322519 Southeastern NM Kidney Center (Fmc)

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 22676 Based on observation, interview, and facility policy review, the facility failed to ensure that staff providing care to patients used appropriate hand hygiene for one of three survey days. This deficient practice had the potential to result in increased infections in all 92 patients receiving care at this hemodialysis facility. Findings include: Observation of the treatment floor on 06/27/24 at 9:15 AM, Patient Care Technician (PCT) 15 was observed providing care to Patient (P) 16 at Station 23. He/she was observed removing his/her gloves and failed to use hand sanitizer or wash his/her hands. He/She was then observed delivering care to P13 at Station 22. He/she then removed his/her gloves and went over to Station 21 and used the hand sanitizer that was dedicated to that station. He/she was then observed P 11 at Station 20 and donning only one glove to adjust settings on the machines. An interview was conducted with PCT 15 on 06/27/24 at 9:30 AM and he/she confirmed the above findings. Observation on 06/27/24 at 9:35 AM Certified Clinical Hemodialysis Technician (CCHT) 8 was observed delivering care to P13 at Station 21. He/she removed his/her gloves and failed to use hand sanitizer or wash hands before adjusting his/her mask and eye shield. An interview with CCHT8 on 06/27/24 at 9:35 AM, confirmed the above findings. Observation on 06/27/24 at 10:15 AM, CCHT12 was observed at the nursing station using hand sanitizer. CCHT12 was seen applying the sanitizer and waving his/her hands through the air to dry the hand sanitizer. CCHT12 then donned new gloves without allowing the hand sanitizer adequate drying time. An interview with CCHT 12 on 06/27/24 at 9:35 AM confirmed the above findings. Observation on 06/27/24 at 12:25 PM, Registered Nurse (RN) 5 was observed removing a central Venous Catheter (CVC) dressing on P12 at Station 19. He/she discarded the dirty dressing, removed his/her gloves and redonned new gloves without using hand sanitizer or washing. An interview with RN5 on 06/27/24 at 12:30 PM confirmed the above findings. An interview with Clinic Manager 2 on 06/27/24 at 1:30 PM confirmed the staff failed to follow appropriate hand hygiene and they failed to follow the facility policy. Review of facility’s policy titled, “Hand Hygiene,” dated 11/06/23, indicated, “Allow alcohol to dry completely allows adequate contact time to kill germs .... Decontaminate using alcohol-based hand rub or with antimicrobial soap ...Immediately after removing gloves ...””

“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: 22676 Based on observation, interview, and policy review, the facility failed to restrict access to the water purification and storage system to only individuals responsible for monitoring and maintenance of the system on one of three survey days. Failure to restrict access to the water purification and storage system to only individuals responsible for monitoring and maintenance of the system had the potential to negatively impact the safety and well-being of the 92 in-center dialysis patients receiving treatments at this facility. Findings include: During tour of the facility on 06/26/24 at 9:45 AM, observed the door leading to the water purification system and the bicarb and acid storage area was propped open with a door stop. The door was also observed to not have a locking mechanism to secure the water room. I was able to walk straight into the water room. During an interview on 06/26/24 at 9:45 AM, Biomedical Technician 6 confirmed access to the water purification and storage system was not restricted to only authorized users who were responsible for the monitoring and operation of the water system. Review of the facility’s policy titled, “Physical Security and Facility Access,” dated 09/05/23, indicated, “The facility must be maintained to prevent unwanted entry by outside persons not involved in the daily operation of the clinic.””

“ENVIRONMENT-SCHEMATIC DIAGRAMS/LABELS CFR(s): 494.40(a) 8 Environment: schematic diagrams/labels Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range. This Standard is not met as evidenced by: 22676 Based on observation and interview, the facility failed to include a schematic diagram that identifies the components, valves, sample ports, and flow direction as required by Federal Regulations Failure to ensure the water area has a schematic drawing of the water system may result in inappropriate operation by the staff which had the potential to negatively impact the safety and well-being of the 92 in-center dialysis patients receiving treatments at this facility. Findings include: During a tour of the facility on 06/26/24 at 9:45 AM, observed that there was no schematic diagram to identify components, valves, sample ports, and flow direction of the water system. An interview with the Biomedical Technician 6 on 06/26/24 at 9:45 AM confirmed there was no schematic drawing of the water system components. He/she stated the facility did not have a policy regarding the schematic diagram, but they followed Federal Regulation.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 22676 Based on observation, interview, and policy review, the facility failed to monitor one of one brine salt tanks, to ensure the tank is at least half full of salt pellets. (Brine is a concentrated saline solution used to flush the resin bed of a water softener.) These findings had the potential to cause harm to all 92 in-center hemodialysis patients receiving care at the facility. Findings include: Observation of the brine salt tank on 06/26/24 at 9:45 AM, the tank was not half full of salt pellets and the water in the tank was about two feet above the salt. In an interview with the Biomedical Technician 6 on 06/26/24 at 9:45 AM he/she confirmed the brine tank was not half full of salt pellets and the water was about two feet above the salt. He/She stated, he/she was trying to let all the salt dissolve so he/she could clean the tank. He/she confirmed he/she had not taken the tank out of regeneration. Review of the facility’s policy titled, “Water Softener,” dated 05/03/24, indicated, “At a minimum, facility staff will monitor and document water softener(s) for the following each operational day: Check brine tank daily to be sure the tank is at least half filled with salt, adding salt pellets if necessary.””

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 22676 Based on review of glucometer logs, interview, policy review, and review of the manufacturer’s instructions, the facility failed to ensure one of one glucometer used was in the control range and follow manufacturer’s instructions. This deficient practice had the potential to provide incorrect blood glucose results and could result in inaccurate glucose level results to all 92 in-center patients receiving care at the facility. Findings included: 1. Review of electronic “Blood Glucose Logs” for the treatment unit, from 04/01/24 through 06/26/24 revealed the following: Review of the meter for the treatment unit labeled “meter labeled 2764” for April revealed: On 04/18/24, the recorded acceptable high control range was 286-386, the recorded high control was 118. 2. Review of the meter for the treatment unit labeled “meter labeled 2764” for May revealed: On 05/06/24, the recorded acceptable low control range was 94-126, the recorded low control was 127. On 05/08/24, the recorded acceptable low control range was 94-126, the recorded low control was 130. 3. Review of the meter for the treatment unit labeled meter labeled 2764” for June revealed: On 06/04/24, the recorded acceptable low control range was 94-126, the recorded low control was 130. On 06/14/24, the recorded acceptable low control range was 94-126, the recorded low control was 162. During an interview on 06/26/24 at 2:15 PM, the Charge Nurse 3 and Biomedical Technician 6, confirmed the findings and agreed the staff did not repeat the low-level and high-level control as required by the manufacturer’s instruction. Review of the facility’s policy titled, “Blood Glucose Monitoring Device,” dated 11/06/23, revealed, under “Policy Training” section revealed, “Calibration and control testing shall be performed each operating day ...” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/2020 revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””

“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: 22676 Based on medical record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for four of eight sampled in-center dialysis patients (Patient (P) 3, P5, P6, and P8). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for all 92 patients receiving in-center dialysis treatments at this facility. Findings include: 1. A review of P3’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (ml/min) and a Dialysate Flow Rate (DFR) of autoflow 2.0 which would be 800 ml/min. A review of two of six “Post Treatment” flowsheets from 06/14/24 through 06/26/24 in the EMR indicated the following: a. On 06/21/24, the BFR was documented at 350 ml/min from 11:39 AM PM until 1:31 PM. b. On 06/26/24, the BFR was documented at 350 ml/min and the DFR was documented at 700 ml/min from 12:07 PM until 1:39 PM and from 1:40 PM until 3:05 PM the BFR was documented at 380 ml/min. There was no documented rationale for the change to the prescribed BFR and DFR. 2. A review of P5 EMR revealed a prescribed BFR of 400 ml/min and a DFR of autoflow 2.0 which would be 800 ml/min. A review of five of six “Post Treatment” flowsheets from 06/14/24 through 06/26/24 in the EMR indicated the following: a. On 06/17/24 the BFR was documented at 300 ml/min and the DFR at 600 ml/min from 12:43 PM until 1:31 PM. b. On 06/19/24 the BFR was documented at 300 ml/min and the DFR at 600 ml/min from 12:43 PM until 1:31 PM. c. On 06/21/24 the BFR was documented at 350 ml/min and the DFR at 500 ml/min from 11:43 AM until 3:54 PM. d. On 06/24/24 the BFR was documented at 350 ml/min and the DFR at 700 ml/min from 1:06 PM until 3:05 PM. e. On 06/26/24 the BFR was documented at 300 ml/min and the DFR at 600 ml/min from 12:32 PM until 2:32 PM. There was no documented rationale for the change to the prescribed BFR and DFR. 3. A review of P6’s EMR revealed a prescribed BFR of 450 ml/min. A review of two of six “Post Treatment” flowsheets from 06/15/24 through 06/25/24 in the EMR indicated the following: a. On 06/20/24 the BFR was documented at 400 ml/min from 5:17 AM until 9:00 AM. b. On 06/22/24 the BFR was documented at 400 ml/min from 5:22 AM until 9:01 AM. There was no documented rationale for the change to the prescribed BFR. 4. A review of P8’s EMR revealed a prescribed BFR of 400 ml/min. A review of two of six “Post Treatment” flowsheets from 06/14/24 through 06/26/24 in the EMR indicated the following: a. On 06/14/24 the BFR was documented at 400 ml/min from 6:01 AM until 9:04 AM. b. On 06/26/ 24 the BFR was documented at 400 ml/min from 5:57 AM until 9:54 AM. There was no documented rationale for the change to the prescribed BFR. During an interview on 06/27/24 at 2:15 PM, the Clinic Manager 2 and the Charge Nurse 3 confirmed the above findings and confirmed that the staff did not follow the physician’s order for dialysis treatment. A review of the facility’s policy titled, “Patient Assessment and Monitoring,” dated 05/01/23, revealed, “Check the prescribed blood flow rate is being achieved or the reason is documented in the medical record if unable to meet prescribed flow rate. Check dialysate flow rate setting is correct, and the correct prescribed flow is being ...””