Quality and Safety Systems

QSSB Scientist serological test

The Division of Laboratory Systems (DLS) works to improve the quality and safety of laboratory testing in clinical and public health settings. DLS accomplishes this goal by collaborating across CDC and engaging broadly with external partners, which include other federal agencies, state agencies and programs, and professional organizations, among others. DLS develops laboratory quality and safety standards, guidelines, recommendations, and tools in collaboration with partners, and fosters the adoption of these products by clinical and public health laboratories. In addition, DLS supports efforts to reduce diagnostic errors that can improve health equity for all.

Our Services

Clinical Laboratory Improvement Amendments (CLIA)

  • Provide scientific and technical support for the CLIA program to ensure the accuracy and reliability of clinical laboratory testing nationwide, working in collaboration with CDC’s CLIA partners, the Centers for Medicare & Medicaid Services (CMS) and the U.S. Food and Drug Administration (FDA), to support CLIA.
  • Learn about the Clinical Laboratory Improvement Advisory Committee

    The Clinical Laboratory Improvement Advisory Committee (CLIAC) provides guidance on studies designed to improve quality, safety, effectiveness, efficiency, timeliness, equity, and patient-centeredness of laboratory services; revisions to the standards under which clinical laboratories are regulated; the impact of proposed revisions to the standards on medical and laboratory practice; the modification of the standards and provision of non-regulatory guidelines to accommodate technological advances, such as new test methods, the electronic transmission of laboratory information, and mechanisms to improve the integration of public health and clinical laboratory practices.

    Manage the Clinical Laboratory Improvement Advisory Committee (CLIAC), the only Federal advisory committee that provides scientific and technical advice and guidance related to laboratory testing quality and practices to HHS and its agencies, including CDC, CMS, and FDA.

  • Develop and revise CLIA technical standards in collaboration with CMS and perform regulatory impact analysis to address new and evolving testing and information technologies used in laboratories.
  • Assess HHS-approved proficiency testing (PT) programs for CLIA compliance.
  • Develop, distribute, and promote CLIA-related training and informational resources for clinical laboratory professionals, clinicians or other healthcare providers, and the general public.
  • Support CDC’s CLIA-certified laboratories with their implementation of CLIA regulations and facilitate communication with CMS regarding CLIA-related laboratory testing topics.

Diagnostic Excellence

  • Collaborate with partners to:
    • Leverage clinical and public health laboratory capabilities and expertise to ensure accurate, timely, equitable, and actionable diagnoses.
    • Assess strategies for advancing the role of the laboratory to support diagnostic excellence.
    • Reduce and prevent diagnostic errors, such as incorrect, delayed, and missed diagnoses, which contribute to negative health outcomes.

Next Generation Sequencing

Workforce Development

  • Provide subject matter expertise and scientific review of laboratory education and training materials for public health and clinical laboratory professionals as well as point-of-care (POC) testers.
  • Inform competencies for laboratory training curricula and field-based fellowship and internship programs.
  • Develop biosafety training courses for laboratory professionals and the communities they serve.

Biosafety

  • Provide technical expertise and guidance in biorisk management to clinical and public health laboratories.
  • Develop and disseminate biosafety recommendations for laboratories nationwide, based on published scientific data.
  • Provide biosafety guidance to clinical and public health laboratories, hospitals, academia, private industries, and the general public.
  • Create and distribute resources that improve safety in the laboratory environment, the quality of testing, and patient safety.
  • Support CDC efforts to address emerging infectious diseases, preparedness, and response to public health threats, such as the COVID-19 pandemic, Ebola and Zika outbreaks, and natural disasters by working with CDC’s Emergency Operations Center (EOC) and state, local, tribal, territorial, and international partners. Learn more about the role of Division of Laboratory Systems in Laboratory Preparedness and Response.
Our Accomplishments and Impact

Clinical Laboratory Improvement Amendments (CLIA)

  • Collaborated with CMS to revise CLIA technical standards including the development of a final rule to update CLIA PT requirements. This rule affects over 33,000 clinical laboratories subject to participation in PT, a critical component of a quality management system.
  • Distributed over 3,800 educational booklets such as “Ready? Set? Test!”, “To Test or Not to Test?”, provider-performed microscopy procedures, and Individualized Quality Control Plan step-by-step workbooks in 2021. Downloads of the documents and other resources from the DLS waived testing website totaled over 12,300 in 2021.
  • Provided CMS with an annual report summarizing PT program compliance with CLIA requirements. The report which assesses CLIA compliance for the eight approved PT programs, is drawn from over 800 summary reports.

Clinical Laboratory Improvement Advisory Committee (CLIAC)

  • Provided scientific input to drive effective regulation. CLIAC addressed issues that have faced the national laboratory and healthcare communities since 1992. The Committee’s insights have resulted in more than 162 formal recommendations, of which 139 have been addressed. Visit the CLIAC Meeting page to find a recommendations table with the date of the recommendation, category, the recommendation text, and current status.
  • Led CLIAC workgroups including the CLIA Regulations Assessment Workgroup, the CLIA Certificate of Waiver and Provider-performed Microscopy Workgroup, and the Next Generation Sequencing Workgroup in collaboration with CMS and FDA.

Diagnostic Excellence

  • Fostered the development of communities of practice, such as the ECHO (Extension for Community Healthcare Outcomes) project on diagnostic excellence. This project engaged over 400 laboratory professionals, clinicians, and leaders in laboratory and healthcare settings in 44 states, over 11 monthly sessions. Participants shared their expertise, captured innovative use of data, and promoted implementation of data-driven processes.

Next Generation Sequencing

  • Brought together organizations involved in writing guidelines or best practices on next generation sequencing (NGS) for the Next Generation Sequencing Best Practices Forum, formed in 2021. The Forum provided an opportunity for open discussion to assess current activities of each organization for Next Generation Sequencing and determine where federal agencies can assist or lead in addressing gaps and challenges with guideline development and implementation in clinical laboratories.
  • Gathered feedback through the DLS led development and publication of a Request for Information (RFI) about the current state, challenges, and practices relevant to personnel performing bioinformatics activities in clinical and public health laboratories; storage and retention of NGS data files; and maintenance of sequence analysis software.
  • Developed and published over 85 customizable, ready-to-implement guidance documents, standard operating procedures, forms, and tools that can serve as a foundational or integrate into existing QMS through the Next Generation Sequencing Quality Initiative. These products serve the needs of laboratory professionals, bioinformaticians, quality managers, epidemiologists, and microbiologists interested in NGS data quality or that have a role in quality management.

Biosafety

Recent Publications on Ensuring Quality and Safety in Clinical and Public Health Laboratories

Lubin IM, Astles JR, Shahangian S, Madison B, Parry R, Schmidt RL, Rubinstein ML. Bringing the clinical laboratory into the strategy to advance diagnostic excellence. Diagnosis (Berl). 2021 Jan 6;8(3):281-294. doi: 10.1515/dx-2020-0119. PMID: 33554526; PMCID: PMC8255320.

Cornish NE, Anderson NL, Arambula DG, Arduino MJ, Bryan A, Burton NC, Chen B, Dickson BA, Giri JG, Griffith NK, Pentella MA, Salerno RM, Sandhu P, Snyder JW, Tormey CA, Wagar EA, Weirich EG, Campbell S. Clinical Laboratory Biosafety Gaps: Lessons Learned from Past Outbreaks Reveal a Path to a Safer Future. Clin Microbiol Rev. 2021 Jun 16;34(3):e0012618. doi: 10.1128/CMR.00126-18. Epub 2021 Jun 9. PMID: 34105993; PMCID: PMC8262806.

Page last reviewed: June 10, 2022