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Tag No.: A0308
Based on records reviewed and interviews the Hospital failed to maintain a data driven QAPI program for one of four contracted services reviewed.
Findings include:
The Automated Endoscope Reprocessor (AER) is a machine used for high level disinfection of flexible endoscopes (a medical device that is used to view within the upper or lower digestive tract).
The preventive maintenance (PM) reports dated 3-21-14, 6/23/14 and 9-16-14, indicated the AER's located on the fourth floor Digestive Disease Service were serviced every three months by Vendor #1. The subsequent PM visit was done by Vendor #2 on 4/28/15, seven months later.
The Manager of the Digestive Disease Center was interviewed at 8:20 A.M. on 7/8/15. The Manager of the Digestive Disease Center said the AER's were to undergo PM's every three months but the Manager said due to a mix up the schedule had not maintained.
The Surveyor interviewed the Director of Hospital Regulatory Affairs at 9:50 A.M. on 7/8/15. The Director of Hospital Regulatory Affairs said the Hospital was unable to provide any quality data related to the AER maintenance vendor.
Tag No.: A0749
Based on observations, records reviewed and interviews the Infection Control Program failed to consistently follow the Hospital's policy and the manufactures directions for ortho-Phthalaldehyde (OPA) use, to ensure the efficacy of the manual high level disinfection process.
Findings include:
High-level disinfection is a process to eliminate all microorganisms in or on an instrument, except for small numbers of bacterial spores. According to the Hospital Policy titled Manual High Level Disinfection using OPA, the temperature of the high level disinfectant must measure a minimum of 68 degrees Fahrenheit or the solution was to be discarded. Also, the temperature measurement of the OPA solution was to be recorded in the log.
The Surveyor observed the reprocessing area on the fourth floor of the Digestive Diseases Service at 11:00 A.M. on 7/7/2015. The 2015 Mobility Probe (used to assess for abnormal digestive muscle contractions) Log indicated manual high level disinfection was used to reprocess the probes between patients. The log did not indicate any temperature monitoring and a thermometer could not be located in the reprocessing area.
The Surveyor interviewed the Scope Technician at 11:15 A.M. on 7/7/15. The Scope Technician said she was unable to locate a thermometer in the reprocessing suite.