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Title: Laboratory Informatics Buyer's Guide for Medical Diagnostics and Research

Edition: 2022 Edition

Author for citation: Shawn E. Douglas and Alan Vaughan

License for content: Creative Commons Attribution-ShareAlike 4.0 International

Publication date: January 2022

Medical labs of all types—from the clinical diagnostics labs of the hospital to the clinical research labs of a medical device manufacturer—at their heart have an overall goal of doing their part towards improving health outcomes among humans and animals. On the surface, this goal sounds relatively mundane; however, the work conducted in these laboratories is anything but mundane. From the use of advanced clinical workflows to the requirement of accurate and timely results, these labs are under a lot of stress to operate effectively, efficiently, and according to regulations. However, well-designed laboratory informatics solutions, when implemented, used, and maintained effectively, provide a means to better achieve that primary goal.

This guide addresses the medical diagnostics and research laboratories in their myriad forms, as well as how laboratory informatics solutions can benefit them. Yet it's more than "here's a laboratory, here's a software system: marry the two, and the magic begins!" These systems have their own intricacies, and its up to laboratory personnel, often not well-versed in such automation solutions, to evaluate and implement them. This guide addresses the numerous considerations that should be made beforehand, and it provides several chapters of resources to help practically put those considerations to work. It also addresses the usefulness of a requirements specification and how to put it to use. In particular, a slightly modified version of LIMSpec is suggested to get the most out of developing and using any requirements specification as part of software and vendor selection.

(NOTE: The PDF output of this guide fails to properly list the references. To see the original document, with references, see here.)

About this book

Introduction

1. Introduction to medical diagnostics and research laboratories

1.1 Medical diagnostics lab

1.2 Public health lab

1.3 Toxicology lab

1.4 Blood bank and transfusion lab

1.5 Central and contract research lab

1.6 Genetic diagnostics lab

1.7 Medical cannabis testing lab

2. Choosing laboratory informatics software for your lab

2.1 Evaluation and selection

2.2 Implementation

2.3 MSW, updates, and other contracted services

2.4 How a user requirements specification fits into the entire process

3. Resources for selecting and implementing informatics solutions

Part 1: Laboratory informatics vendors

3.1 LIMS vendors

3.2 LIS vendors

3.3 ELN vendors

3.4 Middleware vendors

4. Resources for selecting and implementing informatics solutions

Part 2: Other vendors and service providers

4.1 Medical diagnostics instrumentation and equipment vendors

4.2 EHR vendors

4.3 Laboratory business intelligence (BI) and workflow solution vendors

4.4 Laboratory billing service providers

4.5 Consultants

5. Resources for selecting and implementing informatics solutions

Part 3: Industry and community resources

5.1 Trade organizations

5.2 Conferences and trade shows

5.3 User communities

5.4 Books and journals

5.5 Standards, regulations, and guidance

5.6 Further reading

5.7 LIMSpec

6. Taking the next step

6.1 Conduct initial research into a specification document

6.2 Issue some of the specification as part of a request for information (RFI)

6.3 Respond to or open dialogue with vendors

6.4 Finalize the requirements specification and choose a vendor

7. Closing remarks

7.1 Recap and closing

Appendix 1. Blank LIMSpec template for medical diagnostics and research labs

A1. Introduction and methodology

A2. Primary laboratory workflow

A3. Maintaining laboratory workflow and operations

A4. Specialty laboratory functions

A5. Technology and performance improvements

A6. Security and integrity of systems and operations

A7. Putting those requirements to practical use and caveats

A8. LIMSpec in Microsoft Word format