When hospitals began implementing their electronic medical records/electronic health records systems (EMR/HER) the pharmaceutical companies that were conducting clinical trials at those hospitals wanted to sue the date from those systems instead of having the hospitals enter the data in their EHR systems and also in the study data entry system. However, the FDA regulations would require that the hospital systems be "validated". The hospitals and the companies developing the systems argued that was "over-regulation." HIMSS published their Developer Code of Conduct where they said instead they would use Quality Management techniques.
This book covers how to use Quality Management (ISO 9001) to develop computer systems, specifically EMR systems. It gives a basic introduction to how to implement computer systems. It also covers the topic of compliance because the hospitals are required to comply with regulations other than FDS regulations.
The book also discusses the topics of risk management and conducting audits, both of which are part of ISO 9001 quality management of computer systems. The book is designed to give the reader an introduction to the things you have to do when implementing a computer system that has to satisfy some standards and where the accuracy of the information could impact the accuracy of a person’s medical treatment.
Table of Contents
1 Introduction: The Basics
2 Quality Management
3 Managing Patient Information
4 Applying the Organization to Observation Processes
5 Applying Quality Management to Computers
6 The HIMSS-EHR Developer Code of Conduct
7 Developing Standard Operating Procedures (SOPs)
9 Conducting Audits
10 Risk Management
11 Risk Analysis
12 If All Else Fails
Appendix A Deming-Key Principles
Appendix B FDASIA Health IT Report
Appendix C Sample SOPS
Dick Chamberlain has a PhD in Statistics and has consulted with numerous Pharmaceutical, Contract Research Organizations, and Medical Device companies in the areas of Computer Systems Validation, computerized project scheduling, strategic planning, quality management, and qualification.
He has assisted with the development of all varieties of Standard Operating Procedures and other required documentation for Quality Management, Information Quality, and Compliance to Regulations.