Dados do Trabalho

Title

THE IMPORTANCE OF THE QUALITY MANAGEMENT PROGRAM IN AN ASSISTED REPRODUCTION CLINIC

Objective

On December 26, 2022, the new Collegiate Board Resolution (RDC) No. 771 was published, which provides for Good Practices in Germ Cells, Germ Tissues and Human Embryos for therapeutic use. This new Resolution replaces RDC No. 23, of May 27, 2011. One of the main changes in this new RDC was the need to implement a QMS (quality management system) in Assisted Human Reproduction (AHR) clinics. The objective of this work was to evaluate the points that showed improvements after the implementation of a QMS in the clinic.

Methods

After the publication of the new RDC 771, in December 2022, the implementation of the QMS at the BIOS Clinic began. The clinic's quality management system is still being implemented, and in the present study some points initially implemented were evaluated, and in parallel, the improvements that the changes brought about were analyzed.

Results

A thorough validation of the equipment, following a specific standard operating protocol (SOP), demonstrated that their useful life improved considerably, a fact that minimized costs and avoided fluctuations in working conditions, providing a better environment for patient samples.
A quality control inspection of the materials and means used, with the implementation of standardized protocols before releasing them for use, increased the safety and reliability of the technical team in using a given lot.
The control of non-conformities was a differentiating issue, because when management encountered any non-compliance, this was duly documented, and in the event of an imminent recurrence, a solution was promptly found, so that non-compliance could be avoided, carrying out preventive measures in a timely manner, when necessary.
The QMS began to play a key role in ensuring patient safety, which involved establishing an adequate sample tracking system, maintaining ideal laboratory conditions for handling gametes and embryos, with due prevention of cross-contamination and due compliance with biosafety practices, with strict serological screening, meeting all the requirements of the new RDC.
The implementation of the QMS solidified its quest for continuous improvement, which involved reviewing and analyzing performance indicators, identifying areas for improvement, and monitoring results.

Conclusion

The quality management system plays an extremely important role within an assisted human reproduction clinic. The new Resolution of the collegiate board RDC 771 came to emphasize the complexity of the processes involved in an in vitro fertilization treatment.
A quality management system is essential to ensure process quality assurance, and in addition to reducing costs, it minimizes failures and maximizes process efficiency.

Keywords

MANAGEMENT, QUALITY, LABORATORY.