Court filing
21A90 011 Oct 25 2021 Main Document 20211025114856574 Resps. Appendix (U.S.)
Filed September 15, 2021 in Scotus; one of 28 filings from this case.
Record facts
| Court | Supreme Court of the United States |
|---|---|
| Filed | 2021-09-15 |
Supreme Court of the United States · No. 1:21-cv-00242-JDL · Doc. 48 · 2021-09-15 · Docket on CourtListener
Full text
No. 21A90
IN THE
Supreme Court of the United States
JANE DOES 1-6, JOHN DOES 1-3, JACK DOES 1-1000, and JOAN DOES 1-1000
Plaintiffs-Applicants
v.
JANET T. MILLS, Governor of the State of Maine, JEANNE M. LAMBREW, Commissioner
of the Maine Department of Health and Human Services, DR. NIRAV D. SHAH,
Director of the Maine Center for Disease Control and Prevention, MAINEHEALTH,
GENESIS HEALTHCARE OF MAINE, LLC, GENESIS HEALTHCARE, LLC, NORTHERN LIGHT
FOUNDATION, and MAINEGENERAL HEALTH,
Defendants-Respondents.
APPENDIX FOR RESPONDENTS
AARON M. FREY
Attorney General, State of Maine
THOMAS A. KNOWLTON
Deputy Attorney General
Chief, Litigation Division
KIMBERLY LEEHAUG PATWARDHAN*
Assistant Attorney General
VALERIE A. WRIGHT
Assistant Attorney General
kimberly.patwardhan@maine.gov
6 State House Station
Augusta, Maine 04333-0006
207-626-8570
October 25, 2021
* Counsel of Record
Counsel for Respondents Janet T. Mills, Jeanne M. Lambrew, and Nirav D. Shah
NOLAN L. REICHL*
JAMES R. ERWIN
KATHARINE I. RAND
nreichl@pierceatwood.com
Pierce Atwood LLP
254 Commercial Street
Portland, Maine 04101
207-791-1100
*Counsel of Record
Counsel for Respondents MaineHealth, Genesis Healthcare of Maine, LLC, Genesis
Healthcare LLC, and MaineGeneral Health
R.A. i
TABLE OF CONTENTS
Page
Declaration of Kimberly L. Patwardhan (D. Ct. Dkt. No. 48) ..................................... 1
Patwardhan Decl., Ex. 1 (L.D. 798 (129th Legis. 2019))
(D. Ct. Dkt. No. 48-1) .......................................................................................... 7
Patwardhan Decl., Ex. 2 (Tipping, Ryan Testimony)
(D. Ct. Dkt. No. 48-2) ........................................................................................ 10
Patwardhan Decl., Ex. 3 (McDonald, Genevieve Testimony)
(D. Ct. Dkt. No. 48-3) ........................................................................................ 13
Patwardhan Decl., Ex. 4 (Beardsley, Nancy Testimony)
(D. Ct. Dkt. No. 48-4) ........................................................................................ 19
Patwardhan Decl., Ex. 27 (P.L. 2019, ch. 154)
(D. Ct. Dkt. No. 48-27) ...................................................................................... 21
Governor’s Proclamation (D. Ct. Dkt. No. 62-1) ......................................................... 24
Declaration of Donald Wismer (D. Ct. Dkt. No. 49-1) ............................................... 25
Wismer Decl., Ex. 1 (“Immunization Requirements for Healthcare
Workers,” 10-144-264 C.M.R. (effective April 16, 2002))
(D. Ct. Dkt. No. 49-2) ........................................................................................ 27
Declaration of Nirav Dinesh Shah, M.D., J.D. (D. Ct. Dkt. No. 49-4) ....................... 34
Declaration of Sara Gagné-Holmes (D. Ct. Dkt. No. 49-5) ........................................ 49
Gagné-Holmes Decl., Ex. 1 (“Immunization Requirements for
Healthcare Workers,” 10-144-264 C.M.R. (effective April 14, 2021))
(D. Ct. Dkt. No. 49-6) ........................................................................................ 61
Gagné-Holmes Decl., Ex. 2 (Maine CDC’s 2018 Healthcare Worker
Immunization Assessment Report)
(D. Ct. Dkt. No. 49-7) ........................................................................................ 68
Gagné-Holmes Decl., Ex. 3 (“Immunization Requirements for
Healthcare Workers,” 10-144-264 C.M.R. (effective August 12, 2021))
(D. Ct. Dkt. No. 49-8) ........................................................................................ 74
R.A. ii
TABLE OF CONTENTS (cont’d)
Page
Gagné-Holmes Decl., Ex. 4 (Basis Statement, “Immunization
Requirements for Healthcare Workers,” 10-144-264 C.M.R.
(effective August 12, 2021))
(D. Ct. Dkt. No. 49-9) ........................................................................................ 82
Gagné-Holmes Decl., Ex. 5 (Proposed Rule, “Immunization
Requirements for Healthcare Workers,” 10-144-264 C.M.R.
(noticed September 8, 2021))
(D. Ct. Dkt. No. 49-10) ...................................................................................... 83
Declaration of April Nichols (D. Ct. Dkt. No. 50-2) .................................................... 91
Declaration of Judy West (D. Ct. Dkt. No. 50-3) ........................................................ 94
Declaration of Gail Cohen (D. Ct. Dkt. No. 50-4) ....................................................... 97
Declaration of Paul Bolin (D. Ct. Dkt. No. 51-2) ...................................................... 100
UNITED STATES DISTRICT COURT
FOR THEDISTRICT OF MAINE
JANE DOES 1-6, et al.,
Plaintiffs,
v.
JANET T. MILLS, in her official capacity as
the Governor of the State of Maine, et al.,
Defendants.
Civil Action No. 1:21-cv-00242-JDL
DECLARATION OF KIMBERLY L. PATWARDHAN, AAG
1.
My name is Kimberly L. Patwardhan. I am an Assistant Attorney General for the State of
Maine.
2.
The statements made in this declaration are based upon my personal knowledge.
3.
Attached hereto as Exhibit 1 is a true and accurate copy An Act To Protect Maine Children
and Students from Preventable Diseases by Repealing Certain Exemptions from the Laws
Governing Immunization Requirements, L.D. 798 (129th Legis. 2019).
4.
According to records kept by the Maine Legislature and made publicly available, there was
a public hearing on L.D. 798 on March 13, 2019. Hundreds of interested persons submitted
written testimony in favor of, in opposition to, or neither for nor against L.D. 798.
5.
The Maine Legislature published the written testimony on L.D. 798 on its website. In
addition, the Maine State Law and Legislative Reference Library publishes Maine
legislative documents on its website and makes the contents of Maine legislative committee
files available on request.
Case 1:21-cv-00242-JDL Document 48 Filed 09/15/21 Page 1 of 6 PageID #: 277
R.A. 1
6.
Attached hereto as Exhibit 2 is a true and accurate copy of the testimony of Representative
Ryan Tipping, one of the bill’s sponsors, on L.D. 798, which testimony is available on the
Maine Legislature’s website.
7.
Attached hereto as Exhibit 3 is a true and accurate copy of the testimony of Representative
Genevieve McDonald, one of the bill’s sponsors, on L.D. 798, which testimony is available
on the Maine Legislature’s website.
8.
Attached hereto as Exhibit 4 is a true and accurate copy of the testimony of Nancy
Beardsley, Acting Director of the Maine Center for Disease Control and Prevention, on
L.D. 798, which testimony is available on the Maine Legislature’s website.
9.
Attached hereto as Exhibit 5 is a true and accurate copy of the testimony of Rebecca Boulos
on behalf of the Maine Public Health Association on L.D. 798, which testimony is available
on the Maine Legislature’s website.
10.
Attached hereto as Exhibit 6 is a true and accurate copy of the testimony of James Madara,
on behalf of the American Medical Association, on L.D. 798, which testimony is available
on the Maine Legislature’s website.
11.
Attached hereto as Exhibit 7 is a true and accurate copy of the testimony of Deborah
Hagler, M.D., on behalf of the American Academy of Pediatrics, on L.D. 798, which
testimony is available on the Maine Legislature’s website.
12.
Attached hereto as Exhibit 8 is a true and accurate copy of the testimony of Patricia
Endsley, from the Maine Association of School Nurses on L.D. 798, which testimony is
available on the Maine Legislature’s website.
Case 1:21-cv-00242-JDL Document 48 Filed 09/15/21 Page 2 of 6 PageID #: 278
R.A. 2
13.
Attached hereto as Exhibit 9 is a true and accurate copy of the testimony of Lisa Harvey-
McPherson, on behalf of Northern Light, on L.D. 798, which testimony is available on the
Maine Legislature’s website.
14.
Attached hereto as Exhibit 10 is a true and accurate copy of the testimony of Rebecca
Hemphill, M.D., on behalf of MaineHealth, on L.D. 798, which testimony is available on
the Maine Legislature’s website.
15.
Attached hereto as Exhibit 11 is a true and accurate copy of the testimony of Stanley
Chaleff, M.D. on L.D. 798, which testimony is available on the Maine Legislature’s
website.
16.
Attached hereto as Exhibit 12 is a true and accurate copy of the testimony of Tin Ha-Ngoc,
M.D. of Maine on L.D. 798, which testimony is available on the Maine Legislature’s
website.
17.
Attached hereto as Exhibit 13 is a true and accurate copy of the testimony of Emily Keller,
M.D. on L.D. 798, which testimony is available on the Maine Legislature’s website.
18.
Attached hereto as Exhibit 14 is a true and accurate copy of the testimony of Juliana
L’Heureux of the American Nurses Association of Maine on L.D. 798, which testimony is
available on the Maine Legislature’s website.
19.
Attached hereto as Exhibit 15 is a true and accurate copy of the testimony of Peggy McRae
on behalf of the Nursing Leaders of Maine on L.D. 798, which testimony is available on
the Maine Legislature’s website.
20.
Attached hereto as Exhibit 16 is a true and accurate copy of the testimony of Jennifer
Wriggins, Esq. of Maine on L.D. 798, which testimony is available on the Maine
Legislature’s website.
Case 1:21-cv-00242-JDL Document 48 Filed 09/15/21 Page 3 of 6 PageID #: 279
R.A. 3
21.
Attached hereto as Exhibit 17 is a true and accurate copy of the testimony of Suzanne
Lafreniere, on behalf of the Roman Catholic Diocese of Portland, on L.D. 798, which
testimony is available on the Maine Legislature’s website.
22.
Attached here to as Exhibit 18 is a true and accurate copy of the article by John D.
Grabenstein, What the World’s religions teach, applied to vaccines and immune globulins,
which was published in the February 2013 issue of Vaccine and presented to the Education
Committee during the consideration of L.D. 798. This article is available in the committee
file of L.D. 798.
23.
Attached hereto as Exhibit 19 is a true and accurate copy of Committee Amendment A to
L.D. 798, which is available on the website of the Maine State Law and Legislative
Reference Library.
24.
Attached hereto as Exhibit 20 is a true and accurate copy of select pages of the Journal and
Legislative Record of the Maine House of Representatives from April 23, 2019, that
include remarks from the floor of the Maine House on L.D. 798.
25.
Attached hereto as Exhibit 21 is a true and accurate copy of select pages of the Senate
Legislative Record of the Maine Senate from May 2, 2019, that include remarks from the
floor of the Maine Senate on L.D. 798.
26.
Attached hereto as Exhibit 22 is a true and accurate copy of select pages of the Journal and
Legislative Record of the Maine House of Representatives from May 7, 2019, that include
remarks from the floor of the Maine House on L.D. 798.
27.
Attached hereto as Exhibit 23 is a true and accurate copy of select pages of the Senate
Legislative Record of the Maine Senate from May 14, 2019, that include remarks from the
floor of the Maine Senate on L.D. 798.
Case 1:21-cv-00242-JDL Document 48 Filed 09/15/21 Page 4 of 6 PageID #: 280
R.A. 4
28.
Attached hereto as Exhibit 24 is a true and accurate copy of select pages of the Journal and
Legislative Record of the Maine House of Representatives from May 21, 2019, that include
remarks from the floor of the Maine House on L.D. 798.
29.
Attached hereto as Exhibit 25 is a true and accurate copy of select pages of the Journal and
Legislative Record of the Maine House of Representatives from May 23, 2019, that include
remarks from the floor of the Maine House on L.D. 798.
30.
Attached hereto as Exhibit 26 is a true and accurate copy of select pages of the Senate
Legislative Record of the Maine Senate from May 23, 2019, that include remarks from the
floor of the Maine Senate on L.D. 798.
31.
Attached hereto as Exhibit 27 is a true and accurate copy of Chapter 154 of the Maine
Public Laws from 2019, which was signed by the Governor on May 24, 2019.
I DECLARE, PURSUANT TO 28 U.S.C. § 1746, UNDER PENALTY OF PERJURY THAT THE
FOREGOING IS TRUE AND CORRECT.
Dated: September 15, 2021
/s/ Kimberly L. Patwardhan, AAG______
Kimberly L. Patwardhan, AAG
Case 1:21-cv-00242-JDL Document 48 Filed 09/15/21 Page 5 of 6 PageID #: 281
R.A. 5
CERTIFICATE OF SERVICE
I hereby certify that on September 15, 2021, I electronically filed this document and its
attachments with the Clerk of the Court using the CM/ECF system and that the same will be sent
electronically to registered participants as identified in the CM/ECF electronic filing system for
this matter.
/s/ Kimberly L. Patwardhan
KIMBERLY L. PATWARDHAN
Assistant Attorney General
Office of the Attorney General
6 State House Station
Augusta ME 04333-0006
Tel. (207) 626-8570
Fax (207) 287-3145
kimberly.patwardhan@maine.gov
Case 1:21-cv-00242-JDL Document 48 Filed 09/15/21 Page 6 of 6 PageID #: 282
R.A. 6
Printed on recycled paper
129th MAINE LEGISLATURE
FIRST REGULAR SESSION-2019
Legislative Document
No. 798
H.P. 586
House of Representatives, February 12, 2019
An Act To Protect Maine Children and Students from Preventable
Diseases by Repealing Certain Exemptions from the Laws
Governing Immunization Requirements
Reference to the Committee on Education and Cultural Affairs suggested and ordered
printed.
ROBERT B. HUNT
Clerk
Presented by Representative TIPPING of Orono.
Cosponsored by Representative TUCKER of Brunswick, Senator WOODSOME of York and
Representatives: BICKFORD of Auburn, HUBBELL of Bar Harbor, HYMANSON of York,
McDONALD of Stonington, MEYER of Eliot, PERRY of Calais, Senators: GRATWICK of
Penobscot, SANBORN, L. of Cumberland.
EXHIBIT 1
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R.A. 7
Page 1 - 129LR0080(01)-1
1
Be it enacted by the People of the State of Maine as follows:
2
Sec. 1. 20-A MRSA §6355, sub-§3, as amended by PL 2001, c. 326, §2, is
3
repealed.
4
Sec. 2. 20-A MRSA §6359, sub-§3, ¶B, as amended by PL 2001, c. 326, §6, is
5
repealed.
6
Sec. 3. 22 MRSA §802, sub-§4-B, ¶B, as enacted by PL 2001, c. 185, §2, is
7
repealed.
8
Sec. 4. 22 MRSA §8402, sub-§3, ¶A, as amended by PL 2001, c. 645, §10, is
9
further amended to read:
10
A.
The department shall adopt rules regarding the health of staff as required to
11
protect the health and safety of the children. The rules must include a requirement
12
that every 2 years each licensee, administrator or other staff member of the nursery
13
school who provides care for children be declared free from communicable disease
14
by a licensed physician, except that this requirement may be waived for a person who
15
objects on the grounds of sincerely held religious or philosophical belief. Rules
16
adopted pursuant to this paragraph are routine technical rules as defined in Title 5,
17
chapter 375, subchapter II-A 2-A.
18
Sec. 5. Rules. The Department of Education and the Department of Health and
19
Human Services shall amend their rules to remove any rules exempting persons from
20
immunization requirements because of their religious or philosophical beliefs. Rules
21
adopted by the Department of Education must provide that a student who is covered by
22
an individualized education plan on the effective date of this Act and has elected a
23
philosophical or religious exemption from immunization requirements on or before the
24
effective date of this Act may continue to attend school under that student’s existing
25
exemption as long as:
26
1. The parent or guardian of the student provides a statement from an appropriate
27
medical professional that the medical professional has consulted with that parent or
28
guardian and has made that parent or guardian aware of the risks and benefits associated
29
with the choice to immunize; or
30
2. If the student is 18 years of age or older, the student provides a statement from an
31
appropriate medical professional that the medical professional has consulted with that
32
student and has made that student aware of the risks and benefits associated with the
33
choice to immunize.
34
Rules adopted pursuant to this section are routine technical rules as defined in the
35
Maine Revised Statutes, Title 5, chapter 375, subchapter 2-A.
36
SUMMARY
37
Current law allows exemptions from immunization requirements based on religious
38
or philosophical beliefs for students in elementary and secondary schools and
EXHIBIT 1
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R.A. 8
Page 2 - 129LR0080(01)-1
1
postsecondary schools and employees of nursery schools and health care facilities. This
2
bill removes those exemptions. The bill also directs the Department of Education and the
3
Department of Health and Human Services to remove any immunization exemptions
4
based on religious or philosophical beliefs from their rules and requires the Department
5
of Education to adopt rules allowing a student who is covered by an individualized
6
education plan and has elected a philosophical or religious exemption from immunization
7
requirements to continue to attend school under the existing exemption as long as an
8
appropriate medical professional provides a statement that the medical professional has
9
provided information on the risks and benefits associated with the choice to immunize.
EXHIBIT 1
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R.A. 9
Ryan Tipping
279 Main Street
Orono, f\.1E 04473
Phone: (207) 866-4333
Ryan.Tipping@legislature.maine.gov
March 13, 2019
HOUSE OF REPRESENTATIVES
2 STATE HOUSE STATION
AUGUSTA, MAINE 04333-0002
(207) 287-1400
TTY: (207) 287-4469
Testimony of Rep. Ryan Tipping presenting
LD 798, An Act To Protect Maine Children and Students from Preventable
Diseases by Repealing Certain Exemptions from the Laws Governing
Immunization Requirements
Before t/ie Joint Standing Committee on Education a11d Cultural Affairs
Good afternoon, Senator Millett, Representative Kornfield, and esteemed members of the Joint
Standing Committee on Education and Cultural Affairs. My name is Ryan Tipping and it is my
honor to represent most of the wonderful residents of Orono in the House. I am here to present
LD 798, An Act To Protect Maine Children and Students from Preventable Diseases by
Repealing Certain Exemptions from the Laws Governing Immunization Requirements.
Senators, Representatives, please imagine that we are in a boat. The boat is leaking and is almost
filled with water. It would make sense that we would all want to grab our bail buckets and try to
keep afloat. And if, after much hard work, the boat is nearly dry, you could forgive some of us
for relaxing a bit Some might even set aside the bailing buckets. But, sure enough, the leak will
eventually overtake us if we become complacent.
There is a reason the Centers for Disease Control use this metaphor of a leaky boat to represent a
community taldng on the struggle of fighting infectious disease. It is a reminder that when our
foe is a dangerous, intangible entity capable of putting our children's lives at risk, we are in this
together. The actions we take as individuals affect the lives of our neighbors.
In this metaphor, the ultimate solution is to plug the hole. In reality, this can only happen when
we work together as a society to raise our immunity threshold_to the point where a disease cannot
take root, and then keep it at that level until there is no source of that disease left to defend
against. We have been successful m the past at achieving this goal, most notably with smallpox.
But what we are seeing now is a rising tide of diseases that previous generations worked
tirelessly to defeat. In my work on this bill, I have come to realize that there is a generational
District 123: Orono (part)
i I I
EXHIBIT 2
Case 1:21-cv-00242-JDL Document 48-2 Filed 09/15/21 Page 1 of 3 PageID #: 286
R.A. 10
divide. When I talk to my peers about whooping cough or measles, some stare blankly, some
shrug, and I have even had others try to convince me that these diseases are harmless. When I
discuss this same topic wÁth people who have earned the wisdom that only comes with
experience, I get a very different reaction. You will very likely hear some of these stories today,
like what it felt like to hold an infant unsuccessfully gasping for air while in the throes of
pertussis or what it was like to care for a family member paralyzed by polio. I think it is safe to
say that a growing number of people, despite the considerable education campaigns and
widespread access to public health, may not see the value in continuing to bail out our little boat.
I think it is also safe to say that the risk is much more dangerous than getting our feet wet.
We have all seen the news reports from across the country over the last few months. From Clark
County, Washington, to New York City, measles is returning in staggering numbers. Whether
it's because of misinformation, fear, or indecision, people have withdrawn from the public effort
to keep our communities floating high enough within acceptable immunity percentages to avoid
catastrophe.
Members of the committee, the bill before you is an attempt to reverse this trend and ensure that
now and into the future our schools and daycares will be places where children can learn and
grow without fear of serious, harmful, preventable diseases. The bill removes non-medical
exemptions to the decades-old immunization requirements for the institutions where our children
spend most of their waking hours. It also tightens the exemptions for health care workers, many
of whom are here today, and daycare employees. As a matter of practicality, it grandfathers
students who are both currently claiming a non-medical exemption and enrolled in an
individualized education plan. The bill further calls on both the Department of Health and
Human Services and the Department of Education to amend their rules to ensure full
implementation of these changes.
These changes are necessary if we want to prevent headlines from Washington and New York
from appearing instead on the front page of the Bangor Daily News. Headlines like "[Governor]
Inslee Declares State of Emergency" or "Cost of Washington's measles outbreak tops $1 million;
expected to climb higher" or "Measles Outbreak: 1 student got 21 others sick." And, to be clear,
Maine has felt the sting of infectious disease in recent years as well. In 2018, we saw 13
outbreaks of pertussis in schools. In 2017, we had our first case of measles since 1997. And there
are more examples.
These headlines and stories are particularly troubling to people who cannot be inununized,
whether due to illness or age. You will hear from some of these people today, including parents
of young children who, like my daughter, attend daycares where the only protection between
toddlers who have established inununities and infants who do not is a half door or a few feet
between tables in the lunchroom. You will also hear from parents of immunocompromised or
District 123: Orono (pait)
EXHIBIT 2
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R.A. 11
immunosuppressed children who will never achieve the immunities needed to protect them and
rely on their neighbors' vaccinations in order to even be in school at all. You will also hear from
people who cannot receive the immunizations for medical reasons.
I want to take a moment here to say that in the case of medical exemptions, a physician should be
able to sit down with their patient and their parents and look at the best medical science available
to them in order to make a determination on whether or not a medical exemption is warranted. I
do not believe any group of legislators should be limiting a doctor who is practicing within the
scope of their field and using their best medical judgment from doing what is right for their
patient. If this committee needs to clarify this point in rules, I would consider it a friendly
amendment.
Before I wrap.up, I want to make sure to emphasize one point. We are all in this together. We
must confront this issue as a state, not as individuals. I believe everyone who is going to testify
today is doing so in an attempt to protect their loved ones or generally make their state a better
place. We are in this together and we must approach this subject with humility and civility.
In working on this bill, I have had countless conversations with people all over the spectrum of
opinion on this topic. I have tried to react to concerns where I hear them, respond to criticism
constructively, and incorporate new ideas into the bill. I want t.o sincerely thank everyone who
has attempted to reach out and engage on the issue. After today, the work of crafting good policy
will be in the committee's hands. I will try to be a resource as you wrangle with the different
aspects of this problem, but, as you can probably guess, there are people currently in the room far
more qualified than me to answer questions. I encourage you to focus today on the people who
have traveled great distances and save questions for your colleagues until the work session. We
will all have the opportunity to engage with each other and debate the fine points, but today is a
day for public testimony. That said, if you have any pressing questions, I would be happy to try
to answer them.
Thank you for your consideration of LD 798 and for allowing me the time to present it.
District 123: Orono (pait)
EXHIBIT 2
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R.A. 12
<1
g
,
HOUSE
OF REPRESENTATIVES
2 STATE HOUSE STATION
AUGUSTA, MAINE 04333-0002
(207) 287-1400
Genevieve McDonald
TTY: (207) 2874469
129 North Main Street
Stonington, ME
04681
Phone: (207) 266-51 13
Genevieve.McDonald@legislal11re.maine gov
Testimony of Representative Genevieve McDonald
Before the Joint Standing Committee on Education and Cultural Affairs
Cosponsor in FAVOR
of L.D. 798
An
Act To
Protect Maine Children and Students from Preventable Diseases by Repealing Certain
Exemptions from the Laws Governing Immunization Requirements
Senator Millett, Representative Korneld, and Distinguished Members of
the Joint Standing Committee on
Education and Cultural Affairs, I am
Representative Genevieve McDonald of Maine House
District 134 and
I am
testifying before you today as a cosponsor in favor of L.D. 798, An
Act To
Protect Maine Children and Students
from Preventable Diseases by Repealing Certain Exemptions from the Laws Governing Immunization
Requirements.
Immunizations are safe. Immunizations are effective. Immunizations protect public health and prevent the
reintroduction of
infectious diseases into our schools and communities. Immunizations protect our most
vulnerable
citizens my
children are part of
the vulnerable population that depends on herd immunity. Vulnerable populations
should be able to depend on safe schools and safe communities.
Maine has the seventh-highest non-medical exemption rate in the nation. To
put this in perspective, as of March 12,
2019, Clark County, Washington has conrmed
71 cases of
measles. Of
those infected, in 62 cases the patient was
unvaccinated, and in seven cases vaccination status could not be conrmed. In 2018, the average philosophical and
religious exemption rate for kindergarten aged students in Clark County, WA
was 6.7 percent. The average
philosophical and
religious exemption rate for kindergarten-aged students in Hancock County, ME
was 8.7 percent.
Please nd
the attached data from both the Maine CDC
and Washington State Department of
Health. Included are
the immunization exemption rates for individual schools in Hancock County. There are schools experiencing non-
medical exemption rates as high as 33.3 percent. This is unacceptable.
District 134 Cranbeny
Isles, Deer
Isle, Frenchboro, Isle au Haut, North Haven, Southwest Harbor, Stonington, Swans
Island, Tremont and Vinalhaven, plus the unorganized territory of Marshall Island Township
y
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1
21
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it
1
1
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EXHIBIT 3
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R.A. 13
The World Health Organization made
headlines this year for declaring vaccine hesitancy a threat to global health.
With exemption rates this high in Maine, its not a question of
will an outbreak occur, its a question of
when. And
it
is already happening. Maine has the highest rate of
pertussis in the nation, a vaccine-preventable infectious disease
that can be fatal to infants and newborns. This morning
I received an email from a constituent urging me
to support
this legislation. Her son contracted pertussis and has been ghting the illness for ve weeks. She
is a Family Nurse
Practitioner with both personal and professional experience witnessing the impacts of
vaccine hesitancy.
In 2000, the federal government declared measles eliminated in the United States - in 2018 there were 349 cases. As
of March
7, 2019, there are already 228 conrmed
cases, one of which
is in New
Hampshire. Maine
is vulnerable,
not only to measles, but to the reintroduction of
a number of
preventable infectious diseases. Rubella and polio have
also been declared eliminated in the US but for how
long? Oregon
just confirmed
its rst case of
pediatric tetanus
in 30 years, and
that six-year-old little boy suffered greatly.
This proposed legislation isnt forcing anything except a choice, a choice that parents who
choose not to vaccinate
already make. The choice is still theirs, only now
they will have to face the consequences of
their choices along with
the rest of
us. When someone chooses not to vaccinate, it does not impact only their child. I spent three weeks
at
home
last year after an outbreak of
varicella at my
childrens daycare. That was not my
choice. Why
would we
choose to allow a segment of
the population to reintroduce preventable infectious diseases into our schools and
communities?
I support this legislation as a means of
protecting public health and keeping our most
vulnerable
citizens safe. If someones philosophy does not align with
that, they are welcome
to choose an
alternative education
for their child.
When SB
277, the legislation that eliminated philosophical and religious exemptions in California schools went
into
effect, immunization rates increased. I have spoken with parents who
are willing to comply should this legislation
move
forward but are concerned about
their children being able to either remain in or to start school. I encourage the
Committee and the Department of
Education to develop a reasonable time frame for compliance.
I urge you
to please support LD
798. Thank you
for your consideration.
District I34 Cranberry
Isles, Deer
Isle, Frenchboro, Isle au Haut, North Haven, Southwest Harbor, Stonington, Swans
Island, Tremont and Vinalliaven, plus the unorganized territory of
Marshall Island
EXHIBIT 3
Township
Case 1:21-cv-00242-JDL Document 48-3 Filed 09/15/21 Page 2 of 6 PageID #: 290
R.A. 14
Kindergarten Exemption Rates
School Year 2017
- 2018
Maine public and private schools allow for
three types of vaccine exemptions:
medical, religious and philosophical.
A
physician's note
is required for all
medical exemptions.
A parent/guardian note
is required for all
religious or philosophical exemptions.
Data gathered from the 2017-18 Maine
School Immunization Survey.
Exemption Rates
Z]
below 3%
3.1%-4.6%
4.6%
- 5.5%
2
6.6% -6.5%
2
above 6.6%
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infectious diseases and some
cancers. The Maine Immunization Program reviews
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Immunizations remain the single most
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Case 1:21-cv-00242-JDL Document 48-3 Filed 09/15/21 Page 3 of 6 PageID #: 291
R.A. 15
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EXHIBIT 3
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R.A. 16
EXHIBIT 3
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R.A. 17
EXHIBIT 3
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R.A. 18
Governor
ii
Jeanne M. Lambrew, Ph.D.
Commissioner
Janet T_ Milk
Maine Department of Health and Human
Services
Maine Center for Disease Control and Prevention
K,
ll State House Station
A
286 Water
Street
'5? \-=-/
Augusta, Maine 04333-0011
Tel; (207) 287-8016; Fax (207) 287-9058
TTY:
Dial 711 (Maine Relay)
-
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.2
4.
"g
:'»i -
1.,
Testimony of Nancy
Beardsley
Acting Director of the Maine Center for Disease Control and Prevention
Department of Health and Human
Services
Before the Joint Standing Committee on Education and Cultural Affairs
LD
798 An
Act
to Protect Maine Children and Students from Preventable Diseases by
Repealing Certain Exemptions from
the Laws Governing Immunization Requirements
Hearing Date: March 13, 2019
Good
Afternoon Senator Millett, Representative Korneld, and Members of
the Joint Standing
Committee on Education and Cultural Affairs. I am
Nancy
Beardsley and
I am
serving as Acting
Director for the Maine Center for Disease Control and Prevention which
is tasked with providing
essential public health services that preserve, promote, and protect the health and safety of Maine
people.
The Maine CDC
supports LD
798 because
it will keep our children healthy and safe from
unnecessary disease, ensure safe schools and child care centers, and protect vulnerable people
against serious diseases.
Currently, nursery school licensees, administrators, or other staff members are allowed religious
or philosophical exemptions for immunizations. This bill removes these exemptions.
This
bill also directs the Departments of
Education and Health and Human
Services to amend
their rules to remove any exemptions from immunization requirements because of
their religious
or philosophical beliefs. This includes students in elementary, secondary and postsecondary
schools and employees in health care facilities.
The Department of Health and Human
Services (DHHS)
supports these changes.
Protecting individuals and communities from communicable diseases such as measles, mumps
and
pertussis, is a fundamental purpose of Maine CDCs
disease prevention mission.
According
to Vaccination Coverage
for Selected Vaccines, Exemption
Rates, and
Provisional
Enrollment Among
Children in Kindergarten
United
States, 20]
7-18 School Year, Maine
ranks 7th in the nation for the highest non-medical exemption
rates among
school age children.
This survey represents 12,527 students resulting in a 5.3%
overall exemption
rate.
Medical exemptions for Maine
students account for 0.3% While nationally, medical exemptions
are 0.2%. Non-medical exemptions, which include religious and philosophical reasons, were
reported at 5.0%
for Maine, compared
to the national rate of
2.0%. Most of Maines school age
exemptions are non-medical, with the highest rates of
non-medical exemptions being reported in
Page 1 of 2
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EXHIBIT 4
t
Case 1:21-cv-00242-JDL Document 48-4 Filed 09/15/21 Page 1 of 2 PageID #: 295
R.A. 19
Hancock and Waldo
counties. Hancock and Waldo counties also represent two of
the four
counties with the highest reported rates of
pertussis cases in 2018, 56.7 and 158.3 per 100,000
respectively. Not only did high exemption rates likely contribute to higher rates of
pertussis
disease in these two counties, but also in the entire State, as Maine reported the highest rate of
pertussis disease in the country for 2018.
When
someone chooses not to vaccinate, that decision can jeopardize the health and safety of
entire communities, especially the weakest and most vulnerable among
us. Those who
are unable
to be vaccinated, such as young
infants, pregnant mothers or children with cancer, face the most
risk from disease complications.
Thirty-three states do not allow any personal belief exemptions. Maine
is an outlier in this
regard. Evidence shows
that states that have
tighter exemption laws have higher immunization
rates, and less disease.
The
scientic evidence supporting immunization
is overwhelming, sound, and supported by
the
professional medical community. Vaccinations are proven to_be safe and effective. We
at the
Maine CDC
and Department of
Health and Human
Services strongly support the passage of LD
798 for all these reasons, and thank you for your time.
Page 2 of
EXHIBIT 4
2
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R.A. 20
Page 1 - 129LR0080(05)-1
STATE OF MAINE
_____
IN THE YEAR OF OUR LORD
TWO THOUSAND NINETEEN
_____
H.P. 586 - L.D. 798
An Act To Protect Maine Children and Students from Preventable Diseases
by Repealing Certain Exemptions from the Laws Governing Immunization
Requirements
Be it enacted by the People of the State of Maine as follows:
Sec. 1. 20-A MRSA §6355, sub-§2, as amended by PL 2001, c. 326, §2, is
further amended to read:
2.
Medical exemption. The parent or the child provides a physician's written
statement from a licensed physician, nurse practitioner or physician assistant that, in the
licensed physician's, nurse practitioner's or physician assistant's professional judgment,
immunization against one or more of the diseases may be medically inadvisable.
Sec. 2. 20-A MRSA §6355, sub-§3, as amended by PL 2001, c. 326, §2, is
repealed.
Sec. 3. 20-A MRSA §6355, sub-§4 is enacted to read:
4. Student covered by individualized education plan. A student covered by an
individualized education plan on September 1, 2021 who elected a philosophical or
religious exemption from immunization requirements on or before September 1, 2021
pursuant to the law in effect prior to that date may continue to attend school under that
student's existing exemption as long as:
A.
The parent or guardian of the student provides a statement from a licensed
physician, nurse practitioner or physician assistant that the physician, nurse
practitioner or physician assistant has consulted with that parent or guardian and has
made that parent or guardian aware of the risks and benefits associated with the
choice to immunize; or
B. If the student is 18 years of age or older, the student provides a statement from a
licensed physician, nurse practitioner or physician assistant that the physician, nurse
practitioner or physician assistant has consulted with that student and has made that
student aware of the risks and benefits associated with the choice to immunize.
APPROVED
MAY 24, 2019
BY GOVERNOR
CHAPTER
154
PUBLIC LAW
EXHIBIT 27
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R.A. 21
Page 2 - 129LR0080(05)-1
Sec. 4. 20-A MRSA §6358, as amended by PL 2001, c. 326, §3 and PL 2003, c.
689, Pt. B, §6, is further amended to read:
§6358. Rules; requirements; reports
1. Rules authorized. The commissioner and the Director of the Bureau of Health,
Maine Center for Disease Control and Prevention within the Department of Health and
Human Services, shall jointly issue rules necessary for the effective implementation of
this subchapter, including, but not limited to, rules specifying those diseases for which
immunization is required and establishing school record keeping and reporting
requirements or guidelines and procedures for the exclusion of nonimmunized children
from school. The rules may not include any provision governing medical exemptions.
Rules adopted pursuant to this subchapter are routine technical rules as defined in Title 5,
chapter 375, subchapter 2-A except that rules adopted pursuant to this subchapter
specifying the diseases for which immunization is required are major substantive rules as
defined in Title 5, chapter 375, subchapter II-A 2-A.
2. Local requirements authorized. Immunization requirements more stringent than
the provisions of this subchapter may be adopted by ordinance enacted by a municipality,
by regulation of a school board or by policy of a private school's governing board.
3. Report. By January 1st of each odd-numbered year, the Director of the Maine
Center for Disease Control and Prevention within the Department of Health and Human
Services shall submit a report to the joint standing committees of the Legislature having
jurisdiction over health and human services matters and education matters concerning any
new developments in the evaluation of vaccine safety and effectiveness. The joint
standing committees of the Legislature having jurisdiction over health and human
services matters and education matters are each authorized to submit a bill during the
legislative session in which the report was submitted.
Sec. 5. 20-A MRSA §6359, sub-§3, ¶A, as amended by PL 1991, c. 146, §3, is
further amended to read:
A. The parent or the student provides a physician's written statement or a written
statement from a school health provider from a licensed physician, nurse practitioner
or physician assistant that, in the physician's, nurse practitioner's or physician
assistant's professional judgment, immunization against one or more of the diseases
may be medically inadvisable.
Sec. 6. 20-A MRSA §6359, sub-§3, ¶B, as amended by PL 2001, c. 326, §6, is
repealed.
Sec. 7. 20-A MRSA §6359, sub-§6, as amended by PL 1991, c. 146, §4, is
further amended to read:
6. Rules; requirements; reports. The Director of the Bureau of Health Maine
Center for Disease Control and Prevention within the Department of Health and Human
Services shall adopt rules necessary for the effective implementation of this subchapter,
including, but not limited to, rules establishing immunization requirements and medical
EXHIBIT 27
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R.A. 22
Page 3 - 129LR0080(05)-1
exceptions to receiving vaccines or toxoids for each disease, school record keeping and
reporting requirements or guidelines and procedures for the exclusion of nonimmunized
students from school. The rules may not include any provision governing medical
exemptions. Rules adopted pursuant to this subchapter are routine technical rules as
defined in Title 5, chapter 375, subchapter 2-A except that rules adopted pursuant to this
subchapter specifying the diseases for which immunization is required are major
substantive rules as defined in Title 5, chapter 375, subchapter 2-A.
Immunization requirements more stringent than the provisions of this subchapter may be
adopted by a school board or by policy of a private school's governing board.
Sec. 8. 22 MRSA §802, sub-§4-B, ¶A, as enacted by PL 2001, c. 185, §2, is
amended to read:
A. A medical exemption is available to an employee who provides a physician's
written statement from a licensed physician, nurse practitioner or physician assistant
that, in the physician's, nurse practitioner's or physician assistant's professional
judgment, immunization against one or more diseases may be medically inadvisable.
Sec. 9. 22 MRSA §802, sub-§4-B, ¶B, as enacted by PL 2001, c. 185, §2, is
repealed.
Sec. 10. 22 MRSA §8402, sub-§3, ¶A, as amended by PL 2001, c. 645, §10, is
further amended to read:
A. The department shall adopt rules regarding the health of staff as required to
protect the health and safety of the children. The rules must include a requirement
that every 2 years each licensee, administrator or other staff member of the nursery
school who provides care for children be declared free from communicable disease
by a licensed physician, except that this requirement may be waived for a person who
objects on the grounds of sincerely held religious or philosophical belief, nurse
practitioner or physician assistant. Rules adopted pursuant to this paragraph are
routine technical rules as defined in Title 5, chapter 375, subchapter II-A 2-A.
Sec. 11. Rules. The Department of Education and the Department of Health and
Human Services shall amend their rules to remove any rules exempting persons from
immunization requirements because of their religious or philosophical beliefs.
Rules adopted pursuant to this section are routine technical rules pursuant to the
Maine Revised Statutes, Title 20-A, section 6358, subsection 1 and section 6359,
subsection 6.
Sec. 12. Effective date. Those sections of this Act that amend the Maine Revised
Statutes, Title 22, section 802, subsection 4-B, paragraph A and Title 22, section 8402,
subsection 3, paragraph A and that repeal Title 20-A, section 6355, subsection 3 and Title
20-A, section 6359, subsection 3, paragraph B take effect September 1, 2021.
EXHIBIT 27
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R.A. 23
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R.A. 24
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R.A. 25
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R.A. 26
Proofed
4/29/02
10-144
DEARTMENT OF HUMAN SERVICES
BUREAU OF HEALTH
Chapter 264: IMMUNIZATION REQUIREMENTS FOR HEALTHCARE WORKERS
SUMMARY: Healthcare workers are at risk for exposure to and possible transmission of vaccine
preventable diseases due to their contact with patients, or infectious material from patients. The
health and safety of the health-care workers and the patients they care for is an essential area of
concern.
This rule is issued pursuant to the statutory authority of the Department of Human Services to
require immunization of the employees of designated health care facilities as set forth in 22
M.R.S.A.§802, as amended by P.L. 2001, Ch. 185. It prescribes the dosage for required
immunizations and defines responsibilities, exclusion periods, record keeping and reporting
requirements for officials of hospitals and healthcare facilities.
1.
Definitions
A.
"Certificate of Immunization" means a written statement from a physician, nurse
or health official who has administered an immunization agent to an employee,
specifying the vaccine administered and the date it was administered. Secondary
school or collegiate health records, having been compiled and maintained as an
official document based on certificates of immunization, which provide at a
minimum the month and year that the immunization was administered and/or
which contain copies of laboratory evidence of immunity, may also be accepted
as proof of immunization.
B.
"Chief administrative officer" means the person designated as the president, chief
executive officer, administrator, director or otherwise the senior official of a
designated health facility.
C.
"Declination" means a formal process where an individual makes an informed
choice declining Hepatitis B vaccination, following standards and procedures
established by the federal Occupational Safety and Health Administration
(OSHA) regulations (29 CFR 1910.1030(f)(2)(iv) (effective July 6, 1992).
D.
"Designated Healthcare Facility" means a licensed nursing facility, residential
care facility, Intermediate Care Facility for the Mentally Retarded (ICF/MR),
multi-level health care facility, hospital, or home health agency.
EXHIBIT 1
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R.A. 27
10-144 Chapter 264 page 2
E.
"Disease" means the following conditions which may be preventable by
immunization agent:
(1)
Rubeola (measles)
(2)
Rubella (German measles)
(3)
Hepatitis B
(4)
Influenza
(5)
Mumps
(6)
Varicella (chickenpox).
F.
"Employee" means a person who performs a service for wages or other
remuneration for a designated health facility.
G.
"Exemption" means a formal procedure to procure discharge from requirement to
vaccinate.
H.
"Immunization agent" means a vaccine, antitoxin, or other substances used to
increase an individual's immunity to disease.
I.
"Public Health Official" means a local health officer, the Director of the Maine
Bureau of Health, or a designated employee or agent of the Maine Department of
Human Services.
2.
Immunizations Required
A.
Except as otherwise provided by law, each Designated Healthcare Facility in the
State of Maine shall require for all employees proof of immunization or
documented immunity against:
(1)
Rubeola (measles)
(2)
Mumps
(3)
Rubella (German measles)
(4)
Varicella (chicken pox)
(5)
Hepatitis B
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B.
In accordance with 29 CFR 1910.1030(f)(1)(i) (effective July 6, 1992) of the
Occupational Safety and Health Administration (OSHA) regulations, Designated
Healthcare Facilities shall make available the Hepatitis B vaccine to all health
care workers with a risk of occupational exposure, at no cost to the employee.
C.
All Designated Healthcare Facilities shall adopt a policy that recommends and
offers annual immunizations against influenza to all personnel who provide direct
care to residents of the facility.
D.
No chief administrative officer may permit any employee to be in attendance at
work without a certificate of immunization for each disease or other acceptable
evidence of immunity to each disease, or documentation of exemption or
declination.
3.
Exceptions and Declinations
An employee who does not meet the immunization/immunity requirement may be
permitted to attend work under the following conditions:
A.
The employee presents to the designated healthcare facility a physician's written
statement that immunization against one or more of these diseases is medically
inadvisable. If the statement does not include all diseases, the employee must
meet the immunization/immunity requirements for any diseases not covered by
the statement.
B.
The employee states in writing an opposition to immunization because of a
sincere religious belief or for philosophical reasons.
C.
Declination for Hepatitis B pursuant to OSHA Regulations: An exemption is
available to an employee who declines Hepatitis B vaccination in accordance with
the applicable regulations established by the Occupational Safety and Health
Administration.
4.
Certification of Immunization and Proof of Immunity
A.
Certificate of Immunization
To demonstrate proper immunization against each disease, an employee shall
present the designated healthcare facility with a Certificate of Immunization from
a physician, nurse or health official who has administered the immunizing
agent(s) to the employee. Physicians within their own practice may authorize their
own employees to issue a certificate of immunization on behalf of the physician.
The certificate shall specify the immunizing agent, and the date(s), including
month and year, on which it was administered. Physicians, having reviewed
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official patient records created by another practitioner which indicate that a
particular patient has received an immunization on a specified date, demonstrating
at a minimum the month and year the immunization was given, may certify that
the immunization was given. Adequately prepared secondary and/or collegiate
school health records will also be considered acceptable for the purpose of
meeting this requirement.
B.
Proof of Immunity
To demonstrate that an employee is immune to any of the diseases, the employee
shall present the hospital/facility with laboratory evidence demonstrating
immunity, or other acceptable evidence of immunity. (See 7-B Individual Health
Records.)
5.
Immunization Dosage
A.
The following schedule contains the minimally required number of doses for the
immunizing agents addressed under these rules:
(1)
Rubeola (Measles): Two (2) doses of live measles vaccine given after the
first birthday, with a minimum of four weeks separating the 2 doses.
(2)
Mumps: One (1) dose of live mumps vaccine given after the first birthday.
(3)
Rubella (German Measles): One (1) dose of live rubella vaccine given
after the first birthday.
(4)
Varicella (Chickenpox): Two (2) doses of live varicella vaccine given
after the first birthday, with a minimum of four weeks separating the 2
doses.
(5)
Hepatitis B: Three (3) doses of hepatitis B vaccine, the first two given one
month apart and the third given five months after the second.
(6)
Influenza: Annual dose of inactivated influenza vaccine.
B.
Any such immunizing agent must meet the standards for biological products
which are approved by the United States Public Health Service.
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6.
Exclusions from the Workplace
A.
Exclusion by order of Public Health Official
An employee not immunized or otherwise immune from a disease shall be
excluded from the worksite, when in the opinion of a public health official, the
employee's continued presence at work poses a clear danger to the health of
others. The documented occurrence of a single case of rubeola (measles), mumps,
rubella (German measles) or varicella (chickenpox) in a designated healthcare
facility or amongst its employees may be interpreted as a clear danger to the
health of others.
The chief administrative officer shall exclude the employee during the period of
danger or for one incubation period following immunization of the employee,
when one or more cases of disease are present.
B.
The following periods are defined as the "period of danger":
(1)
Measles: 15 days from the onset of symptoms from the last identified case
(2)
Mumps: 18 days from the onset of symptoms from the last identified case
(3)
Rubella: 23 days from the onset of symptoms from the last identified case
(4)
Varicella: 16 days from the onset of symptoms from the last identified
case
C.
Except as otherwise provided for by law, contract or collective bargaining
Agreement, an employer will not be responsible for maintaining an employee in
pay status as a result of this rule.
D.
When a public health official determines there are reasonable grounds to believe a
public health threat exists, an exempted employee may be immunized or tested for
serologic evidence of immunity. Employees without serologic evidence of
immunity and those who become immunized against the disease in question at the
time of a documented case or cases of disease must be excluded from the work
site during one incubation period.
7.
Records and Record Keeping
A.
Designated Record Keeping
The chief administrative officer in each designated healthcare facility shall be
responsible for the maintenance of employee immunization records. The chief
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administrative officer may designate a person to be responsible for record
keeping.
B.
Individual Health Records
Each designated healthcare facility shall adopt a uniform, permanent health record
for maintaining information regarding the health status of each employee. The
immunization status of each employee with regard to each disease shall be noted
on the employee's health record. The health record of each employee shall include
at a minimum the month and year that each immunizing agent was administered.
Where an exception has been granted for medical or religious reason, the written
request for exemption must be on file with the employee health record. Where
laboratory or other acceptable evidence of immunity has been submitted, a copy
of the documentation must also be on file.
C.
List of Non-Immunized Employees
The chief administrative officer or his/her designee in each designated healthcare
facility shall keep a listing of the names of all employees within the facility who
are not currently immunized or do not have documented serological immunity
against each disease. This list shall include the names of all employees with
authorized exemptions from immunization as well as any who are otherwise not
known to be immune and shall state the reason that the employee is not immune.
The purpose of the list is to provide an efficient means to rapidly contact non-
immunized employees in the event of disease outbreaks and exclude them from
the workplace as necessary.
D.
Required Reports
The chief administrative officer of each designated healthcare facility is
responsible for submitting a summary report on the immunization status of all
employees by December 15 of each calendar year, on a form prescribed by the
Department, to the Director of the Bureau of Health of the Department of Human
Services. The summary report will include the following information at a
minimum: Specific information identifying the facility; the chief administrative
officer; the total number of employees; the number of employees born on or after
January 1, 1957; and the number of employees identified by vaccine type as either
immunized, serological proof of immunity, exempt, having declined hepatitis B
vaccine, or out of compliance. The summary report may be constructed so as to
reflect meaningful data by groupings within the facility (e.g., pediatric unit). Each
report shall be signed by the hospital/facility's chief administrative officer as a
certification that the information is accurate.
The Bureau of Health will, from time to time, select a sample of employee health
records for the purpose of comparing reported results against the criteria
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delineated in these rules. The results of this sample survey will be shared with
chief administrative officer of the designated healthcare facility for the purpose of
identifying problem areas that may be occurring in the maintenance of their
employee health records. Any published or unpublished reports of such sampling
of employee health records shall not identify individual employees and/or
designated healthcare facilities, directly or indirectly.
8.
Effective Date
Designated healthcare facilities under this section shall be allowed up to one year from
the effective date of this rule to ensure that all employees are in compliance with the
requirements herein.
STATUTORY AUTHORITY: 22 M.R.S.A.§802
EFFECTIVE DATE:
April 16, 2002
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UNITED STATES DISTRICT COURT
FOR THEDISTRICT OF MAINE
JANE DOES 1-6, et al.,
Plaintiffs,
v.
JANET T. MILLS, in her official capacity as
the Governor of the State of Maine, et al.,
Defendants.
Civil Action No. 1:21-cv-00242-JDL
DECLARATION OF NIRAV DINESH SHAH, M.D., J.D.
I, Nirav Dinesh Shah, hereby declare as follows:
1.
My name is Nirav Dinesh Shah. I am the Director of the Maine Center for Disease Control
and Prevention (“Maine CDC”), a bureau within the Maine Department of Health and
Human Services (Department).
2.
I hold a medical degree (MD) and a law degree (JD), both from The University of Chicago.
3.
I previously served as the Director of the Illinois Department of Public Health from January
2015-February 2019.
4.
I have served as Director of the Maine CDC since June 2019.
5.
My professional experience includes having worked on the public health response to large,
multi-country outbreaks.
6.
I previously worked for the National Institute for Public Health of the Ministry of Health
for the country of Cambodia. There, I was part of a large team that managed the country
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of Cambodia’s response to the outbreak of Severe Acute Respiratory Syndrome (SARS) in
2002.
7.
I have also been part of epidemiological investigation teams that have responded to
outbreaks of dengue fever, falciparum-resistant malaria, multi-drug-resistant tuberculosis,
and HIV, among others.
8.
During my time as Director of the Illinois Department of Public Health, I led the State of
Illinois’s response to large international outbreaks such as Zika virus, among others. I have
also taught classes in mathematical epidemiology and public health at The University of
Chicago Pritzker School of Medicine.
9.
As the Director of the Maine CDC, I have been responsible for coordinating the public
health aspects of the State of Maine’s response to the COVID-19 pandemic. On a daily
basis, I review emerging data and research from the Maine CDC, the United State Centers
for Disease Control and Prevention (USCDC), the United States Food and Drug
Administration (FDA), the World Health Organization (WHO), and academic researchers
around the world, among other sources.
10.
The information in this declaration is based upon my personal knowledge, scientific
expertise, and information that is required to be reported to the Maine CDC.
11.
The 2019 Novel Coronavirus (COVID-19) is a respiratory illness caused by a coronavirus,
known as SARS-CoV-2. COVID-19 was first identified in December 2019 in Wuhan City,
China, and has since spread around the world.
12.
On January 31, 2020, the United States Department of Health and Human Services
determined that as of January 27, 2020, the COVID-19 virus constituted a nationwide
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public health emergency. On March 11, 2020, the World Health Organization declared the
COVID-19 virus to be a global pandemic.
13.
As of September 12, 2021, there have been approximately 219 million cases of COVID-
19 worldwide, including approximately 41 million in the United States alone. There have
been approximately 4.55 million deaths from COVID-19 worldwide; approximately
660,000 of those deaths were in the United States.
14.
As of 12:00 p.m. on September 14, 2021, there have been 81,177 total cases of COVID-19
in Maine, including 969 deaths from COVID-19.
15.
As of September 14, 2021, based on daily reporting to CDC’s Public Health Emergency
Preparedness (PHEP) team, there are 192 people hospitalized with COVID-19 in Maine.
Of those, 66 are in an intensive care unit, and 39 are on a ventilator. Of the 332 ICU beds
available in the state, 61 are available.
16.
As of September 9, 2021, 67% of individuals hospitalized with COIVD-19 in Maine were
not fully vaccinated. That number has fluctuated and was, at one time, as high as 94%. At
certain times in some hospitals in Maine, 100% of all patients in the ICU were not fully
vaccinated.
17.
COVID-19 spreads when an infected person exhales droplets and/or very small aerosol
particles that contain the virus. These droplets and/or aerosols can be inhaled by other
people or land on their eyes, noses, or mouth. People who are closer than 6 feet from the
infected person for more than 15 cumulative minutes are most likely to get infected.
COVID-19 is spread in three main ways:
a.
Breathing in air when close to an infected person who is exhaling small droplets
and particles that contain the virus.
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b.
Having these small droplets and particles that contain virus land on the eyes, nose,
or mouth, especially through splashes and sprays like a cough or sneeze.
c.
Touching eyes, nose, or mouth with hands that have the virus on them.
18.
The COVID-19 virus variants that circulated at the beginning of the pandemic had an
incubation period of up to 14 days. A person could be infected and spread the virus during
that entire time period, sometimes without experiencing any symptoms during that time.
19.
This phenomenon, known as “asymptomatic transmission,” makes control of COVID-19
especially challenging because individuals can transmit the disease before knowing they
may have it. An analysis by the USCDC concluded that approximately 40% of all COVID-
19 transmission of the early variants could occur while individuals were asymptomatic and
approximately 35% of all COVID-19 patients did not have symptoms at all.
20.
Given the length of the pandemic, several variants of SARS-CoV-2 have emerged over
time.
21.
All variants of the COVID-19 virus spread easily between people at a rate faster than
influenza spreads.
22.
An even more contagious variant of the novel coronavirus, known as the Delta variant,
emerged in 2021. According to the USCDC, the Delta variant is more than twice as
contagious as previous variants and may cause more severe illness than previous variants
in unvaccinated people.
23.
According to recent nationwide data published by the USCDC, unvaccinated individuals
are at least 10 times more likely to be hospitalized with COVID-19 than those who have
been vaccinated. The same data showed that unvaccinated individuals are 11 times more
likely to die of the virus as compared with vaccinated individuals.
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24.
The higher contagiousness and potentially greater severity occur because individuals
infected with the Delta variant exhibit a much higher viral load. This higher viral load
makes the virus far more contagious and allows it to spread and multiply in a shorter time
period.
25.
It is possible for an individual infected with the Delta variant to begin spreading it to others
within 24 to 36 hours of exposure.
26.
The Delta variant also exhibits asymptomatic transmission.
27.
Population-level immunity, colloquially referred to as “herd immunity,” is an
epidemiological phenomenon whereby even unvaccinated individuals are protected against
an infectious disease by virtue of being in an environment with sufficiently high
vaccination levels. When population-level immunity is achieved, an individual who is not
able to be vaccinated can enjoy the benefits of being vaccinated because others around
them are vaccinated and can block the virus from spreading from person to person.
28.
The level of vaccination required to achieve population-level immunity varies with the
contagiousness of the infectious disease at issue. The higher the contagiousness, the higher
the vaccination rate required to achieve population-level immunity.
29.
In light of the Delta variant, epidemiological models suggest that at least 90% of a
population would need to be vaccinated against COVID-19 in order to achieve population-
level immunity. Under models formulated based on earlier COVID-19 variants, only
around 70% of the population would have needed to be vaccinated to achieve population-
level immunity.
30.
The treatment of patients with COVID-19 remains a clinical challenge. Though there are
some medical treatments available to physicians, treatment of COVID-19 infection
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consists primarily of supportive care, including supplemental oxygen and ventilator
support when needed.
31.
One drug efficacious in the treatment of COVID-19, remdesivir, received full FDA
approval on October 22, 2020. It is unclear whether or to what extent remdesivir can reduce
mortality in a statistically significant manner. It reduces the length of hospitalization for
severely ill patients by approximately 4 days. Remdesivir does not prevent COVID-19.
32.
Another category of pharmaceutical treatments, monoclonal antibodies, can reduce the
likelihood that a patient infected with COVID-19 will require hospitalization. As with
remdesivir, it is unclear whether or to what extent monoclonal antibodies may reduce
mortality associated with COVID-19. In addition, administration of monoclonal antibodies
is a challenge, requiring either a multi-hour infusion or multiple injections.
33.
There are also therapies like the drug dexamethasone, mainly used for patients who are
hospitalized. While this drug does not treat the underlying virus itself, it can reduce lung
inflammation that is thought to be caused by the SARS-CoV-2 virus.
34.
The gold standard to prevent and stop the spread of communicable diseases, including
COVID-19, is vaccination. The elimination of communicable diseases through vaccination
is one of the greatest achievements of public health in the 20th century.
35.
Today, most people receive vaccinations against measles, mumps, rubella, and varicella
(chicken pox) in childhood. Childhood vaccinations ensure long-term population-level
immunity from communicable diseases. For instance, the following population-level
vaccination rates are necessary to protect against each of the following diseases:
a.
Measles: 95%
b.
Mumps: 92%
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c.
Chickenpox: 90%
d.
Rubella: 85%
36.
Keeping the number of unvaccinated individuals in school settings as low as possible is
necessary to achieve these population-level immunity thresholds and prevent outbreaks of
these infectious diseases in school settings and in the general population.
37.
The same is true for healthcare settings. The rationale for requiring immunization in
healthcare settings is the same as that against vaccine-preventable childhood diseases: high
vaccination rates prevent the spread of disease through the population and amongst
vulnerable population, namely children and patients. Just as there is close contact amongst
children in a classroom, healthcare settings require close contact between health care
professionals and patients.
38.
When vaccination rates fall below the population-level immunity rates above, the health
and safety of both vaccinated and unvaccinated individuals is at risk, especially the most
vulnerable. In particular, the health of individuals with weakened immune systems, infants
too young to be vaccinated, and persons unable to be vaccinated are put in jeopardy.
39.
In general, there are also situations when certain vaccinations may not be advisable, such
as women during pregnancy, individuals undergoing treatment for serious diseases, and
individuals who have a demonstrated allergy to one of the vaccine components. In these
circumstances, vaccination could have adverse health consequences for the patient.
40.
There are three COVID-19 vaccines that are generally available to the public.
a.
On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA)
for the use of the Pfizer-BioNTech COVID-19 Vaccine (“Pfizer vaccine”). The
Pfizer vaccine EUA authorized the administration of two doses of the Pfizer
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vaccine, spaced three weeks apart. On August 23, 2021, the FDA gave full
approval to the Pfizer vaccine.
b.
On December 18, 2020, the FDA issued an EUA for the use of the Moderna
COVID-19 Vaccine (“Moderna vaccine”). The Moderna vaccine EUA authorized
the administration of two doses of the Moderna vaccine, spaced four weeks apart.
c.
On February 27, 2021 the FDA issued an EUA for the use of the Janssen COVID-
19 Vaccine (“J&J vaccine”). The J&J vaccine EUA authorized administration of a
single dose of the J&J vaccine.
d.
None of these vaccines is authorized or approved for administration to children
under the age of 12.
41.
After receiving the final dose of one the three COVID-19 vaccines, an individual is
considered “fully vaccinated” two weeks later, when the vaccine has had time to take effect.
42.
The Pfizer vaccine prevented 95% of individuals in clinical trials from becoming infected
with COVID-19. The Moderna vaccine prevented infection in 94.1% of cases. The
Johnson & Johnson vaccine prevented 66.1% of infections globally; in the United States,
it was 72% effective against infection and 86% effective in preventing severe disease.
43.
Even in the face of the more-contagious Delta variant, the three available COVID-19
vaccines remain effective, particularly with respect to conferring protection against
hospitalization and death.
44.
The first vaccine doses in Maine were administered on December 14, 2020.
45.
In Maine, as of September 9, 20201, 5,723 self-identified health care workers have
contracted COVID-19. Of those, at least 1,900 (or more than one third) have occurred
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since January 18, 2021. The January 18, 2021, date is important because that is the first
date that any person could be considered fully vaccinated against COVID-19.
46.
As of September 3, 2021, of the thirty-three COVID-19 outbreaks under investigation by
Maine CDC, nineteen were occurring in health care facilities that would be covered by the
recent Emergency Rule.
47.
On August 11, 2021, of the fourteen open COVID-19 outbreaks under investigation by
Maine CDC, four were occurring in health care facilities that would have been covered by
the recent Emergency Rule, had it been in effect. These outbreaks were occurring in
facilities such as long-term care facilities and hospitals. The hospitals where these
outbreaks were occurring have strong infection control programs.
48.
Most health care facility outbreaks are the result of health care workers who bring COVID-
19 into the facility.
49.
The Delta variant was first identified in Maine via genomic sequencing May 11, 2021.
50.
As of August 27, 2021, the Delta variant accounted for 96.7% of all positive COVID-19
samples sequenced in Maine. According to the USCDC’s variant tracker, the Delta variant
is now the predominant variant within the United States.
51.
In Maine, since September 1, 2021, the rate of infection in the population of individuals
aged 12 and older is 8 times higher among the unvaccinated.
52.
In Maine, the rate of COVID-19 hospitalization in the 12 and older population is 7.1 times
higher among the unvaccinated, as compared with those who are fully vaccinated. The
USCDC reported on July 25, 2021, that COVID-19 infection and hospitalization rates
among unvaccinated individuals were 4.9 and 29.2 times, respectively, those in fully
vaccinated individuals.
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53.
For the monthly reporting period ending July 31, 2021, the rate of COVID-19 vaccines
among healthcare workers was as follows:
a.
Ambulatory Surgical Centers: 85.9%
b.
Assisted Housing Facilities: 74.7%
c.
Hospitals: 80.3%
d.
Intermediate Care Facilities for Individuals with Intellectual Disabilities: 68.2%
e.
Nursing Homes: 73.0%
54.
All facilities fell significantly below the minimum 90% threshold needed to reduce the
likelihood of facility-based outbreaks.
55.
In light of all of the above, Maine CDC determined that requiring COVID-19 vaccinations
for healthcare workers in certain high-risk settings was necessary to protect public health,
healthcare workers, and Maine’s health care system from the further spread of COVID-19.
Accordingly, the Department and Maine CDC issued an emergency rule (Emergency CDC
Rule) that required Designated Health Care Facilities, Dental Health Practices, and
Emergency Services Organizations to ensure their employees were vaccinated against
COVID-19. Maine CDC determined that these types of facilities and settings posed a
higher risk for transmission of COVID-19 because of the patient populations served and
type of care provided.
56.
There are at least four public health reasons for the issuance of the Emergency CDC Rule:
a.
Protection of individual patients. Many patients receiving care in the settings
covered by the Emergency CDC Rule are particularly vulnerable to developing
serious illness as a result of COVID-19, including the elderly and those with
underlying health problems.
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b.
Protection of individual workers. Workers in these high-risk healthcare settings
are likely to interact with many patients in any given day, increasing the risk that
they will be exposed to an individual with COVID-19. Because employees interact
with not just their patients, but each other, they are also at risk of transmitting
disease amongst themselves.
c.
Protection of the State’s healthcare infrastructure, including the workforce.
In some areas of Maine, an outbreak among healthcare workers requiring them to
quarantine, or to be absent for a longer period as a result of illness caused by
COVID-19, could cripple the facility’s ability to provide care. Combined with
increasing infection rates in the community, this could lead to an insufficient
workforce to respond to the state’s healthcare needs. Even before the onset of
COVID-19, Maine’s healthcare system was fragile due to understaffing. An
outbreak of COVID-19 amongst ICU nurses in a rural hospital could incapacitate
the hospital’s entire ability to care for seriously ill patients.
d.
Reducing the likelihood of facility outbreaks. As noted above, most COVID-19
outbreaks in facilities are caused by an infected healthcare worker bringing the
virus into the facility. Reducing the number of unvaccinated health care workers
statewide lowers the likelihood of health care facility outbreaks. Limiting the
number of outbreaks in high-risk facilities is essential to slowing the spread of
COVID-19 across the state.
57.
In addition to the general reasons stated above, requiring vaccination for employees of
Dental Health Practices is particularly important given the nature of the care they provide.
A patient receiving dental services does not have the option to wear a mask or to physically
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distance; instead, they may spend an hour or more with their mouth open while in close
contact with one or more providers. Under these conditions, it is essential that every
available precaution be taken to prevent transmission of COVID-19, particularly against
the highly transmissible Delta variant.
58.
Requiring vaccination for employees of EMS organizations is essential for a number of
reasons. In many cases, their patients do not have the option of controlling the environment
in which they receive services. Also, their patients in many cases are in acute distress,
increasing the likelihood that they will be unmasked when EMS personnel treat them. The
provision of the emergency services they provide most often cannot be provided while
maintaining the recommended distance; it is likely to require direct physical contact. EMS
workers may spend extended periods of time riding in ambulances, putting them in close
contact with both their colleagues and patients for extended periods. Transport services
carry personnel and patients from one facility to another, and EMS clinicians may interact
with staff at multiple nursing homes, long-term care facilities, and/or hospitals on any given
day. For these reasons, taking every measure to reduce the likelihood of transmission of
COVID-19, and the Delta variant in particular, is essential to protecting public health.
59.
In reaching the decision to adopt this Emergency Rule, Maine CDC considered whether
there were other, less restrictive measures that might be appropriate. Ultimately, we
concluded that there were none.
60.
Prior to the widespread availability of testing, symptom monitoring for COVID-19 prior to
the start of each shift was important for infection control. Symptom monitoring remains
important, though is not the sole strategy to identify individuals who have COVID-19
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because of the large percentage of transmission that occurs while individuals are
asymptomatic.
61.
We considered the possibility of testing covered health care workers on a periodic basis.
But regular testing for the presence of the virus in employees is insufficient to protect
against the Delta variant. Given the speed with which the Delta variant is transmitted,
weekly or twice weekly testing would be ineffective to preventing transmission. This is
because the Delta variant can cause illness and spread to another person as soon as 48 hours
after exposure, rendering occasional testing ineffective. An employee who tests negative
on a Monday morning could be exposed that afternoon, and, within 36 hours, could be
spreading the virus to others over the course of the several days until the next test.
62.
Daily testing was also considered and was rejected. The most effective test utilized for the
detection of the virus that causes COVID-19 is a polymerase chain reaction (PCR) test. A
PCR test requires a minimum of 24 hours before results are available. Because test results
are not available for at least 24 hours, and sometimes up to 72 hours, daily PCR testing is
insufficient for the same reasons that occasional PCR testing is insufficient. Daily testing
likely would require the use of the less-effective rapid antigen test, which provides results
in fifteen minutes, but is more likely to provide false negative results. This means that an
individual could test negative but, in fact, truly be carrying the virus that causes COVID-
19. Moreover, the nation is currently experiencing a shortage of these rapid antigen tests,
which is not expected to be alleviated in the next two months. Daily testing simply would
not be effective at stopping the spread of COVID-19 in covered facilities, particularly in
light of the Delta variant.
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63.
There continues to be significant scientific uncertainty about whether and to what extent
individuals who have previously been infected with COVID-19 develop sufficient
immunity to prevent them from transmitting the virus. For that reason, Maine CDC did
not include a provision within our Emergency Rule providing an exemption from the
vaccination requirement for health care workers who previously had COVID-19.
64.
Although the use of personal protective equipment (PPE) is effective in reducing
transmission, it does not eliminate the possibility of spreading COVID-19, especially in
healthcare settings. As noted, 19 of the 33 COVID-19 outbreaks under investigation as of
September 3, 2021, were in health care facilities that are covered by the Emergency CDC
Rule. Sole reliance on PPE, even when fitted and worn correctly, is insufficient to entirely
stop the spread of COVID-19 in healthcare settings in Maine.
65.
Health care facilities in Maine have continued to use a mixture of these practices—
symptom monitoring, testing, PPE, etc.—throughout the pandemic to reduce the likelihood
of health care workers bringing COVID-19 into a facility and causing an outbreak. But
despite the use of these health and safety protocols, there have been numerous COVID-19
outbreaks at health care facilities in Maine during the past 18 months.
66.
Further, compared with other states, the size of Maine’s healthcare workforce is limited,
such that the impact of any outbreaks among personnel is far greater than it would be in a
state with more extensive healthcare delivery systems. Considering the unique
circumstances of the state of Maine, it is necessary to take every available precaution to
limit the spread of COVID-19 both in healthcare facilities and among their workers.
67.
The three COVID-19 vaccines remain the most effective method to prevent COVID-19
infection and protecting health care workers and the patients they serve.
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I DECLARE, PURSUANT TO 28 U.S.C. § 1746, UNDER PENALTY OF PERJURY THAT THE
FOREGOING IS TRUE AND CORRECT.
Dated: September 15, 2021
_/s/ Nirav D. Shah_____________
Nirav Dinesh Shah, M.D., J.D.
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UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
JANE DOES 1-6, JOHN DOES-1-3, JACK
DOES 1-1000, and JOAN DOES 1-1000,
Plaintiffs,
v.
JANET T. MILLS, Governor of the State of
Maine, JEANNE M. LAMBREW,
Commissioner of the Maine Department of
Health and Human Services, NIRAV D.
SHAH, Director of the Maine Center for
Disease Control, MAINEHEALTH,
GENESIS HEALTHCARE OF MAINE,
LLC, GENESIS HEALTHCARE, LLC,
NORTHERN LIGHT FOUNDATION, and
MAINEGENERAL HEALTH,
Defendants.
Civil Action No. 1:21-cv-00242-JDL
DECLARATION OF SARA GAGNÉ-HOLMES
I, Sara Gagné-Holmes, hereby declare as follows:
1.
I am Sara Gagné-Holmes, an attorney authorized to practice law in Maine since 2001. I
am currently a Deputy Commissioner of the Maine Department of Health and Human
Services (Department). The Department includes several divisions, including the Maine
Center for Disease Control and Prevention (Maine CDC). Since March of 2020, I have
been involved in many aspects of the COVID-19 response including, the creation and
implementation of social supports needed for those who must quarantine or isolate, policy
development regarding testing, vaccine accessibility, vaccine incentives, and outreach to
communities and providers.
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2.
The following declaration is based upon my personal knowledge and information and
documents that are available to me.
3.
The Maine CDC is the lead state agency guiding the State’s public health-based responses
to the ongoing COVID-19 pandemic.
4.
The primary goal of Maine CDC’s management of the COVID-19 pandemic has been to
a) prevent and stop the spread of the virus that causes COVID-19 (SARS-CoV-2) in order
to protect the people of Maine from acute sickness and death, and b) protect Maine’s health
care delivery system from being overwhelmed by an unrestrained pandemic.
5.
Prior to the availability of COVID-19 vaccinations, the United States Center for Disease
Control and Prevention (USCDC) and Maine CDC advised that the most effective way to
limit the spread of the virus was to wear face coverings and distance members of society
from one another by limiting their in-person contact.
6.
Although vaccines were not available until December of 2020, Maine began planning for
vaccine distribution in the spring of 2020. The Department and Maine CDC worked with
hospitals, health care providers, health centers, and many others to develop a plan to
facilitate distribution and administration of any COVID-19 vaccine that received
authorization or approval from the Food and Drug Administration (FDA).
7.
In April of 2020, the Department and Maine CDC began holding weekly remote (Zoom
/telephonic) information session regarding COVID-19. The 60-minute sessions were open
to the medical directors, clinicians, and staff at long term care facilities. The sessions were
held weekly until approximately May of 2021, when they went to bimonthly, and then
monthly in July of 2021. As of September, the sessions reverted back to bimonthly.
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8.
Additionally, beginning in September 2020, Maine CDC staff held weekly Vaccine
Planning Group webinars that provided clinical and administrative updates both clinicians
and health care administrators enrolled in the Maine Immunization Program on issues
related to vaccine planning, distribution, administration, and monitoring. Those sessions
were held weekly through June 2021, and were also recorded and posted to the ME CDC
website.
9.
Once vaccinations became available, the Department and Maine CDC undertook a series
of steps to acquire and distribute those vaccines to Maine Immunization Program providers
to administer to members of the public.
10.
There are three COVID-19 vaccines that have been authorized for use by the FDA:
a.
On December 11, 2020, the FDA issued an Emergency Use Authorization (EUA)
for the use of the Pfizer-BioNTech COVID-19 Vaccine (“Pfizer vaccine”). The
Pfizer vaccine EUA authorized the administration of two doses of the Pfizer
vaccine, spaced three weeks apart. On August 23, 2021, the FDA gave final
approval to the Pfizer vaccine.
b.
On December 18, 2020, the FDA issued an EUA for the use of the Moderna
COVID-19 Vaccine (“Moderna vaccine”). The Moderna vaccine EUA authorized
the administration of two doses of the Moderna vaccine, spaced four weeks apart.
c.
On February 27, 2021 the FDA issued an EUA for the use of the Janssen COVID-
19 Vaccine (“J&J vaccine”). The J&J vaccine EUA authorized administration of a
single dose of the J&J vaccine.
11.
After receiving the final dose of one the three COVID-19 vaccines, an individual is
considered “fully vaccinated” two weeks later, when the vaccine has had time to take effect.
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12.
Maine placed its first order for the COVID-19 vaccine from USCDC on December 4, 2020.
The first allocation was 12,675 doses of Pfizer, allowing 12,675 people to receive a first
dose of the Pfizer vaccine.
13.
Beginning in December of 2020, the Department and Maine CDC started holding twice
weekly telephonic information session regarding COVID-19 vaccines. The 30-minute
sessions were open to any clinician in the State and approximately 30 to 100 clinicians
attended each session. During the sessions, the Department and Maine CDC provided
information on the science of vaccines; vaccine development and approval process; the
mechanism and make up of initial vaccines; vaccine distribution planning; methods for
addressing vaccine hesitancy and patient conversations; vaccine storage, handling and
administration; and reporting and tracking adverse events. Beginning in April of 2021, the
sessions were held biweekly, and then monthly starting in July of 2021.
14.
In December of 2020, the Department and Maine CDC began convening on a monthly
basis (30 minutes) a workgroup consisting of 12 clinicians from across the state
representing different provider types, focused on getting input on the best way to offer
education to clinicians on the COVID-19 vaccine.
15.
First doses of COVID-19 vaccines were Pfizer vaccines administered on December 14,
2020. The first date that any person could be fully vaccinated was January 18, 2020.
16.
Maine CDC prioritized eligibility for the first allocation of Pfizer vaccine, as well as the
subsequent weeks’ allotments of Pfizer and Moderna, to frontline health care professionals
and patient facing staff in the interest of preserving health system capacity. This included,
but was not limited to, hospitals, long-term care facilities, outpatient clinics, physician
practices, home health care, pharmacies, emergency medical services, public health
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settings, dental practices, and school nurses and school health clinics throughout Maine.
Residents of long-term care facilities were also prioritized for eligibility in that first month.
This prioritization was consistent with guidelines issues by USCDC.
17.
Given limited vaccine supply in the first several weeks of distribution, hospitals received
doses of the Pfizer and Moderna vaccine and then administered them to their staff, as well
as other health care providers not on their staff but eligible under Maine guidelines. As
supply expanded, so did the types of health care providers receiving vaccine to provide to
eligible health care workers and long-term care residents.
18.
By December 31, 2020, 27,122 healthcare workers and long-term care residents had
received their first dose of the COVID-19 vaccine.
19.
As Maine received further allocations of vaccines, additional members of the public
became eligible for COVID-19 vaccination.
a.
The week of January 11, 2021, COVID-19 vaccines became available to
firefighters, police, law enforcement personnel, and critical COVID-19 response
personnel.
b.
On January 18, 2021, Maine residents age 70 and older became eligible to receive
a COVID-19 vaccine.
c.
On March 3, 2021, Maine residents age 60 and older became eligible to receive a
COVID-19 vaccine.
d.
On April 1, 2021, Maine residents age 50 and older became eligible to receive a
COVID-19 vaccine.
e.
On April 7, 2021, all Maine residents age 16 and older became eligible to receive a
COVID-19 vaccine.
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f.
On May 12, 2021, all Maine children ages 12 and older became eligible to receive
a COVID-19 vaccine.
20.
In order to facilitate the administration of COVID-19 vaccinations to members of the
public, the Department and Maine CDC partnered with hospital systems to stand up and
operate large throughput vaccination sites across the State. The Department and Maine
CDC formed these partnerships with MaineHealth, Northern Light, Central Maine Medical
Center, and MaineGeneral Health (collectively, “Hospital Systems”).
21.
The Department and Maine CDC provided the COVID-19 vaccines and offered the use of
its newly created call centers for scheduling of vaccinations. The State also allowed for
Maine Responds volunteers to be utilized at the sites.
22.
Maine Responds is a program is a partnership that integrates local, regional, and statewide
volunteer resources to assist our public health and healthcare systems. It is part of a
national initiative to train, coordinate, and mobilize volunteers during an emergency.
Maine Responds coordinates verified, pre-credentialed public health, healthcare and
emergency response volunteers into a single database that can coordinate the need for
volunteers across county, regional, and state lines if needed.
23.
The Hospital Systems managed and operated the large throughput vaccination sites and
provided staff to administers vaccines to members of the public. Maine Responds
volunteers filled in as necessary to assist in the operation of the sites and administration of
vaccines.
a.
MaineHealth operated large throughput vaccination sites at 2 Scarborough Downs
Rd, Scarborough and at 1364 Main St., Sanford.
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b.
Northern Light operated the large throughput vaccination site at Cross Insurance
Center, 515 Main St, Bangor.
c.
MaineGeneral operated the large throughput vaccination site at the Augusta Civic
Center, 76 Community Dr., Augusta.
d.
Central Maine Health Center operated the large throughput vaccination site at the
Auburn Mall, 550 Center St., Auburn.
24.
There were also vaccination sites at numerous designated health care facilities, EMS
organizations, and pharmacies across the State where health care workers and members of
the public could be vaccinated.
25.
On March 9, 2021, the Department began providing free transportation to COVID-19
appointments to Maine residents unable to drive or travel or otherwise without reliable
transportation.
26.
On March 25, 2021, the Maine Legislature passed L.D. 1, “An Act To Establish the
COVID-19 Patient Bill of Rights and To Amend the Governor's Emergency Powers,” on
an emergency basis. P.L. 2021, ch. 28 (effective Mar. 25, 2021). Two parts of that law
increased the number of persons in the State who could be authorized to administer
COVID-19 vaccines.
a.
Part B-2 of that law permitted licensed pharmacists in the State to administer
COVID-19 vaccines licensed or authorized under an EUA to persons 3 years or
older.
b.
Part D of that law allowed individual clinicians authorized to administer vaccines,
under designated circumstances, to delegate their authority to other qualified
persons.
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27.
On April 12, 2021, the Department and Maine CDC, in coordination with the Federal
Emergency Management Agency, began operating a mobile vaccination unit to provide
COVID-19 vaccinations to people in rural and under-served communities across Maine.
The mobile vaccination unit was in use until June 18, 2021.
28.
On May 11, 2021, the Department initiated a public-private partnership to encourage
vaccination against COVID-19. Between May 11, 2021, and May 31, 2021, any person
who got their first dose of a COVID-19 vaccine could receive a complimentary fishing
license, a complimentary hunting license, Maine Wildlife Park Pass, a $20 L.L. Bean gift
card, a ticket to a Portland Sea Dogs game, or an Oxford Plains Speedway Pass.
29.
On June 16, 2021, the State announced a sweepstakes to vaccinated Mainers. The winner
would receive $1 per every person vaccinated in Maine by the Fourth of July weekend.
30.
Maine CDC keeps records of the number of persons that have been vaccinated against
COVID-19.
a.
On January 31, 2021, 10.07% of eligible Mainers had received one dose, and 3.41%
of eligible Mainers were fully vaccinated against COVID-19.
b.
On February 28, 2021, 19.90% of eligible Mainers had received one dose, and
10.85% of eligible Mainers were fully vaccinated against COVID-19.
c.
On March 31, 2021, 37.65% of eligible Mainers had received one dose, and 24.19%
of eligible Mainers were fully vaccinated against COVID-19.
d.
On April 30, 2021, 55.02% of eligible Mainers had received one dose, and 45.39%
of eligible Mainers were fully vaccinated against COVID-19.
e.
On May 31, 2021, 61.48% of eligible Mainers had received one dose, and 60.58%
of eligible Mainers were fully vaccinated against COVID-19.
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f.
On June 30, 2021, 63.40% of eligible Mainers had received one dose, and 67.00%
of eligible Mainers were fully vaccinated against COVID-19.
g.
On July 31, 2021, 65.01% of eligible Mainers had received one dose, and 68.68%
of eligible Mainers were fully vaccinated against COVID-19.
h.
On August 31, 2021, 67.80% of eligible Mainers had received one dose, and
70.65% of eligible Mainers were fully vaccinated against COVID-19.
31.
On April 14, 2021, the Department and Maine CDC issued an amendment to chapter 264
of their rules, “Immunization Requirements for Healthcare Workers” (CDC Rule). A true
and accurate copy of that amendment is attached hereto as Exhibit 1.
32.
Maine CDC periodically conducts immunization assessments of State of Maine Healthcare
Workers. Attached hereto as Exhibit 2 is a true and accurate copy of the 2018 Healthcare
Worker Immunization Assessment Report.
a.
Maine CDC and the Department testified in favor of An Act To Protect Maine
Children and Students from Preventable Diseases by Repealing Certain
Exemptions from the Laws Governing Immunization Requirements, L.D. 798
(129th Legis. 2019).
b.
The support of Maine CDC and the Department for L.D. 798 was at least in part
influenced by the 2018 Healthcare Worker Immunization Assessment Report.
33.
In May of 2021, Maine CDC began requiring that designated health care facilities report
the rate of COVID-19 vaccination for their employees.
a.
As of May 31, 2021, the employee rate of COVID-19 vaccination at ambulatory
surgical centers, hospitals, and nursing homes was 80.6%, 73.5%, and 67.8%,
respectively.
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b.
As of June 30, 2021, the employee rate of COVID-19 vaccination at ambulatory
surgical centers, hospitals, and nursing homes was 85.7%, 78.7%, and 70.8%,
respectively.
c.
As of July 31, 2021, the employee rate of COVID-19 vaccination at ambulatory
surgical centers, hospitals, and nursing homes was 85.9%, 80.3%, and 73.0%,
respectively.
34.
On August 12, 2021, the Department and Maine CDC issued a further amendment to the
CDC Rule on an emergency basis (“Emergency CDC Rule”).
a.
A true and accurate copy of the Emergency CDC Rule is attached hereto as
Exhibit 3.
b.
A true and accurate copy of the basis statement for the Emergency CDC Rule is
attached here as Exhibit 4.
c.
The Emergency CDC Rule is only effective through November 10, 2021.
35.
On August 17, the Department and Maine CDC issued interpretive guidance on the
Emergency CDC Rule through answers to frequently asked questions (FAQs). The
Emergency CDC Rule FAQs explained the definition of employees under the rule:
“Employees are defined as ‘any person who performs any services for wages or other
remuneration for a Designated Health Care Facility, EMS Organization and Dental
Practice.’ For the purposes of this rule, DHHS interprets employee to mean those
physically present at a Designated Health Care Facility EMS Organization or Dental
Practice.”
36.
On August 27, 2021, the Department and Maine CDC updated the Emergency CDC Rule
FAQs to include the following questions and answers:
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Does this rule prohibit Designated Health Care Facilities, Dental Health
Practices, or Emergency Medical Services Organizations from making
accommodations for unvaccinated employees who object to receiving the
COVID-19 vaccine because of sincerely held religious beliefs, as may be
required by the Maine Human Rights Act and/or Title VII of the Civil
Rights Act?
This rule does not prohibit employers from providing accommodations for
employees’ sincerely held religious beliefs or practices that may otherwise
be required by law. For example, this rule does not prohibit employers from
allowing employees to work remotely or reassigning employees to positions
outside of a Designated Health Care Facility, Dental Health Practice, or
Emergency Medical Services Organization. However, if accommodations
provided by a Designated Health Care Facility, Dental Health Practice, or
Emergency Medical Services Organization are not in compliance with this
rule, then the Designated Health Care Facility, Dental Health Practice, or
Emergency Medical Services Organization may be subject to enforcement
action.
If an employee of an organization is not vaccinated and doesn’t plan on
getting the vaccine, should they be dismissed from the organization covered
by the rule on September 17 or can the employee continue to work until
October 1?
Organizations subject to this rule may make their own specific enforcement
policies within the framework of the rule.
37.
On September 2, 2021, the Department and Maine CDC announced that although the
Emergency CDC Rule was not being amended, the Department and Maine CDC would not
begin enforcing its provisions before October 29, 2021, thereby allowing more time for
entities covered by the rule to come into compliance.
38.
On September 8, 2021, the Department and Maine CDC proposed further amendment to
the CDC Rule (Proposed CDC Rule), which rule is subject to a notice and comment period.
A true and accurate copy of the Proposed CDC Rule is attached hereto as Exhibit 5.
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I DECLARE, PURSUANT TO 28 U.S.C. § 1746, UNDER PENALTY OF PERJURY THAT THE
FOREGOING IS TRUE AND CORRECT.
Dated: September 11, 2021
/s/ Sara Gagné-Holmes
__________
Sara Gagné-Holmes, Deputy Commissioner
Maine Department of Health & Human Services
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STATE OF MAINE
IMMUNIZATION REQUIREMENTS FOR HEALTHCARE WORKERS
10-144 CODE OF MAINE RULES
CHAPTER 264
Maine Department of Health and Human Services
Maine Center for Disease Control and Prevention
11 State House Station
Augusta, Maine 04333-0011
Date Amended: April 14, 2021
EXHIBIT 1
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10-144 CMR Ch. 264
2
10-144
DEPARTMENT OF HEALTH AND HUMAN SERVICES
MAINE CENTER FOR DISEASE CONTROL AND PREVENTION
Chapter 264:
IMMUNIZATION REQUIREMENTS FOR HEALTHCARE WORKERS
Purpose: This rule is issued pursuant to the statutory authority of the Department of Health and Human
Services to require immunization of the employees of designated healthcare facilities as set forth in
22 MRS §802 to reduce the risk for exposure to, and possible transmission of, vaccine-preventable
diseases due to healthcare workers’ contact with patients, or infectious material from patients. It
prescribes the dosage for required immunizations and defines responsibilities, exclusion periods, record
keeping and reporting requirements for officials of hospitals and healthcare facilities.
1.
Definitions
A.
Certificate of Immunization means a written statement from a physician, nurse,
physician assistant or health official who has administered an immunization agent to an
employee, specifying the vaccine administered and the date it was administered.
Secondary school or collegiate health records, having been compiled and maintained as
an official document based on certificates of immunization, which provide at a minimum
the month and year that the immunization was administered and/or which contain copies
of laboratory evidence of immunity, may also be accepted as proof of immunization.
B.
Chief Administrative Officer means the person designated as the president, chief
executive officer, administrator, director or otherwise the senior official of a Designated
Healthcare Facility.
C.
Declination means a formal process where an individual makes an informed choice
declining Hepatitis B vaccination, following standards and procedures established by the
federal Occupational Safety and Health Administration (OSHA) regulations (29 CFR
§1910.1030(f)(2)(iv) (effective July 6, 1992).
D.
Designated Healthcare Facility means a licensed nursing facility, residential care
facility, Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID),
multi-level healthcare facility, hospital, or home health agency subject to licensure by the
State of Maine, Department of Health and Human Services Division of Licensing and
Certification.
E.
Disease means the following conditions which may be preventable by immunization
agent:
1.
Rubeola (measles);
2.
Mumps;
3.
Rubella (German measles);
4.
Varicella (chicken pox);
EXHIBIT 1
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10-144 CMR Ch. 264
3
5.
Hepatitis B.; and
6.
Influenza.
F.
Employee means a person who performs a service for wages or other remuneration for a
Designated Healthcare Facility.
G.
Exemption means a formal procedure to procure discharge from requirement to vaccinate.
H.
Extreme Public Health Emergency means a state of emergency declared by the
Governor of the State of Maine pursuant to 22 MRS §802(2-A) and 37-B MRS §742
based upon an occurrence or imminent threat of widespread exposure to a highly
infectious or toxic agent that poses an imminent threat of substantial harm to the
population of the State.
I.
Immunization agent means a vaccine, antitoxin, or other substances used to increase an
individual's immunity to disease.
J.
Public Health Emergency means a declaration by the Department, arising from an
actual or threatened epidemic or public health threat for which the Department may adopt
emergency rules for the protection of the public health, pursuant to 22 MRS §802(2).
K.
Public Health Official means a local health officer, the Director of the Maine Center for
Disease Control and Prevention (Maine CDC), or a designated employee or agent of the
Maine Department of Health and Human Services (Department).
L.
Public Health Threat means a condition or behavior that can reasonably be expected to
place others at significant risk of exposure to a toxic agent or environmental hazard or
infection with a notifiable disease or condition, as defined in 22 MRS §801.
2.
Immunizations Required
A.
Except as otherwise provided by law, each Designated Healthcare Facility in the State of
Maine must require for all employees proof of immunization or documented immunity
against:
1.
Rubeola (measles);
2.
Mumps;
3.
Rubella (German measles);
4.
Varicella (chicken pox);
5.
Hepatitis B; and
6.
Influenza.
EXHIBIT 1
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10-144 CMR Ch. 264
4
B.
In accordance with 29 CFR §1910.1030(f)(1)(i) (effective July 6, 1992) of the
Occupational Safety and Health Administration (OSHA) regulations, Designated
Healthcare Facilities must make available the Hepatitis B vaccine to all healthcare
workers with a risk of occupational exposure, provided at no cost to the employee and at
a reasonable time and place.
C.
In the event of a Public Health Emergency or Extreme Public Health Emergency declared
by the Governor, the Department may impose control measures, including, but not
limited to, mass vaccinations and exclusions from the workplace, and may require
immunization or documented immunity to protect public health and minimize the impact
from the specific communicable disease.
D.
No Chief Administrative Officer may permit any employee to be in attendance at work
without a certificate of immunization for each disease or other acceptable evidence of
immunity to each disease, or documentation of authorized exemption or declination in
accordance with 22 MRS §802(4-B).
3.
Exceptions and Declinations
An employee who does not provide proof of immunization or immunity for a vaccine required
under this rule may be permitted to attend work if that employee is exempt in accordance with
22 MRS §802 (4-B). Documentation for an employee’s immunization exemption must be
maintained in the permanent health record for that employee for a minimum of six years after
termination.
4.
Certification of Immunization and Proof of Immunity
A.
Certificate of Immunization
To demonstrate proper immunization against each disease, an employee must present the
Designated Healthcare Facility with a Certificate of Immunization from a physician,
nurse or health official who has administered the immunizing agent(s) to the employee.
Physicians within their own practice may authorize their own employees to issue a
certificate of immunization on behalf of the physician. The certificate must specify the
immunizing agent, and the date(s), including month and year, on which it was
administered. Physicians, having reviewed official patient records created by another
practitioner which indicate that a particular patient has received an immunization on a
specified date, demonstrating at a minimum the month and year the immunization was
given, may certify that the immunization was given. Adequately prepared secondary
and/or collegiate school health records will also be considered acceptable for the purpose
of meeting this requirement.
B.
Proof of Immunity
To demonstrate that an employee is immune to any of the diseases, the employee must
present the hospital/facility with laboratory evidence demonstrating immunity, or other
acceptable evidence of immunity. (See Section 7-B Individual Health Records.)
EXHIBIT 1
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10-144 CMR Ch. 264
5
5.
Immunization Dosage
A.
The following schedule contains the minimally required number of doses for the
immunizing agents addressed under this rule:
1.
Rubeola (Measles): Two doses of live measles vaccine given after the first
birthday, with a minimum of four weeks separating the two doses.
2.
Mumps: Two doses of live mumps vaccine given after the first birthday.
3.
Rubella (German Measles): Two doses of live rubella vaccine given after the
first birthday.
4.
Varicella (Chickenpox): Two doses of live varicella vaccine given after the first
birthday, with a minimum of four weeks separating the two doses.
5.
Hepatitis B: Three doses of hepatitis B vaccine, the first two given one month
apart and the third given five months after the second.
6.
Influenza: Annual dose of inactivated influenza vaccine or live attenuated
influenza vaccine.
In the event of a Public Health Emergency or Extreme Public Health Emergency declared
by the Governor, the Maine CDC will specify the recommended dose for any vaccination
imposed as a control measure to protect public health.
B.
Any such immunizing agent must meet the standards for biological products which are
approved by the United States Public Health Service.
6.
Exclusions from the Workplace
A.
Exclusion by order of Public Health Official
An employee not immunized or otherwise immune from a disease must be excluded from
the worksite, when in the opinion of a public health official, the employee's continued
presence at work poses a clear danger to the health of others. The documented occurrence
of a single case of rubeola (measles), mumps, rubella (German measles) or varicella
(chickenpox) in a Designated Healthcare Facility or amongst its employees may be
interpreted as a clear danger to the health of others.
The Chief Administrative Officer must exclude the employee during the period of danger
or for one incubation period following immunization of the employee, when one or more
cases of disease are present.
B.
The following periods are defined as the "period of danger:"
1
Measles: 15 days from the onset of symptoms from the last identified case
2.
Mumps: 18 days from the onset of symptoms from the last identified case
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6
3.
Rubella: 23 days from the onset of symptoms from the last identified case
4.
Varicella: 16 days from the onset of symptoms from the last identified case.
C.
Except as otherwise provided for by law, contract or collective bargaining agreement, an
employer will not be responsible for maintaining an employee in pay status as a result of
this rule.
D.
When a public health official determines there are reasonable grounds to believe a Public
Health Threat exists, an exempted employee may be immunized or tested for serologic
evidence of immunity. Employees without serologic evidence of immunity and those who
become immunized against the disease in question at the time of a documented case or
cases of disease must be excluded from the work site during one incubation period.
7.
Records and Record Keeping
A.
Designated Record Keeping
The Chief Administrative Officer in each Designated Healthcare Facility must be
responsible for the maintenance of employee immunization records. The Chief
Administrative Officer may designate a person to be responsible for record keeping.
B.
Individual Health Records
Each Designated Healthcare Facility must adopt a uniform, permanent health record for
maintaining information regarding the health status of each employee. The immunization
status of each employee with regard to each disease must be noted on the employee's
health record. The health record of each employee must include at a minimum the month
and year that each immunizing agent was administered. Health records are to be retained
a minimum of six years after the date the employee is no longer employed.
Where an exception has been granted for a reason authorized by law, the written request
for exemption must be on file with the employee health record. Where laboratory or other
acceptable evidence of immunity has been submitted, a copy of the documentation must
also be on file.
C.
List of Non-Immunized Employees
The Chief Administrative Officer or his/her designee in each Designated Healthcare
Facility must keep a listing of the names of all employees within the facility who are not
currently immunized or do not have documented serological immunity against each
disease. This list must include the names of all employees with authorized exemptions
from immunization as well as any who are otherwise not known to be immune and must
state the reason that the employee is not immune. The purpose of the list is to provide an
efficient means to rapidly contact non-immunized employees in the event of disease
outbreaks and exclude them from the workplace as necessary.
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7
D.
Required Reports
1.
Routine Reporting
The Chief Administrative Officer of each Designated Healthcare Facility is
responsible for submitting a summary report on the immunization status of all
employees by December 15 of each calendar year, on a form prescribed by the
Maine CDC. The summary report will include the following information at a
minimum: specific contact information identifying the facility; the name of the
Chief Administrative Officer; the total number of employees; the number of
employees born on or after January 1, 1957; and the number of employees
identified by vaccine type as either immunized, serological proof of immunity,
exempt in accordance to law, having declined hepatitis B vaccine, or out of
compliance. The summary report may be constructed so as to reflect meaningful
data by groupings within the facility (e.g., pediatric unit). Each report must be
signed by the Chief Administrative Officer as a certification that the information
is accurate.
2.
Maine CDC Sample Survey
The Maine CDC will conduct periodic reviews by selecting a sample of
employee health records for the purpose of comparing reported results against the
criteria delineated in these rules. The results of this sample survey will be shared
with the Chief Administrative Officer of the Designated Healthcare Facility for
the purpose of identifying problem areas that may be occurring in the
maintenance of their employee health records. Any published or unpublished
reports of such sampling of employee health records must not identify individual
employees and/or Designated Healthcare Facilities, directly or indirectly.
STATUTORY AUTHORITY:
22 MRS §802(3)
EFFECTIVE DATE:
April 16, 2002
NON-SUBSTANTIVE CORRECTIONS:
May 13, 2002 - corrected the spelling of DEPARTMENT in header, page 1
May 10, 2004 - spacing, capitalization and punctuation only
EFFECTIVE DATE:
October 6, 2009 to January 4, 2010 - filing 2009-531 (EMERGENCY)
December 8, 2009 – filing 2009-644
April 14, 2021 – filing 2021-068 (ROUTINE TECHNICAL)
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Maine Department of Health and Human Services
Maine Center for Disease Control and Prevention
11 State House Station
286 Water Street
Augusta, Maine 04333-0011
Tel; (207) 287-8016; Fax (207) 287-9058
TTY: Dial 711 (Maine Relay)
Janet T. Mills
Governor
Jeanne M. Lambrew, Ph.D.
Commissioner
Maine Immunization Program
Tel. (207) 287-3746
Fax (207) 287-8127
2018 Healthcare Worker Immunization Assessment Report
The Maine Immunization Program conducts an annual immunization assessment of State of Maine
Healthcare Workers. Rules pursuant to 22 M.R.S. § 802 requires each designated healthcare facility in the
State of Maine to require from all employees proof of immunization or documented immunity against
Measles, Mumps, Rubella, Varicella, and also Hepatitis B for all at-risk employees. The healthcare facility
should also adopt a uniform, permanent health record for maintaining information regarding the health
status of each employee and submit a summary of the immunization status of all employees to the Maine
CDC annually.
The 2018 Healthcare Worker Immunization Survey was conducted online from October to December 31,
2018. The vaccination data reported by all facility types was analyzed and a summary table was
generated (Table 1). Hospital specific data was analyzed separately and graphical representations of
these results by vaccine type can be found on the following pages (Figures 1-5).
Immunization is the most effective and efficient way to ensure that healthcare workers, their family
members, and patients, particularly those who are immunocompromised, are protected against these
vaccine preventable diseases. This is perhaps one of the most important reasons why it would be
advantageous for facilities to meet all requirements of the Maine Immunization Healthcare Workers law
and to help reach the goal of the Maine Immunization Program to bring the State vaccine coverage rate
average for each of these vaccines to 100%.
Table 1: Immunization Rates by Facility Type
2018 Healthcare Worker Immunization Rates
by Facility Type, Statewide
Vaccine
Home
Health
Hospital
Intermediate
Care/MR
Licensed
Nursing
Multi-
Level
Healthcare
Residential
Care
All
Reporting
Facilities
# Facilities Assessed
13
33
9
33
15
113
216
Hepatitis B
79.3%
91.8%
70.4%
73.5%
75.5%
47.9%
84.5%
Measles
88.6%
97.6%
91.5%
86.3%
89.8%
62.6%
93.1%
Mumps
87.8%
97.4%
90.4%
86.1%
89.7%
62.6%
92.9%
Rubella
89.8%
97.9%
91.5%
86.3%
90.0%
62.5%
93.4%
Varicella
95.4%
98.1%
91.1%
85.0%
88.3%
61.8%
93.7%
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Figure 1: Hepatitis B Immunization Rates
Figure 1: The bars in the graph above represent the percent of healthcare workers who are immune to hepatitis B by
vaccination or have laboratory evidence of immunity.
65.8%
91.8%
100.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
2018 Percentage of Paid Employees Vaccinated Against Hepatitis B, by Hospital
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Figure 2: Measles Immunization Rates
Figure 2: The bars in the graph above represent the percent of healthcare workers who are immune to measles by vaccination
or have laboratory evidence of immunity.
76.2%
97.6%
100.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
2018 Percentage of Paid Employees Vaccinated Against Measles, by Hospital
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Figure 3: Mumps Immunization Rates
Figure 3: The bars in the graph above represent the percent of healthcare workers who are immune to mumps by vaccination
or have laboratory evidence of immunity.
75.2%
97.4%
100.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
2018 Percentage of Paid Employees Vaccinated Against Mumps, by Hospital
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Figure 4: Rubella Immunization Rates
Figure 4: The bars in the graph above represent the percent of healthcare workers who are immune to rubella by vaccination
or have laboratory evidence of immunity.
75.2%
97.9%
100.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
2018 Percentage of Paid Employees Vaccinated Against Rubella, by Hospital
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Figure 5: Varicella Immunization Rates
Figure 5: The bars in the graph above represent the percent of healthcare workers who are immune to varicella by vaccination
or have laboratory evidence of immunity.
70.6%
98.1%
100.0%
0.0%
10.0%
20.0%
30.0%
40.0%
50.0%
60.0%
70.0%
80.0%
90.0%
100.0%
2018 Percentage of Paid Employees Vaccinated Against Varicella, by Hospital
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STATE OF MAINE
IMMUNIZATION REQUIREMENTS FOR HEALTHCARE WORKERS
10-144 CODE OF MAINE RULES
CHAPTER 264
Maine Department of Health and Human Services
Maine Center for Disease Control and Prevention
11 State House Station
Augusta, Maine 04333-0011
EMERGENCY ROUTINE TECHNICAL RULE
Effective August 12, 2021
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2
10-144
DEPARTMENT OF HEALTH AND HUMAN SERVICES
MAINE CENTER FOR DISEASE CONTROL AND PREVENTION
Chapter 264:
IMMUNIZATION REQUIREMENTS FOR HEALTHCARE WORKERS
Purpose: This rule is issued pursuant to the statutory authority of the Department of Health and Human
Services to establish procedures for the control and prevention of communicable diseases as set forth in
22 MRS § 802(1)(D) in addition to its authority to require immunization of the employees of designated
healthcare facilities as set forth in 22 MRS §802. This rule requires employees of Designated Health
Facilities to reduce the risk for exposure to, and possible transmission of, vaccine-preventable diseases
resulting from contact with patients, or infectious material from patients. It prescribes the dosage for
required immunizations and defines responsibilities, exclusion periods, record keeping and reporting
requirements for officials of hospitals and healthcare facilities. This rule also requires employees of
Designated Health Care Facilities, Dental Health Practices, and EMS Organizations to become
immunized to COVID-19.
1.
Definitions
A.
Certificate of Immunization means a written statement from a physician, nurse,
physician assistant, or health official who has administered an immunization to an
employee, specifying the vaccine administered and the date it was administered.
Secondary school or collegiate health records, having been compiled and maintained as
an official document based on certificates of immunization, which provide at a minimum
the month and year that the immunization was administered and/or which contain copies
of laboratory evidence of immunity, may also be accepted as proof of immunization.
B.
Chief Administrative Officer means the person designated as the president, chief
executive officer, administrator, director or otherwise the senior official of a Designated
Healthcare Facility, Dental Health Practice, or EMS Organization.
C.
Declination means a formal process where an individual makes an informed choice
declining Hepatitis B vaccination, following standards and procedures established by the
federal Occupational Safety and Health Administration (OSHA) regulations (29 CFR §
1910.1030(f)(2)(iv) (effective July 6, 1992).
D.
Dental Health Practice means, for the purpose of this rule, any practice where dentists
(whose scope of practice is defined in 32 MRS §18371) and dental hygienists (defined in
32 MRS §18374) provide oral health care to patients in the State of Maine.
E.
Designated Healthcare Facility means a licensed nursing facility, residential care
facility, Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID),
multi-level healthcare facility, hospital, or home health agency subject to licensure by the
State of Maine, Department of Health and Human Services Division of Licensing and
Certification.
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F.
Disease means the following conditions which may be preventable by immunization:
1.
Rubeola (measles);
2.
Mumps;
3.
Rubella (German measles);
4.
Varicella (chicken pox);
5.
Hepatitis B.;
6.
Influenza; and
7.
COVID-19.
G.
Employee means any person who performs any service for wages or other remuneration
for a Designated Healthcare Facility, EMS Organization or Dental Health Practice. For
purposes of this rule, independent contractors for any of the listed facilities in this
definition are considered employees.
H.
Emergency Medical Services (EMS) Organization means an EMS ground ambulance
service, non-transporting EMS service, air ambulance service, EMS training center,
and/or emergency medical dispatch center, as defined in the Maine Emergency Services
System Rules at 16-163 CMR Chapter 2.
I.
Exemption means a formal procedure to procure discharge from requirement to
vaccinate.
J.
Extreme Public Health Emergency means a state of emergency declared by the
Governor of the State of Maine pursuant to 22 MRS §802(2-A) and 37-B MRS §742
based upon an occurrence or imminent threat of widespread exposure to a highly
infectious or toxic agent that poses an imminent threat of substantial harm to the
population of the State.
K.
Immunization means a vaccine, antitoxin, or other substances used to increase an
individual's immunity to disease.
L.
Public Health Emergency means a declaration by the Department, arising from an
actual or threatened epidemic or public health threat for which the Department may adopt
emergency rules for the protection of the public health, pursuant to 22 MRS § 802(2).
M.
Public Health Official means a local health officer, the Director of the Maine Center for
Disease Control and Prevention (Maine CDC), or a designated employee or agent of the
Maine Department of Health and Human Services (Department).
N.
Public Health Threat means a condition or behavior that can reasonably be expected to
place others at significant risk of exposure to a toxic agent or environmental hazard or
infection with a notifiable disease or condition, as defined in 22 MRS §801.
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2.
Immunizations Required
A.
Except as otherwise provided by law, each Designated Healthcare Facility in the State of
Maine must require for all employees proof of immunization or documented immunity
against:
1.
Rubeola (measles);
2.
Mumps;
3.
Rubella (German measles);
4.
Varicella (chicken pox);
5.
Hepatitis B;
6.
Influenza; and
7.
COVID-19.
B.
Each EMS organization and Dental Health Practice must require for all employees a
Certificate of Immunization against COVID-19.
C.
In accordance with 29 CFR §1910.1030(f)(1)(i) (effective July 6, 1992) of the
Occupational Safety and Health Administration (OSHA) regulations, Designated
Healthcare Facilities must make available the Hepatitis B vaccine to all healthcare
workers with a risk of occupational exposure, provided at no cost to the employee and at
a reasonable time and place.
D.
In the event of a Public Health Emergency or Extreme Public Health Emergency declared
by the Governor, the Department may impose control measures, including, but not
limited to, mass vaccinations and exclusions from the workplace, and may require
immunization or documented immunity to protect public health and minimize the impact
from the specific communicable disease.
E.
No Chief Administrative Officer may permit any employee to be in attendance at work
without a certificate of immunization for each disease or other acceptable evidence of
immunity to each disease (if applicable), or documentation of authorized exemption or
declination in accordance with 22 MRS §802(4-B).
3.
Exceptions and Declinations
An employee who does not provide proof of immunization or immunity for a vaccine required
under this rule may be permitted to attend work if that employee is exempt in accordance with
22 MRS §802 (4-B). Documentation for an employee’s immunization exemption must be
maintained in the permanent health record for that employee for a minimum of six years after
termination.
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4.
Certification of Immunization and Proof of Immunity
A.
Certificate of Immunization
To demonstrate proper immunization against each disease, an employee must present the
Designated Healthcare Facility, EMS Organization, or Dental Health Practice with a
Certificate of Immunization from a physician, nurse or health official who has
administered the immunization(s) to the employee. Physicians within their own practice
may authorize their own employees to issue a certificate of immunization on behalf of the
physician. The certificate must specify the immunization(s), and the date(s), including
month and year, on which it was administered. Physicians, having reviewed official
patient records created by another practitioner which indicate that a particular patient has
received an immunization on a specified date, demonstrating at a minimum the month
and year the immunization was given, may certify that the immunization was given.
Adequately prepared secondary and/or collegiate school health records will also be
considered acceptable for the purpose of meeting this requirement.
B.
Proof of Immunity
To demonstrate that an employee is immune to any of the diseases, the employee must
present the hospital/facility with laboratory evidence demonstrating immunity, or other
acceptable evidence of immunity. (See Section 7-B Individual Health Records.)
5.
Immunization Dosage
A.
The following schedule contains the minimally required number of doses for the
immunization(s) addressed under this rule:
1.
Rubeola (Measles): Two doses of live measles vaccine given after the first
birthday, with a minimum of four weeks separating the two doses.
2.
Mumps: Two doses of live mumps vaccine given after the first birthday.
3.
Rubella (German Measles): Two doses of live rubella vaccine given after the
first birthday.
4.
Varicella (Chickenpox): Two doses of live varicella vaccine given after the first
birthday, with a minimum of four weeks separating the two doses.
5.
Hepatitis B: Three doses of hepatitis B vaccine, the first two given one month
apart and the third given five months after the second.
6.
Influenza: Annual dose of inactivated influenza vaccine or live attenuated
influenza vaccine.
7.
COVID-19: The number of recommended doses shall be in accordance with the
COVID-19 immunization manufacturer’s Emergency Use Authorization or
labelling. All employees of Designated Healthcare Facilities, EMS
Organizations, and Dental Health Practices must have received their final dose by
September 17, 2021.
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6
In the event of a Public Health Emergency or Extreme Public Health Emergency declared
by the Governor, the Maine CDC will specify the recommended dose for any vaccination
imposed as a control measure to protect public health.
B.
Any such immunization must meet the standards for biological products which are
approved by the United States Public Health Service.
6.
Exclusions from the Workplace
A.
Exclusion by order of Public Health Official
An employee not immunized or otherwise immune from a disease must be excluded from
the worksite, when in the opinion of a public health official, the employee's continued
presence at work poses a clear danger to the health of others. The documented occurrence
of a single case of rubeola (measles), mumps, rubella (German measles) or varicella
(chickenpox) in a Designated Healthcare Facility or amongst its employees may be
interpreted as a clear danger to the health of others.
The Chief Administrative Officer must exclude the employee during the period of danger
or for one incubation period following immunization of the employee, when one or more
cases of disease are present.
B.
The following periods are defined as the "period of danger:"
1
Measles: 15 days from the onset of symptoms from the last identified case;
2.
Mumps: 18 days from the onset of symptoms from the last identified case;
3.
Rubella: 23 days from the onset of symptoms from the last identified case;
4.
Varicella: 16 days from the onset of symptoms from the last identified case; and
5.
COVID-19: The duration of the Department’s declared public health emergency,
effective as of July 1, 2021.
C.
Except as otherwise provided for by law, contract or collective bargaining agreement, an
employer will not be responsible for maintaining an employee in pay status as a result of
this rule.
D.
When a public health official determines there are reasonable grounds to believe a Public
Health Threat exists, an exempted employee may be immunized or tested for serologic
evidence of immunity. Employees without serologic evidence of immunity and those who
become immunized against the disease in question at the time of a documented case or
cases of disease must be excluded from the work site during one incubation period.
7.
Records and Record Keeping
A.
Designated Record Keeping
The Chief Administrative Officer in each Designated Healthcare Facility, EMS
Organization, or Dental Health Practice must be responsible for the maintenance of
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7
employee immunization records. The Chief Administrative Officer may designate a person
to be responsible for record keeping.
B.
Individual Health Records
Each Designated Healthcare Facility, EMS Organization, or Dental Health Practice must
adopt a uniform, permanent health record for maintaining information regarding the
health status of each employee. The immunization status of each employee with regard to
each disease must be noted on the employee's health record. The health record of each
employee must include, at a minimum, the month and year that each immunization was
administered. Health records are to be retained a minimum of six years after the date the
employee is no longer employed.
Where an exception has been granted for a reason authorized by law, the written request
for exemption must be on file with the employee health record. Where laboratory or other
acceptable evidence of immunity has been submitted, a copy of the documentation must
also be on file.
C.
List of Non-Immunized Employees
The Chief Administrative Officer or his/her designee in each Designated Healthcare
Facility, EMS Organization, or Dental Health Practice, must keep a listing of the names
of all employees within the facility who are not currently immunized or do not have
documented serological immunity against each disease. This list must include the names
of all employees with authorized exemptions from immunization as well as any who are
otherwise not known to be immune and must state the reason that the employee is not
immune. The purpose of the list is to provide an efficient means to rapidly contact non-
immunized employees in the event of disease outbreaks and exclude them from the
workplace as necessary.
D.
Required Reports
1.
Routine Reporting
The Chief Administrative Officer of each Designated Healthcare Facility, EMS
Organization, or Dental Health Practice is responsible for submitting a summary
report on the immunization status of all employees by December 15 of each
calendar year, on a form prescribed by the Maine CDC. The summary report will
include the following information at a minimum: specific contact information
identifying the facility; the name of the Chief Administrative Officer; the total
number of employees; the number of employees born on or after January 1, 1957;
and the number of employees identified by vaccine type as either immunized,
serological proof of immunity, exempt in accordance to law, having declined
hepatitis B vaccine, or out of compliance. The summary report may be
constructed so as to reflect meaningful data by groupings within the facility (e.g.,
pediatric unit). Each report must be signed by the Chief Administrative Officer as
a certification that the information is accurate.
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8
2.
Maine CDC Sample Survey
The Maine CDC will conduct periodic reviews by selecting a sample of
employee health records for the purpose of comparing reported results against the
criteria delineated in these rules. The results of this sample survey will be shared
with the Chief Administrative Officer of the Designated Healthcare Facility,
EMS Organization, or Dental Health Practice, for the purpose of identifying
problem areas that may be occurring in the maintenance of their employee health
records. Any published or unpublished reports of such sampling of employee
health records must not identify individual employees and/or Designated
Healthcare Facilities, EMS Organization, or Dental Health Practices directly or
indirectly.
STATUTORY AUTHORITY:
22 MRS §§ 802(1), (3)
EFFECTIVE DATE:
April 16, 2002
NON-SUBSTANTIVE CORRECTIONS:
May 13, 2002 - corrected the spelling of DEPARTMENT in header, page 1
May 10, 2004 - spacing, capitalization and punctuation only
EFFECTIVE DATE:
October 6, 2009 to January 4, 2010: filing 2009-531 (EMERGENCY)
December 8, 2009 – filing 2009-644
April 14, 2021 – filing 2021-068 (ROUTINE TECHNICAL)
August 12, 2021 – filing 2021-166 (EMERGENCY ROUTINE TECHNICAL)
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STATE OF MAINE
IMMUNIZATION REQUIREMENTS FOR EMPLOYEES IN CERTAIN
HEALTHCARE WORKERSSETTINGS
10-144 CODE OF MAINE RULES
CHAPTER 264
Maine Department of Health and Human Services
Maine Center for Disease Control and Prevention
11 State House Station
Augusta, Maine 04333-0011
Date Amended: April 14, 2021
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10-144 CMR Ch. 264
2
10-144
DEPARTMENT OF HEALTH AND HUMAN SERVICES
MAINE CENTER FOR DISEASE CONTROL AND PREVENTION
Chapter 264:
IMMUNIZATION REQUIREMENTS FOR EMPLOYEES IN CERTAIN
HEALTHCARE WORKERS SETTINGS
Purpose: This rule is issued pursuant to the statutory authority of the Department of Health and Human
Services to require immunization of the employees of designated healthcare facilities as set forth in
22 MRS §802. This rule requires employees of certain Healthcare Settings, which include Designated
Healthcare Facilities, EMS Organizations, and Dental Health Practices to become immunized for the
diseases listed in this rule, to reduce the risk for exposure to, and possible transmission of, vaccine-
preventable diseases due to healthcare workers’resulting from contact with patients, or infectious material
from patients. It prescribes the dosage for required immunizations and defines responsibilities, conditions
for exclusion periods, record keeping and reporting requirements for officials of hospitals and Designated
Hhealthcare Ffacilities, EMS Organizations, and Dental Health Practices.
SECTION 1. DEFINITIONSDefinitions
A.
Certificate of Immunization means a written statement from a physician, nurse,
physician assistant, or health official who has administered an immunization agent to an
employee, specifying the vaccine administered and the date it was administered.
Secondary school or collegiate health records, having been compiled and maintained as
an official document based on certificates of immunization, which provide at a minimum
the month and year that the immunization was administered and/or which contain copies
of laboratory evidence of immunity, may also be accepted as proof of immunization.
B.
Chief Administrative Officer means the person designated as the president, chief
executive officer, administrator, director or otherwise the senior official of a Designated
Healthcare Facility or Dental Health Practice.
C.
Declination means a formal process where an individual makes an informed choice
declining Hepatitis B vaccination, following standards and procedures established by the
federal Occupational Safety and Health Administration (OSHA) regulations (29 CFR §
1910.1030(f)(2)(iv) (effective July 6, 1992).
D.
Dental Health Practice means, for the purpose of this rule, any practice where dentists
(whose scope of practice is defined in 32 MRS §18371) and dental hygienists (defined in
32 MRS §18374) provide oral health care to patients in the State of Maine.
ED.
Designated Healthcare Facility means a licensed nursing facility, residential care
facility, Intermediate Care Facility for Individuals with Intellectual Disabilities (ICF/IID),
multi-level healthcare facility, hospital, or home health agency subject to licensure by the
State of Maine, Department of Health and Human Services Division of Licensing and
Certification.
EXHIBIT 5
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FE.
Disease means the following conditions which may be preventable by immunization
agent:
1.
Rubeola (measles);
2.
Mumps;
3.
Rubella (German measles);
4.
Varicella (chicken pox);
5.
Hepatitis B.; and
6.
Influenza.; and
7.
COVID-19.
GF.
Employee means, for the purposes of this rule, any person who performs any service for
wages or other remuneration for a whothat is physically present at a Designated
Healthcare Facility, EMS Organization, or Dental Health Practice. For purposes of this
rule, “employee” includes independent contractors, and any of their employees, who
provide services while physically present at a Designated Healthcare Facility, EMS
Organization, or Dental Health Practice. “Employee” does not include any individual
who exclusively works remotely (while not physically present at a Designated Healthcare
Facility, EMS Organization or Dental Health Practice).
H.G.
Emergency Medical Services (EMS) Organization means an EMS ground ambulance
service, non-transporting EMS service, air ambulance service, or EMS training center,
within the Maine Emergency Services System Rules at 16-163 CMR Chapters 1-19.
I.
Exemption means a formal procedure to procure discharge from requirement to vaccinate.
H.
Extreme Public Health Emergency means a state of emergency declared by the
Governor of the State of Maine pursuant to 22 MRS §802(2-A) and 37-B MRS §742
based upon an occurrence or imminent threat of widespread exposure to a highly
infectious or toxic agent that poses an imminent threat of substantial harm to the
population of the State.
J.
Health Official means, for the purposes of this rule, any person who is authorized to
administer immunization to the employees within this rule.
K.
Healthcare Setting means, for the purpose of this rule, a Designated Healthcare Facility,
EMS Organization, or a Dental Health Practice.
L.I.
Immunization agent means a vaccine, antitoxin, or other substances used to increase an
individual's immunity to disease.
J.
Public Health Emergency means a declaration by the Department, arising from an
actual or threatened epidemic or public health threat for which the Department may adopt
emergency rules for the protection of the public health, pursuant to 22 MRS § 802(2).
EXHIBIT 5
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10-144 CMR Ch. 264
4
MK.
Public Health Official means a local health officer, the Director of the Maine Center for
Disease Control and Prevention (Maine CDC), or a designated employee or agent of the
Maine Department of Health and Human Services (Department).
NL.
Public Health Threat means a condition or behavior that can reasonably be expected to
place others at significant risk of exposure to a toxic agent or environmental hazard or
infection with a notifiable disease or condition, as defined in 22 MRS §801.
SECTION 2. IMMUNIZATIONS REQUIREDImmunizations Required
A.
Except as otherwise provided by law, each Designated Healthcare Facility in the State of
Maine must require for all employees a Certificate of Immunization, or Proof of
Immunity, subject to Section 4(B) of this rule, proof of immunization or documented
immunity against:
1.
Rubeola (measles);
2.
Mumps;
3.
Rubella (German measles);
4.
Varicella (chicken pox);
5.
Hepatitis B; and
6.
Influenza; .and
7.
COVID-19.
B.
Except as otherwise provided by law, each EMS Organization and Dental Health Practice
in Maine must require for all employees a Certificate of Immunization against COVID-
19, or documentation of an applicable exemption.
BC.
In accordance with 29 CFR §1910.1030(f)(1)(i) (effective July 6, 1992) of the
Occupational Safety and Health Administration (OSHA) regulations, Designated
Healthcare Facilities must make available the Hepatitis B vaccine to all healthcare
workers with a risk of occupational exposure, provided at no cost to the employee and at
a reasonable time and place.
C.
In the event of a Public Health Emergency or Extreme Public Health Emergency declared
by the Governor, the Department may impose control measures, including, but not
limited to, mass vaccinations and exclusions from the workplace, and may require
immunization or documented immunity to protect public health and minimize the impact
from the specific communicable disease.
D.
No Chief Administrative Officer may permit any employee to be in attendance at work
without a Ccertificate of Iimmunization for each disease, or other acceptable Proof of
Immunity evidence of immunity to each disease as described in Section 4(B) of this rule,
or documentation of an authorized exemption or declination in accordance with 22 MRS
§ 802(4-B).
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5
SECTION 3. EXEMPTIONS Exceptions and Declinations
An employee who does not provide proof of immunizationa Certificate of Immunization or Proof
of Iimmunity, as described in Section 4(B) for a vaccine required under this rule, may be
permitted to attend work if that employee is exempt in accordance with 22 MRS § 802 (4-B).
Documentation for an employee’s immunization exemption must be maintained in the permanent
health record for that employee for a minimum of six years after termination.
SECTION 4. CERTIFICATE Certification of IMMUNIZATIONImmunization and
PROOF OF IMMUNITYProof of Immunity
A.
Certificate of Immunization
To demonstrate proper immunization against each disease, an employee must present the
Designated Healthcare FacilityHealthcare Setting with a Certificate of Immunization
from a physician, nurse or health official who has administered the immunizing
agentimmunization(s) to the employee. Physicians within their own practice may
authorize their own employees to issue a certificate of immunization on behalf of the
physician. The certificate must specify the immunizing agentimmunization(s), and the
date(s), including month and year, on which it was administered. Physicians, having
reviewed official patient records created by another practitioner which indicate that a
particular patient has received an immunization on a specified date, demonstrating at a
minimum the month and year the immunization was given, may certify that the
immunization was given. Adequately prepared secondary and/or collegiate school health
records will also be considered acceptable for the purpose of meeting this requirement.
B.
Proof of Immunity
To demonstrate that an employee is immune to any of the diseases listed in Section
5(A)(1)-(5), the employee must present the hospital/facilityHealthcare Setting with
laboratory evidence demonstrating immunity, or other acceptable evidence of immunity.
(See Section 7(-B) Individual Health Records.) No Proof of Immunity is available for
COVID-19 or Influenza.
SECTION 5. IMMUNIZATION DOSAGEImmunization Dosage
A.
The following schedule contains the minimally required number of doses for the
immunizing agents immunization(s) addressed underlisted in Section 2(A) of this rule:
1.
Rubeola (Measles): Two doses of live measles vaccine given after the first
birthday, with a minimum of four weeks separating the two doses.
2.
Mumps: Two doses of live mumps vaccine given after the first birthday.
3.
Rubella (German Measles): Two doses of live rubella vaccine given after the
first birthday.
4.
Varicella (Chickenpox): Two doses of live varicella vaccine given after the first
birthday, with a minimum of four weeks separating the two doses.
EXHIBIT 5
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10-144 CMR Ch. 264
6
5.
Hepatitis B: Three doses of hepatitis B vaccine, the first two given one month
apart and the third given five months after the second.
6.
Influenza: Annual dose of inactivated influenza vaccine or live attenuated
influenza vaccine.
7.
COVID-19: The number of recommended doses must be in accordance with the
COVID-19 immunization manufacturer’s Emergency Use Authorization or
labelling.
In the event of a Public Health Emergency or Extreme Public Health Emergency declared
by the GGovernor, the Maine CDC will specify the recommended dose for any
vaccination imposed as a control measure to protect public health.
B.
Any such immunizing agent immunization must meet the standards for biological
products which are approved by the United States Public Health Service.
SECTION 6. EXCLUSIONS FROM THE HEALTHCARE SETTING
Exclusions from the Workplace
A.
Exclusion by order of Public Health Official
A Public Health Official may order a Chief Administrative Officer to exclude from the
worksite an employee who has not been immunized when the employee’s continued
presence poses a clear danger to the health of others. An employee not immunized or
otherwise immune from a disease must be excluded from the worksite, when in the
opinion of a public health official, the employee's continued presence at work poses a
clear danger to the health of others. The documented occurrence of a single case of
rubeola (measles), mumps, rubella (German measles), or varicella (chickenpox), (or
COVID-19 in an EMS Organization, Dental Health Practice, or Designated Healthcare
Facility) or amongst its employees may be interpreted as a clear danger to the health of
others.
The Chief Administrative Officer must exclude the that employee during the period of
danger or for one incubation period following immunization of the employee, when one
or more cases of disease are present., unless otherwise ordered by the Public Health
Official.
B.
The following periods are defined as the minimum "period of danger:" for each disease
listed below:
1
Measles: 15 days from the onset of symptoms from the last identified case;
2.
Mumps: 18 days from the onset of symptoms from the last identified case;
3.
Rubella: 23 days from the onset of symptoms from the last identified case;
4.
Varicella: 16 days from the onset of symptoms from the last identified case;.
C.
There is no defined minimum period of danger for influenza, Hepatitis B, or COVID-19.
Except as otherwise provided for by law, contract or collective bargaining agreement, an
EXHIBIT 5
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10-144 CMR Ch. 264
7
employer will not be responsible for maintaining an employee in pay status as a result of
this rule.
D.
When a public health official determines there are reasonable grounds to believe a Public
Health Threat exists, an exempted employee may be immunized or tested for serologic
evidence of immunity. Employees without serologic evidence of immunity and those who
become immunized against the disease in question at the time of a documented case or
cases of disease must be excluded from the work site during one incubation period.
SECTION 7. RECORDS AND RECORD KEEPINGRecords and Record Keeping
A.
Designated Record Keeping
The Chief Administrative Officer in each Healthcare SettingDesignated Healthcare Facility
must be responsible for the maintenance of employee immunization records. The Chief
Administrative Officer may designate a person to be responsible for record keeping.
B.
Individual Health Records
Each Healthcare SettingDesignated Healthcare Facility must adopt a uniform, permanent
health record for maintaining information regarding the health status of each employee.
The immunization status of each employee with regard to each disease must be noted on
the employee's health record. The health record of each employee must include, at a
minimum, the month and year that each immunizing agentimmunization was
administered. Health records are to be retained a minimum of six years after the date the
employee is no longer employed.
Where an exception exemption has been granted for a reason authorized by law, the
written request for exemptiondocumentation supporting the exemption must be on file
with the employee health record. Where laboratory or other acceptable evidence of
immunityProof of Immunity has been submitted, a copy of the documentation must also
be on file.
C.
List of Non-Immunized Employees
The Chief Administrative Officer or his/her designee in each Healthcare Setting
Designated Healthcare Facility, must keep a listing for each disease of the names of all
employees within the facility who are not currently immunized or and have not provided
Proof of Immunity.do not have documented serological immunity against each disease.
This list must include the names of all employees with authorized exemptions from
immunization, as well as any who are otherwise not known to be immune and must state
the reason that the employee is not immune. The purpose of the list is to provide an
efficient means to rapidly contact non-immunized employees in the event of disease
outbreaks and exclude them from the workplace as necessary.
D.
Required Reports
1.
Routine Reporting
The Chief Administrative Officer of each Healthcare SettingDesignated
Healthcare Facility is responsible for completing the Maine CDC’s annual
EXHIBIT 5
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10-144 CMR Ch. 264
8
survey regarding submitting a summary report on the immunization status of all
employees by December 15 of each calendar year, on a form prescribed by the
Maine CDC. The survey resultssummary report will include the following
information at a minimum:
a. Sspecific contact information identifying the facility;
b. Tthe name of the Chief Administrative Officer;
c. Tthe total number of employees; and
the number of employees born on or after January 1, 1957; and
d. Tthe number of employees identified by vaccine type as either being
immunized, having demonstrated serological proof of immunity, having an
exemption in accordance to with law, having declined hepatitis B vaccine,, or
being out of compliance.
The summary reportsurvey results may be constructed so as to reflect meaningful
data by groupings within the facility (e.g., pediatric unit). Each report must be
signed by the Chief Administrative Officer as a certification that the information
is accurate.
2.
Maine CDC Sample SurveyEnforcement of Immunization Requirements
The Maine CDC will conduct periodic reviews of annual survey results, by
selecting a sample of employee health records for the purpose of comparing
reported results against the criteria delineated in thiese rules. The results of this
reviewsample survey will be shared with the Chief Administrative Officer of the
Healthcare SettingDesignated Healthcare Facility, for the purpose of identifying
problem areas that may be occurring in the maintenance of their employee health
records. Any published or unpublished reports of such sampling of employee
health records must not identify individual employees. and/or Designated
Healthcare Facilities, directly or indirectly. Compliance rates may be made
public, in accordance with 22 MRS §824.
STATUTORY AUTHORITY: 22 MRS §802
EFFECTIVE DATE:
April 16, 2002
NON-SUBSTANTIVE CORRECTIONS:
May 13, 2002 - corrected the spelling of DEPARTMENT in header, page 1
May 10, 2004 - spacing, capitalization and punctuation only
EFFECTIVE DATE:
October 6, 2009 to January 4, 2010: filing 2009-531 (EMERGENCY)
December 8, 2009 – filing 2009-644
April 14, 2021 – filing 2021-068 (ROUTINE TECHNICAL)
August 12, 2021 – filing 2021-166 (EMERGENCY ROUTINE TECHNICAL)
, 2021 – filing 2021- (ROUTINE TECHNICAL)
EXHIBIT 5
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R.A. 90
13757523.1.1.1.1
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
JANE DOES 1-6, JOHN DOES 1-3,
JACK DOES 1-1000, JOAN DOES 1-1000,
Plaintiffs,
v.
JANET T. MILLS, in her official capacity as
Governor of the State of Maine, JEANNE M.
LAMBREW, in her official capacity as
Commissioner of the Maine Department of
Health and Human Services, NIRAV D. SHAH,
in his official capacity as Director of the Maine
Center for Disease Control and Prevention,
MAINEHEALTH, GENESIS HEALTHCARE
OF MAINE, LLC, GENESIS HEALTHCARE,
LLC, NORTHERN LIGHT HEALTH
FOUNDATION, MAINEGENERAL
HEALTH,
Defendants.
CIVIL ACTION
Docket No: 1:21-cv-00242-JDL
DECLARATION OF APRIL NICHOLS
1. My name is April Nichols. I am an individual residing in Hartland, Maine, and I am over
eighteen years of age. The following information is based on my personal knowledge.
2. I am employed by Genesis Administrative Services LLC (GAS) as Regional Vice President
of Operations for Maine. GAS provides management and administrative services for Genesis
entities in Maine and nationally. GAS and named defendants Genesis Healthcare of Maine,
LLC and Genesis Healthcare LLC are indirect subsidiaries of Genesis Healthcare Inc.
Genesis Healthcare of Maine, LLC and Genesis Healthcare LLC are holding companies and
have no employees.
Case 1:21-cv-00242-JDL Document 50-2 Filed 09/15/21 Page 1 of 3 PageID #: 575
R.A. 91
13757523.1.1.1.1
2
3. Collectively, “Genesis” refers to all of the corporate entities involved in the operation of our
Maine facilities. Genesis operates eleven facilities in Maine that provide long-term care and
rehabilitation services through individual operating companies under licenses issued by the
Department of Health and Human Services (DHHS) to those individual operating companies.
Direct care workers and administrators who work on-site at these facilities are employed by
these operating companies. Each licensed operating company is required by the terms of its
license to operate in compliance with federal and state law, including DHHS rules. Under
applicable DHHS rules, each of the operating companies is a Designated Health Care Facility
and is required to comply with the DHHS Immunization Requirements Rule.
4. Genesis did not keep track of employee requests for religious exemptions before vaccines
became available for COVID-19.
5. To incentivize employees to get vaccinated, Genesis held free vaccination clinics on site and
at all times treated time getting the vaccine as compensable.
6. It has been and continues to be Genesis policy and practice to comply with all regulatory
requirements pertaining to infection control, including in particular those from CMS and
OSHA’s Emergency Temporary Standard pertaining to COVID-19, as well as state
requirements in each of the states in which Genesis operates.
7. On August 2, 2021, Genesis announced a company-wide vaccination mandate. Since that
announcement, in Maine the Company has received several requests for religious
exemptions, some of which have been denied for failure to meet the company’s criteria, some
of which have been approved, and some of which are pending further information from or
action by the employee. Employees with approved exemptions are continuing to work until
the effective date of the Immunization Requirements Rule.
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R.A. 92
13757523.1.1.1.1
3
8. At the time Genesis announced its company-wide vaccine mandate, the seven-day rolling
average employee vaccination rate in the State of Maine was 70.5%.
9. To comply with the Immunization Requirements Rule as amended by DHHS, Genesis has
informed all employees at its Maine facilities that they must be fully vaccinated by the date
established for enforcement by the Governor of Maine, unless they are eligible for a valid
exemption. Genesis intends to be in full compliance with the Rule when DHHS begins
enforcement with respect to COVID-19 immunization on October 29, 2021.
10. In my capacity as Regional Vice President of Operations for Maine, I am aware of all
pending employment claims including administrative claims filed with the EEOC and/or the
Maine Human Rights Commission by any employees at any Genesis facility in Maine.
Genesis has received one charge alleging failure to provide both religious and disability-
related accommodations with respect to the Company’s, not the State’s, COVID-19
vaccination mandate. The charge is by a male employee who provides his name and alleges
he was terminated on August 24, 2021. These allegations differ in material respects from
those of John Doe 2, who does not allege disability discrimination or termination and who is
challenging the State mandate, not the Company’s. I therefore do not believe that the
complainant in the charge is a Plaintiff in this lawsuit. Genesis has not received any other
administrative charges by Maine employees alleging religious discrimination against any
Genesis entity in Maine relating to the COVID-19 vaccine.
I declare under the penalties of perjury under the laws of the United States of America that the
foregoing is true and correct.
Date: September 14, 2021
/s/ April Nichols
April Nichols
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R.A. 93
13836255.1.1.1.1.1.1
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
JANE DOES 1-6, JOHN DOES 1-3,
JACK DOES 1-1000, JOAN DOES 1-1000,
Plaintiffs,
v.
JANET T. MILLS, in her official capacity as
Governor of the State of Maine, JEANNE M.
LAMBREW, in her official capacity as
Commissioner of the Maine Department of
Health and Human Services, NIRAV D. SHAH,
in his official capacity as Director of the Maine
Center for Disease Control and Prevention,
MAINEHEALTH, GENESIS HEALTHCARE
OF MAINE, LLC, GENESIS HEALTHCARE,
LLC, NORTHERN LIGHT HEALTH
FOUNDATION, MAINEGENERAL
HEALTH,
Defendants.
CIVIL ACTION
Docket No: 1:21-cv-00242-JDL
DECLARATION OF JUDY WEST
1. My name is Judy West. I am an individual residing in Portland, Maine and I am over
eighteen years of age. The following information is based on my personal knowledge.
2. I am employed by MaineHealth as Chief Human Resources Officer.
3. Collectively, Maine Health operates numerous facilities in Maine that are licensed by the
Maine Department of Health and Human Services (DHHS) as Designated Health Care
Facilities (DCHFs), including 9 hospitals and multiple nursing facilities, home health
agencies, and other licensed locations. Each licensed facility is required by the terms of its
license to operate in compliance with applicable laws, including DHHS rules. Under
Case 1:21-cv-00242-JDL Document 50-3 Filed 09/15/21 Page 1 of 3 PageID #: 578
R.A. 94
13836255.1.1.1.1.1.1
2
applicable DHHS rules, DCHFs are required to comply with the DHHS Immunization
Requirements Rule.
4. As of August 31, MaineHealth had an employee COVID-19 vaccination rate among its
Maine employees of 88.4%.
5. MaineHealth has made COVID-19 vaccines available to all employees free of charge and
onsite at multiple vaccine clinics, and it continues to provide assistance in obtaining vaccine
appointments, which remain free. MaineHealth employees are eligible to be paid for the time
they take to obtain the vaccine. MaineHealth has provided and continues to provide
education sessions and access to additional resources to all employees about the safety and
efficacy of the vaccine, including on a dedicated COVID-19 intranet page.
6. It has been and continues to be the policy and practice of MaineHealth to comply with all
regulatory requirements and guidance pertaining to infection control in the workplace,
including in particular those from CDC, CMS and OSHA’s Emergency Temporary Standard
pertaining to COVID-19, as well as state requirements.
7. On August 3, 2021, MaineHealth announced that COVID-19 vaccinations would be
mandatory for all of its employees, subject to eligibility for a valid exemption, effective
October 1.
8. To comply with the Immunization Requirements Rule as amended by DHHS, MaineHealth
has informed its employees that they must be fully vaccinated by the date established for
enforcement by the Governor of Maine, unless they are eligible for a valid exemption.
MaineHealth intends to be in full compliance with the Rule when DHHS begins enforcement
with respect to COVID-19 immunization on October 29, 2021.
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R.A. 95
13836255.1.1.1.1.1.1
3
9. In my capacity as Chief Human Resources Officer I am familiar with pending employment
claims including administrative claims filed with the EEOC and/or the Maine Human Rights
Commission against MaineHealth. Although the plaintiffs in this case remain anonymous,
based on the facts alleged by the Jane and John Doe plaintiffs, I do not believe that any of
them has filed an administrative charge alleging religious discrimination against
MaineHealth relating to the COVID-19 vaccine.
I declare under the penalties of perjury under the laws of the United States of America that the
foregoing is true and correct.
Date: September 14, 2021
/s/Judy West
Judy West
Case 1:21-cv-00242-JDL Document 50-3 Filed 09/15/21 Page 3 of 3 PageID #: 580
R.A. 96
13827904.1
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
JANE DOES 1-6, JOHN DOES 1-3,
JACK DOES 1-1000, JOAN DOES 1-1000,
Plaintiffs,
v.
JANET T. MILLS, in her official capacity as
Governor of the State of Maine, JEANNE M.
LAMBREW, in her official capacity as
Commissioner of the Maine Department of
Health and Human Services, NIRAV D. SHAH,
in his official capacity as Director of the Maine
Center for Disease Control and Prevention,
MAINEHEALTH, GENESIS HEALTHCARE
OF MAINE, LLC, GENESIS HEALTHCARE,
LLC, NORTHERN LIGHT HEALTH
FOUNDATION, MAINEGENERAL
HEALTH,
Defendants.
CIVIL ACTION
Docket No: 1:21-cv-00242-JDL
DECLARATION OF GAIL COHEN
1. My name is Gail Cohen. I am an individual residing in Hallowell, Maine, and I am over
eighteen years of age. The following information is based on my personal knowledge.
2. I am employed by MaineGeneral Health (MGH) as Chief Human Resources Officer.
3. MaineGeneral Health operates one facility – MaineGeneral Medical Center – that is licensed
by the Maine Department of Health and Human Services (DHHS) as Designated Health Care
Facilities (DCHFs), and two other healthcare facilities that are licensed in other categories.
Each licensed facility is required by the terms of its license to operate in compliance with
Case 1:21-cv-00242-JDL Document 50-4 Filed 09/15/21 Page 1 of 3 PageID #: 581
R.A. 97
13827904.1
2
federal and state law, including DHHS rules. Under applicable DHHS rules, all three
licensed facilities are required to comply with the DHHS Immunization Requirements Rule.
4. As of August 12, 2021, 73.45% of MGH employees were fully vaccinated and an additional
2% had received a first dose. Between August 12 and August 27, an additional 12 employees
reported themselves to be full vaccinated and an additional 76 had received a first dose.
5. To encourage employees to get vaccinated, MGH has been providing weekly COVID-19
communication updates from our CEO that have included information regarding the
Emergency Use Authorization (EUA) of the vaccines, CDC educational information, a free
COVID-19 employee clinic with availability for day, night, weekend and shifts to make it
easy for staff to access, treating time spent getting vaccinated as compensable,
encouragement to talk with their PCP if they had specific questions regarding their own
health history, and an email address to which to submit questions about COVID-19.
6. It has been and continues to be MaineGeneral Health policy and practice to comply with all
regulatory requirements pertaining to infection control, including in particular those from
CMS, CDC and OSHA’s Emergency Temporary Standard pertaining to COVID-19, as well
as state requirements.
7. To comply with the Immunization Requirements Rule as amended by DHHS, MaineGeneral
Health has informed its employees that they must be fully vaccinated by the date established
for enforcement by the Governor of Maine, unless they are eligible for a valid exemption or
reasonable accommodation. MaineGeneral Health intends to be in full compliance with the
Rule when DHHS begins enforcement with respect to COVID-19 immunization on October
29, 2021.
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R.A. 98
13827904.1
3
8. In my capacity as Chief Human Resource Officer I am aware of all pending employment
claims including administrative claims filed with the EEOC and/or the Maine Human Rights
Commission. None of the plaintiffs in this case has filed an administrative charge alleging
religious discrimination against MGH or any licensed facility operated by MGH relating to
the COVID-19 vaccine.
I declare under the penalties of perjury under the laws of the United States of America that the
foregoing is true and correct.
Date: September 13, 2021
/s/ Gail Cohen
Gail Cohen
Case 1:21-cv-00242-JDL Document 50-4 Filed 09/15/21 Page 3 of 3 PageID #: 583
R.A. 99
UNITED STATES DISTRICT COURT
DISTRICT OF MAINE
JANE DOES 1-6, JOHN DOES 1-3,
JACK DOES 1-1000, JOAN DOES 1-1000,
Plaintiffs,
v.
JANET T. MILLS, in her official capacity as
Governor of the State of Maine, JEANNE M.
LAMBREW, in her official capacity as
Commissioner of the Maine Department of
Health and Human Services, NIRAV D. SHAH,
in his official capacity as Director of the Maine
Center for Disease Control and Prevention,
MAINEHEALTH, GENESIS HEALTHCARE
OF MAINE, LLC, GENESIS HEALTHCARE,
LLC, NORTHERN LIGHT HEALTH
FOUNDATION, MAINEGENERAL
HEALTH,
Defendants.
CIVIL ACTION
Docket No: 1:21-cv-00242-JDL
DECLARATION OF PAUL BOLIN
1. My name is Paul Bolin. I am an individual residing in Bangor, Maine and I am over eighteen
years of age. The following information is based on my personal knowledge.
2. I am employed by Northern Light Health as SVP and Chief Human Resources Officer.
3. Northern Light Health operates numerous facilities in Maine that are licensed by the Maine
Department of Health and Human Services (DHHS) as Designated Health Care Facilities
(DCHFs), including 10 hospitals and multiple nursing facilities, home health agencies, and
other licensed locations. Each licensed facility is required by the terms of its license to
operate in compliance with applicable laws, including DHHS rules. Under applicable
Case 1:21-cv-00242-JDL Document 51-2 Filed 09/15/21 Page 1 of 3 PageID #: 609
R.A. 100
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DHHS rules, DCHFs are required to comply with the DHHS Immunization Requirements
Rule.
4. As of August 30, 2021, Northern Light Health had an employee COVID-19 vaccination rate
among its Maine employees of 88%.
5. Northern Light Health has made COVID-19 vaccines available to all employees free of
charge and onsite at multiple vaccine clinics, and it continues to provide assistance in
obtaining vaccine appointments, which remain free. Northern Light Health employees are
eligible to be paid for the time they take to obtain the vaccine. Northern Light Health has
provided and continues to provide education sessions and access to additional resources to all
employees about the safety and efficacy of the vaccine, including on a dedicated COVID-19
intranet page.
6. It has been and continues to be the policy and practice of Northern Light Health to comply
with all regulatory requirements and guidance pertaining to infection control in the
workplace, including in particular those from CDC, CMS and OSHA’s Emergency
Temporary Standard pertaining to COVID-19, as well as state requirements.
7. On August 2, 2021, Northern Light Health announced that COVID-19 vaccinations would be
mandatory for all of its employees, subject to eligibility for a valid exemption, effective when
emergency use authorization was lifted.
8. To comply with the Immunization Requirements Rule as amended by DHHS, Northern Light
Health has informed its employees that they must be fully vaccinated by the date established
for enforcement by the Governor of Maine, unless they are eligible for a valid exemption.
Northern Light Health intends to be in full compliance with the Rule when DHHS begins
enforcement with respect to COVID-19 immunization on October 29, 2021.
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R.A. 101
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9. In my capacity as Chief Human Resources Officer I am familiar with pending employment
claims including administrative claims filed with the EEOC and/or the Maine Human Rights
Commission against Northern Light Health. Although the plaintiffs in this case remain
anonymous, based on the facts alleged by the Jane and John Doe plaintiffs, I do not believe
that any of them has filed an administrative charge alleging religious discrimination against
Northern Light Health relating to the COVID-19 vaccine.
I declare under the penalties of perjury under the laws of the United States of America that the
foregoing is true and correct.
Date: September 15, 2021
/s/ Paul Bolin
Paul Bolin
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