Fmc New Bailie Dialysis

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition 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 facility failed to ensure that the building in which dialysis services were furnished was sanitary and maintained free from damage and defects, to ensure a safe environment for all patients and staff. Excessive moisture could contribute to the growth of mold on surfaces and materials that could cause a range of respiratory issues, including allergic reactions, asthma attacks, and infections. The failure to maintain the integrity of surfaces (floors, ceiling, and walls) could hinder effective cleaning and disinfection of the surfaces, thus provided a potential for microbial growth. These environmental concerns were observed throughout the facility and could negatively affect the health and safety of all staff and 75 patients who were dialyzing at this facility. Findings include: Cross References: V 402 - Failure of the facility to provide a sanitary and safe environment for all patients and staff, as evidenced by unmaintained equipment and building. V 403 - Failure of the facility to have a system in place to ensure that two of two large electrical control panel enclosures (metal boxes that housed components of an electrical control panel) and electrical conduits were maintained in good condition.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observations, a review of records, staff interviews,and a review of facility Policy and Procedures (P & P), 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 75 patients who dialyzed at this facility. Findings include: Cross References: V 402 - Failure of the facility to provide a sanitary and safe environment for all patients and staff, as evidenced by unmaintained equipment and building. V 403 - Failure of the facility to have a system in place to ensure that two of two large electrical control panel enclosures (metal boxes that housed components of an electrical control panel) and electrical conduits were maintained in good condition.”

“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: 49321 Based on observation, staff interviews, a review of the Centers for Disease Control and Prevention (CDC) recommendations, and a review of Policy and Procedures (P&P), it was determined that the governing body failed to ensure that the infection control committee implemented P&P as evidenced by failure of one of one Physician Assistant (PA BB) and two of two Patient Care Technicians (PCT AA and PCT BB) observed, performed hand hygiene (wash hands or use an alcohol based hand sanitizer) after removal of contaminated gloves and between patients and/or stations. Failure to perform hand hygiene increased the risk for cross contamination with the potential to expose all patients and staff to bloodborne pathogens in the dialysis environment. The facility census was 75. Findings include: During observation in the Patient Treatment Room on 12/17/24 from 9:45 a.m. to 12:00 p.m., the following was observed: - PA BB touched Patient (P) #9’s treatment chair at Station (S) 28 (dirty area/task) without wearing gloves and without performing hand hygiene. Then he touched the keyboard and documented (clean area/task). - PA BB then proceeded to S23 and touched P#10’s ankles without wearing gloves and then again, touched the electronic device. - PA BB did not perform hand hygiene when going from dirty task to a clean task. - At S14, PCT AA (with gloves on) touched the dialysis machine (dirty) and silenced an alarm (no glove change or hand hygiene performed), then picked up a roll of tape (clean), tore five strips, and placed them on the arm of the treatment chair. - did not perform hand hygiene when going from dirty task to a clean task. - PCT BB was at S10, silenced the dialysis machine alarm while she held a glove and touched the machine (but did not wear the glove). When finished, she did not perform hand hygiene. - PCT BB then put on a pair of gloves and discontinued P#11’s dialysis treatment at S12. During an interview on 12/17/24 at 10:00 a.m., Registered Nurse (RN) BB stated PA BB must constantly be reminded to wear gloves and wash his hands. On 12/17/24 at 10:40 a.m., PCT AA was asked if she realized she had not changed her gloves or performed hand hygiene after touching the dialysis machine (dirty) and before tearing the tape (clean). PCT AA said she was moving fast. On 12/17/24 at 10:50 a.m., PCT BB stated that she did not realize she had not used hand sanitizer before putting on gloves. When questioned about not entirely putting on the gloves before silencing the machine alarm, she explained that she was not paying attention at that moment. According to the CDC, cross-contamination (going from dirty to clean equipment/tasks/area) could cause the spread of bacteria/infections. A review of Policy # 47554 titled, “Hand Hygiene” published 3/17/23 showed the following: RESPONSIBILITY All staff, patients, patient caregivers, including physician and non-physician practitioners, social workers, dietitians, and other indirect patient care staff must follow the exact requirements for hand hygiene. POLICY Hands will be decontaminated using alcohol-based hand rub or by washing hands with an antimicrobial soap and water: - before and after direct contact with patients - Immediately after removing gloves - After contact with inanimate objects near the patients”

“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: 49321 Based on observation, staff interviews, and a review of facility policy, it was determined that the facility failed to ensure that one of one Dietitian and one of one Registered Nurse (RN) AA observed, used Personal Protective Equipment (PPE) in accordance with the type of patient contact expected and the anticipated exposure. The facility patient census was 75. Findings include: During observation on 12/17/24 from 9:30 a.m. to 11:30 a.m., the following was observed: - The patient (P) (P#7) at Station (S) 16 was rinsed back (blood was returned to patient) and the venous needle was about to be removed. The dietitian stood on the right side of the treatment chair, facing P#7, who had a left upper arm fistula. Without a face shield, the dietitian began talking to the patient as P#7 held access site. Afterward, the dietitian walked over to S24 and spoke to P#8 during the removal of P#8’s arterial needle. The dietitian did not wear a face shield during which spurting or spattering of blood might occur. - At 10:35 a.m., RN AA, still in full PPE, escorted P#8 to the lobby. RN AA remained in the lobby for two minutes while she wore PPE. On 12/17/24 at 10:30 a.m., the dietitian was asked if she should wear a face shield when talking to patients while they hold their access. The dietitian said she never thought about it. During an interview on 12/18/24 at 1:00 p.m., RN AA acknowledged that she went to the lobby in full PPE (mask, gown, face shield, and gloves). Stated that she was unsure of what she would encounter, which was why she chose to wear her PPE. A review of Policy: 47663 titled, “Personal Protective Equipment” Version 6 Published 11/06/23 showed the following: - Personal Protective Equipment (PPE), including a full-face shield or mask and protective eyewear with full side shield, fluid-resistant gowns, and gloves, must be worn to protect employees from blood or other potentially infectious materials (OPIM). - PPE is used to protect employees who are occupationally exposed to blood or OPIM 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). - All personal protective equipment shall be removed prior to leaving the treatment area.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 49321 Based on a review of records and staff interviews, it was determined that the facility failed to ensure that one of one medical director had current Hepatitis B status/vaccination. This deficient practice had the potential to negatively affect the health and safety of all staff employed and 75 hemodialysis patients who received hemodialysis treatment at this facility. Findings include: A review of personnel files revealed that the medical director lacked documented hepatitis B testing, vaccination, or declination and no documented evidence of tuberculosis evaluation. The nurse manager (NM) was notified of the above findings on 12/17/24 at 5:05 p.m. The NM stated the documents were at the physician’s office but as of exit interview on 12/19/24 at 2:00 p.m., the NM did not produce the missing documents.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 49321 Based on staff interviews and a review of facility records, it was determined that the facility failed to ensure that one of five sampled staff (Licensed Practical Nurse [LPN] AA) who verified pH (acidity) and Conductivity (the ability of the dialysate to conduct electricity) using the pHoenix XL Meter (a hand-held device used to verify the conductivity, temperture, and pH of dialysate ) on five of six sampled Patients’ (P) (P#1, P#3, P#4, P#5, and P#6) dialysis machines, had documented training and competency skills/periodic audits. The facility census was 75. Findings include: A review of personnel files revealed that LPN AA did not have documented training nor skills competency checklist in the use of the pHeonix XL Meter. There was also a lack of documented periodic audits performed to evaluate LPN AA’s compliance with the procedures. During an interview on 12/19/24 at 9:30 a.m., the nurse manager stated that LPN AA did not need to be checked off on using the Pheonix XL Meter because she did not verify any dialysis machines for pH or conductivity. During an interview on 12/19/24 at 10:30 a.m., LPN AA stated she had been gone from the facility for a while (maybe a year) and could not remember when she was checked off on the use of the Pheonix XL Meter at this facility or any other facility. LPN AA acknowledged that she signed the second signature, and verified that the dialysate pH and conductivity were correct. A review of the sampled patients’ flowsheets from 12/3/24 through 12/17/24 revealed that LPN AA verified that the pH and conductivity were correct on the following: P#1- 12/14/24. P#3- 12/13/24 and 12/16/24. P#4- 12/7/24 and 12/12/24. P#5 - 12/14/24. P#6 - 12/7/24 and 12/12/24.”

“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 interviews, and a review of the Centers for Disease Control and Prevention (CDC) recommendations, it was determined that the facility failed to maintain a safe environment for all patients and staff, as evidenced by unmaintained equipment that resulted in leakage of acid concentrate (dialysis solution) from behind the chase cabinets (that housed connections for the dialysis machines to receive acid and base concentrates and treated water, and dispose of waste products) which allowed acid concentrate to run onto the treatment floor; a leaking roof that caused wet and water stained ceiling tiles throughout the building; soft and sagging drywalls in the administrative area, treatment area, water room, and biomedical work area; and damaged/cracked/uneven floor in the water treatment room. 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. The failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus provided a potential for microbial growth. These environmental concerns were observed throughout the facility and could negatively affect the health and safety of all staff and 75 patients who were dialyzing at this facility. Findings include: During observation on 10/17/24 from 10:00 a.m. to 5:30 p.m., the following was revealed: The Side Door Area: - The side door near the staff break room that led to the outside, had an elevated threshold with no stairs, caution tape, or warning signs for the drop. - The side door frame (inside the building) had begun separating from the wood and drywall. - The drywall (3 feet from the door) was bulging/swollen, softened, and fell apart when touched. - There were four water-soaked ceiling tiles over the side door. In the Patient Treatment Room: - An area of drywall (four inches wide) next to the inside door that led to the treatment area was soft, swollen, warped, and disintegrated when touched. - The ceiling tiles over Station (S) 10, S12 and outside the isolation room were rust-colored and sagging. -The drywall outside the isolation room was soft and disintegrated when touched. - The drywall of the office in the treatment area, had a hole and had black fuzzy spots coming out from inside of the drywall to the surface. - The light brown countertop around the clean sink on the right-hand side of S15 was deteriorated. - The drywall on the left of the sink was soft and damaged. - The baseboard and the vinyl flooring at S1, S2, S3, S4, S5, S6, S7, S8, and S9 had thick layers of crusted white substance. - A liquid was observed coming out of the cracked chase cabinet onto the treatment floor from S15, S16, S17, S18, and S19. - The rubber baseboard and thick vinyl sheet flooring at S20, S21, S22, S23, S24, S25, S26, S27, S28, and S29 were bubbling out and felt soft to the touch. In the Janitorial Closet: - The floor had deep scratches and was unsanitary. - The mop drain had thick, deep scratches and had a foul odor. In the Water Room: - A bright light shone from beneath the back double doors [approximately 6 foot (ft) long] and had approximately 1 inch space between the door and the floor. - There were rust-like substances at the base of the door frame that easily chipped away. - A 6x3 ft. section of the concrete floor on the left side of the acid mixing tank was deeply degraded. - The floor behind the water softener and the first carbon tank had dark green fuzzy substance that came out of the drain and spread to the surrounding floor. In the Biomedical Work Room: - The ceiling drywall, that extended 6 inches from the wall, showed rust-colored and dark yellow stains over an area measuring 12x4 ft. - The paint was peeling and there were noticeable cracks in the drywall that extended from the center of the ceiling toward the wall. - The small inlet air vent was surrounded by black, fuzzy spots, while the larger outlet vent was covered in thick black particles. - The cement floor had deep scratches. The Parking Lot: - The front parking lot was dark and did not have any lights. During an interview on 12/17/24 at 10:00 a.m., the Nurse Manager stated the facility had sustained roof damage from Hurricane Helene and was in the process of getting a new roof. When asked about safety concerns in the parking lot after dark, she stated that a security guard was present in the front parking lot from 4:00 a.m. to 10:00 a.m. However, there was no security at night, so staff members are encouraged to leave the building in pairs for safety. During an interview with the Biomedical Technician on 12/17/24 at 3:00 p.m., he acknowledged the findings and stated that the building had issues, and the company has been actively working to resolve them. During an interview with Staff AA on 12/19/24 at 10:00 a.m., it was revealed that a room next to the conference room had been sealed off due to mold. Staff AA reported that mold was also present in the bathrooms. Stated the side door and its frame are in poor condition and are at risk of falling out. When it rains, water seeps into the building, causing flooding on the floor by this door. Staff AA stated the company has not addressed the leaking acid pipes on the treatment floor, which continue to leak beneath the heavy vinyl flooring, leading to water accumulation on the floor. Stated despite their ongoing concerns, nothing has been done to resolve those issues. During the exit interview on 12/19/24 at 1:30 p.m., the Facility Administrator was notified and confirmed the above findings. According to the CDC, dialysis wall boxes need to be properly maintained to decrease risk of patient infections. Note: The wall boxes at this facility were referred to as chase cabinets.”

“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: 49321 Based on observation and staff interviews, it was determined that the facility failed to have a system in place to ensure that two of two large electrical control panel enclosures (metal boxes that housed components of an electrical control panel) and electrical conduits were maintained in good condition as evidenced by blackened and oily discoloration around the enclosure vent, dark, beige, and rust-colored substances all over the electrical conduits and dark flaky substance on the floor underneath and around enclosures. During a tour with the covering Bio Medical Technician (BMT) on 12/18/24 at 11:00 a.m., the following was revealed: - There were two large electrical control panel enclosures in the Supply Room. - The base of electrical control panel enclosure #1, had blackened and oily discoloration around the vent. - The floor underneath was covered with rust-colored, thick layers of flaky substance. - The electrical conduits had thick accumulation of dark, beige, rust-colored flaky substance on them. - The electrical control panel enclosure #2 had dark charred substance covering the floor underneath. During an interview on 12/18/24 at 11:15 a.m., the covering BMT acknowledged the above findings and stated that the facility has hired a new BMT because this facility could not keep one. The covering BMT stated the charred area under electrical control panel enclosure #2 was not from a fire. It was from the bicarbonate granules that were building up and turning black.”

“POC-PT/FAMILY EDUCATION & TRAINING CFR(s): 494.90(d) The patient care plan must include, as applicable, education and training for patients and family members or caregivers or both, in aspects of the dialysis experience, dialysis management, infection prevention and personal care, home dialysis and self-care, quality of life, rehabilitation, transplantation, and the benefits and risks of various vascular access types. This Standard is not met as evidenced by: 49321 Based on a review of medical records and staff interviews, it was determined that the facility failed to provide education on infection control practices, such as handwashing and access care for six of six patients (P#1, P#2, P#3, P#4, P#5, and P#6) sampled. This deficient pratice had the potential to negatively impact the health and safety of P#1, P#2, P#3, P#4, P#5, and P#6. The facility census was 75. Findings include: A review of medical records revealed that P#1, P#2, P#3, P#4, P#5, and P#6 did not have documented education on access care and hand hygiene (hand washing and/or use of hand sanitizer). The clinic manager (CM) was notified on 12/18/24, at 10:00 a.m., and stated that all patients have education documentation. However, the CM did not produce the missing documents.”