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ALINITY H-SERIES

PLANNING FOR CHANGE A GUIDE TO TRANSFORMING YOUR LABORATORY WITH CONFIDENCE

CORE DIAGNOSTICS

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

PL ANNING FOR CHANGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

COMMUNICATION STRATEGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

TECHNOLOGY COMPATIBILIT Y ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

TRAINING PL AN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

GOVERNANCE APPROACH . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

IMPLEMENTATION PL AN . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

CELEBRATING SUCCESSES AND RECOGNIZING CHANGE CHAMPIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14

Table of Contents

INTR O DUCTION

This guide was created to help plan for a successful technology transition and to

support you in your laboratory’s transformation. It provides important implementation

considerations and step-by-step recommendations on how to successfully implement the

Alinity h-series in your laboratory. It also summarizes key differences and benefits, both

technically and clinically, of the system.

This guide, along with dedicated training, customer support and other educational

resources, are all designed to help you with the seamless implementation of your Abbott

solution and to give you the confidence you need as you begin your transformation journey.

The adoption of a new hematology

system, like the Alinity h-series, can

result in efficiency gains for your

laboratory. However, technology change

can also disrupt the daily routine of your

laboratory staff. If not addressed early, it

can result in delays in achieving test of

record and also impact staff morale.

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PL ANNING FOR CHANGE

to set expectations, as well as gain early buy in and engagement from all major stakeholder segments

COMMUNICATION STRATEGY

to mitigate any integration issues (connectivity and rules set up) with either middleware or LIS, and help ensure that Alinity h-series is configured to meet your workflow needs

TECHNOLOGY COMPATIBILITY ASSESSMENT for various user segments that is aligned

with how their job may be impacted by the Alinity h-series

TRAINING PLAN

that includes a mix of stakeholders that may be impacted by the introduction of Alinity h-series

GOVERNANCE TEAM

A successful laboratory transformation starts with a detailed change management plan in support of Alinity h-series installation and implementation that typically includes the following elements:

that may be monitored for any necessary course corrections

IMPLEMENTATION PLAN AND SCHEDULE the achievement of key milestones and

recognize change champions

PLAN TO CELEBRATE

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Early and frequent communication with key stakeholders can help ease the adoption of Alinity h-series in your organization. As part of your communication strategy, begin by identifying major stakeholders and how they will be impacted by the transition to Alinity h-series from your current system. Additionally, consider any ways in which your organization can mitigate negative impacts to these stakeholders.

A stakeholder mapping exercise may help you in identifying these key individuals, what’s important to them, important

points to communicate to set appropriate expectations, communication channel and the frequency of communication. A sample template, with considerations for various stakeholders, is provided in the table below. Even before executing the targeted communication plan, it may be appropriate to announce the laboratory’s plan to transition to Alinity h-series in collaboration with the hospital public relations (PR) department and communicate via social media, the hospital newsletter, or other internal channels to ensure overall awareness of the upcoming change.

COMMUNICATION STRATEGY

Stakeholder Care Abouts Communication Points Communication Channel

Frequency of Communication

Communi-cationLead

Medical Technologists

• Impact on workflow

• System operation and performance

• Implementation plan

• Technology differences and similarities

• Staff meeting

• In person workshops and demos

Weekly Project Lead

Laboratory Managers

• Impact on laboratory efficiency

• Clinical performance

• Workflow and KPI considerations

• SOP updates

• Staff meeting

• In person workshops and demos

Weekly Project Lead

IT • Compatibility with LIS and middleware • Provide connectivity requirements • In person planning

meetingWeekly, through integration

IT Represen-tative

Pathologists • Clinical performance

• Provide an update on changes to nomenclature for available parameters / flags

• Discuss any revisions to reference ranges

• Generate evaluation data and review results

• Review any new annotation requirements

• Provide progress updates and go-live date

• Interdepartmental memo

• Medical staff ground rounds

As needed, continuous, post implementation

Program Lead

KEY TAKEAWAYS• Perform a key stakeholder analysis prior to the start of installation and integration

• Develop and execute a comprehensive communication plan that will help ease the transition to

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Alinity h-series LIS Interface Manual (HL7)

Alinity h-series LIS Interface Manual (ASTM)

QUALIT Y MANAGEMENT

ANALYZER & L ABORATORY AUTOMATION SYSTEM MANAGEMENT

REPORTS

Monitors assay and instrument quality performance to help ensure accurate results

Controls the performance of instruments and automation track systems

Track and summarize data from connected analyzers

EXPERT DECISION RULES

TEST MANAGEMENT

SAMPLE MANAGEMENT

Automate workflow and data management processes without the need for manual intervention

Automates the analysis of patient test orders and results

Manages sample workflow, logistics and archiving to optimize sample processing

TECHNOLOGY COMPATIBILIT Y ASSESSMENT

Ensuring and planning for connectivity and compatibility with the Laboratory Information System (LIS) or middleware upfront can help avoid issues later during the implementation and installation of your Alinity h-series system. A member of the IT department should be included as part of your implementation team to support these activities and coordinate with subject matter experts within your organization and within Abbott, and to receive resources regarding connecting the Alinity h-series to your LIS or middleware.

The Alinity h-series (analyzer) supports two types of LIS interfaces: CLSI (ASTM) and Health Level 7 (HL7). The analyzer can be configured to use one or the other; however, the HL7 interface is the recommended interface for Alinity h-series based on additional messaging capabilities, more robust messaging and conformance with the most current In Vitro Diagnostic (IVD) industry standards. Additional details regarding interfacing the system to either LIS interface is provided in detailed manuals that are available in the technical library or through your Abbott Resourceful Advocate.

Your laboratory may also need to include middleware set up as part of your implementation planning. Middleware applications host a variety of capabilities to assist the Hematology laboratory and other disciplines with the management of data, tasks and processes.

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To begin your Alinity h-series to middleware application integration process, we can support your assessment of capabilities that are currently available and any additional needs your laboratory may have. Based on this analysis, an Abbott Resourceful Advocate can work with your laboratory and IT representative to discuss opportunities and, if you have the Abbott middleware solution, AlinIQ AMS, configure your application to optimize the Alinity h-series workflow for the unique patient population served by your laboratory.

Although not directly related to compatibility with LIS or middleware, an additional point to consider is the impact of new, clinically reportable parameters available on the Alinity h-series system that may not have been available on your previous hematology analyzer. These new parameters need

to be factored in to ensure interface and order availability if needed.

Setting up AbbottLink connection for the Alinity h-series is one of the last vital steps in the integration process. AbbottLink transmits critical operational data to technical support in real time, enabling support and service representatives to proactively monitor and address some issues for the Alinity h-series before they arise. We can provide this benefit to your laboratory by connecting your Alinity h-series to AbbottLink. However, it may require a LAN connection for a personal firewall that isolates the instrument from the laboratory network. Working with your IT department and your Abbott representative can help ensure a clear understanding of requirements to support a seamless integration.

KEY TAKEAWAYS• Engage IT early to ensure that they have a seat at the table and are provided with compatibility

requirements for the Alinity h-series (LIS, middleware and AbbottLink)

• As part of the IT integration plan, review any new parameters with your IT representative to ensure interface and order availability

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TRAINING PL AN

Alinity h-series was designed to support an intuitive user experience that extends from reagent and sample management to navigation of the user interface. However, as with the transition to any new hematology system, there are differences that need to be factored into the training plan for operators as well as your customers – clinicians and referring physicians - that use the results to support their decision making.

We also recognize that key stakeholders throughout the organization may have questions regarding the Alinity h-series system and recommend that they are included in your training consideration.

An example of potential training topics and key stakeholders to include are provided in the table below.

The Alinity h-series is an optical system that leverages Advanced MAPSS™ technology; as such, there may be differences relative to your existing hematology system. A few examples and considerations are listed below.

• Available scatterplots: The Alinity h-series supports 54 scatterplots; the ones displayed may need to be customized for your laboratory

• References ranges: If your current analyzer uses impedance as the base technology for red blood cell (RBC) analysis, differing results may be observed in a method comparison study, which may require a re-evaluation of reference ranges with the clinical staff

• Nomenclature and units, and differing methods for the enumeration of parameter results: An optical platelet is provided with every CBC whereas some systems may provide an impedance-based platelet count than reflex to an optical platelet

• Flags available and nomenclature: Red cells are analyzed on a cell-by-cell basis, creating the need to review any new flags and rules set up in either LIS or middleware, as well as workflow updates for a flagged result

Training TopicsLaboratory Scientist/Technologist

Lab Manager/Director Pathologist Ordering

Clinician

Understanding the features and capabilities of Alinity h-series and differences relative to your current system X X X X

Basic instrument operations X X X

Instrument troubleshooting X X X

QC management and how to use moving averages X X

Interpreting the clinical significance of scatterplots X X X X

The principles of Alinity h-series flagging performance X X

Bringing it all together: Abbott-facilitated reviews of your unique cases X X X

Alinity, accreditation and assessing your SOPs X X X

An overview of middleware use and operation X X X

The clinical significance and value of new parameters (e.g., IG) X X X

The basics of hematology X X X X

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To support your organization’s understanding of Alinity h-series, we have created an educational portal, Hematology & Hemostasis Academy (HHA), that offers personalized and relevant training resources. These resources are designed to help refresh your knowledge and keep you informed of the latest hematology laboratory topics, including clinical approaches and technologies. HHA offers a wide range of

courses, case studies, how-to videos and webinars.

We recognize that your institution may have unique educational requirements; an Abbott Resourceful Advocate would be happy to work with you and your team to develop customized courses to help streamline the transition to Alinity h-series.

KEY TAKEAWAYS• Develop a training plan that serves to not only educate stakeholders on Alinity h-series operation, but also

supports your organization’s overall understanding of what may change with the adoption of the system

• Alinity h-series is an optical system – there may be differences in method comparison results and a need to update your reference ranges in collaboration with your clinical and laboratory staff, and to educate key stakeholders regarding these changes

• Review and revise your current protocols and follow up procedures as needed

• Ensure that key clinical stakeholders understand the purpose and value of new parameters

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GOVERNANCE APPROACHImplementation and installation of the Alinity h-series solution in your organization requires disciplined planning, communication and expectation setting (time and resource requirements), understanding of technology differences to identify dependences within your laboratory ecosystems and of course a governance approach to support change and monitor progress.

This governance approach should include resources not only from Abbott, but also mirrored resources from your organization. This governance team should be comprised of the following functional responsibilities; however, it should be adjusted to suit the needs of your organization and the scale of your implementation.

• PROGRAM MANAGER: Responsible for coordination of all aspects of the transition, including tracking and communication of progress against key milestones

• PROJECT LEAD: Responsible for driving and monitoring key activities to achieve major milestones and the coordination of logistical activities (shipment, delivery, verification and validation activities, etc.)

• IT REPRESENTATIVE: Serves as a liaison to the hospital IT department to ensure visibility to compatibility requirements for Alinity h-series

• TRAINING COORDINATOR: Develops and executes training activities for operators and clinical stakeholders

Depending on the scope of your Alinity h-series project (multi-site vs single site, track connectivity, a Pan-Alinity solution), the governance team may be extended to include other stakeholders if required (i.e., a clinical representative may be appointed in the event that a revision to the reference range is warranted), and individuals may serve in a dual capacity (i.e., as both the program and project lead.

In addition to the formation of a governing team, the progress against the key milestone may be monitored by a simple dashboard that:

• Reviews progress against installation and integration activities (what is the status of the instruments?)

• The execution of communication and training plans (what percentage of the operators have completed their training curriculum?)

• And any issues or concerns that have been raised and require remediation

The cadence of team meetings should keep pace with the overall timeline for project execution. A set agenda focused on key priorities may be established for each team meeting to maximize productivity. While the project plan may be reviewed daily, the dashboard may be reviewed on a weekly basis to celebrate areas of progress and re-allocate resources to address any implementation gaps.

KEY TAKEAWAYS• The governance approach to drive the transition to Alinity h-series requires the people (from Abbott and your

organization) and the process (working meetings and tracking dashboards)

• Establishing the governance approach upfront clarifies roles and responsibilities, and streamlines communication between your organization and Abbott 10

IMPLEMENTATION PL AN

The implementation plan is one of the most critical components for ensuring the smooth transition from your existing hematology system to the Alinity h-series solution. The following checklist, which your Abbott Resourceful Advocate will guide you through, includes some of the key elements of a successful implementation plan:

PRE-IMPLEMENTATION IMPLEMENTATION

Decision made on parameters to be reported and evaluated as part of the protocol

Decision made on standards for the validation protocol (precision, accuracy, analytical sensitivity, patient correlation studies, etc.)*

Clinicians within the institution properly informed of new parameters

Confirmed compatibility of tubes routinely used within your laboratory and inform referring physicians or clinics of tube dimension and labeling requirements

Update ordering systems with procurement and assess inventory needs based on sample volumes

Determine reagent storage requirements and location

Establish go-live date

Execute validation protocol and review results with clinician and laboratory stakeholders

Decision made on reference ranges and clinicians within the institution properly informed if necessary

– Overall

– Gender specific

Decisions made on staining protocol and staining protocol customization

Format and comments for LIS report determined

Schedule on-board maintenance at a convenient time, given your laboratory’s workload

Other special considerations agreed upon (i.e. flagging protocol, auto verification rules, etc.)

POST-IMPLEMENTATION

Opportunities for optimization of workflow, including a workflow study facilitated by Abbott and updates to rerun and reflex rules within your middleware, if applicable

Alinity hq uses a combination of photometry, optical counting and fluorescence analysis in order to enumerate cells and cellular constituents. An advanced version of Abbott’s MAPSS™ technology provides enhanced differentiation of various cell types. A blue diode laser forms the center of an alignment-free optical bench and the instrument utilizes a total of eight light scatter detectors including four intermediate angles of light scatter and one fluorescent channel. The system reports on 29 clinical parameters and delivers a 6-part differential, including IG.

Given the potential difference in underlying analysis and

enumeration technology as compared to your current system, your Abbott Resourceful Advocate can support your laboratory in assessing differences in methodology, and how your laboratory can prepare for these differences by LIS/middleware updates, flagging protocol revisions or communication to ordering physicians.

A sample worksheet, with examples of Alinity hq considerations, is provided below. As part of the pre-implementation process and as an output after your readiness workshop, we recommend completing this assessment in collaboration with your Abbott Resourceful Advocate.

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*To aid your institution in establishing standards, please reference the Alinity h-series Operations Manual for expected performance.

TRAINING TOPICS ALINITY HQ CURRENT TECHNOLOGY KEY CONSIDERATIONS

FOR MY LABORATORY

White Blood Cells (WBC) Methodology

• Optical Scatter and Fluorescence

• Dye stains nuclei of all cells (viable and non-viable WBC and NRBC)

• The algorithm utilizes optical scatter along with fluorescence signal to separate different cell types including high fluorescent lymphocytes and NRBC

• 6-part Diff (Neu, Lym, Mono, Eos, Baso, IG)

• IG separate and not as part of the neutrophil count

Nucleated Red Blood Cell (NRBC) Methodology

• Fluorescence

• WBC reagent contains a membrane permeable, fluorescent nuclear dye that stains all nucleated cells (WBC, NRBC); does not stain RBC

Lyse-resistant Red Blood Cells (RBCs)

• rstRBC are separated from WBC based on lack of nuclear fluorescence

• When rstRBC present, WBC count is valid and accurate

• No correction of WBC or reflex testing are needed.

• No need for extended lysis

Platelets• Optical counting

• Multidimensional approach with 6 channels to provide differentiation from RBCs

Staining Performance

• Supports pre-defined protocols for both Wright Giemsa and May-Grunewald-Giemsa

• Offers 3 customizable protocols for each

Flagging Performance

7 morphological flags• Band/Left Shift• BLAST• VAR LYM

Operation and Workflow

• Front loaded system with dedicated STAT lanes

• Parallel vs. serial processing

• Scheduled maintenance activities

Other Considerations

(Tube Compatibility, Labeling Requirements, eQC Programs, Additional parameters (MCV and RDW) that may be impacted by technology)

KEY TAKEAWAYS• Implementation planning includes pre- and post-activities

• Reviewing and preparing for differences in underlying technology vs your current system helps to more effectively prepare the organization for change

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• RBC Frag• rstRBC• HGB Interf• PLT clump Flag

COREL ABOR ATORY ABBOT T 8

When transitioning to a new technology, it is easy to focus only on operational considerations, like technology differences, planning, governance, training and schedules. While they are critical to supporting a successful transition to the Alinity h-series, it’s also important to factor in the people element and their engagement during this transformation journey.

An effective method for engaging stakeholders throughout the organization is to not only communicate key milestones but also celebrate them and the individuals that contributed, publicly. Your Abbott Resourceful Advocate can support you with organizing these events along the way. Some suggested celebration activities include:

CELEBRATING SUCCESSES AND RECOGNIZING CHANGE CHAMPIONS

NEW TECHNOLOGY INTRODUCTION OPEN HOUSE

GO-LIVE RIBBON CUTTING CEREMONY

100,000 PATIENTS SERVED INTERNAL PRESS KIT

• We can support you in organizing an open house to celebrate the arrival of the Alinity h-series system to your organization

• Technology introduction stations can be set up to review the capabilities of Alinity h-series, review educational resources available to accelerate the learning curve, discuss some of the technology differences between Alinity h-series and your current system and also have some fun reviewing patient cases and associated scatterplots

• This is also a great opportunity to identify Change Champions within the organization. These individuals may be paired with an Abbott Representative to staff the technology introduction stations

• The Ribbon Cutting Ceremony is a great way to engage Hospital Administration and Referring Physicians in the achievement of this critical milestone and also to publicly recognize the role that the Change Champions have played along the transformation journey

• Helping to support the care of 100,000 patients is a major achievement for your laboratory and one that deserves to be celebrated

• We can support you in publicizing this accomplishment internally with newsletter templates, imagery suggestions and in some cases, video testimonials featuring some of your Change Champions that may be shared throughout your organization

KEY TAKEAWAYS• Don’t forget about the people; their engagement and support is critical to streamline adoption for the Alinity h-series

• Don’t forget to celebrate key accomplishments along the way

These are just a few ideas to motivate your people through the transition and maintain their engagement from the beginning of the journey and beyond.

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ADDITIONAL REFERENCES AND RESOURCES

ACCREDITATION REQUIREMENTS

e.g. ISO 15189 and CAP checklists

REGIONAL AND INTERNATIONAL GUIDELINES AND RECOMMENDATIONS

• CLSI H26- A2 Validation, Verification and Quality Assurance of Automated Hematology Analyzers

• ICSH Guidelines for the evaluation of blood cell analyzers

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Alinity h-series is available in select countries, not including the US. Alinity hq is a Class I laser product. For in vitro diagnostic use only. Refer to the Operator’s Manual for operational precautions, limitations, and hazards.

© 2020 Abbott. All rights reserved. All trademarks referenced are trademarks of either the Abbott group of companies or their respective owners. Any photos displayed are for illustrative purposes only. Any person depicted in such photos may be a model. ADD-00073370 10/20.

COREL ABORATORY.ABBOT T