with an arteriovenous fistula (AVF) and a blood flow rate (BFR) of 450. A sample review of Patient #1’s dialysis treatment sheets identified the following: a. On 5/30/25 at 1:02 PM Patient #1’s vital signs and machine parameters (blood pressure, pulse, access pressures and fluid removal amount) were taken. At 2:05 PM (1 hour and 3 minutes later) Patient #1’s vital signs and machine parameters were taken. The flowsheet failed to identify vital signs and machine parameters were taken at the thirty (30) minute mark. b. On 6/6/25 at 10:05 AM Patient #1’s vital signs and machine parameters (blood pressure, pulse, access pressures and fluid removal amount) were taken. At 11:02 AM (57 minutes later) Patient #1’s vital signs and machine parameters were taken. The flowsheet failed to identify vital signs and machine parameters were taken at the thirty (30) minute mark. c. On 6/13/25 at 9:09 AM Patient #1’s vital signs and machine parameters (blood pressure, pulse, access pressures and fluid removal amount) were taken. At 10:07 PM (58 minutes later) Patient #1’s vital signs and machine parameters were taken. The flowsheet failed to identify vital signs and machine parameters were taken at the thirty (30) minute mark. 2. Patient #2 had diagnoses that included end stage renal disease. Physician’s orders directed hemodialysis three (3)times weekly for three (3) hours and thirty (30) minutes per treatment, using a 2.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 450, and an autoflow dialysate flow rate while using an arteriovenous fistula (AVF). Review of Patient #2’s treatment records identified the following: a. On 6/9/25, a blood pressure reading of 107/70 was identified at 6:28 AM. The next blood pressure reading of 102/53 was identified at 7:42 PM, one (1) hour and fourteen (14) minutes following the previous reading. b. On 6/13/25, a blood pressure reading of 131/74 was identified at 8:05 AM. The next blood pressure reading of 117/58 was identified at 9:06 AM, one (1) hour and one (1) minute following the previous reading. 3. Patient #4 had diagnoses that included end stage renal disease. Physician’s orders directed hemodialysis three (3)times weekly for three (3) hours and thirty (30) minutes per treatment, using a 2.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 450, and dialysate flow rate (DFR) of 800 while using a central venous catheter (CVC). Review of Patient #4’s treatment records identified the following: a. On 5/30/25, a blood pressure reading of 124/69 was identified at 1:33 PM. The next blood pressure reading of 101/56 was identified at 2:31 PM, fifty-eight (58) minutes following the previous reading. b. On 6/6/25, a blood pressure reading of 106/49 was identified at 1:07 PM. The next blood pressure reading of 143/76 was identified at 2:05 PM, fifty-eight (58) minutes following the previous reading. Interview with the Clinical Manager on 6/17/25 at 3:30 PM identified vital signs and machine parameter checks are to be completed every thirty (30) minutes but not to exceed forty-five (45) minutes. Interview with the Facility Administrator on 6/17/25 at 3:25 PM identified vitals were to be taken every thirty (30) minutes while a patient was receiving treatment, and not to exceed forty-five (45) minutes. Review of the patient assessment and monitoring policy directed during treatment, to obtain blood pressure, pulse rate and machine parameters every thirty (30) minutes or more as needed but not to exceed forty-five (45) minutes.”

“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: 44675 Based on a review of clinical records, interview, and policy review for one (1) of four (4) hemodialysis patients reviewed for adequacy (Patient #3), the facility failed to ensure the patient’s hemodialysis treatment were in accordance with the physician orders. The findings include the following: Patient #3 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three times weekly for three (3) hours and fifteen (15) minutes with a thigh central venous catheter (CVC), blood flow rate (BFR; speed at which blood is pumped from the patient’s body through the dialyzer) of 400 and dialysate flow rate (DFR; rate at which dialysate (cleansing fluid) flows through the dialyzer) of 800. Review of the care plan dated 12/11/24 identified Patient #3 had dialysis adequacy as an area of focus with the goal to have Patient #3’s kt/v greater than or equal to 1.4 with interventions that included to change blood flow rate per physician order and increase dialysis time per physician order. Review of the treatment flowsheet dated 3/15/25 identified Patient #3’s BFR was 350 and DFR was 600 with no rationale as to why the prescription was not met. Review of Patient #3’s kt/v dated 3/15/25 identified Patient #3’s kt/v (adequacy of dialysis treatment) was .56 (inadequate). Review of the treatment flowsheet dated 3/20/25 identified Patient #3’s BFR was 300 and DFR was 300 with no rationale as to why the prescription was not met. Review of Patient #3’s kt/v dated 3/20/25 identified Patient #3’s kt/v was .90 (inadequate). Review of physician orders directed treatment time increase to three (3) hours and forty-five (45) minutes. Review of the treatment flowsheet dated 4/1/25 identified Patient #3’s BFR was 300 with no rationale as to why the prescription was not met. Review of Patient #3’s kt/v dated 4/1/25 identified Patient #3’s kt/v was 1.01 (inadequate). A physician note dated 4/3/25 identified Patient #3 was not meeting compliance clearance. Patient #3 was not completing full treatment time of three (3) hours and forty-five (45) minutes and BFR at 300 when prescribed is 400. It identified if Patient #3 performed prescribed treatment, he/she should meet clearance. Review of the treatment flowsheet dated 4/15/25 identified Patient #3’s BFR was 300 and DFR was 500 with no rationale as to why the prescription was not met. Review of Patient #3’s kt/v dated 4/15/25 identified Patient #3’s kt/v was .96 (inadequate). Interview with the Charge Nurse on 6/17/25 at 1:55 PM identified she was the facility’s adequacy manager. She identified Patient #3’s DFR was increased to 800 to help to increase his/her adequacy labs. She further identified if the BFR is not met during treatment it needs to be documented why, and the physician notified if interventions are needed. Interview with the Regional Operations Manager on 6/17/25 at 2:00 PM identified there is no policy on adequacy but the company goal for adequacy is 1.4 and the standard goal is 1.2. Review of the patient assessment and monitoring policy directed that during treatment staff are to check that the prescribed blood flow is being achieved, or the reason is documented in the medical record in unable to meet the prescribed blood flow.”

“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: 44675 Based on a review of clinical records, interview, and policy review for for three (3) of nine (9) patients reviewed for treatment adherence (Patient #1, #3, and #4) failed to ensure against medical advice (AMA) forms were completed for early termination per facility policy, and for one (1) of five (5) patients (Patient #4), the facility failed to ensure the pre-treatment assessments were entered into the electronic medical record in accordance with facility policy . The findings include the following: 1. Patient #3 was admitted to the facility with diagnoses that included ESRD. Review of the physician’s orders directed hemodialysis three (3) times weekly for three (3) hours and fifteen (15) minutes with a Central Venous Catheter (CVC) located in the thigh, blood flow rate (BFR; speed at which blood is pumped from the patient’s body through the dialyzer) of 400 and dialysate flow rate (DFR; rate at which dialysate (cleansing fluid) flows through the dialyzer) of 800. Review of the care plan dated 12/11/24 identified Patient #3 had treatment adherence as an area of focus with the goal to improve Patient #3’s treatment adherence with interventions that included to provide education and identify and address barriers leading to missed/shortened treatments. A sample review of Patient #3’s dialysis treatment sheets identified the following: a. On 3/4/25 Patient #3 received three (3) hours and three (3) minutes of treatment (terminated 12 minutes early). The flowsheet and nursing notes failed to identified why Patient #3’s treatment was terminated early. Review of Patient #3’s medical record failed to identify an against medical advice (AMA) form was reviewed and completed. b. On 3/15/25 Patient #3 received three (3) hours and one (1) minutes of treatment (terminated 14 minutes early). The flowsheet and nursing notes failed to identified why Patient #3’s treatment was terminated early. Review of Patient #3’s medical record identified an AMA form was signed by two staff because Patient #3 refused to sign, however did not identify the reason for the early termination. c. On 3/20/25 Patient #3 received two (2) hours and fifty (50) minutes of treatment (terminated 25 minutes early). The flowsheet and nursing notes failed to identified why Patient #3’s treatment was terminated early. Review of Patient #3’s medical record failed to identify an AMA form was reviewed and completed. d. On 4/15/25 Patient #3 received three (3) hours and nineteen (19) minutes of treatment (terminated 24 minutes early). The flowsheet and nursing notes failed to identified why Patient #3’s treatment was terminated early. Review of Patient #3’s medical record identified an AMA form was signed by two staff because Patient #3 refused to sign, however did not identify the reason for the early termination. e. On 6/10/25 Patient #3 received three (3) hours and twenty-two (22) minutes of treatment (terminated 23 minutes early). The flowsheet and nursing notes failed to identified why Patient #3’s treatment was terminated early. Review of Patient #3’s medical record failed to identify an AMA form was reviewed and completed. f. On 6/5/25 Patient #3 received three (3) hours and thirty-one (31) minutes of treatment (terminated 14 minutes early). The flowsheet and nursing notes failed to identified why Patient #3’s treatment was terminated early. Review of Patient #3’s medical record failed to identify an AMA form was reviewed and completed. 2. Patient #4 had diagnoses that included end stage renal disease. Physician’s orders directed hemodialysis three (3)times weekly for three (3) hours and thirty (30) minutes per treatment, using a 2.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 450, and dialysate flow rate (DFR) of 800 while using a central venous catheter (CVC). a. Review of Patient #4’s treatment sheets identified the following: a. On 5/26/25, Patient #4’s treatment was administered for two (2) hours and thirty-six (36) minutes (terminated fifty-four (54) minutes early) and failed to identify an AMA form was reviewed and completed. b. On 5/28/25, Patient #4’s treatment was administered for two (2) hours and seven (7) minutes (terminated one (1) hour and twenty-three (23) minutes early) and failed to identify an AMA form was reviewed and completed. c. On 5/30/25, Patient #4’s treatment was administered for two (2) hours and fifty-five (55) minutes ( terminated thirty-five (35) minutes early) and failed to identify an AMA form was reviewed and completed. d. On 6/2/25, Patient #4’s treatment was administered for three (3) hours (terminated thirty (30) minutes early) and failed to identify an AMA form was reviewed and completed. e. On 6/4/25, Patient #4’s treatment was administered for three (3) hours and five (5) minutes (terminated twenty-three (25) minutes early) and failed to identify an AMA form was reviewed and completed. Review of the early termination or arriving late for treatment policy directed treatment duration and frequent if prescribed by a patient’s physician and the facility expects that all patients will adhere to their prescribed treatment time and schedule. If a patient requests to leave treatment early the RN will evaluate the patient and discuss with the patient their reasons for requesting to terminate earlier than prescribed. The RN who evaluates the patient must document the rationale for early termination and reinforce the consequences of not receiving the entire prescribed treatment. The RN is responsible to notify the physician and document on the AMA form. The policy directed AMA’s are signed with each early termination event and filed in the patient’s medical record. 3. Patient #4 had diagnoses that included end stage renal disease. Physician’s orders directed hemodialysis three (3)times weekly for three (3) hours and thirty (30) minutes per treatment, using a 2.0 potassium/2.5 calcium bath, a blood flow rate (BFR) of 450, and dialysate flow rate (DFR) of 800 while using a central venous catheter (CVC). Review of Patient #4’s treatment sheets identified the following: a. On 6/13/25, Patient #4’s treatment was administered for two (2) hours and twenty-one (21) minutes (terminated one (1) hour and nine (9) minutes early) and failed to identify an AMA form was reviewed and completed. b. On 6/11/25, treatment was initiated at 12:06 PM and the pre-treatment assessment was documented in the electronic medical record at 3:49 PM [three (3) hours and forty-three (43) minutes following treatment initiation]. Interview with the Facility Administrator on 6/13/25 at 3:20 PM identified pre-treatment assessments should be entered into the electronic medical record within one hour of treatment initiation. Review of the Nursing Supervision and Delegation policy identified the registered nurse must evaluate each patient preferably within an hour of treatment initiation or according to state requirements.”