Tag Archives: testing protocol

Melanie Neumann, Neumann Risk Services
FST Soapbox

The COVID-19 Record Retention Conundrum

By Melanie J. Neumann
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Melanie Neumann, Neumann Risk Services

During this global pandemic, the U.S. Equal Employment Opportunity Commission (EEOC) green-lighted employers to take temperatures checks of employees and to administer COVID-19 testing for workers prior to returning to work without running afoul of the Americans with Disabilities Act (ADA). This appears straight-forward upon first reading, however, several practical uncertainties about implementation, including confidentiality, discrimination, and how long to retain records remain.

As such, deciding whether to take temperatures and/or require COVID- 19 testing as a return to work strategy is more complicated than it may seem.

Temperature Screening & Testing Considerations

Temperature screening and COVID-19 mandatory testing are both permitted medical examinations during this pandemic but are otherwise prohibited during non-pandemic times. Before adopting, employers should understand the requirements impacting the records these tests generate, including the need to protect confidentiality and to retain records for longer than one may expect.

Temperature Screens
Under normal circumstances, temperature checks are considered a prohibited medical examination under the ADA. During a pandemic, however, the Equal Employment Opportunity Commission (“EEOC”) makes an exception, allowing employers to take temperatures/use temperature checks and exclude employees from the workplace should temperatures exceed public health recommendations. If employers keep records of temperatures, they must retain these records per applicable regulations. This is important because an “employee medical record” would likely result if employers take employees’ temperatures or collect temperature related records. As we will see below, there are regulatory requirements that require how we conduct these screens, and where and for how long we must retain them.

COVID-19 Testing

COVID-19 testing also constitutes a permissible medical exam under ADA during this pandemic, per the EEOC-issued guidance regarding mandatory employee testing.

For medical examinations to be allowed under the ADA, the test must be “job related and consistent with business necessity,” and employers must treat information as a confidential medical exam.

The initial guidance acknowledged that the spread of COVID-19 is a “direct threat,” hence meeting the requirement that a medical exam be “job related and consistent with business necessity” and that temperature screenings were therefore appropriate. For the same reasons, in updated guidance released at the end of April 2020, the EEOC expanded that guidance to clarify that employers may choose to administer COVID-19 testing to employees before they enter the workplace to determine if they have the virus for the same reasons.

When reading the EEOC’s language closely, the permission granted by EEOC appears to be for diagnostic tests, as the guidance states testing is to determine if employees have the virus before allowing employees to return to work. It is unclear whether antibody testing is included in the above analysis because antibody tests do not determine if someone is currently infected.

In addition, there are other considerations employers should assess before adopting a testing protocol. EEOC reminds employers that they must review the accuracy and efficacy of the selected test per FDA and CDC recommendations. Moreover, pragmatic considerations, such as how to maintain social distancing and employee privacy, determining who will perform the testing and at what the frequency, not to mention evaluating whether there is enough test capacity to perform employee-wide testing at a meaningful cadence should be evaluated.

Records Management & Retention

There is another often over-looked question: What do employers do with documented test records? This question applies whether the employer conducts the test, requires tests from employee’s healthcare providers to be off work to self-isolate, or as a return to work requirement.

It was clearly outlined above that temperature records and COVID-19 test records constitute employee medical records. Why is this important? Because there are specific requirements relating to employee medical records, including what appears to be a surprisingly long retention requirement.

Where to retain: An employer should store all medical information related to COVID-19 in existing medical files, separate from the employee’s personnel file, per the ADA, limiting access to this employee confidential information. This includes an employee’s statement that he has COVID-19 or suspects he/she has the disease, or the employer’s notes or other documentation from questioning an employee about symptoms.

How long to retain: That is the 30-year question. The Department of Labor’s Occupational Safety and Health Agency (OSHA) provides retention requirements for employee medical records in certain situations for a period of an employee’s employment plus 30 years.

While COVID-19 test results and temperature screening documentation are deemed medical examinations under the applicable regulations, are the documented results deemed medical records? We turn to applicable EEOC OSHA regulations in section 1910.1020 for answers.

OSHA Requirements

The OSHA general duty clause, section 5(a)(1) requires employers to furnish to each of its employees a workplace free from recognized hazards that are causing or likely to cause death or serious physical harm. COVID-19 appears to rise to this threat level. But is that fact alone dispositive to falling under the applicable OSHA retention requirements?

OSHA regulation section 1910.1020 requires employers to retain employee exposure or employee medical records relating to employee exposure to certain hazards. This section applies to each general industry, maritime and construction employer who makes, maintains, contracts for, or has access to employee exposure or medical records, or analyses thereof, pertaining to employees exposed to toxic substances or harmful physical agents (Emphasis added).

Is SARS-CoV-2, the virus that causes COVID-19, considered a “toxic substance or harmful physical agent?”

Most would quickly assume the answer is ‘yes’. But it may not be as clear as the black and white letter of the law would hope. Let’s review some key definitions in the applicable regulation to help shed more light on this question.

What are Toxic Substances or Harmful Physical Agents?

The record retention requirement pivots on the last phrase of 1910.1020, that is “…pertaining to employees exposed to toxic substances or harmful physical agents.”

Toxic substances or harmful physical agents are defined as follows;

  • 1910.1020(c)(13) “Toxic substance or harmful physical agent” means any chemical substance, biological agent (bacteria, virus, fungus, etc.), or physical stress (noise, heat, cold, vibration, repetitive motion, ionizing and non-ionizing radiation, hypo – or hyperbaric pressure, etc.) which:
    • 1910.1020(c)(13)(i) is listed in the latest printed edition of the National Institute for Occupational Safety and Health (NIOSH) Registry of Toxic Effects of Chemical Substances (RTECS) which is incorporated by reference as specified in Sec. 1910.6; or
    • 1910.1020(c)(13)(ii) has yielded positive evidence of an acute or chronic health hazard in testing conducted by, or known to, the employer; or
    • 1910.1020(c)(13)(iii) is the subject of a material safety data sheet kept by or known to the employer indicating that the material may pose a hazard to human health. (Emphasis added by author).

The use of “or” clarifies that only one of the criteria need to be met. Based on the above, while subsections (c)(13)(i) and (c)(13)(iii) do not appear relevant, subsection (c)(13)(ii) appears to apply as SARS-CoV-2 has shown to result in acute health hazard, resulting in the disease COVID-19. Whether there is a chronic health impact remains to be seen given the novelty of this virus. That said, acute health impact appears sufficient to determine SARS-CoV-2 as a “toxic substance or harmful physical agent” for purposes of this analysis.

This alone doesn’t automatically place an employer in a 30-plus year requirement to retain employee medical records. What constitutes an “employee medical record” and “employee exposure record” for purposes of this regulation must be further understood before determining appropriate retention.

What are Employee Medical Records and Employee Exposure Records?

“Employee medical records” are defined in section 1910.1020(c)(6), and means a record concerning the health status of an employee that is made or maintained by a physician, nurse or other healthcare personnel, or technician, including: Medical and employment questionnaires or histories, the results of medical exams, lab test results, medical opinions/doctor’s recommendations, first aid records, employee medical complaints, and descriptions of treatment or prescriptions.

Section 1910.1020(d)(1)(i) goes on to specifically prescribes a minimum of a 30-plus year retention period as follows: “The medical record for each employee shall be preserved and maintained for at least the duration of employment plus thirty (30) years.”

“Employee exposure records,” are defined in subsection 1910.1020(d)(1)(ii), as: “Each employee exposure record shall be preserved and maintained for at least thirty (30) years,…”. Some exceptions are listed in this subsection for records relating to health insurance claims, first aid records and records relating to employees working less than one year.

What Constitutes Employee Exposure?

One must also look at what “employee exposure” means in light of this regulatory requirement to determine applicability of the 30-plus year retention.

1910.1020(c)(8) defines “exposure” or “exposed” to mean that an employee is subjected to a toxic substance or harmful physical agent in the course of employment through any route of entry (inhalation, ingestion, skin contact or absorption, etc.), and includes past exposure and potential (e.g., accidental or possible) exposure, but does not include situations where the employer can demonstrate that the toxic substance or harmful physical agent is not used, handled, stored, generated, or present in the workplace in any manner different from typical non-occupational situations.

More Questions than Answers

This analysis may leave more questions than answers, as several questions remain after looking closely at the regulatory requirements. For example:

  • How can an employee prove that exposure to SARS-CoV-2 occurred in the course of employment?
  • Does the employee even have to? The regulation clearly states that it is the employer’s burden, in that the “employer demonstrate that a toxic substance or harmful physical agent was not present in the workplace in any manner different from typical, non-occupational situations”.
  • How can an “employer demonstrate” that the harmful physical agent was not present? In other words, how can employers demonstrate that its employees are at any greater exposure by coming to work than they are in their every day lives, like going to the grocery store?
  • How do employers prove absence? Is it even possible given several people are asymptomatic?
  • Does this analysis differ by food industry sectors? What about meat and poultry processors with known high rates of infection in their workplace? Would the analysis differ?

Conclusion

Short of additional guidance issued by Department of Labor’s OSHA, ultimately this will likely be decided by the courts when the first lawsuit on this topic arises, known as decision via case law. What do employers do in the interim while these shades of gray are not yet adjudicated? It is recommended to err on the side of caution. Find ways to adjust your company’s record retention procedures and systems to be able to accurately retain these records for the duration of your employee’s employment plus 30 years.

Resources

  1. OSHA Laws & Regulations. OSH Act of 1970. SEC 5. Duties. Retrieved from https://www.osha.gov/laws-regs/oshact/section5-duties
  2. OSHA Standards. Part 1910, Standard 1910.1020. Retrieved from https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.1020
  3. OSHA. Access to Medical and Exposure Records. (2001). U.S. Department of Labor, OSHA. Retrieved from https://www.osha.gov/Publications/pub3110text.html
  4.  U.S. Equal Employment Opportunity Commission. “What You Should Know About COVID-19 and the ADA, the Rehabilitation Act, and Other EEO Laws”. (Updated May 7, 2020). Retrieved from https://www.eeoc.gov/wysk/what-you-should-know-about-covid-19-and-ada-rehabilitation-act-and-other-eeo-laws. See A. 6 and B.1.
Raj Rajagopal, 3M Food Safety
In the Food Lab

Pathogen Detection Guidance in 2020

By Raj Rajagopal
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Raj Rajagopal, 3M Food Safety

Food production managers have a critical role in ensuring that the products they make are safe and uncontaminated with dangerous pathogens. Health and wellness are in sharp focus for consumers in every aspect of their lives right now, and food safety is no exception. As food safety becomes a continually greater focus for consumers and regulators, the technologies used to monitor for and detect pathogens in a production plant have become more advanced.

It’s no secret that pathogen testing is performed for numerous reasons: To confirm the adequacy of processing control and to ensure foods and beverages have been properly stored or cooked, to name some. Accomplishing these objectives can be very different, and depending on their situations, processors rely on different tools to provide varying degrees of testing simplicity, speed, cost, efficiency and accuracy. It’s common today to leverage multiple pathogen diagnostics, ranging from traditional culture-based methods to molecular technologies.

And unfortunately, pathogen detection is more than just subjecting finished products to examination. It’s become increasingly clear to the industry that the environment in which food is processed can cross-contaminate products, requiring food manufacturers to be ever-vigilant in cleaning, sanitizing, sampling and testing their sites.

For these reasons and others, it’s important to have an understanding and appreciation for the newer tests and techniques used in the fight against deadly pathogens, and where and how they might be fit for purpose throughout the operation. This article sheds light on the key features of one fast-growing DNA-based technology that detects pathogens and explains how culture methods for index and indicator organisms continue to play crucial roles in executing broad-based pathogen management programs.

LAMP’s Emergence in Molecular Pathogen Detection

Molecular pathogen detection has been a staple technology for food producers since the adoption of polymerase chain reaction (PCR) tests decades ago. However, the USDA FSIS revised its Microbiology Laboratory Guidebook, the official guide to the preferred methods the agency uses when testing samples collected from audits and inspections, last year to include new technologies that utilize loop-mediated isothermal amplification (LAMP) methods for Salmonella and Listeria detection.

LAMP methods differ from traditional PCR-based testing methods in four noteworthy ways.

First, LAMP eliminates the need for thermal cycling. Fundamentally, PCR tests require thermocyclers with the ability to alter the temperature of a sample to facilitate the PCR. The thermocyclers used for real-time PCR tests that allow detection in closed tubes can be expensive and include multiple moving parts that require regular maintenance and calibration. For every food, beverage or environmental surface sample tested, PCR systems will undergo multiple cycles of heating up to 95oC to break open DNA strands and cooling down to 60oC to extend the new DNA chain in every cycle. All of these temperature variations generally require more run time and the enzyme, Taq polymerase, used in PCR can be subjected to interferences from other inhibiting substances that are native to a sample and co-extracted with the DNA.

LAMP amplifies DNA isothermally at a steady and stable temperature range—right around 60oC. The Bst polymerase allows continuous amplification and better tolerates the sample matrix inhibitors known to trip up PCR. The detection schemes used for LAMP detection frees LAMP’s instrumentation from the constraints of numerous moving pieces.

Secondly, it doubles the number of DNA primers. Traditional PCR tests recognize two separate regions of the target genetic material. They rely on two primers to anneal to the subject’s separated DNA strands and copy and amplify that target DNA.

By contrast, LAMP technology uses four to six primers, which can recognize six to eight distinct regions from the sample’s DNA. These primers and polymerase used not only cause the DNA strand to displace, they actually loop the end of the strands together before initiating amplification cycling. This unique looped structure both accelerates the reaction and increases test result sensitivity by allowing for an exponential accumulation of target DNA.

Third of all, it removes steps from the workflow. Before any genetic amplification can happen, technicians must enrich their samples to deliberately grow microorganisms to detectable levels. Technicians using PCR tests have to pre-dispense lysis buffers or reagent mixes and take other careful actions to extract and purify their DNA samples.

Commercialized LAMP assay kits, on the other hand, offer more of a ready-to-use approach as they offer ready to use lysis buffer and simplified workflow to prepare DNA samples. By only requiring two transfer steps, it can significantly reduces the risk of false negatives caused by erroneous laboratory preparation.

Finally, it simplifies multiple test protocols into one. Food safety lab professionals using PCR technology have historically been required to perform different test protocols for each individual pathogen, whether that be Salmonella, Listeria, E. coli O157:H7 or other. Not surprisingly, this can increase the chances of error. Oftentimes, labs are resource-challenged and pressure-packed environments. Having to keep multiple testing steps straight all of the time has proven to be a recipe for trouble.

LAMP brings the benefit of a single assay protocol for testing all pathogens, enabling technicians to use the same protocol for all pathogen tests. This streamlined workflow involving minimal steps simplifies the process and reduces risk of human-caused error.

Index and Indicator Testing

LAMP technology has streamlined and advanced pathogen detection, but it’s impractical and unfeasible for producers to molecularly test every single product they produce and every nook and cranny in their production environments. Here is where an increasing number of companies are utilizing index and indicator tests as part of more comprehensive pathogen environmental programs. Rather than testing for specific pathogenic organisms, these tools give a microbiological warning sign that conditions may be breeding undesirable food safety or quality outcomes.

Index tests are culture-based tests that detect microorganisms whose presence (or detection above a threshold) suggest an increased risk for the presence of an ecologically similar pathogen. Listeria spp. Is the best-known index organism, as its presence can also mark the presence of deadly pathogen Listeria monocytogenes. However, there is considerable skepticism among many in the research community if there are any organisms outside of Listeria spp. that can be given this classification.

Indicator tests, on the other hand, detect the presence of organisms reflecting the general microbiological condition of a food or the environment. The presence of indicator organisms can not provide any information on the potential presence or absence of a specific pathogen or an assessment of potential public health risk, but their levels above acceptable limits can indicate insufficient cleaning and sanitation or operating conditions.

Should indicator test results exceed the established control limits, facilities are expected to take appropriate corrective action and to document the actions taken and results obtained. Utilizing cost-effective, fast indicator tests as benchmark to catch and identify problem areas can suggest that more precise, molecular methods need to be used to verify that the products are uncontaminated.

Process Matters

As discussed, technology plays a large role in pathogen detection, and advances like LAMP molecular detection methods combined with strategic use of index and indicator tests can provide food producers with powerful tools to safeguard their consumers from foodborne illnesses. However, whether a producer is testing environmental samples, ingredients or finished product, a test is only as useful as the comprehensive pathogen management plan around it.

The entire food industry is striving to meet the highest safety standards and the best course of action is to adopt a solution that combines the best technologies available with best practices in terms of processes as well –from sample collection and preparation to monitoring and detection.