Other·June 14, 2023

F726 §483.35 Nursing Services The facility must have sufficient nursing staff with the appropriate competencies and skills sets to provide nursing and related services to assure resident safety and attain or maintain the highest practicable physical, mental, and psychosocial well-being of each resident, as determined by resident assessments and individual plans of care and considering the number, acuity and diagnoses of the facility’s resident population in accordance with the facility assessment required at §483.70(e). §483.35(a)(3) The facility must ensure that licensed nurses have the specific competencies and skill sets necessary to care for residents’ needs, as identified through resident assessments, and described in the plan of care. §483.35(a)(4) Providing care includes but is not limited to assessing, evaluating, planning and implementing resident care plans and responding to resident’s needs.

F727 §483.35(b) Registered nurse §483.35(b)(1) Except when waived under paragraph (e) or (f) of this section, the facility must use the services of a registered nurse for at least 8 consecutive hours a day, 7 days a week. §483.35(b)(2) Except when waived under paragraph (e) or (f) of this section, the facility must designate a registered nurse to serve as the director of nursing on a fulltime basis. §483.35(b)(3) The director of nursing may serve as a charge nurse only when the facility has an average daily occupancy of 60 or fewer residents.

F755 §483.45 Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §483.70(g). The facility may permit unlicensed personnel to administer drugs if State law permits, but only under the general supervision of a licensed nurse. §483.45(a) Procedures. A facility must provide pharmaceutical services (including procedures that assure the accurate acquiring, receiving, dispensing, and administering of all drugs and biologicals) to meet the needs of each resident. §483.45(b)(2) Establishes a system of records of receipt and disposition of all controlled drugs in sufficient detail to enable an accurate reconciliation; and §483.45(b)(3) Determines that drug records are in order and that an account of all controlled drugs is maintained and periodically reconciled. On 4/12/23, at 10:02 AM, the California Department of Public Health (the Department) made an unannounced visit to the facility to investigate a facility reported incident regarding an incident of quality of care/treatment and pharmaceutical services. Specifically, involving two sampled patients (Patient 1 and 2). As a result of the investigation, the Department determined that the facility failed to: Designate a Registered Nurse (RN) to serve as the Director of Nursing (DON) since June of 2022 (10 months) on a full-time basis to oversee the facility’s Nursing Department. Due to the lack of a DON and an oversight of the Nursing Department, this deficient practice resulted in the following: 1. Two licensed nurses (Licensed Vocational Nurse 1 and Registered Nurse 1) failed to follow the facility’s policy on Controlled Medications (medications which have a potential for abuse and may also lead to physical or psychological dependence, also referred to as controlled substance [CS]), Controlled Medications Disposal, and Medication Destruction to keep a safe, accurate account, documentation, and maintain the disposition (the process of returning and/or destroying unused medications) of controlled medications by failing to account for 14 doses of Patient 1’s Pregabalin (a CS used to treat nerve and muscle pain) on the Controlled Drug Record Form (form where the inventory of CS is maintained, and administration of dose documented) for the month of April 2023, which was discontinued by the physician on 3/31/23. In addition, the facility failed to account for eight doses of CS administrations for Patient 2’s Pregabalin, on the Controlled Drug Record Form, for the month of April 2023, during an inspection of the controlled substance (CS) drawer (Medication Cart Station 1). 2. The facility’s licensed nurses verbalized that the current facility process was to hand over the CS to the Administrator (ADM) awaiting controlled medication disposal with the Consultant Pharmacist and an RN. The facility’s policy indicated that only authorized, licensed nursing and pharmacy personnel should have access to controlled medications. 3. Five licensed nurses interviewed, did not have the appropriate competencies (applied skills and knowledge that enable people to successfully perform at their profession) and skills necessary to care for patients on Controlled Medications in accordance with the facility’s policy on Controlled Medications, Disposal, and Medication Destruction. Subsequently, four licensed nurses (Registered Nurses 1 and 2, Licensed Vocational Nurses 1, 2, and 3) provided controlled medication administration to Patients 1 and 2 having the potential to result in patients not receiving the quality care needed to prevent physical or psychosocial harm. A review of Patient 1’s Admission Record indicated the facility admitted a 98 year old, female on 3/20/23 with diagnoses including osteoarthritis of knee (when the cartilage in your knee joint breaks down, enabling the bones to rub together) and Type 2 diabetes melliitus (condition that happens because of a problem in the way the body regulates and uses sugar as fuel). A review of Patient 1’s History and Physical dated 3/31/23, indicated Resident 1 did not have the capacity to understand and make decisions due to a diagnosis of dementia (a term used to describe a group of symptoms affecting memory, thinking and social abilities). A review of Patient 1’s physician phone order, dated 3/30/23 at 3:07 PM, indicated that Patient 1 was prescribed Pregabalin 75 milligram (mg- unit of measure) orally one time a day, for joint pain. A review of Patient 1’s physician phone order, dated 3/31/23 at 7:48 PM, indicated that Patient 1’s Pregabalin order was discontinued. A review of Patient 1’s Medication Administration Records ([MAR] – document that shows medication administrations for a resident) for 3/1/23 to 3/31/23, indicated Resident 1’s Pregabalin oral capsule 75 mg was ordered on 3/30/23 timed at 3:07 PM and discontinued on 3/31/23 timed at 7:48 PM. The MAR indicated a prescheduled time to administer the Pregabalin 75 mg at 9 AM, once a day. The MAR box indicated it was signed as administered and showed LVN 2’s initials, on 3/31/23 at 9 AM. A review of Patient 1’s Controlled Drug Record Form indicated Resident 1’s name and “Pregabalin 75 mg capsule” with “Fill Date” of 3/31/23. The Controlled Drug Record Form indicated under “Quantity” as 14 capsules. The Controlled Drug Record Form did not have any documentation from a licensed staff to indicate that the CS was removed out from the CS drawer. The Form indicating “Disposition of Remaining Doses” where an RN and a witness signature was required, remained blank. A review of Patient 2’s Admission Record indicated the facility readmitted a 72 year old, female on 8/9/22 with diagnoses including polyneuropathy (simultaneous malfunction of many peripheral nerves throughout the body) and Type 2 diabetes mellitus. A review of Patient 2’s undated History and Physical indicated Resident 2 had the capacity to understand and make decisions. A review of Patient 2’s Order Summary Report, active orders as of 4/01/23, indicated that Patient 2 was prescribed Pregabalin 50 mg orally two times a day, for neuropathy (weakness, numbness, and pain from nerve damage, usually in the hands and feet). During a review of Patient 2’s MAR for 4/1/23 to 4/30/23 on 4/12/23 at 10:25 AM, indicated Resident 2’s Pregabalin oral capsule 50 mg was ordered on 8/28/22. The MAR indicated prescheduled times to administer the Pregabalin 50 mg at 9 AM and 9 PM. The MAR boxes indicated the Pregabalin 50 mg were signed as administered two times a day (9 AM and 9 PM) and showed the initials of the licensed staff that administered the medication. During an observation in Medication Cart Station 1 on 4/12/23 at 10:25 AM, in the presence of LVN 2 and concurrent review of Resident 2’s Controlled Drug Record Form (Fill Date 2/25/23), there were dates in the form where Pregabalin 50 mg did not have documentation from a licensed staff to indicate that the CS was removed out from the CS drawer, for the month of April 2023. The following dates (below) indicated the dates/times the signature of the licensed nurse that administered the Pregabalin 50 mg dose were not documented on the Controlled Drug Record Form at the indicated dates/times the medication was removed from the CS drawer: a. 4/1/23 – 9 AM and 9 PM dose b. 4/2/23 – 9 AM dose c. 4/3/23 – 9 AM dose d. 4/4/23 – 9 AM dose and PM dose e. 4/5/23 – 9 AM dose f. 4/6/23 – 9 AM dose During an interview on 4/12/23 at 11:30 AM, the ADM stated that one bubble pack for Patient 1 containing 14 Pregabalin 75 mg pills were missing and had not been found. The ADM stated that facility investigation indicated that RN 1 removed Resident 1’s Pregabalin bubble pack from Medication Cart Station 1, since the order was discontinued (on 3/31/23). The ADM stated that RN 1 placed the Pregabalin capsules in the regular medication incineration bin located in a locked cabinet in the Nursing Station. During the same interview, on 4/12/23 at 11:30AM, the ADM stated that Medication Cart Station 1 contained two Pregabalin bubble packs delivered for Resident 2. The ADM stated the first bubble pack for AM (morning) dose had 3/25/23 date, handwritten on the bottom of the bubble pack, and the second bubble pack for PM (evening) dose had 3/31/23 date, handwritten on the bottom of the bubble pack. The ADM stated that LVN 1 and RN 1 informed her (ADM) that possibly an old Pregabalin bubble pack was used for the PM doses which caused the uneven medication count between the two bubble packs. The ADM stated that the two licensed staff (RN 1 and LVN 1) removed the extra capsules from the Pregabalin AM bubble pack with the intent to destroy the CS, so that both bubble packs and Controlled Drug Record Form would match in count. During an interview on 4/12/23 at 1:20 PM, the ADM stated it is important to have accountability amongst peers for CS. The ADM stated the facility failed to follow the policy regarding CS administration, documentation, destruction, and storage. During a phone interview on 4/12/23 at 3:15 PM, the facility’s Consultant Pharmacist stated on 4/6/23, during his monthly visit to the facility, the Consultant Pharmacist observed a blank Controlled Drug Record Form for Pregabalin 75 mg for Patient 1 located in the CS Reconciliation folder. The Consultant Pharmacist stated he looked for Patient 1’s Pregabalin 75 mg oral capsule bubble pack but was unable to locate the bubble pack in Medication Cart Station 1. The Consultant Pharmacist stated he notified the Administrator (ADM) and nursing staff. The Consultant Pharmacist stated they started a facility wide search for Patient 1’s Pregabalin bubble pack. The Consultant Pharmacist stated the facility was only able to locate the top portion of Patient 1’s Pregabalin bubble pack containing the patient’s name and medication information, in the document shredder. The Consultant Pharmacist stated the bottom portion of the bubble pack containing the Pregabalin oral capsules were missing. The Consultant Pharmacist stated the 14 Pregabalin capsules for Patient 1 had not been found. Furthermore, the Consultant Pharmacist stated that during the same visit on 4/6/23, he observed Patient 2’s Pregabalin 50 mg bubble packs were kept in the regular medication drawer of Medication Cart Station 1, and not in the secured CS drawer, as indicated in the facility’s policy. The Consultant Pharmacist stated that Patient 2’s Pregabalin PM (post meridiem- after midday) doses in the bubble pack were partially full while the AM (ante meridiem- before midday) Pregabalin doses in the bubble pack were full. The Consultant Pharmacist stated that the AM and PM Pregabalin bubble packs did not match in quantity used. During the same phone interview, on 4/12/23 at 3:15 PM, the Consultant Pharmacist stated he could not find discrepancies for Patient 2’s Pregabalin counts during the CS reconciliation, due to the lack of Controlled Drug Record Forms for Pregabalin 50 mg removed for Patient 2. The Consultant Pharmacist stated Patient 2’s eMAR (electronic medication administration record- a report that serves as a legal record of the drugs administered) indicated all doses of Pregabalin 50 mg capsules were administered. The Consultant Pharmacist stated that the lack of education to nursing staff on proper CS processes, storage, documentation, reconciliation, and disposition, contributed to the failures for the accountability records of Patient 1 and 2’s Pregabalin orders. The Consultant Pharmacist stated it is important to have tight oversight and accountability with CS processes, to ensure they are securely stored, and accurately documented on the Controlled Drug Record form to prevent loss or diversion (illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber), accidental exposure of harmful substances to patients and staff, and prevent overdose or underdose to patients. The Consultant Pharmacist stated on 4/6/23, he provided an informal in-service to the nur