CLIA Laboratory Compliance
CLIA sets the requirements for laboratory personnel, quality systems, and proficiency testing. Our directors are responsible for keeping your laboratory in compliance with those requirements, including at inspection.
Regulatory Compliance
Compliance-First. At Every Level. Always.
We have seen what happens when compliance is treated as a checklist. Inspectors find the same gaps: physician documentation that has not been updated, QC records that exist but were never reviewed, personnel files that are incomplete. Our compliance work is built into how we operate, not added on top of it.
HIPAA Privacy & Security
We operate under Business Associate Agreements with every laboratory we work with. Privacy Rule requirements, security risk assessments, and incident response protocols are part of the engagement, not an add-on.
Stark Law & Anti-Kickback
Physician-laboratory relationships carry real legal risk if they are not structured correctly. Every agreement we enter is reviewed for Stark Law and Anti-Kickback compliance before it is signed.
OIG Compliance Program
Our compliance program follows OIG guidance: written policies, regular risk assessments, and a reporting structure that does not depend on people volunteering problems.
Medicare & Medicaid Standards
CMS coverage rules change. LCD and NCD updates affect what gets reimbursed and under what conditions. We stay current on those changes so your laboratory's claims reflect current coverage requirements.
Laboratory Accreditation
Accreditation inspections surface problems that have been building for months. We run gap assessments and mock surveys so that when the real inspection happens, the findings are minimal and the corrective actions are already documented.
State Licensure Management
Operating across state lines means managing multiple laboratory licenses and keeping physician licensure current in every state where results are reported. We track that and handle renewals before they become lapses.
Information Blocking Rules
The 21st Century Cures Act created new obligations around patient access to health information. Laboratories and physicians that do not meet those requirements face information blocking penalties. We make sure those obligations are met.
Get Started
Make compliance your default, not your scramble.
Bring us in before the next inspection, not after the findings. We will assess where you stand, close the gaps, and keep your laboratory and physicians in compliance going forward.