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:
A facility failed to reconcile liquid controlled narcotics during a shift change count. An RN counted only the pill narcotics in the locked med cart box and left 7 bottles of liquid controlled meds uncounted, stating liquid morphine was hard to count. Other staff, including the DON and consulting pharmacist, confirmed that all controlled meds, including liquids, should be reconciled shift to shift per policy.
Incorrect Medication Route Transcribed on MAR: A resident with cerebral infarction, dysphagia, and gastrostomy status had an order for acetaminophen 650 mg by mouth PRN pain, but the MAR reflected the route incorrectly. During observation, the resident received medications through the G-tube, and the LVN stated she had transcribed the wrong route into PCC even though the resident was NPO. The DON stated new orders are transcribed by the charge nurse and reviewed by nurse managers.
A resident with cognitive intactness, wheelchair use, and multiple diagnoses had groin redness and a provider order for nystatin powder, but staff also kept an unlabeled bottle of 2% miconazole nitrate at the bedside without a provider order. Staff and the resident described self-administration, yet the TMA documented the ordered nystatin as given even though she later said it remained in the cart and was not administered, and staff were unclear about which antifungal powder was being used.
Failure to Monitor Controlled Narcotics in E-kit: The facility failed to monitor controlled narcotic medications in an E-kit stored in a med cart. RN-A stated the plastic numbered tag on the E-kit was not checked daily or documented, and both RN-A and TMA-A said there would be no way to know if the kit had been opened and narcotics removed until the kit was accessed for needed meds. The E-kit contained controlled meds including tramadol, hydrocodone/APAP, lorazepam, and morphine solution, and the DON stated staff should have been monitoring the tag number.
A resident with diabetes had insulin glargine documented as held on multiple occasions even though the DON stated it was administered as ordered, and a second resident's PRN Norco was signed out on the controlled drug record but not documented on the MAR. Facility policy required medications to be given per MD order and controlled meds to be documented on both the accountability record and MAR.
An LVN prepared medications for two residents on one tray and intended to administer them one after the other, rather than for one resident at a time. One resident had osteoarthritis and the other had liver cancer; both were cognitively intact and required substantial to maximal assistance with ADLs. During observation, the LVN carried two medication cups and water into the roommates’ room, gave one resident’s medication while the other was busy, and stated she saw no issue with preparing and administering both residents’ medications together. The DON stated medications should be prepared and given to one resident at a time, and facility policy said medications are administered when prepared and are not pre-poured.
Failure to Reconcile Liquid Controlled Narcotics During Shift Change
Penalty
Summary
The facility failed to reconcile liquid controlled narcotic medications in 1 of 2 medication carts during the shift change narcotic count. During observation and interview, RN-B counted the narcotic pills in the locked box of the medication cart while LPN-A confirmed the pill count, then RN-B locked the box and cart without picking up or confirming the amounts of 7 bottles of liquid narcotic medications also stored in the locked box. RN-B stated the liquid morphine was not counted because it is hard to tell as a liquid, although the facility documented administration of the liquid narcotics in the narcotic book. The unreconciled medications included liquid morphine, codeine solution, and lorazepam solution for residents R7, R8, R23, R26, R36, and R53. Interviews with other nursing staff, the DON, the regional clinical service director, and the consulting pharmacist confirmed that all controlled medications, including liquid narcotics, should be reconciled shift to shift. Staff stated that everything in the locked box should be counted to confirm the correct amount remained, and the DON identified that nurses should count all narcotics between two staff members. Review of the facility's controlled medication policy stated that all controlled medications are to be verified when delivered and that each time the keys secure the controlled medication locked box, the oncoming and off-going nurse or medication aide should reconcile all controlled medications to ensure the count matches the remaining amount listed.
Incorrect Medication Route Transcribed on MAR
Penalty
Summary
The facility failed to provide pharmaceutical services to meet the needs of Resident #35 by inaccurately transcribing a physician-ordered medication onto the Medication Administration Record. Resident #35 was an adult male admitted with diagnoses including cerebral infarction, dysphagia of the oropharyngeal phase, and gastrostomy status, and his care plan identified that he required tube feeding related to stroke. His orders included NPO status and an order for acetaminophen 325 mg tablets, 2 tablets by mouth every 6 hours as needed for pain. During observation of medication administration, the resident did not receive acetaminophen, and scheduled medications were administered through the gastrostomy tube. Record review showed the MAR documented acetaminophen 650 mg as given, but the route was reflected incorrectly. The LVN who received the original order stated she had accidentally marked the wrong route when transcribing it into PCC and that she administered the dose through the gastrostomy tube because the resident was NPO. The DON stated the charge nurse is responsible for transcribing new physician orders into PCC right away and that the incorrect route was missed during review.
Medication Given and Documented Without Proper Order
Penalty
Summary
The facility failed to follow provider orders for medication and failed to ensure medication administration was correctly documented for one resident who was cognitively intact, used a wheelchair, and had diagnoses including bilateral subdural hematomas related to a fall, congestive heart failure, and chronic kidney disease. The resident was occasionally incontinent of urine and required moderate assistance with lower body dressing and toileting. A nursing progress note documented redness in the groin related to moisture, and the provider later ordered nystatin external powder to the groin three times daily for 14 days for candidiasis related to rash and other nonspecific skin eruption. Despite that order, the resident’s record did not contain a provider order for 2% miconazole nitrate powder. Surveyors observed a container of 2% miconazole nitrate antifungal powder on the resident’s bedside table on two occasions, and the container did not have a pharmacy prescription label. The resident stated staff had given him the powder and that he could use it as needed, while a nursing assistant stated staff were supposed to help apply it but the resident preferred to do it himself and refused staff assistance or removal of the medication from the room. During interviews, nursing staff stated orders should be in the system for all medications, including topicals and self-administered medications. A review of the MAR showed the nystatin powder was documented as administered, but the TMA later stated it had remained in the cart that morning and was not given, and that she charted it as administered after the resident said he would do it later and later told her he had done it himself. The TMA also produced a separate bottle of 2% miconazole nitrate from the medication cart and confused it with the nystatin order, while the DON stated no medications should be administered without a provider order and that medication administration should be documented accurately.
Failure to Monitor Controlled Narcotics in E-kit
Penalty
Summary
The facility failed to monitor controlled narcotic medications in 1 of 1 emergency kits (E-kits) to prevent potential diversion. During observation and interview, the E-kit was found stored in the medication cart, with a small plastic E-kit box inside a locked box on the cart containing controlled narcotic medications. RN-A stated the nurses did not monitor the plastic numbered tag on the E-kits daily, and the tag was not documented anywhere to confirm the correct tag remained in place. Both TMA-A and RN-A stated there would be no way to know if someone had opened the E-kit and removed narcotics until the nurse accessed it for needed medication, and RN-A acknowledged the kit and the smaller box were not opened regularly, so medication could be missing for quite some time before anyone would notice. Review of the E-kit medication list showed controlled narcotics including Tramadol 50 mg, Hydrocodone/APAP 5/325 mg, Lorazepam 0.5 mg, and Morphine solution 20 mg/ml. The DON stated staff should have been monitoring the number on the plastic tag of the E-kit and the E-kit located inside the locked box on the medication cart, and a policy on monitoring controlled narcotic medications was requested but not provided.
Medication Administration and Controlled Drug Documentation Errors
Penalty
Summary
Pharmaceutical services were not provided in accordance with physician orders for two residents. For one resident with diabetes mellitus, the physician ordered insulin glargine 27 units subcutaneously at bedtime and regular human insulin before meals and at bedtime per sliding scale. The order summary did not include any hold parameters for insulin glargine, yet the MAR showed the insulin glargine dose was held on multiple dates in July 2026. On those same dates, the regular human insulin was held appropriately based on the documented blood sugar values. During interview and record review, the DON acknowledged the insulin glargine doses were shown as held on the MAR but stated the medication had been administered as ordered. For another resident, the physician ordered hydrocodone-acetaminophen 5-325 mg, one tablet by mouth every four hours as needed for severe pain, not to exceed 3 g in 24 hours. The facility's controlled medication record showed one tablet was dispensed and signed out, but the MAR did not show documentation that the dose was administered. The resident's H&P indicated the resident had the capacity to understand and make decisions. An LVN and later the DON reviewed the record and verified that the medication had been pulled and that there was no documented evidence on the MAR. Facility policy required medications to be administered according to physician orders and required controlled medications to be documented on both the accountability record and the MAR at the time of administration. The survey findings showed that insulin glargine was documented as held on the MAR despite the DON stating it had been given, and that a controlled pain medication was signed out but not documented as administered on the MAR.
Medication Prepared for Two Residents on One Tray
Penalty
Summary
The facility failed to ensure that an LVN did not prepare medication for two residents on one tray with the intent of administering the medications sequentially. Resident 4 had osteoarthritis, intact cognition, and required substantial to maximal assistance with ADLs; his physician’s order included hydrocodone-acetaminophen 10-325 mg, one tablet every 4 hours as needed for severe pain. Resident 5 had liver cancer, intact cognition, and required substantial to maximal assistance with ADLs; her physician’s order included oxycodone HCl 5 mg every eight hours for pain. During a medication administration observation, the LVN was seen carrying two medication cups, each with one pill, and two cups of water on one tray to the roommates’ room. When Resident 5 was being transferred from a wheelchair to the bed, the LVN stated she would administer Resident 4’s medication first and return later for Resident 5’s medication. The LVN stated she knew both residents well and saw no issue with preparing and administering their medications together. The DON stated medications should be prepared and given to one resident at a time because preparing medication for multiple residents simultaneously could result in giving the wrong medication to the wrong resident. The facility policy stated medications are administered at the time they are prepared and are not pre-poured, and medications are administered without necessary interruptions.
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