What we do

Four services. One outcome.

Every ALP engagement is designed to produce a single result: a laboratory that passes its inspection and sustains compliance independently. The four service lines below are the paths we use to get there.

  • Laboratory technician reviewing accreditation documentation at a workstation
    CAP & CLIA

    Accreditation Readiness

    A comprehensive gap analysis against the current CAP checklist or CLIA requirements — delivered as a prioritized action plan, not a raw deficiency list. We tell you exactly what needs to change, in what order, and why it matters to an inspector.

    • Full checklist review against CAP or CLIA standards
    • Deficiency ranking by inspection risk and remediation effort
    • Written gap report with section-by-section findings
    • Mock inspection walkthrough with verbal debrief
    • Pre-inspection readiness confirmation visit
    Start with a gap assessment
  • Quality management team reviewing laboratory procedures in a meeting room
    Quality Systems

    QMS Implementation

    A quality management system that exists only on paper fails the moment an inspector asks a staff member to explain it. We build QMS programs that your team understands, owns, and can defend — from document control to corrective action to management review.

    • Document control system design and implementation
    • Nonconformance and corrective action (CAPA) workflows
    • Internal audit program with trained auditor support
    • Management review process and meeting facilitation
    • Staff training on QMS principles and daily use
    Build a sustainable QMS
  • Laboratory scientist writing standard operating procedures at a desk
    Documentation

    SOP Development

    Standard operating procedures that are accurate, readable, and actually used. We write SOPs from scratch or overhaul existing documentation — drawing on a library of 400+ validated templates refined across 500+ lab engagements.

    • New SOP authoring from validated ALP templates
    • Existing SOP gap review and revision
    • Procedure formatting aligned to CAP and CLIA expectations
    • Version control and annual review scheduling
    • Staff sign-off tracking and training documentation
    Overhaul your documentation
  • New laboratory facility being set up with modern equipment
    New Labs

    Lab Startup Consulting

    From CLIA registration to first patient specimen — we guide new laboratories through every regulatory and operational step. Whether you're opening a physician office lab, a reference lab, or a specialty testing facility, we've done it before.

    • CLIA certificate application and registration support
    • Director and personnel qualification review
    • Test menu selection and method validation planning
    • Facility and workflow design consultation
    • Accreditation pathway selection (CAP vs. CLIA)
    Launch your lab right

Common questions

What labs ask us most

If your question isn't here, the free consultation is the right next step — we'll answer it in the first five minutes.

  • Most readiness engagements run 8–16 weeks depending on the lab's current compliance posture and the scope of remediation needed. Labs with significant documentation gaps or no prior accreditation history typically need the full 16 weeks. Labs preparing for re-accreditation with minor deficiencies can often complete the process in 6–8 weeks. We provide a timeline estimate in your free consultation.

  • Yes — and this is one of our most common engagements. A failed inspection or a deficiency notice from CAP or CLIA is a defined problem with a defined solution. We review the inspection report, build a corrective action plan, and prepare you for the follow-up visit. Our 100% first-attempt success rate applies to labs we prepare from scratch; for remediation engagements, we focus on clearing every cited deficiency before the re-inspection.

  • Absolutely. CAP accreditation satisfies CLIA requirements for most testing categories, but there are specific CLIA obligations — particularly around personnel qualifications, proficiency testing enrollment, and certificate maintenance — that require separate attention. We conduct a CLIA-specific gap review against your existing CAP program and identify any areas that need supplemental documentation or process changes.

  • The 30-minute consultation includes a review of your current accreditation status, identification of your top three compliance risk areas based on what you share with us, a realistic scope and timeline estimate for an engagement, and a clear explanation of what working with ALP would look like. There is no obligation and no sales pressure — the call is yours to keep regardless of next steps.

  • Both. Most of our documentation work, gap analysis, and training can be delivered remotely via video and shared document platforms. Mock inspections and pre-inspection walkthroughs are typically conducted on-site, as are lab startup facility consultations. We serve labs in 35+ states and schedule on-site visits based on engagement scope and geography.

  • We price by engagement scope, not by the hour. After the free consultation, we provide a fixed-fee proposal covering the full scope of work. This means you know the total cost upfront — no billing surprises as the engagement progresses. Scope changes are handled through a simple change order process.

Don't see your question? We're happy to answer anything about accreditation, compliance, or working with ALP.

Ask a question

Get started

Not sure which service
your lab actually needs?

Most labs come to us knowing they have a compliance problem but not knowing where it lives. The free assessment call is designed to answer that question in 30 minutes.