Failure to Reconcile and Verify Methadone Doses from External Opioid Treatment Programs
Summary
The deficiency involves the facility’s failure to establish and maintain a system to accurately reconcile, verify, and oversee methadone medications received from external opioid treatment programs. Facility policies on controlled substance handling, medication administration, and consultant pharmacist services required accurate receipt, logging, and administration of controlled drugs, as well as verification of the five rights of medication administration using the electronic MAR and prescription labels. However, the facility had no policy or procedure specific to methadone received from opioid treatment programs and could not provide any documented agreement outlining coordination with those programs. Surveyors identified 10 residents, all diagnosed with opioid use disorder and various comorbidities such as endocarditis, heart failure, anemia, asthma, coronary artery disease, diabetes, hypertension, cerebral infarction, schizophrenia, benign prostatic hypertrophy, and viral hepatitis, whose methadone administration records showed discrepancies between physician orders and the dosages labeled on methadone bottles. In several cases, the physician’s order reflected a lower dose than the bottle label (for example, 60 mg ordered vs. 70 mg labeled, 115 mg ordered vs. 125 mg labeled, 80 mg ordered vs. 90 mg labeled, 120 mg ordered vs. 130 mg labeled, and 280 mg ordered vs. 295 mg labeled), while in other cases the physician’s order reflected a higher dose than the bottle label (for example, 40 mg ordered vs. 30 mg labeled, 95 mg ordered vs. 85 mg labeled, 30 mg ordered vs. 24 mg labeled, 20 mg ordered vs. 30 mg labeled, and 90 mg ordered vs. 80 mg labeled). Despite these discrepancies, the MARs documented administration of the physician-ordered doses, and controlled drug accountability records, when present, reflected the physician-ordered doses rather than the doses indicated on the clinic-supplied bottles. Interviews with nursing staff and medical providers revealed that methadone from the external clinics was handled without systematic reconciliation against physician orders or clinic documentation. Nurses reported that residents were escorted to methadone clinics, and the escort returned with labeled methadone bottles that were handed to the unit nurse, who logged only the number of bottles in the controlled drug record and stored them in a locked box. Nurses stated they did not receive paperwork from the clinics to verify dosage or changes, did not cross-check the dosage on the bottle against the physician’s order, and often relied only on the resident’s name on the bottle or familiarity with the resident. The attending physician stated that orders were entered by nurses based on the bottle labels and then signed, that they did not receive physical or electronic orders from the clinics, and that they were unsure of the correct methadone dosages but believed residents must receive the dosage indicated on the bottle and that the physician’s order and bottle label did not necessarily need to match. The consultant pharmacist reported that regimen reviews were limited to medications dispensed from the linked pharmacy and that there was no way to verify the correctness of methadone orders from the clinics. The Medical Director acknowledged not knowing the delivery process, stated that clinic reports were signed without review, and later characterized the situation as a system failure. The Administrator stated that nurses were responsible for reconciling physician orders with methadone regimens on the bottles and that attending physicians should have performed monthly record reviews to identify discrepancies. This combination of missing policies, lack of formal agreements, and staff practices resulted in methadone dosages that were inconsistent between physician orders and clinic-labeled bottles for multiple residents. The situation was determined to have caused no actual harm but posed a likelihood for serious harm that constituted Immediate Jeopardy to residents receiving methadone maintenance therapy.
Removal Plan
- The Director of Nursing reviewed all residents receiving methadone from an external opioid treatment program, confirmed residents with dosage discrepancies, and clinically assessed those residents with no signs/symptoms of toxicity or adverse reactions.
- The Director of Nursing contacted each methadone clinic to confirm the current prescribed methadone dose and frequency.
- The Director of Nursing contacted the Medical Director and obtained telephone orders to ensure the physician orders correspond with the doses on the methadone bottles.
- The Pharmacy Consultant completed a regimen review of residents prescribed methadone and confirmed discrepancies were corrected and no other discrepancies were identified.
- The facility created and implemented a new policy and procedure for methadone administration, order verification, reconciliation, and chain of custody, including use of a Reconciliation and Chain of Custody Receipt Form completed by the methadone clinic, reconciliation by the receiving licensed nurse against the facility physician order, escalation/verification steps for discrepancies, documentation in nursing progress notes, and retention of forms in a binder in the nursing office.
- All licensed nurses, attending physicians, the pharmacy consultant, and facility escorts received in-service training on the new policy.
Penalty
Resources
Below are regulatory guidelines relevant to this citation:
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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