Davita Berlin Dialysis Center

“CFC-PHYSICAL ENVIRONMENT CFR(s): 494.60 This Condition is not met as evidenced by: 44367 Based on the overall findings of the survey, the facility’s Governing Body, Administration, and the Medical Director failed to meet the Condition for Coverage for Physical Environment (CfC: 494.60), as evidenced by: 1) staff failure to ensure dialysis machines were assembled per the manufacturer’s recommendations before conducting safety checks; and 2) staff failure to remove expired supplies from patient care areas in a timely manner. This failure placed all patients at increased risk for harm and/or injury. Findings included: Cross-reference to tag V0403- Physical Environment - Equipment Maintenance.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 44367 Based on observations, review of pertinent documentation, and staff interviews, it was determined that the facility’s Governing Body and the Medical Director failed to ensure that the facility administration provided sufficient numbers of patient care personnel, as evidenced by the facility’s consistent practice of downsizing the clinical staff (patient care technicians) and assigning patients to the Charge Nurse, when there was greater than nine patient receiving dialysis. This failure placed all patients at an increased risk for harm and/or injury and resulted in a finding that the facility was out of compliance with the Condition for Coverage for Governance (CFC: 494.180). Findings included: Cross-reference to tag V0757 - Governance - Staff Numbers & Ratio Meet Patient Needs.”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44367 Based on clinical observations and interviews with the administrative staff, the facility’s governing body failed to ensure that all expired medications were removed and were not available for use in the event of an emergency. This failure placed the patients at potential risk of infection and cross contamination. Findings include: Review on 03/19/2024 of the facility’s policy 1-06-01 entitled, “Medication Policy” revealed, “All medications in the facility are checked monthly for expiration dates...Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory area and disposed of per state/local regulations.” 1. Inspection of the Facility’s crash cart on 03/20/2025 revealed the following: “ One 1000 ml bag of 0.9% Sodium Chloride, lot number V23018J, expired 10/2024. “ Thirteen 1000 ml bags of 0.9% Sodium Chloride, lot number Y4166581, expired 08/2024. The Facility Administrator was informed of the findings on 03/20/2025.”

“ESRD EP Training Program CFR(s): §494.62(d)(1): Condition for Coverage: (d)(1) Training program. The dialysis facility must do all of the following: (i) Provide initial training in emergency preparedness policies and procedures to all new and existing staff, individuals providing services under arrangement, and volunteers, consistent with their expected roles. (ii) Provide emergency preparedness training at least every 2 years. Staff training must: (iii) Demonstrate staff knowledge of emergency procedures, including informing patients of- (A) What to do; (B) Where to go, including instructions for occasions when the geographic area of the dialysis facility must be evacuated; (C) Whom to contact if an emergency occurs while the patient is not in the dialysis facility. This contact information must include an alternate emergency phone number for the facility for instances when the dialysis facility is unable to receive phone calls due to an emergency situation (unless the facility has the ability to forward calls to a working phone number under such emergency conditions); and (D) How to disconnect themselves from the dialysis machine if an emergency occurs. (iv) Demonstrate that, at a minimum, its patient care staff maintains current CPR certification; and (v) Properly train its nursing staff in the use of emergency equipment and emergency drugs. (vi) Maintain documentation of the training. (vii) If the emergency preparedness policies and procedures are significantly updated, the dialysis facility must conduct training on the updated policies and procedures. This Standard is not met as evidenced by: 44367 Based on observation and review of the facility’s policies and procedures, the facility’s administration failed to ensure that 1) the facility conducted fire drills quarterly, per the facility’s policy; and 2) all of the facility’s clinical staff maintained acceptable Basic Life Support/Cardiopulmonary Resuscitation (BLS/CPR) certification. This failure placed the patients and visitors at potential risk of harm in the event of a fire or a medical emergency. Staff: #7 Findings include: Review on 03/20/2025 of the facility’s policy 4-07-01 entitled “Facility Emergency Management Plan” revealed, “Fire safety drills: Required on a Quarterly basis.” 1. During review of the emergency preparedness binder on 03/20/2025, the surveyor noted that the facility conducted the following drills in 2024: a fire drill on 04/14/2024 and 04/19/2024 and then 09/17/2024 and 09/18/2024. The facility does two drills to ensure all patients are provided the training. There were no fire drills documented before 04/14/2024 or after 09/18/2024 until 01/05/2025. If the facility conducts fire drills per policy, then the documentation should reflect four drills a year. The Facility Administrator was given the opportunity to provide additional information; However, no additional documentation was provided. The Facility Administrator corroborated that the facility had not conducted fire drills quarterly as required per policy. 2. Staff must maintain current CPR (Cardiopulmonary Resuscitation) certification for healthcare providers through a CPR training provider whose training includes hands-on practice and in-person skills assessment. Occupational Safety and Health Administration (OSHA), institutions, and States have determined that online-only certification (computer-based training without a hands-on skill component or verification of competent skill performance) is not acceptable. Review on 03/21/2025 of the “National CPR Foundation” website revealed: “Online training is a legal and acceptable form of training, however, NCPRF (Trademark) does not offer in-person training...Therefore, we cannot guarantee that our certification will be accepted in every situation. “ Review of the facility’s personnel files on 03/21/2025 revealed that Staff #7 did not have an acceptable BLS/CPR certification. According to the Staff #7’s BLS/CPR card issued by National CPR Foundation, the course was completed 01/14/2024. The surveyor asked Facility Administrator if the course was taken online only or online and in-person. The Facility Administrator stated that was unknown to him/her. The surveyor noted that the provider of the CPR/BLS course only provides online courses and does not provide any in-person CPR/BLS course. Staff #7 has consistently worked in the clinical treatment area providing direct patient care from 01/14/2024 through 03/21/2025. Staff #7 worked: 2/1/2025, 02/12/2025, 02/13/2025, 02/14/2025, 02/22/2025, 02/27/2025, 03/02/2025, 03/06/2025, and 03/15/2025. According to the Facility Administrator, he/she was unaware that Staff #7 did not possess the proper CPR certification. The Clinical Manager corroborated that Staff #7 did not possess an acceptable BLS/CPR certification and Staff #7 will be removed from the schedule until an updated BLS/CPR card is obtained.”

“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: 44367 Based on clinical observations, the facility’s administration failed to ensure that the standards of care related to hand hygiene and glove use requirements were followed by all staff who come in contact with the dialysis patients in the facility. This failure placed the patients and staff at potential risk for nosocomial infections (infections acquired while in a healthcare setting). Staff: PD Nurse Findings included: Review on 03/19/2025 of the facility’s policy 1-05-01 entitled, “Infection Control For Dialysis Facilities” states that, “Gloves shall be changed when: After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” On 03/19/2025 at 12:52 p.m., during observation of a Peritoneal Dialysis (PD) training of Patient #9 in treatment room 2, the surveyor noted that the PD Nurse removed gloves after assisting Patient #9 with the PD catheter; however, the PD nurse did not perform hand hygiene. The PD Nurse proceeded to assist Patient #9 with his/her PD catheter. The Facility Administrator was informed of the findings on 03/19/2025.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 44367 Based on clinical observations, a review of the dialysis water room logs, a review of the facility’s policies and procedures, and interviews with the clinical and biomedical staff, the governing body failed to ensure that the clinical staff followed procedure for the disinfection of the hemodialysis machines. This failure placed all patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings included: Review on 03/19/2025 of the dialysis machine manual entitled “2008T Hemodialysis Machine Operator’s Manual” determined that page 196 stated, “After a chemical disinfection cycle, the machine must be checked for residual disinfectant before initiating dialysis. A sample for testing for residual disinfectant can be obtained from a dialysate line or the drain line.” Review on 03/19/2025 of the facility’s form entitled “Fresenius Dialysis Delivery System Clean and Disinfect Log” from 11/01/2024 thru 03/18/2025 revealed that the staff did not clean the dialysis machines daily with citric acid and heat or did not check each machine for residual after the weekly bleach cycle prior to treatment initiation. On 03/19/2025, during an interview, the Biomedical Technician stated that the facility had a total of 32 dialysis machines, including 4 backup machines. The machines are to be cleaned daily with citric acid and heat at the end of the day and bleached at the end of the day every Thursday. The residual checks are to be completed every Friday morning before treatment initiation to ensure the machines are free of bleach. Review of the “Dialysis Delivery System Disinfection Log” revealed the following: “ On 11/01/2024 and 11/8/2024, the residual bleach checks were not done on 32 out of 32 dialysis machines. “ On 11/15/2024, 32 out of 32 dialysis machines were not disinfected with citric acid and heat as required. “ On 11/22/2024 and 11/29/2024, the residual bleach checks were not done on 32 out of 32 dialysis machines “ On 12/21/2024, 32 out of 32 dialysis machines were not disinfected with citric acid and heat as required. “ On 12/27/2024, the residual bleach checks were not done on 32 out of 32 dialysis machines. “ On 01/10/2025, the residual bleach checks were not done on 32 out of 32 dialysis machines. “ On 02/05/2025, 32 out of 32 dialysis machines were not disinfected with citric acid and heat as required. “ On 02/21/2025 and 02/28/2025, the residual bleach checks were not done on 32 out of 32 dialysis machines. The Facility Administrator was informed of the findings on 03/19/2025.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 44367 Based on clinical observations and interviews with the administrative staff, the facility’s governing body failed to ensure that all expired medications are removed and not available for use. This failure placed the patients at potential risk of infection and cross contamination. Findings include: Review on 03/19/2024 of the facility’s policy 1-06-01 entitled, “Medication Policy” revealed, “Disposal of expired medications, including all over the counter and nutritional product samples, are removed from the treatment and inventory areas and disposed of per state/local regulations...All medications in the facility are checked monthly for expiration dates.” 1. Inspection of the Peritoneal Dialysis area on 03/19/2025 revealed the following: · One box of Dianeal Low Calcium with 4.25% Dextrose Peritoneal Dialysis Solution, lot number LB59770, expired 08/2024. · One box (25) of Cefezolin 1 gram/vial, lot number 1L0736A18, expired 04/2024. The Peritoneal Dialysis Nurse was informed of the findings on 03/19/2025.”

“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: 44367 Based on observations and review of the facility’s policies and procedures, the governing body and the medical director failed to ensure that the clinical staff complied with the appropriate catheter care techniques and procedures. This failure placed patients at potential risk of infection or harm in maintaining their central venous catheter. Staff: #2 and #3 Findings include: According to the National Institute of Health (NIH), “A central venous catheter (CVC) is an indwelling device inserted into a large, central vein (most commonly the internal jugular, subclavian, or femoral) and advanced until the terminal lumen resides within the inferior vena cava, superior vena cava, or right atrium [parts of the heart].” Review on 03/19/2025 of the facility’s policy 1-04-02B entitled “Central Venous Catheter (CVC) with clearguard HD antimicrobial end caps” states to “Perform a 15 second hub scrub every time a CVC is connected or disconnected from the blood lines, such as during line reversal, or if the patient is disconnected during treatment for any reason.” The policy also states, “Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides and the end of the hub thoroughly... “Clean exit site with 2% Chlorhexidine Gluconate 70% Isopropyl Alcohol swab for a minimum of 30 seconds, apply to the CVC exit site in a “back and forth” pattern, using gentle friction progressing from the insertion site to the periphery.” 1. During observation of the clinical treatment area on 03/19/2025 at 10:05 a.m., during initiation of treatment of a CVC patient at station #13, Staff #2 cleaned the venous and arterial limbs, but did not remove the caps and cleaned the hubs. Staff #2 cleaned the hubs without removing the caps. Once Staff #2 removed the caps the syringe was placed immediately without cleaning the hubs. 2. During observation of the clinical treatment area on 03/19/2025 at 11:46 a.m., during initiation of treatment of a CVC patient at station #17, Staff #2 cleaned the exit site for only 14 seconds. The patient touched the exit site after it was cleaned, Staff #2 did not re-clean the site. The Facility Administrator was informed of the findings on 03/19/2025.”

“BACT OF H20-MEDICAL DIRECTOR RESPONSIBLE CFR(s): 494.40(a) 4.1.2 Bacteriology of water: med dir resp The facility medical director is responsible to ensure the manufacturer or supplier of a complete water treatment and distribution system demonstrates that the complete water treatment, storage, and distribution system is capable of meeting these requirements at the time of installation Following installation of a water treatment, storage, and distribution system, the user is responsible for continued monitoring of the water bacteriology of the system and for complying with the requirements of this standard, including those requirements related to action levels. This Standard is not met as evidenced by: 44367 Based on review of the Reverse Osmosis (RO) water, dialysate, and Hemodialysis (HD) machine culture logs, and interviews with the biomedical technician, the governing body and medical director failed to ensure that systems were continually monitored for bacteria colony forming units and endotoxins. This failure to provide oversight for the RO water, dialysate, and HD machine cultures placed the facility’s patients at risk of harm and potential exposure to infection. Findings included: Review on 03/18/2024 of the facility’s policy, “AAMI Chemical Analysis of Water and Dialysis,” determined that page 5 states, “Medical Director must review and sign each chemical analysis report obtained during the review period.” Review on 03/18/2025 of the facility’s monthly RO water, dialysate, HD machine culture reports, and an interview with the Biomedical staff and the Facility Administrator revealed that the medical director does not sign and date (proof of acknowledging the culture collection results during the review period) the reports as required. The Medical Director did not sign the reports from June 2024 through February 2025. The Biomedical Technician and the Facility Administrator corroborated that culture reports were not signed by the medical director.”

“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: 44367 Based on observations, record reviews, and staff interviews, the facility’s governing body failed to ensure that 1) the facility staff assembled the dialysis machines in accordance with the manufacturer’s recommendations prior to initiating safety testing; and 2) the facility was free of all expired supplies. This failure placed the patients at potential risk of injury and harm. Staff: #1 Findings include: On 03/20/2025 at 10:45 a.m., review of the Fresenius 2008T Machine Operator’s Manual, determined that page 63 stated: “Warning! The tubing beneath the venous drip chamber must be inserted into the venous line clamp and the optical detector.” Review on 03/20/2025 of the facility’s policy 1-03-06V entitled, “Machine Start Up and Priming a Single Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Nipro or Combiset Blood Lines for First Shift of the Day,” determined that the policy states, “Thread venous blood line through line clamp of air detector, Press “Reset” to clear the air detector alarm. NOTE: This step must be completed to verify that the line clamp is operational during treatment and in an alarm condition. Perform pressure holding and alarm tests per procedure.” On 03/20/2025, during observations of the treatment floor, the surveyors observed the following: At 10:40 a.m., Staff #1 was testing the dialysis machine #15 located in Station #13 without the tubing beneath the venous drip chamber inserted into the venous line clamp and the optical detector (air detector). At 10:41 a.m., the Facility Administrator and the the assigned Patient Care Technician (Staff #1) corroborated that the machine #15 located in Station #13, was not properly assembled prior to conducting the safety test and during the safety tests. At 10:43 a.m., the Clinical Specialist instructed Staff #1 to tear down the system, assemble the machine with new tubing and re-test dialysis machine #15. At 10:45 a.m., as a result of the surveyor findings, the Facility Administrator and the Clinical Specialist immediately initiated education and training to the entire staff regarding the machine set-up prior to and during the safety check testing process, per the manufacture’s recommendation and the facility’s policy. 2) When medications and supplies are no longer needed, they should be disposed of promptly. Healthcare providers should remove expired medications and supplies as quickly as possible to help reduce the chances that others accidentally receive or intentionally misuse them. The following expired supplies were identified throughout this survey: a) Inspection of the supply room on 03/20/2025 revealed the following expired supplies: · 250 packs of Safe Touch Tulip Twin Pack 14 gauge Fistula Needles, lot 19K21G, expired 10/31/2024. · 100 Durapore tape, lot number 104061849, expired 10/25/2024 b) Inspection of the PD nurses station area revealed: · One box Dianeal Low Calcium 4.25% Dextrose Dialysis Solution, lot number L3B9770, expired 01/2024. · One Blood Culture Kit, lot number 440-2, expired 02/10/2025. · 10 Red top blood tubes, lot number 3170985, expired 11/30/2024.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on record review of medical records, the Facility’s Administration and the Medical Director failed to ensure that initial nursing assessments were performed by the assigned registered nurse prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patient(s) at risk for receiving insufficient and ineffective care, and denied the patients their rights. Patients: #1 and #3 Findings included: The facility’s policy 1-03-07 “New Patient Pre-Treatment Evaluation” determined that page 1 states, “An RN, as required by federal regulation, will perform an initial pre-treatment evaluation of all new patients prior to the initiation of their first treatment at the facility.” During inspection of the patients’ charts on 03/20/2025, the surveyor noted that 2 out of the 9 (23%) selected patients did not have an initial nursing assessment in their charts. 1. Patient #1 was admitted to the facility on 12/26/2024. No initial nursing assessment was found in Patient #1’s paper or electronic chart. 2. Patient #3 was admitted to the facility on 12/13/2021. No initial nursing assessment was found in Patient #’s paper or electronic chart. The Facility Administrator corroborated that Patient #1 and Patient #3 did not have an initial nursing assessment completed.”

“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: 44367 Based on review of the dialysis patients’ treatment flowsheets, the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were documented and followed as prescribed by the Nephrologist. This failure placed the patients at potential risk of harm and denied the patients their rights. Staff: #7 and #8 Patients: #1 and #2 Findings included: The hemodialysis prescription includes the number of treatments per week, the length of treatment time, the dialyzer, the primary access being used for the patient; specific parameters of the dialysis delivery system, such as the blood flow rate (BFR), dialysate flow rate (DFR), and electrolyte composition of the dialysate; anticoagulation, and the patient’s target weight. Review on 03/19/2025 of the facility’s policy 1-03-08, titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” determined that page 4 number 10 stated, “If the dialysis prescription is not being met (including the inability to obtain prescribed blood flow rate or BFR) the reason will be documented, and the licensed nurse informed.” A review of the seven (7) selected patients’ treatment flowsheets on 03/19/2025 revealed that two (2) of the seven (7) patients did not receive the correct dialysis prescription as ordered by the Nephrologist. · On treatment date 03/13/2025, Patient #1’s BFR was prescribed for 250 ml/min. However, the BFR was set at 350 ml/min from 11:44 a.m. to 02:32 p.m. There was no documentation from the clinical staff explaining why Patient #1’s BFR was not set on the dialysis machine as prescribed. · On treatment date 03/18/2025, Patient #1’s BFR was prescribed for 250 ml/min. However, the BFR was set at 300 ml/min from 12:01 p.m. to 02:44 p.m. There was no documentation from the clinical staff explaining why Patient #1’s BFR was not set on the dialysis machine as prescribed. · On treatment date 03/11/2025, Patient #2’s BFR was prescribed for 350 ml/min. However, the BFR was set at 400 ml/min from 07:03 a.m. to 10:50 a.m. There was no documentation from the clinical staff explaining why Patient #2’s BFR was not set on the dialysis machine as prescribed. · On treatment date 03/13/2025, Patient #2’s BFR was prescribed for 350 ml/min. However, the BFR was set at 300 ml/min from 07:09 a.m. to 10:28 a.m. There was no documentation from the clinical staff explaining why Patient 2’s BFR was not set on the dialysis machine as prescribed. · On treatment date 03/15/2025, Patient #2’s BFR was prescribed for 350 ml/min. However, the BFR was set at 300 ml/min from 07:04 a.m. to 10:09 a.m. There was no documentation from the clinical staff explaining why Patient #2’s BFR was not set on the dialysis machine as prescribed. · On treatment date 03/18/2025, Patient #2’s BFR was prescribed for 350 ml/min. However, the BFR was set at 400 ml/min for the entire treatment. Staff #8 documentation stated: “Treatment started without complications; bfr at 400 for bloodwork approved by RN;EB.” However, there were no documented orders to reflect the change for the BFR from the Nephrologist. Review on 03/18/2025 of the facility’s policy: 3-02-03 entitled “Physicians orders for Patient Care” stated that, “Written orders are to be filed in the patient’s medical record in the Orders section, as applicable. All orders must be entered into the electronic health record upon receipt.” Review of Patient #2’s medical records revealed that on 12/12/2024, the assigned Nephrologist wrote the following: “Per Dr. A..., this is your current prescription in order for you to obtain the most effective dialysis: BFR 400 Treatment time: 4 hours and 15 minutes...If you are unable to follow the prescription written by Dr... and we feel that you are not receiving safe treatment then we have been instructed to terminate treatment.” Patient Note entered on 12/12/2024 at 1:49 p.m. by Staff #7 stated, “correspondence sent to Dr..., he wants pt to run for 4.15 minutes, bfr of 400...CCC and...FA aware and forms were signed with the patient to ensure understanding of the treatment order/expectations.” This document was signed on 12/12/2024 by Patient #2, the Clinical Coordinator and the Facility Administrator. Review of Patient #2’s treatment flowsheets from 03/11/2025, 03/13/2025, 03/15/2025, and 03/18/2025 revealed that the Patient #2’s prescription was Blood Flow Rate (BFR) was 350 and treatment time was 4 hours. The surveyor asked the Facility Administrator to provide the documented order change requested by the Nephrologist on 12/12/2024; However, no documented proof of the change was provided. The surveyor asked why the order was never changed, but the Facility Administrator was unable to provide a reason. The Facility Administrator corroborated that the order was never changed in Patient #2’s medical record as requested by the Nephrologist.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that an initial comprehensive assessment and Plan of Care (POC) was completed for all in-center patients within the latter of 30 calendar days or 13 Hemodialysis sessions beginning with the first outpatient dialysis session. This failure placed the affected patients at potential risk of harm and denied patients their rights. Patients: #5 and #7 Findings included: Review on 03/20/2025 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care,” revealed that: “A comprehensive assessment will be conducted on all patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” On 03/20/2025, during a review of the seven (7) selected in-center hemodialysis (ICHD) patients’ plans of care (PoC), the surveyor noted that two out of the seven patients did not have a 30-day PoC completed. The documentation revealed the following: · Patient #5’s paper or electronic chart did not contain a completed 30-day PoC. · Patient #7’s paper or electronic chart did not contain a completed 30-day PoC. The Facility Administrator corroborated that the two (2) identified patients did not have a completed 30-day PoC.”

“PA-F/U REASSESSMENT-WITHIN 3 MO OF INITIAL CFR(s): 494.80(b)(2) A follow up comprehensive reassessment must occur within 3 months after the completion of the initial assessment to provide information to adjust the patient’s plan of care specified in §494.90. This Standard is not met as evidenced by: 44367 Based on the patients’ medical record reviews and interviews with the facility’s administration, the governing body and interdisciplinary team (IDT) failed to ensure that a 3 month (90-day) comprehensive assessment and Plan of Care (PoC) was completed 3 months after the completion of the initial (30-day) comprehensive assessment and PoC. This failure placed the affected patients at potential risk of harm and denied patients their rights to effective care. Patients: #7 Findings included: Review on 03/20/2025 of the facility’s policy 1-14-01 entitled “Patient Assessment and Plan of Care”, revealed that: “A follow-up 90-day reassessment will be completed to evaluate the patient’s status and provide information to adjust the patient’s plan of care.” Review on 03/20/2025 of the seven (7) selected patient in-center and peritoneal dialysis patients’ medical records revealed that one (1) out of seven (7) selected patients did not have a 90-day PoC. the following: Patient #7’s paper or electronic chart did not contain a 90-day PoC. The Facility Administrator corroborated that the identified patient did not have a 90-day PoC completed.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 44367 Based on observations and review of the facility’s policies and procedures, the facility’s administration and the Medical Director failed to ensure that the clinical staff complied with the appropriate procedures when assessing the patients’ vascular access prior to cannulation and practiced the correct infection control protocol. This failure placed the safety and well-being of the patients at risk of harm in maintaining their vascular access. Staff: #5 Findings included: Review on 12/04/2024 of the facility’s policy 01-04-01E entitled “Cannulation of Fistula or Graft” determined that the policy states: “Do not palpate insertion site once area has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” 1. Observation of the clinical treatment area on 03/19/2025 at 10:49 a.m. revealed that during treatment initiation at station #1, Staff #5 palpated the patient’s access after cleaning prior to cannulation. Staff #5 did not re-clean the access. The Facility Administrator was informed of the findings on 03/19/2025.”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 44367 Based on review of the Peritoneal Dialysis (PD) Quality Assessment and Performance Improvement (QAPI) meeting minutes and data, and review of the agency’s policies and procedures, the governing body and the Medical Director failed to ensure the facility’s interdisciplinary team (IDT) adjust action plans related to Peritonitis when goals were not being met. This failure denied patient effective and safe dialysis which placed the patients at risk for infection and harm. Findings include: Review on 03/21/2025 of the facility’s policy 1-14-06 entitled “Continuous Quality Improvement Program” revealed that “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following: Infection Control, including incidence of infections, Vascular access, Mortality Review - review of deaths, Hospitalizations and Emergency Ambulance Transfers; Page 2 number 8 states, “Continuous monitoring of above indicators will be reflected in the meeting minutes, Any area identified as underperforming will be reviewed to identify root cause for underperformance, will have an action plan identified that will result in performance improvement, and will track this change in performance over time to verify improvement and sustained”; Number 9 states, “Each action plan will be evaluated as priority with Patient Safety and Clinical Outcomes indicators for the highest priority.” During review on 03/21/2025 of the Peritoneal Dialysis Quality Assessment and Performance Improvement (QAPI) meeting minutes from February 2024 through February 2025, the surveyor noted that the facility did not adjust the goal for the Peritonitis rate since 2022. Despite not making goals, the facility did not adjust the action, and intervention plans and adjust the goals for peritonitis. There were no measurements or documentation documented for the months of March 2024, April 2024, and May 2024. The Facility Administrator and the PD Nurse were asked why the documentation for March, April, and May 2024 were not documented, but neither could provide a reason. The Facility Administrator and the PD Charge Nurse corroborated the lack of documentation and that the action plans and goals were not adjusted to decrease the peritonitis rate.”

“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: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all of the facility’s patient’s medical records were completed and accurate. This failure placed patients at risk of ineffective care. Patients: #3 Findings included: Review on 03/20/2025 review of the facility’s policy 3-02-02 entitled “Medical records Documentation Guidance” revealed: “All handwritten entries must be legible in the medical record...Do not chart in advance (before the service, observation or order)...Document accurately and concisely but completely.” Review on 03/20/2025 of Patient #3’s chart revealed that the Hemodialysis Consent form was incomplete. The form did not have a date to indicate when the form was signed. The surveyor could not validate that the consent form was completed prior to Patient #3 receiving their first dialysis treatment. The Facility Administrator was informed of the findings on 03/20/2025.”

“MR-COMPLETE RECORDS PROMPTLY CFR(s): 494.170(b)(1) (1) Current medical records and those of discharged patients must be completed promptly. This Standard is not met as evidenced by: 44367 Based on medical record review, the facility administrator and medical director failed to ensure that all the facility’s patient medical records were completed promptly by changing a patient’s prescription when ordered by the Nephrologist. This failure placed patients at risk of ineffective care and harm. Patient: #2 Findings Include: Review on 03/18/2025 of the facility’s policy: 3-02-03 entitled “Physicians orders for Patient Care” determined that the policy stated, “Written orders are to be filed in the patient’s medical record in the Orders section, as applicable. All orders must be entered into the electronic health record upon receipt.” Review on 03/18/2025 of Patient #2’s medical record revealed that the Nephrologist wrote orders to change the patient treatment prescription on 12/12/2024. Patient #2’s treatment flowsheets from 03/11/2025, 03/13/2025, 03/15/2025, and 03/18/2025 did not reflect the requested change. The Nephrologist request that the Blood Flow Rate (BFR) to be 400 ml/min and the treatment duration for 4 hours and 15 minutes. The actual prescription was entered for a BFR of 350 ml/min and a duration of 4 hours. The Facility Administrator was unable to provide documentation that the Nephrologist requested order was entered in on 12/12/2024 or any time after. The Facility Administrator corroborated that Patient #2’s medical record was not promptly completed to reflect the Nephrologist written prescription from 12/12/2024.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 44367 Based on review of the facility staffing logs, staffing exception reports, and interviews with randomly-selected staff members and the facility’s administration, the facility’s governing body failed to ensure that the Charge Nurse was free and kept out of the staffing ratio by consistently sending patient care techncians home and assigning three patients to the Charge Nurse even when there were greater than nine patients receiving treatment. This practice compromised the safety and well-being of its patients and staff. Findings include: The state regulations for Freestanding Kidney Dialysis Centers at COMAR (Code of Maryland Regulations) 10.05.04.06C. Dialysis Monitoring states: (1) Staffing Ratio. (a) In-Center Daytime Hemodialysis. When in-center daytime hemodialysis is performed, the monitoring individual-to-patient ratio at each center shall be: (i) A minimum of one staff member to three participants; and (ii) Sufficient to meet the needs of patients. ... (c) The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. (d) The charge nurse may not be included in the staffing ratio except: (i) When there are nine or fewer patients; or (ii) In the event of an emergency. (2) Staffing Exception Reporting. (a) The center shall have a staffing exception reporting protocol in a format approved by the Department for reporting to the governing body when emergency staffing situations arise that require the charge nurse to be included in the staffing ratio. The report shall include, at a minimum: (i) The date and shift of the exception; (ii) A description of the emergency staffing situation; (iii) Actions taken in response; and (iv) Any measures taken to ensure the center’s future compliance. (b) The exception reporting protocol shall be included in the center’s quality assurance process. (c) The staffing exception reports shall be made available to the Office of Health Care Quality and the Commission on Kidney Disease when they are conducting an inspection or survey of the center to assure compliance with §C(1) of this regulation. 1. On 03/20/2025 at 12:09 p.m., the surveyors went to the clinical treatment area to retrieve documents when it was noted that there were only two Patient Care Technicians (PCTs) on the unit with 13 patients receiving treatment. The surveyor asked one PCT where the other staff members were. The PCT stated that a third PCT was “dumping trash” and the Charge Nurse was off the unit on a phone call. The Charge Nurse returned to the unit at 12:15 p.m. and informed the surveyor that he/she was on a call regarding a patient and the third PCT returned to the unit at 12:45 p.m. The Charge Nurse corroborated that he/she was assigned to three patients despite 13 patients receiving treatment. Interviews were conducted with random staff throughout the survey revealed the following: “ One staff member, who requested anonymity stated, they are “always sending people home inappropriately.” “ One Staff member, who requested anonymity stated that they “always assign the Charge Nurse three patients after 2nd shift” is on the machine. “ One staff member, who requested anonymity stated that they “downsize for productivity” (budget). 2. According to the Facility Administrator (FA), the Regional Operations Director (ROD) instructed them to downsize in order to increase productivity. The Surveyor asked the FA if the ROD requested that they downsize PCT staff and assign the Charge Nurse three patients despite having more than nine patients on the machine receiving treatment. The FA did not provide an answer. 3. On 03/20/025, during review of the Staffing Assignments sheets and the Take off Lists from 02/01/2025 to 03/20/2025 totaling 41 treatment days, it was noted that the Charge Nurse was assigned to three patients every day despite there being more than nine patients on the machine. The Facility Administrator and staff corroborated that it was a regular practice to assign the Charge Nurse three patients despite the census being greater than nine. The facility was short staffed 25 out of the 41 treatment days. Staffing exceptions were requested, but the Facility Administrator did not provide the documentation. The staffing assignment sheets and the Take Off List from 02/01/2025 through 03/20/2025 revealed the following: “ On 02/01/2025, with 10 patients, 2 PCTs were sent home, leaving 3 PCTs. 1 of the PCTs and the Charge Nurse were assigned 3 patients each and 2 PCTs were assigned 2 patients each to take off the machine. “ On 02/03/2025, with 17 patients, 2 PCTs were sent home, leaving 4 PCTs. 3 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned 2 patients to take off the machine. “ On 02/04/2025, with 18 patients, 1 PCT was sent home, leaving 5 PCTs. All PCTs and the Charge Nurse were assigned 3 patients each to take off the machine. “ On 02/05/2025, with 16 patients, no PCTs were sent home. 3 PCTs and the Charge Nurse were assigned to 3 patients each and 1 PCT was assigned to 4 patients to take off the machine. “ Unable to determine assignments for 02/06/2025 due to lack of documentation. “ On 02/07/2025, with 13 patients, 3 PCTs were sent home, leaving 4 PCTs. 3 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 1 patient to take off the machine. “ On 02/08/2025, with 11 patients, 4 PCTs were sent home, leaving 3 PCTs. 2 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 2 patients to take off the machine. “ On 02/10/2025, with 15 patients, 1 PCT was sent home, leaving 5 PCTs. 4 of the PCTs were assigned to 3 patients each, 1 PCT was assigned to 1 patient and the Charge Nurse was assigned to 2 patients to take off the machine. “ On 02/11/2025, with 14 patients, 3 PCTs were sent home, leaving 4 PCTs. 3 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 2 patients to take off the machine. “ On 02/12/2025, with 15 patients, 2 PCTs were sent home, leaving 5 PCTs. 3 of the PCTs and the Charge Nurse were assigned to 3 patients each, 1 PCT was assigned to 1 patient, and 1 PCT was assigned to 2 patients to take off the machine. “ On 02/13/2025, with 17 patients, 2 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 2 patients to take off the machine. “ On 02/14/2025, with 15 patients, 2 PCTs were sent home, leaving 4 PCTs. All PCTs and the Charge Nurse were assigned to 3 patients each to take off the machine. “ On 02/15/2025, with 15 patients, 2 PCTs were sent home, leaving 4 PCTs. All the PCTs and the Charge Nurse were assigned to 3 patients each to take off the machine. “ On 02/017/2025, with 16 patients, 2 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 1 patient to take off the machine. “ On 02/018/2025, with 16 patients, 2 PCTs were sent home, leaving 5 PCTs. 2 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 2 patients to take off the machine. “ On 02/019/2025, with 16 patients, 1 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 1 patient to take off the machine. “ Unable to determine assignments for 02/20/2025 due to lack of documentation. “ Unable to determine assignments for 02/21/2025 due to lack of documentation. “ On 02/22/2025, with 16 patients, 2 PCTs were sent home, leaving 5 PCTs. 2 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 2 patients to take off the machine. “ On 02/24/2025, with 16 patients, 1 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 1 patient to take off the machine. “ On 02/25/2025, with 16 patients, 1 PCT was sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned to 1 patient to take off the machine. “ On 02/26/2025, with 15 patients, 3 PCT were sent home, leaving 4 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each to take off the machine. “ Unable to determine assignments for 02/27/2025 due to lack of documentation. “ On 02/28/2025, with 15 patients, 1 PCT was sent home, leaving 5 PCTs. 4 of the PCTs were assigned 3 patients each, one PCT was assigned 1 patient, and the Charge Nurse was assigned to 4 patients to take off the machine. “ Unable to determine assignments for 03/01/2025 due to lack of documentation. “ On 03/03/2025, with 17 patients, 2 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned 3 patients each, 1 PCT was assigned 2 patients to take off the machine. “ On 03/04/2025, with 14 patients, 2 PCTs were sent home, leaving 4 PCTs. 3 of the PCTs and the Charge Nurse were assigned 3 patients each, 1 PCT was assigned 2 patients to take off the machine. “ On 03/05/2025, with 17 patients, 2 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned 3 patients each, 1 PCT was assigned 2 patients to take off the machine. “ On 03/06/2025, with 12 patients, 2 PCTs were sent home, leaving 4 PCTs. 2 of the PCTs and the Charge Nurse were assigned 3 patients each, 1 PCT was assigned 2 patients, and 1 PCT was assigned 1 patient to take off the machine. “ On 03/07/2025, with 14 patients, 2 PCTs were sent home, leaving 4 PCTs. 3 of the PCTs and the Charge Nurse were assigned 3 patients each, 1 PCT was assigned 2 patients to take off the machine. “ On 03/08/2025, with 14 patients, 2 PCTs were sent home, leaving 4 PCTs. 3 of the PCTs and the Charge Nurse were assigned 3 patients each, 1 PCT was assigned 2 patients to take off the machine. “ Unable to determine assignments for 03/10/2025 due to lack of documentation. “ Unable to determine assignments for 03/11/2025 due to lack of documentation. “ On 03/12/2025, with 16 patients, 2 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned 1 patient to take off the machine. “ On 03/13/2025, with 14 patients, 1 PCT was sent home, leaving 4 PCTs. 3 of the PCTs and the Charge Nurse were assigned 3 patients each, and 1 PCT was assigned 2 patients to take off the machine. “ On 03/14/2025, with 15 patients, 2 PCTs were sent home, leaving 5 PCTs. 4 of the PCTs and the Charge Nurse were assigned to 3 patients each, and 1 PCT was assigned 1 patient to take off the machine. “ On 03/15/2025, with 12 patients, 3 PCTs were sent home, leaving 3 PCTs. All PCTs and the Charge Nurse were assigned 3 patients each to take off the machine. “ On 03/17/2025, with 18 patients, 1 PCTs were sent home, leaving 5 PCTs. All PCTs and the Charge Nurse were assigned 3 patients each to take off the machine. “ Unable to determine assignments for 03/18/2025 due to lack of documentation. “ Unable to determine assignments for 03/19/2025 due to lack of documentation. “ On 03/20/2025, with 12 patients, 3 PCTs were sent home, leaving 3 PCTs. All PCTs and the Charge Nurse were assigned 3 patients each to take off the machine. The Facility Administrator, the Clinical Specialist and the Charge Nurse were informed of the findings on 03/20/2025.”

“GOV-INTERNAL GRIEVANCE SYS ID/IMPLEMENTED CFR(s): 494.180(e) The facility’s internal grievance process must be implemented so that the patient may file an oral or written grievance with the facility without reprisal or denial of services. The grievance process must include- (1) A clearly explained procedure for the submission of grievances. (2) Timeframes for reviewing the grievance. (3) A description of how the patient or the patient’s designated representative will be informed of steps taken to resolve the grievance. This Standard is not met as evidenced by: 44367 Based on review of the patient grievance log, the facility’s policies and procedures, and interviews with facility staff and patients, the governing body and the facility’s administration failed to follow the facility’s internal grievance process. This failure denied the patients their rights to advocate for themselves for effective care. Findings included: Review on 06/06/2024 of the facility’s policy #3-01-06A entitled “Addressing Patient Grievances: DaVita Teammates” determined that the policy states: “ 1. Patient grievances may be verbal or written. They may be submitted directly to a facility teammate or submitted to the DaVita Guest Services department: 2. Complaints/Grievances should be documented on the facility Patient Grievance Log. 3. All details of patient grievances and discussions will be documented.” During an interview 03/18/2025 at 09:40 a.m., Patient #2 stated that he/she complained to the Facility Manager and “everyone” about having “issues” with Staff #6 on several occasions. Patient #2 informed the surveyor that Staff #6 “scolded” him/her about her blood work results, in the lobby in front of other patients. Patient #2 stated that, despite management being informed, no one followed up with any details of an investigation. Review of the Grievance log from 01/2024 through 03/2025 did not provide any complaints regarding Patient #2. According to the Facility Administrator, Patient #2 did mention “something” about Staff #6, but a complaint was not filed on Patient #2’s behalf. The Social Worker and the Clinical Coordinator both denied receiving a complaint from Patient #2. On 03/18/2025, the Facility Administrator and the Social Worker corroborated that no grievances were filed on behalf of Patient #2.”