Incomplete and Inaccurate Controlled Substance Documentation and Oversight
Summary
The deficiency involves the facility’s failure to maintain complete and accurate records for controlled (scheduled) medications, including shipping manifests, Controlled Drug Records (CDRs), Medication Administration Records (MARs), Automated Dispensing Cabinet (ADC) dispense reports, and destruction logs for multiple residents. The DON and Medical Records Director (MRD) described a system in which controlled medications were delivered with a shipping manifest, signed by the nurse, and stored in the medication cart with a corresponding CDR used to document each removal, while administration was documented on the MAR. However, when surveyors requested all shipping manifests, CDRs, and ADC dispense reports for a defined period, the facility was unable to produce complete documentation, and multiple discrepancies were identified between the various records. During interviews and record reviews, staff nurses and the DON confirmed that the ADC did not generate a receipt or CDR for controlled medications dispensed. An ADC usage report for a specified time frame showed that hydrocodone-acetaminophen tablets were dispensed for two residents, but the DON and MRD were unable to locate any documentation in the medical records showing that these doses were administered or destroyed. For another resident, a shipping manifest documented delivery of 90 oxycodone-acetaminophen tablets, but CDRs accounted for only 60 tablets, and the facility did not have a CDR to account for the remaining 30 tablets. Additional shipping manifests for several other residents showed delivery of various hydrocodone- and oxycodone-containing prescriptions, but the DON stated there were no corresponding CDRs for those manifests. Further comparison of existing CDRs with MARs revealed additional inconsistencies. For one resident, the DON identified a CDR for hydrocodone-acetaminophen tablets and acknowledged that a documented removal on the CDR did not have a matching administration entry on the MAR. For another resident, the DON reviewed a CDR for hydrocodone-acetaminophen and found multiple CDR removals without corresponding MAR administration entries on specific dates and times. For a third resident, the DON confirmed that a CDR removal of hydrocodone-acetaminophen did not have a corresponding MAR administration entry. The DON acknowledged that the facility lacked required shipping manifests and CDRs and that information between CDRs and MARs was inaccurate, despite facility policies on controlled substances and pharmacy services that required controlled substance inventories and related records to be monitored, reconciled, complete, and accurate. The consultant pharmacist’s role and oversight were also implicated in the deficiency. The DON produced the pharmacist’s Medication Regimen Review & Report and Monthly Pharmacy Inspection Reports for selected months within the review period and stated that these reports did not document any issues with incomplete or inaccurate controlled medication records. The DON also reviewed the facility’s policy for the role of the consultant pharmacist, which required the consultant pharmacist to provide consultation on all aspects of pharmacy services and to collaborate with the facility and medical director to develop, implement, evaluate, and revise procedures for pharmacy services. The DON stated it was the facility’s expectation that issues with scheduled medications should have been identified, but the pharmacist inspection reports did not reflect the discrepancies and missing documentation that were later found during the survey. An administrative review of the facility’s Policy for Controlled Substances, revised in November 2022, showed that the policy required controlled substance inventory to be monitored and reconciled to identify loss or potential diversion, and specified that the system of reconciling receipt, dispensing, and disposition of controlled substances must include records of personnel access and usage, MARs, and declining inventory records. Despite these written requirements, the facility’s actual practice, as demonstrated by missing shipping manifests, absent or incomplete CDRs, lack of ADC receipts or CDRs, and mismatches between CDRs and MARs, did not meet the policy standards. The DON acknowledged these discrepancies and confirmed that the facility’s expectation was that all controlled substance documentation be complete and accurate, which was not achieved during the period reviewed. Additionally, interviews with LVN staff highlighted operational gaps in the controlled medication record system. One LVN described the expected process of reviewing shipping manifests and CDRs upon receipt of controlled medications, signing the manifest, securing the medications in the cart, and using the CDR and MAR for ongoing documentation, with completed CDRs sent for retention and remaining medications and CDRs forwarded to the DON upon discontinuation. However, the same LVN reported that the ADC did not provide a receipt or CDR for controlled medications dispensed, creating a gap in the documentation chain. Another LVN identified the location and use of the Rx Now ADC but did not provide evidence of a parallel documentation process to replace the missing ADC receipts and CDRs. These descriptions, combined with the record review findings, demonstrate that the facility’s actual practices did not ensure a complete and accurate record system for controlled substances as required by its own policies. The facility’s policies for controlled substances and the role of the consultant pharmacist, as reviewed during the survey, explicitly required accurate, monitored, and reconciled documentation of controlled substances, including shipping manifests, CDRs, MARs, and records of personnel access and usage. Despite these policies, the survey findings showed that the facility did not maintain all required documents, did not reconcile controlled substance inventories, and did not identify or correct discrepancies between different record sources. The DON acknowledged that the facility did not have the required shipping manifests and CDRs and that there were inaccuracies between CDRs and MARs, and also acknowledged that the pharmacist inspection reports did not identify these issues, even though it was the facility’s expectation that such issues would be detected under the existing policies.
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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