Incomplete and Inaccurate Controlled Substance Documentation and Oversight
Summary
The deficiency involves the facility’s failure to maintain complete and accurate records for controlled (scheduled) medications, including shipping manifests, Controlled Drug Records (CDRs), Medication Administration Records (MARs), Automated Dispensing Cabinet (ADC) dispense reports, and destruction logs for multiple residents. The DON and Medical Records Director (MRD) described a system in which controlled medications were delivered with a shipping manifest, signed by the nurse, and stored in the medication cart with a corresponding CDR used to document each removal, while administration was documented on the MAR. However, when surveyors requested all shipping manifests, CDRs, and ADC dispense reports for a defined period, the facility was unable to produce complete documentation, and multiple discrepancies were identified between the various records. During interviews and record reviews, staff nurses and the DON confirmed that the ADC did not generate a receipt or CDR for controlled medications dispensed. An ADC usage report for a specified time frame showed that hydrocodone-acetaminophen tablets were dispensed for two residents, but the DON and MRD were unable to locate any documentation in the medical records showing that these doses were administered or destroyed. For another resident, a shipping manifest documented delivery of 90 oxycodone-acetaminophen tablets, but CDRs accounted for only 60 tablets, and the facility did not have a CDR to account for the remaining 30 tablets. Additional shipping manifests for several other residents showed delivery of various hydrocodone- and oxycodone-containing prescriptions, but the DON stated there were no corresponding CDRs for those manifests. Further comparison of existing CDRs with MARs revealed additional inconsistencies. For one resident, the DON identified a CDR for hydrocodone-acetaminophen tablets and acknowledged that a documented removal on the CDR did not have a matching administration entry on the MAR. For another resident, the DON reviewed a CDR for hydrocodone-acetaminophen and found multiple CDR removals without corresponding MAR administration entries on specific dates and times. For a third resident, the DON confirmed that a CDR removal of hydrocodone-acetaminophen did not have a corresponding MAR administration entry. The DON acknowledged that the facility lacked required shipping manifests and CDRs and that information between CDRs and MARs was inaccurate, despite facility policies on controlled substances and pharmacy services that required controlled substance inventories and related records to be monitored, reconciled, complete, and accurate. The consultant pharmacist’s role and oversight were also implicated in the deficiency. The DON produced the pharmacist’s Medication Regimen Review & Report and Monthly Pharmacy Inspection Reports for selected months within the review period and stated that these reports did not document any issues with incomplete or inaccurate controlled medication records. The DON also reviewed the facility’s policy for the role of the consultant pharmacist, which required the consultant pharmacist to provide consultation on all aspects of pharmacy services and to collaborate with the facility and medical director to develop, implement, evaluate, and revise procedures for pharmacy services. The DON stated it was the facility’s expectation that issues with scheduled medications should have been identified, but the pharmacist inspection reports did not reflect the discrepancies and missing documentation that were later found during the survey. An administrative review of the facility’s Policy for Controlled Substances, revised in November 2022, showed that the policy required controlled substance inventory to be monitored and reconciled to identify loss or potential diversion, and specified that the system of reconciling receipt, dispensing, and disposition of controlled substances must include records of personnel access and usage, MARs, and declining inventory records. Despite these written requirements, the facility’s actual practice, as demonstrated by missing shipping manifests, absent or incomplete CDRs, lack of ADC receipts or CDRs, and mismatches between CDRs and MARs, did not meet the policy standards. The DON acknowledged these discrepancies and confirmed that the facility’s expectation was that all controlled substance documentation be complete and accurate, which was not achieved during the period reviewed. Additionally, interviews with LVN staff highlighted operational gaps in the controlled medication record system. One LVN described the expected process of reviewing shipping manifests and CDRs upon receipt of controlled medications, signing the manifest, securing the medications in the cart, and using the CDR and MAR for ongoing documentation, with completed CDRs sent for retention and remaining medications and CDRs forwarded to the DON upon discontinuation. However, the same LVN reported that the ADC did not provide a receipt or CDR for controlled medications dispensed, creating a gap in the documentation chain. Another LVN identified the location and use of the Rx Now ADC but did not provide evidence of a parallel documentation process to replace the missing ADC receipts and CDRs. These descriptions, combined with the record review findings, demonstrate that the facility’s actual practices did not ensure a complete and accurate record system for controlled substances as required by its own policies. The facility’s policies for controlled substances and the role of the consultant pharmacist, as reviewed during the survey, explicitly required accurate, monitored, and reconciled documentation of controlled substances, including shipping manifests, CDRs, MARs, and records of personnel access and usage. Despite these policies, the survey findings showed that the facility did not maintain all required documents, did not reconcile controlled substance inventories, and did not identify or correct discrepancies between different record sources. The DON acknowledged that the facility did not have the required shipping manifests and CDRs and that there were inaccuracies between CDRs and MARs, and also acknowledged that the pharmacist inspection reports did not identify these issues, even though it was the facility’s expectation that such issues would be detected under the existing policies.
Penalty
Resources
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Insulin Pen Not Primed Before Administration: An LVN administered Lantus to a resident with diabetes without priming the insulin pen first. The resident had orders for Lantus 30 units BID, and the LVN stated he was not familiar with priming the pen. The DON stated the pen should be primed before use to ensure the resident receives the appropriate dose.
A resident with restlessness, agitation, pain, palliative care, and a frontotemporal neurocognitive disorder had mismatched Ativan directions across the physician order, narcotic book, EMAR, and bubble pack card. The LPN, pharmacist, and DON all confirmed the entries should have matched, and the pharmacy card lacked notation for the different tablet strength listed in the EMAR.
Incorrect Sertraline Dose Administered: A resident with major depressive disorder and intact cognition was ordered sertraline 150 mg daily, but an MA administered only 100 mg after noticing the order called for 1.5 tablets and not pausing to clarify the discrepancy. The med label also showed 1 tablet, and the DON/VPCS stated staff should check orders against the MAR before administration; the facility policy required verifying the label and dose.
Expired influenza vaccines were found in the refrigerator of The Arbors medication room during an observation. Nurses stated they were responsible for checking medication rooms for expired meds, but the expired vaccines remained in storage despite staff being told to remove them before expiration. The DON, ADON, and Administrator each identified staff responsibility for checking medication rooms, and the facility policy stated multi-dose vials are discarded according to the manufacturer’s expiration date.
Controlled medications awaiting disposal were found stored in a locked cabinet in the med room, including Pregabalin, Lorazepam, Tramadol, Fentanyl patches, and Morphine. An LVN said the meds had been there for about a week, were not counted after placement, and one Morphine count sheet was missing from the cabinet. The DON said discontinued narcotics were supposed to be brought to her immediately for reconciliation and locked storage, but she had forgotten to retrieve them.
A resident with DM, ESRD, bipolar disorder, and autism had an order for Ritalin 20 mg BID for ADHD, but the medication was not administered for five days and nine scheduled doses were missed. Nursing notes repeatedly documented the drug as pending delivery, pending approval, or pending script, and the MAR showed each dose signed off with Code 9. The physician was not aware the resident had not received the medication, and the DON stated the delay occurred because the facility had to fax the hard copy prescription to the pharmacy.
Insulin Pen Not Primed Before Administration
Penalty
Summary
The facility failed to provide pharmaceutical services to meet the needs of each resident when LVN B administered Lantus insulin to Resident #97 without priming the insulin pen first. Resident #97 was a cognitively intact male with diagnoses that included diabetes, peripheral vascular disease, acquired absence of left toes, and acquired absence of the right leg below the knee. His orders included Lantus 100 unit/mL insulin, 30 units subcutaneously twice daily, and his care plan identified diabetes with interventions for administering medications as ordered. During observation, LVN B obtained the insulin pen from the medication cart, inserted a needle into the rubber seal without cleaning it first, did not prime the pen, dialed the dose to 30 units, and injected the resident. When interviewed, LVN B stated he was not familiar with priming an insulin pen and did not fully know the technology behind priming it, despite having skills training within the year that included insulin use. The DON stated that an insulin pen should be primed before administration and checked for air bubbles because priming ensures the resident receives the appropriate dose. The Lantus package insert also stated to perform the safety test before each injection to ensure an accurate dose.
Medication Transcription Mismatch for Narcotic Order
Penalty
Summary
The facility failed to transcribe medication orders according to standards of practice for medication management for one resident with restlessness and agitation, pain, palliative care, and a frontotemporal neurocognitive disorder. The resident’s physician order for Ativan 0.5 mg solutabs directed that 0.25 mg be given by mouth every 4 hours as needed for restlessness, but the corresponding narcotic book page listed Ativan 5 mg every 4 hours as needed, while the EMAR listed 0.5 mg solutabs with directions to give 0.25 mg by mouth every 4 hours as needed. The bubble pack card for Ativan listed lorazepam 0.25 mg solutab with directions to dissolve 1 tablet by mouth three times a day and dissolve 1 tablet by mouth every 4 hours as needed, and the pharmacy card did not include a sticker or other notation to indicate the different tablet strength listed in the EMAR and not on the card. During observation of the medication cart, the narcotic drawer contained the resident’s Ativan 0.25 mg by mouth card, while the narcotic book page listed Ativan 5 mg every 4 hours as needed and the EMAR listed 0.5 mg solutabs with 0.25 mg by mouth every 4 hours as needed. The LPN confirmed the transcribed locations for the same order did not match and should have. The LPN described the facility process for receiving and transcribing new narcotics, including verification by two nurses and use of the index and narcotic book during counts. The pharmacist confirmed all three areas for the order, narcotic book, and card should match and stated that if there was a change in dose or tablet strength, the card should have had a sticker or other notation, but it did not. The DON stated staff were expected to enter orders received from the pharmacy, have two nurses count and verify the medications, write the correct directions for use in the narcotic book, and compare all areas during narcotic count and medication administration. A policy for medication transcription was requested but not provided.
Incorrect Sertraline Dose Administered
Penalty
Summary
Pharmaceutical services failed to meet the needs of Resident #16 when the facility did not ensure the ordered dose of sertraline was administered. Resident #16 was a [AGE]-year-old female admitted on [DATE] with diagnoses including major depressive disorder, recurrent, unspecified. Her quarterly MDS reflected a BIMS score of 13, indicating intact cognition, and documented that she was prescribed an antidepressant medication. The physician’s order dated 6/25/2026 directed sertraline HCl 100 mg tablets, 1.5 tablets by mouth in the morning for depression, with documentation in the progress notes that the Zoloft dose had been increased from 100 mg daily to 150 mg daily for improved symptom control. During observation on 7/09/2026 at 7:53 AM, MA A prepared medications for Resident #16 and the sertraline package label identified the medication as sertraline HCl 100 mg with instructions to give 1 tablet by mouth in the morning for depression. MA A administered 1 tablet of sertraline 100 mg instead of the ordered 1.5 tablets. In interview immediately afterward, MA A stated she noticed the order said one and a half tablets but was nervous and did not want to pause medication administration to clarify the order before giving the medication. She also stated she was not informed of a change to the sertraline dosage and should notify the nurse if she noticed a discrepancy between the medication order and the label. The VPCS stated staff should check all orders before administering medications and that the potential harm was medication error. The facility policy required staff to check the medication label against the MAR and re-check the dose to confirm the proper dose.
Expired Influenza Vaccines Left in Medication Room Refrigerator
Penalty
Summary
The facility failed to provide pharmaceutical services to ensure the accurate acquiring, receiving, dispensing, and administering of medications for 1 of 2 medication storage rooms reviewed, The Arbors. During an observation on 7/7/2026 at 10:41 am, the refrigerator in the medication room contained 3 boxes of influenza vaccine for the 2025-2026 season, lot #AX615A, that had expired on 6/30/2026. LVN A was present in the medication room and stated nurses were responsible for checking medication rooms daily, but she was not aware the vaccines were expired and said she would discard them. During interviews, RN B stated night shift nurses were responsible for checking medication rooms for expired medications and said she was not aware the expired influenza vaccines were in The Arbors medication room. The ADON stated nurses were responsible for checking medication rooms at night and said she had instructed staff before the end of June 2026 to remove the vaccines, but they were not removed. The DON stated nurses were responsible for daily night shift checks for expired medications and said staff had been told to remove the flu vaccines before they expired, but they did not. The Administrator stated the pharmacist, DON, and ADON were responsible for checking medication rooms and said they should be checked weekly for expired medications. Record review of the facility policy titled Medication Labeling and Storage, revised June 2026, stated that multi-dose vials that are not opened or accessed are discarded according to the manufacturer's expiration date.
Controlled Medications Left Unreconciled in Medication Room
Penalty
Summary
The facility failed to establish a system for the receipt and disposition of controlled drugs in sufficient detail to allow accurate reconciliation and an account of all controlled medications. During an observation in the medication room, controlled medications awaiting disposal were found stored underneath a counter in a locked cabinet that all nurses had a key to, including Pregabalin 25 mg tablets, Lorazepam 0.5 mg tablets, Tramadol 50 mg tablets, Fentanyl 50 mcg patches, and Morphine 100 mg/5 ml. LVN B stated the controlled medications had been under the cabinet for about a week and that discontinued narcotics were supposed to be taken to the DON immediately to be logged and locked in the DON's office. She also stated no one counted the medications once they were placed in the medication room and that the cabinet was missing a count sheet for one Morphine bottle, which she found folded in the narcotic count sheet book. The DON stated her locked area for discontinued narcotic medications was in the ADON's office and that she was the only one with keys. She said she intended to retrieve the discontinued narcotic medications on Monday but forgot, and that her expectation was for nurses to bring discontinued medications to her immediately after removal from the medication cart so she could reconcile them and lock them in her double-locked area. The DON also stated she normally checked with nurses on Monday, Wednesday, and Friday mornings to ensure narcotic medications were reconciled properly. The Administrator stated discontinued narcotic medications should be taken to the DON immediately and that the DON was responsible for ensuring no controlled medications were stored in the medication room.
Delay in Obtaining Ordered Ritalin
Penalty
Summary
The facility failed to provide pharmaceutical services to meet the needs of each resident when it did not ensure timely acquisition and administration of an ordered CNS stimulant medication for one resident. The resident was admitted with diagnoses including Type 2 diabetes, end stage renal disease, bipolar disorder, and autistic disorder. A physician order for Ritalin 20 mg by mouth twice daily for ADHD was entered with a start date of 06/26/2026, but the medication was not administered through 06/30/2026, resulting in a five-day delay and nine consecutive missed scheduled doses. The June 2026 MAR showed each scheduled dose of Ritalin was signed off with Code 9, indicating other, see progress notes, and no doses were given during the review period. Nursing documentation repeatedly noted the medication was pending delivery, pending approval, or pending script, and one note stated the resident was out for dialysis. The resident's initial MDS assessment was still in progress and the initial care plan assessment had not been completed. During interviews, the physician stated he was not aware the resident had not received Ritalin because it was pending from pharmacy and said the effect would be that the resident would not be able to concentrate. An LVN stated that if a medication was unavailable, the physician should be called for a prescription and the DON notified if doses were missed. The ADON stated staff should check the automated medication dispensing system, obtain a retrieval code from the pharmacy, and notify the physician immediately if the medication was unavailable, and acknowledged there had been miscommunication with the pharmacy. The DON stated the nurses were responsible for verifying admission orders and that the five-day delay occurred because the facility had to fax the hard copy prescription to the pharmacy.
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