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The health inspectors referenced in this particular Wall Street Journal's (WSJ) investigative report were from the US regulator Centers for Medicare and Medicaid Services (CMS), which has two main responsibilities, one, to ensure healthcare contractors comply with Medicare and Medicaid regulations, and two, to oversee and regulate CLIA accreditations of clinical labs in the US. To understand the issues CMS may have with a CLIA-accredited lab like Theranos, it would help to first understand the process of CLIA-accreditation and then ascertain how often CMS discovers serious problems in a CLIA-accredited lab.The Process Of CLIA-accreditationIn 1988, the US Congress passed the Clinical Laboratory Improvement Amendments (CLIA) to establish quality standards for all laboratory testing to assure patients their tests were accurate and reliable no matter where they're performed. As part of this process, laboratories that perform diagnostic tests on US patients need to apply for CLIA accreditation. There are 6 CMS-approved accreditation organizations and thousands of CLIA-accredited clinical labs in the US, (see below from https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/statacrd.pdf and https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/HowObtainCLIACertificate.pdf). Thus, according to CMS, there are >16000 CLIA-accredited labs in the US. Some labs are accredited by more than one accreditation organization. A clinical entity, Theranos may have more than one CLIA accredited lab and may be accredited by more than one accreditation organization, especially since its labs are located in more than one state.Part of CLIA accreditation requires enrolling in the CLIA Proficiency testing (PT) program. Three times a year, a CLIA-accredited lab will receive some unknown samples from a CMS-approved PT program provider (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/ptlist.pdf) that it has to test the same way it does patient samples and report these results back to their PT program provider. As the CMS web-site states (Proficiency Testing Programs),'Section 353(d)(1)(E) of the Public Health Service Act requires the laboratory to “treat proficiency testing samples in the same manner as it treats materials derived from the human body referred to it for laboratory examinations or other procedures in the ordinary course of business, except that no proficiency testing sample shall be referred to another laboratory for analysis as prohibited under subsection (i)(4)”'.Clinical testing labs perform a variety of tests. As far as PT is concerned, tests are either waived or nonwaived. PT applies to all nonwaived tests a CLIA accredited lab performs on patient samples. The program then grades these test results using prescribed CLIA grading criteria and reports scores that show how well the lab performed in the PT. As Section 353(d)(1)(E) of the Public Health Service Act clearly states, PT applies to the entire lab test process, i.e., a lab has to run PT samples in the same manner and on the same instruments it uses to run patient samples.How often CMS Discovers Serious Problems In A CLIA-accredited LabCMS explains in detail both PT (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/downloads/cliabrochure8.pdf) as well as detailed instructions on how to anonymously report complaints about a CLIA-accredited lab (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAbrochure9.pdf). Complaints, which include PT cheating, are part of a system of checks and balances that ensure a feed-back loop to help CMS become aware of CLIA violations, a huge deal since CLIA-accredited labs perform clinical tests that impact human health outcomes. Thus, apart from audits and inspections, such complaints are part of the process by which CMS discovers problems in CLIA-accredited labs.With respect to publicly available statistics, CMS has listed its top 10 Deficiencies and Conditions in all US CLIA-accredited labs as of Jan 2016 (see below) (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA/Downloads/CLIAtopten.pdf).Since WSJ's Theranos reports of Oct 15, Dec 20, Dec 27, 2015, allege PT cheating and inappropriate patient sample dilutions, issues that fall under CMS purview (Hot Startup Theranos Has Struggled With Its Blood-Test Technology; U.S. Probes Theranos Complaints; At Theranos, Many Strategies and Snags), this answer highlights nation-wide rates of PT violations reported by CMS to serve as a comparator.As these tables show, deficiencies pertaining to PT were reported in 360 CLIA-accredited labs (2.1%) under regulation 493.803 (https://www.gpo.gov/fdsys/pkg/CFR-2012-title42-vol5/pdf/CFR-2012-title42-vol5-sec493-803.pdf), and in 221 (1.3%) under 493.801 (https://www.gpo.gov/fdsys/pkg/CFR-2004-title42-vol3/pdf/CFR-2004-title42-vol3-sec493-801.pdf). These PT complaints refer to Improper PT and Intentional PT referral, specifically to violations of the following CLIA regulations:42 CFR 493.801(b)Testing of proficiency testing samples.42 CFR 493.801(b)(3)Laboratories that perform tests on proficiency testing samples must not engage in any inter -laboratory communications.42 CFR 493.801(b)(4)qThe laboratory must not send PT samples or portions of samples to another laboratory.So based on publicly available data, if CMS' latest issues with Theranos pertain to PT, such problems are less common compared to others.However, WSJ's latest report in Jan 2016 (The Wall Street Journal, John Carreyrou, Christopher Weaver, Michael Siconolfi, Jan 24, 2016. Deficiencies Found at Theranos Lab), the one this question references, is much less specific about the alleged deficiencies.'U.S. health inspectors have found serious deficiencies at Theranos Inc.’s laboratory in Northern California, according to people familiar with the matter.The problems were found during an inspection by the Centers for Medicare and Medicaid Services, the chief federal regulator of clinical labs, at the bloodtesting company’s facility in Newark, Calif. Failing to fix the problems could put the Theranos lab at risk of suspension from the Medicare program.The inspection results are expected to be publicly released soon, these people said. A spokesman for the agency said it “can’t confirm any survey conclusions or results at this time'.Since WSJ's latest report doesn't specify which regulations these deficiencies pertain to, it isn't presently possible to estimate how common such problems might be. If such data's made available in the future, these CMS tables would be useful reference guides.Thanks for the A2A, Kritika Gupta.

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It’s hard to assess the validity of medical research. I spent many years in biological research. I understand a lot of technical terms, have a fair grasp of statistics, know what doing research is like, but often find it difficult to judge the quality of a given medical report. Here’s some useful rules:Where was it published?Most of the articles you find by searching Google Scholar (https://scholar.google.com/) are in academic journals and books. That includes the article cited in the question, which was published in PLOS, a fairly reliable source.The same goes for any article you find here: National Center for Biotechnology Information or National Library of MedicineArticles in academic journals have been peer reviewed. That doesn’t guarantee that the material is correct but it means a couple of working scientists have looked at and haven’t found anything invalid. Those scientists could still be biased.Scholarly books tend not to be peer-reviewed but chapters in them are often written by the leaders in a given field.There are also many reliable science news sources. Here’s a few I trust:Science News, Articles, and InformationThe World's Largest General Scientific SocietyNature Research: science journals, jobs, information and services.This Week's Strangest Science NewsThe most trustworthy science news sites give links to the scientific research they are reporting.Sites that are trying to push some non-orthodox agenda might be untrustworthy. Any website that is pushing a viewpoint that isn’t widely accepted by scientists might be invalid. Sadly, creationist websites generally fall in this category. Even more sadly, some unorthodox views eventually get accepted by the scientific community and become the new standard.Is it reliable?The article cited in the question provides a great introduction to the problem of unreliable research: Why Most Published Research Findings Are False.Surprising findings in a single study might not turn out to be reliable when other investigators look into the issue.You can get around those problem by looking at literature reviews. I often search Google Scholar using the key words review or meta-analysis. If I’m lucky, I find one or more articles summarizing what previous studies have found. If I am very lucky, I get an article that summarizes the results of many studies in a graph, like this one, or a table.[1][1][1][1] This table shows, by the way, that people who eat a lot of sugar tend to get diabetes in a great many studies.[2][2][2][2]Are the authors of the article well respected?Google Scholar allows you to find out how often a given person has been cited by other scientists. The author of the article, listed in the link, has been cited 164629 times by other scientists.Citation counts aren’t 100% trustworthy. They can be unfair to mavericks who pursue unusual research ideas. Gregor Mendel is a great example of a scientist whose work was mostly ignored for many years.[3][3][3][3]Is there reason to think the author is biased?The opinion of people trying to sell a product might not be trustworthy. That includes most nutritional supplement websites. They are trying to get you to buy their product.People whose job depends on a particular viewpoint might not be trustworthy. An obvious example would be the opinions of people in the coal industry on air pollution or drug manufacturers on drug safety.You can’t automatically reject all such people. (I got some of my funding from the food and fragrance industry.) You need to evaluate what they say extra carefully.Judging statistics is hard.You might think that large samples are better but that isn’t always true.Surveys are only accurate if they cover a fair, representative sample of people. Alfred Kinsey’s research on human sexuality involved thousands of people but his samples weren’t representative, and therefore not accurate.[4][4][4][4]Even if a survey has been well done, there is no guarantee that it’s conclusions are valid. There are lots of good studies showing that people who eat a lot of sugar tend to become diabetic but it still isn’t certain whether sugar really causes diabetes.[5][5][5][5]Studies in some fields, like animal research and clinical cases, can’t ever include more than a handful of animals or people. Occasionally, studies of a single person have been very revealing. A good example is HM, a person who lost his ability to form new permanent memories. Studies of what he could and couldn’t do have been enormously helpful.[6][6][6][6] [7][7][7][7]There is a controversial statistical technique called P-hacking. This XKCD article does a better (funnier) job of explaining it than I can: 882: SignificantIs the report clear and logical?Look for evidence of logic, clear thinking, and whether they cite their sources.Poor reasoning in an article is always a bad sign. This can be hard to judge if the science is complex or obscure but you should try to judge as best you can.Be suspicious of people who make strong claims based on only a little evidence.Citing sources is important because it means that the author is letting you check to see if their claims might be valid.If you can, take the time to understand the background.If someone makes a claim about the benefits of something, for example, look up a textbook or general article to get a better sense of the science behind those claims.I do that, from time to time, when I see claims nutritional supplements. If, for example, someone claims that ketones are good for you, try looking up an article on their roles in biochemistry and physiology. Time is precious and you can’t often do that but it might make sense to invest that time before you spend money on something.More to readEvaluating scientific claims (or, do we have to take the scientist's word for it?)What is a Good Study?: Guidelines for Evaluating Scientific StudiesScientific evidence: What is it and how can we trust it?For more studies like the link cited in the question, check out Google Scholar’s page on John P. A. Ioannidis:https://scholar.google.com/citations?user=A9e6sPYAAAAJ&hl=en&oi=aoKeep in mind that not everyone agrees with him. I haven’t seen a good systematic discussion.Footnotes[1] Consumption of sugar sweetened beverages, artificially sweetened beverages, and fruit juice and incidence of type 2 diabetes: systematic review, meta-analysis, and estimation of population attributable fraction[1] Consumption of sugar sweetened beverages, artificially sweetened beverages, and fruit juice and incidence of type 2 diabetes: systematic review, meta-analysis, and estimation of population attributable fraction[1] Consumption of sugar sweetened beverages, artificially sweetened beverages, and fruit juice and incidence of type 2 diabetes: systematic review, meta-analysis, and estimation of population attributable fraction[1] Consumption of sugar sweetened beverages, artificially sweetened beverages, and fruit juice and incidence of type 2 diabetes: systematic review, meta-analysis, and estimation of population attributable fraction[2] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[2] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[2] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[2] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[3] Israel Ramirez's answer to Why was the discovery of genetics by Mendel not widely known until 40 years after publication? Sure, it was in German, but Haeckel was one of many German Darwinists. Why did he not grasp its significance?[3] Israel Ramirez's answer to Why was the discovery of genetics by Mendel not widely known until 40 years after publication? Sure, it was in German, but Haeckel was one of many German Darwinists. Why did he not grasp its significance?[3] Israel Ramirez's answer to Why was the discovery of genetics by Mendel not widely known until 40 years after publication? Sure, it was in German, but Haeckel was one of many German Darwinists. Why did he not grasp its significance?[3] Israel Ramirez's answer to Why was the discovery of genetics by Mendel not widely known until 40 years after publication? Sure, it was in German, but Haeckel was one of many German Darwinists. Why did he not grasp its significance?[4] Kinsey Reports - Wikipedia[4] Kinsey Reports - Wikipedia[4] Kinsey Reports - Wikipedia[4] Kinsey Reports - Wikipedia[5] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[5] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[5] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[5] Israel Ramirez's answer to Why is there no clear correlation between refined sugar consumption and diabetes?[6] The Legacy of Patient H.M. for Neuroscience[6] The Legacy of Patient H.M. for Neuroscience[6] The Legacy of Patient H.M. for Neuroscience[6] The Legacy of Patient H.M. for Neuroscience[7] HM, the Man with No Memory[7] HM, the Man with No Memory[7] HM, the Man with No Memory[7] HM, the Man with No Memory