Brockton Dialysis Center, LLC

“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: 10249 Based on observation, Centers for Disease Control and Prevention (CDC) guidance, and interview, the facility failed to consistently provide a sanitary environment to minimize the transmission of infectious agents within the patient treatment area. Findings Include: The CDC defines a “sanitary environment” as an environment that meets “Standard Precautions” for an in-patient hospital setting plus the more stringent precautions which are recommended for hemodialysis units because of the increased potential for contamination with blood and pathogenic microorganisms. On 5/12/25 at 9:30 A.M., during the flash tour of the dialysis treatment area the surveyor observed patients receiving dialysis treatment in 12 of 19 hemodialysis treatment stations. Between patients, when the dialysis chairs were vacant, the surveyor observed the following: *At station 3, 4, 6, 7, 8, 9, 11, 14, 15, 16, 18, and 19, the surveyor observed cracks, rips/tears, or missing material on the right or left, or both arm rests, of the dialysis chairs. This prevented the staff from being able to adequately disinfect the arm rests. *At station 3, 7, 11, and 18, there were tears (approximately 4 inches long) in the seat of the dialysis chair, preventing the staff from being able to adequately disinfect the area. During an interview on 5/13/25 at 9:40 A.M., the Clinical Regulatory Manager (CRM) said they identified the need to replace the dialysis chairs in March 2025, but only able to replace 2 dialysis chairs a month due to the cost. The CRM said they had a purchase order (PO) dated 3/20/25, but there was no date that the PO had been approved, and she was unsure when the first two chairs would be delivered. During an interview on 5/13/25 at 10:30 A.M., RN #5 said she was aware of the tears and cracks on the dialysis chairs, and they would be getting some new chairs, but not sure when. She said they put a cover over the seat, but unable to cover the arms of the chair when the patient is receiving dialysis treatment. During an interview on 5/13/25 at 10:50 A.M., Patient #1 said the dialysis chairs were uncomfortable and they had many cracks and tears on the arms.”

“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: 10249 Based on observation, interview, and policy review, the facility failed to ensure that 2 staff members (Patient Care Technician [PCT] #1, and Certified Clinical Hemodialysis Technician [CCHT] #1) wore personal protective equipment appropriately when there was a risk of blood splatter 1.) during termination of dialysis treatment for 1 patient (#9) with an arteriovenous fistula (AVF) and; 2.) during cleaning and disinfection of a dialysis station. Findings include: 1. Review of the facility’s policy titled, AVF Cannulation Treatment, Initiation, and Termination, last revised 6/20/24, included the following: *The patient caregiver will perform hand hygiene and don clean gloves, full face protection, and a fluid-resistant gown. 1. On 5/12/25 at 3:45 P.M., the surveyor observed PCT #1 terminate treatment for Patient #9. During the procedure, only the top two buttons of PCT #1’s gown were secured, and the bottom of the gown was open exposing the front of her shirt and pants. During an interview on 5/12/25 at 4:15 P.M., the Clinic Manager said she had spoken with PCT #1 in the past to close her gown, but said she could not. 2. Review of the facility’s policy titled, Cleaning and Disinfection of Equipment, Supplies, and Treatment area, lasted revised 6/20/25, indicated the following: *Standard precautions, including use of appropriate personal protective equipment (PPE) will be used by all associates when cleaning and disinfecting equipment and supplies. After cleaning and disinfecting, gloves will be removed and discarded when soiled and replaced with a clean one. On 5/13/25 at 9:15 A.M., the surveyor observed CCHT #1 cleaning and disinfecting equipment within dialysis station #16 for the next patient. During the cleaning and disinfection process only the top two buttons of CCHT #1’s gown were secured, and the bottom of the gown was open exposing her shirt and pants. During an interview on 5/13/25 at 9:25 A.M., CCHT #1 said she would remember to close it (gown) the next time.”

“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: 44223 Based on observation, staff interview, and policy review, the facility failed to 1.) ensure 2 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #11 and CCHT # 1) observed, adequately disinfected contaminated surfaces, medical devices, and equipment within the dialysis station, increasing the risk of cross contamination with blood borne pathogens; 2.) ensure that 1 of 2 staff members (CCHT #11) did not dispose of prime waste into the dialysis station wall box; and 3.) ensure 10 of 19 blood pressure (BP) cuffs observed were free from lint and debris to allow for proper disinfection. Findings Include: Review of the facility’s policy titled, Cleaning and Disinfection of Equipment, Supplies and Treatment Area, revised 6/20/24, indicated the following: *All routinely touched reusable equipment and surfaces in each patient’s treatment area must be disinfected after each patient’s treatment. Caregivers will ensure that cracks/crevices come in contact with the bleach solution. This includes, but is not limited to: -Dialysis machine. -Chair, including the top and bottom of the chair-side table(s). -Bedside table. -Television, phone. -Counters and wall boxes. *Containers used to discard saline prime from dialyzers will be disinfected after each treatment and when visibly contaminated with blood. The external and internal surfaces of the container will be wiped with disposable cloth soaked with the bleach/water mixture used to disinfect the rest of the machine. The cloth is discarded after use. 1. The facility failed to ensure that CCHT #11 and CCHT #1 adequately cleaned and disinfected the station for the next patient. A. On 5/12/25 at 10:05 A.M., the surveyor observed CCHT #11 disinfect station 11 for the next patient. He was observed to disinfect the hemodialysis machine and hemodialysis chair using 1:100 bleached soaked pads. CCHT #11 was observed to disinfect the two stethoscopes that were hanging on the IV pole. He then hung the stethoscopes back on the IV pole without disinfecting the IV pole, recontaminating the two stethoscopes. He also failed to disinfect the inside of the prime waste bucket and the wall box. During an interview on 5/12/25 at 2:00 P.M., CCHT #11 said he did not realize that he did not clean the IV pole before hanging the clean stethoscopes on the hook, and should have cleaned the wall box. B. On 5/13/25 at 9:15 A.M., The surveyor observed CCHT #1 disinfect station 16 for the next patient. She was observed to disinfect the hemodialysis machine and hemodialysis chair using 1:100 bleached soaked pads. CCHT #1 was observed to disinfect the equipment within the station except she failed to disinfect the television within dialysis station. She then retrieved dialysis equipment for the next patient and placed them on the dialysis chair for setup. During an interview on 5/13/25 at 9:25 A.M., CCHT #1 said that she missed the TV, but would clean it. 2. The facility failed to ensure that CCHT #11 did not dispose of prime waste into the dialysis station wall box. On 5/12/25 at 10:05 A.M., the surveyor observed CCHT #11 disinfect station 11 for the next patient. CCHT #11 removed the prime waste bucket from the machine and disposed of the contents into the wallbox, located behind the dialysis chair, not in the dirty sink. During an interview on 5/12/25 at 2:00 P.M., CCHT #11 said the prime waste should be disposed of in the dirty sink, not the wall box. During an interview on 5/12/25 at 4:15 P.M., the Regional Clinical Director said that prime waste should be disposed of in the dirty sink, not the wall box. 3. The facility failed to ensure 10 of 19 blood pressure (BP) cuffs were free from debris to allow for proper disinfection. On 5/12/25 at 9:00 A.M., during an observation of the treatment floor, the surveyor observed 10 of 19 BP cuffs, including those at station 1, 2, 4, 5, 7, 10, 11, 14, 16, and 18, laden with lint and debris embedded in the Velcro of the BP cuff, making it difficult to adequately disinfect between patients. During an interview on 5/13/25 at 9:40 A.M., the Clinic Manager said they had replaced all the blood pressure cuffs in March 2025 because of the buildup of lint on the Velcro section. She also said they purchased “sleeves” to place on the patient’s arm then apply the blood pressure cuff over the sleeve to prevent the build of lint from the patients’s clothing. She said that it is difficult to disinfect/clean when there is lint in the Velcro. 10249”

“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: 44223 Based on observation, and staff interview, the facility failed to provide dialysis patients and staff a functional and comfortable treatment environment. Findings include: On 5/12/25 at 8:50 A.M., during the initial tour of the water treatment and storage room, the surveyor observed the following: *The water treatment and storage room floor was cement and gray in color. In multiple areas the floor was noted to be cracked and broken with missing pieces. These missing pieces caused divots in the flooring, putting staff at risk for tripping. *The eye wash station, located outside of the Biomedical Technician office, had a large crack on the floor causing a small divot. *In the water treatment area, there were two large circular areas where the floor was missing the top layer, causing divots in the floor. *Under the Reverse Osmosis (RO) machine the floor was broken with missing pieces, causing divots in the floor. *Between the RO machine and the Bicarbonate station there was an area where there was broken floor. This was in front of the sample port where staff obtain water for chlorine testing. The broken floor caused a divot in the floor, putting staff at risk for tripping. *In front of the acid storage tanks there were broken areas of the floor, causing divots in the floor. *Under the electrical panel the floor was broken and cracked with notable broken pieces on the floor. During an interview on 5/12/25 at 4:15 P.M., the Clinical Regulatory Manager said the floor does need fixing and that she would alert cooperate of the concerns. During an interview on 5/13/25 at 10:30 A.M., the Biomedical Technician said the floor is very old, and although they have tried to fix it many times, it doesn’t hold up for a long time.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 10249 Based on record review, interview, and policy review, the facility failed to ensure a comprehensive assessment was completed by the Interdisciplinary Team (IDT) when determined by the facility to be unstable, for 1 applicable patient (#4), from a total sample of 9 patients. Findings include: Review of the facility’s policy titled, Comprehensive Patient Assessments, last revised 3/28/2023, indicated the following: *The IDT (Interdisciplinary Team) must determine if a patient is stable or unstable based on data obtained from the Comprehensive Patient Assessment (CPA). Patients will be defined as unstable based on the criteria noted in this policy. *”Stable” or “Unstable” patients status is documented in the electronic medical record system using the appropriate designation in the problem list. *Some unstable patients may never be able to meet the formal criteria for stability. In those cases, when the IDT (including the patient) has determined the condition is chronic and active treatment plan adequately addresses the issues, the patient may be considered “stable” as long as ongoing documentation reflects actions taken to maintain the patient’s status at the most optimal level possible. *The following criteria shall be used by the IDT whenever a CPA is done to determine if the patient is or has become unstable. -Frequent hospitalizations (more than 3 hospitalizations in one month). -Extended hospitalization (longer than 15 days). -Concurrent: Inadequate dialysis, poor nutritional status, unmanaged anemia. -Significant change in psychosocial needs. -Marked deterioration in health or functional status. -At risk for involuntary discharge or transfer. -Acute kidney injury. *After a patient has been deemed unstable, there must be documentation that the patient has been re-assessed monthly (for at least 1 month) with the plan of care revised to address the issues related to the unstable status. If the IDT (including the patient) deems that the patient’s status has either returned to stable or is chronic and the active care plan adequately addresses the issues, then the patient may be deemed stable. Patient #4 was admitted to the facility in May 2023 with a diagnosis of End Stage Renal Disease, requiring dialysis treatment 3 times a week. Review of the clinical record, including the Comprehensive Patient Assessment (CPA) and care plans indicated that Patient #4 was deemed unstable on the following dates: -12/11/23 -1/22/24 -2/14/24 -3/20/24 -4/15/24 -5/17/24 Review of the CPA and care plan, dated 5/17/24, indicated that the patient was deemed unstable due to frequent hospitalizations (more than 3 in one month) and extended hospitalization (longer than 15 days). The care plan also indicated that “per the findings of this assessment, the patient is deemed unstable”. There was no documented evidence that the patient was reassessed 30 days later. During an interview on 5/13/25 at 11:30 A.M., the Clinical Regulatory Manager said there is no documentation by the physician that Patient #4 was deemed stable after the 5/17/24 care plan review, and should have been reassessed in June 2024.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 10249 Based on record review, and interview, the facility failed to ensure the dialysis treatment order was delivered as prescribed, relative to Blood Flow Rate (BFR-speed measured in milliliters per minute [ml/min]) in which the patient’s blood is pushed through the dialyzer and back into the body) and Dialysate Flow Rate (DFR-the measurement of how fast the dialysate solution flows in ml/min to draw toxins from the patient’s blood) for 1 of 7 applicable patient (#1) records reviewed, out of total sample of 9 patients. Findings include: Patient #1 was admitted to the facility in March 2025 with a diagnosis of End Stage Renal Disease (ESRD), requiring hemodialysis treatments 3 times a week. Review of the physician orders dated 4/21/25 indicated the dialysis order included a BFR to be delivered at a rate of 400 ml/min., and the DFR to be delivered at a rate of 500 ml/min. Review of 9 hemodialysis flowsheets, dated 4/22/25 through 5/10/25, indicated the BFR/DFR had not been delivered as prescribed for 3 of 9 treatments, including the following: *4/22/25 - The DFR was delivered at a rate of 800 ml/min, not the 500 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *4/24/25 - The BFR was delivered at a rate of 350 ml/min for 2 hours, not the 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. *4/2625 - The BFR was delivered at a rate of 200 ml/min for 3 hours, not the 400 ml/min as ordered, and there was no documentation to indicate why the physician’s order was not followed. During an interview on 5/13/25 at 1:30 P.M., the Clinical Regulatory Manager said the expectation is that staff document on the treatment sheets if there is a change in the BFR/DFR.”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 10249 Based on observation, interview, and policy review, the facility failed to ensure that 1 of 2 staff members (Certified Clinical Hemodialysis Technician [CCHT] #8 observed, did not use a tourniquet when initiating treatment for 1 of 1 applicable patients (#8) with a Arteriovenous Graft (AVG), out of a total sample of 9 patients. Findings include: Review of the facility policy, titled AVF-AVG Cannulation, Treatment Initiation, and Termination, last revised 6/20/24, included the following: *Tourniquets are not used on grafts because the graft is made of synthetic material that does not expand and contract like blood vessels do. On 5/12/25 at 11:15 A.M., the surveyor observed CCHT #8 initiate dialysis treatment for Patient #8, who receives treatment via an AVG. CCHT #8 assessed the AVG, washed the AVG, disinfected both access sites, applied a tourniquet, then cannulated both access sites. During an interview on 5/12/25 at 11:30 A.M., CCHT #8 said she did use a tourniquet on Patient #8, but does not usually care for him/her. During an interview on 5/12/25 at 11:40 A.M., Registered Nurse (RN) #2 said CCHT #8 should not have used a tourniquet when initiating treatment on Patient #8.”

“QAPI-MONITOR/ACT/TRACK/SUSTAIN IMPROVE CFR(s): 494.110(b) The dialysis facility must continuously monitor its performance, take actions that result in performance improvements, and track performance to ensure that improvements are sustained over time. This Standard is not met as evidenced by: 44223 Based on review of the Quality Assessment Performance Meeting (QAPI) documentation, staff interview, and policy review, the facility failed to continuously monitor performance, take actions that resulted in performance improvements, and track performance to ensure that improvements are sustained over time. Findings Include: Review of the facility’s policy titled, Quality Assurance and Performance Improvement (QAPI), revised 1/13/25, indicated the following: *The Interdisciplinary team (IDT) must demonstrate effective communications and must devote sufficient time and attention to produce effective QAPI activities that positively influence outcomes. *QAPI outcomes will be continually monitored and the IDT in each IRC center will meet monthly to discuss trends and develop action plans as necessary to improve outcomes. QAPI meeting minutes will be documented in the QAPI application. *The QAPI program must: -Continually look at indicators for patterns and associates as they are available. -Trend outcomes. -Identify any commonalities among patients who do not reach minimum expected targets. -Develop an improvement plan when indicated by the data. -Implement an action plan. -Monitor the effectiveness of the plan. -Adjust portions of the plan to achieve success. -Review in-center hemodialysis and home program patient separately (also review home hemodialysis and PD patients separately). Review of the QAPI data between November 2024 and April 2025 indicated that vascular access percentages and phosphorus levels were trending high. The data indicated that the clinic was not meeting the clinic goals that had been set. Review of the QAPI data for patient vascular accesses indicated the clinic goal was to have less than 10% of patients with long term catheter vascular accesses. Between November 2024 and April 2025 the data indicated consistent months where the percentage rate was between 12% and 14%. Specifically, review of the February 2025 QAPI data showed an increase in rate of catheters to 14.81%. Review of the documentation indicated, that although an action plan was put in place, there was no documented evidenced of a date when the plan was implemented. There was no documented evidence that the action plan was reviewed, monitored for, or adjusted to achieve success. Review of the QAPI data for Bone Disease indicated the clinic had established a goal of less than 12% of patients will have phosphorus levels greater than 7 milligram/deciliter (mg/dl). Between November 2024 and April 2025 the data indicated consistent months where the percentage rate was between 13% and 18%. Specifically, review of the November 2024 data showed an increase in patient phosphorus levels to 18.75%. Further review of the January 2025 data indicated that patient phosphorus levels above 7 mg/dl were still running at 16.05%, and not meeting the goal of less than 12%. Review of the documentation failed to indicate that an action plan was put in place to monitor, track, and improve results. During an interview on 5/13/25 at 2:30 P.M., the Clinic Manager said she could not say when the action plan for the vascular access was implemented. She said she had no documented evidence of when the education of the action plan was provided to staff. The Clinic Manager said that an action plan should have been implemented for high phosphorus levels when it was seen that the levels were high month over month. She said that an action plan should have been put in place in January 2025 when the data continued to show the percentage still higher than the percentage goal of less than 12%.”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 44223 Based on record review and interview, the facility failed to maintain complete and accurate medical records for 1 of 7 applicable patient records (#3) reviewed, out of a total sample of 9 patients. Findings include: For Patient #3 staff failed to ensure that a physician’s order for the patient to receive a 1K (dialysate bath with a potassium concentration of 1 mEq/L) for the first two hours of treatment, and then switch to a 2K bath was documented as completed in the clinical record. Patient #3 was admitted to the facility in January 2023 with a diagnosis of End Stage Renal Disease, requiring hemodialysis three times a week. Review of Patient #3’s physician orders, dated 4/11/25, included a dialysis order that indicated the following: *Bath: Potassium 1K for first 2 hours then 2K, Calcium 2.5, with a total dialysis duration time of 3 hours and 30 minutes. Review of 6 of 9 hemodialysis flowsheets, dated 4/17/25 through 5/6/25, indicated there was no documented evidence that the dialysis bath was switched from 1K to 2K after the first 2 hours of treatment including the following: *5/6/25- treatment started at 11:24 A.M. and ended at 2:43 P.M., with no documented evidence that the dialysis bath was changed from 1K to 2K after 2 hours of treatment. *5/3/25-treatment started at 11:20 A.M. and ended at 2:33 P.M., with no documented evidence that the dialysis bath was changed from 1K to 2K after 2 hours of treatment. *4/26/25- treatment started at 11:15 A.M., and ended at 2:33 P.M., with no documented evidence that the dialysis bath was changed from 1K to 2K after 2 hours of treatment. *4/24/25- treatment started at 11:18 A.M. and ended at 2:34 P.M., with no documented evidence that the dialysis bath was changed from 1K to 2K after 2 hours of treatment. *4/22/25- treatment started at 11:05 A.M. and ended at 2:20 P.M., with no documented evidence that the dialysis bath was changed from 1K to 2K after 2 hours of treatment. *4/19/25- treatment started at 11:18 A.M., and ended at 2:39 P.M., with no documented evidence that the dialysis bath was changed from 1K to 2K after 2 hours of treatment. During an interview on 5/13/25 at 2:45 P.M., the Clinic Manager said she could not find any documentation that the dialysis bath was changed as ordered. She said the expectation is that staff document on the treatment sheets that the dialysis bath had been changed.”