Concerto Maryland, LLC

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 47759 The facility’s governing body failed to maintain a safe and effective system for infection prevention and control, as evident by multiple standard level deficiencies related to infection control identified during the survey. The cumulative effect of these deficient practices placed all patients at increased risk of harm and infections and resulted in a finding of the facility being out of compliance with the Condition for Coverage (CfC: 494.30) for Infection Control. Findings included: 1. The facility’s governing body failed to ensure that the standards of care related to hand hygiene requirements were complied with by the clinical staff - Cross Reference: Infection Control-Wear gloves/hand hygiene (V0113). 2. The facility’s governing body failed to ensure that non disposable items taken to patient stations were cleaned and disinfected before being returned to their designated “clean area.” Cross Reference: Infection Control-If To Station=dispose/dedicate or Disinfect (V0116). 3. The facility’s governing body failed to ensure that common supply carts used to store clean supplies were at sufficient distance from areas where contamination may occur. Cross Reference: Infection Control-Supply Cart Distant (V0119). 4. The facility’s governing body failed to ensure that the clinical staff followed the standard infection control precaution in the cleaning and disinfection of contaminated equipment being used in the facility. Cross Reference: Infection Control-Disinfect Surfaces/equip/written Protocol (V0122). 5. The facility’s governing body failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures the facility put in place to prevent intravascular catheter-related infections. Cross Reference: Infection Control-Catheters: general (V0146).”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 47759 The facility’s governing body failed to ensure compliance with the facility policies and procedures established to ensure patients receive quality water. These failure placed the patients’ safety at risk of harm by receiving potentially poor water quality and resulted in a finding of the facility being out of compliance with the Condition for Coverage (CFC: 494.40) for Water and Dialysate Quality. Findings Included: 1. The facility’s governing body failed to ensure that 1) pH was performed before starting the treatment of each patient and 2) staff members demonstrated knowledge of the acceptable range for the final dialysate pH result. -Cross Reference: Dialysate proportion-monitor pH/conductivity (V0250). 2. The facility’s governing body failed to ensure proper labeling and schematic flow was available for easy and quick reference in case of serious events. Cross Reference: Environment-Schematic Diagram/labels (V0187). 3. The facility’s governing body failed to ensure: 1) that enough salt pellets were inside the brine tank; and 2) that the softener timer was set to correct time. Cross Reference: Softeners-Auto Regenerate/timers/salt Lvl (V0190).”

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 47759 Based on the overall findings of the survey, the facility’s governing body failed to maintain a safe and comfortable environment for patients at all times, as evidence by: 1) failure to maintain a treatment environment with reasonable noise levels; 2) failure to ensure that the all surfaces within the facility were intact, clean, and free of damage; 3) failure to ensure that the facility had sufficient space to provide services, prevent cross-contamination, and accommodate medical emergency staff and equipment; and 4) failure to ensure visibility of patients’ vascular access during treatment. The cumulative effect of these failures placed patients at risk of harm, including injury or infection, and resulted in a finding of the facility being out of compliance with the Condition for Coverage (CFR 494.60) for Physical Environment. Findings included: 1. The facility’s governing body failed to ensure a dialysis facility environment that is maintained with reasonable noise levels. Cross Reference: Physical Environment -Safe/functional/comfortable Environment (V0401). 2. The facility’s governing body failed to ensure a dialysis facility that is maintained in a manner that ensured the integrity of all surfaces were kept intact, clean and free of damage. Cross Reference: Physical Environment-Building Construct/maintain for Safety (V0402). 3. The facility’s governing body failed to ensure a dialysis facility that has sufficient space to provide needed care and services, prevent cross-contamination, and accommodate medical emergency equipment and staff. Cross Reference: Physical Environment-Sufficient Space (V0404). 4. The facility’s governing body failed to ensure a that every patient’s vascular access was visible during hemodialysis treatment. Cross Reference: Physical Environment-Hemodialysis Patients in view during treatment (V0407).”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44367 Based on observations, record review, review of policies and procedures, and interviews with a facility staff member, the facility’s governing body failed to ensure that all required emergency supplies were readily available in the event of an emergency. This failure placed patients at potential risk of harm and danger during a life threatening situation. Findings include: On 04/29/2025, review of the facility’s policy titled “Emergency and Disaster Preparedness Program” revealed that: “The Charge Nurse or designated Patient Care Technician will ensure that emergency supplies are available and maintained.” Site #3 04/29/2025 at 10:30 a.m., Inspection of Site #3’s Automated External Defibrillator (AED) and the daily check list revealed that the AED did not have a battery for the entire month of January 2025 and was not available in the event of an emergency. The surveyor asked the charge nurse what interventions were done to ensure that a working AED was available. According to the Charge Nurse, management was aware of the situation; however, the AED was not fixed until the following month.”

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 44367 Based on observations and record review of policies and procedures, the facility’s governing body failed to ensure that the facility’s patients were educated on emergency preparedness and disconnection procedures. This failure placed patients at potential risk of harm and danger in the event of an emergency. Findings include: On 04/29/2025 review of the facility’s policy titled “Emergency and Disaster Preparedness Program” revealed that the policy stated: “Concerto patients to be educated on emergency preparedness and emergency disconnect procedures.” Sites: #3 and #6 1. On 04/29/2025, review of the 4 selected patient records at Site #3 revealed that one (1) out of the four (4) or 25% of the selected patients have not received education on emergency preparedness and disconnect procedures. 2. On 04/30/2025, review of the 4 selected patient records at Site #6 revealed that three (3) out of the four (4) or 75% of the selected patients have not received education on emergency preparedness and disconnect procedures.”

“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: 47759 Based on observations and review of policies and procedures, the facility’s governing body failed to ensure that the standards of care related to hand hygiene requirements were complied with by the clinical staff. This failure placed patients at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Infection Control” (Policy CRS-700-001) determined that page 1 number 2 stated: “Hand hygiene will be performed after gloves are removed and between patient contacts, as well as after touching blood, body fluids, secretions, excretions, and contaminated items.” In addition, according to the Centers for Disease Control and Prevention (CDC), gloves should be changed: 1.) When going from a “dirty” area or task to a “clean” area or task; 2.) After touching one patient or their machine and before arriving to care for another patient or touch another patient’s machine. Finally, according to the CDC, hand hygiene should be performed: 1.) Immediately after gloves are removed. Site #1 1. On 04/28/2025 between 10:00 a.m. -11:00 a.m., the surveyor observed the following: a. During turnover, the transition period from 1st shift to 2nd shift, the surveyor observed Staff #3 use the same gloves to push patient A’s chair out of the treatment floor and bring patient H’s chair inside the treatment floor. b. During access care of Patient I, the surveyor observed Staff #2 address the patient’s machine alarm and proceed to perform access care while using the same gloves. c. During access care of Patient H, the surveyor observed Staff #2 step away from Patient H with gloves on and reach into the clean drawer. Site #2 1. On 04/29/2025 between 09:10 a.m. -09:30 a.m., the surveyor observed the following: a. During access care of Patient B, the surveyor observed Staff #2 address the patient’s machine alarm and proceed to perform access care while using the same gloves. b. During care between patients sitting in machine #3 and #5, the surveyor observed Staff #2 fail to perform hand hygiene twice when performing glove change. Site #7 1. On 04/30/2025 between 09:30 a.m. - 09:50 a.m., the surveyor observed the following: a. During care of the patient sitting in machine #11, the surveyor observed staff #2 not perform hand hygiene on multiple occasions in between glove changes. b. During care of the patients sitting in machine #11 and machine #12, the surveyor observed that Staff #2 would continue to wear gloves used for the patient sitting in machine #11 and would partially wear the glove located on top of machine #12 to attend to machine #12’s alarm. This observation was observed at least three times. 2. On 04/30/2025 at 09:50 and at 11:59 a.m., the surveyor observed Staff #2 reach into the clean supplies with gloves on. 3. On 4/30/2025 at 09:57 a.m., during care of the patient sitting in machine #6, the surveyor observed Staff #3 did not perform hand hygiene on multiple occasions in between glove changes.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 47759 Based on observations and review of policies and procedures, the facility’s governing body failed to ensure that non disposable items taken to patient stations were cleaned and disinfected before being returned to their designated “clean area”. This failure placed the patients and staff at potential risk for exposure to blood-borne pathogens and other infectious diseases. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Infection Control” (Policy CRS 700-001) determined that page 1 number 3 stated, “Only supplies and equipment needed for the current patient treatment will be brought to the station. Any items taken to the patient’s dialysis station, including those placed on top of the machine should be disposed of, or dedicated for use on a single patient, or disinfected before returning to a common clean area for use on another patient.” Site #7 On 04/30/2025 at 11:26 a.m., during observations of the treatment floor, the surveyor observed Staff #2 bring the pH strip container and the cup designated to checking pH to Station #11 and Machine #11 and then taken back to the common area. Site #8 During observations on the clinical treatment floor on 5/1/2025 at Site #8, it was noted that the patient care technician (PCT) took one of the dialysis patients’ pre-treatment temperature using a digital thermometer. The thermometer was observed to have touched the patient’s forehead. The PCT then returned the thermometer to the designated cart without disinfecting it. This is was discussed with Staff #19 at the end of the observation period on 5/1/2025.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of policies and procedures, the facility’s governing body failed to ensure that common supply carts used to store clean supplies were at sufficient distance from areas where contamination may occur. This failure placed the patients at potential risk of infection through cross contamination. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Medication Handling, Preparation, Administration, and Storage” (Policy CRS-900-001) deteermined that page 2 number 1 stated, “Prepare medications in a clean designated medication area.” Facility policy titled “Disinfection of Treatment area and equipment” (Policy CRS 700-011), page 2 stated, “Clean areas should be clearly designated for the preparation, handling, and storage of unused supplies, equipment, and medication. Clean areas should be separated from contaminated area where used supplies and equipment are handled to prevent potential cross-contamination.” Site #1 On 04/28/2025 at 09:20 a.m., during physical inspection of the site, the surveyor observed that the medication preparation area was in close proximity to the trash container as well as the sink where staff members wash their hands. Site #2 On 04/29/2025 at 09:10 a.m., during physical inspection of the site, the surveyor observed that the clean supplies such as blankets and bicarb cartridges were in close proximity to the trash, biohazard container, and the needle container. At 09:25 a.m., the surveyor also observed that clean dialysis supplies as well as staff members’ drinks were found in close proximity to the sink where Staff #2 was observed washing his/her hands. Site #8 During observations on the clinical floor on 5/1/2025 at Site #8, it was noted that a rolling gray trash bin was placed approximately 6 inches from the metal clean supply shelf containing unused/clean bicarts, dialyzers, tubings, acid jugs, and clamps. This finding was confirmed by Staff #19 upon observation.”

“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: 47759 Based on observations and review of policies and procedures, the facility’s governing body failed to ensure that the clinical staff followed the standard infection control precaution in the cleaning and disinfection of contaminated equipment being used in the facility. This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Disinfection of treatment area and equipment” (Policy CRS 700-011) determined that page 1 stated, “Wipe down all non-disposable items and equipment such as the blood pressure cuffs, the inside and outside of the prime container, clamps, dialysis chairs, and dialysis machines with an appropriate disinfectant after every treatment.” On page 2, the policy stated, “Equipment .... will be wiped clean with a 1:20 bleach solution post treatment when patient has left the dialysis station.” Site #2 On 04/29/2025 between 09:40 a.m. - 09:55 a.m., during disinfection of stations 1 and 2, the surveyor observed Staff #2 did not disinfect the tv and jugs at each station from the previous shift. Site #7 On 04/30/2025, at 12:18 p.m., the surveyor observed Staff #4 bringing the patient assigned to station #13 and starting the disinfection process of machine #13. The surveyor then observed that Staff #4 did not completely remove all the items (such as a dialyzer cap and tape) from the previous patient as he/she started the disinfection process. Site #8 During observations on the clinical floor on 5/1/2025 at Site #8, a geriatric nurse assistant (GNA) brought a patient in a wheelchair to the dialysis unit. The GNA asked the staff if the dialysis chair had already been cleaned to which the dialysis staff responded, “No.” Neither the GNA nor the dialysis staff took the initiative to clean the dialysis chair and left the patient waiting next to it. The charge RN then showed the GNA where to get some wipes to be used and the GNA began cleaning the chair while missing the inner sides of the armrests. When surveyor #3 interviewed the GNA if he/she has had any in-service training in cleaning and disinfecting dialysis chairs, he/she stated, “Yes, we were given in-service. But I don’t clean the chairs, I only leave the patient by the door when I bring patients to dialysis.””

“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 review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures the facility put in place to prevent intravascular catheter-related infections. This failure placed patients at potential risk of infection. Findings Include: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Central Venous Catheter Care & Dressing Change “ (Policy CRS-600-008) determined that page 2 number 7 stated that for each type of antiseptic solution, “ Using gentle back and forth motion, disinfect the exit site beginning in the center and continuing outward for a minimum of 30 seconds. “ Page 3 number 9 stated, “Remove the catheter cap from one of the catheter limbs. Perform hub scrub (scrub threads/end of the hub with friction) for 15 seconds.” Facility policy titled “Central Venous Catheter (CVC) Care and Dressing Change (CRS-600-008), “ page 3 number 3 stated, “Apply the face mask on the patient, covering the nose and mouth to decrease contamination of the catheter exit site by respiratory bacterial flora.” Site #7 On 04/30/2025, during CVC procedure observation, the surveyor observations the following: 1. At 10:16 a.m., the surveyor observed Staff #2 scrub the hub of the patient’s access [sitting by machine #12] for 6 seconds for one hub and 5 seconds for the other. 2. At 12:30 p.m., the surveyor observed Staff #4 disinfect the patient’s exit site [sitting by machine #3] for 17 seconds. Site #5 1. During clinical observations on the treatment floor on 4/30/2025 at Site #5, it was noted that the patient care technician (PCT) cleaned the CVC site of the patient at chair #9 for 12 seconds and allowed the skin to dry for 10 seconds before placing a new dressing. This finding was confirmed by Staff #20 who was with surveyor #3 during the observation period on 4/30/2025. Site #8 1. During clinical observations on the treatment floor on 5/1/2025 at Site #8, it was noted that the PCT cleaned the CVC site of the patient for 15 seconds. This finding was confirmed by Staff #19 who was with surveyor #3 during the observation period on 5/1/2025. Site #4 During clinical observations on the treatment floor on 4/29/2025 at Site #4, it was noted that Patient A’s mask was beneath the nose during central venous catheter put on. This observation was confirmed by the regional manager while the patient care technician was performing the initiation of dialysis treatment on a patient with a CVC.”

“ENVIRONMENT-SCHEMATIC DIAGRAMS/LABELS CFR(s): 494.40(a) 8 Environment: schematic diagrams/labels Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow. If water system manufacturers have not done so, users should label major water system components in a manner that not only identifies a device but also describes its function, how performance is verified, and what actions to take in the event performance is not within an acceptable range. This Standard is not met as evidenced by: 47759 Based on review of facility policies and procedures, observations, and staff interviews, the facility’s governing body failed to ensure proper labeling and schematic flow was available for easy and quick reference in case of serious events. This failure placed the patients at potential risk of harm. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Schematic Diagrams and Labels” (Policy CRS-1200-003) determined that page 1 stated, “Water systems should include schematic diagrams that identify components, valves, sample ports, and flow direction. Additionally, piping should be labeled to indicate the contents of the pipe and direction of flow.” Site #1: On 04/28/2025 at 11:15 a.m., the surveyor observed that the water system of Site #1 did not have labels on all valves, sample ports, meters, and flow direction that properly identified each component. Site #7: On 04/30/2025 between 08:20 a.m.-08:30 a.m., the surveyor observed that the water system of Site #7 did not have labels for all valves, sample ports, meters, and flow direction that properly identified each component. Interviews with the bio-medical manager stated that there should be labels for all valves, sample ports, and meters.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 47759 Based on observations, staff interviews, and review of policies and procedures, the facility’s governing body failed to ensure 1.) that enough salt pellets were inside the brine tank; and 2.) that the softener timer was set to correct time. This failure placed the patients at potential risk of harm by potentially causing damage to the water system. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s “daily water treatment log” determined that the log asks the following to guide staff members to ensure that the water components are properly being monitored: “-All pretreatment timers are set for the correct time of day? ...-Salt level in brine tank at least half full. Salt just above the water? “ Site 7: On 04/30/2025 at 08:20 a.m. and again at 01:00 p.m., the surveyor observed the following: 1. The timers for the two carbon tanks and the water softener tank were set an hour behind. a. According to the bio-medical manager, the 3 tanks were set an hour behind and needed to be updated. 2. The salt level of the brine tank was roughly filled about 40% and was below the water level. a. According to the bio-medical personnel, the brine tank needed more salt.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 47759 Based on observations, record review, and staff interview, the facility’s governing body failed to ensure that: 1) pH was performed before starting the treatment of each patient; and 2) staff members demonstrated knowledge of the acceptable range for the final dialysate pH result. This failure placed the affected patients at potential risk of harm. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Dialysate pH testing Policy” (Policy CRS-1200-022) determined that page 1 stated, “Manual pH testing must be performed prior to each patient’s treatment and whenever a different composition of acid concentrate is used ....pH testing should be performed before attaching dialysate connectors to the dialyzer ...pH must read between (6.9 - 7.6).” Page 2 stated, “Report any out-of-range readings to Nurse and Biomed.” Site #7 On 04/30/2025 between 10:20 a.m. -10:45 a.m., interviews and observations revealed the following: 1. At 10:20 a.m., the surveyor interviewed Staff #3 to ask what the normal range was for machine pH testing. According to Staff #3, the normal range was “7.4-7.9.” 2. At 10:22 a.m., the surveyor interviewed Staff #2 to ask what the normal range was for machine pH testing. According to Staff #2, the normal range was “6.9-8.5” 3. At 10:45 a.m., the surveyor observed Staff #2 set up the machine at Station #12 and awaited for machine pH testing. The surveyor observed Staff #2 proceed without checking machine #12’s pH. The surveyor asked Staff #2 if the machine pH was performed and what it was, the surveyor was informed that the pH was 6.8 and proceeded with patient care. 4. The surveyor compared the information provided by Staff #2 with the policy and immediately met with Staff #6. 5. According to Staff #6, the information provided by Staff #2 was out of range. According to Staff #6, the staff members needed further education on the normal range of pH. The site leadership initiated staff re-education immediately.”

“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: 47759 Based on observations and record review, the facility’s governing body failed to maintain an environment with reasonable noise levels to ensure the comfort of the patients during dialysis treatment. This failure placed the patients and staff at potential risk for stress, anxiety, and negative impact on overall well being. Findings included: The Occupational Safety and Health Administration (OSHA) addresses the importance of a safe and healthy work environment, which would include minimizing unnecessary noise. Dialysis sessions can last several hours, and a quiet atmosphere helps patients rest, relax, or even sleep during treatment, which can reduce stress and anxiety. A quiet environment is crucial in dialysis because excessive noise can negatively impact patient and staff well-being, potentially affecting treatment outcomes and overall safety. Noise can interfere with patient concentration, exacerbate existing conditions, and contribute to stress and burnout among staff, ultimately leading to increased risks of medical errors and reduced quality of care. Site #8 During clinical observations on 5/1/2025 at Site #8, it was noted that the television (TV) at the dialysis area closest to the nurse’s table was unusually loud while other patients were having their dialysis treatment. When staff was interviewed if earphones are provided for these patients, the patient care technician stated that the patients are given their individual earphones at the time of their initial dialysis treatment but end up losing them in the nursing home. No replacement earphones are provided thereafter. It was also noted that after the patient had vacated that area, the TV continued to play and the volume was not turned down.”

“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: 47759 Based on observations and review of facility policies and procedures, the facility’s governing body failed to ensure the that all surfaces in the treatment environment of the dialysis facility were kept intact, clean and free of damage. This failure increased the risk of ineffective cleaning, and the potential for unseen microbial growth and safety issues. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Physical Plant” (CRS-1200-016) determined that page 1 stated, “There should be no areas that pose infection control risks, such as broken work surfaces ....All systems in the dialysis unit, such as lighting and heating and air conditioning, should be operational ....The dialysis facility must maintain a comfortable temperature within the facility ...a comfortable room temperature is generally considered between 68-74 degrees Farenheight.” Page 2 stated, “Ceiling tiles must be intact and stain-free. The treatment floor, water room, storage room, and any other room attached to the dialysis den must be free of rust.” Site #1 1. On 04/28/2025, during inspection of the site’s physical environment, the surveyor observed the following: a. Brown residue on the water room ceiling; b. Uneven flooring inside the water room. Site #2 1. On 04/29/2025, during inspection of the site’s physical environment, the surveyor observed holes and orange brown stains on the side tables of the dialysis chairs. Site #7 1. On 04/30/2025, during inspection of the site’s physical environment, the surveyor observed the following: a. Temperature that ranged from 80-85 degree Fahrenheit despite the portable cooling device as part of the facility’s immediate plan. i. According to Staff #6, the facility’s Heating, Ventilation, and Air Conditioning was not in working order that day. ii. According to an anonymous source, the facility’s temperature is either “too hot or too cold” and needs to be fixed. According to the anonymous source, “It’s been an ongoing problem for weeks.” b. Unsecured ceiling tiles located in the water room. c. Malfunctioned clock located in the water room. d. Malfunctioned clock located at the treatment floor by Station #5-#8. e. A copious amount of debris surrounding the water heater inside the water room. f. Water room door that does not close or open properly. g. Cabinet handles located near the nursing stations with missing handles. Site #4 1. During observations in the clinical treatment room of Site #4 on 4/29/2025, the following were noted: a. Red-brown splatter markings on the wall behind every dialysis and Reverse Osmosis (RO) machine. b. Only one working television available out of 5 television mounts in the dialysis unit c. Reddish brown, rough, powdery substances surrounding the metal television handles. d. Peeling wall paint at the back of the dialysis chairs/machines. e. Three dialysis chairs had multiple tears located in various areas such as the seats, backrests, and armrests. f. Broken and warped window blinds. g. These findings were discussed with Staff #28 at the end of the survey day of Site #4 on 4/29/2025. Site #5 1. During observations at Site #5 on 4/30/2025, the following were noted: a. The flooring of the three under sink cabinets located in the dialysis treatment room, had peeling black-brown substances. Reddish brown, rough, powdery substances were also noted on the door hinges of these cabinets. b. 7 out of 9 dialysis chairs had various tears in different spots such as the seats, back and armrests, and lower sides. Attached chairside tables have reddish-brown permanent stains. c. The drawers of the counter located between chairs 9 and 10 had broken knobs. d. The base of the toilet in the staff’s restroom was unstable. e. These findings were discussed with Staff #19 and #20 at the end of the survey day of Site #5 on 4/30/2025.”

“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: 47759 Based on observations, staff interviews, and review of facility policies and procedures, the facility’s governing body failed to ensure a dialysis facility with sufficient space to provide needed care and services, prevent cross-contamination, and accommodate medical emergency equipment and staff. This failure placed affected patients at potential risk of harm. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Patient Care Environment” (Policy CRS-400-017) determined that page 1 number 1 stated, “Sufficient Space” to prevent cross-contamination would allow space to: ... Caregivers to provide emergency care including cardiopulmonary resuscitation (CPR), the use of emergency equipment including access to needed supplies, stretcher and emergency personnel.” Code of Maryland Regulations found at 10.05.04.11A. Physical Plant requires: A. Floor Space. (1) The kidney dialysis center shall have usable floor space of at least 80 square feet per patient station. (2) Floor space may include bed or chair space, nursing space, and work area, but excludes storage space. (3) At least 20 square feet of the patient station floor space shall be available on the side of the patient to be occupied by the dialysis assembly. (4) Arrangement of space shall be sufficiently flexible to provide access to any of the patient’s four extremities. B. Treatment Area. ... (2) The kidney dialysis center shall have sufficient space for maintenance and storage of equipment and supplies, and for preparing and testing dialyzers. Site #1 On 04/28/2025 at 09:30 a.m., during shift turnover, the transition period from 1st shift to 2nd shift, the surveyor observed that two patients were transferred into the dialysis unit consecutively and were placed side by side blocking access and exit pathway of stations #6 and 7. Interviews with Staff #1 revealed concerns of patient safety in case of an emergency. According to Staff #1, the practice observed was not an isolated event. Staff #1 stated that in case of an emergency, he/she would like to get to the patients in need “immediately.” Interviews with the Regional Manager revealed similar concerns. Site #4 During observations in the clinical treatment room on 4/29/2025 at Site #4, it was noted that the distance between 2 patients when reclined while undergoing dialysis treatment is approximately 12-24 inches apart, leaving no room for the clinical staff to move around to perform other clinical duties as well as provide sufficient floor space to accommoate emergency medical equipment when the need arises. This finding was discussed with the regional manager at the end of the survey day on 4/29/2025.”

“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: 36839 Based on observations, the facility’s governing body failed to ensure that every patient’s vascular access was visible during hemodialysis treatment. This failure placed the patients at potential risk of harm and possible death. Findings included: The dialysis access site must be visible at all times during treatment to ensure the safety of the patient and the integrity of the dialysis process, according to the American Nephrology Nurses Association (ANNA). Failure to visualize the access and bloodlines has been identified as a cause of patient harm, including needle dislodgement and potential complications. Keeping the access site visible also allows for proper monitoring of the patient’s condition during treatment and ensures that any necessary adjustments can be made in a timely manner. Site #5 During observations on the clinical floor on 4/30/2025 at Site #5, it was noted that the patients at chairs 2 and 8 had their access sites covered with a blanket during dialysis treatment from 10:55 a.m.-11:30 a.m. This finding was confirmed by the charge nurse during the observation period on 4/30/2025.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 47759 Based on observations and review of the policies and procedures, the facility’s governing body failed to ensure that the clinical staff members complied with the facility’s access assessment and cannulation protocol. This failure placed patients at potential risk for infection. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Cannulation and Decannulation of AVF/AVG” (Policy CRS -600-007) determined that page 2 number 5 stated, “Evaluate the entire length of AVF/AVG for patency with a clean stethoscope. When auscultating listen for Bruit (low-pitched swoosh considered appropriate).” Page 3 number 4 stated to cleanse the access prior to cannulation with an approved antiseptic cleanser and to “Clean the access area beginning in the center and continuing outward in a back-and-forth motion around the access site using gentle friction for 30 seconds.” Page 5 number 5 stated, “ If additional assessing of the access and/or palpation is required, step 4 should be repeated. (once disinfected, do not allow the access to be recontaminated).” Site #1: 1. On 04/28/2025 at 11:00 a.m., during observations of an AVF/AVG procedure, the surveyor observed the following: a. The surveyor observed that Staff #2 did not listen to the patient [sitting by machine #3]’s access. b. The surveyor observed that Staff #2 disinfected the patient [sitting by machine #3]’s access site, palpated the patient’s access, and did not disinfect again prior to cannulation. Site #2: 1. On 04/29/2025 at 11:03 a.m., during observations of an AVF/AVG procedure, the surveyor observed the following: a. The surveyor observed that Staff #2 did not listen to the patient [sitting by machine #1]’s access b. The surveyor observed that Staff #2 disinfected the patient [sitting by machine #1]’s access site for 5 seconds each, palpated the patient’s access, and did not disinfect again prior to cannulation.”

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 47759 Based on record review, the facility’s governing body failed to ensure that: 1) the implementation of the initial plan of care began within 30 days after admission to the dialysis facility or 13 hemodialysis sessions beginning with the first outpatient dialysis session; and 2) the plan of care completed was based upon the comprehensive assessment recently performed. This failure placed the affected patients at potential risk of harm and denied patients their rights to a minimum standard of care. Findings Included: On 05/02/2025 at 12:00 p.m., review of the facility’s policy titled “Comprehensive Interdisciplinary Patient Assessment (CIPA)” (Policy CRS-400-006) determined that page 1 stated, “The comprehensive assessments must be used to develop the patient’s treatment plan and expectation of care.” On 05/01/2025 between 08:00 a.m. - 04:10 p.m., medical record review revealed the following: Site # 8 1. Review of 3 out of 4 patient plans of care revealed plans of care that were completed late. a. Patient B, admitted on 02/14/2025, had his/her 30 day plan of care completed on 04/30/2025, which was approximately 2 months late. b. Patient C, admitted on 01/27/2025, had his/her 30 day plan of care completed on 03/31/2025, which was approximately 1 month late. c. Patient D, admitted on 01/27/2025, had his/her 30 day plan of care completed on 03/27/2025, which was approximately 1 month late. Site #2 1. Review of 4 out of 4 patient plans of care revealed plans of care that were completed prior to the interdisciplinary team’s completion of patient assessments. a. Patient A: 30 Day- Assessment was last signed and approved by the Social Worker on 02/28/2025. Plan of Care was signed on 02/21/2025 b. Patient B: 30 Day- Assessment was last signed and approved by the Social Worker on 06/29/2024. Plan of Care was signed on 06/18/2024. c. Patient B: 90 Day -Assessment was last signed and approved by the Social Worker on 09/27/2024. Plan of Care was signed on 09/24/2024. d. Patient C: 30 Day-Assessment was last signed by the Social Worker on 03/31/2025. Plan of Care was signed on 02/20/2025. Site #7 1. Review of 1 out of 8 patient plans of care revealed plans of care that were completed prior to the interdisciplinary team’s completion of patient assessments. a. Patient C: Assessment was last signed and approved by the registered nurse on 04/23/2024. Plan of Care was signed on 03/26/2024. Site #8 Review of 2 out of 4 patient plans of care revealed plans of care that were either completed prior to the interdisciplinary team’s completion of patient assessments or were completed late. a. Patient A: Assessment was last signed and approved by the Social Worker on 05/01/2025. Plan of Care was signed on 04/13/2025. b. Patient C, admitted on 01/27/2025, with a plan of care completed on 03/31/2025, which was over a month late.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to: 1) compare their performance with community-based standards and with other facilities in their State, Network, and the United States; and 2) identify ways to improve their outcomes where needed. This failure denied patients their rights for quality care. Findings included: 1. On 05/02/2025, during review of the facility’s Dialysis Facility Report (DFR) for the fiscal year 2025, the surveyor observed the following: a. “At this facility, the 2020-2023 Standard Mortality Rate (SMR) is 1.62, which is 62% more deaths than expected at this facility. Among all U.S. facilities, 97% of facilities had a four-year SMR lower than 1.62. This difference is statistically significant (p<0.05), so this higher mortality is unlikely to be due to random chance and probably represents a real difference from the expected mortality in the nation. The 2020-2023 SMR of observed to expected deaths is 0.95 and 1.00 for your State and Network, respectively.” b. “The percentage of Medicare dialysis patients at this facility hospitalized with septicemia during 2020-2023 is 19%, compared to 12% in your State, 13% in your Network, and 12% nationally. It may be useful to review infection control at this facility.” c. “In 2023, 48% of eligible hemodialysis patient-months had a hemoglobin value below 10 g/dL, compared to 25% in your State, 25% in your Network, and 23% nationally.” 2. On 05/02/2025, during review of the facility’s Quality Assurance and Performance Improvement (QAPI), the surveyor observed the following: a. Under “Patient Activity Trends I,” the surveyor observed that for the months of January 2025-March 2025, 1) there were no documented discussion of the facility’s comparative performance of SMR with community-based standards and with other facilities in their State, Network, and the United States; and 2) there were no documented discussion of ways to improve outcomes and/or efforts to reduce the SMR. b. Under “Hospital and BSI’s,” the surveyor observed that for the months of January 2025-March 2025, there was no documented discussion of the facility’s comparative performance of patients hospitalized with septicemia with community-based standards and with other facilities in their State, Network, and the United States. Additionally, there was a total of 7 hospital diagnosis blood stream infection reported; however, the surveyor observed that there were no documentation of the sources for the documented BSIs. There was also no evidence of re-evaluation for the 3 unchanged action plans documented for the months of January 2025-March 2025. c. Under “Anemia Management,” the surveyor observed that for the months of January 2025-March 2025, 1) there were no documented discussion of the facility’s comparative performance of Anemia Management with community-based standards and with other facilities in their State, Network, and the United States; and 2) there were no documented discussion of ways to improve the number of patients who can reach their anemia target goals.”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 47759 Based on record review and staff interviews, the facility’s governing body failed to 1) identify potential problems that may be hindering patients from achieving anemia target goals; and 2) identify opportunities to increase the number of patients who can achieve anemia target goals. This failure denied patients their rights for quality and effective care. Findings Included: On 05/02/2025, during review of the facility’s policies and procedures titled “Quality Assessment and Performance Improvement (QAPI) Program (CRS-100-011), page 1 stated, “The purpose of QAPI is to focus on indicators related to improved health outcomes.” One of the indicators included “Anemia Management.” On 05/02/2025, during review of the facility’s QAPI Program documentation, the surveyors observed that one of the facility’s goal was to have at least 80% of their patients with a hemoglobin range of 9-11. Document review showed that 19 out of 19 (100%) of the facility’s sites did not reach that goal. Upon further review of the facility’s QAPI, the surveyors observed that the problem written was to “be able to document panic HgB 80% of results” for the months of January 2025 through March 2025. In addition, action plan written from January through March revealed the same action plan with no re-evaluation documented. During an interview with the Director of Quality, he/she corroborated that the QAPI for anemia 1) failed to identify potential issues that may be preventing patients from meeting anemia target goals; and 2) failed to outline strategies to prevent hemoglobin levels from falling to critical levels thereby identifying opportunities to increase the number of patients who can achieve anemia target goals. This highlighted the need for a more comprehensive plan to improve the number of patients who can reach their anemia target goals.”