OpEd: State Guidelines Are Defeating the Power of Testing to Keep People Safe from SARS-COV-2 Infection in Massachusetts

June 30, 2020

Submitted by Ann Kiessling, PhD

Wednesday, July 1, the Joint Committee on Education has scheduled a hearing on the status of early education and care and is collecting written testimony until 5 pm on Tuesday, July 7.

Click this link to learn more about the July 1 hearing.

If you are not able to attend the hearing, written testimony may be submitted to [email protected] and [email protected] with the subject line “EEC Oversight Hearing Testimony”

I am urging all persons interested in child care and education to respond and request SARS-CoV-2 strategies for children in day care facilities and schools in the Commonwealth that include regular testing.  It is obvious that the safest place for a child of any age is an environment in which regular testing is employed to identify contagious persons.

Background:  Early Saturday morning, February 29, CLIA-licensed labs around the country received emails from the Food and Drug Administration urging them to develop tests for the new corona virus, SARS-CoV-2.  The logic was that laboratories already federally licensed to do high complexity testing could rapidly re-tool to test for SARS-CoV-2.  The goal was to provide adjunct testing resources as quickly as possible because the public health laboratories in each state, part of the network of the Centers for Disease Control, were already overwhelmed, and identifying infected persons is known to be fundamental to controlling a pandemic.  This directive by the FDA has proven to be the single most effective government action during the pandemic.

Hundreds of CLIA-licensed laboratories – large and small – across the country mobilized to develop assays for SARS-CoV-2.  The experts convened by Harvard Medical School Dean George Daley in early March confirmed testing as the most important tool to get ahead of the spread of the virus.  Governor Baker’s COVID19 task force, fortified by McKinsey consulting staff, began working 24/7 in early March to assist all qualifying laboratories across the Commonwealth in their efforts to ramp-up testing capacity to meet the pressing need.  The COVID19 task force helped source supplies and connect hospitals and long term care facilities in need of testing with CLIA-licensed labs that had followed FDA guidance and were ready to test for SARS-CoV-2.  By late March, the massive and welcome testing capacity of The Broad Institute, and large commercial laboratories like Quest and Lab Corp, further expanded testing capacity to the health care community.  By mid-April, testing capacity had increased to the level that all persons could be tested, not just those with symptoms or known exposure.  The goal is 100,000 tests per day by August.

Current Problems:  But state bureaucracy has not kept pace with these developments.  Summer camps desperately seeking information about access to testing for staff and kids, and how often to test, did not receive that guidance.  Instead, they received far more expensive and less effective guidance about social distancing, use of masks, and lists of activities that will not happen, such as swim lessons, as if testing for SARS-CoV-2 was not possible.  The new “social distancing” guidelines erase the value of summer camp for youth development and impose such a financial and liability burden on camp organizers that most have chosen to not open up this year.  The loss to society of invaluable childhood learning experiences and summer employment for counselors will be felt for many years.

Some of the hardest-hit institutions are daycare centers, which are unraveling at an alarming rate.  Child care resources have improved markedly in the past couple of decades with competent, licensed centers providing safe, enriching programs for children.  But the financially crushing “social distancing” guidelines issued by the Massachusetts Department of Early Education and Care do not include testing, not even in the section labeled “Strategies to Reduce the Risk of Transmission” issued June 6.  Parents and child welfare experts are concerned about the developmental impact on small children of the “social distancing” and mask guidelines, considerations of which are glaringly omitted in the EEC directives.  The overall impact on families are also not part of the guidelines, a remarkable oversight considering the fact that the safest place for children would be an environment in which all staff and children are routinely tested for SARS-CoV-2.

This extraordinary disconnect between the guidelines released by Commonwealth regulatory bodies, and the technical power of Commonwealth laboratories to identify infected persons, is not justified by lack of testing resources.  The Boston Globe recently reported that less than half of the testing capacity in the state is being utilized, an observation supported by a recent report in MIT Technology Review  (https://www.technologyreview.com/2020/06/27/1004545/us-covid-19-coronavirus-test-capacity-unused-available-reopening/)

The cost of testing is far less than the cost of the financially burdening “social distancing” modifications needed to physical plants.  Businesses, like manufacturing, not in frequent contact with the public, that are interested in using periodic testing instead of the less effective and more expensive “social distancing” practices, are told by local Boards of Health that testing does not replace the social distancing guidelines, and they would still be subject to the “Cease and Desist Orders” and fines that can be imposed on businesses not in compliance with current “Opening Up” guidelines.

Hence, instead of offering incentives for people to get tested, Commonwealth regulatory bodies are offering reasons to not get tested. This totally defeats Governor Baker’s goal of wide-spread testing of 100,000 persons per day by August, 2020.

Remedies: How can the testing barriers be overcome to take advantage of the markedly increased ability of testing over “social distancing” to control the spread of COVID19? (http://www.mhtc.org/wp-content/uploads/2020/05/MHTC-COVID-19-Briefing-v33-5.13.20.pdf)  An estimated half of infections are spread by people who do not know they are infected.

An immediate and effective approach would be to rescind the current guidelines and adopt the FDA strategy:  provide SARS-CoV-2 testing guidance to entities already licensed for their activities, such as daycare facilities and summer camps.  Since those entities have already proven to state authorities that their practices adequately care for the safety of staff and kids, what they need now is guidance from public health authorities about testing frequency and testing access.  Algorithms need to be available to make informed decisions about what testing interval is a good compromise between identifying 100% of infected persons (daily testing everyone, like Major League Baseball) and lesser efficacy, e.g. perhaps once every two weeks might detect 90% of infected persons.  Everyone is aware that the dynamics of virus spread are not known with certainty, and that all estimates are just that, estimates, but enough is now known that the efficacy of “social distancing” strategies to prevent spread are not nearly as powerful as widespread testing to identify infected persons.

Similar considerations apply to care facilities and businesses not in regular contact with the public.  Expensive and less effective “social distancing” guidelines need to be replaced by access to testing and risk/benefit protocols for testing frequency.

The FDA and Medicare recognize two forms of testing for SARS-CoV-2: (1) diagnostic and (2) work-place safety.  Diagnostic testing in the Commonwealth requires a physician’s test requisition, a requirement counter to the Obama administration’s push for direct access testing country-wide.  Twenty years ago, the Institute of Medicine recommended that health care in the U.S. become “patient-centric” instead of “physician-centric” as a way of improving access to care.  Obama’s Affordable Care Act embraced that concept and most states in the U.S. have eliminated the need for a physician’s test requisition to receive most tests at licensed laboratories.  But not Massachusetts.  This requirement was, in fact, set aside in Massachusetts during the early years of the HIV/AIDS pandemic, but has not been set aside for SARS-CoV-2 testing.  Needing a physician’s test requisition greatly complicates access to testing, and is an unnecessary barrier to effectively tracking the path, and genetic variation, of the virus.

Work place safety testing can be performed without a physician’s test requisition by methods considered “CLIA-waived”, such as the Abbott instrument frequently touted by Donald Trump.  There are currently four such platforms cleared by the FDA:  Abbott Diagnostics, ID NOW COVID 19; Mesa Biotech, Accula SARS-CoV-2 Test; Cepheid, Xpert Xpress SARS-CoV-2 Test; and Quidel Corporation, Sofia 2 SARS Antigen FIA.  A CLIA-license is required to perform the test, but can be obtained by anyone designated as the “lab director” who can follow the manufacturer’s instructions for performing the test.  All businesses and other entities are eligible to apply, the form is relatively simple.  These one-at-a-time, point of use tests are criticized for being not accurate, but have been cleared by the FDA to identify a highly contagious individual within a few minutes.  The goal is wide-spread work place safety.

Schools opening up in the fall do not need an entirely new set of “social distancing” guidelines for SARS-CoV-2.  What they need to know is how best to incorporate testing, including “work place safety” testing, into their daily operations that have already been inspected for school safety.  Some communities will require more frequent testing, other communities less frequent, depending on the local infection incidence.  And each School Board should be allowed to determine what risk/benefit testing frequency is comfortable for their constituency.  It is obvious that the safest place for a child of any age is an environment in which regular testing is employed to identify contagious persons.

Nowhere in the U.S. is there greater scientific capacity to identify and contain the spread of SARS-CoV-2 than Massachusetts.  It is imperative that capacity not be thwarted by state bureaucracy that has not kept pace with available resources and best pandemic containment guidelines.

Submit written testimony to mailto:[email protected] and mailto:[email protected]with the subject line “EEC OVERSIGHT HEARING TESTIMONY” by July 7th at 5:00 PM.

Editor’s Note: Ann Kiessling is the Director of the Bedford Research Foundation and an elected member of the Bedford Board of Health

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