Start Here — Your current molecular testing picture

• How many molecular tests does your lab run on an average weekday? Options: <10, 10-50, 51-200, 201-500, >500, Not tracked
• Which sample types (for example, nasopharyngeal swabs, blood culture, tissue) are you running most often on those assays? Options: Respiratory swabs, Blood culture specimens, Urine, Tissue/biopsy, CSF, Other
• Tell me which instrument classes currently handle your rapid molecular testing and approximate daily throughput per class
• In a typical month, how many samples require same-day or within-6-hour reporting? Options: None, 1-20, 21-100, 101-500, >500, Not sure
• Who on your team currently owns molecular validation and ongoing QA activities? Options: Lab director, Molecular lead/manager, Quality manager, Shared across teams, Contracted external validation team, Other
• Describe your current staffing model for molecular work, including number of FTEs trained in molecular techniques and their typical shift coverage.
• Has your lab secured capital approval or an approved budget line for a new molecular instrument this fiscal year? Options: Yes, approved and available, Approved but conditional, Budget requested but not approved, No budget requested, Unknown

Where slowdowns cost patients and budgets

• If a delayed molecular result leads to a one-day longer hospitalization for a typical patient, estimate the additional cost per case to your institution. Options: <$500, $500-$2,000, $2,001-$10,000, >$10,000, Unknown
• How often do instrument downtime or reagent backorders cause turnaround times to exceed your clinical targets? Options: Daily, Weekly, Monthly, Quarterly, Rarely, Never
• Which step in your current workflow creates the most hands-on time per sample? Options: Sample accessioning and labeling, Extraction/preparation, Setup of amplification/run, Result interpretation and sign-out, Manual LIS entry, QC and documentation, Other
• When a new assay fails initial validation, who makes the go/no-go call and on what criteria?
• Provide an example of a recent case where a slower molecular result changed clinical treatment, and the downstream consequence.
• If regulatory or payer pressures required same-day reporting for a new panel, would that make you move forward with a new platform within 3 months? Options: Yes, we would accelerate procurement, Possibly, with conditional approvals, No, constraints prevent that, Unsure

How samples actually move through your lab on a busy day

• Walk me through the last time a STAT sample arrived, from accessioning to result reporting, and where the clock slipped.
• On average, how long does accessioning, extraction, amplification, and reporting take today for a typical syndromic panel? Options: <1 hour, 1-3 hours, 3-6 hours, 6-24 hours, >24 hours, Varies widely
• List the LIS or middleware messages that are automated versus manual in your current result flow.
• Who gets alerted when a critical positive result posts, and how quickly do clinical teams receive that notification? Options: Attending physician directly, Primary team via pager/phone, Infection control, Pharmacy, Automatic EHR notification only, Other
• Describe any manual reconciliation steps required between instrument output and patient chart before sign-out.
• Identify the single operational constraint that, if unresolved, would prevent deployment within your target window. Options: Lab space, Power/ventilation, Staffing, LIS integration, Regulatory approval, Supply chain, Other

Validation and quality, the gatekeepers of go-live

• Name the validation milestone in your process that has the highest chance of failure and would delay go-live.
• Estimate the number of full clinical runs you require for internal verification before clinical use. Options: 1-3, 4-10, 11-25, >25, Depends on assay
• List the roles that must sign the validation report for the new assay to be accepted into routine testing.
• Provide the typical acceptance criteria thresholds you use for sensitivity, specificity, and limit of detection.
• Would the requirement for matrix-specific validation without available residual specimens be sufficient to stop approval? Options: Yes, that would stop approval, No, we can obtain specimens, We would postpone until specimens are available, Depends on clinical priority
• State the frequency at which you run internal QC for molecular runs during routine operations. Options: Each run, Daily, Weekly, Per batch, Other

Alternatives you're weighing and their real chances

• Outline the alternatives your team is seriously considering, including staying with the incumbent, switching vendors, or building internally.
• Share the single condition about your current approach that would have to be true for you to remain with it instead of changing.
• Rank these possibilities by likelihood, stay with incumbent; move to a commercial platform; develop in-house; hybrid model. Options: Stay with incumbent, Move to commercial platform, Develop in-house, Hybrid model
• Indicate whether any internal groups have proposed an in-house solution and who would lead it. Options: Yes, pathology/molecular lab, Yes, IT/engineering, Yes, outsourced lab partnership, No internal proposal, Unknown
• Give an example of a competitor capability or internal plan that, if matched, would cause you to pause vendor selection.
• Would an incumbent offer of an extended 12-month reagent pricing guarantee be sufficient to keep you from switching? Options: Yes, No, Maybe, depends on other factors

Can your lab support a new platform on day one?

• Confirm whether your lab could provide dedicated space and a 20A circuit for the instrument within 8 weeks. Options: Yes, ready within 8 weeks, Yes, but requires minor changes, No, needs major renovation, Unsure
• Enumerate the IT and LIS interfaces required for result transmission and who owns each connection.
• Assess whether your network allows outbound secure messaging from instruments, and whether a test endpoint is available for integration testing. Options: Yes, outbound allowed and test endpoint available, Outbound allowed but no test endpoint, Outbound blocked, Unsure
• Indicate whether biosafety approvals, institutional review, or other compliance steps are needed before clinical use. Options: Biosafety approval required, Institutional review required, Both required, None required, Unsure
• State the headcount you can commit to training and go-live support, by role and percent FTE during the first 90 days.
• Choose whether a required lab upgrade that pushed deployment beyond your target window would stop the project or only shift the timeline. Options: Stop the project, Shift the timeline, Proceed with mitigation, Undecided

Decision drivers and financial thresholds

• Identify the financial metric you will use to judge a platform investment: total cost per test, 3-year ROI, cost per avoided hospital day, or a different KPI. Options: Total cost per test, 3-year ROI, Cost per avoided hospital day, Payback period, Other
• Estimate your target total cost per test that would justify replacing current workflows. Options: <$25, $25-$50, $51-$100, >$100, Undetermined
• Confirm whether reagent supply agreements or capital approval are already budgeted for this fiscal year. Options: Reagent supply budgeted, Capital approved, Both budgeted, Neither budgeted, Budget request submitted
• Select the procurement hurdles that would delay or block a contract, capital committee approval, contract review, procurement vetting, or supply chain concerns. Options: Capital committee approval, Contract legal review, Procurement vetting, Vendor qualification, Supply chain vetting, Other
• Can you commit to a letter of intent within 30 days if a pilot meets your performance targets? Options: Yes, can commit within 30 days, Yes, but requires internal approvals, No, cannot commit within 30 days, Need to discuss further
• Name the decision-makers by title who must approve purchase and their primary concern category, clinical, operational, financial, or IT.

Next steps and pilot success signals

• Assuming the pilot meets acceptance criteria, what would accelerate full rollout to a signed contract?
• Choose the top three measurable success signals you will track during pilot, TAT reduction, sensitivity, hands-on time, operator error rate, reagent cost per test, LIS integration time. Options: TAT reduction, Analytical sensitivity, Hands-on time per sample, Operator error rate, Reagent cost per test, LIS integration time
• Select how often you want schedule checkpoints during pilot, weekly, biweekly, or monthly. Options: Weekly, Biweekly, Monthly, Other
• Outline the escalation path and SLA expectations for critical tickets during pilot and first 90 days.
• Decide whether a pilot that fails to meet more than one primary acceptance criterion would require a re-run, a root cause analysis with named owners, or termination of the project. Options: Re-run pilot, Root cause analysis with named owners, Terminate project, Depends on severity
• By when do you expect a procurement decision if pilot signals match targets, immediately after pilot, within 30 days, within 90 days, or longer? Options: Immediately after pilot, Within 30 days, Within 90 days, Longer than 90 days, Unsure

• Clinical Workflow Experience Session

• Confirm the current state and its cost
• You confirm the demonstrated workflow delivers results within your target turnaround time and removes the delays you described.
• Provide four weeks of specimen volumes by specimen type and target turnaround times for modeled runs.
• Walk a real sample pathway end to end
• You confirm the operator tasks and staffing model shown will fit your available staff without requiring unacceptable additional FTEs or space.
• Run a site-specific sample forecast and deliver a modeled throughput, reagent burn-rate, and operator task map before the follow-up session.
• Prove turnaround and reporting in your scenario
• Share your LIS message format requirements and any existing integration constraints for a connectivity feasibility check.
• You agree on the validation evidence and acceptance criteria that will be required before go live.
• Draft proposed validation acceptance criteria based on the demonstrated runs for joint review at the next meeting.
• Review validation and acceptance criteria
• Validate alignment explicitly
• Agree next steps and commitments

• Clinical Workflow Experience Session
• Clinical Workflow Experience Deck
• Clinical Workflow Solution Brief

• meeting
• slides
• document

• Deliver and install instrument
• Perform IQ/OQ/PQ qualification
• Provide assay validation kits and protocols
• Deploy syndromic multiplex panels
• Deploy antimicrobial-resistance detection panels
• Configure and test LIS (HL7) interface
• Train laboratory operators and competency certification
• Supply reagents and consumables under contract
• Provide preventive maintenance and onsite repair
• Install and validate high-throughput automation module
• Support parallel-run verification and go-live assistance
• Provide instrument financing and lease agreement

Deliver and install instrument

• What instrument model will you accept for delivery (include model number and any pre-installed options)?
• How much clear bench footprint (cm) and door width will you provide at the planned install location?
• Which facility access requirements apply at your site on delivery day (e.g., loading dock hours, PPE, credentialing)? Options: Standard business hours, Loading dock access only, After-hours required, Site escort required
• Do you require on-site heavy rigging or soft-floor protection during installation? Options: Yes, No
• Who will be your on-site contact for delivery and sign-off (name and phone)?

Perform IQ/OQ/PQ qualification

• When do you expect formal IQ/OQ/PQ to occur relative to delivery (select intended window)? Options: Within 3 days, Within 7 days, 2-4 weeks, TBD
• Where will your IQ/OQ/PQ documentation be stored (LIS, laboratory QMS, or paper file)? Options: LIS/LIMS, Electronic QMS, Paper, Other
• List the regulatory standards your qualification must reference (e.g., CLIA, CAP, ISO 15189).
• Provide the acceptance criteria you require for operational qualification runs (e.g., percent concordance, limit of detection, control performance).
• Estimate how many IQ/OQ/PQ run replicates you require per assay or instrument channel. Options: Single replicate, Triplicate, 5+ replicates, As per protocol

Provide assay validation kits and protocols

• Confirm which assay panels you will validate first (list panel names or targeted pathogens).
• Specify the lot numbers and expiration windows you need included with each validation kit.
• Are there required comparator methods for your validation (e.g., culture, reference PCR, sequencing)? Options: Culture, Reference PCR, Sequencing, Other
• Select the sample types you will use for validation (e.g., nasopharyngeal swab, sputum, whole blood). Options: Nasopharyngeal swab, Sputum, Whole blood, Stool, Other
• Identify any local regulatory submissions you must file to accept validation data (e.g., IRB notification, local health authority).

Deploy syndromic multiplex panels

• Describe the clinical use cases you expect for the syndromic panels (e.g., respiratory triage, neonatal sepsis, ED admission screening).
• Indicate the target turnaround time you require from sample accession to report for each panel (hours). Options: <2 hours, 2-6 hours, 6-24 hours, >24 hours
• Assign projected daily throughput for each syndromic panel (tests per 8-hour shift). Options: 1-10, 11-50, 51-200, 200+
• Name the control materials and external quality assessment (EQA) programs you will run for these panels.
• Attach any institutional testing algorithm or formulary that dictates when the syndromic panel is ordered.

Deploy antimicrobial-resistance detection panels

• State which resistance markers (genes or mutations) must be covered by your AMR panels (e.g., mecA, blaKPC, NDM).
• Measure the acceptable positive predictive value or concordance threshold you require for resistance calls (%). Options: >95%, >90%, Custom
• Report how you will route AMR results into your antimicrobial stewardship workflows (e.g., automatic alert to ID physician, pharmacy notification).
• Clarify which specimen types will carry AMR testing at your site (e.g., blood culture, wound swab, respiratory aspirate). Options: Blood culture, Wound swab, Respiratory aspirate, Urine, Other
• Outline the turnaround time requirement for AMR panel results to impact therapy decisions (hours). Options: <2 hours, 2-6 hours, 6-24 hours

Configure and test LIS (HL7) interface

• Choose the HL7 message types you need supported at go-live (e.g., ORM^O01 for orders, ORU^R01 for results). Options: ORM^O01 (orders), ORU^R01 (results), SIU^S12 (schedule), ACK
• Enter the primary receiving IP/port and expected secure transport method for your LIS connection (MLLP, VPN, TLS).
• Supply the LOINC and SNOMED codes you require for structured results reporting or indicate if you want us to map them.
• Record the patient and specimen accessioning fields from your LIS that must be preserved (e.g., medical record number, accession number, specimen ID).
• Set the test result turnaround time (TAT) SLA you expect for reported HL7 messages. Options: <60 minutes, 1-4 hours, 4-24 hours

Train laboratory operators and competency certification

• What operator roles at your laboratory require training and competency certification (e.g., technologist, supervisor)? Options: Technologist, Supervisor, Lab director, Other
• How many operators need initial training and how many will require annual competency refreshers at your site?
• Which competency assessment format do you prefer for operators (observed run, written test, proficiency panel)? Options: Observed run, Written test, Proficiency panel, Other
• Do you require operator competency certificates to be issued and tracked in your learning management or training system? Options: Yes, No
• Who at your organization will be authorized to sign operator competency acceptance for go-live?

Supply reagents and consumables under contract

• When do you expect the first reagent shipment relative to installation (choose timing)? Options: At install, Within 1 week, 2-4 weeks, After validation
• Where should routine reagent and consumable shipments be delivered for your site (central receiving, lab door, off-site warehouse)? Options: Central receiving, Lab door, Off-site warehouse
• List the reagent SKUs and your forecasted monthly usage per SKU.
• Provide the desired contract term and any minimum annual purchase commitment you require. Options: 1 year, 2 years, 3 years, Custom
• Estimate required on-shelf stability or cold-chain constraints for your consumables (e.g., -20°C, 2-8°C). Options: Room temperature, 2-8°C refrigerated, -20°C frozen, Cold-chain needed

Provide preventive maintenance and onsite repair

• Confirm your preferred preventive maintenance frequency for the instrument (monthly, quarterly, semi-annual). Options: Monthly, Quarterly, Semi-annual, Annual
• Specify the maximum acceptable mean time to repair (hours) for critical failures at your site. Options: 24 hours, 48 hours, 72 hours, On-site SLA
• Are you subject to uptime or availability requirements that mandate scheduled maintenance windows? Options: Yes, No
• Select the spare-part coverage you desire under contract for your instrument. Options: Critical consumables only, Full parts list, Customer provides spares
• Identify any on-site safety or lockout/tagout (LOTO) procedures your technicians must follow.

Install and validate high-throughput automation module

• Describe the automation module capacity you need and how it should integrate with your upstream sample preparation (samples per hour).
• Indicate the space and service requirements you must provide for the automation module (power amps, compressed air, floor loading).
• Assign the barcode and sample plate formats the automation must accept at your lab (e.g., 96-well, 384-well, 15 mL tube). Options: 96-well plate, 384-well plate, 15 mL tube, Other
• Name the throughput acceptance criteria you require for the automation (minimum tests per shift and acceptable sample rejection rate).
• Attach any validated SOPs or robotics safety assessments your site requires prior to start-up.

Support parallel-run verification and go-live assistance

• State the duration of the parallel run you require before switching routine reporting to the new system (days). Options: 1 day, 3 days, 7 days, 14+ days
• Measure the concordance threshold you require between the new system and the comparator method for go-live (%). Options: >95%, >90%, Custom
• Report who at your organization will own discrepancy review during parallel runs and how you will provide rapid feedback.
• Clarify which patient cohorts or specimen types must be included in your parallel verification. Options: All specimen types, Selected panels only, High-risk cohorts only
• Outline the escalation steps you want if parallel-run concordance falls below the agreed threshold.

Provide instrument financing and lease agreement

• Choose the financing structure you prefer for procurement of the instrument. Options: Capital purchase, Operating lease, Service-inclusive lease, Phased lease
• Enter the desired lease term and any end-of-term options you require (purchase, return, renewal). Options: 12 months, 24 months, 36 months, Custom
• Supply the internal approvals or credit documentation your finance group requires for financing.
• Record any budget or capital-approval deadlines we must meet for your procurement cycle.
• Set your payment cadence preference and billing entity for the agreement. Options: Monthly, Quarterly, Annual

• Purchase Agreement
• Order Confirmation
• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Consumables & Reagent Supply Agreement
• Validation Acceptance Protocol
• Delivery & Go‑Live Schedule
• Service Level Agreement (SLA)
• Payment Schedule & Commercial Terms
• Acceptance Certificate
• HIPAA Business Associate Addendum (conditional)

• Go‑live Health Check (weeks 1–4)
• First Measurement Review (weeks 4–10)
• Acceptance Gate Meeting (around day 90)
• Ongoing Quarterly Success Review

• Schedule operator refresher training for identified competency gaps and confirm dates.
• Publish an operator retraining plan and updated SOPs addressing identified gaps.
• Resolve or escalate high‑impact support tickets affecting test run failure rate before the Acceptance Gate.
• Restate acceptance criteria and numeric targets
• Produce a documented acceptance decision with a named signatory for the buying organization.
• For any failed criteria, agree a remediation plan with deadlines and evidence requirements.
• Confirm the status of incumbent decommissioning and data migration to avoid dual‑system fallbacks.
• Publish the formal acceptance record with the named signatory and archive it in the shared workspace.
• List remediation tasks for unmet criteria with deadlines and evidence deliverables.
• Complete incumbent system decommissioning steps or publish the retention and read‑only plan and archive confirmation.
• Operational metrics review
• Confirm the system continues to meet the key operational targets or document a remediation trajectory.
• Reduce the count of high‑priority open support tickets and agree closure dates.
• Prioritize enhancement requests for the next quarter with acceptance criteria and delivery windows.
• Publish the quarterly metrics report showing trends against Solution Scope targets.
• Update the enhancement backlog with priorities, acceptance criteria, and planned delivery quarters.
• Reconfirm success criteria and ownership
• All deployment validation checkpoints are confirmed or have scheduled remediation.
• Active issues are logged with remediation actions and target dates.
• Date for the First Measurement meeting is confirmed.
• Publish the deployment validation checklist with status and remediation dates.
• Update the shared issue log with prioritization and expected resolution dates.
• Confirm data sources and owners for the metrics to be presented at the First Measurement meeting.
• Agree a prioritized set of corrective actions with resolution dates and evidence required for acceptance.
• Present first outcome data against targets
• Determine whether each named metric is trending toward the Solution Scope target and document reasons for any shortfalls.
• Confirm the acceptance gate date and required deliverables for the Acceptance Gate meeting.
• Run targeted root cause analyses for the top two underperforming metrics and deliver a diagnosis document.
• Present outcome data for each acceptance criterion
• Persistent issue burn‑down and ticket review
• Root cause diagnosis for gaps
• Deployment and migration validation
• Document pass or fail per criterion and capture signatory
• Operator proficiency and training review
• Enhancement and improvement backlog review
• Early adoption signals and usage patterns
• Support tickets and remediation plan
• Open issues and blockers
• Agree remediation plan for any unmet criteria
• Training and staffing forecast
• Confirm path and timeline to the Acceptance Gate
• Immediate remediation actions and next steps
• Incumbent system decommissioning and data migration status
• Agree next quarter actions and short checklists