Santa Clara Valley Renal Care Center

“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: 38573 Based on interview and record review, the facility failed to perform safety checks during the setup of hemodialysis machines to ensure intravenous (IV, administered into a vein) 0.9% sodium chloride solution (also known as normal saline [NS]- a common medical solution containing a mixture of water and sodium chloride that has the same concentration of solutes as blood and body fluids) was administered per facility policy for nine of 10 sampled patients (Patients 1,2,3,4,5,6,7,8 and 9). This failure resulted in IV NS not being administered, which had the potential to compromise the health and safety of the patients. Findings: During a concurrent interview and record review on 4/3/25 at 3:04 p.m., with the Registered Nurse-Clinical Nurse (RN-CN), the RN-CN stated that on 1/25/25, she was working PM shift (evening shift also known as third shift) and found out that Lactated Ringer’s (LR, a medical solution that contains water, sodium chloride, sodium lactate, potassium chloride, and calcium chloride) was hooked up to Patients 1,3,5,6,7,8 and 9. The RN-CN stated she notified the Assistant Nurse Manager (ANM) right away and was told by the ANM to change the LR to NS. The RN-CN further stated that per facility policy and procedure (P&P), NS should have been used to prime the machines (to remove air and other material from the machine’s circuit by instilling medical solution). During an interview on 4/3/25 at 3:24 p.m., with Registered Nurse-Clinical Nurse 11 (RN- CN 11), RN-CN 11 stated he worked PM shift on 1/25/25 and he forgot to check the IV solution that was hooked up to his Patients. RN-CN 11 further stated he should have checked as part of his responsibility, and per facility P&P, that it was NS that was used to prime the machines. During a concurrent interview and record review on 4/3/25 at 3:42 p.m., with Dialysis Technician A (DT A), DT A stated he worked PM shift on 1/25/25. DT A confirmed that LR was used to prime the machines for Patients 1 and 3 instead of NS. DT A further stated the ANM and RN-CN were aware of the incident and instructed him to change the LR to NS. During a concurrent interview and record review on 4/3/25 at 3:58 p.m., with DT B, DT B stated she worked PM shift on 1/25/25. DT B stated she missed checking the IV solution that was hooked up to Patient 2, who was assigned to her that day. DT B further stated the ANM and RN-CN were aware of the incident and instructed her to change the LR to NS. During a concurrent interview and record review on 4/3/25 at 4:14 p.m., with the Nurse Manager (NM), the NM stated the wrong IV solution was delivered to the facility on 1/25/25. The NM explained that instead of NS, the facility received LR. The NM further stated facility staff assumed it was NS that was delivered, because NS was the only solution that the facility was using. The NM reviewed the facility’s P&P titled “Initiation of Hemodialysis using B. BRAUN Hemodialysis Delivery System.” The P&P indicated to verify and document that machine checks are done, and that the NS line is double clamped. The P&P further indicated the Certified Hemodialysis Technician (CHT) and/or Registered Nurse (RN) must independently verify machine checks prior to initiation of the procedure. The NM also reviewed the facility’s P&P titled “Set up and Priming B Braun Hemodialysis Delivery System using Streamline Bloodlines.” The P&P indicated to use 1000 milliliters (ml, unit of measurement) of NS. During a concurrent interview and record review on 4/3/25 at 4:54 p.m., with the ANM, the ANM confirmed that for Patients 1,2,3,4,5,6,7,8 and 9, facility staff used LR instead of NS to prime the machines on 1/25/25. During a concurrent interview and record review on 5/29/25 at 10:59 a.m., with Registered Nurse-Clinical Nurse 111 (RN-CN 111), RN-CN 111 stated that on 1/25/25, he worked PM shift, and he was notified by the ANM to check his patient’s IV solutions. RN-CN 111 stated he found out that LR was used to prime the machines of Patients 2 and 4. RN-CN 111 stated that per facility P&P, staff should have primed the machines with NS, not LR. The facility’s P&P titled “Medication Preparation and Administration,” revised 2/24, indicated medications are prepared and administered by clinical staff within their respective scopes of practice. The P&P indicated to verify the provider order in the electronic health record and check the medication label. The P&P further indicated that before administering medication, clinical staff must confirm the 7 rights of medication administration (right person, right medication, right dose, right time, right route, right reason, and right documentation).”

“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: 10918 Based on observation, interview and record review the facility failed to ensure facility policies were followed regarding evaluating the integrity of home medications for use in the facility, medication reconciliation, and accurately documenting patient allergies for one of two sampled patients (Patient 1).Patient 1’s home medications were not checked and determined safe by a physician or pharmacist for facility use. Also, Patient 1 had adverse reactions to certain tapes and medications and the items were not noted as allergies. These failures had the potential to cause patient health complications and resulted in inaccurate record keeping. Findings: During a dressing change observation on 12/19/23 at 6:42 a.m., Patient 1 had a tunneled dialysis catheter (TDC, tube placed under the skin and into a major vein to allow dialysis, procedure using a special filter connected to a dialysis machine to remove waste and excess fluid from the blood) to his right upper chest. Patient 1’s skin around the catheter appeared bumpy with reddish brown discoloration approximately 6 inches by 10 inches in size. Registered nurse A (RN A) applied clobestasol spray on Patient 1’s TDC site and surrounding skin. During the same observation and interview on 12/19/23 at 6:42 p.m., RN A described Patient 1’s skin as irritated, sensitive and with discharge and stated the patient had allergies to some adhesives and medications. During the same observation and interview at on 12/19/23 at 6:42 a.m., Patient 1 had with him a triamcinolone acetonide ointment (medication used to treat skin conditions), mupirocin ointment (antibiotic to treat skin infection), aquaphor (skin moisturizer), clobestasol spray 0.02% (corticosteriod used to treat skin conditions), telfa dressing and swab sticks. Patient 1 then stated he brought the items from home and had purchased the spray. Review of Patient 1’s undated Dialysis Overview form, indicated to clean TCD with hypochlorous spray then apply clobetasol 0.05% ointment. The same form indicated Patient 1 was only allergic to two oral medications. The record lacked accurate documentation of allergies and lacked clarification of physician’s orders, i.e. clobestasol prescription strength and whether spray rather than ointment was acceptable. During an interview on 12/19/23 at 8:26 a.m., the nurse manager (NM) who reviewed the record acknowledged the patient’s prescribed medications should be clarified and allergies noted. Review of Patient’s Own Medications policy, dated 12/8/2022, indicated before use or administration, the physician or pharmacist must identify all medications brought into the hospital, including visually evaluating the medications’ integrity. The Ambulatory Service, Renal Care Center policy, revised 06/2020, indicated the primary nurse had total responsibility and accountability for nursing care to include monthly medication review and review/update patient problem list and allergies.”