Davita Harrisonburg Dialysis

“ESRD Patient Orientation Training CFR(s): The dialysis facility must provide appropriate orientation and training to patients, including the areas specified in paragraph (d)(1) of this section. This Standard is not met as evidenced by: 46466 Based on interview, medical record and facility documentation review, the facility failed to perform quarterly patient fire safety training for two (2) of fifteen (15) patients included in the survey sample. The findings include: On August 19, 2024 and August 20, 2024, the survey team reviewed fifteen (15) patient medical records. A review of Patient #6’s medical record revealed that Patient #6’s last quarterly Fire Safety Training was conducted on January 9, 2024. There was no documented evidence to support that Patient #6 received Fire Safety Training after January 9, 2024. A review of Patient #9’s medical record revealed that Patient #9’s last quarterly Fire Safety Training was conducted on March 5, 2024. There was no documented evidence to support that Patient #9 received Fire Safety Training after March 5, 2024. On August 20, 2024 at 12:00 PM, Staff Member #1 verified that the facility had no evidence related to Patient’s #6 and #9 receiving Fire Safety Training in the second quarter of 2024. A review of the facility’s policy “Facility Emergency Management Plan (ICHD, Home)”, revised April 2024 indicated in part: “...Training and Education. Emergency Management Plan 1. The FA, or designee, is responsible to provide training of EMP:...b. Patients...ii. Quarterly: 1. Fire Safety Preparedness...”. The findings were discussed with Staff Members #1, #2, #15, #16 and #17 on August 20, 2024 at 2:00 p.m.”

“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: 21229 Based on observation, staff interview and facility document review, the facility staff failed to ensure infection protocols for hand hygiene preventing the transmission of infections were followed. The findings include: On 8/19/24, at 11:15 a.m. during observations of care on the treatment unit, the surveyor observed Staff Member #9 remove gloves after caring for a patient at 3/3 (pod 3, station 3). The staff member did not sanitize hands after removing the gloves, then donned clean gloves and silenced an alarm on 3/4 (pod 3, station 4). The staff member was then observed to go to 4/2 and adjust settings on the machine wearing the same gloves. Staff member #9 was also observed to clean a station at 3/2 and after cleaning the station, removed gloves, did not sanitize hands, and entered information in the computer at the station. Without sanitizing or washing hands, staff member #9 retrieved supplies and placed them at the station for the next patient treatment. At 11:50 a.m., Staff Member #9 was observed removing gloves after assisting a patient at 2/4 (pod 2, station 4) and without sanitizing or washing hands, donned clean gloves and retrieved supplies needed at 2/4. The staff member was observed to remove gloves, and without sanitizing hands, retrieve one glove and use the glove to adjust the settings on 2/3. The facility policy “Infection Control for Dialysis Facilities (April 2023)” was reviewed and evidenced, in part: “Hand Hygiene: 1. All teammates, Physicians, and non-Physician (NPP) will perform hand hygiene...b. prior to gloving and immediately after the removal of gloves...d. after patient and dialysis delivery system contact...g. before touching clean areas such as supplies, supply cart, and chairside keyboard/mouse...” The surveyor discussed the observations with Administrative Staff #1 and #2 on 8/20/24 at 11:45 a.m. and the requirements for new staff regarding competency checks and monitoring. Staff Member #1 indicated all staff should have a competency checklist prior to being on the floor, however, there were no checklists found for Staff Members #9 or #10. Staff Member #2 explained that the employees should have had the checklist “before going on the floor”. The facility provided the surveyor with documents related to the “Skills Verification Checklists” for teammates. The fifteen (15) page “PCT (patient care technician) checklist” document evidenced, in part: “1. After the new teammate completes the applicable (Rise StarLearning) course which includes review of the policies and procedures corresponding to the skills referenced...the teammate will then explain and demonstrate the procedural skill to the preceptor while being corrected and reinstructed as needed. After completion...the skills verification checklist will be initialed and dated by the preceptor. 2. After sufficient guidance and practice, when the preceptor considers the new teammate proficient, the registered nurse overseeing the training will evaluate the new teammates performance...required the initials of the registered nurse to verify satisfactory performance of skill...” The surveyor again discussed the observations at the exit conference on 8/20/24 at 2:00 p.m. with Staff Members #1, 2, 15, 16, and 17.”

“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: 46466 Based on observations and interviews, facility staff failed to wear proper attire while caring for patients on the treatment floor. The findings include: On August 19, 2024 at 11:50 AM, a staff member was observed on the treatment floor, caring for patients while wearing Croc’s (Croc’s are a rubberized shoes that have open holes throughout the shoe). At 12:20 PM, a different staff member was observed on the treatment floor wearing Croc’s. On August 19, 2024 at approximately 3:00 PM, Staff Member #2 explained that Croc’s shoes are not appropriate to wear on the treatment floor. The findings were discussed with Staff Members #1, #2, #15, #16 and #17 at the exit conference on August 20, 2024, at 2:00 PM.”

“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: 21229 Based on observation, staff interview, and facility document review, the facility staff failed to follow infection control guidelines for the cleaning and disinfection of a patient treatment station. The findings include: On 8/19/24 at 11:15 a.m., during observation on the treatment floor, the surveyor observed Staff Member #9 cleaning a dialysis treatment station in preparation for the next patient. The surveyor observed that staff member #9 did not clean the attached IV (intravenous pole), did not clean left or right outer sides of the machine, did not remove, empty, nor disinfect the prime receptacle bucket (contained approximately two inches of fluid), did not open the cover of machine for the Hanson connectors and cleaned them or their housing. When cleaning the treatment chair, Staff Member #9 did not clean the sides of the chair underneath the tray tables on either side. The staff member was observed to remove gloves, and without sanitizing retrieve supplies to place at the station for the next patient. The surveyor intervened and discussed with Staff Member #9 that the station was not clean and ready for another patient. Staff Member #9 did re-clean the station. The surveyor at the time, discussed the observation with an experienced Staff Member (#4). The facility policy “Infection Control for Dialysis Facilities (April 2023)” was reviewed and evidenced, in part: “13. At the end of each treatment, the dialysis station will be cleaned and disinfected. a. 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 cuff) and frequently contacted by healthcare personnel (e.g., control paned; top, front and sides of dialysis machine; touchscreens, countertops) ...ii. priming containers are to be emptied prior to disinfection...” The surveyor discussed the observations with Staff Member #1 and #2 on 8/20/24 at 11:45 a.m., and again at the exit conference on 8/20/24 at 2:00 p.m. with Staff Members #1, 2, 15, 16, and 17.”

“IC-HBV-TEST PTS/STAFF POST LAST DOSE CFR(s): 494.30(a)(1)(i) Hepatitis B Screening: Patients and Staff Test all vaccines [patients and staff] for anti-HBs 1-2 months after last primary vaccine dose. -- If anti-HBs is <10 mIU/mL, consider patient or staff member susceptible, revaccinate with an additional three doses, and retest for anti-HBs. -- If anti-HBs are =10 mIU/mL, consider immune, and retest patients annually. -- Give booster dose of vaccine to patients if anti-HBs declines to <10 mIU/mL and continue to retest patients annually. This Standard is not met as evidenced by: 46466 Based on interviews, medical record and facility document review, the facility staff failed to administer tuberculosis screenings for one (1) of fifteen (15) patient records sampled. The findings include: On August 20, 2024, the surveyors reviewed fifteen (15) patient medical records. Patient #2’s medical record indicated that Patient #2 had a previous positive PPD (purified protein derivative) test. A PPD test is used to diagnose a person for latent tuberculosis infection (LTBI). Patient #2 had a chest x-ray performed on January 25, 2021. There was no documented evidence that Patient #2 received tuberculosis (TB) symptoms screenings in 2022, 2023 and 2024. On August 20, 2024 at 11:30 AM, Staff Member #1 confirmed that there was no documentation to support that Patient #2 received TB screenings in 2022, 2023 and 2024. A review of the facility’s policy “Tuberculosis Infection Control Policy”, last revised 4/2024, stated in part: “...1. Patients with chronic kidney disease (CKD)...will be screened for TB prior to first treatment, as well as participated in ongoing surveillance following admission...2. TB surveillance will be performed on admission, annually and as indicated...”. The findings were discussed with Staff Members #1, #2, #15, #16 and #17 at the exit conference on August 20, 2024, at 2:00 PM.”

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 46466 Based on interview and facility document review, the facility staff failed to train four (4) new staff members in water skills, acid concentrate and bicarb mixing skills and document completion of these competencies. The findings include: On August 20, 2024, the surveyors reviewed six (6) personnel files. Staff Members #9, #10, #18, #19, and #20’s personnel files did not include any evidence that their water skills, acid concentrate mixing skills and bicarbonate mixing skills competencies were completed. An interview was conducted with Staff Members #2 on August 20, 2024 at 11:00 AM. Staff Member #2 stated that all of these staff members were new hires and had completed their ten (10) week training course and were currently working on the treatment floor delivering direct patient care. Staff Member #2 also confirmed that all of these staff members had not completed their water skills, acid concentrate mixing skills and bicarbonate mixing skills competency checklists and they should have been completed. A review of the facility’s “Digital Teammate Files Document Guidance Checklist”, last updated January 2023, indicated in part: “Onboarding Documents...Verification of Competency...Annual Documents...Water Skills Checklist...”. The findings were discussed with Staff Members #1, #2, #15, #16 and #17 at the exit conference on August 20, 2024 at 2:00 PM.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 46466 Based on interview and facility document review, the facility staff failed to provide evidence that staff members knowledge and skills were maintained according to facility policy. The findings include: On August 20, 2024, the surveyors reviewed six (6) personnel files. Staff Members #9, #10, #18, #19, and #20’s personnel files did not include any evidence that their competencies were verified prior to performing direct patient care. Their personnel files also did not include verification of their water skills, including bicarb and acid concentrate mixing. An interview was conducted with Staff Members #2 on August 20, 2024 at 11:00 AM. Staff Member #2 stated that all of these staff members were new hires and had completed their ten (10) week training course and were currently working on the treatment floor performing direct patient care. Staff Member #2 also confirmed that all of these staff members should have completed the training and have documentation of the verification of competencies and water skills checklists in their personnel files but the documentation was not there and could not be found. A review of the facility’s “Digital Teammate Files Document Guidance Checklist”, last updated January 2023, indicated in part: “Onboarding Documents...Verification of Competency...Annual Documents...Water Skills Checklist...”. The findings were discussed with Staff Members #1, #2, #15, #16 and #17 at the exit conference on August 20, 2024 at 2:00 PM.”