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3000 N I-35

DENTON, TX 76201

QAPI GOVERNING BODY, STANDARD TAG

Tag No.: A0308

This STANDARD was not met as evidenced by:
Based on interview and Contract Clinical Record review, The governing body did not ensure that a contractor of services furnished service that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services, which includes demonstrated involvement in its QAPI program, citing 3 of 3 reports for July 2012 .

Findings included:
1. Monthly Environmental Testing Log for July 2012 revealed equipment # H11 microbial culture redrawn on 7/9/12 microbial culture results were >600 CFU/ml with a contamination level >200 CFU/ml. (Action level required for disinfection of equipment re-culture and Equipment pulled from service where possible). There is not a date recorded in the contractor log when the equipment was removed and replaced with back up equipment necessary for patient safety requirements.
2. Monthly Environmental Testing Log for July 2012 revealed equipment # H20 microbial culture redrawn on 7/13/12 microbial culture results were >600 CFU/ml with a contamination level >200 CFU/ml. (Action level required for disinfection of equipment re-culture and Equipment pulled from service where possible).There is not a date recorded in the contractor log when the equipment was removed and replaced with back up equipment necessary for patient safety requirements.

3..Monthly Environmental Testing Log for July 2012 revealed equipment # R.O. 1265547(Reverse Osmosis) microbial culture redrawn on 7/9/12 microbial culture results were >600 CFU/ml with a contamination level >200 CFU/ml. (Action level required for disinfection of equipment re-culture and Equipment pulled from service where possible).There is not a date recorded in the contractor logs when the equipment was removed and replaced with back up equipment necessary for patient safety requirements.

During an interview with the contracted Chief Bio-Medical Technician, (Staff # 4) on 8-29-12 at 2:15 PM confirmed the above findings. The Chief Bio-Medical Technician stated he had not documented the date and replacement of back up equipment on contractor logs.

During an interview with the Quality Staff of the acute care facility, (Staff # 5) on 8/30/12 at 1040 AM confirmed that the above findings had not been received in a timely manner from the contracted service for the hospital QAPI team to trend, analize, and evaluate and that there is not a mechanism in place for the monthly review of QAPI from the contracted services with the hospital quality program.