Planning Quality Project Management of (EMR/EHR) Software Products

Richard Chamberlain

• Publisher: Productivity Press
• Year: 2017
• ISBN:
  9781351388054
• Edition: 1
• Topic: Negocios y empresa
• Subtopic: Operaciones

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.

Chapter 1

Introduction: The Basics

Patient Safety

We are going to be discussing the implementation and support of computer systems used for managing patient medical information.

We will first cover some notions related to quality that are very important to the treatment of patients, including topics such as

Quality

Quality Assurance

Quality Management

We will then go through the steps of implementation and use of a computer system (the plan) and how quality is incorporated into the implementation.

Whenever this is done here or in other documents the number one concern is always patient safety.

Is anything happening that could negatively affect the safety of the patient or make the patient safer?

Even if a related topic is being examined, like the cost of doing an MRI, the safety of the patient for each cost alternative could be considered.

We will consider patient safety throughout our discussions here.

Quality

The safety of the patient will inevitably be a function of the quality of the procedures used to manage their information and the procedures used to see and treat the patient.

Since we are talking about quality management, quality is very important.

There is a point regarding quality that is often overlooked. That point is that to really do quality management you and almost everyone in the organization has to live and breathe quality.

Quality has to be a way of life. It has to permeate almost everything and everyone. This is based on actual history by the icons of quality.

During W.E. Deming’s time, there was a notion that quality was P-D-C-A, where the letters stand for the following.

Plan–Do–Check–Act

The idea is that you Plan what you are going to do, then you Do it according to that plan. Then, you Check it to see whether it is all correct and Act based on what you see.

Deming referred to this as a “corruption.” He said it should be P-D-S-A. Where you Plan what you are going to do, then you Do it according to that plan. Then you Study it to see whether you really are doing things the best way, and then Act based on what you see. Essentially, there is more to it than just checking. You need to really consider everything you are doing to see whether there is not a better way.

Throughout his work he tried to implant quality throughout an organization.

He is also well known for his 14 points that he considered the basis for “Profound Knowledge.” See Appendix A.

One can tell by these “Key Principles” that quality is the way you do things.

There is another reference, Well Made in America, which is the story of the recovery of Harley Davidson. Harley Davidson almost went out of business in the 1970s. It was bought by AMF (the bowling people). After a couple of years, about a dozen managers in AMF raised some money, bought Harley Davidson back, and took it public. At the same time they decided to improve the quality of the bikes. The quality of the bikes was really bad. They said one year the paint jobs were so bad that as people walked by them in the show room, the air would make the paint flake off and fall on the floor. They also said that 50% of the bikes coming off the assembly line would not start.

They went through a lot of effort and now Harley Davidson motor bikes are arguably some of the highest quality bikes on the market. (I know because I own one.)

In the book above, AMF said they attributed the success of increasing the quality of their bikes to three things.

The first was called EI, or Employee Involvement. They found that they had to involve everyone in the increase of quality. You cannot assign quality to a focus group in the corner and everyone else keeps on working.

The second was JIT, Just In Time, which was an inventory procedure. The problem was that 50% of the materials they were receiving from their suppliers were bad. So what do you do in that situation? They ordered twice as much as they needed and were building huge, worthless inventories. Essentially, they had a lot of bad procedures.

The third thing to which they attributed their success was Statistical Quality Control. The one thing they said they did wrong was, they implement Quality Control (QC) last when they should have done it first.

One definition of the word quality is: producing or providing products or services of high quality or merit.

Much of this notion carries over into the International Organization for Standardization (ISO) and some other standards such as, World Health Organization (WHO), IEEE Software Engineering Standards, American College of Physicians, and the Project Management Institute Body of Knowledge (PMIBOK).

That is, quality involves everyone. It has to become a way of life for it to be effective. It is not something you can assign to a group in the corner.

Auditing

Auditing is a very important component of quality and compliances and a few other issues we are discussing here. Under a 1994 standard [1] and some other documents, the auditing process could be adequately addressed by performing the following compliance auditing:

■Tell me what you are supposed to do (describe the business process)

■Show me where that is written (reference the procedure manuals)

■Prove that is what happened (exhibit evidence in documented records)

■Is this the best you can do?

These steps are basically an audit. Auditing is a very important part of quality assurance.

Most of the discussions of quality will include the phrase, the ability to demonstrate. In other words, there has to be documentation or some other kind of product to show that you are operating according to certain rules or regulations when you do the Study step. It can be very difficult if there is nothing to study.

These rules typically generate a series of steps derived to make it possible for us to follow the rules and produce the desired product. Many of us follow good business practices. The regulatory bodies will argue that the regulations are just good business practice. In any case, there is a need for an underlying process that has been defined and that we try to follow, and this process is defined to have us satisfy any business or regulatory requirements; thus, the need for the processes we have been discussing.

When we have a series of steps that we follow, the questions can be asked: Are you following the process?, Are you producing the desired product?, and Can you show that you are?.

One good way to show you are following the process and producing the desired result is to use quality assurance (QA) practices.

A recommendation: fairly early in becoming compliant, your group should sit down and compile a list of the business practices you are expected to follow and if necessary, any regulations that might apply.

It should become obvious that one of the functions of the ISO 9000 is to show that quality is built in to what you are doing; it is a way of doing things.

Quality Management

Before getting into quality management, it is important to lay out some practice and procedures that have to be understood which form the basis for quality management.

Quality management is quality that is applied to processes. In many cases, these processes are not well-defined or well-understood.

Quality management is a very broad area. Although not the only guidance on quality management, certainly one of the most referenced is ISO 9000. There is extensive documentation on how to apply it and it has its own set of documents that refine or expand on the different parts of the standard.

Even the Food and Drug Administration (FDA), in the document, The Food and Drug Administration Safety and Innovation Act (FDASIA), emphasizes that quality management is required in Electronic Health Records (EHR) systems instead of requiring regulations.

See FDASIA in Appendix B for the following.

The application of quality management principles, including...