Davita Santa Maria Dialysis

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 32661 Based on observation, interview, and record review, the facility failed to ensure a licensed nurse (LN) 1 labeled and dated a central venous catheter (CVC - a device used for gaining entry into the bloodstream) dressing during catheter care for one of two sampled patients (Patient 6). This failure had the potential to result in compromising the patient’s safety due to lack of traceability and accountability. Findings: During an observation on 6/25/25 at 1:15 p.m. Patient 6 was reclined in the dialysis chair while receiving hemodialysis (medical procedure that removes waste and excess fluid from the blood when the kidneys are unable to perform this function adequately). Patient 6 had a right CVC access used for hemodialysis. The dressing on the patient’s right CVC was not dated and did not have LN 1’s initials, who performed the dressing change. During a concurrent observation and interview on 6/25/25 at 1:20 p.m. with LN 1, LN 1 inspected Patient 6’s right CVC dressing and concurred the dressing was not dated and initialed and should have been. According to the National Institutes of Health (NIH), “Label the dressing with the date, time, and your initials, as well as the date the dressing should be changed again. Labeling is a quality measure to promote ongoing adherence to agency policies and recommendations.” During a review of the facility’s policy and procedure (P&P) titled, “CENTRAL VENOUS CATHETER (CVC) WITH CLEARGUARD HD MICROBIAL END CAPS PROCEDURE,” dated (revised) April 2025, the P&P indicated in part, “13. Apply label to the dressing indicating: * Date dressing change was performed. * Initials of TM performing procedure”.”

“MIXING SYSTEMS-LABELING CFR(s): 494.40(a) 5.4.4.1 Mixing systems: labeling Labeling strategies should permit positive identification by anyone using the contents of mixing tanks, bulk storage/dispensing tanks, and small containers intended for use with a single hemodialysis machine. Mixing tanks: Prior to batch preparation, a label should be affixed to the mixing tank that includes the date of preparation and the chemical composition or formulation of the concentrate being prepared. This labeling should remain on the mixing tank until the tank has been emptied. Bulk storage/dispensing tanks: These tanks should be permanently labeled to identify the chemical composition or formulation of their contents. Concentrate jugs: At a minimum, concentrate jugs should be labeled with sufficient information to differentiate the contents from other concentrate formulations used at the facility. This Standard is not met as evidenced by: 32661 Based on observation, interview, and record review, the facility failed to ensure patient care staff dated and initialed open containers of acid dialysate (blend of water and chemicals that washes wastes and fluid out of the blood) used during hemodialysis (a life-sustaining treatment for patients with failing kidneys). This failure had the potential to result in compromising the patient’s safety due to lack of traceability and accountability. Findings: During an observation on 6/23/25 at 3:25 p.m. in the dirty sink area, three empty containers of acid dialysate were observed without any labels indicating the date they were opened and staff initials of who opened the jugs. During a concurrent observation and interview on 6/23/25 at 3:40 p.m. with a licensed nurse (LN) 1, at the dirty sink area, LN 1 inspected the three empty acid dialysate containers and concurred that the emptied containers were missing labels indicating the date they were opened and the initials of the staff who opened them. During a review of the facility’s policy and procedure (P&P) titled, “ACID CONCENTRATE SYSTEM, INCOMING ACID CONCENTRATE AND USE OF ACID CONCENTRATE CONTAINERS,” revised October 2024, the P&P indicated in part, “ACID CONCENTRATE CONTAINERS ... 20. Upon opening an acid concentrate container, label container with date opened, and initials of teammate.””

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 32661 Based on observation, interview, and record review, the facility failed to ensure staff reported a change of condition of a patient’s current health status for one of two sampled patients (Patient 6). This failure had the potential to result in inadequate treatment, patient harm, and suffering. Findings: During an observation on 6/25/25 at 10:30 a.m., Patient 6 was in dialysis chair undergoing dialysis (medical procedure that removes waste and excess fluid from the blood when the kidneys are unable to perform this function adequately). Patient 6 used the call light/bell to summon staff and PCT 3 promptly responded. Patient 6 told PCT 3 he was hungry and was not feeling well. Patient 6 was requesting his power bar (snack). PCT 3 responded by stating, “Your nurse will give it to you” and left heading towards another patient. PCT 3 did not report to the licensed nurse (LN 2) who was assigned to Patient 6 about his request for a power bar. During an interview on 6/25/25 at 10:45 a.m. with LN 2, LN 2 was surprised and responded she was not notified by PCT 3 about Patient 6’s request for a power bar. LN 2 stated, “The PCT should have communicated the request to me.” During a review of Patient 6’s “Comprehensive Encounter,” dated 2/19/2024, Patient 6’s medical history included a diagnosis of uncontrolled diabetes. During a review of the facility’s policy and procedure titled, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT”, dated (revised) April 2024, indicated in part “ABNORMAL FINDINGS: Members of the patient care team should report ANY changes in patient conditions or concerns of patient well-being immediately to the licensed nurse at any time.””

“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: 43745 Based on record review and interview, the facility failed to ensure assessments and responses to interventions for episodes of hypertension (high blood pressure) and hypotension (low blood pressure) during hemodialysis treatment (a life-sustaining treatment for patients with failing kidneys) for two of six sampled patients (Patients 1 and 3) were documented by a licensed nurse. These failures had the potential to compromise patient safety. Findings: During a concurrent interview and record review on 6/26/25 at 2:15 p.m. with the facility’s Clinical Coordinator (CC), Patient 1’s “Treatment Details Report (TDR),” dated 5/12/25 was reviewed. The “Intradialytic (occurring during dialysis) Vitals...” section of the TDR, where blood pressure readings were documented, indicated Patient 1 had episodes of high blood pressure with no documented follow up assessments and evaluations from a licensed nurse. CC acknowledged the findings and verbalized that a nurse should have followed up on Patient 1. During a concurrent interview and record review on 6/26/25 at 2:15 p.m. with the CC, Patient 3’s “TDR,” dated 6/11, 6/13, 6/16, 6/18, 6/20, and 6/23/25 were reviewed. The “Intradialytic Vitals ...” section of the TDRs, where blood pressure readings were documented, indicated Patient 3 had episodes of low blood pressure with no documented follow-up assessments and evaluations from a licensed nurse. CC acknowledged the findings and verbalized that a nurse should have followed up on the patient. During a review of the facility’s P&P titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment,” revised 4/2024, the P&P indicated in part, “PURPOSE: To obtain and document baseline information about the patient before, during and after the dialysis treatment through data collection and nursing assessment. This information will be used in planning and documenting the patient’s dialysis treatment, monitoring during treatment and for reviewing the patient’s response to the treatment and status prior to discharge.” The P&P indicated further, “INTRADIALYTIC DATA COLLECTION/ASSESSMENT ... 11) Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately (refer to “Abnormal Findings” section in this policy). The licensed nurse will use her his/her clinical judgment based on the individual patient needs to determine if any clinical interventions are necessary ...” A section of the P&P titled, “Abnormal Findings Job Aid: ICHS/DSD,” dated 4/1/24, indicated in part, “Purpose: ...The medical record should indicate the finding, the intervention, physician notification, orders, and the patient response ... Teammates should closely monitor for trending of all patient vital signs ... PRE-TREATMENT & INTRADIALYTIC Blood Pressure (BP): Systolic greater than 180 mm/Hg (millimeters of mercury - unit of pressure used in measuring blood pressure) or less than 90 mm/Hg, Diastolic (bottom number in a BP reading) greater than or equal to 100 mm/Hg or less than 50 mm/Hg ....” The job aid also indicated, “The ANNA (American Nephrology Nurses Association) Core Curriculum identifies that a difference of 20 mm/Hg increase or decrease from the patient’s last intradialytic treatment BP reading is significant and should be reported to the licensed nurse.””

“POC-IDT DEVELOPS PLAN OF CARE CFR(s): 494.90(a) The interdisciplinary team must develop a plan of care for each patient. This Standard is not met as evidenced by: 40861 Based on record review and interview the facility failed to develop a comprehensive, personalized plan of care (POC) for one of six sampled patients (Patient 1). This failure had the potential for Patient 1 to not receive appropriate interventions in order to meet their health care needs. Findings: During a review of Patient 1’s “IDT Patient Profile Report,” undated, the “Report” indicated, Patient 1’s hemodialyisis (a medical procedure that cleans the blood for non functioning kidneys) was performed through a Central Venous Catheter (CVC - a short term access site for providing hemodialysis) in the right femoral artery, beginning 4/28/25. The report also indicated Patient 1’s last hemoglobin (red blood cells crucial for carrying oxygen from your lungs to your body) on 4/30/25 was 7.8g/dl. Patient 1 also had a documented SPKT/V (a measure of dialysis adequacy) of 0.73 on 5/9/25. During a review of Patient 1’s “Patient Plan of Care (POC),” dated 6/2/25, the “POC” indicated, “Access: Support maintenance and functioning of permanent dialysis access, Adequacy: Maintain adequacy goal, Anemia: Hemoglobin is in range for patient”. During an interview on 6/26/25 at 1:50 p.m. with the Clinical Coordinator (CC), the CC agreed that the POC for Patient 1 was not developed based on their needs as Patient 1’s CVC is not a permanent access site and goals should be in place to remove it and Patient 1 was not meeting adequacy or hemoglobin goals based on the latest test results and interventions should be in place for meeting those goals and are not. During a review of the facility’s policy and procedure (P&P) titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan Of Care, revised October 2024, the P&P indicated “...The facility’s interdisciplinary team will develop and implement a written, individualized comprehensive plan of care that specifies the services necessary to address the patient’s needs”...The plan of care will address, but not limited to, the following: ... An incenter hemodialysis Kt/V of at least 1.2, ... the necessary care and services to achieve and sustain the clinically appropriate hemoglobin level ...timely referrals to achieve and sustain vascular access.””

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 43745 Based on observation, interview, and record review, the facility failed to ensure its infection control and medication policies and procedures (P&P) were implemented when expired medications and supplies were found in the patient treatment area readily available for use. These failures had the potential to result in unsafe medication and treatment administration which could affect the health and safety of the patients. Findings: During a concurrent observation and interview on 6/23/25 at 3:15 p.m., with the facility’s Clinical Coordinator (CC), the clean supply cabinets in the treatment area were inspected. Expired (expiration date: 3/31/25) recirculation connectors (external adapters used to connect hemodialysis [a life-sustaining treatment for patients with failing kidneys] tubings) were found in one of the supply cabinets. CC verified the expiration dates and acknowledged that expired supplies should not be used and must be discarded. During a concurrent observation and interview on 6/25/25 at 3:30 p.m. with licensed nurse (LN 1), the medication supply cabinets at the nurse station were inspected. On inspection, a box containing three tubes of expired (expiration date: 2/28/25) Glutose 15 Oral Glucose Gel (used to treat low blood sugar levels) were found. LN 1 verified the expiration date and verbalized that expired medications should not be used and must be discarded. During a review of the facility’s “P&P” titled, “Infection Control for Dialysis Facilities,” revised 4/2023, the P&P indicated in part, “PURPOSE: To minimize the spread of infections or bloodborne pathogens (infectious microorganisms present in human blood that can cause disease in humans) in the dialysis (a treatment that filters waste and excess fluid from your blood when your kidneys are failing) facility environment.” The P&P indicated further, “SUPPLIES ... 8) Supplies will be stored in a manner that maintains their integrity ... b) Expiration date and package integrity will be verified prior to use.” During a review of the facility’s “P&P” titled, “Medication Policy,” revised 10/2023, the P&P indicated in part, “PURPOSE: To provide guidance for medication management in the facility and to provide guidance for the safe and aseptic (free from contamination caused by harmful bacteria, viruses or other microorganisms) preparation of all medications.” The P&P indicated further, “POLICY: ... 13) All open or unopened medication packages (i.e., vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired ... 32) Disposal of expired medications, including all over the counter and nutritional product samples are removed from the treatment inventory areas and disposed of per state/local regulations.””

“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: 43745 Based on observation, interview, and record review, the facility failed to ensure facility records containing patients’ protected health information (PHI - refers to any information that relates to a patient’s past, present, or future physical or mental health, the provision of healthcare to the patient, or the payment for healthcare, and that can be used to identify the individual) were stored in secured locations. This failure had the potential to result in unauthorized access to patients’ PHI. Findings: During a concurrent observation and interview on 6/26/25 at 2:30 p.m. with the Acting Facility Administrator (AFA), a hanging wall file was noted on the back hallway, mounted near the entrance to the treatment floor. The wall file had two folders containing facility records with patient information. AFA verbalized that the records were left there for the physicians to sign because it was more accessible for them. Although AFA felt the current location of the wall file was secure, AFA acknowledged transferring the wall file back to the front receptionist’s office, where it was originally located, was more appropriate for proper staff oversight of patient/facility records. During a review of the facility’s policy and procedures (P&P) titled, “Medical Records Custodian (one that guards or protects) and Maintenance,” revised 4/2025, the P&P indicated in part, “PURPOSE: To verify that medical records have a custodian and are maintained in proper order with current information and retained in a manner that federal and state regulations while facilitating patient care. The P&P indicated further, “POLICY: ... The responsibilities of the custodian of the medical records include: ... Safeguards the confidentiality of the medical record in accordance with established policy and legal requirements ... Verifies that all medical records are stored in a safe manner to protect against loss, destruction or unauthorized use.””