Fresenius Kidney Care Frederick

“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: 36839 Based on observations and a review of the facility’s policies and procedures, the governing body failed to ensure that all clinical staff followed the infection control policies when caring for their patients. This failure placed the patients and staff at risk for nosocomial infections (infection acquired while in a health care setting). Findings included: Gloves act as a barrier against exposure to bodily fluids, blood, and other potentially infectious materials, reducing the risk of acquiring infections. Routine exposure to blood and potentially contaminated items can be anticipated during hemodialysis therefore, gloves are required whenever caring for a patient or touching the patient’s equipment. During observations on the dialysis treatment floor on 2/19/2025 from 12:20 to 12:30 p.m., it was noted that the physician went to stations #9, #10, #11 and #12, spoke with the patients, touched the buttons of the dialysis machines, and tapped/touched the patients’ hands without any gloves on or performing any hand hygiene in between patients.”

“IC-SUPPLY CART DISTANT/NO SUPPLIES IN POCKETS CFR(s): 494.30(a)(1)(i) If a common supply cart is used to store clean supplies in the patient treatment area, this cart should remain in a designated area at a sufficient distance from patient stations to avoid contamination with blood. Such carts should not be moved between stations to distribute supplies. Do not carry medication vials, syringes, alcohol swabs or supplies in pockets. This Standard is not met as evidenced by: 36839 Based on observations, the facility’s administration failed to comply with infection control procedures as set in the Centers for Disease Control and Prevention (CDC) guidelines that clean equipment should remain in a designated area at a sufficient distance from the patient stations to avoid contamination with blood. This failure placed the patients and staff at potential risk of harm for cross-contamination during hemodialysis treatments. Findings included: According to the CDC’s recommendation for preventing transmission of infections among chronic hemodialysis patients, if common devices, equipment and supplies are used, they must be kept in a designated area away from any areas where the spurting of blood or fluid may occur. During observations on the clinical floor on 2/19/2025, it was noted that a set of privacy screens and 2 intravenous (IV) poles were placed approximately 2 feet from the dialysis chair at patient station #10.”

“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, the facility’s administration failed to ensure that all supplies used for the patients were maintained in a manner that provided safety. This failure placed the affected patients at potential risk of harm. Findings included: Expiration date is the date after which a consumable product should not be used because it may be spoiled, damaged or ineffective. When medications and supplies have reached their expiration date, they should be disposed of promptly. During inspection of supplies in the laboratory area of the clinical treatment room, it was noted that 6 red tiger-top blood collection tubes packed in transplant kits had gone past the expiration dates. Two tubes had an expiration date of 6/30/2024, one tube had an expiration date of 9/30/2024, and three tubes had an expiration date of 1/31/2025.”

“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: 36839 Based on review of the dialysis patients’ treatment flowsheets and the facility’s policies and procedures (P&P), the facility’s administration and clinical staff failed to ensure that the dialysis prescriptions were the same as what the patients received. The failure to ensure that the dialysis prescription was implemented according to the doctor’s orders placed the patients at potential risk of harm or injury. Patients: #2 and #3 Findings included: In order to have an effective dialysis treatment, the Blood Flow Rate (BFR) must be accurate and reflect the doctor’s prescription. The staff member must verify that the rate on the readout is correct. According to The Centers for Medicare and Medicaid Services (CMS), the BFR is part of the order for treatment; there could be a “sliding scale” guide or protocol for adjusting the BFR. If not, there would need to be an order for the change. If the staff is not able to achieve the ordered BFR, the record should address this issue, including the date and time that this problem was communicated to the physician. The facility’s P&P on Patient Assessment and Monitoring (FMS-CS-IC-I-110-131C) states, “Check machine settings and measurements. Check prescribed blood flow is being achieved or reason is documented in medical record if unable to meet prescribed blood flow.” Upon review of the sampled patients’ treatment flowsheets on 2/20/2025, the clinical staff failed to provide supporting documentation as to why the patients’ dialysis prescriptions were not followed: 1. On treatment date 2/14/2025, Patient #2’s BFR was adjusted to 400 mL/min by the third hour of treatment. On treatment date 2/17/2025, the patient’s BFR was set at 400 mL/minute throughout the patient’s treatment time. No supporting documentation was found explaining why the prescribed BFR of 450 mL/minute was not followed on both days. 2. On treatment date 2/15/2025, Patient #3’s BFR was set at 400 mL/minute during the first hour of dialysis treatment. On treatment date 2/18/2025, the patient’s BFR ran at 300 mL/minute during the first 2 hours of treatment. No supporting documentation was found explaining why the prescribed BFR of 475 mL/minute was not followed on both days. These findings were reviewed and verified by the facility’s clinical manager during the review of the medical records and again discussed with the administrative team during the exit conference on 2/20/2025.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 36839 Based on the review of patient records and the facility’s policies and procedures (P & P), the governing body failed to ensure that all clinical staff complied with the monitoring and performing of appropriate procedures when certain parameters exceeded the normal values during their patients’ dialysis treatments. This failure placed all affected patients at potential risk of harm. Patients: #2 and #3 Findings included: The facility’s P & P on Patient Assessment and Monitoring (FMS-CS-IC-1-110-131C) states, “An abnormal finding confirmed by the registered nurse (RN) will be reported to the attending physician, if necessary, as determined by the clinical judgement of the RN for assessment and intervention... that the direct patient care staff must notify the nurse when a patient’s systolic blood pressure (BP) is greater than 180 mmHg and/or a diastolic blood pressure greater than 100 mmHg. On 2/20/2025, a review of the sampled patients’ treatment flowsheets revealed that no documentation was made by the clinical staff addressing these patients’ blood pressures that have exceeded the normal values: 1. On treatment date 2/14/2025, Patient #2 had a BP reading of 205/81 mmHg at 11:30 a.m. and 210/83 mmHg at 12:10 p.m. On treatment date 2/17/2025, the patient had a BP reading of 212/76 at 11:47 a.m., 224/143 mmHg at 12:06 p.m., 186/73 mmHg at 2:00 p.m. and a 190/77 at 3:14 p.m. 2. On treatment date 2/18/2025, Patient #3 had a BP reading of 184/92 mmHg at 12:20 p.m., 184/92 at 12:59 p.m., and 181/91 mmHg at 1:36 p.m.”

“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 the sampled patients’ medical records, the governing body failed to ensure that the facility’s interdisciplinary team (IDT) completed the 90-day follow-up comprehensive assessment. This failure placed the affected patient at risk for receiving inadequate health care and denied the patient his/her rights. Patients: #1 Findings included: The IDT should conduct a comprehensive plan of care (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. Upon review of Patient #1’s medical records with the clinical manager on 2/20/2025, it was revealed that Patient #1, whose first dialysis treatment at the facility was on 1/20/2023, with an initial PoC conducted on 2/10/2023, had a follow-up PoC done on 6/28/2023 which was greater than 90 days from the date of the initial PoC.”