so you want to test employees for covid-19?the fda regulates in vitro diagnostics as class ii...
TRANSCRIPT
Colleen Faddick
Michael Gaba
Sean Gallagher
Iliana Peters
Lindsay Ryan
So You Want to Test Employees for COVID-19?
What Employers Need to Know
Testing Basics
Testing Logistics
Employee Privacy
Employment Decisions and Issues
Liability Considerations
Agenda
Three types of COVID-19 [SARS-CoV-2] tests
Molecular – tests for active virus to detect genetic material using a
specific process called polymerase chain reaction – amplified so small
amount of genetic material can be detected
This test is diagnostic
Specimen types: respiratory (nasal passage), possibly saliva (limited options
now)
Pros: high sensitivity (reduced false negatives)
Cons: test time – while results may be possible in 4 hours, backlog and capacity
make turnaround times up to 72 hours or more; moment is time – negative result
is for that test date only
Testing Basics – Types of Tests
Three types of COVID-19 [SARS-CoV-2] tests
Serology – tests for one or more types of antibodies to SARS-CoV-2, which
may indicate that a person was exposed to the virus
This is not a diagnostic test
IgM – antibodies developed within days or weeks of an infection
IgG – antibodies developed many weeks or months post-infection
Specimen types: blood
Pros: some tests can be resulted quickly; long term value for immunity (quantitative)
Cons: quality/reliability an issue for many; most are qualitative, not quantitative; no
known level of antibodies necessary for immunity (or for how long); all (except for one)
may be performed in only high complexity labs; no predictive value of immunity and
should not be used to make employment or admission decisions for congregate settings
Testing Basics – Types of Tests
Three types of COVID-19 [SARS-CoV-2] tests
Antigen – tests for active virus by detecting proteins that are a part of
the SARS-CoV-2 virus.
This test is diagnostic
Specimen types: respiratory (nasal passage)
Pros: Highly specific for SARS-CoV-2 proteins, so positive results are highly
reliable; test time can be very short
Cons: Sensitivity lags molecular testing, so negative results are not necessarily
negative (additional molecular verification may be necessary to substantiate
negative result)
Testing Basics – Types of Tests
The FDA regulates In Vitro Diagnostics as Class II medical
devices
The FDA has emergency powers under a public health
emergency (PHE) to permit rapid market entry of tests
Emergency use authorization (EUA)
Exercising oversight authority after market entry
Maintains current list of qualified tests on website
FAQs on Testing for SARS-CoV-2
Employers need to know the FDA status of the tests they use
Testing Basics - The FDA’s Role
Emergency Use Authorization
Limited in Duration
Termination of an EUA declaration
Upon determination that underlying PHE no longer exists
Upon approval of a device such that EUA status is no longer needed
Limited in Scope
For products intended to be used to address the public health emergency
That are not cleared or approved for that intended use
COVID-19: diagnostic tests; PPE; treatments; ventilators
Testing Basics – FDA’s Role
The FDA regulates manufacturers of lab test; labs developing
their own tests
FDA does not regulate employers
Considerations
Use of FDA authorized tests
Compliance with FDA’s approved instructions for use that may impact
the specimen collection
Impact on general liability
Testing Basics – FDA’s Role
FDA permits labs and manufacturers to use and market tests under
one of 4 methods available under the FDA’s PHE guidance
High complexity labs validating their own developed tests (not sold to others)
(LDTs), prior to EUA submission
State-authorizations of high complexity labs conducting testing (no EUA
needed)
Commercial manufacturer development of tests prior to EUA submission
Commercial manufacturer development of serology tests prior to EUA
submission and laboratory development of serology tests with or without an
EUA submission
FDA Authorization & Categorization
Only laboratories may perform COVID-19 testing, even point of care
Each EUA determines the category of laboratory under CLIA that may
perform the test
Serology tests without an EUA may be performed only in a high complexity lab
This is true for all tests, even the rapid single cartridge tests
Some lab tests with EUAs are permitted to be conducted in the CLIA
Certificate of Waiver setting (point of care)
CLIA governs all labs in the US (with limited exceptions) – three types
of certification: high complexity, moderate complexity and waived
settings
FDA Authorization & Categorization
Employers must first determine the type of testing to conduct –
considering the value of the test (reliability of results) and its
purpose (considering employment decisions to be made)
Unless the employer is itself a lab (e.g., hospitals are high
complexity labs and employers), it must contract with a lab to
perform the testing
Employers must consider the order requirements, the specimen
collection and result reporting in the context of state and federal
law, in addition to the privacy, employment and liability issues
Testing Logistics
Is an “order” for testing required?
Federal law (CLIA) – authorized person under state law
Federal law (FDA) -by “health care provider” if person is asymptomatic
State law – practitioner scope of practice; laboratory licensure laws
Executive orders have expanded scope for pharmacists, others
CMS has removed order requirements for Medicare payment purposes (doesn’t
change state law requirements)
Consider protocol orders developed by physicians, nurse practitioners
Consider in the context of employment decisions and liability
Testing Logistics - Ordering
Based on test performed, what type of specimen is used?
Nasopharyngeal (NP)
Nasal swab/self-swab
Lab test may dictate, availability of swabs my dictate
Who may collect?
NP may require clinician who is authorized with scope (RN, others)
Nasal my be self-swab with appropriate oversight
Does employer have access to these resources?
Testing Logistics – Specimen Collection
Generally must contract with a third party lab
Considerations
Appropriate CLIA certification (generally, high complexity, though some
labs may have point-of-care options)
Capacity for expected volume
Reasonable turn-around times
Pricing (employers generally paying based on purpose of test, but
states with mandatory testing of certain facilities may pay)
Reporting mechanism
Testing Logistics – Lab Contracting
Employers should develop and follow specific testing policies
and procedures related to:
Who is tested
Frequency
Type of testing
Ordering protocols
Specimen collection
Result reporting
Maintenance of records
Testing Logistics – Policies & Procedures
Employee Privacy
State Law Consents/HIPAA Authorizations: HIPAA Privacy Rule 45
C.F.R. § 164.508
Tests Paid for by Employer for OSHA Compliance: HIPAA Privacy Rule
45 C.F.R. § 164.512(b)
Fitness For Duty Exams: HIPAA Privacy Rule 45 C.F.R. § 164.508
Serious and Imminent Threat: HIPAA Privacy Rule 45 C.F.R. §
164.512(j)
Employee Privacy Issues
Molecular Testing
EEOC issued guidance stating that mandatory viral testing (e.g., nasal
swab) is permissible under the ADA if “job-related and consistent with
business necessity.”
Employers may take steps to determine if an employee entering the workplace
has COVID-19 because, if so, they will pose a direct threat to the health of others
MAY Employers Test Employees for COVID-19?
Molecular Testing (Cont.)
But, employers should “ensure that the tests are accurate and
reliable”
Review guidance from the FDA about what constitutes safe and accurate testing,
as well as guidance from the CDC and other public health authorities
Consider “the incidence of false-positives or false-negatives associated with a
particular test”
EEOC cautions that negative test now does not mean an employee
cannot test positive later
Employers should still require that employees observe social distancing and other
infection control measures to prevent transmission
MAY Employers Test Employees for COVID-19?
Serology or Antibody Testing
The EEOC has not yet commented on whether antibody tests would
satisfy the “direct threat” standard
Even if they did, employers would need to consider the reliability and
accuracy of such tests
MAY Employers Test Employees for COVID-19?
Generally, employers are not required to implement any detection measures
(including viral testing), however, employers have an obligation to provide a
safe and healthy workplace under OSHA’s “General Duty” clause, which
includes preventing occupational exposure to COVID-19
OSHA suggests that employers “consider” adopting screening measures
particularly in areas where community transmission of COVID-19 is occurring:
Verbal symptoms screening (before entering the workplace)
Temperature checks – check workers for fevers of 100.4F or greater at start of
workday
OSHA/CDC do not currently recommend virus testing
SHOULD Employers Test Employees for COVID-19?
Whom to Test?
Avoid suspicion-based testing which could create perception of
discriminatory intent
Implement consistent, non-discriminatory protocol for when employee
is required to submit to testing (e.g., all employees, symptomatic
employees, employees returning from out-of-state travel, etc.)
Note: Asymptomatic, pre-symptomatic and mildly symptomatic
individuals may all transmit the virus to others
Mechanics of Employee COVID-19 Testing
How to Test?
Engage Qualified Third Party: As a general rule, most employers
should not undertake to self-administer or require employees to self-
administer any tests; best to outsource to a qualified laboratory
Use appropriately trained professionals – e.g., nurses or qualified health care
professionals for specimen collection
Examiners should be properly trained on social distancing, proper personal
protective equipment (“PPE”) and other infection control measures while testing
Ensure that method of testing being used is safe, accurate and reliable
Mechanics of Employee COVID-19 Testing
How to Test? (Cont.)
Social Distancing: Maintain social distancing for employees waiting to
be tested
Safety & Privacy: Maintain social distancing and privacy for those who
may be required to leave the testing site without entering the workplace
based on test results
Wage & Hour: Consider how non-exempt personnel who are required
to undergo testing will be compensated for time spent waiting to be
tested, taking the test, and waiting for a test result
Mechanics of Employee COVID-19 Testing
When?
To have best chance of identifying all cases of COVID-19 among
employees, daily testing would be needed.
However, until rapid and reliable on-site tests are widely available:
Consider more sporadic but routine testing of all employees
Consider testing employees who are experiencing symptoms, have traveled to
high risk areas, or have reported an incident of potential exposure
Test new employees after conditional job offer
Must also rely on other forms of screening (e.g., symptom screening
and temperature) and/or implement other infection control measures
Mechanics of Employee COVID-19 Testing
Notice & Consent
Clearly articulate to employees what the screening/testing process will
look like
Recommended to secure consent and authorization of employees for
testing, even though employers can require employees to submit to
such medical examinations as a condition of continued employment (at
least during pandemic)
Mechanics of Employee COVID-19 Testing
Privacy
ADA requires that results of employee medical examinations be kept
confidential, and separate from personnel files
Responding to a Positive Case
Tell employee’s supervisor that employee is unable to work or will be
teleworking, but do not disclose the employee’s symptoms, test results
or health status to co-workers or other colleagues without consent
Conduct an investigation – inform employees who may have been
exposed and follow CDC recommendations for self-isolation; Do not
identify the infected employee without consent
Mechanics of Employee COVID-19 Testing
When to Return Employees to Workplace
CDC has issued minimum criteria for return to work:
At least 3 days of under 100.4F temperature, without fever reducing medication
Other COVID-19 symptoms have improved
10 days have passed since employee’s symptoms first appeared
NOTE: Depending on employee’s health care provider’s advice and availability of
testing, might be able to get tested to see if still have COVID-19. If tested, employee
can return when they receive two negative test results in a row (at least 24 hours
apart), in addition to first two criteria.
Mechanics of Employee COVID-19 Testing
When to Return Employees to Workplace (Cont.)
All employees should consult with their health care provider for
guidance on when it’s safe for them to return to work
Employers may require fitness-for-duty documentation upon the employee’s
return, however, consider being flexible as to type of documentation required to
relieve burden on health care providers
May also require individual to re-submit to screening procedures
Consistency is key – treat all positive/negative findings the same
Mechanics of Employee COVID-19 Testing
Consider what consequence will result if an employee refuses to
participate in screening measures
Employer’s policy on mandatory testing, including consequences of
refusal, should be clearly set forth in writing and communicated to
employees
Train examiners/supervisors on how to respond to employee concerns
regarding testing
Consider reason for employee's refusal – if on basis of disability or
religious grounds, consider possible reasonable accommodations
Consequences of Refusing the Test?
Discrimination/Retaliation Claims
Unlawful medical examinations/disability inquiries under ADA
Discriminatory testing practices
Failure to accommodate
Failure to Maintain Safe & Healthy Workplace
Penalties for OSHA violations (can be significant)
OSHA or epidemiological investigation could result in shutdown of operations
Workers’ Compensation Claims
Wrongful termination/retaliation claims for adverse employment actions in
response to exercising any right created by OSHA
Wage & Hour Claims
Liability Considerations - Employment
Risks associated with testing methodologies
Bad tests, false negatives
FDA approval (or not)
Methodology / testing compliance
Conducting testing directly when not authorized (i.e., employer not a
lab)
Considerations vis-à-vis third parties
Employees
Customers/others
Liability Considerations – Third Parties
Considerations vis-à-vis third parties
Premises Liability Statutes
Negligence Based Claims
Medical Monitoring
Misleading Advertising / Consumer Protection Acts
Misrepresentation
Liability Considerations – Third Parties
Steps to Minimize Liability Risk
Know the scope of your insurance coverage
Follow government guidance and regulations, as applicable
Robust training
Don’t oversell
Follow through
Review insurance and other relevant agreements
Minimizing the Liability to Third Parties
Contact Us with Questions:
Colleen Faddick – [email protected]
Michael Gaba – [email protected]
Sean Gallagher – [email protected]
Iliana Peters – [email protected]
Lindsay Ryan - [email protected]
Thank You
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