Davita Renal Center of the Hills

“PERSONNEL-TRAINING PROGRAM/PERIODIC AUDITS CFR(s): 494.40(a) 9 Personnel: training program/periodic audits A training program that includes quality testing, the risks and hazards of improperly prepared concentrate, and bacterial issues is mandatory. Operators should be trained in the use of the equipment by the manufacturer or should be trained using materials provided by the manufacturer. The training should be specific to the functions performed (i.e., mixing, disinfection, maintenance, and repairs). Periodic audits of the operators’ compliance with procedures should be performed. The user should establish an ongoing training program designed to maintain the operator’s knowledge and skills. This Standard is not met as evidenced by: 22676 Based on review of staff personnel records, tracking form, interview, and review of the facility document, the facility failed to validate the competencies of the staff mixing acid (one of the components used to mix the dialysate solution used in the dialysis treatment) on an annual basis for two out of three staff records reviewed. This deficient practice had the potential to cause harm to all 66 patients receiving care at the facility by failure to ensure staff did not need additional training on the mixing of the acid. Findings Include: 1. Review of personnel training records for Certified Clinical Hemodialysis Technician (CCHT) 11, revealed his/her annual training had not been done since 01/29/21. Further review of the form indicated the part of the form used to access his/her skills was illegible and the skills “theory” section could not be read. The form was signed off by CCHT11 even though he/she could not see what the training was covering. The form was also signed by CCHT13 who was the mixologist (a term used by DaVita indicate the person can train staff to mix acid) at the time. Review of the acid mixing logs from 10/01/23 through 01/05/24 revealed that CCHT11 mixed acid on 01/05/24, 01/03/24, 12/04/23, 12/08/24, 11/10/23, 10/11/23, and 10/06/23. 2. Review of personnel training records for CCHT13, revealed him/her annual training had not been completed since 03/02/20. Review of the acid mixing logs from 10/01/23 through 01/05/24 revealed that CCHT13 mixed acid on 12/13/23, 11/15/23, 10/20/23, and 10/18/23. During an interview with Group Facility Administrator 2, Manager of Clinical Services 3 and Area Biomedical Technician on 01/12/24 at 4:00 PM confirmed the above staff had not had training on an annual basis. Group Facility Administrator 2 stated “they did not have a written policy, but the form titled ‘Clinical Teammate (TM) Training Folder: Skills Checklist’ was the facilities policy for training requirements.” The Group Facility Administrator 2 and Manager of Clinical Services 3 both agree CCHT13 training was illegible. The Area Biomedical Technician confirmed the above findings. He/she stated “CCHT 13 is no longer a mixologist.” Review of “Clinical Teammate (TM) Training Folder: Skills Checklist,” dated 07/20, revealed the form for CCHT 11 and CCHT 13 indicated that the training was late.”

“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 manufacturer’s directions for use, the facility failed to ensure the glucometers control quality control (QC) were verified prior to use and follow manufacturer’s instructions for one of two glucometers. This deficient practice had the potential to provide incorrect blood glucose results that could result in mistreated blood glucose levels and cause harm to all incenter patients receiving care at the facility, total census 66. Findings included: Review of Blood Glucose logs for the HD Unit from 10/23 through 12/23 revealed the logs were incomplete. The form had a blank titled: meter# date and control findings. a.Review of the glucometer log for meter EE21HA01866 revealed that the dates 10/18/23 through 10/21/23 were listed as if the unit was used that day, but no control results were recorded. b. Review of a second glucometer log for 10/23 revealed that the meter # was missing on the form. Two dates, 10/13/23 and 10/14/23, were recorded on the form as if the glucometer were used that day with no results recorded. c. Review of a log for 11/23 revealed there was no meter# recorded on the form. There were two dates listed, 11/01/23 and 11/02/23, as if the meter were used but no findings were recorded. d. Review of a log for 12/23 revealed there was no meter number recorded on the log and the meter was used twice in the month of December on2/18/23 and 12/19/23. During an interview on 01/10/24 at 2:15 PM, the Group Facility Administrator 2 and Manager of Clinical Services 3, confirmed the staff did not complete the logs including meter number for tracking of the meter # being used. Both confirmed they did not know why dates would be listed on the log and no control recorded. Review of the facility’s policy titled, “Blood Glucose Testing” dated 09/20, revealed, under the “Quality Control (QC)” section “QC procedures are performed according to manufacturer instructions and approved DaVita policies and procedures. QC procedures are being formed and documented every day the monitor is used or more often as required by state regulation. The first QC procedures of the day are performed before the monitor is used for patient testing.” Review of the “Embrace Pro” blood glucose monitoring system manufactures instruction revision date 09/20 revealed, “ ...p. Quality Control - if the meter ever gives a reading that seems lower or higher than what is expected, then the test should be repeated with a new test strip ...Quality Control should be done prior to use.””

“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: 22676 Based on record reviews, interview, and policy review, the facility failed to follow the individualized dialysis (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) prescription as determined by the medical provider for three of eight sampled in-center patients (Patient (P) 11, P 20 and P 21). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact the effectiveness of the prescribed dialysis treatments for the all 66 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of 11’s electronic medical record (EMR) revealed a prescribed blood flow rate (BFR) 350 milliliters per min (ml/min). Review of one of six “Post Treatment” flowsheets from 12/26/23 through 01/09/24, in the EMR indicated the following: On 01/02/24, the BFR was documented at 300 ml/min from 12:32 AM until 2:32 PM. There was no documented rationale for the change to the prescribed BFR. 2. Review of 20’s EMR revealed a prescribed BFR 400 ml/min. Review of three of six “Post Treatment” flowsheets from 12/09/23 through 01/09/24, in the EMR indicated the following: On 12/09/23, the BFR was documented at 350 ml/min from 7:54 AM until 10:33AM. On 12/12/23, the BFR was documented at 350 ml/min from 11:18 AM until 2:49 PM. On 01/06/24, the BFR was documented at 350 ml/min from 12:02 PM until 3:03 PM. There was no documented rationale for the change to the prescribed BFR. 3. Review of 21’s EMR revealed a prescribed BFR 400 ml/min. Review of one of six “Post Treatment” flowsheets from 12/29/23 through 01/10/24, in the EMR indicated the following: On 12/29/23, the BFR was documented at 350 ml/min from 12:04 PM until 1:02 PM There was no documented rationale for the change to the prescribed BFR. During an interview on 01/12/24 at 3:30 PM, Clinic Manager 3 confirmed the above findings and confirmed that staff did not follow the facility’s policy. Review of the facility’s policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring, and Assessment,” dated 10/23, revealed, “The Nursing assessment will be performed and documented ...Verification of the prescription including machine parameters ...””

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 22676 Based on medical record reviews, interviews, review of the facility’s policy and the Comprehensive Interdisciplinary Assessment and Plan of Care form, the facility failed to ensure six of seven patients (Patient (P) 11, P 19, P 21, P 22, P 23, and P 25) plan of care (POC) reviewed was completed within 15 days of the reassessment as required by federal regulations. Failure to ensure the POC was developed using current assessment information had the potential to negatively impact the effectiveness of the dialysis treatments for all 66 patients receiving dialysis at this facility. Findings include: 1. Review of P11’s POC in the electronic medical record (EMR) under the “Plan of Care” section, indicated that the 90-day POC meeting was held on 06/22/23. The Registered Dietician (RD) completed the assessment on 03/30/23, the Registered Nurse (RN) completed the assessment on 04/26/23, the Social Worker (SW) completed the assessment on 04/25/23. All three assessments are greater than 15 days from the POC meeting. 2. Review of P19’s POC in the EMR under the “Plan of Care” section, indicated that the annual POC meeting was held on 06/08/23. The RD completed the assessment on 03/24/23 which was more than 15 days from the POC meeting. 3. Review of P21’s POC in the EMR under the “Plan of Care” section, indicated that the annual POC meeting was held on 09/06/23. The SW completed the assessment on 06/02/23 which was more than 15 days from the POC meeting. 4. Review of P22’s POC in the EMR under the “Plan of Care” section, indicated that the 30-day POC meeting was held on 08/11/23. The RD completed the assessment on 06/21/23, and the SW completed the assessment on 06/26/23 which was more than 15 days from the POC meeting. Review of the 90-day POC revealed the POC meeting was held on 11/28/23. The RD completed the assessment on 10/09/23, the SW completed the assessment on 09/18/23 and the RN completed the assessment on 10/16/23 which was greater than 15 days from the POC meeting. 5. Review of P23’s POC in the EMR under the “Plan of Care” section, indicated that the 30-day POC meeting was held on 08/23/23. The physician completed the assessment on 08/27/23, the RD completed the assessment on 08/28/23, the SW completed the assessment on 08/31/23 and the RN completed the assessment 09/28/23 which after the POC meeting. 6. Review of P25’s POC in the EMR under the “Plan of Care” section, indicated that the annual POC meeting was held on 08/08/23. The RD completed the assessment on 07/13/23 and the SW completed the assessment on 07/15/23 which was more than 15 days from the POC meeting. During an interview on 01/12/24 at 10:30 PM, the Group Facility Administrator 2 and the Manager of Clinical Services 3 confirmed the above findings. They both confirmed the facility failed to follow Federal Regulations and the facility’s policy. Review of the facility’s policy titled “Interdisciplinary Team Assessment (IDT) Patient Assessment and Plan of Care,” dated 07/23, under the “Plan of Care” column indicated,” ...Complete patient plan of care meeting within 15 days of the completion of the re-assessment and POC.””

“LAB-CLIA LABS/MEET NEEDS OF PTS CFR(s): 494.130 The dialysis facility must provide or make available, laboratory services (other than tissue pathology and histocompatibility) to meet the needs of the ESRD patient. Any laboratory services, including tissue pathology and histocompatibility must be furnished by or obtained from, a facility that meets the requirements for laboratory services specified in part 493 of this chapter. This Standard is not met as evidenced by: 22676 Based on record review, interview, review of the facility’s policy and the manufacturer’s directions for use (DFU), the facility failed to ensure the “Diastix Reagent Strips” Laboratory strips used for testing urine glucose (sugar levels) had not expired for one of one bottle found in the Peritoneal Dialysis (PD) Unit. These findings have the potential to cause harm to all 40 patients in the PD unit giving abnormal glucose urine levels. Finding include: During a tour of the PD unit revealed a bottle of “Diastix Reagent Strips” was located opened, but not dated. The expiration on the bottle was 06/30/23. Since the bottle was not dated when opened there was no way to know if it was used after it expired. Expired biologicals should be removed from the unit once they expire. During an interview on 01/10/23 at 9:30 AM with Group Administrator 2 and Manager of Clinical Services 3 confirmed the bottle was opened. Review of facility policy titled, “Infection Control for Dialysis Facilities,” dated April 2023 indicated, “ ...supplies will be stored in a way that maintains their integrity. Expiration date and package integrity will be verified prior to use. Supplies will not be opened until time of use ...” Manufacturer’s instructions for “Diastix Reagent Strips,” dated 2022, indicated, “ ...bottles should be discarded 6 [sic] months from opening.””