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Tag No.: C0283
Based on observation, interview, and policy review, the provider failed to ensure medications were properly stored and used in one of one observed computerized tomography (CT) room. Findings include:
1. Observation on 4/7/10 at 11:00 a.m. of medication storage in the CT room revealed:
*The door to the CT room was not locked and did not have a locking mechanism.
*Single use vials of Omnipaque injection were stored in a contrast media warmer.
*The above vials were not marked with a date when they were placed in the contrast media warmer.
*The temperature of the contrast media warmer was measured at 30 degrees celsius (C).
*The above contrast media warmer was not secured to prevent diversion or tampering of the medications stored inside.
*There were 29 bottles of barium sulfate suspension with an expiration date of February 2010 stored on an unsecured shelf.
*There were two opened and partially used vials of Omnipaque injection stored on an open shelf and were exposed to light.
*There were posted instructions for diluting the Omnipaque injection so it could be used orally.
Interview on 4/7/10 at 11:00 a.m. with radiology technician 1 revealed radiology personnel:
*Placed the vials of Omnipaque injection in the contrast media warmer when received from the manufacturer.
*Did not mark the vials of Omnipaque injection with the date they were placed in the contrast media warmer.
*Used the opened partial bottles of Omnipaque injection as an oral supplement to the injection for certain procedures.
*Used the partial vials of Omnipaque injection as an oral supplement to reduce costs.
*Discarded the opened partial vials of Omnipaque injection once a month.
*No longer used the barium sulfate suspension for CT studies and were not aware the product on the shelf was outdated.
Review of the provider's 10/7/08 policy for CT oral contrast usage revealed:
*Either the barium sulfate suspension or Omnipaque injection could be used as oral contrast media.
*The directions to dilute the Omnipaque for oral use were to add 15 milliliters (ml) of Omnipaque injection to 450 ml of water.
*There were no precautions to not use the opened partial vials of Omnipaque injection.
Review of the manufacturer's prescribing information for Omnipaque injection dated May 2008 revealed it:
*Should have been stored at controlled room temperature of 20 degrees C to 25 degrees C.
*Could have been stored in a contrast media warmer for up to one month at 37 degrees C.
*Was sterilized by autoclaving and contained no preservatives.
*Was a single use item and unused portions should have been discarded.
*Was sensitive to light and should have been protected from exposure to light.