Process control and process analysis

To analyze a process for either quality management or risk management purposes, one must have knowledge of the normal parameters of its operation. This requires both reliable information on the historical performance of the process and knowledge of its inherent variability. It is important to think like a statistician - scary as that might seem Indeed, TQM (of which risk management is one element) requires that scientific method and statistical thought pervade all considerations of process...

Standard operating procedures or SOPs

Writing SOPs can be quite a daunting task, especially for a new IVF lab or one that has taken the decision to move from its traditional mode of operation (perhaps as a university-based lab) to a proper mode of operation including formal accreditation. There is no absolute standard for what an SOP must contain or look like. However, in the USA the National Council for Clinical Laboratory Standards (NCCLS) has a set of guidelines on how to prepare SOPs (NCCLS, 2002) that are acceptable to...

Quality management

Quality management is the integration of quality activities, which include quality control, quality assurance and quality improvement, into a management philosophy. Historically, quality management has its roots in the rebirth of the Japanese manufacturing industry after World War II, when Japan had a reputation for producing some of the worst manufactured goods in the world. However, by the 1960s Japanese products were often the highest quality ones in various market areas. This philosophy of...

What does it take

To develop a quality lab that achieves the highest success rates and minimizes its risks requires a broad spectrum of resources, a shortfall in any one of which can cause the whole endeavour to fail. 1. For any organization to be able to change, there is an absolute need for slack (DeMarco, 2001). Insufficient slack will compromise the availability of vital human resources and the stress on the morale of critical personnel will destroy their commitment to the process of change. 2. Everyone in...

Creating a quality IVF lab

Creating a quality IVF lab is neither a simple nor short task. Certainly it is easier to create such a lab when one is starting afresh with a new facility, but most IVF labs don't have that opportunity, they have to rebuild and reorganize what they have - usually while having to maintain services with already limited human resources. Nonetheless, it is a daunting task that many Lab Directors will have to face anywhere that accreditation is pursued, but especially within the European Union as...

Reference populations

Often there is a definite need to be able to compare Indicators (usually some measures of clinical outcome such as pregnancy rates or live birth rates) across many IVF Centers, especially for such purposes as a national registry. In these situations, each Center's results are not just reported en masse, usually with stratification according to female patient age bands, but also in terms of some sort of reference population that is designed to be consistent between all the Centers to allow...

References and recommended reading

S. (1988) Significance of reactive oxygen species and antioxidants in defining the efficacy of sperm preparation techniques. Journal of Andrology, 9 367-376. Almeida, P. A. and Bolton, V. N. (1995) The effect of temperature fluctuations on the cytoskeletal organisation and chromosomal constitution of the human oocyte. Zygote, 3 357-365. Alper, M. M., Brinsden, P. R., Fischer, R., and Wikland, M. (2002) Is your IVF programme good Human Reproduction, 17 8-10....

Whenwhy do you need to use culture oil

Why does an IVF lab use culture oil What functions is it considered to perform - and what advantages is it perceived to confer or possible risks might its use incur We have always been of the opinion that oil is a nuisance in the IVF lab and have restricted its use to only those situations where its benefits are proven. The logic for that position is considered briefly below - not in an attempt to convert other embryologists but simply as the basic information upon which proper informed...

How do we get there

There are no short-cuts to achieving excellence, but a bird's-eye perspective ofthe road map is shown in Figure 13.3, the general concepts of which should be pretty familiar by now. 1. Establish the goals and get buy-in from everyone in the organization. This buy-in must be reinforced along the way, any setbacks or unresolved problems will create doubt in some of your people's minds, and once someone has lost faith in the process it's very much harder to get them back on board. 2. Educate...

Introduction

It seems that we hear news reports of disasters in IVF clinics almost weekly. Public concern over these reports has resulted in governments introducing regulation of IVF labs around the world, and within our profession there is a growing recognition of the need for accreditation of IVF labs to ensure that the potential for such errors occurring is minimized. Quality systems, which have an inherent role in all modern accreditation schemes, are essentially based on the principles of ISO 9000 and...

Temperature control during oocyte retrieval

Because of the meiotic spindle, the oocyte is exquisitely temperature-sensitive. Cooling causes depolymerization of the spindle (Pickering etal., 1990 Almeida and Bolton, 1995 Wang etal., 2001), releasingthe chromosomes into the ooplasm. Although the spindle repolymerizes upon warming, there is considered to be a significant risk that one or more chromosomes might not become reattached to the spindle and hence a state of aneuploidy would be created at the second meiotic division, which occurs...

Illustrative examples of risk management in the IVF lab

The following examples have not been presented in the strict format of formal risk analyses, but rather as explanations of the issues and how each IVF lab should go about evaluating and managing the risks for itself. Table 9.1 Major elements of a risk management plan as described in the proposed revised version of AS NZS 4360 (Standards Australia www.standards.com.au) Table 9.1 Major elements of a risk management plan as described in the proposed revised version of AS NZS 4360 (Standards...

Identifying high risk IVF laboratories

IVF is an area of rapidly advancing technology, meaning that continual training and proficiency testing are imperative. But these tactics in isolation will not prevent the type of problems that keep appearing in the mass media, and we must recognize that the overall environment in which people work can either support or obstruct both technical training and improvements in operational systems. Is it possible for a hospital or Fertility Center to identify whether their IVF laboratory is at...

Troubleshooting a process

An example of needing to look at many systems together when troubleshooting is illustrated in an investigation of low fertilization rates. It had been shown in numerous studies that a low glucose environment was beneficial for embryo development from the zygote to 8-cell stage, and so many laboratories used this type of medium in place ofthe glucose-containing medium that they had previously used for all of the gamete handling, fertilization and early embryo development steps. In some of these...

Protecting IVF laboratory staff from unfair litigation

As risk management moves from the manufacturing industry to healthcare there is a far greater - or at least more immediately obvious -impact of risk on customers' wellbeing. Although the underlying issue and driving force for risk management is patient safety, the increasing focus on financial risk, not just medical risk, has substantial implications for healthcare workers - and hence IVF Centers. A leader in the medical application of RCA stresses that Errors must be accepted as evidence of...

What sort of embryology work station is best

There is a wide range of possible configurations of microscope work station where one can perform the various technical procedures involved in routine IVF. (This analysis does not relate equally to a work station where embryos are processed for freezing and thawing since there are different requirements for temperature and pH control.) At the simplest level, the common modern alternatives include the following permutations Vertical laminar flow (VLF) cabinet Neonatal isolette-style IVF Chamber...

Labeling OPU tubes

It is a standard accreditation requirement, and good laboratory practice, that all containers holding a patient's tissues and fluids be labeled (ideally with two unique identifiers see Figure 5.12). An example of where this may not be followed in some IVF labs is in the labeling of the OPU tubes. If the IVF Center is one in which there is always a 30-60 minute gap between oocyte retrievals, then the management might not consider this risk to be very great. However, if the Center is a very busy...