Davita White Lane 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: 47734 Based on observation, interview and record review, the facility failed to follow the policies and procedures (P&P) titled: 1. “Bleach Policy” when two of six sampled bleach containers were uncovered. This failure had the potential to result in bleach solution to become less effective for disinfection. 2. “Labeling Containers” when three of four bottles containing an unknown clear liquid were not labeled with the name of the solution, emergency information, hazards, storage information and personal protective items to be worn during use. This failure had the potential to result in the unsafe use of the liquid in the unlabeled bottles. This failure had the potential for staff to use the solution in the bottles unsafely. 3. “Medication Policy” when one of one Intradialytic Parenteral Nutrition (IDPN - medication, liquid nutrition given through the veins [IV]) was stored safely. This failure had the potential to result for the IDPN to be unsafe for use. Findings: 1. During a concurrent observation and interview on 10/18/24 at 10:55 a.m. with Clinical Coordinator (CC) by the clean sink counter, were two bleach containers with their lids off. CC stated the bleach containers should be covered CC stated she did not know how long the containers had been uncovered. During a review of the facility’s policy and procedure (P&P) titled, “Bleach Policy,” dated October 2023, the P&P indicated, “5. Bleach solution needs to be covered with a secure lid ...without a secure lid, the bleach solution is open to air causing the solution to degrade over time and become less effective.” 2. During a concurrent observation and interview on 10/18/24 at 11:27 a.m. with CC by the clean sink, a bottle filled with clear liquid had no label to indicate what liquid was in the bottle a spray bottle, on the counter by clean sink 1, was unlabeled and undated. There was no indication on the bottle of the contents of the bottle. CC stated she did not know what the solution in the bottle was because the bottle was not labeled. During a concurrent observation and interview on 10/18/24 at 11:30 a.m. with Patient Care Technician (PCT) 1 by in the clean sink, the bottle with no label filled with clear liquid had no label to indicate what liquid was in the bottle. PCT 1 stated he never uses it, and he does not know what was in the bottle because the bottle was not labeled. During an interview on 10/18/24 at 11:32 a.m. with CC, CC stated the unlabeled bottle should not be in the treatment area. During a concurrent observation and interview on 10/18/24 at 11:35 a.m. with CC, by a second clean sink, were two more unlabeled bottles filled with clear liquid. The first bottle was half full and the second bottle was full of the clear liquid. CC stated she did not know what the liquid was in the bottles. During a review of the facility’s P&P titled “Labeling Containers” dated October 2023, the P&P indicated, “All containers of chemicals/materials released for use in the facility will be properly labeled and the chemical/material information verified prior to use...2. The manufacturer, improper, or distributor label must have the following information at a minimum: - Product Identifier (located in Section 1 of the SDS) - The name, address, and emergency telephone number of the company that made or imported the chemical/material - Signal Word (Danger or Warning: indicates level of severity of the hazard) - Physical hazards (explosive, flammable, reactive, etc.) - Pictograms - Storing or handling instructions - Health hazards (toxic, carcinogenic, etc.) - Precautionary statements such as, protective clothing, equipment and procedures to use when working with the chemical/material.” 3. During a concurrent observation and interview on 10/18/24 at 11:33 a.m. with CC, in the treatment floor, the IV bag for Patient 1 was stored on a shelf with the office binders CC stated it the IV bag contained IDPN for Patient 1 and should not have been stored on the shelf. During an interview on 10/18/24 at 12:35 p.m. with CC, CC stated the IDPN should have been stored inside the locked cabinet while it gets to room temperature. CC stated the medication should not be left alone without proper supervision from staff. During a review of the facility’s P&P titled, “Medication Policy,” dated October 2023, the P&P indicated, “11...Non-refrigerated medications are to be stored in cabinet(s) and locked at the close of each business day or if not under supervision by the licensed teammate.””

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 47734 Based on interview and record review, the facility failed to follow their policy and procedures (P&P) titled “Daily Water Treatment System Monitoring” when staff did not document correct values or did not document any values on six of six daily waterlogs. This failure had the potential to result in staff to not be aware if the water system was operating safely for patient treatments. Findings: During a concurrent interview and record review on 10/18/24 at 1:29 p.m. with Biomedical Technician (BMT), facility’s log titled “Daily Water Treatment Log” (WTL), dated July and August 2024, the log was inaccurately completed, and with missing values. BMT stated on 7/8/24, 7/15/24, 7/22/24, 8/12/24, and 8/26/24, in line number 35, there should be the time when the chemical disinfection was started. BMT stated the documentation was a “no” documented instead of a time which was wrong. BMT stated BMT stated there were missing values for line 32 on 7/8/24, 7/10/24, and 7/12/24. BMT stated there were missing values for line 31, 32. BMT stated there was no staff signature for line 33 on 7/13/24. BMT stated there was no documentation of any values from line 35 to line 40 on 7/11/24. BMT stated there were missing values on 7/19/24, 7/20/24, 8/7/24, 8/9/24, 8/13/24, and 8/30/24. During a review of the facility document titled “Daily Log Explanation” (DLE) (undated), the DLE indicated, “Chemical Disinfection Initiated (Time) ... Enter the time of day the “RO Chemical Disinfection” was initiated. This should be completed weekly. Note any alarms.” During a review of the facility’s policy and procedure (P&P) titled, “Daily Water Treatment System Monitoring” dated April 2023, the P&P indicated, “6. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log. A separate entry of time and initials is provided for the teammate performing end of day hardness testing. 7. A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. Upon satisfactory of this review, the licensed nurse initials and signs the log form where indicated.””

“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: 47734 Based on interview and record review, the facility failed to follow their policy and procedures (P&P) titled “Daily Water System Total Chlorine Monitoring” when there were missing initials on one of one daily chlorine monitoring log. This failure had the potential for licensed nurse to not verify the chlorine levels were within limits and safe for patients to continue treatment. Findings: During a concurrent interview and record review 10/18/24 at 11:12 a.m. with Clinical Coordinator (CC), facility’s log titled “Routine Total Chlorine Testing Log” (TCT), dated August 2024 was reviewed. The TCT indicated on 8/15/24 at 11:45 a.m., there was no signature of Licensed Nurse to verify the result of the test. CC stated the signatures should be completed and there should be no blanks on the logs. During an interview on 10/18/24 at 1:12 p.m. with Biomedical Technician (BMT), BMT stated he does not audit the [TCT] logs. During a review of the facility’s policy and procedure (P&P) titled, “Daily Water System Total Chlorine Monitoring,” dated October 2024, the P&P indicated, “11...Record results on the “Routine Total Chlorine Testing” log which contains entries for day, date, test number, test time, signature of person performing the test, test results, and signature of licensed nurse verifying that each test on the daily log is complete and results appropriate.””

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 47734 Based on observation, interview and record review, the facility failed to ensure Registered Nurse (RN) documented medication administration at the right time for one of one sampled patients (Patient 2) when medication was still at Patient 2’s chairside but was documented as given in the treatment flowsheet. This failure had the potential for Patient 2 to not get the medication prescribed. Findings: During a concurrent observation and interview on 10/18/24 at 10:59 a.m. with Clinical Coordinator (CC) on the treatment floor by station 16, an orange pill (Calcitriol - treats low calcium levels) was seen on Patient 2’s chairside. CC stated Patient 2 liked to take her medication at the end of her treatment and CC stated medication should be given to Patient 2 when she was ready to take it. During a concurrent interview and record review on 10/18/24 at 11:12 a.m. with RN, Patient 2’s “Treatment Flowsheet” (TF), dated 10/18/24 was reviewed. The TF indicated medication was administered on 10/18/24 at 8:49 a.m. RN stated he documented the medication was given at 8:49 a.m. but the medication was not yet administered to Patient 2. During a review of the facility’s policy and procedure (P&P) titled, “Medication Policy” dated October 2023, the P&P indicated, “9. Medications are administered as prescribed and then documented in the patient’s medical record.””