Davita Effingham North Dialysis

“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 policy and procedures, and manufacturer’s Directions for Use (DFU), it was determined that the facility failed to ensure that two of two Patient Care Technicians (PCT) (PCT AA and PCT BB) observed, verified the hemodialysis machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU per ANSI/AAMI RD52: 2004 guidelines. This deficient practice had the potential to negatively affect the health and safety of four of four patients who were receiving hemodialysis treatment at Station (S) 4, S5, S8 and S12 at the time of observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could 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 could be altered. The facility census was 23. Findings include: Cross Reference: V 250 - Failure of the facility to accurately perform independent testing of the machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (acidity) and conductivity (ability of the dialysate to conduct electricity) according to the Manufacturer’s DFU prior to the initiation of each patient treatment.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observations, staff interviews, a review of the manufacturer’s Directions for Use (DFU), 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 23 in-center hemodialysis patients who were receiving hemodialysis treatment at this facility. Findings include: Cross Reference: V 250 - Failure of the facility to accurately perform independent testing of the machine’s dialysate (a solution of pure water, electrolytes and salts such as bicarbonate and sodium) pH (acidity) and conductivity (ability of the dialysate to conduct electricity) according to the Manufacturer’s DFU prior to the initiation of each patient 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: 49321 Based on observation, staff interviews, and a review of policy and procedures (P&P), it was determined that the infection control committee failed to ensure one of three Patient Care Technicians (PCT AA) observed, failed to change gloves when going from a “dirty” area/task to a “clean” area/task. This deficient practice increased the risk for cross contamination with the potential to expose Patient (P) #6 and P#2 to bloodborne pathogens in the dialysis environment. The facility census was 23. Findings include: During observation in the Patient Treatment Room on 1/8/25 at 10:00 a.m. to 12:00 p.m., the following was observed: - PCT AA wore gloves and touched the dialysis machine (dirty). Then she cleaned/disinfected P#6’s access, inserted the fistula needles, connected the needles to bloodlines (clean tasks) and started the patient’s dialysis treatment. PCT AA did not change her gloves when going from a “dirty” area/task to a “clean” area/task. - PCT AA was observed during discontinuation of P#2’s dialysis treatment. PCT AA reinfused P#2’s blood (rinsed blood back), touched the dialysis machine, sharps container, and P#2’s blanket (dirty areas/tasks). PCT AA then tore three pieces of tape (clean task) and placed them on top of the gloves, removed P#2’s needles, held pressure to establish hemostasis (stop the bleeding) and applied gauze and used the tape on her gloves to secure the gauze (clean tasks). PCT AA did not change gloves when going from a “dirty” task to a “clean” task. During an interview on 1/8/25 at 11:20 a.m., PCT AA stated that she is going so fast that sometimes she forgets to change her gloves. During an interview with the Facility Administrator on 1/10/25 at 1:00 p.m., she stated her staff are aware of clean and dirty. Stated PCT AA was not her normal staff, but she will be retrained on cross contamination before she can come back to this facility. A review of Policy 1-05-01 titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES” dated April 2023 showed the following: PPE (i.e., gloves eye protection, face sheild) 7. a. Gloves should be changed when: ii, When going from a “dirty” area or task to a “clean” area or task.”

“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: 49321 Based on observation, staff interview, and a review of facility policy, it was determined that the infection control committee failed to ensure that one of one dietitian wore appropriate personal protective equipment (PPE) such as face shield, while she talked to a patient whose dialysis needles were being removed, during which spurting or spattering of blood could occur. Findings include: During observation in the Patient Treatment Room on 1/8/25 at 10:00 a.m. to 12:00 p.m., the following was observed: - Patient (P) #6 was seated at Station (S) 3. Patient Care Technician (PCT) AA removed both arterial and venous needles from P#6’s access sites (during which spurting or spattering of blood could occur) while the dietitian stood on the side of the patient’s treatment chair and talked to P#6. The dietitian did wear a face shield to protect herself when spurting or spattering of blood might occur. During an interview on 1/8/25 at 10:26 a.m., the dietician stated that she thought a face shield was warranted only when the patient’s treatment was started and when the treatment was completed. A review of Policy 1-05-01 titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES” dated April 2023, showed the following: PPE (i.e., gowns, gloves, eye protection, face shield) 5. Appropriate PPE will be worn whenever there is the potential for contact with body fluids, hazardous chemicals, contaminated equipment and environmental surfaces, for example, patient areas.”

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 49321 Based on observation, staff interview, and a review of policy and procedures, it was determined that the Infection Control Committee failed to ensure that two of three Patient Care Technicians (PCT AA and PCT BB) observed, failed to perform disinfection of equipment after use and prior to returning it to the clean/designated area. This deficient practice increased the risk for cross contamination with the potential to expose 23 patients and staff to bloodborne pathogens in the dialysis environment. Findings include: During observation in the Patient Treatment Room on 1/8/25 at 10:00 a.m. to 12:00 p.m., the following was observed: - PCT AA used the Myron-L Meter at Station (S) 1. The Myron-L Meter was placed on top of the dialysis machine (dirty). When finished, the Myron-L Meter was placed back in the clean/designated area. The meter was not cleaned or disinfected before it was returned in the clean/designated area. - PCT BB used the Myron-L Meter at S8. The Myron-L Meter was placed on top of the dialysis machine. When finished, the Myron-L Meter was placed back in the clean/designated area. The meter was not cleaned or disinfected before it was returned in the clean/designated area. During an interview on 1/8/25 at 10:25 a.m., PCT BB acknowledged that she did not clean the Myron-L Meter before putting it back in the clean area. During an interview on 1/8/25 at 10:35 a.m., PCT AA was unsure if the meter should be cleaned because she stated the dialysis machine was clean. During an interview with the Facility Administrator on 1/10/25 at 1:00 p.m., she stated PCT AA was not her normal staff, but she will be retrained on cross contamination. A review of Policy 1-05-01 titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES” dated April 2023 showed the following: DISINFECTION 12. Cleaning and/or disinfection of equipment and work surfaces will be performed as soon as possible following exposure to blood or other potentially infectious materials (i.e. used or brought into the station) and prior to returning to clean/designated area or removal from treatment area.”

“IC-HBV-VACCINATE PTS/STAFF CFR(s): 494.30(a)(1)(i) Hepatitis B Vaccination Vaccinate all susceptible patients and staff members against hepatitis B. This Standard is not met as evidenced by: 49321 Based on a review of facility records, a review of personnel file, and staff interview, it was determined that the facility failed to ensure that three of five patients (P) sampled (P#1, P#2, and P#5) and one of one Medical Director, who were susceptible to hepatitis B virus, were vaccinated against hepatitis B. Findings include: A review of the facilities “Vaccination and Surveillance Report” revealed the following: - Hepatitis B surface Antibody (HBsAb) = A test measures the level of antibodies in blood that body produces to fight the hepatitis B virus (HBV). - HBsAb 10 or greater = Immunity - HBaAb less than 10 means the person is susceptible - P#1 was tested for HBsAb on 11/8/24 and resulted 7. P#1 received the Hep B vaccine on 10/16/24, 9/18/24/, and 8/23/24 outside of the facility and was scheduled to received Engerix B vaccine (Hepatitis B vaccine) at the facility on 11/22/24. The dose was not given. There was no declination note in the patient’s chart. - P#2 was tested for HBsAb on 11/8/24 and resulted 4. Last Engerix 40 mg vaccine dose was given on 6/22/22. There was no counseling or declination in the patient’s chart. - P#5 was tested for HBsAb on 10/18/24 and resulted 3. Last Engerix 40 mg vaccine dose was given on 4/24/24. There was no counseling or declination noted in the patient’s chart. - The Medical Director’s last HBsAb was drawn on 3/29/21. The result was reactive and did not have a numeric value. There was a lack of Hepatitis B Core antibody, or a Hepatitis B surface Antigen drawn nor a declination in MD’s personnel file. During an interview with the Facility Administrator on 1/10 25 at 1:00 p.m., she acknowledged that staff should have been monitoring the patients’ Hep B vaccinations more closely. She also stated the Medical Directors office staff only offered the labs that were drawn 3/29/21. A review of Policy: 1-05-02 titled, “Hepatitis B SURVEILLANCE, VACCINATION, INFECTION CONTROL MEASURES AND ISOLATION GUIDANCE” last revised April 2024 showed the following: 13. Test all vaccinated patients for HBsAb one (1) to two (2) months after the last dose of full vaccine series (adequate response is defined as greater than or equal (>) 10mIU/mL. a. If hepatitis B surface antibody (HBsAb) is less than (<) 10 mIU/mL, consider the patient susceptible, revaccinate with additional full series, and retest for HBsAb one (1) to two (2) months after the last dose of the second series. A review of Policy: 4-06-03 titled, “Teammate Hepatitis B Monitoring and Follow-Up Guidance “ with latest revision date of April 2024 showed: 2. Teammates providing evidence of hepatitis B surface antibodies of 10 mIU/mL or greater upon hire will be considered immune and will not require initial or ongoing testing. Acceptable documentation of anti-HB titers will be either a copy of: 1. An official laboratory results 2. Or a prior employer’s health monitor form Documentation must contain testing dates and NUMERIC titer results. Results documented as only positive will not be accepted.”

“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 policy and procedures, and manufacturer’s Directions for Use (DFU), it was determined that the facility failed to ensure that two of two Patient Care Technicians (PCT) (PCT AA and PCT BB) observed, verified the hemodialysis machine’s final dialysate conductivity (ability of the dialysate to conduct electricity) and pH (acidity), according to the manufacturer’s DFU per ANSI/AAMI RD52: 2004 guidelines. This deficient practice had the potential to negatively affect the health and safety of four of four patients who were receiving hemodialysis treatment at Station (S) 4, S5, S8 and S12 at the time of observation. Complications as minor as nausea and fatigue or as severe as metabolic acidosis (decrease in pH that could 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 could be altered. The facility census was 23. Findings include: During observation in the Patient Treatment Room on 1/8/25 between 10:00 a.m. and 12:00 p.m., the following was observed: - PCT AA was observed during machine set-up at S5. When finished, she summoned a patient from the waiting area and conducted the pre-treatment assessment and vital signs. Meanwhile, PCT CC (who was called in to work/help out) went to S5 and offered to test/verify dialysate pH and conductivity. PCT AA stated she has done them. However, this surveyor’s attention was focused exclusively on the machine set-up procedure and initiation of dialysis on the patient in S5, did not observe any staff tested/verified the final dialysate of the machine at S5. PCT AA initiated the patient’s dialysis treatment without checking the dialysate pH and conductivity. This was confirmed by PCT CC on 1/8/25 at 10:18 a.m. During an interview on 1/8/25 at 10:25 a.m., PCT AA was asked by this surveyor to demonstrate how she checked the pH and conductivity of the dialysis machine. PCT AA removed the blue hanson from the dialyzer and allowed the dialysate to flow into the meter cup on the Myron-L Meter. The meter was then placed on top of the dialysis machine. PCT AA inserted the plunger, did not agitate the sample, pressed the black button, and documented the result. PCT AA then placed an RPC K100-0117CT E-Z pH test strip inside the Myron -L Meter cup, removed the strip from the cup, and immediately compared the strip to the color chart on the RPC bottle. PCT AA did not wait between 20 and 25 seconds to compare test results to the color scale per manufacturer’s DFU. PCT AA was asked how many times the Myron-L Meter should be rinsed with dialysate before reading the conductivity. PCT AA stated I have never rinsed the Myron-L Meter with dialysate. When asked about testing for pH, PCT AA stated she dipped the RPC strip and compared it immediately. Stated she never knew she had to wait before reading the result. - PCT BB was observed as she checked the dialysis machine’s pH and conductivity at S8. PCT BB retrieved dialysate from the blue Hanson with a syringe. She then poured the dialysate into the meter cup, inserted the plunger, pressed the black button, and documented her reading. She then inserted an RPC K100-0117 E-Z pH test strip inside the Myron-L meter cup, removed the strip from the cup, and immediately compared the strip to the color chart on the RPC bottle and did not wait for the color to develop per manufacturer’s DFU. During an interview on 1/8/25 at 10:35 a.m., PCT BB was asked how many times should the Myron-L meter be rinsed with dialysate before a conductivity reading was taken, PCT BB said she was educated to put the dialysate in the meter cup and read the conductivity. She also admitted that sometimes, when rushing, she does not use the Myron-L meter. When asked how many seconds she should wait before comparing the RPC strips to the color chart, she stated she did not know. . The Bio-Medical Technician (BMT) and the Acting Facility Administrator were notified of the findings on 1/8/25 at 10:45 a.m. The BMT stated staff would be immediately retrained on correctly using the RPC K100-0117CT E-Z pH test strips and the Myron-L Meter. A review of Policy: 1-03-02 titled, “Testing pH and Conductivity of Proportioned Dialysate and Verification of Temperature of Proportioned Dialysate” revised October 2024 showed: - Manual pH testing must be performed prior to each patient’s treatment. A review of the RPC K100-0117CT E-Z Chek 6.8- 8.5 pH Test Strips’ manufacturer’s DFU showed the following: Instructions for use 3. Dip or wet the strip pad for one second with fresh solution to be tested. 4. Briskly shake off excess solution. Compare test results to the color scale on the bottle between 20 and 25 seconds. Retest if the results are not read within the 25-second time frame. A review of the “Myron L Conductivity Meter (D-1) skills checklist” dated May 2023 showed the following: Operation of the Myron L Conductivity Meter 3. Fill the meter cell cup with sample so upper electrode is immersed, insert plunger. Agitate sample with plunger by moving up and down 3 to 4 times and then discard sample. Perform these steps at least 3 times. 4. Obtain another proportioned dialysate sample, fill the meter, drop the plunger in the solution, and press the black button. When the pointer stops, immediately read and release the button. Repeat this step twice, press the Read/Check button, and document the conductivity reading. According to ANSI/AAMI RD52: 2004 Section 5.6, “Dialysate Proportioning”, 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.”

“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: 49321 Based on observation and staff interview, 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. Failure to maintain the integrity of all surfaces could hinder effective cleaning and disinfection of the surfaces, thus providing a potential for microbial growth. These environmental concerns were observed in one of one Patient Treatment Room and one of one Supply Room. The facility census was 23. Findings include: During a tour of the facility on 1/8/25 from 12:00 p.m. to 1:00 p.m. with the Biomedical Technician, the following was observed: In the Patient Treatment Room: - The drywall behind the wall box and drain (connections for the dialysis machine to receive acid, base concentrate, treated water, and dispose of waste products) at Station (S) 2 had approximately 3 feet of rust colored substance above the base molding. The floor around this area was wet. - There were two buckled floor tiles around the support beam between S10 and S11 that were separated from the tile bed. Dirt particles were present underneath the lifted tiles. In the Supply Room: - The floor was uneven with noticeable grooves all over the entire floor. - There were four large supply racks that were stored against the wall. Underneath the supply racks showed dust and dirt particles. During an interview with the Biomedical Technician on 1/8/25 at 1:15 p.m., he stated the wall at S2 had been stained for a while and the floor is wet because the dialysis machine is leaking. He also stated that he put in a ticket for the Supply Room floor to be resurfaced with Epoxy and was waiting for an estimate.”