COLA

What COLA does

COLA (Commission on Laboratory Accreditation) is a U.S. non-profit organization that accredits clinical laboratories under federal CLIA requirements and provides complementary education, ISO 15189 international accreditation, and FDA 510(k) Third Party Review services. Founded in 1988 and headquartered in Columbia, Maryland, COLA accredits approximately 7,000 laboratories across all types, sizes, and complexities — including physician office labs, hospitals, reference laboratories, health systems, pathology and cytology labs, public health facilities, surgery centers, EMS/mobile labs, rural health clinics, plasma centers, and long-term care facilities. It is the only physician-directed laboratory accreditor in the United States and was the first organization to obtain federal approval under CLIA; in June 2026 it achieved CMS deemed status for all nine CLIA specialties (Hematology, Chemistry, Immunohematology, Immunology, Microbiology, Pathology, Radiobioassay, Cytogenetics, and Histocompatibility), and in March 2024 received the maximum six-year CMS reapproval. COLA also operates as an ISO 15189 accreditation body in compliance with ISO 17011 and is an Associate Member of the Inter-American Accreditation Cooperation (IAAC).

COLA's core technology assets are a cloud-based learning management platform (COLA Academy) and an online customer portal (COLAcentral) for accreditation management, multi-laboratory dashboards, and educational content delivery. The organization operates under an ISO 9001:2015-certified quality management system. Supporting products include the Laboratory Director CME Certification course (7 modules, 2 assessments), the Waived Testing Toolkit (with $80–$1,200 tiered pricing), and continuing-education courses. Editorial and event assets include the COLA inSights publication (30+ years), Laboratory Watch blog, Talk Lab To Me podcast, and the annual Laboratory Enrichment Forum (Nashville 2026; Lexington, KY 2027). Additional initiatives include the Workforce Action Alliance (with ASCP, ASM, APHL, AABB, NSH and others) and the GiveBack 365 scholarship program.

COLA's business model is fee-based across four revenue streams: (1) recurring CLIA and ISO 15189 laboratory accreditation fees (quote-based, tied to a two-year cycle covering application, initial, surveillance, and reapproval assessments plus travel); (2) FDA 510(k) Third Party Review fees (professional services, with customer exemption from FDA Medical Device User Fees); (3) educational products and courses (one-time/perpetual licenses, publicly priced at $80–$1,200 per tier); and (4) event revenue from the Laboratory Enrichment Forum. GTM combines direct phone/field sales (800-981-9883), website self-service enrollment, channel partnerships with hospital accreditors DNV and CIHQ, and the ASCP Leading Laboratories Supporting Partner program. COLA reports 98% year-over-year customer satisfaction, 100,000+ on-site surveys conducted, and a workforce of surveyors with an average 10 years of laboratory management experience receiving 40+ hours of annual technical training.

Name

COLA

Legal name

COLA Inc.

Website

https://cola.org

Company type

Private

Founded year

1993

Operating status

Operating

Short description

COLA is a U.S. non-profit that accredits approximately 7,000 clinical laboratories under federal CLIA requirements and provides ISO 15189 accreditation, FDA 510(k) Third Party Review, and continuing education to physician offices, hospitals, reference labs, and health systems.

Ownership category

akta.pro rank

Product category

Medical Laboratory Accreditation Services

akta.pro primary industry

Laboratory Quality Systems, Accreditation & Proficiency Testing Programs (HLAJAIAM)

Keywords

• Laboratory accreditation services
• CLIA compliance certification
• ISO 15189 accreditation
• FDA third party review
• Medical laboratory education

Headquarters

HQ city

Columbia

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Marketing or Sales, Others

Revenue model

1. Laboratory Accreditation Fees: COLA charges fees for participation in its accreditation programs covering application process, initial assessments, surveillance assessments, reapproval assessments, and associated travel costs. Fees vary by laboratory size and complexity.
2. FDA 510(k) Third Party Review: COLA reviews 510(k) applications for medical devices as an FDA-recognized third party. Companies pay COLA for the review and are exempt from FDA's Medical Device User Fees.
3. Educational Products and Courses: COLA Academy offers courses including Laboratory Director CME Certification ($500), Waived Testing Toolkits ($400-$1200), and other training programs for continuing education credits.
4. ISO 15189 Accreditation Program: Fees cover application process, initial assessments, surveillance assessments, reapproval assessments, extraordinary assessments, and travel costs for international recognition.

Pricing tiers

Go-to-market motion3 records

Distribution channels5 records

Marketing channels8 records

Core offering

COLA is a physician-directed, non-profit laboratory accreditation organization that accredits approximately 7,000 clinical laboratories of all types, sizes, and complexities across the United States under federal CLIA requirements, providing CMS-deemed status for all nine CLIA specialties. Its core offering combines on-site surveys, the COLAcentral customer portal, and educational self-assessment tools with paid continuing education courses, ISO 15189 accreditation, and FDA 510(k) Third Party Review services for medical device manufacturers.

Product overview

COLA (Commission on Laboratory Accreditation) operates as a physician-directed, non-profit laboratory accrediting organization offering a portfolio of accreditation and education services. The core offering is the CLIA Accreditation Program, providing CMS-deemed status across all nine CLIA specialties (Chemistry, Hematology, Microbiology, Immunology, Immunohematology, Pathology, Cytogenetics, Radiobioassay, and Histocompatibility). Supporting this is the ISO 15189 Accreditation Program for international quality standards compliance, and FDA Third Party Review Services for accelerated 510(k) device approvals. COLA Academy serves as the cloud-based learning platform hosting courses including Laboratory Director CME Certification, Waived Testing Toolkit, and Quality Matters IQCP courses. The education portfolio extends through publications like COLA inSights and Laboratory Watch blog, plus the Laboratory Enrichment Forum annual conference. COLAcentral provides the customer portal for accreditation management. Additional initiatives include the Workforce Action Alliance addressing labor shortages and the GiveBack 365 scholarship program. Together, these products form an integrated ecosystem supporting laboratory compliance, education, and professional development.

Differentiator

Problem solved

Functional benefit

Products and services

• CLIA Accreditation Program Primary accreditation program for clinical laboratories of all types, sizes and complexities under federal CLIA and state requirements, providing CMS-deemed status across nine CLIA specialties including Clinical Laboratory, Multi-Laboratory Systems, Pathology, and EMS/Mobile testing. Designed for physician office labs, hospital labs, reference labs, health systems, pathology/cytology labs, public health facilities, surgery centers, EMS/mobile labs, rural health clinics, plasma centers, and long-term care facilities.
• ISO 15189 Accreditation Program Accreditation program evaluating laboratories against ISO 15189 international quality standards, delivered in full compliance with ISO 17011 by experienced ISO assessors with at least ten years of laboratory experience. Available to U.S. and international laboratories seeking international recognition for quality and patient care.
• FDA Third Party Review Services FDA 510(k) third-party review services for medical device manufacturers seeking clearance for clinical chemistry and microbiology devices. Companies using the program receive a 30-day FDA determination timeline and are exempt from FDA's Medical Device User Fees.
• COLA Academy Learning Management Platform Cloud-based learning management platform offering courses, webinars, training resources, and continuing education credits for laboratory directors, scientists, and healthcare professionals. Accessed via education.lms.cola.org and forms the infrastructure for COLA's paid course offerings.
• Laboratory Director CME Certification Comprehensive certification course priced at $500 per enrollment that prepares physicians to direct moderate complexity laboratories, covering CLIA responsibilities, laboratory operations management, and staff oversight. Includes 7 modules and 2 assessments, with over 600 enrollments and 500+ certifications awarded and 97% of learners recommending the course.
• Waived Testing Toolkit Instructional toolkit providing best practices for producing accurate and reliable waived test results, developed by laboratory medicine experts and offered in three pricing tiers: All Access ($1,200), Administrative Access ($400), and individual Best Practices for Quality Results course ($80).
• Quality Matters! Implementing a Meaningful IQCP Educational course explaining the history, implementation, and regulatory requirements of Individualized Quality Control Plan (IQCP) for clinical laboratories.

Quantifiable outcome

• 98% customer satisfaction rate year over year
• +4 more outcomes

Named customers1 record

Segments7 records

Ideal customer profiles5 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Partnerships

Five partnerships are on record, tiered core, flagship and minor.

• Inter-American Accreditation Cooperation (IAAC)coreStrategic or Co-development Partner · 3 September 2025COLA became an Associate Member of IAAC on September 3, 2025. IAAC is an association of accreditation bodies in the Americas and other organizations interested in conformity assessment. This membership reflects COLA's commitment to maintaining internationally recognized accreditation practices.
• American Society for Clinical Pathology (ASCP) - Leading Laboratories ProgramflagshipGTM or Marketing PartnerCOLA is a Supporting Partner of the ASCP Leading Laboratories program. This program creates a gold standard for laboratory recognition, validating excellence in quality and patient outcomes. COLA supports laboratories that support patients.
• DNV (Det Norske Veritas)minorChannel Partner/ Reseller/ DistributorDNV is a CMS-approved hospital accreditation organization that shares COLA values including standardized and educational approach to compliance. DNV welcomes COLA laboratory accreditation in their accredited hospitals.
• Center for Improvement in Healthcare Quality (CIHQ)minorChannel Partner/ Reseller/ DistributorCIHQ is a CMS-approved hospital accreditor that welcomes COLA laboratory accreditation in their accredited hospitals, sharing COLA's standardized and educational approach to compliance challenges.
• CDC Laboratory Outreach Communication System (LOCS)coreStrategic or Co-development PartnerCOLA has established a CDC Updates page to quickly transmit CDC public health messages to clinical laboratories. COLA engages with CDC's Division of Laboratory Systems (DLS) to share health alerts, outbreak guidance, and testing recommendations with member laboratories.

Scale indicators13 records

Recent moves8 records

Expansion highlights6 records

Direct peers

• College of American Pathologists (CAP): CAP operates the CAP Laboratory Accreditation Program, the largest CMS-approved accreditor for clinical laboratories. It is the most direct competitor to COLA, serving similar physician office, hospital, and reference laboratory customers with CMS-deemed CLIA accreditation.
• AABB: AABB is a CMS-approved accreditor specializing in transfusion medicine, blood banks, and cellular therapy laboratories. It is directly comparable to COLA's specialized accreditation services in transfusion and immunohematology, overlapping in niche subspecialty segments.
• Accreditation Commission for Health Care (ACHC): ACHC offers CMS-recognized laboratory accreditation as part of a broader portfolio of healthcare facility accreditation programs, competing with COLA for physician office and specialty lab customers and offering bundled accreditation solutions.
• DNV Healthcare: DNV is a CMS-approved hospital accreditation organization and COLA's channel partner for cross-recognition of laboratory accreditation. It competes with COLA in serving hospital-based labs while collaborating on integrated compliance offerings.
• Center for Improvement in Healthcare Quality (CIHQ): CIHQ is a CMS-approved hospital accreditation organization that accepts COLA laboratory accreditation in its accredited hospitals. It is a direct competitor in the integrated hospital-and-laboratory accreditation market.
• Healthcare Facilities Accreditation Program (HFAP): HFAP is a CMS-approved healthcare and laboratory accreditation organization competing with COLA for hospital and clinical laboratory accreditation customers, particularly in integrated healthcare system settings.

Broad incumbents

• The Joint Commission: The Joint Commission is a major CMS-approved hospital and healthcare accreditation organization whose laboratory accreditation services compete with COLA, particularly for hospital and health-system labs bundled within broader institutional accreditation.

Emerging players

• American Society for Histocompatibility and Immunogenetics (ASHI): ASHI accredits histocompatibility laboratories, a CLIA specialty where COLA recently received CMS deemed status. It is a direct competitor in the histocompatibility subspecialty and an emerging point of overlap as COLA expands into this specialty.

Others

• AOAC International: AOAC develops analytical methods and standards used by clinical and food laboratories. While not a direct accreditor, it serves a related role in laboratory quality standards, intersecting with COLA's mission of laboratory quality assurance and proficiency testing.
• Clinical and Laboratory Standards Institute (CLSI): CLSI develops clinical laboratory standards and guidelines referenced by accreditation programs including COLA's. It is an adjacent ecosystem participant rather than a direct accreditor, but its standards underpin COLA's accreditation criteria.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights6 records

Customer concentration

• Xx.com/cola_inc
• Facebookfacebook.com/ColaInc
• LinkedInlinkedin.com/company/cola
• Instagraminstagram.com/cola.inc

Compliance5 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about COLA