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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') [https://www.hhs.gov/hipaa/for-professionals/special-topics/hipaa-covid19/index.html Office for Civil Rights] and their COVID-19 announcements and guidance, as well as the Centers for Medicare & Medicaid Services (CMS) [https://www.cms.gov/About-CMS/Agency-Information/Emergency/EPRO/Current-Emergencies/Current-Emergencies-page emergencies page].
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| 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. [https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/Downloads/CMS116.pdf Form CMS-116] will need to be completed and submitted to your [https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIASA.pdf 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 [https://www.cms.gov/regulations-and-guidance/legislation/clia CMS page for CLIA], [https://www.cdc.gov/clia/quick-tips.html CDC page for CLIA], and resources available from professional organizations like the [https://www.aafp.org/family-physician/practice-and-career/managing-your-practice/clia.html 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<ref name="CMSFAQ">{{cite web |url=https://www.cms.gov/files/document/clia-laboratory-covid-19-emergency-frequently-asked-questions.pdf |format=PDF |title=Frequently Asked Questions (FAQs), CLIA Guidance During the COVID-19 Emergency |author=Centers for Medicare and Medicaid Services |accessdate=20 August 2020}}</ref>:
| | ==''Introduction to Quality and Quality Management Systems''== |
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| | | text = This book should not be considered complete until this message box has been removed. This is a work in progress. |
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| | The goal of this short volume is to act as an introduction to the quality management system. It collects several articles related to quality, quality management, and associated systems. |
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| <blockquote>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).</blockquote>
| | ;1. What is quality? |
| | :''Key terms'' |
| | :[[Quality (business)|Quality]] |
| | :[[Quality assurance]] |
| | :[[Quality control]] |
| | :''The rest'' |
| | :[[Data quality]] |
| | :[[Information quality]] |
| | :[[Nonconformity (quality)|Nonconformity]] |
| | :[[Service quality]] |
| | ;2. Processes and improvement |
| | :[[Business process]] |
| | :[[Process capability]] |
| | :[[Risk management]] |
| | :[[Workflow]] |
| | ;3. Mechanisms for quality |
| | :[[Acceptance testing]] |
| | :[[Conformance testing]] |
| | :[[Clinical quality management system]] |
| | :[[Continual improvement process]] |
| | :[[Corrective and preventive action]] |
| | :[[Good manufacturing practice]] |
| | :[[Malcolm Baldrige National Quality Improvement Act of 1987]] |
| | :[[Quality management]] |
| | :[[Quality management system]] |
| | :[[Total quality management]] |
| | ;4. Quality standards |
| | :[[ISO 9000]] |
| | :[[ISO 13485]] |
| | :[[ISO 14000|ISO 14001]] |
| | :[[ISO 15189]] |
| | :[[ISO/IEC 17025]] |
| | :[[ISO/TS 16949]] |
| | ;5. Quality in software |
| | :[[Software quality]] |
| | :[[Software quality assurance]] |
| | :[[Software quality management]] |
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| On the HIPAA side of things, you'll want to tap into resources such as the HHS' [https://www.hhs.gov/hipaa/for-professionals/training/index.html HIPAA training materials and resources], as well as their previously mentioned COVID-19 announcements and guidance.
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| Other considerations include<ref name="PaulAGuide20">{{cite web |url=https://www.clinicallabmanager.com/insight/a-guide-to-setting-up-a-coronavirus-covid-19-clinical-diagnostic-testing-laboratory-22850 |title=A Guide to Setting up a Coronavirus (COVID-19) Clinical Diagnostic Testing Laboratory |author=Paul, S. |work=Clinical Lab Manager |date=29 May 2020 |accessdate=13 September 2021}}</ref><ref name="BuchanInterim19">{{cite web |url=https://asm.org/ASM/media/Policy-and-Advocacy/Biosafety-white-paper-2019.pdf |format=PDF |title=Interim Clinical Laboratory Guideline for Biological Safety |author=Buchan, B.W.; Mahlen, S.D.; Relich, R.F. |publisher=The American Society for Microbiology |date=January 2019 |accessdate=20 August 2020}}</ref><ref name="CDCFrequently20">{{cite web |url=https://www.cdc.gov/coronavirus/2019-ncov/lab/faqs.html |title=Frequently Asked Questions about Coronavirus (COVID-19) for Laboratories |author=Centers for Disease Control and Prevention |publisher=Centers for Disease Control and Prevention |date=24 August 2021 |accessdate=13 September 2021}}</ref><ref name="OSHACOVID20">{{cite web |url=https://www.osha.gov/coronavirus/control-prevention/laboratory |title=COVID-19 - Control and Prevention - Laboratory Workers and Employers |publisher=Occupational Safety and Health Administration |accessdate=13 September 2021}}</ref>:
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| * 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"<ref name="ISO15189">{{cite web |url=https://www.iso.org/standard/56115.html |title=ISO 15189:2012 Medical laboratories — Requirements for quality and competence |publisher=International Organization for Standardization |date=August 2014 |accessdate=20 August 2020}}</ref>;
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| * 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;
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| * 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<ref name="NASNRCBiosec12">{{cite book |url=https://www.ncbi.nlm.nih.gov/books/NBK196149/ |chapter=Appendix E - Country and Region Overviews |title=Biosecurity Challenges of the Global Expansion of High-Containment Biological Laboratories: Summary of a Workshop |author=National Academy of Sciences and National Research Council |publisher=National Academies Press |pages=193–204 |year=2012 |isbn=9780309225786 |doi=10.17226/13315}}</ref>); and
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| * understanding and training on Occupational Safety and Health Administration (OSHA) requirements for laboratory workers and employers for COVID-19.
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| ==References==
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| {{Reflist|colwidth=30em}}
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