Accreditation for Laboratories Outside the USA: What to Expect

The CAP’s accreditation programs provide an engaging, dynamic, collaborative process that fosters an environment of continuous improvement. The program’s peer inspection model, combined with annual checklist updates and year-round education, strengthens each laboratory’s ability to deliver high-quality service that ensures the best patient care possible.

From application to completion, we provide the tools and guidance you need so you can focus on what matters most—patient care.

The Guide to Accreditation contains all of the requirements and key processes necessary to become CAP accredited.

1. The laboratory must have a qualified laboratory director.
2. The laboratory must enroll in CAP Proficiency Testing (PT)/External Quality Assurance (EQA) for a minimum of six months prior to initiating the CAP application process.
3. Each separately accredited laboratory must be enrolled in CAP PT under its own CAP number.
4. All disciplines practiced by the laboratory at the same location, under the same directorship, must be listed in the application. All disciplines will be inspected, as the CAP does not accredit portions of laboratories.

If English is not the operational language of your laboratory, the following requirements must be met:

1. Prior to scheduling an inspection, English language translations of the following documents must be available:
   1. Laboratory organizational structure
   2. Instrument list
   3. Quality assurance/improvement programs
   4. Quality control programs
   5. A sample procedure for each laboratory discipline
2. Responses to any deficiencies cited at the on-site inspection must be provided in English.
   1. Certain supporting documentation to a deficiency may be in your native language provided that the key elements that demonstrate compliance, as well as titles and major headings, are in English.

NOTE: The CAP may not be able to accept laboratories located in some geographic regions if there are commercial prohibitions or any other country risks.

Once you apply for CAP accreditation, you’ll unlock the collection of accreditation resources in our customer portal, e-LAB Solutions Suite (e-LSS), including:

• Online, modular Inspection Preparation Course: Getting Ready for Your First Inspection
• Inspection preparation worksheet, guidelines, and other templates
• Answers to our most common checklist questions
• Recordings of Focus on Compliance Webinars

We have an extended team of specialists who can answer all your detailed questions—from your initial application to inspection logistics, specific inspection questions, or compliance advice. Additionally, we offer a complimentary onboarding call tailored to your specific questions and concerns.

Our accreditation program brings together more than 8,000 laboratories in over 50 countries outside the USA. This allows for benchmarking and idea-sharing of quality protocols and standards, including from many of the top globally-recognized institutions.

Use our searchable database to find laboratories and biorepositories accredited by the CAP.

We are proud to share the following news from some of our recently accredited laboratories:

• Primary Health Care Corporation (PHCC) Health Centers – Qatar
• Pantai Premier Pathology, IHH Healthcare – Malaysia
• ACT Genomics Holdings – Hong Kong
• CORE Diagnostics – India
• American Mission Hospital (AMH) – Bahrain