Increased consistency and efficiency in routine potency testing by bioassay with direct use of cryopreserved (ready-to-plate) cells.

The use of cells as a cryopreserved, readily available reagent has facilitated high-throughput screening of new drug candidates by bioassay. This practice is considerably less labor intensive and allows more flexibility in laboratory testing than traditional continuous cell culture. We have shown that this practice can be adapted to cell proliferation and reporter gene assay formats used in routine sample testing for determination of relative potency of commercial product in a Quality Control Laboratory. The ability to use the same, optimized population of cells provides consistency in an assay over time. Measures of assay performance to indicate maintenance of the validated state of a method and to determine benefit on variation in potency results were compared between cultured and cryopreserved (frozen ready-to-plate) cells. Control of the cellular component, which is the most variable aspect of most cell based potency assays, allowed detection of more minor contributors to variability. In a cell proliferation assay format, the final result was a highly precise bioassay (repeatability CV of 2%). An improvement in process capability (Cp) was noted when ready-to-plate cells were used in the studies completed over long periods of time.

Provider adherence to COPD guidelines: relationship to organizational factors.

RATIONALE, AIMS AND OBJECTIVES: A clinical practice guideline for chronic obstructive pulmonary disease (COPD) was implemented in all Veterans Health Administration (VHA) hospitals in the US. The aim of the current analyses is to describe current adherence rates and the organizational factors related to provider adherence to the COPD guideline. METHODS: We administered a survey to key informants that assessed adherence to the COPD guideline, approaches to disseminating and implementing the COPD guideline, providers' views of the COPD guideline and guidelines in general, and attitudes about the organizational climate. RESULTS: Surveys were returned by 242 key informants (58%) at 130 of the 143 VHA hospitals (91%). Adherence to the COPD clinical practice guideline is perceived by quality managers within the VHA to be good. The final multivariable predictor model identified five measures that were related to provider adherence with the COPD guideline (R(2) = 0.43): responsibilities were changed to support adherence to the COPD guideline, physicians believe that guidelines implemented in the past year were applicable to their practice, patient care providers consistently participate in activities to improve the quality of care, the regional network office monitors the pace at which guidelines are implemented, and there is a system to provide feedback on routinely collected guideline adherence data collected in addition to External Peer Review Program data. CONCLUSIONS: Organizations can play an important role in providing a supportive climate to facilitate their providers' adherence to guidelines by implementing processes and culture changes that involve these five measures.