A new frontierand a new hope was given to infertile couples since the successful birth of Louise brown the first invitro fertilization baby in 19781.According to WHO 15% of couples were infertile in India2, 3. NowadaysIVF is commonly accepted and has become a routine practice for the treatment ofInfertility. Several new techniques such as cryopreservation by vitrification,micromanipulation of gametes and pre gestational diagnosis (PGD) requiresquality control and quality assessment to produce repeatable process4, 5.Here we focussed on the recent approaches such as setting up of an ARTlaboratory, operating a best class of laboratory to improve the efficacy of theIVF treatment and discusses the design and use of quality management systems.QUALITY CONTROL,QUALITY ASSESSMENT & QUALITY IMPROVEMENTQualitycontrol (QC) is the activity performed to ensure specific procedures or piecesof equipment operates appropriately. It runs concurrently with laboratory activities.
An example of a QC activity is recording the temperature of a specific piece ofequipment. Quality control is designed to check that a piece of equipment willproduce the same result every time. Quality assurance (QA) is a comprehensivemethod to monitor and evaluate the entire process that goes on within thelaboratory. QA activities are reviewed retrospectively. Quality assurance itemswould include such items as QC activities such as the maintenance of anup-to-date, comprehensive laboratory manual, a continuing-education program(CME) for all laboratory personnel, a proficiency-testing program and a safetyprogram.
Thus, QA is the overall surveillance of all things related to qualitywhich includes monitoring of outcomes, accuracy of reports, and patientsatisfaction. A good QC/QA program includes review of the accuracy andprecision of procedures that is undertaken within the laboratory. Quality improvement (QI) is a method to enhance laboratoryperformance in all phases. This includes those procedures that are incorporatedin an effort to improve a specific aspect of the laboratory. Ideas for theseimprovements were obtained from literature read by laboratory personnel or fromlectures or conversations heard by these individuals. Total Quality Management (TQM) is a global view of QA, QC and QIwhich an optimal product as efficiently as possible. Basic principle of Quality Management GoodLABORATORY practice Laboratorysafety programme needs every employee’s participation and cooperation. Failureto act in accordance not only endangers the individual, it also endangers thehealth and safety workers and patients.
It might also result in loss of gameteand or embryos. Patient consent should be verified before starting anyprocedure. It is the responsibility of the laboratory personnel to check theworking condition of all the equipment’s in the laboratory. Any problems likefrayed wires were found it should be reported immediately to the authorisedcompany or to the biomedical department and has to be rectified immediately. InIncubators temperature, gas concentration and humidity has to be recalibratedatleast annually.
Instruments should be maintained according to themanufacturer’s maintenance guidelines and institutional policies. Goodlaboratory practice includes the following 1.Staffing and direction:Accordingto the national rules laboratory should be maintained by a scientist or amedical doctor and appropriate number of staffs should be appointed toundertake the workload of the laboratory.
New staffs appointed should be givenan Introduction programme and a comprehensive orientation. Continuing MedicalEducation is recommended by ESHRE for all the personnel’s involved.Responsibility of the individual staffs should be indicated in a writtenprocedure. 2.Policies and procedures:It isnecessary to include provision for patient’s unique identity while maintainingpatient confidentiality in all laboratory procedures. Laboratory procedure hasto be reported in a written form which should be validated, dated and includepatient identity. Interpretation of the laboratory results should be accurate,comprehensive and clinically relevant. Record for all reagents, calibration andquality control has to be maintained.
All the laboratory procedures has to begathered in a manual kept in the laboratory and available for consultation. Aseparate log book should be maintained for regular evaluation of the results. 3.Laboratory construction:Laboratoryshould be designed in such a way that adequate spacing is given to achieve agood laboratory practice. Constructionof the laboratory should be in such a way that it should ensure asepticcondition and optimal handling of gametes and embryos in all phases of thetreatment. Equipment’s like incubators, centrifuges and cryo equipment’s shouldbe planned for efficacy and safety within the working area. Record keeping anddata entry should be done in a separate office space. General wet area for washingshould be separate to maintain aseptic condition.
Laboratoryequipment:Mostrecently developed instrument should be preferred for setting up an ARTlaboratory. Equipment’s should be adequate, easy to clean and disinfect.Incubators and frozen embryo equipment’s should be monitored and alarmedappropriately. In the event of power failure , all the embryology laboratoryshould have automatic emergency generator backup. Minimum of two incubators isrecommended.
Gas cylinders should be placed in a separate room with anautomatic backup system. Frequent cleaning and sterilization is necessary forincubators whereas nitrogen tanks should be cleaned and sanitized annually.