Key success factors for the implementation of quality management systems in developing countries.

Background: Despite the tremendous progress made in advancing laboratory medicine in low- and middle-income countries (LMICs), inadequate quality management systems (QMSs) remain a problem and barrier to provision of reliable laboratory services in resource-limited settings. Therefore, it is useful to study the experience of medical laboratories in LMICs that have successfully implemented QMS. Aim: This review identified key success factors (KSFs) for medical laboratories in LMICs implementing QMS in accordance with the International Organization for Standardization standard 15189 as a pathway to improving laboratory quality. Methods: Applying Preferred Reporting Items for Systematic Reviews procedures, we conducted a targeted search of studies from LMICs published between 2012 and 2022 to identify KSFs. Thirty-two out of 952 references retrieved were considered relevant and included in this review. Grounded theory was used to extract key features of the included studies to derive KSFs. Results: Ten KSFs for medical laboratories striving to implement QMS were identified and described. These KSFs were integrated to create a model of success for laboratory QMS implementation. The model consists of three underlying factors, namely preparing for change, resource availability, and effective project management, each comprising three separate KSFs. Institutional commitment was identified as the core of the model and is integral to ensuring the quality of laboratory services. Conclusion: Laboratories planning to implement a QMS can benefit from understanding the KSFs demonstrated in this study as this would help them to identify the necessary changes to implement and set realistic expectations about the outcomes of QMS implementation.

Bacterial ghosts as adjuvants in syngeneic tumour cell lysate-based anticancer vaccination in a murine lung carcinoma model.

Instead of relying on external anticancer factors for treatment, immunotherapy utilizes the host's own immune system and directs it against given tumour antigens. This study demonstrated that it is possible to overcome the documented immunosuppressive properties of tumour cell lysate by supplementing it with appropriate adjuvant. Lewis lung carcinoma (LLC)­challenged C57BL/6 mice were treated with LLC cryo­lysate mixed with either bacterial ghosts (BGs) generated from E. coli Nissle 1917 or B. subtilis 70 kDa protein as adjuvants. Median and overall survival, the size of metastatic foci in lung tissue and levels of circulating CD8a+ T cells were evaluated and compared to the untreated control mice or mice treated with LLC lysate alone. After primary tumour removal, a course of three subcutaneous vaccinations with LLC lysate supplemented with BGs led to a significant increase in overall survival (80% after 84 days of follow­up vs. 40% in untreated control mice), a significant increase in circulating CD8a+ T cells (16.57 vs. 12.6% in untreated control mice) and a significant decrease in metastasis foci area and incidence. LLC lysate supplemented with B. subtilis protein also improved the inspected parameters in the treated mice, when compared against the untreated control mice, but not to a significant degree. Therefore, whole cell lysate supplemented with BGs emerges as an immunostimulatory construct with potential clinical applications in cancer treatment.