2007 OPEN FORUM Abstracts
SUB-OPTIMAL TEST PERFORMANCE AND QUALITY CONTROL PRACTICES DELAY PULMONARY LABORATORY READINESS FOR CLINICAL TRIALS
S. Blonshine1, R. L. Harris2, S. Cangiamilla2
Failure to achieve optimal quality assurance and testing performance has been reported in pulmonary function laboratories (PFLs) worldwide. Mannkind Corporation (Valencia, CA) has implemented a multi-national clinical trial program, including pulmonary function testing, to support Technosphere® Insulin Inhalation System research. As part of this program, Mannkind implemented on-site equipment verification and staff training. Prior to subject testing, each PFL was required to perform mechanical and biologic control testing and demonstrate acceptable quality standards. An analysis of participating PFLs was completed to assess the barriers and time required to achieve a competence performance level for quality control (QC), spirometry, DLCO, and lung volumes by plethysmography.
Methods: Each PFL received one to two days of on-site training and was provided with written instructions for subject testing, mechanical, and biologic controls. Each PFL was asked to submit quality control data daily until released for testing. All submitted QC data was independently reviewed, and any deficiency was addressed with additional education. Data from 83 PFLs worldwide was analyzed to determine latency from first acceptable QC test to completion of 10 acceptable BioQCâs. Syringe loops, syringe DLCO and DLCO simulations were also monitored for acceptability.
Average days to release 81.8,
Median 64 days,
Max 307 days,
Min 11 days
The primary barriers to PFL release for subject testing is poor understanding of the 2005 ATS/ERS recommendations specifically related to quality control and lung volume testing. We found that the training intensity for quality control (DLco simulations and syringe testing) and lung volume measurements is greater than for spirometry and lung diffusion testing. Our analysis indicates that PFL orientation programs or accreditation initiatives should require training in quality control and test methods.