Smart Oversight. Stronger Margins. Direct Support without Agencies

Get exactly the expertise you need, only for the hours you need it. Lab Compliance Simplified provides experienced on-demand Technical Consultants (TC) and Technical Supervisors (TS) for CLIA oversight, test expansion, and operational efficiency without the cost, commitment, or overhead of a full-time hire.

Whether you’re adding non-waived testing or realizing your current team can’t fully support it, we deliver the expertise your lab needs at the right time and in the right amount. Our fractional consulting model keeps your lab compliant, inspection-ready, and operating efficiently while your front-line clinical and provider staff stay focused on patient care.

Core Services

✔️ Technical Consulting & Technical Supervisory Oversight

  • Permanent or temporary fractional Technical Consultant/Supervisor (TC)(TS) to meet CLIA, CAP, COLA, TJC, and CA requirements

  • Training your clinical staff to qualify as Technical Consultants in California (when eligible)

✔️ Training, Competency & Personnel Support

  • Remote/on-camera Direct Observation of Competency Assessments (6-month, 12-month, annual)

  • Onsite Direct Observation of Competency Assessment (California)

  • Creation of training checklists, competency tools, and documentation

  • Guidance for testing personnel on efficient, compliant workflows

✔️ Test Menu Expansion & Method Validation

  • Support with adding new tests

  • Validation/verification planning and execution

  • Statistical analysis of validation/verification data and finalized report

  • Calibration, linearity, comparison studies (data review + statistical analysis)

✔️ Quality Management & Continuous Improvement

  • Remote QC review and quality monitoring

  • Corrective Action / Preventive Action (CAPA) support

  • IQCP review and updates

  • Workflow and operational efficiency (Lean Six Sigma trained)

✔️ Compliance, Accreditation & Inspection Readiness

  • CLIA, CAP, COLA, TJC, and California regulatory support

  • Full internal audits / self-inspections

  • Ongoing compliance monitoring to stay survey-ready

✔️ SOPs, Documentation & Policy Development

  • SOP creation, review, and approval

  • Updates based on regulatory changes or new manufacturer instructions

  • Standardized templates for logs, records, workflows, and competencies

✔️ LIS, Automation & Digital Optimization

  • LIS/LIMS selection advising

  • Support implementing AI-enabled or automated systems

  • Workflow integration and optimization

✔️ Proficiency Testing (PT) Oversight

  • Ensure enrollment in appropriate PT programs

  • Oversight to ensure PT is performed correctly (as patient samples)

  • Review of PT results and required corrective actions

  • Laboratory director responsibilities that can be delegated to a qualified Technical Supervisor/ Technical Consultant include:

    • Ensuring proficiency testing samples are tested in the same manner as patient samples

    • Ensuring that the corrective action plan is followed when PT results are found to be unsatisfactory

    • Ensuring that Quality Control and Quality Assessment programs are established and maintained to identify failures in quality as they occur Laboratory director responsibilities that can be delegated to a qualified General Supervisor include:

    • Ensuring that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning

    • Providing orientation to all testing personnel

    • Annually evaluating and documenting the performance of all testing personnel

    • The Laboratory Director remains responsible for ensuring the performance of all delegated duties.

  • Yes, CMS has REMOVED the requirement under the responsibilities of Technical Supervisors and Technical Consultants, stating competency assessment of testing personnel must be performed onsite in the laboratory. Remote observation for the direct observation components of competency assessment is now considered compliant. Note: States may differ.

  • In most cases the answer is no, but this depends on the training and education of your RNs, your state, your accreditor, and sometimes how the lab is owned (POL vs non-POL). Fill out an intake form and we can discuss the requirements for your lab.

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  • Founder

    I’m Michelle Spinosa, MPH, CLS, MLS(ASCP), Lean Six Sigma Green Belt, and a clinical laboratory leader with 20+ years of experience. I’ve spent my career building efficient, compliant labs—starting two hospital laboratories from the ground up and later earning ASCP’s 40 Under Forty award for leadership.

    As Lab Director for the California Testing Task Force, I led California’s rapid expansion and contraction of COVID-19 and Flu testing, designing scalable processes that supported millions of tests annually.

    Over two decades, I’ve seen how large healthcare systems—despite their strengths—often create layers of complexity that make innovation difficult in outpatient and physician-office settings. My consulting practice exists to give small and moderate-sized labs the expertise, independence, and structure they need to expand testing, improve margins, and stay inspection-ready without carrying the cost of senior lab staff.

    I’m passionate about leading change, simplifying compliance, and helping labs grow efficiently, profitably, and sustainably.

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