Wakefield Dialysis Center

“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: 21613 41729 Based on surveyor observation, record review and staff interview, it has been determined that the facility failed to ensure that proper glove use, hand hygiene and infection control practice were observed relative to 1 of 3 observations related to an access of arteriovenous fistula (AVF, a connection that is made between an artery and a vein for dialysis access) for initiation of dialysis, Patient ID #9 and during 1 of 3 observations relative to disinfecting of a dialysis machine, Machine #12. Findings are as followings: 1. Review of the facility’s policy and procedure titled, “AVF-AVG [arteriovenous graft, a tube that is surgically placed superficially under the skin, to connect between an artery and a vein for dialysis access] Cannulation, Treatment Initiation and Termination”, last revised on 11/15/2023, states in part, “...The first needle insertion site is identified and the area cleaned using aseptic non-touch technique (ANTT) with an appropriate antiseptic product...The second needle insertion site is prepared as just described...If the access is touched after being disinfected, it must be disinfected again before needle insertion...Once the fistula has been prepped, touching it will contaminate the site...” Record review revealed Patient ID #9 has been admitted to the facility with a diagnosis of end stage renal disease and is receiving hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney are used to clean the blood three times a week). During a surveyor observation on 6/10/2024 at 11:10 AM, a Registered Nurse, Staff A was observed accessing the AVF on the patient’s left upper arm for initiation of dialysis treatment. Staff A was observed with gloves on, he cleaned the access site with antiseptic product, he then inserted the first needle into the access site, and then secured it with tape. Staff A with the same used gloves, proceeded to evaluate the cannulation site for the second needle by palpating it and adjusting the patients arm, sleeve and tourniquet (a device for stopping the flow of blood through a vein or artery, typically by compressing a limb with a cord or tight bandage). Staff A then inserted the second needle into the access site without disinfecting the site after he palpated and touched the site. During a surveyor interview with the Clinical Manager on 6/12/2024 at approximately 11:30 AM, she revealed that she would expect staff to disinfected the site again after it was touched, before needle insertion as indicated in the facility’s policy. 2. During a surveyor observation on 6/10/2024 at 1:40 PM, a Certified Clinical Hemodialysis Technician (CCHT), Staff B was observed cleaning and disinfecting dialysis Machine #12 after it had been used for a patient’s treatment. Staff B removed her gloves and failed to perform hand hygiene. Staff B proceeded to obtain clean supplies from a countertop and from a supply cabinet. Staff B brought the supplies back to the machine, put on a clean pair of gloves without performing hand hygiene. During a surveyor interview on 6/10/2024 at 2:20 PM with Staff B, she acknowledged that she did not perform hand hygiene after removing her used gloves. During a surveyor interview on 6/12/2024 at 2:40 PM with the Clinical Manager, she indicated that she would expect the staff to perform hand hygiene after removing her gloves.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 21613 Based on surveyor observation, record review and staff interview, it has been determined that the facility failed to ensure the staff thoroughly disinfect all surfaces of the dialysis stations and treatment areas for 2 of 3 staff observations during cleaning and disinfection of the treatment areas, Staff A and C. Findings are as follows: Review of the facility’s policy and procedure titled, “Cleaning & Disinfection of Equipment, supplies & Treatment Area”, last revised on 1/11/2024, states in part, “PURPOSE: To prevent transmission of infectious agents in the dialysis center. POLICY... 7. All routinely touched reusable equipment and surfaces in each patient’s treatment area are disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but not limited to the: -dialysis machine -chair, including the top and bottom of the chair-side table (s) -bedside table -television, phone -counter and wall boxes...” Surveyor observations of the patient treatment areas, after dialysis treatments were terminated and the patients had vacated, revealed the following: 1. On 6/10/2024 at 1:18 PM, Registered Nurse, Staff A, was observed cleaning and disinfecting Station #9. Staff A failed to clean the following areas; -TV, counter and wall box (area where the dialysate fluid is dispensed from the wall to the dialysis machine) -bottom of the chair-side table -between the arm rest and downside of the chair cushion -left and right side (outside chair surface) of the chair arm rest 2. On 6/10/2024 at 2:00 PM, Registered Nurse, Staff C was observed cleaning and disinfecting Station #21. Staff C failed to clean the following areas; -bottom of the chair-side table -between the arm rest and downside of the chair cushion -left and right side (outside chair surface) of the chair arm rest -wall box During a surveyor interview with the Clinical Manager on 6/12/2024 at approximately 11:00 AM, she revealed that she would expect staff to clean the dialysis stations and treatment areas as indicated in the facility policy.”

“IC-HBV-ISOLATION-MACHINES/EQUIP/SUPPLIES CFR(s): 494.30(a)(1)(i) Isolation of HBV+ Patients To isolate HBsAg positive patients, ... dedicate machines, equipment, instruments, supplies, and medications that will not be used by HBV susceptible patients. This Standard is not met as evidenced by: 21613 41729 Based on surveyor observation, record review, and staff interview, it has been determined that the facility failed to ensure that the staff that is providing care to a positive Hepatitis B (a serious liver infection that is caused by the hepatitis B virus) patient use a separate gown in the isolation room and remove the gown before leaving the isolation room for 1 of 1 patient on isolation, Patient ID #1. Findings are as follows: Record review revealed Patient ID #1 was admitted to the facility in April of 2015 with diagnoses including, but not limited to, Hepatitis B and end stage renal disease and is receiving hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney are used to clean the blood three times a week). During a surveyor observation on 6/10/2024 at 9:20 AM, a Registered Nurse, Staff A was observed entering the patient’s isolation room wearing a gown and a pair of gloves. Staff A went to the dialysis machine and made some adjustments to the machine while the patient was receiving treatment. Staff A removed his gloves, exiting the room and failed to change his gown. Staff A proceeded to another patient’s machine while wearing the same gown. During a surveyor interview with the Clinical Manager on 6/10/2024 at 12:21 PM, she acknowledged that she witnessed Staff A did not change his gown after exiting the isolation room. The Clinical Manager further indicated that she would expect the staff to put on a designated gown before entering the room, and that gown needed to be remove before exiting the room.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 21613 46539 Based on surveyor observation, and staff interview, it has been determined that the facility failed to ensure that the water purification and storage system was secure and only accessible to individuals responsible for monitoring and maintenance of the system for 1 of 1 water purification and storage system areas observed. Findings are as follows: During a surveyor interview with the Clinical Manager on 6/10/2024 at 8:15 AM, she revealed that all the entry codes to the doors within the facility are the same. When questioned what the entry code was to the water purification and storage system, she revealed that it was the same entry code for all the doors. During a surveyor observation on 6/10/2024 at 8:57 AM, revealed the door to access the water purification and storage system room from the waiting area utilized the same entry code as the rest of the dialysis unit. The water purification and storage system room was not restricted to only those individuals responsible for monitoring and maintenance of the system. During a surveyor observation while in the water purification and storage system room on 6/10/2024 at 9:10 AM revealed the back entrance to the water purification and storage system room’s door was propped open, allowing direct access to the water purification and storage system room. During a surveyor interview with the Clinical Manager on 6/10/2024 at 9:59 AM, she acknowledged that the water purification and storage system had the same access entry code as the rest of the dialysis unit. She further acknowledged that the water purification and storage system should be in a secure area that is accessible to authorized users only and that the door should not be propped open. Additionally, she was unable to provide evidence that access to the purification system was restricted to those individuals responsible for monitoring and maintenance of the system.”

“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: 21613 46539 Based on surveyor observation, record review, and staff interview, it has been determined that the facility failed to ensure that conductivity (the degree to which a specified material conducts electricity) and pH (acidity or alkalinity of a solution) meters are maintained in accordance with the manufacturer’s recommendations for 1 of 1 water purification and storage system areas observed. Findings are as follows: During surveyor observation on 6/11/2024 at 10:28 AM of the water purification and storage system area, in the presence of the Facility Technical Manager (FTM), revealed one “pH Buffer Standard Solution” was open and in use and had a manufacturer expiration date of 5/1/2024. Further observation revealed 4 unopened bottles, two bottles expired on 3/1/2024 and 2 expired on 5/1/2024. An additional observation revealed 9 bottles of “H&S Conductivity Standard Solution” with the following expiration dates, one bottle expired on 1/5/2024, two bottles expired on 1/25/2024, one bottle expired on 4/5/2024, four bottles expired on 4/19/2024, and one bottle expired on 5/1/2024. During a surveyor interview with the FTM on 6/11/2024 at 10:35 AM, he acknowledged that the above-mentioned solutions were expired. He further acknowledged that the open bottles were used on 6/11/2024 to calibrate the Myron machine (a device used for water quality testing) and the pHoenix meter (device is designed for use by hemodialysis professionals to verify the conductivity, temperature, and pH of solutions in the hemodialysis setting). Furthermore, he revealed that the expired items should be disposed of and not used for calibration of the above-mentioned meters.”

“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: 21613 46539 Based on surveyor observation, record review and staff interview, it has been determined that the facility failed to ensure that each patient, vascular access site and bloodline connections (two tubes that are connected to the patient to clean the blood and return the blood to the patient) were able to be seen by staff throughout the dialysis treatment for 1 of 3 patients reviewed with a central venous catheter (CVC, a long, flexible, y-shaped tube that is inserted through one of the central veins found in your neck, chest or groin to allow access to the bloodstream), Patient ID #4. Findings are as follows: Record review revealed Patient ID #4 was admitted to the facility in April of 2024 with a diagnosis of end stage renal disease and is receiving hemodialysis. During a surveyor observation on 6/10/2024 at 11:28 AM, revealed Patient ID #4 was receiving his/her hemodialysis treatment via his/her CVC. Further observations on 6/10/2024 revealed the following times when the vascular access site and bloodline connections were not visible to the staff as it was fully covered with his/her clothing: -11:55 AM -12:50 PM -1:57 PM -2:00 PM During a surveyor observation on 6/10/2024 at 2:00 PM in the presence of a CCHT, Staff D, she acknowledged that the patient’s clothing was covering his/her access site and connection which were unable to be seen. She further revealed that the access site and connections should be visible to the staff at all time while receiving treatment. During a surveyor interview on 6/12/2024 at 2:40 PM with the Clinical Manager, she revealed that she would expect that the residents access site to be visible during the resident’s treatment.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 21613 41729 Based on surveyor observation, record review, and staff interview it has been determined that the facility failed to ensure that staff follow the dialysis prescriptions when administering dialysis treatments for 2 of 4 sample patients reviewed, Patient ID #1 and 4. Findings are as follows: 1. Record review revealed Patient ID #1 was admitted to the facility in April of 2015 with a diagnosis of end stage renal disease and is receiving hemodialysis (a procedure where a dialysis machine and a special filter called an artificial kidney are used to clean the blood three times a week). Review of a physician’s order dated 6/10/2024 revealed a blood flow rate (BFR) of 450 ml/min (milliliters/minutes). Review of the patient’s treatment sheets failed to reveal evidence that the above-mentioned dialysis prescription was followed and failed to document a rationale on the follow dates and times: -6/10/2024: 8:27 AM, BFR at 425 ml/min 9:56 AM, BFR at 375 ml/min -6/3/2024: 9:07 AM, BFR at 400 ml/min 9:37 AM, BFR at 400 ml/min 10:07 AM, BFR at 400 ml/min 10:37 AM, BFR at 400 ml/min 5/31/2024: 9:07 AM, BFR at 400 ml/min 9:37 AM, BFR at 400 ml/min 10:07 AM, BFR at 400 ml/min 5/29/2024: 7:42 AM, BFR at 425 ml/min 8:12 AM, BFR at 425 ml/min 8:41 AM, BFR at 425 ml/min 8:53 AM, BFR at 425 ml/min 9:42 AM, BFR at 425 ml/min 10:12 AM, BFR at 425 ml/min 2. Record review revealed Patient ID #4 was admitted to the facility in April of 2024 with a diagnosis of end stage renal disease and is receiving hemodialysis. Review of a physician’s order dated 6/7/2024 revealed a dialysate (a fluid that is used in dialysis treatment that is made up of water, electrolytes, and salt) with potassium 3.0 and calcium 2.5. During a surveyor observation in the presence of a Certified Clinical Hemodialysis Technician (CCHT), Staff E on 6/12/2024 at 1: 10 PM, the patient was observed receiving dialysate with potassium of 2.0. During a surveyor interview immediately following this observation with Staf E, she acknowledged that the patient was receiving his/her dialysate with potassium 2.0 instead of 3.0, as ordered. Staff E further indicated that the patient had began receiving his/her treatment at 11:28 AM. During surveyor interviews with the Clinical Manager on 6/12/2024 at 12:14 PM and at 1:45 PM, she indicated that she would expect the staff to follow the prescribed dialysis treatments, as ordered. The Clinical Manager further indicated that if a patient BFR was changed for any reasons, she would expect the staff to document the rationale of this change. Additionally, the manager indicated that she would expect two staff to verify the dialysate treatment prior to the patient starting treatment.”