F0755

K

Failure to Reconcile and Verify Methadone Doses from External Opioid Treatment Programs

Bronx, New York Survey Completed on 02-24-2026

Penalty

No penalty information released

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.