Aqua Dialysis Livingston

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 48653 Based on observations, record review, and staff interviews, the facility staff failed to monitor and provide a sanitary environment to minimize the transmission of infectious agents within the dialysis center’s in-center treatment area. Findings include: During a tour of the facility’s in-center treatment area on 10/28/2024 with Staff # 8 the surveyor observed the following infection control issues: * A staff member’s personal lotion was stored in the drawer with sterile patient supplies * The dialysis clamps were not completely submerged in the bleach water solution for proper disinfection. * The chair at dialysis station # 11was torn in 2 spots. The chair could not be adequately disinfected due to the damaged material. * The sink labeled “clean” had a large build-up of brown and black substance near the hot and cold handles and in the drain. * Station # 11 acid and bicarb wall box had a build-up of dried white crystals inside it and on the wall surrounding the wall box. A review of the facility policy, “Infection Control Policy” with an effective date of 01/29/2020 revealed, “Personnel Practices ... 2. Staff should not smoke, eat, drink, or apply cosmetics or lip balm in the dialysis treatment area ... Equipment/Supplies: 1. All equipment and supplies should be stored in a cool, dry area and kept off the floor ... Disinfection and sterilization: 4. Special attention is given to the entire area in which dialysis is performed including, dialysis chairs, dialysis machine (front, back, and sides), lines to the wall box, and trash cans in the immediate area. All surfaces require cleaning with 1:100 bleach solution unless blood is visible then 1:10 solution is used. 5. Tourniquets are cleaned between patients with 1:100 chlorine bleach solution ...” An interview was conducted with Staff # 8 on 10/28/2024 at 11:30 AM. Staff # 8 confirmed the facility’s in-center treatment area infection control issues that were identified.”

“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: 48653 Based on observation and interview, the facility’s direct care staff failed to ensure that all patients’ vascular access was in view during the dialysis treatment. One (Patient # 2) of 6 patient vascular accesses were covered with a blanket and were not visible to the staff during their dialysis treatments. Failure to ensure the patient’s dialysis access was visible throughout treatment had the likelihood to result in the patient’s needle becoming dislodged. A dislodged needle could result in the patient bleeding out without the facility staff recognizing it. Findings include: During a tour of the facility’s in-center treatment area on 10/28/2024 at 11:00 AM, the surveyor observed Patient # 2 undergoing hemodialysis treatment on machine # 21 at Station # 3. The patient’s dialysis access was not visible and was covered with a blanket. The direct care staff did not recognize the patient’s access was covered for more than 10 minutes. The surveyor had to alert the dialysis staff of the patient’s covered dialysis site. An interview was conducted on 10/28/2024 at 11:30 AM with Staff # 8 (Dialysis Technician). Staff # 8 confirmed the dialysis site was covered and alerted the patient’s assigned dialysis tech to the covered site. Staff # 10 uncovered the patient’s dialysis site.”

“PR-PTS INFORMED OF RIGHTS WHEN BEGIN TX CFR(s): 494.70 The dialysis facility must inform patients (or their representatives) of their rights (including their privacy rights) and responsibilities when they begin their treatment and must protect and provide for the exercise of those rights. This Standard is not met as evidenced by: 48653 Based on record review and staff interview, the facility failed to ensure a properly executed informed consent for hemodialysis treatment was completed for 1 (Patient # 1) of 1 patient medical records reviewed. Findings include: A review of Patient # 1’s medical records revealed the patient was admitted to the facility on 10/27/2023 for hemodialysis treatment. Patient # 1 signed the “Dialysis Consent Form” on 10/27/2024. The “Dialysis Consent Form” revealed, “I authorize the performance of hemodialysis and related procedures that my physicians have recommended that I undergo. I understand that I suffer from kidney failure, a condition in which my kidneys do not remove impurities and waste from my blood. The procedure is necessary to treat my condition and has been explained to me by the consenter. I understand dialysis as defined below: Hemodialysis is a treatment that involves the passage of the patient’s blood from his/her circulatory system via the dialysis machine to a filter (dialyzer). This process removes certain impurities and excess fluid from the blood. I have been made aware of certain risks and complications that can be associated with hemodialysis, which are listed below: 1. Hypotension (low blood pressure) 2. Hypertension (high blood pressure) 3. Air embolism (air bubbles in blood vessels) resulting in possible death or paralysis. 4. Cardiac arrhythmias (irregular heart rhythms) 5. Infections of bloodstream, access site, or blood-borne (for example, Hepatitis B, Hepatitis C) 6. Hemorrhage (severe bleeding as a result of clotting problems or due to disconnection of the bloodline). 7. Nausea, vomiting, cramps, headaches, and mild confusion during and/or temporarily after dialysis 8. Allergic reaction 9. Chemical imbalances and metabolic disorders (unintended change in blood minerals) 10. Pyrogenic reactions (fever) 11. Hemolysis (rupture of red blood cells) 12. Graft/Fistula damage including bleeding, aneurysm formation (ballooning of vessel), clotting (closure), of graft/fistula. I am aware that maintenance hemodialysis treatments will not cure my kidney disease. It is a treatment option for kidney failure that will replace some of the kidney’s function. I am also aware of other options currently available for kidney failure which include: *in-center hemodialysis *home hemodialysis *Peritoneal dialysis *Kidney Transplantation *refusal of treatment I understand that it is necessary for me to follow certain dietary restrictions, including restricting how much fluids I drink. It is my responsibility to follow all dietary guidelines, and doctor’s medication orders, and complete all my dialysis treatments as scheduled. I also understand that the practice of medicine is not an exact science, and there are no guarantees, expressed or implied. The degree of success of my treatments depends, to a large degree, on my compliance with the doctor’s orders. I acknowledge that I have read and understand this consent for hemodialysis. I have had time to ask questions about the in-center hemodialysis treatment option and feel comfortable deciding to start my in-center hemodialysis treatments. I hereby consent to the administration of hemodialysis treatments by the staff of this clinic as prescribed by my nephrologist, as well as further consent to any care that is considered necessary due to complications, which may develop during my in-center hemodialysis treatment.” Staff # 13 (Registered Nurse) witnessed the “Dialysis Consent Form” on 10/27/2024. There was no time documented on the consent. It was unknown if the patient signed the consent prior to the first dialysis treatment on 10/27/2024 because there was no time on the consent form. It was unclear if the physician explained the risks and benefits of dialysis treatment prior to the consent being signed by Patient #1. There was no documentation by the physician that the risks and benefits were explained to the patient. An interview with Staff # 1 and Staff # 14 on 10/28/2024 at 12:30 PM confirmed there was no documentation by the physician explaining risks and benefits to the patient prior to the consent being signed and there was no time on the consent form to verify consent was signed prior to treatment initiation.”

“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: 48749 Based on observation, record review, and interview, it was determined that the facility staff failed to label multiple dose vials of medication; once the medication vial had been opened. Also, the facility failed to follow its medication policy. This deficient practice had the likelihood to cause an error with expired medication being administered to a patient. Findings include: 1. A vial of Epogen had been opened and there was no label to indicate the date of when the vial was opened, or what staff member had opened the vial. 2. A vial of Venofer had been opened and there was no label to indicate the date of when the vial was opened, or what staff member had opened the vial. A review of the facility’s policy “Multi-Dose Vials” dated 01/29/2020 revealed the following: “POLICY: Multi-dose vials are to be labeled with the date, time, and the initials of the nurse opening the vial. Multi-dose Epogen vials are to be discarded after 21 days. All other multi-dose vials are to be discarded after 30 days. 1. The vial will be opened in a suitable manner (sterile techniques will be used). 2. No foreign material (liquid or solid) will be injected into the vial. * Exception: NS must be injected into Vancomycin vial for reconstitution 3. The vial will be stored in the proper manner. (Refrigerated or room temperature). 4. The person opening vial must date and initial stated vial. 5. The vial will be discarded after thirty (30) days if not utilized. * Epogen vials with preservatives are only good for 21 days after opening * 1 1/2 Inch dose-saver syringes are to be used with all Epogen vials * Multidose Epogen vials are not to be inverted. 6. The vial will be discarded if abnormal coloring or sediment is present. 7. The vial will be discarded if the rubber diaphragm shows visible penetration. 8. If a vial is found opened, with no date or initials on it, it must be discarded” An interview with Staff #1 on 06/12/2024 at 10:15 AM confirmed the medication bottles were not labeled with the date, time, and initials of the staff that opened the medication vial.”

“ACID BULK STORAGE TANKS-SAFETY CONTROLS CFR(s): 494.40(a) 5.4 Concentrate preparation 5.4.3 Bulk storage tanks (acid concentrate): safety controls Procedures should be in place to control the transfer of the acid concentrate from the delivery container to the storage tank to prevent the inadvertent mixing of different concentrate formulations. If possible, the tank and associated plumbing should form an integral system to prevent contamination of the acid concentrate. The storage tanks and inlet and outlet connections, if remote from the tank, should be secure and labeled clearly. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility staff failed to ensure that the acid mixer and the transfer acid valve did not contain the contaminated acid solution from the acid build-up on the transfer valve outlets, connectors, and acid mixer. This deficient practice had the likelihood to cause harm to all patients receiving in-center hemodialysis at the facility by receiving exposed contaminated acid. Findings include: On a tour of the water room on 06/12/2024 at 10:18 AM, observed there was a white crystallized substance build-up around the transfer outlet valves and connectors. Also, a large amount of crystallized white substance build-up was underneath the acid mixer on the floor and around the connectors to the filter. An interview with Staff #4 on 06/12/2024 at 10:18 AM confirmed a large amount of acid (white crystallized substance) build-up underneath the acid mixer on the floor and acid build-up on the connectors of transfer outlet valves.”

“ACID CONC DIST-CONC LABELED & COLOR-CODED RED CFR(s): 494.40(a) 5.5.3 Acid concentrate distribution systems: labeled & color-coded red Acid concentrate delivery piping should be labeled and color-coded red at the point of use (at the jug filling station or the dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. If the acid system remains intact, no rinsing or disinfection is necessary. More than one type of acid concentrate may be delivered, and each line should clearly indicate the type of acid concentrate it contains. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility’s staff failed to ensure that the dialysis stations’ wall boxes #1 through #12 (acid dispensing outlets) had no leaks and were properly cleaned. This deficient practice had the likelihood of causing nonbacterial contamination and evaporation in the wall boxes and infecting the patients receiving in-center hemodialysis at the facility. Findings include: A tour of the in-center treatment area on 06/12/2024 at 10:20 AM observed that wall boxes had dried crusted white sediment in the outlet boxes. The splash was such a large amount that the back of the dialysis machines, connecting hoses, and back of the wall chase were covered in splattered dried crusted white sediment. Staff #3 was on the tour and observed the wall boxes had dried crusted white sediment. The surveyor asked who was responsible for cleaning the wall boxes. Staff # stated, “The staff members are responsible for cleaning the wall boxes”. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections.” A review of the facility’s policy titled; “Infection Control Policy” revealed the following: “Disinfection and sterilization 1. Staff should wear gloves, a shield, and an apron/disposable gown during the cleaning procedure. Vigorous cleaning is avoided which possibly could aerosolize microorganisms. 2. Products marked as disposable are not reused or disinfected for reuse. 3. The machine and its parts is disinfected with Bleach weekly. Prolonged contact with the active agent is necessary. The machine is rinsed until bleach tests negative. 4. Special attention is given to the entire area in which dialysis is performed including, the dialysis chair, dialysis machine (front, back and sides), lines to the wall box, and trash cans in the immediate area. All surfaces require cleaning with 1:100 bleach solution unless blood is visible then 1:10 solution is used.” An interview with Staff #3 on 06/12/2024 at 10:30 AM confirmed the wall boxes had dried crusted white sediment in all the in-center stations’ wall boxes and the backs of the dialysis machines.”

“BICARB CONC DIST-COLOR CODED BLUE & SEALED CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: color coded blue & sealed Bicarbonate concentrate delivery piping should be color-coded blue at the point of use (at the jug filling station or dialysis machine connection). All joints should be sealed to prevent leakage of concentrate. This Standard is not met as evidenced by: 29191 Based on observation and interview, the facility failed to ensure that wall boxes #1 through #12 (Bicarbonate dispensing outlets) at the dialysis stations had no leaks and were properly cleaned. This deficient practice had the likelihood of causing bacterial growth in the wall boxes and infecting the patients who were receiving in-center hemodialysis at the facility. Findings include: Observation of the wall boxes at each dialysis station on 06/12/2024 at 10:20 AM revealed that the stations had been leaking bicarbonate solution around the seals’ outlets. The boxes were noted to have crusted white sediment that was splattered down the wall box. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections.” A review of the facility’s policy titled; “Infection Control Policy” revealed the following: “Disinfection and sterilization 1. Staff should wear gloves, a shield, and an apron/disposable gown during the cleaning procedure. Vigorous cleaning is avoided which possibly could aerosolize microorganisms. 2. Products marked as disposable are not reused or disinfected for reuse. 3. The machine and its parts is disinfected with Bleach weekly. Prolonged contact with the active agent is necessary. The machine is rinsed until bleach tests negative. 4. Special attention is given to the entire area in which dialysis is performed including, the dialysis chair, dialysis machine (front, back and sides), lines to the wall box, and trash cans in the immediate area. All surfaces require cleaning with 1:100 bleach solution unless blood is visible then 1:10 solution is used.” An interview with Staff #3 on 06/12/2024 at 10:30 AM confirmed there was white-crusted sediment on the wall boxes down the chase wall and along the connecting hoses.”

“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: 29191 Based on observation and interview, the facility staff failed to ensure the dialysis facility was maintained in a safe, functional, and comfortable treatment environment for dialysis stations #1 through #12. This deficient practice has the likelihood of causing harm to dialysis patients receiving treatment at the facility. Findings Include: *Observed a build-up of a large brown-orange colored floor spot under the chase wall at station #1 *Observed missing floor tile at station #6 under the chase wall. Also, observed the dialysis fluid waste bucket was sitting directly on the floor behind the dialysis machine. * Observed a white cap, large dust bunny particle, and blue clamp on the back of the chase wall behind station #7. There was no way to know if the chase wall and dialysis station had been cleaned between patients. The second-shift patients were being placed on the dialysis machines as the surveyor toured. *Observed that the entire in-center treatment floor was discolored with large areas of black spots by each dialysis station #1 through #12. A review of the CDC guidelines related to dialysis wall boxes revealed the following: “Dialysis wall boxes are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water and dispose of waste products. There are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection. Thus, wall boxes need to be cleaned, disinfected, and properly maintained to decrease risk of patient infections.” A review of the facility’s policy titled; “Infection Control Policy” revealed the following: “Disinfection and sterilization 1. Staff should wear gloves, a shield, and an apron/disposable gown during the cleaning procedure. Vigorous cleaning is avoided which possibly could aerosolize microorganisms. 2. Products marked as disposable are not reused or disinfected for reuse. 3. The machine and its parts is disinfected with Bleach weekly. Prolonged contact with the active agent is necessary. The machine is rinsed until bleach tests negative. 4. Special attention is given to the entire area in which dialysis is performed including, the dialysis chair, dialysis machine (front, back, and sides), lines to the wall box, and trash cans in the immediate area. All surfaces require cleaning with 1:100 bleach solution unless blood is visible then 1:10 solution is used.” An interview with Staff #3 on 06/12/2024 at 10:30 AM confirmed that there were numerous black spots around the entire in-center treatment floor, missing tile, and large brown-orange spots at station #1. The in-center treatment floor had a very unclean appearance.”

“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: 29191 Based on observation and staff interviews, the facility failed to ensure the emergency pull cord was accessible for a patient in the event they fell on the floor in the lobby patient’s bathroom. The emergency pull cord should be within 6 inches of the floor. This deficient practice has the likelihood of causing harm to patients in an emergency. Findings include: Upon entering the facility’s lobby patients’ bathroom on 06/12/2024 at 9:05 AM, the emergency pull cord was wrapped around the handrail and was not accessible for a patient to call for help in the event the patient fell on the floor. An interview with Staff # 3 on 06/12/2024 at 9:05 AM confirmed the pull cord was wrapped around the safety rail.”