• Booth: 756

A2LA is an internationally recognized accreditation body whose primary mission is to provide comprehensive accreditation services for laboratories, inspection bodies, proficiency testing providers, reference materials producers, and product certification bodies. Assessments are conducted using international standards and field-specific technical requirements developed in cooperation with the government and industry.

 Press Releases

• A2LA Clinical Testing Lab Accreditation Programs (Jul 29, 2024)

  A2LA is the only accreditation organization in the world to achieve the Centers for Medicare and Medicaid Services (CMS) Deemed Status and International Laboratory Accreditation Cooperation (ILAC) Recognition for ISO 15189.

  The A2LA Clinical Accreditation Program accredits clinical laboratories to four comprehensive accreditation programs. Each program advances clinical laboratories within the field and provides lasting solutions to challenges commonly faced by laboratories.

• A2LA Newly Published Mission and Vision (Jul 29, 2024)

  The organization updates its mission and vision for the first time in eight years, with a focus on its role in creating a safer, healthier world 

  Frederick, Md (January 30, 2024)— The American Association for Laboratory Accreditation (A2LA), a global accreditation body, is excited to share its newly published mission and vision statements. The publication coincides with the start of the organization’s 2024 strategic plan, which focuses on safety, integrity, quality, and growth.  

            Mission
            We embody the highest integrity and expertise to create trust, safety, and quality throughout the world. 

           Vision
            We create a safer, healthier world. 

• ISO 20387 vs ISO 15189 (Jul 29, 2024)
  In August of 2018, International Organization for Standardization (ISO) released the first standard specific to biobanks, ISO 20387:2018. Because medical laboratories and biobanks have many functions in common, there are areas of overlap between this new standard and ISO 15189:2012 for medical laboratories, as well as some important differences that pertain to each type of facility. In general, ISO 20387 focuses on collection, acquisition, preparation, preservation, and distribution of all types of biological samples. ISO 15189, on the other hand, is specific to human samples; it also covers the sample collection process, but includes more information on examination and result reporting. For medical laboratories that have internal biobanks, the standards dovetail together to create a much more comprehensive process for all potential stages of sample handling, but each standard also serves independently for facilities with one dedicated function.
  Both standards cover impartiality, confidentiality, and ethics in a very similar way. Both also address competency of personnel and appropriate competency testing. Each standard contains specifics about management and organizational structure, but ISO 15189 goes into more detail about leadership functions and organizational requirements. There are few differences in the specifics about quality control measures, validation and verification of methods, audit procedures,and the handling of complaints, as well as things like appropriateness of the facility and equipment. These areas of overlap are important to create consistency between standalone laboratories and biobanks. For facilities that serve both functions, fulfilling the requirements of ISO 15189 fulfills many requirements of ISO 20387 and vice versa, making accreditation to both standards at once a quicker, less costly process than assessing for each individually.
  The key differences between the two standards lie in the handling and intended purpose of the samples. Biobanks are intended to keep samples for significantly longer than a typical medical lab, so ISO 20387 addresses the preparation and longterm preservation of material, requirements for long-term sample traceability, and includes more specifics about the life cycle of samples and how they are stored. Because it includes provisions for human and non-human samples, it has more detailed requirements for the acquisition or collection and documentation procedures for all materials and requires that the intended use of samples be documented. Also, ISO 20387 differs in how it provides for the transport or transfer of banked materials. What ISO 20387 does not cover in any significant detail is examination of samples and reporting the results of those examinations; those functions are comprehensively covered by ISO 15189. In addition, ISO 15189 contains details about
  examination procedures, verification of results, measurement uncertainty, interlaboratory comparison, and other functions related to ensuring the reliability of test results. Because medical laboratories report these results to other facilities or individuals, there are also requirements about reporting that ISO 20387 does not address.
  Both standards contain nuanced provisions specific to each type of facility. This is not an exhaustive explanation of either standard, but it
  is an overview of significant similarities and differences. ISO 20387 was developed in response to major biobank failures in the last several
  years and addresses biobank-specific requirements and procedures that other standards do not cover. Because many different types of
  facilities now contain biobanks, ISO 20387 can be applied to a variety of organizations and can complement other ISO standards. This creates
  a more comprehensive system that helps to minimize risk, optimize efficiency, and ensure that ideal results are consistently achievable.

• AnnCon25 Call for Speakers (Jul 29, 2024)

  A2LA Annual Conference

  AnnCon25 Call for Speakers

  Opens August 5 – September 13

  Are you a dynamic presenter dedicated to compliance, quality, and competency? With 45+ session slots available, the A2LA Annual Conference (AnnCon) is the place to showcase your wealth of knowledge with quality professionals at every level from a multitude of industries. This is your opportunity to share your expertise with the accreditation community on a global stage! We’re looking for sessions to include topics in and around:

  • audit techniques	• leadership	• continuous improvement	• Microsoft basics
  • AI integration	• measurement uncertainty	• calibration	• forensics
  • risk assessment	• training and tools	• operational excellence	• soft skills
  • food safety	• cannabis	• clinical testing	• and possibly [your topic here]!