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300 W 5TH ST

MILLER, SD 57362

DRUGS AND BIOLOGICALS ARE APPROPRIATELY STORE

Tag No.: C0922

45383

Based on observation, interview, record review, and policy review the provider failed to ensure one of one contrast dye warmer was maintained at a safe temperature for patient use. Findings include:

Observation on 8/15/23 at 10:00 a.m. in the Computerized Tomography (CT) scan room revealed:
*There was a warmed cabinet on top of the counter that contained two bottles of contrast dye used for patient imaging.
*The thermometer had registered a temperature of 101.6 degrees Fahrenheit (F).

Interview during the above observation with radiology technician (RT) B revealed:
*The highest temperature that she had recorded in the warmer was 102 degrees F.
*She was unsure of the safe warming range for the contrast dye.

Interview on 8/16/23 at 9:00 a.m. with RT D and RT C regarding the contrast dye warmer temperature monitoring revealed:
*They both thought that 102 degrees F was a safe temperature to warm the contrast dye to.
*The highest temperature recorded for the warmer was 104 degrees F.
*The injector arm on the CT machine had a warming ability to 98 degrees F.
*They both stated that it took less than ten minutes to remove the contrast dye from the warmer for injection into the patient.
*They had not rechecked the temperature prior to injecting the contrast dye into the patient.
*RT C and RT D both stated they had reviewed the manufacture's product insert and were unable to find a recommended warming temperature for the contrast dye.

Interview on 8/16/23 at 9:45 a.m. with administrator A regarding the warmer for contrast dye in the CT room revealed:
*He had observed the contrast dye warmer in the CT room and stated that the warmer had no dial to regulate the temperature.
*The administrator A agreed that following the manufacturers recommendation would have been the best practice for patient safety.

Review of the February 2022 manufacturers product insert revealed:
*Contrast dye was to be stored at 68-77 degrees F.

Review of the provider's EmPowerCTA Injection System User's Guide revealed:
*"Warmer: A device that attached to the contrast dye syringe to maintain the pre-warmed contrast at a steady temperature state of approximately 98 degrees F."

Review of the provider's January 2023 IV (intravenous) and Oral Contrast Storage revealed:
*"Iodinated contrast will be stored in a locked room in the main Imaging department and in CT."
*"General storage temperature range is 68-77 degrees F."
*"Two bottles of 100 milliliters iodinated contrast should be stored in the contrast warmer at all times."
*"Iodinated contrast may be kept in the contrast warmer for one month."
*"Contrast warmer will be documented on at least weekly. 95.9-101.3 degrees F is considered optimal with some variance in temperature."