Fresenius Medical Care Matthews

“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: 32003 Based on policy review observation and staff interview, the facility staff failed to ensure the primary oxygen tank was maintained at the required level for 1 of 1 observation. Review on March 14, 2025 of the facility’s policy, “Emergency Administration of Oxygen” published November 1, 2021 revealed, “Purpose ...Responsibility ...Background ...Policy ...Oxygen Cylinders ...Check pressure after each us and if the pressure reads less the 500 psi, obtain a new full tank. ...” Observation on March 12, 2025 at 12:20 PM revealed, the primary oxygen tank was attached to the code card and the oxygen level reading was 0 psi. Interview on March 14, 2025 at about 12:00 PM with a staff member from a sister-facility revealed, the primary oxygen cylinder should be checked weekly, with the last check occurred March 8, 2025 and the next check was scheduled for March 15, 2025.”

“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: 32003 Based on policy review, observations and staff interview, the facility staff failed to prevent the spread of potentially infectious disease by not ensuring patients performed hand hygiene at treatment discontinuation for 4 of 4 observations. Review on March 14, 2025 of the facility’s policy, “Hand Hygiene” published November 6, 2023 revealed, “Purpose ...Responsibility ...Policy [space] Hand hygiene included either washing hands with soap and water or using a waterless alcohol-based antiseptic hand rub with 60-90% alcohol content ...Soap and Soap Dispensers ...Alcohol Based Hand Rubs ...Additional Guidelines for Home Therapies ...Hand Hygiene: [space] Patients should perform hand hygiene if able, prior to and after each dialysis treatment. ...” 1. Observation on March 12, 2025 at 11:50 AM revealed, Patient #1 treatment was completed. The technician performed catheter care and the patient exited the treatment area. Observation revealed, the facility staff failed to offer hand hygiene, soap and water or hand antiseptic rub to the patient. Interview on March 13, 2025 at 2:45 PM with staff revealed patients should be offered soap and water or hand antiseptic rub for hand hygiene. 2. Observation on March 12, 2025 at 2:55 PM revealed, Patient #18 treatment was completed. The technician removed the needles and the patient applied manual pressure to the access site with a gloved hand. Hemostasis was achieved and the patient exited the treatment area. Observation revealed the facility staff failed to offer hand hygiene, soap and water or hand antiseptic rub to the patient. Interview on March 13, 2025 at 2:45 PM with staff revealed patients should be offered soap and water or hand antiseptic rub for hand hygiene. 3. Observation on March 13, 2025 at 9:25 AM revealed, Patient #16 treatment was completed. The technician removed the needles and the patient applied manual pressure to the access site with a gloved hand. Hemostasis was achieved and the patient exited the treatment area. Observation revealed the facility staff failed to offer hand hygiene, soap and water or hand antiseptic rub to the patient. Interview on March 13, 2025 at 2:45 PM with staff revealed patients should be offered soap and water or hand antiseptic rub for hand hygiene. 4. Observation on March 13, 2025 at 9:45 AM revealed, Patient #12 treatment was completed. The technician performed catheter care and the patient exited the treatment area. Observation revealed, the facility staff failed to offer hand hygiene, soap and water or hand antiseptic rub to the patient. Interview on March 13, 2025 at 2:45 PM with staff revealed patients should be offered soap and water or hand antiseptic rub for hand hygiene.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 32003 Based on policy reviews, observations and staff interview, the facility staff failed to prevent cross contamination by not ensuring the dialysis stations were vacated, cleaned, and disinfected between patient use for 2 of 2 observations and failed to ensure the Hoyer lift and sling pad was disinfected between patient use for 1 of 1 observation. The findings include: 1. Review on March 14, 2025 of the facility’s policy, “Cleaning and Disinfections the Dialysis Station” published September 5, 2023 revealed, “Purpose ...Responsibility ...Background ...Definition [space] ... Equipment in the dialysis station may include (but is not limited to) the following: Dialysis machine ...General Cleaning ...Cleaning of the Dialysis Machine [space] Externally disinfect the dialysis machine with 1:100 bleach solutions after each treatment ...Cleaning of the Dialysis Wall Boxes ...Work Surface Cleaning and Disinfection w/out Visible Blood using Bleach Solutions ...Work Surface Cleaning and Disinfection with Visible Blood < 10ml and Other Potentially Infectious Material using Bleach Solutions ...Work Surface Cleaning and Disinfection with Visible Blood > 10ml and Other Potentially Infectious Material using Bleach Solutions ...Repair and Maintenance ...Bleach-Solutions ...For Unknown Hepatitis B ...Vacating the Machine [space] To prevent cross-contamination between patient, it is important that the previous patient completely vacate the station before staff begin cleaning and disinfections of the statin and set up for the next patient. ...” A. Observation on March 13, 2025 at 9:25 AM revealed, Patient #17 treatment was completed, Technician #1 removed the needles, and the patient held pressure with a gloved hand. The technician removed the blood lines and hung new blood lines for the next patient while the current patient, Patient #17 was still in the station chair. Observation revealed the dialysis station was not vacated, cleaned, and disinfected before set up for the next patient. Interview on March 13, 2025 at 9:45 AM with Technician #2 revealed, the dialysis station should be vacated, cleaned, and disinfected before stringing new blood lines for the next patient. B. Observation on March 13, 2025 at 9:45 AM revealed, Patient #15 treatment was completed and the patient held pressure with a gloved hand. The dialysis machine was hung with new blood lines for the next patient while the current patient, Patient #15 was still in the station chair. Observation revealed the dialysis station was not vacated before set up for the next patient. Interview on March 13, 2025 at 9:45 AM with Technician #2 revealed, Patient #15 received dialysis treatment and that the dialysis station should be vacated, cleaned, and disinfected before set up for the next patient. Review on March 14, 2025 of the personnel worksheet revealed, Technician #1 was from a sister-facility and was not listed on the personnel worksheet. 2. Review on March 14, 2025 of the facility’s policy, “Guidelines for Use of the Hoyer Lift” published August 30, 2024 revealed, “Purpose ...Responsibility ...Background ...Policy: Sling Use ...Policy: Transfer ...Policy: Training ...Training ...Disinfection [ space] The sling must be surface disinfected with 1:100 bleach solution after use. If contaminated with visible blood use 1:10 bleach solution to clean, followed by 1:100 bleach solution for surface disinfection. ...” C. Observation on March 13, 2025 at 9:50 AM revealed two staff members used to Hoyer lift to transfer Patient #13 from the station chair #7 to the wheelchair after treatment completion. After use, the Hoyer lift and sling pad was stored in front of the nursing station adjacent to the weight scale. At 10:15 AM, a staff member obtained the Hoyer lift and sling pad from in front of the nursing station. A second staff member join to assist with getting the sling pad under Patient #14. The staff transferred the patient from the recliner chair to station chair #2. After use, the Hoyer lift and sling pad was stored back in-front of the nursing station adjacent to the weight scale. Observation revealed the Hoyer lift and sling pad was not disinfected between patient use. Interview on March 13, 2025 at 2:45 PM with staff revealed the Hoyer lift and sling pad should be disinfected between patient use.”

“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: 32003 Based on observation, water pre-treatment log review and staff interview, the facility staff failed to ensure the correct day of the week was set for 1 of 1 water softener tank timer. The findings include: Observation on March 13, 2025 at 8:00 AM with the Area Technical Operations Manager revealed, the regeneration day for the water softener tank was set on day 2 when it was actually day 5. Review on March 13, 2025 of the water pre-treatment log revealed the time settings were correctly set March 1st, 3rd, 4th, 5th, 6th, 7th, 8th, 10th, 11th, and 12th. Review failed to reveal when the day of the week was changed. Interview on March 13, 2025 at 8:00 AM with the Area Technician Operations Manager revealed, Sunday was day 1 and the day of the observation was day 5 and the water softener tank was set on day 2. Interview revealed it was important for the settings to be correct to ensure the water softener tank regenerated as programmed.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 32003 Based on policy review, medical record reviews and staff interview, the facility staff failed to ensure a post-treatment nursing assessment was performed for 2 of 2 patients (Patients #2 and #7). The findings include: Review on March 14, 2025 of the facility’s policy, “Patient Assessment and Monitoring” published May 1, 2023 revealed, “Purpose...Responsibility...Definitions...Delegation...Data Collection...Pre-Treatment...During Treatment...Step 1...Step 3 [space] Machine Parameters and Extracorporeal Circuit [space] 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...Post-Treatment [space] Weight, Blood Pressure, Pulse, Respiration, Temperature, Observations, Access, Reported by the patient, State of well-being/Reported by the patient/General observations, Lungs sounds, Edema, Heart sounds...” 1. Open medical record review on March 13, 2025 revealed, Patient #2 was admitted to the in-center facility in 2018. Treatment sheet review from March 1, 2025 through March 12, 2025 (six consecutive treatments) revealed, a pre-treatment nursing assessment was not performed for 1 of 6 treatments, March 5, 2025 Interview conducted March 13, 2025 at about 2:00 PM with the Interim Clinical Manager revealed, a pre-treatment nursing assessment was not performed for the patient on February 7, 2025. 2. Open medical record review on March 13, 2025 revealed, Patient #7 was admitted to the in-center facility in 2019. Treatment sheet review from March 1, 2025 through March 12, 2025 (six consecutive treatments) revealed, a pre-treatment nursing assessment was not performed for 1 of 6 treatments, March 5, 2025 and a post-treatment nursing assessment was not performed for 1 of 6 treatments, March 11, 2025. Interview conducted March 13, 2025 at about 2:00 PM with the Interim Clinical Manager revealed the patient was not dialyzed at the prescribed rate for 6 of 6 treatments.”

“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: 32003 Based on policy review, medical record reviews and staff interview, the facility staff failed to follow the adequacy plan of care by not dialyzing a patient at the prescribed blood flow rate for 2 of 2 patients (Patients #2 and #7). The findings include: Review on March 14, 2025 of the facility’s policy, “Patient Assessment and Monitoring” published May 1, 2023 revealed, “Purpose...Responsibility...Definitions...Delegation...Data Collection...Pre-Treatment...During Treatment...Step 1...Step 3 [space] Machine Parameters and Extracorporeal Circuit [space] 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...” 1. Open medical record review on March 13, 2025 revealed, Patient #2 was admitted to the in-center facility in 2018. Order summary review revealed that the blood flow rate was ordered at 450 for 240-minutes each treatment for three days per week. Treatment sheet review from March 1, 2025 through March 12, 2025 (six consecutive treatments) revealed, the patient was not dialyzed at the prescribed blood flow rate for 6 of 6 treatments and there was no documentation of any action taken by the staff. Interview conducted March 13, 2025 at about 2:00 PM with the Interim Clinical Manager revealed the patient was not dialyzed at the prescribed rate for 6 of 6 treatments. 2. Open medical record review on March 13, 2025 revealed, Patient #7 was admitted to the in-center facility in 2019. Order summary review revealed that the blood flow rate was ordered at 400 for 240-minutes each treatment for three days per week. Treatment sheet review from March 1, 2025 through March 12, 2025 (six consecutive treatments) revealed, the patient was not dialysis at the prescribed blood flow rate for 1 of 6 treatments and there was no documentation of any action taken by the staff. Interview conducted March 13, 2025 at about 2:00 PM with the Interim Clinical Manager revealed the patient was not dialyzed at the prescribed rate for 6 of 6 treatments.”