Davita Kidney Dialysis Center

“CFC-INFECTION CONTROL CFR(s): 494.30 This Condition is not met as evidenced by: 49321 Based on observation, staff interview, a review of Centers for Disease Control and Prevention (CDC) recommendations, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that two of two Registered Nurses (RN AA and RN BB), one of one Licensed Practical Nurse (LPN AA), and five of five Patient Care Technicians (PCT AA, PCT BB, PCT CC, PCT DD and PCT EE), promptly and thoroughly cleaned and disinfected blood-contaminated surfaces and dialysis equipment when first observed and after patients completed their hemodialysis treatments. This deficient practice increased the risk for cross-contamination and transmission of dangerous pathogens, that could negatively affect the health and safety of 28 of 28 patients (P) #1, P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, P#24, P#25, P#26, P#27, and P#28),who were undergoing hemodialysis treatment at the time of this observation. The facility census was 114 in-center hemodialysis patients. Findings include: V 122 - Failure of the Infection Control Committee to ensure that two of two Registered Nurses (RN AA and RN BB), one of one Licensed Practical Nurse (LPN AA), and five of five Patient Care Technicians (PCT AA, PCT BB, PCT CC, PCT DD and PCT EE), promptly and thoroughly cleaned and disinfected blood-contaminated surfaces and dialysis equipment when first observed and after patients completed their hemodialysis treatments.”

“CFC-GOVERNANCE CFR(s): 494.180 This Condition is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of facility 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 114 in-center hemodialysis patients who were under the care of this facility. Findings include: Cross Reference: V 757 - Failure of the Governing Body to ensure the facility had adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis.”

“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: 49321 Based on observation, staff interview, a review of Centers for Disease Control and Prevention (CDC) recommendations, and a review of the facility’s Policies and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that two of two Registered Nurses (RN AA and RN BB), one of one Licensed Practical Nurse (LPN AA), and five of five Patient Care Technicians (PCT AA, PCT BB, PCT CC, PCT DD and PCT EE), promptly and thoroughly cleaned and disinfected blood-contaminated surfaces and dialysis equipment when first observed and after patients completed their hemodialysis treatments. This deficient practice increased the risk for cross-contamination and transmission of dangerous pathogens, that could negatively affect the health and safety of 28 of 28 patients (P) #1, P#2, P#3, P#4, P#5, P#6, P#7, P#8, P#9, P#10, P#11, P#12, P#13, P#14, P#15, P#16, P#17, P#18, P#19, P#20, P#21, P#22, P#23, P#24, P#25, P#26, P#27, and P#28),who were undergoing hemodialysis treatment at the time of this observation. The facility census was 114 in-center hemodialysis patients. Findings include: During observation in the Patient Treatment Room on 8/6/25 from 8:30 a.m. to 11:30 a.m., the following was revealed: 1. Sharps Containers: - The top plastic lids of the Sharps Containers at Station (S) 1, S3, S4, S5, S6, S7, S9, S12, S13, S14, S15, S16, S20, S21, and S22, had three to eight dried drops of blood in various sizes from a pinhead size to approximately 0.5 cm to 1.0 centimeter (cm) in diameter. 2. The Wall: - The walls below 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 waste products), specifically at S21, between S15 and S16, and at S3) had three to five dried splatters of blood each, also varying in sizes and shapes (approximately 0.5 cm width and 1.0 cm length). 3. The Wall on the side of the clean sink: - There was a Sharps Container on the side of the clean sink. The top plastic cover of the Sharps Container had four dried drops of blood approximately 0.5 cm to 1.0 cm in diameter. Additionally, the lower wall next to the clean sink had a splattered blood (approximately 0.5 cm). During an interview with the Charge Nurse/Registered Nurse (RN AA) on 8/6/24 at 9:00 a.m., RN AA stated that Sharps Containers were to be wiped down immediately when blood is visualized. According to CDC guidelines, failure in environmental cleaning and disinfection have led to transmission of bloodborne pathogens (e.g., Hepatitis B virus) and other infections from one patient to another in hemodialysis units. Correct cleaning and disinfection of environmental surfaces (including floors, patient chair or bed surfaces, dialysis equipment surfaces, adjacent tables and work surfaces, etc., especially with blood splatters) must be performed between patient uses to prevent transmission of dangerous pathogens. A review of Policy #1-05-01, titled, “INFECTION CONTROL FOR DIALYSIS FACILITIES”, last revised April 2023, stated: 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. iii Cleaning of visible blood should be performed when first observed.”

“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: 49321 Based on observation, staff interview, a review of the Centers for Disease Control and Prevention (CDC) guidelines and recommendations, and a review of facility Policies and Procedures (P&P), it was determined that the Infection Control Committee failed to ensure that one of one Licensed Practical Nurse (LPN) AA and one of one Registered Nurse (RN) BB observed during discontinuation of hemodialysis (HD) treatment on two of two patients (P#1 and P#2), who had Central Venous Catheters (CVC- a catheter that goes directly into the heart), as their primary dialysis access, utilized appropriate infection control techniques to prevent cross contamination. This breach in infection control techniques had the potential to cause central line associated bloodstream infections (when germs enter a patient’s bloodstream through the central line). This deficient practice could negatively affect the health and safety of P#1, P#2 and 30 other patients who had a CVC, as their dialysis access. The facility census was 114. Findings include: During observation in the Patient Treatment Room on 8/6/25 from 8:30 a.m. to 11:30 a.m., the following was revealed: - LPN AA was observed during discontinuation of P#1’s HD treatment with a CVC at Station (S) 26. LPN AA did not scrub the catheter hub after disconnecting the lines and before administering the Normal Saline (NS) flushes. Then wearing the same contaminated gloves (dirty), LPN AA obtained a clean blue pad as a liner, from the clean supply drawer. LPN AA placed the blue liner under both ports and exposed the blue (venous) hub to air for 15 seconds, while changing gloves. LPN AA did not perform hand hygiene between glove changes. - During an interview with LPN AA on 8/6/25 at 10:00 a.m., LPN AA stated that she was the dialysis caregiver for four patients at S13, S14, S15, and S16) and was also the nurse responsible for nursing duties to four additional patients at S9, S10, S11, and S12. She stated that she may have been rushing during the procedure. - RN BB was also observed during discontinuation of HD treatment of P#2, who had a CVC at S16. RN BB repeated the same breach in infection control techniques as mentioned above (re: LPN AA). RN BB did not scrub the catheter hubs after disconnecting the bloodlines and before administering the NS flushes. RN BB did not perform hand hygiene between glove changes and before using the computer keyboard. RN BB also exposed the blue (venous) hub to air for 45 seconds while entering data on the computer keyboard. RN BB did not perform hand hygiene before donning a new pair of gloves after using the keyboard. - RN BB was observed at S26 removing a needle from P#10’s access (left arm fistula). RN BB walked down to the sharps container located at S23 (approximately a 9-foot distance) to dispose of the needle. This deficient practice had the potential for cross contamination and safety risk. - During an interview with RN BB on 8/6/25 at 10:15 a.m., RN BB stated that she was assigned as a dialysis caregiver to four patients at S23, S24, S25, and S26 and as a nurse responsible for nursing duties to four additional patients at S1, S18, S27, and S28. RN BB stated that she may have been rushing during turnover. According to the CDC, 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. Also, according to the CDC, the two most common routes of catheter infection were (1) migration of skin organisms through the insertion site ...; and (2) contamination of the hub, resulting in intraluminal colonization of the catheter... Rigorous hand hygiene and adherence to aseptic technique in order to reduce risks for contamination were recommended. CDC’s Steps for “Scrub the Hub”, included the following: 1. Perform hand hygiene and don clean gloves. 2. Remove the cap from the CVC. 3. Scrub the catheter hub: (top and sides) with a sterile antiseptic pad or swab, using vigorous friction... Key considerations: * Frequency: Perform this every time the catheter is accessed or disconnected... A review of Policy # 1 -04-02B, titiled, “CENTRAL VENOUS CATHETER (CVC) WITH CLEARGUARD HD ANTIMICROBIAL END CAPS PROCEDURE”, last revised April 2025, stated: -Use dialysis precautions and aseptic technique throughout procedure. - Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.”

“GOV-STAFF # & RATIO MEET PT NEEDS CFR(s): 494.180(b)(1) The governing body or designated person responsible must ensure that- (1) An adequate number of qualified personnel are present whenever patients are undergoing dialysis so that the patient/staff ratio is appropriate to the level of dialysis care given and meets the needs of patients; This Standard is not met as evidenced by: 49321 Based on observation, staff interviews, and a review of facility records, it was determined that the Facility Administrator failed to ensure the facility employed an adequate number of qualified staff to meet the needs of all patients as evidenced by a lack of at least one licensed and qualified nurse (who was not counted as a dialysis care giver in the staff-to-patient ratio of one dialysis care giver to four patients), who was readily available to provide nursing care, take charge, and deal with unexpected complications of dialysis, for every 12 patients who were receiving dialysis care; and that each care giver was not assigned more than four patients each shift. This deficient practice had the potential to cause a delay in monitoring patients for issues such as fluid overload (an excessive amount of fluid in the body), changes in vital signs, or problems with the dialysis equipment. Additionally, insufficient staffing could mean slower responses to alarms, delayed adjustments, or missed complications including but not limited to intradialytic hypotension (sudden drops in blood pressure which can occur when fluid is removed too rapidly), arrhythmias (irregular heartbeat), and other medical issues and emergencies related to hemodialysis. The facility census was 114. Findings include: During observation in the Patient Treatment Room on 8/6/25 between 8:30 a.m. and 11:30 a.m., the following was revealed: At a Clean Counter in front of Station (S) 14: - There were three bottles of Venofer Injection (iron supplement to treat iron deficiency), and three Heparin Injection-filled syringes (for anticoagulation), labeled but without nurse’s initials and time of medication preparation. At 9:00 a.m. on 8/6/25, this surveyor asked Registered Nurse (RN AA, who was also the Charge Nurse), who prepared the medications. RN AA stated that Licensed Practical Nurse (LPN AA), who was assigned as a dialysis caregiver to a Pod (section) of four patients at S13, S14, S15, and S16, was also the nurse responsible for perforning her nursing duties including but not limited to: pre and post patient assessments, medication preparation and administration, and other nursing responsibilities to an additional four patients in Pod #6 at S9, S10, S11, and S12, whose primary dialysis caregiver was a Patient Care Technician (PCT AA). - During an interview on 8/6/25 at 11:59 a.m., LPN AA stated that she was always assigned to eight patients per shift, as a direct caregiver to four patients that included but not limited to: setting up of four machines (pre-dialysis) and disconnection and cleaning process of machines (at the end of dialysis), per shift in addition to performing her nursing duties to four other patients who were assigned to a PCT. LPN AA added that she made sure all pre and post assessments were done, medications were prepared and administered to all eight patients assigned to her, as well as performing CVC (Central Venous Catheter - a catheter that goes directly into the heart, as a dialysis access) care, which can only be performed by nurses, not PCTs. She also added that this was a lot and was very stressful. During an interview with RN BB on 8/6/25 at 12:23 p.m., RN BB stated that she was assigned to four patients at Pod #1 at (S23, S24, S25, and S26), as a dialysis caregiver per shift, as well as performed nursing responsibilites for Pod #1. RN BB also stated that she was also assigned as a nurse to perform nursing responsibilities to four other patients at S1, S18, S27, and S28. RN BB also added that she was trying to keep up and found herself moving too quickly, and today (8/6/25), was very overwhelming. RN BB also added that she had just completed her hemodialysis orientation and training. Her nursing background was as a nurse at a neonatal care for two years, prior to hemodialysis. During an interview with RN AA on 8/6/25 at 12:40 p.m., RN AA stated that the facility had 28 Stations with 28 patients during the first and second shifts, and she can only be responsible for nursing duties to 12 patients per shift. RN AA added that sometimes another Charge Nurse was responsible for the other 12 patients. LPN AA always had a Pod of four patients (as a dialysis caregiver), and when there was only one Charge Nurse, someone had to perform nursing duties to other patients and today (8/6/25), it had to be LPN AA and RN BB. A review of the facility’s Staff/Patient schedule between 7/29/25 through 8/6/25, revealed the following: - LPN AA was the dialysis caregiver for four patients at her assigned Pod and performed nursing duties for four other patients seated at S9, S10, S11, and S12. Both Pods had four patients per first and second shifts and one patient on third shift. This schedule was the same on 7/29/25, 8/2/25, 8/5/25, and 8/6/25. - RN AA was assigned as Charge Nurse for 12 patients. - RN BB was assigned as a float nurse (to help where needed), until 7/31/25, then as Charge Nurse for 12 patients on 8/4/25 and 8/5/25. On 8/6/25, RN BB was assigned as a dialysis caregiver to four patients and as a nurse to four other patients. - The staffing schedule on 8/4/25 - three RNs, two LPNs and three PCTs for 28 patients per first and second shifts. - On 8/5/25 - two RNs, two LPNs and four PCTs. - On 8/6/25 - two RNs, one LPN, five PCTs.”