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Tag No.: A0724
Based on record review and interview, the facility did not maintain one critical patient-care appliance to ensure an acceptable level of safety to patients due to the frequency of testing and inspection being less than the manufacturer recommended frequency. This deficiency affected all 13 operation rooms in the facility.
Findings include
During the record review of medical equipment maintenance and testing with Staff A(clinical engineering operations manager) on 3/3/15 between 11 am and 1 pm, surveyor observed that the Covidien electrosurgical unit (cauterizer) used in operation rooms were tested and maintained on 4/1/14 and 4/1/13 and not maintained at least as often as the manufacturer recommeded, which is semiannual in accordance with the manufacturer's operation manual, Force FX-8C Service Manual.
On 3/3/15 between 12:40 pm and 1 pm, surveyor reviewed the manufacturer's operation manual of the electrosurgical unit together with Staff A, who had brought the manual into the conference room. Staff A showed page 5-13 of the manual to surveyor, which pointed out that the recommended maintenance of the unit was semiannual.
When interviewed on 3/3/15 between 11 am and 1 pm, Staff A stated that the testing and maintenance of the electrosurgical unit was scheduled as an annual maintenance.
The above deficient practice was confirmed at the time of discovery by a concurrent observation and interview with staff A.
Page 5-13 of the Force FX-8C Service Manual of the electrosurgical unit was later received from Staff F (vice-president of operations) via email on 3/4/15 at 5:29 pm upon request from surveyor during the record review on 3/3/15. The periodic safety check on page 5-13 of the manual stated "Perform the following safety check every six months to verify that the generator....."