Davita Loop Renal Center

“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: 50411 Based on document review and interview, it was determined that for 3 of 8 staff (E #1, E#6 and E #7) observed on the dialysis treatment floor for the usage of personal protective equipment (PPE), the facility failed to ensure that the proper PPE was donned, as required. Findings include: 1. The Facility’s policy titled, “Infection Control for Dialysis Facilities” (Revision Date: April 2023) was reviewed, and required, “...PPE (i.e. gown, 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 care areas...” 2. On 02/03/2025, between 9:45 AM and 12:20 PM, during an observational tour of the dialysis treatment floor, the following was observed: - E#7 (Patient Care Technician/PCT) was observed in the treatment area without the appropriate eye protection as required for the duration of the observational tour; - At approximately 10:30 AM, E#1 (Facility Administrator) walked in the treatment area and went to the nurse’s station without the appropriate PPE (gown, mask, and face shield or goggles); - At approximately 11:00 AM, E# 6 (Biomed Technician) walked in the treatment area and went to the nurse’s station to obtain some documents without the appropriate PPE (gown and face shields/goggles): 3. On 02/05/2025 at approximately 9:32 AM, an interview was conducted with the Facility Administrator (E#1). E#1 stated that PPE should be worn at all times when entering the treatment area. E#1 stated that eye protection such as face shield or goggles should also be worn when in the treatment area..”

“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: 50411 Based on observation, document review, and interview, it was determined that for 1 of 1 patient observed for CVC (central venous catheter) care, the facility failed to ensure that CVC care was performed as required. Findings include: 1. On 02/03/2025 between 9:45 AM and 12:20 PM, an observational tour of the dialysis treatment area was conducted. At approximately 10:23 AM, the Patient Care Technician (PCT/E #3) was observed preparing to initiate the dialysis treatment for a patient (Pt.#3) at Station #18. E #3 did not change the existing CVC dressing for Pt.#3 as required. 2. On 02/04/2025, the Facility’s policy titled, “Central Venous Catheter (CVC) Care” (Revision Date: October 2022) was reviewed and required, “... 2. Dressings are changed every dialysis treatment and on: - newly inserted dialysis catheters, Cuffed catheter exit sites that are not well healed...” 3. On 2/4/2025, the clinical record of Pt. #3 was reviewed. Pt. #3 was admitted on 5/31/2024 with a diagnosis of end stage renal disease (ESRD). The treatment sheets for 1/29/2025 through 2/03/2025 was reviewed and indicated that the CVC dressing for Pt.#3 was not changed on these dates. 4. On 02/03/2025 at approximately 12:10 PM, an interview was conducted with the Registered Nurse (E #2). E #2 stated, the CVC dressings are to be changed every dialysis treatment. 5. On 2/5/2025 at approximately 9:32 AM, an interview was conducted with the Facility Administrator (E#1). E#1 stated that CVC dressings should be changed prior to 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: 50411 Based on document review, observation, and interview, it was determined that for 1 of 2 Patient Care Technicians - PCT (E #3 and E #4) observed for pH testing, the Facility failed to ensure that staff performed appropriately the pH testing (measure of acidity/alkalinity) of dialysate before starting the treatment of the next patient as required. Findings include: 1. On 02/04/2025, the manufacturer’s guidelines for pH test strips, “K100-0117CT, E-Z Chek 6.8-8.5 pH Test Strips Instructions for Use” (undated), was reviewed and required, “...4) ...Compare test results to color scale on bottle between 20 and 25 seconds...” 2. On 02/04/2025, the Facility’s policy titled, “Testing pH of Citric Acid Base Dialysate...” (Revision Date: 2/2024) was reviewed and required, “...Procedure... 4. Within 20 to 25 seconds, compare the color reaction on strip to the color chart on bottle to determine the closest match...” 3. On 02/03/2025 between 9:45 AM and 12:20 PM, an observational tour was conducted of the in-center dialysis treatment area. The following was observed: - At 11:50 AM, PCT-E#4 was observed at station #7 checking the pH. E#4 immediately compared the strip to the color chart and did not wait the 20-25 seconds. 4. On 02/03/2025 at 11:55 AM, an interview was conducted with PCT-E #4. E#4 stated that pH testing is done prior to the start of each dialysis treatment. E#4 stated that after obtaining a sample, the strip is dipped in the sample and the excess liquid shaken off and can compare the strip to the color chart right away. 5. On 02/05/2025 at approximately 9:50 AM, an interview was conducted with a PCT/E #7. E #7 stated that when checking the pH prior to dialysis treatments, a sample of the water is obtained and the strip is dipped into the sample, the excess water is shaken off the strip. E #7 stated that E #7 waits about 30 to 35 seconds before comparing to the color chart. 6. On 02/05/2025 at approximately 1:30 PM, the above finding were discussed with the Facility Administrator (E #1). E #1 stated that staff should check the pH strips according to the manufacturer’ guidelines.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 32741 Based on document review and interview, it was determined that for 2 of 9 (Pt #1 and Pt. #4) in-center hemodialysis clinical records reviewed, it was determined that the Facility failed to ensure that the prescribed DFR (Dialysate Flow Rate) was maintained for adequate hemodialysis. Findings include: 1. On 02/04/2025, the Facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” (dated April 2024) was reviewed and required, “...If the dialysis prescription is not being met (including the dialysis flow rate or change to/inability to obtain prescribed blood flow rate), the reason will be documented...” 2. On 02/04/2025, the clinical record of Pt #1 was reviewed. Pt #3 was admitted to the facility on 03/16/2023 with a diagnosis with ESRD (end stage renal disease). Pt #1’s record noted the following: - Pt #3’s clinical record included a physician’s order dated 09/06/2024, and included “Hemodialysis...for 3 hours...Dialysate Flow Rate: 800...” The clinical record lacked documentation of a reason for not meeting the prescribed DFR on the following dates: -On 1/20/2025, Pt #1 was dialyzed with a DFR of 500 (not the prescribed 800). -On 1/29/2025, Pt #1 was dialyzed with a DFR of 500 (not the prescribed 800). 3. On 02/04/2025, the clinical record of Pt. #4 was reviewed. Pt. #4 was admitted to the facility on 05/19/2023 with a diagnosis of ESRD. Pt. #4’s record noted the following: -Pt. #4’s clinical record included a physician’s order dated 01/08/2025, “Hemodialysis for 3 hours and 30 minutes...DFR 500.” Pt. #4’s clinical record lacked documentation of a reason for not meeting the prescribed DFR on the following dates: -On 01/20/2025, Pt. #4 was dialyzed with a DFR of 600 (not the prescribed 500). -On 01/22/2025, Pt. #4 was dialyzed with a DFR of 800 (not the prescribed 500). 4. On 02/04/2025 at 2:00 PM, an interview was conducted with the Facility Administrator (E #1). E #1 stated that the DFR should be followed as per the physician’s order.”

“PA-DIALYSIS ACCESS TYPE & MAINTENANCE CFR(s): 494.80(a)(8) The patient’s comprehensive assessment must include, but is not limited to, the following: (8) Evaluation of dialysis access type and maintenance (for example, arteriovenous fistulas, arteriovenous grafts and peritoneal catheters). This Standard is not met as evidenced by: 50411 Based on document review, observation, and interview it was determined that 1 of 2 patients (Pt. #11) for evaluation of dialysis access, the Facility failed to ensure that vascular access site had an appropriate physician’s order to utilize vascular access clamps. Findings include: 1. The Facility’s policy titled “Utilizing Vascular Access Clamps” (Revised April 2019), was reviewed and required “ ... 2. A physician’s order is always required for utilization of vascular access clamps ...” 2. The clinical record for Pt. #11 was reviewed on 02/04/2025. The clinical record for Pt.#11 lacked active orders to utilize vascular access clamps. 3. During a tour of the Facility’s treatment area on 02/03/2025, between approximately 9:45 AM and 12:20 PM, a clamp was used on each of Pt. #11’s access sites after the dialysis needles were removed. 4. An interview was conducted with the Facility Administrator (E#1) on 2/5/2025, at approximately 9:32 AM. E#1 stated that a physician’s order for the use of clamps on the vascular access of patients should be obtained before using clamps.”

“PA-FREQUENCY REASSESSMENT-UNSTABLE Q MO CFR(s): 494.80(d)(2) In accordance with the standards specified in paragraphs (a)(1) through (a)(13) of this section, a comprehensive reassessment of each patient and a revision of the plan of care must be conducted- At least monthly for unstable patients including, but not limited to, patients with the following: (i) Extended or frequent hospitalizations; (ii) Marked deterioration in health status; (iii) Significant change in psychosocial needs; or (iv) Concurrent poor nutritional status, unmanaged anemia and inadequate dialysis. This Standard is not met as evidenced by: 50411 Based on document review and interview, it was determined that for 1 of 1 (Pt. #1) unstable patient, the Facility failed to ensure an assessment and care plan was completed monthly. Findings include: 1. The Facility’s policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” was reviewed on 02/04/2025 and included, “...7. A comprehensive re-assessment of each patient and a revision in the plan of care will be conducted:... At least monthly for unstable patients including, but not limited to, patients with the following: extended or frequent hospitalizations, marked deterioration in health status, significant changes in psychosocial needs, concurrent poor nutritional status, unmanaged anemia and inadequate dialysis...” 2. The clinical record of Pt. #1 was reviewed on 2/4/2024. Pt. #1 was admitted on 03/16/2023 with the diagnosis of end stage renal disease (ESRD). The record included the care plan that was completed on 6/28/2024, and Pt. #1 was determined as unstable. The clinical record did not include any monthly assessments for August 2024 and November 2024. Pt.#1 was determined to be stable on the last care plan dated 12/13/2024. 3. On 2/5/2025 at approximately 9:13 AM, an interview was conducted with the Social Worker (E#5). E#5 stated that E#5 keeps track of all patient plan of care and when they become due. E#5 stated that when a patient is identified as unstable, a plan of care is completed monthly until such time the patient is identified as stable.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 32741 A. Based on document review and interview, it was determined that for 8 of 9 (Pt. #1, Pt. #2, Pt. #3, Pt. #4, Pt. #5, Pt. #7, Pt. #8 and Pt. #9) clinical record reviewed for shortened treatments, the Medical Director failed to ensure that the staff adhered to patient care policies, by notifying the physician of shortened hemodialysis treatments and ensuring that an AMA (against medical advice) form was completed. Findings include: 1. The Facility’s policy titled, “Prescribed Treatment Time Not Met” (dated 4/2024), was reviewed on 2/4/2025, and required, “A. Completion of the Early Termination of Treatment Against Medical Advice Form. 1. The RN [Registered Nurse] will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time...If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist to discuss the appropriate intervention...” 2. The clinical record for Pt. #1 was reviewed on 2/4/2025. Pt. #1 was admitted to the facility on 3/16/2023, with a diagnosis of ESRD (end stage renal disease). The treatment order (dated 9/6/2024), included a treatment time of 180 minutes (3 hours). Pt. #1’s treatment sheets dated 9/6/2024, 9/11/2024, 9/16/2024 and 1/20/2025 through 1/31/2025), were reviewed and included the following days with shortened treatments: -On 9/6/2024: “Duration 2 hours and 21 minutes (not prescribed time of 3 hours).” -On 9/11/2024: “Duration 2 hours and 36 minutes (not prescribed time of 3 hours).” -On 9/16/2024: “Duration 2 hours and 38 minutes (not prescribed time of 3 hours).” -On 1/20/2025: “Duration 2 hours and 51 minutes (not prescribed time of 3 hours).” -On 1/22/2025: “Duration 2 hours and 16 minutes (not prescribed time of 3 hours).” -On 1/24/2025: “Duration 2 hours and 46 minutes (not prescribed time of 3 hours).” -On 1/27/2025: “Duration 2 hours and 47 minutes (not prescribed time of 3 hours).” -On 1/29/2025: “Duration 2 hours and 47 minutes (not prescribed time of 3 hours).” -On 1/31/2025: “Duration 2 hours and 45 minutes (not prescribed time of 3 hours).” Pt. #1’s clinical record lacked an AMA form or notification to the physician of shortened treatments for these shortened treatment dates. 3. The clinical record for Pt. #2 was reviewed on 2/4/2025. Pt #2 was admitted to the facility on 6/26/2019, with a diagnosis of ESRD. The treatment orders (dated 11/13/2024), included a treatment time of 240 minutes (4 hours) three times a week. Pt #2’s treatment sheets, from 1/20/2025 through 1/31/2025, were reviewed and included the following days with shortened treatments: - On 1/20/2025: “Duration 2 hours and 47 minutes (not prescribed time of 4 hours).” Treatment record noted patient choice. There was no AMA form dated 1/20/2025. - On 1/22/2025: “Duration 3 hours and 30 minutes (not prescribed time of 4 hours).” Treatment record noted patient choice. There was no AMA form dated 1/22/2025. Pt #2’s clinical record lacked an AMA form or notification to the physician of shortened treatments for these shortened treatment dates. 4. The clinical record for Pt. #3 was reviewed on 2/4/2025. Pt. #3 was admitted to the facility on 5/31/2024, with a diagnosis of ESRD. The treatment orders (dated 12/9/2024), included a treatment time of 240 minutes (4 hours) three times a week. Pt. #3’s treatment sheets, from 1/20/2025 through1/31/2025, were reviewed and included the following days with shortened treatments: -On 1/22/2025: “Duration 3 hours and 16 minutes (not prescribed time of 4 hours).” Treatment record dated 1/22/2025 noted patient choice. There was no AMA form dated 1/22/2025. -On 1/29/2025: “Duration 3 hours and 25 minutes (not prescribed tome of 4 hours).” Treatment record dated 1/29/2025 noted patient choice. There was no AMA forma dated 1/29/2025. Pt. #3’s clinical record lacked an AMA form or notification to the physician of shortened treatments for these shortened treatment dates. 5. The clinical record for Pt. #4 was reviewed on 2/4/2025. Pt. #4 was admitted to the facility on 5/19/2023, with a diagnosis of ESRD. The treatment orders (dated 1/8/2025), included a treatment time of 210 minutes (3 hours and 30 minutes). Pt. #4’s treatment sheets, from 1/17/2025 through 1/31/2025, were reviewed and included the following days with shortened treatments: -On 1/17/2025: “Duration 2 hours and 39 minutes (not prescribed time of 3 hours and 30 minutes).” Treatment record dated 1/17/2025 noted patient choice. There was no AMA form dated 1/17/2025. -On 1/27/2025: “Duration 2 hours and 42 minutes (not prescribed time of 3 hours and 30 minutes).” Treatment record dated 1/27/2025 noted patient choice. There was no AMA form dated 1/27/2025. Pt. #4’s clinical record lacked an AMA form or notification to the physician of shortened treatments for these shortened treatment dates. 6. The clinical record of Pt. #5 was reviewed on 2/4/2025. Pt. #5 was admitted to the facility on 5/24/2021, with a diagnosis of ESRD. The treatment orders (dated 12/10/2024), included a treatment time of 240 minutes (4 hours). Pt. #5’s treatment sheets, from 1/20/2025 thru 1/31/2025, were reviewed and included the following days with shortened treatments: -On 1/20/2025: “Duration 2 hours and 40 minutes (not prescribed time of 4 hours).” Treatment record dated 1/20/2025 noted patient choice. There was no AMA form dated 1/20/2025. -On 1/22/2025: “Duration 3 hours and 8 minutes (not prescribed time of 4 hours).” Treatment record dated 1/22/2025 noted patient choice. There was no AMA form dated 1/22/2025. -On 1/24/2025: “Duration 3 hours and 31 minutes (not prescribed time of 4 hours).” Treatment record dated 1/24/2024 did not give a reason for the shortened treatment and did not include an AMA form. -On 1/27/2025: “Duration 3 hours and 2 minutes (not prescribed time of 4 hours).” Treatment record dated 1/27/2025 noted patient choice. There was no AMA form dated 1/27/2025. -On 1/29/2025: “Duration 3 hours and 6 minutes (not prescribed time of 4 hours).” Treatment record dated 1/29/2025 noted patient choice. There was no AMA form dated 1/29/2025. -On 1/31/2025: “Duration 3 hours and 11 minutes (not prescribed time of 4 hours).” Treatment record dated 1/31/2025 noted patient choice. There was no AMA form dated 1/31/2025. Pt. #5’s clinical record lacked an AMA form or notification to the physician for shortened treatments for the shortened treatment dates. 7. The clinical record of Pt. #7 was reviewed on 2/4/2025. Pt. #7 was admitted to the facility on 5/12/2020, with a diagnosis of ESRD. The treatment orders (dated 1/6/2025), included a treatment time of 240 minutes (4 hours). Pt. #7’s treatment sheets, from 1/13/2025 thru 1/31/2025, were reviewed and included the following days with shortened treatments: -On 1/13/2025: “Duration 3 hours and 6 minutes (not prescribed time of 4 hours).” Treatment record dated 1/13/2025 noted patient choice. There was no AMA form dated 1/13/2025. -On 1/20/2025: “Duration 3 hours and 45 minutes (not prescribed time of 4 hours).” Treatment record dated 1/20/2025 noted patient choice. There was no AMA form dated 1/20/2025. Pt. #7’s clinical record lacked an AMA form or notification to the physician for shortened treatments for the shortened treatment dates. 8. The clinical record of Pt. #8 was reviewed on 2/4/2025. Pt. #8 was admitted to the facility on 11/1/2021, with a diagnosis of ESRD. The treatment orders (dated 12/27/2024), included a treatment time of 240 minutes (4 hours). Pt. #8’s treatment sheets, from 1/15/2025 thru 1/31/2025, were reviewed and included the following day with the shortened treatment: On 1/27/2025: “Duration 3 hours and 26 minutes (not prescribed time of 4 hours).” Treatment record dated 1/27/2025 lacked a reason for shortened treatment and lacked an AMA form. Pt. #8’s clinical record lacked an AMA form or notification to the physician for shortened treatments for the shortened treatment dates. 9. The clinical record of Pt. #9 was reviewed on 2/4/2025. Pt. #9 was admitted to the facility on 5/2/2016, with a diagnosis of ESRD. The treatment orders (dated 1/6/2025), included a treatment time of 240 minutes (4 hours). Pt. #9’s treatment sheets, from 1/20/2025 thru 1/31/2025, were reviewed and included the following days with shortened treatments: -On 1/20/2025: “Duration 3 hours and 2 minutes (not prescribed time of 4 hours).” Treatment record dated 1/20/2025 noted patient choice. There was no AMA form dated 1/20/2025. -On 1/22/2025: “Duration 3 hours and 10 minutes (not prescribed time of 4 hours).” Treatment record dated 1/22/2025 noted patient choice. There was no AMA form dated 1/22/2025. -On 1/24/2025: “Duration 3 hours and 19 minutes (note prescribed time of 4 hours).” Treatment record dated 1/24/2025 noted patient choice. There was no AMA form dated 1/24/2025. -On 1/27/2025: “Duration 3 hours and 24 minutes (not prescribed time of 4 hours).” Treatment record dated 1/27/2025 noted patient choice. There was no AMA form dated 1/27/2025. -On 1/29/2025: “Duration 3 hours and 2 minutes (note prescribed time of 4 hours).” Treatment record dated 1/29/2025 noted patient choice. There was no AMA form dated 1/29/2025. Pt. #9’s clinical record lacked an AMA form or notification to the physician for shortened treatments for the shortened treatment dates. 10. On 2/3/2025 at 1:30 PM, an interview was conducted with the Facility Administrator (E #1). E #1 stated that patients shorten their treatments due to transportation. 50411 B. Based on document review, observation and interview, it was determined that for 1 of 1 Registered Nurse (E #2) observed for medication supervision, the Facility failed to ensure that all medications were stored in a secured area to prevent patient access. This had the potential to affect all 28 patients on census. Findings include: 1. On 2/4/2025, the Facility’s policy titled, “Medication Policy” (Revision Date: October 2023) was reviewed and indicated, “...23. Medications and needle/syringe storage are done in accordance with state regulations...” 2. On 2/3/2025 between 9:45 AM and 12:20 PM, an observational tour was conducted in the dialysis treatment area. The following was observed: -There were 4 syringes (labeled Heparin [blood thinner] with names of 2 patients) filled with a medication on top of the counter at the nurses’ station at 11:20 AM which were left unattended. -There was 30ml (milliter) vial labeled Heparin (with contents) left on the counter by the nurses’ station at 11:25 AM which was left unattended. - All medication cabinets and medication refrigerator were unlocked when left unattended during the observational tour. 3. On 2/3/2025 at approximately 12:10 PM, an interview was conducted with Registered Nurse (E #2). E#2 stated that all medications should be placed in a locked cabinet when left unattended.”