Getting Oriented: Your POCT Snapshot

• Tell me about your current point-of-care testing footprint, including which units use devices and the typical number of devices per unit.
• How many active POCT devices does your program manage today? Options: 1-10, 11-25, 26-50, 51-100, 100+
• Which test categories are you running at the point of care today? Options: Cardiac markers (troponin), Blood gases/electrolytes, Coagulation/INR, Infectious disease rapid tests, Glucose/ketones, Urinalysis, Other
• Walk me through a typical ED or OR patient scenario where a POCT result changes the immediate clinical decision.
• Who on your team is the day-to-day owner for POCT operations and who is the escalation contact for critical issues?

Where Turnaround Time and Errors Hurt Most

• When turnaround time exceeds your target, which patient flow or clinical decision is most at risk? Options: ED throughput / boarding, Time to cath lab activation, OR case start delays, ICU admission delays, Other
• How often does your program miss the target time-to-result for high-impact tests such as troponin or arterial blood gas? Options: Daily, Weekly, Monthly, Rarely, Unknown
• Describe the last incident where operator error produced a delayed or invalid result, and the consequences that followed.
• Which downstream metrics—left without being seen, length of stay, cath lab activation—show measurable change when POCT underperforms? Options: Left without being seen (LWBS), ED length of stay, Door-to-balloon / cath activation, OR turnover time, Other
• What single operational failure would make you stop a new POCT deployment immediately?

The Other Paths You Are Weighing

• Explain the external vendors, incumbent solutions, or internal builds you are actively evaluating to close these POCT gaps.
• Are there internal proposals to build equivalent testing or connectivity capabilities instead of partnering with a vendor? Options: Yes, No, Under discussion
• Name what would have to be true for your organization to stay with the current approach rather than switch to an outside partner.
• Estimate the likelihood you will choose an internal build versus a third-party vendor, expressed as a percentage range. Options: 0-25%, 26-50%, 51-75%, 76-100%
• Detail any concessions or contract elements from the incumbent that would cause you to remain with them.

Who Signs Off and Who Suffers When Things Go Wrong

• Who loses credibility internally when a POCT result is questioned, and how does that affect program momentum?
• Name the committee or individuals who must approve changes to test menus, instruments, or connectivity, and their typical approval timeline.
• To what extent does procurement influence consumable pricing and service-level negotiations for POCT? Options: Primary decision maker, Significant influence, Advisory only, Not involved
• If the pilot proves performance and compliance, who can sign the contract and what is the fastest timeline for that sign-off?

Clinical Goals: Outcomes That Matter

• What clinical outcome would make your stakeholders say the POCT program delivered on its promise?
• List the clinical metrics you currently track or wish you could track to measure POCT impact. Options: Time to specific result, Concordance with central lab, ED length of stay, Time to definitive therapy, Patient disposition accuracy, Other
• State your target time-to-result for high-impact tests such as troponin and arterial blood gases, in minutes.
• At what level of agreement with central lab methods would clinicians accept POCT results without reflex testing? Options: Statistically equivalent within allowable bias, Within clinically acceptable variance, Requires reflex testing for now, Undecided
• Assuming a pilot meets your time-to-result and concordance targets, what would stop you from executing a procurement decision within the following 30 days?

Daily Workflows: How POCT Fits Into Care

• Recall the last time a non-laboratory operator ran a POCT test that required supervisor intervention, what happened and why?
• Estimate whether most POCT tests are performed by nursing, respiratory therapy, physicians, or laboratory staff on an average shift. Options: Mostly nursing, Mostly respiratory therapy, Mostly lab staff, Mixed across groups
• Outline the operator steps from patient identification through result documentation in your standard workflow.
• When a critical result is generated at the bedside, who is notified and what is your target notification time?
• Assuming a controlled pilot demonstrated an 80% reduction in operator errors, would that remove barriers to broader deployment and which departments would you add first? Options: Emergency Department, Operating Rooms, ICU, Inpatient wards, Ambulatory clinics, Other

Integration and Data: Will Results Flow Where You Need Them?

• List the interfaces that must be live for a pilot to be considered valid and name the owners for each.
• Do your current devices connect directly to an LIS, to middleware, or to both? Options: LIS directly, Middleware only, Both, None
• Identify who will provision API access or HL7 channels and the expected lead time for each.
• Provide your typical lag time, in minutes, between device result generation and availability in the LIS today.
• Point to the integration failure that would force you to stop a pilot immediately.

Quality, Compliance, and Training: Proof You Can Run It

• Imagine an external audit flagged recurring QC failures on POCT, what immediate actions would leadership expect?
• Do you have a centralized QC schedule and clear ownership for QC tasks? Options: Yes, centralized and assigned, QC exists but is decentralized, No formal QC program
• State the frequency of proficiency testing or split-sample comparisons with the central lab. Options: Weekly, Monthly, Quarterly, Ad-hoc, None
• Outline your training cadence for non-lab operators and how you currently demonstrate ongoing competency.
• Would a regulatory requirement to return specific tests to the central lab prevent you from adopting additional POCT for those analytes? Options: Yes, No, Depends on analyte/regulation

Consumables, Service, and Cost: The Real Budget Impact

• Tell me about a consumable or service cost that surprised you when scaling POCT to more units.
• Identify the top three line items that drive your POCT operating budget and rank them by annual spend.
• Select the pricing model you prefer for consumables: per-test, subscription, or capital purchase. Options: Per-test pricing, Subscription, Capital purchase, Hybrid
• Provide your typical SLA requirement for instrument uptime and on-site response, expressed in hours or business days.
• Would a four-week consumable lead time halt new deployments until supply chains are improved? Options: Yes, No, Maybe

Practical Constraints: Do You Have What It Takes?

• Point to the single internal dependency, if unresolved, that would block starting a pilot.
• Specify the third-party systems that must be connected and confirm whether APIs or HL7 endpoints already exist.
• Enter the number of FTEs your team can dedicate to implementation and the number of weeks they can commit.
• Are there legal, compliance, or contracting review gates that routinely add time, and who manages that queue? Options: Yes - legal manages, Yes - compliance manages, No formal gate, Other
• At what point, in weeks, would you withdraw from a pilot if key dependencies remain unresolved? Options: 2 weeks, 4 weeks, 6 weeks, 8 weeks, Would not withdraw

Signals That Move the Deal Forward

• Pinpoint the single acceptance criterion that would trigger a purchase decision within 30 days of a successful pilot.
• Select which measurable outcomes will signify pilot success, choose up to three. Options: Time-to-result target met, Concordance with central lab, Reduction in operator errors, Improved ED throughput, Reduced length of stay, Other
• Indicate the pilot duration you require to consider results compelling, in weeks. Options: 1-2 weeks, 3-4 weeks, 5-8 weeks, 9+ weeks
• Specify the staff and IT roles you will commit to the pilot and the percent of their time.
• If we deliver a written pilot plan by next week, can you commit to a technical workshop within two weeks that would accelerate internal approvals? Options: Yes, No, Need to check internal schedule

• Solution Experience Session

• Confirm the current state and its cost
• You confirm the restated current state and quantify the cost in time, rework, or risk.
• Provide a list of critical POCT assays, current target TATs, and the LIS interface specification for the sites in scope.
• You confirm the demonstrated workflow eliminates the specific rework and turnaround delays described in Discovery for the shown scenario.
• Map a buyer scenario end-to-end
• Run a method comparison using your provided sample data and deliver the accuracy and bias summary before the follow-up session.
• Draft proposed measurable acceptance criteria and a tentative deployment timeline for review.
• You confirm the connectivity and QC handling meet your operational needs or identify specific gaps to close before decision.
• Demonstrate validated operator workflow and QC handling
• Prove connectivity and result posting to your LIS
• You and the seller agree the remaining evidence, acceptance criteria, and a tentative timeline to move toward commercial review.
• Identify named owners for connectivity, QC, and operator training and share their contact details.
• Validate the future state with you
• Agree remaining evidence and next acceptance criteria

• Solution Experience Session
• Solution Experience Deck
• Solution Brief

• meeting
• slides
• document

• Deploy point-of-care analyzers
• Install wireless LIS/EMR connectivity (HL7)
• Configure centralized fleet management software
• Load barcode patient and operator ID
• Deliver operator training and competency certification
• Implement embedded quality control and auto-QC rules
• Set up auto-verification and result routing
• Supply consumables and automated replenishment
• Perform onsite calibration and preventive maintenance
• Provide 24/7 technical support and remote troubleshooting
• Install firmware and software updates
• Provide proficiency testing materials and documentation support

Deploy point-of-care analyzers

• Which analyzer models and quantities must be delivered to each clinical area (ED, ICU, OR, clinic)? Include model IDs and counts.
• How many deployments require mobile-cart configuration versus fixed benchtop or wall-mounted installation? Options: Mobile cart, Benchtop, Wall-mounted, Combination
• Who at your site will be the receiving and inventory owner for delivered units (role and contact preferred)?
• When must the devices be clinically available (go-live date) in each unit? Options: Within 2 weeks, 2-4 weeks, 4+ weeks, Custom date
• Confirm the acceptance criteria for an installed analyzer and the evidence you will require (operational checklist, first QC pass, LIS result ingestion, signed delivery form). Options: Operational hardware checklist, First QC pass log, LIS/EMR patient result record, Signed delivery and inventory form

Install wireless LIS/EMR connectivity (HL7)

• Where will the HL7 interface terminate (integration engine hostname, LIS listener IP, or EMR endpoint)? Provide the integration endpoint type. Options: Integration engine, Direct LIS listener, EMR integration endpoint, Other
• Do you require HL7 over TCP/IP, MLLP, or a secured channel (VPN/DTLS) for analyzer-to-LIS messaging? Options: HL7 over TCP/IP (MLLP), HL7 over VPN, HL7 via integration engine (HTTPS / API), Other
• Are there firewall, port or certificate requirements we must provision for the analyzer IPs to communicate with your integration endpoint? Options: Yes, No
• Specify the message-delivery and result-concordance thresholds you will require to accept HL7 connectivity (for example: delivery success rate %, max message latency seconds, ORU-to-LIS mapping validation checks).
• List the HL7 message types and events required for each device (for example: ORU^R01 for results, ORM^O01 for orders, ADT for patient context). Options: ORU (results), ORM (orders), ADT (patient), Other

Configure centralized fleet management software

• Provide the fleet-management features you require: device inventory, QC tracking, operator roster, alerting, usage analytics, or patch management. Options: Device inventory, QC tracking, Operator roster, Alerting/notifications, Usage analytics, Patch management
• Estimate the number of devices and number of fleet-management users that will need accounts and role-based access. Options: Less than 25 devices, 25-100 devices, 101-500 devices, 500+
• Select required integrations for the fleet console (LIS, EMR, SSO/LDAP, asset management system). Options: LIS, EMR, SSO/LDAP, Asset management, Other
• Describe your required alerting cadence and channels for device offline events and QC failures (real-time push, email, SMS, dashboard). Options: Real-time push, Email, SMS, Dashboard only, Daily digest
• Indicate any regulatory or reporting formats needed from the fleet tool for audits (CLIA, CAP, ISO export formats, CSV templates). Options: CLIA audit log format, CAP inspection package, ISO audit export, Custom CSV

Load barcode patient and operator ID

• Identify the barcode symbologies and patient ID formats used at your facility (for example: hospital MRN barcode, wristband Code 128, QR for specimen labels). Options: Code 128, QR, DataMatrix, Other
• Choose the operator identity source you will use for analyzer login: synced employee directory (LDAP), local operator roster, or badge scan. Options: Employee directory (LDAP/SSO), Local operator roster, Badge scan, Manual entry
• Explain how patient demographics and order lookups should occur at the bedside (ADT feed, order feed from EMR, or manual barcode-to-order match). Options: ADT patient feed, Order feed (ORM), Manual barcode-to-order, Hybrid
• State any existing barcode printers, label sizes, or label templates we must support on-site.
• Report the evidence you will require to accept patient/operator barcode scanning in production (sample scan log export, timestamped EMR result entry, or audit trail). Options: Scan log export, Timestamped EMR result, Audit trail export, Other

Deliver operator training and competency certification

• Rate the operator groups that require training and certification (nurses, respiratory therapists, physicians, lab techs) and approximate counts per group. Options: Nursing, Respiratory therapy, Physicians, Lab techs, Other
• Assign preferred training modalities: in-person classroom, on-device supervised sessions, virtual instructor-led, or self-paced e-learning. Options: In-person instructor, On-device supervised, Virtual instructor-led, Self-paced e-learning
• Pick who will own ongoing competency tracking and re-certification (POCT coordinator, lab education team, unit manager). Options: POCT coordinator, Lab education team, Unit manager, Other
• Outline the documentation or checklist format you require for competency sign-off (SOP-based checklist, electronic competency record, or paper form). Options: SOP checklist, Electronic competency record, Paper form, Other
• Name the pass criteria that will define competency sign-off (for example: percent correct on checklist, number of supervised runs, or successful QC completion). Options: ≥90% checklist score, 3 supervised successful runs, Successful supervised run + QC pass, Other

Implement embedded quality control and auto-QC rules

• Enter required QC frequency and levels per test (for example: daily level 1 and level 2, per-shift QC, or QC on lot change). Options: Daily, Per shift, On lot change, Other
• Share the regulatory retention requirement for QC logs and audit trails (number of days required for CLIA/CAP). Options: CLIA minimum retention, Custom retention (days), Site-specific policy
• Measure the allowable QC drift or tolerance thresholds that should trigger corrective action for critical analytes.
• Quantify whether you require automatic device lockout for critical QC failures and which tests must enforce lockout. Options: Yes, full lockout, Yes, selective lockout, No lockout, alert only
• Map the format of QC evidence you require for audits (electronic audit log, printed QC run, or CSV export). Options: Electronic audit log, Printed QC record, CSV export, Other

Set up auto-verification and result routing

• Which auto-verification rules do you require for each analyte (QC pass required, range checks, delta checks relative to prior result)?
• How should critical or abnormal results be routed in your workflow (ED physician inbox, lab alert, on-call pager, or nurse notification)? Options: ED physician inbox, Lab alert, On-call pager, Nurse notification, Other
• Who at your site has authority to override or disable auto-verification, and what documentation is required for overrides?
• When must auto-verification be blocked pending manual review (examples: critical value, QC failure, specimen mismatch)? Options: Critical value, QC failure, Specimen mismatch, Other
• Where should verified results be routed (LIS accession, EMR result field, clinician inbox) and which routing endpoint must be prioritized? Options: LIS accession, EMR result field, Clinician inbox, Other

Supply consumables and automated replenishment

• Do you have a preferred SKU list and average monthly usage rates for cartridges, reagents, and QC material to enroll in automated replenishment? Options: Yes, No
• Are there specific receiving locations for consumable shipments (central supply, unit storeroom, biomedical engineering)? Options: Central supply, Unit storeroom, Biomedical engineering, Other
• Specify minimum on-hand par levels or reorder triggers you want enforced per SKU (for example: maintain 2 weeks of supply). Options: Maintain 2 weeks, Maintain 1 month, Custom par levels
• List any cold-chain, hazardous materials, or disposal requirements for consumables we must follow during delivery and stocking. Options: Cold-chain required, Hazardous materials handling, Special disposal, No special requirements
• Provide preferred billing cadence for consumables (monthly invoice, per shipment, or consignment reporting). Options: Monthly invoice, Per shipment, Quarterly, Consignment

Perform onsite calibration and preventive maintenance

• Estimate the preventive maintenance cadence you require for each analyzer class (monthly, quarterly, semi-annual). Options: Monthly, Quarterly, Semi-annual, Custom
• Confirm who will provide site access and safety procedures for onsite PM (biomed, facilities, unit manager) and any site-specific LOTO requirements.
• Select when the first calibration and PM should occur relative to delivery (at delivery, within 30 days, after initial QC verification). Options: At delivery, Within 30 days, After initial QC verification, Other
• Describe the tolerances or drift thresholds that should trigger corrective maintenance for your critical analytes.
• Indicate whether you require technician service reports that include serial-numbered parts used, hours on-site, and calibration records. Options: Yes, No

Provide 24/7 technical support and remote troubleshooting

• Identify preferred after-hours support channels for critical incidents (phone hotline, secure chat, remote desktop access). Options: Phone hotline, Secure chat, Remote desktop, Email
• Choose target response-time SLA for a device-down critical incident (for example: under 1 hour, 1-4 hours). Options: <1 hour, 1-4 hours, 4-8 hours, Next business day
• Explain the escalation path at your site for unresolved technical issues and who will be the primary escalation contact.
• State whether remote troubleshooting requires hospital VPN credentials, jumpbox access, or local desktop sharing to access fleet consoles. Options: VPN required, Jumpbox required, Desktop sharing, No remote access allowed
• Report monitoring integrations you require for proactive alerts (SNMP trap, API health checks, email alerting). Options: SNMP, API health checks, Email alerts, None

Install firmware and software updates

• Rate the change-control process required for firmware updates at your site (IT change advisory board, lab director sign-off, or automated rollout). Options: IT CAB approval, Lab director sign-off, Automated rollout, Other
• Assign allowed maintenance windows for software and firmware updates (nightly, weekends, scheduled windows) and blackout periods. Options: Nightly (off-hours), Weekends, Scheduled window (specify), No blackout
• Pick who will perform post-update validation testing (POCT coordinator, lab validator, biomed) and which test-suite or SOP will be used. Options: POCT coordinator, Lab validator, Biomedical tech, Other
• Outline rollback and backup requirements if a firmware update causes regressions (image backup, staged rollout, or immediate rollback). Options: Image backup + staged rollout, Immediate rollback, No rollback required
• Name any approval artifacts you require before updates are applied (signed change record, validation checklist, or CAB ticket number). Options: Signed change record, Validation checklist, CAB ticket number, Other

Provide proficiency testing materials and documentation support

• Enter which proficiency testing programs or providers you participate in and which analytes require PT submissions.
• Share how frequently you require PT materials and whether on-site split-sample support is needed for submission windows. Options: Quarterly, Annually, Per PT schedule, On-demand split-sample
• Measure who will track PT results submission and corrective actions (POCT coordinator, lab quality officer, or external vendor). Options: POCT coordinator, Lab quality officer, External vendor, Other
• Quantify the documentation packages you need for accreditation inspections (templated SOPs, QC logs, operator competency records). Options: Templated SOPs, QC logs bundle, Operator competency records, Full accreditation package
• Map acceptable turnaround time for PT result review and corrective-action support (for example: 24-48 hours for initial analysis). Options: 24-48 hours, 3-5 business days, Other

• Purchase Agreement
• Master Services Agreement (MSA)
• Statement of Work (SOW)
• Service Level Agreement (SLA)
• Subscription Order Form (Software)
• Acceptance Test Plan
• Consumables Supply Agreement
• Hardware Warranty and Returns Policy
• Data Processing Agreement / HIPAA BAA (conditional)
• Regulatory Compliance and Responsibilities Addendum
• Payment Schedule and Invoice Terms

• Go-live Health Check (weeks 1-4)
• First Measurement Review (weeks 4-10)
• Acceptance Gate Review (around day 90)
• Quarterly Operational Review (ongoing)

• Deliver the quarterly consumables usage report and reorder recommendations.
• Schedule any required targeted operator retraining sessions and log competency reassessments.
• Restate acceptance criteria from Solution Scope
• Each acceptance criterion recorded in Solution Scope is marked pass or fail and documented with supporting evidence.
• A formal acceptance decision is captured with the named signatory and role for the buying organization.
• Remediation plans and final verification dates are agreed for any failed criteria.
• Produce and circulate the formal acceptance record with pass/fail annotations and the signatory name and role.
• Publish remediation tasks for any failed criteria with acceptance tests and final verification dates.
• Archive the evidence package used for the acceptance decision in the shared success channel.
• Trend review of core metrics
• Confirm that median troponin time-to-result and QC control pass rate remain at or above Solution Scope targets or document remediation if they do not.
• Prioritize the open issue backlog and enhancement requests with target dates for resolution.
• Validate consumable supply levels and agree any purchasing or logistics actions to avoid interruptions.
• Update the issue tracker with prioritized tickets, target resolution dates, and acceptance tests.
• Schedule a detailed review technical investigation for any metric that missed target for two consecutive quarters.
• Re-confirm success criteria and owners
• Confirm deployment checklist items are complete or have owners and target close dates.
• Validate that connectivity to the LIS is performing basic transactions and log any exceptions.
• Identify any early adoption blockers and document remediation actions with dates.
• Publish a deployment defect log with each item, owner, and target close date.
• Deliver list of operators who completed competency assessments and those requiring follow-up training.
• Provide raw connectivity transaction samples for any failed LIS transactions flagged during validation.
• Present first measurement data
• Determine whether troponin median time-to-result, percent auto-verified to the LIS, and QC failure rate are trending toward the Solution Scope targets.
• Document root causes for any metric gaps and agree concrete corrective actions with target dates.
• Confirm the date and data package required for the Acceptance Gate meeting.
• Distribute the measurement dataset and calculation method used for each metric within 48 hours.
• Create a corrective action register that lists each remediation task, acceptance criteria, and target close date.
• Present outcome data against each criterion
• QC and compliance findings
• Deployment and connectivity validation
• Diagnose gaps and root causes
• Document pass or fail per criterion
• Operator onboarding and competency signals
• Open issue backlog and enhancement requests
• Agree corrective actions and timelines
• Early usage and error log review
• Confirm readiness timeline for Acceptance Gate
• Consumables and supply chain check
• Capture formal acceptance decision and signatory
• Open issues, owners, and immediate remediation plan
• Agree remediation and final close plan for any failed criteria
• Agree next quarter actions and owners