Tell Me About Your Lab — Where Should I Start?

• In one sentence, how would you describe your anatomic pathology operation (sites covered, academic vs community, and primary case mix)?
• How many pathologists and full-time equivalent lab staff support diagnostic sign-out and slide preparation? Options: 1–5, 6–15, 16–30, 31–60, 60+
• What percent of cases today are handled primarily on a microscope versus any digital review? Options: 0–10%, 11–25%, 26–50%, 51–75%, 76–100%
• Which slide types make up your routine workload? Pick all that apply and add others below. Options: H&E, Immunohistochemistry (IHC), Special stains, Frozen sections, Cytology, Other
• Roughly how many slides (or whole slide images) do you process in a typical week? Options: <500, 500–2,000, 2,001–5,000, 5,001–15,000, 15,000+
• Who typically initiates a change to workflow tools (e.g., scanners, viewer, LIS integrations) in your organization? Options: Pathology Chair, Lab Director/Manager, Health system CIO, Procurement, Clinical Operations, Other

If We Kept Doing What We’re Doing, What’s the Price?

• What current problems have become 'normal' in your lab that you suspect are costing clinical quality or staff morale?
• How often do these problems lead to measurable patient-impact events (delayed diagnoses, specimen misrouting, consult delays)? Options: Weekly, Monthly, Quarterly, Rarely, Never / unsure
• Tell me about a recent case where the existing workflow failed to meet expectations—what happened and who had to compensate?
• Which outcomes are you most worried will get worse if nothing changes in the next 12–24 months? (Select up to three.) Options: Turnaround time (TAT), Diagnostic accuracy/concordance, Pathologist recruitment/retention, Operational cost, Regulatory compliance risk, Ability to enable remote sign-out
• How does it feel day-to-day to manage those frustrations—frustrating, overwhelming, tolerable, energizing to fix? Options: Frustrating, Overwhelming, Tolerable, Motivated to fix, Other

What’s Really Causing the Slowdowns and Risks?

• Where do bottlenecks most often occur in your slide-to-diagnosis flow (pre-analytic, scanning, QC, image retrieval, reporting)? Options: Pre-analytic (prep/staining), Scanning throughput, Scanning QC failures, Network or storage access, Viewer performance/UX, LIS integration/reporting
• What is your current scanner footprint (models, throughput per day, on-site vs shared service)?
• How frequently do scanning QC errors (focus, artifacts, slide orientation) require re-scans or delay reporting? Options: Daily, Several times/week, Weekly, Monthly, Rarely/never
• Tell me about your storage architecture and constraints—what retention policy, usable capacity, and growth rate are you planning for? Options: On-prem SAN/NAS, Object storage (on-prem), Private cloud, Public cloud, Hybrid
• How integrated is your image management/viewer solution with your LIS and EMR today? Options: Tight (bi-directional, single sign-on), Partial (some integrations, manual steps), Minimal (file links or separate systems), None / planning to integrate
• Do you have network or bandwidth constraints that slow remote access to whole slide images? Options: Yes, significant, Moderate, Minor, No constraints / unsure

Who’s Holding the Keys — And Who’s Quietly Suffering?

• If you had to name the five stakeholders who must be convinced to move forward, who are they and what does each care about most?
• Which stakeholder or group is most likely to resist a move from microscope to digital sign-out, and why? Options: Staff pathologists, Department leadership, IT, Compliance/Quality, Finance, Other
• Who would be the project executive sponsor and who would own day-to-day operational implementation?
• How do frontline pathologists talk about digital pathology today—curious, skeptical, cautiously interested, or actively pushing for it? Options: Curious, Skeptical, Cautiously interested, Actively advocating, Indifferent
• Have you identified local champions or early adopters who would lead validation and help peers accept screen-based sign-out? Options: Yes, several, One or two, None yet, Unsure

Picture That Future — What Does Success Feel Like?

• Imagine primary-diagnostic digital sign-out is routine here — what three changes would convince you this program is a clear success?
• Which measurable success signals matter most to you? Select up to three. Options: Faster TAT, High diagnostic concordance with glass, Increased remote sign-outs/coverage, Reduced consult turnaround, Fewer re-cuts/re-scans, Lower per-slide operational cost, AI-assisted detection improving accuracy
• What timeline would make a digital validation and phased rollout feel acceptably fast but realistic? Options: 3–6 months, 6–9 months, 9–12 months, 12–18 months, Longer / unsure
• What would you consider a minimum acceptable concordance rate between digital sign-out and glass-based sign-out for primary diagnosis? Options: ≥98%, 95–97%, 90–94%, I don’t know / need guidance
• How important is the ability to add regulatory-cleared AI tools versus deploying non-cleared research tools in a controlled way? Options: Essential (only cleared tools), Important but flexible, Prefer research-first, Unsure

What Would Make You Stop Worrying and Say Yes?

• What are your non-negotiable requirements before you would approve a purchase (e.g., FDA clearance, local validation, budget cap, reference visits)?
• How much validation evidence do you need from a vendor (internal validation reports, multi-site studies, peer-reviewed publications, reference site visits)? Options: Internal + one reference site, Multi-site published data, Peer-reviewed independent studies, Regulatory clearance is enough, Unsure
• How would you prefer validation to be staged—consultation/pilot only, pilot → phased roll-out, or full validation before deployment? Options: Consultation then pilot, Pilot then phased roll-out, Full validation before any clinical use, Other
• What level of training and proctoring would make pathologists and lab techs feel confident at go‑live? Options: In-person proctored sessions, Remote live training + on-demand modules, Vendor-led on-site validation, Train-the-trainer model, Combination
• Which commercial/contract terms would be deal-breakers for you (e.g., CAPEX-only, no performance SLAs, lack of maintenance/support)?

First Small Steps — Who Does What and When?

• If we agreed to a pilot today, what would a successful 90-day pilot look like to you?
• Who must be named as owners for these areas: clinical validation, IT integration, procurement, and training?
• What internal approvals and timelines do we need to factor in (budget cycle, IRB/QA review, credentialing)? Options: Quarterly budget cycle, Annual budget cycle, Immediate/available budget, Requires IRB/QA review, Other
• What KPIs should we include to objectively evaluate the pilot (select up to four)? Options: Percent digital sign-outs, TAT change, Concordance rate, Number of rescans/QC failures, User satisfaction score, Storage cost per TB
• What would success governance look like after pilot—how often should we meet, who signs acceptance, and what remediation path is acceptable?
• Finally, is there anything we haven’t asked that keeps you up at night about going digital? Tell us the single biggest unknown we'd need to solve.

• Current State & Consequence Workshop
• Clinical Use-Case Mapping & Acceptance Criteria
• Solution Proof Walkthrough: Scanners, Viewer, Storage, and AI
• Live Case Simulation — Pathologist Acceptance Session
• Integration & Operational Readiness Review (Pre-POC Governance)

• Decide whether to proceed to a broader POC/pilot or re-run a targeted remediation simulation.
• Recap Current State & Success Signals
• Produce a use-case map tying each workflow step to the operational outcome it must enable.
• Document explicit, measurable pathologist acceptance criteria for each prioritized use-case.
• Select and prioritize the 2–3 use-cases we will prove in the POC/Live Simulation.
• Agree on acceptable failure modes and temporary mitigations during POC.
• Seller to produce an Acceptance Criteria Matrix (per use-case) with numeric thresholds and circulate for sign-off.
• Customer to nominate pathologist SMEs and confirm list of representative cases for POC.
• Both parties to agree on POC success metrics and how they will be measured (e.g., concordance %, viewer latency ms).
• One-sentence Future State Recap
• Provide demonstrable evidence (only) that the proposed solution can achieve the agreed future-state outcomes.
• Force explicit customer validation (yes/no) against each acceptance criterion demonstrated.
• Identify and rank remaining gaps that must be closed before POC sign-off.
• Agree scope of the hands-on POC (cases, duration, performance metrics to collect).
• Seller to deliver recorded proof artifacts and measured performance numbers (latency, throughput, concordance samples) within 3 business days.
• Customer to confirm which demonstrated items are accepted and which require remediation, with rationale.
• Both parties to finalize detailed POC scope document (cases, duration, metrics to capture) and sign it off.
• Session Objectives & Success Criteria
• Obtain explicit pathologist pass/fail on acceptance criteria for each tested case type.
• Capture detailed usability issues and clinical concerns with owners assigned for remediation.
• Introductions & Meeting Objective
• Customer to return structured pass/fail votes and qualitative feedback within 48 hours after the session.
• Seller to supply a remediation plan for any failed acceptance criteria with timelines and resource commitments.
• Both parties to confirm the pilot start date (if accepted) and validation measurement cadence.
• Recap Decisions from Proof & Acceptance Sessions
• Finalize integration requirements, owners, and a realistic timeline for pilot deployment and validation.
• Agree the validation plan with sample counts, concordance targets, and checkpoints that will constitute POC success.
• Establish governance and procurement decision gates tied to pilot outcomes.
• Seller to deliver integration specification documents (LIS/EMR interfaces, network diagrams) and a pilot runbook.
• Customer to nominate IT and pathology leads with contact details and confirm infrastructure readiness dates.
• Both parties to sign off on the validation plan and pilot kickoff date to trigger procurement/governance workflows.
• Create and agree a single-sentence current-state statement that everyone accepts.
• Quantify the business and clinical consequences in concrete metrics and dollars/time where possible.
• Agree 3–5 measurable success signals that will define POC/validation success.
• Identify required data or slide samples needed for subsequent proof sessions and assign owners.
• Customer to confirm and circulate the one-sentence current-state statement to all attendees.
• Customer to deliver missing metrics or slide-sample inventory (volumes, TAT, storage) within 5 business days.
• Seller to prepare consequence summary (cost/time/risk conversions) and propose initial target success signal thresholds.
• Define Target Outcomes by Use-Case
• Integration Architecture Review
• POC Scope & Success Metrics
• Environment Check & Access
• Customer Current-State Statement
• Walk Through Real-Case Workflows
• Evidence Review: Data & Metrics
• Storage, Retention, and Cost Model Confirmation
• Remote Sign-out Simulation
• Scanner Proof Points (Diagnosis)
• Validation Plan & Timeline
• Viewer Proof Points (Validation)
• Define Pathologist Acceptance Criteria
• Consult / Multi-user Workflow Simulation
• Consequence Mapping
• AI-assisted Review Simulation
• Operational Roles & Runbook
• Storage & Retrieval Proof
• Stakeholder Impact & Priority
• Identify Failure Modes & Mitigations
• Collect Structured Feedback & Vote
• Agree Success Signals (Metrics of Future State)

• Install high-throughput whole-slide scanners and consumables
• Calibrate scanners and set 20x/40x acquisition parameters
• Provision enterprise WSI storage with tiering and redundancy
• Deploy image management system and configure role access
• Integrate IMS with LIS (HL7/API) and single sign-on
• Configure diagnostic viewer with annotation and measurement tools
• Enable remote consultation workspace and secure case sharing
• Migrate existing WSI archives into the image platform
• Deploy and integrate AI analysis models and inference pipelines
• Onsite training for histology technicians and pathologists
• Install network security, encryption, and audit logging
• Perform routine maintenance and remote scanner monitoring
• Provide 24/7 technical support and incident resolution

Install high-throughput whole-slide scanners and consumables

• How many physical sites/locations will require scanner installation? Options: 1, 2-3, 4-10, More than 10
• How many scanners do you anticipate needing at each location (by model or approximate count)?
• What is your expected daily slide throughput (average and peak) per site? Options: Less than 100 slides/day, 100-500 slides/day, 500-1,500 slides/day, More than 1,500 slides/day
• Which slide types need routine scanning (select all that apply)? Options: H&E, IHC, Special stains, Cytology/thin prep, Frozen sections
• Do you require manufacturer-supplied consumables and managed inventory (cartridges, trays, etc.)? Options: Yes, No, Partially
• Are there physical constraints at the install sites (power, rack space, lab bench footprint, HVAC)? Please describe.

Calibrate scanners and set 20x/40x acquisition parameters

• Which primary diagnostic magnification do you plan to use for primary reads? Options: 20x, 40x, Mixed (20x for most, 40x for select cases)
• Do you have existing color profile / stain normalization requirements to match glass microscope appearance? Options: Yes, No, Unsure — need guidance
• What acceptable scan failure rate (e.g., re-scan rate) do you require as an acceptance criterion? Options: <0.1%, <0.5%, <1%, Acceptable up to 2%
• Do you have standardized QC slides or phantom slides to validate scanner calibration? Options: Yes, No, We will acquire them during validation
• Preferred file format and compression policy for acquisition (e.g., SVS/OME-TIFF, JPEG2000, lossy/lossless)?
• How often would you like routine calibration and QC performed (daily/weekly/monthly) and who should perform it? Options: Daily, Weekly, Monthly, Quarterly, Ad-hoc/As-needed

Provision enterprise WSI storage with tiering and redundancy

• Estimated current and annual growth of WSI storage needs (TB/year)?
• Preferred deployment model for storage? Options: On-premises SAN/NAS, Colocated private cloud, Public cloud, Hybrid (hot on-prem, archive cloud)
• What retention policy is required for diagnostic WSIs (e.g., 7 years, indefinite, state-mandated)? Options: 1 year, 3 years, 7 years, State/Regulation-defined, Indefinite
• Which redundancy and availability requirements apply (RAID levels, multi-site replication, RPO/RTO targets)?
• Do you require tiered storage (hot/warm/cold) and automated lifecycle policies? Options: Yes, No, Unsure — need recommendation
• Are there constraints or preferences for encryption at-rest or in-transit, and key management approach? Options: Encryption required at-rest, Encryption required in-transit, Both, No preference

Deploy image management system and configure role access

• How many total users will access the image management system (approximate)? Options: <10, 10-50, 51-200, 201-500, >500
• Which user roles should be defined (select all that apply)? Options: Pathologist, Histotechnician/Scanner Operator, Lab Director, IT Admin, QA/Compliance, External Consultant
• Do you require role-based access control and audit trails for regulatory compliance (HIPAA/GxP)? Options: Yes, No, Partially
• Will you require case assignment, routing, or triage workflows within the IMS? Options: Yes — automatic routing, Yes — manual assignment, No
• Do you need high-availability or clustering for the IMS (SLAs for uptime)? Options: Yes, No, Unsure — need recommendation
• Any specific compliance or reporting requirements the IMS must support (audit reports, e-discovery)?

Integrate IMS with LIS (HL7/API) and single sign-on

• Which LIS vendor and version are you using (or 'Custom')?
• What integration method does your LIS support/prefer? Options: HL7 v2 messaging, FHIR, Proprietary API, Flat-file/drop folder, Other
• Which message types and flows are required (accession feeding, order status, results posting, image links)? Options: Order/Accession feed, Result/status updates, Image availability notifications, All of the above
• Do you require single sign-on (SSO) integration and which identity provider (Azure AD, Okta, LDAP, other)? Options: Azure AD, Okta, LDAP/AD, SAML2 provider, Other/Custom
• Are persistent accession identifiers and case linking rules already defined or do they need mapping? Options: Already defined, Need mapping assistance, Unknown
• What is your target timeframe for completing LIS-IMS integration and go-live? Options: <1 month, 1-3 months, 3-6 months, 6+ months

Configure diagnostic viewer with annotation and measurement tools

• Which viewer features are mandatory for sign-out (select all that apply)? Options: Pan/zoom performance, Measurement/caliper tools, Annotations/ROIs, Multi-slide synchronization, Side-by-side comparisons, IHC quantification overlays
• Do pathologists require FDA-cleared viewer workflows for primary diagnosis? Options: Yes, No, Some users only
• Are there specific image rendering or color fidelity acceptance criteria for the viewer? Options: Yes — defined criteria, No — vendor default, Need help defining criteria
• Do you need template-based reporting, embedded measurements into reports, or direct LIS export from the viewer? Options: Template reporting, Direct LIS export, Embed measurements in report, None
• Expected concurrency: how many simultaneous viewers/sessions should be supported? Options: 1-5, 6-20, 21-50, 50+
• Any preferred third-party plugins or integrations (e.g., specialty tools, IHC quant modules)?

Enable remote consultation workspace and secure case sharing

• Will you be sharing cases externally with unaffiliated institutions or only internally across sites? Options: External (unaffiliated), Internal (multi-site), Both
• Do external consultations require anonymization/de-identification of PHI prior to sharing? Options: Yes — always, No — sharing permitted with PHI, Case-by-case
• Which user roles should be allowed to initiate remote consults and what approval workflow is required?
• What security controls are required for remote review (time-limited links, watermarking, download restrictions)? Options: Time-limited links, Watermarking, Disable downloads, IP-restricted access, All of the above
• Do you need integrated telepathology/live-view streaming or asynchronous case sharing only? Options: Live streaming/telepathology, Asynchronous sharing only, Both
• Are there contractual, licensing, or legal requirements for cross-jurisdictional data sharing we should be aware of? Options: Yes, No, Unsure — need guidance

Migrate existing WSI archives into the image platform

• What is the size and format of your current WSI archive (TB and file formats)?
• Do you need full migration, phased migration, or on-demand/browse-only access to legacy WSIs? Options: Full migration, Phased migration, On-demand access only
• Are legacy WSIs indexed with metadata that can be mapped to new IMS fields (accessions, stains, dates)? Options: Yes — fully indexed, Partially indexed, No — unstructured
• Do you require deduplication, reformatting, or reprojection of legacy images during migration? Options: Deduplication, Reformatting (file format), Recompression, No changes
• What is the target timeline for completing archive migration and validation sampling rate? Options: <1 month, 1-3 months, 3-6 months, 6+ months
• Who will own validation of migrated images (internal QA team, vendor, joint)? Options: Internal QA, Vendor, Joint validation

Deploy and integrate AI analysis models and inference pipelines

• Which AI use cases are you pursuing (select all that apply)? Options: Primary diagnosis assistance, IHC quantification, Cell counting, Tumor detection/segmentation, Quality control/scan QC, Research/experimental models
• Do you require FDA-cleared/regulated AI models, research-use-only models, or both? Options: FDA-cleared only, R&D models only, Both
• Preferred hosting for inference pipelines? Options: On-prem inference, Cloud-hosted inference, Hybrid (edge + cloud)
• What throughput and latency requirements exist for AI (real-time during sign-out vs batch overnight)? Options: Real-time (sub-second to seconds), Near real-time (minutes), Batch overnight
• What validation dataset size and acceptance metrics will you require for model deployment (sensitivity, specificity thresholds)?
• Do you require model explainability, versioning, and audit trails for outputs? Options: Yes, No, Partial — only for select models

Onsite training for histology technicians and pathologists

• How many histology technicians and how many pathologists require training (by role)?
• Preferred training format? Options: Onsite instructor-led, Remote live workshops, Self-paced e-learning, Blended
• Which topics should be included in training (select all that apply)? Options: Scanner operation, QC and maintenance, Viewer sign-out workflows, AI tool interpretation, LIS/IMS workflows, Security/compliance
• Do you require competency assessments or certification post-training? Options: Yes — competency tests, No — optional assessment, Supervisor sign-off only
• Will you need go-live onsite hypercare support and for how long? Options: No hypercare, 1 week, 2 weeks, 1 month, Custom
• Are there preferred times/days for training to minimize disruption to diagnostic services? Options: Weekdays (business hours), Weeknights/weekends, Staggered sessions

• Non-Disclosure Agreement (NDA)
• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Equipment Purchase Agreement
• Software License & Subscription Agreement
• Data Processing Agreement (DPA)
• Service Level Agreement (SLA) & Support
• Validation & Acceptance Plan
• Reference Site & Clinical Validation Checks
• Implementation Governance & Procurement Plan
• Pricing, Payment Schedule & Purchase Order
• Change Order / Variation Agreement
• Warranty, Maintenance & Spare Parts Agreement
• Training & Competency Acceptance
• IP Escrow & Software Continuity Agreement

• Clinical Outcomes Validation — Post‑Deployment Review
• Operational & Infrastructure Health Check
• Clinical Validation & Regulatory Closeout
• Product Optimization & Enhancement Prioritization Workshop
• Support Handoff & Ongoing Governance Cadence

• Agree top priorities and a roadmap with owners and timelines for pilots/implementations.
• Ensure all outcomes are explicitly tied back to the problems described in Discovery.
• Document pass/fail status for each acceptance criterion and circulate validation report.
• Assign owners and deadlines for any remediation tasks; schedule re‑validation session.
• Capture any follow‑up data queries needed to close evidence gaps.
• Meeting Kickoff & Scope
• Verify infrastructure meets agreed performance targets and identify any operational risks.
• Agree on monitoring and alerting configurations to ensure early detection of regressions.
• Assign remediation owners and delivery dates for high‑priority operational issues.
• Create prioritized technical ticket list with owners, SLAs, and verification steps.
• Configure/adjust monitoring alerts and share dashboard access with ops stakeholders.
• Schedule a follow‑up health check after remediation completion (2–4 weeks).
• Objectives & Attendees
• Obtain formal QA/regulatory acceptance or documented mitigation and re‑validation plan.
• Finalize and locate the validation documentation package for audit readiness.
• Define triggers and cadence for periodic re‑validation and change control.
• Finalize validation report and secure QA/regulatory signatures.
• Store validation artifacts in the agreed repository and record retention system.
• Create schedule for periodic re‑validation and change‑control reviews.
• Workshop Goals & Rules
• Capture a complete list of post‑deployment enhancement requests tied to concrete impacts.
• Introductions & Objectives
• Ensure each prioritized item includes validation and regulatory considerations where applicable.
• Create prioritized backlog tickets with impact statements and owners.
• Schedule pilot dates and validation scope for top roadmap items.
• Estimate engineering and QA effort and present a release proposal in the next governance meeting.
• Confirm Support Model & Roles
• Establish a clear support and escalation model with agreed SLAs and contacts.
• Set and calendar recurring governance meetings tied to specific outcomes and KPIs.
• Ensure operational stakeholders have access to dashboards and know reporting triggers.
• Publish support contact list, escalation matrix, and SLA document to stakeholders.
• Create recurring calendar invites for agreed cadence and share meeting charters.
• Provision dashboard access and schedule a short training for local admins.
• Confirm whether clinical success signals are met or identify specific gaps.
• Obtain formal sign‑off or a prioritized remediation and re‑validation plan with owners.
• Escalation Paths & SLAs
• One‑Sentence Current State (Infra)
• One‑Sentence Current State
• One‑Sentence Validation Status
• One‑Sentence Current State (Pain Points)
• Regular Meeting Cadence
• Enhancement Requests Capture
• Consequence Summary
• Throughput & Uptime Metrics
• Walkthrough of Validation Results
• Trace to Acceptance Criteria & Risk Assessment
• One‑Sentence Future State
• Storage, Backups & Cost Metrics
• KPI Dashboard & Reporting
• Impact & Consequence Assessment
• Evidence Review — Key Metrics
• Documentation Package Review
• Image Viewer & Network Performance
• Training Refresh & Change Management
• Feasibility & Effort Estimation
• Prioritization Exercise
• LIS & Workflow Integrations
• Regulatory/QA Sign‑off & Archival
• Representative Case Reviews
• Governance Next Steps