Bma-Laplata

“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, patients and the facility’s administration, the facility’s governing body failed to ensure that the facility was sufficiently staffed on every treatment day. This practice compromised the safety and well-being of its patients and staff. Findings include: The Code of Maryland Regulations 10.05.04.06C(1)(a)(b)(c)(i)(ii) for Freestanding Kidney Dialysis Centers states “Dialysis Monitoring. Staffing Ratio. The monitoring individual-to-patient ratio at each center shall be a minimum of one staff member to three participants (patients) and staffing shall be sufficient to meet the needs of patients. The center shall establish provisions for back-up staff coverage during unexpected illnesses, vacations, and holidays. The charge nurse may not be included in the staffing ratio except when there are nine or fewer patients; or in the event of an emergency.” Review on 06/11/2025 of the staffing assignments sheets and staffing exception forms from 03/1/2025 to 06/10/2025 revealed the facility did not have a sufficient number of clinical staff to support the expected patient ration of 3:1 (3 patients to 1 patient care technician) on each treatment day. According to the staffing assignments sheets the facility had insufficient staff on approximately eight treatment days during the above date range. Three of the eight days did a staffing exception form was completed. The treatment days that were short staffed and did not have a staffing exception form were 04/23/2025, 05/12/2025 and 06/09/2025. The Clinical Manager corroborated that a staffing exception form was not completed for every treatment day that was short staffed.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 36839 Based on observations, the facility administration failed to ensure that personal protective equipment (PPE) was properly worn by all staff and patients whenever and wherever it is needed. This failure posed a risk of cross-contamination among patients, staff and visitors to infectious diseases and blood-borne pathogens. Findings included: 1. While this surveyor was at the facility’s reception area on 8/27/2024 at 11:26 a.m., a patient care technician (PCT), wearing complete PPE gown, mask and gloves, brought a patient in a wheelchair from the dialysis treatment room to the lobby. The Centers for Disease Control and Prevention’s (CDC) ‘Core Infection Prevention and Control Practices for Safe Healthcare Delivery in All Settings’ states: “Remove and discard PPE upon completing a task before leaving the patient’s room or care area.” 2. During clinical observations on the treatment floor on 8/27/2024 at 12:20 p.m., it was noted at dialysis station #6 that the patient’s mask was beneath the nose during the central venous catheter (CVC) put-on procedure. The National Kidney Foundation Vascular Access Guideline recommends the use of surgical masks to prevent airborne contaminants from both patients and staff when the catheter lumens or exit site are exposed. Staff, as well as patients and care partners, must wear a mask that covers the nose and mouth everytime the CVC is being accessed during the initiation and discontinuation of dialysis treatment, as well as catheter dressing change. These findings were discussed with the administrative team during the exit conference on 8/28/2024.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 36839 Based on observations and interviews with facility staff, the Facility Administrator and Medical Director failed to ensure that clean areas and patient supplies were protected from potential cross contamination (unintentional transfer of bacteria or other contaminants from one surface or substance to another especially because of unsanitary handling procedures). This failure placed the patients at potential risk for exposure to blood-borne pathogens and infectious diseases. Findings included: The patient treatment area should have designated “clean” and “dirty” areas. The Centers for Disease Control and Prevention (CDC) defines a “dirty” area as an area where there is a potential for contamination with blood or body fluids and areas where contaminated or “used” supplies, equipment, blood supplies or biohazard containers are stored or handled. A “clean” area is an area designated only for clean and unused equipment and supplies and medications. Staff must remain aware of the separation of clean and dirty areas to prevent cross-contamination. During observation on the clinical treatment floor, the following were noted: 1. In the isolation room, 2 empty plastic jugs, 1 container of vinegar, an unopened bag of dialysis bloodlines, a face shield, a glucometer set, and 3 boxes of gloves were placed next to the clean sink. 2. An empty reusable spray bottle, an iPad and iPad dock were placed next to the clean sink located across station #6. These findings were discussed with the administrative team during the exit conference on 8/28/2024.”

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 36839 Based on observations, the facility’s administration failed to ensure an environment free from defects in order to maintain safety and functionality. This failure placed the well being and safety of patients, staff, and visitors at potential risk for harm and possible exposure to infectious diseases. Findings included: Dialysis facilities must be defect-free with intact, clean surfaces to ensure effective cleaning and disinfection, preventing microbial growth. During inspection of furniture, equipment and supplies in various areas of the facility on 8/27/2024, the following were noted: 1. The dialysis chair at station #6 had 2 tears on the seat measuring approximately 0.5 inches in length. 2. One of the chairs at the patient’s waiting room had tears on the leather seat. These findings were shown to the facility administrator and discussed with the administrative team during the exit conference on 8/28/2024.”

“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, the facility’s administration failed to ensure that all supplies essential to the delivery of appropriate dialysis treatment were maintained in a manner that provided for patient safety. This failure placed the affected patients at potential risk of harm. Findings included: When medications and supplies have reached their expiration date, 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. During inspection of medications and supplies in the clinical treatment room on 8/27/2024, 2 sets of 15 g fistula needles with lot # 190410351 had expired on 4/10/2024. This finding was confirmed by the charge nurse on 8/27/2024.”

“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: During observations on the clinical floor on 8/27/2024, it was noted that the vascular access site of the patient at station #11 was covered with a blanket during dialysis treatment from 3:30 p.m. to 3:55 p.m. This finding was confirmed by the charge nurse upon observation, and discussed with the administrative team during the exit conference on 8/28/2024.”

“PR-RIGHTS POSTED,STATE/NW ONTACT INFO CFR(s): 494.70(c) The dialysis facility must prominently display a copy of the patient’s rights in the facility, including the current State agency and ESRD network mailing addresses and telephone complaint numbers, where it can be easily seen and read by patients. This Standard is not met as evidenced by: 36839 Based on observations, the governing body failed to ensure that the contact information for the State Survey Agency and Renal Network were current and accurate. This failure denied the patients their rights. Findings Included: The Centers for Medicare and Medicaid Services (CMS) requires that all in-center dialysis facilities post the current contact information for the applicable End-Stage Renal Disease (ESRD) Network and State Survey Agency (SSA) and the current complaint telephone numbers for each. The purpose of this posting is to ensure that patients are aware of their rights and have access to important contact information should they need to file a complaint or report a concern. However, it is important to note that this posting is meant to supplement, not replace, individual communication with each patient about their rights in a way that they can understand. During observations at the patient’s waiting room, it was noted that the contact information of the Office of Health Care Quality (OHCQ) and Quality Insights Renal Network 5 were not up to date. This finding was discussed with the administrative team during the exit conference on 8/27/2024.”

“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 a 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. 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: #1 and #6 Findings included: In order to have an effective dialysis treatment, the prescription order must be followed. The Blood Flow Rate (BFR), heparin order, treatment time, as well as the frequency of the patient assessment based on each facility’s policy must all be completed and documented. The reason being, an appropriate hemodialysis prescription is individualized to meet the dialysis needs of the patient. Through data collection and nursing assessment, providers can review the patient’s response to the treatment and make changes accordingly. A review of the sampled patients’ treatment flowsheets on 8/28/2024 revealed that 2 out of 6 sampled patients’ prescribed BFRs were not followed, and were not supported by any documentation explaining why the clinical staff deviated from the patients’ BFR prescription without the doctor’s order. 1. On treatment date 8/24/2024, Patient #6’s BFR ran at 300 mL/minute instead of 450 mL/minute. 2. On treatment date 8/26/2024, Patient #1’s BFR was turned down to 300 mL/minute instead of the prescribed BFR of 350 mL/minute beginning at the second hour until the end of the patient’s dialysis treatment. These findings were discussed with the administrative team during the exit conference on 8/28/2024.”

“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 patient record review, the facility’s administration failed to ensure that the clinical staff followed standard clinical practices in addressing blood pressures that went beyond the normal limits. This failure placed the affected patients at potential risk of injury or even death. Findings included: Because of the adverse effects of End Stage Renal Disease (ESRD), many patients experience lability of blood pressure (BP) and fluid management, the management of which may require reassessment of medication needs, adjustments in target weight, and changes to the Plan of Care (POC). Patients’ blood pressures must be monitored before, during and after dialysis treatment, and abnormally high or low values must be addressed. The patient records should show evidence that the patient’s individual dialysis needs have been assessed and the current dialysis prescription evaluated as to whether it is meeting those needs. Upon review of the sampled patients’ treatment flowsheets on 8/28/2024, it was noted that on treatment day 8/26/2024, Patient #3 had a BP reading of 201/121 mmHg at 11:29 a.m. and 204/112 mmHg at 2:10 p.m. No documentation was found addressing these high BP readings. This finding was discussed with the administrative team during the exit conference on 8/28/2024.”

“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. Patient #2 Findings included: A review of the sampled patients’ medical records on 8/28/2024 showed that Patient #2’s first dialysis treatment at the facility was on 2/16/2024; however, the initial PoC was not completed until 4/15/2024 which was greater than 30 days from the patient’s first dialysis session. This finding was discussed with the administrative team during the exit conference on 8/28/2024.”

“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: 36839 Based on observations and a review of the related policies and procedures, the facility’s administration failed to ensure that the clinical staff complied with the appropriate procedures in assessing the patients’ vascular access prior to cannulation, and practiced the correct infection control protocols. This failure placed the safety and well being of the patients at potential risk of harm in maintaining their vascular access. Findings included: During observations on the clinical floor on 8/28/2024, the following were noted: 1. At station #11, upon cannulation of Patient #7’s arteriovenous fistula (AVF), it was noted that the patient care technician (PCT) did not use a tourniquet. The facility’s policy on Needle Placement for Arterio-Venous (AV) Fistula and Graft (FMS-CS-IC-I-115-008A) states: “Needles will be placed into an AV fistula or AV graft to achieve access to the circulatory system in a manner that will minimize trauma and complications, and to ensure good blood flow through the dialysis system. A light tourniquet must be used with all fistulas.” 2. At station #14, the PCT touched the patient’s arterial access immediately prior to needle insertion after skin antiseptic had already been applied. The facility’s policy (Reference #45178) on skin disinfection prior to cannulation states: “#3 Do not touch cannulation sites after skin disinfection. Observe cannulation sites for any reaction to antimicrobial solution.” These findings were discussed with the administrative team during the exit conference on 8/28/2024.”