Declaration of Dr. Michael Klompas

Summary

Michael Klompas, Hospital Epidemiologist at Brigham and Women’s Hospital, gives a declaration in the civil action brought by Together Employees against Mass General Brigham Incorporated (MGB) in the District of Massachusetts. The declaration describes MGB’s COVID-19 Vaccination Policy, announced to staff on or about June 24, 2021, with an October 15, 2021 vaccination deadline and a September 3, 2021 deadline to request an exemption. It says MGB determined the policy was necessary given the Delta variant and the vulnerability of patients, and that masking, periodic testing and social distancing were not adequate. It also describes separate review processes for disability and religious exemption requests. The certificate of service carries the signature of Katherine A. Perrelli.

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Full text

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UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS
TOGETHER EMPLOYEES, by Individual
Representatives, ROBERTA LANCIONE,
JOYCE MILLER, MARIA DIFRONZO,
MICHAEL SACCOCCIO, ELIZABETH
BIGGER, NATASHA DICICCO, NICHOLAS
ARNO, and RUBEN ALMEIDA
Plaintiffs,
v.
MASS GENERAL BRIGHAM
INCORPORATED,
Defendant.
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Civil Action No. 1:21-cv-11686
DECLARATION OF DR. MICHAEL KLOMPAS
I, Dr. Michael Klompas, am above the age of 18 and competent to testify.  All the
information in this declaration is based on my personal knowledge.
1.
My name is Dr. Michael Klompas, and I am currently Hospital Epidemiologist at
Brigham and Women’s Hospital, a member hospital of Massachusetts General Brigham (“MGB”).
2.
I am an infectious disease physician, hospital epidemiologist, and professor of
population medicine.  I have published widely on surveillance, diagnosis, prevention, and
treatment of hospital-acquired pneumonia, ventilator-associated events, sepsis, and SARS-CoV-2
transmission in healthcare settings.
3.
I attended medical school at the University of Toronto, completed my residency at
Brigham & Women’s Hospital, and my fellowship at Massachusetts General Hospital and Brigham
and Women’s Hospital.  I am board certified in Internal Medicine and Infectious Disease.
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4.
I was one of the team of senior leaders at MGB who decided to implement MGB’s
COVID-19 Vaccination Policy (the “Vaccination Policy”).  The background for the decision and
timeline for the roll-out is set forth below based upon my own personal knowledge of that process
and knowledge of those with whom I work at MGB.
A.
MGB’S Mission
5.
MGB is comprised of 16 entities across the health care continuum with 6,500
physicians, 9,100 nurses, and another 78,000 individuals who collectively provide safe, quality
care in hospitals, labs, physicians’ offices, outpatient centers, rehab facilities, urgent care clinics,
and homes.
6.
MGB’s workforce cares for 1.5 million patients annually.  We provide medical care
to some of the most complicated and vulnerable patients in the world.
7.
MGB is also the largest academic health system and private employer in
Massachusetts, and it is incredibly important that we are, and are perceived to be, the safest place
for acutely ill patients in the Commonwealth of Massachusetts.
8.
Since the onset of the pandemic, MGB has cared for many thousands of COVID-
19 patients.
B.
MGB’s Announcement of a COVID-19 Vaccination Policy
9.
On or about June 24, 2021, MGB’s Chief Executive Officer (CEO) announced to
all staff that it would soon be requiring staff to receive the COVID-19 Vaccination as a condition
of employment, absent an approved medical or religious exemption.  A true and accurate copy of
that announcement is Exhibit 1.
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10.
On or about August 10, 2021, MGB’s President and CEO sent a notice to staff
members explaining its COVID-19 Vaccination Policy (the “Vaccination Policy”).  A true and
accurate copy of the President’s communication is at Exhibit 2.
11.
The Vaccination Policy was broadly disseminated, including via the MGB’s
internal broadcast system, to managers, and to the various unions.  A true and accurate copy of
an example of such communications is Exhibit 3.
12.
The August 10, 2021 announcement included links to forms that employees could
use to request a disability or religious exemptions from the vaccine requirement.  See Exhibit 2.
The links to the request forms was also available on MGB’s employee intranet site.  Managers
were also empowered to help direct employees to the forms.
13.
The Policy initially indicated that employees should be fully vaccinated by
October 15, 2021, unless they were granted a religious or disability exemption.  (Later MGB
revised the Vaccination Policy to require a first dose of a two-dose series by October 15, 2021,
followed by a later second dose.)  A true and accurate copy of an announcement explaining the
change is Exhibit 3.
14.
The deadline for employees to request an exemption was September 3, 2021.
15.
The Vaccination Policy stated:  “The COVID-19 vaccines are safe and effective
and recommended for all of the healthcare workforce. Requiring vaccination as a condition of
employment has been demonstrated to be necessary to achieve the highest levels of workforce
vaccination and increase safety for all employees, patients and visitors to the health care settings.
All Mass General Brigham workforce are required to receive vaccination for COVID-19 unless
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exempted by this policy, in order to achieve a fully vaccinated workforce.” A true and accurate
copy of the Vaccination Policy as updated September 8, 2021 is Exhibit 4.
16.
As we approached the pending deadlines set for requests for exemptions to be
submitted, and for employees to receive a first vaccine dose, there were near-daily notifications
to all staff about those deadlines and later targeted notices to those not in compliance about the
consequences of being out of compliance with the COVID-19 Vaccination Policy.
C.
The Decision to Implement the COVID-19 Vaccination Policy
17.
Prior to issuing the COVID-19 Vaccination Policy, we recognized the immense
burden that COVID-19 had placed on MGB, its patients and employees.  Because of patients’
uniquely vulnerable status, COVID-19 is particularly deadly.  Even with all of our careful controls,
there was still spread in hospitals, and there was a necessity for more measures to protect patients
and staff including a staff vaccination requirement.
18.
The decision to enact the COVID-19 Vaccination Policy was not one MGB took
lightly.  Some of the most senior leaders at MGB, including world renowned experts in infectious
disease and infection control, were involved in making this important decision, as were MGB
leaders in Human Resources, Occupational Health, Operations, Legal, and Diversity, Equity and
Inclusion.
19.
MGB determined that the COVID-19 Vaccination Policy was necessary given the
unique emergency created by the COVID-19 pandemic; the unique threat of severe illness and
death associated with COVID-19 especially in hospitalized patients, the additional stresses on our
already overburdened system created by the highly contagious Delta variant; our responsibility to
maintain the highest possible level of patient care; our need to protect patients, staff and visitors;
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our need to keep staffing levels adequate to provide patient care; and our need as a major hospital
to inspire trust with the public so that the public would feel safe accessing medical care; and our
concern that the fall of 2021 and winter of 2022 would see a rise in COVID-19 cases.
20.
In the global COVID-19 pandemic, MGB recognized that it had a heightened
responsibility (i) for the health and safety of its health care staff and patients, (ii) to continue to
provide essential services to patients the world over who have no other options, and (iii) as a role
model to other healthcare organizations throughout the country.
21.
There is an extra onus on health care workers to protect themselves from COVID-
19 in order to protect patients.  Every day, MGB treats medically vulnerable people at higher risk
for serious disease and death from COVID-19 than the general public, including—to name just a
few examples—elderly patients; cancer patients and others with weakened immune systems;
patients with severe heart and lung disease; infants in the neonatal intensive care unit; pregnant
patients; and pediatric patients who are not yet eligible to be vaccinated.
22.
 The decision to mandate a vaccine for health and safety reasons is not new to MGB.
Prior to the COVID-19 Vaccination Policy, MGB had already been requiring flu vaccination
annually (since 2018) and MMR vaccination.
23.
Clinical data and trends clearly demonstrate that: (i) COVID-19 vaccines have high
efficacy to prevent symptomatic COVID-19 and even higher efficacy to prevent hospitalizations
and deaths; (ii) COVID vaccines have similar or better safety profiles than other vaccines currently
fully FDA approved; (iii) full vaccination offers advantages regarding patient and healthcare
personnel safety; (iv) morbidity and mortality of COVID-19 far exceeds that of influenza; (v)
COVID-19 has been uniquely disruptive to hospital operations and workforce continuity, far more
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so than influenza; (vi) health care workers and other essential workers have higher rates of
infection than people in other fields; (vii) masking diminishes risk of nosocomial transmission but
they are not perfect; vaccines provide additional and constant protection without requiring
reminders, persuasion, mask-fitting aids, or other behavioral changes.
24.
I personally co-wrote an article citing many of these reasons for the mandate for
the Annals of Internal Medicine entitled “The Case for Mandating the Covid-19 Vaccine for Health
Care Workers,” published July 13, 2021.  A true and accurate copy of the article is Exhibit 5.
25.
When we made the decision to implement the Vaccination Policy, we found
additional support in the prioritization set by the federal and state government that included all
hospital workers in the first wave of vaccinations in Dec. 2020-March 2021, regardless of whether
they were front-line workers.  This government prioritization was consistent with the need to
preserve the integrity of the healthcare workforce during this pandemic.
26.
One important consideration for our decision to implement the COVID-19
Vaccination Policy is public and patient trust in the safety of MGB.  A major stressor on the health
system in Massachusetts, then and now, is the extremely high census (number of patients) and
acuity (severity of health issues) in hospitals, which we believe is attributable at least in part to
deferral of care during the pandemic.  Many patients or members of the public were afraid to come
to the hospital or doctor’s office because they feared contracting COVID-19.  This caused them to
be sicker and to need more acute care when they did reach their provider at MGB.  This is a crucial
reason why it is imperative to assure both safety and the perception of safety at MGB.
27.
The Vaccination Policy also helps MGB to ensure that it is a safe place for visitors
to the hospital.  Indeed, visitors like patients have an expectation of safety.  Many medically
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vulnerable people visit MGB offices every day to provide support to hospitalized family members.
For example, a patient may need a ride home after receiving anesthesia; pediatric patients require
an adult parent or guardian to accompany them to appointments; elderly or disabled patients may
require a companion to access health care; many patients need emotional support from a family
member or friend during their time at MGB.
28.
MGB made the decision to include remote employees in the vaccine requirement
laid out in the COVID-19 Vaccination Policy for numerous reasons including that (i) all MGB
employees are expected to be deployable to the hospital as needed; (ii) remote employees may
need to occasionally interface with personnel on the front lines in patient-facing positions; (iii) all
remote employees are providing critical support to the health care community during this pandemic
and thus their absence due to illness can impact critical operations; and (iv) unvaccinated remote
employees are more vulnerable to COVID-19 infection, which can result in gaps in essential
staffing.
29.
MGB leadership, including myself, determined that the COVID-19 Vaccination
Policy was critical to its health and safety priorities and that allowing any employee to decide
instead just to mask, engage in periodic testing, and socially distance was not adequate to meet
MGB’s urgent health and safety priorities and protect its vulnerable patient population.  This is
for many reasons including that:  (i) in many MGB positions it is not practicable to adequately
socially distance from other staff, patients and visitors; (ii) testing by itself is not adequate to
identify when an employee is infected and contagious because employees are at constant risk of
infection; testing once per week will miss infections that might arise the other 6 days of the
week; testing daily is unduly onerous on the system and impractical; testing can convey to
healthcare workers a false sense of safety that may lead to lapses in other safety measures; (iii) if
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an employee does test positive they may have already been contagious for two or more days; and
(iv) it is now well established that even if a vaccinated individual gets infected they are at least
50% less likely to transmit infection compared to unvaccinated people.
D.
Many Other Leading Health Care Systems Have Also
Mandated COVID-19 Vaccines for Their Employees
30.
MGB joins many other leading health care systems in the United States in making
COVID-19 vaccination for its employees a requirement, ensuring that patients are being cared for
in the safest clinical environment possible.
31.
Similarly, the following healthcare entities issued a consensus statement on the
issue: the Society for Healthcare Epidemiology of America (SHEA) and the Society for Post Acute
and Long-Term Care Medicine (AMDA), the Association for Professionals in Epidemiology and
Infection Control (APIC), the HIV Medicine Association (HIVMA), the Infectious Diseases
Society of America (IDSA), the Pediatric Infectious Diseases Society (PIDS), and the Society of
Infectious Diseases Pharmacists (SIDP) and they recommended that the COVID-19 vaccination
should be a condition of employment for all healthcare personnel in facilities in the United States.
32.
Also in July 2021, 58 signatories in the health care field, including the American
Academy of Nursing and the American College of Physicians, signed on to a “Joint Statement in
Support of Covid Vaccine Mandates for all workers in Health and Long Term Care.”  A true and
accurate copy of the Joint Statement is Exhibit 6.
E.
Urgent Health and Safety Concerns Guided MGB’s Exemption
Processes
33.
MGB implemented one process for reviewing disability exemption requests, and
another process for reviewing religious exemption requests. Different teams participated in each
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review process.  (See Declarations of Ramona Nichols and Dr. Dean Hashimoto filed
simultaneously herewith).
34.
Both the committee processing religious exemption requests, and the medical
panels processing medical exemption requests, were advised of MGB’s urgent health and safety
priorities, and the necessity therefore of developing a rigorous, rapid, and efficient review
process. These priorities were developed by senior leadership and health experts at MGB.
35.
First, the review process needed to be prompt, given the ongoing and rapid spread
of the COVID-19 Delta variant, the constant threat of nosocomial transmission of COVID-19,
and the need to have employees vaccinated by the deadlines set out in MGB’s Vaccination
Policy.  Second, the review process was to be as rigorous as possible in accordance with the law,
so as to minimize the number of unvaccinated staff at MGB given the risks that unvaccinated
staff presented to MGB’s medically vulnerable patient population, other employees, and visitors
and to ensure MGB staff remain available to respond to the ongoing public health crisis.  Third,
it would be an undue hardship for MGB to allow large numbers of employees to remain
unvaccinated and thus a constant source of potential threat to MGB’s medically vulnerable
patient population, other employees and visitors.
36.
Those processing medical and religious exemption requests were advised that the
pandemic, and particularly the rapid spread of the Delta variant of COVID-19, was a public
health emergency, and that MGB had an urgent responsibility to continue serving its large and
complex patient population, as well as to protect its staff, medically vulnerable population and
visitors from infection.  They were also aware that as a major hospital, the perception of safety
was critical for patients, visitors and the public.
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37.
Those processing medical and religious exemption requests were tasked with
designing a process that would be consistent with those urgent health and safety priorities.  They
were advised that that the impending fall and winter seasons were particularly concerning for
new waves of COVID-19 infection especially given the Delta variant.
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I declare under penalty of perjury that the foregoing is true and correct to the best of my
knowledge and belief.  Executed this 29th day of October, 2021.
____________________________
Dr. Michael Klompas
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CERTIFICATE OF SERVICE
I hereby certify that on November 1, 2021, a copy of the foregoing document was filed
electronically through the Court’s electronic filing system (“ECF system”) and that counsel for
Plaintiffs is a registered user of the ECF system.  Notice of this filing will be sent by operation of
the Court’s ECF system to all parties indicated on the electronic filing receipt.  Parties may
access this filing through the Court’s ECF system.
/s/ Katherine A. Perrelli
Katherine A. Perrelli
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