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), and destruction logs. The Medical Records Director (MRD) explained that scheduled medications were delivered by the pharmacy with a corresponding shipping manifest, which served as documentation that the medications were delivered and received, and that these manifests, along with CDRs, were to be retained by the facility. When surveyors requested shipping manifests and CDRs for a specified period, the MRD was unable to locate all of the requested shipping manifests, indicating gaps in the documentation of controlled substance receipt. Further review and interviews at the medication cart with an LVN showed that the facility’s described process required each controlled medication to arrive with a shipping manifest and a corresponding CDR, with the medication locked in the cart and the CDR kept at the cart to document each removal of medication. Administration was to be documented on the MAR, and completed CDRs, along with any remaining medications upon discontinuation, were to be sent to the Director of Nursing. However, when the Assistant Director of Nursing (ADON) later attempted to match shipping manifests with CDRs for several residents’ narcotic prescriptions, the facility could not locate the corresponding CDRs for specific oxycodone and hydrocodone-acetaminophen prescriptions, demonstrating that the record system for these controlled medications was incomplete. In addition, the ADON identified CDRs and corresponding MARs for multiple residents and found that the documentation on the CDRs did not match the MARs on several listed dates and times for hydrocodone-acetaminophen and oxycodone orders. The ADON acknowledged that the facility did not have shipping manifests that matched the CDRs for these medications and that the information between the CDRs and MARs was inaccurate. Review of the facility’s Controlled Substances policy, dated November 2022, showed that the system was required to reconcile receipt, dispensing, and disposition of controlled substances using shipping manifests, CDRs, MARs, and destruction/return records, and that controlled substance inventory was to be monitored and reconciled to identify loss or potential diversion. The ADON also reviewed Pharmacy QAPI reports and the consultant pharmacist policy and stated that the consultant pharmacist reports for the relevant quarters did not document issues with incomplete or inaccurate controlled medication records, despite the facility’s expectation that such issues should have been identified. The consultant pharmacist’s role, as outlined in the facility’s Policy for Pharmacy Services – Role of the Consultant Pharmacist (Revision Date April 2019), included providing consultation on all aspects of pharmacy services and collaborating with the facility and medical director to develop, implement, evaluate, and revise procedures for pharmacy services. Nonetheless, the Pharmacy QAPI reports for the specified quarters did not reflect the problems with incomplete or inaccurate controlled substance documentation that were identified during the survey. This combination of missing shipping manifests, absent CDRs for certain delivered narcotics, and discrepancies between CDRs and MARs for multiple residents’ controlled medications constituted the documented deficiency in the facility’s controlled substance record-keeping system.
Penalty
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Two residents with intact cognition and significant pain-related conditions did not receive scheduled opioid analgesic doses because the medications were not available. One resident with multiple vertebral compression fractures and COPD missed an ordered oxycodone dose, and another resident with polyneuropathy, DM2, prostate cancer, and anxiety disorder missed an ordered oxycodone-acetaminophen dose. In both cases, MAR review showed the 6:00 p.m. doses were not documented as given, the residents reported missed pain medication due to unavailability, and the DON confirmed the medications were not on hand for administration.
A resident with multiple chronic conditions and an order for a Fentanyl 25 mcg patch every three days did not receive the ordered patch on one scheduled administration, with no documentation explaining the omission or recording pain level on the MAR. Pharmacy records showed four Fentanyl patches were delivered and signed for by an LPN, but the patches were never logged into the narcotic drawer. The LPN later stated she remembered only one narcotic card in the bag, believed the patches may have been discarded with the pharmacy bag, and admitted she signed the receipt without verifying it against the actual narcotics received. Subsequent Fentanyl doses for the resident were supplied from facility stock medications, and leadership confirmed the nurse should have reconciled the narcotics against the delivery slip and that there was no narcotic delivery policy in place.
A resident admitted with a hip fracture and multiple chronic conditions had several scheduled medications ordered for pain control, muscle spasms, and other needs, including acetaminophen, celecoxib, baclofen, aspirin, gabapentin, modafinil, and PRN oxycodone. Shortly after admission, staff documented that no medications were available, and the resident was not yet in the pharmacy or provider systems, requiring new entry and prescription processing. MAR review showed that scheduled acetaminophen, aspirin, baclofen, and celecoxib were not administered on the first two days, while the resident reported severe pain. Regional nurse consultants confirmed these medications were not given despite policies directing staff to obtain initial doses from starter stock or an automatic dispensing system and to contact the pharmacy if medications could not be located.
A resident with COPD, respiratory failure, lung cancer, heart failure, syncope, and recent hip fracture was discharged from the hospital on Midodrine 10 mg PO TID for orthostatic hypotension, with the last hospital dose given the morning of discharge and the next dose due that evening. At readmission, the facility entered the Midodrine order and scheduled it for AM, mid-day, and HS, but the mid-day and evening doses on the first day and the AM and mid-day doses on the following day were not administered because the medication was not available from the contracted pharmacy and was not stocked in the Omnicell emergency supply. Nursing notes documented missed doses due to waiting on pharmacy delivery, while ED records showed the resident received Midodrine during an ED visit and that her blood pressure returned to baseline after administration. Pharmacy delivery schedules, cut-off times, and staff interviews, including with the DON and an RN, confirmed that although twice-daily deliveries and stat ordering were available, the facility did not obtain Midodrine in time to administer multiple ordered doses as scheduled.
A resident with chronic pain and an order for PRN oxycodone 5 mg had doses signed out on the narcotic log by an LPN on two occasions, but these doses were not documented as administered on the MAR. The DON acknowledged the discrepancy between the narcotic log and MAR and referenced a prior resident interview from another misappropriation investigation, though no documentation showed the resident was interviewed about these specific undocumented administrations. The resident reported receiving medications as requested and having no concerns with other nurses, while the facility’s controlled substances policy addressed receipt and logging of medications but did not prevent the identified documentation inconsistencies.
A resident with severe cognitive impairment and multiple neuropsychiatric diagnoses was ordered clonazepam at different doses and times. An RN administered a 1 mg clonazepam dose by removing the medication from another resident’s controlled medication card instead of from the correct resident’s supply. The discrepancy was discovered at shift change when controlled drug counts did not reconcile. This occurred despite facility policy requiring verification of the resident’s identity and triple-checking the medication label to ensure the five rights of medication administration.
Failure to Ensure Availability of Ordered Opioid Analgesics
Penalty
Summary
The facility failed to ensure that ordered opioid analgesic medications were available for administration as prescribed, resulting in missed scheduled doses for two residents. One resident, admitted with wedge compression fractures of multiple thoracic vertebrae, muscle weakness, and COPD, had an order for oxycodone 10 mg every six hours. Review of the MAR showed the 6:00 p.m. dose on 04/27/26 was not signed as administered. The resident reported that the facility had recently run out of his routine oxycodone and that he missed a scheduled pain medication dose. The DON confirmed that the 6:00 p.m. oxycodone dose on 04/27/26 was not given because the medication was not available. Another resident, admitted with diagnoses including polyneuropathy, type 2 diabetes mellitus, prostate cancer, and anxiety disorder, had an order for oxycodone-acetaminophen 5-325 mg every six hours. Review of the MAR showed the 6:00 p.m. dose was not signed as administered. The resident reported that in the previous month there was a day when he did not receive his scheduled pain medication because it was not available. The DON confirmed that the 6:00 p.m. dose of oxycodone-acetaminophen on 03/16/26 was not administered due to the medication not being available. This deficiency was identified during complaint investigations under Complaint Numbers 2704502, 2656097, and 2673312.
Failure to Reconcile Delivered Narcotic Patches With Pharmacy Delivery Slip
Penalty
Summary
The facility failed to reconcile narcotic medications delivered from the pharmacy with the pharmacy delivery slip upon delivery, resulting in missing Fentanyl patches for a resident. The resident had multiple chronic conditions including multiple sclerosis, hypertension, malignant neoplasm of the lymphoid, chronic pain, spinal stenosis, and polyneuropathy, and had a physician’s order for a Fentanyl 25 mcg patch to be applied every three days. Review of the MAR showed the Fentanyl patch was not administered as scheduled on 03/27/26, with no documentation explaining the missed dose and no pain level documented on the MAR. A pain assessment indicated the resident had experienced occasional pain in the last five days, though at the time of observation the resident had intact cognition, was sitting up in a wheelchair, eating dinner, and had no complaints of pain. The controlled substance delivery sheet showed that four Fentanyl 25 mcg patches were delivered for the resident and signed for by an LPN on 03/24/26 at 6:38 A.M. The LPN’s written statement indicated she remembered receiving only one narcotic card in the pharmacy bag, did not recall seeing the Fentanyl patches, and believed the patches may have been stuck in the bag and thrown away. She acknowledged signing the order receipt without verifying that the contents matched the delivery slip and without logging the patches into the narcotic drawer. Subsequent pharmacy transaction records showed that Fentanyl patches for the resident were later pulled from facility stock medications rather than from the originally delivered supply. The Regional Nurse confirmed that the nurse should have checked the narcotics in upon receipt and compared them to the pharmacy delivery slip, and it was noted that the facility did not have a narcotic delivery policy or procedure per the Administrator.
Failure to Provide Ordered Pain and Other Medications for New Admission
Penalty
Summary
The deficiency involves the facility’s failure to ensure ordered medications were available and administered to meet a resident’s needs. A cognitively intact resident with multiple sclerosis, osteonecrosis of the left femur, unilateral primary osteoarthritis of the left hip, fatigue, PTSD, and a recent hip fracture was admitted in the evening and had multiple pain, muscle relaxant, and other medications ordered to start on the day of admission. These included acetaminophen (in two strengths and dosing schedules), celecoxib for pain, baclofen for muscle spasms, gabapentin for pain, aspirin, modafinil, and PRN oxycodone for pain. A progress note documented that shortly after admission the resident did not have medications at the facility, and when staff contacted the pharmacy and the provider’s system, the resident was not yet in either system. The nurse then worked to have the resident entered as a new admission and to obtain a new prescription and status update from the pharmacy. Review of the Medication Administration Record (MAR) showed that on the first and second days, there were “x” marks in place of nurse initials for scheduled acetaminophen doses, aspirin, baclofen, and celecoxib, indicating the medications were not administered. Additional MAR review showed the resident was documented as having 10/10 pain on one day and 6/10 pain the following day. Regional nurse consultants confirmed that there was no indication the resident received acetaminophen or aspirin on the first two days and that these medications would be expected to be available from house stock, and also confirmed the resident did not receive celecoxib or baclofen on those days. Facility policies stated that to avoid delaying patient care, initial doses should be obtained from starter supply or an automatic dispensing machine, and that if a medication with an active order could not be located, staff should search other areas and contact the pharmacy or use the starter box, but the documentation showed the ordered medications were not available or administered as required.
Failure to Ensure Timely Pharmacy Delivery and Administration of Ordered Midodrine
Penalty
Summary
The deficiency involves the facility’s failure to ensure contracted pharmacy services provided timely delivery of a newly ordered medication, Midodrine, so that it could be administered as ordered for a resident with complex medical conditions. The resident was admitted with diagnoses including COPD, acute on chronic respiratory failure with hypoxia, lung cancer, dependence on supplemental oxygen, heart failure, syncope and collapse, sepsis, and shock. After an unwitnessed fall in the facility resulting in a left hip fracture, the resident was hospitalized and later discharged back to the facility with an order for Midodrine 10 mg by mouth three times a day before meals to treat symptomatic orthostatic hypotension. Hospital records showed the resident received Midodrine 10 mg three times a day during the hospitalization, with the last dose given on the morning of discharge and the next dose due that evening. Upon the resident’s return to the facility, the physician’s order for Midodrine 10 mg by mouth three times a day was entered on the day of discharge, and the facility scheduled administration times on the MAR as AM, Mid, and HS. A subsequent order added parameters to hold the medication if the systolic blood pressure was above 120 mmHg. On the day of readmission, the mid-day dose was not administered, and the MAR was coded with “9 – other/see progress notes.” Nursing progress notes documented that the scheduled Midodrine dose due that evening could not be given because the facility was waiting on the pharmacy to deliver the medication. Later that night, the resident developed shortness of breath with oxygen saturation levels around 78–80%, was sent to the emergency department via EMS, and did not receive the HS dose at the facility because she was out of the building. In the ED, she was given Midodrine 10 mg by mouth, and ED documentation indicated her blood pressure decreased but returned to baseline after receiving Midodrine. Following the ED visit, the resident returned to the facility the next morning. Review of the April MAR showed that the resident did not receive the scheduled AM or mid-day doses of Midodrine that day; the first documented dose administered at the facility was the HS dose. A nursing note that morning again documented that Midodrine 10 mg was not administered as ordered because the medication had been ordered and was not available. The facility’s Omnicell emergency contingency supply contained 116 medications, but Midodrine was not among them. Posted information from the contracted pharmacy described twice-daily deliveries with specific cut-off times for new orders and refills, and staff interviews confirmed that routine and new orders had to be submitted by certain times to be delivered the same day, with stat orders available within four hours. The DON and an RN both acknowledged ongoing struggles with the pharmacy, and the DON stated there was no reason the resident’s Midodrine should not have been available by the evening dose on the day after readmission, indicating that pharmacy services did not ensure timely availability of the medication as ordered. The facility’s written policy on Pharmacy Hours and Delivery Schedule stated that a schedule of pharmacy hours and delivery times would be established and posted, and that the Administrator, DON, and provider pharmacy would establish a daily delivery and pick-up schedule for medication orders, but it did not specify exact delivery times. Interviews revealed uncertainty by the DON about the exact delivery times and about whether a local backup pharmacy could be used when medications needed to be obtained more quickly than the contracted pharmacy could provide. An RN reported that the pharmacy was a “struggle sometimes” and that if staff “stayed on them,” medications would be delivered, and also stated that a stat order could have resulted in Midodrine being delivered within four hours if it had been entered that way at readmission. Overall, the record review, MAR documentation, nursing notes, pharmacy delivery information, and staff interviews showed that the facility did not ensure its contracted pharmacy services provided Midodrine in time for multiple ordered doses to be administered as scheduled for this resident. This deficiency was cited for one resident out of three reviewed for pharmacy services, with a facility census of 87, and was investigated under Complaint Number 2976676. The failure centered on the lack of timely availability and administration of Midodrine as ordered, despite clear physician orders, documented hospital use of the medication, and established pharmacy delivery processes that could have supported earlier delivery if used effectively. The Omnicell inventory, pharmacy cut-off times, and staff statements collectively demonstrated that the medication was not stocked in the emergency supply and was not obtained from the contracted pharmacy in time to meet the resident’s ordered dosing schedule on multiple occasions.
Inaccurate Documentation of PRN Controlled Substance Administration
Penalty
Summary
The deficiency involves the facility’s failure to ensure accurate documentation of controlled substances in the medical record for a resident receiving PRN opioid pain medication. The resident was admitted with hypertension and anemia and had an order for oxycodone 5 mg by mouth every four hours as needed for pain, with a care plan identifying chronic pain related to an internal orthopedic device and left knee pain. The care plan interventions included administering medications as ordered and observing for effectiveness and side effects. The resident’s MDS indicated intact cognition and that the resident had pain and received opioid medication. Record review showed that on two separate dates in February, an LPN signed out oxycodone 5 mg on the narcotic log at specific morning times, but there were no corresponding entries on the MAR indicating that the medication was administered at those times. The DON acknowledged that the LPN had signed out the medication on the narcotic log without signing it as administered on the MAR and stated they did not believe there was a concern for diversion or misappropriation, referencing an interview with the resident in another investigation. However, there was no statement in the misappropriation investigation documentation indicating that the resident had been interviewed about these specific instances of medications being signed out without MAR documentation. The resident later reported receiving medications as requested and having no concerns with other nurses. The facility’s written controlled substances policy addressed receipt, verification, and logging of controlled medications but did not prevent the discrepancy between the narcotic log and MAR documentation identified in this case.
Plan Of Correction
1. Resident #99 was interviewed by Director of Nursing on 2/25/26 and had no ill effects related to the inconsistent documentation in the medical record as it relates to her controlled substance pain medication. 2. Like Residents are identified as residents who utilize controlled substance PRN pain medications. An audit will be completed by the Director of Nursing or designee for like residents utilizing the Controlled Substance Audit Tool which was created on 4/20/26 by the Director of Nursing for the purpose of this POC to ensure PRN controlled substance pain medications that are signed off the control sheet are documented in the resident medical record as well. This audit along with identified corrections will be completed on or before 5/13/26. 3. The Director of Nursing or designee will re-educate licensed nurses on the Controlled Substances Policy to include appropriate documentation of controlled substances. This education will be completed on or before 5/13/26. 4. Utilizing the Controlled Substance Audit Tool which was created on 4/20/26 by the Director of Nursing for the purpose of this POC, the Director of Nursing or designee will complete an audit 3 residents per med cart for a total of 27 residents who utilize controlled substance PRN pain medication weekly for four weeks, beginning 5/14/26 to ensure PRN controlled substance pain medications that are signed off the control sheet are documented in the resident medical record as well. Discrepancies noted during the audits will be investigated and documentation corrected to accurately reflect medicine administered. Negative findings to be addressed immediately and negative trends or system wide issues will be reported to the QAPI committee, and the action plan will be adjusted as needed.
Medication Taken from Another Resident’s Controlled Supply
Penalty
Summary
The deficiency involves the facility’s failure to ensure a resident received medication labeled with their own name, as required by facility policy and pharmaceutical service standards. A resident with severe cognitive impairment and diagnoses including dementia with behavioral disturbance, metabolic encephalopathy, mood disorder, history of traumatic brain injury, and catatonic disorder was admitted with physician orders for clonazepam 1 mg at 6:00 P.M. and 12:00 A.M., and clonazepam 0.5 mg at 12:00 P.M. A nursing progress note documented that on 03/24/26 at 9:24 P.M., the resident received clonazepam 1 mg instead of the ordered 0.5 mg dose. The facility’s investigation of a medication error for wrong dose confirmed that the resident received a 1 mg dose instead of the ordered 0.5 mg dose. During interviews, the ADON confirmed that an RN administered clonazepam 1 mg to the resident as ordered for the 6:00 P.M. dose but obtained the medication from another resident’s controlled medication card. The RN stated he did not believe he made a medication error because the resident ultimately received the correct 1 mg dose for that time, although he initially thought it was an error due to the separate 0.5 mg order at 12:00 P.M. The error was discovered at shift change when the controlled medication counts for the two residents did not match. The RN acknowledged that the five rights of medication administration include the right resident and right medication. The facility’s “Administering Medications” policy requires staff to verify the resident’s identity before administration and to check the medication label three times to ensure the right resident, medication, dosage, time, and method, which did not occur in this instance.
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