§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) 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.
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Observations:
Based on review of select facility policy and controlled drug records and observation and staff interview, it was determined that the facility failed to implement pharmacy procedures to promote accurate administration, and records accounting for controlled drugs for five of eight residents sampled (Resident 13, 7, 24, 19, and 8), and reconciliation of controlled drugs on one of two medication carts (North).
Finding include:
A review of the facility policy "Medication ordering, receiving, and storage" (Controlled Substance), and "Medication Storage in the facility" (ID3: Controlled medication storage) last reviewed by the facility October 20, 2023, stated nursing staff must count controlled medications at the end of each shift. The nurse coming on duty and the nurse going off duty will make the count together. They must document and report any discrepancies to the director of nursing services. The director or designee investigates and makes every reasonable effort to reconcile all reported discrepancies. If a major discrepancy, or a pattern of discrepancies occur, or if there is apparent criminal activity, the director of nursing notifies the administrator, medical director, and pharmacy immediately.
During the observation of the medication administration pass, on February 27, 2024, at approximately 8:26 AM, revealed Employee 1, Licensed Practical Nurse (LPN), on the North medication cart. A review of the shift-to-shift accountability form, as identified by Employee 1 (LPN), untitled, for February 2024, for the North Hall, revealed that the on-coming nurse and/or off-going nurse failed to sign the sheets during shift change on the following date to verify that nursing staff counted the controlled drugs in the respective medication cart: February 20, and 21, 2024.
A review of Resident 13's clinical record revealed he was admitted to the facility on May 10, 2023, with diagnoses to include pain. A physician order dated May 17, 2023, was noted for Tramadol (an opioid pain medication) 50 milligram (mg), give 0.5 tablet (25 mg) by mouth every 12 hours for chronic pain.
The "controlled substance record", accounting for Resident 13's supply of Tramadol 50 mg, 0.5 tablet, (25 mg) revealed that on February 23, 2024, at 2100 (9:00 PM), dose given 1, amount remaining 26. However, a closer look revealed the nurse failed to sign the sheet.
Interview with Employee 1, LPN, on February 27, 2024, at approximately 8:30 AM, confirmed the above observations of the shift to shift, and the controlled substance record was not signed and that the expectation is that it should have been signed.
A continued observation of medication administration pass on February 27, 2024, at approximately 8:53 AM, revealed Employee 2, (LPN) on the South Medication cart. A review of Resident 7's clinical record revealed she was most recently admitted to the facility on January 1, 2024, with diagnoses to include anxiety, and pain.
A physician order dated January 25, 2024, was noted for Hydrocodone-Acetaminophen (an opioid pain medication) 10-325 mg, give 1 tablet by mouth every 4 hours for chronic pain.
The "controlled substance record", accounting for Resident 7's supply of Hydrocodone-Acetaminophen 10-325 mg revealed that on February 22, 2024, at 0400 (4:00 AM), dose given 1, amount remaining 59, February 23, 2024, at 0800 (8:00 AM), dose given 1, amount remaining 58, February 23, 2024, at 1200 (12:00 PM), dose given 1, amount remaining 57, February 23, 2024, at 1600 (4:00 PM), dose given 1, amount remaining 56, February 23, 2024, at 2000 (8:00 PM), dose given 1, amount remaining 55, and February 24, 2024, at 0000 (12:00 AM), dose given 1, amount remaining 54. (The dose given on February 22, 2024, at 0400 [4:00 AM] was incorrectly dated the 22nd, the correct date should have been February 23, 2024).
A physician order dated January 1, 2024, was noted for Lorazepam (antianxiety medication) 1 mg, give 1 tablet by mouth two times a day related to anxiety.
The "controlled substance record", accounting for Resident 7's supply of Lorazepam 1 mg, revealed that on February 17, 2024, at 1620 (4:20 PM), dose given 1, amount remaining 28, February 18, 2024, at 0500 (5:00 AM), dose given 1, amount remaining 27, February 18, 2024, at 1615 (4:15 PM), dose given 1, amount remaining 26, February 18, 2024, at 0500 (5:00 AM). (The previous dose given on February 18, 2024, at 0500 [5:00 AM] was incorrectly dated February 18, the correct date should have been February 19, 2024). February 21, 2024, at 1610 (4:10 PM), dose given 1, amount remaining 20, February 22, 2024, at 0500 (5:00 AM), dose given 1, amount remaining 19, February 22, 2024, at 1550 (3:50 PM), dose given 1, amount remaining 18, and February 22, 2024, at 0500 (5:00 AM), dose given 1, amount remaining 17. (The previous dose given on February 22, 2024, at 0500 [5:00 AM] was incorrectly dated February 22, the correct date should have been February 23, 2024).
A review of Resident 24's clinical record revealed he was most recently admitted to the facility on November 24, 2023, with diagnoses to include cerebral infarction (stroke), dementia (group of symptoms affecting memory, thinking and social abilities), and right sided hemiplegia and hemiparesis (weakness on one side of the body).
A physician order dated September 22, 2023, was noted for Lorazepam (antianxiety medication) 0.5 mg, give 1 tablet via G-tube (feeding tube) every 8 hours with agitation, related to dementia.
The "controlled substance record", accounting for Resident 24's supply of Lorazepam 0.5 mg, revealed that on February 19, 2024, at 0000 (12:00 AM), dose given 1, amount remaining 36, February 19, 2024, at 0900 (9:00 AM), dose given 1, amount remaining 35, February 19, 2024, at 1642 (4:42 PM), dose given 1, amount remaining 34, and February 19, 2024, at 12 AM, dose given 1, amount remaining 33. (The previous dose given on February 19, 2024, at 12 AM was incorrectly dated February 19, the correct date should have been February 20, 2024). And on February 22, 2024, at 0000 (12:00 AM), dose given 1, amount remaining 28, February 22, 2024, at 0900 (9:00 AM), dose given 1, amount remaining 27, February 22, 2024, at 1707 (5:07 PM), dose given 1, amount remaining 26, and on February 22, 2024, at 0000 (12:00 AM), dose given 1, amount remaining 25. (The previous dose given on February 22, 2024, at 0000 (12:00 AM), was incorrectly dated February 22, the correct date should have been February 23, 2024).
A review of Resident 19's clinical record revealed she was most recently admitted to the facility on July 15, 2023, with diagnoses to include anxiety.
A physician order dated March 22, 2023, was noted for clonazepam (antianxiety medication) 1 mg, give 1 tablet by mouth every 12 hours for anxiety.
The "controlled substance record", accounting for Resident 19's supply of clonazepam 1 mg, revealed that on February 10, 2024, at 0915 (9:15 AM), dose given 1, amount remaining 53, February 10, 2024, at 2132 (9:32 PM), dose given 1, amount remaining 52, and on February 10, 2024, at 0930 (9:30 AM), dose given 1, amount remaining 51. (The previous dose given on February 10, 2024, at 0930 (9:30 AM), was incorrectly dated February 10, the correct date should have been February 11, 2024).
A review of Resident 8's clinical record revealed she was admitted to the facility on May 11, 2023, with diagnoses to include chronic pain, anxiety, conversion disorder with seizures or convulsions.
A review of current physician orders dated November 28, 2023, was noted for Pregabalin (a controlled anticonvulsant) capsule 75 mg, give 2 capsules by mouth 1 time a day for restless leg syndrome.
A continued review of current physician orders dated December 13, 2023, revealed Pregabalin capsule 75 mg, give 1 capsule by mouth 1 time a day for chronic pain.
A review of February 2024, Medication Administration Record (MAR), revealed Lyrica (Pregabalin), oral capsule 75 mg, give 1 capsule by mouth one time a day for chronic pain, 0900 (9:00 AM), and Pregabalin oral capsule 75 mg, give 2 capsule by mouth one time a day for restless leg syndrome, 2100 (9:00 PM).
The "controlled substance record", accounting for Resident 8's Pregabalin, stated, Pregabalin (Lyrica) capsule 75 mg, take 1 capsule by mouth once daily and take 2 capsules (150 mg) by mouth at bedtime. Handwritten, in three (3) different locations on the controlled substance record was the words "PM dose", "PM", and "P.M." A closer look revealed that on February 21, 2024, at 2020 (8:20 PM), dose given 1, amount remaining 16, February 21, 2024, at 2008 (8:08 PM), dose given 1, amount remaining 15, (The previous dose given on February 21, 2024, at 2008 (8:08 PM), was incorrectly dated February 21, the correct date should have been February 22, 2024).
The facility failed to identify the discrepancies between the resident's controlled substance records, and the shift-to-shift accountability forms, failing to implement procedures to promote accuracy in administration, and accounting of controlled drugs and decrease the potential for drug diversion.
During an interview with the Director of Nursing (DON) on February 28, 2024, at approximately 12:00 PM, confirmed the above findings, and stated that her expectation is that the controlled substance record accurately reflect the medication accounting/use and administration to the resident, and that at change of shift to demonstrate that they completed the count of the controlled drugs to identify potential discrepancies and that the facility failed to implement procedures reconciliation and accurate controlled drug medication records.
Refer F761
28 Pa. Code 211.19(a)(1)(k) Pharmacy services
28 Pa. Code 211.5 (f) Medical records
28 Pa. Code 211.12 (d)(3)(5) Nursing services
| | Plan of Correction - To be completed: 04/29/2024
1. Medication Reports were completed for the discrepancies noted on the controlled substance records for resident 13, resident 7, resident 24, resident 19 and resident 8. 2. An audit was completed on the controlled substance records for individual residents and the shift-to-shift accountability form to ensure accurate and complete documentation for the past 30 days. 3. Licensed nurses were re-educated on "Medication ordering, receiving and storage/ controlled substances" policy by DON. DON will randomly audit weekly controlled substance records and shift-to-shift accountability forms to ensure that there are no discrepancies. 4. The DON/Designee will audit the Shift-to-Shift Accountability Forms and the Residents' Controlled Medication record for complete and accurate documentation weekly x 4 then monthly x 2. The results of the audit will be reviewed by the QAPI Committee for review and analysis of need for ongoing review.
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