Quality and Safety Systems

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

Lead the Next Generation Sequencing (NGS) Quality Initiative with the CDC’s Deputy Director for Infectious Diseases (DDID) and Association of Public Health Laboratories (APHL) to develop an NGS-focused quality management system (QMS) and support the development and implementation of NGS-based tests.
Partner with state and local public health laboratories to identify quality-related challenges, align quality standards, and provide resources that empower laboratories to report accurate results.

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.
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.
- There have been over 6,500 downloads of NGS guidance resources and tools between 2019 and 2022. Documents related to process management, equipment, and personnel had the highest number of downloads.
- There have been over 21,000 total page views on the NGS website since 2019. The most visited pages are QMS Tools and Resources, Next Generation Sequencing Quality Initiative, and the Find Additional NGS Materials.

Biosafety

Planned, developed and co-sponsored the bi-annual CDC International Symposium on Biosafety in collaboration with the Eagleson Institute and the American Biological Safety Association (ABSA) to discuss emerging topics and developing trends. The 2020 symposium was attended by over 300 participants from the areas of clinical care, public health, research, and animal care.
Led, initiated, and contributed to publications on national or international standards and guidelines that addressed laboratory quality and safety needs, such as the Biosafety in Microbiological and Biomedical Laboratories-6th Edition and ISO 35001:2019(en), Biorisk management for laboratories and other related organizations. Other initiatives included publications about specialized laboratory testing areas, such as cancer diagnostics, genetic testing, and microbiology testing.
Provided subject matter expertise and scientific review of laboratory education and training materials for public health and clinical laboratory professionals and point-of-care (POC) testers. DLS currently has more than 100 training resources available in a variety of formats, including eLearning and virtual reality (VR) courses, job aids, and microlearnings on topics such as safe operation of biosafety cabinets, centrifuges, chemical fume hoods, and fundamentals of personal protective equipment. Find more information about training visit training and workforce development.
Contributed subject matter expertise to both agency-level and DLS webpages including Interim Guidelines for Biosafety and COVID-19 | CDC, Guidance for SARS-CoV-2 Rapid Testing Performed in Point-of-Care Settings | CDC, Point-of-Care Testing: Risk Assessment Basics | CDC, Biological Risk Assessment: General Considerations for Laboratories, and Biological Risk Management for Point-of-Care Testing Sites which combined have over 1,432,000 views since 2019.
Received and addressed over 380 inquiries on biosafety and CLIA from a wide variety of clinical laboratory, medical, healthcare, media, and public audiences. The most frequent topics include personal protective equipment usage and shortage, specimen handling and processing, and equipment safety.
Contributed COVID-19 biosafety guidance and risk assessment updates on Clinical Laboratory COVID-19 Response Calls since 2020.

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.