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<article xmlns:xlink="http://www.w3.org/1999/xlink" xmlns:mml="http://www.w3.org/1998/Math/MathML" article-type="research-article"><?properties manuscript?><front><journal-meta><journal-id journal-id-type="nlm-journal-id">9421549</journal-id><journal-id journal-id-type="pubmed-jr-id">2992</journal-id><journal-id journal-id-type="nlm-ta">Clin Chem</journal-id><journal-id journal-id-type="iso-abbrev">Clin. Chem.</journal-id><journal-title-group><journal-title>Clinical chemistry</journal-title></journal-title-group><issn pub-type="ppub">0009-9147</issn><issn pub-type="epub">1530-8561</issn></journal-meta><article-meta><article-id pub-id-type="pmid">31130737</article-id><article-id pub-id-type="pmc">6534266</article-id><article-id pub-id-type="doi">10.1373/clinchem.2012.195362</article-id><article-id pub-id-type="manuscript">HHSPA1022257</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>CDC Recommendations: Good Laboratory Practices for Biochemical Genetic Testing and Newborn Screening for Inherited Metabolic Disorders</article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Shahangian</surname><given-names>Shahram</given-names></name></contrib><contrib contrib-type="author"><name><surname>Chen</surname><given-names>Bin</given-names></name><xref rid="CR1" ref-type="corresp">*</xref></contrib><aff id="A1">Division of Laboratory Science and Standards, Office of Surveillance, Epidemiology and Laboratory Services, Centers for Disease Control and Prevention, Atlanta, GA.</aff></contrib-group><author-notes><fn fn-type="con" id="FN1"><p id="P1"><bold>Author Contributions:</bold> All authors confirmed they have contributed to the intellectual content of this paper and have met the following 3 requirements: (a) significant contributions to the conception and design, acquisition of data, or analysis and interpretation of data; (b) drafting or revising the article for intellectual content; and (c) final approval of the published article.</p></fn><corresp id="CR1"><label>*</label>Address correspondence to this author at: Division of Laboratory Science and Standards, Office of Surveillance, Epidemiology and Laboratory Services, Centers for Disease Control and Prevention. Mailstop G-23, 1600 Clifton Rd., NE, Atlanta, GA 30329. Fax 404-498-2372; <email>bkc1@cdc.gov</email>.</corresp></author-notes><pub-date pub-type="nihms-submitted"><day>24</day><month>4</month><year>2019</year></pub-date><pub-date pub-type="ppub"><month>12</month><year>2012</year></pub-date><pub-date pub-type="pmc-release"><day>24</day><month>5</month><year>2019</year></pub-date><volume>58</volume><issue>12</issue><fpage>1728</fpage><lpage/><!--elocation-id from pubmed: 10.1373/clinchem.2012.195362--><self-uri xlink:href="http://clinchem.aaccjnls.org/content/58/12/1728"/></article-meta></front><body><p id="P2">On April 6, 2012, the Centers for Disease Control and Prevention (CDC) published recommendations for good laboratory practices that address the quality-management needs of biochemical genetic testing and newborn screening (<xref rid="R1" ref-type="bibr">1</xref>). The CDC recommendations were developed on the basis of the recommendations and input of 3 federal advisory committees (the Clinical Laboratory Improvement Advisory Committee; the Secretary&#x02019;s Advisory Committee on Genetics, Health, and Society; and the Secretary&#x02019;s Advisory Committee on Heritable Disorders in Newborns and Children), as well as stakeholders and organizations representing newborn-screening laboratories. The specific areas covered in these recommendations include quality-management systems; planning and preparing for the introduction of new tests; establishing and verifying test performance; preanalytical (e.g., provision of test information, informed consent, test requests, specimen submission), analytical (e.g., quality control, proficiency testing, and alternative performance assessment), and postanalytical (e.g., test result reporting, result record retention, quality assessment) aspects; confidentiality of patient information and test results; and personnel qualifications and responsibilities. These recommendations provide a comprehensive guide for all those involved in laboratory testing for the screening, detection, diagnosis, monitoring, and clinical management of inherited metabolic diseases.</p></body><back><ack id="S1"><p id="P3">The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the CDC.</p></ack><fn-group><fn fn-type="COI-statement" id="FN3"><p id="P4"><bold>Authors&#x02019; Disclosures or Potential Conflicts of Interest:</bold> Upon manuscript submission, all authors completed the author disclosure form. Disclosures and/or potential conflicts of interest:</p><p id="P5"><bold>Employment or Leadership:</bold> S. Shahangian, CDC; B. Chen, CDC.</p><p id="P6"><bold>Consultant or Advisory Role:</bold> None declared.</p><p id="P7"><bold>Stock Ownership:</bold> None declared.</p><p id="P8"><bold>Honoraria:</bold> None declared.</p><p id="P9"><bold>Research Funding:</bold> None declared.</p><p id="P10"><bold>Expert Testimony:</bold> B. Chen, Secretary&#x02019;s Advisory Committee for Heritable Disorders in Newborns and Children.</p><p id="P11"><bold>Patents:</bold> None declared.</p></fn></fn-group><ref-list><title>Reference</title><ref id="R1"><label>1.</label><mixed-citation publication-type="journal"><collab>CDC.</collab>
<article-title>Good laboratory practices for biochemical genetic testing and newborn screening for inherited metabolic disorders.</article-title>
<source>MMWR Recomm Rep</source>
<year>2012</year>;<volume>61</volume>:<fpage>1</fpage>&#x02013;<lpage>44</lpage>. <comment><ext-link ext-link-type="uri" xlink:href="http://www.cdc.gov/mmwr/pdf/rr/rr6102.pdf">http://www.cdc.gov/mmwr/pdf/rr/rr6102.pdf</ext-link> (Accessed October 2012)</comment>.</mixed-citation></ref></ref-list></back></article>