Vedant Health Blood Bank Validations Providing True Quality Assurance

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1 Vedant Health Blood Bank Validations Providing True Quality Assurance Introduction Blood Bank systems are, by far, the most complex applications in any healthcare environment. They deal with patient safety in every aspect of the system. Therefore, ensuring these systems are compliant and safe at all times is critical. Taking this to heart, Vedant Health has built a series of validation services which ensures both compliance and continued safety. This document will describe our approach and outcome. Tradition & Test Tools In today s world, there are many ways to test a hospital system. While there are a lot of technologybased options available, most turn to the manual testing approach. The hospital staff, or a small testing team, work through documented workflows. Unfortunately, this approach is slow, time-consuming and has a very low percentage of actual testing coverage. This manual testing provides a confidence level for the people performing the testing since that has been their traditional approach. We understand why this inadequate manual approach has been desired over all others. Commercial test tools are another option but are simply too unreliable. While they are very good tools in their own right, one must program (script) them to provide the keystrokes required to replicate the desired workflow to test. In a healthcare environment, this workflow is fluid in that the processing path changes with each system version, day of the week, and patient history. Processing a patient cannot be repeated in the same way every time. The maintenance of these scripts requires a professional programmer spending an inordinate amount of time constantly making changes to keep up with the evolution of the workflows. While initially a less expensive option, the constant maintenance becomes a very expensive venture. This unreliable scripted approach is a serious issue as you cannot trust the end results. This is especially critical when it comes to the complex validation of blood banks.

2 Our Approach Our challenge was to provide a solution which applied the advantage of technology and automation, yet was reliable and more importantly repeatable and adaptive to environmental changes. This is why Vedant Health invested in automation technology to create TestStream and our Classic Validation service. The Vedant Health validation approach works on the principal of applying intelligent technology and the right people: - TestStream provides AI-based intelligent automation that, upon installation, learns each facility s configuration and provides feedback on the state of the system. It then utilizes that same intelligence to process through workflows performing continuous large-scale validations of the system. TestStream is not a test tool. It actually looks at the screen, determines what to do next, then uses the mouse and keyboard exactly like a human would. This ensures reliable and realistic validations that are completely automated. - Our Classic Validation is completed when machines for the automation approach cannot be created at the client site. This validation is performed by our qualified blood bank staff manually utilizing a local technology which tracks and records the elements of the process to provide our normal Gold Standard validation package. This comprehensive package is complete and ready for regulatory inspectors. - Personnel is of significant importance when performing validations. They must interpret the guidelines and requirements correctly to ensure a complete validation is achieved. At Vedant Health, our experienced blood bank staff has previously been responsible for managing, inspecting and teaching at blood banks across the country. Our blood bank staff is utilized for the management of upgrade projects instead of external consultants as is typical with other 3 rd party validation companies. Validating a blood bank system is one of the most critical projects in any healthcare system. The published AABB testing standards for Blood Establishment Computer Systems (BECS), ICCBBA requirements and other accrediting agencies around the world define how a system should work.

3 Our method to ensuring a complete validation is not only to interpret and successfully validate against these standards but to also look beyond them and work from experience to provide additional testing. This ensures not just a compliant system but also a very safe one. The standards and requirements certify that every part of the system will work as expected and going beyond that ensures massive testing coverage. By utilizing this intelligence and technology approach, large scale reliable testing covers the crucial Patient/Unit Compatibility and Result Reactions Interpretations rules validation. Each rule is built separately and independently in every hospital system, so rules outside of the typical workflows are tested as well. An untested rule is a potential problem waiting to happen, and you don t know what you don t test. It is not just vital to provide validation of these important workflows but also to show proof of testing documentation. Our validation package delivers workflow details (scenarios), screen prints, pass and fail reports, issue descriptions and resolution documentation as well as a sophisticated cross-reference matrix. This matrix illustrates the requirements that were tested and in which part of each workflow.

4 This package deliverable, often referred to as the Gold Standard, ensures proof of testing and proof of compliance for all regulatory agencies. As part of this package, the results DVD contains a standalone result reviewing system for the inspectors. Simply insert the DVD and review all of the results. Knowledge and Understanding The blood bank systems of today are very complex and made up of many moving parts. The build (or configuration) must be exact and carefully updated. These configurations are manually created and modified at every facility worldwide. All testing performed is based on the state of the build which must be accurate, therefore the state of the build must be determined prior to the start of any testing cycle. The Vedant Health TestStream solutions contain data analysis tests which are designed to aid in understanding the state of the build. These Data Collection tests execute for a few hours and during that time, extract all of the relevant information from the system. During this extraction of the build elements it is able to determine problems and point them out one-by-one. At the end of the data collection phase, a spreadsheet of all fundamental build issues is presented. This is analyzed by our blood bank personnel who then report the issues back to the client.

5 This Data Collection phase is an important step in regression testing as it contains a snapshot of the build at a specific point in time. Executing multiple Data Collections across multiple environments over certain timeframes can help to determine the changes to a system prior to a regression test or differences in the build between the test environment and the production system. This fundamental understanding of the complex system setup and issue resolution continues our tried and tested approach to validations. Recognizing the differences in the setup between the test and production system also determines the type of tests to be performed. With TestStream, this is a very straight-forward approach and this ability provides critical and valuable knowledge of the system. Risk Assessment Dynamics The goal of any validation project is either to prove the system is reacting as expected or find the situations where it is not and resolve them. When issues are found it is important to fully document the flaw, the potential risk to the patient and a resolution path. During our blood bank validation projects, the timeline is separated in three phases; validation on a frozen build, issue resolution and retest. Any issues found must be collated by risk. For example, if a process works but ultimately the patient is not billed for their blood tests the issue needs to be resolved but fortunately does not harm the patient therefore is a low risk. If an issue is found where a quarantined product can easily be dispensed to a patient this has a very high-risk potential to harm the patient. If the former cannot be resolved prior to go-live it affects the hospital bottom-line, however, if the latter is not resolved before go-live, patients can be seriously affected.

6 The design of all Vedant Health s Blood Bank Validation packages puts this risk assessment front and center when reviewing issues found in the system. More than a decade ago, TestStream was given the ability to understand this concept of patient safety. When large-scale testing is performed there is potential for many issues to be identified. When talking about dozens, if not hundreds of issues identified in a testing cycle, this risk assessment is vital. Which errors should be reviewed first? This concept was developed by inviting several regulatory inspectors to collaborate and design the rules and risk assessment dynamics currently built into TestStream s intelligence system. While a blood banker will be reviewing the output of the automated test runs, this initial risk assessment helps lay out the requirements and timelines for subsequent system fixes and repairs. The TestStream Risk Assessment is then utilized to provide feedback of systems over time. At what point in time was my system at its best and at its worst and why? This intelligence gives you control of the Quality Assurance of the system at any given moment.

7 Regression Testing Keeping the System Safe Ensuring a compliant and truly safe system is important prior to a major system go-live event. However, the system only remains safe when proposed build changes and periodic software updates are tested completely before being added into the production system. After go-live, things change. Regression testing has always been a difficult and time-consuming task since build changes and service pack/software updates are continuously rolled out. Manually performing regression tests is simply not practical. However, through the intelligence-based approach of TestStream, the repeatability of tests under ever-changing conditions is accomplished entirely. Regression tests can be setup once -- triggering every 2-3 weeks or can be simply executed after a change. The Vedant HealthAssure package ensures continued safety checks against these ever-changing systems, protecting patients all day, every day, throughout the year.