Scope of Testing
Specify which assays, panels, and specimen types are covered, acceptance criteria, test methods, and any exclusions. Define turnaround targets and conditions for expedited or reflex testing to avoid scope disputes.
Used by providers and labs, a Healthcare Testing Agreement clarifies deliverables, protects patient data under HIPAA, allocates risk, and documents billing and liability terms. Clear written terms reduce disputes, support regulatory audits, and establish expectations for turnaround, reporting, and consent.
Healthcare providers, diagnostic laboratories, public health agencies, and third-party testing vendors commonly use Healthcare Testing Agreements to formalize services and responsibilities.
Appropriate signatories include authorized clinical directors, lab managers, and corporate officers; include counsel when regulatory provisions require review.
Specify which assays, panels, and specimen types are covered, acceptance criteria, test methods, and any exclusions. Define turnaround targets and conditions for expedited or reflex testing to avoid scope disputes.
Detail collection procedures, labeling, transport, storage temperatures, chain-of-custody requirements, and responsibilities for lost or contaminated specimens. Include acceptable courier services and timelines for custody transfer.
Define report format, data elements, electronic delivery method (HL7, PDF), turnaround time, critical value notification procedures, and recipient list. Specify retention and retransmission policies for corrected reports.
Set pricing per test or bundled rates, billing cycles, payment terms, late fees, responsibility for insurance billing, and procedures for disputed invoices or adjustments due to sample issues.
Include HIPAA-compliant data handling, Business Associate Agreement (BAA) clauses when applicable, encryption standards for transmission and storage, minimum necessary rules, and patient authorization language for disclosures.
Allocate liability caps, indemnification obligations, exclusions for consequential damages, insurance requirements, and dispute resolution procedures including venue, governing law, and options for mediation or arbitration.
Agree scope, pricing, compliance, and timelines.
Signatory authorization and dating completed.
Samples collected per protocol; testing performed within SLA.
Deliver reports and retain records per retention rules.
Immediate notification within established minutes/hours.
Deliver routine reports within agreed turnaround days.
Report notifiable conditions per state and CDC timelines.
Provide notice 30 to 90 days before expiration.
Allow 30 days for BAA negotiation and execution.
| Workflow Field Mapping and Configuration | Set element type, required flag, routing, and validation rules |
|---|---|
| Signer Authentication | Choose email, SMS, KBA, or SSO per signer role |
| Signature Fields | Add signature, initial, date, and checkbox fields |
| Conditional Fields | Use conditional visibility for results and billing fields |
| Integration Mapping | Map report delivery to EMR, LIMS, or secure storage |
| Document | Healthcare Testing Agreement | Alternative Agreement |
|---|---|---|
| Primary Focus | clinical testing services | operational lab services |
| PHI Coverage | ||
| Typical Signer | clinical director | lab operations lead |
| When to Use | patient testing | lab outsourcing |
| signNow | DocuSign | Adobe Sign | PandaDoc | HelloSign | |
|---|---|---|---|---|---|
| Starting Price | $8/user/mo | $15/user/mo | $14/user/mo | $19/user/mo | $15/user/mo |
| Free Trial | 7-day free trial | Varies | Varies | Varies | Varies |
| Bulk Send | Yes | Yes | Yes | Yes | No |
| Audit Trail | Yes | Yes | Yes | Yes | Yes |
| HIPAA Compliant | Yes | Yes | Yes | No | No |