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Background: The evolving approach of health literate health care organizations (HLHO) receives considerable support from health policy makers. Up to now, there are no performance measures available to assess the application of health literacy strategies by health care professionals in the primary care setting. This paper describes the development and validation of the Health Literate Primary Care Practice screener (HLPC). The screener can be used as a self-assessment tool for primary care organizations (PCO) that aim to elucidate the health literacy responsiveness of their organization. Methods: The HLPC is a 4-item screener developed in a multi-level process following a theory-driven approach including a literature review, consultations with scientists and cognitive tests with patients in PCO. The screener was applied in a national random sample of N = 1125 adults living in Germany. Item and psychometric properties were analyzed by determining item discrimination and reliability as well as performing a confirmatory factor analysis (CFA) to test the instruments unidimensionality. Criterion validity was investigated by performing bivariate correlations between the HLPC score and heath care quality measures. Results: The HLPC scale demonstrated good item discrimination and internal consistency (α = 0.86). CFA verified a one-factor structure of the scale and analysis on the criterion validity revealed a significant correlation between the HLPC score and patients satisfaction with the general practitioner, accessibility of the PCO and support in care-coordination received in the PCO. Conclusions: The HLPC is a valid screener to provide insights in the extent of the utilization of health literacy strategies in primary care practices. [ABSTRACT FROM AUTHOR]