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What We Do
The Colaborate team has over 30 years of experience assisting laboratories nationwide with their compliance and regulation needs. We go above and beyond to ensure standards required of your laboratory are being met. Our team is comprised of more than CLIA consultants – we offer consulting and advisory services focused on CAP, CLIA and COLA:
- Education
- Inspections
- Regulations
- Equipment
- Certifications
- Safety
- Compliance
- Testing
Who We Serve
Our CAP, COLA and CLIA laboratory consulting services are designed for the following organizations:
Health Systems
Pathology Groups
Physician Group Practices
Academic Medical Centers
Clinical Laboratories
Higher Education
Independent Schools
Community Hospitals
Healthcare Purchasers
Corporate Campuses
And More!
Contact our CAP, COLA & CLIA Laboratory Consultants
Colaborate is here to help you determine what is required of your lab and what you will need to become CAP, CLIA and COLA compliant. Learn more about how we have helped hundreds of clients just like you! Contact us today by phone at 813-240-4646 or fill out a quick contact form to get in touch with our team.
Compliance & Inspections
What happens if my lab fails a CLIA inspection?
First, don’t panic, but do act quickly. You’ll need to submit a Plan of Correction within 10 days. What happens next depends on the severity:
| FINDING | CONSEQUENCE |
|---|---|
| Standard Deficiency | Plan of Correction required |
| Condition-Level | Immediate corrective action may be required |
| Immediate Jeopardy | Sanctions, suspension, or emergency action |
Continued non-compliance can escalate to penalties of $10,000/day, Medicare suspension, or certificate revocation. But labs recover from this every day. A strong Plan of Correction and quick follow-through make all the difference.
Received deficiencies? We’ve helped hundreds of labs respond effectively and get back on track.
What is EKRA and how does it affect labs?
EKRA (Eliminating Kickbacks in Recovery Act) is federal law prohibiting payment for patient referrals involving lab testing. What makes EKRA different from the Anti-Kickback Statute? It applies to all payers, not just federal programs. That includes commercial insurance.
EKRA affects labs through specimen collection arrangements, marketing agreements, sales commissions, and physician relationships. Violations carry criminal penalties including fines and imprisonment. If you have referral arrangements in place, have healthcare counsel review them for EKRA compliance.
What SOPs does a clinical laboratory need?
Most clinical laboratories need 75 to 100+ individual SOPs covering every aspect of operations:
- Pre-analytical: Collection, handling, processing, rejection criteria
- Analytical: Test procedures, calibration, QC, troubleshooting
- Post-analytical: Result review, reporting, critical values
- Quality: QA program, PT, competency assessment
- Safety: Chemical hygiene, bloodborne pathogens, emergency procedures
- HR: Training records, competency assessments, personnel qualifications
All SOPs must be reviewed annually by the director. We offer a document management solution to help labs stay organized and inspection-ready, and our guide on Developing Comprehensive SOPs covers the full process.
How do I prepare for a CAP or COLA inspection?
The labs that ace their inspections treat readiness as an ongoing practice, not a last-minute scramble. Here’s what that looks like:
- Complete the CAP or COLA self-inspection checklist before they arrive
- Review all policies, SOPs, and operational records for currency
- Verify personnel files are complete (credentials, competency, CE)
- Confirm QC records are complete with documented corrective actions
- Run a mock inspection to catch anything you missed
Labs that follow this approach walk into inspection day confident. We run mock inspections for clients and can tell you exactly where to focus your prep time.