Davita Central Dallas 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: 22676 Based on observation, interview, facility policy review and review of Centers for Disease Control (CDC) guidance, the facility failed to ensure that the 13 out of 16 wall boxes (dispensing outlets) at dialysis stations and 13 out of 16 dialysis machines was cleaned and the buildup of white crystals and yellow substance removed. This deficient practice had the potential to cause bacteria to grow in the wall boxes and cause harm by infecting the 39 patients receiving in-center hemodialysis at the facility. Findings included: Observation of the wall boxes on 01/15/24 at 2:25 PM, at each dialysis station, stations numbered 1, 2, 3, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 16 revealed a dark yellow sediment with white sediment build-up on the wall boxes. Observations on 01/15/24 at 2:25 PM revealed that dialysis machines on the treatment floor numbered 1, 2, 3, 4, 6, 7, 9, 11, 13, 16, 17, 18 and 19 had a dark orange build up on the front and the bottom. During an interview on 01/15/24 at 2:45 PM, the Biomed stated that he/she did not know when the wall boxes were to be cleaned. He/she confirmed all 13 wall boxes were visibly dirty with white sediments and dark yellow build up and all 13 dialysis machines were visually dirty with a dark yellow build up. Review of facility policy titled, “Infection Control for Dialysis Facilities,” dated April 23, indicated, “. . .equipment including the dialysis delivery system ... wiped clean with bleach solution of the appropriate strength ...thought out the workday and after each treatment. . .” Review of the “CDC Dialysis Safety” located on the CDC website at www.cdc.gov titled “Wall boxes and Drains” indicated, “All box surfaces should be disinfected at least daily (e.g., at the end of the day after all patients have dialyzed); cleaning and disinfection might be needed more frequently (e.g., when visibly dirty). Cleaning and disinfection of the wall box should be performed after the patient has left the station, and not during patient care activities. . .More than one disinfectant wipe or application may be needed to ensure all wall box surfaces are visibly wet with disinfectant to achieve contact time specified by the manufacturer.””

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 22676 Based on interview, document review, and policy review, the facility failed to change the Granuflo (a type of acid base used in dialysis treatments) mixing tank filter after the sixth batch. This had the potential to cause harm to all 76 in-center hemodialysis patients receiving care at the facility. Findings include: Review of the facility’s form titled, “Granuflo Batch Procedure Record,” dated revised October 2023, “ indicated, “ ...replace filter after 6 [sic] batches.” Review of the record for ten batches mixed from 10/26/23 to 12/21/23 revealed there were a total of eight batches mixed prior to the filter change. Documentation revealed there were a total of eight batches made between filter changes. During an interview with the Biomed on 01/17/23 at 10:00 AM, confirmed there was no evidence the mixing filter had been changed as required, and he/she agreed that the facility did not have a system to track when the filter was changed. Review of the facility’s policy titled, “Granuflo Concentrate Dissolution Unit Mixing Procedure,” dated April 2023, failed to include the filter changing schedule or a procedure to document that the filter had been changed other than on the Batch Productions Record.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 22676 Based on observation, record review, interview, review of the facility’s policy, the facility staff failed to test the bicarbonate solution (part of the solutions used in the dialysis treatment) prior to releasing the solution to the treatment floor as required. This s deficient practice had the likelihood to affect all 38 in-center hemodialysis patients receiving care at the facility. Findings include: During a tour of the water room on 01/16/24 at 10:00 AM, revealed the bicarbonate tank sign contained only the date and time of mixing and the initial of the staff member mixing the bicarbonate. There was no conductivity or specific gravity recorded. The Biomed confirmed the sign did not contain conductivity or specific gravity. A review of the bicarbonate mixing log from 10/02/23 through 01/16/24 revealed there was no documentation of conductivity or specific gravity on the log. An interview with the Biomed on 01/16/24 at 10:00 AM confirmed staff doesn’t record the testing of the bicarb on log, and they don’t test the bicarbonate prior to releasing the solution to the floor. The Biomedical Technician confirmed the manufacturer did not specify if a conductivity of specific gravity should be done or not and he agreed that if the manufacturer did not set a range, the facility should set the range for the staff to follow. A review of Fresenius Dry Bicarbonate bag revealed the manufacture had no recommendations regarding the testing of reconstituted bicarbonate concentrate for conductivity, specific gravity, or pH (acidity or alkalinity of a solution). A review of the facility’s policy titled, “Better Water-Central Bicarb Mixing and Delivery” dated 05/08/13, revealed the following, “. .10. Test sample of solution from valve B9 for proper concentrations per facility protocol, if applicable ...” The federal regulations adopted the ANSI/AAMIRD52:2004 which gives guidance on the mixing of Bicarbonate and revealed the following, “The mixing logs must demonstrate complete documentation of this required information. Test results may include conductivity or specific gravity. Facility policy must stipulate the expected ranges for the test(s) used to verify correct mixing. Standards used to calibrate the instrument used to measure conductivity should encompass the expected results; for example, it would be unacceptable to use a “14” standard for an expected result of “70”. . .Verifying mixing and test results” means the staff member performing this task checks the results against the expected ranges for the test and does not release mixtures for use that test outside those ranges. The facility failed to have a policy that sets the test range for the facility staff to follow.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 22676 Based on review of glucometer logs, interview, facility policy review, and review of manufacturer’s instructions, the facility failed to ensure the glucometers were in the control range and follow manufacturer’s instructions for one of one glucometer used in the facility. This had the potential to provide inaccurate glucose results that could result in mistreated blood glucose levels to all 40 patients receiving care at the facility. Findings include: Review of Blood Glucose logs for the facility (no meter number listed) from 11/01/23 through 01/08/24 revealed the acceptable low blood glucose control range should be 94-126. On 12/30/23, the recorded low control was 130. During an interview on 01/16/24 at 1:35 PM, with the Facility Administrator he/she confirmed the staff did not repeat calibration of the abnormal low testing level. Review of the facility’s policy titled, “EmbracePRO Blood Glucose Monitoring System Quality Control” dated September 2020, revealed, “. . . 16. If control results fall outside the acceptable range the test must be repeated.” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/2020 revealed, “ ...p. eleven, if the “test fall outside the range printed on the test strip vial, repeat the test ...””