Davita Cedar Valley 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: 50072 Based on review of policy, manufacturer’s instructions, observation and staff interview, the facility failed to ensure outdated items were removed from the facility or discarded to prevent use. The facility staff reported an in-center hemodialysis patient census of 80 at the time of the survey. Failure to ensure outdated medical supplies are removed and/or discarded from the facility could result in those items being used for beyond a date the manufacturer can guarantee its authenticity or accuracy. 1. Review of facility policy titled Policy: 1-06-01, Medication Policy, reads in part: “30. All medications in the facility are checked monthly. Insulin and other medications with preservatives are dated and initialed once opened. All medications are checked monthly for expiration dates. 31. Medications are ordered and replaced prior to expiration. Unless an exact expiration date is specified, medications with an expiration date of month/year are considered expired the last day of the state month. For example, a drug that expires 6/08 will be considered expired after 6/30/08. 32. Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment and inventory areas and disposed of per state/local regulations.” 2. Review of manufacturer’s instructions indicates a vial of Tubersol which has been entered and in use for 30 days should be discarded. 3. Observation of the medication room refrigerator on 11/04/24 at 11:15 AM showed a box with a vial labeled Tubersol Tuberculin Purified Protein Derivative, intended to aid in diagnosis of tuberculosis infection (TB). The handwritten expiration date was 10/08/24. 4. During an interview with the Facility Administrator on 11/06/24 at approximately 3pm, they acknowledged all expired items should be removed from the facility each month to prevent use on patients.”

“BACT CONTROL-DISINFECT 1X/MO/DWELL CFR(s): 494.40(a) 7 Strategies for bacterial control 7.1 General: disinfect monthly/disinfection dwell Routine low-level disinfection of the pipes should be performed to control bacterial contamination of the distribution system. The frequency of disinfection will vary with the design of the system and the extent to which biofilm has already formed in existing systems, but disinfection must be performed at least monthly. A mechanism should be incorporated in the distribution system to ensure that disinfectant does not drain from pipes during the disinfection period. This Standard is not met as evidenced by: 36083 Based on documents review and interviews, the facility failed to disinfect the CWP RO unit (a reverse osmosis water system that produces water for dialysis) for 3 of 9 weekly water treatment log reviewed (9/2 - 7/24, 9/16 - 21/24, and 10/7 - 12/24), and the facility failed to document residual testing after disinfection for 1 of 9 weekly water treatment logs reviewed (9/23 - 28/24). The facility reported a census of 80 in-center hemodialysis patients at the time of the survey. Findings include: 1. The procedure titled, “CWP RO POST CHEMICAL DISINFECTION START UP PROCEDURE” with a revision date of 6/29/22, directs the operator to complete weekly disinfection of the CWP RO unit and document in the weekly water log sheet. The procedure also directs the operator to test for residual peracetic acid following disinfection to ensure that the water is free of disinfectant, and document on the weekly water log sheet. 2. The document titled, “DaVita DAILY WATER TREATMENT LOG” from 9/2/24 through 10/31/24, showed the facility’s record for weekly disinfection of the CWP RO unit. The lines in the water log for chemical disinfection showed no entries on 9/424, 9/18/24 and 10/9/24, indicating the procedure was not completed during those dates. The water log also showed chemical disinfection was completed on 9/25/24, however, chemical residual test was not completed on 9/26/24. 3. On 11/6/24 at 11:10 AM, patient care technician (PCT) A stated chemical disinfection for the CWP RO unit takes place every Wednesday and staff members should complete a chemical residual test the following day (Thursday) before running the CWP RO unit. 4. On 11/6/24 at 2:02 PM, the biomedical staff (BS) indicated that his responsibilities include monthly audits of the water log to ensure completion of tasks, steps, and procedures in the water room. The BS stated he conducts random audits and there were no set dates to cover for the audits. The BS verified that the water log did not show an entry on 9/4/24 to show disinfection of the CWP RO unit, and the water log showed that on 9/5/24, the log indicated an error for chemical residual test because the unit was not disinfected. The BS also verified that the water log on 10/9/24 noted “NA” indicating the CWP RO unit was not disinfected, and an entry on 10/10/24, indicated there was no chemical residual test conducted because the CWP RO unit was not disinfected. The BS further verified that the water log showed the CWP RO unit was disinfected on 9/25/24, but did not show completion of chemical residual test the following dialysis treatment day on 9/26/24. The BS stated he did not audit the missed CWP RO unit disinfection procedure on 9/18/24, and did not audit the missed test for chemical residual on 9/26/24. 5. On 11/6/24 at 4:02 PM, the facility administrator (FA) acknowledged that the facility did not consistently disinfect the CWP RO water system, and did not document testing for chemical residual after disinfection according to policy.”

“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 policy, medical records, and staff interview, the facility failed to ensure a physician ’ s order was obtained prior to using dialysis access clamps after the dialysis treatment. Failure to follow a dialysis prescription, including failure to obtain a physician’s order to use post treatment clamps, can affect the care a patient receives which may cause complications to the fistula (the dialysis fistula is a surgically created connection between an artery and a vein in the arm or leg that allows for hemodialysis needles to be placed for dialysis treatments), serious illness, and the potential for harm to the patient. The facility reported a census of 80 hemodialysis patients at the time of the survey. Observation of 1 of 40 hemodialysis patients that had clamps used after treatment (Patient #2) include: 1. Review of the facility policy titled “Utilizing Vascular Access Clamps”, last revised in April 2019, revealed in pertinent part, a physician ’ s order is always required for utilization of vascular access clamps. 2. In an observation on 11/6/24 beginning at 2:06 PM, Staff A, Patient Care Technician, applied 2 clamps to the Patient #2’s fistula access site with Staff G, Registered Nurse (RN), standing at a mobile computer stand observing the care Staff A provided to the patient. 3. Patient #2’s medical record with a date range of 10/6/24 to 11/6/24, did not include an order for the patient to have vascular clamps placed after the dialysis treatments. 4. In an interview on 11/6/24 at 4:02 PM, the Facility Administrator reported that the order (for the patient to have clamps used to achieve hemostasis) should have been entered.”

“PA-ASSESS B/P, FLUID MANAGEMENT NEEDS CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: Blood pressure, and fluid management needs. This Standard is not met as evidenced by: 44475 Based on review of policy, medical records, and staff interview, the facility failed to address the patient ‘s elevated heart rate pre-dialysis, during the dialysis treatment, and post-dialysis to show the patient ‘s health care provider was notified. Failure to ensure staff addressed elevated pre-dialysis BPs and/or elevated heart rates during the patient ‘s dialysis treatment without notification to their provider could potentially result in an ineffective dialysis treatment, ineffective fluid removal, and/or failure to provide the necessary care, services, and dialysis treatment to meet the patient needs which could result in adverse patient outcomes and a decrease in the patient ‘s quality of life. The facility reported a census of 80 hemodialysis patients at the time of the survey. Review of 2 of 7 hemodialysis patient medical records (Patient #2 and Patient #3) findings include : 1. Review of the facility policy titled “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment”, last revised in April 2024, revealed in pertinent part, unless other abnormal parameters are established by the facility Governing Body and documented in the Governing Body Meeting minutes, the following are considered abnormal findings and should be reported to the licensed nurse and documented in the patient ’ s medical record...Heart or Pulse Rate Pre/Intra/Post: · Less than 60 beats per minute or greater than 100 beats per minute and/or an irregular heart beat... 2. Review of Patient #2 ’ s medical record included dialysis treatment flow sheets dated 10/22/24 through 10/31/24. Further review showed the following: a. Dialysis treatment flow sheet dated 10/22/24 showed heart rates of 113, 114, and 142 during treatment. The medical record did not contain documentation that the patient’s provider was notified of the high heart rates. b. Dialysis treatment flow sheet dated 10/24/24 showed a standing post treatment heart rate of 117. The patient had heart rates of 114 two times during treatment. The medical record did not contain documentation that the patient’s provider was notified of the high heart rates. c. Dialysis treatment flow sheet dated 10/26/24 showed a standing pre treatment heart rate of 120. The patient had heart rates of 111, 113, and 120 two times during treatment. The medical record did not contain documentation that the patient’s provider was notified of the high heart rates. d. Dialysis treatment flow sheet dated 10/31/24 showed a heart rate of 120 that occurred two times during treatment. The medical record did not contain documentation that the patient’s provider was notified of the high heart rates. 3. Review of Patient #3’s medical record included dialysis treatment flow sheets dated 10/22/24 through 11/2/24. Further review showed the following: a. Dialysis treatment flow sheet dated 10/22/24 showed a sitting post treatment heart of 113. The patient had a heart of 120 two times during treatment. The medical record did not contain documentation that the patient’s provider was notified of the high heart rates. b. Dialysis treatment flow sheet dated 10/31/24 showed a heart of 111, 114, 117, and 125 during treatment. The medical record did not contain documentation that the patient’s provider was notified of the high heart rates. c. Dialysis treatment flow sheet dated 11/2/24 showed a sitting post treatment heart rate of 113. The patient had a heart rate of 120 during treatment. The medical record did not contain documentation that the patient’s provider was notified of the high heart rates. 4. In an interview on 11/6/24 at 8:44 AM, the FA (Facility Administrator) reported that the heart rate parameters were per policy. The FA acknowledged that the provider needed to be notified if a patient ‘s heart rate is higher than 110.”