Fmc - Rai-Eagles Landing-Stockbridge

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of the Mar Cor 4400M Digital Reverse Osmosis System Installation, Operation, and Maintenance Manual, it was determined that the facility failed to ensure that the Reverse Osmosis (RO) system (used to purify water for dialysis) was maintained and free from water leakage and accumulated white, yellow, and green substances on the membrane housings and system frame. A review of the Mar Cor 4400M Reverse Osmosis Installation and Maintenance Manual revealed that a leaking membrane can mean internal failure (allowing feed water to bypass the membranes, leading to unfiltered water entering the product water), or housing, or O-ring failure (which can compromise pressure and system safety), which means the water is no longer reliably purified, posing a high risk to patients on dialysis. This failure had the potential risk to negatively affect the health and safety of all 63 in-center hemodialysis patients who were dialyzing at this facility. On 7/25/25 at 2:20 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the likelihood to cause harm to all 63 in-center hemodialysis patients who dialyzed at this facility. The Director of Operations and the Facility Manager were informed of the IJ finding on 7/25/25 at 2:20 p.m. The noncompliance related to the IJ was identified to have existed on 7/25/25 at 2:20 p.m. The IJ situation was abated on 7/25/25 at 3:00 p.m., when the facility implemented their “IJ Removal Plan”, that included but not limited to: a Governing Body meeting, review of policies and procedures with the Biomed Technician and Direct Patient Care (DPC) staff (nurses and patient care technicians), replacing the end caps of the membrane housings (#2, #3, and #4) of the RO Machine. The RO machine to be disinfected after repair per facility policy and if the RO machine cannot be repaired, a Deionization (DI - used for water purification) system will immediately be installed, and a plan to monitor was put in place. Findings include: Cross References: V199 - Failure of the facility to ensure that the Mar Cor Purification 4400M Reverse Osmosis System was free of membrane leakage, that no O-rings were compromised, and that the system was clean and free of residue.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observations, a review of facility records, staff interviews, a review of facility Policy and Procedures (P & P), and a review of the Mar Cor 4400M Digital Reverse Osmosis System Installation, Operation, and Maintenance Manual, 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 63 in-center hemodialysis patients who dialyzed at this facility. Findings include: Cross References: V199 - Failure of the facility to ensure that the Mar Cor Purification 4400M Reverse Osmosis System was free of membrane leakage that could potentially compromise system pressure and safety, and was clean and free of residue. V405 - Failure of the facility to ensure there was a comfortable temperature for all patients and staff at the Patient Treatment Room, specifically: at Station (S) S1, S2, S3, S4, S5, S6, S7, S8, S19, S20, and S21), staff conference room, and the hall leading out to the staffs’ parking lot.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the Infection Control Committee failed to ensure that one of one Licensed Practical Nurse (LPN AA) observed, practiced infection control techniques to prevent cross contamination. This failure had the potential to negatively affect the health and safety of five of five patients seated at Station (S) 20, S21, S1, S3, and S8 and the other 58 patients who were under the care of this facility. Findings include: During observation on 7/9/25 from 7:00 a.m. to 9:00 a.m., the following was revealed: LPN AA was observed carrying a small basket that contained six 5 mL (milliLiter) cups containing oral medications. LPN AA, wearing the same gloves, went to each patient station (S20, S21, S1, S3, and S8), distributing the medication cups and placing them on each patient’s side table. During an interview with LPN AA on 7/9/25 at 8:30 a.m., LPN AA stated that she did not realize she was doing anything wrong. According to the CDC, measures to prevent contamination of clean or sterile items include... c) delivering medications separately to each patient: common medication carts must not be used to deliver medications.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the Infection Control Committee failed to ensure that one of one Patient Care Technician (PCT BB), and one of one Medical Director observed, practiced infection control techniques to prevent cross contamination. This failure had the potential to negatively affect the health and safety of all 63 patients who were under the care of this facility. Findings include: During observation in the Patient Treatment Room on 7/9/25 from 7:00 a.m. to 9:00 a.m., the following was revealed: - The Medical Director was observed making rounds at Station (S) 5, S3, S20, S14, S13, and S15, using his personal stethoscope (to assess the patients’ lung and heart sounds), which he kept around his neck after each patient’s assessment. The stethoscope was not sanitized between patient uses. During an interview with the Medical Director on 7/9/25 at 10:00 a.m., the Medical Director stated that he cleansed his stethoscope at the end of patient rounds. - PCT BB was observed picking up a syringe filled with heparin injection (anticoagulant), from the floor (dirty) under the hemodialysis chair at S19. PCT BB placed the contaminated heparin injection syringe on top of the blue pad (clean) being used by Registered Nurse (RN AA) to prepare heparin injection doses for the next shift . RN AA, unaware of the contaminated heparin injection (that was picked up from the floor by PCT BB), moved the contaminated heparin injection syringe to the right corner of the same pad and proceeded to open sterile syringes, and placed them on the same blue pad in preparation to draw up heparin injections for the next shift.. During an interview on 7/9/25 at 11:00 a.m., PCT BB stated she did not know what to do with the medication, so she placed it on the nurse’s pad. According to the CDC, any item taken to a patient’s dialysis station could become contaminated with blood and other body fluids and serve as a vehicle of transmission to other patients either directly or by contamination from the hands of personnel. Additionally, according to the CDC, measures to prevent contamination of clean or sterile items include... b) not handling or storing potentially contaminated supplies... in areas where medications and clean supplies are handled;”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of the Mar Cor 4400M Digital Reverse Osmosis System Installation, Operation, and Maintenance Manual, it was determined that the facility failed to ensure that the Reverse Osmosis (RO) system (used to purify water for dialysis) was maintained and free from water leakage and accumulated white, yellow, and green substances on the membrane housings and system frame. A review of the Mar Cor 4400M Reverse Osmosis Installation and Maintenance Manual revealed that a leaking membrane can mean internal failure (allowing feed water to bypass the membranes, leading to unfiltered water entering the product water), or housing, or O-ring failure (which can compromise pressure and system safety), which means the water is no longer reliably purified, posing a high risk to patients on dialysis. This failure had the potential risk to negatively affect the health and safety of all 63 in-center hemodialysis patients who were dialyzing at this facility. On 7/25/25 at 2:20 p.m., a determination was made that a situation in which the facility’s noncompliance with 42 CFR 494.40, Water and Dialysate Quality, resulted in an Immediate Jeopardy (IJ) with the likelihood to cause harm to all 63 in-center hemodialysis patients who dialyzed at this facility. The Director of Operations and the Facility Manager were informed of the IJ finding on 7/25/25 at 2:20 p.m. The noncompliance related to the IJ was identified to have existed on 7/25/25 at 2:20 p.m. The IJ situation was abated on 7/25/25 at 3:00 p.m., when the facility implemented their “IJ Removal Plan”, that included but not limited to: a Governing Body meeting, review of policies and procedures with the Biomed Technician and Direct Patient Care (DPC) staff (nurses and patient care technicians), replacing the end caps of the membrane housings (#2, #3, and #4) of the RO Machine. The RO machine to be disinfected after repair per facility policy and if the RO machine cannot be repaired, a Deionization (DI - used for water purification) system will immediately be installed, and a plan to monitor was put in place. Findings include: During a tour of the facility on 7/8/25 at 9:30 a.m., it was observed that the Mar Cor Purification 4400M Digital Reverse Osmosis System was leaking water from the second membrane housing. - On 7/25/25 at 10:30 a.m., the Mar Cor Purification 4400M Reverse Osmosis System was still leaking water from the second membrane housing located at the rear of the RO system. Additionally, water was also leaking from the first membrane housing. - The four steel membrane barrels on the RO system were covered with thick white, yellow, and green substances. - The booster pump had a thick white substance on its surface. - The base of the RO system’s frame was flaking and coated with thick brown and gold-colored substances. During an interview on 7/8/25 at 2:00 p.m., the Biomedical Technician (BMT) stated that the RO system (4400M) was 20 years old. He stated the facility would need a new RO system. During a telephonic interview on 7/11/25 at 6:00 p.m., the Mar Cor Customer Service Technician (CST #1) stated that the water quality is compromised anytime the RO system is leaking. During a telephonic interview on 7/25/25 at 11:40 a.m., the Mor Cor (CST #2) stated that the Mar Cor 4400M system should not leak. The pressure is compromised which can cause the unfiltered water to be mixed with the filtered water or product water. A review of the Mar Cor 4400M Digital Reverse Osmosis System Installation, Operation, and Maintenance Manual, stated: 1. A leaking membrane can mean: * Internal failure, allowing feed water to bypass the membrane____ leading to unfiltered water entering your product water. * Or, housing or o-ring failure, which can compromise pressure and system safety. This means your water is no longer reliably purified, which is dangerous in medical, dialysis, or critical lab settings. If the system is used in any of the following: * Dialysis... ... then using it in this condition could compromise patient safety or product integrity. You should: 1. Stop using the system immediately. 2. Shut off feedwater and power. 3. Inspect both membranes __ replace them. 4. Disassemble and clean the housings. 5. Sanitize the full system... 6. Verify performance after restart (conductivity, pressure, flow rates). - Based on the above corrective actions, the IJ was removed; however, the Condition remained out of compliance.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 49321 Based on observation, staff interview, a review of the facility’s Policy and Procedures (P&P) and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was clean and maintained free from damage and defects to ensure the safety of the patients and staff. Unsanitary environments and excessive moisture could contribute to mold growth on surfaces and materials that could cause various respiratory issues, including allergic reactions, asthma attacks, and infections. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thereby creating a potential environment for microbial growth. These environmental concerns were observed in one of one Patient Treatment Room, one of one Supply Room, one of one Water Treatment/Dialysate Preparation Room, one of one Conference Room, and hallway. Findings include: During a tour of the facility with the Nurse Manager and the Biomedical Technician (BMT) on 7/8/25 at 9:30 a.m., the following was revealed: In the Patient Treatment Room: - The dialysis wall box and drain (frame recessed into the wall at each hemodialysis station that contains connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of waste products), inside the Isolation Room had thick, flaky white, yellow, green, and black substances, running down toward the drain. - The dialysis wall box and drain at Station (S) 13 had a thick, white substance. - The wall to the left of S21 had chipped paint and was covered with multiple black marks. Additionally, there was a large industrial fan in the area, and underneath the fan was a large amount of thick, bronze and black substances. - The corner counter behind S21 was deeply chipped. - The glass partition/barrier on the right side of the sink (located in front of S13 and S14) had a thick, white film that ran down the right side of the wooden panel to the floor. In the Supply Room: - The floor was covered with dirt and white particles. The two wooden crates had a sticky, dark substance around and underneath them. In the Water Treatment/Dialysate Preparation Room: - The floor in front of and behind the Brine Tank (holds salt and water as part of the water softener system) and the two large Media Tanks (part of the water softener system) was covered with white particles. Thick layers of these particles were also present around the bottom of all three tanks. - The bottom of the wall/divider separating the Brine Tank and the RO (reverse osmosis) system was wet, buckling at the bottom, and leaking water. A rust-colored substance and water were seen coming from this bottom area. The surrounding floor was wet. - The drain station of the Concentrate Delivery System (CDS) contained a thick, white and green substances. The wall next to the drain had yellow and white crusty particles on it. - The floor on the left side of the Acid Mixing Tank was covered with a thick, white substance. The floor beneath the Acid Mixer was also coated with this white substance. Additionally, the holding tank to the left of the mixing tank, along with its tubing, was covered with the same thick, white substance. - The floor drains behind the RO system, carbon tanks, and the drain next to the Granuflo acid tank had a thick brown, yellow, and green slimy substances around the drains. In the Conference Room: - There were seven large ceiling tiles that had noticeable dark brown stains that covered significant portions of the surface. In the Hallway: - There were four ceiling tiles that had dark brown stains. - One of two light fixtures had thick white substance on the inside of the plastic cover. On 7/8/25 at 9:45 a.m., the Nurse Manager and the BMT both acknowledged the above findings. A review of Policy #47685, titled, “General Cleanliness and Infection Control Guidelines”, Verson 8, published 5/5/25, stated: - All areas must be kept clean and organized, including but not limited to treatment areas, water/supply rooms, offices and restrooms. - Facility staff are accountable for cleaning rooms/area not assigned to contracted cleaning staff (water room). Such cleaning should be done regularly using a schedule developed by the facility. According to the CDC, it is important to address moisture issues in buildings to prevent mold and mildew growth, which can be harmful to human health. Standing water can create a breeding ground for mold and mildew, leading to various issues.”

“PE-COMFORTABLE TEMPERATURE CFR(s): 494.60(c)(2) The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for the patients who are not comfortable at this temperature. This Standard is not met as evidenced by: 49321 Based on observation, a review of facility records, a review of facility Policy and Procedures (P & P), and staff interviews, it was determined that the facility failed to ensure that there was a comfortable indoor temperature for all patients and all Direct Patient Care (DPC) staff (nurses and patient care technicians), as evidenced by thermostat (a device that regulates the temperature by controlling the air conditioner’s [AC’s] operation), #4 registering 79 degrees Fahrenheit at 10:00 a.m. on 7/8/25, in the Patient Treatment Room, specifically affecting Station (S) 1, S2, S3, S4, S5, S6, S7, S8, S19, S20, and S21, as well as the hallway leading to the staffs’ conference room and offices, and all the way out to the staffs’ parking lot. Additionally, the AC unit #6 (which was to cool these above mentioned areas), was not operational. This failure to provide a comfortable environment to patients and DPC staff had the potential to negatively affect the health and safety of all 63 patients who dialyzed at this facility and all DPC staff. Findings include: During entrance into the facility on 7/8/25 at 9:30 a.m., this surveyor observed that the hallway leading to the offices and the staff conference room (where the survey team was stationed from 7/8/25 to 7/10/25), were noticeably warm upon entry. The thermostat #4 that was located in the back area of the Patient Treatment Room (that regulated the temperature in half of the Patient Treatment Room, specifically the back area, affecting patients seated at S1, S2, S3, S4, S5, S6, S7, S8, S19, S20, and S21), as well as the hall leading to the offices, conference room, and all the way out to the staff parking lot, registered 79 degrees Fahrenheit at 10:00 a.m. During an interview with Licensed Practical Nurse (LPN AA) on 7/8/25 at 10:00 a.m., she confirmed that the AC system had been partially nonfunctional for approximately one year, specifically stating that AC unit #6 was not functioning. LPN AA also stated that patients had voiced complaints about the uncomfortably warm temperatures and that facility administration was aware of the issue. She also added that she had to leave work early on two occasions (6/24/25 and 7/4/25), because she felt “overheated” and started vomiting. She added that working in the Patient Treatment Room while wearing PPE (Personal Protective Equipment, such as gown, mask and face shield), exacerbated the discomfort caused by the high temperatures. During an interview with the Nurse Manager on 7/8/25 at 11:00 a.m., she confirmed that AC unit #6 had issues, specifically losing freon (a refrigerant in AC systems and plays a crucial role in cooling by facilitating the transfer of heat), as well as leakage of water through the ceiling, since the previous summer. The Nurse Manager added that the thermostats were now remotely controlled by the facility company’s Field Support Center and that she had contacted them multiple times, both by phone and by email, requesting that the temperature setting be adjusted to a lower setting, but was unsuccessful. The Nurse Manager also confirmed that DPC staff had been experiencing illness, which she attributed to the elevated temperatures in the Patient Treatment Room. The Nurse Manager also stated that AC technicians had been working on AC unit #6 for a year and everyone knew it needed to be replaced. During a telephonic interview with patient (P) #12 on 7/9/25 at 2:00 p.m., P#12 stated that the area where he and other patients in his section (back area), while undergoing hemodialysis treatment, felt the warm temperatures rising by 10:00 a.m. P#12 stated that they had previously complained about the warm temperatures and requested to be moved to the front area of the Patient Treatment Room. However, they were informed that because their treatment ran longer than three hours, they must be assigned in the back section of the Patient Treatment Room. P#12 also added that similar conditions occurred last year, and staff responded by turning on a large, noisy fan, which they felt only made the situation worse. During an interview with PCT AA on July 10, 2025 at 8:00 a.m., she stated that the heat was unbearable at times and it was really bad when wearing full PPE. PCT AA also stated that she had to run off the treatment floor to vomit because she got “overheated” on 7/4/25 and 7/7/25. The patients that dialyzed in the back of the Patient Treatment Room were always complaining to staff how hot it was in the Patient Treatment Room. PCT AA also added that on 7/4/25, LPN AA almost passed out because it was so hot in the Patient Treatment Room. A review of the facility’s (company name) Temperature Control Setting, stated: 1. Normal Operating Parameters To reduce energy consumption, the room controllers are programmed to “set back” during unoccupied periods. In the SUMMER this will raise the temperature to 80 degrees Fahrenheit. Prior to the clinic opening the controller will automatically begin a morning cooldown so that the clinic is cooled prior to occupant’s arrival.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 49321 Based on observation, staff interview, and a review of the facility’s Policy and Procedure (P & P), it was determined that the facility failed to ensure that six of of 18 patients observed, who were dialyzing at Station [S] 1, S3, S16, S17, S18, and S20), had their faces and vascular access (dialysis access) sites, and bloodline connections uncovered/visible to the Direct Patient Care (DPC) staff (nurses and patient care technicians) throughout their dialysis treatment, to ensure patient safety. This deficient practice limited the DPC staffs’ ability to monitor patients for signs of distress or changes in condition; and could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (a severe and potentially fatal blood loss). The facility in-center hemodialysis census was 63. Findings include: During observation in the Patient Treatment Room on 7/9/25 at 7:00 a.m., the following was revealed: - The patients who were dialyzing at S1, S3, and S20 had their faces covered, preventing clear observation by staff. - The patients who were dialyzing at S16, S17, and S18 had their vascular access sites and bloodline connections covered by blankets. On 7/9/25 at 7:05 a.m., Licensed Practical Nurse (LPN) AA was notified and confirmed the above findings. A review of Policy #45284, titled, “Patient Assessment and Monitoring”, version 4, Published 5/1/23, stated: General Observation/Mental Status -All patients must be under visual observation by clinical staff during treatment -Ensure each patient’s face is visable and uncovered. Access: Observe connections are secure and visible. Ensure access remains uncovered throughout the treatment.”