Building the Laboratory

This chapter focuses on the critical aspects of building a laboratory in a private practice setting as part of an assisted reproductive technology (ART) clinic. Knowledge of these factors is essential for ART professionals planning a new facility or redes

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Building the Laboratory Dean E. Morbeck and Marlena Duke 3.1

Introduction – 22

3.2

Laboratory Layout – 22

3.2.1 3.2.2 3.2.3

 eneral Considerations – 22 G Small IVF Center (500 Cycles/Year) – 23

3.3

Room Construction – 24

3.4

Laboratory Support Systems – 24

3.4.1 3.4.2 3.4.3

 lumbing – 24 P Electrical System – 25 Alarm System – 25

3.5

Other Laboratory Features – 25

3.6

New Construction: Validation Before Patient Care – 26

3.7

Conclusions – 26

Review Questions – 26 References – 26

© Springer Nature Switzerland AG 2019 Z. P. Nagy et al. (eds.), In Vitro Fertilization, https://doi.org/10.1007/978-3-319-43011-9_3

3

22

D. E. Morbeck and M. Duke

Learning Objectives

3

55 To understand the key differences in laboratory design for different size clinics. 55 Describe the essential elements of the plumbing, electrical, and alarm systems. 55 Process for validation before patient care.

3.1  Introduction

As new in  vitro fertilization (IVF) laboratories continue to appear in private practice settings, it is paramount that the reproductive endocrinologist and laboratory director are well-versed in laboratory design. Unlike large institutions, where specialized engineers and contractors are available to design and build clean room-quality operating rooms and laboratories, professionals in the assisted reproductive technologies (ART) must navigate a specialty for which they have little training or experience. Unfortunately, there are limited resources and references available to ART professionals when setting out to build a new laboratory. Standards for IVF laboratories published by professional societies and accrediting agencies are mostly lacking, and those that exist are superficial at best. Both ESHRE and ASRM provide minimal guidelines for laboratory space and design [1, 2]. This leaves the individual responsible for the design and supervision of building the laboratory to rely on other sources, particularly standards that exist for operating rooms and clean rooms. These two types of rooms represent the range of quality one should aspire for their facility: the operating room at a minimum and the class 10 or class 100 clean room as the maximum. Even within these types of facilities, there are aspects of design and management that are unique to an IVF laboratory. This chapter focuses on the critical aspects of building a laboratory in a private practice setting as part of an ART clinic. The details presented here will delve into issues of laboratory design and construction, with the notable exception of the heating, ventilation, and air conditioning (HVAC) system. The goal of the well-designed IVF laboratory is an environment that fosters both good working conditions and air quality compatible with excellent IVF outcomes. Air quality is a function of HVAC design, room design, choice of building materials, and activities conducted therein and adjacent to the laboratory. Air quality management deserves its own chapter and merits emphasizing the importance of hiring a design-buil