- American College of Medical Genetics (ACMG)
- Centers for Disease Control and Prevention (CDC)
- Chen B, Gagnon M, Shahangian S, Anderson NL, Howerton DA, Boone DJ: Good laboratory practices for molecular genetic testing for heritable diseases and conditions. MMWR Morb Mortal Wkly Rep 2009, 58:1–29
- Chen B, Mei J, Kalman L, et al. Good Laboratory Practices for Biochemical Genetic Testing and Newborn Screening for Inherited Metabolic Disorders MMWR Recomm Rep. April 6, 2012 / Vol. 61 / No. RR–2
- Screening Tests To Detect Chlyamidia trachomatis and Neisseria gonorrhoeae Infections
- Public Health Service Interagency Guidelines for Screening Donors of Blood, Plasma, Organs, Tissue, and Semen for Evidence of Hepatitis B and C
- Alter MJ, Kuhnert WL, Finelli L. Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. Centers for Disease Control and Prevention. MMWR Recomm Rep 2003 Feb 7;52(RR-3):1-13, 15.
- Chen B, O'Connell CD, Boone DJ, Amos JA, Beck JC, Chan MM, Farkas DH, Lebo RV, Richards CS, Roa BB, Silverman LM, Barton DE, Bejjani BA, Belloni DR, Bernacki SH, Caggana M, Charache P, Dequeker E, Ferreira-Gonzalez A, Friedman KJ, Greene CL, Grody WW, Highsmith Jr WE, Hinkel CS, Kalman LV, Lubin IM, Lyon E, Payne DA, Pratt VM, Rohlfs E, Rundell CA, Schneider E, Willey AM, Williams LO, Willey JC, Winn-Deen ES, Wolff DJ: Developing a sustainable process to provide quality control materials for genetic testing. Genet. Med. 2005, 7:534–549
- Association of Molecular Pathologists (AMP)
- Association for Molecular Pathology statement. Recommendations for in-house development and
operation of molecular diagnostic tests. American Journal of Clinical Pathology.
- College of American Pathologists (CAP)
- CLIA - Clinical Laboratory Improvement Amendments
- Clinical and Laboratory Standards Institute (CLSI)
- Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline—Third Edition (MM01-A3)
- Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline - Second Edition (MM03-A2)
- Nucleic Acid Amplification Assays for Molecular Hematopathology; Approved Guideline—Second Edition (MM05-A2)
- Quantitative Molecular Methods for Infectious Diseases; Approved Guideline - Second Edition (MM06-A2)
- Nucleic Acid Sequencing Methods in Diagnostic Laboratory Medicine; Approved Guideline (MM09-A)
- Handling, Transport, and Storage of Specimens for Molecular Methods Quick Guide (MM13-A)
- Design of Molecular Proficiency Testing/External Quality Assessment; Approved Guideline—Second Edition (MM14-A2)
- Verification and Validation of Multiplex Nucleic Acid Assays; Approved Guideline (MM17-A)
- Interpretive Criteria for Identification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline (MM18-A)
- Establishing Molecular Testing in Clinical Laboratory Environments; Approved Guideline (MM19-A)
- Quality Management for Molecular Genetic Testing; Approved Guideline (MM20-A)
- Clinical Molecular Genetics Society
- European Molecular Genetics Quality Network (EMQN)
- FDA (Food and Drug Administration)
International Organization of Standardization
- International Organization for Standardization: ISO 15189 Medical Laboratories: Particular Requirements for Quality and Competence, Geneva, International Organization for Standardization, 2007
- ISO Guide 33:2000
Uses of certified reference materials.
- ISO Guide 34:2009
General requirements for the competence of reference material producers.
- ISO Guide 35:2006
Reference materials: general and statistical principles for certification.
- ISO 17511:2003
In vitro diagnostic medical devices-measurement of quantities in biological samples-metrological traceability of values assigned to calibrators and control materials.
- ISO 15194:2009
In vitro diagnostic medical devices-measurement of quantities in samples of biological origin-description of reference materials.
Organisation for Economic Co-operation and Development (OECD)
New York State Clinical Laboratory Evaluation Program (CLEP) Laboratory Standards.
Washington State Medical Test Site Rules (Chapter 246-338 WAC).