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Standard 8 - QUALITY ASSURANCE / QUALITY CONTROL
An efficient and effective quality assurance and
quality control program shall be followed, ensuring the results provided
by the unit meet acceptable standards.
Commentary
The slow rate of bone loss in the general population necessitates that
a very high level of attention be afforded to quality assurance procedures
to ensure that densitometry equipment is operating as precisely and accurately
as possible. An efficient and effective quality assurance and quality
control (QC) program will include procedures able to detect real changes
in instrument performance that will affect the measured BMD value or the
short or long term precision of the patient measurements.
- 1. QC and equipment maintenance procedures shall be performed regularly
as recommended by the manufacturer. In addition to the routine calibration
and QC testing of densitometry equipment, additional QC monitoring shall
be performed to the standards outlined in Appendix
2 and Appendix 4. If the unit fails any of
the QC procedures the instrument shall be evaluated. With repeated failure,
patient measures shall be suspended until the instrument is more thoroughly
evaluated. If there is a suspicion that previous patient results may
be inaccurate, a retrospective re-analysis of the data shall be performed.
- A vital component of QC is maintenance of equipment. A maintenance
program shall be in place and all aspects of the densitometer performance
shall be checked according to the manufacturers specifications. All
faults discovered must be remedied, and the fault and remedial action
recorded in a form available for inspection.
- Compliance testing of equipment shall be performed. A sufficient program
for compliance testing is described in Appendix 7.
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