BRIO OSHA Emergency Temporary Standard Compliance Statement

The Occupational Safety and Health Administration (OSHA) has issued a vaccine mandate for employers with 100 or more employees. This Emergency Temporary Standard (ETS) issued by OSHA has also defined Covid-19 testing requirements and expectations for unvaccinated employees.Under the ETS a compliant Covid-19 test, or test system is defined by specific characteristics

BRIO OSHA Emergency Temporary Standard Compliance Statement:The Occupational Safety and Health Administration (OSHA) has issued a vaccine mandate for employers with 100 or more employees. This Emergency Temporary Standard (ETS) issued by OSHA has also defined Covid-19 testing requirements and expectations for unvaccinated employees.Under the ETS a compliant Covid-19 test, or test system is defined by specific characteristics:

  1. Cleared, approved, or authorized including EUA by the FDA to detect current infection (e.g., a viral test)
  2. Administered in accordance with instructions, and
  3. Not both self-administered and self-read. Self-testing is not considered self-administered and self-read if test results are digitally reported with date and time.

Brio’s line of self-testing options provides for the innovative use of technology to mitigate the impact of the pandemic on the workforce and American public. Brio meets and exceeds the components outlined under the ETS subpart (U), paragraph (g) through incorporating FDA EUA authorized rapid point-of-care (POC) testing solutions. The software application offered by Brio meets the Federal Drug Administration’s (FDA) criteria for digital reporting of medical and test information as stated under the Appendix (A) of their Policy for Device Software Functions and Mobile Medical Applications. Additionally, the point-of-care test and digital reporting are further supported by Brio’s end-point-testing (EPT) image upload for observed result verification, and to ensure integrity of results.All the features of Brio’s self-testing solutions are supported further with laboratory compliance oversight and in conjunction with an authorized healthcare providers guidance. A supplemental list of key requirements related to testing has been provided as an attachment to this memo.Signed by,
Lee B. Springer PhD, MLS(ASCP)
Director of Diagnostics Laboratory PartnershipsAttachment A:Occupational Safety and Health Administration (OSHA) has provided a summary of key items and a checklist that can be found below. The items outlined in this attachment relate solely to testing and is not to be considered the entirety of expectations placed on employers by the OSHA Emergency Temporary Standard (ETS). OSHA ETS Summary
OSHA Employee Hazard ChecklistEmployer Policy on Vaccination The ETS requires covered employers to develop, implement, and enforce a mandatory COVID-19 vaccination policy, with an exception for employers that instead establish, implement, and enforce a policy allowing employees who are not fully vaccinated to elect to undergo weekly COVID-19 testing and wear a face covering at the workplace. BRIO Compliance

  • FDA EUA authorized Covid-19 antigen and PCR testing
  • Compliant digitally reported self-testing
  • Visual test verification to ensure result integrity

Determination of employee vaccination statusThe ETS requires employers to determine the vaccination status of each employee, obtain acceptable proof of vaccination, maintain records of each employee’s vaccination status, and maintain a roster of each employee’s vaccination status. BRIO Compliance

  • Vaccination reporting and recording meeting OSHA ETS requirements
  • Vaccination documentation file upload
  • Dashboard organization for administrative convenience
  • Report generation for compliance submission

COVID-19 testing for employees who are not fully vaccinatedThe ETS requires employers to ensure that each employee who is not fully vaccinated is tested for COVID-19 at least weekly (if in the workplace at least once a week) or within 7 days before returning to work (if away from the workplace for a week or longer). The ETS does not require employers to pay for any costs associated with testing. However, employer payment for testing may be required by other laws, regulations, or collective bargaining agreements or other collectively negotiated agreements. In addition, nothing prohibits employers from voluntarily assuming the costs associated with testing. BRIO Compliance

  • FDA EUA authorized Covid-19 antigen and PCR testing
  • Compliant digitally reported self-testing
  • Visual test verification to ensure result integrity

Employee notification to employer of a positive COVID-19 test and removalThe ETS requires employers to: (1) require employees to promptly provide notice when they receive a positive COVID-19 test or are diagnosed with COVID-19; (2) immediately remove any employee from the workplace, regardless of vaccination status, who received a positive COVID-19 test or is diagnosed with COVID-19 by a licensed healthcare provider; (3) keep removed employees out of the workplace until they meet criteria for returning to work. BRIO Compliance

  • FDA EUA authorized Covid-19 antigen and PCR testing
  • Compliant digitally reported self-testing
  • Visual test verification to ensure result integrity
  • Dashboard offers quick access to employee testing records and status
  • Administrative notifications of test results

Availability of recordsThe ETS requires employers to make available for examination and copying an employee’s COVID-19 vaccine documentation and any COVID-19 test results to that employee and to anyone having written authorized consent of that employee. Employers are also required to make available to an employee, or an employee representative, the aggregate number of fully vaccinated employees at a workplace along with the total number of employees at that workplace. BRIO Compliance

  • Dashboard offers quick access to employee testing records and status
  • Vaccination reporting and recording meeting OSHA ETS requirements
  • Report generation for compliance submission