Davita Ellicott City Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedure, the facility’s governing body failed to ensure a sanitary environment at all times. This failure placed the patients and the staff at potential risk for exposure to infectious diseases through cross contamination. Findings Included: On 05/16/2024 at 07:30 a.m., during review of the facility’s policies and procedures titled “Infection Control for Dialysis Facilities (Policy 1-05-01) page 1 number 1 letter b and d states, “all teammates will perform hand hygiene prior to gloving and immediately after removal of gloves. All teammates will perform hand hygiene after patient and dialysis delivery system contact “Page 5 number 19 letter b states “Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.” On 05/14/2024, during observation of the treatment floor, the surveyor observed the following: 1. At 10:15 a.m., Staff #2 (1) did not practice hand hygiene after direct patient care and after removal of gloves (2) did not wear gloves prior to touching machine number 6, a machine that was currently being used and therefore considered contaminated and (3) did not practice hand hygiene prior to gloves being put on. 2. At 12:07 p.m., a partially opened jug, which according to Staff #2 was drinking water for the patients, was observed located in the “clean sink” area where staff members were observed washing their hands and where cross contamination may occur. 3. At 12:08 p.m., a sink was observed located approximately 1 ft away from the medication preparation area where cross contamination may occur.”

“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: 47759 Based on observations and review of the facility’s policies and procedure, the facility’s governing body failed to ensure that personal protective equipment (PPE)s are (1) worn in the treatment area and removed prior to leaving the treatment areas and (2) followed as to protect facility staff members from needle stick injuries. This failure posed a risk of exposure to infectious diseases and blood borne pathogens to other staff members, as well as patients. Findings Included: On 05/16/2024 at 07:30a.m., during record review of the facility ’ s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01) page 2 number 5 states “Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces .... PPE is to be: a. Removed prior to leaving the treatment area.” According to the Occupational Safety and Health Administration, in an environment where an employee is at risk for foot injuries, employees must wear footwear that protects them from foot injuries. 1. On 05/14/2024 at 11:09 a.m. during observations of the clinical treatment floor, the surveyor observed holes in Staff #5’s footwear exposing the employee’s feet to injury from dropped contaminated needles and sharps. 2. On 05/14/2024 at 09:44 a.m., during observations of the clinical treatment floor, the surveyor observed Staff #6 with a white/lab coat which was not removed prior to leaving the treatment floor.”

“ENVIRONMENT-ACCESS TO PORTS/METERS CFR(s): 494.40(a) 8 Environment: access to ports/meters The layout of the water purification system should provide easy access to all components of the system, including all meters, gauges, and sampling ports used for monitoring system performance. This Standard is not met as evidenced by: 47759 Based on observations, the facility’s governing body failed to ensure easy access to all components of the system such as: (1) meter and (2) water valves. This failure placed the water system at risk for possible damage that may affect patient care. Findings Included: According to the American National Standards Institute (ANSI/AAMI RD52:2004), the layout of the water purification system should provide easy access to all components of the system, including all meters, gauges and sampling ports used for monitoring system performance. On 05/14/2024 at 01:16 p.m., during observations of the water room, the surveyor observed that several jugs of Naturalyte 2K 2.5 Ca jugs were piled on top of a black pellet that was blocking the back flow preventer valve, 2 meter gauges, and the D.I. monitoring system. This observation was observed and confirmed by Staff #1.”

“SOFTENERS-AUTO REGENERATE/TIMERS/SALT LVL CFR(s): 494.40(a) 5.2.4 Softeners: auto regen/timers/salt/salt level Prior to exhaustion, softeners should be restored; that is, new exchangeable sodium ions are placed on the resin by a process known as “regeneration,” which involves exposure of the resin bed to a saturated sodium chloride solution. 5.2.4 Softeners Refer to RD62:2001, 4.3.10 Automatically regenerated water softeners: Automatically regenerated water softeners shall be fitted with a mechanism to prevent water containing the high concentrations of sodium chloride used during regeneration from entering the product water line during regeneration. The face of the timers used to control the regeneration cycle should be visible to the user. 6.2.4 Softeners Timers should be checked at the beginning of each day and should be interlocked with the RO system so that the RO is stopped when a softener regeneration cycle is initiated. The softener brine tank should be monitored daily to ensure that a saturated salt solution exists in the brine tank. Salt pellets should fill at least half the tank. Salt designated as rock salt should not be used for softener regeneration since it is not refined and typically contains sediments and other impurities that may damage O-rings and pistons and clog orifices in the softener control head. This Standard is not met as evidenced by: 47759 Based on record review, observations and interviews, the facility’s governing body failed to ensure that enough sodium chloride is inside the brine tank. This failure placed the patients at potential risk of harm by potentially causing damage in the reverse osmosis (RO) machine. Findings Included: The major purpose of softeners in hemodialysis water systems is to keep hard water deposits from damaging delicate reverse osmosis membranes. A reverse osmosis (RO) system is the primary method for purifying water for dialysis treatments, ensuring patients receive safe, clean water. According to the manufacturer’s Directions for Use (DFU) posted on the facility’s brine tank, the staff must “verify salt level is above water level in the brine tank. As needed, add salt to the brine tank & record salt addition on daily log.” On 05/14/2024, during observations of the water room, the surveyor observed that (1) the salt level was filled less than 1/2 of the brine tank and (2) was below water level. Staff #1 corroborated that the salt level should be above the water level as stated on the DFU.”

“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: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure an environment free from defects or hazards in order to maintain safety and functionality.This failure placed the patients, staff and visitors at potential risk of harm including injury or infection. Findings included: On 05/16/2024 at 07:30 a.m., during review of the facility’s policies and procedures titled “Physical Environment” (Policy: 08-04-01) page 1 number 1 states, “The dialysis facility will be designed, constructed, equipped and maintained to provide dialysis patients, teammates and the public safe, functional, and comfortable treatment environment.” Number 2 states “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public.” On 05/14/2024, during inspection of the treatment floor, the surveyor observed the following: 1. At 11:40 a.m., the surveyor observed tears on the dialysis chairs located in stations #1, #5, #9, and the isolation room. 2. At 11:45 a.m.,the surveyor observed peeling wallpaper adjacent to Station #17. 3. At 11:50 a.m., the surveyor observed: a. A non functional sink adjacent to the weighing scale. b. Loose handle bar located at the bottom cabinet of the lab area. On 05/14/2024, interviews with staff and patients revealed the following: 1. Interviews with 4 out of the 6 patients 67% [G, C, H, and K] revealed that there are problems with the patients’ chairside television a. As an example, according to Patient H “TV does not work. It sucks. The TV is not clear. TV needs to be replaced or be maintenanced. If you’re sitting here a long time, you’ve got to do something.” i. To follow up on this complaint, staff #4 was interviewed and it was revealed that this issue was a known issue by the facility. According to Staff #4, TV monitors in stations #4, #6, #7, #11, #13, #15, and #16 malfunction frequently. 2. Interviews with patients [G and C] states that machine tests fail and cause delay in treatment. a. As an example, according to Patient C, “Sometimes I have to miss some or part of my treatment because machine tests fail and I have to be out on time due to transportation.” i. To follow up on this complaint, 4 staff members were interviewed. 4 out of 4 staff members [Staff #4, #6, #7, and #8] corroborated that machines have been problematic in which the test fails the first time almost all the time and at times cause delay in treatment. This problem according to the staff members have been brought up to Staff #1. ii. Interview with Staff #1 revealed that he/she was aware of the problem that staff members were claiming, and corroborated that no investigation or inquiry to the manufacturer about the known problem has been discussed or documented until the surveyor’s arrival.”

“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: 47759 Based on staff interviews and record review, the facility’s governing body failed to have the preventative maintenance completed prior to the due date thereby failing to ensure that all equipment were in functional working condition. This failure placed the patients and staff at potential risk of harm Findings included: On 05/14/2024 at 12:00 p.m., during inspection of the facility ’ s ancillary equipment, the surveyor observed that the following have not had their preventative maintenance due 05/10/2024. 1. Weighing scale serial number (SN) H1301 2. Lab Centrifuge: SN: P1438 and GM140 3. IV Pumps: SN: D15000, SN: A16563, and SN: B11349 4. Concentrators: SN: GD4054, GD4053, A16667, and P1010 5. AED: SN: G2675”

“POC-VA MONITOR/PREVENT FAILURE/STENOSIS CFR(s): 494.90(a)(5) The patient’s vascular access must be monitored to prevent access failure, including monitoring of arteriovenous grafts and fistulae for symptoms of stenosis. This Standard is not met as evidenced by: 47759 Based on observations and review of the facility’s policies and procedures, the facility’s governing body failed to ensure that the clinical staff complied with the facility’s implemented infection control protocol. This failure placed the safety and wellbeing of the patients at potential risk of harm in maintaining their vascular access. Findings included: On 05/16/2024 at 07:30 a.m., during review of the facility’s policies and procedures titled “Cannulation of Fistula or Graft”, (Procedure 01-04-01E) Page 3 number 12 states “apply alcohol using a circular rubbing motion, center out for 60 seconds and allow to dry for 15 seconds prior to cannulation.” Page 3 number 13 states: “Do not palpate insertion site once area has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.” On 05/14/2024, during observation of the treatment floor, the surveyor observed the following: 1. At 10:53 a.m., during AVF/AVG treatment initiation, the surveyor observed Staff #2 disinfect the access site of [Patient in station #12] for 10 seconds and then touched the access site several times prior to cannulation without disinfecting the access site again. 2. At 11:18 a.m., during AVF/AVG treatment initiation, the surveyor observed Staff #3 disinfect the access site of [Patient in station #16], placed his/her stethoscope to auscultate, and then touched the access site several times prior to cannulation without disinfecting the access site again. 3. At 11:30 a.m., during AVF/AVG treatment initiation, the surveyor observed Staff #2 disinfect the access site of [Patient in station #10] for 9 seconds and then touched the access site several times prior to cannulation without disinfecting the access site again. On 05/15/2024, during AVF/AVG treatment initiation, the surveyor observed Staff #4 disinfect the access site of [Patient in station #14] for 7 seconds total and cannulated.”

“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: 47759 Based on a review of the facility’s policies and procedures, the medical director and the facility’s administration failed to ensure that the staff adhered to their own policies and procedures. This failure posed a potential risk of safety to the patients, and denied patients their rights to a minimum standard of medical care. Findings included: 1. “Machine Start Up and Priming a Single Use Dialyzer Utilizing Fresenius 2008 Series Dialysis Delivery Systems and Streamline BloodLines for First Shift of the Day” (Policy 1-03-06Q) indicates that the pH has to be checked before the connection of hansen lines to the dialysate lines. See step by step procedure below: a. page 9 number 43 states, “Check independent pH with approved test method for final dialysate” number 44 states, “document these numeric values in the patient ’ s electronic treatment record or flowsheet.” Number 45 states, “Open shunt door and attach dialysate lines to dialyzer verifying that the red colored hansen is connected to the arterial end of the dialyzer and the blue colored hansen is connected to the venous end of the dialyzer, Close shunt door. 2. “Infection Control for Dialysis Facilities (Policy 1-05-01) page 1 number 1 letter b and d states, “all teammates will perform hand hygiene prior to gloving and immediately after removal of gloves. All teammates will perform hand hygiene after patient and dialysis delivery system contact “Page 5 number 19 letter b states “Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.” 3. “Infection Control for Dialysis Facilities” (Policy 1-05-01) page 2 number 5 states “Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces .... PPE is to be: a. Removed prior to leaving the treatment area.” 4. “Physical Environment” (Policy: 08-04-01) page 1 number 1 states, “The dialysis facility will be designed, constructed, equipped, and maintained to provide dialysis patients, teammates, and the public safe, functional, and comfortable treatment environment.” Number 2 states “The building in which dialysis services are furnished will be constructed and maintained for the safety of the patients, the teammates, and the public.” 5. “Cannulation of Fistula or Graft”, (Procedure 01-04-01E) Page 3 number 12 states “apply alcohol using a circular rubbing motion, center out for 60 seconds and allow to dry for 15 seconds prior to cannulation.” Page 3 number 13 states: “Do not palpate insertion site once area has been prepped. Rationale: Once the access site has been prepped, touching it will contaminate the site and possibly allow for the introduction of bacteria during cannulation.””