Davita Brown Deer Dialysis

“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: 27438 Based on observations, interview, and policy review, the facility failed to ensure staff wear personal protective equipment (PPE-used to prevent potential exposure) appropriately during initiation of dialysis treatment for one of two survey days. Failure to ensure proper use of disposable masks and/or shields provided a mode of cross contamination with the potential spread of infection which could negatively impact patients receiving dialysis treatments in this facility. Findings include: 1. Observations of the hemodialysis treatment area on 07/24/24 at 8:55 AM, revealed Patient Care Technician (PCT)9 initiating graft (type of access used for hemodialysis patients) arm access for Patient (P)7 at Station 7. PCT 9’s nose and mouth were uncovered during initiation of treatment. During an interview on 07/24/24 at 9:10 AM, PCT9 verified he/she had left both nose and mouth uncovered during initiation and that the facility policy is staff are to ensure the staff wore his/her disposable mask to cover both the nose and mouth during the initiation treatment to protect from blood during initiation of treatment. Review of the facility’s policy/procedure titled, “AV Fistula or Graft Cannulation with JMS Sysloc Mini Safety Fistula Needles (SFN) and Administration of Heparin Loading Dose,” revision date October 2022, indicated, “Put on PPE ...PPE is worn to protect teammate.” 2. Observations of the hemodialysis treatment area on 07/24/24 at 10:00 AM, revealed PCT13 initiating Central Venous Catheter (CVC-(type of fixed access used for hemodialysis patients) chest access for P8 at Station 19. PCT13’s eyes were uncovered during initiation of treatment when the face shield was raised above his/her eyes. During an interview on 07/24/24 at 10:12 AM, PCT13 verified his/her shield had been left above eye level during initiation of treatment and that the facility policy is staff are to ensure the staff wore his/her shield to cover both the eyes if not wearing protective eyewear during the initiation of CVC treatment to prevent contamination. Review of the facility’s policy/procedure titled, “Central Venous Catheter (CVC) with Clearguard HD Anti-microbial End Caps in Procedure,” revision date October 2023, indicated, “PPE-personal protective equipment (face protection, gloves, fluid resistant/fluid impervious barrier garment...PPE is worn by teammate.””

“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: 27438 Based on observation, interview, and review of policy, the facility failed to ensure that each disposable container for sharp objects was disinfected for the next patient’s use. This deficient practice had the potential to cause harm by transmission of bloodborne pathogens (infectious microorganisms in human blood that can cause disease in humans) from one patient to another in 6 of 20 dialysis stations, which could negatively impact patients receiving incenter dialysis treatments in this facility. Findings included: During an observation on 07/25/24 (a closed for treatment day at the facility) between 8:45AM and 9:00 AM, , revealed needle waste containers Stations 5, 7, 10, 16, 17, and 18 were observed to have brown drops around the outside top opening of the lid area used to drop the needles into. The needle waste containers are used for multiple patient treatments until the container level of full is reached. During an interview on 07/25/24 at 9:40 AM, Facility Administrator confirmed the observation of brown drops on the needle waste containers at Stations 5, 7, 10, 16, 17, and 18. The Facility Administrator verified the staff should disinfect needle waste containers as soon as possible and/or at least at the end of the treatment to ensure no “blood drops” are left on the container Review of the facility’s policy titled, “Infection Control for Dialysis Facilities,” revision date April 2023, indicated, “Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or potentially infectious materials. . .”””

“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: 27438 Based on observation, interview, and policy review, the facility failed to restrict access to the water purification room to only authorized users. Failure to restrict access to the water purification room to only authorized users who were responsible for monitoring and maintaining the water purification, had the potential to negatively impact the safety and well-being of the 31 in-center dialysis patients receiving treatments at this facility. Findings include: During the flash tour observation on 07/24/24 at 8:30 AM, the Registered Nurse (RN)11 used a five-digit keyless security code to unlock the door to enter the locked clean supply room. Upon completing a tour of the clean supply room, RN11 used the same five-digit keyless security code to enter the designated water purification system room. RN11 confirmed at that time that the same five-digit keyless security code opened the clean supply room door, the water purification system room door, and the door to the treatment area. During an interview on 07/24/24 at 10:10 AM, the Facility Administrator confirmed he/she was aware the security door to the water purification system should be programed differently. During an interview on 07/24/24 at 2:00 PM, the Biomedical Technician confirmed not all facility staff are trained and/or authorized to operate facility water purification system and the security door to the water purification system should be programed differently. Review of the facility’s policy titled, “Physical Environment,” revision date April 2018, indicated, “The dialysis facility will be designed, constructed, equipped, and maintained to provide patients, teammates, and the public a safe, functional, and comfortable treatment environment.””

“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: 27438 Based on facility documentation review, interview, policy, and manufacturer’s directions for use (DFU) review, the facility failed to follow the manufacturer’s DFU, and facility DFU policy for Preventative Maintenance of the “2008T Blue Star Hemodialysis System” (machines used to provide dialysis), and the facility failed to follow the manufacturer’s DFU and facility policy on injectable medications and storage. Failure to follow the manufacturer’s DFU, and the facility policy DFU had the potential to negatively impact the safety and wellbeing of the 31 patients receiving in-center hemodialysis treatments at this facility. Findings include: 1. Review of facility documentation of the 2008T Blue Star Hemodialysis System machine maintenance for Annually and Semi-annually (machine maintenance completed at one year and in between the annual at six months) revealed missing annual checklist documentation of the following machines: 2, 4, 9, 11, and 14. During an interview on 07/25/24 at 2:45 PM, Biomedical Technician verified the facility was unable to produce the verification checklist documentation for machines 2, 4, 9, 11, and 14 and verified biomedical staff are responsible for completing the Annual and Semi-Annual checklist as part of the documentation to verify work completed. Review of the facility’s policy titled, “Documentation of Repairs, Maintenance, and Calibration on Equipment,” revision date April 2023, indicated, “. . .2. All repairs, maintenance and calibrations by a trained Biomed teammate on any related equipment will be documented in BART within 72 hours. NOTE: BART, Biomedical Application for Repair Tracking. 3. All Repairs, maintenance and calibration of equipment will be performed in accordance with the manufacturer’s recommendations and specifications. 4. Each time a preventative maintenance is performed on a piece of equipment, a checklist of the necessary procedures will be filled out and initialed by the BIOMED teammate ...This check will be completed in addition to each of the other documentation items described above.” Review of the manufacturer’s DFU titled, “2008T Preventive Maintenance Procedures,” dated 2008-2023, indicated, “Scheduled maintenance is performed based on timed intervals or number of hours a machine is operated, whichever comes first. The time and hour intervals are as follows ...Six (6) months, Annually or after 4000 hours of operation ...” 2. Observation on 07/24/24 at 9:25 AM of the medication area, revealed two open vials of Hectorol (injectable Vitamin D) multidose vial containing four micrograms (measurement of dose) per two milliliters (measurement of dose) without the initials of the person opening the vials and the expiration date of the vials. During an interview on 07/24/24 at 10:35 AM, Registered Nurse (RN)12 verified the once opened medication vials should be initialed and dated with the expiration date. Review of the manufacturer’s DFU titled, “Highlights of Prescribing Inforamtion,” dated April 2023, indicated, “Important Administration Instructions for Hectorol Injection ...After initial vial use: discard unused portion of the single-dose vial; store opened multi-dose vial for up to 3 days ...Discard unused multidose vial after 3 days.” Review of the facility’s policy titled, “Medication Policy,” revision date October 2023, indicated, “Each vial is to be labeled with initials of the person opening the vial and the expiration date...Hectorol multidose vials must be discarded 3 days after opening or accessed (e.g., needle punctured.)”