Fresenius Kidney Care Cascade

“Develop EP Plan, Review and Update Annually CFR(s): §403.748(a), §416.54(a), §418.113(a), §441.184(a), §460.84(a), §482.15(a), §483.73(a), §483.475(a), §484.102(a), §485.68(a), §485.542(a), §485.625(a), §485.727(a), §485.920(a), §486.360(a), §491.12(a), §494.62(a). The [facility] must comply with all applicable Federal, State and local emergency preparedness requirements. The [facility] must develop establish and maintain a comprehensive emergency preparedness program that meets the requirements of this section. The emergency preparedness program must include, but not be limited to, the following elements: (a) Emergency Plan. The [facility] must develop and maintain an emergency preparedness plan that must be [reviewed], and updated at least every 2 years. The plan must do all of the following: * [For hospitals at §482.15 and CAHs at §485.625(a):] Emergency Plan. The [hospital or CAH] must comply with all applicable Federal, State, and local emergency preparedness requirements. The [hospital or CAH] must develop and maintain a comprehensive emergency preparedness program that meets the requirements of this section, utilizing an all-hazards approach. * [For LTC Facilities at §483.73(a):] Emergency Plan. The LTC facility must develop and maintain an emergency preparedness plan that must be reviewed, and updated at least annually. * [For ESRD Facilities at §494.62(a):] Emergency Plan. The ESRD facility must develop and maintain an emergency preparedness plan that must be [evaluated], and updated at least every 2 years. . This Standard is not met as evidenced by: 50244 Based on document review and staff interview, it was determined that the facility failed to ensure the facility’s Emergency Preparedness Plan (EPP) was evaluated and updated at least every 2 years. The facility census was 67. Findings were: A review of the facility’s EPP and Governing Body Meeting minutes revealed a lack of documented review and evaluation of the EPP. This finding was acknowledged by the Director of Operations and the Clinic Manager on 3/20/24 at 3:00 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: 50244 Based on observation, staff interviews, and a review of facility policy and procedure and Centers for Disease Control (CDC) recommendations, it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse (RN HH), two of two Patient Care Technicians (PCT AA and PCT DD), and eight of eight patients (P#24, P#25, P#26, P#27, P#28, P#29, P#30, and P#31) observed, changed gloves between each patient/station; and/or performed hand hygiene (washed hands with soap and water or used an alcohol based hand sanitizer) after removal of contaminated gloves. This failure increased the risk for cross contamination with the potential to expose all staff and 62 in-center hemodialysis patients who dialyzed at this facility, to bloodborne pathogens in the dialysis environment. Findings were: 1. During observation in the Patient Treatment Room on 3/18/24 from 9:00 a.m. through 12:00 p.m., the following was revealed: - At 9:45 a.m., P#29 held pressure to dialysis access site and left the facility without performing hand hygiene after glove removal. - At 10:15 a.m., PCT AA left Station (S) 2 and went to S4 while she wore contaminated gloves used at S2. PCT AA entered data in the computer at S4 while she still wore the same gloves worn at S2. When finished, she then removed contaminated gloves and did not perform hand hygiene prior to donning clean gloves. - At 10:24 a.m., PCT AA returned to S4, removed contaminated gloves but did not perform hand hygiene. She then obtained gauze from a clean supply drawer . - Between 10:26 a.m. and 11:05 a.m., P#24, P#25, P#26, P#27, and P#28 held pressure to their dialysis access sites and left the facility without performing hand hygiene after glove removal. The above findings were discussed with the Director of Operations (DO) on 3/18/24 at 11:00 a.m. She then discussed the above breach in infection control with PCT AA. 2. During observation in the Patient Treatment Room on 3/19/24 from 8:50 a.m. through 11:00 a.m., the following was revealed: - At 8:30 a.m., RN HH responded to a machine alarm at S16. When finished, she removed her gloves and did not perform hand hygiene. - At 8:33 a.m., PCT DD responded to a machine alarm at S16. He removed the contaminated groves and did not perform hand hygiene. - Between 8:35 a.m.- 8:40 a.m., PCT AA performed patient care at S7, S1, and S2 while she wore the same gloves. - Between 9:14 a.m. and 9:25 a.m., RN HH removed one glove and accompanied a patient from S5 to the scale. She did not perform hand hygiene, then weighed the patient. She then removed the second glove, did not perform hand hygiene, and went back to S5 for data entry. - Between 9:28 a.m. and 9:30 a.m., P#30 and P#31 held pressure to their dialysis access sites and left the facility without performing hand hygiene after glove removal. The staff did not remind P#24, P#25, P#26, P#27, P#28, P#29, P#30, and P#31 to wash their hands or offer hand sanitizer after removal of contaminated gloves. A review of policy titled, “Hand Hygiene” dated 11/6/23 showed the following: Hands will be decontaminated using alcohol based rub or by washing hands with antimicrobial soap and water immediately after removing gloves. According to CDC recommendations, even with glove use, hand hygiene is necessary after glove removal because hands can become contaminated through small defects in gloves and from the outer surface of gloves during glove removal.”

“PE-HD PTS IN VIEW DURING TREATMENTS CFR(s): 494.60(c)(4) Patients must be in view of staff during hemodialysis treatment to ensure patient safety, (video surveillance will not meet this requirement). This Standard is not met as evidenced by: 50244 Based on observation and staff interview, it was determined that the facility failed to ensure that six of first shift patients (P#5, P#6, P#7, P#8, and P#9) observed in the Patient Treatment Room, had their vascular access sites uncovered/visible to the staff throughout dialysis treatment, to ensure patient safety. This deficient practice could provide an opportunity for accidental needle dislodgement or a line disconnection to go undetected and could result in exsanguination (severe loss of blood). The facility in-center hemodialysis census was 62. Findings were: During observation in the Patient Treatment Room on 3/18/24 at 8:10 a. m.., P#5 P#6, P#7, and P#8 had their access sites covered with a blanket. PCT AA was informed of the above findings on 3/18/24 at 8:12 a.m. An observation on 3/19/24 at 7:25 a.m., P#9 and P#10 had their access sites covered with a blanket and were not visible to the staff during their treatment. PCT AA was informed of the above findings on 3/19/24 at 7:26 a.m. and uncovered P#9’s and P#10’s access sites. A review of policy titled, “Patient Assessment and Monitoring” dated 5/21/23 stated: Ensure access remains uncovered throughout the treatment.”