Detroit Kidney Center LLC

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 45246 Based on observation, interview and record review, the facility failed to take measures to maintain sanitary environment, properly disinfect equipment, separate clean and dirty areas, properly handle infectious waste, and follow infection control precautions during access site care, resulting in the risk for transmission of infectious agents among all patients who receive dialysis treatments in the facility. Findings include: See Specific Tags: V-111 Failure to provide/maintain clean sanitary environment V-116 Failure to disinfect equipment between use V-117 Failure to separate clean and dirty items/areas V-121 Failure to properly handle infectious waste V-146 Failure to appropriately care for intravascular catheter”

“CFC-PATIENT ASSESSMENT CFR(s): 494.80 This Condition is not met as evidenced by: 45246 Based on observation, interview and record review, the facility failed to ensure that the physician signed the Comprehensive Interdisciplinary Assessment (CIA) for 3 (P-8, 9, 11) of 15 patients reviewed and staff followed the prescribed treatment plan for dialysis for 3 (P-1, 2, 4) of 15 patients reviewed resulting in the potential for unidentified patient needs and poor patient outcomes. Findings include: See Specific Tags: V-501 Failure to sign Comprehensive Interdisciplinary Assessment by physician V-503 Failure to ensure patients planned dialysis treatments administered according to physician’s orders”

“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: 45246 Based on observation, interview and record review, the facility failed to take measures to maintain a sanitary environment resulting in the risk for transmission of infectious agents among all patients who receive dialysis treatments in the facility. Findings include: During the initial tour of the facility on 8/19/25 from 1001 to 1245 the following observations were made on the treatment floor. Three tall cardboard boxes were observed sitting on the floor next to the crash cart. A box of disposable 3 ml (milliliter) syringes and a package with blue gowns (personal protective equipment) were found stored in the cabinet under the hand washing sink. The 10 ml syringe with approximately 6 ml of blood in it was observed lying on the floor behind station #10. There was a streak of blood approximately 3 inches in length next to the syringe. Patient was receiving dialysis treatment at this time at station #10. Hoyer lift was observed stored in a corner with bubble wrap wrapped around its base. The counter ledge trim behind station #21 separated from the wall and had adhesive and a dry wall exposed. There was a puddle of clear fluid observed under the back ledge of station #12. All the above findings were shared with facility interim administrator, Staff A, after the tour. On 8/20/25 from 0936 to 1100, during the treatment floor observations, the puddle of clear fluid again was observed under the back ledge of station #12. There was a large puddle of clear fluid under the patient chair at station #24. During an interview with Biomed technician, Staff C, on 8/20/25 at 0955 he confirmed the findings. Multiple debris (paper wrapping, plastic caps and capped needle) were observed on the floor around stations # 22 and 24. During the interview with facility administrator, Staff B, on 8/21/24 at approximately 0935, she stated that the facility had a contract with a cleaning company, and it was also staff responsibility to maintain a sanitary environment. Facility “Janitorial Service Agreement Facility Cleaning Procedures” document was reviewed and revealed: “Dialysis treatment area. A. Nightly. 6. Floors. Dust mop using treated dust mop. Damp mop using disinfectant solution. Remove chemical spills using bleach solutions. Exhibit A. 3. Housekeeping Service Policy. This dialysis facility provides the housekeeping and maintenance services necessary to maintain a sanitary and comfortable environment. Such services are in accordance with laws, rules and regulations set forth by the State Department of Public Health. The facility provides sufficient housekeeping and maintenance personnel to maintain the interior and exterior of the facility in a safe, clean, orderly and attractive manner. Housekeeping personnel. using accepted practices and procedures, keep the facility free from offensive orders, accumulations of dirt, rubbish, dust and safety hazards. Floors are cleaned regularly.””

“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: 45246 Based on observation, interview and record review, the facility failed to discard unused supplies prior to the next patient treatment and clean and disinfect multiuse equipment between patient use resulting in potential for spread of infection and negative outcomes for all patients receiving dialysis treatment in a facility. Findings include: During the initial tour of the facility on 8/19/25 at 1033 supplies wrapped in a blue chuck were observed in a wire basket on the side of dialysis machine at station # 22. There were multiple syringes with normal saline and a syringe with capped needle with approximately 2 ml (milliliters) of clear liquid poking through the basket. The station was set up for a new patient with all needed clean supplies lying on a chair side table covered with the blue chuck. Later, at 1230, a new patient was observed at station #22 receiving dialysis treatment. The above-described supplies were still in the side basket with the same syringe poking through. On 8/20/25 at 0940, during interview with interim facility administrator, Staff A, she stated that all medications and supplies brought to the dialysis station are for that patient use only. 50223 On 8/19/25 at 1036 patient care technician, Staff I, was observed to pick up a testing meter that was resting on top of a bin of bags of fluids, brought it to patient’s dialysis station, used it on a patient’s dialysis circuit, then replace it on top of the bin of fluid bags. No disinfection was observed before or after use. On 8/20/25 at 1002 Staff I was observed setting up a dialysis station. Staff I removed a broken chair from the station and retrieved another chair from a storage area and brought it to the station. The chair was not disinfected prior to patient use. On 8/20/25 at 1400, during an interview, the facility administrator, Staff A, explained that all multiuse equipment should be disinfected before and after each patient use. A review of the facilities policy titled “G40 Infection Control”, dated:01/21 revised: 11/22, revealed the following: “12. Only the supplies and equipment needed for the current patient treatment will be placed on the dialysis machine or in the patient’s treatment area. For example, only the bags of saline needed for the current patient’s treatment may be opened and placed on the dialysis machine. 27. Reusable supplies will not be shared between patients without being disinfected between each use per the appropriate procedure; this includes blood pressure cuffs and stethoscopes.””

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 27408 Based on observation, interview, and record review, the facility failed to maintain clean areas separated from dirty items, resulting in the potential for the spread of infectious disease to the 13 patients receiving dialysis treatment at the time of observation. Findings include: On 08/20/25 at 1100, during observation, it was noted that next to a sink that was labeled “Dirty Sink” there were 2 bins labeled “Chlorine Bleach 1/10”. The bins did not have the required covers on and were susceptible to being splashed with contaminated material. The covers were located behind the faucet, standing in an upright position, of the “Dirty Sink”. On 08/20/25 at 1102, Patient Care Technician (PCT), Staff I was queried as to if the Chlorine Bleach bins should be covered. Staff I stated “Yes, they should be, to be clean and not splashed in.” On 08/20/25 at 1330, during review of the document titled “G40 Infection Control, Infection Control Measures, #16. Each center will maintain and clearly label “clean” and “dirty” work areas. Clean items such as medications and gloves are kept in designated “clean” areas. Contaminated items such as lab samples are to be stored in the designated “dirty” areas. “Dirty” areas are those where contamination with blood and other biohazardous substances would be expected to be encountered (e.g., treatment area, bathrooms, etc.). Depending on the center layout and configuration, clean and dirty areas will be designated in a manner that decreases the risk of cross contamination.””

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [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- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 27408 Based on observation, interview, and record review, the facility failed to ensure biohazard waste was contained in a safe manner, resulting in the potential for the spread of infection amongst the 13 patients receiving dialysis at the time of observation. Findings include: On 08/19/25 at 1110, during observation, one large biohazard bin was observed with the lid left in an open position. It was lined with a red biohazard bag containing biohazard waste, including used blood tubing. The biohazard bin was observed across from station #21. There was also one large biohazard bin, with the lid in an open position. It was lined with a red biohazard bag containing biohazard waste, including used blood tubing. The biohazard bin was observed across from station #5. At the time of observations, Patient Care Technician (PCT) Staff I, was queried as to what the bins were used for, and if it should be left in an open position or shut once waste products were placed in the bin. Staff I stated, “that bin is mainly for our bloody tubing and we need to keep it closed.” On 08/19/25 at 1520, during review of the policy titled “G40 infection Control #1. Standard precautions and infection control measures as outlined in this policy will be used by all associates at all times.” On 08/20/25 at 1145, the Medical Director, Staff H, was interviewed, and he stated that he expected “the staff to follow facility policies”.”

“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: 50223 Based on observation, interview, and record review, the facility failed to follow infection control precautions during access and dressing change of central venous catheters (CVC) for one patient (P-13) of three patients observed for CVC care, resulting in the potential for bloodstream infections for all patients with a CVC in the facility. Findings include: On 8/19/25 at 1027 patient care technician, Staff I, was observed initiating dialysis for P-13. Staff I was observed to remove the gauze dressing from P-13’s right chest central venous catheter (CVC) with gloved hand. Staff I then placed the dirty dressing on P-13’s chair tray table which contained clean supplies. Staff I then removed their gloves and also placed them on the tray table. Staff I then picked up another pair of gloves from the same tray that were touching the dirty gloves and donned them. Staff I then cleaned P-13’s CVC site with alcohol preps and placed the used alcohol preps on the tray table. Staff I then removed their gloves and again placed them on the tray table, then picked up another pair of gloves from the tray and donned them. Staff I then picked up a piece of gauze from under the dirty gloves on the tray and applied it to P-13’s CVC site. Staff I then cleaned the infusion ports of P-13’s CVC with alcohol pads that were obtained from the same tray, then placed the used alcohol preps back on the tray. Staff I then picked up blood collection supplies from the tray containing the dirty supplies and obtained a blood sample from P-13’s CVC. Staff I then wrapped the dirty supplies in the barrier and left them on the tray table. On 8/19/25 at 1309 the dirty supplies were observed still present on P-13’s tray table. On 8/20/25 at 1320, during an interview, Staff I explained that they have not received any infection control education at the facility but that they know how to do things since they have been doing this for 27 years. On 8/20/25 at 1400, during an interview, the facility’s administrator Staff A explained that dirty and clean supplies should never touch and explained that staff should be following the policies and procedures for the care of CVCs. A review of the facility’s policy titled “Infection Control”, dated 01/21 and revised 11/22, revealed the following: “Aseptic technique will be used to prepare the access site prior to needle insertion and to clean the CVC exit site. All blood line, fistula needle and CVC connections will be handled using proper aseptic technique.” (a set of practices used in healthcare settings to prevent infection and control the spread of bacteria, viruses, and other microorganisms during medical procedures.)”

“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: 22050 Based on observation, interview, and record review, the facility failed to clean and maintain the physical plant affecting 59 patients, resulting in the increased likelihood for cross-contamination and bacterial harborage. Findings include: On 08/19/25 at 12:40 P.M., an environmental flash tour was conducted with BioMed (BM) “C” and Facility Technical Manager (FTM) “J”. The following items were noted: Treatment Room: 1 of 5 Clean Hand Sink vanity drawer interiors were observed soiled with accumulated and encrusted dust, dirt, and debris. (BM) “C” indicated he would thoroughly clean the drawer interior as soon as possible. 4 of 4 Clean Hand Sink vanity drawer interiors were observed soiled with accumulated and encrusted dust, dirt, and debris. (BM) “C” indicated he would thoroughly clean the drawer interiors as soon as possible. 1 of 2 Dirty Hand Sink vanity cabinet interiors were observed to be etched, scored, and had particulate present. (BM) “C” indicated he would make necessary repairs as soon as possible. The #2 “Frigidaire” refrigerator freezing compartment was observed one-third occluded with ice dams. (BM) “C” indicated he would defrost and clean the “Frigidaire” refrigerator and freezing compartments as soon as possible. On 08/19/25 at 01:08 P.M., An interview was conducted with Facility Technical Manager (FTM) “J” regarding the current housekeeping vendor. FTM “J” stated the facility has a vendor and they are onsite Monday thru Saturday. 6 of 6 Hand sanitizer drip trays were observed soiled with accumulated and encrusted (dust, dirt, debris). 6 of 6 Hand sanitizer metal stand bases were observed extremely corroded and rusty. The vinyl tile flooring surface, directly beneath the metal stand base, was also observed stained and severely discolored. (BM) “C” indicated he would remove the metal stand bases and clean or replace the stained flooring tile as soon as possible. The #1 Hemodialysis Station pipe chase was observed with accumulated acid crystallization deposits. (BM) “C” stated: “The connections sometime leak and create build-up.” The (#1, #7, #8, #10, #11, #12, #13, #15, #17, #18, #19, #23) hemodialysis dialysate connection boxes were observed soiled with accumulated and encrusted dust, dirt, and had corrosion. (BM) “C” indicated he would contact the current housekeeping vendor for necessary cleaning protocols. Laboratory Supply Area: The Dirty Hand Sink vanity cabinet interior was observed soiled with accumulated and encrusted dust, dirt, and chemical (bleach) residue. (BM) “C” indicated he would contact the current housekeeping vendor for necessary cleaning protocols. Heparin Drawing Station: The Clean Hand Sink vanity cabinet interior was observed soiled with accumulated and encrusted dust, dirt, and particulate (rust) corrosion. The stainless-steel paper towel dispenser, eyewash control valve assembly gauge, four chrome metal escutcheons, and four metal door hinge assemblies were also observed extremely corroded. The vanity cabinet interior flooring surface was additionally observed with accumulated particulate corrosion deposits. (BM) “C” indicated he would contact the current housekeeping vendor for necessary cleaning protocols. (BM) “C” also indicated he would make necessary repairs as soon as possible. The “Danby” Laboratory Specimen Refrigerator was observed at 50 degrees Fahrenheit. Fourteen cold packs were also observed stored within the refrigerator and freezing compartments. The cold packs were additionally observed soft, pliable, and supple. (BM) “C” stated: “Maybe the breaker tripped.” 3 of 3 wall mounted hand sanitizer drip trays were observed soiled with accumulated and encrusted (dust, dirt, sanitizer residue). (BM) “C” indicated he would contact the current housekeeping vendor for necessary cleaning protocols. Janitor Closet: The mop bucket strainer assembly was observed heavily soiled and corroded with accumulated and encrusted dust, dirt, and rust. (BM) “C” indicated he would replace the mop bucket strainer assembly as soon as possible. Biohazard Storage Room: 2 of 4 overhead 48-inch-long fluorescent T8 light bulbs were observed non-functional. (BM) “C” indicated he would replace the faulty bulbs as soon as possible. Twelve 24-inch-wide by 24-inch-long acoustic ceiling tiles were observed stained from previous moisture leaks. (FTM) “J” indicated he would have staff replace the stained ceiling tiles as soon as possible. Lobby: 2 of 2 drinking fountain mouthpieces were observed soiled with accumulated and encrusted dust, dirt, and grime. (BM) “C” indicated he would contact the current housekeeping vendor for necessary cleaning protocols. On 08/20/25 at 10:30 A.M., Record review of the “Janitorial Service Agreement Facility Cleaning Procedures” dated (no date) revealed under Dialysis Treatment Area: “(A) Nightly: (5) Cabinets, Counter Fronts and Partitions: Spot clean with damp cloth using disinfectant cleaner. (6) Floors: Dust mop using treated dust mop. Damp mop using disinfectant solution. Remove chemical spills using bleach solutions. Recoat bleached area using identical floor wax.””

“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: 50585 Based on observation, interview, and record review, the facility failed to ensure the thermometer attached to the medication refrigerator was within the calibration due date for 1 of 2 medication refrigerator thermometers observed resulting in the increased likelihood of negative consequences for all patients. Findings include: On 8/19/2025 at 1230, the thermometer attached to the medication refrigerator that stored the patient’s parenteral nutrition solutions had a calibration due date of December 8, 2024. Interim Facility Administrator Staff A confirmed the findings at the time of discovery. According to the facility’s policy, Medications: Handling, Administration, Storage, & Disposal,” dated 6/11/2025, “Medications are stored, mixed, and administered per manufacturer instructions and applicable (Facility) policies.””

“PA-IDT MEMBERS/RESPONSIBILITIES CFR(s): 494.80 The facility’s interdisciplinary team consists of, at a minimum, the patient or the patient’s designee (if the patient chooses), a registered nurse, a physician treating the patient for ESRD, a social worker, and a dietitian. The interdisciplinary team is responsible for providing each patient with an individualized and comprehensive assessment of his or her needs. The comprehensive assessment must be used to develop the patient’s treatment plan and expectations for care. This Standard is not met as evidenced by: 27408 Based on record review, and interview, the facility failed to ensure that the physician failed to sign the Comprehensive Interdisciplinary Assessment (CIA) that was completed by the Physician’s Assistant (PA), for 3 (P-8, P- 9 and P-11) of 15 patients reviewed, resulting in the potential for unidentified patient needs and poor patient outcomes. Findings include: On 08/19/25 at 1400, during review of P-8’s medical record, it was revealed the physician did not sign the CIA that was completed on 07/24/25 by his PA. On 08/19/25 at 1415, during review of P-9’s medical record, it was revealed that the physician did not sign the CIA that was completed on 07/24/25 by his PA. On 08/19/25 at 1430, during review of P-11’s medical record, it was revealed the physician did not sign the CIA that was completed on 08/14/25 by his PA. On 08/21/25 at 1030 during review of the document titled “Assessment, Plan of Care CAPOC” “Policy for Comprehensive Assessment: 1. The comprehensive assessment is completed by the facility’s interdisciplinary team (IDT) that consists of, at minimum: *The patient or the patient’s designee (if the patient chooses). *Registered Nurse *Physician treating the patient for ESRD (or the Nurse Practitioner or Physician’s Assistant) *Social Worker *Dietician On 08/21/25 at 1145, the Medical Director, Staff H, was interviewed, and he stated that he “should’ve signed off on the assessment”.”

“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: 45246 Based on observation, interview and record review, the facility failed to ensure that staff followed the prescribed treatment plan for dialysis for three patients (P-1, 2 and 4) of 15 patients reviewed, resulting in the potential for negative patient outcomes for these patients. Findings include: On 8/19/25 at 1115 order and treatment data were reviewed with registered nurse, Staff T for P-1 at station #2. The order indicated Blood flow rate (BFR) at 400, and Dialysate flow rate (DFR) at 700. The machine parameters were set up for BFR at 400 and DFR at 500. Staff T was asked why DFR was running at 500. She explained that sometimes the rates need to be adjusted based on patient’s condition and how they tolerate the treatment. When asked if staff need to document the adjustment, Staff T stated that the nurse should be notified. Also, she wasn’t sure if anything else needs to be documented since she was still new in her role in the facility. On 08/20/25 at approximately 1200 P-1 treatment record for 8/19/25 was reviewed and indicated that treatment was administered with DFR at 500. No nursing note was found with explanation of the reason DFR was adjusted to 500 and no physician notification regarding adjustment was documented. On 8/21/25 at 1045 during interview with facility Medical director, Staff H, he stated that staff need to notify him in case treatment parameters were adjusted and were different from physician’s order. Staff H also stated that staff should follow facility’s policies and procedures. 27408 On 08/19/25 at 1330, review of treatment sheets for P-2 revealed the following documentation: (P-2’s treatment orders dated 08/06/25 indicated: BFR (blood flow rate)- 250 ml/minute, DFR (dialysate flow rate)- 500 ml/minute.) P-2’s treatment dated 08/09/25, started at 0625, and was completed at 0926. For the entire treatment the BFR was run at 400 ml/minute. P-2’s treatment dated 08/12/25, started at 0559, and was completed at 0945. For the entire treatment the BFR was run at 400 ml/minute. P-2’s treatment dated 08/14/25, started at 0555, and was completed at 0946. For the entire treatment the BFR was run at 400 ml/minute. P-2’s treatment dated 08/16/25, started at 0552, and was completed at 0949. For the entire treatment the BFR was run at 350 ml/minute. P-2’s treatment dated 08/19/25, started at 0600, and was completed at 0949. For the entire treatment the BFR was run at 400 ml/minute. 50585 On 8/19/2025 at 1400, P-4’s dialysis flow treatment sheets were reviewed. P-4 had an order for a Blood Flow Rate (BFR) of 400 milliliter (mL) per minute (min). The following treatment times and corresponding BFRs were documented in P-4’s medical record: On 7/21/2025, P-4’s BFR on initiation at 0611 was (200 mL/min), 0630 (325 mL/min), 0700 (300 mL/min), 0730 (315 mL/min), 0800 (315 mL/min), 0830 (315 mL/min), 0900 (315 mL/min), and at end of treatment at 0918 (00). There was no documentation for that treatment in P-4’s notes that revealed why the BFR was administered at a lower rate. On 7/23/2025, P-4’s BFR on initiation at 0622 was (350 mL/min), 0632 (300 mL/min), 0702 (285 mL/min), 0732 (285 mL/min), 0802 (250 mL/min), 0833 (300 mL/min), and at end of treatment at 0854 (00). There was no documentation for that treatment in P-4’s notes that revealed why the BFR was administered at a lower rate. On 8/2/2025, P-4’s BFR on initiation at 0817 was (200 mL/min), 0829 (400 mL/min), 0846 (400 mL/min), 0900 (300 mL/min), 0929 (300 mL/min), 0959 (300 mL/min), 1029 (300 mL/min), and 1034 end of treatment (300 mL/min). There was no documentation for that treatment in P-4’s notes that revealed why the BFR was administered at a lower rate. According to the facility’s policy “Monitoring & Documentation of Patient Care During Treatment,” dated 11/29/2022, “Information that must be entered manually includes, but is not limited to: interventions for unexpected situations, such as slowing blood flow for access problem, target weight change, decease in UFR (Ultrafiltration Rate), etc.” and “if the patient’s prescription was not met for any reason a detailed progress note must be entered explaining why the prescription was not met and actions taken to address the situation.””

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to follow national standards to ensure employee competencies were consistently performed for 5 (Staff E, N, Q, R, and S) of 15 staff reviewed resulting in increased likelihood of negative consequences for all patients. Findings include: On 8/21/2025 at 1300, a review of the facility’s personnel file grid under the column “Annual Competencies Documented Date,” revealed that the last reported competencies for 5 employees (Staff E, N, Q, R, and S) were performed in 2023, while others had competencies completed in 2024 and 2025. Interim Facility Administrator Staff A confirmed the findings at the time of discovery and revealed that was “all they could find” in the records. On 8/21/2025 at 1047, Medical Director Staff H was queried how they ensure staff were competent and Staff H revealed that “falls on administrators” and “Clinic Managers directly responsible.” According to the facility’s policy “Associates Training and In-Services,” dated 12/22/2023, “The center’s medical director is responsible for ensuring that all center associates receive the appropriate education and training to competently perform their job responsibilities. The medical director must assure that associates are competent to carry out their assigned duties and follow (Facility) policies and procedures.””

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 27408 Based on interview, and record review, the Medical Director failed to ensure that the facility staff received appropriate education and training to competently perform their job duties, resulting in an increased risk for poor patient outcomes, for the 59 patients being served by the facility. Findings include: On 08/21/25 the facility’s personnel files were reviewed with the Interim Facility Administrator, Staff A. During review the following staff files were reviewed for dialysis specific education and training. The following 3 employees did not have updated unit specific training for Emergency Procedures: CCHT, Staff N CCHT, Staff I CCHT, Staff R The following 4 employees did not have updated unit specific training for Infection Control: CCHT, Staff N CCHT, Staff L CCHT, Staff I Administrative Assistant (AA), Staff S On 08/21/25 at 0930 during review of the facility’s policy “Associates Training and In-Services,” dated 12/22/2023, “The center’s medical director is responsible for ensuring that all center associates receive the appropriate education and training to competently perform their job responsibilities. The medical director must assure that associates are competent to carry out their assigned duties and follow (Facility) policies and procedures.” On 8/21/25 at 1045, Medical Director Staff H was queried as to how staff are educated and competent, Staff H stated that “falls on administrators” and “Clinic Managers directly responsible.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 45246 Based on observation, interview, and record review, the facility failed to ensure the Medical Director oversaw the implementation of the facility’s policies and procedures, resulting in the potential for negative outcomes for all patients receiving dialysis in the facility. Findings include: During the initial tour of the facility on 8/19/25 from 1001 to 1245 the following observations were made on the treatment floor. Two syringes with medication (Heparin 1:1000 Units) were observed on the chair side table at station # 12. Syringes had patient’s name, date and medication documented on the label attached to syringes. There were no times when medication was drawn up and no initials of the staff who prepared the medication documented on the labels. There were three syringes with Heparin observed on the clean supplies cart left in the sponges’ card box. Syringes did not have time and initials marked on them. Two syringes with Heparin were observed lying on the windowsill next to the station # 7. Syringes did not have time and initials marked on them. At the medication preparation station there was an opened vial with medication (Zemplar). Vial contained medication, was previously opened/accessed and was not dated or initialed by the staff. Medication refrigerator was inspected and contained multiple boxes of vaccines stored on the bottom shelf with the nutritional supplements (Nepro) stored in the door shelves. On 8/20/25 at 0936 the medication refrigerator was inspected again. It had a vial with medication (Retacrit) opened and stored in the box. Vial was not dated or initialed by staff when opened. On 8/20/25 at 0940 the interim facility administrator, Staff A, was interviewed and stated that staff should date and itial any opened multi-dose vials. She also confirmed that Heparin syringes should be timed and initialed by staff at the time of preparation. On 8/20/25 at 0946 two syringes with Heparin were observed lying on the coounter. Syringes did not have time and initials marked on them. Facility policy “infection Control”, effective 01/2021 and revised 11/29/22, was reviewed and revealed: “18. Multi-dose medication vials will be labeled with the date they are first entered and initialed by the center associate opening the vials. 22. Medications, including normal saline flushes, should be drawn up just prior to administration. However, unless the manufacturer package insert or other manufacturer information specifies that the medication must be drawn up immediately prior to administration, medications may be drawn up no more than 4 hours before the anticipated time of administration. 23. Medications, including normal saline flushes, drawn up and stored prior to administration must have the needle covered with a sterile cap, or the luer connection covered with a sterile end cap. They must always be clearly labeled with the following information: -Patient’s name -Medication name and dose -Date and time medication was drawn up -Initials of the nurse who drew up the medication 25. No dialysis supplies or medications may be used after the manufacturer expiration date printed on the package, label, or carton. 26. Each center will have separate refrigerators for labs, medications and food. Each refrigerator will be labeled for its specific use”. 50223 On 8/20/25 at 1030 P-14 was observed receiving dialysis with approximately 15 minutes left of a 3 hour and 45 minute treatment time. Patient Care Technician, Staff R, was asked to demonstrate the verification and review of P-14’s dialysis treatment orders. Staff R compared a printed paper order to the settings on the dialysis machine which indicated an order for dialysate containing K 2.0 (potassium) Ca 2.5 (calcium). When the connection to the dialysate at the wall connection was observed the patient was found to be receiving K:3.0 dialyzer. Staff R removed the tubing from the K:3.0 connection and connected the tubing to the K:2.0 connection. When asked what the complications of receiving the wrong dialyzer could be, Staff R explained that the patient could experience a headache or nausea or various symptoms. On 8/20/25 at 1040 Staff R was observed talking to Registered Nurse Staff G. On 8/20/25 at 1042 Staff R was asked if they notified the nurse that P-14 was receiving the wrong dialyzer and Staff R responded “no”. On 8/20/25 at 1330 P-14’s treatment flowsheet was reviewed and revealed that the order verification/safety check was marked as completed by patient care technicians, Staff R and by Staff I. Further chart review revealed a pre-dialysis nursing assessment documented at 0615 by Staff G. On 8/20/25 at 1400, during an interview, the facility administrator Staff A explained that treatment orders are printed the day before and that the patient care techs refer to the printed order when setting up the machines. Staff A explained that the set up must be checked by a second staff member and that the Registered Nurse ensures that it is correct during their pre-dialysis assessment which takes place within one hour of the start of treatment. Staff A explained that an incident report should have been completed for P-14 receiving the wrong dialyzer, the nurse should have been notified, and the doctor should have been called. A review of the facilities policy titled “Monitoring & Documentation of Patient Care During Treatment”, dated 01/21 and revised 11/22, revealed the following: “The following must be documented before starting the patients treatment in the electronic documentation system ...treatment RX (prescription)-indicating caregiver review and verification of all patient treatment data and machine set-up information ...Two signatures are required before starting the patients treatment in the electronic documentation system: First signature-person actually initiating the treatment. Second signature-nurse who verifies the patients set up matches the order, or a non-nurse can verify that the patients set up matches the order if a nurse rounding note is documented within 1 hour of treatment initiation ...””

“GOV-GB INFORMS MED STAFF OF P&P/QAPI PROG CFR(s): 494.180(c)(2),(3) The governing body- (2) Ensures that all medical staff who provide care in the facility are informed of all facility policies and procedures, including the facility’s quality assessment and performance improvement program specified in §494.110. (3) Communicates expectations to the medical staff regarding staff participation in improving the quality of medical care provided to facility patients. This Standard is not met as evidenced by: 27408 Based on record review, and interview, the governing body failed to inform the members of the medical staff of any information accumulated from the Quality Assessment Performance Improvement (QAPI) program resulting in the potential for less-than-optimal outcomes for the 59 patients. Findings include: On 08/21/25 at 1130, during review of the Quality Program from January 2025 through July 2025, it was revealed the Governing Body failed to discuss any information accumulated by the QAPI program. Staff A stated that this “did not happen, there are no emails or notes sent out to the medical staff.” On 8/21/2025 at 1047, Medical Director, Staff H, was queried in regard to communication with other medical staff of the accumulated information from the QAPI program, and Staff H stated that he does “Not share the information.””

“CFC-PATIENTS- RIGHTS CFR(s): 494.70 This Condition is not met as evidenced by: 38304 Based on record review and interview, the Facility failed to have Against Medical Advice (AMA) documentation per their policy concerning early termination of dialysis treatments in 3 (P-1, 4, 5) of 7 records reviewed for shortened treatments, out of a total of 8 sampled records (See V 456); failed to ensure patients received treatments and services as outlined in the plan of care (POC) in 4 (P-1, 3, 4, 5) of 5 records reviewed with Heparin administered during dialysis treatments, out of a total of 8 records reviewed (See V 463). The cumulative effect of these systemic problems resulted in a high potential for poor clinical outcomes for the condition of coverage CFR 494.70 Patients’ Rights.”

“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: 47976 Based on observation and record review, the agency failed to provide and monitor a sanitary environment to minimize the transmission of infectious agents within the facility, resulting in less than effective means for infection control and an increased risk for infection for the 20 patients receiving dialysis services at the time of observation. Findings include: **Policy titled “A515 Hand Hygiene” (dated 10/28/22) stated on page 6, “Fingernails should be natural and no longer than ¼ inch in length from the tip of the finger.” During dialysis floor observation of patient care on 6/10/24 at 1145, it was observed a Certified Clinical Hemodialysis Technician (Staff J) had painted fingernails greater than ¼ inch from the tip of the finger. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 6/12/24 at 1100.”

“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: 46476 Based on observation, record review, and interview, the facility failed to ensure staff remove soiled gloves and perform hand hygiene when moving from a dirty task to a clean task in 1 (Station #19) of 2 observations where disinfection of a dialysis station was observed. This practice could potentially result in the transmission of infectious agents to the 14 patients being served by the facility at the time of the observation. Findings include: Facility policy titled “A515 Hand Hygiene”, Effective Date: 10/28/2022, was reviewed on 6/12/24. On page 3-4., it stated “3. Gloves should be removed ... A. When leaving the patient care area (bedside) to: i. Obtain clean supplies from cupboards or storage spaces. C. Change gloves ... iii. When going from a “dirty” area or task to a “clean” area or task. On 6/11/24 at 0955 during hemodialysis floor observations, a patient care technician (PCT), Staff O, was observed while preparing to disinfect Station #19. It was observed that Staff O removed a used (bloody) dialyzer and blood lines from the dialysis machine and disposed of them in the biohazard container nearby. Staff O then went straight to another area of the treatment floor without first removing the used gloves or performing hand hygiene. With the soiled gloves, Staff O retrieved wipes from a full package of clean dry wipes, opened a bleach container, immersed the wipes into the bleach container, pulled them back out, and went back to Station #19 to begin the disinfection of the station. Staff O continued with the same gloves during the entire disinfection process. On 6/12/24, these findings were reviewed and acknowledged with the Medical Director (Staff B) during interview at 0920 and with the Facility Administrator (Staff A) during interview at 1300. Staff B stated that it is expected that all staff follow the policies and procedures of the facility. Staff A stated that the gloves should have been removed and hand hygiene performed after disposing of the used dialysis equipment.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 46476 Based on observation, record review, and interview, the facility failed to ensure disinfection of the Central Venous Catheter (CVC) hub ends were performed according to the antiseptic manufacturer’s instructions, per facility policy, during 4 (Station #’s 14, 17, 19, and 22) of 6 observations of CVC hub end disinfection resulting in an increased risk of bloodstream infections for all patients with a CVC receiving care at this facility. Findings include: Facility procedure titled “IC05A CVC: Initiation & Discontinuation of Treatment”, Effective Date: 01/2021, was reviewed on 6/11/24. On page 1., it stated “2. Disinfect according to manufacturer’s instructions with one of the following products: ... 70% Alcohol (sterile pad) ... Allow disinfection to air dry ... 5 ... remove the arterial cap, and disinfect the hub with a new antiseptic pad. Scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue ...”. On page 5., it stated “25. Disinfect the venous hub with a new antiseptic pad. Scrub the sides (threads) and end of the hub thoroughly with friction, making sure to remove any residue ...”. On 6/10/24 at 1115 during hemodialysis treatment floor observations, a patient care technician (PCT), Staff N, was observed while preparing to discontinue dialysis for the patient at Station #17. The patient had a CVC. It was observed that after removing the dialysis blood lines, Staff N scrubbed the two hubs (open end of the catheter) separately with an alcohol prep pad for 2 seconds each prior to placing an end cap on the hub. After the procedure, Staff N was asked what the policy was for how long to scrub the hub. Staff N stated that she was unaware of how long to scrub the hub for and that she was never told. On 6/11/24 at 0920 during hemodialysis treatment floor observations, a Certified Clinical Hemodialysis Technician (CCHT), Staff L, was observed while preparing to discontinue dialysis for the patient at Station #14. The patient had a CVC. It was observed that after removing the dialysis blood lines, Staff L scrubbed one of the two hubs with an alcohol prep pad for 5 seconds and the other hub for 7 seconds prior to placing an end cap on the hub. After the procedure, Staff L was asked what the policy was for how long to scrub the hub end. Staff L stated 30 seconds. Staff L was asked how long he scrubbed the hubs for, and he stated, “probably 10 seconds”. On 6/11/24 at 0945 during hemodialysis treatment floor observations, a PCT, Staff O, was observed while preparing to discontinue dialysis for the patient at Station #19. The patient had a CVC. It was observed that after removing the dialysis blood lines, Staff O scrubbed the two hub ends separately with an alcohol prep pad for 10 seconds each. On 6/11/24 at 1130 during hemodialysis treatment floor observations, Staff O was observed while preparing to initiate dialysis for the patient at Station #22. The patient had a CVC. It was observed that after removing the hub end caps, Staff O scrubbed one of the two hub ends with an alcohol prep pad for 6 seconds, and the other hub end was scrubbed for 8 seconds prior to each being connected to a sterile syringe and then dialysis blood lines. On 6/11/24 at 1400, the Facility Administrator (Staff A) was queried to the policy for how long to scrub the hub ends of CVC’s. Staff A stated that she believed it was 30 seconds and then reviewed the policy which stated that the scrub time should be as directed by the antiseptic manufacturer’s instructions. Staff A was not able to provide the guideline from the antiseptic manufacturer and it was unclear what the manufacturer’s guideline were. On 6/12/24 at 1045, Staff A provided an “updated” copy of the procedure for “Initiation of Treatment”, which included that the hub ends of a CVC should be scrubbed for 15 seconds each. Staff A stated that the 15 second scrub time for CVC hub ends would be the policy moving forward. On 6/12/24, these findings were reviewed and acknowledged with the Medical Director (Staff B) during interview at 0920.”

“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: 39083 Based on observation and interview, the facility failed to maintain a sanitary water room and equipment, resulting in the potential for increased risk of infections, affecting all patients receiving treatment at the facility. Findings include: On 6/10/24 at 12:30 PM, three floor drains, located in the water room, were observed to have black biofilm accumulation on the floor drain grates. At this time, Biomed “P” stated that the floor and drains of the water room are cleaned as needed. Additionally, stagnant water and floating mold-like growths were observed accumulating in the interior bottom surface of the reverse osmosis (RO) unit, where the reverse osmosis membranes reside. During an interview on 6/10/24 at 1:41 PM, Biomed “P” stated that the RO unit had leaks repaired on 4/25/24 and the interior of the RO hasn’t been inspected since the repairs were confirmed to be successful. Biomed “P” continued to say that the water accumulation, “was a complete surprise to me.” During an interview 6/10/24 at 2:10 PM, Biomed “P” stated that they don’t have a policy for cleaning the water room.”

“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: 47976 Based on observation, record review and interview, the facility failed to ensure patient access sites were in view of staff during dialysis treatment at 4 of 20 stations (Station # 7 twice, 11, 23), resulting in the potential for needle dislodgement or line disconnection to go undetected and for significant bleeding to occur. Findings include: **Policy titled “IC08 Monitoring & Documentation of Patient Care During Treatment” (last revised 11/29/22) stated on page 3, “The patient’s vascular access should remain uncovered and readily visible throughout the course of the patient’s treatment.” During dialysis floor observation of patient care, the following observations were noted on 6/10/24: At 1055, it was noted the access site for the patient at station #23 was completely covered with a blanket. Several staff members were observed in and around this station at the time. At 1118, the patient’s access site was still covered. The licensed practical nurse (Staff E) was asked if he was able to see the access site. Staff E reported he was not able to and went to the station to have it uncovered. At 1153, it was noted the patient at station #7 was laying on his side under a blanket and his access site was not visible. At 1201, Staff G (Certified Clinical Hemodialysis Technician - CCHT) was observed at station #7 with the patient, however, she did not ensure the site was visible. At 1210, Staff F (CCHT) was observed at station #7. She also did not ensure the site was visible as the patient remained on his side under a blanket. At 1216, Staff F was asked if she was able to see the access site on the patient at station #7. Staff F admitted she could not and returned to station #7 to uncover the site. At 1408, it was noted the access site for the patient at #7 was completely covered again by a blanket. At 1415, Staff F was observed at station #7 with the patient. She did not ask him to uncover his access site. Staff F was asked at that time if she was able to see his access site. She reported that she could not and stated, “he always does that.” On 6/11/24: At 0905, it was observed the access site for the patient at station #11 was completely covered with a blanket. At 0913, Patient Care Technician (Staff N) was observed talking with the patient at station #11. She did not ask the patient to uncover his access site. At 0915, Staff N was asked if she was able to see the patient’s access site. She admitted she could not and returned to station #11 to uncover the site. Findings were reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 6/12/24 at 1230.”

“PR-PARTICIPATE IN CARE;DISC/REFUSE TX CFR(s): 494.70(a)(5) The patient has the right to- (5) Be informed about and participate, if desired, in all aspects of his or her care, and be informed of the right to refuse treatment, to discontinue treatment, and to refuse to participate in experimental research; This Standard is not met as evidenced by: 47976 Based on record review and interview, the agency failed to ensure proper documentation regarding early termination of dialysis treatment by the patient for 4 (P-1, 4, 5 and 7) of 7 records reviewed, resulting in the potential for the patient to not understand their right to refuse or the possible consequences of early termination. Findings include: **Policy titled “G26 Against Medical Advice” (last revised 12/22/2023) stated, “The AMA (against medical advice) process should NOT be used to document patient non-adherence for matters that are not likely to cause serious or immediate harm to the patient or others such as the patient insisting on regularly signing off treatment early. In these cases, there must be a detailed progress note entered in the patient’s medical record that explains the situation each time it occurs. Each note must provide details of patient counseling of the potential risks to the patient of not following medial orders/advice and the patient’s response, and notification of the patient’s physician as applicable.” P-4: This 33-year-old patient started dialysis treatment at this facility on 8/26/22 with the diagnosis of end stage renal disease (ESRD) and was ordered to receive dialysis treatments 3 times per week. During record review on 6/11/24, it was determined the patient’s visit on 5/29/24 was shortened by 36 minutes. Upon further review of the treatment sheet for that day, it was noted the section under “Teaching” stated, “Disposition: Taken off early due to .....Reason: Pt Arrived Late” On 5/31/24, it was determined the patient’s visit was shortened by 27 minutes. Upon further review of the treatment sheet for that day, it was noted under “Notes” in the “Dialysis Treatment” log that, “pt had 36 mins left wanted to come off the machine LPN Robinson gave the ok.” [sic] There was no detailed progress note on either day with information regarding patient counseling of the potential risks of not following medical orders/advice per policy. P-5: This 43-year-old patient started dialysis treatment at this facility on 10/1/21 with the diagnosis of ESRD and was ordered to receive 3 dialysis treatments per week. During record review on 6/11/24, it was determined the patient’s visit on 4/26/24 was shortened by 144 minutes. Upon further review of the treatment sheet for that day, it was noted the section under “Teaching” stated, “Disposition: Signed off early, Reason: Other, Notes: Patient requested to come off treatment early.” On 4/29/24, it was determined the patient’s visit was shortened by 86 minutes. Upon further review of the treatment sheet for that day, it was noted under “Notes” in the “Dialysis Treatment” log that “pt had 1:26 mins left always wants to come off the machine at 1:30 RN Maricris gave the ok” [sic] Under “Teaching,” it stated, “Disposition: Signed off early, Reason: Other.” On 5/1/24, it was determined the patient’s visit was shortened by 69 minutes. Upon further review of the treatment sheet for that day, it was noted under “Notes” in the “Dialysis Treatment” log that treatment was “terminated early at patient request.” Under “Teaching” it stated, “Disposition: Taken off early due to .....Reason: Pt refused.” On 5/8/24, it was determined the patient’s visit was shortened by 103 minutes. Upon further review of the treatment sheet for that day, it was noted under “Notes” in the “Dialysis Treatment” log that “treatment terminated, all blood returned pt wanted to come off the machine pt had 1:43 mins left RN Mracris gave the ok.” [sic] Under “Teaching” it stated, “Disposition: Signed off early, “Reason: Other.” On 5/15/24, it was determined the patient’s treatment was shortened by 99 minutes. Upon further review of the treatment sheet for that day, it was noted under “Notes” in the “Dialysis Treatment” log that “pt had 1:42 mins left to go wanted to come off the machine early RN Terry gave the ok.” [sic] Under “Teaching” it stated, “Disposition: Signed off early, “Reason” Pt Arrived Late.” On 5/22/24, it was determined the patient’s treatment was shortened by 106 minutes. Upon further review of the treatment sheet for that day, it was noted under “Notes” in the “Dialysis Treatment” log that “tx. Dc’d 1 hour 55 min early pt. request.” [sic] Under “Teaching” it stated, “Disposition: Signed off early, Reason: Other.” There was no detailed progress note on either day with information regarding patient counseling of the potential risks of not following medical orders/advice per policy. The Administrator (Staff A) was asked during an interview on 6/12/24 at 1140 if there is another place in the record to find the detailed progress note with information regarding patient counseling of the potential risks of not following medical orders/advice if it was not on a daily treatment sheet. Staff A reported the daily treatment sheet would be the only place it would be and acknowledged the findings that the facility is not following their policy regarding leaving AMA. 38304 P-1: This 51-year-old patient was admitted to the dialysis facility on 8/10/2023, with diagnosis which included end stage renal disease, hypertension, and diabetes-type 2. P-1 was receiving treatments 3 times per week (Tues-Thur-Sat) for an ordered duration of 4 hours each treatment. On 6/11/24, record review of P-1’s six most recent dialysis treatment sheets found 2 of 6 treatments were terminated early according to the following documentation: 6/6/24: 215 minutes of dialysis (shortened by 25 minutes). Documentation of educating the patient of the dangers of shortening treatment times or AMA (against medical advice) documentation was not found the medical record. Documentation of a detailed progress note which explained why the treatment was cut short and physician notification was not evidenced in the medical record. 5/28/24: 187 minutes of dialysis (shortened by 53 minutes). Documentation of educating the patient of the dangers of shortening treatment times or AMA (against medical advice) documentation was not found the medical record. Documentation of a detailed progress note which explained why the treatment was cut short and physician notification was not evidenced in the medical record. The Facility Administrator (Staff A) reviewed and acknowledged the above findings during an interview on 6/12/24 at 1210. The Facility failed to ensure staff adhered to its policy “G26 Against Medical Advice” concerning P-1’s shortened treatments noted above. 46476 P-7: This 24-year-old patient was admitted to the facility on 10/4/22 with diagnoses which included end stage kidney disease and high blood pressure. The medical record was reviewed on 6/12/24 and included 6 hemodialysis treatment flowsheets dated between 5/29/24 through 6/10/24. During review it the following were noted: On the treatment flowsheet dated 6/3/24, the patient’s treatment was shortened by 19 minutes. There was a note that stated that the needles clotted, and the patient refused to continue the treatment. There were no detailed progress notes entered by the registered nurse (RN) indicating that the patient had been counseled on risks of not following medical orders. On the treatment flowsheet dated 6/7/24, the patient’s treatment was shorted by 42 minutes. There were no detailed progress notes entered by the RN indicating the reason the treatment was shortened or that the patient had been counseled on the risks of not following medical orders. On 6/12/24 during interview at 1300, these findings were reviewed and acknowledged by the Facility Administrator, Staff A.”

“PR-RECEIVE SERVICES OUTLINED IN POC CFR(s): 494.70(a)(12) The patient has the right to- (12) Receive the necessary services outlined in the patient plan of care described in §494.90; This Standard is not met as evidenced by: 46476 Based on observation, record review and interview, the facility failed to ensure patients received treatments and services as outlined in the plan of care (POC) in 5 (P-1, P-3, P-4, P-5, and P-6) of 7 sample records reviewed concerning medication administration, and failed to ensure the correct dialysate concentration as prescribed during 1 (Station #10) of 4 dialysis floor observations resulting in patients receiving either the wrong dose, or the wrong reason for dialysis medications and the potential for adverse patient outcomes. Findings include: P-6: This 67-year-old patient was admitted to the facility on 11/9/2018 with diagnoses which included end stage kidney disease; chronic obstructive pulmonary disease; and type 2 Diabetes. The medical record was reviewed on 6/11/24 and included 6 hemodialysis treatment flowsheets dated between 5/29/24 and 6/10/24. During review, it was noted on the treatment flowsheet dated 6/5/24 that P-6 had a pre-dialysis sitting blood pressure (BP) of 129/86 millimeters of mercury (mm/Hg). At 0958 dialysis was initiated and the BP was recorded as 127/74. At 1001, the BP was recorded as 135/71. At 1004, the Registered Nurse (RN) gave a standing order medication, Clonidine HCL 0.1 mg, by mouth for hypertension. There was no documentation by the RN regarding the reason for this medication to be given. The following BP’s were taken after the administration of the Clonidine: At 1201 the BP was recorded as 114/64 At 1231 the BP was recorded as 106/20 At 1232 the BP was recorded as 97/51 At 1301 the BP was recorded as 105/57 At 1318 the BP was recorded as 78/26 and the treatment was terminated At 1319 the BP was recorded as 103/52 Post dialysis sitting BP was recorded as 110/58 at 1328. It was unclear why Clonidine was given. On 6/12/24 during interview at 1300, the Facility Administrator (Staff A) was queried to why this patient received Clonidine during the above treatment. Staff A stated that it was unclear why the Clonidine was given since the patient was not having hypertension at the time of the dosing. Staff A was queried to the standing order indication and stated that the indication was written “for hypertension”. Staff A was queried to what was meant by “hypertension” and Staff A stated that hypertension was a Systolic BP of 200 or greater and/or a Diastolic BP of 100 or greater and that the nurses are aware that those numbers. There was no evidence to support the need for this medication at the time that it was given. This finding was also reviewed and acknowledged by the Medical Director on 6/12/24 during interview at 0920. On 6/10/24 during hemodialysis treatment floor observations at 1420, a Certified Clinical Hemodialysis Technician, Staff F, was asked to verify the prescription for a patient actively receiving hemodialysis treatment at Station #10. It was noted that the dialysate fluid lines were connected to the wall box behind the station with the dialysate fluid which contained a potassium concentration at 3.0 milliequivalent per Liter (mEq/L) and calcium concentration of 2.5 mEq/L. During the verification, it was observed that Staff F quickly paused the hemodialysis treatment and switched the dialysate fluid lines to the dialysate fluid which contained a potassium concentration of 2.0 and calcium concentration of 2.5, and then quickly resumed the treatment. Staff F was queried as to why the dialysate fluid lines were changed. Staff F stated that the patient’s prescription was for the dialysate to have a potassium concentration of 2.0 and that the dialysate fluid had not been connected to the correct dialysate fluid concentration from the wall box. It was noted that the patient’s hemodialysis treatment had been initiated at 1139 and only had 15 minutes left of a 3-hour treatment. On 6/12/24 during interview at 1300, this finding was reviewed with Staff A. Staff A was queried to whether the RN verifies hemodialysis prescriptions during treatment. Staff A stated that the RN is supposed to verify the details of the prescription within 1 hour of the hemodialysis treatment initiation and acknowledged that this must not have been done. 38304 P-1: This 51-year-old patient was admitted to the dialysis facility on 8/10/2023, with diagnosis which included end stage renal disease, hypertension, and diabetes-type 2. P-1 was receiving treatments 3 times per week (Tues-Thur-Sat) for an ordered duration of 4 hours each treatment. On 6/11/24, record review of P-1’s 6 most recent treatment sheets (5/28/24 through 6/8/24) revealed Heparin (a medication used for blood thinning) was ordered (effective 12/6/2023) and to be administered at 500 Units/Hour times 4 hours for a total dose of 2,000 units. Additional record review noted the treatment sheet dated 6/4/24, had documented no Heparin was administered throughout the treatment. This finding was reviewed and acknowledged by the Facility Administrator (Staff A) during an interview on 6/12/24 at 1220. Staff A explained the certified clinical healthcare technician (CCHT/Staff L) likely failed to hit the button to start the running dose of Heparin and that the RN (Staff C) failed to recognize the medication error as documentation pertaining to the above finding was not evidenced in the medical record. P-3: The admission date to this dialysis facility was on 2/14/2023, with diagnosis of end stage renal disease, anemia, and hypertension. P-3 received dialysis treatments 3 times per week (Mon-Wed-Fri) for an ordered duration of 3 hours and 45 minutes each treatment. On 6/11/24, record review of P-3’s 6 most recent treatment sheets (5/15/24 through 5/27/24) revealed Heparin was ordered (effective 2/14/2023) and to be administered a one-time bolus of 1,000 units just prior to initiating dialysis treatment. In addition, Heparin was ordered (effective 2/14/2023) and to be administered throughout every treatment at 500 Units/Hour times 3 hours and 45 minutes, for a total dose of 1,875 units. Additional record review noted Heparin administration errors in 5 of 6 treatment sheets which are detailed as follow: 5/27/24: Heparin dose of 1,000 units given at 0555 as ordered (correct). Dialysis treatment initiated at 0600, and another 1,000 units of Heparin administered at 0600 (medication error) by patient care technician (PCT) Staff N. Additional review noted no running dose of Heparin was administered throughout the treatment. Subsequently, the ordered running dose of 1,875 units was never administered, resulting in another medication error. This finding was reviewed and acknowledged by the Facility Administrator (Staff A) during an interview on 6/12/24 at 1236. Staff A again explained (PCT/Staff N) likely failed to hit the button to start the running dose of Heparin and that the RN (Staff C) failed to recognize the medication error as documentation pertaining to the above finding was not evidenced in the medical record. 5/24/24: Treatment started at 0547 with no bolus of 1,000 units Heparin given prior to treatment as ordered. Heparin (1,000 units) was administered at 0621 (medication error due to delay of 34 minutes) by CCHT/Staff L. Treatment ended at 0934 with RN/Staff D approving the treatment at 0938 with no issues noted. 5/22/24: Treatment started at 0633 with a bolus of 1,000 units Heparin given at 0628 (correct). Treatment ended at 1029, with a running Heparin dose total of 3,700 units, or double the ordered rate of 500 units per hour. This medication error was administered by CCHT/Staff F and approved by RN/Staff P at 1131 with no issues noted. 5/20/24: Treatment started at 0624 with a bolus of 1,000 units Heparin given at 0618 (correct). Treatment ended at 0954 (3.5 hours), with a running Heparin dose total of 3,500 units, or double the ordered rate of 500 units per hour. This medication error was administered by CCHT/Staff Q and approved by RN/Staff C at 1010 with no issues noted. 5/17/24: Heparin administered as ordered. No issues found. 5/15/24: Treatment started at 0700 with a bolus of 1,000 units Heparin given at 0649 (correct). Treatment ended at 1045, with a running dose total of 1,300 units (medication error) of Heparin administered by PCT/Staff K. This failed to calculate out to the ordered 1,875 Heparin units as ordered for a treatment time of 3 hours and 45 minutes. The above findings were reviewed and acknowledged by the Facility Administrator (Staff A) during an interview on 6/12/24 at 1242. An additional request was made to review the Facility’s policy concerning medication administration by non-RN staff (PCT, CCHT) and the oversight/supervision provided by the RN. Staff A submitted “G48 Medications: Handling, Administration, Storage & Disposal” (revised 06/2023) section 19 stated, “IV heparin, saline and/or intradermal lidocaine may be drawn up and administered by patient care technicians (PCTs) as allowed by State regulations.” No further language was found which pertained to safety measures/supervision implemented to prevent medication errors by non-RN staff. The facility failed to ensure high risk medications (Heparin) was administered to patients as ordered, resulting in the potential for poor clinical outcomes. 47976 P-4: This 33-year-old patient started dialysis treatment at this facility on 8/26/22 with the diagnosis of end stage renal disease (ESRD) and was ordered to receive dialysis treatments 3 times per week for 3 hours and 45 minutes. During record review on 6/11/24, it was determined the patient had orders for Heparin (a medication used for blood thinning) to be administered at 500 units/hour for 2 hours and 45 minutes and an additional bolus of 1000 units at each treatment. During further record review, it was noted the column on the “Dialysis Treatment” log under “Heparin” (which measures the amount of Heparin infused during treatment) was recorded as “0” for the entire treatment (0749 to 1139). There was no evidence the Heparin was administered as ordered. P-5: This 43-year-old patient started dialysis treatment at this facility on 10/1/21 with the diagnosis of ESRD and was ordered to receive dialysis treatments 3 times per week for 3 hours and 45 minutes. During record review on 6/11/24, it was determined the patient had orders for Heparin (a medication used for blood thinning) to be administered at 1500 units/hour for 4 hours and an additional bolus of 4000 Units every treatment. During further record review, it was noted the column on the “Dialysis Treatment” log under “Heparin” (which measures the amount of Heparin infused during treatment) was recorded as “0” for the entire treatment (1111 to 1335). There was no evidence the Heparin was administered as ordered. The Facility Administrator (Staff A) was interviewed on 6/12/24 at 1140 AM regarding this finding. Staff A reported the staff “forgot to push a button” to start the recording of heparin infusion. She acknowledged the findings at that time.”

“PA-FREQUENCY REASSESSMENT-STABLE 1X/YR CFR(s): 494.80(d)(1) 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- (1) At least annually for stable patients; This Standard is not met as evidenced by: 47976 Based on record review and interview, the agency failed to ensure a complete comprehensive assessment was completed annually in 1 (P-4) of 7 records reviewed, resulting in the potential for unidentified and unmet care needs. Findings include: P-4: This 33-year-old patient started dialysis treatment at this facility on 8/26/22 with the diagnosis of end stage renal disease (ESRD) and was ordered to receive dialysis treatments 3 times per week for 3 hours and 45 minutes. During record review on 6/11/24, it was noted the comprehensive assessment by the physician dated 4/30/24 reported “HTn (high blood pressure) uncontrolled non compliant with meds” [sic] and “Increase Procardia (a medicine used to treat high blood pressure) to 60 mg bid (2 times per day)”. This indicates that the patient was experiencing issues with high blood pressure during this treatment period. Upon further review of the comprehensive assessment, it was noted the following goal was written under blood pressure: “Goal - Maintenance of adequate blood pressure during dialysis. Goal met: Yes” Under this goal, the record reported “recurrent intradialytic hypertension (high blood pressure)” and “Three or more episodes in current month requiring intervention with medication: Yes.” As a result, the assessment of the blood pressure goal being met is an inaccurate assessment of the patient’s current blood pressure status. The Facility Administrator (Staff A) was interviewed regarding the above findings on 6/12/24 at 1140. Staff A agreed the assessment on the patient’s goal status should have been marked as “No.” She acknowledged the findings.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 38304 Based on record review and interview, the Facility failed to ensure staff notified the registered nurse (RN) of elevated blood pressure (BP) readings, and failed to ensure the RN provided medication to treat sustained elevated BP readings per facility policy in 3 (Patient #2, 4, 5) of 7 records reviewed for BP, out of sample of 8 records reviewed, and failed to report a change in target weight per facility policy in 3 (Patients #2, #6, and #8) of 8 records reviewed for TW, resulting in the potential for the continuance of uncontrolled BP readings, unrecognized changes in volume status, and poor patient outcomes for all 76 in-center hemodialysis patients currently receiving treatment. Findings include: P-2: This patient was admitted to the Facility on 12/19/2023 with diagnoses which included end-stage renal disease with AKI (acute kidney injury), diabetes-type 2, and hypertension. P-2 was receiving treatments 3 times per week (Tues-Thur-Sat) for an ordered duration of 3 hours and 45 minutes each treatment. On 6/11/24, record review of P-2’s six most recent dialysis treatment sheets found that on 5/28/24, 9 of 13 diastolic BP readings exceeded the documented Facility limit of 100 mm/Hg. and failed to meet Facility expectations to medicate the patient with sustained uncontrolled BP readings. The BP recordings on 5/28/24 were documented by PCT (patient care technician/Staff N) and are as follow: Pre-treatment BP of 149/102 (no documented time noted)-no RN notification was documented. 0646, B/P was 154/97-N/A. 0700: B/P was 162/104-no documentation that the nurse was notified. 0730: B/P was 158/109-no documentation that the nurse was notified. 0759: B/P was 171/117-no documentation that the nurse was notified. 0802: B/P was 166/117-no documentation that the nurse was notified. 0830: B/P was 161/106-no documentation that the nurse was notified. 0900: B/P was 145/97-N/A. 0930: B/P was 140/90-N/A. 1000: B/P was 132/92-N/A. 1030: B/P was 152/103-no documentation that the nurse was notified. 1034: B/P was 146/103-no documentation that the nurse was notified. 1038: Post-treatment-sitting B/P was 145/101-no documentation that the nurse or physician was ever notified of any of the above readings with no documented medication administered on 5/28/24 by the RN (Staff D). No patient refusal of BP medication was evidenced. On 6/6/24, P-2 had again unreported, untreated elevated sustained diastolic BP readings in 15 of 18 recordings which are as follow: Pre-treatment BP of 164/101 (no documented time noted)-no RN notification was documented. 0643, B/P was 157/98-N/A. 0700: B/P was 156/103-no documentation that the nurse was notified. 0730: B/P was 162/112-no documentation that the nurse was notified. 0736: B/P was 158/108-no documentation that the nurse was notified. 0800: B/P was 157/99-no documentation that the nurse was notified. 0830: B/P was 168/105-no documentation that the nurse was notified. 0900: B/P was 169/113-no documentation that the nurse was notified. 0902: B/P was 168/116-“bp elevated RN (Staff D) aware” with no medication administered. 0904: B/P was 166/108-no documentation that the nurse was notified. 0917: B/P was 166/106-no documentation that the nurse was notified. 0918: B/P was 157/101-no documentation that the nurse was notified. 0930: B/P was 170/115-no documentation that the nurse was notified. 0934: B/P was 162/102-no documentation that the nurse was notified. 1000: B/P was 176/122-no documentation that the nurse was notified. 1002: B/P was 167/108-no documentation that the nurse was notified. 1030: B/P was 153/96-N/A. 1036: Post-treatment-sitting B/P was 156/100-no documentation that the nurse or physician was notified other than the 0902 reading. No documented medication administration by Staff D was noted on 5/28/24. No patient refusal of BP medication was evidenced. An interview was conducted on 6/12/24 at 1216 with the Facility Administrator (Staff A) who reviewed and acknowledged the above findings. Staff A was queried at what point should the RN (Staff D) have medicated P-2 on 5/28/24. Staff A responded, “Between the 3rd and 4th reading (0700-0730) she should have given Clonidine (BP medication).” Staff A noted Clonidine 0.1 mg. dose is administered as a standing order when BP readings warrant its use. Staff A was again queried at what point should the RN (Staff D) have medicated P-2 on 6/6/24. Staff A responded, “Between the 4th and 5th reading (0730-0736) Clonidine should have been given.” The RN (Staff D) failed to meet Facility expectations in medicating P-2 for BP readings which exceeded acceptable levels and the PCT (Staff N) failed to adhere to Facility policy referenced below. Facility Policy: “IC07A Charge Nurse Notification Protocol” (revised 10/20/23) pg. 1 stated, “Events reportable to the nurse by direct patient care staff... B/P Diastolic > (greater) than 100 (mmHg/millimeters of mercury).” Additional record review of P-2’s post-treatment target weights (TW) had exceeded the Facility’s safety parameters established in the above policy (IC07A) which stated “1.0 kg. < (less) or > EDW (estimated dry weight) post-treatment” would warrant acknowledgement in the treatment sheet documentation for potential RN/physician interventions for TW adjustments. The dates and amount of Kg above TW post-treatment are as follow: 5/4/24: 3.0 Kg above TW. 5/7/24: 2.7 Kg above TW. 5/9/24: 1.4 Kg above TW. The three dialysis treatments above were reviewed and acknowledged by Staff A on 6/12/24 at 1258. Staff A also acknowledged there was no documentation in any of the three treatment sheets which acknowledged the elevated weights for potential safety adjustments. P-8: This patient was admitted to the Facility on 12/19/2023 with diagnoses which included end-stage renal disease, anemia, and hypertension. P-8 was receiving treatments 3 times per week (Tues-Thur-Sat) for an ordered duration of 3 hours and 45 minutes each treatment. On 6/12/24 at 0935, record review revealed 9 consecutive elevated post-treatment target weights which are as follow: 5/2/24: 3.6 Kg above TW. 5/4/24: 2.0 Kg above TW. 5/7/24: 2.7 Kg above TW. 5/9/24: 1.7 Kg above TW. 5/11/24: 1.1 Kg above TW. 5/14/24: 2.3 Kg above TW. 5/16/24: 1.9 Kg above TW. 5/21/24: 2.6 Kg above TW. 5/23/24: 2.2 Kg above TW. The nine dialysis treatments above were reviewed and acknowledged by Staff A on 6/12/24 at 1304. Staff A also acknowledged there was no documentation in any of the nine treatment sheets which acknowledged the elevated weights for potential safety adjustments. 46476 Facility Procedure Number: “IC07A Charge Nurse Notification Protocol”; Revised 10/20/23, was reviewed on 6/12/24. On page 1., it stated “Events reportable to the nurse by direct patient care staff... Weight 1.0 kg < or > EDW post treatment”. P-6: This 67-year-old patient was admitted to the facility on 11/9/2018 with diagnoses which included end stage kidney disease; chronic obstructive pulmonary disease; and type 2 Diabetes. The medical record was reviewed on 6/11/24 and included 6 hemodialysis treatment flowsheets dated between 5/29/24 and 6/10/24. The patient’s target weight (or Estimated Dry Weight- EDW) was 78.5 kilograms (kg). During review, it was noted that 5 of the 6 hemodialysis treatment flowsheets included documentation of a post dialysis weight which was greater than 1.0 kg of the EDW as follows: On 5/29/24, the post dialysis weight was recorded as 81.4 kg (2.9 kg above EDW). On 5/31/24, the post dialysis weight was recorded as 80.9 kg (2.4 kg above EDW). On 6/3/24, the post dialysis weight was recorded as 80.5 kg (2 kg above EDW). On 6/7/24, the post dialysis weight was recorded as 79.8 kg (1.3 kg above EDW). On 6/10/24, the post dialysis weight was recorded as 81.1 kg (2.6 kg above EDW). There was no documentation on any of the above hemodialysis treatment flowsheets that the Registered Nurse was notified of the post dialysis treatment weights which were greater than 1.0 kg above this patient’s EDW. This finding was reviewed and acknowledged by the Facility Administrator (Staff A) on 6/12/24 during interview at 1300. 47976 P-4: This 33-year-old patient started dialysis treatment at this facility on 8/26/22 with the diagnosis of end stage renal disease (ESRD) and was ordered to receive dialysis treatments 3 times per week for 3 hours and 45 minutes. During record review on 6/11/24, the following blood pressures were recorded during treatment: On 5/31/24: 0902 = 199/127 (adjusted cuff and retaken) 0903 = 189/124 (retaken again) 0907 = 151/104 0932 = 149/106 1102 = 185/105 There was no documentation of the nurse being notified after blood pressure remained high after rechecking. On 6/7/24: 0832 = 178/105 0902 164/100 There was no documentation of the nurse being notified of high blood pressures. On 6/10/24: 0932 = 187/107 1032 = 176/107 1102 = 174/106 There was no documentation of the nurse being notified of high blood pressures. P-5: This 43-year-old patient started dialysis treatment at this facility on 10/1/21 with the diagnosis of ESRD and was ordered to receive dialysis treatments 3 times per week for 3 hours and 45 minutes. During record review on 6/11/24, the following blood pressures were recorded during treatment: On 4/26/24: 1147 = 167/104 1159 = 175/115 (rechecked) 1202 = 168/110 (rechecked) 1229 = 155/106 1259 = 143/107 There was documentation the CCHT (Certified Clinical Hemodialysis Technician) was aware the blood pressure was high and came down a little, however, there was no documentation of the nurse being notified of high blood pressures. On 5/1/24: 1046 = 193/116 1057 = 168/101 1059 = 167/105 1259 = 153/101 There was documentation the CCHT (Certified Clinical Hemodialysis Technician) was aware the blood pressure was high at 1259, however, there was no documentation of the nurse being notified of high blood pressures. The Facility Administrator (Staff) A was asked about the above findings during an interview on 6/12/24 at 1140. Staff A stated the blood pressures above should have been reported to the nurse and acknowledged the findings.”

“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: 47976 Based on record review and interview, the facility failed to achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 (the professionally-accepted clinical practice standard for adequacy of dialysis) in 1 (P-5) of 7 records reviewed, resulting in the potential for poor patient outcomes due to ineffective dialysis treatment. Findings include: P-5: This 43-year-old patient started dialysis treatment at this facility on 10/1/21 with the diagnosis of ESRD and was ordered to receive dialysis treatments 3 times per week for 3 hours and 45 minutes. During record review on 6/11/24, it was noted the patient’s adequacy (values that measure the effectiveness of dialysis treatments) were below the professionally-accepted clinical practice standard of Kt/v = 1.2. Upon review of the last comprehensive assessment (dated 3/6/24), it was noted the Kt/v was measured at 1.45. However, upon review of the Kt/v values in 2024, it was determined that only 3 of 9 values were >1.2. Furthermore, upon review of the data from all of 2023, it was determined that only 5 of 47 values were >1.2. The Facility Administrator (Staff A) was asked regarding this patient’s adequacy values during an interview on 6/12/24 at 1140. Staff A stated the patient is non-compliant with coming to visits and often shortens his treatments and that’s why he is adequacy is low. Staff A was unable to show evidence of documentation to support changes made in the plan of care to attempt to improve values. Staff A acknowledged the findings. The Medical Director (Staff B) was also interviewed regarding these findings during an interview on 6/12/24 at 1400. Staff B reported these values were unacceptable and he would expect a patient to be made unstable to allow more frequent monitoring if Kt/v values fell below 1.2 for more than 2 months in a row. Staff B also acknowledged the findings.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 47976 Based on observation, record review, and interview, the Medical Director failed to ensure staff followed policies and procedures regarding medication handling in clean and dirty areas, resulting in the potential for poor patient outcomes Findings include: **Policy titled “G48 Medications: Handling, Administration, Storage & Disposal” (last revised 6/2023) stated, “4. Medications must never be left unsecured or left unattended.” **Policy titled “G40 Infection Control” (last revised 11/29/22) stated on page 3, “16. Each center will maintain and clearly label separate “clean” and “dirty” work areas. Clean items, such as medications and gloves are kept in the designated “clean” areas.” During dialysis floor observation and tour on 6/10/24 at 1134, 2 syringes of Heparin were observed to be left unattended on a counter next to a handwashing sink (dirty area) near the nurse’s station next to jugs of cleaning solution. The syringes were still there at 1230. During an interview on 6/12/24 at 1000, the Medical Director (Staff B) was asked if he expected the staff to follow the agency’s policies and procedures. Staff B agreed that this was his expectation and acknowledged the findings. Findings were also reviewed with and acknowledged by the Facility Administrator (Staff A) during an interview on 6/12/24 at 1400.”

“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: 47976 Based on record review and interview, the agency failed to ensure the dialysis records were accurate in 1 (P-4) of 7 records reviewed, resulting in an inaccurate representation of the patient’s treatment and the potential for poor patient outcomes. Findings include: P-4: This 33-year-old patient started dialysis treatment at this facility on 8/26/22 with the diagnosis of end stage renal disease (ESRD) and was ordered to receive dialysis treatments 3 times per week for 3 hours and 45 minutes. During record review on 6/11/24, it was noted the patient was given a 0.1 mg tablet of Clonidine HCL (a medication used to treat high blood pressure) at 1229. Upon further review of the record, it was noted the patient’s treatment ended at 1139. At completion of dialysis, the patient’s blood pressure was recorded as 168/102 with no symptoms noted. There is no documented evidence of the patient staying almost an hour after treatment ended or of any reason to give Clonidine at that time. The Facility Administrator (Staff A) was interviewed on 6/12/24 at 1140 regarding the above finding. Staff A reported there is no way the patient was there at that time as he always leaves immediately after treatment. Staff A stated it must have been a documentation error and acknowledged the findings.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 47976 Based on observation, record review and interview, the agency failed to ensure privacy and confidentiality in personal medical records, resulting in the potential for unauthorized access to protected health information. Findings include: **Policy titled “Confidentiality of Protected Health Information (PHI)” (last revised 10/10/22) stated all employees sign a Confidentiality Agreement regarding confidentiality of patient information upon hire. The document titled “Appendix 1 - American Renal Associates - Employee Confidentiality and Security Agreement” stated, “12. I will practice good workstation security measures such as locking up electronic media, including diskettes, when not in use, using screen savers with activated passwords appropriately, and position screens away from public view.” During dialysis floor observation and tour on 6/10/24, the following was noted: At 1030, a computer station with an unlocked screen with patient names and information was left unattended and visible to the clinic patient area near station #19. At 1100, it was noted nobody had used the computer and the screen was still unlocked and visible. At 1100, a daily patient schedule (paper) with first and last names was left face up on a supply cart near station #17 where patients often walk past to get to their station. At 1055, a computer station with an unlocked screen with patient names and information was left unattended and visible to the clinic patient area near station #9. There was also a daily patient schedule (paper) left face up on the computer station. The screen was still unlocked and visible at 1115. At 1134, 2 syringes of Heparin and a medication order sheet with patient name and information was left face up on a sink counter visible to patients entering and exiting the clinic. The items were still on the counter at 1230. On 6/11/24: At 0855, computers near stations #7 and #17 with unlocked screens with patient names and information were left unattended and visible to the clinic. These were both still open and visible at 0910. At 1018, two computers near station #13 with unlocked screens with patient names and information were left unattended and visible to the clinic. These were both still open and visible at 1030. Findings were reviewed with and acknowledged by Facility Administrator (Staff A) during an interview on 6/12/24 at 1200.”

“GOV-INVOL DISCHARGE PROCESS REQUIREMENTS CFR(s): 494.180(f)(4) The medical director ensures that no patient is discharged or transferred from the facility unless - (4) The facility has reassessed the patient and determined that the patient’s behavior is disruptive and abusive to the extent that the delivery of care to the patient or the ability of the facility to operate effectively is seriously impaired, in which case the medical director ensures that the patient’s interdisciplinary team- (i) Documents the reassessments, ongoing problems(s), and efforts made to resolve the problem(s), and enters this documentation into the patient’s medical record; (ii) Provides the patient and the local ESRD Network with a 30-day notice of the planned discharge; (iii) Obtains a written physician’s order that must be signed by both the medical director and the patient’s attending physician concurring with the patient’s discharge or transfer from the facility; (iv) Contacts another facility, attempts to place the patient there, and documents that effort; and (v) Notifies the State survey agency of the involuntary transfer or discharge. (5) In the case of immediate severe threats to the health and safety of others, the facility may utilize an abbreviated involuntary discharge procedure. This Standard is not met as evidenced by: 15195 Based on interview and record review, the facility failed to ensure the State Agency and Renal Network were notified of an involuntary discharge, and failed to follow involuntary discharge requirements for 1 (#10) of 1 patients reviewed for involuntary discharge, resulting in the potential for poor patient outcomes for all 79 patients receiving services at the facility. Findings include: On 11/7/23 at approximately 0900 during entrance conference, the Facility Manager A was queried and requested to identify any patients involuntarily discharged from the facility in the last six months. Facility Manager A stated that a patient was discharged due to failure to return to facility. Patient #10 was identified by the facility to be an involuntary discharge. On 11/7/23 at approximately 1200, electronic record review revealed that the patient of concern was a 59-year-old female with end stage renal disease and multiple chronic comorbid conditions, new to dialysis and admitted to the outpatient dialysis clinic on 4/18/23. The patient’s first treatment was on 4/20/23 and last treatment was on 6/15/23. Further medical record documented that the patient was a “No call, No show” on 6/10/23, 6/17/23, 6/24/23, 6/27/23, 6/29/23, 7/1/23, 7/4/23, 7/8/23, 7/11/23, 7/13/23, 7/15/23. The patient was in the hospital on 6/20/23, 6/22/23 and canceled her treatment on 7/6/23. The Nurse documented that the patient was noncompliant with treatment, last treatment was 6/15/23. The Progress Notes documented “Pt involuntarily discharged from clinic on 7/17/2023.” No order, no patient letter, no note regarding Renal Network or State Agency notifications were documented and verified by the Facility Manager. On 11/7/23 at approximately 1400, review of the facility policy titled “G04 Admission & Discharge of Patient, revised 11/15/23” documented, “Patients who are being discharged involuntarily will receive a 30-day notice of the planned involuntary discharge in order to make plans to receive care at another dialysis facility. The facility associates will assist the patient with finding another center to provide dialysis services that is within reasonable proximity to the patient’s residence.” On 11/7/23 at approximately 1405, the Facility Manager was queried about any other policy or procedure which specified other requirements or notifications for involuntary discharges. She stated that she checked with Regulation Specialist, and there were no other policies or procedures regarding involuntary discharge requirements. The facility did not send a 30-day notice to the patient or provide a listing of other nearby facilities. The policy did not document the requirement to notify the Renal Network and State Agency. The policy did not document the attending physician role and medical director role in required documentation needed, which included an order by these physicians.”