Bringing transparency to federal inspections
Tag No.: C0922
Based on observation, interview, and record review the provider failed to ensure one of one contrast dye warmer was maintained and monitored at a safe temperature for patient use. Findings include:
1. Observation and interview on 4/30/25 at 1:30 p.m. in the computerized tomography (CT) scan room with radiology technician (RT) B revealed:
*There was a contrast warming cabinet stored on top of the counter.
*The contrast warming cabinet contained one bottle of contrast dated 4/20 and three bottles dated 4/26.
*The thermometer in the contrast warming cabinet had registered a temperature of 98 degrees Fahrenheit (F).
*They had stored contrast in the warming cabinet at 98 F for up to 30 days.
*The dates written on the contrast bottles were when they had been placed in the contrast warming cabinet.
*They had not documented the temperature of the contrast warming cabinet.
Interview on 4/30/25 at 2:00 p.m. with radiology director A revealed:
*She confirmed safe storage of contrast was between 68 and 77 degrees F per the manufacturer's instructions for use (IFU).
*She confirmed they had not had a method of logging the contrast warming cabinet's temperature and agreed that would have been best practice.
*She had been unaware of how long contrast could have been stored in the contrast warming cabinet.
Review of the contrast manufacturer's April 2023 IFU revealed contrast dye was to be stored between 68 and 77 degrees F.
Review of the 4/30/25 fax letter received from the contrast warmer's manufacturer revealed:
" Contrast media should be stored as specified in the package insert and should not be kept in the warmer for any period of time longer than that reasonably needed to reach body temperature or to assure that a supply of properly warmed media is readily available."
On 4/30/25 at 1:45 p.m. a contrast dye storage policy was requested and was not provided by the end of the survey process.