Fresenius Medical Care Hephzibah

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of facility records, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 48 in-center hemodialysis patients who were under the care of this facility. Findings include: Cross Reference: V757 - Failure of the Facility Administrator to ensure that the facility had adequate number of qualified Patient Care Technicians (PCTs) as dialysis caregivers to meet the needs of all patients, to provide safe patient care and to be in compliance with the minimum state required staff-to-patient ratio of one dialysis caregiver to four patients.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, a review of facility records, and a review of the minimum state required staffing ratios, it was determined that the Facility Administrator failed to ensure the facility had adequate number of qualified Patient Care Technicians (PCTs) as dialysis caregivers, to meet the needs of all patients and to be in compliance with minimum state required staff-to-patient ratio of one dialysis caregiver to four patients, as evidenced by seven of seven PCTs (PCT AA, PCT BB, PCT CC, PCT DD, PCT EE, PCT FF and PCT GG), were assigned one PCT to five patients, on two of three shifts on the Mondays-Wednesdays-Fridays (MWF) schedule and on two of two shifts on the Tuesdays-Thursdays-Saturdays (TTS) schedule. This deficient practice had the potential to negatively affect the health and safety of all 48 in-center hemodialysis (ICHD) patients who were under the care of this facility. Findings include: During observation in the Patient Treatment Room on 3/27/25 between 9:00 a.m. and 9:10 a. m., there were eight patients (P), (P#1, P#2, P#3, P#4, P#5, P#6, P#7, and P#8), who were receiving hemodialysis treatment. One patient (P#9), had just completed treatment and was leaving the facility. There were two PCTs (PCT AA and PCT BB) and one Registered Nurse (RN - RN AA), who were present at the time of this observation. During Staff interviews on 3/27/25, between 9:30 a.m. and 10:40 a.m., the following was revealed: - The Nurse Manager stated at 9:30 a.m., that this facility had 11 patient stations (S), and was open six days a week. There were three shifts on the MWF schedule and two shifts on the TTS schedule. The Nurse Manager also added that the daily staffing was one RN and two PCTs, with five patients assigned to each PCT. - At 9:42 a. m., RN AA confirmed that each PCT was assigned to five patients per shift. RN AA added that each PCT was responsible for: setting up the machine, initiate their patients’ treatments, monitor their patients, discontinue their patients’ treatments, disinfect their patient stations, etcetera (etc.). RN AA also explained that the nurse’s responsibility was to initiate patient’s treatment of all patients with CVCs (Central Venous Catheters - a thin, flexible tube inserted into a large vein in the neck, chest, or groin, to allow easy access to the bloodstream for dialysis treatments), as their primary hemodialysis access. RN AA further explained that the nurses only initiated treatments on patients with CVCs, but the PCTs monitored and rinsed these patients back (returned their blood) after treatment. In addition, the nurse was responsible for preparing and administering medications, monitoring laboratory results, monitoring patients’ blood pressures (BPs), performing pre and post nursing assessments for all patients, calling the doctors when needed, making rounds with the doctors, and managing any emergencies that may arise. RN AA also added that the PCTs were aware that they were responsible for the five patients assigned to them per shift. - At 10:11 a. m., the Administrative Assistant (AA), confirmed that each PCT was assigned to five patients per shift, and the nurse was responsible for the entire treatment room, to call the doctor, to handle any emergencies, to make appointments for patients, etc. - At 10:24 a.m., PCT AA also confirmed that she was responsible for five patients in her section. PCT AA added that when she started to work at this facility, she was told that she could only have four patients per shift. When she completed her orientation, she was told that the nurses could not take patients so each PCT had to take five patients per shift. PCT AA also stated that it was a lot of work. On the MWF schedule there were three shifts with 10 patients on the first and second shifts and eight on the third shift. PCT AA further stated that no one came to relieve them. They came in to work at 4:30 a.m. and they didn’t leave the facility until 9: 30 p.m., on the MWF schedule. - At 10:39 a.m., PCT BB confirmed that she was responsible to care for five patients per shift, and she added that it was tiring and stressfull especially on the MWF schedule. She further stated that the Administration was aware, but they didn’t care so why complain. A review of the Patient and Teammate Schedule (planned schedule of the number of patients for hemodialysis treatment each shift and the number of PCTs and Licenced Nurses providing dialysis care services), from March 3, 2025 through March 26, 2025, revealed the following: - On the MWF schedule, there were three shifts, with a total of 10 patients on first and second shifts, and nine patients on third shift and on the TTS schedule, there were two shifts, with a total of 10 patients per shift. A review of the actual Patient/Teammate Schedule (when patients did not show up for treatment due to no shows/absences or hospitalizations, etc.), for the following scheduled treatment dates revealed: - March 3, 2025 (Monday): PCT AA - first and second shifts (five patients per shift); then four patients on the third shift. PCT BB - five patients per shift on all three shifts. - March 4, 2025 (Tuesday): PCT AA - first shift (four patients); second shift (five patients). PCT DD - first shift (three patients); second shift (five patients). - March 5, 2025 (Wednesday): PCT AA - four patients per shift during first, second and third shifts. PCT BB - five patients during the first and second shifts and four patients on third shift. - March 6, 2025 (Thursday): PCT AA - five patients per shift. PCT DD - first shift (three patients); second shift (five patients). - March 7, 2025 (Friday): PCT AA - first shift (four patients); second shift (five patients); third shift (four patients). PCT DD - first and second shifts (five patients per shift); third shift (four patients). - March 8, 2025 (Saturday): PCT CC - first and second shifts (five patients per shift). PCT BB - first shift (four patients); second shift (three patients). - March 10, 2025 (Monday): PCT CC - first shift (four patients); second shift (five patients); third shift (four patients). PCT EE - first shift (four patients); second shift (five patients); third shift (five patients). - March 11, 2025 (Tuesday): PCT AA - first shift (five patients); second shift (four patients). PCT BB - first shift (five patients); second shift (five patients). - March 12, 2025 (Wednesday): PCT CC - first shift (four patients); second shift (five patients); third shift (four patients). PCT FF and PCT GG (split the shift - meaning PCT FF worked for a number of hours and was relieved by PCT GG) - first shift (four patients); second shift (five patients); third shift (three patients). - March 13, 2025 (Thursday): PCT AA - first shift (four patients); second shift (five patients). PCT BB - first shift (three patients); second shift (four patients). - March 14, 2025 (Friday): PCT CC - first shift (four patients); second shift (four patients); third shift (three patients). PCT BB - first shift (five patients); second shift (five patients); third shift (four patients). - March 15, 2025 (Saturday): PCT FF - first shift (five patients); second shift (five patients). PCT DD - first shift (four patients); second shift (four patients). - March 17, 2025 (Monday): PCT CC - first shift (four patients); second shift (four patients); third shift (three patients). PCT FF - first shift (five patients); second shift (five patients); third shift (three patients). - March 18, 2025 (Tuesday): PCT GG - first shift (five patients); second shift (five patients). PCT DD - first shift (four patients); second shift (five patients). - March 19, 2025 (Wednesday): PCT CC - first shift (four patients); seconds shift (five patients); third shift (three patients). PCT BB - first shift (five patients); second shift (five patients); third shift (five patients). - March 20, 2025 (Thursday): PCT AA - first shift (five patient); second shift (five patients). PCT DD - first shift (five patients); second shift (five patients). - March 21, 2025 (Friday): PCT AA - first shift (five patients); second shift (four patients); third shift (two patients). PCT BB - first shift (five patients); second shift (five patients); third shift (three patients). - March 22, 2025 (Saturday): PCT CC - first shift (four patients); second shift (five patients). PCT BB - first shift, four patients, second shift, five patients. - March 24, 2025 (Monday): PCT CC - first shift (four patients); second shift (five patients); third shift (four patients). PCT BB - first shift (five patients); second shift (five patients); third shift (three patients). - March 25, 2025 (Tuesday): PCT AA - first shift (four patients); second shift (five patients). PCT DD - first shift (four patients); second shift (four patients). - March 26, 2025 (Wednesday): PCT AA - first shift (four patients); second shift (five patients); third shift (three patients). PCT BB - first shift (five patients); second shift (five patients); third shift (three patients).”

“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: 50523 Based on observation, a review of facility Policy and Procedures (P&P), and staff interview, it was determined that the Infection Control Committee failed to ensure that one of one Patient Care Technician (PCT) (PCT CC) observed during preparation of access (needle insertion sites) and cannulation (insertion of fistula needle), changed gloves when moving from an access that was not yet cleaned (prior to skin antisepsis) to cannulation sites after skin disinfection, to prevent cross contamination. This failure increased the risks for cross contamination for three of three patients (P) (P#11, P#12, and P#13) observed, who were assigned to PCT CC at the time of these observation. Findings include: During observation in the Patient Treatment Room, the following was observed: - On 9/10/24 at 12:28 p.m., PCT CC was observed at Station (S) 7 while disinfecting P#11”s access. PCT CC wiped both needle insertion sites with alcohol pads in an up and down motion. She then palpated (examined by touch) P#11’s access right before cannulating the first and second sites (after the sites had been disinfected), while she wore contaminated gloves used to clean P#11’s access. - On 9/12/24 at 11:45 p.m., PCT CC was observed at S11 while disinfecting P#12’s needle insertion sites with alcohol pads in an up and down motion. It was observed right before PCT CC inserted the first and second needles, that she grabbed the disinfected areas of P#12’s access when cannulating both sites one at a time, while she wore contaminated gloves used to clean P#12’s access. - It was also observed at 12:09 p.m. at S2, that PCT CC disinfected both sites of P#13’s access with alcohol pads in an up and down motion. It was observed right before PCT CC inserted the first and second needles, that she grabbed the disinfected areas of the patient access when cannulating both sites one at a time, while she wore gloves used to clean P#13’s access. A review of Policy 45178 titled, “Access Assessment and Cannulation” published May 6, 2024, version 4 stated the following: Clean the access site beginning in the center and continuing outward two inches in a concentric circle for 30 seconds. Perform skin antisepsis on one site at a time, allow to dry and then cannulate. Do not touch cannulation sites after skin disinfection. The Lead Facility Administrator was notified of the above findings on 9/12/24 at approximately 2:50 p.m. and did not offer any comments.”

“IC-SINKS AVAILABLE CFR(s): 494.30(a)(1)(i) A sufficient number of sinks with warm water and soap should be available to facilitate hand washing. This Standard is not met as evidenced by: 32734 Based on observation, a review of policy, and staff interviews, it was determined that the facility failed to ensure that two of two handwashing sinks in one of one Patient Treatment Room had warm water available, to encourage handwashing of patients who were coming in for their hemodialysis treatment and for those patients who had completed their treatment; and for all staff who worked at this facility. The facility census was 49. Findings include: During a tour of the Patient Treatment Room on 9/12/24 at 12:40 p.m., two of two sinks designated as “clean sink”, located on opposite sides of the nurses’ stations which were used for handwashing by the staff and patients, did not have warm running water for handwashing. The water in each sink failed to warm up after running for more than three minutes. A review of Policy Reference Number 47664 titled, “Hand Hygiene” published 11/6/23 stated: A sufficient number of sinks with soap and plumbed with both hot and cold water shall be available to facilitate hand washing. During an interview with the Clinical Manager, Lead Facility Administrator, Area Technical Operations Manager, and Quality Manager on 9/12/24 at 2:45 p.m., all acknowledged that the water in the sinks did not warm up.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 32734 Based on observation, a review of policy, and staff interviews, it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT) (PCT BB) observed during termination of dialysis, wore goggles or face mask (personal protective equipment). This failure placed PCT BB at risk for exposure to blood should spurting or spattering of blood occur. Findings include: During observation in the Patient Treatment Room at 1:45 p.m. on 9/11/24, the following was observed: - During the termination of dialysis treatment on a patient with an arteriovenous fistula (AVF - dialysis access) at Station 10, PCT BB wore eyeglasses and a face mask. PCT BB failed to wear goggles or a face shield during the procedure. A review of policy titled, “Personal Protective Equipment” dated 11/6/23 version 6 stated: Spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Protective eyewear is provided by the facility and must be eye protection designed under normal conditions of use to prevent blood and OPIM from reaching the eyes. Prescription corrective eyewear is not considered appropriate eye protection. During an interview on 9/11/24 at 1:50 p.m., the Charge Nurse was made aware that PCT BB was not wearing a face shield or goggles and immediately advised PCT BB of not wearing appropriate PPE. During the exit interview on 9/12/24 at 3:00 p.m., the Clinical Manager, Lead Facility Administrator, and the Quality Manager acknowledged and agreed that PCT BB should have worn goggles or face shield during the procedure.”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 50523 Based on review of facility records, staff interviews and a review of facility Policy and Procedures (P&P), it was determined that the facility failed to ensure that the total chlorine test (test for presence of chlorine in the water used for dialysis) was performed and documented every four hours. Two of two Registered Nurses (RN) (RN AA and RN BB) failed to perform and document the total chlorine test in a timely manner per facility P&P. Residual levels of total chlorine in the water used for dialysis could result in the destruction of patient’s red blood cells (hemolysis). The facility census was 49. Findings include: A review of the “Post Worker Carbon Tank-TCL-1” log revealed the following: - On 8/1/24, the water check was due at 9:17 a.m. RN AA documented that the water test was performed at 9:52 a.m. The water test was completed 35 minutes late. - On 8/20/24, the water check was due at 12:31 p.m. RN BB documented that the water test was performed at 12:35 p.m. The water test was completed four minutes late. On 8/31/24, the water check was due at 4:50 p.m. RN BB documented that the water test was performed at 4:56 p.m. The water test was completed six minutes late. During staff interviews on 9/10/24 and 9/11/24 the following was revealed: - On 9/10/24 at 2:25 p.m., the Clinical Manager (CM) stated that the RNs were to document when any sort of entry was late and explain the reasoning behind the cause. CM also said that the monthly QAI (Quality Assurance Meeting) had not been done for the month of August, therefore, the late performed water test was not yet reviewed or addressed. - On 9/10/24 at 3:13 p.m., PCT CC stated that the RNs performed the total chlorine testing, and the results were confirmed by the PCTs. The RNs set a timer on the treatment floor with a time set at three hours and 30 minutes as a reminder for the next total chlorine test. - On 9/11/24 at 2:47 p.m., RN AA explained that on 8/1/24, she performed the total chlorine test on time. Due to multiple patient’s needing assistance, RN AA said she forgot to document the time the test was completed. RN AA explained that by the time she remembered to document a note concerning the correct time it was performed, it was too late. RN AA said that she always set an alarm on the treatment floor to go off every three hours and 30 minutes to give her time to perform the total chlorine test before it reached the four-hour mark. A review of facility policy: 46310 titled, “Carbon Filtration Monitoring for Incenter Central Water Systems” published November 7, 2022 version 9 revealed the following: Test prior to the initiation of the first patient treatment of the day and at a minimum of every four hours.”

“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: 32734 Based on observation and staff interviews, it was determined that the facility failed to maintain a safe and sanitary environment for all 49 patients who dialyzed at this facility and for three of three Registered Nurses (RN) (RN AA, RN BB, RN CC), and four of four Patient Care Technicians (PCT) (PCT AA, PCT BB, PCT CC, and PCT DD) who worked at this facility as evidenced by unsanitary equipment that posed infection control risks; water on the floor and broken floor tiles that presented risks for fall. These environment concerns were observed in one of one Water Treatment Room. Findings include: During a tour of the facility on 9/10/24 at 12:00 p.m., accompanied by the Clinical Manager (CM), the following was observed: In the Water Treatment Room: - The floor drain located in front of the DI (deionized) water system had brownish-rust discoloration and dirt. - Approximately 1-2 feet area between the acid and bicarbonate mixing tanks had crystalized white dried substance and dirt buildup. - The top of the acid mixer and the pump had white crystallized splashed across the pump and lid of the holding tanks. - The door leading into the water treatment room was splashed with white colored residue. - There was approximately 3-5 feet of water on the floor between the booster pump and reverse osmosis (water treatment system). - The pipes of the backflow preventor had a green colored substance/discoloration. - There was appromimately 1-2 feet of dark stains across two large ceiling tiles. - There were 14 small cracked tiles and two small missing floor tiles (approxitmately 3x4 feet area) located in front of the door leading into the Water Treatment Room During an interview with the CM on 9/10/24 at 12:10 p.m., and on 9/10/24 at 1:00 p.m, with the Biomed Technician, both acknowledged the above findings.”