Health inspection·August 21, 2024

§483.45 Pharmacy Services §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. § 72523(a) Patient Care Policies and Procedures. (a)Written patient care policies and procedures shall be established and implemented to ensure that patient related goals and facility objectives are achieved. On 6/11/2024 the California Department of Public Health (CDPH) received an Entity Reported Incident (ERI), indicating the facility was missing eight tablets of Morphine Sulfate (a drug used to treat moderate and severe pain and can be addictive) from one of two emergency medication kits ([E-Kit] a kit that contains drugs required to meet the immediate needs of residents but are not available in time to prevent risk of harm to patients). On 6/12/2024 at 12 p.m., CDPH conducted an unannounced visit to the facility to investigate the ERI. Upon investigation CDPH determined the facility's E-Kit 1 had a red tag placed on it, indicating it had been opened by an unknown person and the whereabouts of eight tablets of Morphine Sulphate was unaccounted for. The facility failed to: 1. Ensure licensed nurses monitored E-Kit 1, which was located inside a locked compartment of a Medication cart on Nursing Station 1, to ensure the contents of the E-Kit was accurate, by signing/initialing that it was monitored. 2. Ensure licensed nurses adhered to the facility's Policy and Procedure, (P/P), titled, "Medication Ordering and Receiving from Pharmacy," and "Medication Storage in the Facility," that indicated, if the E-Kit had been opened (red tagged), the outgoing charge nurse must endorse the status of the emergency kit during shift change, and a physical inventory of all controlled substances, including the emergency supply, was conducted by two licensed nurses. This deficient practice resulted in the loss or diversion (when a medication is taken for use by someone other than whom it was prescribed or for an indication other than what it was prescribed) of eight tablets of Morphine Sulfate from the facility's E-Kit 1, which could potentially place residents at risk of receiving care by an impaired individual and/or unavailable medication. A review of the facility's Initial Investigation regarding Missing Medications dated 6/10/2024 indicated, at approximately 2:30 p.m. (6/10/2024), the Director of Nursing (DON) was notified of possible missing medication. Audits revealed eight pills of Morphine Sulfate were missing from one E-Kit (E-Kit 1). A review of the facility's three Controlled Sign in Sheets (a document of form used by nursing staff to keep track of and document the administration and inventory of narcotic medications within a healthcare facility) for Incoming and Outgoing Nurses dated 6/2024, indicated licensed nurses' signature/initials were missing from each of the three Controlled Sign in Sheets, indicating controlled substances were not counted in the respective medications carts and/or the E-Kit was not monitored, as follows: 1. Controlled Sign in Sheet 1 - five signatures were 2. Controlled Sign in Sheet 2 - six signatures were missing 3. Controlled Sign in Sheet 3 - 18 signatures were missing During a telephone interview on 6/13/2024 at 11:43 a.m., Licensed Vocational Nurse (LVN 3) stated on 6/8/2024 he came to work at 3 p.m., and he and LVN 6, who was the outgoing LVN from the 7 a.m. to 3 p.m. shift, checked E-Kit 1, that was located inside a locked compartment inside of Station 1's Medication Cart. LVN 3 stated the E-Kit had a red tag on it, indicating it had been opened. LVN 3 stated he and LVN 6, while reconciling the contents of E-Kit 1, identified that eight Morphine tablets were missing. LVN 3 stated there was no receipt in E-Kit 1 identifying which resident(s) received the Morphine and there was no signature to indicate which staff removed the eight tablets of Morphine. LVN 3 stated controlled medications in the E-Kit should be reconciled before and after each shift to ensure controlled substances were accounted for. During a telephone interview on 6/13/2024 at 12:45 p.m., LVN 6 stated it was the first time she had ever checked the E-Kit in the locked compartment of a medication cart with another licensed nurse. LVN 6 stated whenever she counted the individual controlled medications in the medication cart with another licensed nurse, she and the licensed nurse never checked the E-Kit. During an interview on 6/13/2024 at 2:31 p.m., the DON stated it was the responsibility of the incoming and outgoing licensed nurses to ensure the E-Kit's medications were accounted for before and after the shift to confirm safe storage, timely replacement, and prevention of accidental and/or intentional loss of the controlled medications. The DON stated the licensed nurses must sign the Controlled Sign in Sheets to indicate the count of the controlled drugs, including the E-Ki was conducted. A review of the facility's P/P, titled, "Medication Ordering and Receiving from Pharmacy," updated 8/2020, the P/P indicated the facility's emergency medications which includes antibiotics, controlled substances and products for infusion must be contained in sealed containers and maintained at a designated area, secured with a green seal, denoting the emergency box has not been opened and is intact. The P/P indicated the inventory count of the controlled medications must be updated and if the emergency kit has been opened (red tagged), the outgoing charge nurse must endorse the status of the emergency kit during shift change report for transfer of new medication orders and follow-up of replacement of the emergency kit. A review of the facility's P/P, titled, "Medication Storage in the Facility," updated 8/2019, indicated a controlled substance accountability record for all controlled medications, including those in the emergency supply must be completed upon dispensing or receipt of a controlled substance or use of a controlled substance form the emergency supply and at each shift, or when keys are transferred, a physical inventory of all controlled substances, including the emergency supply, is conducted by two licensed nurses and is documented. The facility failed to: 1. Ensure licensed nurses monitored E-Kit 1, which was located inside a locked compartment of a Medication cart on Nursing Station 1, to ensure the contents of the E-Kit was accurate, by signing/initialing that it was monitored. 2. Ensure licensed nurses adhered to the facility's Policy and Procedure, (P/P), titled, "Medication Ordering and Receiving from Pharmacy," and "Medication Storage in the Facility," that indicated, if the E-Kit had been opened (red tagged), the outgoing charge nurse must endorse the status of the emergency kit during shift change, and a physical inventory of all controlled substances, including the emergency supply, was conducted by two licensed nurses. This deficient practice resulted in the loss or diversion (when a medication is taken for use by someone other than whom it was prescribed or for an indication other than what it was prescribed) of eight tablets of Morphine Sulfate from the facility's E-Kit 1, which could potentially place residents at risk of receiving care by an impaired individual and/or unavailable medication. This violation presented a direct cause or is likely to cause significant serious safety and well-being concerns for all the residents of the facility and the community.