Employee Enrollment Change Forms Are Required For: Fill & Download for Free

Oh …check your organization's credentials and quickly begin look out for change as your organisation looks to be financially stresses.Have you joined just now i.e.3 months back and organisation is big and reputation on creditworthiness is good ,try to understand process of employee enrollment and have you been given proper offer letter ,have you received ID card with employee enrollment number ,have you been asked to fill EPF PF ESI forms ,then organisation may be ok your HR has delayed internal processes.Look at your employment is it off role ? They might have sent your papers to empanelled agency and it may be taking time .Finally have word with senior in HR and your immediate supervisor he is required to take care of employees satisfaction and salary delay is serious serious concern.

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.

Don’t Resign without a Job in Hand“You will not get job anywhere if you don’t resign” (Will I, if I resign?)First, HR threatens the employee that if they did not resign, company will blacklist them and employee will not get job anywhere outside. In this scenario what the employee should do?Please understand HR making statements like this is completely unethical. We work in the company for several years. Now, if the company says if you resign on your own you are a good employee else you are bad, then it is completely against ethical process. This is absolute blackmailing by the company.If HR uses this tactics, don’t lose your temper or become emotional and take decision. Never, ever submit your resignation immediately on hearing such threats. If company has real authority to terminate employees, then they will issue termination letter. They will not come and request/threaten employees to resign. The company’s intention is to make employee resign on their own. After the employee resigns, company will show this as attrition to outside world. So don’t fall prey to such words from your HR representatives.After joining NDLF, I have spoken with more than 100 people who faced such interviews with HRs. I observed that more than 98% of the employees submit the resignation after the above threat. The main reason for this reaction is all are afraid that if they are blacklisted, they will not get new job outside and it affects their career. So many employees resign within 10 minutes of HR interview after this threat.I want to narrate the stories of 2 of my friends who worked with me.Kandaswamy (name changed) is a senior employee and he was asked to resign in Oct 2016. He submitted resignation after HR interview and his last date of working is end Nov 2016. He has around 20 years of experience in IT industry and part of testing back ground.He searched for job and unfortunately he did not able to find any job till now even after 9 months. In the initial days, he got response from some of the companies. But now-a-days he is not getting any calls. As the gap between jobs increased, he lost his hope of getting new job.I asked him if he is doing any business but he replied he is not doing anything. Till May he managed his family needs with gratuity money he got. As schools reopened for his kids, he started using his PF money. This makes me very sad. But unfortunately this is the situation of many of the people who resigned.I talked with another friend named Antony who is having 15 years of experience in IT industry. His story is also the same. He searched for jobs for 6 months staying in Chennai. As he did not find any suitable job, he shifted to his native place leaving IT field. He had worked day and night for the company and he felt very bad about the treatment he got from the company. He wanted to fight against this but he did not know what to do and gave up on corporate pressureIT employees should understand the nature of battle they are facing now. Now almost all IT companies want to oust senior employees above 15 years of experience as they want to clear the top of the pyramid. So unless your skill is very niche and there is huge requirement for that skills, it is becoming difficult for many people to get new jobSo what I am suggesting is as I told before, don’t ever and never submit your resignation without getting a new job. There is a proverb in English that known devil is better than unknown angel. So don’t submit resignation with a perception that you will get a better job.If HR calls for such interviews, try to explore options such as lodging complaints through various grievance mechanism within company. In the meantime, try for job outside and if you get better job, submit resignation and go. I hope everyone will agree for my suggestion of not resigning on HR threats.You enroll with NDLF in the meantime and explore options for seeking various legal protection you will be getting as part of Industrial dispute act. I will briefly talk about these protections in forthcoming parts. It is always better to form a group of affected people and fight together. In such events, a trade union is the required form of such group. To register with NDLF, please write to us at [email protected] or call us at 9003198576“We will stop PF and Gratuity” (You dare!)Let us now try to find the answer for the second threat of HR about company stopping Provident fund and gratuity if they terminate employee.The above statement is really amateur statement and if your HR representative used this statement for threatening, then you consider him/her as real amateur. I don’t think any company will ask HR representative to make such statements to employees. The problem here is many HR representative are also doing these type of exit interviews for the first time and they are also not aware on what to talk in such exit interviews.Bangalore garment workers protesting against government restrictions on PF money use (April 2016)Provident fund and gratuity are the money earned by the employee and if the company try to hold that money for longer time, then employee has the right to complain under criminal clause against the company.The PF money deducted from employee’s salary and the company contribution should be deposited with PF authority. If company depositing the money, it should pay 5% interest for 2 months delay, 10% interest for 2-4 months delay, 15% interest for 4-6 months delay.So if HR threatens that you will not get provident fund, don’t show your laughter at him/her, just ignore that statement“Wont give Relieving Letter” (Are you joking?)Let us look at the last query which threatens employee about not giving relieving letter. If a company does not gives relieving letter, does that mean the employee did not work in the company for several years. Did the company not pay salary into the employee account for so many months?There is a proverb in Tamil which state if you stole the comb, wedding will be stopped. So threatening employees of not providing relieving letter is also amateur statement and definitely it is the company responsibility to close all exit formalities while doing employee separation.So basically while trying to find answer to all queries, what we understand is HR representatives are doing their job of trying to make employee resign by making various threats. So as I told earlier, refuse politely to resign and don’t fall prey to HR threats and submit your resignation.Now we will try to answer more common threats employee faced during separation process.My company is one of the largest reputed companies in IndiaMy company has strong legal team and it is not possible to fight against the company as their legal team will crush my legal argumentMy company owner is one of the richest business men and has high reputation