Keep your lab in control.
Olyx & Sons consults for CLIA, CAP and COLA laboratories nationwide. We help you open, pass inspection, answer citations and run a sound operation.
Request a consultationWhat a lab consultant does for you
We turn federal and state rules into the daily systems your lab runs on: personnel, procedures, quality control, proficiency testing and records.
CLIA (42 CFR Part 493) sets the federal standards and CMS administers the program. States and accrediting organizations such as CAP, COLA and The Joint Commission inspect against them, and many states add their own facility or personnel licensure. We work out how those layers apply to your test menu and complexity level, then build documentation a surveyor can follow.
Services
Lab director and consultant roles
CLIA requires named, qualified people for moderate- and high-complexity testing. We fill laboratory director, clinical consultant, technical consultant, and technical and general supervisor roles, and we check every qualification against the personnel rules.
New lab setup and licensure
Test menu and complexity planning, the CMS-116 application, state licensure, site and instrument selection, method verification and validation, procedures, QC, and proficiency testing enrollment.
Inspection preparation and mock surveys
We assess your lab against the CLIA, CAP and COLA checklists before the surveyor arrives, then hand you a ranked list of what to fix first.
Plans of correction and 2567 responses
When deficiencies are cited, we write the response with you: root cause, corrective action, evidence and monitoring. That includes condition-level findings, proficiency testing failures and cease-testing letters.
Quality systems, IQCP and competency
Quality management documents, Individualized Quality Control Plans, competency assessment across all six CLIA elements, and corrective action when proficiency testing goes wrong.
Multi-site compliance programs
One set of procedures, oversight schedules and records across several CLIA certificates, so every site is ready on the same day.
Lab billing and revenue cycle
Clean claims, denial management, payment posting, patient billing support and requisition processing, so compliant testing also gets paid.
Surveys grade evidence
Surveyors look for signed procedures, documented competency, proficiency testing corrective action and personnel records that match each person's role. Good testing without that paper trail still gets cited.
We work in these standards every day, so we can find the gaps before a surveyor does. If a citation has already landed, we write a response that addresses the root cause.
How an engagement works
Consultation
Tell us about your lab, test menu, certificate type and any deadline: a survey date, a 2567 due date or an opening date.
Scope and quote
You get a written scope of work and a price before anything starts.
Gap review
We check your documents, personnel files, QC, proficiency testing and records against the standards that apply to you.
Fix and build
We draft or correct procedures, plans of correction, competency forms and QC plans, then train your staff on them.
Ongoing oversight
If you want it: recurring director or consultant duties, proficiency testing review and survey support.
Who we work with
- Independent clinical laboratories
- Hospital and health system labs
- Pathology and reference labs
- Toxicology and specialty labs
- Physician office labs
- Urgent care and surgery centers
- Skilled nursing and long-term care labs
- Behavioral health and drug testing labs
- Mobile phlebotomy and specimen collection
- Research and academic labs
- Multi-site healthcare networks
- Lab startups and new owners
Questions
What does a lab consultant do?
A lab consultant helps a clinical laboratory meet CLIA, state and accreditation requirements: personnel qualifications, procedures, quality control, proficiency testing, competency assessment and survey preparation. Many also fill required CLIA roles such as laboratory director or technical consultant.
Do I need a technical consultant?
Labs running moderate-complexity tests under CLIA must have a qualified technical consultant. High-complexity labs need a technical supervisor and a general supervisor instead. Labs doing only waived testing do not need these roles.
Can you help after a failed CLIA, CAP or COLA survey?
Yes. We help you write a plan of correction or 2567 response that covers root cause, corrective action, evidence and monitoring, including after proficiency testing failures and cease-testing letters.
Do you work with labs in my state?
We support laboratories nationwide, remotely and on-site, and we account for each state's own licensure requirements.
How much does it cost?
It depends on your lab's complexity and number of instruments. You get a written scope of work and a price before any work starts.
Tell us about your lab
Include your test menu, certificate type and any deadline. We will reply by email with next steps.