The FBI says a genetics testing company with tens of millions of dollars in federal contracts is most likely providing Americans' health data to China. Fulgent Genetics' proprietary technology platform has created a broad, flexible test menu and the ability to continually expand and improve its proprietary genetic reference library while. However,youwill not be subject to any corrective action for non-compliance while the department is reviewingyouraccommodationrequest and/or engaging in the interactive process. If an employee works for two departments, there will be two separate interactive process meetings. While waiting for a response to a Request forAccommodation, youwill be subject to workplace safety requirements, such as masking, physical distancing, and regular COVID-19 testingin order tocomply with the policy in the interim. In order to safely, securely and efficiently confirm vaccination status and track the results of routine COVID-19 tests, as required by State health officer orders and County policy, the County opted to engage a leader in the healthcare field for this endeavor. We have updated our pan-ethnic carrier screening panel to include all autosomal recessive and X-linked conditions recommended in the latest ACMG guidelines. If my medical condition changes and I believe my medical condition supports a medical exemption/accommodation, can I file a request for medical exemption/accommodation? Where can I find a listing of all the County-approved testing sites? The employee will not receive back pay for the period of suspension. Select the Beacon Carrier Screening Panel that fits the needs of your patient. The chairman of the committee, former Treasury secretary Jack Lew, introduced Hsieh, and Chinese ambassador Qin Gang shared remarks while former Transportation secretary Elaine Chao presented Hsieh with an award. Who is required to provide proof of vaccination at this time? What is the risk? China passed a national security law in 2017 requiring companies to grant access to data upon request from the government. This website features an integrated map locator and offers the ability to filter testing sites by testing modality (walk-up vs. drive-up) and day of the week. The statement will NOT address the underlying medical condition or disability that prevents you from being vaccinated. DHRs determination is consideredfinal. The effectiveness of the protections afforded by OSHAs Vaccination and Testing ETS relies on employees providing truthful and accurate information, including, where applicable, proof of vaccination status and COVID-19 test results, to their employers, and on their employers maintaining accurate records of vaccination status and testing results. A sincerely held religious belief, practice, or observance that conflicts with receiving a COVID-19 vaccine. Explore the best option for your patient needs. What happens if my Request for Accommodation is denied? Please use one of the following Browsers: Microsoft Edge. Hsieh was the guest of honor at the committee's annual gala earlier this month. If your request is approved, your designated department personnel will send to you theApproval ofAccommodationForm. The risks associated with shallow nasal swab testing are very minor there is a chance of minor discomfort or possibly nosebleed during the supervised sample collection. Fulgent offers free specimen collection kits for physicians and genetic counselors within the continental United States. Fulgent is viewed as a leading provider of COVID-19 testing solutions at the national level. Internet Explorer is not supported. REQUEST NOW Quality Our Lab is CLIA-certified and CAP accredited and surpasses the standards of diagnostic testing. Should this occur, advanced notice would be provided to departments, employees and HR personnel. It is only authorized during the duration of the COVID-19 emergency declaration by federal regulators under Section 564(b)(1) of the Act, 21 U.S.C. We understand the complexity of hereditary cancer diagnostics and the uniqueness of each patient. Why did the County contract with Fulgent to conduct vaccine verification and COVID-19 testing? Withinten(10) business days from submitting your request form, you must also submit Healthcare Provider Certification form completed by your physician that states you cannot receive the vaccination due to permanent or temporary restrictions. YES. In the event of a positive result, samples may be held for up to 14-days for subsequent NGS analysis of the viral genome and then destroyed as outlined above. Employee home addresses are not provided to the County, nor are they shown on any dashboard the County has access to. The full cost of the test will be covered by the employees insurance (for additional information, please see response to Why am I asked to provide my health insurance information?). Our Lab is CLIA-certified and CAP accredited and surpasses the standards of diagnostic testing. The CDC awarded a $35.8 million contract to Fulgent in March to sequence coronavirus variants. Nosebleeds during this collection process are very rare and often associated with dry weather condition or outdoor testing. Villanueva said Fulgent Genetics has "strong ties" to Chinese technology and genomics companies though he did not specify what those ties were, according to the Los Angeles Times. Primer and probe set sequences are based on CDC recommended guidelines that identify two known distinct regions within the SARS-CoV-2 genome. Please visit https://lac.fulgentgenetics.com/residence_appointment/info/locations for list of current testing sites. The stock is off nearly 50% since its all-time high in February, but its results in 2020 and guidance for 2021 should . If a request for additional information is appropriate, you will haveten(10) business days to submit a completedReligious Organization Certification Formfrom your religious leader, religious scholar, or person knowledgeable regarding your religious belief(s), practice(s)or observance(s) to support your request. . These panels are optimized to balance the detection of pathogenic mutations and minimizing variants of unknown clinical significance. In the event of a positive result for COVID-19, the sample will be completely anonymized / deidentified and the viral genome onlywill be analyzed by next generation sequencing (NGS) for the purpose of reporting the specific virus variant to the CDC. Villanueva pointed to Fulgent's privacy policy as one cause for concern. Scheduling on the new platform will begin later today (7/13/20). Today, Fulgent continues to offer an unrivaled catalog of genetic testing. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. How will my accommodation request be handled? The FBI did not respond to a request for comment. L.A. County is mandating that first responders register their vaccination status through Fulgent Genetics, an international technology company with ties to China, with the required consent to release their personal and genetic information to foreign nations. New genes added: CTNNA1, GREM1, NTHL1, SLC45A2. The site requires individuals to provide their name, date of birth and the cell phone or email associated with their vaccine record in order to submit a request. Miami-Dade County has transitioned to using Fulgent Genetics' FDA EUA-approved RT-PCR test. Registering online ahead of time is preferred though, as it will help to speed up the testing process. To best protect its workforce members and others in County facilities, and fulfill its obligations to the public, effective October 1, 2021, the County is requiring that all County employees be vaccinated against COVID-19. U.S. officials have expressed concerns over state-sponsored harvesting of genetic data. Will I be considered in compliance after October 1, 2021 if I submitted a complete Request for Accommodation by that date? It offers genes and panels, known mutation, hereditary cancer, carrier screening, and tumor profiling solutions. That's given the company confidence to guide for 200% year-over-year revenue growth in the core business. The combination of CSIs extensive molecular diagnostics test menu and Fulgents NGS expertise, given its proprietary technology platform, will create a novel, comprehensive cancer testing solution for customers across the United States. The employee data is based on information from people who have self-reported their past or current employments at Fulgent Genetics. , Personal or philosophical objections to a COVID-19 vaccine are not sufficient justification for granting anaccommodationunder this Policy. What happens if my Request for Reconsideration is denied by the Department of Human Resources? Q2. Unique genetic markers of the virus can be found in RNA that only remains in the body while the virus invades and replicates itself. This diagnostic firm offers various Covid-19, molecular diagnostic, and genetic tests. Fulgent expects to bolster the scale of CSIs offerings with a new state-of-the-art cancer testing laboratory in California, which it believes will complement CSIs existing operations in Alpharetta, Georgia. Los Angeles County contracted Fulgent Genetics Corporation to harvest data about Wuhan coronavirus vaccination status and to administer testing for the disease. Regular testing is to be conducted through Fulgent through the sites and process dictated by the department. Recent legislation (California Senate Bill 510) requires health insurance providers to cover the cost of all COVID-19 diagnostic and screening tests. full-time, part-time, recurrent, temporary, and as-needed County employees), as well as all interns and volunteers supporting County services and/or working from County facilities must provide the County with proof of vaccination status. Q4 2021 Fulgent Genetics Earnings Conference Call. Ming Hsieh, Fulgent's founder and CEO, serves on the committee's board of directors alongside executives from Disney, Apple, and other companies vying for access to China's market. Employee may request anaccommodationdue to the following reasons: You must submit theRequest for MedicalAccommodationFormto your Departmental HR Manager (DHRM) or their designeeas soon as possible to remain in compliance with the COVID-19 Vaccination Policy. PLEASE NOTE: Orders may only be placed by physicians and medical institutions. We expect the addition of CSI will deliver customers a superior experience relative to competitors who offer one-dimensional NGS testing or broader menus without NGS expertise., This is an exciting day for CSI Laboratories team members, clients and patients, and we are excited to join forces with a company that shares our same level of commitment to the cancer community, said Ron Ghafary, founder of CSI Laboratories. This means that while the laboratory performing this test has validation data to support offering this test, it has not been approved or cleared by the FDA. "The individual's DNA is not sequenced as part of Fulgent Genetics' COVID-19 testing. The option to retest if indeterminate is available. You may find the Exemption/Accommodation Request forms online at https://employee.hr.lacounty.gov/vaccine-mandate-exemption. Employees may present their health insurance information when they arrive at the testing site, or they can submit it in advance when scheduling a testing appointment online at https://lac.fulgentgenetics.com/residence_appointment/info/locations. Why am I asked to provide my health insurance information? Villanueva said Fulgent has worked with BGI and other Chinese companies linked to the state's surveillance apparatus, including Huawei. A multi-analyte blood test for earlyliver cancer detection, From CNV to exome: Integrated genetic testing. Is health insurance information required to test? If getting to any of the available testing sites presents a hardship (due to distance or hours of operation), employees should work with their supervisor and HR office to determine what other options may be available. ), a member of the Senate Intelligence Committee. Any employee who submits false information or falsified documentation related to their compliance with the Policy may be subject to discipline up to and including discharge. masking, social distancing, regular testing) following an accommodation approval? If your request is approved, your designated department personnel will send to you theApproval ofAccommodationForm. * This test has been authorized by the FDA under an Emergency Use Authorization (EUA). Fulgent Genetics Reports Second Quarter Financial Results. No; the COVID-19 Vaccination Policy requires that all County workersto be fully vaccinated against COVID-19 and provide proof of full vaccination status, unless otherwise exempted due to medical or religious reasons. Uyghurs, Obama's Man in China Now Beijing's Man in Washington. COVID-19 Supplemental Paid Sick Leave (SPSL), COVID-19 Vaccination Accommodation Exemption, Countywide Policies, Procedures and Guidelines (PPG) 640 COVID-19 Vaccination Policy, Accommodations Requests/Exemptions to the Vaccine Policy, https://lac.fulgentgenetics.com/residence_appointment/info/locations, https://employee.hr.lacounty.gov/vaccinationsmandate, California Code of Regulations Sections 2500, https://www.osha.gov/sites/default/files/publications/OSHA4157.pdf, https://publichealth.lacounty.gov/Coronavirus/vaccine, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html, https://www.youtube.com/watch?v=L_1UgXM9tqw, https://vimeo.com/manage/videos/668473924, https://employee.hr.lacounty.gov/vaccine-mandate-exemption, CDCs Interim Clinical Considerations for Use of COVID-19 Vaccines, LA County COVID-19 Vaccine LA County Department of Public Health, A California Department of Public Health (CDPH) digital vaccine card QR code, or, A digital photo of your hard copy vaccination card. Founded in 2011, Fulgent is a California based company that strives to create the most effective and wide ranging tests on the market. Its lab is CLIA-certified and CAP accredited and surpasses the standards of diagnostic testing. It was the first clinical laboratory to offer copy number variation detection using NGS technology in the United States. Lew hosted an event in February for Politburo member Yang Jiechi, who called on the United States to "stop meddling" in China's affairs by criticizing the regime for its human rights abuses in Tibet, Xinjiang, and Hong Kong. Clarification of the request may be sought from the employee where needed. Will the County mandate booster shots for employees? At this time, employees are not required to receive boosters. Fulgent Genetics Inc. and its subsidiary, Fulgent Therapeutics LLC, allege in a petition filed Jan. 21 in Los Angeles Superior Court that Villanueva, in a Nov. 29 letter to the Board of Supervisors and published on the LASD website, falsely stated that the FBI warned him against using Fulgent's COVID-19 testing services because of "concerning You may find the Exemption/Accommodation Request form online at https://employee.hr.lacounty.gov/vaccine-mandate-exemption. A quick link to schedule appointments and a Frequently Asked Questions guide are also available. Where can I go for more questions about vaccination requirements? Test results will be labeled positive, negative, or indeterminate. In compliance with state and federal laws, we have implemented a process for employees who cannot be vaccinated to request an exemption from the vaccination policy, known as a reasonable accommodation. This includes contraindications to the vaccines, perthe most up to date COVID-19 vaccine guidelines from the Centers for Disease Control and Prevention (CDC), including,but not limited to: See theCDCs Interim Clinical Considerations for Use of COVID-19 Vaccinesfor details. If an employee is uncomfortable providing this information, they can simply respond with the prefer not to state option. During this period,youwill be required to continue to adhere to all COVID-19 safety protocols, such as testing, masking, symptom-screening and physical distancing while in the County workplace or worksite. Chinese government officials have used events hosted by the National Committee on U.S.-China Relations to criticize U.S. government policy regarding China, often without pushback from the committee. Will there be a penalty to the employee if there is a delay with submitting the requested forms? Your supervisor will not see your vaccination status or specific test results. 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