Every finding on record at St. Elizabeth Comm Hosp HHA

The following reflects the findings of the California Department of Public Health during a recertification survey conducted from 4/25/23 to 4/28/23. Representing the Department: 23083, Health Facility Evaluator Nurses (HFEN) 32041, HFEN Unduplicated Census: 520 Current census: 98 Sample: 12 Home visits: 4 Records reviewed: 12

A review of all current medications CFR(s): 484.55(c)(5) A review of all medications the patient is currently using in order to identify any potential adverse effects and drug reactions, including ineffective drug therapy, significant side effects, significant drug interactions, duplicate drug therapy, and noncompliance with drug therapy. This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the Home Health Agency (HHA) failed to accurately assess and document the intravenous (IV) medications in the home for one of 12 sampled patients (Patient 7). Patient 7 had an inaccurate dose of heparin (anti-coagulant) transcribed to the physician's orders and her Medication Profile. Discrepancies were not identified and/or clarified until a home visit 20 days after Patient 7's initial start of care date on 4/6/23. This failed action had the potential for adverse side effects, drug interactions, and ineffective drug therapy. Findings: A review of Patient 7's record indicated she was admitted to the HHA on 4/6/23 with diagnoses that included cardiac disease and bacteremia (a serious infection in the bloodstream). A review of Patient 7's physician's orders dated 4/6/23, prescribed Ampicillin (antibiotic) 2 grams intravenous solution every eight hours and Ceftriaxone (antibiotic) 2 grams (gm) every 12 hours for 79 doses. Additionally, prescribed on 4/5/23 at time of Patient 7's referral was normal saline syringes flushes 10 milliliters (ml) before and after the administration of each antibiotic followed by heparin (anti-clotting solution) 10 units /per ml, to administer 3 to 5 ml after the normal saline. A home visit was conducted on 4/6/23 at 8:45 am with Registered Nurse (RN) A. Patient 7 was observed lying in bed with a Peripherally Inserted Central Catheter (PICC line, an IV access device that was inserted in a large vein to administer antibiotics and fluids). Concurrently at 9:25 am, the two antibiotics and flushes were observed in the home. At 9:34 am, the Care Giver (CG) stated she and a friend were taught how to administer the IV antibiotics at the hospital by a nurse from the community pharmacy. She stated she wanted the friend to know how to administer the medication in case something happened to her. A concurrent review of the label on the elastomeric bulb, with RN A, she confirmed the label read Ampicillin 2 gm in 100 ml NS (normal saline) Elastomeric infuse IV over 30 minutes every 8 hours. The label indicated the contents were compounded (mixed/prepared) by the community pharmacy. At 9:37 am, RN A stated at this time she had never encountered a Patient or Caregiver compounding their own antibiotic in the home, and that she would contact the pharmacy. She confirmed that the label on the Elastomeric bulb was misleading and if someone were to grab it they might think the Ampicillin was already in the Elastomeric bulb. Concurrently the CG was observed by RN A mixing the 2 gram vial bottle of powdered Ampicillin with 10 ml normal saline and injecting the contents into the Elastomeric bulb (a balloon pump device that administers medication via gravity). The medication was returned to the refrigerator and labeled for the next administration time (2 pm). A review of the label on the vial of powdered Ampicillin instructed to add 14.8 ml of sterile water to the vial for direct IV use and not the 10 ml of normal saline that was observed mixed by the CG. A review of a prefilled syringe of Heparin flush matched the prescribed dosage (10 units /per ml) but did not match a printed Medication Profile provided or the 4/6/23 physician's plan of care (POC ) provided prior to the home visit. The Medication Profile and the POC in error indicated Patient 7 was receiving Heparin lock flushes 100 units/ml and not the 10 units/ml as prescribed on the original order dated 4/5/23. A review of the heparin flushes in the home were correct as ordered, 10/units per ml. On 4/28/23 at 9:30 am, the outside community Pharmacy Director (Pharm Dir) was interviewed. He stated there was 90 ml of normal saline instilled by the pharmacy in the Elastomeric bulb when the supplies were delivered so that was considered compounding by the pharmacy. He stated there was another label that came with the medication and supplies that explained the reconstituting of the Ampicillin. He stated their directly on the Elastomeric bulb would not fit all the instructions. Pharm Dir stated there was the potential for a different caregiver to think the bulb contained the medication and administer the contents without the added medication. Pharm Dir stated that the vial of powdered Ampicillin could be mixed with normal saline per the manufacture’s guidelines. Pharm Dir stated that the prescribed heparin flushes were 10 units/per ml and not 100 units /per ml. On 4/28/23 at 9:40 am, RN A was interviewed. She stated she had noticed the heparin dosage was incorrect on Patient 7’s Medication Profile and she had changed it during the home visit. She stated she notified the Administrative Director (Admin/Dir) of the discrepancies during the home visit on 4/26/23. On 4/28/23 at 10:40 am, RN B was interviewed. She stated she opened Patient 7 to the HHA services on 4/6/23 (start of care). RN B stated it was part of the process to evaluate all of the medications in the home regardless of the previous education provided in the hospital. She stated she did not observe Patient 7's CG administer the IV medications or flushes on 4/6/23 or subsequent visit on 4/12/23. She stated the CG verbally walked her through the administration process of the Ampicillin. She stated she checked the vial of Ampicillin and the flushes. She stated she did not walk her through the process of the administration of the Ceftriaxone antibiotic. RN B stated when she arrived at the home all the medications had been put in the refrigerator and the printed material had been put away. During an interview with the Admin/Dir on 4/28/23 at 2:34 pm, stated it was the agency's practice to review all patients medications at the patients start of care and every nursing visit. She stated it was her expectations when there were documentation errors that it needed to be fixed and when there are medication discrepancies they are clarified with the Manager and the physician. A review of a “Medication Profile" policy, revised 2/15/22 lists its purpose to review and appropriately document prescribed and over the counter medications currently used by the patient . Upon admission the Agency admitting Clinician will initiate a medication profile and document the current medication regimen. The policy directed staff that the medication profile will be updated at a resumption of care (after a hospitalization), recertification, and with any medication changes. During subsequent home visits, the medication profile will be used as a care planning and teaching guide to ensure the patient, care giver and clinicians understand the medication. Any discrepancies will be clarified with the physician and documented.

Provide services in the plan of care CFR(s): 484.75(b)(3) Providing services that are ordered by the physician or allowed practitioner as indicated in the plan of care; This ELEMENT is not met as evidenced by: Based on observation, interview and record review, the agency failed to provide services that were ordered by the physician as indicated in one of 12 sampled patients (Patient 7). Patient 7's Care Giver (CG) was not visually observed administering the prescribed intravenous (IV) antibiotic medications by the Home Health Agency (HHA) Registered Nurses (RNs) until twenty days after Patient 7’s start of care on 4/6/23. This action failed to ensure the CG had the ability to safely administer the medications, demonstrate adequate care of the IV, and to adhere to the medication regimen. This had the potential for improper dosing, infection, air embolism and blood clots to occur. Findings: Patient 7 was admitted to the HHA on 4/6/23 with diagnoses that included cardiac disease and bacteremia (a serious infection in the bloodstream). A review of patient 7’s 4/6/23 physicians plan of care ordered Skilled Nursing services one time a week for nine weeks (1wk9) and 3 prn (as needed) for infusion and cardiac complications. The physicians’ orders directed Skilled Nursing to teach and monitor Patient/Care Givers ability to self-administer medications and infusion procedures. The physicians’ orders prescribed Patient 7 to receive: Ampicillin (antibiotic) 2 grams (gm) intravenous solution every eight hours and Ceftriaxone (antibiotic) 2 gm intravenous every 12 hours for 79 doses. A start of care order dated 4/5/23 prescribed normal saline flushes 10 milliliters (ml) before and after each antibiotic medication, and Heparin (anti-clotting solution that prevents blood clotting and ensures smooth blood to flow) 10 units/ml 2 to 5 ml to maintain IV access patency. A home visit was conducted on 4/26/23 at 8:45 am, with Registered Nurse (RN) A. Patient 7 was observed lying in her bed with a Peripherally Inserted Central Catheter, (PICC line, a access device that is inserted in a large vein to administer antibiotics, and fluids). The PICC line was observed sutured in place to her left shoulder area. Patient 7's CG stated at this time she was administering the ordered antibiotics to Patient 7. Concurrently at 9:25 am, the IV antibiotics and IV supplies provided by an outside community pharmacy were observed with RN A. The CG verbally stated step by step how she administered and the dosing times of the two prescribed antibiotics. The CG had printed instructions from the pharmacy she followed. At 9:34 am, the CG stated she was taught how to administer the IV antibiotics at the hospital by a nurse from the community pharmacy. CG stated the HHA nurses had never actually observed her administer the Ampicillin, Ceftriaxone or the prescribed saline and heparin flushes. Patient 7 had been on service with the HHA for 20 days at this time. At 9:37 am, the CG was observed by RN A mixing the 2 gm vial bottle of powdered Ampicillin in normal saline and injecting the contents into an elastomeric bulb (a balloon pump device that administers medication via gravity) demonstrating proper technique. The medication was returned to the refrigerator and labeled for the next administration time (2 pm). At 10:06 am, the CG was observed administering the normal saline flush before and after the Ceftriaxone medication using proper technique. Prior to administering the Heparin flush RN A was observed stopping the CG and had her make sure the heparin syringe was primed and did not contain any air in the tip of the syringe prior to it being administered (preventing an air embolism to occur). The CG again stated this was the first time a nurse from the HHA had watched her administer the medication. RN A acknowledged this was the third visit conducted by an RN from the HHA. On 4/28/23 at 10:40 am, RN B was interviewed. She stated she opened Patient 7 to the HHA on 4/6/23 (start of care). She stated she did not observe Patient 7’s CG administer either of the antibiotic or the flushes. She stated the CG verbally stated… “walked her through” verbally how she would administer the Ampicillin antibiotic. RN B stated she did not have her walk her through the administration of the Ceftriaxone antibiotic. On 4/28/23 at 2:34 pm, during an interview with the Administrative/Director (Admin/Dir) she acknowledged that the agency failed to provide services that were ordered by the physician when the RNs failed to observe Patient 7’s CG administer the IV antibiotic medications and flushes. Admin/Dir acknowledged the administration in the home setting needed to be visually demonstrated to ensure adequate care, safety and adhere to the medication regimen to Patient 7. A review of a “Plan of Care and Physician and Allowed Practitioner Orders” policy, revised on 4/17/23, instructed staff the goal of the agency is to develop an individualized plan of care (POC) with services consistent with the physician’s plan of care. A review of a “Medication Administration by the Patient or Caregiver” policy, revised 2/13/23, indicated the RN would assess throughout the episode of care the ability of the patient, caregiver, or family to safely self-administer medication.