Onsite High Complexity Laboratory Solutions
Build the Operational Framework Around Onsite High Complexity Testing
TMS helps healthcare organizations evaluate, implement, and manage the operational workflow surrounding onsite high-complexity testing, including analyzer planning, staff processes, quality-system support, documentation, vendor coordination, and ongoing program management.
The healthcare organization remains responsible for meeting all regulatory, personnel, quality, licensing, and operational requirements applicable to its onsite testing program.
Program reality
High Complexity Testing Requires More Than an Analyzer
An analyzer is only one part of an onsite high-complexity testing program.
TMS helps practices organize the operational components around the testing program so equipment, people, documentation and workflow are planned together rather than in sequence.
Equipment alone does not create a laboratory program. The workflow, people, quality system, and regulatory responsibilities matter just as much.
Healthcare organizations may also need to address:
- Regulatory requirements
- Qualified personnel
- Method verification or validation as applicable
- Quality control
- Proficiency testing
- Documentation
- Maintenance
- Training
- Workflow
- Specimen handling
- Result reporting
- Referral testing where appropriate
The challenge
The Operational Burden Can Be Significant
Practices evaluating onsite high-complexity testing typically encounter six operational workstreams at once.
Analyzer Selection
Equipment needs to align with the intended workflow and testing model.
Staffing
High-complexity testing may require personnel who meet applicable qualification requirements.
Quality Systems
Quality control, maintenance, documentation, and review processes must be organized.
Regulatory Requirements
Applicable federal and state requirements may vary based on the testing model and location.
Workflow Integration
Specimen processing and reporting need to fit the practice's clinical operations.
Ongoing Management
Programs require continuing attention after launch.
Implementation framework
The TMS Implementation Framework
A structured sequence TMS uses to support practices. Duration depends on the practice's model, staffing and vendor timelines.
Practice Assessment
Review goals, testing model, clinical workflow, staffing, and current infrastructure.
Operational Feasibility
Identify major workflow, staffing, vendor, facility, and regulatory considerations.
Analyzer / Vendor Coordination
Support evaluation and coordination with appropriate equipment or vendor resources.
Workflow Design
Map specimen handling, analyzer workflow, documentation, reporting, and referral processes.
Staff Implementation
Support role definition, process training, and operational readiness.
Quality-System Support
Help organize applicable documentation, QC processes, maintenance tracking, and review workflows.
Launch Support
Support implementation and troubleshooting during rollout.
Ongoing Program Support
Help the practice maintain structured operational processes as needs evolve.
Regulatory responsibility
Regulatory Responsibility Stays With the Testing Organization
Onsite high-complexity laboratory testing may be subject to CLIA and other applicable federal, state, local, personnel, proficiency-testing, quality-system, validation/verification, licensing, and reporting requirements. The organization operating the testing program remains responsible for determining and meeting requirements applicable to its specific operation.
TMS role boundary
TMS provides operational consulting and implementation support. TMS does not provide legal advice and does not independently certify that a practice is compliant.
Role ownership
Who Owns What
Three parties, three distinct sets of responsibilities. TMS supports the operational framework; it is not the testing laboratory.
Healthcare Practice
The testing organization.
- Clinical responsibility
- Laboratory operation
- Personnel and oversight
- Licenses and certificates
- Quality-control approval
- Result interpretation
TMS
Consulting and operational support.
- Implementation support
- Workflow design
- Vendor coordination
- Documentation processes
- Staff education
- Ongoing operational support
External Laboratory / Vendor
Separately contracted parties.
- Referral testing where applicable
- Equipment and vendor support
- Laboratory services as separately contracted
- Its own licensing and regulatory responsibilities
Quality system
A Quality System Is a Continuous Loop
The practice owns and approves each stage. TMS supports the operational framework that keeps the loop organized.
TMS supports the operational framework around these activities. The practice performs and approves them.
Specimen path
How an Onsite Testing Workflow Moves
The practice performs onsite testing. When additional or referral testing is appropriate, the specimen moves to a qualified laboratory partner.
- 01
Provider Order
- 02
Specimen Collected
- 03
Practice Analyzer
- 04
QC / Analytical Workflow
- 05
Result Available
- 06
Provider Review
Branch from QC / Analytical Workflow
Qualified Reference Laboratory
If additional or referral testing is required
TMS support areas
What TMS Can Support
Operational support areas TMS has confirmed for onsite high-complexity programs.
Program Assessment
Review of goals, testing model, staffing, workflow and existing infrastructure.
Workflow Design
Mapping of specimen handling, analyzer workflow, documentation and reporting steps.
Analyzer & Vendor Coordination
Support evaluating operational requirements and coordinating with appropriate vendor resources.
Staff Implementation
Support for role definition, process training and operational readiness.
Documentation Processes
Help organizing the documentation practices that surround an onsite testing program.
Quality-System Organization
Support organizing quality-control, maintenance-tracking and review workflows.
Reference Laboratory Coordination
Coordination of workflows and relationships with qualified laboratory partners.
Ongoing Operational Support
Continued program support as staffing, volume and operational needs change.
Quick answers
Onsite High Complexity Testing, Answered Plainly
Direct answers for organizations evaluating or operating onsite high-complexity testing.
What is onsite high-complexity testing?
It is laboratory testing classified as high complexity that a healthcare organization performs at its own location rather than sending to an outside laboratory.
Because of that classification, the testing organization takes on personnel, quality-system, documentation and regulatory responsibilities in addition to the analyzer itself.
Does TMS operate an onsite laboratory?
No. TMS provides consulting, implementation and operational support. The healthcare organization operates its own onsite testing program.
What does TMS support?
Program assessment, workflow design, analyzer and vendor coordination, staff implementation, documentation processes, quality-system organization, reference laboratory coordination and ongoing operational support.
Who is responsible for CLIA and regulatory requirements?
The organization operating the testing program. It remains responsible for determining and meeting the requirements applicable to its specific operation.
TMS does not provide legal advice and does not certify compliance.
Can TMS help with analyzer selection?
TMS can help evaluate operational requirements and coordinate with appropriate vendors. Final equipment decisions remain with the healthcare organization.
Can TMS help with quality-control workflows?
TMS can help organize the operational processes and documentation practices around applicable quality systems. The practice performs and approves quality control.
How does reference laboratory coordination work?
Where it is part of the approved program, TMS helps coordinate workflows and relationships with qualified laboratory partners that perform referral testing.
FAQ
Frequently Asked Questions
No. TMS provides consulting, implementation, and operational support. The healthcare organization operating onsite testing is responsible for its laboratory operations and applicable regulatory requirements.
No, unless TMS has specifically confirmed a separate operational role. In the standard consulting model, testing is performed by the healthcare organization or qualified laboratory partners.
TMS can help practices evaluate operational requirements and coordinate with appropriate vendors. Final equipment decisions remain with the healthcare organization.
No. TMS may support compliance-oriented processes and documentation, but the testing organization is responsible for determining and meeting applicable regulatory requirements.
TMS may support operational implementation and workflow education. Personnel qualification and competency requirements remain the responsibility of the testing organization.
Yes, where part of the approved program, TMS can help coordinate relationships and workflows with qualified laboratory partners.
TMS can help organize operational processes and documentation around applicable quality systems.
Contact TMS to review your current model, goals, staffing, testing needs, vendor relationships, and operational requirements.
Have a Question?
Build a More Structured Onsite Testing Program
Talk with TMS about your testing model, analyzer workflow, staffing, quality-system processes, reference laboratory relationships, and implementation goals.