HospitalInspections.org

Based on interview and document review, the facility's QAPI program failed to conduct a complete investigation into an event involving the administration of expired influenza vaccine, specifically;
- The investigation did not explore whether the expired influenza vaccine was administered to any patients and did not identify that expired vaccine was administered to a staff member on 9/19/13 in addition to the identified administration on 9/25/13.
- There was no evidence of corrective action specific to pharmacy staff, nor was there any evidence to indicate measures were implemented in the Pharmacy to ensure expired medications are not available for use.

Findings Include:

Review on 12/18/13 of the Staff Influenza Consent forms revealed Afluria CSL Biotherapies 0.5 ml (Influenza vaccine), Lot #P59808 with an expiration date of 30 JUN 2013 was administered to one staff member on 9/19/13 by Staff # 5, Registered Nurse (RN), and to twenty-three staff members on 9/25/13 by Staff #1, RN.

Interview on 12/18/13 at 9:10am with Staff #2, Administrator and Staff #3, Director of Nursing (DON) revealed on 9/25/13 Staff # 1, RN, administered the annual influenza vaccine to employees using expired doses left over from the previous year. The vaccine was received from Staff #4, Pharmacist. While administering vaccine from the third box of 10 doses, Staff #1 recognized the vaccine was expired. Staff #1, RN, notified Staff #3, DON, who confirmed the expiration dates and immediately went to discuss the issue with Staff #4, Pharmacist. A check to determine whether the expired vaccine was administered to patients was not done, nor was it identified that one dose of expired influenza vaccine had been administered by Staff #5, RN to another staff member on 9/19/13.

Review of the Pharmacy monthly medication inspection audits from July to September 2013 revealed no audits for the pharmacy refrigerator(s) were submitted.

Based on interview and document review, nursing did not ensure the influenza vaccine that was administered on 9/19/13 and 9/25/13 was current.

Findings Include:

Review on 12/18/13 of the Staff Influenza Consent forms revealed Afluria CSL Biotherapies 0.5 ml (Influenza vaccine), Lot #P59808 with an expiration date of 30 JUN 2013 was administered to one staff member on 9/19/13 by Staff # 5, RN, and to twenty-three staff members on 9/25/13 by Staff #1, RN.

Interview on 12/18/13 at 9:10am with Staff #2, Administrator and Staff #3, DON revealed on 9/25/13 Staff # 1, RN administered the annual influenza vaccine to employees using expired doses left over from the previous year. The vaccine was received from Staff #4, Pharmacist. While administering vaccine from the third box of 10 doses, Staff #1 recognized the vaccine was expired. Staff #1 notified Staff #3 who confirmed the expiration date and the issue was discussed with Staff #4. It was not recognized that Staff # 5, RN, had also administered one dose of expired influenza vaccine to another staff member on 9/19/13.

Based on document and policy review, the Pharmacist failed to follow facility policy to ensure outdated drugs are not available for patient use.

Findings Include:

Review on 12/18/13 of Policy #31.0 "General Pharmacy Policy and Drug Standards" last reviewed 10/10 revealed a licensed pharmacist is responsible for destroying medications and biologicals whose effectiveness has expired.

Review on 12/18/13 of Policy #31.16 "Drug Storage Rules" last reviewed 10/10 revealed all items with expiration dates will be checked monthly by personnel under the direct supervision of a pharmacist.

Review of the Pharmacy monthly medication inspection audits from July to September 2013 revealed no audits for the pharmacy refrigerator(s) were submitted.

Review on 12/18/13 of the Staff Influenza Consent forms revealed Afluria CSL Biotherapies 0.5 ml (Influenza vaccine), Lot #P59808 with an expiration date of 30 JUN 2013 was administered to one staff member on 9/19/13 by Staff # 5, RN, and to twenty-three staff members on 9/25/13 by Staff #1, RN.

Review of Staff #4, Pharmacist, attestation of the event dated 9/25/13 indicates an inventory of the pharmacy refrigerator for any remaining 2012-2013 influenza vaccine had not been done. When the 2013-2014 influenza vaccine arrived, the technician placed it behind the vaccine from last year.