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Tag No.: A0404
Based on observation, interview, and record review, the nursing staff failed to monitor the temperatures of 3 of 14 medication/biological refrigerators observed and report unsafe temperatures to ensure that drugs and biologicals were kept at safe temperatures per manufacturers' recommendations to ensure the efficacy of the drugs and biologicals.
The findings include:
1. During tour of the CCU on 3/18/2010 at 11am, an observation of the thermometer in the hypothermia refrigerator revealed that the temperature was 30 degrees F which was out of range for medication that they had in the refrigerator. A review of the temperature log for the hypothermia refrigerator showed: 3/18/2010 30 degrees F, 3/17/2010 34 degrees F, 3/15/2010 33 degrees F. There were 4 vials of TB test injections in this refrigerator, 3 were sealed and one was opened. The manufacturer's recommended storage temperature for these vials was 36-46 degrees. The pharmacy was never notified and no interventions were taken to ensure that the contents of the vials were still safe to administer.
2. During the tour on the Neuro ICU, a review of the temperature log for the medication refrigerator revealed that on 3/4/2010 the temperature was logged as being greater than 46 degrees F. The temperature is logged for this refrigerator every twelve hours. In an interview with the unit manager on 3/18/2010 at 11:55am she agreed that the temperature of the refrigerator could have been out of range for 12 hours and that no intervention was taken to retest the temperature or to notify the pharmacy to see if the medications in the refrigerator were still safe to administer.
3. During a tour on 3/19/2010 at 9am on 6 North Internal Medicine Unit, the internal thermometer on the medication refrigerator read 30 degrees, below acceptable range, and a digital thermometer connected to probe inside the refrigerator read 50 degrees. The refrigerator did not feel too warm inside, nor was anything frozen.
On 3/19/10 at 1:50pm a revisit was made to 6 North with the Risk Manager to see if maintenance had repaired the medication refrigerator. The internal temperature on the thermometer still read 30 degrees, and the digital thermometer connected to probe was at 50 degrees. Flu vaccines stored in the refrigerators should have been 36-46 degrees. While on 6 North, the Pharmacist was interviewed regarding safety of medications inside the refrigerator. The Pharmacist removed the flu vaccines and stated that the main pharmacy tracks temperatures recorded by the internal probe and were also concerned about the readings. He/she also expressed concern that the probe was being blocked by a medicine bin next to the probe and therefore may not be reading accurately. He further stated that they would be doing a calibration check on thermometers to determine accuracy. He called the main pharmacy and requested manufacturers specifications that addressed temperature variations and safety of medications stored outside acceptable range.