Davita Glen Burnie Home Training

“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: 41168 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 05/10/2024 at 12:00 p.m., during record review of the facility’s policy titled “Infection Control for Dialysis Facilities” (Policy 1-05-01) page 5 number 19a states “Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.” Page 5 number 16 states “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.” On 05/08/2024 from 10:30 a.m.-11:00 a.m., during observations of the Transitional Care Unit (TCU), the surveyor observed the following: 1. At 10:32 a.m., the surveyor observed the TCU’s medication preparation area was approximately 1 foot away from the sink. On 05/10/2024, during the exit conference, the Program Home Manager corroborated that this finding was a concern for cross contamination and agreed to address the finding promptly. 2. At 10:35 a.m., the surveyor observed disinfecting bleach located on the “clean area” of TCU stations #1, #3, and #6 along with clean items such as gloves, phone, clean clamps, clean wipes. 3. At 10:50 a.m., the surveyor observed a white yellow residue surrounding the eyewash station. Staff #1 corroborated that the residuals were a concern for cross contamination and an infection control if the eye wash station was used. On 05/08/2024 from 12:00 p.m-12:30 p.m., during observations of the home hemodialysis and home peritoneal dialysis training rooms, the surveyor observed the following: 1. At 12:00 p.m., the surveyor observed that training equipments located in training room #3 were not labeled. Staff #4 corroborated that training equipment should have been labeled. 2. At 12:15 p.m., the surveyor observed that the call light strings located in training rooms #3, #4 and #5 were touching the floor. Staff #4 corroborated that this finding was a concern for cross contamination and agreed to address the finding promptly”

“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: 41168 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 05/10/2024 at 11:00 p.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.” On 05/08/2024 and 05/10/2024, during observations of the clinical treatment floor, the surveyor observed holes in Staff #1’s footwear exposing the employee’s feet to injury from dropped contaminated needles and sharps. On 05/10/2024 at 11:30 a.m., during observations of the clinical treatment floor, the surveyor observed Staff #5 wear PPE (gown) outside the treatment area and enter Staff #6’s office”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 41168 Based on observations and interviews with the facility’s staff, the facility’s governing body failed to (1) ensure that the integrity of all surfaces were intact and allow effective cleaning and (2) ensure an environment free from potential hazards in order to maintain safety of its staff members. This failure placed the patients and the staff at potential risk for exposure to infectious diseases through cross contamination. Findings included: On 05/10/2024 at 12:00 p.m., during record review of the facility’s policy titled “Physical Environment” (Policy 8-04-01) Page 2 number 10 states “The dialysis facility will store supplies in a manner that is consistent with fire safety and other appropriate regulations. Supplies will not obstruct any fire exits or hallways.” On 05/08/2024 from 12:00 p.m-12:30 p.m., during inspection of the home hemodialysis and home peritoneal dialysis training rooms, the surveyor observed black splatters on the walls of training room #3 and brown residuals observed on the utility sink located in training room #3. On 05/08/2024 at 01:00 p.m., during inspection of the storage room on the home hemodialysis and home peritoneal dialysis training room side, the surveyor observed several stacks of boxes scattered around the storage room and an obstructed interior room located in the storage room. On 05/10/2024 at 03:00 p.m., the home program manager corroborated that the storage room will have to be reorganized for the safety of the staff members and agreed to address the finding immediately.”

“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: 41168 Based on record review and staff interview, the facility’s governing body failed to document reasons why the prescribed orders (target weight and blood flow rate) were not followed. This failure to follow prescribed orders for target weight and blood flow rate increased the risk for patient harm by delaying re-evaluation of the appropriateness of dialysis. Findings Included: On 05/10/2024 at 12:00 p.m., during review of the facility’s policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (Policy 1-03-08) Page 4 Number 11 states “Abnormal findings ...will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on the individual patient needs to determine if any clinical interventions are necessary.” Number 13 states “All findings, interventions, and patient response will be documented in the patient’s medical record.” Number 16 states “If an abnormal finding (s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge.” On 05/10/2024, at 01:00 p.m., during record review of the sampled patients’ treatment flowsheet, the surveyor noted the following: 1.On treatment date 05/03/2024, 05/06/2024, 05/08/2024, and 05/09/2024 [Patient J] did not meet the ordered and calculated target weight of 120 kg post treatment. During review of [Patient J] ’ s treatment flowsheets, the surveyor observed that the post weight varied from 122 kg -122.8 kg which were 2-2.8 kg higher than the ordered target weight. Review of [Patient J]’s flow sheet showed no supporting documentation acknowledging the abnormal finding or explaining why the ordered prescription was not followed. 2. On treatment date 05/06/2024, [Patient B] did not meet the ordered and calculated target weight of 95 kg post treatment. During review of [Patient B] ’ s treatment flowsheets, the surveyor observed that the post weight was 97.2 kg which was 2.2 kg higher than the ordered target weight. Review of [Patient B]’s flow sheet showed no supporting documentation acknowledging the abnormal finding or explaining why the ordered prescription was not followed. . 3. On treatment dates 05/03/2024 and 05/06/2024, [Patient K] had a blood flow rate (BFR) order of 300 mL/minute. During review of [Patient K] ’ s treatment flowsheets, the surveyor observed that the BFR on both dates was set at 400 mL/minute with no supporting documentation explaining why the BFR was not followed. On 05/10/2024 at 02:00 p.m., the Clinical Manager corroborated that the staff members should be documenting the reason why the treatment order was not followed.”

“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: 41168 Based on observations, staff interviews and review of the facility’s policies and procedures, the medical director and the governing body failed to ensure that the facility’s staff members 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. “Infection Control for Dialysis Facilities” (Policy 1-05-01) page 5 number 19a states “Clean supplies or equipment will not be placed adjacent to a sink unless a splash guard is in place.” Page 5 number 16 states “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.” 2. “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.” 3. “Physical Environment” (Policy 8-04-01) Page 2 number 10 states “The dialysis facility will store supplies in a manner that is consistent with fire safety and other appropriate regulations. Supplies will not obstruct any fire exits or hallways.” 4. “Water Culture Policy” (Policy 2-06-01) page 1 number 2 states “The Medical Director documents a review of all water culture results monthly.” a. On 05/09/2024 at 09:00 a.m., record review of the facility ’ s culture results did not have documented signatures verifying that the medical director has reviewed the water culture results. 5. “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (Policy 1-03-08) Page 4 Number 11 states “Abnormal findings ...will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgment based on the individual patient needs to determine if any clinical interventions are necessary.” Number 13 states “All findings, interventions, and patient response will be documented in the patient’s medical record.” Number 16 states “If an abnormal finding (s) or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge.””