Fmc - Somerset

“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: 35949 Based on observation, interview, and facility policy review, the facility failed to ensure 3 (Registered Nurse [RN] #3, Certified Clinical Hemodialysis Technician [CCHT] #7 and CCHT #8) of 3 observed staff performed hand hygiene after removal of gloves, before they touched patient care supplies, and before they touched patient care equipment (dialysis machine). Failure to perform hand hygiene provided a mode of cross contamination with the potential spread of pathogens, which could negatively impact the health and well-being of the 76 patients who received dialysis treatments and/or home therapy oversight at the facility. Findings included: A facility policy titled, “Hand Hygiene,” published 11/06/2023, indicated, “The table below identifies when hands shall be washed specifically with soap and water or when alcohol-based hand rubs can be used.” In part, the table indicated, hands will be “Decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water. Before and after direct contact with patients” and “immediately after removing gloves.” Observation of the water test on 11/04/2024 at 11:34 AM with the Clinical Manager in the water purification area revealed RN #3 and CCHT #7 each wearing a pair of gloves. After performing the water test, RN #3 and CCHT #7 each removed their pair of gloves. RN #3 and CCHT #7 confirmed there was no availability in the water treatment area to perform hand hygiene after removing their pair of gloves. Observations of the dialysis treatment area on 11/05/2024 with the CM revealed the following: - At 9:25 AM, CCHT #8 was observed in Station 11 while wearing a pair of gloves. CCHT #8 touched her personal protective equipment (PPE) face shield and then touched the patient care supplies on the chairside table. - At 9:40 AM, CCHT #8 was observed entering the treatment area. CCHT #8 applied a previously used PPE gown and face shield and obtained and applied a pair of gloves. CCHT #8 entered Station 11 and touched the dialysis machine. During an interview on 11/05/2024 at 10:10 PM, CCHT #8 acknowledged she did not perform hand hygiene before she touched the patient care supplies and equipment. CCHT #8 confirmed she was trained and expected to perform hand hygiene before she touched patient care supplies and equipment. During an interview on 11/06/2024 at 2:15 PM, RN #3 confirmed she was trained and expected to perform hand hygiene after she removed gloves and before she touched patient care equipment and supplies. During an interview on 11/06/2024 at 2:30 PM, CCHT #7 confirmed he was trained and expected to perform hand hygiene after he removed gloves and before he touched patient care supplies and equipment. During an interview on 11/07/2024 at 10:31 AM, the Medical Director confirmed staff should perform hand hygiene after they removed gloves and before they touched patient care supplies and equipment.”

“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: 35949 Based on observation, interview, manufacturers’ directions for use (DFU) review, and facility procedure and policy review, the facility failed to maintain all equipment in a safe and functional condition when 5 of 13 stored oxygen tanks were not protected from falling over, failed to follow the bloodline manufacturer’s DFU by not maintaining the arterial drip chamber fluid levels at 85% - 95% full and the venous drip chamber fluid levels at 65% - 75% full during 3 of 3 observations, and failed to follow the manufacturer’s DFU for maintaining the integrity of the water purification system during 3 of 3 observations. Failure to maintain all equipment in a safe and functional condition and follow the manufacturers’ DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 60 patients who received in-center dialysis treatments at the facility. Findings included: 1. A facility policy titled, “Emergency Administration of Oxygen,” published 11/01/2021, indicated, “Oxygen cylinders must be secured in an area where they will not fall.” During a concurrent interview and environmental tour of the supply storage area on 11/04/2024 at 9:45 AM with the Clinical Manager and the Biomedical Technician, there were 5 of 13 oxygen tanks not stored in a manner to prevent falling over. The Biomedical Technician confirmed he was trained and expected to store oxygen tanks in a manner to prevent falling over 2. A facility procedure titled, “Priming an Optiflux Single Use E-beam Dialyzer,” published 06/28/2024, indicated, “Fill the Pre-pump arterial chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 85% - 95% full and tighten cap.” Further review indicated, “Fill the venous chamber: Vent the chamber by loosening the cap and opening the clamp on the level adjust line. Fill chamber 65% - 75% full.” The manufacturer’s DFU titled, “CombiSet True Flow Series Hemodialysis Blood Tubing Set with Priming Set and Transducer Protectors,” indicated, “During Treatment a. Periodically check the extracorporeal circuit for any evidence of possible Separation [sic] or leaks. b. Maintain fluid level in pre-pump arterial chamber at 85 to 95% full, post-pump arterial and venous chambers at 65 to 75% full. Levels may rise or drop during the treatment due to changes in pressure or flow rate. Readjust levels as needed. Air Leaks will also cause the chamber levels to fluctuate.” Observation of the hemodialysis treatment area on 11/04/2024 at 9:29 AM revealed the arterial drip chamber fluid levels were less than (<) 85% full in Stations 3, 4, 9, 10, 11, 12, 13, 16, 18, 19, and 21, and the venous drip chamber fluid levels were greater than (>) 75% full in Stations 2, 3, 4, 5, 6, 8, 9, 11, 16, 18, 19, and 21. Observation of the hemodialysis treatment area on 11/04/2024 at 9:50 AM revealed the arterial drip chamber fluid levels were < 85% full in Stations 3, 10, 11, 13, 16, 18, 19, and 21, and the venous drip chamber fluid levels were > 75% full in Stations 2, 3, 4, 5, 6, 9, 10, 11, 16, 18, 19, and 21. Observation of the hemodialysis treatment area on 11/04/2024 at 1:20 PM revealed the arterial drip chamber fluid levels were < 85% full in Stations 17, 18, and 21, and the venous drip chamber fluid levels were > 75% full in Stations 2, 6, 8, 10, 12, 13, 17, 18, and 21. During an interview on 11/04/2024 at 9:57 AM, Registered Nurse (RN) #4 confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 11/04/2024 at 10:23 AM, the Clinical Manager reviewed the manufacturer’s DFU and acknowledged the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 11/06/2024 at 2:15 PM, RN #3 confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 11/06/2024 at 2:30 PM, Certified Clinical Hemodialysis Technician #7 confirmed the arterial and venous drip chamber fluid levels were not maintained according to the bloodline manufacturer’s DFU. During an interview on 11/07/2024 at 10:31 AM, the Medical Director confirmed the staff were expected to follow the bloodline manufacturer’s DFU. 3. A facility policy titled, “Equipment Installation -Operation-Maintenance-Repair-And [sic] Disposal,” published 07/06/2021, indicated, “This policy applies to all equipment that: Removes, infuses, touches, measures, controls, or has the potential to affect the outcome of patient treatments or dialysis fluid. Is deemed essential in performing dialysis in a safe manner; and/or Is essential to the safe operation of the facility. This includes but is not limited to: Medical Equipment, Electrical Systems, Plumbing Equipment/Systems, Meters or Measurement Devices, Television Mounting Hardware, Concentrate Production and Delivery Equipment, Water Purification Equipment, HVAC [heating, ventilation, and air conditioning] Systems, Life Safety Equipment/Systems, Dialysis Chairs, Physical Plant (ceilings, floors, etc.).” Further review indicated, “Unless otherwise directed by company policy and procedures, all equipment will be installed, operated, maintained, and repaired in accordance with manufacturer’s instructions for use (IFU).” and “Any equipment or device that is not fully functioning in accordance with IFU or company policy, must be repaired or replaced as soon as reasonably possible.” An undated manufacturer’s DFU titled, “Installation, Maintenance, & Repair Series 909, LF909, 909RPDA, LF9098RPDA,” indicated, “Troubleshooting Guide - Backflow Preventers” in part, indicated, “Problem: A. Valve spits periodically from the vent, Cause: A.1 Fluctuating supply pressure. A.2 Fluctuating downstream pressure. Solution: A.1 Install a soft seated check valve immediately upstream of the device. A.2 Install a soft seated check valve downstream of the device close as possible to the shutoff valve. B. Valve drips continually from the vent. B.1 Fouled first check, B.1 Flush valve. If flushing does not resolve problem, disassemble valve and clean or replace first check. B.2. Damage or fouled relief valve seat. B.2 Clean or replace relief valve seat. B.3 Relief valve piston O-ring not free to move due to pipe scale, dirt or buildup of mineral deposits. B.3. Clean, grease or replace the piston O-ring.” Observation of the water purification system on 11/04/2024 at 9:47 AM revealed the discharge port of the backflow preventer valve leaked and was wet to the touch. A sign adhered to the wall above the backflow preventer valve indicated the discharge port should not leak. Observation of the water purification system on 11/04/2024 at 11:37 AM revealed the discharge port of the backflow preventer valve leaked and was wet to the touch. A sign adhered to the wall above the backflow preventer valve indicated the discharge port should not leak. During a concurrent interview and observation of the water purification system on 11/06/2024 at 9:00 AM with the Clinical Manager, Biomedical Technician, and Area Technical Manager revealed the discharge port of the backflow preventer valve leaked and was wet to the touch. A sign adhered to the wall above the backflow preventer valve indicated the discharge port should not leak. The Area Technical Manager stated the backflow preventer valve was inspected by an outside “professional” source and he believed the backflow preventer valve component functioned properly. During an interview on 11/07/2024 at 10:31 AM, the Medical Director was informed of the three observations of the backflow preventer valve discharge port being wet to the touch. The Medical Director stated, “It leaks,” and further stated that the issue would be addressed and agreed the leak should be fixed. The Medical Director also agreed the water system should be a closed system and the integrity of the water system should be maintained.”

“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: 35949 Based on interview, record review, and facility policy review, the facility failed to follow the individualized dialysis prescription as prescribed by the medical provider for 3 (Patients #1, #2, and #3) of 3 sampled in-center patients. Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 60 patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Physician Order Documentation,” published 07/03/2023, indicated, “Nurse practice acts require nurses to carry out treatment care, medication administration, lab tests, procedures, and other treatments, based on physician orders.” 1. Patient #1’s treatment sheet dated 10/16/2024 revealed a prescribed blood flow rate (BFR) of 350 milliliters per minute (mL/min). Patient #1’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient #1’s treatment sheet dated 10/18/2024 revealed a prescribed BFR of 350 mL/min. Patient #1’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient #1’s treatment sheet dated 10/21/2024 revealed a prescribed BFR of 350 mL/min. Patient #1’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. Patient #1’s treatment sheet dated 10/23/2024 revealed a prescribed BFR of 350 mL/min and a prescribed dialysate flow rate (DFR) of 1.5 times the BFR. Patient #1’s BFR was documented as 400 mL/min from 7:03 AM until 10:30 AM and the DFR was documented as 500 mL/min from 10:30 AM until the treatment was terminated at 10:50 AM. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient #1’s treatment sheet dated 10/25/2024 revealed a prescribed BFR of 350 mL/min and a prescribed DFR of 1.5 times the BFR. Patient #1’s BFR was documented as 400 mL/min from 7:01 AM until the treatment was terminated at 10:39 AM and the DFR was documented as 700 mL/min from 7:01 AM until 8:02 AM. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient #1’s treatment sheet dated 10/28/2024 revealed a prescribed BFR of 350 mL/min. Patient #1’s BFR was documented as 400 mL/min from 7:00 AM until 7:30 AM and as 450 mL/min from 7:30 AM until the treatment was terminated at 10:35 AM. There was no rationale documented why the prescribed BFR was not achieved. Patient #1’s treatment sheet dated 10/30/2024 revealed a prescribed BFR of 350 mL/min and a prescribed DFR of 1.5 times the BFR. Patient #1’s BFR was documented as 400 mL/min and the DFR was documented as 500 mL/min from 7:15 AM until the treatment was terminated at 10:40 AM. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient #1’s treatment sheet dated 11/01/2024 revealed a prescribed BFR of 350 mL/min and a prescribed DFR of 1.5 times the BFR. Patient #1’s BFR was documented as 400 mL/min and the DFR was documented as 300 mL/min from 7:03 AM until 8:03 AM and the BFR was documented as 450 mL/min from 8:03 AM until the treatment was terminated at 10:35 AM. There was no rationale documented why the prescribed BFR and DFR were not achieved. Patient #1’s treatment sheet dated 11/04/2024 revealed a prescribed BFR of 350 mL/min. Patient #1’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. 2. Patient #2’s treatment sheet dated 10/31/2024 revealed a prescribed dialysate flow rate (DFR) of 1.5 times the blood flow rate (BFR) of 400 milliliters per minute (mL/min) (400 x 1.5 = 600). Patient #2’s DFR was documented as 800 mL/min during the entire treatment. There was no rationale documented why the prescribed DFR was not achieved. 3. Patient #3’s treatment sheet dated 10/23/2024 revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Patient #3’s BFR was documented as 200 mL/min from 11:56 AM until 1:30 PM. There was no rationale documented why the prescribed BFR was not achieved. Patient #3’s treatment sheet dated 10/30/2024 revealed a prescribed BFR of 450 mL/min. Patient #3’s BFR was documented as 400 mL/min during the entire treatment. There was no rationale documented why the prescribed BFR was not achieved. During an interview on 11/04/2024 at 11:20 AM, the Clinical Manager confirmed the identified deficiencies on the patients’ treatment sheets and stated staff were expected to document a reason when the prescribed BFR and/or DFRs were not followed. During an interview on 11/06/2024 at 2:15 PM, Registered Nurse #3 stated staff were trained and expected to “document when not achieved” when a patient’s BFR and/or DFR were not as prescribed. During an interview on 11/06/2024 at 2:30 PM, Certified Hemodialysis Technician #7 stated staff were expected to document a reason for changes to the prescribed BFR and/or DFR. During an interview on 11/07/2024 at 10:31 AM, the Medical Director stated staff were expected to document a reason when the prescribed BFRs and/or DFRs were not achieved.”