Clinical Laboratory Compliance Specialists
The OIG has defined exactly what an effective compliance program looks like. Its Seven Elements framework is the federal standard — and the benchmark used when enforcement comes. Regulatory Solutions Group builds programs structured around those Seven Elements from day one, for clinical labs, physician groups, and any healthcare organization that wants to demonstrate genuine compliance.
Barb Senters was among a select group of compliance officers invited to Washington, D.C. by the HHS Office of Inspector General to help develop the definitive federal resource on compliance program effectiveness:
Measuring Compliance Program Effectiveness: A Resource GuideThe Department of Justice has since published its own guidance on effective compliance programs. RSG builds to both standards. https://www.justice.gov/criminal/criminal-fraud/page/file/937501/dl?inline
Every engagement is led personally by Barb Senters, CCEP, CHC, PHR — no hand-offs to junior staff.
On-demand Chief Compliance Officer leadership for labs navigating transitions, rapid growth, or regulatory scrutiny. We provide experienced oversight of OIG compliance program elements, medical necessity policies, and lab-specific billing compliance — without the cost of a full-time executive hire.
Especially critical when a lab is under MAC audit, responding to an OIG inquiry, or scaling operations faster than internal compliance can keep pace.
We design and build compliance programs structured around the OIG's Seven Elements of an Effective Compliance Program — the federal standard for what "effective" actually means. For clinical laboratories, that means written policies and procedures, designated compliance leadership, targeted training, open lines of communication, internal monitoring and auditing, disciplinary standards, and a clear response and corrective action process. Each element is built for your lab's specific risk profile, not copied from a template.
A Seven Elements program built for labs — covering medical necessity frameworks, CLIA infrastructure, billing and coding policies, and OIG audit readiness. Built to hold up under scrutiny, not just on paper.
Comprehensive, risk-based assessments that identify compliance gaps and prioritize remediation. For clinical labs, this means targeted review of medical necessity documentation, ordering physician relationships, test utilization patterns, and billing practices — benchmarked against OIG work plan priorities and current enforcement trends.
Our proprietary methodology is published as a best practice by the Health Care Compliance Association.
Strategic guidance for organizations under regulatory oversight — including OIG Corporate Integrity Agreements, DOJ investigations, MAC audits, RAC audits, and other enforcement actions. We led the successful exit of a CIA that the OIG specifically praised for its innovative whistleblower engagement strategy.
If you're already in the crosshairs, this is where our track record matters most.
Qualified expert witness testimony and analysis in complex compliance, fraud, and regulatory matters — including False Claims Act cases, medical necessity disputes, and laboratory billing litigation. We bring deep subject matter expertise and a credible track record to litigation and dispute resolution engagements.
Retained in FCA cases, medical necessity disputes, and lab billing litigation nationwide.
Compliance-focused due diligence and post-close integration support for mergers, acquisitions, and private equity transactions. We have supported deals exceeding $1.5 billion, including transactions involving laboratory and healthcare services businesses where billing compliance and regulatory exposure are central to deal risk.
Lab acquisitions carry hidden compliance risk. We surface it before it becomes your problem.
Executive-ready compliance reporting, board presentations, and advisory services that translate complex regulatory risk into clear, actionable intelligence for leadership and governance bodies — including lab owners, PE-backed management teams, and public company boards.
Boards need to understand lab compliance risk in plain language. We make that happen.
End-to-end compliance program design and SEC readiness support for companies preparing to go public. We built and guided Core Scientific's GRC program through rigorous SEC scrutiny ahead of its Nasdaq launch — the same structured approach applies to healthcare and lab companies on a public company path.
Lab companies going public face unique compliance disclosure requirements. We've navigated them.
Professional Development
Having the right policies isn't enough — you need a compliance officer who knows how to use them. Barb Senters works directly with compliance officers and compliance teams to build the skills, confidence, and practical judgment that turn a compliance program on paper into one that actually functions.
Personalized coaching for compliance officers navigating complex regulatory environments, enforcement pressure, or organizational resistance. Covers program structure, board communication, audit response, and the judgment calls that don't come with a manual.
Structured support for compliance officers stepping into a new role — whether building a program from scratch or inheriting one that needs work. Barb helps new COs assess what they have, identify gaps, and build a credible roadmap quickly.
Targeted training for compliance staff on the OIG's Seven Elements framework, audit methodology, documentation standards, and regulatory priorities. Practical, scenario-based, and tailored to your organization's specific risk profile.
Helping leadership understand what an effective compliance program looks like — and what their oversight responsibilities actually require. Designed for executives and board members who need to ask the right questions, not just receive reports.
Whether you're building a Seven Elements program from scratch, strengthening an existing one, preparing for a transaction, or already under OIG oversight — Regulatory Solutions Group delivers the expertise clinical laboratories need.