Failure to Safely Manage and Reconcile Controlled Substances, Including Oxycodone
Summary
The deficiency involves the facility’s failure to maintain a safe and effective medication system for controlled substances, specifically oxycodone, by not following its own policies and procedures for counting, documenting, and removing narcotic medications. The facility’s written policy required controlled substances to be counted upon delivery, jointly verified and signed by the receiving nurse and the delivery person, stored in separately locked compartments, and reconciled at each shift change by the oncoming and offgoing nurses. The policy also required that only one dose at a time be removed from the emergency medication kit as needed, with proper documentation and reconciliation of all controlled substances, including waste and destruction. Surveyor review showed that these procedures were not consistently followed, leading to an unaccounted-for card of oxycodone and undocumented doses removed from the emergency medication kit. The resident involved had multiple medical conditions, including a fracture of the lower end of the right femur, cognitive communication deficit, major depressive disorder, osteoarthritis of the knee, seizure disorder, chronic pain, and severe cognitive impairment as indicated by a BIMS score of 7. The resident used a wheelchair, had limitations in both arms and legs, was dependent on staff for ADLs, and reported moderately rated pain. Hospital discharge orders included oxycodone 5 mg every eight hours as needed for moderate to severe pain, and the facility’s physician orders later reflected oxycodone 5 mg every four hours as needed for pain. On one occasion, an RN documented that after giving scheduled pain medication, the resident continued to experience significant pain, including yelling and screaming during care and dressing changes, and the RN removed three oxycodone 5 mg tablets from the emergency kit, administering one dose but not documenting the disposition of the remaining two tablets. Record review and staff interviews revealed systemic failures in controlled substance handling and documentation. The facility’s investigation showed that nurses could not consistently recall how many oxycodone cards were present for the resident, and the DON found that none of the interviewed nurses had signed the Controlled Drug Count sheet for the relevant dates, despite their statements that counts were done at shift change. The Daily Controlled Substances Audit form showed nurses were signing to verify card counts without actually performing the required counts. When medication cards were destroyed, nurses documented changes such as +1 or -2 without initials or clear indication of which card was added or subtracted. One LPN reported that on a later date he/she observed that a previously present third card of oxycodone was missing, with the corresponding narcotic count sheet page folded over as if for destruction or return, but with no documentation. Multiple nurses, including LPNs and RNs, stated they routinely removed multiple doses (e.g., several tablets at once) from the emergency medication kit, sometimes eight or nine tablets, and then included any unused tablets in the narcotic count, explaining that they had been trained by other nurses to do this, even though the DON and Administrator stated staff were expected to remove and document only one dose at a time from the emergency kit. These actions and inactions resulted in an unaccounted-for card of oxycodone and undocumented controlled substance doses, in violation of the facility’s controlled substance policy. Additional interviews with leadership confirmed the expectations that were not met. The DON stated that controlled substances should be counted at each shift change by both oncoming and offgoing nurses, that each medication cart and each card’s pill count should match the narcotic count sheets, and that staff should sign the narcotic count book and count medications each time the medication room keys changed hands. The DON also stated that staff should remove only one dose at a time from the emergency medication kit and document removals in the emergency kit carbon notebook for communication with the pharmacy. The Administrator similarly stated that staff were expected to follow the facility’s policy on counting controlled substances and to remove only one dose at a time from the emergency medication kit. Despite these stated expectations, the documented practices and staff interviews showed that counts were not reliably performed or reconciled, documentation was incomplete or inaccurate, and multiple doses were removed from the emergency kit at once without proper tracking, leading to the identified deficiency in the facility’s medication management system for controlled substances.
Penalty
Resources
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Surveyors found loose pills in drawers on two medication carts, indicating medications were not stored in their original packaging or assigned resident-specific areas as required by facility policy. On one cart, two loose tablets later identified as Carbidopa-Levodopa and Zofran were discovered with a medication aide who stated she was responsible for checking the cart at the start of her shift. On the second cart, four loose tablets identified as Allopurinol, Metoprolol, Lasix, and Amlodipine were found with another medication aide, who also reported routinely checking the cart for cleanliness and loose medications. The DON and ADM both reported they were unaware of the loose medications and stated that medication aides, nurses, and charge nurses were responsible for proper medication storage, monitored through administrative and pharmacy cart audits.
Surveyors found that the facility failed to follow its own medication storage policy when medicated ointments and solutions were left unsecured in several resident rooms. A resident with heart failure had Diclofenac ointment on the sink, another resident with bladder cancer had Ciclopirox topical solution on the nightstand, and a severely cognitively impaired resident with a history of cerebral infarction had hydrophilic wound dressing stored in a bedside basket on multiple observations. Staff, including an LPN, a wound care nurse, and the ADON, stated that medications and ointments were supposed to be kept on locked carts and not at the bedside, and that residents were not permitted to keep medications in their rooms, demonstrating noncompliance with the facility’s written storage policy and federal requirements.
Medication cart security was not maintained for Cart 700. Facility policy required the cart to be locked when out of the medication nurse’s sight, but an RN walked away from the cart and later entered a resident room while leaving it unlocked and unattended. The RN confirmed the cart should have been locked, and the President of Clinical Operations confirmed carts should be locked when unattended.
Loose medications were found in 2 of 8 observed med carts, including five loose pills in one cart, one loose pill in another, and one loose blue pill in a third cart. A bottle of Active Liquid Protein also lacked an open date. Staff interviews confirmed that carts are checked by nurses, unit managers, DON, and pharmacy, and the facility policy requires the date opened to be recorded on multi-dose containers.
Insulin Storage and Labeling Deficiency: The short hall med cart contained multiple insulin items that were not properly dated, including an open Lantus vial, an unopened Novolin vial, a Lantus pen, and a Novolog pen. The ADON said insulin containers should be dated for 28 days when removed from refrigeration and opened, but she was unsure when the items were taken out. The DON also confirmed insulin should be labeled with the expiration date when removed from the refrigerator, and the facility policy required pens to be dated when placed into use.
Unlocked treatment cart and improper medication storage were observed in multiple areas. An unlocked, unattended treatment cart was found in a hallway, and the East Medication Room contained personal items mixed with medication supplies. Opened Tubersol vials in two refrigerators and multiple opened meds in the A Hall and C Hall medication carts were not dated, and an LPN confirmed several of the findings.
Loose Medications Found on Two Medication Carts
Penalty
Summary
The deficiency involves the facility’s failure to ensure that drugs and biologicals were stored properly on two medication carts. During an observation of the Station 1 medication cart with a medication aide, surveyors found two loose pills in a drawer. The medication aide acknowledged that the cart should not contain loose pills and stated she was responsible for the cart once she received the keys, usually checking it at the beginning of her shift for loose or expired medications and cleaning it prior to medication pass. The Director of Nursing (DON) later identified the loose pills as Carbidopa-Levodopa 25-100 and Zofran 4 mg. The facility’s policy on Medication Labeling and Storage, revised February 2023, states that medications and biologicals are to be stored in the packaging or dispensing systems in which they are received, and that medications are to be stored in an orderly manner with each resident’s medications assigned to an individual cubicle or drawer to prevent mixing. A similar issue was identified on the Station 2 medication cart, where four loose pills were found in the drawers during an observation with another medication aide. The DON identified these pills as Allopurinol 100 mg, Metoprolol 25 mg, Lasix 20 mg, and Amlodipine 5 mg. The second medication aide also stated that the cart should not contain loose pills and that she was responsible for checking the cart for cleanliness and loose medications at the beginning of each shift. In interviews, the DON and the Administrator both stated they were not aware that there were loose medications on the carts, and each indicated that medication aides and nurses or the charge nurse were responsible for proper storage of medications on the carts. Both referenced that nursing administration and the pharmacy consultant conducted periodic or monthly cart audits, and the DON and Administrator described potential negative outcomes such as residents missing medications or inventory control issues. These findings demonstrate that medications were not consistently stored in accordance with the facility’s policy and accepted professional principles.
Unsecured Medicated Ointments and Solutions Left in Resident Rooms
Penalty
Summary
Surveyors identified a deficiency in the facility’s labeling and storage of drugs and biologicals when medicated ointments and solutions were found unsecured in multiple resident rooms on the second floor. During observation, a container of Diclofenac ointment was seen on top of the sink in one resident’s room, and a container of Ciclopirox topical solution was observed on another resident’s nightstand. Both of these residents’ clinical records showed they had no cognitive impairment, with diagnoses including heart failure for one resident and malignant neoplasm of overlapping sites of the bladder for the other. Additional observations showed a tube of hydrophilic wound dressing stored in a basket on a different resident’s nightstand on two separate occasions. Clinical records for this resident indicated admission with a diagnosis of cerebral infarction due to embolism of the right middle cerebral artery and severe cognitive impairment. These findings conflicted with the facility’s written “Storage of Medications” policy, revised January 2026, which states that all drugs and biologicals are to be stored in locked compartments under proper environmental controls. Staff interviews confirmed that medications and ointments were expected to be kept on locked carts and not at the bedside, and that residents were not allowed to keep medications in their rooms, indicating that the observed bedside storage of medicated products did not comply with facility policy and regulatory requirements.
Plan Of Correction
The facility continues to ensure that all drugs and biologicals are stored appropriately. IMMEDIATE CORRECTIVE ACTION Medications were immediately removed from room for residents #58, #20, and #29 on 5/11/26. Residents #58, #20, and #29 were not adversely affected by alleged deficient practice. IDENTIFICATION OF OTHER RESIDENTS HAVING POTENTIAL TO BE AFFECTED All active residents in the facility can potentially be affected by the alleged deficient practice. No residents were adversely affected by the alleged deficient practice. Director of Nursing and/or designee conducted a facility-wide observation audit to ensure that drugs and biologicals are stored appropriately on 05/12/2026. SYSTEMATIC CHANGES The Director of Nursing and/or designee initiated ongoing in-service education with staff on standards. of drug and biological storage on 05/20/2026. MONITORING Nursing Supervisor and/or designee will conduct random observation audits to ensure drugs and biologicals are stored appropriately, 5 days a week for 1 month, then weekly for 3 months. The Director of Nursing and/or designee will report findings of observation/audits to the quality assurance committee monthly for 4 months to ensure continued substantial compliance.
Medication Cart Left Unlocked and Unattended
Penalty
Summary
The facility failed to ensure medications were securely stored in 1 medication cart, Cart 700, out of 3 medication carts reviewed. The facility policy titled, Medication Administration General Guidelines, dated 9/18, stated that during medication administration, the medication cart is to be kept closed and locked when out of sight of the medication nurse. During observation on 5/12/2026 at 7:40 AM, RN A walked away from Cart 700, leaving the cart unlocked and unattended. During another observation on 5/12/2026 at 8:01 AM, RN A entered room [ROOM NUMBER] and again left the medication cart unlocked and unattended. RN A later confirmed she should have locked the medication cart when it was left unattended, and the [NAME] President of Clinical Operations confirmed the medication carts should be locked when left unattended.
Loose medications and missing open date in medication carts
Penalty
Summary
The facility failed to ensure drugs and biologicals used in the facility were labeled and stored in accordance with accepted professional principles for 2 of 8 medication carts observed. During observation on 05/07/2026, RN B’s medication cart contained five loose pills, and RN A’s medication cart contained one loose pill. LVN D’s medication cart also contained one loose, small round blue pill, and a bottle of Active Liquid Protein did not have an open date written on it. Staff interviews confirmed that loose medications were found in the carts and that the open date was not documented on the liquid protein container. During interviews, RN B stated nurses, unit managers, the DON, and pharmacy check medication carts, and that pharmacy checks them monthly. RN A stated loose pills in the medication cart could cause confusion. LVN D stated staff would not be able to identify a medication if it was loose in the cart and reported loose pills were disposed of in the pill incinerator. The DON stated nurses should clean their medication carts after each shift and that staff are expected to write the open date on medications, while the ADM stated staff should check their medication carts to ensure there are no loose pills. The facility policy stated the expiration or beyond-use date is checked before administering medications and that when opening a multi-dose container, the date opened is recorded on the container.
Insulin Storage and Labeling Deficiency
Penalty
Summary
The facility failed to ensure drugs and biologicals used in the facility were labeled in accordance with currently accepted professional principles, including the expiration date for 1 of 2 medication carts reviewed for medication storage. During an observation and interview with the ADON, the short hall medication cart was found to contain a Novolog insulin pen dated [DATE], an open Lantus insulin vial that was undated, an unopened Novolin insulin vial in the manufacturer’s box that was undated, a Lantus insulin pen that was undated, and a Novolog insulin pen that was undated. The ADON stated that all insulin containers should be dated for 28 days when removed from the refrigerator and opened, and she was unsure when the five insulin containers had been removed from the refrigerator. The ADON said it was the nurse’s responsibility to maintain the contents of the carts and that the nurse responsible for the cart had left work early. She was unsure whether the date on the Novolog pen was the expiration date or the date the pen was opened. In an interview with the DON, she stated that all insulin containers should be labeled with the expiration date by the nurse as soon as they are removed from the refrigerator, and she was unsure why the cart contained inaccurately labeled insulin pens and vials. The facility policy titled Insulin Pen Use stated that once an insulin pen is taken out of cool storage, it can be used for up to 28 days and must be dated when placed into use.
Unlocked Treatment Cart and Improper Medication Storage
Penalty
Summary
The facility failed to properly secure a treatment cart while it was not in use and failed to properly store medications in the East Medication Room, the A Hall Medication Cart, and the C Hall Medication Cart. Facility policies reviewed indicated medication carts are to be kept closed and locked when out of sight of the medication nurse, and compartments containing drugs and biologicals are to be locked when not in use. The policy also stated that when opening a multi-dose container, the date opened shall be recorded on the container. During an observation on the East side, the treatment cart was found in the hallway near a room, unlocked and unattended. An LPN confirmed the cart had been left unlocked and unattended. In the East Medication Room, surveyors observed personal items and clothing stored with medication-related supplies, including cups, a tote bag, sweaters, pants, blankets, wheelchair cushions, and leg rest bags. The East first hall and second hall refrigerators each contained two opened vials of Tubersol solution that were not labeled with a date. In the A Hall Medication Cart, surveyors observed opened Nystatin liquid, Latanoprost eye drops, and a Trelegy Ellipta inhaler that were not dated, along with a coffee cup, pastry, sliced red peppers, and a personal cell phone in the cart compartment; an LPN confirmed the items belonged to her. In the C Hall Medication Cart, surveyors observed opened Robitussin cough suppressant, Milk of Magnesia, Miralax powder, and lactulose liquid that were not labeled with a date, and an LPN confirmed the findings.
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