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In the previous chapter, the regulatory hurdles of the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvement Amendments (CLIA) were addressed. For those laboratories that are already operating in the clinical laboratory sphere, it should be relatively simple to address the additional considerations and pandemic-specific changes to those two regulations as described previously. In addition to that information, you can always periodically check the U.S. Department of Health & Human Services' (HHS') Office for Civil Rights and their COVID-19 announcements and guidance, as well as the Centers for Medicare & Medicaid Services (CMS) emergencies page.
If for some reason you're not a clinical lab—or want to start a new lab—and want to take on COVID-19 and other clinical testing, you're going to need to get fast tracked into the CLIA program, for starters. Fortunately, CMS has already displayed a willingness to help labs wanting to perform COVID-19 testing receive their CLIA certificate rapidly. Form CMS-116 will need to be completed and submitted to your state survey agency contact. Of course, while you're waiting, you'll also want to become familiar with the trappings of CLIA by tapping into resources like the CMS page for CLIA, CDC page for CLIA, and resources available from professional organizations like the American Academy of Family Physicians. If all goes as planned, and directions are followed, you should have your CLIA certificate in no time. CMS adds[1]:
We want to ensure that laboratories located in the United States applying for a CLIA certificate are able to begin testing for COVID-19 as quickly as possible. Once the laboratory has identified a qualified laboratory director and has provided all required information on the CMS-116 application, a CLIA number will be assigned. Once the CLIA number has been assigned, the laboratory can begin testing as long as applicable CLIA requirements have been met (e.g., establishing performance specifications).
On the HIPAA side of things, you'll want to tap into resources such as the HHS' HIPAA training materials and resources, as well as their previously mentioned COVID-19 announcements and guidance.
Other considerations include[2][3][4][5]:
- taking the time to get accredited to ISO 15189:2012 Medical laboratories — Requirements for quality and competence, "used by medical laboratories in developing their quality management systems and assessing their own competence"[6];
- understanding and training on packaging (e.g., UN3373 Biological Substance, Category B) and shipping COVID-19 specimens (e.g., International Air Transport Association (IATA) Dangerous Goods Regulations), if you will be conducting such activities;
- understanding the significance of and validating workflow procedures to at least Biosafety Level 2 (note there is no single U.S. government entity which has total responsibility for enforcing biosafety levels[7]); and
- understanding and training on Occupational Safety and Health Administration (OSHA) requirements for laboratory workers and employers for COVID-19.
References
- ↑ Centers for Medicare and Medicaid Services. "Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency" (PDF). https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf. Retrieved 20 August 2020.
- ↑ Paul, S. (29 May 2020). "A Guide to Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Laboratory". Clinical Lab Manager. https://www.clinicallabmanager.com/insight/a-guide-to-setting-up-a-coronavirus-covid-19-clinical-diagnostic-testing-laboratory-22850. Retrieved 13 September 2021.
- ↑ Buchan, B.W.; Mahlen, S.D.; Relich, R.F. (January 2019). "Interim Clinical Laboratory Guideline for Biological Safety" (PDF). The American Society for Microbiology. https://asm.org/ASM/media/Policy-and-Advocacy/Biosafety-white-paper-2019.pdf. Retrieved 20 August 2020.
- ↑ Centers for Disease Control and Prevention (24 August 2021). "Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories". Centers for Disease Control and Prevention. https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html. Retrieved 13 September 2021.
- ↑ "COVID-19 - Control and Prevention - Laboratory Workers and Employers". Occupational Safety and Health Administration. https://www.osha.gov/coronavirus/control-prevention/laboratory. Retrieved 13 September 2021.
- ↑ "ISO 15189:2012 Medical laboratories — Requirements for quality and competence". International Organization for Standardization. August 2014. https://www.iso.org/standard/56115.html. Retrieved 20 August 2020.
- ↑ National Academy of Sciences and National Research Council (2012). "Appendix E - Country and Region Overviews". Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories: Summary of a Workshop. National Academies Press. pp. 193–204. doi:10.17226/13315. ISBN 9780309225786. https://www.ncbi.nlm.nih.gov/books/NBK196149/.
