Vulnerable arrangements in employee COVID-19 testing programs can lead to significant regulatory and legal problems, say experts in new report
As companies focus on the safety of their customers and employees during the COVID-19 public health emergency, employee testing has become a key focus. Employee testing is seen as one way that companies can take health and safety measures and continue operating in areas where COVID-19 is present.
The increased need for employee testing and for a cohesive testing strategy has caused some states to even incentivize these efforts. The state of Kansas, for example, announced that it has set aside $52 million for companies that contribute to a unified test strategy. Such efforts likely will factor into employer and employee COVID-19 testing programs.
While testing employees for COVID-19 may initially seem somewhat straightforward, there are a variety of legal and regulatory considerations that clinical laboratories and employers must consider. For example, the Equal Employment Opportunity Commission’s (EEOC’s) guidance prohibits employers from requiring certain forms of COVID-19 testing. Specifically, an employer cannot require an employee to receive antibody testing.
Implications of COVID-19 Employee Testing Programs
Every decision is critical when developing an employer-related testing program, with legal and regulatory considerations among the most important first steps. Failing to follow even one of the many essential, and sometimes complex, requirements involved with COVID-19 employee testing, can have significant financial and legal consequences for clinical laboratories and employers.
To provide expert guidance for employer-related COVID-19 testing program development, The Dark Intelligence Group has released a new Special Report, How to Develop a COVID-19 Employee Testing Program: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues for Clinical Laboratories and Employers. In the report, which is available for download now, nearly a dozen of top laboratory and legal experts provide their insights and expertise for navigating clinical laboratory-employer arrangements for COVID-19 workplace testing.
“A number of factors exist in employee testing that don’t really apply in the traditional diagnostic setting,” explained Richard S. Cooper, Co-chair for the National Healthcare Practice Group of McDonald Hopkins, during a recent COVID-19 STAT Live Call. These tests impact an individual’s ability to work and collect compensation, and they present different legal exposures and liabilities for clinical laboratories.
McDonald Hopkins is one of the five law firms specializing in the area of healthcare law and/or employment law, labor and benefits, that provide guidance for clinical laboratories and employers in the new Special Report.
Comprehensive Guide Available for Launching COVID-19 Employee Testing
How to Develop a COVID-19 Employee Testing Program for clinical laboratories and employers begins by highlighting the top 10 regulatory essentials involved with launching a COVID-19 testing program for employees. This section of the report highlights nuances of different regulatory components.
The Special Report explores in-depth how to address individual test eligibility considerations, as well as privacy considerations for COVID-19 testing in employer-related testing programs. Of interest will be the additional insights offered in the endnotes and breakout action items that are included at the end of each chapter.
One significant mistake that many clinical laboratories or employers make involves contractual and liability details that must be included in employer COVID-19 testing arrangements. The Special Report dedicates an entire chapter to helping clinical laboratories and employers avoid contractual issues that can result in unintended negative consequences.
Also in the COVID-19 Employee Testing Guide
- Critical areas of responsibility in partnering for employee COVID-19 testing,
- Billing methods to avoid,
- Guidance for consent and waiver documents, and
- Vulnerable arrangements.
Beyond the legal and regulatory insights, the Special Report combines actionable resources, including sample COVID-19 screening questionnaires, consent forms, orders for testing, and business intelligence from recent issues of The Dark Report, to form a comprehensive guide to assist clinical laboratory directors and employers in partnering for the purpose of employee COVID-19 workplace testing.
The Special Report also ties abstract legal and regulatory concepts together by examining a case study of a major laboratory in New York City that implemented an innovative testing program using many of the principles that are outlined in the report. This case study illustrates the essential components of adhering to legal and regulatory requirements by examining them in a real-life setting.
While developing an employee COVID-19 testing program may have many potential regulatory and legal pitfalls, such a program may also be a potential source of new outreach revenue for clinical laboratories. Labs and employers, that are building, planning, or who have already embarked on a COVID-19 employee testing program, will benefit from the expert advice and insights covered in this new Special Report, offered by The Dark Report, Dark Daily, and the COVID-19 STAT Intelligence Briefings Service.
How to Develop a COVID-19 Employee Testing Program: Essential Guidance on Legal, Risk Management, Regulatory, and Compliance Issues for Clinical Laboratories and Employers is available at a cost of $499 and can be ordered by visiting Dark Daily at the following URL: https://www.darkdaily.com/how-to-develop-a-covid-19-employee-testing-program-what-clinical-laboratories-need-to-know/
—By Caleb Williams, Editor, COVID-19 STAT
Related Resources:
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