Regulation and licensing of IVF

Regulation and licensing are systems that are imposed on an organization, such as a clinical laboratory or an IVF Center. These systems, which are not optional, are usually created and enforced via legislation and consequently vary widely between countries, and even between states in countries such as Australia and the USA. Licensing bodies (e.g. the Human Fertilisation and Embryology Authority, the HFEA, in the UK) typically issue a licence after an inspection process to confirm that an organization is, indeed, operating in accordance with the law. While this process does create some sort of minimum standards to which the facility or organization will operate, there is often no consideration of performance standards or quality within the terms of the licensing process.

Regulation and licensing are therefore not particularly relevant to the focus of this book, and will be left for other authors to explore. Instead, our focus will be on the setting of - and compliance with -Standards that go beyond meeting minimum standards, an approach that can be described simplistically as seeking to achieve best practice. The formalization of such an approach is usually referred to as Certification or Accreditation. As defined above, "Certification" is typically used when referringto standards such ISO Standards (see below), while "Accreditation" is a more broad-based approach founded upon a perpetual process of quality improvement.

As a final word, we must all be aware of other regulations that we are obliged to follow in any workplace:

• Regulations that affect the employer/employee relationship, such as those that create statutory requirements pertaining to maximum work hours, statutory holidays, annual leave, etc. Labor relations in general is an area that no employer can ignore - if for no other reason than a disgruntled employee will be sure to remind him/her ofthem!

• Regulations that concern the handling and use of hazardous materials such as flammable solvents, strong acids and alkalis, liquid nitrogen, radioactive materials, etc. All materials used in the IVF lab must be stored, handled and used correctly for the safety of everyone -and the facility. For example, in Canada and the USA the Workplace Hazardous Materials Information System (WHMIS) is designed to reduce the risk from hazardous products in the workplace at all levels (i.e. suppliers, workers and employers) through proper training and the requirement that a Material Safety Data Sheet (MSDS) for each product must be available to anyone who comes into contact with it.

• General occupational health and safety regulations.

• Fire regulations.

Add to this such things as European Directives and there is a veritable minefield of regulation that affects almost everything we do, from designing a lab to how high a fire extinguisher can be placed above the floor! Just because someone works in a (small) private IVF lab and, in their opinion, "such-and-such doesn't matter here," does not give them any right to break such regulations. Ignore them at your peril!

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100 Pregnancy Tips

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