Davita Sweetwater Ridge Dialysis

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 37489 Based on document review, observation, and interview, it was determined that the facility failed to ensure staff label pre-drawn medication syringes with the time and their initials which has a potential risk of staff administering an expired medication. Findings include: The policy/procedure titled “Medication Policy” requires: “...All syringes prepared from single use vials/ampules (without preservatives) or multidose vials should be prepared and administered within a four (4) hour period... If the medication is not administered or is to be administered by another teammate, the medication must be labeled with the patient name, name of the medication, date, time prepared, dose and initials of teammate preparing the medication....” Observation on 12/03/2024, revealed Employee #3 had prepared six (6) Heparin syringes for administration. The pre-drawn heparin syringes were stored in a medication lock box and did not have the time the medication was drawn up or the preparer’s initials. Employees #1 and 3 confirmed on 12/03/2024 that there was no time or initial on any of the pre-drawn heparin syringes.”

“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: 37489 Based on document review, observation, and staff interview, it was determined that the facility failed to ensure staff aseptically performed CVC (central venous catheter) dressing change/catheter care prior to initiation of treatment. Failure to perform CVC dressing change and catheter care correctly poses a potential risk for increased CVC and/or bloodstream infection and adverse outcomes for dialysis patients. Findings include: The facility policy titled “Central Venous Catheter (CVC) with Clearguard HD Antimicrobial End Caps Procedure” requires: “...DaVita’s first choice for CVC care is 2% Chlorhexidine/70% Alcohol swab...Check for patient sensitivity to preferred skin antiseptic...refer to Central Venous Care (CVC) policy for alternate skin antiseptic....” The facility policy titled “Central Venous Catheter Care Policy” requires: “...Acceptable germicidal/disinfectant solutions may include: ...Hypochlorite (ExSept Plus) only for skin including exit site cleaning....” Observation on 12/03/2024 revealed Employee #11 performing CVC care and dressing change on the patient at Station #16. Employee #11 used ExSept Plus to apply to the catheter exit site after removal of the old dressing. The application or contact time was 32 seconds, with a dry time of 2 minutes and 15 seconds prior to placing a new CVC dressing. Employee #1 confirmed on 12/03/2024 that when the alternate disinfectant ExSept Plus is used to disinfect the catheter exit site during the dressing change procedure that the contact application time required is 60 seconds and that Employee #11 did not follow the requirements for skin disinfection. Employee #8 confirmed on 12/04/2024 that the alternate disinfectant ExSept Plus is used in the same manner as for skin disinfection prior to cannulation with fistula needles and that the required contact time is 60 seconds with a dry time of 2 minutes.”

“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: 37489 Based on review of the Association for the Advancement of Medical Instrumentation (AAMI) guidelines, facility documents, and staff interview, it was determined that the facility failed to ensure: 1. staff performed chlorine/chloramine tests every 4 hours to ensure the absence of chlorine/chloramines in dialysis water during the delivery of patient care; 2. the licensed nurse verified completion of chlorine tests and the appropriateness of results; and 3. staff legibly and accurately documented the date and time chlorine tests were performed. Failure to ensure staff accurately and thoroughly monitor and document the time and results of chlorine tests performed for dialysate water has the potential for life threatening complications from chlorine toxicity to patients if staff do not identify a failure in the water treatment system resulting in a chlorine breakthrough reaching the patient. Findings include: 1. 2. and 3. The practice guidelines for the Association for the Advancement of Medical Instrumentation (AAMI) for “Dialysate for hemodialysis” (ANSI/AAMI RD52:2004) requires: “...The guidance provided by this recommended practice should help protect hemodialysis patients from adverse effects arising from known chemical and microbial contaminants that may be found in improperly prepared dialysate...Monitoring...Carbon adsorption performance is monitored by measuring free chlorine and/or chloramine concentrations in the water exiting the first carbon bed of a series-connected pair...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...Intensive monitoring of carbon adsorption beds is recommended because of the long history of adverse events related to chloramine contamination of dialysate...patient safety can only be ensured by intensively monitoring the performance of the carbon adsorption bed...Results of monitoring of free chlorine, chloramine, or total chlorine should be recorded in a log sheet....” 1. The facility “Routine Total Chlorine Testing Logs” dated September 2024 through November 2024, revealed a chlorine/chloramine test was not performed approximately every 4 hours on the following dates. 10/05/2024 - tests were performed at 0654, 0430, 0740, an illegible entry, and at 1830 10/15/2024 - tests were performed at 0426, 0526, 0812, 1130, and at 1833 10/24/2024 - tests were performed at 0419, 0443, 0824, 1138, and 1547 11/21/2024 - tests were performed at 0426, 0446, 0837, 1230, and an entry listed as “424” Employees #1, 8, and 9 confirmed on 12/04/2024 that staff did not document having performed a chlorine/chloramine test for greater than approximately every four hours on the aforementioned dates. 2. The facility “Routine Total Chlorine Testing Logs” dated September 2024 through November 2024, revealed that the nurse did not sign the chlorine log verifying chlorine tests and appropriateness of the results on the dates listed below. 11/26/2024 1933 11/30/2024 1906 Employees #1, 8, and 9 confirmed on 12/04/2024 that the Registered Nurse did not verify the test result on the aforementioned date and time. 3. The facility “Routine Total Chlorine Testing Log” dated September 2024 through November 2024, revealed illegible handwriting for the time chlorine tests were performed on the following days. 09/04/2024 10/05/2024 The illegible handwriting resulted in the inability to determine the exact time chlorine tests were performed and the amount of time elapsed between tests. The logs also revealed incomplete, inaccurate, and/or missing dates on the chlorine testing log as follows. 09/09/2024 through 09/14/2024 - no year listed in the date 09/18/2024 - this date was listed two days in a row for a Thursday and a Friday 09/23/2024 through 09/28/2024 - no year listed in the date 09/30/2024 - no year listed in the date 10/05/2024 - no year listed in the date 10/07/2024 through 10/10/2024 - no year listed in the date 10/14/2024 through 10/18/2024 - no year listed in the date 10/23/2024 through 10/25/2024 - no year listed in the date 10/28/2024 through 10/31/2024 - no year listed in the date 11/08/2024 through 11/09/2024 - no year listed in the date 11/25/2024 through 11/28/2024 - no year listed in the date Employees #1, 8, and 9 confirmed on 12/04/2024 that staff did accurately or legibly document chlorine tests as required on the testing log.”

“MICROB MONITOR-MO H20 SAMPLES/METHOD CFR(s): 494.40(a) 7.2 Microbial monitoring methods: monthly water samples/method 7.2.1 General Culture water ...weekly for new systems until a pattern has been established. For established systems, culture monthly unless a greater frequency is dictated by historical data at a given institution. Monitoring can be accomplished by direct plate counts, in conjunction with the measurement of bacterial endotoxin. 7.2.2 Sample collection Water samples should be collected directly from outlet taps situated in different parts of the water distribution system. In general, the sample taps should be opened and the water should be allowed to run for at least 60 seconds before a sample is collected in a sterile, endotoxin-free container. A minimum of 50 mL of water, or the volume specified by the laboratory performing the test, should be collected. Sample taps should not be disinfected. This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to ensure four (4) validations for dialysate culture and endotoxin testing were in acceptable limits for (2) of (22) new dialysis machines prior to being put into service on the treatment floor which has a potential for patient harm due to elevated bacteria or endotoxins. Findings include: The facility policy titled “MICROBIALVALIDATION AND ELECTOLYTE ANALYSIS OF DIALYSIS DELIVERY SYSTEM” requires: “...DaVita Biomed Services is responsible for establishing the initial microbial validation testing of each newly installed dialysis delivery system(s) using proportioned dialysate...Each newly installed dialysis delivery system...should be disinfected...Dialysate samples will be collected after they system(s) has been initially disinfected. Prior to patient use, the dialysis delivery system will be tested to verify that the proportioned dialysate samples meet the current DaVita standards for bacteria and endotoxin...Samples will be obtained once a week for at least four (4) consecutive weeks...If acceptable samples are obtained week 1, the facility may use the dialysis delivery system for patient treatments. Continue to collect samples weeks 2, 3 and 4, if acceptable samples are obtained, proceed to normal DaVita procedures for monthly microbial sampling. If samples results are at or above the action level for week 1, 2, 3, or 4, disinfect the dialysis delivery system and repeat sample(s). If four (4) consecutive acceptable weekly samples are not obtained, the series must be repeated until four (4) consecutive acceptable weekly samples are achieved....” Review of facility dialysis machine validation logs for dialysate culture and endotoxin revealed (2) of (22) new machines placed into service did not have four consecutive weeks of samples in acceptable limits as follows. Machine # 284338 Dialysate Endotoxin - 07/16/2024, 07/26/2024, and 07/31/2024 Dialysate Culture - 07/16/2024, 07/26/2024, and 07/31/2024 Machine # 284342 Dialysate Endotoxin - 07/11/2024 (Action level with redraw on 07/16/2024), 07/26/2024, and 07/31/2024 Dialysate Culture - 07/11/2024, 07/26/2024, and 07/31/2024 Employees #8 and 9 confirmed on 12/04/2024 that the two machines listed above did not have four consecutive weekly dialysate culture and endotoxin test results within acceptable limits prior to being placed into service and put on a rotating yearly schedule.”

“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: 37489 Based on document review and interview, it was determined that the facility failed to ensure staff follow protocol or policy for use of low potassium dialysate which poses a potential risk of harm to patient. Rapid removal of potassium poses a risk for cardiac arrythmias in susceptible patients. Cross Reference tag V505 Findings include: The policy/procedure titled “USE OF LOW POTASSIUM DIALYSATE” requires: “...1. Initiation of low potassium dialysate less than 2K+ (<2K+) is restricted to patients with a pre-dialysis potassium level greater than 6mEq/L (>6) and management and follow up consistent with this policy...3. No order for <2K+ dialysate will exceed one (1) month duration. 4. Dialysate requests in Pharos are approved up to 90-days. A renewal task will trigger for the facility 28 days prior to the expiration. A submission is required for clinical review by the Clinical Pharmacy Management for continued use of low potassium dialysate. 5. Patients with orders for <2K+ dialysate will have follow-up pre-dialysis serum potassium levels checked weekly and referred to the dietitian for additional dietary counseling. a. if follow-up pre-dialysis serum potassium level is <6 mEq/L, RN will contact nephrologist or Non-physician Practitioner (NPP) for review who will decide subsequent changes to dialysate potassium level prior to next treatment...6. Facility Health Meeting (FHM) will review all patients on <2K+ dialysate, their weekly pre-dialysis serum potassium results, dialysate order start date, id patient’s nephrologist/NPP was contacted, and any dialysate order changes.” Patient #4’s medical record revealed the following. 1. Initial Dialysis Treatment order for 1K, 2.5 Ca was started on 07/09/2024, discontinued on 11/12/2024, and renewed on 11/12/2024. 2. Order for weekly Serum Potassium draw; missed on 7/27/2024, 8/22/2024, 11/21/2024. 3. Serum Potassium was <6 on 7/24/2024, 09/19/2024 4. Order for <2K+ dialysate exceeded on month. 5. Renewal task for continued use of low potassium dialysate unclear. 6. No evidence that Nephrologist or NPP notified for review when serum potassium was <6. 7. No evidence of review in Facility Health Meetings including their weekly serum potassium results, progress note that a nephrologist or NPP was notified, dialysate order, additional nutrition counseling by Dietitian or and dialysate order changes. Employee #1 confirmed on 12/04/2024 the 1K+ dialysate order exceeded the one month and that the weekly serum potassium labs were not complete. When the Serum potassium lab was completed and below 6, there was no evidence of follow up or progress note stating the nephrologist or NPP was notified for potential order changes. Employee #1 also confirmed that there was not a discussion in Facility Health Meetings to discuss the use of low potassium dialysate.”

“PA-ASSESS LAB PROFILE CFR(s): 494.80(a)(3) The patient’s comprehensive assessment must include, but is not limited to, the following: (3) Laboratory profile, This Standard is not met as evidenced by: 37489 Based on document review and interview, it was determined that the facility failed to: 1. follow weekly pre-dialysis Serum Potassium lab draws for patient #4; and 2. notify the Nephrologist or NPP for follow up on Serum Potassium levels <6. Failure to follow lab orders and report results poses a potential risk for lack of oversight by the patients Nephrologist in providing appropriate care. Findings include: 1. and 2. The policy/procedure titled “USE OF LOW POTASSIUM DIALYSATE” requires: “...1. Initiation of low potassium dialysate less than 2K+ (<2K+) is restricted to patients with a pre-dialysis potassium level greater than 6mEq/L (>6) and management and follow up consistent with this policy... 5. Patients with orders for <2K+ dialysate will have follow-up pre-dialysis serum potassium levels checked weekly and referred to the dietitian for additional dietary counseling. a. if follow-up pre-dialysis serum potassium level is <6 mEq/L, RN will contact nephrologist or Non-physician Practitioner (NPP) for review who will decide subsequent changes to dialysate potassium level prior to next treatment...6. Facility Health Meeting (FHM) will review all patients on <2K+ dialysate, their weekly pre-dialysis serum potassium results, dialysate order start date, id patient’s nephrologist/NPP was contacted, and any dialysate order changes....” 1. Patient #4’s medical record revealed the following. -Dialysis Treatment orders for 1K, 2.5 Ca have been in effect since 12/01/2023. -Orders for weekly pre-dialysis Serum Potassium draws have been effect since 12/01/2023. -February 2024-2 of 4 weekly labs were not collected -March 2024-1 of 4 weekly labs were not collected -May 2024-2 of 4 weekly labs were not collected -June 2024-2 of 4 weekly labs were not collected -July 2024-3 of 4 weekly labs were not collected -August 2024-3 of 4 weekly labs were not collected -September 2024-2 of 4 weekly labs were not collected -October 2024-2 of 4 weekly labs were not collected -November 2024- 3 of 4 weekly labs were not collected Employee #1 and Employee #8 confirmed on 12/04/2024 the weekly labs draws from 12/01/2023 to 12//02/2023 have not been completed as ordered. 2. Patient #4’s Serum Potassium lab results were <6mEq/L on 01/04/2024, 01/30/2024, 02/08/2024, 04/11/2024, 04/26/2024, 05/09/2024, 05/28/2024, 06/20/2024, 06/27/2024, 07/24/2024, 08/22/2024, 09/12/2024, 09/19/2024, 10/29/2024, 11/21/2024 -Patient #4’s medical record did not contain evidence that Nephrologist or NPP notified for review when serum potassium was <6mEq/L. - Patient #4’s medical record and review of Facility Health Meeting Minutes for the last 6 months did not contain evidence of a review including their weekly serum potassium results, progress note that a nephrologist or NPP was notified, dialysate order, additional nutrition counseling by Dietitian or and dialysate order changes. Employee #1 and Employee #8 confirmed on 12/04/2024, the weekly serum potassium labs were not complete. In addition, when the Serum potassium lab was completed, and resulted <6, there was no evidence of follow up or progress note stating the nephrologist or NPP was notified for potential order changes. Employee #1 also confirmed that there was not a discussion in Facility Health Meetings to discuss the use of low potassium dialysate.”