BILL ANALYSIS �
Senate Committee on Labor and Industrial Relations
Ted W. Lieu, Chair
Date of Hearing: April 25, 2012 2011-2012 Regular
Session
Consultant: Gideon L. Baum Fiscal:Yes
Urgency: No
Bill No: SB 1318
Author: Wolk
As Introduced/Amended: April 17, 2012
SUBJECT
Health facilities: influenza vaccinations.
KEY ISSUE
Should the Legislature require that all employees, contractors,
students, volunteers, persons with privileges on the medical
staff, and all other onsite health care workers at health
facilities and clinics be vaccinated against influenza or wear a
facemask?
PURPOSE
To repeal the existing process for employees of general acute
care hospitals to decline the influenza vaccination and create
new influenza vaccination requirements for workers employed by
and affiliated with health facilities and clinics.
ANALYSIS
Existing law provides for the Occupational Safety and Health
Standards Board (OSHSB), which consists of seven individuals
appointed by the Governor for four year terms. Two members must
be from the field of management, two members must be from the
field of labor, one member must be from the field of
occupational health, one member must be from the field of
occupational safety and one member must be from the general
public (Labor Code ��140 and 141).
Existing law empowers OSHSB, by an affirmative vote of four or
more members, to adopt, amend, or repeal occupational safety and
health standards. The procedure to adopt, repeal, or amend
occupational safety and health standards must follow the process
for promulgating regulations, unless otherwise stated in Labor
Code (Labor Code ��142.3 and 142.4).
Existing law requires that the Department of Occupational Safety
and Health (DOSH) enforce all occupational safety and health
standards adopted by OSHSB (Labor Code �142).
Existing law requires that OSHSB develop or revise certain
specific occupational safety and health standards, including
bloodborne pathogens, hazardous substance removal work,
agricultural field sanitation, and lead-related construction.
(Labor Code ��142.7, 144.7, 6712, & 6717)
Existing OSHA Regulations create an occupational safety standard
requiring certain protections for workers who may be exposed to
an Aerosol Transmissible Disease (ATD). The ATD standard is not
for seasonal influenza, although it would cover new variants of
influenza (swine and bird flu, for example).
(California Code of Regulations, Title 8, �5199)
Existing law requires that each general acute care hospital, in
accordance with the Centers for
Disease Control guidelines, take all of the following actions:
a) Annually offer onsite influenza vaccinations to all
hospital employees at no cost to the employee. Each general
acute care hospital shall require its employees to be
vaccinated, or if the employee elects not to be vaccinated,
to declare in writing that he or she has declined the
vaccination;
b) Institute respiratory hygiene and cough etiquette
protocols, develop and implement procedures for the
isolation of patients with influenza, and adopt a seasonal
influenza plan;
c) Revise an existing or develop a new disaster plan that
includes a pandemic influenza component. The plan shall
also document any actual or recommended collaboration with
local, regional, and state public health agencies or
Hearing Date: April 25, 2012 SB 1318
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Senate Committee on Labor and Industrial Relations
officials in the event of an influenza pandemic.
(Health and Safety Code �1288.7)
Existing law defines a "health facility" as any facility, place,
or building that is organized, maintained, and operated for the
diagnosis, care, prevention, and treatment of human illness,
physical or mental, including convalescence and rehabilitation
and including care during and after pregnancy, or for any one or
more of these purposes, for one or more persons, to which the
persons are admitted for a 24-hour stay or longer. This
includes general acute care hospitals. (Health and Safety Code
�1250)
Existing law defines a "clinic" as an organized outpatient
health facility that provides direct medical, surgical, dental,
optometric, or podiatric advice, services, or treatment to
patients who remain less than 24 hours, and that may also
provide diagnostic or therapeutic services to patients in the
home as an incident to care provided at the clinic facility.
(Health and Safety Code �1200)
This bill would repeal, as of July 1, 2013, existing requirement
covering general acute care hospitals and would instead
institute, as of July 1, 2013, the following:
a) Requires all health facilities to annually offer its
employees onsite influenza vaccinations, if available, at
no cost to the employee;
b) Repeals the ability of an employee to decline
vaccination through a written declaration;
c) Requires that, if an employee declines an immunization,
the employee must use a health facility-provided surgical
or procedural mask, or other mask that covers the mouth and
nose area of the face while this person is performing his
or her duties in any patient care area of the health
facility during the influenza season, as defined by the
State Health Officer or a local health officer, or both;
d) Extends the vaccination or masking requirements to all
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contractors, students, volunteers, persons with privileges
on the medical staff, and all other onsite health care
workers affiliated with the health facility;
e) Requires the health facility to maintain influenza
vaccination records of employees, contractors, students,
volunteers, persons with privileges on the medical staff,
and all other onsite health care workers affiliated with
the health facilities who were vaccinated onsite or
offsite. If the health facility does not have records of a
worker being vaccinated onsite, the health facility must
require that the worker either provides documentation of an
offsite vaccination or documentation that he or she refused
the vaccination;
f) Requires each health facility to develop policies to
ensure its employees, contractors, students, volunteers,
and other onsite health care workers affiliated with the
health facility, not including medical staff , are in
compliance with the vaccination requirements imposed by
this section.
g) Requires the medical staff to develop policies
independent of the policies established by the health
facility to ensure that persons who have privileges on the
medical staff are in compliance with the vaccination
requirements of this section.
h) Specifies that nothing in this section shall be
construed to prevent a health facility from instituting
additional measures to maximize influenza vaccination rates
and to prevent health care workers affiliated with the
health facility from contracting and transmitting the
influenza virus;
i) Continues the requirement on general acute care
hospitals to take all of the following actions:
i. Institute respiratory hygiene and cough
etiquette protocols, develop and implement procedures
for the isolation of patients with influenza, and
adopt a seasonal influenza plan; and
Hearing Date: April 25, 2012 SB 1318
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ii. Revise an existing or develop a new disaster
plan that includes a pandemic influenza component. The
plan shall also document any actual or recommended
collaboration with local, regional, and state public
health agencies or officials in the event of an
influenza pandemic.
a) Defines "Health care worker affiliated with the health
facility" as a person who is either a volunteer or is
employed by, paid by, or receives credit or any other form
of compensation from the health facility. This includes,
but is not limited to, physicians, nurses, nursing
assistants, therapists, technicians, emergency medical
service personnel, dental personnel, pharmacists,
laboratory personnel, autopsy personnel, students and
trainees, and contractual staff not employed by the health
facility.
b) Defines "Medical staff" as professional medical
personnel who are approved and given privileges to provide
health care to patients in a health facility and who are
responsible for the adequacy and quality of care rendered
to patients. Medical staff includes physicians, and, where
dental or podiatric services are provided, dentists or
podiatrists.
This bill would also extend the requirements listed above to
clinics.
COMMENTS
1. A Brief Discussion on the Influenza Virus and Vaccine:
According to the Centers for Disease Control and Prevention
(CDC), the influenza virus, also known as the flu, is a
contagious respiratory illness that infect the nose, throat,
and lungs. It can cause mild to severe illness, and at times
can lead to death. Most experts believe that flu viruses
spread mainly by droplets made when people with flu cough,
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sneeze or talk. These droplets can land in the mouths or noses
of people who are nearby. Less often, a person might also get
flu by touching a surface or object that has flu virus on it
and then touching their own mouth, eyes or possibly their
nose.
There are two types of flu vaccines: the traditional "Flu
shot", which is the inactivated vaccines (containing killed
virus) that are given with a needle, and the nasal-spray flu
vaccine, which is a vaccine made with live, weakened flu
viruses that is given as a nasal spray. As will be discussed
below, both vaccines have certain restrictions.
Since 2010, the CDC has recommended that everyone over six
months of age should get a flu immunization, including
healthcare workers. However, certain individuals should not
get the flu vaccine for health reasons. They include
individuals who are allergic to eggs or have other severe
allergies, individuals who have had Guillain-Barr� Syndrome,
and anyone currently suffering from fever or illness.
Additionally, certain individuals should only get the
inactivated vaccine, including adults over 50 years of age,
pregnant women, and anyone with certain muscle disorders.
2. What are the CDC Recommendations for Seasonal Influenza in the
Healthcare Setting?
The current law flu vaccine requirements are based on CDC
recommendations on how to control the spread of influenza in
the healthcare setting. The most recent recommendations focus
on promoting influenza vaccination for all healthcare
personnel (HCP), which includes nurses physicians, and those
not directly involved with patient care but could spread the
flu. As part of a systemic strategy to combat the flu, the
CDC suggests providing the vaccine at no cost, requiring
personnel to sign declination forms to acknowledge that they
have been educated about the benefits and risks of
vaccination, as well as simply mandating the flu vaccine.
The CDC also provides facemask recommendations. Several of
the recommendations cover ill patients or ill HCP. Outside of
those examples, the guidelines suggest the use of a facemask
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upon entering the room of a patient and discarding the mask
immediately upon leaving the room. In the event that the
employee has opted out, the guidelines suggest to not use a
facemask, but rather "to provide employees with alternative
personal protective equipment, this equipment should provide
the same protection of the nose and mouth from splashes and
sprays provided by facemasks (e.g., face shields and N95
respirators or powered air purifying respirators)."
Finally, the CDC also makes suggestions on sick leave policies
for healthcare personnel. Specifically, the CDC suggests that
healthcare employers develop "sick leave policies for HCP that
are non-punitive, flexible and consistent with public health
guidance to allow and encourage HCP with suspected or
confirmed influenza to stay home." The CDC also suggests
temporary reassignment for healthcare personnel who come back
from sick leave due to the flu.
3. Face Mask Efficacy and Influenza:
From the Senate Health Committee Analysis:
"There is some question about the value of surgical masks
protection against the flu, and several studies point to
differing outcomes. For example, a 2009 study published in
JAMA found that surgical masks appear to be nearly as
effective as N95 respirators (which the CDC recommends for the
protection of health care workers who come in direct contact
with patients with H1N1) at preventing flu in health care
workers performing routine care. On the other hand, a 2008 CDC
study in the journal Emerging Infectious Diseases concluded
that health care workers could contaminate their skin or
clothes with pathogens during the removal of personal
protection equipment (such as surgical masks), resulting in
accidental self-inoculation and virus spread to patients and
other health care workers."
4. Possible Amendments:
As currently written, SB 1318 would pose some unique issues
from the perspective of California Labor Law that the
Committee may wish to consider. Specifically:
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Required Vaccinations and Workers' Compensation:
As has already been discussed, students and volunteers are
included in the requirement of being vaccinated against
influenza. However, as they do not have an employment
relationship with either the hospital or a related vendor,
they would not be covered by the workers' compensation system.
As such, in the event of an adverse reaction to the influenza
vaccination, they would be required to pay for their own
healthcare. The Committee may wish to consider if such an
outcome is appropriate.
Employment-Related Vaccinations and Their Provision:
SB 1318 currently provides that both health facilities and
clinics must make the influenza vaccine available to their
employees at no cost. However, the bill does not extend a
similar requirement to contractors, students, volunteers,
persons with privileges on the medical staff, and all other
onsite health care workers. This creates an
employment-specific requirement to these individuals, but
requires that they fulfill that requirement using their own
resources. The Committee may wish to consider if such an
outcome is appropriate.
Differing Vaccination Requirements between Physicians and
non-Physicians:
As was discussed above, SB 1318 requires the creation of a
different vaccine compliance policy for physicians and
specialists. It is unclear how creating dueling compliance
policies would further the goal of increased influenza
vaccination. While the health facility and clinic may only
have a contractual relationship with Medical Staff, these
individuals are offering direct patient treatment and could
spread influenza to patients. The Committee may wish to
consider if separate compliance programs are efficacious.
The Goal of Mandatory Facemasks:
As was discussed above, the CDC unambiguously suggests
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influenza vaccines for nearly all healthcare personnel.
However, the use of facemasks in lieu of influenza vaccines
may be problematic; if the 2008 CDC study is correct, it may
perversely make healthcare personnel more likely to come down
with the flu. Additionally, mandatory masking may be viewed
by some employees as a tool to push towards vaccination due to
the discomfort of wearing the mask on a regular basis.
Rather than eliminating the existing declaration process, it
may be worthwhile to instead focus on educating employees and
others on the efficacy of the influenza vaccine and its low
level of adverse side effects. As was discussed in the recent
National Vaccine Advisory Committee report, most HCP declined
the influenza vaccine due to fear of an adverse reaction. The
Committee may wish to consider if eliminating the vaccine
declaration is efficacious.
Noting the above mentioned issues, as well as the need to
protect patients from the influenza virus, the Committee may
wish to consider the following amendments, which would:
a) Keep the expansion of the vaccination requirement to
all health facilities and clinics as well as the same
groups of healthcare professionals;
b) Remove students and volunteers to avoid workers'
compensation issues;
c) Combines vaccination compliance programs and
clarifies who pays for the vaccinations; and
d) Retains the existing declaration structure in the
event a healthcare professional does not wish to be
vaccinated.
1) On page 3, strike lines 23 to 40;
2) On page 4, strike lines 1 to 36;
3) On page 4, line 39 strike "By July 1, 2007, the" and
insert "The";
4) On page 4, line 40, strike "general acute care
hospital," and insert "clinic and health facility";
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Senate Committee on Labor and Industrial Relations
5) On page 5, line 4, strike "hospital" and insert
"contractors, persons with privileges on the medical staff,
and all other onsite health care workers affiliated with
the clinic or health facility" after "employees,";
6) On page 5, line 4, strike "to the employee";
7) On page 5, lines 4 and 5, strike "general acute care
hospital" and insert "clinic and health facility";
8) On page 5, line 5, insert ", contractors, persons with
privileges on the medical staff, and all other onsite
health care workers affiliated with the clinic or health
facility" after "employees";
9) On page 5, line 6, insert ", contractor, person with
privileges on the medical staff, or onsite health care
worker affiliated with the clinic or health facility" after
"employee";
10) On page 5, between lines 15 and 16, insert the
following:
(d) For purposes of this section, the following definitions
shall apply:
(1) "Health care worker affiliated with the clinic or
health facility" means a person who is employed by, paid
by, or receives credit or any other form of compensation
from the clinic or health facility. Health care worker
affiliated with the clinic includes, but is not limited to,
physicians, nurses, nursing assistants, therapists,
technicians, emergency medical service personnel, dental
personnel, pharmacists, laboratory personnel, autopsy
personnel, and contractual staff.
(2) "Medical staff" means professional medical personnel
who are approved and given privileges to provide health
care to patients in a clinic or health facility and who are
responsible for the adequacy and quality of care rendered
to patients. Medical staff includes physicians and
surgeons, and, where dental or podiatric services are
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provided, dentists or podiatrists.
11) On page 5, strike lines 16 to 40;
12) On page 6, strike lines 1 to 40;
13) On page 7, strike lines 1 to 4.
5. Proponent Arguments :
The California Medical Association (CMA), co-sponsor of this
bill, argues that masking policies have proven to be the most
effective policy to increase vaccination compliance rates and
protect its patients. CMA states that California hospitals
with the highest vaccine compliance rate are those that have
such policies in place. CMA asserts that the sole purpose of
this bill is to protect patients from contracting the flu
virus in health care settings and do it in the most proven
effective and efficient way possible. The Health Officers
Association of California (HOAC), co-sponsor of this bill,
states that this bill will increase influenza vaccination
rates at hospitals in California, resulting in a healthier
workforce and a healthier population. According to The
American Congress of Obstetricians and Gynecologists, District
IX (California), SB 739 required California's acute care
hospitals to offer the vaccine free of charge, but
unfortunately the success of that legislation has fallen short
of achieving desired compliance rates, and we need to look at
other options to protect our most vulnerable populations.
The California Association for Nurse Practitioners (CANP),
co-sponsor of this bill, writes that several counties and
numerous hospitals have gone beyond state law and have
established mandatory vaccination policies. CANP states that
according to their members, receiving an annual flu vaccine
has become a standard practice for health care providers, and
this bill will ensure that this practice becomes even more
firmly entrenched as a practice.
6. Opponent Arguments :
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The American Federation of State, County and Municipal
Employees, AFL-CIO (AFSCME) and the United Nurses Associations
of California/Union Health Care Professionals (UNAC/UHCP)
write that it is unreasonable to mandate a questionably
effective vaccine on onsite health care workers and that it is
more sensible to work on educating workers on better infection
control and improve screening and triaging of patients,
families, and visitors who enter health care facilities.
AFSCME and UNAC/UHCP state that that hospitals, clinics,
doctors' offices should work to ensure environmental cleaning
staff have the training, equipment, and time (adequate
staffing levels) to do all the cleaning required to clean
surfaces routinely, especially around symptomatic patients.
The California Nurses Association (CNA) writes that this bill
provides for the medical staff at health facilities and
clinics to develop an independent influenza policy, and that
having two separate influenza policies for employees who work
in the same clinics and health facilities is confusing for
those attempting to implement the new policy, and in
particular for the employees who are navigating through two
separate policies. CNA also asserts that transmission of the
influenza virus does not delineate between classifications of
health care workers and that having two policies jeopardizes
patients, workers and the public who enter the health
facilities and clinics. CNA states that there is no sound
public policy that supports two standards, and they strongly
object, stating it is divisive and could lead to future
discrimination issues in the workplace.
7. Prior Legislation :
SB 739 (Speier), Chapter 526, Statutes of 2006, creates the
existing influenza vaccination structure for general acute
care hospitals.
SUPPORT
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Senate Committee on Labor and Industrial Relations
California Association for Nurse Practitioners (co-sponsor)
California Medical Association (co-sponsor)
Health Officers Association of California (co-sponsor)
American Congress of Obstetricians and Gynecologists - District
IX California
California Association for Nurse Practitioners
California Pharmacists Association
California Psychiatric Association
California Society of Health-System Pharmacists
Californians for Patient Care
Santa Clara County Board of Supervisors
OPPOSITION
American Federation of State, County and Municipal Employees,
AFL-CIO
California Labor Federation, AFL-CIO
California Nurses Association
Laborers' Locals 777 and 792
Service Employees International Union (unless amended)
United Nurses Associations of California/Union of Health Care
Professionals
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Senate Committee on Labor and Industrial Relations