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:
The facility failed to ensure accurate pharmaceutical services for two residents and related medication storage and recordkeeping. An LPN administered a resident’s insulin glargine pen without priming it first, and a controlled medication log for another resident’s hydrocodone-acetaminophen did not match the blister pack count. In addition, a controlled substance reconciliation log for a medication aide cart had been signed before shift change, and an expired IV tubing supply was found in the LTC medication room.
Medication Error Not Investigated or Documented: The facility failed to investigate, document, and address a reported Zepbound medication error for a resident with moderate cognitive impairment and multiple diagnoses. The event report noted a wrong dose, but the record contained no clear explanation of what occurred, no documented root cause investigation, and no documented actions taken; the DON and RN both stated the process was incomplete, and the consultant pharmacist noted the expected documentation and follow-up for medication errors.
Controlled medications were not properly tracked because the narcotic accountability sheets in one medication cart had multiple entries without the required signatures from two nurses. During the audit, RN #1 and the DON both confirmed that two nurses should have signed the narcotic count sheets.
Controlled substance records were not properly maintained for the Hall A and Hall B medication carts because shift-change narcotic count signatures were missing on multiple occasions. LVNs stated that two nurses were not verifying the count by signing the book, and the DON, ADM, and CCN confirmed that missing signatures meant there was no proof the count was completed and accurate. The facility policy required a physical inventory of controlled meds at each shift change by two licensed nurses or an allowed nurse and med aide.
Incorrect Zyprexa Dose Remained Active on MAR: A resident with psychotic disorder and hallucinations had a Zyprexa dose reduced per MD order, but the prior 10 mg order was not discontinued and both the 5 mg and 10 mg doses remained active on the MAR. The MAR showed both doses were administered daily until clarification was entered, and the LVN stated he entered the new order but thought the old order had been discontinued.
A resident with ESRD, DM2, depression, anxiety, bipolar disorder, and parkinsonism did not receive ordered Renvela for an extended period despite an active EMAR order. Review showed repeated hold periods and no doses administered across multiple months, while the dialysis RD said the medication was used for elevated phosphorus and had been filled previously. Staff interviews showed confusion about whether dialysis or the facility pharmacy should refill the medication, and the DON confirmed the medication was not readily available even though it should have been.
Pharmaceutical Services and Controlled Substance Recordkeeping Deficiencies
Penalty
Summary
The facility failed to provide pharmaceutical services to meet resident needs and to ensure drug records were in order for two residents, one medication cart, and one medication room. Resident #8 had diagnoses including heart failure, high blood pressure, high cholesterol, and type 2 diabetes mellitus, and his MDS documented severe cognitive impairment and insulin use. During a medication pass observation, an LVN administered 15 units of Insulin Glargine pen without priming the pen first. The LVN stated priming was important to ensure the pen was working properly and that failure to prime could affect the dose received. Resident #20 had diagnoses including asthma, depression, high cholesterol, high blood pressure, and sciatica, and her MDS documented severe cognitive impairment and active sciatica. During observation of the nurse cart, the controlled medication log for Hydrocodone-Acetaminophen 7.5-325 mg did not match the blister pack count: the log showed 6 tablets should have been available, but the pack contained 5 tablets. The LVN stated the tablet should be logged out immediately after administration. The facility also observed that the controlled medication reconciliation log for the 500 hall medication aide cart had been signed in advance of the next shift change, and the medication aide stated it should not be signed early because the cart could be taken away and something could go missing. During observation of the LTC unit medication room, an expired IV tubing supply was found on the shelves with medication equipment and supplies. The LVN stated expired items should not be in the storage room, and the DON and Administrator both stated expired supplies should not be in the medication rooms. The facility policy for insulin pen use required a safety test before each injection, and the controlled medications policy required immediate documentation after administration and a physical inventory at each shift change.
Medication Error Not Investigated or Documented
Penalty
Summary
The facility failed to ensure a reported medication error involving Zepbound for a resident with moderate cognitive impairment and diagnoses including morbid obesity, cerebral palsy, and obstructive sleep apnea was investigated, documented, and addressed in accordance with facility policy. The resident’s event report identified a wrong dose on 4/22/26, but the report did not identify any investigation into the event or any actions taken to prevent further events, and the medical record contained no further information about the incident. During interviews, the DON stated there was a lapse in the process and that an investigation was not completed. The DON reported staff explained the medication did not come from the pharmacy and that the resident did not receive the dose, although the event report stated wrong dose. RN-A also stated there was no documentation explaining what occurred or what actions were taken. The consultant pharmacist stated staff were expected to complete a thorough root cause investigation and analysis, with follow-up and detailed documentation for any medication error, including resident assessment, physician notification when indicated, monitoring for adverse effects, and measures to prevent recurrence. The facility policy stated that when a medication error occurs, the licensed nurse provides any necessary immediate care and notifies the attending provider and resident or resident representative when nursing or medical intervention, observation, or treatment is indicated, and that medication errors are tracked and trended for quality improvement purposes.
Incomplete Narcotic Count Documentation
Penalty
Summary
Controlled medications were not tracked and kept secure from potential theft and/or diversion because the facility failed to ensure the narcotic accountability sheets were properly signed by licensed nurses. During a medication cart audit, multiple dates were found on the narcotic accountability sheets without a documented on-coming or off-going licensed nurse signature, including several entries in late April, May, and early June. RN #1 stated that two nurses should have signed the narcotic accountability sheet and had not, and the DON also stated that two nurses should have signed off on the narcotic count sheets.
Missing Controlled Substance Count Signatures on Medication Carts
Penalty
Summary
The facility failed to determine that controlled drug records were in order and that an account of all controlled drugs was maintained and periodically reconciled for the Hall A and Hall B medication carts. During record review, the narcotic books for both carts were found to have missing signatures documenting shift-to-shift controlled substance counts. On the Hall A medication cart, signatures were missing on 12/30/2025, 1/1/2026, 1/2/2026, 1/19/2026, 1/26/2026, 1/30/2026, 1/31/2026, 2/12/2026, 3/9/2026, 3/11/2026, 3/26/2026, and 4/2/2026. On the Hall B medication cart, signatures were missing on 5/3/2026 and 5/30/2026. During interviews, LVN G and LVN F stated that two nurses were not verifying the narcotic count by signing the book and that, if the count was off, there would be no way to know who to contact or verify that two nurses had counted the medications. The DON stated that when the narcotic book lacks signatures, the count could be incorrect and directly affect the medications the resident receives. The ADM stated missing shift-count signatures can result in an inaccurate count and lead to missing medication doses for residents. The CCN stated that without the narcotic sheet signatures, there is no physical proof that a medication count was completed and accurate. The facility policy required a physical inventory of controlled medications at each shift change by two licensed nurses or an allowed nurse and medication aide, documented on an audit record or accountability record.
Incorrect Zyprexa Dose Remained Active on MAR
Penalty
Summary
Pharmaceutical services were not provided to meet the needs of Resident #32 when the facility failed to discontinue an old Zyprexa 10 mg order after the dose was changed to 5 mg in the evening. Resident #32 was admitted with a diagnosis of psychotic disorder with hallucinations and was documented as rarely/never understood with severely impaired cognition. The resident’s care plan addressed psychotropic medication use and gradual dose reduction considerations, and a pharmacy recommendation was made to decrease Zyprexa from 10 mg to 5 mg in the evening, which was signed by the physician on 5/22/2026. The active order summary showed both Zyprexa 5 mg and Zyprexa 10 mg as active, and the MAR showed both doses were administered daily from 5/22/2026 until a clarification order was entered on 6/3/2026. During interview, LVN A stated he received the dose reduction order, notified the hospice provider, entered the new 5 mg order, and thought he had discontinued the 10 mg order, but did not know why it remained active. The DON stated the charge nurse was responsible for entering new orders into the MAR and later obtained clarification from hospice regarding the medication dose.
Failure to Provide Ordered Phosphate Binder
Penalty
Summary
The facility failed to provide pharmaceutical services to ensure accurate acquiring, receiving, dispensing, and administration of medications for Resident #59, who was admitted with ESRD, type 2 diabetes mellitus with unspecified complications, depression, anxiety, bipolar disorder, and parkinsonism. The resident’s annual MDS showed a BIMS score of 15, indicating intact cognition. Review of the EMAR showed an order for Sevelamer Carbonate (Renvela) 800 mg, 1 tablet by mouth before meals for disorders of phosphorus metabolism, with a start date of 04/17/2026, but the resident did not receive the medication from 04/18/2026 through 04/30/2026. Further review of the May 2026 EMAR showed the same Renvela order with multiple hold periods, and the resident did not receive any doses during that month. Review of the June 2026 EMAR showed the medication remained on hold and had not been administered from 06/01/2026 through the time of review. The dialysis RD stated the resident was on a fluid restriction and was prescribed Sevelamer Carbonate because of elevated phosphorus, that dialysis and the facility communicated through forms and faxed orders, and that the medication had been filled last on 03/27/2026 and 04/20/2026. Staff interviews revealed the facility believed dialysis normally refilled the medication, but the pharmacy said it could fill it if needed. The DON stated she did not know the resident had gone without the medication and confirmed the facility did not have it readily available even though it should have.
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