Question 1

What is ACHC Clinical Laboratory Accreditation?

Accepted Answer

ACHC Clinical Laboratory Accreditation is a CMS-approved accreditation program that grants clinical laboratories deemed status under the Clinical Laboratory Improvement Amendments (CLIA). ACHC-accredited laboratories are deemed to meet CLIA requirements, replacing routine CMS and state survey agency inspections. Standards evaluate personnel qualifications, quality management systems, pre-analytic and post-analytic processes, analytic processes including quality control, proficiency testing, and physical environment and safety.

Question 2

Does ACHC laboratory accreditation satisfy CLIA requirements?

Accepted Answer

Yes. ACHC holds CMS-approved deeming authority under CLIA for clinical laboratory accreditation. An ACHC-accredited laboratory is deemed to meet CLIA requirements, which means CMS and state survey agencies do not conduct routine CLIA inspections of ACHC-accredited labs. The laboratory must still maintain CLIA certification and comply with all applicable CLIA requirements — ACHC accreditation is the verification mechanism.

Question 3

What types of laboratories can pursue ACHC accreditation?

Accepted Answer

ACHC laboratory accreditation is available to hospital-based laboratories, independent clinical laboratories, reference laboratories, physician office laboratories (POLs) performing moderate or high-complexity testing, and other CLIA-certified testing facilities. Both high-complexity and moderate-complexity testing facilities can pursue ACHC accreditation.

Question 4

What are the major standards domains in ACHC laboratory accreditation?

Accepted Answer

ACHC Laboratory Accreditation evaluates: Organization and Governance (including laboratory director qualifications), Personnel Qualifications and Competency Assessment, Quality Management System (quality plan, document control, CAPA), Pre-Analytic Processes (test ordering, specimen handling, rejection criteria), Analytic Processes (method verification/validation, quality control, equipment calibration), Post-Analytic Processes (result reporting, critical values, corrected reports), Proficiency Testing, and Safety and Physical Environment.

Question 5

How often does ACHC conduct laboratory inspections?

Accepted Answer

ACHC laboratory accreditation is valid for two years. ACHC conducts on-site inspections on a biennial cycle by laboratory science professionals. ACHC may also conduct complaint-based inspections and follow-up visits when significant deficiencies require validation of corrective actions.

Question 6

What are the most common deficiencies in ACHC laboratory inspections?

Accepted Answer

Common ACHC laboratory inspection deficiencies include: Personnel competency documentation gaps (incomplete annual competency assessments, missing initial competency records), Quality Control failures (improper QC frequency, failure to investigate QC failures), Proficiency Testing violations (failure to test PT samples in the same manner as patient samples, failure to investigate unsatisfactory results), Method verification and validation deficiencies (incomplete verification for new tests), document control failures (outdated SOPs without review signatures), and safety program gaps.

Question 7

What is the difference between ACHC and CAP laboratory accreditation?

Accepted Answer

Both ACHC and CAP (College of American Pathologists) hold CLIA deemed status for laboratory accreditation. CAP is the most widely used laboratory accreditor, particularly for hospital and reference laboratories with pathology services. ACHC offers an alternative accreditation pathway with a consultative survey approach and biennial inspection cycle. CAP uses peer inspector teams drawn from its pathologist membership; ACHC uses employed laboratory science professionals. The standards content overlaps significantly, as both must meet CLIA requirements.

Question 8

Do I need to maintain CLIA certification in addition to ACHC accreditation?

Accepted Answer

Yes. ACHC laboratory accreditation provides deemed status under CLIA but does not replace the CLIA certificate. Laboratories must maintain their CLIA certificate (issued by CMS) and pay CLIA fees, while using ACHC accreditation as the mechanism for demonstrating compliance with CLIA requirements through deemed status.

Question 9

What is proficiency testing and how does ACHC evaluate PT compliance?

Accepted Answer

Proficiency testing (PT) is a CLIA requirement for laboratories performing moderate and high-complexity testing on regulated analytes. PT providers send unknown samples that laboratories must test and report results to compare against peer laboratory performance. ACHC evaluates PT enrollment for all regulated analytes, timely PT participation, investigation of unsatisfactory PT results, and — critically — that PT samples are tested in exactly the same manner as patient samples, using the same operators and same testing systems. PT referral (sending PT samples to another lab) is a serious violation evaluated in every inspection.

Question 10

How long does ACHC laboratory accreditation take?

Accepted Answer

Most laboratories should plan 9 to 12 months from initial preparation to ACHC accreditation. The timeline depends heavily on the maturity of your quality management system, the completeness of personnel competency documentation, and the currency of your SOP library. Laboratories with mature quality systems that are primarily addressing documentation gaps may move faster; laboratories building QMS infrastructure from the ground up should plan for the full 12 months.

Question 11

What happens if a laboratory receives a deficiency citation from ACHC?

Accepted Answer

ACHC issues Conditions of Deficiency (CODs) for significant inspection findings. The laboratory must submit a Plan of Correction (POC) within the specified timeframe demonstrating how each deficiency has been or will be corrected. For serious deficiencies, ACHC may conduct a follow-up validation visit to verify corrective actions. ACHC may also refer significant deficiencies to CMS for potential CLIA enforcement action in cases involving immediate patient safety risk.

Question 12

How does IHS support ACHC laboratory accreditation?

Accepted Answer

IHS provides standard-by-standard gap analysis, quality management system development, personnel competency program architecture, SOP review and development, mock inspection preparation, and Plan of Correction development for cited deficiencies. Our work is led by Thomas G. Goddard, JD, PhD, former Chief Operating Officer and General Counsel of URAC, directly involved in every laboratory accreditation engagement.

ACHC Clinical Laboratory Accreditation — Frequently Asked Questions