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 resident with COPD, respiratory failure with hypoxia, and sleep apnea had nebulizer treatments documented as complete even though the nebulizer cup still contained medication during observations. Staff found the nebulizer left assembled on the resident’s end table, and an RN and LPN confirmed medication remained in the cup. A self-administration assessment stated the resident was not safe to self-administer inhalants without supervision, but the record was not updated to reflect that change, and the facility’s nebulizer policy required staff to remain with the resident and clean the equipment after use.
The deficiency centers on multiple failures in controlled substance management, including diversion, tampering, and administration of discontinued narcotics. Discontinued Lorazepam, Oxycodone, and Hydrocodone/Acetaminophen remained in controlled substance boxes on med carts instead of being promptly returned to the pharmacy, leading to inaccurate narcotic counts and missing tablets. Several blister packs of Oxycodone and Hydrocodone/Acetaminophen were found taped or perforated, with tablets replaced by Metoprolol, Seroquel, Hydroxyzine, or lower-dose opioids, while declining count sheets and return logs documented that some pills "did not match." A nurse admitted administering Lorazepam and Oxycodone to residents without checking the eMAR, removing doses after the physician orders had been discontinued and without corresponding MAR entries. Staff interviews described discovering taped blister packs and non-matching pills during shift-change narcotic counts, and the DON and regional clinical leadership identified that discontinued controlled substances were not being removed from the carts and returned as required, allowing misappropriation and use of medications without active orders.
Failure to Properly Reconcile and Destroy Controlled Medications: The facility failed to ensure accurate and periodic reconciliation and proper disposal of controlled meds. The DON and Administrator found the double locked drawer for discontinued narcotics full, with the last documented destruction occurring months earlier and only one of six pages in the destruction log containing the required witness signature. The DON stated she had not conducted any narcotic destruction since her hire, and facility policy required disposal of controlled substances within 3 days of discontinuation with two witness signatures.
The facility failed to follow safe medication administration practices by leaving medications unattended at the bedside and not directly observing residents taking them, even though no residents were authorized to self-administer. In multiple instances, an RN and an LPN placed cups of medications on bedside surfaces and left, or medications were found unattended, including for a cognitively intact hospice patient and a resident with ESRD, as well as a resident with severe recurrent MDD with psychotic features and a history of suicidal ideation. Staff acknowledged leaving medications at the bedside as a routine way to encourage ingestion, despite facility policies requiring medications to remain under direct observation during passes and prohibiting unauthorized bedside storage or self-administration.
The facility failed to maintain complete and accurate records for controlled medications, including shipping manifests, Controlled Drug Records, and the Narcotic Take Back Log, for multiple residents. Staff described procedures for receiving, storing, transferring, and destroying narcotics, but record review showed missing nurse signatures, undated entries, and instances where a single nurse signed as both the nurse returning and the RN accepting discontinued controlled drugs. These documentation gaps involved various narcotic pain medications and conflicted with facility policies requiring detailed reconciliation of receipt, dispensing, and disposition of controlled substances, resulting in the potential for undetected loss and diversion.
The facility failed to maintain accurate clinical records for several residents receiving antihypertensive medications with specific BP and pulse parameters. For multiple residents with vascular dementia, CHF, hypertensive heart disease, and stroke history, the MARs showed blood pressure medications as administered even when recorded vital signs were below ordered hold parameters, and there were no corresponding nursing notes explaining the discrepancies. Staff interviews indicated that CMAs and LVNs report following parameters and sometimes mis-clicking in the electronic MAR, leading to incorrect documentation, while the DON acknowledged there was no process to verify whether medications were actually given or held when vitals were out of range, despite a policy requiring vital sign checks and holding medications per parameters.
Nebulizer Treatment Not Fully Supervised or Completed
Penalty
Summary
The facility failed to ensure medication administration was completed and supervised as ordered for one sampled resident who used a nebulized medication. The resident had an intact cognition and diagnoses of COPD, respiratory failure with hypoxia, and sleep apnea, and required moderate assistance with transfers, dressing, and hygiene. On one observation, the resident’s handheld nebulizer was found on the end table still connected to the machine with approximately half of the medication remaining in the cup, even though the MAR showed the treatment had been documented as completed hours earlier by an RN. The RN who observed the setup stated nursing should have followed up to ensure the medication was fully administered and that the nebulizer should have been disassembled and rinsed after use. A second observation the next morning again found the resident’s nebulizer assembled on the end table with about one-quarter of the medication still in the cup while the resident was asleep in bed. The LPN confirmed the nebulizer was still present with medication remaining and reviewed the MAR, which showed the last treatment had been given overnight. A self-administration assessment completed after the resident returned from the hospital stated the resident was not capable of self-administering inhalants or using inhalers without supervision and was not safe to self-administer at that time. The consultant who completed the assessment acknowledged the resident’s record was not updated to reflect that she was no longer safe to self-administer nebulizer treatments, and the interim DON stated staff were expected to follow the facility’s nebulizer policy requiring staff to remain with the resident during the procedure and clean the nebulizer after completion.
Controlled Substance Diversion, Tampering, and Use of Discontinued Narcotics
Penalty
Summary
The deficiency involves the facility’s failure to maintain effective safeguards and systems to prevent diversion and misuse of controlled substances, and to ensure discontinued controlled medications were promptly removed from use and accurately tracked. For multiple residents, discontinued narcotics and other controlled medications remained in the controlled substance boxes on medication carts for extended periods after the physician orders had been discontinued. Declining count sheets and return logs showed that large quantities of Lorazepam, Oxycodone, and Hydrocodone/Acetaminophen remained on the carts and were not returned to the pharmacy at the time of discontinuation, resulting in inaccurate narcotic counts. Surveyors identified specific instances of tampering and drug substitution in blister packs for several residents. For one resident, a discontinued Lorazepam 0.5 mg order left 90 tablets on the cart; the declining count sheet later showed 83 tablets remaining, but only 82 were actually returned to the pharmacy, with one tablet missing. For another resident with an Oxycodone 5 mg prescription, the declining count sheet and subsequent investigation revealed that three Oxycodone tablets had been removed and replaced with Metoprolol tablets, while the count sheet initially still reflected 90 tablets until the discrepancy was corrected to 87 Oxycodone tablets returned. For a resident prescribed Hydrocodone/Acetaminophen 10/325 mg, the blister pack was found to have one tablet replaced with a lower-dose Hydrocodone/Acetaminophen 5/325 mg, and only 42 of the original 60 tablets were returned. Additional residents’ Oxycodone blister packs were also found to be tampered with and to contain substituted medications. One resident with a short-term Oxycodone 5 mg order had a blister pack where six tablets did not match; investigation determined that three tablets had been replaced with Seroquel, two with Metoprolol, and one with Hydroxyzine, and only 12 Oxycodone tablets were ultimately returned. Another resident with a brief Oxycodone 5 mg order had one tablet replaced with Metoprolol, with eight Oxycodone tablets returned. Multiple nurses reported seeing narcotic blister packs on the carts that were taped on the back or had small breaks in the foil, and some packs contained pills that did not match the ordered narcotic. One nurse acknowledged that she sometimes taped blister packs back up when pills popped out, and several staff described discovering taped blister packs and pills that did not match the expected appearance of Oxycodone. The facility also failed to prevent administration of discontinued controlled medications. For one resident whose Lorazepam 0.5 mg order had been discontinued, the declining count sheet showed tablets being removed on several dates months later by two nurses, despite there being no active physician order and no corresponding entries on the Medication Administration Records. One of these nurses stated that her “system was not good,” that she administered medications based on what she believed residents received without checking the electronic MAR, and that whenever she removed Lorazepam for this resident, she administered it. For another resident whose Oxycodone 5 mg order had been discontinued, the declining count sheet showed doses removed on later dates by the same nurse, again without an active order and without MAR documentation. The DON and Regional Clinical Director repeatedly identified the core system failure as the lack of timely removal and return of discontinued controlled substances from the medication carts, which allowed misappropriation, tampering, and administration of medications without active physician orders. Throughout these events, documentation and verification processes for controlled substances were inconsistent or incomplete. Some pharmacy delivery receipts were unsigned, some declining count sheets lacked nurse signatures for doses removed, and notes on the count sheets documented that certain pills “did not match” the ordered medication. Staff interviews confirmed that taped blister packs and non-matching pills were observed during shift-change narcotic counts, and that concerns were not always immediately escalated. The cumulative findings showed that the facility’s systems for controlled substance storage, counting, discontinuation handling, and verification were ineffective, resulting in inaccurate narcotic counts, missing tablets, tampered blister packs, and removal and administration of controlled medications without active physician orders.
Failure to Properly Reconcile and Destroy Controlled Medications
Penalty
Summary
The facility failed to ensure the accurate and periodic reconciliation and proper disposal of controlled medications. During review of the controlled substance destruction records with the DON and Administrator, the double locked drawer used to store discontinued narcotics was observed to be full. The logbook showed that the last documented destruction of narcotics occurred on 11/06/25, and only one of six pages in the destruction log contained the required witness signature to validate the destruction process and ensure accountability. In a joint interview, the DON and Administrator stated that all discontinued narcotics were kept in a double locked drawer in the DON's office and acknowledged a significant accumulation of discontinued controlled substances. The DON reported that since her hire in December 2025, she had not conducted any narcotic destruction. They reviewed the narcotic destruction logbook and confirmed that the last documented destruction was on 11/06/25 and that only one of six pages contained the required witness signature. Facility policy titled Discarding and Destroying Medications stated that controlled substances were to be disposed of immediately, no longer than 3 days after discontinuation, and that disposal records were to include the signatures of two witnesses.
Medications Left Unattended at Bedside Without Observation
Penalty
Summary
The deficiency involves the facility’s failure to ensure safe administration of medications in accordance with standards of nursing practice by leaving medications at the bedside and not directly observing residents taking them, despite no residents being assessed or authorized to self-administer medications. One resident was observed being handed a cup of medications, including Renvela and Tums for ESRD, by an RN who then left the room without observing ingestion; the resident placed the cup on the bed without taking the medications. Another resident was found with a cup of multiple medications left unattended on the bedside table with water; an LPN later entered, picked up the unattended cup, and then observed the resident take the medications. The facility’s Medication Storage policy requires that during a medication pass, medications must be under the direct observation of the person administering them or locked in a storage area or cart. Additional residents were also found with medications left at the bedside. One cognitively intact male resident receiving hospice care, with a history including dialysis and cancer, had a medication cup with three pills sitting on a cardboard box used as a bedside table; he stated that staff told him to take the medications “now,” but he did not always want to take them immediately. Another female resident with a history of hypertension, obesity, PTSD, urinary incontinence, weakness, and severe recurrent major depressive disorder with psychotic features had medication cups placed on her bedside table by an RN, who then left the room; the resident reported this occurred at other times and identified one cup as Tylenol for later and another cup with several pills for immediate use. The same RN acknowledged leaving medications at the bedside because it was the only way the resident would take them, stated she knew it was wrong, and confirmed awareness of the resident’s history of suicidal ideation. The facility’s self-administration policy requires IDT determination before self-administration and mandates reporting any unauthorized medications found at the bedside, and the DON confirmed that no residents were approved to self-administer medications.
Incomplete and Inaccurate Controlled Substance Accountability Records
Penalty
Summary
The facility failed to maintain a complete and accurate controlled medication record system for residents 1–11, involving documents such as pharmacy shipping manifests, Controlled Drug Records (CDRs), Medication Administration Records (MARs), and destruction logs (Narcotic Take Back Log). The Medical Records Director stated that shipping manifests and CDRs were scanned and retained electronically beginning 3/23, but surveyors found that the facility did not have complete or accurate records. A nurse (LVN 1) described receiving scheduled medications, signing the shipping manifest, placing medications in the cart, and filing the CDR at the cart, as well as transferring discontinued medications to the DON with both signing the CDR. The ADON described that unit nurses were to hand remaining medications and the CDR to the DON, document the amount transferred in the Narcotic Take Back Book, and have both the nurse and DON sign, with the DON and pharmacist later destroying the medications and signing the log. Record review with the ADON showed multiple deficiencies in documentation. For Resident 1, two CDRs with the same number for hydrocodone/APAP 5/325 mg tablets lacked the nurse’s signature, date, and number of doses received in the designated spaces. Review of the Narcotic Take Back Log (pages 6–22, total 137 line items) revealed 21 entries where one nurse signed as both the nurse giving back and the accepting RN for various residents’ controlled medications, and 79 entries were incomplete due to missing the “LN giving” signature. The ADON acknowledged these missing and improper signatures. The facility’s written policies on controlled substances and discarding/destroying medications required a system of reconciling receipt, dispensing, and disposition of controlled substances, including records of personnel access and usage, and required accountability records for discontinued controlled substances to be kept with the unused supply until destruction, in sufficient detail to enable accurate reconciliation. The report states these failures resulted in the potential for undetected loss and diversion (theft).
Inaccurate MAR Documentation for Antihypertensive Medications with Parameter Orders
Penalty
Summary
The deficiency involves the facility’s failure to maintain complete, accurate, and systematically organized medical records for multiple residents, specifically related to the documentation of blood pressure (BP) and pulse parameters for antihypertensive medications. For three residents with significant cardiovascular and cognitive conditions, the Medication Administration Records (MARs) showed that BP medications were documented as administered even when recorded vital signs were outside the physician-ordered parameters to hold the medications. The facility’s Medication Administration policy required staff to obtain and record vital signs when applicable or per physician orders and to hold medications when vital signs were outside prescribed parameters, but the documentation did not accurately reflect whether medications were held or given. For one male resident with vascular dementia, congestive heart failure, hypertension, and a history of cerebral infarction, orders for Lisinopril and Carvedilol included parameters to hold the medications for systolic blood pressure (SBP) less than 110 and pulse less than 60. The April MAR showed that Carvedilol was documented as administered during an evening medication pass when the SBP was recorded at 109/57, which was below the ordered SBP parameter. The MAR listed the hold parameters, but there was no corresponding nursing progress note addressing the out-of-parameter SBP or clarifying whether the medication was actually given or held. For a second male resident with vascular dementia, cerebral infarction, and hypertensive heart disease, orders for Carvedilol, Hydralazine, and Losartan included parameters to hold the medications for SBP less than 100 or 110 (depending on the drug) and pulse less than 60. The March MAR showed that all three antihypertensive medications were documented as administered during a morning medication pass when the pulse was recorded at 54, below the ordered pulse parameter. The MAR reflected the hold parameters, but there were no nursing progress notes documenting the out-of-parameter pulse or any clinical decision-making related to the medications. For a female resident with vascular dementia, hypertension, and chest pain, orders for Lisinopril, Nifedipine ER, and Metoprolol Tartrate included parameters to hold the medications for BP less than 110/60 and pulse less than 60. The April MAR showed multiple instances where these medications were documented as administered despite recorded vital signs that were outside the ordered parameters, including pulses of 57, 59, and 58, and BPs with diastolic readings below 60. These discrepancies occurred on several different days and times prior to the resident’s discharge to the hospital for a UTI. There were no nursing progress notes documenting that BP or pulse readings were out of parameters on those dates. Surveyor observations of current medication passes by CMAs and LVNs showed that staff were obtaining BP and pulse, entering them into the electronic record (PCC), and checking parameters before selecting and administering antihypertensive medications, which was described as following professional guidelines. In interviews, CMAs and LVNs consistently stated that they always check BP and pulse, follow parameters, and hold medications when vital signs are outside ordered ranges, and one LVN acknowledged that she may have clicked the wrong box in the MAR, resulting in incorrect documentation even when a medication was held. The DON reported that there was no process in place to verify whether staff actually gave or held medications when vitals were outside parameters and confirmed that, although parameters were considered best practice and referenced in the medication policy, there was no separate policy requiring parameters. The policy review confirmed that staff were expected to obtain and record vital signs when applicable and to hold medications for vital signs outside prescribed parameters, and to correct discrepancies and report them to the nurse manager, which did not occur in the cited cases.
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