Davita Sandia Peak Dialysis

“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: 35949 Based on observation, interview, mix log review, and facility policy review, the facility failed to perform and/or document test results in a permanent record, after reconstituting and prior to distribution of bicarbonate solution, when batches of bicarbonate solution were produced 65 of 65 times. The facility also failed to have a policy stipulating the expected ranges used to verify the correct solution mixture to prevent distribution of mixtures testing outside those ranges. Failure to perform testing and failure to have a policy which included the expected ranges to verify correct mixing had the potential to negatively impact the dialysate necessary for dialysis and potentially impact the safety and well-being of the 23 in-center patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Bicarbonate Concentrate System Mixing,” revised 04/2024, indicated, “13. Preparation of bicarbonate concentrate is documented on a log at the time of preparation and verified by a second teammate prior to dispensing. The log should include: * The concentrate formula produced * The number and expiration date of bags used for that batch- * The volume of the batch * The lot numbers of powdered concentrate packages * The date and time of mixing * Any verification test results - if required by the manufacturer, verification of conductivity of the bicarbonate concentrate used at the facility.” During an interview on 07/16/2024 at 10:43 AM, the Biomedical Technician stated the reconstituted bicarbonate solution was not checked prior to distribution, and testing was performed only at the dialysis machines in the treatment area prior to initiation of each dialysis treatment. The Biomedical Technician further stated there was no testing device available and/or utilized in the mixing area. During an observation of the bicarbonate mixing area and interview on 07/16/2024 at 2:00 PM, Patient Care Technician (PCT) #6 stated there was no device in the area. PCT #6 stated she did not test the reconstituted bicarbonate solution prior to distribution. During an interview on 07/18/2024 between 2:20 PM and 3:10 PM, the Medical Director stated the facility was expected to follow federal regulations for testing of the bicarbonate solution prior to distribution. A “Bicarb [bicarbonate] Mix Log,” for the date range 04/13/2024 to 07/16/2024, revealed bicarbonate solution was mixed 65 times with no documentation of the reconstituted bicarbonate solution test results.”

“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: 35949 Based on observation, interview, manufacturer’s directions for use (DFU) review, and facility policy review, the facility failed to follow the bloodline manufacturer’s DFU during dialysis treatments by not maintaining the venous drip chamber fluid levels at 3/4 full during 4 of 4 observations. Failure to follow the bloodline manufacturer’s DFU had the potential to result in equipment malfunction and/or failure and negatively impact the safety and wellbeing of the 23 patients who received dialysis treatments in the facility. Findings included: A facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024, indicated, “e. The arterial and venous drip chamber levels should be observed and adjusted as needed.” The manufacturer’s DFU titled, “Nipro Instructions for use ... Nipro Set Blood Tubing Set,” revised 03/22/2019, indicated, “Dialysis Treatment Precautions: 1. Before initiating dialysis treatment, check the following: a. Drip chambers are in the upright position and have the fluid level at ¾ full.” In addition, the DFU indicated, “b. Periodically check fluid level in drip chamber and adjust if required.” An observation of the hemodialysis treatment area on 07/16/2024 at 10:15 AM revealed the venous drip chamber fluid levels were greater than ¾ full in Stations 1, 2, 4, 5, 8, and 10. An observation of the hemodialysis treatment area on 07/18/2024 at 10:00 AM revealed the venous drip chamber fluid levels were greater than ¾ full in Stations 1, 2, 3, 4, 5, 8, 10, and 11. An observation of the hemodialysis treatment area on 07/18/2024 at 10:15 AM revealed the venous drip chamber fluid levels were greater than ¾ full in Stations 1, 2, 3, 4, 5, 8, 10, and 11. An observation of the hemodialysis treatment area on 07/18/2024 at 10:26 AM with the covering Facility Administrator revealed the venous drip chamber fluid levels were greater than ¾ full in Stations 1, 2, 4, 5, 7, 8, 10, and 11. During an interview on 07/18/2024 at 10:26 AM, the covering Facility Administrator confirmed the venous drip chamber fluid levels were not adjusted to ¾ full during the dialysis treatments according to the manufacturer’s DFU. During an interview on 07/18/2024 at 2:20 PM, the Medical Director confirmed the staff were trained and expected to follow the manufacturer’s DFU for adjusting the fluid levels in the drip chambers. During an interview on 07/18/2024 at 3:56 PM, Patient Care Technician #6 stated she was trained to fill the venous drip chamber “to the line” and did not remember being trained according to the manufacturer’s DFU. During an interview on 07/18/2024 at 4:16 PM, Registered Nurse #4 stated he was trained to maintain the venous drip chamber at “the line” during treatments and was not familiar with the manufacturer’s DFU.”

“PA-FREQUENCY-INITIAL-30 DAYS/13 TX CFR(s): 494.80(b)(1) An initial comprehensive assessment must be conducted on all new patients (that is, all admissions to a dialysis facility), within the latter of 30 calendar days or 13 hemodialysis sessions beginning with the first dialysis session. This Standard is not met as evidenced by: 35949 Based on interview, record review, and facility policy review, the facility failed to complete an initial comprehensive assessment conducted by all members of the interdisciplinary team (IDT - a registered nurse, a physician who treated the patient for end stage renal disease, a social worker, and a dietitian [Registered Dietician (RD]) within 30 calendar days after admission, for 1 (Patient #4) of 1 sampled home therapy patients new to dialysis and admitted to the facility within the last 90 days. Failure to complete an initial comprehensive assessment performed by all members of the IDT within 30 calendar days after admission for patients new to dialysis provided opportunities for areas of concern to be unidentified and left unaddressed related to the patients’ plan of care, and had the potential to negatively impact the care and well-being of the 12 patients who received home therapy oversight at the facility. Findings included: A facility policy titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care,” revised 07/2023, indicated, “4. A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines.” A “Patient Summary Report” revealed Patient #4 admitted to the facility on 04/09/2024. A “Comprehensive Assessment Report” revealed a completion date by the RD on 05/22/2024, 43 days from the date of admission. During an interview on 07/17/2024 at 1:51 PM, the covering Facility Administrator confirmed Patient #4’s initial comprehensive assessment was late and past the 30-day timeline. During an interview on 07/18/2024 at 2:27 PM, the RD stated he was not aware of an “exact reason” why Patient #4’s initial comprehensive assessment was past the 30-day timeline for completion. The RD stated he was trained and expected to complete the initial comprehensive assessment within 30 days from the admission date. During an interview on 07/18/2024 at 2:20 PM, the Medical Director confirmed the staff were trained and expected to complete the initial comprehensive assessment on newly admitted patients within 30 days of the admission date.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 35949 Based on interview, record review, and facility policy review, the facility failed to monitor patients’ vital signs and/or machine parameters according to their policy for 2 (Patient #2 and Patient #3) of 3 sampled in-center patients. Failure to monitor patients’ vitals and machine parameters according to the facility’s policy provided an opportunity for changes to the patients’ condition during dialysis treatments to be unrecognized and unaddressed and negatively impact the care provided to the 23 patients who received dialysis treatments at the facility. Findings included: A facility policy titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 04/2024, indicated, “Vital signs and treatment monitoring Non-nocturnal treatments are completed at least every thirty (30) minutes.” 1. Patient #2’s “Treatment Details Report,” dated 06/27/2024, revealed monitoring was not documented for 59 minutes, from 7:58 AM until 8:57 AM. Patient #2’s “Treatment Details Report,” dated 07/09/2024, revealed monitoring was not documented for 60 minutes, from 6:54 AM until 7:54 AM. 2. Patient #3’s “Treatment Details Report,” dated 07/09/2024, revealed monitoring was not documented for 61 minutes, from 2:18 PM until 3:19 PM. During an interview on 07/18/2024 at 8:25 AM, the covering Facility Administrator stated staff were trained and expected to monitor patients every 30 minutes according to the facility’s policy. During an interview on 07/18/2024 at 2:20 PM, the Medical Director confirmed staff were trained and expected to monitor patients every 30 minutes. During an interview on 07/18/2024 at 3:56 PM, Patient Care Technician #6 stated she was trained and expected to perform and document patient monitoring every 30 minutes. During an interview on 07/18/2024 at 4:16 PM, Registered Nurse #4 stated patient monitoring should be performed and documented every 30 minutes as trained and expected.”

“MR-PROTECT PT RECORDS FM LOSS/CONFIDENTIAL CFR(s): 494.170(a) The dialysis facility must- (1)Safeguard patient records against loss, destruction, or unauthorized use; and (2) Keep confidential all information contained in the patient’s record, except when release is authorized pursuant to one of the following: (i) The transfer of the patient to another facility. (ii) Certain exceptions provided for in the law. (iii) Provisions allowed under third party payment contracts. (iv) Approval by the patient. (v) Inspection by authorized agents of the Secretary, as required for the administration of the dialysis program. This Standard is not met as evidenced by: 35949 Based on observation, interview, contract review, and facility policy review, the facility failed to store medical records in a location that provided security, controlled accessibility, and protected against unauthorized use. Failure to store medical records in a secure location provided an opportunity for unauthorized use and/or access and had the potential to negatively impact the integrity of protected health information for 14 patients who had or were currently receiving care at the facility in the home therapy area. Findings included: A facility policy titled, “Administrative, Technical and Physical Safeguards for Protected Health Information,” reviewed 06/2022, indicated, “1. All Teammates of [name] are responsible for ensuring that physical access control and other administrative, technical and physical safeguards are implemented to limit physical access to the facilities and to protect PHI [protected health information] against unauthorized access.” In addition, the policy indicated, “i. Medical Records must be locked in a drawer or filing cabinet when not in use and at the end of each workday.” A facility contract titled, “Facilities Management Services,” dated 03/11/2013, indicated, “Assumptions” that included “Hallways, corridors, stairwells” and “Cleaning hours - cleaning performed: Only on days of operation, After clinic has completed the day operations.” During an observation on 07/16/2024 at 10:10 AM of the home therapy area, 14 medical records were observed on an open wheeled metal shelving cart at the end of the hallway at the nurses’ station. During an interview on 07/16/2024 at 10:35 AM, Patient Care Technician #7 stated the housekeeping staff cleaned the facility “after [business] hours.” During an interview on 07/17/2024 at 8:00 AM, both the covering Facility Administrator and Registered Nurse (RN) #5 confirmed there were 14 medical records (12 current patients and two additional patients) stored in an open wheeled metal shelving cart at the end of the hallway near the nurses’ station in the home therapy area. Both the covering Facility Administrator and RN #5 confirmed the medical records contained protected health information and were not protected from unauthorized access by the housekeeping staff that presented to the facility after business hours. During an interview on 07/18/2024 at 2:20 PM, the Medical Director confirmed medical records should be securely stored.”