Davita Meadows East Dialysis

“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: 52066 Based on observation, interview, and facility policy review, the facility failed to ensure 2 of 6 staff observed performed hand hygiene after glove removal and prior to patient contact (Certified Clinical Hemodialysis Technicians [CCHT] #5 and Registered Nurse [RN] #1). In addition, CCHT #5 and RN #1 were observed to use gloved hands to touch the patient dialysis equipment. The failure to perform hand hygiene and the improper use of gloves provided a mode for cross contamination with a potential spread of pathogens, which could negatively impact the health of all 38 patients receiving dialysis treatment at the facility. The findings include: Review of the facility policy titled, “Infection Control for Dialysis Facilities,” revised date 04/2023, revealed, “Hand Hygiene 1. All teammates, Physicians and Non-Physicians will perform hand hygiene a. upon entering and exiting the patient treatment area, b. prior to gloving and immediately after removal of gloves.” Per the policy, “7. Disposable gloves will be worn when caring for the patient or touching the patient’s equipment at the dialysis station,” to include patients and visitors assisting with procedures such as self-cannulation or holding access sites. Continued review revealed gloves should be changed when soiled with blood, dialysate or other body fluids; when going from a “dirty” area or task to a “clean” area or task; and when moving from a contaminated body site to a clean body site of the same patient. Further review revealed gloves were also to be changed after touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s delivery system. 1. During observation of the treatment room floor on 01/20/2025 at 11:50 AM, at Station #4, CCHT #5 donned a pair of clean gloves and applied antiseptic to the patient’s left upper access without first performing hand hygiene. CCHT #5 was then observed to input information into the computer without performing hand hygiene and was visualized to put on clean gloves without performing hand hygiene. Further observation revealed CCHT #5 cannulated the patient’s access site, and initiated treatment. During interview on 01/20/2025 at 12:15 PM, CCHT #5 stated she “probably” had not performed hand hygiene. CCHT #5 stated she sometimes forgot to perform hand hygiene because she moved so fast. 2. During an observation of the treatment room floor on 01/21/2025 at 12:12 PM, RN #1 obtained one clean glove, wrapped a portion of the glove around his finger and silenced a dialysis machine alarm at Station #11. Per observation, RN #1 then used the same glove wrapped around his finger and silenced a dialysis machine alarm at Station #12. During observation of the treatment room floor on 01/21/2025 at 12:40 PM, RN #1 touched the dialysis machine screen at Station #9 without gloves on, while a patient was receiving treatment. Further observation revealed RN #1 did not perform hand hygiene after that and prior to typing on a computer. During interview on 01/21/2025 at 1:46 PM, RN #1 acknowledged not wearing gloves when he touched the dialysis machine. The RN said gloves were to be worn when he touched the dialysis machine. He reported he had “gotten into a bad habit.” RN #1 confirmed the expectation and his training were to wear gloves and perform hand hygiene. During interview on 01/22/2025 at 11:55 AM, the interim Facility Administrator acknowledged staff had been trained and were expected to perform hand hygiene before and after glove use. The interim Facility Administrator further stated staff were expected to apply gloves before they touched the dialysis machines. During an interview on 01/22/2025 at 4:28 PM, the Medical Director acknowledged staff were expected to perform hand hygiene and wear gloves when they touched the dialysis machines because of the potential of blood contact.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 52066 Based on observation, interview, and facility policy review, the facility failed to ensure staff performed aseptic technique during preparation of intravenous medications for administration during 2 of 2 observations. Registered Nurse (RN) #1’s failure to utilize aseptic technique during medication preparation of intravenous medications for administration provided an opportunity for contamination and the potential to impact the health and well-being of the 38 patients receiving dialysis treatment at the facility. The findings include: Review of the facility policy titled, “Preparation and Administration of Parenteral Medications,” revised 04/2024, revealed, “7. If the medication is in a vial, remove the vial cap, and clean vial stopper with an alcohol prep pad. A new alcohol prep pad is used prior to each time a vial is entered.” During observation of the medication preparation area on 01/21/2025 at 11:23 AM and 12:45 PM, revealed RN #1 failed to disinfect the diaphragm of a medication vial prior to punturing it with a syringe with a needle attached to it. During interview on 01/21/2025 at 1:46 PM, RN #1 said staff were trained and expected to disinfect the diaphragm of a medication vial once the cap was removed and before the septum was punctured with a needle attached to a syringe, during the preparation of intravenous medications. During interview on 01/22/2025 at 11:55 AM, the interim Facility Administrator stated staff were trained and expected to disinfect the diaphragm of a medication vial before puncturing it with a needle attached to a syringe during preparation of intravenous medications for administration. During interview on 01/22/2025 at 4:28 PM, the Medical Director stated staff were expected to disinfect the diaphragm of a medication vial prior to insertion of a needle with a syringe.”

“ENVIRONMENT-SECURE & RESTRICTED CFR(s): 494.40(a) 8 Environment: secure & restricted The water purification and storage system should be located in a secure area that is readily accessible to authorized users. The location should be chosen with a view to minimizing the length and complexity of the distribution system. Access to the purification system should be restricted to those individuals responsible for monitoring and maintenance of the system. This Standard is not met as evidenced by: 52066 Based on observation, interview, and facility policy review, the facility failed to secure and restrict access to the water purification and storage system to only authorized personnel responsible for monitoring and maintenance of the water system. The failure had the likelihood to allow unauthorized personnel to access the water purification and storage system with the potential to negatively impact the safety and well-being of the 38 patients who received dialysis treatment at the facility. The findings include: Review of the facility policy titled, “Physical Environment,” revised 04/2018, revealed, “9. Systems to assure patient safety will be in place, such as...Access to patient treatment areas, water treatment systems, supply storage and dialysis equipment is restricted to authorized personnel only. Further review revealed access limitation did not “preclude visitors or tours by individual(s) authorized and supervised by facility personnel.” Review of the facility policy titled, “Water Treatment Systems Minimum Component Requirement,” revised 10/2021, revealed, “2. New and renovated water purification and distribution systems should be located in a secure area that is readily accessible to authorized teammates.” Per review, a location was to be chosen which minimized the length and complexity of the distribution system. Continued review revealed access to the water treatment system should be restricted to those personnel/trained teammates responsible for monitoring, maintenance of the system and supply ordering. Further review revealed an exception “to this may be made for janitorial services for maintenance of the physical environment. All deliveries made in close proximity to the water treatment system must be supervised.” During observation on 01/20/2025 at 10:15 AM, the Manager of Clinical Services entered a numeric code on the lock of the door which led into the supply area and access to the water purification and storage system. Observation revealed the code entered by the Manager of Clinical Services was the same numeric code used to access all interior doors of the facility. During interview on 01/22/2025 at 11:10 AM, the Biomedical Technician stated the numeric code used to access the supply area and water purification and storage system, was the same numeric code used throughout the facility. The Biomedical Technician further stated the numeric code use for accessing the supply area, and water purification and storage system, was known by staff who were not responsible for monitoring and maintenance of the water purification and storage system. During interview on 01/22/2025 at 4:45 PM, the Medical Director stated access to the water purification and storage system should be restricted to staff responsible for monitoring and maintenance of the water purification and storage system.”

“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: 35949 Based on observation, interview, and the manufacturer’s directions for use (DFU), the facility failed to follow the manufacturers’ DFU to maintain the integrity of the water purification system for 3 of 3 observations. The failure to follow the manufacturers’ DFU had the potential for equipment malfunction and introduction of pathogens into the water purification system, negatively impacting the safety and well-being of the 38 patients who received dialysis treatment at the facility. The findings include: Review of the manufacturer’s DFU titled, “Model 375, 375B Reduced Pressure Principle,” revised 03/2024, revealed, “Problem 2. Light Intermittent Drip Possible Causes 1. Slightly fouled #1 check Correction Action A. Clean #1 check and turn check valve seal ring over or replace.” Per the manufacturer DFU, “Continuous discharge of the relief valve” signified a failure of some part of the device and to help determine the specific area of failure, “close the #2 shut-off valve. If the discharge stops, the #2 check requires service. If the discharge continues, the #1 check requires service.” During observation of the water purification system on 01/20/2025 at 10:15 AM and at 2:30 PM, the discharge port of the backflow preventer valve was observed to leak and was wet to the touch. During observation of the water purification system on 01/22/2025 at 11:20 AM, the discharge port of the backflow preventer valve was observed to leak and was wet to the touch. In interview with the Biomedical Technician, at the time of the observation, the Technician stated no area in the water purification system should have water leaking from the discharge port of the backflow preventer. During interview on 01/22/2025 at 4:50 PM, the Medical Director stated she would be worried about a leak if she felt water under the backflow preventer port. The Medical Director stated the integrity of the water system should always be maintained. 52066”

“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: 35949 Based on interview, record review, and facility policy review, the facility failed to follow the individualized dialysis prescription as prescribed by the medical provider for 3 of 5 sampled patients (Patients #1, #2, and #4). The failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the 38 patients who received dialysis treatment at the facility. The findings include: Review of the facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024, revealed, “3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment with the exception of blood flow rate which is verified and documented when the ordered rate is obtained after onset of treatment. Per review, the prescription components were confirmed by a licensed nurse within one (1) hour of treatment initiation along with the nursing assessment “or as allowable by state law.” Further review of the policy revealed, “10. If the dialysis prescription is not being met (including dialysis flow rate or change/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.” 1. Review of Patient #1’s treatment sheet dated 01/02/2025, revealed a prescribed blood flow rate (BFR) of 450 milliliters per minute (mL/min). Continued review revealed Patient #1’s BFR was documented as 420 mL/min from 12:19 PM until the treatment was terminated at 2:05 PM. Further review revealed however, no rationale documented as to why the prescribed BFR was not achieved. Review of Patient #1’s treatment sheet dated 01/07/2025, revealed a prescribed BFR of 450 mL/min. Continued review revealed Patient #1’s BFR was documented as 400 mL/min during the entire treatment. Further review revealed however, no rationale documented as to why the prescribed BFR was not achieved. 2. Review of Patient #2’s treatment sheet dated 01/04/2025, revealed a prescribed blood flow rate (BFR) of 400 milliliters per minute (mL/min). Continued review revealed Patient #2’s BFR was documented as 450 mL/min during the entire treatment. Further review revealed however, no rationale documented as to why the prescribed BFR was not achieved. 3. Review of Patient #4’s treatment sheet dated 01/04/2025, revealed a prescribed blood flow rate (BFR) of 250 milliliters per minute (mL/min). Continued review revealed Patient #4’s BFR was documented as 200 mL/min from 7:45 AM until the treatment was terminated at 9:50 AM. Further review revealed however, no rationale documented as to why the prescribed BFR was not achieved. Review of Patient #4’s treatment sheet dated 01/07/2025 revealed a prescribed BFR of 250 mL/min. Continued review revealed Patient #4’s BFR was documented as 200 mL/min during the entire treatment. Further review revealed however, no rationale documented as to why the prescribed BFR was not achieved. Review of Patient #4’s treatment sheet dated 01/09/2025 revealed a prescribed BFR of 250 mL/min. Continued review revealed Patient #4’s BFR was documented as 200 mL/min from 10:08 AM until the treatment was terminated at 11:08 AM. Further review revealed however, no rationale documented as to why the prescribed BFR was not achieved. Review of Patient #4’s treatment sheet dated 01/18/2025 revealed a prescribed BFR of 350 mL/min. Continued review revealed Patient #4’s BFR was documented between 180 mL/min and 300 mL/min from 8:59 AM until the treatment was terminated at 10:17 AM. Further review revealed however, no rationale documented as to why the prescribed BFR was not achieved. During interview on 01/21/2025 at 11:10 AM, the interim Facility Administrator stated staff were expected to document the reasons when patients’ prescribed BFRs were not achieved. During interview on 01/22/2025 at 2:25 PM, Registered Nurse #3 stated she was trained and expected to document a reason when the prescribed BFRs were not achieved. During interview on 01/22/2025 at 2:35 PM, Certified Clinical Hemodialysis Technician #5 said he was trained and expected to document a reason a patient’s BFRs were not achieved. During interview on 01/22/2025 at 4:15 PM, the Medical Director stated staff were expected to document a reason or rationale for changes to a patient’s prescribed BFRs.”