The purpose of accreditation ISO 9001,ISO 17025 and ISO 15189, which is voluntary, is to ensure that quality management and quality assurance methods meet highly set standards of quality control.
Several countries have in recent years introduced prescribed requirements for treatment and monitoring of outcomes, as well as a licensing or accreditation requirement for in vitro fertilization (IVF) clinics and their laboratories. It is commonplace for Assisted Reproductive Technology (ART) laboratories to be required to have a quality control system. However, more effective Total Quality Management systems are now being implemented by an increasing number of ART clinics. In India, it is now a requirement to have a quality management system in order to be accredited and to help meet customer demand for improved delivery of ART services.
Quality of care is a multi-dimensional concept, encompassing treatment efficacy and impact on health and welfare of both patients and offspring. In addition, the concept of quality includes the cost in financial and human terms of achieving the desired outcome.There has been increased demand for transparency pertaining to the safety aspects, effectiveness and health outcomes of ART treatments both from the general public, patients and regulators. The important components that make a laboratory great are the people, procedure, equipment and the laboratory design.
To optimize quality using the Total Quality Management approach, it is necessary to map all processes, to thoroughly describe all procedures involved in the processes, and to define performance targets for each procedure.Setting up of an ideal In Vitro or fertility laboratory is vital to the success in ART and the critical determinants of the function of the IVF laboratory are people, procedures, equipment and the laboratory design.
The guidelines set up by the ESHRE constitute the minimal requirements for any laboratory offering assisted reproduction techniques (ART). The implementation of guidelines for good practice in IVF laboratories requires a quality management programme to be in place, integrating quality control, quality assurance and quality improvement. This should be done by the design of a quality policy and a consequent implementation of a quality system that encompasses and integrates the operative units, the processes and procedures that represent the core of ART clinics.
What is the need for Quality management Control in IVF Laboratory?
In IVF laboratories, the diversification of the applied procedures necessitates a major attention and concentration, a systematic check of the results obtained, and a more complex training programme. Extensive research is necessary before admitting new procedures to standard technique protocols which are routinely performed in IVF laboratories.
As future perspectives, the IVF laboratory is deeply involved in defining novel techniques to be admitted (i) as standard clinical protocols which are routinely performed to expand ART indications, such as freezing of oocytes and ovarian tissue and in vitro maturation of oocytes, and improving embryo implantation through a better selection of gametes, zygotes and embryos; (ii) in basic research such as the generation of embryonic stem cell lines.
All these involvements require high-laboratory standards with highly qualified personnel, as well as defined quality management systems. ESHRE guidelines for good practice in IVF laboratories, together with the European Tissue Directives, no longer represent an option, but a prerequisite, to operate and provide the best clinical outcome in a safe working
Total quality management(TQM) is an integrative philosophy of management for continuously improving the quality of services and processes. Through the years,this concept has become fundamental in Healthcare, a field in which a high standard of treatment should constantly be pursued. Quality management focus on all processes performed within fertility units and how they can be influenced and improved by TQM in order to provide patients with the best and most safe treatments and procedures available. TQM can be a useful tool to improve efficacy and efficiency, also with reference to financial and administrative aspects.
Quality Control in the IVF Laboratory
Quality Control (QC) and Quality Assurance (QA) in the IVF laboratory play an important role in the success of any IVF program. The role of QC procedures in the IVF laboratory is to fine tune existing protocols in order to more effectively help infertile patients in their quest to have a healthy baby. The three most important physical conditions in the IVF laboratory that can be controlled are the temperature, pH and osmolality of the IVF culture medium. Laboratories are required to document and monitor these physical conditions regularly as part of their ongoing QC/QA programs. Monitoring and documentation of temperatures inside incubators, refrigerators and freezers is an integral part of routine day to day QC in the IVF laboratory.
Written procedures should be present describing the various phases of IVF techniques. Rules concerning the correct handling and identification of gametes and embryo samples should be established by a system of checks and, where needed,double-checks.
International standard and accreditation for IVF centres
ISO 9001 is the basic standard for ISO certification and is a requirement before other standards are implemented such as EN 17025 and 15189. IVF is a clinical enterprise that involves physicians, nurses and others whose tasks go far beyond a clinical laboratory. In fact, it is the integration of the clinical team with the laboratory that requires the most attention to ensure that the highest quality service will prevail.
ISO 9001 forms the basis for a quality management system internationally. Other standards may be sought afterwards by those that may be interested in taking their quality systems further. it is to be noted that ISO implementation can be costly, and careful attention should be made to not set too many standards as a requirement. ISO 9001 serves as an excellent worldwide standard. All IVF centres and IVF Laboratories must be encouraged to consider implementing a quality management system. Experience has shown that, when conscientiously and properly implemented, ISO 9001 can improve employee and patient satisfaction and overall quality. Newly implemented ISO 15189 may offer new and improved standards for clinical laboratories.
The purpose of accreditation, which is voluntary, is to ensure that quality management and quality assurance methods meet highly set standards of quality control. All these involvements require high-laboratory standards with highly qualified personnel, as well as defined quality management systems.
There has been increased demand for transparency pertaining to the safety aspects, effectiveness and health outcomes of ART treatments both from the general public, patients and regulators. The important components that make a laboratory great are the people, procedure, equipment and the laboratory design. Recruiting the right people is the critical step in setting up the best IVF laboratory. An IVF center is only as good as the staff it employs and there is an absolute need to ensure consistent and continuous education and training. QMS, that have been proven effective by other industries, can be used by ART clinics to meet existing requirements by monitoring and controlling the way in which services are delivered. Thus, by determining and meeting the expectations of patients and other stakeholders, implementation of QMS will also be a vital tool for setting, planning and meeting advancements through documented processes enabling continuous improvement.
To design ,built and setting up complete world class IVF center or lab is important turnkey project and you need an expert to take care of it.You need Specialist of IVF lab design like:Shivani Scientific Industries Pvt Ltd.They extends comprehensive service for implementation of ISO 9001 and ISO 17025. Quality Management System provides quality control, quality assurance and quality improvement activities. ISO 9001 system helps ART centers in ensuring quality service for not only the customers but also improving performance in organizations, creating a calibration protocol for equipments, creating proper documentation as per national and international guidelines.
For additional information on this Total Quality Management service, please contact them at +912228966770 or at http://www.ivftraining.com/Services.aspx or at http://ivftraining.wordpress.com/2014/02/08/quality-management-system-in-fertility-ivf-laboratory [Further details of Various Issue of Fertility labs are available on the website.]