Bay Area Regl Dialysis Ctr - Saginaw Riverside

“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: 45246 Based on observation, interview, and record review, the facility failed to ensure clean supplies and patients’ equipment were not in close proximity with dirty materials, and patients’ belongings were stored off the floor, resulting in the potential for the spread of infection and potential for negative patients’ outcomes for all patients receiving dialysis treatment at the facility . Findings include: During the initial tour of the facility on 07/28/25 from 1000 to 1130, in a pod A area red biohazard bin was observed touching the supplies cart with 2 clean packs of bleach towels stored on the second shelf. The patient’s wheelchair was observed positioned next to the large gray trash can and trash bag was touching the chair. On 07/28/25 at approximately 1540, the facility administrator, Staff A, confirmed that clean supplies and patients’ belongings should be stored away from the dirty materials. Facility policy titled “Dialysis Precautions”, dated 01/04/2012, was reviewed and revealed: “Clean versus Dirty Areas. Clean areas should be clearly designated for the preparation and handling storage of medications and unused supplies and equipment. Clean areas should be clearly separated from dirty areas where used supplies, equipment or blood samples are handled or stored”. 38269 On 07/28/2025 during the initial tour of the facility from 1000 to 1130, eight (8) of twenty (20) stations (station # 8, #14, #18, #20, #21, #22, #23, and #24) were observed to have patient belongings setting directly on the treatment room floor. On 07/28/2025 at 1140, the facility administrator, Staff A, confirmed that patient belongings should not be stored on the treatment floor. On 07/28/2025 policy was requested and received: Facility policy titled “General Cleanliness and Infection Control Guidelines”, dated 05/05/2025, was reviewed and revealed: page 1 of 6 Supplies or patient’s belongings should not be kept or stored behind the machine. Without reference to storing personal belonging bags etc. directly on the treatment station floor.”

“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: 48030 Based on observation, interview and record review, the facility failed to maintain a clean environment, resulting in the potential for less than optimal outcomes related to infection prevention for the 94 patients that receive dialysis treatment at the facility. On 7/28/2925 at 1020 while entering the treatment care area for observations it was observed a rolling mop bucket with a mop and brownish water was sitting outside of the Supply Room adjacent to the patient care area and in close proximity to treatment station #21. On 7/29/2025 at 1050 while entering the treatment care area for observations it was observed the rolling mop bucket with a mop and brownish water was sitting outside of the Supply Room in the same location. On 7/29/2025 at 1050 during observation at station #10 a patient was viewed bleeding from her access site and a large amount of blood was noted on the dialysis chairside table and the floor next to the chair. During further observation at station #10 at 1050 Staff J was observed cleaning station #10 dialysis chairside table where visible blood was observed and the floor next to the treatment chair with disposable cloths soaked in a bleach solution. Staff K was observed bringing a mop with a rolling bucket to the chairside and using the mop to clean up the large amount of blood on the floor. It was observed Staff K mopped the floor and rolled the mop and bucket back over to the other side of the dialysis unit in front of the Supply Room. Staff K and Staff H were queried about the cleaning of the dialysis chairside table and floor and the visible blood. Staff K was asked what concentration of bleach was used and and responded they were using a 1:10 bleach solution in the mop bucket water. When queried how often the mop head and mop bucket water are changed, Staff K responded every morning. When queried if the mop and bucket are always stored on the unit in the patient care area, Staff K responded, “yes”. On 7/30/2025 at 1150 an interview with the Medical Director (Staff C) was conducted. During the interview Staff C was queried whether it was an expectation for facility staff to adhere to policies and procedures and replied, “yes, but there is always room for improvement”. On 7/29/2025 review of facility policy titled, “General Cleanliness and Infection Control Guidelines”, policy #47685, version 8, published 5/5/2025 revealed on page 3, in section titled “Detergents Germicides and Cleaning Supplies”, that “All cleaning supplies shall be stored in a designated area (i.e. janitorial closet) and “A clean mop head shall be used at the beginning of the day and after cleaning up large spills of blood and body substances.””

“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: 26222 Based on observation and interview, the facility failed to maintain the patient treatment area and storage in a clean and safe manner and failed to maintain building plumbing, resulting in the potential for contamination of the treatment area and the building water supply system. Findings include: On 07/28/25 at 10:00 AM, the storage room adjacent to the treatment floor was observed with the following conditions noted: the door was held open with a rubber door wedge; wheel casters, a cardboard box, dust and debris was on the floor; and a bottle of toilet bowl cleaner was on the top left shelf adjacent to clean supplies. BioMed Staff B was interviewed at this time and stated that the contracted housekeeping service is responsible for cleaning the room. When asked about the toilet bowl cleaner, BioMed Staff B stated it was likely for cleaning the toilet room next to the storage room. On 07/28/25 at 10:15 AM, the housekeeping closet in the service corridor was observed to have a mop sink faucet with a built in Atmospheric Vacuum Breaker (AVB) with a chemical dispensing system connected to the faucet. The water handles were observed in the on position, subjecting the AVB to constant pressure, which it is not designed or approved for, potentially causing it to malfunction over time. With the AVB in the open position and under constant pressure, contaminated water can be introduced to the water supply in a backsiphonage situation. On 07/28/25 at 11:30 AM, BioMed Staff B was queried on the presence of residential style dehumidifiers observed on the treatment floor. BioMed B stated that they do not have any oversight of that equipment or any preventative maintenance schedule for the dehumidifiers. Facility Administrator (FA) Staff A stated at this time that the patient care technicians empty the collection basins twice daily in the morning and again during the day, and that the contracted housekeeping staff are also asked to empty the basins when full. When asked about any cleaning or maintenance of the units, no response was provided. On 07/28/25 at 11:40 AM, the dehumidifiers on the patient treatment floor were observed with BioMed Staff B: A “Frigidaire 50 pint” dehumidifier unit was observed adjacent to stations 26 and 27. A “bucket full” red indicator light was on the front of the unit. Once opened, the bucket was observed approximately 3/4 full of water. Heavy dust accumulation was observed on the unit handle. A “Dayton” dehumidifier unit was observed near the nurse station. The bucket was observed nearly empty when removed and a layer of slimy debris was observed accumulated in the bottom of the bucket. A dehumidifier was observed near station 5. The bucket was approximately 1/3 full, and dust accumulation was observed on the back of the unit. A “Frigidaire” dehumidifier unit was observed near station 15. The bucket was approximately 1/3 full and dirt and dust accumulation was observed on the side where the air output was located. This surveyor could feel air movement blowing directly towards the patient located at station 15. A large floor fan was observed on the treatment floor near the exit door along the wall facing the river side of the room. Dust accumulation was observed on the blades of the fan. When queried about the fan, BioMed Staff B was unaware of the fan being on the treatment floor. Patient Care technician (PCT) Staff M stated it isn’t used and could possibly be from housekeeping when cleaning the floor. On 07/28/25 at 1:50 PM, FA Staff A was interviewed regarding the dehumidifiers. When asked if there were issues with the Heating Ventilation and Air Conditioning (HVAC) system of the building, FA Staff A responded that the HVAC system cannot keep up with the humidity and that the dehumidifiers were the solution they were given.”

“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: 45246 Based on observation, interview and record review, the facility failed to ensure that staff adhered to policy and procedure regarding food consumption, medication labeling and storage, and personal protective equipment use, resulting in the potential for negative patient outcomes and the potential for the spread of infection to all patients receiving dialysis treatment at the facility. Findings include: During the initial tour of the facility on 07/28/25 from 1000 to 1130, medication cabinets were found unlocked and with no staff in attendance/supervision. Medications were accessible and unsecured. Two medication vials were observed on the counter at the medication preparation station (next to dialysis station#1). Medication vials were opened and had medication solutions in them. Vials were not dated or initialed. There were two vials of Heparin 1:1000 found on the clean supply cart between dialysis stations # 12 and 16 (across form the nurses’ station) that were opened, not dated or initialed. Registered nurse, Staff N, confirmed the findings. During the tour registered nurse, Staff N, was observed transporting patients from the lobby to their dialysis treatment floor, completing patients’ assessments and transporting them to their dialysis stations. Staff N was wearing a white gown, untied, with an exposed back. The nurse proceeded to wear the same gown while exiting to the lobby, bringing multiple patients in and transporting them to their stations. When questioned regarding the gown use in the lobby (off the treatment floor) Staff N stated that staff has to wear gowns when providing patients’ care. On 07/29/25 approximately at 1410, during the interview the facility administrator, Staff A, confirmed that medications must be secured and labeled (dated). Additionally, Staff A stated that gowns need to be taken off when leaving the treatment area (in the lobby). On 07/30/25 at 1145, during the interview, facility’s medical director Staff C confirmed that all staff has to follow facility’s policies and procedures. Facility policy titled “Medication Preparation and Administration”, dated 02/06/2023, was reviewed and revealed: “Purpose: To administer medications with the goals of staff and patient safety, optimal therapeutic response, and infection control. Labeling vials. When preparing medications if the vial is not used immediately in its entirety, the nurse or PCT (patient care technician, if allowed by state regulations), must place the date and time the vial was opened on the medication label along with their initials. Note: To ensure all open vials are properly marked, the nurse must never walk away from an opened multi-dose vial without writing the date and time the vial was opened. Label any open multi-dose vial that is not used immediately and store vial accordingly. Securement. The following steps must be taken for the securement: All medications will be kept in a locked cabinet except when in use. One key to the medication cabinet will be kept by the charge nurse/team leader. The Clinical Manager will retain a spare key, kept in a secure location”. Facility policy titled “Personal Protective Equipment”, dated 11/06/2023, was reviewed and revealed: “The purpose of this policy is to identify Personal Protective Equipment (PPE) and potential areas for use. Employees who may have occupational exposure shall be provided, without cost, appropriate PPE including gloves, fluid resistant gowns, face shields masks, eye protection with full side shields. All personal protective equipment shall be removed prior to leaving the treatment area”. 38269 On 07/28/2025 during the initial tour of the facility from 1000 to 1130, twenty (20) of twenty-five (25) patients receiving hemodialysis treatment were observed eating and drinking with-in the dialysis treatment station. On 07/28/2025 at 1050, Staff I, Patient Care Technician (PCT) was queried regarding the patient food consumption during hemodialysis treatment. Staff I stated, “I have worked in other places and have never seen anything like this, they even order in, and the drinks are not really regulated either. We have a policy, but it is not really enforced.” On 07/29/2025 at 1430, the Director of Operations (registered dietician), Staff G, confirmed that patients eating during treatment should be limited to extenuating circumstances (such as diabetic needs) for patient safety. “Patients should not be consuming meals in the dialysis treatment area.” On 07/30/2025 at 1142, during an interview with the Medical Director, Staff C, it was confirmed that the expectation is that policies and procedures are followed for patient safety and best outcomes with improvements made when necessary. On 07/30/2025 at 1150, Facility Administrator, Staff A, was queried regarding patient food consumption during active hemodialysis treatments. Staff A stated, “patients are educated about the risks of food intake during treatments, but it has been out of control since Covid.” On 07/30/2025, review of the facility policy titled “Eating and Drinking Hot Liquids on Dialysis” published 02/01/2023: “Only physician prescribed supplements shall be consumed while on dialysis. Other restrictions: All other forms of eating and drinking are discouraged. Patients who need a snack or drink should consume any food or beverage in the waiting room before or after their treatment.””