395395
10/08/2024
River's Bend Health & Rehab Center
800 King Russ Road Harrisburg, PA 17109
F 0755
Level of Harm - Minimal harm or potential for actual harm
Residents Affected - Some
Provide pharmaceutical services to meet the needs of each resident and employ or obtain the services of a licensed pharmacist.
Based on clinical record review, facility document review, and staff interview, it was determined that the facility failed to ensure a system of recording the disposition of all controlled drugs in sufficient detail to enable accurate reconciliation and to ensure an account of all controlled drugs is maintained and periodically reconciled for prompt identification of loss or potential diversion of controlled substance for one of three residents reviewed (Resident 1).
Findings include: Review of facility policy, titled 5.3 Storage and Expiration Dating of Medications and Biologicals, last revised August 1, 2024 stated, 18. Controlled Substance Storage: 18.1(2)Controlled medications must be counted with another designated staff member when there is an exchange of keys. Review of Resident 1's clinical record revealed diagnoses that included dementia (progressive, irreversible degenerative disease of the brain that results in decreased contact with reality and decreased ability to perform activities of daily living) and anxiety disorder (excessive and uncontrollable feelings of worry and/or fear). Review of Resident 1's physician orders revealed an order for lorazepam (schedule IV controlled substance) 0.5 milligrams (mg - metric unit of measure) by mouth every six hours for anxiety. Review of Resident 1's Controlled Medication Utilization Record, revealed that on June 10, 2024, the facility received 120 tablets of lorazepam 0.5 mg for administration. Review of the form revealed it provided space for licensed nursing staff to document each administration of Ativan including the date and time the medication was prepared/administered, the amount of tablets prepared/administered, the number of pills that remained, and an area for the licensed staff to sign. Further review of the aforementioned Controlled Medication Utilization Record, revealed that the amount of pills that remained from administrations on June 19, 2024, at 12:00 PM, to June 23, 2024, at 6:00 AM was altered. The original number of pills remaining was written as 85 and then was written over top of to look like a 65, which represented a loss of 20 controlled medication pills. Review of the written over numbers, it appeared that numbers 85 through 58 that black ink was used, at times, over original blue ink. Further, some numbers were not legible as a result of writing over original numbers.
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395395
10/08/2024
River's Bend Health & Rehab Center
800 King Russ Road Harrisburg, PA 17109
F 0755
Level of Harm - Minimal harm or potential for actual harm
Review of the Controlled Medication Utilization Record revealed that licensed staff documented an additional 46 administrations after the document was suspected of being altered. The administrations after alteration took place between June 23, 2024 and July 7, 2024. At no time during the aforementioned period of staff accessing the altered document did staff identify a possible diversion of a controlled substance by transposing the wrong, lessened number.
Residents Affected - Some Review of Resident 1's clinical record revealed that Resident 1 resided on H-Hall unit. Review of Controlled Medication Shift Reconciliation sheet for May 2024 and June 2024, H hall revealed the following: Controlled medication shift reconciliation sheet labeled May 2024 for Nursing Unit: H-Hall, was not completed for nine of 31 days (partial shifts). Controlled medication shift reconciliation sheet labeled June 2024 for Nursing Unit: H-Hall, was not completed for six of 30 days (partial shifts). Controlled medication shift reconciliation sheet labeled June for Nursing Unit GH, was not completed for 16 of 30 days (partial shifts). At no time during the aforementioned controlled substance reconciliation (completed at shift change) did staff identify that medications may have possibly been diverted from Resident 1's lorazepam medication. On September 3, 2024, facility staff attempted to refill Resident 1's exhausted supply of lorazepam 0.5 mg tablets, however, the pharmacy alerted the facility staff that Resident 1's prior amount should not have been exhausted as of September 3, 2024. Only at that time, did facility staff identify a possible diversion of medication. As a result of the facility investigation, the facility identified an additional diversion of lorazepam of Resident 1. Review of facility documentation revealed that on May 18, 2024, the facility received 120 pills of lorazepam 0.5 mg for Resident 1. Review of available documentation revealed the facility was unable to locate the Controlled Medication Utilization Record for lorazepam 0.5 mg tablets that would have documented the preparation/administration of pills 120 down to pill 31. The missing Controlled Medication Utilization Record form(s) would have been for dates between May 18, 2024, and May 31, 2024. The least possible amount of diverted medication identified would have been a total of 38 pills of lorazepam 0.5 mg. Review of the facility's response to the investigation of controlled substance diversion revealed the facility did not have a documented response or staff education of altering originally transcribed amounts of controlled medications. During an interview with the Nursing Home Administrator on October 8, 2024, at approximately 12:45 PM, it was revealed that it was the facility's expectation that staff would identify and report when the count numbers of controlled substances appear altered or written over. During the staff interview, it was revealed that staff are to account for all controlled medications with a second licensed
395395
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395395
10/08/2024
River's Bend Health & Rehab Center
800 King Russ Road Harrisburg, PA 17109
F 0755
staff member when ever there is a change in shift and/or when the access keys are transferred from one staff member to another.
Level of Harm - Minimal harm or potential for actual harm
As of October 8, 2024, at 4:00 PM, the facility had no further information to provide.
Residents Affected - Some
28 Pa code 201.18(b)(2)(3) Management 28 Pa code 211.9(j.1)(5) Pharmacy services 28 Pa code 211.12(d)(1)(5) Nursing services
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