Tehran University of Medical Sciences Health Technology Assessment in Action 2645-3835 4 3 2021 06 09 53 53 Abbasali Dorosti 1. Anesthesiologist and Vice Chancellor for Health, member of the Medical faculty of Tabriz University of Medical Sciences, Tabriz, Iran Mostafa Farahbakhsh Research center of psychiatry and behavioral sciences, Tabriz University of medical sciences, Tabriz, Iran Mahdi Nouri 3. PhD Candidate Student in Healthcare Management, Tabriz Health Services Management Research Center, Health Management and Safety Promotion Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran. Majid Karamoz 4. East Azerbaijan Province Health Center, Tabriz University of Medical Sciences, Tabriz, Iran Hojat gharaee 5. Health Center of Hamadan City, Hamadan University of Medical Science, Hamadan, Iran Hossien Khosroshi 6. East Azerbaijan Province Health Center, Tabriz University of Medical Sciences, Tabriz, Iran Salar Mohammaddokht Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran Saber Azami-Aghdash Tabriz Health Services Management Research Center, Health Management and Safety Promotion Research Institute, Tabriz University of Medical Sciences, Tabriz, Iran 2021 04 06 2021 04 07 Background: Safety has been neglected in primary health care (PHC). A review of the literature shows that a comprehensive and specific framework to assess the safety of service recipients (SRs) in PHC has not yet been developed. Objectives:Therefore, this study aimed to design and validate a framework for assessing the safety of SRs in PHC. Methods: This study was a qualitative research based on a grounded theory approach, designed and conducted by the Vice-Chancellor for Health of Tabriz University of Medical Sciences in 2020. The present study was conducted at three stages: conducting a comprehensive literature review, consulting 15 experts and officials of the country and the province, and conducting two stages of the Delphi technique with the participation of 23 experts. Content analysis was used to analyze the data. Results: In the literature review phase, 114 criteria were identified from 16 references. Finally, 71 criteria (six main areas and 20 subareas) were identified for assessing the safety of SRs in PHC. The main areas included management and leadership (26 criteria), process management (eight criteria), SRs’ safety audit (15 criteria), human resources (five criteria), SRs and community participation (five criteria), and occupational safety (12 criteria). Conclusions: In this study, a comprehensive and systematic framework was designed, and criteria for measuring the safety of SRs in PHC were validated, which can be used by policymakers and officials of PHC. https://htainaction.tums.ac.ir/index.php/hta/article/view/53 https://htainaction.tums.ac.ir/index.php/hta/article/download/53/41