Fresenius Kidney Care Broadway Street

“BICARB MIX SYS-EMPTY/DISINFECT/PREV CORROSION CFR(s): 494.40(a) 5.4.4.3 Bicarbonate concentrate mixing systems: empty/ disinfect/prevent corrosion Bicarbonate concentrate mixing tanks should be designed to drain completely. Mixing tanks should have a tight-fitting lid and should be designed to allow all internal surfaces to be disinfected and rinsed. Because concentrate solutions are highly corrosive, mixing systems should be designed and maintained to prevent corrosion. This Standard is not met as evidenced by: 36839 Based on review of the bicarbonate system daily rinse logs, the facility’s policies and procedures and interviews with the bio-medical personnel, the governing body and the medical director failed to ensure that the assigned staff member rinsed and cleaned the bicarbonate system on a daily basis. This failure placed the patients at potential exposure to contaminated dialysate. Findings included: Water quality is of utmost importance in the treatment of dialysis patients, according to the Association for the Advancement of Medical Instrumentation (AAMI). Failure to adequately rinse and disinfect the bicarbonate concentrate system can pose potential hazards. Daily and weekly cleaning of the bicarbonate system is essential, as inadequate maintenance may lead to four significant consequences: (1) bacterial build-up, (2) biofilm formation, (3) precipitation build-up, and (4) the presence of disinfectant residue. Ensuring the proper preparation of bicarbonate concentrate is imperative for the safe and effective delivery of dialysis treatment. According to the facility’s policy on bicarbonate concentrate mixing (reference #45007, pages 4-5), “Bicarbonate solution expires 24 hours after mixing and must be used within this time period. To assure this, the following will occur: The entire system must be rinsed clear of bicarbonate concentrate within the 24-hour period. The rinse must include all jugs (if used), mix tank(s), header or distribution tank(s), and bicarb loop(s)...The results of bicarbonate mixing and quality assurance will be documented on the Bicarbonate Mixing log form BM-1 or company-approved electronic records system.” On 1/12/2024, a review of the bicarbonate rinse logs from 10/1/2023 to 1/11/2024 showed no documentation that the bicarbonate tank was cleaned and rinsed at the end of the day on the following dates: 11/6/2023, 11/17/2023, 11/27/2023, 12/8/2023, 12/20/2023 and 12/24/2023. These findings were verified by the biomedical manager at the time of log review, and again discussed with the facility’s administrative team during the exit conference on 1/12/2024.”

“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: 36839 Based on observations, the governing body failed to ensure that the facility’s environment is free from defects or hazards. This failure to maintain safety and functionality placed the patients, staff and visitors at potential risk for harm and possible exposure to infectious diseases. Findings included: To guarantee safety and operational efficiency, it is essential to keep a dialysis facility devoid of defects and hazards. All surfaces must remain intact, clean and undamaged to facilitate thorough cleaning and disinfection, preventing the proliferation and spread of microbial organisms. During an inspectional tour of the facility on 1/12/02024 it was noted that the surface of the flooring in the supply room was peeling and had multiple cracks in various areas. This finding was confirmed by the clinical manager and discussed with the administrative team during the exit conference on 1/12/2024.”

“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: 36839 Based on observations and interviews with the clinical and administrative staff, the governing body failed to ensure that all equipment used in the facility and patient supplies used for dialysis treatment, were free from defects and were maintained in a manner that provided for patient safety. This failure placed the affected patients at potential risk of harm. Findings included: Removing expired supplies in healthcare settings is crucial for patient safety, maintaining quality standards, accurate recordkeeping, regulatory compliance, and ensuring effective infection control. Expired supplies and broken or non-functional equipment may compromise patient well-being, violate quality assurance standards, and undermine infection control efforts. During observations and inspection of supplies and equipment on the clinical floor on 1/12/2024, the following were noted: 1. A broken soap dispenser located at the clean sink facing stations #8 and # 17. 2. 28 expired 16-gauge needles with lot# 180813351 had an expiration date of 8/13/23. These findings were verified with the charge nurse and discussed with the administrative staff during the exit conference on 1/12/2024.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 36839 Based on observations, the facility’s governing body failed to ensure that every patient’s vascular access was visible during hemodialysis treatment. This failure placed the patients at potential risk of harm and possible death. Findings included: A staff member must maintain visual access to every patient, including their face, vascular access site, and bloodline connections, throughout the dialysis procedure. Covering these areas might lead to undetected accidental needle dislodgement or line disconnection, which, within minutes, could cause severe blood loss and endanger the patient’s life. Patients can refuse aspects of their treatment plans, but if a patient declines to keep their access uncovered during dialysis, the facility should educate them about the risks, assess their reasons, and create a care plan. Simply having a patient sign a waiver does not absolve the facility from monitoring the access site. During observations on the clinical floor on 1/12/2024, it was noted that the vascular access site of the patient at station #1 was covered with a blanket during dialysis treatment from 10:05 a.m. to 10:25 a.m. This finding was confirmed by the charge nurse upon observation, and discussed with the administrative team during the exit conference on 1/12/2024.”

“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: 36839 Based on patient record review, the governing body and the interdisciplinary team (IDT) failed to ensure that a Plan of Care (PoC) has been conducted on all new patients within the latter of 30 calendar days, or 13 treatments beginning with the first outpatient dialysis session. This failure placed the affected patient at potential risk of harm and denied the patients their rights. Patients: #2 and #3 Findings included: The Centers for Medicare and Medicaid Services (CMS) require a PoC to be completed for each new dialysis patient within 30 days or 13 treatments, whichever comes first, starting from the first dialysis session. The purpose of this assessment is to provide a comprehensive evaluation of the patient’s physical, psychosocial, and medical status, which is used to develop an individualized care plan for the patient. A review of the sampled patients’ medical records on 12/1/2024 showed that: 1. Patient #2’s initial dialysis treatment in the facility was on 8/8/2022. No initial PoC was found in the patient’s medical records. 2. Patient #3’s initial dialysis treatment in the facility was on 5/12/2023; the initial PoC was done on 7/12/2023 which was greater than 30 days or 13 hemodialysis treatments from the patient’s first dialysis session. These findings were verified by the clinical manager and discussed with the administrative team during the exit conference on 1/12/2024.”

“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: 36839 Based on review of medical records, the governing body failed to ensure that the facility’s interdisciplinary team (IDT) completed a follow-up Plan of Care (PoC) 90 days after the initial PoC, on all their patients. This failure placed the affected patient at risk for receiving inadequate health care and denied their patient rights. Patients: #2 and #3 Findings included: The IDT should conduct a follow-up PoC 90 days after establishing the initial PoC. This assessment evaluates health changes, PoC effectiveness, and identifies new needs. Collaborating with the patient (or designee), a nephrologist, nurse, social worker, and dietitian ensures proper addressing of patient needs and PoC adjustments if health status changes. For experienced dialysis patients moving to a new facility, the receiving IDT must reassess within three months of admission. Upon review of the sampled patients’ medical records on 1/12/2024, the following were noted: 1. Patient #2’s first dialysis session in the facility was on 8/8/2022; no initial PoC was found in the patient’s medical records. A “follow-up” PoC was dated 4/12/2023 which was done 7 months after the patient’s initial dialysis session. 2. Patient #3’s initial PoC was done on 7/12/2023. The follow-up PoC was done on 11/7/2023 which was greater than 90 days from the initial PoC. These findings were discussed with the administrative team during the exit on 1/12/2024.”

“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: 36839 Based on observations and a review of the facility’s policies and procedures, the medical director and the facility’s administration failed to ensure that the staff adhered to their policies and procedures. This failure posed a potential risk of safety to the patients and denied patients their rights to a minimum standard of medical care. Findings included: A review of the facility’s policy on Medication Preparation and Administration (Reference #47488, page 3) states, “Pre-drawing medications: Medications may be pre-drawn up to 4 hours prior to administration. These pre-drawn medications shall be labeled and must be kept under the preparer’s control or in a locked designated medication storage area, or refrigerated, if necessary, until delivery to the appropriate patient for administration.” During observations on the clinical floor on 1/12/2024 at 10:35 a.m., two labeled 10-mL syringes containing pre-drawn heparin were noted to be placed on the left side table of an unoccupied dialysis chair at station #5. The clinical staff assigned to that station was attending to another patient at the time. This finding was discussed with the administrative team during the exit conference in 1/12/2024.”