Start here: Quick lab snapshot

• On a typical weekday, how many patient samples does your lab process? Options: Under 200, 200 to 1,000, 1,001 to 5,000, Over 5,000, Prefer to describe
• What percentage of your daily volume arrives during the first three morning hours? Options: Under 20%, 20% to 40%, 40% to 60%, 60% to 80%, Over 80%
• Which analyzer platforms are in active use today and what is the average age of each?
• Describe your current shift patterns and where sample flow most often queues or stalls.
• Who on your team owns daily sample triage and STAT prioritization decisions? Options: Lab director, Operations manager, Senior technologist, Rotating staff, Other
• When results run late, which clinical services raise the most urgent escalations? Options: Emergency department, Intensive care unit, Oncology, Surgical teams, Primary care, Other
• If an analyzer missed your morning throughput target three days in a row, would you be prepared to begin a replacement evaluation? Options: Yes, immediately, Yes, after internal review, No, we would troubleshoot first, Unsure

Where morning surges are winning and losing

• If a 30% reduction in morning sample processing time required swapping a workflow, what would stop you from trying it?
• Walk me through the steps samples take from accession to result during your busiest hour.
• Which specific tests create the longest delays during the surge and how many extra minutes do they add on average?
• Give a recent example of a morning bottleneck that caused clinician impact, describing what happened and how the lab responded.
• What single equipment or workflow change would eliminate the majority of your morning TAT breaches?

Where the current analyzers fall short

• Name the recurring failure mode on your current analyzers that most often forces manual intervention.
• How often do you experience unplanned analyzer downtime per month on average? Options: None, 1 to 2 incidents, 3 to 5 incidents, 6 to 10 incidents, More than 10
• Who typically performs first-line troubleshooting and how quickly can they restore partial function?
• List the maintenance tasks that consume staff time most weeks, for example calibration, reagent swaps, or cleaning. Options: Calibration, Reagent swaps, Daily cleaning, Preventive maintenance, Software updates, Other
• Estimate the annual cost you allocate to parts and emergency service for your current analyzers. Options: Under $10,000, $10,000 to $50,000, $50,000 to $150,000, Over $150,000, Unknown
• Would a guaranteed 99.5% uptime and a defined replacement timeline convince you to proceed with a new system within the quarter? Options: Yes, within the quarter, Yes, but would need more time, No, Need more data

Regulatory and quality gates that could pause deployment

• Identify the regulatory or accreditation requirement that would block deployment today if unmet.
• By whom are CAP and CLIA signoffs typically granted in your organization, and what is the usual approval timeline?
• Describe the test menu validations or method crosswalks that must be completed before a new analyzer can release patient results.
• Estimate how many validation days and dedicated FTEs your lab would need to complete IQ, OQ, and PQ activities for an additional analyzer. Options: Under 5 days / 1 FTE, 5 to 10 days / 1-2 FTEs, 10 to 20 days / 2-3 FTEs, Over 20 days / More than 3 FTEs
• Would you proceed if validation required more than 10 calendar days and 3 dedicated FTEs? Options: Yes, No, Only with vendor support

Alternatives on the table

• Tell us which alternative you would choose if this project stalled: remain with the current platform, develop an internal solution, switch to another vendor, or pause the effort. Options: Remain with current platform, Develop internal workflow, Switch to another external vendor, Pause the project, Undecided
• List the aspects of your incumbent solution that you still find acceptable or hard to replace. Options: Throughput, Test menu breadth, Existing integrations, Service relationship, Capital cost, Other
• Name any stakeholders who have proposed solving this without an outside vendor and summarize the resource tradeoffs they identified.
• Under what conditions would you keep your current approach rather than switch, for example specific uptime, cost per test, or reagent reliability thresholds?
• Tell us the single proof point an alternative would need to show for you to stop evaluating other solutions. Options: Higher sustained throughput, Lower total cost per reportable result, Faster service response, Longer reagent stability, Better LIS integration, Other

Do you have what it takes to onboard fast

• Identify any integration or facility constraint that would prevent installation on your preferred timeline.
• Detail the laboratory information system endpoints that must connect and the technical owners for each endpoint.
• Do you have API access for data exchange, or will we need file-based transfers, and who manages the credentials? Options: APIs available and managed internally, APIs available via third party, Only file-based transfers available, Undetermined
• How many staff FTEs can your team allocate to project tasks such as validation, connectivity, and training? Options: 0.5 FTE, 1 FTE, 2 FTEs, 3+ FTEs, TBD
• Please list the compliance approvals that must clear before you can run a pilot, for example IT security attestation and legal review.
• Assuming your IT requires vendor-hosted deployment, would that change your timeline or budget expectations? Options: No change, Extended timeline, Increased budget, Both timeline and budget, Unsure

Decision drivers and what success looks like

• Pinpoint the measurable improvement that would convince medical leadership this project succeeded.
• Provide the KPIs you currently publish for lab performance, such as turnaround time by STAT and routine, throughput, uptime, or cost per reportable. Options: Mean TAT STAT, Mean TAT routine, Samples per hour, Analyzer uptime, Cost per result, Other
• When do you expect to see measurable gains after installation: 30 days, 90 days, 6 months, or another timeframe? Options: 30 days, 90 days, 6 months, Other
• Please state who will sign off on acceptance criteria and the budget authority level required to trigger purchase.
• Given a 90-day pilot that delivers 20% higher throughput and 15% lower cost per reportable, could your team commit to contracting that same month? Options: Yes, No, Need leadership approval, Need legal review

Who's accountable and what's the earliest realistic timeline

• For your preferred timeline, identify the initial owners and target dates required to hit a realistic go-live.
• Select the vendor support levels that would be mandatory during installation, for example on-site engineers or a dedicated project manager. Options: On-site engineer, Remote configuration, Dedicated project manager, Operator training sessions, Inventory coordination
• Explain how reagent and consumable lead times will affect your acceptance and stocking timeline.
• Provide the procurement steps required before issuing a purchase order and the approximate duration for each.
• Could naming a cross-functional steering owner today accelerate your internal decision process to within 30 days? Options: Yes, No, Maybe, need alignment

• Solution Walkthrough — Analyzer Throughput, Reagent Stability, and Service Commitments

• Confirm the current state and its cost
• You confirm the demonstrated analyzer configuration clears your morning backlog within your turnaround-time target.
• Provide your consolidated morning sample volumes by test type and peak-hour distribution for a final throughput run.
• Quantify the consequence to operations
• You confirm reagent stability and supply terms shown prevent mid-shift lot changes and reduce operator intervention to acceptable levels.
• Run the throughput and uptime model against the provided sample mix and deliver a short report with queue clearance time and expected reagent change events.
• Throughput proof using your scenario
• Provide your lab acceptance criteria for a successful installation (throughput, TAT targets, uptime %) to be used in the commercial scope and validation plan.
• You agree the service response and uptime commitments address the downtime scenarios you flagged and meet your acceptance criteria for operational continuity.
• Schedule a follow-up decision review with named owners and the projected validation timeline once the throughput report is delivered.
• Reagent stability and supply proof
• Service and uptime commitments walkthrough
• Validation check, confirm this matches your need

• Solution Walkthrough — Analyzer Throughput & Service
• Solution Walkthrough Deck
• Solution Brief — Analyzer Throughput, Reagent Stability, and Service

• meeting
• slides
• document

• Deliver and Install Analyzer Systems
• Execute IQ/OQ and Validation Documentation
• Integrate Analyzer with LIS via Interface Mapping
• Load Reagents and Configure Onboard Stability
• Provide Initial Reagent Stocking and Replenishment
• Deploy Onboard Quality Control Protocols
• Operator Training and Competency Certification
• Perform Scheduled Preventive Maintenance Visits
• Provide Technical Support with Guaranteed Response Time
• Provision Spare Parts Kit and Critical Parts Stocking
• Configure High-Throughput Sample Handling Workflows
• Provision Reagent Inventory and Shelf-Life Tracking
• Deliver Financing Options and Incentive Qualification

Deliver and Install Analyzer Systems

• Describe the physical installation site including room name/number, footprint dimensions, door clearances, and ceiling height.
• Provide the lab electrical feed details required (voltage, single/three-phase, dedicated circuit rating) and note any planned upgrades.
• Which HVAC and environmental set points are available in the room (acceptable temperature and relative humidity ranges)? Options: Within 18-26°C and 20-60% RH, Requires HVAC upgrade, Unknown — on-site assessment needed
• How many analyzer units and accessory racks will be delivered and installed at this location? Options: 1, 2, 3 or more
• When should delivery and on-site installation be scheduled to avoid peak morning sample surges (preferred date windows and time-of-day constraints)?
• What installation acceptance criteria will you require to sign off on delivery and installation (site checklist items, power verification, successful instrument power-on smoke test)?

Execute IQ/OQ and Validation Documentation

• What IQ, OQ and PQ documentation formats do you require for records (paper protocols, PDF reports, electronic CSV export compatible with your documentation system)? Options: Paper protocol set, Electronic protocol bundle (PDF/CSV), Direct LIS/electronic archival
• Which instrument performance metrics must be demonstrated during PQ (target throughput in samples/hour, assay imprecision coefficient of variation percent, turnaround time 90th percentile)?
• Identify the representative patient or control samples and analyte ranges to be used for PQ runs (include expected concentration ranges for high/low controls).
• Who will be the authorized laboratory signatory for IQ/OQ/PQ completion and what are their role titles (e.g., laboratory director, QA manager)?
• What measurable validation acceptance criteria will you require for PQ sign-off (for example CV ≤ X% for listed analytes, method comparison concordance ≥ Y% vs your reference method)?

Integrate Analyzer with LIS via Interface Mapping

• List the LIS vendor and version and indicate whether HL7 v2.x, FHIR, or ASTM message protocols are available for integration.
• Which specific HL7 message types must be supported for go-live (for example ORM for orders, ORU for results, ADT for demographics)? Options: ORM orders, ORU results, ADT demographics, Other
• Indicate whether you will provide an existing test-code mapping table or if mapping needs to be created from your current test codes and result nomenclature. Options: Mapping provided, Mapping needs creation, Partial mapping provided
• How will specimen ID barcodes be formatted and which barcode symbologies must the analyzer accept (for example Code128, QR, Data Matrix)? Options: Code128, QR, Data Matrix, Not barcoded/label only
• When do you require bidirectional LIS connectivity to be operational relative to instrument installation (same week, within 2 weeks, within 30 days)? Options: Same week as install, Within 2 weeks, Within 30 days, No strict requirement

Load Reagents and Configure Onboard Stability

• Describe the available reagent storage conditions at your site (2-8°C refrigerators, ambient cabinets, dedicated on-deck cooling) and available storage space. Options: 2-8°C fridge available, Ambient storage only, Onboard cooling required, Unknown — needs assessment
• How many reagent lot numbers per assay do you plan to load initially and will you require lot-to-lot verification runs before production use? Options: 1 lot per assay, 2-3 lots, More than 3 lots, Not applicable
• Which specific assays or panels have onboard stability constraints that require refrigerated shipping or immediate use (list assay names)?
• Specify the minimum onboard reagent stability you require for open bottles or cartridges expressed in days. Options: 48 hours, 7 days, 14 days, 30+ days
• Confirm whether you require documentation of reagent lot numbers, expiry dates, and initial QC results at the time reagents are loaded on the analyzer. Options: Yes — full documentation, No — informal confirmation only, Partial (lot nos and expiry only)

Provide Initial Reagent Stocking and Replenishment

• Estimate expected daily sample volumes by assay class for the first 30 days post-install (clinical chemistry, immunoassay, hematology).
• Choose your preferred replenishment model for reagents: vendor-managed automated inventory, scheduled deliveries, or on-demand ordering. Options: Vendor-managed (automated), Scheduled deliveries, On-demand ordering
• Provide your target safety stock in days of expected reagent use to be held on-site. Options: 3 days, 7 days, 14 days, 30 days
• How will refrigerated reagent receiving be managed (who accepts shipments, 2-8°C transfer process, temperature logging)?
• Are formal lot-change control procedures or stability bridging studies required before placing a new reagent lot into production? Options: Yes — required, No — not required, Depends by assay

Deploy Onboard Quality Control Protocols

• List the internal quality control (IQC) materials you will run on the analyzer and the required control frequencies per assay.
• Identify acceptable control rules and limits for critical assays (for example Westgard rules, control SD thresholds).
• How often should shift-level or daily QC runs occur on the analyzer during routine operations? Options: Every shift, Daily, Weekly, Other
• Provide your CAP/CLIA proficiency testing schedule and indicate whether proficiency testing (PT) samples must be run on this analyzer before production release.
• How should QC data be exported and retained — LIS integration, local instrument archive, or both? Options: Export to LIS, Local instrument storage, Both

Operator Training and Competency Certification

• Describe the number of staff and their roles who will require initial operator training (FTE count and role titles).
• Which competency assessments will you accept for operator sign-off (observed runs, written test, return demonstration)? Options: Observed runs, Written test, Return demonstration, Combination
• Specify the target timeframe for completing operator competency after installation (number of days). Options: 7 days, 14 days, 30 days, Custom
• What criteria will define successful operator competency for final acceptance (for example three observed error-free runs and correct execution of routine maintenance)?
• How should ongoing refresher training be scheduled and recorded (annual, biannual, or on-demand after incidents)? Options: Annual, Biannual, On-demand after incidents, Other

Perform Scheduled Preventive Maintenance Visits

• Which preventive maintenance (PM) frequency do you require for major service (quarterly, biannual, annual)? Options: Quarterly, Biannual, Annual, Custom schedule
• Specify the target uptime SLA percentage per calendar month that should inform PM and spare-parts planning. Options: 99%, 98%, 95%, Custom
• List routine PM tasks you expect to be included (for example filter replacement, alignment, software updates, consumable replacements).
• Who will be the lab access contact responsible for scheduling PM visits and coordinating lockout/tagout procedures?
• Indicate whether PM visits should include onsite spare parts stocking or a loaner unit policy during extended repairs. Options: Onsite spare parts required, Loaner unit available during long repairs, No loaner required

Provide Technical Support with Guaranteed Response Time

• Which response-time tier do you require for critical down incidents (for example remote response within X hours, on-site within Y hours)?
• Select your preferred urgent-ticket contact methods (hotline phone, web portal, integrated ticketing channel, or email). Options: Phone hotline, Web portal, Integrated ticket channel, Email
• How will incident criticality levels be defined at your site (complete down, partial degradation, reagent supply issue) and who assigns priority?
• Do you require spare technician visits to be included within the SLA or invoiced per incident? Options: Included in SLA, Per-incident billing, Hybrid model
• Which remote monitoring telemetry are you willing to enable for proactive alerts (instrument logs only, remote health agent, both)? Options: Instrument logs only, Remote telemetry agent, Both, None

Provision Spare Parts Kit and Critical Parts Stocking

• List the critical spare parts you want stocked onsite initially (for example pump modules, detector modules, barcode readers) and target quantities.
• Specify the maximum acceptable mean time to repair (MTTR) for critical parts by type expressed in hours or days. Options: <4 hours, 4-24 hours, 24-72 hours, >72 hours
• How should consumables and spare parts be rotated against expiry — FIFO, lot-tracking with alerts, or manual rotation? Options: FIFO, Lot tracking with alerts, Manual rotation
• When should parts replenishment be triggered based on a stock threshold (percent of starting kit remaining)? Options: 10% remaining, 25% remaining, 50% remaining, Other
• Indicate whether you require vendor-provided replacement assistance for critical parts installation or whether your staff will perform replacements. Options: Vendor installs critical parts, We install with vendor guidance, We install independently

Configure High-Throughput Sample Handling Workflows

• Describe your peak morning sample surge profile including samples per hour between 06:00 and 10:00 by specimen type.
• Which sample rack formats and tube types must the analyzer accept (for example 13x75, 16x100, capped, barcode position)?
• Specify desired throughput targets for both surge and steady-state operation expressed in samples per hour. Options: <200/hr, 200-500/hr, 500-1,000/hr, 1,000+/hr
• How should priority or STAT samples be flagged and routed (for example LIS priority flags, separate STAT rack input)?
• Identify any upstream pre-analytical steps (centrifugation, aliquoting, decapping) that must integrate with the analyzer's sample handling workflow.

Provision Reagent Inventory and Shelf-Life Tracking

• Which reagent inventory management method is used today at your site (inventory software, spreadsheet, manual logs)? Options: Inventory software, Spreadsheets, Manual tracking, Other
• Specify the desired expiry-alert lead time to receive notifications before reagent lots expire (days prior to expiry). Options: 7 days, 14 days, 30 days, 60+ days
• How should reagent lot traceability be recorded and reported (required fields: lot number, expiry, receiving date) and should this export to the LIS? Options: Record locally only, Export to LIS, Both local and LIS export
• When should automated reorder thresholds trigger replenishment (based on units remaining, days remaining, or both)? Options: Units remaining threshold, Days remaining threshold, Both, Manual reorder

• Purchase Agreement
• Order Confirmation
• Master Services Agreement (MSA)
• Statement of Work (SOW) — Installation & Validation
• Service Level Agreement (SLA)
• Reagent Supply Agreement
• Delivery & Installation Schedule and Acceptance
• Payment Schedule & Invoicing Terms
• Warranty & Spare Parts Agreement
• Change Order Agreement
• Data Protection & Regulatory Addendum (HIPAA Business Associate Addendum - BAA)

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

• Publish a one-year ticket closure summary showing resolved and persistent issues for internal audit and quality records.
• Close or escalate high-severity tickets in the shared channel and provide updates in 48 hours.
• KPI trend review
• Confirm whether instrument uptime percentage and reagent stockout incidents meet or are trending toward the Instrument & Service Scope targets.
• Reduce the open high-priority ticket count and agree prioritization for outstanding enhancement requests.
• Agree operational mitigations for top identified risks for the next quarter.
• Publish a prioritized list of enhancement requests with estimated delivery windows and acceptance criteria.
• Schedule any required preventive maintenance or calibration windows that impact uptime and communicate to operations.
• Update reagent inventory thresholds and place orders to prevent next-quarter stockouts where risk was identified.
• Annual KPI summary
• Confirm whether annual average turnaround time and total cost per reportable result met the Instrument & Service Scope targets or require remediation.
• Document the top persistent issues and agree a remediation or process-change plan with timelines.
• Agree a schedule for annual competency refresh and documentation updates to support sustained performance.
• Produce the annual performance report that includes KPI comparisons to the Instrument & Service Scope targets and a remediation plan for any misses.
• Create a schedule for training refresh sessions and SOP updates to be completed within the next 90 days.
• Re-confirm acceptance criteria and owners
• Confirm deployment and validation steps completed or have assigned remediation with dates.
• Document the top 3 early-adoption risks and agree short-term actions to mitigate them.
• Publish a one-page deployment status summary with open issues and owners within 48 hours.
• Set up the shared ticketing channel and confirm access for the buyer's operations and the seller's support teams.
• Schedule targeted refresher training for any operators flagged as needing additional support.
• Present first measurement data vs targets
• Establish whether throughput and STAT turnaround time are trending toward the Instrument & Service Scope targets and identify root causes for any shortfalls.
• Confirm incumbent system has been decommissioned or is scheduled and documented as retained-read-only with data archived.
• Agree a time-bound remediation plan that moves the engagement to the next acceptance checkpoint or steady state.
• Produce a remediation plan that lists each corrective action, expected impact on the named metrics, and resolution date.
• Adjust reagent buffer levels or delivery cadence to eliminate observed stockout risks and document new reorder triggers.
• Deployment and validation status
• Regulatory and quality review
• Root-cause diagnosis for any gaps
• Service SLA and maintenance review
• Ticket burn-down and enhancement backlog
• Persistent issues and root causes
• Incumbent system wind-down status
• Early adoption signals and usage patterns
• Open issues triage
• Service ticket and escalation review
• Operational risk and contingency review
• Training and competency refresh plan
• Agree immediate remediation actions
• Agree corrective actions and timeline to acceptance
• Short action planning