A new frontier
and 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. Nowadays
IVF is commonly accepted and has become a routine practice for the treatment of
Infertility. Several new techniques such as cryopreservation by vitrification,
micromanipulation of gametes and pre gestational diagnosis (PGD) requires
quality control and quality assessment to produce repeatable process4, 5.
Here we focussed on the recent approaches such as setting up of an ART
laboratory, operating a best class of laboratory to improve the efficacy of the
IVF treatment and discusses the design and use of quality management systems.
QUALITY ASSESSMENT & QUALITY IMPROVEMENT
control (QC) is the activity performed to ensure specific procedures or pieces
of equipment operates appropriately. It runs concurrently with laboratory activities.
An example of a QC activity is recording the temperature of a specific piece of
equipment. Quality control is designed to check that a piece of equipment will
produce the same result every time.
Quality assurance (QA) is a comprehensive
method to monitor and evaluate the entire process that goes on within the
laboratory. QA activities are reviewed retrospectively. Quality assurance items
would include such items as QC activities such as the maintenance of an
up-to-date, comprehensive laboratory manual, a continuing-education program
(CME) for all laboratory personnel, a proficiency-testing program and a safety
program. Thus, QA is the overall surveillance of all things related to quality
which includes monitoring of outcomes, accuracy of reports, and patient
satisfaction. A good QC/QA program includes review of the accuracy and
precision of procedures that is undertaken within the laboratory.
Quality improvement (QI) is a method to enhance laboratory
performance in all phases. This includes those procedures that are incorporated
in an effort to improve a specific aspect of the laboratory. Ideas for these
improvements were obtained from literature read by laboratory personnel or from
lectures or conversations heard by these individuals.
Total Quality Management (TQM) is a global view of QA, QC and QI
which an optimal product as efficiently as possible.
Basic principle of Quality Management
safety programme needs every employee’s participation and cooperation. Failure
to act in accordance not only endangers the individual, it also endangers the
health and safety workers and patients. It might also result in loss of gamete
and or embryos. Patient consent should be verified before starting any
procedure. It is the responsibility of the laboratory personnel to check the
working condition of all the equipment’s in the laboratory. Any problems like
frayed wires were found it should be reported immediately to the authorised
company or to the biomedical department and has to be rectified immediately. In
Incubators temperature, gas concentration and humidity has to be recalibrated
atleast annually. Instruments should be maintained according to the
manufacturer’s maintenance guidelines and institutional policies.
laboratory practice includes the following
Staffing and direction:
to the national rules laboratory should be maintained by a scientist or a
medical doctor and appropriate number of staffs should be appointed to
undertake the workload of the laboratory. New staffs appointed should be given
an Introduction programme and a comprehensive orientation. Continuing Medical
Education is recommended by ESHRE for all the personnel’s involved.
Responsibility of the individual staffs should be indicated in a written
Policies and procedures:
necessary to include provision for patient’s unique identity while maintaining
patient confidentiality in all laboratory procedures. Laboratory procedure has
to be reported in a written form which should be validated, dated and include
patient identity. Interpretation of the laboratory results should be accurate,
comprehensive and clinically relevant. Record for all reagents, calibration and
quality control has to be maintained. All the laboratory procedures has to be
gathered in a manual kept in the laboratory and available for consultation. A
separate log book should be maintained for regular evaluation of the results.
should be designed in such a way that adequate spacing is given to achieve a
good laboratory practice. Construction
of the laboratory should be in such a way that it should ensure aseptic
condition and optimal handling of gametes and embryos in all phases of the
treatment. Equipment’s like incubators, centrifuges and cryo equipment’s should
be planned for efficacy and safety within the working area. Record keeping and
data entry should be done in a separate office space. General wet area for washing
should be separate to maintain aseptic condition.
recently developed instrument should be preferred for setting up an ART
laboratory. Equipment’s should be adequate, easy to clean and disinfect.
Incubators and frozen embryo equipment’s should be monitored and alarmed
appropriately. In the event of power failure , all the embryology laboratory
should have automatic emergency generator backup. Minimum of two incubators is
recommended. Gas cylinders should be placed in a separate room with an
automatic backup system. Frequent cleaning and sterilization is necessary for
incubators whereas nitrogen tanks should be cleaned and sanitized annually.