Davita Woburn 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: 10249 Based on observation, staff interview, and policy review, the facility failed to ensure that one staff member (Patient Care Technician [PCT] #4) removed PPE (Personal Protective Equipment), such as a gown, after caring for a patient on Transmission Based Precautions for bed bugs, to protect against the potential spread of infestation. Findings include: Review of the facility policy, titled Ectoparasitic Infestations (Fleas, Lice, Common Bed Bugs) Management, revised April 2024, indicated the following, but not limited to: Transmission Based Precautions: Additional Precautions include: *Gowns-Separate long sleeved garment that is removed and discarded after caring for the patient. On 1/28/25 at 9:55 A.M., the surveyor observed PCT #4 terminating dialysis treatment for a patient with a known bed bug infestation. When PCT #4 completed the termination, the patient left the station, and PCT #4 followed the patient to be weighed. The patient left the treatment floor and without removing his gown, PCT #4 was then observed to enter station 13 and treat another patient. PCT #4 failed to remove his gown after he treated the patient, who was known to have bedbugs. During an interview on 1/28/25 at 10:15 A.M., PCT #4 said he did not remove his gown when he left station #15 before treating another patient. PCT #4 pointed toward a hanging gown, just to the left of station 15, and said that’s my other gown I should have changed into.”

“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: 10249 Based on observation, staff interview, and policy review, the facility failed to ensure that there was separation of clean and contaminated items on the dialysis unit. Specifically, the facility failed to 1. ensure 2 of 2 staff (Registered Nurse [RN] #2, and RN #3) removed potentially contaminated personal protective equipment (PPE) before entering a clean area for preparation of intravenous (IV) medications; and 2. ensure contaminated PPE did not come into contact with “clean” and “dirty” surfaces. Findings Include: 1. The facility failed to ensure RN #2 and RN #3 removed potentially contaminated PPE before entering and preparing heparin (blood thinner administered via IV) in the medication preparation room, a clean area. Review of the facility policy, titled Preparation and Administration of Parenteral Medications, revised April 2024, indicated the following: *If the facility has a dedicated medication preparation room, no PPE is needed during medication preparation. If the mediation preparation area is located in the treatment area, a gown or labcoat is to be worn at all times. a. During an observation on 1/28/25 at 9:00 A.M., the surveyor observed RN #2 enter the clean medication preparation room without removing his PPE goggles, causing concern for cross contamination. RN #2 proceeded to prepare the heparin medication while his goggles were located on the top of his head. During an interview on 9/28/25 at 9:20 A.M., RN #2 said he did not realize his goggles were on his head and he should have taken them off before entering the mediation room. b. During an observation on 1/29/25 at 12:05 P.M., the surveyor observed RN #3 enter the clean medication preparation room without removing her PPE goggles, causing concern for cross contamination. RN #3 proceeded to prepare the heparin medication while her goggles were located on the top of her head. During an interview on 1/29/25 at 12:10 P.M., RN #3 said they told her not to wear goggles in the med room. During an interview on 1/29/25 at 12:45 P.M., the Clinical Coordinator said the staff should not be wearing goggles in the medication room. 2. The facility failed to ensure contaminated PPE did not come into contact with clean surfaces. a. On 1/28/25 at 8:45 A.M., an observation of the hallway, entering the treatment area, revealed 3 gowns hanging from hooks. The gowns were overlapping each other, causing concern for cross contamination. On 1/29/25 at 10:50 A.M., the surveyor observed 3 gowns hanging from hooks in the hallway, entering the treatment area. The gowns were overlapping each other, causing concern for cross contamination. b. On 1/29/25 at 12:05 P.M., the surveyor observed RN #3 as she was preparing to enter the medication prep room. RN #3 removed her PPE gown. While holding the gown in one hand, she removed a sweatshirt from a hook on the wall, to the right of the medication room door, and then placed her gown on the hook, and placed the sweatshirt over the gown. RN #3 then entered the medication room. Upon exiting the medication room, RN #3 was observed to remove the sweatshirt, that was placed over the gown, put the gown on and placed the sweatshirt back on the hook. During an interview on 1/29/25 at 12:10 P.M., RN #3 said the sweatshirt was hers and it was not a good place for it to be. During an interview on 1/29/25 at 1:45 P.M., the Facility Administrator and the Clinical Coordinator both said they need to create more separation between stored PPE.”

“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: 44223 Based on observation, interview, and policy review, the facility failed to ensure that 14 of 17 hemodialysis chair tray tables were free from tape debris to allow for proper disinfection to reduce the risk of spread of infection. Findings Include: Review of the facility policy, titled Infection Control for Dialysis Facilities, revised April 2023, included the following: *At the end of each treatment, the dialysis station will be cleaned and disinfected. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel; top, front, and sides of dialysis machine; touchscreens; countertops). On 1/28/25 at 8:55 A.M., during observation of the treatment floor, the surveyor observed the residue of previous used paper tape on the hemodialysis chair tray tables at 14 of 17 stations, including 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, making it difficult to disinfect the tray tables. During an interview on 1/29/25 at 8:40 A.M., the Clinical Coordinator said it is difficult to adequately disinfect the tray tables with the tape being left on there.”

“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: 44223 Based on observation, interview, and policy review, the Medical Director failed to ensure that 1 of 2 staff members (Patient Care Technician [PCT] #2) observed, administering heparin (a blood thinner used to minimize blood loss due to clotting of the dialysis system during treatment), adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Findings Include: Review of the policy, titled AV Fistula or Graft Cannulation with Nipro or Medisystems Safety Fistula Neeedles (SN) and Administration of Heparin Loading Dose, revised April 2019, included the following: *Attach heparin loading dose to venous fistula needle, as applicable. Unclamp and gently flush heparin back and forth 3-5 times into fistula or graft. Flushing promotes heparin administration systemically. *Do not initiate dialysis for three (3) to five (5) minutes after administering heparin loading dose. Allows heparin to circulate systemically. Clotting is to be avoided because it may decrease the patient’s hematocrit or it may decrease the available surface area of the dialyzer, which can impact the adequacy of the hemodialysis treatment. *After three (3) to five (5) minutes initiate dialysis per procedure. For Patient #10, the Medial Director failed to ensure PCT #2 adhered to the heparin administration policy and waited 3-5 minutes after administration to initiate treatment. Review of the medical record indicated Patient #10 had a physician’s order for heparin bolus 3000 units IV, every dialysis treatment. On 1/28/25 at 11:00 A.M., the surveyor observed PCT #2 initiate treatment for Patient #10 through an Arteriovenous Graft (AVG). At 11:11 A.M., PCT #2 connected a syringe to the venous port and administered 3000 units of heparin. Without waiting 3-5 minutes he/she removed the syringe from the access port and attached the blood lines. Treatment was started at 11:13 A.M., 2 minutes after administration. During an interview on 1/28/25 at 11: 15 A.M., PCT #2 said he/she almost waited the 3 minutes before starting treatment, but did not.”