Fresenius Medical Care of Bulloch County

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 32734 Based on observations, staff interviews, a review of Centers for Disease Control and Prevention guidelines, and a review of facility Policy and Procedures, it was determined that the facility failed to ensure that five of eight Direct Patient Care Staff (PCT AA, PCT BB, PCT CC, PCT DD and LPN AA) practiced infection control measures to prevent transmission of dangerous pathogens in the hemodialysis unit. This deficient practice had the potential to negatively affect all staff and 52 in-center hemodialysis patients who dialyzed at this facility. Findings were: Cross References: V 113 - Failure of the facility to ensure that staff changed gloves when going from a “dirty” area or task to a “clean” area or task, and/or performed hand hygiene (washed hands or used an alcohol-based hand sanitizer) after removal of contaminated gloves. V115- Failure of the facility to ensure that all staff removed contaminated personal protective equipment (PPE such as gowns, face shields, and gloves) prior to leaving the treatment area and/or wore appropriate PPE while they performed direct patient care and during shift change, when the spurting or spattering of blood might occur. V 122 - Failure of the facility to ensure that staff performed intermediate-level disinfection (immediately and thoroughly clean surfaces with a cloth soaked with 1:100 bleach solution and apply disinfectant a second time using a new cloth) of surfaces contaminated with visible blood.”

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of facility document/policy and procedures, it was determined that the facility failed to ensure that three of three Patient Care Technicians (PCT BB, PCT DD, and PCT AA) observed during preparation of hemodialysis (HD) machine/extracorporeal circuit, verified the machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (acidity), using an independent testing device prior to each patient treatment, to ensure that the dialysate was safe for HD treatment. This failure had the potential to negatively affect the health and safety of three of three in-center HD patients (P#5, P#6, and P#7) observed during initiation of treatment. The facility census was 52. Findings were: Cross Reference: V 250 - Failure of the facility to ensure that staff verified the machine’s dialysate pH with an independent method prior to the initiation of each HD treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observations, staff interviews, and a review of records, it was determined that the Governing Body failed to demonstrate responsibility and accountability for the operations of the facility. This failure had the potential to negatively affect the health and safety of 52 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 110 - Failure of the governing body to ensure that all Direct Patient Care Staff practiced infection control measures to prevent transmission of dangerous pathogens in the hemodialysis unit. V 250 - Failure of the governing body to ensure that staff verified the machine’s dialysate pH and conductivity with an independent method prior to the initiation of each HD treatment.”

“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: 32734 Based on observation, staff interviews, a review of facility Policy and Procedures, and Centers for Disease Control and Prevention (CDC) Recommendations, it was determined that the Infection Control Committee failed to ensure that one of one Licensed Practical Nurse (LPN AA) and two of four Patient Care Technicians (PCT AA and PCT CC) observed, changed gloves when going from a “dirty” area or task to a “clean” area or task, and/or performed hand hygiene (washed hands or used an alcohol-based hand sanitizer) after removal of contaminated gloves. Failure to perform infection control techniques increased the risk for cross contamination with the potential to expose patients and staff to bloodborne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect all staff and 52 in-center hemodialysis patients who dialyzed at this facility. Findings were: During observation in the Patient Treatment Room on 5/15/24 between 9:30 a.m. and 12:00 p.m., the following was observed: - At 10:12 a.m., due to a machine issue, Patient (P) #1 was moved from Station (S) 18 to S17 by PCT AA. PCT AA failed to change gloves after setting up the machine at S17 and prior to moving P#1. - At 10:15 a.m., LPN AA set up the machine for P#4 in S3 after his dialyzer (artificial kidney) clotted (blood clotted in the dialzyer that rendered it unusable). LPN AA touched the machine (dirty), keyboard (clean), patient’s chair (dirty) and then reconnected P#4’s bloodlines while she wore the same contaminated gloves. LPN AA did not change gloves during the entire procedure. - At 10:25 a.m., PCT CC was observed during termination of dialysis treatment on P#3 at S9. PCT CC touched the dialysis machine and keyboard, then proceeded to reinfuse (return) P#3’s blood. When finished, she removed P#3’s fistula needles while she wore the same gloves. PCT CC also failed to perform hand hygiene after glove removal. During an interview on 5/15/24 at 11:58 a.m., PCT CC stated she has been in her role as a Preceptor for five years. When asked if she was aware that she touched the machine, keyboard, and removed P#3’s fistula needles while she wore the same pair of gloves, she stated “Oh, I didn’t change gloves?” During an interview on 5/15/24 at 12:13 p.m., LPN AA stated she was in the process of completing her training and will take her test on 5/22/24. She also stated that she had been taught to wash her hands and change gloves, especially when performing catheter care. When asked if she was aware that she touched the dialysis machine, the chair table, and the keyboard, then reconnected the P#4’s bloodlines and restarted his treatment while she wore the same pair of gloves, she stated “I thought I changed my gloves”. A review of Policy: 47663 titled, “Personal Protective Equipment” dated 11/6/23 showed the following: Gloves Staff must remove gloves and wash hands after: - Patient care... - Touching any surfaces within the patient station. A review of Policy: 47664 titled, “Hand Hygiene” dated 11/6/23 showed the following: Hands will be decontaminated using alcohol-based hand rub or by washing hands with antimicrobial soap and water: - Before and after direct contact with patients... - Immediately after removing gloves. - After contact with inanimate objects near the patient... 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 ...”

“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: 32734 Based on observation, staff interview, and a review of facility Policy and Procedures, it was determined that the Infection Control Committee failed to ensure that five of eight Direct Patient Care Staff (PCT AA, PCT BB, PCT CC, PCT DD and LPN AA) and one of one Clinical Educator observed, removed contaminated personal protective equipment (PPE such as gowns, face shields, and gloves) prior to leaving the treatment area and/or wore appropriate PPE while they performed direct patient care and/or during shift change, when the spurting or spattering of blood might occur. This deficient practice had the potential to negatively affect the health and safety of PCT AA, PCT BB, PCT CC, PCT DD and LPN AA. The facility census was 52. Upon entering the Patient Lobby on 5/15/24 at 9:00 a.m., PCT DD was observed pushing a patient out to the lobby in a wheelchair while she wore contaminated gown, face shield, and gloves. PCT DD opened the door and returned to the treatment floor wearing the same PPE. During observation in the Patient Treatment Room on 5/15/24 from 9:30 a.m. - 12:00 p.m., the following was revealed: - PCT AA, PCT BB, PCT CC, PCT DD and LPN AA wore gowns that were not tied completely and did not cover the back of the body. - At 10:00 a.m., the Clinical Educator was observed holding her gown across her arm while walking/talking to patients and staff on the treatment floor during shift change, when the spurting or spattering of blood might occur. - At 10:05 a.m., PCT DD was observed terminating treatment on a patient at Station 3 while she wore a gown with sleeves rolled up that exposed her arms from wrist to below the elbow. - At 10:10 a.m., PCT AA and PCT DD wore gown with sleeves rolled up that exposed their arms from wrist to just below the elbow. - At 10:12 a.m., PCT AA left the Patient Treatment Room and went to the Clean Supply Room while she wore contaminated gown and face shield. During an interview on 5/15/24 at 12:25 p.m., PCT DD stated “it gets hot out there”. A review of Policy: 47663 titled, “Personal Protective Equipment” dated 11/6/23 showed the following: PPE... must be worn to protect employees from blood or other potentially infectious materials... All PPE shall be removed prior to leaving the treatment area.”

“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: 32734 Based on observation, staff interview, a review of Centers for Disease Control (CDC) recommendations, and a review of the facility’s policies and procedures, it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT BB) observed during cleaning and disinfection of the hemodialysis station between patients, performed intermediate-level disinfection (immediately and thoroughly clean surfaces with a cloth soaked with 1:100 bleach solution and apply disinfectant a second time using a new cloth) of surfaces contaminated with visible blood. This failure could lead to the transmission of dangerous pathogens through cross contamination. This deficient practice had the potential to negatively affect the health and safety of one of one Patients (P) #2, who was preparing to receive hemodialysis treatment at Station (S) 20. The facility census was 52. Findings were: - At 10:00 a.m., there was a small triangle-sized smear of blood on the left side of the treatment chair and a quarter-sized pool of blood on the floor at S20 that was left from the first shift patient. - At 10:45 a.m., P#2, a second shift patient for S20 was standing in front of the treatment chair where blood was observed dripping from the right side of the frame onto the floor. - At 10:50 a.m., PCT BB was in the process of preparing P#2 for treatment. She placed the clean fistula needles and supplies (used for the initiation of dialysis treatment) in the trash can that contained trash, which was sitting against the wall across from the patient’s chair. When PCT BB was asked by this surveyor why the clean supplies were in the trash can, she retrieved the supplies from the trash can and was preparing to place them on the patient’s chair when she was stopped by the Clinic Manager. She was pulled aside and informed of the blood dripping from the inside of the treatment chair. PCT BB wiped the quarter-sized blood spill from the floor, then used the same cloth to clean the outer right side of the treatment chair and the chair table. PCT BB did not perform an intermediate-level disinfection. During an interview on 5/15/24 at 12:32 p.m., PCT BB stated “I just put the set-up on the trash can for a minute because the patient was getting upset that it was taking so long to put him on. The blood was on the bar inside the chair. PCT CC cleaned the chair before me, so I thought the chair was clean”. A review of CDC Table 2. Disinfection procedures recommended for commonly used items or surfaces in hemodialysis units showed the following: Item or Surface Gross blood spills or items contaminated with visible blood required an intermediate-level disinfection. A review of Policy: 47806 titled, “Cleaning and Disinfecting the Dialysis Station” dated 9/5/23 showed the following: Work Surface Cleaning and Disinfection with Visible Blood <10 ml and Other Potentially Infectious Material using Bleach Solution: Use 1:100 bleach solution to clean surfaces with visible blood. After cleaning up all visible blood, use new cloth with 1:100 bleach solution for a second cleaning of surface. Clean and disinfect any surfaces contaminated with blood or other potentially infectious material immediately or as soon as feasible.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of facility document/policy and procedures, it was determined that the facility failed to ensure that three of three Patient Care Technicians (PCT BB, PCT DD, and PCT AA) observed during preparation of hemodialysis (HD) machine/extracorporeal circuit, verified the machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (acidity), using an independent testing device prior to each patient treatment, to ensure that the dialysate was safe for HD treatment. This failure had the potential to negatively affect the health and safety of three of three in-center HD patients (P#5, P#6, and P#7) observed during initiation of treatment. The facility census was 52. Findings were: During observation in the Patient Treatment Room on 5/15/24 between 10:00 a.m. to 11:30 a.m., the following was revealed: - At 10:00 a.m, the HD machine at S20 had undergone machine pressure holding test and alarm tests, and showed “test complete” on the machine’s screen. PCT BB proceeded to initiate P#5’s treatment without first testing the final dialysate for pH using an independent testing device. - At 10:15 a.m., PCT DD was observed setting the HD machine/extracorporeal circuit at S11. When the machine alarms and internal functions tests were completed, PCT DD initiated P#6’s dialysis treatment. PCT DD did not verify the dialysate’s pH with independed method, prior to starting P#6’s treatment. - At 10:17 a.m., PCT AA moved P#1 from S18 to S17 because of a machine malfunction. PCT AA did not measure the dialysate pH with an independent method before restarting P#1’s dialysis treatment. This facility used Fresenius 2008T Bluestar machines but did not use a bibag disposable (used as the bicarbonate source for the treatment). During an interview with PCT AA on 5/15/24 at 10:18a.m., she stated “I check my pH and conductivity first thing in the morning”. During an interview on 5/15/24 at 10:19 a.m., the Clinical Educator stated “Our policy is to check each machine’s pH and conductivity manually before the start of every treatment”. On 5/15/24 at 10:30 a.m., PCT DD stated “S11 was not my section. I put the patient’s needles in, and I thought the other PCT has checked the machine”. During an interview on 5/15/24 at 11:36 a.m., RN AA stated “We have not had a manager for two years and most of the PCTs are float”. The Clinic Manager was notified of the above findings on 5/15/24 at 11:45 a.m. and stated she will have a talk with the staff. - A review of facility document Reference Number: 64339 Version: 3 titled, “TSB - Regulatory Guidance for Using the 2008 Independent Conductivity and pH” dated 2/1/23 showed the following: Machine Instructions For Use Advances in the Fresenius 2008 Technology in Relation to Independent Conductivity and pH Verification The latest 2008T Bluestar functional software version 2.72 or later now incorporates a method for the machine to independently verify conductivity and pH when used in accordance with the machine instruction for use and using the bibag disposable, which states: “Note: If the Service Mode ‘Independent Cond Test’ option is enabled (functional software version 2.72 or later), the Independent Conductivity self-test will be listed among the selftests... When the bibag disposable is used as the bicarbonate source for the treatment, the Independent Conductivity self-test will be displayed as ‘Independent Conductivity/pH’ and the machine will then independently verify the conductivity and pH during the self-test.” Determining Independent Verifications If the machine is using a bibag disposable, the machine will independently verify both conductivity and pH. Refer to “Independent Conductivity and pH Verification” below. For machines that are not using a bibag disposable, only conductivity is verified independently... Staff will have to test the pH of dialysate with a meter or test strips in accordance with Fresenius Kidney Care policy and procedures. - A review of Policy: 25912 titled, “Checking Conductivity and pH of Final Dialysate” dated 5/6/24 showed the following: Two staff members will verify the conductivity and pH prior to each patient’s treatment.”