Davita Mountain Park Dialysis

“CFC-WATER & DIALYSATE QUALITY CFR(s): 494.40 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, review of Fresenius Medical Care 2008K Hemodialysis Machine Operator’s Manual and a review of facility policy, it was determined that the facility failed to ensure that there was a safe environment for patients as evidenced by failure of three of three Patient Care Technicians (PCT AA, PCT BB, and PCT CC), and one of one Licensed Practical Nurse (LPN AA) to follow the manufacturer’s directions for use and facility’s policy regarding independently testing the machines’ dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (Acidity) using RPC K100-0117 E-Z Chek 6.8-8.5 pH test strips; and independently testing the conductivity (ability of the dialysate to conduct electricity) using the Myron L D-1 meter. This deficient practice had the potential to negatively affect the health and safety of seven of seven patients (P#2, P#3, P#4, P#7, P#8, P#10, and P#14) observed, during initiation of dialysis treatment. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that can cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) can result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance can be altered. Findings were: Cross Reference: V 250 - Failure of the facility to independently test the machine’s dialysate pH and conductivity according to the manufacturer’s directions for use and facility’s policy prior to the initiation of each dialysis treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and 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 70 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V 250 - Failure of the facility to ensure that staff independently tested the machine’s dialysate pH and conductivity according to the manufacturer’s directions for use and facility’s policy, prior to the initiation of each dialysis treatment.”

“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, review of Fresenius Medical Care 2008K Hemodialysis Machine Operator’s Manual and a review of facility policy, it was determined that the facility failed to ensure that there was a safe environment for patients as evidenced by failure of three of three Patient Care Technicians (PCT AA, PCT BB, and PCT CC), and one of one Licensed Practical Nurse (LPN AA) to follow the manufacturer’s directions for use and facility’s policy regarding independently testing the machines’ dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (Acidity) using RPC K100-0117 E-Z Chek 6.8-8.5 pH test strips; and independently testing the conductivity (ability of the dialysate to conduct electricity) using the Myron L D-1 meter. This deficient practice had the potential to negatively affect the health and safety of seven of seven patients (P#2, P#3, P#4, P#7, P#8, P#10, and P#14) observed, during initiation of dialysis treatment. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that can cause rapid breathing, confusion, dizziness, shortness of breath, chest pain) can result if dialysate composition is incorrect. And if conductivity is off, the effectiveness of the treatment is reduced and patient electrolyte balance can be altered. During observation in the Patient Treatment Room between 10:15 a.m. and 2:00 p.m., the following was revealed: - PCT AA was observed during preparation of the hemodialysis machines/extracorporeal circuits [the tubing, blood pump, heparin (blood thinner) pump, artificial kidney, and monitors for blood flow, blood pressure, and air bubbles] at Station (S) 2, S3, and S4 for the second shift patients (P#2, P#3, and P#4). - PCT AA was also observed during initiation of P#2, P#3, and P#4’s dialysis treatment. - PCT AA did not independently test pH and conductivity of final dialysate utilizing appropriate test strips and meter prior to each patient treatment. - PCT BB was observed during preparation of the hemodialysis machines/extracorporeal circuits at S7, S8, and S10 for the second shift patients (P#7, P#8, and P#10). - PCT BB was also observed during initiation of P#7, P#8, and P#10’s dialysis treatment. - PCT BB did not independently test pH and conductivity of final dialysate utilizing appropriate test strips and meter prior to each patient treatment. - LPN AA was observed during preparation of the hemodialysis machine/extracorporeal circuit at S14 for P#14. - LPN AA was also observed during initiation of P#14’s dialysis treatment. - LPN AA did not independently test pH and conductivity of final dialysate utilizing appropriate test strip and meter prior to P#14’s treatment. During staff interviews on 7/17/24, the following was revealed: - At 2:25 p.m., PCT AA was asked why he did not independently check the dialysate pH and conductivity on machines at S2, S3, and S4. He stated “we were taught to check our dialysis machines one time before the first shift patients get on the machine. Everyone here does it the same way, one time in the morning”. - At 2:55 p.m., PCT BB stated “I am a Preceptor and I was trained to check my dialysis machines for pH and conductivity before each shift. However, we were told here that we only have to check the pH and conductivity in the morning before the first shift patients get on the machine”. - At 3:20 p.m., LPN AA stated “the machines are checked every morning, it is also done like this at another sister facility (named) as well. Everyone does it every morning”. - At 3:47 p.m., the Charge Nurse was asked about performing pH and condictivity once daily, she stated “the Facility Administrator is responsible for training the staff. Yes, we only test the dialysis machines once in the morning for pH and conductivity”. - At 5:20 p.m., the Director of Operations (DO) was notified that staff was manually checking the dialysate pH and conductivity on dialysis machines once a day (in the morning only, before the first shift treatment starts). The DO stated “yes, okay”. A review of the Fresenius Medical Care 2008K Hemodialysis Machine Operator’s Manual, page 14 stated: The operator should always check conductivity and approximate pH of the dialysate with an independent device prior to initiating treatment and whenever concentrates are changed during operation. A review of Policy 1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” dated 2020 stated: Notes: * Manual pH testing must be performed prior to each patient treatment. * Requiement for independent conductivity testing is determined by Manufacturer’s guidelines. Refer to specific hemodialysis machine priming policies and procedures to determine the requirement of performing independent conductivity testing in the facility. Policy: 1. Trained teammates will test pH and conductivity of final dialysate utilizing appropriate test strips and/ or meter proir to each patient treatment.”