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Tag No.: C0278
Based on observation, interview and record review the hospital failed to ensure adequate surveillance methods for checking sterilization procedures were employed. The control and the processed biological indicators incubating on 7/8/15 failed to have the same lot number as per the manufacturer's recommendations. The hospital's failure to check sterilization procedures created the potential for healthcare acquired infections.
Findings Include:
Observation 7/8/15 at 8:30 a.m. during initial tour in the autoclave room revealed two biological indicators incubating. The positive control lot number was "2015-01DE." The processed indicator's lot number was "2016-04DA".
Interview 7/8/15 at 8:35 a.m. with the Director of the Operating Room (ID# G) revealed he was not aware the lot numbers of the control and processed indicator had to be from the same lot number.
Record review of the Brochure for the Attest Pack stated "The Attest Pack is specifically designed to routinely challenge the steam sterilization process ...Directions for Use: 13.) The positive control indicator should be from the same manufacturing date and lot number as the processed biological indicator ...
Tag No.: C0322
Based on observation, interview and record review the hospital failed to document a post anesthesia evaluation on 4 of 4 outpatients reviewed that received moderate sedation. (Patient ID#'s 13, 14, 15, and 16).
Findings include:
Observation 7/9/15 from 9:40 a.m. to 11:00 a.m. revealed outpatient ID#'s 13 and 14 received moderate sedation for colonoscopy procedures by a certified registered nurse anesthetist.
Review of the surgery schedule dated 7/9/15 revealed patient ID#'s 13, 14, 15, and 16 had colonoscopy procedures.
Review of the medical records for patient ID#'s 13, 14, 15, and 16 revealed these patients were discharged the same day of the procedure. Record review revealed no documentation of a post anesthesia evaluation in the above mentioned records.
Interview 7/9/15 at 3:30 p.m. with the Nursing Director of the operating room (ID# G) confirmed the anesthetist did not document a post anesthesia evaluation for patient ID#'s 13, 14, 15, and 16.
Review of the Operating Room policies and procedures dated 12/18/14 revealed no policy addressing the need for post anesthesia evaluations. The policy and procedure manual only referenced the need for a pre-anesthesia evaluation.