Davita Lake Hearn Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 33921 Based on observation, staff interviews, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of two of two Registered Nurses (RN AA, and RN CC/Charge Nurse) and one of one Patient Care Technician (PCT BB) observed, to independently verify the hemodialysis (HD) machine’s dialysate Conductivity (ability of the dialysate to conduct electricity) and pH (Acidity), before each patient’s HD treatment. This failure had the potential to negatively affect the health and safety of three of three patients (P#2, P#3 and P#5) observed, whose machine’s dialysate pH and Conductivity were not independently tested and the other six patients (P#4, P#6, P#7, P#8, P#9 and P#10), who were undergoing hemodialysis at the time of this observation. The facility census was 60. Findings include: Cross Reference: V 250 - Failure of the facility to independently test the machine’s dialysate pH and Conductivity prior to the initiation of HD treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 33921 Based on observation, facility record review, staff interviews, 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 60 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 250 - Failure of the facility to ensure that the machine dialysate’s pH and Conductivity were independently tested prior to initiation of hemodialysis treatment. V713 - Failure of the medical director to ensure that facility staff members received appropriate training to competently perform their job responsibilities.”

“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: 33921 Based on observation, staff interviews, a review of facility Policy and Procedure, and Centers for Disease Control and Prevention (CDC) Recommendations, it was determined that the Infection Control Committee failed to ensure that two of two Direct Patient Care (DPC) Staff [Registered Nurse (RN BB) and Patient Care Technician (PCT BB)], performed hand hygiene (washed hands or used an alcohol-based hand sanitizer), after removal of contaminated gloves, between glove changes and after touching contaminated equipment. Failure to perform infection control techniques such as hand hygiene, increased the risk for cross contamination with the potential to expose patients and staff to blood-borne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect 60 in-center hemodialysis patients who dialyzed at this facility and 10 DPC staff. Findings include: During observation in the Patient Treatment Room on 1/4/24 between 11:30 a.m. and 1:00 p.m., the following was revealed: - RN BB was observed during initiation of hemodialysis treatment of Patient (P) #4 at Station (S) 3. RN BB did not perform hand hygiene between glove changes. - PCT BB reset the alarm (dirty task) at S14, then removed his contaminated gloves and touched the computer keys (clean) without performing hand hygiene. Then PCT BB put on new gloves without first performing hand hygiene. - PCT BB was also observed resetting the alarms at S18 and S19 without changing gloves between machines and without performing hand hygiene. Both RN BB and PCT BB acknowledged their failure to perform hand hygiene between glove changes, performing hand hygiene and changing gloves between machines and before touching clean areas, on 1/4/24 between 5:35 p.m. and 5:45 p.m., respectively. - A review of the facility’s Policy #1-05-01 titled, “Infection Control for Dialysis Facilities” with latest revision date of April 2023, stated: Hand Hygiene: 1. All teammates, Physicians and Non-Physician (NPP) will perform hand hygiene: b. prior to gloving and immediately after removal of gloves, c. after contamination with blood or other infectious material, d. after patient and dialysis delivery system contact... g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse 2. Patients and caregivers will be encouraged to: a. Wash their hands and access extremity upon entering the treatment area prior to the initiation of dialysis. b. Perform hand hygiene after treatment before leaving treatment area... 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-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 33921 Based on observation, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, a review of facility Policies and Procedures (P&P), and staff interview, it was determined that the Infection Control Committee failed to ensure that one of one Registered Nurse (RN AA) observed during initiation of hemodialysis (HD) treatment on one of one patient (P#2)observed who had a Central Venous Catheter (CVC), utilized appropriate infection control techniques to prevent cross contamination. This breach in infection control techniques could negatively affect the health and safety of P#2, and 19 other patients who had CVC, as their dialysis access. The facility census was 60. Findings include: During observation in the Patient Treatment Room between 11:30 a.m. and 1:00 p.m., the following was revealed: - RN AA was observed during initiation of hemodialysis treatment on P#2, who had a CVC at Station (S) 16. RN AA returned used bloody syringes (contaminated) back to the blue liner with the clean/sterile supplies, such as Heparin (anticoagulant) syringes, gauze, Normal Saline Solution syringes (used for flushing), and alcohol pads (clean). - RN AA acknowledged this observation on 1/4/24 at 4:30 p.m. and agreed that contaminated/used supplies should not be mixed with clean/sterile supplies. According to the CDC, cross contaminating (going from dirty to clean equipment/tasks/area), could cause the spread of bacteria/infections. A review of facility Procedure: 1-04-02B titled, “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps” with latest revision date of 10/22, stated: NOTES: Use Dialysis Precautions and aseptic technique throughout the procedure. 21 - Aseptically discard syringe containing indwelling solution from arterial limb and attach a saline filled syringe. Repeat step for venous limb...”

“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: 33921 Based on observation, staff interviews, and a review of facility records, it was determined that the facility failed to ensure that there was a safe environment for all patients as evidenced by failure of two of two Registered Nurses (RN AA, and Charge Nurse (RN CC) and one of one Patient Care Technician (PCT BB) observed, to independently verify the hemodialysis (HD) machine’s dialysate Conductivity (ability of the dialysate to conduct electricity) and pH (Acidity), before each patient’s HD treatment. This failure had the potential to negatively affect the health and safety of three of three patients (P#2, P#3 and P#5) observed, whose machine dialysate’s pH and Conductivity were not independently tested and the other six patients (P#4, P#6, P#7, P#8, P#9 and P#10), who were undergoing hemodialysis at the time of this observation. The facility census was 60. Findings include: During observation in the Patient Treatment Room on 1/4/24, between 11:30 a.m. and 1:00 p.m., the following was revealed: - RN AA initiated P#2’s HD treatment at Station (S) 16, without independently testing the dialysate’s pH and Conductivity, prior to initiating patient treatment. RN AA stated on 1/4/24 at approximately 1:00 p.m., that patients were moved around and she was told at the last minute that P#2 was her patient. She didn’t realize that the machine dialysate’s pH and Conductivity were not tested. She added that she was hurrying up because patients were waiting outside and they had started late today for a “huddle” (informal staff) meeting. - PCT BB did not independently test the dialysate’s pH and Conductivity at S18 before initiating P#3’s HD treatment. PCT BB admitted that he did not independently test the dialysate’s pH and Conductivity at S18 on 1/4/24 at approximately 12:10 p.m. - RN CC also failed to independently test the dialysate’s pH and Conductivity at S17 prior to initiating P#5’s HD treatment. RN CC acknowledged not independently testing the dialysate’s pH and Conductivity prior to treatment initiation, on 1/4/24 at approximately 12:40 p.m. - The Facility Administrator was notified about the failure of RN AA, RN CC and PCT BB to independently test the machine’s dialysate pH and Conductivity prior to initiating patients’ HD on 1/4/24 at 12:45 p.m. The Regional Director of Clinical Services (who was in the facility prior to the surveyors’ arrival), was also notified about the above observation on 1/4/24 at 12:50 p.m. She stated that she and the Manager of Clinical Services came earlier today, per the Facility Administrator’s request to assist with staff supervision, audits, and whatever staff might need.”

“MD RESP-STAFF ED, TRAINING & PERFORM CFR(s): 494.150(b) Medical director responsibilities include, but are not limited to, the following: (b) Staff education, training, and performance. This Standard is not met as evidenced by: 33921 Based on observation, a review of Operator’s Manual, staff interviews, and a review of personnel files, it was determined that the Medical Director failed to ensure that two of three Registered Nurses (RN AA and RN BB) and one of one Patient Care Technician (PCT BB), were competent to perform their job responsibilities in alarms troubleshooting. This deficient practice resulted in Patient (P) #4’s loss of approximately 150 mL of blood, due to clotted dialyzer (artificial kidney) and clotted blood tubing; and had the potential to cause harm to the other 59 patients who were receiving hemodialysis treatment at this facility. Findings include: During observation in the Patient Treatment Room on 1/4/24 between 12:25 p.m. and 12:48 p.m., the following was revealed: - The machine at Station (S) 3 began to sound an alarm that showed high arterial pressure. (One of the functions of a hemodialysis machine is to measure and display arterial and venous pressures as well as to notify the operator when these pressures fluctuate outside of an established alarm limit. Arterial and venous pressure monitoring provides information regarding vascular access and the extracorporeal circuit (all of the apparatus carrying the blood outside the body such as blood tubing, blood pump, and dialyzer) in which a patient’s blood is circulating. It is the responsibility of the operator or Direct Patient Care Staff who monitors and interprets these pressure readings to determine how effectively or safely a treatment is being performed and to initiate appropriate interventions). - RN AA touched the reset button on the machine, but the machine alarm continued to beep. RN AA requested PCT BB to help reset the alarm. PCT BB opened the door of the blood pump of the machine at S3, then closed it. The monitor showed, “ART BP NO COMM”. (According to Fresenius Medical Care 2008T Operator’s Manual P/N 490122 Rev N, page 163, Alarms Trouble-shooting, “Art BP no comm” means the Blood Pump has lost communication with the machine. “ACTION REQUIRED: Turn machine power Off and back On. If alarm is not cleared, manually return the blood to the patient if the alarm occurs during treatment (see page 129 for instructions). Take the machine out of service and alert a qualified service technician”. - PCT BB went to ask RN BB for help. RN BB adjusted P#4’s blood pressure cuff, checked P#4’s blood pressure and obtained a blood pressure reading of 130/84 (which had nothing to do with the machine’s alarm - the BP on the machine alarm monitor stands for Blood Pump and not Blood Pressure). Then RN BB went to ask for help from the Charge Nurse (RN CC). RN CC stated on 1/4/24 at approximately 12:45 p.m., “I don’t have time for this, just rinse patient back”. RN BB attempted to return P#4’s blood or to rinse him back, but P#4’s blood (approximately 150 mL) in the extracorporeal system had clotted (due to a lack of circulation). RN CC walked over to S3, and turned the machine off and back on. RN CC told RN BB to manually rinse P#4 back and move him to another chair/station. RN AA stated on 1/4/24 at 4:30 p.m., that today was the worst day, which was unusual, because the machines didn’t work and they had to move patients around. RN CC stated on 1/4/24 at 4:40 p.m., that today was hectic because patient treatments were delayed due to their “huddle” meeting (an informal staff meeting). A review of Personnel File revealed the following: - RN AA (new to dialysis) started hemodialysis training on 8/21/23 and completed satisfactory performance of the Procedural Skills Verification Checklist on 12/2/23, which included Troubleshooting - properly operates and troubleshoots the facility specific dialysis delivery system... Demonstrates monitoring and documentation of venous pressure... Demonstrates monitoring and documentation of arterial pressure...Properly performs basic operator troubleshooting per manufacturing guidance... - RN BB (new to dialysis) started hemodialysis training on 9/5/23 and completed satisfactory performance of the Procedural Skills Verification Checklist on 12/8/23, which also included the above-mentioned skills checks. - PCT BB (hired on 6/20/22), had an Annual Procedural Skills Verification Checklist that was completed on 10/19/23, which also included the above-mentioned skills checks. There was a lack of documented evidence that performance audits/evaluations were conducted after the initial training and skills verification checklist were completed, to ensure comprehension of training and to ensure that skills were maintained or applied.”