Davita Lake Hartwell 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 one of one Registered Nurse (RN AA) and two of two Patient Care Technicians (PCT AA and PCT DD) observed, to correctly verify the hemodialysis (HD) machine’s dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s Directions For Use (DFU); and failure of one of one Patient Care Technician (PCT AA) to correctly perform the Total Chlorine (chemical used to kill bacteria, fungi, and viruses in municipal water) Testing, according to the Manufacturer’s DFU. These failures had the potential to cause harm to 10 of 10 patients (P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, and P#15), who were undergoing hemodialysis at the time of this observation. The in-center hemodialysis census was 35. Findings include: Cross References: V 196 - Failure of the facility to follow the manufacturer’s DFU in testing the Total Chlorine of the dialysate. V 250 - Failure of the facility to follow the manufacturer’s DFU in verifying 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 observations, facility record review, staff interviews, a review of the manufacturer’s Directions for Use (DFU) and a review of facility Policy and Procedure (P & P), 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 35 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross References: V 196 - Failure of the Governing Body to ensure that one of one Patient Care Technician (PCT AA) followed the manufacturer’s DFU and facility P & P for Total Chlorine Testing and one of one Registered Nurse (RN AA) correctly validated the level of Total Chlorine in the water used for dialysis. V 250 - Failure of the Governing Body to ensure that two of two Patient Care Technicians (PCT AA and PCT DD) and one of one Registered Nurse (RN AA) observed, followed the Manufacturer’s DFU and the facility P&P regarding testing the machines’ dialysate pH (acidity) and conductivity (ability of the dialysate to conduct electricity) using RPC E-Z Chek K100-0117 6.8 - 8.5 pH strips and Myron L Conductivity Meter (D-1).”

“Dialysis Emergency Equipment CFR(s): §494.62(b)(9) Condition for Coverage: [(b) Policies and procedures. The dialysis facility must develop and implement emergency preparedness policies and procedures, based on the emergency plan set forth in paragraph (a) of this section, risk assessment at paragraph (a)(1) of this section, and the communication plan at paragraph (c) of this section. The policies and procedures must be reviewed and updated at least every 2 years. At a minimum, the policies and procedures must address the following:] (9) A process by which the staff can confirm that emergency equipment, including, but not limited to, oxygen, airways, suction, defibrillator or automated external defibrillator, artificial resuscitator, and emergency drugs, are on the premises at all times and immediately available. This Standard is not met as evidenced by: 33921 Based on observation, staff interview, and a review of the Food and Drug Administration (FDA) recommendations, it was determined that the facility failed to ensure that expired medications in one of one Medication Drawer, and in one of one Medication Refrigerator, were removed and not made available for use; and to ensure that prepared medication in syringes and opened multidose vial of Heparin (anticoagulant) and a vial of sterile water were labeled/dated, and expired lab supplies in one of one Peritoneal Dialysis (PD) laboratory supply cabinet were not made available for use. This deficient practice had the potential to negatively affect the health and safety of 35 in-center hemodialysis patients and eight PD patients who were under the care of this facility. Findings include: During a tour of the facility with the Facility Administrator on 5/1/24 between 10:50 a.m and 11:30 a.m., the following medications and supplies had expired, thus these were not suitable for use. In the PD Training Room Lab Supply Cabinet: - three blue top lab tubes expired 4/10/24 - two red top lab tubes expired 10/31/23 In the In-Center Lab Supply cabinet: - one red top lab tube expired 4/30/24 In the In-Center Medication Refrigerator: - two vials of Epogen 20,000 units (for the treatment of Anemia) - expired 3/2024 - one vial of unopened Tubersol (Tuberculin Purified Protein Derivative, is indicated to aid diagnosis of tuberculosis infection (TB) in persons at increased risk), expired 4/29/24. In the In-Center Medication Drawer: - there were two medication cups. One medication cup had two orange caplets and the other medication cup had four orange caplets. No labels in each cup. - there were four 10-cc syringes that had clear liquid in each of them. No labels in each syringe. The Registered Nurse (RN AA) stated on 5/1/24 at approximately 11:30 a.m., that the syringes had Heparin in them., and added that some patients did not show up for treatment today. - two bottles of Liquacel Liquid (Protein supplement) expired 3/2024. When notified about the above observation, RN AA stated, “Okay”, on 5/1/24 at 11:35 a.m. According to FDA recommendation dated 2/8/21, drug and supplies’ expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medication or using expired supplies. Once the expiration date has passed there is no guarantee that the medicine or supplies will be safe and effective. A review of facility Policy: 1-06-01, titled, “Medication Policy” with latest revision date of November 2023, stated: 13. All open or unopened medication packages (i.e. vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired. 16. Medication labels are to be printed on the patients’ treatment day(s). 17. Medication preparation should be performed only for the current shift of patients... 18. All syringes prepared from single use vials/ampules (without presevatives) or multidose vials should be prepared and administered within a four (4) hour... period... 20. If medications are prepared and administered immediately, by the same licensed nurse teammate, the medications do not need to be labeled. If the medication is not immediately administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of medication, date, time prepared, dose and initials of teammate preparing the medication. The above unlabeled medications (stored in the drawer), not immediately given, and there were more than one medication cup without labels and four unlabeled syringes. This had the potential for mistakes or given to the wrong patients, or potential for expired time (when prepared and when eventually given).”

“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 interview, a review of facility Policy and Procedures (P& P), and Centers for Disease Control and Prevention (CDC) Recommendations, it was determined that the Infection Control Committee failed to ensure that two of two Patient Care Technicians (PCT AA and PCT DD) observed, 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 bloodborne pathogens in the dialysis environment. This deficient practice had the potential to negatively affect all 35 in-center hemodialysis patients who dialyzed at this facility. Findings include: During observation in the Patient Treatment Room on 5/3/24 between 10:30 a.m. and 11:30 a.m., the following was revealed: - PCT AA was observed resetting the machine alarm (dirty) at Station (S) S. PCT AA did not perform hand hygiene between glove changes and before entering data in the computer keyboard (clean). In addition, PCT AA, while setting up the machine’s blood line connections, dropped the other uncapped tip (sterile) of the arterial bloodline which touched the floor (dirty). This had the potential for cross-contamination. PCT AA was about to connect this tip to the dialyzer when this surveyor brought it to her attention. PCT AA asked this surveyor if she should change it, on 5/3/24 at approximately 11:15 a.m. This surveyor in turn, asked PCT AA, what would you do? - PCT DD touched the machine at S8 (dirty), with one glove (left hand). PCT DD removed her left hand glove, and entered data in the computer, touching the computer keyboard (clean) without performing hand hygiene. - 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 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 ...”

“CARBON ADSORP-MONITOR, TEST FREQUENCY CFR(s): 494.40(a) 6.2.5 Carbon adsorption: monitoring, testing freq Testing for free chlorine, chloramine, or total chlorine should be performed at the beginning of each treatment day prior to patients initiating treatment and again prior to the beginning of each patient shift. If there are no set patient shifts, testing should be performed approximately every 4 hours. Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet. Testing for free chlorine, chloramine, or total chlorine can be accomplished using the N.N-diethyl-p-phenylene-diamine (DPD) based test kits or dip-and-read test strips. On-line monitors can be used to measure chloramine concentrations. Whichever test system is used, it must have sufficient sensitivity and specificity to resolve the maximum levels described in [AAMI] 4.1.1 (Table 1) [which is a maximum level of 0.1 mg/L]. Samples should be drawn when the system has been operating for at least 15 minutes. The analysis should be performed on-site, since chloramine levels will decrease if the sample is not assayed promptly. This Standard is not met as evidenced by: 33921 Based on observation, a review of the manufacturer’s directions for use (DFU) for testing Total Chlorine (test for presence of Chlorine in the water used for dialysis) using the RPC (K100-0118 (/F) Ultra-Low Total Chlorine Test Strips, a review of the facility’s Policy and Procedures (P&P), a review of the Total Chlorine logs, and staff interviews, it was determined that the facility failed to ensure that one of one Patient Care Technician (PCT AA) observed, who was assigned the task of testing the water quality and one of one Registered Nurse (RN AA), who was responsible for validating the test result, performed and validated, respectively, the Total Chlorine Test according to the manufacturer’s DFU. Residual levels of Total Chlorine in the water used for dialysis may result in the destruction of patient’s red blood cells (hemolysis) and had the potential to cause harm to 10 of 10 patients (P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, and P#15), who were undergoing hemodialysis at the time of this observation. The in-center hemodialysis patient census was 35. Findings include: During observation of PCT AA’s performance of the Total Chlorine test on 5/1/24 at 12:05 p.m., the following was observed: - PCT AA swished the RPC strip in the water sample for 60 seconds and immediately compared the test strip to the color chart without waiting for 20 seconds for the color to develop, according to the manufacturer’s DFU. In addition, when PCT AA was asked what she was testing, she stated on 5/1/24 at 12:07 p.m., that she didn’t know what she was testing. - RN AA read the result of the Total Chlorine Test with PCT AA without looking at the clock and without correcting PCT AA that she needed to wait for 20 seconds before comparing the strip to the color chart. In addition, on 5/1/24 at 12:08 p.m., RN AA told PCT AA that you just wait for a couple of seconds while you’re discarding the water sample and that’s all you need to do. A review of the facility’s Procedure: 12-14-03A titled, “Total Chlorine Test Using RPC Ultra Low Total Chlorine Test Strip” with latest revision date of October 2020 stated: 3. Remove the test strip and shake once, briskly, to remove excess water. 4. Wait 20 seconds for the test strip color to develop... During a review of the facility’s Daily Water Logs for Total Chlorine Testing, this surveyor found out that the facility used CM130 Automated Monitoring System (the HACH CM130 monitors total chlorine levels in pre-treatment water used in hemodialysis). The Total Chlorine Logs reviewed between March 2024 through May 1, 2024, showed that the Total Chlorine Test was performed every four hours. A review of the facility’s Policy: 1-18-09 titled, “Daily Water System Total Chlorine Monitoring for Facilities with the CM130 Automated Monitoring System” with latest revision date of October 2022 stated: 3. The CM130 Total Chlorine Analyzer, requires a comparison to a manual total chlorine test on a daily basis prior to the first patient treatment of the day to verify operation... - The Facility Administrator and the Clinical Services Specialist were notified of this observation on 5/1/24 at 12:35 p.m.”

“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 one of one Registered Nurse (RN AA) and two of three Patient Care Technicians (PCT AA and PCT DD) observed, to correctly verify the hemodialysis (HD) machine’s dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s Directions For Use (DFU) and facility’s procedure. This failure had the potential to negatively affect the health and safety of seven of seven patients (P#6, P#7, P#8, P#9, P#10, P#11, P#12), who were undergoing hemodialysis at the time of this observation. The facility In-Center Hemodialysis (ICHD) patient census was 35. Findings include: During observation in the Patient Treatment Room on 5/3/24 between 10:15 a.m. and 11:25 a.m., the following was revealed: - RN AA was observed independently verifying the dialysate’s conductivity using the Myron L Conductivity Meter (D-1). RN AA filled the meter cell cup with the dialysate sample and agitated the sample with the plunger by moving the plunger three times then she discarded the sample. RN AA repeated the above steps one more time, a total of two times instead of at least three to four times. RN AA filled the meter with a fresh sample, dropped the plunger into the solution and pressed the black button to check the conductivity. RN AA did not repeat this process twice, per manufacturer’s DFU and per facility procedure. - PCT AA and PCT DD, obtained dialysate sample from machines #13 and #12 respectively. After agitating and rinsing the meter cell cup three times, both proceeded to obtain a fresh dialysate sample, filled the meter, dropped the plunger in the solution and pressed the black button to check the conductivity. Both PCTs AA and DD did not repeat this process twice per manufacturer’s DFU and per facility’s procedure. - During testing of the dialysate’s pH using RPC Test Strip, PCT AA dipped the RPC test strip into the dialysate sample then without looking at the clock, she stated that she waited 10 seconds before comparing the test strip to the color chart. The surveyor’s watch showed that PCT AA only waited seven seconds. PCT AA stated on 5/3/24 at 11:04 a.m., that she didn’t look at the clock but counted in her head. - PCT DD tested the dialysate’s pH using RPC Test Strip, by swishing the test strip into the dialysate sample for 10 seconds, then immediately compared the test strip to the color chart. PCT DD stated on 5/3/24 at 10:34 a.m., that she swished the strip for 10 seconds because she worked for a different company that used a different device for checking pH and conductivity. A review of the facility’s Procedure: 2-08-01B titled, “Operation of Portable Myron L Conductivity Meter (D-1)” with latest revision date of April 2020 stated: 2. Obtain proportioned dialysate sample... utilizing the DI meter dipper side of the plunger or clean disposable collection cup. 3. Fill meter cell cup with sample so upper electrode is immersed. Insert plunger. 4. Agitate sample with plunger by moving up and down 3 or 4 times and then discard sample. 5. Repeat steps #3 and #4 - at least 3 times. RATIONALE: Verifies that any prior sample solution has been rinsed free from the cell. 6. Obtain another proportioned dialysate sample and fill the meter, drop plunger in the solution and press the black button. When the pointer stops, immediately read and release the button. 7. Repeat step #6 twice and press Read/Check button and record conductivity reading. RATIONALE: Helps assure accurate reading. A review of the facility’s Procedure: 2-08-01K titled, “Testing pH for Acetate Based Dialysate Using RPC E-Z Chek K100-0117 6.8 - 8.5 Test Strips” with latest revision date of October 2023 stated: 2. Obtain dialysate sample using a disposable collection cup, then dip the strip into the solution for one (1) second... 3. Remove the strip from the fluid and shake off excess dialysate. After 10 seconds, compare the strip to the color chart on the bottle. The Manager of Clinical Services was notified of this observation on 5/3/24 at 11:20 a.m.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 33921 Based on observation, staff interview, and a review of Centers for Disease Control and Prevention (CDC) recommendation, it was determined that the facility failed to ensure that the building in which dialysis services were provided, was maintained free from damage and defects to ensure the safety of the patients and staff. This failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. This deficient practice was observed in one of one Supply Room, one of one Patient Treatment Room, and one of one Dialysate Preparation Room. Findings include: During a tour of the facility on 5/1/24 between 10:50 a.m. and 11:30 a.m., the following was revealed: In the Patient Treatment Room: - The Dialysis Wall Boxes and Drains (are frames recessed into the wall at each hemodialysis station that contain connections for the dialysis machine to receive acid and base concentrates and treated water, and dispose of products), at Stations 1, 2, 3 and 4 were covered with orangy-brown discoloration. In the Supply Room: - Dirty white crystallized substance covered the floor drainage grill. - The cement floor was chipped and corroded. In the Dialysate Preparation Room: - Peeled off paint on the right side of the Reverse Osmosis (R.O. system) - CWP MarCor Purification. - The concrete floor next to the R.O. System was chipped and corroded and there was standing water next to it. The Facility Administrator, who was present during this tour, on 5/1/24 at 11:20 a.m., confirmed these findings. According to CDC, there are several infection prevention and control issues unique to wall boxes. They can become easily contaminated with microorganisms, which can subsequently be transferred to dialysis patients, a vulnerable group at high risk of infection.”