ACHC Clinical Laboratory Accreditation Consulting

By Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC

CMS-Approved CLIA Deemed Status for Clinical Laboratories — Expert Guidance from the Former COO and General Counsel of URAC

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What Is ACHC Clinical Laboratory Accreditation?

ACHC Clinical Laboratory Accreditation is a CMS-approved accreditation program that grants clinical laboratories deemed status under the Clinical Laboratory Improvement Amendments (CLIA). Laboratories accredited by ACHC are deemed to meet CLIA requirements, substituting ACHC's inspection process for routine CMS/state survey agency inspections. ACHC laboratory accreditation standards encompass personnel qualifications, quality systems, proficiency testing, test management, pre-analytic and post-analytic processes, and physical environment and safety — providing a comprehensive quality framework for high-complexity and moderate-complexity testing facilities. ACHC's laboratory accreditation program is designed to support continuous quality improvement while ensuring ongoing regulatory compliance.

Integral Healthcare Solutions (IHS) provides expert consulting to clinical laboratories pursuing initial ACHC accreditation and to currently accredited laboratories preparing for re-inspection. Our work is led by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC.

Why ACHC for Clinical Laboratory Accreditation?

Laboratories seeking CLIA deemed status can choose from several CMS-approved accreditation organizations. ACHC offers distinctive advantages for many laboratory settings:

Consultative Survey Approach: ACHC laboratory inspectors work collaboratively with lab leadership and staff, providing real-time education and clarification during inspections rather than conducting adversarial review processes.
Comprehensive Standards Framework: ACHC laboratory standards are organized around a quality systems approach that encompasses the full testing cycle — pre-analytic, analytic, and post-analytic processes — rather than focusing narrowly on individual test performance.
Two-Year Inspection Cycle: ACHC laboratory accreditation is valid for two years, with on-site inspections conducted by laboratory science professionals who understand the operational context of clinical testing.
Responsive Standards Support: ACHC's accreditation support team provides direct access to standards interpretation, which matters critically during inspection preparation and when resolving ambiguous requirements.
Recognition Across Settings: ACHC laboratory accreditation is recognized by CMS, state agencies, and many managed care organizations as evidence of quality and compliance.

ACHC Laboratory Accreditation Standards: Core Domains

ACHC Clinical Laboratory Accreditation evaluates facilities across the following standard domains:

Organization and Governance: Laboratory director qualifications and responsibilities, organizational structure, and compliance program requirements.
Personnel Qualifications and Competency: Qualification requirements for laboratory director, technical supervisor, clinical consultant, testing personnel, and general supervisor roles; competency assessment programs and documentation.
Quality Management System: Laboratory quality plan, document control, nonconforming event management, corrective and preventive action processes, and quality indicator monitoring.
Pre-Analytic Processes: Test ordering procedures, specimen collection requirements, specimen handling and transport, specimen acceptance and rejection criteria, and requisition processes.
Analytic Processes: Test method verification and validation, equipment qualification, calibration and calibration verification, quality control procedures, reagent and supply management, and reference interval establishment.
Post-Analytic Processes: Result reporting requirements, critical value notification, corrected report procedures, and result retention.
Proficiency Testing: PT program enrollment, PT performance, PT investigation requirements, and prohibition of PT referral.
Safety and Physical Environment: Chemical hygiene plan, biohazard controls, fire safety, and laboratory physical plant requirements.

How IHS Supports ACHC Laboratory Accreditation

Phase 1: Gap Analysis and Standards Mapping

IHS conducts a standard-by-standard gap analysis comparing your laboratory's current quality system, personnel documentation, test management practices, and facilities against ACHC Laboratory Accreditation Standards. We identify deficiencies by domain and risk level, with particular attention to personnel competency documentation, quality control procedures, proficiency testing compliance, and quality management system maturity — the areas that most frequently produce inspection findings. You receive a prioritized remediation roadmap.

Phase 2: Quality System Development and Documentation

IHS works with your laboratory director and quality staff to build or strengthen the quality management infrastructure required by ACHC standards. This includes quality plan development, document control procedures, corrective action workflows, nonconforming event management processes, and quality indicator tracking. For laboratories with significant personnel qualification or competency documentation gaps, we provide structured programs for building compliant assessment records.

Phase 3: Mock Inspection and Inspection Readiness

Before applying, IHS conducts a mock inspection modeled on ACHC's laboratory inspection methodology. We review quality system documentation, personnel files, equipment records, proficiency testing performance, and quality control data. We evaluate your physical environment against safety requirements and assess your staff's ability to demonstrate and explain your processes to an inspector. The mock inspection produces a formal findings report with specific remediation steps.

Who Benefits from Laboratory Accreditation Consulting?

Hospital Laboratories Seeking Deemed Status: In-hospital labs transitioning from state survey CLIA oversight to ACHC accreditation.
Independent Clinical Laboratories: Reference and specialty laboratories pursuing initial ACHC accreditation for the first time.
Physician Office Laboratories: POLs performing moderate or high-complexity testing that are building the quality infrastructure required for accreditation.
Labs with Prior Inspection Deficiencies: Facilities that received condition-level or standard-level deficiencies on previous CLIA inspections or ACHC re-inspections.
Multi-Site Laboratory Networks: Health systems or lab management companies operating multiple CLIA-certified locations that need a standardized ACHC accreditation approach.

Why IHS?

IHS is led by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC. IHS brings accreditation consulting expertise across more than 28 program areas, including laboratory, hospital, pharmacy, and health plan settings. Dr. Goddard personally leads IHS's ACHC engagements.

Prepare Your Laboratory for ACHC Accreditation

Schedule a free discovery session to discuss your laboratory's current readiness, the specific gaps in your quality system, and how IHS can guide your path to ACHC accreditation and CLIA deemed status.