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The key allegations in the John Carreyrou WSJ article of Oct 15, 2015 (1) on Theranos are aboutAlleged Clinical Laboratory Improvement Amendments (CLIA)-mandated proficiency tests (PTs) cheating (see extended quotes* from 1 at end of the answer).Alleged test protocol violations (allegedly inappropriately diluting test samples when they shouldn't) when using traditional machines (see extended quotes** from 1 at end of the answer).Why are these two the key allegations? Because they raise the most important and alarming suspicion about Theranos, namely, can we trust their test results? Less important issue is whether they were using their proprietary nanotainers to collect blood samples for the tests they offer as they claimed to have done.Cost, convenience, and test accuracy and reliability are the main elements to successfully challenge incumbents in the clinical blood diagnostics space. In the US, incumbents such as Quest and LabCorp already have accurate and reliable tests so a newcomer needs to prove they do too. Who cares about cost and convenience if test results are inaccurate? Certainly not me nor those dear to me.How could regulatory authorities assess if clinical testing labs generate accurate data? There are two steps.First, such labs need to be accredited. In the US, clinical labs that perform clinical laboratory testing on humans get accredited, i.e., CLIA-88, by the credentialing regulatory authority, Centers for Medicare and Medicaid Services (CMS), which falls under the United States Department of Health and Human Services.'Congress passed the Clinical Laboratory Improvement Amendments of 1988 to set criteria to improve the quality of clinical laboratory services. The goal of this law was to standardize laboratory testing across the United States in all sites conducting testing on human specimens for health assessment or for the diagnosis, prevention, or treatment of disease. Failure to comply with these requirements may result in sanctions by the Health Care Financing Administration (HCFA***), whose task is that of implementing CLIA-88' (2).*** in 2001, HCFA morphed into the current CMS.Second, once accredited, CLIA-certified clinical labs are required to enroll and participate in a Proficiency testing (PT) program administered by the CMS (3, 4).PT is conducted 3 times a year with 5 tests (analytes) per time.Test scores should be >80%, i.e., the results the lab generates in at least 4 of those 5 tests should meet previously established consensus acceptance criteria.Unsatisfactory test performance for a particular analyte on 2 consecutive PTs or for 2 out of 3 triggers sanctions against that lab.The regulations that oversee PT specify (5):'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)”. Additionally, this requirement is emphasized in the CLIA regulations at §493.801(b). A laboratory is not to test PT samples on more than one instrument/method unless that is how they test patient specimens. Repeated analysis of PT samples is not appropriate unless patient specimens are similarly tested'.Mandatory PTs are the mechanism to ensure clinical lab tests are accurate (2):'Successful participation in a CLIA-88 approved proficiency testing program is mandated. Proficiency testing determines how well a laboratory’s results compare with those of other laboratories that use the same methodologies and can identify performance problems not recognized by internal mechanisms. Proficiency testing samples are tested along with the laboratory’s regular workload by staff who usually perform the testing using routine methods...Written procedures of the proper handling, analysis, review, and reporting of proficiency testing materials are required. There must be evidence of the identification and review of problems discovered through the use of this program and the documentation of corrective actions taken.When the laboratory uses different methodologies or instruments, or performs testing at multiple testing sites, a system has to be in place that evaluates and verifies the comparability between these test results...This must be documented biannually'.When a clinical testing lab uses, or claims to use, proprietary technologies it claims have no peers, as Theranos claims it does (see 6; the interview with Jonathan Krim at WSJ.D Live on Oct 21, 2015), they need to have a system in place to evaluate and verify comparability of their test results with standard tests. The key allegation pertaining to PT suggests either Theranos didn't or was trying to circumvent such comparisons. Either is a form of PT cheating (1, see * below). Key questions are:For a given analyte, was Theranos testing both patient and PT samples on their proprietary systems or not?For a given analyte, was Theranos testing patient samples on their proprietary system but PT samples on another system?If the former, then those PT results should be comparable to standard PT results for the same analyte, i.e., Theranos should have developed a transparent system for regulators to assess such comparisons. OTOH, the latter would be a 'violation of the state and federal requirements' (1). This last bit brings us to the current conundrum regarding CLIA guidelines in general and to PTs in particular.Realizing that the 1988 CLIA guidelines lack substantial regulatory oversight of technologies that evolved in subsequent decades, the FDA published draft guidelines on October 3, 2014, noting (7),'In summary, the FDA has determined that the following attributes of modern LDTs [Laboratory Developed Tests], which are not attributes of the types of LDTs offered in 1976, create potential increased risk for patients in the absence of appropriate oversight. Many modern LDTs are:• manufactured with components that are not legally marketed for clinical use• offered beyond local populations and manufactured in high volume• used widely to screen for common diseases rather than rare diseases• used to direct critical treatment decisions (e.g., prediction of drug response)• highly complex (e.g., automated interpretation, multi-signal devices, use of non-transparent algorithms and/or complex software to generate device results)However, FDA recognizes that, as with all IVDs [In vitro Diagnostic Devices], there is a wide range of risks associated with the wide variety of LDTs. Thus, FDA believes that a risk-based approach to regulatory oversight of LDTs is appropriate and necessary to protect patient safety. A comprehensive framework that describes FDA’s enforcement policy for different classes and categories of LDTs will help provide clarity to LDT manufacturers and protect patients'.Tests performed using Theranos' proprietary technologies including Edison, i.e., LDT, fall into this grey area. As the Wired's Nick Stockton highlighted in his Oct 21, 2015 article, this grey area currently incompletely regulated by CLIA guidelines led to the FDA, 'increasing its oversight of lab developed tests' (8). These loopholes apply to Theranos' technology and the way they're used/could be used. By submitting their tests for approval by the FDA, Theranos is not so much going above and beyond the norm as they repeatedly claim but rather merely following the mandate of a rapidly evolving regulatory landscape that's finally trying to come to grips with the explosion in healthcare-related technological innovations over the past decade.The irony is that the FDA's increased focus on goings-on in this arena likely had originally nothing to do with concerns about Theranos, which is after all nothing but a traditional clinical lab and not biotech in the classical sense of the word. Rather, the FDA appears to have been extremely alarmed about the rise of DTC (Direct-to-Consumer) genomic tests. Witness their warning letters to Pathway Genomics in 2010 (9) and 2015 (10), and to 23andMe in 2013 (11). Two years later, 23andMe is coming out of the tunnel, having changed its research focus to drug discovery by partnering with Genentech (12).Yet, however the Theranos unraveling began, unravel it certainly has. In that regard, John Carreyrou's follow-up WSJ article of Oct 16, 2015, contained even more damaging information (13) since it alleges that FDA inspectors recently made an unannounced visit to Theranos' offices followed by an audit by CMS. 'Food and Drug Administration inspectors recently showed up unannounced at Theranos, the person familiar with the matter said... Since the inspection by FDA officials, Theranos has also been audited by the Centers for Medicare and Medicaid Services, the main regulatory overseer of clinical labs, according to people familiar with the matter.' (13). In the US medicine and healthcare space, an unannounced visit by FDA inspectors is as bad as it gets.* From 1: 'Whether labs buy their testing instruments or develop them internally, all are required to prove to the federal Centers for Medicare and Medicaid Services that they can produce accurate results. The process is known as proficiency testing and is administered by accredited organizations that send samples to labs several times a year.Labs must test those samples and report back the results, which aren’t disclosed to the public. If a lab’s results are close to the average of those in a peer group, the lab receives a passing grade.In early 2014, Theranos split some of the proficiency-testing samples it got into two pieces, according to internal emails reviewed by the Journal. One was tested with Edison machines and the other with instruments from other companies.The two types of equipment gave different results when testing for vitamin D, two thyroid hormones and prostate cancer. The gap suggested to some employees that the Edison results were off, according to the internal emails and people familiar with the findings.Senior lab employees showed both sets of results to Sunny Balwani, Theranos’s president and chief operating officer. In an email, one employee said he had read “through the regulations more finely” and asked which results should be reported back to the test administrators and government.Mr. Balwani replied the next day, copying in Ms. Holmes. “I am extremely irritated and frustrated by folks with no legal background taking legal positions and interpretations on these matters,” he wrote. “This must stop.”He added that the “samples should have never run on Edisons to begin with.”Former employees say Mr. Balwani ordered lab personnel to stop using Edison machines on any of the proficiency-testing samples and report only the results from instruments bought from other companies...In March 2014, a Theranos employee using the alias Colin Ramirez alleged to New York state’s public-health lab that the company might have manipulated the proficiency-testing process.Stephanie Shulman, director of the public-health lab’s clinical-lab evaluation program, responded that the practices described by the anonymous employee would be a “violation of the state and federal requirements,” according to a copy of her email.What the employee described sounded like “a form of PT cheating,” Ms. Shulman added, using an abbreviation for proficiency testing. She referred the Theranos employee to the public-health lab’s investigations unit'.**From 1: 'In addition to the 15 tests run on the Edison system, Theranos did about 60 more on traditional machines using a special dilution method, the former senior employee says. The company often collected such a small amount of blood that it had to increase those samples’ volume to specifications required by those traditional machines, former employees say...For tests done with dilution, the process caused the concentration of substances in the blood being measured to fall below the machines’ approved range, three former employees say. Lab experts say the practice could increase the chance of erroneous results.Most labs dilute samples only in narrow circumstances, such as when trying to find out by how much a patient has overdosed on a drug, say lab experts.“Anytime you dilute a sample, you’re adulterating the sample and changing it in some fashion, and that introduces more potential for error,” says Timothy R. Hamill, vice chairman of the University of California, San Francisco’s department of laboratory medicine. Using dilution frequently is “poor laboratory practice.”'.BibliographyThe Wall Street Journal, John Carreyrou, Oct 15, 2015. Hot Startup Theranos Has Struggled With Its Blood-Test TechnologyFetsch, Patricia A., and Andrea Abati. "The clinical immunohistochemistry laboratory: regulations and troubleshooting guidelines." Immunocytochemical Methods and Protocols. Humana Press, 2010. 399-412.Page on gpo.govEhrmeyer, Sharon S., and Ronald H. Laessig. "Has compliance with CLIA requirements really improved quality in US clinical laboratories?." Clinica chimica acta 346.1 (2004): 37-43. Page on researchgate.netProficiency Testing ProgramsTheranos CEO Elizabeth Holmes Goes on Stage at WSJDLive 2015 — Live BlogPage on fda.govWired, Oct 20, 2015, Nick Stockton. Fixing the Laws That Let Theranos Hide Data Won’t Be EasyPage on fda.govPage on fda.gov 23andMe, Inc. 11/22/13Forbes, , Oct 14, 2015, Matthew Herper. 23andMe Wins A Second Life: New Business Plan Scores $115 Million From InvestorsThe Wall Street Journal, John Carreyrou, Oct 16, 2015. Hot Startup Theranos Dials Back Lab Tests at FDA’s BehestThanks for the A2A, Jay Wacker.

I am writing from IIM Udaipur’s perspective, considering parameters like campus and infrastructure, recognition, scholastics, exposure and opportunities, and student life. Your ultimate choice would depend upon your weightage of these factors across B-schools (basically giving preference to what is important to you).1. Campusa. Location – The institute, which relocated in October 2016, became the first among new IIMs to move to a permanent campus. Spread across 300 acres in the picturesque Aravali range, the campus is situated in Balicha, which is about 8 km from Udaipur city. Udaipur, called the ‘City of Lakes’, is rich in culture, heritage and unparalleled scenic beauty. It is well connected to all major cities via rail, road and air transport.b. Infrastructure and Facilities – A fully operational campus houses an academic block including state-of-the-art technology-enabled classrooms, a 330-seater auditorium, largest Bloomberg Financial Lab in India with 12 terminals, and a 1200-seater open-air amphitheatre along with a residential block including fully furnished single and double seater air-conditioned hostels and a hygienic mess. A huge open plaza in the heart of the academic block overlooks the entire campus, with an artificial lake on one side and the amphitheatre and hostel block on the other side. The green campus houses a gym (with regular visiting trainer), a yoga room, and sports facilities such as indoor games room for TT, chess, and carrom. The entire campus, including the academic block, hostel block, mess, and canteen area, has 24x7 high-speed WiFi connectivity and LAN ports are provided in all hostel rooms and classrooms. Here’s a look at the campus - Welcome to IIM Udaipur Balicha Campus.c. Recognition – We are proud to say that the institute’s growth is internationally recognized on premier platforms. We are the youngest Indian management institute to achieve feats like the coveted AACSB accreditation, and listings in the QS 2020 and FT MIM 2019 global rankings. IIMU is ranked 5th among Indian B-schools in research by the UT Dallas’ ranking. Also, we are ranked 13th in the NIRF Management rankings of 2019, making us the first among new IIMs in the list. For details, visit our website - Ranking and Accreditation.2. Scholasticsa. Academics – Our Director, Prof. Janat Shah strongly believes in academic excellence as a strong foundation to an individual’s persona, and the same is part of our core values. IIM Udaipur is known for its exceptional focus towards imparting quality education. Learning goes beyond the classroom, through collaboration with alumni to be industry-prepared, and frequent seminars by our esteemed Board members and corporate experts. The institute provides a transformational journey to its students to become global leaders of the future.b. Placements and Preparation – Our summer and final placement reports uphold the tenet of transparency through auditing with the IPRS (Indian Placement Reporting Standards). The best companies, offers, and roles are brought in each year by the year-long dedicated efforts of the Placement Office, facilitated by a committed team of executives and students. Click here to take a look at our placement reports - Placement Reports.c. Faculty and Research – IIM Udaipur is famous for its excellent research facilities, exposure, and capabilities. Our faculty-base consists of renowned and experienced alumni and consultants from internationally acclaimed universities and organizations. You can browse through our faculty profiles here - Faculty. We also host guest faculties from other leading universities. Further, to connect academics with the industry, guest sessions are frequently organized under ‘Netratva’, the leadership talk series.3. Exposure and Opportunitiesa. International – Our global partnerships help provide exceptional international exposure to students to study and work abroad to gain an international business perspective. Through the Student Exchange Program (STEP), students can study in reputed B-schools across France and Germany for 3 months and pursue their elective courses. Details and international partner B-schools’ list is here - Global Opportunities. For a corporate exposure, International Business Practice (IBP) is a second-year innovative elective course wherein student teams act as consultants to international clients with a 2-week on-site exposure. We also provide summer internships in some of the most sought-after international organizations based in Dubai.b. Rural Immersion – IIMU believes that holistic professional growth can be achieved only by understanding and experiencing one’s own surroundings. Through a mandatory course in the first year, students experience life in various remote villages of Rajasthan for a week and present their insights through assigned projects such as livelihood surveys and menstrual hygiene, among others. To read about one such experience, visit our blog - Musings from the Rural Immersion - IIMU BLOG.c. Competitions – IIM Udaipur stands at par with prestigious B-schools in its participation in top corporate competitions such as ICICI Beat the Curve and the CFA Research Challenge. Students and alumni continue to glorify the institute’s name by bagging national awards.4. Student Lifea. Student-run Campus Organizations and Governing Bodies – We are a completely student-run campus, hence student clubs and committees overlook the entire student experience and well-being. You can look at the different types of clubs and their responsibilities here - Extraordinary Extra-curricular . We have administrative, functional and social committees, which are managed by a central governing body. We also have an internal constitution, as well as different policies and protocols to maintain order.b. Fests and Summits – The management, cultural, and sports fests are calendar events for IIMU, along with other functional and social summits that cater to the diverse community’s interests. Audacity, an enthralling cultural fiesta, this year saw a musical night by Guru Randhawa and a stand-up performance by Rahul Subramanian, among others. Solaris, the 2-day management extravaganza brings to life a myriad of business events, summits and talk sessions by corporate and non-corporate leaders alike.c. Events – Life at IIMU is about inclusion and enjoyment. All festivals and cultural events are carefully planned by the Cultural Committee and the Mess Committee, to make students feel at home and enjoy all festivities. Birthdays and special occasions of all community members are celebrated each month in the common mess area. The institute comes together to celebrate all achievements and successes of their fellow community members. Experience life at IIMU yourself through these pictures - Photo Gallery. You can also follow the YouTube channel to get an insight into the latest happenings - IIM Udaipur.Further, considering the current coronavirus pandemic and lockdown situation, IIMU is leaving no stone unturned to provide quality education and learning experience along with the summer internships. We have partnered with leading online learning platforms (such as Coursera) and renowned consultants to provide certification courses and interactive classes to upskill students. While the institute has ensured complete safety of all the community members, decisions of upgrading and encouraging students to achieve merits will surely help them gain the best out of their learning experience at IIMU in such uncertainty.

WHAT DOES A SECURITY AUDITOR DO?A Security Auditor probes the safety and effectiveness of computer systems and their related security components.After conducting a security audit, you will issue a detailed report that outlines the effectiveness of the system, explains any security issues and suggests changes and improvements.Security Auditor ResponsibilitiesIn this mid-level role, you may be required to:Plan, execute and lead security audits across an organizationInspect and evaluate financial and information systems, management procedures and security controlsEvaluate the efficiency, effectiveness and compliance of operation processes with corporate security policies and related government regulationsDevelop and administer risk-focused exams for IT systemsReview or interview personnel to establish security risks and complicationsExecute and properly document the audit process on a variety of computing environments and computer applicationsAssess the exposures resulting from ineffective or missing control practicesAccurately interpret audit results against defined criteriaWeigh the relevancy, accuracy and perspective of conclusions against audit evidenceProvide a written and verbal report of audit findingsDevelop rigorous “best practice” recommendations to improve security on all levelsWork with management to ensure security recommendations comply with company procedureCollaborate with departments to improve security compliance, manage risk and bolster effectivenessTravel extensivelySome Security Auditors work as independent consultants; others are integral members of IT security teams. Senior Security Auditors, like Senior Security Architects, may answer to C-level executives.Security Auditor Career PathsJust starting out on your career path? Consider an entry-level job that will give you some exposure to security issues. For example:Security AdministratorNetwork AdministratorSystem AdministratorOn the rung above this level are dedicated IT security positions such as:Security SpecialistSecurity AnalystSecurity EngineerSecurity ConsultantSome auditors choose to stay forever in the world of technical testing. But if you’re interested in shifting to management, you could investigate:Security ManagerIT Project ManagerSecurity DirectorCISOSimilar JobsSecurity Auditors are known by a variety of names. Some of them (like IT Auditor) may have testing tasks that are unrelated to security.Information Security AuditorInformation Systems AuditorIA AuditorIT AuditorSECURITY AUDITOR SALARIESAccording to Payscale, the median salary for an IT Auditor is $67,278 (2014 figures). Overall, you can expect to take home a total pay of $46,027 – $102,274. This includes your base annual salary, bonuses, profit sharing, tips, commissions, overtime pay and other forms of cash earnings, as applicable.SECURITY AUDITOR JOB REQUIREMENTSDegree RequirementsSince this is a technical position, hiring agencies and employers will want to see a bachelor’s degree and/or a master’s degree in Computer Science, Information Systems, Cyber Security or a related technical field.You can burnish your résumé with further training and professional certifications.Work ExperienceMany security auditors have little dedicated security experience, but have done lots of work in IT. Broadly speaking, Security Auditors are expected to have around 3-6 years of experience in general IT. Senior Security Auditors often have 5+ years of auditing experience.Hard SkillsWherever and whenever you can, gain experience in auditing computer applications and information systems of varying complexity. Employers may also specify a working knowledge of:Working knowledge of regulatory and industry data security standards (e.g. FFIEC, HIPAA, PCI, NERC, SOX, NIST, EU/Safe Harbor and GLBA)ISO 27001/27002, ITIL and COBIT frameworksWindows, UNIX and Linux operating systemsMSSQL and ORACLE databasesC, C++, C#, Java and/or PHP programming languagesACL, IDEA and/or similar software programs for data analysisFidelis, ArcSight, Niksun, Websense, ProofPoint, BlueCoat and/or similar auditing and network defense toolsFirewall and intrusion detection/prevention protocolsSoft SkillsBrush up on your oral and written communication skills – a Security Auditor is often judged by the clarity and thoroughness of his/her reports. Employers will also be looking for candidates who aren’t afraid of travel. Auditors frequently have to visit a wide variety of sites to gather data.Certifications For Security AuditorsWhen it comes to auditing accreditations, the most valuable certification may be the CISA. We would also suggest looking into the CISSP. Both appear frequently in job requirements.CISA: Certified Information Systems AuditorCISM: Certified Information Security ManagerCISSP: Certified Information Systems Security protection.