Improper Medication Storage and Labeling
Penalty
Summary
The facility failed to ensure that medications and biologicals were stored and labeled according to accepted pharmaceutical principles. This deficiency was identified during a recertification survey for a resident who had two unlabeled tubes of Voltaren analgesic cream on their nightstand. The resident, who had a diagnosis of Diabetes Mellitus and Peripheral Vascular Disease, was observed with these tubes in their room without any staff present. The resident stated they applied the cream to their hands, but there was no physician's order for the Voltaren cream, and it was not included in the resident's comprehensive care plan. Interviews with facility staff revealed that residents are not permitted to self-medicate without an assessment and physician's orders, and medications should not be stored in resident rooms. The Licensed Practical Nurse/Patient Care Coordinator and the Director of Nursing Services were unaware of the presence of the Voltaren cream in the resident's room, indicating a lapse in the facility's medication management and storage protocols.
Plan Of Correction
Plan of Correction: Approved January 10, 2025 **NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** I. The following actions were accomplished for the residents identified in the sample: Resident #19 On 12/5/24, the Nurse Manager met with the resident to discuss the tubes of [MEDICATION NAME] observed in his room and removed the tubes following discussion with the resident and the need for a physician order [REDACTED]. The medicated hand cream was delivered by the provider pharmacy with a label that included the resident’s name and directions for use. The resident was evaluated for self-administration and a determination was made to keep the medication on the medication cart and allow the resident to self-administer. The Licensed Practical Nurse/Patient Care Coordinator #1 was reeducated by the Chief Nursing Officer on her responsibility to ensure that all medications/ointment/creams are properly labeled and stored for individual resident use. II. The following corrective actions will be implemented to identify other residents who may be affected by the same practice: All residents have the potential to be affected by the same practices. The Chief Nursing Officer directed the unit Nurse Managers to check each resident’s room for unlabeled medications including medicated creams/ointments that were not ordered by the Physician. Discussions will be held with any resident who has a medication in their room that was not ordered by the Physician, is not appropriately labeled with the resident’s name and directions for and without an order for [REDACTED]. The Chief Nursing Officer has arranged for all medication storage areas and med carts to be inspected to ensure that there are no outdated or opened items that should be discarded, all medications for discharged residents have been discarded, all medications are properly labeled, and that items that require light sensitive storage are properly stored. III. The following system changes will be implemented to assure continuing compliance with regulations: The Administrator, Consultant Pharmacist and Chief Nursing Officer reviewed the facility’s policy and procedure for labeling and storage of drugs and biologicals, including protocols related to parameters for a resident keeping medications in their room and determined that the policies did not require revision. Re-education will be provided by the Staff Educator/designee to all Nurses regarding the appropriate storage of drugs and biologicals and will include the identified survey issue in this education. This education will be included during orientation of licensed nurses and be reviewed on an as needed basis. Weekly monitoring of the medication carts, medication storage areas and refrigerators will be conducted by the Unit Manager/Shift Supervisors to ensure appropriate storage. The nurses responsible for medication administration will be responsible for completing a visual check of the resident’s room for medications that have not been ordered. Immediate corrective action, such as staff re-education related to proper labeling and storage, or removal of an inappropriately stored item will be implemented as needed. Each nurse will continue to be responsible for the proper storage of medications on their cart and upon receipt of medications from pharmacy deliveries. Pharmacy consultant will continue to reinforce proper storage of drugs and biologicals during routine monthly inspection visit. IV. The facility’s compliance will be monitored utilizing the following quality assurance system: The facility will develop an audit tool to monitor compliance with storage of drugs and biologicals, including protocols related to a resident not keeping medication in their room unless there is a Physician order [REDACTED]. The Nurse Manager/designee will audit storage areas and resident rooms on a monthly basis for 3 months and then quarterly for an additional 2 quarters. Storage of drugs and biologicals audit findings will be reported to the Administrator and Chief Nursing Officer monthly for 3 months and quarterly for 2 quarters. Corrective actions, such as removal of improperly stored items or staff re-education, will be implemented as needed. The Chief Nursing Officer will report storage of drugs and biological audit findings to the QAPI Committee monthly for 3 months and then quarterly for an additional 2 quarters for evaluation and follow-up discussion. The accepted level of compliance is 95%. At the end of the third quarter the Committee will decide on the need for additional auditing or a change in the frequency of auditing. Completion Date: 01/31/2025 Responsible Person: Chief Nursing Officer