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
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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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