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Medpoint explain the
concepts of Quality Assurance and Quality Control in the context of the ART
laboratory, drawing on international guidelines. Factors contributing to an
effective quality management system are highlighted, including staffing,
competencies, traceability, and managing risks and adverse incidents.
“Quality
management is a discipline for ensuring that outputs or services and the
processes by which these are delivered meet stakeholders’ requirements and a
fit for purpose.”
It
also suggests that quality management has four components;
·
Quality planning, which describes the
processes and metrics that will be used and should be agreed with relevant
stakeholders to ensure that their expectations for quality are correctly
identified.
·
Quality assurance, which is the
overarching approach that provides confidence that processes and services are
being well-managed, are consistent or standardized and are performed by
personnel with the right skills, attitudes and resources.
·
Quality control consists of inspection
testing and measurement that confirms that outputs actually meet specification,
are fit for purpose and meet stakeholder expectations. In other words, quality
control tests weather acceptance criteria have – or, indeed, have not – been
met.
·
Commitment by the Management &
Evaluations of the Operations
“Quality of care” it
is widely acknowledged to embrace multiple levels-from patient to health
system, and multiple dimensions, including safety as well as efficiency.
Several countries in
recent years introduced prescribed requirements for treatment and monitoring of
outcomes, as well as licensing or accreditation requirement for in vitro
fertilisation (IVF) clinics and their laboratories. Total quality management
system is now being implemented by an increasing number of ART clinics in
India.
The Indian council of
Medical Research i.e. ICMR recently finalised national guidelines for the
regulation of ART clinics in India. According to ICMR guidelines, Infertility
clinics have been categorised into three levels based on the availability of
complexity of ART service. The guidelines provides minimum requirement
regarding staff in infertility clinics as well as physical requirements for an
ART clinic.
For ART programmes,
such specific and relevant standards and guidelines have been issued by the
American Fertility Society(1992), the Association of Clinical Embryologists
(1996) and the European Society for Human Reproduction and Embryology (ESHRE).
International
standards for organisation (ISO) should be implemented. ISO standards that can
be considered for implementation in an ART programme are ISO 9001(2000), ISO
17025(2000) and ISO 15189(2002).
Implementing and following
any ethical guidelines would mean that doctors would have to look critically at
issues of informed consent, screening donors, legal and ethical issues
including the misuse of sex-pre-selection technologies like pre-implantation
diagnosis.
The
Role of Reproductive Laboratories in the ART clinic.
Creating
a Patient –Oriented Best-in-class In Vitro Fertilisation Laboratory
Reproductive
laboratories (RL) are key elements of clinics performing assisted reproductive
technology (ART).They include both the Andrology and the Embryology clinical
laboratories, which may also work in association with other laboratories, such
as genetic, endocrine, and pathology.
Reproductive
laboratories main goals are to meet patients and physician’s needs. Specific
function includes proper identification, transportation, storage, processing,
and examination of human gametes with subsequent reporting of results.
Reproductive laboratories attempting to accomplish the above-cited tasks in a
quality management philosophy should address three questions that constitute
the primary pillars of quality, that is (1) what do you do?(2) How do you do
it? and (3)How do you make sure that what do you is being done in the proper
manner?
The concept of Total
Quality Management can be described as a systematic program that monitors and
evaluates the quality of services being provided to make sure they meet or
exceed customer’s expectations. A quality management system designed for
reproductive laboratories should integrate all quality-related functions and
activities at all levels, which includes:
• Quality Control (QC),
• Quality Assurance (QA), and
• Quality Improvement (QI),
It should involve all
employees and other people associated with laboratory processes. Quality
control is the establishment of quality specifications for each piece of
equipment and/or procedure and involves ensuring that they conform to
established limits and standards. Quality assurance focus on documentation to
ensure that a product or service satisfy its required quality characteristics,
while QI focuses on the progressive increase in the quality and efficiency of
each aspect of the work and activities related to patient care and internal
production.
Despite not being
universally mandatory for ART clinics, implementation of a quality management
system has been enforced by regulatory/accreditation agencies in several
countries. Specific recommendations for accreditation of ART clinics and
certification of its employees have been designed with the purpose to protect
public health and to ensure safety in assisted reproductive techniques.
Reproductive
laboratories should define the list of procedures under their scope of
activity. Even though the embryology laboratory is the core of ART clinics, the
roles of the andrology laboratory cannot be underestimated as it comes into
play not only in the diagnosis of male factor infertility, which is
contributory in 50-60% of infertile couples, but also in infertility
treatments.
ANDROLOGY
LABORATORY
The Andrology lab
performs the following activities (1) diagnostic testing on semen, seminal
plasma, and cervical mucus ;( 2) sperm cryopreservation; and (3) sperm
processing for therapeutic procedures.
The Andrology lab is
a controlled environment with a dedicated and independent air filtration and
positive pressurisation system. Laboratory access for maintenance and
replacement of equipment and materials is restricted, and the access is
controlled and monitored 24 hrs by surveillance camera.Technical personnel
access to the laboratory is made through an antechamber with an area for
dressing and hand-washing. The Andrology lab has an individual air cooling
system.
EMBRYOLOGY
LABORATORY
The embryology lab
performs procedures involving human reproductive tissues, gametes, and embryos
for therapeutic purposes.
The embryology
laboratory and its adjacent areas (operating room, dressing room and embryo
transfer room) were designed as an integrated cleanroom facility controlled by
a dedicated central air-handling system for humidification, cooling and
filtering particulates and volatile organic compounds by means of HEPA
filters.Technical personnel access to the laboratory is made through an
antechamber with an area for dressing and hand-washing. A separate antechamber
is used for cleanroom gowning. Laboratory access is controlled and monitored by
24 hrs a day surveillance camera. The embryology lab is equipped with stainless
steel workstations designed to optimise comfort and cleaning during routine
workload.
There is no source of
Ultraviolet or ionising radiation and illumination is made by using controlled
intensity incandescent lamps only. Remote system monitors Temperature, Humidity
and pressure 24 hrs a day.
The laboratory and
adjacent areas have an emergency power backup system with 120hour autonomy.
Carbon dioxide tanks
are located outside the laboratory and incubators are fed with co2 using a dual
system stainless steel pipelines.
Equipment and
consumables and supporting physiological processes
All consumables that
come in contact with gametes and embryos must be validated as non-toxic to
embryos and supportive of normal embryo development. All new equipment must be
validated before use; it should be reliable in function, and be tolerant of
non-ideal conditions. The equipment must be acquired on the characteristics of
performance, but not on its price. The fur key environmental variables;
temperature, PH, Osmolarity and contamination, must be controlled and carefully
monitored from the “Tip-to-Tip” of the culture system (tip of the oocyte
aspiration needle to the tip of the embryo transfer catheter).It is critical
that the variables are measured at the point where the embryos are handled. For
example, it must be ensured that the temperature of the culture medium is the
dish is 37deg c .The temperature of the heated stage then needs to be set at
whatever value is needed to maintain the temperature of the medium in the dish
at the desired level.
All process should be
mapped, using appropriate flow chart methodology. The process map then forms
the basis of descriptions of procedures and how they should be performed and
what outcome is to be expected (Key performance indicators- KPI).These
descriptions are often called Standard Operating Procedures (SOPs).
Essential
Qualification of an ART Team
The practice of ART
requires a well-orchestrated team work between the five functional areas of an
IVF clinic: Clinical, Nursing, embryology, counselling and administration. The
staff should have formal qualifications in their area of responsibility and
their actual performance should be monitored again set standards.
Testing of
consumables in IVF laboratories for quality management
ESHRE guidelines also
refer to the quality testing of consumables. In the vast majority of cases this
is addressed by the manufacturers, for example Medpoint makes its
certifications and licenses public on its website and invests in
state-of-the-art production facilities. This is intended to guarantee a
high-quality product that ensures good performance and patient safety, which
you’ll see summarized in your Certificate of Analysis.
On the flip-side,
please be aware that, if you choose to manufacture (such as making your own
media or vitrification devices) you should really be providing a similar level
of testing. This may also apply to altering a product, unless specified in the
manufacturer’s instructions for use.
Quality
management of equipment in IVF labs
The guidelines cover
layout and ergonomics. But in terms of quality management, the critical considerations
are that it’s validated, calibrated and maintained and, importantly, that there
is enough of it to facilitate the workload anticipated. Just like having enough
staff, IVF labs must have enough incubators, for example. It’s also important
that staff know how to use the equipment they’re provided with and that
critical equipment is continuously monitored and alarmed. It’s also worth
mentioning here that quality management would require the lab to have
well-documented and communicated contingency plans for incidents of equipment
failure.
As part of the risk
management the alarms are a minimum requirement for incubators, storage dewars
and I would suggest media fridges. Better still, a monitoring or surveillance
system is a more robust system and performs the required regular checks of
equipment performance. This can be done manually but it’s much more
time-consuming and labour-intensive. The advantage of a monitoring system is
that it will also allow you to assess performance of individual pieces of equipment
and then perhaps think about how that piece of equipment is used – whether it’s
overused or underused – and whether process workflow can be modified to use the
facilities provided in the optimal way.
Looking at a little
bit more detail, new equipment can be subject to a User Requirement
Specification which sets out exactly what it should do and detail any specific
issues such as size, capacity and voltage that relates specifically to where
it’s being used. Every piece of equipment needs to be validated, demonstrating
that it does what it should. You would do this, typically, at installation
(“Installation Qualification” / IQ). You would repeat it once it’s set up and
operating (“Operating Qualification”/OQ) and then for a period of routine-use
Performance Qualification (PQ). This would then be reviewed periodically with
an Equipment Qualification Review (EQR). It’s important to ensure that
equipment is properly maintained, serviced and calibrated and, of course, this
has to be recorded. Typically, this servicing, date etc would be recorded on
the instrument itself so it’s clearly visible.
The EQR – the
Equipment Qualification Review – will be updated periodically to show the
instrument is still fit for purpose but further full validations would typically
be performed if the instrument is repaired or modified in any way.
Verifying
conformance in IVF laboratories for quality management
We now move on to
checking that what we said we would do, we do, and we do it to a good standard.
Verifying conformance ensures just this; it records compliance with guidelines,
regulations and standards as well as checking that one meets in-house targets.
After establishing targets it’s necessary to record sufficient data to be able
to confidently analyse performance and show compliance. These data are then
reviewed as a team.
Performance
Reviews for quality management in IVF labs
My colleague Martine
Nijs talks more about monitoring performance in her webinar ‘Evaluation of IVF
laboratory outcomes with key performance indicators’ so I’ll simply say at this
point that one needs to record data and analyse KPIs to judge how the lab’s performing.
But we can extend this to checking satisfaction of service users, looking at
incidents and complaints, checking training records and perhaps monitoring
research output. Of course, this can be done at various levels; groups of
clinics, individual labs or, indeed, individual operator (whether embryologist,
doctor, nurse or administrator).
Quality
Control in IVF labs
To understand lab
performance, quality control forms a key part. This is the inspection, testing
and measurement parameters that ensure performance meet expectations. We
mentioned that at the outset, but internal quality control should be used in a
way that answers particular questions about performance, so that it’s truly
reflecting laboratory performance and not variations in the patient population,
for example. Added to iQC (Internal Quality Control), EQA (External Quality
Assurance) primarily allows for inter-laboratory comparisons. This is a scheme
that allows you to submit data that shows how you would make decisions [and]
how you would assess things, and then compare it with people around the world
or within the country. there are a number of schemes available for andrology
and embryology.
Risk
Assessment Analysis and Quality Management in IVF laboratories
We’ve talked about
risk assessment in a number of areas but, specifically, it’s mentioned in the
ESHRE guidelines. It’s important to remember it should cover all processes and
all areas and it’s intended to determine the appropriate response to any risk
identified. The response will depend on the type of risk and it will depend
whether it can be eliminated, reduced or managed, or just accepted (were no
action is really possible that will reduce the risk).
We should all be
striving to optimize the skills, processes and facilities at our disposal to
optimize outcomes for patients. To back this up, maintain quality and drive
improvements, a robust system of audits and evaluation is required, and these
audits can be at all levels whether of people and processes. We should foster a
culture that encourages complaints and feedback as a learning tool, and we
should use internal Quality Control and External Quality Assurance proactively
to monitor and improve the way a lab performs. Finally, we should be evaluating
performance at all levels and interrogating on a regular basis.