Ara - Adelphi

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 44367 Based on observations, staff interviews, and record review, the facility’s administration and the Medical Director failed to confirm that issues with emergency equipment was resolved to ensure equipment will work in the event of an emergency; and supplies were packaged and stored properly. This failure placed the safety and well-being of the patients at potential risk of harm in the event of an emergency. Findings included: Review on 02/25/2024 of the facility’s policy EPM-17 “Crash Cart”, page 1, “The crash cart is to be kept secure with numbered breakaway locks.; weekly checks should include ensuring adequate oxygen supply; and monthly checks should include ensuring supply expiration.” During inspection of the facility’s crash cart on 02/25/2025 revealed the following: · One package of Stat Padz II Adult Electrodes was completely open. The package has wires that was manufactures to be outside of the pack in order to attach to the AED without opening the pack. · Inspection of the facility’s AED revealed the batteries were low. According to the Clinical Manager the batteries were just changed on 02/24/2024. According to the facility’s form entitled “Weekly Code Cart Checklist” dated from 11/20/2024 through 01/16/2024, a staff member wrote “need AED Battery.” the surveyor asked the BioMedical Manager and the Clinical Manager if the AED consistently needs new batteries what should be done and should the AED be checked more frequently. The BioMedical Manager informed the surveyor that a “new AED should be ordered.” The Clinical Manager corroborated that the AED batteries have been replaced several times and the AED will be checked on a “daily basis” until the battery has been replaced. · Review of the facility’s form entitled “Emergency Equipment & Medications Checklist” from 01/02/2025 through 02/25/2025 stated, “Note Any comments/actions on the back of this form.” Despite ongoing issues with the AED batteries, there was no documentation of actions taken to resolve the issue. The section labeled “AED batteries” was left blank.”

“EP Training and Testing CFR(s): §403.748(d), §416.54(d), §418.113(d), §441.184(d), §460.84(d), §482.15(d), §483.73(d), §483.475(d), §484.102(d), §485.68(d), §485.542(d), §485.625(d), §485.727(d), §485.920(d), §486.360(d), §491.12(d), §494.62(d). *[For RNCHIs at §403.748, ASCs at §416.54, Hospice at §418.113, PRTFs at §441.184, PACE at §460.84, Hospitals at §482.15, HHAs at §484.102, CORFs at §485.68, REHs at §485.542, CAHs at §486.625, “Organizations” under 485.727, CMHCs at §485.920, OPOs at §486.360, and RHC/FHQs at §491.12:] (d) Training and testing. The [facility] must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. *[For LTC facilities at §483.73(d):] (d) Training and testing. The LTC facility must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least annually. *[For ICF/IIDs at §483.475(d):] Training and testing. The ICF/IID must develop and maintain an emergency preparedness training and testing program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training and testing program must be reviewed and updated at least every 2 years. The ICF/IID must meet the requirements for evacuation drills and training at §483.470(i). *[For ESRD Facilities at §494.62(d):] Training, testing, and orientation. The dialysis facility must develop and maintain an emergency preparedness training, testing and patient orientation program that is based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, policies and procedures at paragraph (b) of this section, and the communication plan at paragraph (c) of this section. The training, testing and orientation program must be evaluated and updated at every 2 years. 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 the facility provided and maintained a safe treatment environment for its patients by ensuring the facility conduct fire drills quarterly per the facility’s policy. This failure placed the patients and visitors at potential risk of harm in the event of a fire. Review on 02/26/2024 of the facility’s policy: RM715 “Fire Safety Preparedness” page 1 number 4, “Fire drills will be conducted quarterly.” 1. During review of the emergency preparedness binder on 02/26/2025, it was noted that the facility had not conducted any fire drills since October 2023. The Clinical Manager was given the opportunity to provide additional documentation; However, no additional documents were provided. The Clinical Manager corroborated that the facility did not conduct fire drills and have “recognized that this is an area that needs improvement.””

“IC-TRAINING & EDUCATION CFR(s): 494.30(a)(1)(i) Infection Control Training and Education Infection control practices for hemodialysis units: intensive efforts must be made to educate new staff members and reeducate existing staff members regarding these practices. This Standard is not met as evidenced by: 44367 Based on record review, the Clinical Manager and the Medical Director failed to assure that facility staff members received the appropriate education and training on infection control practices for Hemodialysis as required.This failure placed patients, visitors and staff at potential risk for exposure to bloodborne pathogens and infectious diseases. Staff: #4, #5, #6 and #7 Findings include: According to the Occupational Safety and Health Administration (OSHA), dialysis staff must receive bloodborne pathogen training annually with personnel records reflecting staff having received appropriate infection control training. Furthermore, the Centers for Disease Control and Prevention (CDC) also states that they recommend infection control training initially on employment and annually. Review on 02/25/2025 of the facility’s policy “G40 Infection Control” revealed “1. All IRC associates and infection control measures as outlined in the policy will be used by all associates at all times. 2. All IRC associates will be trained regarding IRC policies and procedures for infection control.” On 02/27/2025, during record review of the facility’s personnel files, it was noted that 4 out 16 or 25% of the employees did not receive annual infection control training. The Clinical Manager was given the opportunity to provide additional information.”

“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: #1 and #2 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 02/25/2025 of the facility’s policy “ICS05A CVC: Initiation & Discontinuation of Treatment”, page 4 number 17, “Disinfect the arterial connection prior to disconnection.” Page 4 number 21 states, “Disinfect the venous connection with a new antiseptic pad. Disconnect the venous blood line from the venous catheter limb.” Review on 02/25/2025 of the facility’s policy ICO5C CVC: “Dressing Change” revealed that “Unless otherwise recommended by the catheter manufacturer, the Innovative Renal Care and American Renal Associates’ (IRC/ARA) procedure for dressing changes will require cleaning and disinfection with one of the following, used per the manufacturer’s instructions: 2% Chlorhexidine with alcohol, > 70% Alcohol, > 10% Povidone-iodine.” 1. During observation of the clinical treatment area on 02/25/2025 at 10:29 a.m. at station #11, the surveyor noted that Staff #1 did not clean the CVC arterial hub or the venous hub before or after disconnecting the bloodline to return the patient’s blood. 2. During observation of the clinical treatment area on 02/25/2025 at 11:04 a.m. at station #5, the surveyor noted that Staff #2 cleaned the catheter exit site with an alcohol pad. The surveyor asked the Clinical Manager if the patients’s catheter was manufactured to use alcohol or another cleansing agent. According to the Clinical Manager, the facility only uses alcohol wipes on all the patients’ catheters. The Clinical Manager corroborated that alcohol is the only cleaning agent for all the patients’ catheters.”

“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 despite several abnormal results. 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 02/24/2025 of the facility’s policy, “AAMI Chemical Analysis of Water and Dialysis” page 5 states, “Medical Director must review and sign each chemical analysis report obtained during the review period.” Review on 02/25/2025 of the facility’s policy, “Water Documentation” states, “All Spectra and D&D microbiology results, must be printed from a PDF file, either from the laboratories website or a laboratory email. The PDF is then presented, during the monthly TQM and signed by the Medical Director.” Review on 02/25/2025 of the facility’s monthly RO water, dialysate, HD machine culture reports, and an interview with the Biomedical staff and the Clinical Manager revealed that the medical director did not sign and date (proof of acknowledging the culture collection results during the review period) reports monthly as per policy, despite abnormal results. The Biomedical Technician and the Facility Administrator corroborated that the culture reports were not signed by the medical director monthly. 1. Water cultures results from 02/15/2024 through 04/30/2024 had several abnormal results. The Medical Director signed the results from 02/15/2024 though 04/30/2024 on 05/23/2024 despite abnormal results for the month on February 2024, March 2024 and April 2024. 2. Water cultures results verified on 11/13/2024 and 11/15/2024 were not signed by The Medical Director until 01/23/2025. (Cross referenced with V0715)”

“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: 44367 Based on observations and interviews with the facility’s administration, the governing body failed to ensure that the physical structure of the dialysis facility and the water treatment room was kept intact and obstacle free at all times. This failure placed the patients at potential risk of harm including exposure to hazardous or infectious material from a potentially contaminated water system. Findings included: On 02/25/2025, according to the “American Journal of Kidney Diseases” the “Physical environment requirements of the CfC address building safety, equipment maintenance, the patient care setting, emergency preparedness, and fire safety. This includes the ensurance of proper maintenance and repair of such items as the dialysis equipment, operating systems, water treatment systems, and physical building and grounds.” On 02/25/2025 at 10:30 a.m., inspection of the clinical treatment area and the water treatment room revealed the following: · The drain under Valve 41 (V41) had a large black stain inside of the drain and smaller brown stains on the outer surface. · Gross amount of crystallization, approximately one inch thick, covering the entire surface under the Bicarbonate Tank. · Gross amount of crystallization, approximately one inch thick, covering the area of the floor to the right of the Bicarbonate Tank. · Moderate amount of white and brownish stains covering the entire surface of three large blue barrels of 2.0 K 2.5 Ca acid. The Clinical Manager and the Biomedical Manager were informed of the findings on 02/25/2025 and 02/26/2025.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 44367 Based on review of medical records, and interviews with the facility’s administrative staff, the governing body failed to ensure that a registered nurse (RN) completed an initial nursing assessment prior to the patients’ initial dialysis treatment when being admitted to the facility. This failure placed the affected patients at risk for harm. Patients: #3 and #5 Findings included: Review on 02/26/2025 of the facility’s policy IC 07 entitled “Patient Assessment: Pre and Post Dialysis” revealed that “If the patient is a new admission and has not been treated in the facility previously an RN must perform and document the full pre-dialysis assessment before the initiation of or at the beginning of the first treatment in the center to identify and address any problems that may prohibit or complicate the dialysis treatment.” During a review of four (4) selected patients’ medical records on 02/26/2025, the surveyor noted that one (1) out of the four (4) or 25% of the selected patients’ initial nursing assessment was completed one day after Patient #4 first dialysis treatment. The missing documentation was as follows: · Patient #3 was admitted to the facility on 02/17/2024. The initial nursing assessment was completed on 02/18/2024, which is one day after admission. Review on 02/27/2025 of the facility’s policy entitled “Cardiac Arrest” stated, “Document the event on Cardiac/Respiratory Arrest Record.” · Review on 02/27/2025 of the facility’s Mortality Review forms from 02/01/2024 through 02/26/2025 revealed Patient #5 suffered a cardiac arrest event while receiving a dialysis treatment. There was no Cardiac/Respiratory Arrest Record found in Patient #5’s paper or electronic chart. The Clinical Manager corroborated that the Cardiac/Respiratory Arrest Record was not completed when Patient #5 experienced cardiac arrest. The Clinical Manager corroborated that the assessment was completed one day after admission.”

“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 the same as what the patients received. Failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm, injury, and denied the patients their rights. Patients: #4 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 02/26/2025 of the facility’s policy entitled “Monitoring & Documentation of Patient Care During Treatment” stated, “the following must be documented before “starting” the patient’s treatment in the electronic documentation system: Treatment RX - indicating caregiver review and verification of all patient treatment data and machine set-up information.” A review of 4 patients’ treatment flowsheets on 02/26/2025 revealed that one (1) out of the four (4) or 25% of the selected patients did not receive the correct dialysis prescription as ordered by the Nephrologist. · On treatment date 02/21/2025, Patient #4’s BFR was prescribed for 350 ml/min.; However, the BFR was set at 400 ml/min from 12:18 p.m. to 4:10 p.m. There was no documentation found explaining why Patient #4’s BFR was not set on the dialysis machine as prescribed. The Clinical Manager was informed of the findings on 02/26/2025.”

“POC-COMPLETED/SIGNED BY IDT & PT CFR(s): 494.90(b)(1) The patient’s plan of care must- (i) Be completed by the interdisciplinary team, including the patient if the patient desires; and (ii) Be signed by the team members, including the patient or the patient’s designee; or, if the patient chooses not to sign the plan of care, this choice must be documented on the plan of care, along with the reason the signature was not provided. This Standard is not met as evidenced by: 44367 Based on the patient record review and interviews with the facility’s administration and patients, the governing body and interdisciplinary team (IDT) failed to ensure that all patients were given the opportunity to participate in his or her plan of care (POC). This failure denied patients their right to be involved in his/her care and the ability to advocate for themselves. Patient: #1 and #3 The patient has the right to 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. Patients have the right to know about and participate in their care and treatment to the extent they desire. The patient should be informed of the plan of care meeting and given the opportunity to attend. Review on 02/26/2025 of the facility’s policy entitled “Comprehensive Patient Assessments”, page 1 number 1 revealed, “The comprehensive patient assessment is completed by the facility’s interdisciplinary team (IDT) that consist if the, at minimum: The patient or patient’s designee.” Review on 02/26/2025 of the facility’s medical records revealed that two (2) out of the four (4) or 50% of the selected patients did not sign their comprehensive assessments care plan meeting as evidence of attending or opting not to attend the meeting. 1. Patient #1 was admitted to the facility on 05/09/2024. The 30-day care plan meeting held on 06/06/2024 and 90-day care plan meeting held on 08/06/2024 were not signed by Patient #1. 2. Patient #3 was admitted to the facility on 03/05/2024. The 90-day care plan meeting held on 07/25/2024 was not signed by Patient #3. The Clinical Manager corroborated that Patient #1 and #3 did not sign the mentioned care plans.”

“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: 44367 Based on observations, staff interviews and review of the facility’s policies and procedures, the medical director and the governing body failed to ensure that the facility’s staff members adhered to their own policies and procedures related to abnormal water cultures. This failure posed a potential risk of safety to the patients. Findings include: Review on 02/25/2025 of the facility’s “Technical Operations Manual” revealed “Microbiological Standard: Standard level exceeded occurs when a parameter surpasses or equals the predefined maximum value set by regulatory standards,,,An action level is the level at which remedial steps must be taken...If the standard is exceeded: An incident report will be completed; Plan of correction will be reported and documented in QAPI.” Review on 02/25/2025 of the facility’s policy entitled “Clinical Incident Review and Reporting” stated, “All incidents must be reported through ARA’s incident reporting system, and the incident report should be submitted within 24 hours of the occurrence of the incident..” Review on 02/25/2025 of the facility’s water culture results from February 2024 through December 2024 revealed several abnormal results. The surveyor requested an incident report for results that exceeded acceptable parameters for water cultures results for March 2024, April 2024, May 2024, June 2024, July 2024, August 2024, and December 2025; However, no incident reports were provided. The Clinical Manager and the Biomedical Manager corroborated that incident reports were not completed for the abnormal water cultures. (Cross-referenced with V0179)”