Health inspection·September 20, 2024

Code of Federal Regulations, Title 42, Section §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(f). 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) Service Consultation. The facility must employ or obtain the services of a licensed pharmacist who- §483.45(b)(1) Provides consultation on all aspects of the provision of pharmacy services in the facility. §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. California Code of Regulations, Title 22, Section TT22 72369. Pharmaceutical Service -Controlled Drugs. (a) Drugs listed in Schedules II, III and IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 shall not be accessible to other than licensed nursing, pharmacy and medical personnel designated by the licensee. Drugs listed in Schedule II of the above Act shall be stored in a locked cabinet or a locked drawer separate from noncontrolled drugs unless they are supplied on a scheduled basis as part of a unit dose medication system. (b) Separate records of use shall be maintained on all Schedule II drugs. Such records shall be maintained accurately and shall include the name of the patient, the prescription number, the drug name, strength, and dose administered, the date and time of administration and the signature of the person administering the drug. Such records shall be reconciled at least daily and shall be retained at least one year. If such drugs are supplied on a scheduled basis as part of a unit dose medication system, such records need not be maintained separately. (c) Drug records shall be maintained for drugs listed in Schedules III and IV of the above Act in such a way that the receipt and disposition of each dose of any such drug may be readily traced. Such records need not be separate from other medication records. Note: Authority cited: Sections 208(a) and 1275, Health and Safety Code. Reference: Section 1276, Health, and Safety Code. TT22 72371. Pharmaceutical Service -Disposition of Drugs. (c) Patient's drugs supplied by prescription which have been discontinued and those which remain in the facility after discharge of the patient shall be destroyed by the facility in the following manner: (1) Drugs listed in Schedules II, III or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be destroyed by the facility in the presence of a pharmacist and a registered nurse employed by the facility. The name of the patient, the name and strength of the drug, the prescription number, the amount destroyed, the date of destruction and the signatures of the witnesses required above shall be recorded in the patient's health record or in a separate log. Such log shall be retained for at least three years. (2) Drugs not listed under Schedules II, III or IV of the Federal Comprehensive Drug Abuse Prevention and Control Act of 1970 shall be destroyed by the facility in the presence of a pharmacist or licensed nurse. The name of the patient, the name and strength of the drug, the prescription number if applicable, the amount destroyed, the date of destruction and the signatures of the person named above, and one other person shall be recorded in the patient's health record or in a separate log. Such log shall be retained for at least three years. On 8/5/2024 10:39 am, the California Department of Public Health (CDPH, the Department) conducted an unannounced visit to the facility to conduct a recertification survey. The facility failed to have a system in place to ensure safeguarding of all prescribed medications including controlled medications (medications with a high potential for abuse) for Residents 18, 20, 25, 27, 28, 34, 37, 45, 51, 55, 57, 71, 84, 97, 148, 150, and 151 by failing to: 1. Maintain accountability records for all controlled substances/medications that were disposed of or destroyed with the unused supply between 1/1/2024 through 8/8/2024 and ensure each resident's individual controlled drug record for each controlled medication was used for accurate accountability of controlled medications for Residents 34, 71,97, 148, 150 and 151). Controlled medications included lorazepam and clonazepam (medications used to treat anxiety, a mental disorder characterized by persistent feelings of worry, nervousness, or unease strong enough to interfere with daily activities), zolpidem (medication used to treat insomnia, difficulty falling asleep), lacosamide and clobazam (medication used to treat seizures, a sudden rush of abnormal electrical activity in your brain). 2. Ensure medication carts and cabinets contained controlled medications and biologicals, were maintained locked, and not left unattended when not in use to prevent the potential for unauthorized access to medications that included noncontrolled medications stored in medication carts in two of two nursing stations (West Nursing Station Medication Cart and East Nursing Station Medication Cart) for Residents 18, 20, 25, 27, 28, 37, 45, 51, 55, 57 and 84). 3. Ensure the access keys were not the same keys to access other medications and controlled medications and were not stored inside the medication carts and failed to ensure licensed nurses (all licensed nurses) maintained possession of the keys to controlled medications and the keys were not left inside of an unlocked medication cart in the East Nursing Station. These failures resulted in a facility wide system failure to secure and accurately account for and reconcile controlled medications for Residents 18, 20, 25, 27, 28, 34, 37, 45, 51, 55, 57, 71, 84, 97, 148, 150 and 151. The failure placed the facility at risk for medication errors, residents to receive more or less medication than prescribed, adverse reactions (harmful or unpleasant reaction, resulting from an intervention related to the use of a medication) such as: falls, hospitalizations, harm, and inability to readily identify the loss or drug diversion (illegal distribution of abuse of prescription drugs or their use for unintended purposes) of controlled medications. 1. During a concurrent observation of the controlled medication storage inside the DON's office, and interview with the DON, on 8/7/2024 at 3:03 PM. The DON stated the DON's office was shared with the DSD and the IP. The DON stated controlled medications awaiting disposal were stored in a cabinet inside of the DON's office and the DSD kept the key to the cabinet. The cabinet was observed unlocked. The DON stated the DON placed the controlled medications, awaiting disposal, on top of a box inside of a cabinet. The DON stated the DON did not have a designated or secure location to store controlled medications awaiting disposal. The DON stated the CDR forms were for Residents 34, 71, 97, 148, 150 and 151. During a concurrent interview with the DON and record review on 8/7/2024 at 3:08 PM, the DON stated the signatures on the bottom of the CDR forms belonged to the DON and Pharm 1. The DON stated discontinued and expired controlled medications were last destroyed on 7/30/2024 with Pharm 1. The DON stated the section for dispensed medications on the CDR forms labeled for individual residents were left blank. The DON stated the facility did not accurately account for the discontinued and expired controlled medications. During an interview with the DON on 8/7/2024 at 3:15 PM, the DON stated both the DON and Pharm 1 would not go back to compare Residents' (Residents 34, 71, 97, 148 150 and 151's) MARs with each CDR form to ensure all doses of controlled medications were administered as ordered by the physician and to address the discrepancy between the original quantity and the disposal of medications. The DON stated, the DON and Pharm 1 did not verify or account for the disposal/destruction of controlled medications for each dose of controlled medication that were not recorded on the CDR forms. The DON stated the licensed nurses did not document on the CDR forms when controlled medications were removed and administered to the residents. The DON stated when Pharm 1 came to the facility to dispose controlled medications with the DON, the DON and Pharm 1 did not go back to compare with the residents' MAR or any residents' medical records. The DON stated the facility did not have a system to ensure all doses of the controlled medications were administered to the residents or to reconcile or account for the discrepancy between the original quantity delivered to the facility and the quantity destroyed. The DON stated the facility did not have a system to account for each dose of controlled medication being wasted, refused, or not administered to a resident as prescribed. The DON stated there was no shift change audit (a controlled medication reconciliation document signed by two nurses during shift change) done between the oncoming nurse (nurse starting the shift) and the outgoing nurse (nurse leaving) to verify that all controlled medications inside the medication carts were accurate and accounted for before endorsing the medication carts from one nurse to the next nurse. During a concurrent observation of the medication cart in the West Nursing Station and interviews with LVN 3 and LVN 4 on 8/7/2024 at 3:40 PM, there were controlled medications stored together with noncontrolled medications in the medication cart. LVN 3 showed a large binder located on the West Nursing Station that was filled with CDR forms and had prescription labels from the facility's dispensing pharmacy. LVN 4 stated licensed nurses never filled the CDR forms out to account for each dose of controlled medications removed for administration to the residents. LVN 4 stated the licensed nurses did not count the controlled medications during shift change before endorsing the medication carts to the nurses from the next shift. During an interview on 8/7/2024 at 3:50 PM with LVN 3 and LVN 4, LVN 4 stated LVN 4 would not have any idea if controlled medications were missing, diverted for personal use, or if all the controlled medications for each resident were accounted for because nurses did not count the controlled medications between shifts. LVN 3 stated the licensed nurses would not know if controlled medications became missing or were misused because the medications were kept among the noncontrolled medications, and the controlled medications were not counted each day. During a telephone interview on 8/8/2024 at 8:19 AM with the DON and Pharm 1, Pharm 1 stated the facility's licensed nurses were supposed to document on the controlled drug count down sheet (CDR) each time they remove a controlled medication for resident administration. Pharm 1 stated the nurses were also expected to verify the controlled medications with two nurses during the change of shift to make sure the controlled medication count was accurate before the outgoing nurse endorsed (hands over the medication cart key) to the oncoming nurse, and if there were any discrepancies with the controlled medications, two nurses could work to resolve any concerns. Pharm 1 stated, "that was the standard of practice for handling-controlled medications." Pharm 1 stated the controlled medication count down sheets (CDR) needed to be filed away as a permanent record to ensure controlled medication accountability. Pharm 1 was asked why Pharm 1 signed the blank (not filled in) CDR forms for Residents 34, 71, 97, 148, and 150 during controlled medication disposal when the original quantity was different from the quantity being destroyed for each resident-controlled medication, Pharm 1 stated Pharm 1 just destroyed what was presented to Pharm 1. Pharm 1 stated, "I would not know if any medications [were] diverted or lost. Pharm 1 stated "I am only documenting the narcotic medication I am disposing of right there." Pharm 1 stated "I do not look at any other document to see or reconcile with the unused controlled medication that I am disposing of." Pharm 1 stated Pharm 1 had not provided any training to the facility's staff on medication storage or handling controlled medications. During an interview on 8/8/2024 at 8:50 AM with the DON, the DON stated the facility's practice was not using the CDR sheets during the removal of routine controlled medications since before the DON started working at the facility more than a year and half ago. During a telephone interview on 8/8/2024 at 9 AM with the DON and the facility's dispensing pharmacist (Pharm 2) Pharm 2 stated, Pharm 2 sent a CDR form for each resident's controlled medication to the facility. Pharm 2 stated, CDR forms were used to keep track of what was dispensed and administered to the residents. Pharm 2 stated, "it was up to the facility's policy" what process for keeping track of controlled medications the facility should follow. Pharm 2 stated it was the responsibility of the facility's Consulting Pharmacist (in general) to help keep the facility compliant with regulations. Pharm 2 stated Consulting Pharmacist needed to follow the facility's policy for handling controlled medications and ensuring the monitoring and accounting of controlled medications. Pharm 2 stated the facility must order controlled medications each time before a resident runs out of their medication by either calling the dispensing pharmacy or sending a faxed refill request. During a concurrent telephone interview with Pharmacist Technician (PhTech) from the facility's dispensing pharmacy, and record review on 8/8/2024 at 11:13 AM, the Controlled Medication Report dated from 1/1/2024 through 8/8/2024 were reviewed, the Controlled Medication Report indicated the facility received the following controlled medications from the dispensing pharmacy for 35 individual residents and the total number of doses for each medication delivered to the facility from 1/1/2024 through 8/8/2024 were as follow: 1. Lorazepam 0.5 mg - 951 tablets 2. Lorazepam 1 mg - 1,861 tablets 3. Clonazepam 0.5 mg - 210 tablets 4. Clonazepam 1 mg - 3,101 tablets 5. Clonazepam 2 mg - 472 tablets 6. Zolpidem 10 mg - 60 tablets 7. Lacosamide 50 mg - 402 tablets 8. Lacosamide 200 mg - 180 tablets During an interview on 8/8/2024 at 3:14 PM with the ADM and the DON, the DON stated Pharm 1 had been to the facility many times and had not identified any concerns with the facility's handling of controlled medications. 2. During a concurrent observation of the controlled medication storage inside the DON's office, and interview with the DON, on 8/7/2024 at 3:03 PM. The cabinet was unlocked. The DON stated the DON placed the controlled medications, awaiting disposal, on top of a box inside of the cabinet. The DON stated the DON did not have a designated or secure location to store controlled medications awaiting disposal. During an interview on 8/7/2024 at 3:27 PM with DON and the DSD inside of the DON's office, the DSD stated, the DSD had the key to the cabinet inside of the DON's office that contained discontinued and expired controlled medications awaiting disposal. The DSD stated the key to the cabinet was hung and stored on a wallboard located inside of the DON's shared office space. The DON stated the cabinet was not kept locked. During an observation of the West Nursing Station Medication Cart and the East Nursing Station Medication Cart with the DON on 8/7/2024 from 3:44 PM to 4:26 PM, the following resident medications were observed and stored mixed together with noncontrolled medications: West Nursing Station Medication Cart included the following controlled medications for: a. Resident 27 b. Resident 28 c. Resident 20 d. Resident 55 e. Residen