Davita Windsor Heights Dialysis

“IC-SANITARY ENVIRONMENT CFR(s): 494.30 The dialysis facility must provide and monitor a sanitary environment to minimize the transmission of infectious agents within and between the unit and any adjacent hospital or other public areas. This Standard is not met as evidenced by: 36083 Based on documents review, interviews, and observations, the facility did not ensure a safe and sanitary environment by its failure to discard multiple expired and outdated supplies, and an outdated tuberculin solution, from facility circulation, thereby creating a risk for usage. The facility reported a census of 65 patients at the time of the survey. Findings include: 1. The policy # 1-05-01, titled, Infection Control for Dialysis Facilities, provides for its purpose to minimize the spread of infections in the dialysis facility environment, and that supplies will be stored in a manner that maintains their integrity. 2. The manufacturer’s information sheet, titled, Tuberculin Purified Protein Derivative (Tubersol) dated October 2021, provides, “A vial of TUBERSOL which has been entered and in use for 30 days should be discarded.” 3. Observations on 5/19/25, beginning at 10:15 AM, showed the following: 12 intravenous (IV) infusion sets that expired on 3/9/25, found in the emergency evacuation luggage bag; 1 vial of Tubersol, dated as opened on 4/11/25, was stored in the medication refrigerator; 11 test strips in a container labeled, “RPC 4.5-10 PH test strips” with an expiration date of 2/28/25 was on the medication preparation counter; and approximately 50 sets of AVF (arteriovenous) G14 needles with expiration date of 4/30/25 and approximately 25 sets of AVF (arteriovenous) G14 needles with expiration date of 1/31/25, were stored in a plastic container in the supply storage area, readily accessible for staff members to get supplies from. 4. On 5/19/25 at 10:45 AM, registered nurse (RN) B stated, “Yes, those are clearly expired, and should have been tossed.” RN B verified that the medication and the supplies identified were expired. 5. On 5/21/25 at 2:00 PM, the facility administrator (FA) and the manager of clinical services (MCS) acknowledged the risk of usage for keeping expired supplies accessible for staff.”

“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: 50072 Based on review of facility policies and procedures, observations and staff interviews, the facility staff failed to ensure staff properly disinfected the CVC (Central Venous Catheter) and site with antiseptic during site care according to facility policy. Failure to properly disinfect the patient’s skin prior to initiation of dialysis and failure to properly disinfect the CVC prior to initiation of dialysis treatment and during disconnect after dialysis could potentially cause cross contamination of the hemodialysis patients. The facility staff reported a census of 65 hemodialysis patients at the time of the recertification survey. Findings for observations on 3 of 3 patients with a Central Venous Catheter (CVC) access include: 1. Review of facility policy 1-04-02B, titled Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure, revised April 2025, reads in part: Notes: Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines ... 8 ...clean exit site with 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol swab for a minimum of 30 seconds ...Effective contact time for 2% Chlorhexidine Gluconate/70% Isopropyl Alcohol is 30 seconds and dry time is 60 seconds. 16 ...Using aseptic technique, remove each cap. One at a time, disinfect each CVC hub with a new alcohol prep pad. Scrub each CVC hub for 15 seconds including the sides, threads and end of hub thoroughly with friction making sure to remove any residue ...34 ...Remove syringes and disinfect the CVC hubs with a new alcohol prep pad for each CVC hub. Scrub the sides, threads and end of hub thoroughly with friction for 15 seconds. 2. Observations on 05/19/25 at 11:50 am showed PCT (Patient Care Technician) C completing CVC exit site care on Patient #2. Observation showed PCT C used a ChloraPrep swab stick on the skin around the patient’s access for less than the amount of time specified in the facility’s written policy. PCT C cleaned the area around the CVC exit site with a ChloraPrep swab stick for 16 seconds, allowing for the appropriate drying time, before applying the dressing. Continued observation at 1:03 pm showed PCT C completing CVC exit site care on Patient #10. Observation showed PCT C used a ChloraPrep swab stick on the skin around the patient’s access for less than the amount of time specified in the facility’s written policy. PCT cleaned the area around the CVC exit site with a ChloraPrep swab stick for 15 seconds, allowing for the appropriate drying time, before applying the dressing. 3. An observation on 5/19/25 at 3:50 PM showed PCT H at station #12 completing catheter (CVC) exit site care (cleaning and changing the dressing) for Patient #9. PCT H cleaned or “scrubbed” the skin around Patient #9’s CVC with an antiseptic for 10 seconds. PCT H allowed the antiseptic to dry for 30 seconds before covering the area with a Tegaderm (a transparent medical dressing used to cover/protect catheter sites). 4. During an interview on 05/19/25 at 1:25 pm, PCT G reported the ChloraPrep swab stick scrub time is 30 seconds. PCT G acknowledged the posted signs on the treatment floor serve as a good reminder for staff because it does get confusing since scrub times are different for each product. 5. During an interview on 05/21/25 at 1:00 pm, the Medical Director acknowledged staff practices and verified staff should refer to the posted signs on the treatment floor regarding scrub times for each product because it is important with regards to infection control. 51639”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 50072 Based on documents review and staff interviews, the facility failed ensure the Biomedical Technician was notified when the water treatment system readings did not fall within specified limits. The facility reported a census of 65 patients at the time of survey who could potentially be adversely affected by the deficient practice. Findings include: 1. Review of Policy: 1-17-02, titled DAILY WATER TREATMENT SYSTEM MONITORING, last revised April 2025, reads in part that 2. All observations and test results must be recorded on the approved Daily Water Treatment Log and required IT Clinical System entries ... 6. All observations and test results will be within the limits specified on the Daily Water Treatment Log. If observations or test results are found outside the specified limits, follow the instructions given on the Daily Water Treatment Log for the parameter(s) in question. In addition to following the log form instructions, the teammate completing the log will notify the Facility Administrator/designee and Biomed teammate assigned to the facility of any observation or test result found outside the limit specified on the Daily Water Treatment Log ... 8. A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory completion of this review, the licensed nurse initials and signs the log form where indicated. 2.Review of facility document titled “CWP Daily Water Log,” dated 03/03/05 - 05/17/25, shows: a. Line 19 read “Ultra Filter Inlet Pressure” with an acceptable limit of “>60psi (pounds per square inch); <100psi.” Entries outside of the acceptable limits were recorded on 03/05/25, 03/07/25, 03/24/25, 03/26/25, 03/31/25, 04/02/25, 04/04/25, 04/07/25, 04/09/25, 04/11/25, 04/28/25, 04/30/25, 05/02/25, 05/05-05/07/25; 05/10/25, and 05/12-05/17/25. Entries outside the acceptable limits ranged from 40-60 psi. b. Line 20 read “Ultra Filter Outlet Pressure” with an acceptable limit of “>60psi; <100psi.” Entries outside of the acceptable limits were recorded on 03/05/25, 03/07/25, 03/24/25, 03/26/25, 03/31/25, 04/02/25, 04/04/25, 04/07/25, 04/09/25, 04/11/25, 04/28/25, 04/30/25, 05/02/25, 05/05/25-05/07/25; 05/10/25, and 05/13/25-05/17/25. Entries outside the acceptable limits ranged from 40-60 psi. c. Line 24 read “If Required, Time when Biomed Contacted for Direction or Assistance.” Entries for line 27 is “NA” on all of the above dates recorded outside the acceptable limits. d. Line 25 reads “Initials of Licensed Nurse (Verifying that Log is Complete & Results are within Acceptable Limits). Line 25 is initialed on each date confirming the log was reviewed and the entries are within acceptable limits despite the values being outside the acceptable limits and no notification to the Biomedical Technician was recorded. 3. On 05/19/25 at 10:30 am, Staff F (Biomedical Technician) verified the information included in the CWP Daily Water Logs. Staff F confirmed they audit the water logs for completion and make adjustments based on trends. Staff F reported he/she expects to be notified of any readings outside the acceptable limits recorded on the water log, even if it’s a small variation. 4. On 05/20/25 at 11:30 am, PCT (Patient Care Technician) E confirmed if the entries on the log are outside the acceptable limits and reported staff are to advise Biomed of the results and document on the CWP Daily Water Log. 5. On 05/21/25 at 1:00 pm the Medical Director confirmed both the Biomedical Technician and the Facility Administrator are tasked with auditing the water logs for accuracy. The Medical Director further reported staff should be alerting the Biomedical Technician of any entries on the water log that are outside the acceptable limits.”

“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: 44475 Based on review of Facility Documents, Clinical Records, and staff interview, the facility failed to verify dialysis prescriptions after hospitalization and before dialysis treatment resumed for 2 of 2 patients reviewed for hospitalizations (Patients #1 and #2). The facility reported a census of 65 in center hemodialysis patients at the time of the survey. Findings include: The facility document titled “Transition of Care: Post-Hospitalization Checklist (All Modalities)”, undated, directed in part, to complete the steps below in order to help prevent readmissions. The RN (Registered Nurse) was to contact the nephrologist to review tx (treatment) orders/protocols and prescription changes. 1. The facility’s hospitalization report provided during the survey on 5/19/25, listed Patient #2 for hospital admission related to infection on 12/27/24. 2. The Patient Summary Report for Patient #1 revealed that the patient was hospitalized 3/21/25 to 3/30/25 and 4/18/25 to 4/24/25. 3. During a review of Patient #2’s Treatment Details Report, dated 1/1/25, indicated Patient #2’s return for treatment after a hospitalization. However, there was lack of any documentation to show that Patient #2’s dialysis prescription was reviewed after the hospitalization, and before resumption of dialysis treatment. 4. In a concurrent clinical record review and interview on 5/21/25 at 8:48 AM with Staff A, Manager of Clinical Services, no documentation was found in Patient #1’s clinical record that the patient ’ s dialysis treatment prescription was verified before dialysis treatment was resumed after the patient was hospitalized for the two hospitalizations. Staff A reported that dialysis treatment prescriptions should be reviewed after a patient was hospitalized and before dialysis treatment resumed. Staff A reported that the facility does not have a policy related to prescription verification after patients are hospitalized and before dialysis treatment resumed. 5. During interview on 5/21/25 at 9:00 AM, the facility administrator (FA) stated Patient #2 was hospitalized from 12/27/24 through 12/31/24, and had in-center dialysis treatment on 1/1/25. 6. In an interview on 5/21/25 at 10:23 AM, Staff B, RN, reported that she called the provider to verify prescription before resuming treatments for patients that were hospitalized. When asked where the verification was documented, Staff B reported that it should be in the patient ’ s clinical record, but that it does not always get documented. 7. In an interview on 5/21/25 at 1:12 PM, the Medical Director reported that there was a process in place to bridge continuity of care of the dialysis treatment order when patients are discharged from the hospital to ensure the order was given to the dialysis facility before the patient resumes treatment. The Medical Director reported that dialysis nurse verification of the dialysis prescription order before treatment resumes was a standard of practice for the facility. 36083”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 36083 Based on documents review, observation, and interviews, the facility did not ensure the correct dialysate for 1 of 4 patients (Patient #8) in the sample observed for dialysis prescription verification. The facility reported a census of 65 patients at the time of the survey. Findings include: 1. The policy #1-03-08, titled, Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessments, effective April 2024, directs staff members to verify patients’ prescriptions prior to the initiation of treatments. The prescription components to be verified include the correct dialysate composition such as the potassium and calcium. 2. The document titled, Patient Summary Report, showed Patient #8’s dialysis prescription with a start date of 4/18/25, showing dialysate bath of 2 K (potassium) and 2.5 Ca (Calcium), and a treatment time of 4 hours. 3. On 5/19/25 at 2:50 PM, Patient #8’s treatment was ongoing at Station #4. Observation showed that Patient #8’s dialysis treatment was connected to the dialysate port that delivered 3 K and 2.5 Ca. The dialysis machine indicated that Patient #8 had 1 hour and 24 minutes of remaining treatment time. Registered Nurse (RN) B, who was present during the observation, verified that Patient #8 was on the wrong dialysate bath. RN B stated Patient #8 should have been on a 2 K and 2.5 Ca dialysate as prescribed. RN B also verified that Patient #8 had been on treatment for 2.5 hours. 4. The document titled, Treatment Details Report, dated 5/19/25, noted Patient #8’s dialysate order as 2 K and 2.5 Ca, and that patient care technician (PCT) G verified Patient #8’s prescription at 11:59 AM. Patient #8’s treatment was initiated at 12:13 PM. The document also showed 2 staff members, PCT H and RN B, re-verified Patient #8’s prescription at 13:53 PM. The document did not reflect that Patient #8 received dialysis with a 3 K and 2.5 Ca dialysate as observed at 2:50 PM. 5. On 5/22/25 at 2:00 PM, the manager of clinical services (MCS) and the facility administrator (FA) acknowledged the importance of thorough verification and implementation of patients’ treatment orders.”

“POC-EFFECTIVE NUTRITIONAL STATUS CFR(s): 494.90(a)(2) The interdisciplinary team must provide the necessary care and counseling services to achieve and sustain an effective nutritional status. A patient’s albumin level and body weight must be measured at least monthly. Additional evidence-based professionally-accepted clinical nutrition indicators may be monitored, as appropriate. This Standard is not met as evidenced by: 36083 Based on documents review, and staff interviews, the facility did not address the low trending albumin for 1 of 6 patients (Patient #4) reviewed for nutritional needs. The facility reported a census of 65 patients at the time of the survey. Findings include: 1. The policy #1-14-01, titled, Interdisciplinary Team (IDT) Patient Assessment and Plan of Care, dated October 2024, provides that the facility’s IDT will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs. The policy provides that the plan of care will address the “nutritional status which addresses the necessary care and counseling services provided by the IDT to achieve and sustain effective nutritional status. The policy also provides that a patient’s albumin level should be measured at least monthly. 2. The document titled, Patient Note, dated 1/31/25, indicated Patient #4 had a low albumin (nutritional indicator) of 3.4 g/dL (grams/deciliter) for the month of 1/25. The document also indicated Patient #4 was on protein supplement at home and disliked the ONS (oral nutritional supplement) in center. 3. The document titled, ICHD Comprehensive Note, dated 3/7/25, noted Patient #4’s low albumin of 3.1 g/dL on 2/24/25. The document did not show any action plan or intervention. 4. The document titled, Limited Note, dated 3/24/25, acknowledged Patient #4’s low albumin of 3.1 g/dL on 2/24/25, noted for pushing protein supplements at home. The document also indicated Patient #4 was on ONS in-center. 5. However, Patient #4’s Patient Summary Report, printed on 5/19/25, did not show any order for ONS among Patient #4’s in-center medications. The report also showed a low trending albumin, as follows: 3.2 g/dL on 3/24/25, 0 results for 4/25, and 3 g/dL on 5/9/25. 6. The document titled, ICHD Comprehensive Note, dated 5/16/24, also showed Patient #4’s latest albumin of 3 g/dL on 5/9/25. The document did not show any action plan or intervention to address the low albumin. 7. On 5/21/25 at 2:00 PM, the manager of clinical services (MCS) verified there was lack of evidence to show how Patient #4’s albumin was being addressed, despite the low trend.”

“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: 36083 Based on documents review, and staff interviews, the facility did not ensure staff members completed the annual tuberculosis (TB) risk assessment for 8 of 13 staff members (Registered Nurse [RN] H, Administrative Assistant [AA] I, Patient Care Technician [PCT] J, Social Worker [SW] K, PCT M, Licensed Practical Nurse [LPN] N, PCT O, Facility Administrator [FA] P) who currently worked at the facility. The facility reported a total census of 65 patients at the time of the survey. Findings include: 1. The policy #4-06-05, titled, Tuberculosis Monitoring and Follow-Up, dated October 2024, outlines the policy purposes, including annual teammate requirements for completion of TB individual risk assessment and symptom evaluation. 2. A review of the personnel files for PCT M, showed the latest TB risk assessment and symptoms evaluation on file was dated 1/10/24. Further review of the personnel worksheet that the facility provided on 5/20/25, showed additional staff members with outdated TB risk assessment and symptoms evaluation, as follows: a. RN H dated 1/10/24 b. AA I dated 6/24/24 c. SW K dated 1/12/24 d. LPN N dated 1/10/24 e. PCT O dated 4/15/24 f. FA P dated 1/11/24 3. During an interview on 5/20/25 at 2:55 PM, FA P verified the lack of evidence to show completion of the required TB risk assessment and symptoms evaluation for the identified staff members listed above.”