Northpoint Dialysis, LLC

“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: 36839 Based on observations and an interview with the clinic manager, the governing body failed to ensure that all clinical staff adhered to the facility ’ s infection control policy regarding the use of personal protective equipment (PPE) on the clinical treatment floor. This failure placed all patients and staff at risk of exposure to infectious diseases and bloodborne pathogens. Findings included: According to the Centers for Disease Control and Prevention (CDC), used personal protective equipment (PPE) is considered contaminated if it has been, or is likely to have been, in contact with body sites, materials, or environmental surfaces where infectious organisms may reside. Therefore, when a gown or full PPE is worn, it must be removed prior to leaving the treatment area. During observations on the treatment floor on 9/10/2025 at 11:10 a.m., it was noted that Patient Care Technician (PCT) #1 exited the dialysis treatment room to bring in a patient in a recliner waiting in the hallway. The PCT did not remove her PPE gown and mask, which she had been wearing while providing care to a previous patient. This observation was confirmed by the clinic manager upon observation on 9/10/2025.”

“IC-CATHETERS:GENERAL CFR(s): 494.30(c)(2) (2) The “Guidelines for the Prevention of Intravascular Catheter-Related Infections” entitled “Recommendations for Placement of Intravascular Catheters in Adults and Children” parts I - IV; and “Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients,” Morbidity and Mortality Weekly Report, volume 51 number RR-10, pages 16 through 18, August 9, 2002. The Director of the Federal Register approves this incorporation by reference in accordance with 5 U.S.C. 552(a) and 1 CFR Part 51. This publication is available for inspection as the CMS Information Resource Center, 7500 Security Boulevard, Central Building, Baltimore, MD or at the National Archives and Records Administration (NARA). Copies may be obtained at the CMS Information Resource Center. For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_regulations/ibr_locations.html This Standard is not met as evidenced by: 36839 Based on observations and a review of the facility ’ s policies and procedures (P&P), the governing body failed to ensure that all clinical staff performed central venous catheter (CVC) care in accordance with facility P&P. This failure placed patients at increased risk of acquiring an infection at the CVC site. Findings include: The facility’s P&P titled Initiation/Termination of Hemodialysis Using Dual Lumen Catheter (Reference #8102) states: “#13. Holding the catheter with the non-dominant hand and using aseptic technique, clean the exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds. Apply to the CVC exit site in a ’ back and forth ’ pattern, using gentle friction progressing from the insertion site to the periphery, using both sides of the swab. Then wait 60 seconds for air dry time.” On 9/10/2025 at 11:45 a.m., during clinical observations on the treatment floor, Patient Care Technician (PCT) #2, who was initiating dialysis treatment for a patient with a CVC at station #1, cleaned the CVC hub for 5 seconds and the catheter exit site for 6 seconds during dressing change. This finding was discussed with the clinic manager following the observation and was subsequently reviewed with the administrative team during the exit conference on 9/10/2025.”

“PE-PT CARE ENVIRONMENT-SUFFICIENT SPACE CFR(s): 494.60(c)(1) The space for treating each patient must be sufficient to provide needed care and services, prevent cross-contamination, and to accommodate medical emergency equipment and staff. This Standard is not met as evidenced by: 36839 Based on observations, the facility ’ s governing body failed to ensure that the space allocated for each patient during dialysis was sufficient to provide care and services while preventing cross-contamination and exposure to blood and body fluids. This failure posed a potential risk of exposure to blood and body fluids and other infectious agents. Findings include: The Code of Maryland Regulations at 10.05.04.11A(1)(2)(3)(4)B(2) states: “Floor Space - The kidney dialysis center shall have usable floor space of at least 80 square feet per patient station. Floor space may include bed or chair space, nursing space, and work area, but excludes storage space. At least 20 square feet of the patient floor space shall be available on the side of the patient to be occupied by the dialysis assembly. Arrangement of space shall be sufficiently flexible to provide access to any of the patient ’ s four extremities. The kidney dialysis center shall have sufficient space for maintenance and storage of equipment and supplies, and for preparing and testing dialyzers.” On 9/10/2025, during observations on the clinical treatment floor, it was noted that each dialysis station measured less than 80 square feet. At station #3, the dialysis chair was approximately 2 inches away from the dirty sink. In addition, the lab area, which included a small refrigerator and a centrifuge machine placed on the counter, was approximately 3 feet from this dialysis chair. This finding was confirmed by one of the clinic managers, who measured the floor space of each dialysis station. The concern was subsequently discussed with the administrative team during the exit conference on 9/10/2025.”

“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: 36839 Based on observations and a review of the facility ’ s policy, the governing body failed to ensure the maintenance of a comfortable environmental temperature for patients. This failure posed a potential risk of harm to all affected patients. Findings include: The dialysis facility must: (i) Maintain a comfortable temperature within the facility; and (ii) Make reasonable accommodations for patients who are not comfortable at this temperature. According to the provider ’ s policy titled Patient Care Environment (Reference #2003), “A comfortable temperature of 68-72°F shall be maintained within the facility.” On 9/10/2025, during observations of the treatment room, it was noted that the room was unusually warm. When this surveyor requested to check the thermostat, the temperature was found to be 75°F. Maintenance staff were called to adjust the temperature; however, after one hour, the thermostat automatically returned to 75°F. This finding was discussed with administrative staff during the exit conference on 9/10/2025.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 36839 Based on medical record reviews, the governing body failed to ensure that initial nursing assessments were completed by the assigned registered nurse (RN) prior to patients ’ initial dialysis treatments upon admission to the facility. This failure placed affected patients at risk for receiving insufficient and ineffective care and denied them their rights. Patient #2 Findings include: According to the facility ’ s policy titled Medical Record Content (Reference #9002, page 3), “An initial nursing assessment must be completed prior to the first dialysis treatment.” A review of two sampled patient records with the clinic manager on 9/10/2025 revealed that Patient #2 was admitted to the facility on 12/6/2024. The initial nursing assessment, however, was not completed until 1/2/2025. This finding was discussed with the administrative team during the exit conference on 9/10/2025.”