Qualification
Faster Diagnostic Decisions, for the Right Practices
The goal is a more controlled path from specimen to treatment decision without adding daily laboratory work for providers. That path still demands clinical demand, space, qualified people, and a decision-maker who can carry it — where those are missing, the honest answer is no.
For independent physician-owned primary-care, urgent-care, OB/GYN, and multispecialty practices — especially those without an existing in-house PCR laboratory. Physician-owners, managing partners, medical directors, and practice administrators should be involved in the evaluation.
What a workable practice looks like
01
Independent physician-owned group
The practice controls its own clinical and business decisions, so a laboratory can be owned and governed inside the practice rather than through a hospital or health system.
02
Meaningful infectious-disease testing demand
Respiratory, urinary, STI, women's health, or gastrointestinal testing is already a recurring part of the practice's week, sufficient to support a menu, quality control, and competency over time.
03
Multiple providers or locations
Enough clinical volume exists to keep a menu running consistently, and the laboratory can serve more than one provider schedule or site.
04
Significant send-out testing
The practice can see what it currently sends out, what it waits for, and what those waits cost in follow-up work and delayed decisions.
05
Physician-owner or administrator involvement
Someone with authority is engaged in the evaluation and can carry a space, configuration, and staffing decision through the practice's approval process.
06
Ability to hire qualified laboratory personnel
The practice is willing to employ qualified laboratory leadership and testing personnel, or to put a compliant contracted arrangement in place.
07
Desire to improve clinical control and turnaround time
The motivation is diagnostic capability and operational independence, not an expectation of passive revenue.
Where we will tell you no
If a practice is looking for an unattended laboratory, guaranteed reimbursement, or a passive revenue stream, this is the wrong model. Those expectations cannot survive contact with CLIA, payer rules, or a surveyor.
Limited testing volume
A menu that runs only a few specimens a week cannot sustain competency, quality control, or reagent continuity, so the operating effort outweighs the clinical benefit.
No available space
Without a defined, separated area for specimen handling and instrumentation, the laboratory cannot be operated properly, and a shared bench in a corridor is not a workable plan.
No willingness to employ qualified laboratory personnel
A laboratory without qualified staff is not an operating laboratory. It is an unstaffed instrument that will not hold up in a survey or a quality review.
No decision-maker access
If the people who can approve space, configuration, and hiring are not in the conversation, the assessment cannot become a project.
Expectation of guaranteed reimbursement or guaranteed profit
Coverage, medical necessity, coding, and payer contracts determine payment. We do not sell a guaranteed financial outcome, and we will not model one to win a project.
Seeking an unattended or unstaffed operation
A laboratory that runs itself is not something CLIA permits. It requires qualified personnel, named leadership, and documented oversight, so we would rather decline than build an operation that cannot be run.
Six dimensions, reviewed together
01
Clinical demand
Which results would change management, for which patients, and how often.
02
Volume
Whether testing patterns can support a menu, quality control, and competency over time.
03
Space and facilities
Whether a separated laboratory area exists or can be created without disrupting care.
04
People
Who will direct and staff the laboratory, and how those roles will be employed.
05
Compliance
State licensure, certificate type, and the documentation the laboratory will need to hold.
06
Economics
Cost structure, payer realities, and the practice's own assumptions about return.
Qualification is not determined by a single volume threshold. The decision depends on menu, seasonality, payer realities, space, personnel, and state requirements.
Find out where your practice actually stands
Submit your practice profile to request a paid feasibility review. We evaluate volume, space, staffing, and implementation conditions, then recommend a launch path or explain why the model does not fit.
For qualified practices. Subject to state, payer, volume, staffing, and compliance requirements.