report on sexual assault in college and university campuses

Influenza Vaccination Watch Group

555 Main Street

Northridge, CA 55555

555-555-5555

March 30, 2015

Mr. John Doe, Senior Lobbyist

California Advocacy Group

555 South Street

Sacramento, CA 55555

Dear Mr. Doe:

The Influenza Vaccination Watch Group has been excited to see much of the new legislation you have been able to bring before the state senate. We also know that we share a common concern for diminishing the pandemic effects of vaccine preventable illnesses. We are interested in working with your firm. We have prepared a proposal that outlines our findings and recommendations regarding increasing vaccination uptake in California's health care workers. Please take the time to read and consider our proposal. If you have any questions please call me at (555) 555-5555. Thank you for your time and consideration of our proposal.

Sincerely,

Director

Influenza Vaccination Watch Group

cs.ivwg.org

Enclosures (1)

Request for Stronger State Level Influenza Vaccination

Regulation for California’s Health Care Personnel

Director

Influenza Vaccination Watch Group

555 Main Street

Northridge, CA 55555

Date: April 28, 2015

Submitted to: California Advocacy Group

Abstract

Table of Contents

Title Page..........................................................................................................................................i

Abstract............................................................................................................................................ii

Table of Contents.............................................................................................................................v

Executive Summary.........................................................................................................................1

Introduction......................................................................................................................................2

Background......................................................................................................................................2

Proposal............................................................................................................................................3

Current California Regulation..........................................................................................................3

Comparison Legislation and Policies...............................................................................................4

National Agencies Policies..................................................................................................4

Individual State Legislation.................................................................................................4

Individual Facility Policy.....................................................................................................5

Issues With California Regulations.................................................................................................6

Recommendations for Change.........................................................................................................7

Conclusion.......................................................................................................................................8

Appendix A......................................................................................................................................9

References......................................................................................................................................10

Bibliography..................................................................................................................................12

Executive Summary

Influenza is a highly contagious disease that can have severe complications, especially in high risk populations (CDC, 2014b). One of the best ways to help prevent the spread of flu is to receive annual flu vaccinations. Vaccinations are especially important for health care personnel because the populations they work with can be highly susceptible to influenza infection. Current legislation in California places the majority of the burden on individual facilities to generate policies. This creates a system where each county, city, and even facility can have very different policies from the next. The minimal legislation currently in place is not as effective as it could be. Clear definitions and enforceable consequences could have a greater effect on vaccination uptake. The CDC has strong recommendations and keeps current on the most up-to-date practices. Policies that require adoption of CDC recommendation will keep facilities current and up to date with innovations in health. The state of New York strengthened legislation. They also require CDC adherence, resulting in a quick and dramatic increase in vaccination uptake in health care personnel. There are also individual facilities with stronger policies that have seen almost complete adherence and uptake. The greater the strength of policy and consequences for noncompliance, the greater the vaccination uptake for health care personnel. Incorporating CDC recommendations, masking policies, and enforcement into legislation can potentially help states improve their influenza vaccination uptake in health care workers. California needs to improve their legislation by making it clear, strong, enforceable, and unified.

Introduction

Hypocrites, one of the fathers of medicine, said that doctors should first do no harm (USNLM [United States National Library of Medicine], 2012). This charge still holds true today. Most health care personnel would not choose to out rightly harm someone, however, some are and do not even realize it. Unvaccinated healthcare personnel have a greater risk of spreading pathogens which can have deadly consequences. (Catania, 2014). Because of this fact, it is important for states to have strong legislation protecting patients from unnecessary risks. The Influenza Vaccination Watch Group is seeking to change California Legislation to better protect this vulnerable population.

Background

The Centers for Disease Control (CDC) asserts that influenza is a highly contagious disease that can have severe complications, especially in high risk populations (CDC, 2014b). The flu is an infection caused by a variety of viruses. The CDC states that it has a wide range of symptoms, such as sneezing, coughing, fever, vomiting, sore throat and headache (CDC, 2014b). The viruses are highly contagious and can be transmitted in aerosol or droplet form through air and surfaces; mainly entering the body through the nose and mouth (CDC, 2014b). The Mayo Clinic asserts that one of the best ways to help prevent the spread of flu is to receive annual flu vaccinations. Though the flu vaccine is not a guarantee against the flu, failing to vaccinate leaves individuals more susceptible to flu and its consequences (Mayo Clinic, 2014). Since the vaccine changes each year, it is important that vaccinations are received annually. It is recommended that everyone ages six months and older obtain a flu vaccine (Mayo Clinic, 2014). However, even with the evidence showing the benefits of vaccinations, many people are still unvaccinated. An article in the Respiratory Care and Critical Care Journal found a strong association between intensive care unit flu related admissions and a low rate of vaccinations (Catania, 2014). Jelena Catania, Loretta G. Que, Joseph A. Govert, John W. Hollingsworth, and Cameron R. Wolfe assert that people who do not receive the flu vaccination are more susceptible to acquiring the flu virus (Catania, 2014).

Many do not realize that vaccinations not only benefit the person who is receiving the immunization, but also the people around them by preventing the spread of the virus. Health care personnel (HCP) are regularly in close contact with vulnerable and high risk populations. For young children, the elderly, and people who are immune compromised, the flu can have very damaging and even deadly consequences (CDC, 2014b). The flu, along with complications such as pneumonia, is the eighth leading cause of death in the United States, with 53,826 deaths in 2011 (CDC, 2014b). The flu also can aggressively aggravate asthma, chronic heart conditions, respiratory problems, and even diabetes (CDC, 2014b). These special populations and other vulnerable people are the ones found in many hospital beds around the state. The California Department of Public Health (CDPH) reveals that the vaccination coverage in health care personnel is still at a relatively low 74 percent (CDPH, 2014). It is imperative that we limit the spread of the Influenza Virus in our health care facilities.

Proposal

Health care facilities offer differing policies and varying levels of stringency (Randall, 2013). The inconsistency in policy can cause confusion and even lead some HCP to quit and seek employment in hospitals with differing policies (Winston, 2014). In efforts to lead change in the issue of uptake (making use of the vaccine) and create uniform policy, regulations must be mandated at state level. The Influenza Vaccination Watch Group proposes that the state legislature construct a clear amendment that will provide stricter regulation and stronger language regarding influenza vaccination uptake for HCP. We encourage the legislative body to further investigate the inconsistency of uptake in HCP and to quickly seek an appropriate solution. The mark of success would be an increase in influenza vaccination uptake among HCP and all California health care facilities meeting the Healthy People 2020 (HP2020) national guidelines of 90 percent HCP vaccination rates (HP2020, 2015). With this success, California could lead the nation on improved uptake in HCP and set an example for all Americans.

Current California Legislation

California Senate Bill Number 739 (CSB739), approved and filed on September 28, 2006, outlines the state requirements for HCP to vaccinate against influenza in order to protect against hospital acquired infections (CSB739, 2006). CSB739 first establishes the Hospital Infections Disease Control Program, which requires a tri-year efficacy review of hospital policy and action on vaccination uptake and compliance. (CSB739, 2006). The legislation has a large portion that focuses on collection of information and statistics for use by the state. These will come in the form of surveillance and compliance reports that are sent to the state and federal agencies (CSB739, 2006). Individual facilities are given the responsibility to create and enforce policy surrounding uptake. The main legislative components are:

Tracking and reporting necessary uptake statistics (CSB739, 2006).
Requiring a written declaration of refusal (CSB739, 2006).
Offering free flu vaccinations (CSB739, 2006).

The bill places more responsibility on hospitals to create, maintain, and evaluate their own vaccination uptake programs and policies (CSB739, 2006). The only basic state mandated policy requirements for facilities are the written declaration, offering of vaccinations, and production of reports. (CSB739, 2006). CSB739 fails to clearly define HCP and who the legislation applies to. CSB739 also leaves most of the policy creation to the facilities and provides little instruction on application and enforcement. The bill does not provide any action to be taken for noncompliance by facilities or HCP. The CDPH, in efforts to help increase compliance and uptake, is urging all hospitals to review CDPH key findings data and to evaluate their own programs and policies (CDPH, 2014). The CDPH is encouraging hospitals to do their part in helping the state reach the Healthy People 2020 national target of a 90 percent health care personal influenza vaccination rate (CDPH, 2014). See Appendix A for full comparison table.

Comparison Legislation and Policies

California is not alone in the fight against Influenza. All states have varying regulations regarding HCP Influenza vaccination uptake. The CDC also has produced policy recommendations for the entire nation. Individual health care facilities also create their own policies regarding vaccination uptake. The variety of policies can be confusing to navigate and each has its own level of effectiveness in increasing influenza vaccination uptake.

National Agencies Policies

The CDC produced a National Healthcare Safety Network Manual that includes a Healthcare Personnel Vaccination Module and Influenza Vaccination Summary (CDC,2014a). The CDC manual, last updated in August of 2014, outlines the national recommendations published by the agency regarding annual influenza vaccinations for HCP. All attempt to follow most of the CDC’s federal recommendations such as:

Employing effective strategies
Offering free vaccinations, training, and education
Tracking and submitting uptake statistics
Providing written or electronic documentation of vaccination and declaration of refusal
Completing annual CDC HCP Influenza vaccination survey forms

These recommendations carry weight, but do not have legal implications, leaving it up to the state to interpret, create, regulate, and enforce policy. Many states like California take cues from the CDC policies, but do not mandate that all CDC requirements be adhered to. See Appendix A for full comparison table.

Individual State Legislation

The New York Department of Public Health (NYDPH) instituted statewide mandatory HCP influenza vaccination policies (NYDPH, 2015b). The NYDPH created regulations that took effect on July 31, 2013, which apply to all health care facilities, including but not limited to: hospitals, nursing homes, diagnostic and treatment centers, and adult day care facilities. The NYDPH states that the regulations require all persons who sign a declaration forgoing the vaccination, due to specified objections or contraindications, to wear a mask at all times during shifts (NYDPH, 2015b). The masks must be used through the influenza peak season, which will be outlined each year, and all health care personnel must comply. Exceptions will be made for patients needing to lip read or for speech therapists modeling words with their mouths (NYDPH, 2015b). The policy outlines how each facility is responsible for policy creation regarding enforcement, discipline, level of mask use (other than regulation standard of basic surgical), use of masks in common areas and break areas, use by non-health care employees, and further application of the policies to non-health care personnel (NYDPH, 2015b). The NYDPH regulation addresses a number key topics:

Providing written or electronic documentation of vaccination and declaration of refusal (NYDPH, 2015b).
Offering free vaccinations, training, and education (NYDPH, 2015b).
Following all CDC recommendations (NYDPH, 2015b).
Masking requirements (NYDPH, 2015b).
Defining HCP and Extending policy to all HCP including office workers, contract workers, students, volunteers, and anyone with potential patient contact (NYDPH, 2015b).

See Appendix A for full comparison table.

Individual Facility Policies

In 2005, the Virginia Mason Medical Center (VMMC) in Seattle, Washington, was one of the first facilities in the United States to institute a mandatory vaccination program with strict enforcement (Schnirring, 2010). Launched during the 2005-06 flu season and affecting 5,000 employees, Virginia Mason's vaccination mandate states that vaccinations are a "fitness-for-duty" condition for continued employment (Schnirring, 2010). If HCP fail to provide documentation their employment will be terminated (Schnirring, 2010). Vaccination rates increased from 54 percent to 97 percent the next year and then to 99 percent by 2007 (Schnirring, 2010;VMMC, 2008). The success of the program has been shown by the dramatic increase in vaccinations; due in part to enforcement through strong negative consequences (Galanakis,2013). (See Chart 1) The policy also clearly defines HCP and extends the policy to all office workers, contract workers, students, volunteers, and anyone with potential patient contact.

The policies include:

Requiring documentation of vaccination or declaration of refusal for approved reasons (Galanakis,2013).
Offering free vaccinations, training, and education (Galanakis,2013).
Offering vaccinations all year and by all methods (Galanakis,2013).
Masking requirements (Galanakis,2013).
Strong and clear policies and enforcement (Galanakis,2013).

Virginia Mason approved 31 exemptions during the first year of the mandatory requirement and that number has not dramatically increased (VMMC, 2008). Only a handful of workers have left the hospital because of the policy (Schnirring, 2010). The nurses union appealed to the courts, stating that the masking policy violated their union agreements. However, the courts upheld the policy. See Appendix A for full comparison table.

Chart 1. Vaccination rate trends of Virginia Mason Medical Center. Chart1 shows the dramatic change after the policies were enacted.

Source: Schnirring, 2010;VMMC, 2008

Issues With California Regulations

Critics of California's current regulations state that the law is a "relatively permissible requirement" (Harris,2014). Harris et al. found that on average, California’s health care personnel knew about the policy and still many remained noncompliant. Harris et al. noticed that there were not a significant number of HCP being punished for blatant disregard of the policy (Harris,2014). The California legislation has many of the same constructs as the stricter policies in other states and facilities, however there is little in the legislation about enforcement. It is left to the facility to create a more comprehensive policy (Harris,2014). Thus, the state is left with a patchwork of differing policies and different levels of enforcement resulting in a lack of overall success in the uptake rate. Mandatory policies need enforcement power by means of strong negative consequences (Galanakis,2013). The rates of influenza vaccination uptake since the legislative action, are not statistically significant when compared to other states (Harris,2014). California's 2006 legislation prompted a slow increase of vaccination uptake (CDPH, 2014). In comparison, when New York's 2013 comprehensive and stringent regulations were enacted, there was an increase in uptake that surpassed California's statistics within a year (CDPH, 2014; NY data, 2014). There are some that have concerns that mandatory programs can infringe on civil liberties and be seen as coercion (Galanakis,2013). Since current regulation has failed to meet uptake standards, the benefits of stronger regulation outweigh the potential harm (Galanakis,2013). See chart 2

Chart 2. Comparison of Influenza vaccination uptake trends in New York and California. Chart shows the quick rise in New York uptake after the new legislation.

Source: CDPH, 2014; NYDPH, 2015a

The void left by weak state legislation has left different counties and health districts trying to close the holes. Jonathan E. Fielding, the Director and Health Officer for Los Angeles County, issued a letter mandating the county to follow guidelines for health care worker (HCW) influenza vaccinations. Fielding states the mandate is in addition to the current California guidelines, as well as individual facility guidelines, will be applied to the whole of Los Angeles County. The letter orders that all HCP refusing vaccination must wear a surgical mask for the duration of the influenza season to prevent transmission while working in patient care areas (Fielding, 2013). Fielding clarifies that this applies to all HCP, including paid, unpaid, contract, student, and volunteer workers who serve in patient care areas or have direct patient contact (Fielding, 2013). This again can lead to confusion with differing polices within the state.

Recommendations for Change

In efforts to meet the National Healthy People Guidelines by 2020, California needs to consider the development of a comprehensive policy that adopts new strategies and will provide stronger enforcement. (HP2020, 2015) The Influenza Vaccination Watch Group asserts that the following items should be considered:

Mandatory state wide policy
Mandatory masking policies
Specific state wide enforcement policy
Investigations into hospitals not meeting guidelines
Stronger and more specific language
Fewer exemptions
A strong recommendation to follow new CDC advisements
Broader definitions of HCP and facilities
Mandatory training and education

Conclusion

Despite the fact that vaccinations can dramatically aid in the prevention of many illnesses, many of the vaccine preventable illnesses still remain a major health threat (Galanakis, 2013). HCP are at a higher risk for both contracting and transmitting infections to high risk populations (Galanakis, 2013). Because high risk populations entrust their care to HCP, it is morally justified to require strong mandatory vaccination regulation. If HCP are going to follow the charge of Hypocrites, then we need to make sure they are doing no harm, even if it is unknowingly (USNLM [United States National Library of Medicine], 2012). In addition, California is falling short of the Healthy People 2020 national objectives for HCP influenza vaccinations rates. In order to reach goals and promote health most efficiently and effectively, we need clear and unified state wide legislation. Strengthening the legislation regulation will not only help California reach national goals, but will help us lead the way to a better health care future.

Appendix A

Comparison table of policies and legislations. The table shows regulations at different levels and with different strengths. The state legislation comes from California and New York. The CDC is a federal agency and the VMMC is an individual facility level policy. These items are general policy ideas and topics and are not exhaustive of all related policy and legislation components.

Current California Legislation	CDC National Recommended Policies
Produce annual surveillance	Employ effective strategies
Produce annual compliance reports	Offer free flu vaccinations
Individual facility policy creation around uptake	Offer training and education
Provide annual vital statistics	Track and submit statistics
Require a written declaration of refusal	Written or electronic documentation of vaccination
Offer free flu vaccinations	Written or electronic declaration of refusal
Prepare influenza disaster plans	Completion of CDC annual HCP Influenza vaccination survey forms
New York Legislation	Virginia Mason Medical Center Policy
Individual facility policy creation around uptake and enforcement	Offer training and education
Require a written declaration of refusal (limited permitted reasons)	Offer free flu vaccinations
Follow CDC recommendations	Masking requirements
Offer free flu vaccinations	Require a written declaration of refusal (limited permitted reasons)
Masking requirements	Termination of employment as a enforcement
Extends policy to all HCP with potential patient contact	Extends policy to all HCP with potential patient contact
	Offered vaccination all year and in all methods

Source: CDC,2014a; CSB739, 2006; Galanakis,2013; NYDPH, 2015b

References

Catania, J., Que, L. G., Govert, J. A., Hollingsworth, J. W., & Wolfe, C. R. (2014). High Intensive Care Unit Admission Rate for 2013–2014 Influenza Is Associated with a Low Rate of Vaccination. American Journal of Respiratory and Critical Care Medicine, 189(4), 485-487. doi:10.1164/rccm.201401-0066LE

CDC, Centers For Disease Control and Prevention, Division of Healthcare Quality Promotion. (2014a). The National Healthcare Safety Network (NHSN) Manual Healthcare Personnel Vaccination Module: Influenza Vaccination Summary (pp. 1-1-A-2). Atlanta,, GA.

CDC, Key Facts about Influenza (Flu) & Flu Vaccine. (2014b, September 09). Retrieved February 4, 2015, from http://www.cdc.gov/flu/keyfacts.htm

CDPH, California Department of Public Health. (2014). California Department of Public Health Influenza Vaccinations Among Health Care Personnel in California's Hospitals for the 2013-2014 Respiratory Season Key Findings and Public Health Actions [Press release]. Retrieved March 30, 2015, from http://www.cdph.ca.gov/programs/hai/Documents/FLU_Vax_HCP_KeyFindings_2012-13_Final050614.pdf

CSB739, Health and Safety Code, relating to health facilities, Chapter 2 of Division 2, S. 739, 109R Cong. 2006

Fielding, Jonathan E. "Health Officer Order for Annual Influenza Vaccination Programs for Healthcare Personnel." Letter to Licensed Acute Care Hospitals, Skilled Nursing Facilities, Long-. 02 Oct. 2013. MS. Los Angeles County, CA.

Galanakis, E., Jansen, A., Lopalco, P., & Giesecke, J. (2013). Ethics of mandatory vaccination for healthcare workers. Eurosurveillance, 18(45), 20627. doi:10.2807/15607917.ES2013.18.45.20627

Harris, K., Pines, L., Han, B., Lindley, M., & Lorick, S. (2014). The impact of influenza vaccination requirements for hospital personnel in California: Knowledge, attitudes, and vaccine uptake. American Journal of Infection Control, 42(3), 288-293. doi:10.1016/j.ajic.2013.09.030

HP2020, Healthy People 2020. (2015). Retrieved March 30, 2015, from http://www.healthypeople.gov/

Mayo Clinic, Infant and toddler health. (2014, October 22). Retrieved February 4, 2015, from http://www.mayoclinic.org/healthy-living/infant-and-toddler-health/expert-answers/flu-shots/faq-20058448

NYDPH, influenza Vaccination Rates for Health Care Personnel by Facility Chart for 2013-2014 [Chart]. (n.d.). In New York State Department of Health. Retrieved March 30, 2015a, from https://health.data.ny.gov/browse/embed?limitTo=charts&q=influenza%2Bhealth%2Bcare&sortBy=relevance&utf8=%E2%9C%93

NYDPH , United States, New York Department of Public Health. (2015, January 1). Frequently Asked Questions Regarding Title 10, Section 2.59. Retrieved March 23, 2015b, from http://www.health.ny.gov/diseases/communicable/influenza/seasonal/providers/prevention_of_influenza_transmission/docs/faq_flu_mask_requirements.pdf

Randall, L. H., Curran, E. A., & Omer, S. B. (2013). Legal considerations surrounding mandatory influenza vaccination for healthcare workers in the United States. Vaccine, 31(14), 1771-1776. doi:10.1016/j.vaccine.2013.02.002

Schnirring, L. (2010, August 03). First hospital to mandate flu vaccination reports on challenges, success. Retrieved March 29, 2015, from http://www.cidrap.umn.edu/news-perspective/2010/08/first-hospital-mandate-flu-vaccination-reports-challenges-success

USNLM. (2012, February 7). U.S National Library of Medicine (United States, National Library of Medicine). Retrieved April 16, 2015, from http://www.nlm.nih.gov/hmd/greek/greek_oath.html

VMMC, Virginia Mason Medical Center. (2008). Best Practices for Increasing Influenza Vaccination Levels among Healthcare Workers [Press release]. Retrieved March 30, 2015, from http://www.izsummitpartners.org/wp-content/bestpractices/BP_Mason.pdf

Winston, L., Wagner, S., & Chan, S. (2014). Healthcare Workers Under A Mandated H1N1 Vaccination Policy With Employment Termination Penalty: A Survey to Assess Employee Perception. Vaccine, 32, 4786-4790. http://dx.doi.org/10.1016/j.vaccine.2014.06.001

Bibliography