Ellicott Center for Rehabilitation and Nursing
February 7, 2025 Complaint Survey

Standard Health Citations

FF15 483.45(a)(b)(1)-(3):PHARMACY SRVCS/PROCEDURES/PHARMACIST/RECORDS

REGULATION: §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.

Scope: Widespread
Severity: Potential to cause more than minimal harm
Citation date: April 24, 2025
Corrected date: N/A

Citation Details

**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, interview, and record review conducted during an Abbreviated (#NY 834) survey completed on 2/7/25, the facility did not provide pharmaceutical services to meet the needs of each resident and the facility did not ensure that drug records were in order and that an account of all controlled drugs are maintained and periodically reconciled for four (River View, Harbor View, City View, and Sky View) of four units. Specifically, on 8/19/24, 93 narcotic (medication used to treat moderate to severe pain) medications were unaccounted for on the River View unit. Additionally, on 2/5/25 one narcotic reconciliation book with the keys to a medication cart and narcotic cupboard were left unattended in the River View medication room, and two narcotic reconciliation books with the keys to 2 medication carts and 2 narcotic cupboards were left unattended in the Sky View medication room. Licensed Practical Nurse #1 was observed to have completed a narcotic reconciliation by themselves without the presence of the nurse going off duty on City View. Furthermore, the controlled drug records for all the unit shift to shift counts were not consistently signed off as completed. The findings are: The facility policy titled Controlled Substance Management dated 8/22 documented the medication nurse is responsible for proper storage of controlled drugs in a double door, double locked, double keyed, steel, wall mounted, controlled drug cabinet during non-med pass times and in locked controlled drug compartment of medication cart during med pass times. Additionally, separate records shall be maintained on all controlled substances in the form of a declining inventory record. Such records shall be accurately maintained, and such records shall be reconciled by the incoming and outgoing nurse. Two nurses must count the remaining medication at each shift and any handoff of narcotic keys. 1. The facility Investigation Form dated 8/22/24 documented at approximately 7:15 AM on 8/19/24 Administrative staff were notified several narcotic blister packs were missing from the River View medication room. Licensed Practical Nurse #2 arrived for the day shift on 8/19/24, Licensed Practical Nurse #3 had left the facility prior to completing a narcotic reconciliation with the incoming nurse. Licensed Practical Nurse #2 completed the narcotic reconciliation alone and discovered 5 narcotic blister packs were missing. The following narcotic medications were missing: -[MEDICATION NAME] 10/325 mg (milligrams) 10 tablets. -[MEDICATION NAME] 5 mg (milligrams) 7 tablets. -[MEDICATION NAME] 5/325 mg (milligrams) 47 tablets. -[MEDICATION NAME]/[MEDICATION NAME] 7.5/325 mg (milligrams) 29 tablets. The facility investigation documented the keypad to access River View medication room was not functioning and staff were able to access the medication room via employee swipe badge thus bypassing the keypad. The River View maintenance log documented staff reported the lock on the narcotic cupboard was broken. The log notated a lock was ordered on [DATE]. The statement signed and dated by maintenance on 2/5/25 documented the lock on the narcotic cupboard was repaired on 8/19/24, after the narcotics went missing. During an observation of the River View medication room on 2/5/25 at 6:34 AM, one narcotic reconciliation book was observed with the keys to a medication cart and narcotic cupboard placed inside the front cover of each book. During an observation of the Sky View medication room on 2/5/25 at 7:06 AM, two narcotic reconciliation books were observed sitting on the counter with two sets of keys to the medication carts and narcotic cupboards placed next to the narcotic books. During a telephone interview on 2/5/25 at 1:10 PM, Registered Nurse #1 stated they worked on the River View unit in (MONTH) 2024 and the keypad access to the River View medication room was not functioning. Additionally, the lock on one of the narcotic cupboards affixed to the wall was broken. During a telephone interview on 2/6/25 at 6:09 AM, Licensed Practical Nurse #3 stated they worked on the River View unit 8/19/24 until 7:00 AM and instead of counting the narcotic medications with the oncoming nurse, they reconciled the narcotic medications alone. They stated the count was correct when they left the keys in the narcotic book and left the building. Additionally, they stated the locks on the narcotic cabinet were broken. During a telephone interview on 2/5/25 at 10:07 AM, the Registered Nurse Director of Nursing at the time of the incident stated there was a malfunction of the keypad on the River View medication room door on 8/19/24 and employees were able to utilize their badge to access the medication room. Additionally, no staff were able to state how long the keypad had been malfunctioning. Furthermore, they directed maintenance to repair the keypad and the narcotic cupboard lock. During a telephone interview on 2/5/25 at 10:18 AM, the consultant Pharmacist stated narcotics should be store appropriately based on all laws/regulations and double locked. Additionally, it was unacceptable to leave narcotic and medication cart keys in the medication room without reconciling the narcotics with the oncoming shift. 2a. During an observation/interview in the medication room on the City View unit on 2/5/25 at 7:00 AM, Licensed Practical Nurse #1 was observed performing a narcotic count reconciliation with no other nurse present. Licensed Practical Nurse #1 stated the narcotic and medication cart keys were left in the medication room with the narcotic reconciliation book by the nurse from the 11:00 PM - 7:00 AM shift. Additionally, Licensed Practical Nurse #1 stated they frequently count the narcotics alone. 2b. Review of the Shift Count (Narcotic Count Records) from 1/5/25-2/4/25 the following lacked documented evidence that narcotic reconciliation was completed by the oncoming and outgoing nurses: - River View A side cart had 68 shifts - River View B side cart had 55 shifts - Harbor View A side cart had 56 shifts - Harbor View B side cart had 35 shifts - City View A side cart had 40 shifts - City View B side cart had 46 shifts - Sky View A side cart had 77 shifts - Sky View B side cart had 48 shifts During an interview on 2/5/25 at 9:30 AM, the Director of Nursing stated narcotics should be reconciled by the outgoing and incoming nurse prior to the exchange of keys to ensure a correct narcotic count and prevent diversion. Additionally, it was unacceptable to leave the narcotic and medication cart keys in the medication room without performing the narcotic reconciliation with the outgoing and oncoming nurse. During a telephone interview on 2/5/25 at 10:18 AM, the consultant Pharmacist stated narcotics should be store appropriately based on all laws/regulations and it was unacceptable to leave narcotic and medication cart keys in the medication room without reconciling the narcotics with the oncoming shift. Additionally, narcotics should be reconciled every shift to ensure the narcotic count is accurate and to prevent diversion. 10 NYCRR 415.18(a)(b)(3)Based on interview and record review conducted during an Onsite Post Survey Revisit #1 completed on 4/24/2025, the facility did not ensure that drug records were in order and that an account of all controlled drugs was maintained and periodically reconciled for three (Harbor View, River View, and City View) of four resident units. Specifically, the controlled substance records for the unit shift to shift counts were not consistently signed off as completed. This is a continuing deficiency. The finding is: The policy and procedure titled Controlled Substance Management dated 8/2022 documented that separate records shall be maintained on all controlled substances in the form of a declining inventory record. Such records shall be accurately maintained and shall be reconciled by the incoming and outgoing nurse. Review of the controlled substance book for Harbor View Unit Cart A, there were missing signatures from the incoming and outgoing nurses on 4/19/2025. Review of the controlled substance book for River View Unit Cart A, revealed there were missing signatures from the incoming and outgoing nurses on 4/5/2025, 4/17/2025, and 4/22/2025. Review of the controlled substance book for River View Unit Cart B, there were missing signatures from the incoming and outgoing nurses on 4/11/2025 and 4/14/2025. Review of the controlled substance book for City View Unit Cart B, there were missing signatures from the incoming and outgoing nurses on 4/7/2025, 4/11/2025, and 4/19/2025. During an interview on 4/23/2025 at 9:40 AM with Licensed Practical Nurse Nursing Supervisor #1, they stated that the nurses were supposed to sign the controlled substance book after they completed the narcotic count between the incoming and the outgoing nurse. They stated the book should have been signed on those days. During an interview on 4/23/2025 at 10:00 AM with Licensed Practical Nurse Unit Manager #2, they stated that nurses were supposed to sign the controlled substance book when they completed a narcotic drug count for the residents. They said it should have been signed by the nurses. During an interview on 4/23/2025 at 10:10 AM with Licensed Practical Nurse Unit Manager #3, they stated that nurses should count the narcotics and then sign the controlled substance book. They stated that the unit managers were responsible for making sure there were signatures in the book. During an interview on 4/23/2025 at 10:39 AM with the Director of Nursing, they stated that they expected the nurses on the unit to sign the controlled substance book after the narcotics were counted. They stated that they reviewed the controlled substance book every Friday and the controlled substance book should have been corrected. During an interview on 4/24/2025 at 1:36 PM with the Administrator, they stated that they and the Director of Nursing were ultimately responsible for ensuring that the controlled substance books were signed by the nurses. They stated that the unit managers were to monitor the controlled substance books to ensure they were signed by the incoming and outgoing nurses after the narcotic drug count. During an interview on 4/24/25 at 2:40 PM, the Director of Nursing stated that the facility had been cited previously for F755 in the past and that the unit managers need to be auditing the narcotic books on the unit on a daily basis. The Director of Clinical Services was present during the interview and stated that they have noted scattered missing signatures but there was about 60% noted improvement in compliance of staff signatures. The Director of Clinical Services stated that they felt their plan of correction for the F755 effective because there was tremendous improvement but not as fast as they expected. 10 NYCRR 415.18 (b)(3)

Plan of Correction: ApprovedMay 9, 2025

LPN# 1 and LPN #3 were placed on administrative leave, then thereafter were counseled regarding the Controlled Substance Management Policy; LPN#3?ÇÖs counseling emphasized that off-going shift nurse must remain on the unit with the keys until the on-coming nurse arrives and a narcotic count is performed with both nurses and documented in the Narcotic Book(s). It was also emphasized that keys are to be kept with the nurse on shift at all times and can not be left unattended in the medication room or anywhere else at anytime. LPN #2 was counselled to report the off going nurse leaving before counting off narcotics, to supervision right away. Provider assessed residents whose narcotics were missing to ensure there are no adverse effects as a result of the missing medication. Education was provided on the process of handing off keys and signing of Narcotics in relation to, not leaving the unit prior to having a relief, ensuring all signatures are in place and match the narcotic count. No residents were affected by the deficient practice All Narcotics on the units were audited and accounted for; no other issues were identified. No residents were affected by the deficient practice The Controlled Substance Management Policy and Medication Administration policy were reviewed by the DON; no revisions required. All licensed nurses will be educated on the Controlled Substance Management Policy and Medication Administration policy with emphasis placed on the shift-to-shift count process with key hand off and expectation that off going nurse is to remain on the unit with keys on their person until oncoming nurse arrives and count is performed ?Çô keys are not to be left unattended at anytime. Medication competency with licensed nursing staff will be completed to ensure compliance. Unit Managers/Designee will conduct audits on Narcotic reconciliation book on their assigned unit weekly x 4 weeks, then bi-weekly for 2 months. Audit will ensure that medication reconciliation records have two nurse signatures for each shift-to-shift count with no missing entries. Unit Managers/Designee will monitor 1 shift count on each shift twice weekly x 2 weeks, then weekly x 4 weeks to ensure off going nurse and oncoming nurse are counting narcotics appropriately, handing off keys appropriately, and documenting Audit findings will be reported to the QAPI committee for review monthly. Responsible Person: DON