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Tag No.: A0490
Based on review of documentation, staff interview and policy review it was determined the facility failed to ensure pharmacologicals were secure. (A502) The cumulative effect of this systemic practice resulted in the facility's inability to ensure patient safety.
Tag No.: A0502
Based on review of documentation, staff interview and policy review it was determined the facility failed to ensure pharmacologicals were secure. The active census was 189.
Findings include:
Review of a Safety Security Conduct Event (#313707) revealed a housekeeping employee was found unresponsive in a restroom adjacent to the post anesthesia care unit on 10/21/15 at 10:55 AM. The employee was found with a tourniquet around the left leg along with a syringe, four empty vials of midazolam (a sedative of the Benzodiazepine class used in the induction of anesthesia) and one vial of Diprivan (short acting hypnotic/amnestic agent used for general anesthesia) with residual amounts in the bottle. A code blue was initiated and the employee could not be resuscitated. An internal investigation ensued with an organizational plan of action.
Interview with Staff B, Staff F and Staff G on 12/08/15 at 11:08 AM confirmed the facility determined the incident to be a serious safety event and documented as such on 11/11/15. Staff B confirmed a pharmacy audit was completed and found no discrepancies in scheduled and/or controlled medications. This serious safety event was reported to the Springfield Police Department, Occupational Safety and Health Administration, State of Ohio Board of Pharmacy and to the County Coroner. The autopsy and toxicology reports are pending to date. Review of the action plan revealed the facility lacked data for the specific action items with target dates of 10/21/15, 11/16/15 and 12/04/15. Staff B stated in an interview on 12/09/15 at 10:37 AM action items three and four do not have a completion date since it is currently being reviewed across the organization.
Review of an electronic communication document dated 09/06/15 with regard to drug handling revealed a housekeeper in the operative area found a partially used, unlabeled Propofol syringe in the women's locker room. This was reported to the charge nurse on 09/03/15. The syringe was forwarded to the pharmacy department in a biohazard bag and a safety security conduct event was created. Review of the safety conduct report dated 09/03/15 lacked evidence of follow up until 11/11/15 in which it was documented an unknown substance was handed over to an unknown nurse.
Staff C electronically communicated with the Springfield Regional Medical Center Physicians and Certified Registered Nurse Anesthetists (CRNAs) via email on 10/25/15 and 11/16/15 with instructions on a pharmacy update on how to properly dispose of pharmaceutical hazardous waste.
An interview was conducted with Staff C on 12/08/15 at 3:30 PM to discuss the proper disposal of pharmaceutical waste in the operative setting. Staff C confirmed all anesthesia medications are locked in the PYXIS machine (fingerprint and password protected) and monitored by pharmacy. The current practice is that medication left in a vial is wasted in a non- retrievable form; such as in a paper towel and/or cotton ball. The bottle is then disposed of in the appropriate container located in each operating room suite.
The operating room/procedural area pharmaceutical waste segregation contract states the red sharps container should include needles, empty broken ampules and/or empty broken glass. The black sharps container should include vials with medication, syringes with medication and piggybacks with medication and should include no controlled substances. Observation confirmed the containers are placed in the soiled utility room and zip locked when full. The Stericycle company picks up the containers and disposes of them three times weekly.
During the tour of the surgical department on 12/09/15 at 3:30 PM a 17 gallon red sharps container was observed with a 20 ml vial of Propofol lying on top of the contents. This observation was immediately after a surgical case was completed. The vial of Propofol was easily visualized and contained a small amount of residual medication. This finding was confirmed with Staff C at this time. Surgical suite six lacked a black sharps container at this time.