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2200 EAST SHOW LOW LAKE ROAD

SHOW LOW, AZ 85901

FACILITIES, SUPPLIES, EQUIPMENT MAINTENANCE

Tag No.: A0724

Based on manufacturer's recommendations, hospital policy/procedure, patient's acquisition records and staff interviews, it was determined the facility failed to ensure the Alice sleep study equipment was calibrated prior to each patient's polysomnography.

Findings include:

Respironics manufacturer's recommendations "Setup and User's Guide" requires: "...verify that the Alice 5 equipment is operating properly before starting an acquisition...Check Bio-Calibration...connect...and check the connections...ask the patient to lie on...back with arms along the body, eyes closed...Test the sensors by asking the patient to follow the instructions in Table...below...."

Hospital policy titled "Calibration of Sleep Study Equipment Guidelines requires: "...patient related equipment that requires calibration is calibrated prior to and after each study and pre and post calibrations are stored...."

Review of twenty-one (21) patient acquisitions (Patient's #'s 1 and 16 through 35) revealed the following patients did not receive the required calibration checks prior to their sleep studies (Patient #'s 1, 16, 17, 18, 19, 20, 21 and 22).

The Sleep Technician/Polysomnographer and the Interim Cardiopulmonary Director confirmed during an interview conducted on 06/26/14, that the Patient Acquisitions did not contain the required documentation of the calibration checks.

The Director of Quality Management confirmed during the same interview that the facility did not follow their calibration policy for the Alice sleep study equipment.