Point-of-Care Diagnostics
Regulated development and commercialization journeys where clinical, quality, and market access align.
Inside this journey
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POCT Discovery
Align on clinical priorities, current workflows, failure modes (TAT, operator errors, QC gaps), stakeholders, and measurable success signals.
Discovery Questions
Start Here: Who You Are and What's Top of Mind
- What is your primary role in the POCT program?
- Roughly how many point-of-care devices or testing locations do you oversee (or influence)?
- In one sentence, what is the single most important outcome you want POCT to deliver for your patients or service line?
- Which of these objectives best describe your top 3 priorities right now?
- How do you currently measure success for POCT (select all that apply)?
Are You Comfortable with the Status Quo?
- What’s one thing about your current POCT setup that you suspect is quietly failing patients or staff?
- How often does that issue occur in a typical month?
- Can you share a recent example or story where that failure affected clinical decisions, safety, or staff morale?
- When this problem appears, who usually notices it first and how does it get escalated?
- On a scale from 1–5, how emotionally charged is this issue among your frontline staff (1 = low frustration, 5 = constant grievance)?
Where Does Time Slip Away?
- If you could magically remove the single biggest delay in patient care tied to testing, what would that be?
- What are your target turnaround times (TAT) for these critical tests today?
- What typical TATs are you actually observing today for troponin, ABG, and urgent coagulation tests? Please specify ranges or examples.
- How often does TAT variability—not just average TAT—change a disposition decision (admit, discharge, cath lab activation)?
- Describe a recent case where quicker testing at the bedside would have altered the patient pathway.
Who Really Owns Quality?
- Do you feel responsibility for POCT quality is clearly assigned — or does it fall into the gap between departments?
- Which parties are formally responsible for QC, instrument maintenance, and corrective actions today?
- How often do you encounter QC failures or out-of-range controls that require investigation?
- When QC issues happen, how long does it typically take to identify root cause and resolve them?
- Tell me about the last time a QC event created regulatory risk or an audit finding. What happened and how did it land with leadership?
When Tech and People Collide
- How often do operator errors or connectivity failures cause you or clinicians to distrust a bedside result?
- What are the most common operator errors you see (select up to 3)?
- How do you currently track operator competency and turnover for non-lab staff who run tests?
- Describe the connectivity and interface pain points you see between POCT devices and your LIS/EMR (e.g., lost results, duplicate entries, delayed uploads).
- Which connectivity features would reduce manual work and errors for your team?
What Would Clinical Confidence Look Like?
- Imagine clinicians trusted every POCT result as much as central lab data — what would change in patient flow or decision-making?
- Which clinical scenarios would you prioritize to demonstrate that confidence (pick up to 3)?
- What minimum evidence do your clinicians require before they rely on POCT results for high-stakes decisions?
- If a pilot proved reliability, what operational changes would you reasonably expect (e.g., fewer central lab orders, protocol changes, new nurse standing orders)?
- Which metrics would you track to prove clinical impact at 30, 90, and 180 days?
Who Needs to Be in the Room (and Who Won’t Let This Happen Without Them)
- If one influential stakeholder said 'not another device,' who would that be and what’s their core objection?
- Which stakeholders must sign off before a POCT purchase or pilot can proceed (select all that apply)?
- For each critical stakeholder, what is their primary decision criterion (e.g., accuracy, cost, ease of use, interoperability)?
- Who do you consider the likely internal champion for change, and what motivates them?
- Are there known political or budgetary blockers we should plan for? If so, what are they and how long have they been an issue?
Let’s Talk Practical Next Steps and Acceptance
- What would make you say 'yes' to piloting or purchasing a POCT solution within 90 days?
- What type of pilot would convince you (select one)?
- What are the non-negotiable acceptance criteria for a pilot to be considered successful (pick up to 5)?
- What resources or constraints will affect your timeline (e.g., staffing, IT prioritization, capital approvals)?
- Realistically, when would you be prepared to start a pilot if terms and resources aligned?
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Solution Experience
Walk through outcome-driven scenarios (e.g., ED troponin, blood gas in critical care) using the customer’s context to validate clinical impact, operator workflows, and connectivity needs.
Experience Workshops
- Current State & Impact Alignment
- Future State & Success Criteria Definition
- Scenario Workshop: ED Troponin (Outcome-Driven Walkthrough)
- Scenario Workshop: Critical Care Blood Gas (Outcome-Driven Walkthrough)
- Synthesis & Pilot Design (Consolidation Session)
Issues & Enhancements
- Introductions & Objectives
- Produce a single, measurable future-state sentence that all parties endorse.
- Agree on 4–6 quantified success metrics with explicit thresholds and measurement ownership.
- Document any constraints or non-goals that will shape scenario proof points.
- Stakeholders to confirm KPI thresholds in writing and name the owner who will validate each metric.
- Seller to produce a one-page 'Future State & Success Criteria' artifact for use in scenario workshops.
- IT/POCT to list windows for connectivity work and any change control processes required during pilot.
- Scenario Setup & Objectives
- Validate that the proposed device+workflow reduces ED troponin median and 90th percentile TAT to agreed thresholds.
- Confirm operator steps and training needs are acceptable to nursing and POCT leadership.
- Agree the exact connectivity tasks and test cases required to prove auto-verification and data capture during pilot.
- POCT coordinator to nominate pilot ED rooms and schedule 2–3 hands-on role-play sessions with frontline nurses.
- IT lead to provide connectivity test accounts, middleware endpoint details, and a timeline for integration work.
- Seller to provide a step-by-step operator checklist and a trial pack for pilot devices and consumables.
- Scenario Framing & KPI Targets
- Prove that device QC and operator workflow changes will reduce ABG decision latency to target levels while maintaining analytical quality.
- Confirm RT and ICU nursing acceptance of device placement and operator steps for urgent ABG testing.
- Agree a specific connectivity test plan for urgent notifications and result routing during the pilot.
- ICU/RT to provide two recent urgent ABG case timelines for baseline comparison.
- Seller to deliver device QC schedule and an abbreviated operator competency checklist tailored to ICU workflows.
- IT to approve connectivity test windows and designate a contact for urgent EHR mapping during pilot.
- Executive Recap of Findings
- Produce a signed pilot charter that maps scope, KPIs, roles, timeline, and measurement approach.
- Ensure all technical and operational owners accept their responsibilities and the reporting cadence.
- Identify and assign mitigations for the top risks that could prevent proving the future state in pilot.
- Circulate the pilot charter for formal signoff by POCT director, ED MD, ICU MD, and IT manager.
- Schedule the pilot kickoff, operator training sessions, and the first weekly KPI review meeting.
- Seller to prepare pilot device kits, consumables, and operator quick-reference guides for delivery prior to kickoff.
- Agree on one clear, customer-worded current-state sentence that will guide all subsequent scenarios.
- Surface and quantify the top 2–3 consequences (time, safety, cost, throughput) tied to current POCT failures.
- Identify primary stakeholders and decision owners for the Solution Experience and pilot.
- Customer to deliver POCT logs, recent QC failure reports, and sample patient flow times for the past 30/90 days.
- Seller to draft and circulate the single-sentence current-state and consequence summary for signoff.
- Assign owners for stakeholder validation if any party is absent.
- Recap Current State & Consequences
- Articulate One-Sentence Future State
- Pilot Scope & Objectives
- Baseline Walkthrough (Current State)
- Current Workflow Mapping
- Scope Confirmation
- Define Success Metrics & Thresholds
- Current State One-Sentence
- Roles, Training & Operational Plan
- Clinical Consequence Review
- Consequence Tie‑back
- Connectivity & IT Milestones
- Consequence Quantification
- Solution Proof Points (Targeted)
- Targeted Proof: Device & QC Behavior
- Operational Constraints & Non-Goals
- Role‑Play & Validation Checkpoints
- Validation Rules
- Success Measurement & Reporting Cadence
- Stakeholder Impact Map
- Workflow Role-Play & RT Validation
- Connectivity & Data Flow Confirmation
- Connectivity in Critical Path
- Validation & Agreement
- Risk Register & Mitigations
- Pilot Readiness & Risks
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Solution Scope
Define instruments, test menus, connectivity, QC and compliance controls, training, consumables, and acceptance criteria for each care area.
Scope Configuration
- Deliver and install POCT analyzers
- Power up and perform initial instrument calibration
- Load QC materials and run control sequences
- Configure patient and operator barcode scanning
- Integrate analyzers with LIS/EMR interfaces
- Enroll devices into centralized fleet management software
- Provision user accounts and role-based device access
- Conduct hands-on operator training — basic workflows
- Conduct hands-on operator training — troubleshooting & maintenance
- Deploy wireless networking and security settings
- Supply initial consumable and QC inventory kits
- Install peripheral hardware (printers, UPS, barcode scanners)
- Configure automatic result transmission and auto-verification rules
Scope Questions
Deliver and install POCT analyzers
- How many analyzers are you requesting to be delivered and installed?
- Which care areas/locations will receive analyzers?
- Do any installation locations require special handling or restricted access (e.g., locked units, infection control)? Please describe.
- Preferred timeline for delivery and installation:
- Will the site provide on-site contacts and escorts for installers?
- Are there vendor site entry policies (badging, vaccination, background checks) we should know about?
Power up and perform initial instrument calibration
- Do you require vendor staff to perform power-up and initial calibration, or will local biomedical/lab staff perform this?
- What are the electrical supply characteristics at each install site (e.g., voltage, dedicated circuit)?
- Do instruments require connection to a UPS or isolated power circuit?
- What acceptance criteria do you require for initial calibration/verification (e.g., bias vs central lab, CV limits)?
- Is lab/BMET staff availability planned for calibration/validation windows?
- Do you require documented calibration records be uploaded to your LIMS or supplied as PDFs?
Load QC materials and run control sequences
- Who will provide initial QC materials for first-run controls?
- How many control levels are required per test/analyzer (e.g., 2-level, 3-level)?
- What QC frequency policy should be used during acceptance (e.g., per shift, daily, per lot)?
- Do you require vendor to run initial control sequences and sign off on results?
- Are there storage or temperature constraints for QC materials at the install site?
- What control acceptance limits or Westgard rules should be applied during acceptance testing?
Configure patient and operator barcode scanning
- Do you currently use barcode patient IDs and operator IDs at the bedside?
- Which barcode symbologies must be supported (select all that apply)?
- Will labels be printed at the device location or pre-printed from the EMR/LIS?
- Do you require integration with Active Directory or single sign-on for operator authentication?
- Will barcode scanners be provided by site or require vendor-supplied hardware?
- Describe any scanning workflow exceptions we should support (e.g., patient wristbands not available, manual entry policies).
Integrate analyzers with LIS/EMR interfaces
- Which LIS and/or EMR systems will the analyzers need to interface with? (list vendor and version)
- Which interface standards are required/preferred?
- Do you require automatic result routing and order matching (i.e., auto-verify/auto-match)?
- Do you have existing interface specifications or an interface engine (e.g., Cloverleaf, Rhapsody)?
- Are there network/firewall or security constraints (e.g., static IP, port restrictions) IT must approve?
- Who will own interface validation and certification testing (vendor, hospital IT, third party)?
Enroll devices into centralized fleet management software
- Do you intend to enroll devices into the vendor's fleet management/cloud monitoring service?
- Approximately how many devices will require enrollment?
- Do you require role-based dashboards, alerts, and device-level reporting?
- What retention period is required for device logs and event history?
- Do you have data residency or regional cloud restrictions we must comply with?
- Who will administer fleet software accounts (POCT coordinator, IT, vendor-managed)?
Provision user accounts and role-based device access
- How many end users need accounts initially, and what roles do they perform?
- Which user roles do you require (select all that apply)?
- Do you require integration with SSO/AD/LDAP for authentication?
- What password and session security policies must we enforce (e.g., password complexity, session timeout)?
- Who is the approver workflow for new account provisioning and deactivation?
- Do you require audit trails and privilege escalation logs for regulatory compliance?
Conduct hands-on operator training — basic workflows
- Which user groups should receive basic workflow training?
- How many learners per hands-on session do you prefer?
- Preferred training delivery format:
- Do you require competency assessments and completion certificates after training?
- Are there language or accessibility requirements for training materials?
- What shifts or scheduling constraints must we accommodate for training (e.g., nights/weekends)?
Conduct hands-on operator training — troubleshooting & maintenance
- Do you require a separate advanced troubleshooting curriculum for superusers/biomed staff?
- Which maintenance topics should be included (select all that apply)?
- Do you want hands-on practice with simulated instrument faults during training?
- Would you like vendor-delivered maintenance SOPs and quick-reference guides customized to your site?
- How frequently do you want refresher or competency recheck sessions scheduled?
- Do you require spare parts and first-line consumables training (e.g., how to change UPS battery, replace scanners)?
Deploy wireless networking and security settings
- Will devices connect via hospital Wi‑Fi, wired Ethernet, or a dedicated network?
- Which Wi‑Fi security/EAP methods are required (if Wi‑Fi)?
- Do devices require static IPs, DHCP reservations, or NAT traversal?
- Do you require a site survey or RF assessment prior to deployment?
- Are there network segmentation, firewall port, or proxy requirements we should plan for?
- Describe any cybersecurity policies that impact device onboarding (e.g., device certificates, periodic vulnerability scans).
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Mutual Commit
Finalize commercial terms, service and supply agreements, responsibilities for regulatory compliance, and go/no-go acceptance criteria.
Agreement Modules
- Commercial Proposal / Order Form
- Statement of Work (SOW)
- Master Services Agreement (MSA)
- Service Level Agreement (SLA)
- Consumables & Supply Agreement
- Warranty & Returns Policy
- Training & Competency Acceptance
- Connectivity & Integration Agreement
- Regulatory & Compliance Responsibilities
- Acceptance Criteria & Go/No-Go Checklist
- Pricing & Payment Schedule
- Change Order Agreement
- Data Processing Agreement (DPA)
- Spare Parts & Loaner Equipment Agreement
- Termination & Exit Plan
- Insurance, Liability & Indemnity Terms
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Deployment
Plan and execute rollout with device placement, connectivity setup, training schedule, validation checks, and defined owners for each task.
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Success
Confirm outcomes against success signals (TAT, accuracy, operator competency, QC), capture lessons, and maintain a shared channel for issues and enhancements.
Success Reviews
- Success Validation Review
- Clinical Case Review — Impact & Exceptions
- Lessons Learned & Continuous Improvement Workshop
- Operational Support & Shared Channel Setup
- 90-Day Success Checkpoint (Cadence & Template)
Issues & Enhancements
- Define an enhancement triage process that feeds into the continuous improvement backlog.
- Complete RCAs for each exception and publish findings to the shared channel.
- Update operator training and job aids based on RCA outcomes.
- Share anonymized case summaries with cross-functional stakeholders for transparency.
- Recap Deployment Outcomes
- Produce a prioritized continuous improvement backlog with owners and measurable acceptance criteria.
- Define short-cycle pilots for the top 1–2 opportunities to quickly validate impact.
- Document lessons in a shared repository for cross-team learning.
- Deliver the prioritized improvement backlog and publish it to the shared channel.
- Assign owners and set milestones for the top 3 improvement items.
- Schedule pilot start dates and identify evaluation windows.
- Prepare updated training materials or SOPs for items requiring workflow changes.
- Support Model Overview & Roles
- Create and operationalize a single shared channel for issues, monitoring, and enhancements.
- Agree SLAs, escalation contacts, and monitoring responsibilities to ensure timely resolution.
- Introductions & Meeting Objectives
- Create the shared channel, invite stakeholders, and publish channel governance rules.
- Publish the agreed SLA and escalation contact list to the channel and internal sites.
- Configure monitoring alerts and assign dashboard watchers.
- Document the enhancement request template and triage workflow.
- Purpose of Ongoing Checkpoints & Proposed Cadence
- Agree and schedule the recurring success checkpoint cadence and owners.
- Approve the recurring status template and metric snapshot for efficient reviews.
- Ensure a clear escalation path and criteria for elevating issues from checkpoints.
- Schedule recurring checkpoint meetings and invite confirmed attendees.
- Populate the dashboard template and automate data extracts for each checkpoint.
- Publish the checkpoint agenda template and distribution list.
- Identify the rotating meeting chair and note-taker for the next three checkpoints.
- Validate whether each care area meets the pre-agreed acceptance criteria for TAT, accuracy, operator competency, and QC.
- Declare pass/remediate decisions with accountable owners and timelines for any remediation items.
- Ensure all measurement artifacts are complete and recorded in the shared success folder.
- Produce final validation report listing pass/fail status per metric and care area.
- Assign remediation owners and deadlines for each exception identified.
- Log unresolved items into the shared channel for tracking and monitoring.
- Schedule remediation follow-up meeting within agreed SLA window.
- Meeting Objectives & Scope
- Demonstrate and validate the clinical impact of POCT through documented cases.
- Identify safety risks and agree prioritized mitigations with accountable owners.
- Obtain clinical stakeholder confirmation that the solution meets operational needs or list required changes.
- Structured Lessons Capture (Start/Stop/Continue)
- Define Shared Channel(s) and Access
- Review Standard Status Template & Key Metrics
- Selected Case Walkthroughs
- Pre-work & Data Package Review
- Agree SLAs and Escalation Paths
- Restate Current State and Consequence
- Prioritization by Impact vs Effort
- Map Outcomes to Patient Flow & Consequence
- Sample 90-Day Metric Review
- Define Owners, Acceptance Criteria, and Timelines
- Escalations and Top-of-Backlog Review
- Review Near-Misses and Adverse Events
- Review Acceptance Criteria and Success Signals
- Monitoring, Alerts, and Dashboard Ownership
- Assign Regular Owners & Schedule Recurring Meetings
- Plan Small Pilots for Top Items
- Metric-by-Metric Validation
- Root-Cause Analysis for Exceptions
- Enhancement Submission & Prioritization Process
- Exceptions & Variance Log