Other·September 15, 2023

T22 § 72523. 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. § 72353. Pharmaceutical Service - General. (a) Arrangements shall be made to assure that pharmaceutical services are available to provide patients with prescribed drugs and biologicals. (b) Dispensing, labeling, storage and administration of drugs and biologicals shall be in conformance with state and federal laws. § 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. F755 §483.45 Pharmacy Svcs/Procedures/Pharmacist /Records Pharmacy Services The facility must provide routine and emergency drugs and biologicals to its residents, or obtain them under an agreement described in §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 8/3/23 at 12:30 pm, an unannounced visit was conducted at the facility to investigate a Facility Report Incident (FRI) regarding quality of care and pharmacy services that involved Patient 1. As a result of the investigation, the Department determined that the facility failed to maintain a system-wide method of accountability for controlled medications (medication with a high risk of abuse or theft) in accordance with the policy and procedure, titled “Controlled Substances” revised April 2019 and “Administering Medication” revised April 2019 and failed to: 1. Ensure the Controlled Drug-Count Records (the title of the document the facility uses for the controlled medication reconciliation [a process of counting all the controlled medication in the medication cart between the nurse leaving and the nurse coming on duty to determine if there are any discrepancies]) were signed by two nurses coming on duty and going off duty between shift changes from 6/3/23 and 8/2/23, totaling 102 times for three of three sampled medication carts (Medication Carts 1, 2, and 3). 2. Ensure the Director of Nurses (DON) maintain adequate oversight of Patient 1’s Norco (a controlled medication used to treat pain) 5/325 mg (mg – a unit of measure for mass) “Record Controlled Substances” (a log containing the date, time, and nurse’s signature for all administered doses of a specific supply of a controlled medication) corresponding to the facility’s pharmacy delivered supplies of Patient 1’s Norco 5/325 mg, dated 7/16/23, during the licensed nurses daily controlled medication reconciliation between 7/16/23 to 8/2/23. As a result of these deficient practices, the facility was unable to account for 28 doses of Norco 5/325 milligrams for Patient 1. In addition these deficient practices increases the risk of diversion (the illegal distribution or abuse of prescription drugs or their use for purposes not intended by the prescriber) of controlled medications, staff working in an impaired state, increases the risk that medications are not available to patients when needed, and potential for accidental exposure to controlled substances for 94 of 94 total patients (facility census on 8/4/23) residing in the facility, resulting in respiratory depression (the inability to breathe) leading to hospitalization or death. A review of Patient 1’s Face Sheet, dated 8/3/23, indicated Patient 1 was admitted to the facility on 6/1/23 with diagnoses including essential hypertension (high blood pressure) and muscle weakness. A review of Patient 1’s Minimum Data Set (MDS – a comprehensive patient assessment tool) indicated the patient’s cognition (thought process) was moderately impaired. A review of Patient 1’s History and Physical note (H&P – the formal document that physicians produce through the interview with the patient, the physical exam, and the summary of the testing either obtained or pending) dated 6/3/23, indicated Patient 1 had the capacity to understand and make decisions. A review of Patient 1’s physician order dated 6/9/23 indicated the physician prescribed Norco 5/325 mg to take one tablet by mouth every six hours as needed for moderate pain (pain score 4 to 6). A review of Patient 1’s eMAR (electronic Medication Administration Record), for the month of August 2023 and printed 8/3/23, indicated one dose of Norco 5/325 mg was given to Patient 1 on 8/1/23 at 10:58 PM and no additional doses were given on 8/2/23. A review of Patient 1’s Care Plan, dated 6/1/23, indicated Patient 1 was at risk for chronic (frequent) pain due to neuropathy (nerve pain), arthritis (inflammation of the joint) in her left knee and bursitis (inflammation of tissue that cushions bones, tendons, and muscles near joints) in her left knee with interventions to monitor for pain every shift and administer Norco 5/325 mg every 6 hours as needed. A review of a pharmacy delivery receipt, dated 7/16/23, indicated a previous delivery was made to the facility for 60 tablets of Norco 5/325 mg on 7/16/23 timed at 1:23 AM for Patient 1. A review of the pharmacy delivery receipt dated 8/2/23, indicated 30 tablets of Norco 5/325 mg (replacement supply) were delivered to the facility on 8/2/23 timed at 10:30 PM for Patient 1. On 8/3/23 at 3:29 PM, during an interview, the DON stated Licensed Vocational Nurse (LVN) 1 was assigned on the morning shift (7 AM to 3 PM) on 8/2/23 and LVN 2 was assigned on the preceding night shift of 8/1/23 (11 PM to 7 AM) to Station 2’s Medication Cart 2. The DON stated that at the start of LVN 1’s morning shift on 8/2/23 (7 AM to 3 PM shift) around 9 AM, LVN 1 notified her that there were “14 tablets” of Norco 5/325 mg missing from Patient 1’s controlled medications supply. The DON stated she looked for Patient 1’s Norco 5/325 mg medications in Medication Cart 2, all other medication carts, and medication storage rooms in the facility but could not locate the medications. The DON stated she contacted the pharmacy to provide a replacement supply of Norco 5/325 mg, on 8/2/23. The DON stated the facility’s pharmacy authorized one dose of Norco 5/325 mg from the controlled medication emergency kit (e-kit) and advised that the facility pharmacy would provide a replacement supply of Patient 1’s Norco 5/325 mg. The DON stated the newly ordered replacement supply of Norco 5/325 mg was delivered to the facility on 8/2/23 at around 11 PM. During the same interview, on 8/3/23 at 3:29 PM, the DON stated that the facility’s pharmacy had delivered Norco 5/325 mg supplies with pharmacy delivery receipt dated 7/16/23. The DON stated Patient 1’s “Record of Controlled Substances” that corresponds to the missing supply of Patient 1’s Norco 5/325 mg delivered on 7/16/23 was also missing. During the same interview, on 8/3/23 at 3:29 PM, the DON stated LVN 1 and LVN 2 stated they signed the “Controlled Drugs – Count Record” but did not perform the controlled medication reconciliation for Medication Cart 2 together, as indicated in the facility’s policy, during LVN 1 and 2’s shift change (8/2/23 at 7 AM). During the same interview, on 8/3/23 at 3:29 PM, the DON stated LVN 3 administered the last known dose of Norco 5/325 mg from the missing supply (pharmacy delivery dated 7/16/23) on 8/1/23 at around 9 PM. The DON stated LVN 3 worked on 8/1/23 during the 3 PM to 11 PM shift and was also assigned to Medication Cart 2. The DON stated on 8/1/23 at around 11 PM, when LVN 3 was ready to leave the facility at the end of the shift, LVN 2 who was scheduled to work the 11 PM to 7 AM shift, had not yet arrived at the facility. The DON stated LVN 3 performed a controlled medication reconciliation with Registered Nurse (RN) 1 who was scheduled during the same at around 11 PM. The DON stated RN 1 later (unknown time) performed a controlled medication reconciliation for Medication Cart 2 with LVN 4 who was assigned as a charge nurse team leader during the 11 PM to 7 AM shift on 8/1/23. The DON stated LVN 4 (11 PM to 7 AM shift) and LVN 2 (11 PM to 7 AM shift) performed a controlled medication reconciliation for Medication Cart 2 “at some point” prior to leaving the facility at approximately 7 AM on 8/2/23. On 8/3/23 at 4:20 PM, during an interview, LVN 3 stated she was assigned to Medication Cart 2 on 8/1/23 for the 3 PM to 11 PM shift. LVN 3 stated that on 8/1/23, LVN 3 performed a controlled medication reconciliation with RN 1 around 10:50 PM because her shift was nearing its end, and LVN 2 (11 PM to 7 AM shift LVN) had not yet arrived at the facility. LVN 3 stated she provided one dose of Norco 5/325 mg to Patient 1 around 10:45 PM on 8/1/23. LVN 3 stated, after arriving on her shift (3 PM to 11 PM) the next day, on 8/2/23 around 3:20 PM, LVN 3 performed a controlled medication reconciliation with the DON because Patient 1’s Norco 5/325 mg had been reported missing earlier that day. LVN 3 stated there was no Norco 5/325 mg available for Patient 1 during her shift that day, on 8/2/23. LVN 3 stated she assessed Patient 1 for pain during her shift around 4 PM or 5 PM and Patient 1 indicated her pain level was 4 to 5/10 (pain score on a scale from 0 to 10 where 0 is no pain and 10 is the worst possible pain). On 8/4/23 at 10:39 AM, during a telephone interview with the Pharmacy Manager (PM), PM stated LVN 1 called the facility pharmacy at around 9 AM on 8/2/23 and stated Patient 1’s Norco 5/325 mg was missing. PM stated the pharmacy processed a refill of the Norco 5/325 mg which was delivered later that evening and provided the access code to the controlled medication e-kit for immediate use. PM stated he was unaware whether the facility utilized any Norco 5/325 mg from the e-kit. On 8/4/23 at 10:52 AM, during a telephone interview, LVN 1 stated she worked on 8/2/23 during the 7 AM to 3 PM shift but did not arrive until right before 8 AM. LVN 1 stated LVN 2 (previous shift [11 PM to 7 AM]) had already left by the time she arrived at the facility, so LVN 1 did not count the controlled medications with any other nurses. LVN 1 stated she would not have known at that time if Patient 1’s controlled medication supply of Norco 5/325 mg for Patient 1 was missing because the corresponding “Record of Controlled Substances” document was also missing. LVN 1 stated she administered Tylenol to Patient 1 for pain level assessed at 2/10 pain at around 9 AM. LVN 1 stated she searched Medication Cart 2 to determine whether the Norco 5/325 mg was available in case the Tylenol was ineffective. LVN 1 stated she could not find Patient 1’s Norco medications. LVN 1 stated she immediately informed the DON that Patient 1’s Norco 5/325 mg were missing. LVN 1 stated the DON proceeded to search Medication Cart 2 and all other facility carts and medication storage rooms but was unable to locate the medication. LVN 1 stated she failed to document that Patient 1’s Norco 5/325 mg was missing in Patient 1’s progress notes on 8/2/23. LVN 1 stated she performed a controlled medication reconciliation with LVN 3 before leaving from her shift around 3 PM on 8/2/23. LVN 1 stated she failed to perform controlled medication reconciliation with LVN 2 when she started her shift in the morning, on 8/2/23. LVN 1 stated it was important to ensure the controlled medication counts were correct to ensure the availability of the medications for the Patients. LVN 1 stated if controlled medications are missing, there was a chance Patients could experience medical complications like increased pain or accidental exposure which could cause decreased quality of life. On 8/4/23 at 12 PM, during a concurrent observation and interview in Patient 1’s room, Patient 1 was observed sitting up on her bed. Patient 1 stated that on 8/2/23 she requested Norco 5/325 mg for “severe” pain at 4:45 PM and at 11 PM. Patient 1 stated she was told by the licensed nurses (could not recall which licensed nurse) at both times the facility was “out of the Norco.” Patient 1 stated she did not remember which specific licensed nurse attended to her at those times. Patient 1 stated her pain was worsened because she did not receive her pain medication at those times, and she was supposed to be able to get the Norco every six hours. Patient 1 stated she would describe her pain at that time as “severe.” Patient 1 stated she never asks the licensed nurses for Tylenol. Patient 1 stated sometimes licensed nurses tell her they will have to come back with her Norco because “we keep them in a different place.” A review of the facility’s “Controlled Drug - Count Record” for Medication Cart 1 indicated the document was not signed a total of 28 times between 6/1/23 to 8/2/23. A review of Patient 1’s eMARs (printed 8/3/23) dated July and August 2023, indicated the following information: A review of Patient 1’s July 2023 MAR indicated Patient 1 received a total of 31 doses of Norco 5/325 mg between 7/16/23 (the date the previous supply of Norco 5/325 mg was received from the pharmacy) to 7/31/23. A review of Patient 1’s August 2023 MAR indicated Patient 1 received a total of 1 dose of Norco 5/325 mg on 8/1/23 to 8/2/23 (the date the Norco 5/325 mg goes missing). A review of Patient 1’s July and August 2023 MARs indicated that between 7/16/23 (the date the previous supply of Norco 5/325 mg was received from the pharmacy) to 8/2/23 (the date the Norco 5/325 mg goes missing) indicated a total of 28 doses out of the 60 doses of Norco 5/325 mg supply of Patient 1’s Norco 5/325 mg were unaccounted for. A review of the facility’s “Controlled Drug - Count Record” for Medication Cart 2 indicated the document was not signed for a total of 13 times between 6/1/23 to 8/2/23. A review of the “Controlled Drug - Count Record” for Medication Cart 3 indicated the document was not signed for a total of 61 times between 6/1/23 to 8/2/23. A review of the “Controlled Drug - Count Record” for Medication Carts 1, 2, and 3 indicated the documents were not signed for a total of 102 times, facility-wide between 6/1/23 to 8/2/23. On 8/4/23 at 12:48 PM, during a telephone interview, LVN 2 stated she was assigned to Medication Cart 2 on the night shift on 8/1/23. LVN 2 stated she arrived at the facility at around 12:10 AM and did not count the controlled medications with anyone at the time. LVN 2 stated LVN 3 was assigned to Medication Cart 2 for the previous shift (3 PM to 11 PM) but already left the facility. LVN 2 stated she counted everything that was in her lockbox inside Medication Cart 2 by herself but did not count any of Patient 1’s Norco. LVN 2 stated all of Patient 1’s supplies of Norco in Medication Cart 2 had been removed from Medication Cart 2 and relocated inside Medication Room 1 and put into a lock box there. LVN 2 stated this change occurred about a month ago at t