Empowering Laboratory Teams: Taking Charge of Software Change Management
While many laboratories recognize the importance of software change management, they often entrust the process solely to their IT department. This tendency doesn't necessarily stem from resistance to the concept or process itself, but rather from a lack of awareness regarding the potential benefits of effectively managing changes across critical software, including Laboratory Information Systems (LIS) and middleware products. However, delegating the entire process to a third party comes with significant drawbacks, as the IT department may overlook the laboratory's specific requirements and fail to consider the impacts and consequences of configuration and maintenance changes. Given that the functionality of laboratory software is influenced by various internal and external factors, it's essential to be prepared to address each one effectively to uphold the integrity of lab dedicated software systems.
What is Software Change Management?
Laboratory software change management refers to the structured process of implementing and controlling alterations or updates within and across the laboratory environment. This includes managing changes to hardware, software versions, configurations, processes, and procedures to ensure that any modifications does not disrupt the stability, functionality, or security of the laboratory infrastructure.
The process typically involves several stages, including planning, assessing the impact of proposed changes, obtaining approvals, implementing changes, testing to ensure compatibility and functionality, and finally, documenting and communicating the changes to relevant stakeholders.
Effective change management aims to minimize risks associated with changes, such as system downtime, data loss, or security breaches, by following standardized procedures, utilizing change management tools, and involving key stakeholders throughout the process. It helps to maintain the integrity and reliability of the laboratory software environment while enabling necessary updates and configuration changes testing that improve the workflow and usability of the laboratory software systems.
What Changes need to be Managed by the Lab?
It is good practice to categorize and specify the types of anticipated changes within the laboratory software assets, including interconnected systems. Each category should follow a standardized pathway for review and implementation. However, it's crucial to acknowledge that there may be unique circumstances or requirements that warrant consideration when cataloging these change categories.
Here is a list of changes to consider for change management.
System configuration changes (e.g. new tests, reference ranges, units, calculations, comments)
Software additions (e.g. auto-verification, new modules, add-ons to current functionality)
Software updates and upgrades
Hardware replacements, updates or upgrades
Upstream and downstream adjacent software changes, updates & upgrades
Replacement of current system software systems
Global system changes that impact the entire organization (network, infrastructure)
Who should be Involved in the Change Management Process?
An effective change management system ensures smooth transitions when implementing new software or making significant updates. In this context, "software stakeholders" refers to individuals or groups who have a vested interest in the software being implemented or modified. For a lab environment, this typically includes clinical subject matter experts, laboratory management, IT personnel, end-users including the customers that the laboratory serves.
The inclusion of laboratory users, clinical experts and management recognizes the importance of integrating clinical knowledge into the change management process, particularly in healthcare settings where software often directly impacts patient care. Involving clinical subject matter experts ensures that changes align with medical best practices, regulatory requirements, and the needs of healthcare professionals and patients. This collaboration helps to identify potential challenges early, tailor solutions to fit clinical workflows, and ultimately increase the likelihood of successful adoption and positive outcomes.
Change Management Process – Defining the Process
Encouraging shared responsibility and collaboration within the change management process framework ensures that every stakeholder plays a role in decision-making. This collective approach enhances the likelihood of the change management process persisting throughout the software systems' lifecycle and becoming a standard and enduring practice.
Defining a software change management process typically involves several key steps:
Identify Goals and Objectives: Begin by grasping the rationale behind the necessity of change management for software systems. The planning team should then proceed to define clear goals and objectives that align with the overarching strategy for the change management process. These objectives might encompass enhancing software reliability and stability, elevating user satisfaction, minimizing downtime, or mitigating clinical errors. Prioritize these goals and objectives accordingly to ensure focused and effective implementation.
Stakeholder Analysis: The change management team should Identify all stakeholders involved in the software change process. This includes clinical users, management, IT personnel, and any other relevant parties. Each stakeholder or group(s) should be interviewed to determine their needs, concerns, and expectations that will help tailor the change management process to fit their requirements.
Document Current State: Document the current state of the software system, including its architecture, functionality, and any existing processes for change management. This provides a baseline against which to measure the impact of proposed changes.
Risk Assessment: The primary objective of change management is to mitigate the risks associated with any alterations to the software and its interconnected systems. It is crucial to identify potential risks related to software changes, including compatibility issues, data loss, security vulnerabilities, operational disruptions, and their potential effects on patient care. Conducting a thorough risk assessment for each change is essential to gauge its impact on staff, other software systems, and ultimately patient care.
Define Change Management Procedures: Clear procedures should be developed for managing software changes from request initiation to implementation. This typically includes steps for requesting changes, assessing their impact, testing, approval, deployment, and monitoring. Roles and responsibilities should be defined for each step to ensure accountability. A flow chart can identify the steps in the process including interaction points for each stakeholder.
Communication Plan: Developing both an internal and external communication strategy is essential to keep stakeholders informed throughout the change management process. Internally, stakeholders need to be notified of upcoming changes, provided with regular status updates, their concerns addressed, and their feedback actively sought. Externally, a communication plan should be established specifically tailored to the lab's customers, informing them of major clinical changes and any planned or unplanned downtime that may affect their operations or services.
Testing and Quality Assurance: A critical element of the change management process lies in crafting a standardized testing strategy to validate changes prior to deployment. This entails a comprehensive approach, encompassing unit testing, integration with upstream and downstream systems, and acceptance testing, all aimed at verifying that the software operates as intended and adheres to quality standards. It's imperative to establish clear agreements for each testing type or category, outlining methodologies, testing tools, documentation needs, and delineating responsibilities for approval and sign-off.
Training and Support: Any change that modifies existing workflows or introduces new ones should be complemented by a comprehensive training program aimed at supporting users and stakeholders impacted by the software changes. Such a program facilitates swifter adoption of the software and helps to alleviate frustration and misunderstandings.
Deployment and Rollback Procedures: A holistic change management plan must include standard procedures for deploying changes into production environments and rolling them back in case of issues or failures. This includes contingency plans and backup strategies for all systems impacted to minimize disruptions to operations.
Continuous Improvement: The majority stakeholders should periodically monitor, evaluate and report back to all stakeholders the effectiveness and opportunities for improvement. The owners of the change management process should select key indicators to track performance and grade themselves on the outcomes of initial projects and illicit feedback on the actual performance over time.
Summary
Once software systems are placed into operation, they become subject to inevitable change. Establishing a robust change management process becomes imperative to safeguard the safety, effectiveness, and stability of the software system(s) and interconnected systems. This process orchestrates a careful collaboration among stakeholders, spanning from identifying necessary changes to their full implementation. It entails not only the technical aspects of maintaining system functionality but also the delicate balance of addressing end-user needs and expectations. Smooth implementation of changes is essential to mitigate risks while enhancing both the end-user experience and the quality of patient care.