How your lab runs day to day

• Tell me about a typical 24-hour period in your core lab, from sample receipt through result reporting.
• How many patient samples does your core lab process in an average 24-hour period? Options: Under 1,000, 1,000–5,000, 5,001–15,000, 15,001–30,000, Over 30,000
• Which analyzer categories in your lab are currently processing those samples, and which one carries the majority load? Options: Hematology, Chemistry, Coagulation, Urinalysis, Specimen processing automation, Other
• Who on your team is responsible for first-line troubleshooting, and who is the formal owner of analyzer uptime in your organization? Options: Lab technologists, Lead technologist / bench manager, Lab operations manager, Biomedical engineering on site, External clinical engineering partner, Other
• Describe your current scheduled maintenance cadence per analyzer and how often that scheduled work pushes tests into delayed reporting windows in your lab.
• Does failure to meet your TAT targets make equipment replacement an urgent procurement this fiscal year? Options: Yes, immediate priority, Yes, within current fiscal year, Planned but lower priority, No, we will postpone

Where throughput and uptime fall short

• What single recurring equipment or workflow bottleneck in your lab this quarter is causing the biggest backlog in result reporting?
• How many hours of turnaround-time delay do you typically see in your lab per unplanned downtime event? Options: Less than 1 hour, 1–4 hours, 4–12 hours, 12–24 hours, Over 24 hours
• Walk me through the last unplanned outage in your lab that required vendor service, including root cause, parts needed, and time to restore.
• Which assays or clinician groups in your lab are most affected when throughput drops below target? Options: STAT chemistry, Routine chemistry panels, Hematology CBC, Coagulation, Urinalysis, Pediatrics / newborn screening, Other
• If unplanned downtime drove turnaround time past clinical expectations at your organization for four consecutive weeks, what immediate operational or safety consequence would trigger an executive escalation?

Where reagent and service costs eat margin

• How much does your combined reagent and consumable spend per reportable result differ from the target your team needs for acceptable ROI?
• List the contract types your lab uses for reagents and consumables. Options: Supply purchase orders, Consignment, Vendor-managed inventory, Reagent rental / consumable bundled, Short-term manual purchasing, Other
• What is your current cost per test by modality for hematology, chemistry, and coagulation in your environment?
• Who on your side holds approval authority for reagent pricing changes and rebate negotiations? Options: Lab director, Procurement / supply chain, Finance, Hospital system contract office, Shared committee, Other
• If your reagent spend rose 15% next fiscal year, which planned investment or program in your organization would you delay or cancel? Options: Delay capital replacement, Reduce preventive maintenance frequency, Cut staff training, Reduce test menu, Accept higher operating budget, Other

Integration, interfaces, and validation friction

• What would make your LIS or middleware require a multi-week rework before a new analyzer could be accepted into production in your environment?
• List the integration endpoints in your environment and the internal owner for each, for example LIS, middleware, specimen accessioning, and inventory.
• Select which connectivity options your environment supports today. Options: Bidirectional HL7, Unidirectional HL7, SOAP/REST API, Middleware with routing, SFTP or flat file exchange, VPN / secure tunnel, None of the above
• Tell me about past validation windows your lab has used for new instruments, including how many days of on-site runs and operator sign-off you require.
• What single integration or data mismatch in your environment would render a new instrument unusable until resolved?

Decision makers, timelines, and blockers

• Name the single internal veto or operational concern in your organization that would stop approval even if a pilot meets the technical targets.
• Identify the typical procurement timeline in your organization from initial quote to signed purchase order for capital equipment. Options: Under 2 weeks, 2–6 weeks, 6–12 weeks, 3–6 months, Longer than 6 months
• When was the last time your leadership accelerated a lab equipment replacement and what specifically drove that decision?
• How long is your preferred payment or capitalization window from installation to capital approval in your organization? Options: Immediate on receipt, Net 30, Net 60, Install then capitalize in next quarter, Custom finance term
• Would a required change to your standard warranty or service term be a deal stopper for your procurement team, and if so which change? Options: Shorter warranty period, Longer response time, No stocked parts locally, Different billing terms, None would stop the deal

The other options on your table

• Identify the incumbent vendor, an internal build, or another alternative your team is actively considering, and the single reason that option looks safer or more attractive for your lab.
• Select the alternatives your team has evaluated for this procurement. Options: Renew with incumbent under existing contract, Buy from a different vendor, Internal build or workflow redesign, Leasing or reagent rental, Do nothing, Other
• What would have to be demonstrably true about your current approach for your team to keep it instead of changing to a new vendor?
• Has anyone on your team proposed solving this internally without a vendor, and if so who is advocating for that approach? Options: Yes, internal engineering, Yes, lab operations redesign, No internal proposal, Other
• Would an incumbent offering matched uptime guarantees and reagent pricing make your team cancel a vendor pilot? Options: Yes, would cancel pilot, Maybe, depends on contract terms, No, still pursue change

Site, power, and people readiness

• Name the single site or infrastructure gap at your facility that, if not fixed, would prevent installation on your planned date.
• Provide the current power, space, and environmental constraints at your intended site footprint.
• Are network endpoints, firewall rules, and test credentials available in your IT environment for vendor integration work? Options: All available now, Partially available, need coordination, Not available, requires IT approval, Unknown
• Estimate the headcount and roles your team can provide on the days you will need on-site validation and operator training. Options: 1–2 people, 3–5 people, 6–10 people, More than 10 people
• State whether a site upgrade or approval process in your organization that takes longer than eight weeks would cancel the project or simply move the timeline. Options: Cancel the project, Delay the timeline, Need to re-evaluate budget, Other

Clear acceptance criteria and next steps

• What measurable acceptance criteria will cause your team to sign off within 48 hours after go-live in your lab? Options: Uptime percentage over 14 days, Median TAT under target for 7 days, Successful parallel run for key assays, Operator competency checklists completed, LIS interfaces passing test cases
• Provide the named approvers in your organization and the evidence each requires for go-live sign-off.
• Choose the KPIs your team will track in the first 90 days to judge success. Options: Analyzer uptime, Median TAT by assay, Percent of tests needing repeat, Consumable runout incidents, Service response time, Parts availability
• Pinpoint the final contractual or operational gating item that could still delay your full deployment after a successful pilot.
• How soon would your team be willing to schedule a structured pilot once readiness items are cleared? Options: Immediately, Within 2 weeks, 2–6 weeks, 2–3 months, Unsure

• Solution Experience — Operational Validation

• Confirm the current state and its cost
• You confirm the demonstrated workflow meets your stated throughput and turnaround-time targets in core lab scenarios.
• Run a sample-throughput model using the buyer's provided sample volume spreadsheet and deliver a comparative throughput and uptime projection before the follow-up session.
• Provide sample volumes by shift, current analyzer mix, recent uptime logs for the last 6 months, and current LIS interface point-of-contact and endpoints.
• Confirm acceptance targets
• You accept the projected reduction in downtime and related operational costs based on the presented maintenance and uptime assumptions.
• Walk a representative end-to-end workflow
• You agree on the remaining evidence and measurable acceptance criteria required before a commercial decision.
• Agree on measurable acceptance criteria for go-live validation, including target uptime percentage, turnaround-time thresholds, and validation test cases.
• Prove uptime and maintenance assumptions
• Demonstrate LIS and connectivity scenarios
• Validate the future state with the team

• Solution Experience — Operational Validation
• Solution Experience Deck
• Solution Brief — Throughput, Uptime, and Connectivity

• meeting
• slides
• document

• Onsite Instrument Installation and Validation
• Analyzer Performance Verification and Compliance Package
• Operator Training and Competency Certification
• Bidirectional LIS Interface Implementation
• Onboard Calibration and QC Setup
• Reflex Testing Configuration and Rule Setup
• Specimen Processing Automation Deployment
• Reagent and Consumable Supply Agreement Activation
• Just-in-Time Reagent Delivery and Kitting
• Preventive Maintenance Program Enrollment
• Service Level Agreement Activation and Reporting
• Extended Warranty and Parts Consignment Plan
• Analyzer Decommissioning and Replacement
• Financing and Acquisition Structuring

Onsite Instrument Installation and Validation

• Do you have a site single-line diagram (SLD) and room layout showing instrument footprint, power panels, and HVAC vents for the intended installation bay? Options: Yes, No, Partial
• During installation, provide available power circuits, breaker sizes, uninterruptible power supply (UPS) capacity, and whether isolated ground or dedicated circuits are required.
• For validation runs, list the preferred dates, blackout periods, and expected daily validation sample volume so we can schedule on-site engineering and lab staff.
• Which lab-level documents must be completed and signed at handover (for example, installation checklist, electrical certificate, and safety sign-off)? Options: Installation checklist, Electrical certificate, Safety sign-off, All of the above, Other
• What objective acceptance criteria will confirm a successful onsite installation (for example, completed installation checklist, connectivity tests to the LIS passing test cases, and successful patient/control runs)?

Analyzer Performance Verification and Compliance Package

• Provide the target throughput for each analyzer (samples per hour) and the peak-order profile we must validate against. Options: <100 s/hr, 100-500 s/hr, 500-1,000 s/hr, >1,000 s/hr
• Identify the test menu and analyte list by your internal test codes or CPT codes that must be included in the verification package.
• Describe the proficiency or external quality programs you follow (for example, CAP proficiency surveys, state programs) so we align verification to the same acceptance expectations. Options: CAP proficiency, State program, Other, None
• Provide the allowable precision or bias thresholds for critical analytes (for example, %CV threshold for hematology CBC parameters or allowable total error for basic metabolic panel analytes).
• How will you define done for the performance verification package (for example, passing precision and bias criteria across three runs, documented certificate of verification, and signed compliance report)?

Operator Training and Competency Certification

• How many operators and how many shifts require initial hands-on training and competency sign-off for each analyzer type? Options: 1-2 operators per shift, 3-5 operators per shift, 6+ operators per shift
• List the operator tasks that must be included in competency checks (for example, run daily QC, load reagents, perform routine maintenance, clear alarms, and run validation samples).
• Indicate preferred training delivery formats and language requirements (classroom, hands-on bench, train-the-trainer, or digital modules). Options: Classroom, Hands-on bench, Train-the-trainer, Digital modules, Hybrid
• Select the certification artifacts you require after training (competency checklist, signed certificate, LMS record). Options: Competency checklist, Signed certificate, LMS record, Other
• Who will act as your local training coordinator to schedule sessions and maintain competency records in your quality management system?

Bidirectional LIS Interface Implementation

• Do you have a Laboratory Information System (LIS) test environment and does it support Health Level 7 (HL7) v2.x messaging for ORM and ORU transactions? Options: Yes - HL7 v2.x test environment, Yes - other interface type, No test environment
• Supply the LIS project contact, available test endpoint details, and whether an isolated test VLAN or host will be provided for integration testing.
• Identify required message types and mapping artifacts (for example, ORM/ORU triggers, OBR/OBX mapping rules, LIS test codes and specimen type codes) to be included in the interface scope.
• How will you validate interface performance end-to-end (for example, HL7 ORU test cases, sample-to-result latency under peak load of X orders/hour, and error-handling scenarios)?
• State any network or security constraints for cutover such as firewall rules, VPN credentials, scheduled change windows, or port whitelisting requirements.

Onboard Calibration and QC Setup

• Detail calibrator lot numbers, target values, and acceptable ranges that must be entered during initial calibration for each assay.
• State which QC materials and levels you will provide versus those you expect us to supply during setup and initial validation. Options: Buyer provides QC materials, Seller provides QC materials, Shared provision
• Describe the QC rules to implement (for example, Westgard multi-rules) and the action thresholds that will reject a run or require re-run.
• Choose how QC results should be archived and shared: LIS integration via HL7, exportable CSV, or quality management system import. Options: LIS HL7 ORU, CSV export, QMS import, Other
• Who is responsible for approving calibrator lot changes and maintaining the calibration change log that accompanies release-to-production?

Reflex Testing Configuration and Rule Setup

• Detail the reflex rules required by analyte and trigger value (for example, if TSH < X then reflex to free T4; include lab test codes used by your LIS).
• Give the desired execution location for each rule (analyzer onboard, middleware rules engine, or LIS), and note any existing middleware in use. Options: Analyzer onboard, Middleware, LIS, Hybrid
• Name the audit trail fields that must be captured when a reflex triggers (operator ID, timestamp, original result, reflex result, rule version).
• Estimate the acceptable turnaround time impact for reflex workflows (for example, maximum added delay of 30 minutes to STAT specimens). Options: No added delay, Up to 15 minutes, 15-60 minutes, Custom
• Flag any local regulatory or accreditation constraints that affect reflex testing (for example, CLIA reporting rules or state-specific requirements).

Specimen Processing Automation Deployment

• Supply the tube types, barcode symbologies, and sample volumes your lab uses (for example, SST, EDTA, capped barcoded primary tubes) so we validate gripper and vial compatibility.
• Describe required sorting and routing rules (for example, STAT lanes, centrifuge-required specimens, hold-for-aliquot) and expected hourly throughput for the automation.
• Submit rack format, conveyor footprint or dimension diagrams and any ceiling or floor constraints that could affect automation layout.
• Choose whether pre-analytic tasks such as centrifugation and aliquoting are in scope for deployment and who will own their validation. Options: In scope - we validate, In scope - you validate, Out of scope
• Assign the local owner for specimen automation SOP updates and acceptance testing sign-off.

Reagent and Consumable Supply Agreement Activation

• Provide the initial reagent SKUs and catalog numbers to be activated and the lot numbers if the initial shipment must match validation lots.
• Estimate annual and monthly consumption by SKU so we size minimum commitments and replenishment cadence. Options: Provide detailed volumes, Provide ranges, Unknown - needs forecast support
• Select the commercial position on minimum annual commitment: standard minimum, phased ramp to minimum, or request exception discussion. Options: Standard minimum works, Need phased ramp, Need exception discussion
• List refrigerated storage capacity and cold-chain handling constraints at site for perishable reagents.
• Who is the procurement contact for purchase orders, invoicing, and supply reconciliation under the agreement?

Just-in-Time Reagent Delivery and Kitting

• Describe preferred delivery cadence and receiving windows for JIT shipments and whether same-day or timed deliveries are required. Options: Daily window, Weekday delivery only, Scheduled day/time, Flexible
• Provide receiving constraints such as dock hours, lift availability, temperature-controlled receiving, and maximum pallet weight.
• List kitting requirements for validation and go-live (pre-labeled kits, lot-matched reagent sets, QC packs) and whether barcode verification of kits is required.
• Indicate minimum on-hand safety stock by SKU to prevent operational disruption during supply delays.
• Assign the receiving owner who will quarantine, inspect, and accept JIT reagent shipments and state whether a signature or electronic acceptance is required.

Preventive Maintenance Program Enrollment

• Select the preventive maintenance cadence you prefer for each analyzer class (for example, quarterly for high-throughput, annual for bench-top). Options: Quarterly, Biannual, Annual, Custom
• Provide preferred maintenance windows and any blackout periods when PM cannot be scheduled due to clinical load.
• State whether PM records must be uploaded to your asset management system and the required format (PDF, CSV, direct API). Options: PDF, CSV, API, No upload required
• Name any on-site safety, lockout/tagout (LOTO), or PPE procedures technicians must follow during PM visits.
• Who will approve PM completion and sign the maintenance report for asset records?

Service Level Agreement Activation and Reporting

• Specify target uptime and response-time tiers you require in the SLA (for example, 99.5% uptime, 4-hour on-site response for critical instruments).
• Provide escalation contacts and after-hours support expectations including phone, email, and portal notification preferences.
• Choose the cadence for SLA performance reporting (portal dashboard, monthly PDF, quarterly review). Options: Portal dashboard, Monthly PDF, Quarterly review, Custom
• Indicate whether you require parts availability guarantees or loaner instrument provisions during outages and your maximum acceptable downtime before a loaner is deployed.
• Describe the ticket metadata fields and notification recipients required when an SLA breach occurs (ticket ID, impacted analyzer serial, incident owner, breach timestamp).

Extended Warranty and Parts Consignment Plan

• Select the extended warranty term options you are evaluating beyond standard coverage (1, 2, or 3 years or custom term). Options: 1 year, 2 years, 3 years, Custom
• Provide a prioritized list of critical spare parts you request for consignment stocking at your site (fan assemblies, pump modules, optical cartridges etc.).
• Specify replenishment triggers for consignment parts (for example, after X uses, when quantity ≤ Y, or automatic reorder weekly).
• Describe billing preferences for parts used from consignment (bill-per-use, monthly reconciliation, prepaid credits). Options: Bill-per-use, Monthly reconciliation, Prepaid credits, Other
• Who will manage consignment inventory and perform periodic audits against the consignment ledger?

• Purchase Agreement
• Order Confirmation
• Statement of Work (SOW)
• Master Services Agreement (MSA)
• Service Level Agreement (SLA)
• Reagent & Consumable Supply Agreement
• Installation & Validation Acceptance
• Warranty & Preventive Maintenance Agreement
• Training Agreement
• Payment Schedule & Terms
• HIPAA Business Associate Addendum (conditional)

• Go-live Health Check (weeks 1-4)
• First Measurement Review (weeks 4-10)
• Operational Review (quarterly)
• Annual Performance Review

• Publish the prioritized improvement plan with clear success metrics and timelines for the next 12 months.
• Create a remediation plan listing specific technical, workflow, or inventory actions with target completion dates.
• Open or update service tickets with attached logs and expected resolution SLA for each critical incident.
• Quarterly KPI trends and variance analysis
• Identify and schedule resolution for any persistent issues preventing targets from being met.
• Ensure preventive maintenance and spare parts inventory are aligned with observed failure rates.
• Adjust consumable ordering cadence to maintain required days-on-hand and avoid stockouts.
• Publish the quarterly trend report with identified persistent issues and the planned remediation timeline.
• Update the preventive maintenance schedule and parts reorder thresholds based on recent incident history.
• Refine the consumable forecast model and submit revised purchase proposals for the next quarter.
• Year-to-date KPI summary
• Confirm whether annual performance met the Solution Scope targets for uptime and turnaround time.
• Verify SLA adherence over the year and close any outstanding contractual remediation items.
• Agree on a prioritized set of operational improvements and measurement criteria for the coming year.
• Produce the annual performance report with recommendations and distribute to the shared workspace.
• Record any agreed SLA remediation commitments and schedule follow-up checkpoints to confirm completion.
• Re-confirm success criteria and ownership
• Confirm that the deployment and interfaces are functioning without critical errors.
• Confirm operator onboarding status and identify any immediate training needs.
• Produce a short remediation list for critical open issues with target dates.
• Publish the go-live health summary and remediation list to the shared channel within 24 hours.
• Collect screenshots and logs for any connectivity or instrument faults to attach to service tickets.
• Schedule targeted operator follow-up training sessions for any gaps identified.
• Present first-run metrics vs targets
• Establish whether uptime percentage and median turnaround time are trending toward the Solution Scope targets.
• Confirm consumable forecast accuracy and identify adjustments required to avoid stockouts or excess inventory.
• Close the loop on incumbent decommissioning status when applicable.
• Publish the measurement dashboard with supporting data sources and a short narrative on identified root causes.
• Open incidents and ticket burn-down
• Service-level adherence and retrospective
• Deployment and connectivity validation
• Root-cause analysis for metric gaps
• Preventive maintenance and spare parts compliance
• Early adoption signals and usability
• Consumable cost per reportable result and inventory performance
• Incumbent system wind-down status (if applicable)
• Shared communication and ticketing channel health
• Consumable forecast and inventory planning
• Open issues and incident triage
• Service ticket and spare parts review
• Agree corrective actions and timelines
• Enhancement requests and backlog status
• Agree multi-quarter operational improvements
• Agree immediate remediation actions