FertQMS
From MedITEX - Wiki
National and international quality and safety standards within the fertility sector such as the HFEA, EU Tissue and Cells Directive and ISO, require all establishments collecting and processing human tissues and cells to implement a Quality Management System (QMS).
Quality Management
The Human Fertilisation and Embryology Authority’s 8th Code of Practice requires a licensed centre to “put in place a quality management system and implement this system to continually improve the quality and effectiveness of the service provided in accordance with the conditions of this licence and the guidance on good practice as set out in the HFEA’s Code of Practice”.
A quality management system is defined as “the organisational structure, defined responsibilities, procedures, processes and resources for implementing quality management (i.e., the co-ordinated activities to direct and control an organisation with regard to quality), including all activities which contribute to quality, directly or indirectly” (International Organization for Standardization (ISO)).
Compliance, Efficiency, Safety and Productivity
Matcher™ - Peace of Mind
Specifically created for IVF clinics and donor banks, Matcher assists in preventing error through misidentification of patients and their gametes and embryos. Matcher is the only witnessing system better than human double checking that photographs all procedures, throughout the entire treatment cycle. Photographic reports provide visual chain of custody evidence, and additional peace of mind for both staff and patients.
The introduction of the Matcher® (electronic barcode) system has enhanced our IVF lab traceability, eliminating the possible risks of egg, sperm or embryo misidentification due to human error. This reassures our clients of the highest level of security and traceability throughout their treatment cycle.
The Matcher® system is designed to confirm, match and monitor every procedure and process that occurs within the IVF laboratory. It provides a photographic record of every procedure, recording what procedure is carried out, when and where the procedure was carried out and by whom.
Every client is allocated a unique identification number that will be used throughout all their cycles and procedures for identification and traceability and then applied to all dishes, tubes and sample pots which contain their gametes, embryos or blood. Whenever these samples are used in any procedure. Furthermore, clients attending for IVF and IUI treatment cycles will have their photograph taken for cross reference and verification.
Barcode labels are generated for the client(s) and used on all the labware in which their eggs, sperm and embryos are contained and all their associated paperwork. Whenever these samples are used in any procedure, the barcode is scanned and matched against the patient’s notes before the next stage of the process can continue. The Matcher™ system also provides full traceability for all records, labware and culture media used throughout a treatment cycle.
The electronic witnessing system offers patients increased confidence that their gametes and embryos are safe at all times during treatment and storage.