St. Louis County is the largest county in the state of Missouri. Since this practice was implemented in 1999, the county population was 1,016,315, according to US census 2000 data. Subsequently, US census 2010 data showed a slight decline in total population from 1,016,315 to 998,692. Food handlers were our target population. Based on hepatitis A vaccination consent form data between 2000 through 2003, there were 218,146 food handlers in the county. This data includes food handlers who received their first hepatitis A shot at the St Louis County community clinics only and those vaccinated by community outreach by STLCODOH nurses. Since the practice mandated all food handlers get vaccinated, 56% of food handlers received their first shot between Jan 2000 through Dec 2003, (n=122,452) and 44% received their second shot in that period. (n=95,694). Food handlers who received their first shot at the health centers did not necessarily have the second shot at the same clinics. Also note these food handlers were not necessarily St Louis County residents. Of 218,146 food handlers, 93% were 18 through 65 years old. Gender, ethnicity and socio economic data is unavailable. Overall there are 4500 food establishments in the region. Source: Division of Environmental Protection (DEP) 2012
Hepatitis A is an acute, self-limiting and rarely fatal disease but poses a significant economic burden. During 1993 to 1999, St. Louis County had three hepatitis A outbreaks, each involving major food establishments. The continuing high case rate, frequently occurring outbreaks, and the high cost of providing IG to exposed persons strained the County’s resources. During the 1999 outbreak, despite strict implementation of all the recommended control measures, cases continued to rise. The St. Louis County Department of Health (STLCODOH) decided that mandatory vaccination of food handlers against hepatitis A could be the best solution to control the recurring outbreaks. The primary goal of STLCODOH was to mandate vaccine among food handlers to reduce morbidity and to prevent future outbreaks. The practice intended to lower hepatitis A incidence in the region. Number of cases started to decline from 110 in 1999 to 27 in 2000. The incidence rate has been below 1 per 100,000 in the last decade, between 2000 through 2011. Hepatitis A is a vaccine preventable illness. This vaccine has been in use since 1995, has fewer side effects and is affordable. Food handlers are not more likely to get the virus, but if infected they pose a major public health risk for spreading hepatitis A to hundreds of people. Newer evidence based studies suggest that mandatory vaccination policy is the strongest predictor of vaccine uptake. For the reasons mentioned above this practice can be easily adopted by LHDs.
The ordinance mandating hepatitis A vaccine for food handlers was passed in December 1999 and went into effect in July 2000.Informational brochures were sent out to the food establishments. A press release and media messages were posted on the county`s website. The St Louis County Council funded the cost of vaccine. Initially, vaccine was offered at a minimal cost through St. Louis County Department of Health community health centers. The STLCODOH hired additional staff and nurses to provide on- site vaccination, at various food establishments. More sites were added later.
The rate of hepatitis A cases declined from 10.82 in 1999 to <1 (0.98) per 100,000 in 2001. There have been no outbreaks reported since 2000.Due to the fact that between 2000 through 2003, more than 40% food handlers were vaccinated, cases declined 10 fold and no outbreaks were reported during that time, our primary goal was met. Collaboration with key stakeholders, information sharing with the target audience through media outlets, the STLCODOH website, flyers, ease of access to vaccination through community health centers, and affordability were some of the key factors that led to the success of this practice. It is now proven that mandating vaccine is the strongest predictor of vaccine uptake.
The public health issue that this practice addressesHepatitis A is self-limiting and rarely fatal disease but poses a significant economic burden. According to World Health Organization, “In the United States, a region of relatively low hepatitis A endemicity, calculations based on surveillance data from 1989 indicated annual medical and work-loss costs of approximately US$ 200 million.” In the US there are more than 20,000 cases of Hepatitis A reported each year although rates have been declining. Outbreaks are seen occasionally. Food handlers are not more likely to get the virus, but if infected they pose a major public health risk for spreading hepatitis A to hundreds of people.
During 1993 to 1999, St. Louis County had three hepatitis A outbreaks, each involving major food establishments. In 1993 alone, St. Louis County had 205 cases, for a case rate of 20.5 per 100,000. Although the annual case rate declined to 1.1 per 100,000 in 1998, there was an uptick in 1999 when 110 cases were reported; with a rate of 10.82 per 100,000. STLCODOH nurses provided preventive Immune globulin G (IG) to more than 7000 citizens during these outbreaks. The continuing high case rate, frequently occurring outbreaks, and the high cost of providing IG to exposed persons strained the County’s resources.
The process used to determine the relevancy of the public health issue to the communityHepatitis A is a reportable condition in the state of Missouri. Through routine surveillance, outbreaks were detected. Epidemiological data analysis linked all three outbreaks to major food establishments. The evidence also traced the primary index cases to infected food handlers at the facilities. Additionally, environmental inspection of the facilities also confirmed person to person transmission.
How the practice address the issueDuring the 1999 outbreak, despite strict implementation of all the recommended control measures such as hand hygiene, proper food handling and storage protocols, and numerous inspections of food establishments, cases continued to rise. The Communicable Disease Control Services Division (CDCS) and the Division of Environmental Protection (DEP) of the STLCODOH identified the need for a major policy change to reduce the rising case counts and further control recurring outbreaks. Initially a proposed ordinance required immunization against hepatitis A for restaurant and supermarket staff only. In December of 1999, the St. Louis County Council, with the support of St. Louis Chapter of the Missouri Restaurant Association and major food chain owners, passed an ordinance that mandated hepatitis A immunization for all food handlers working in the County. The ordinance went into effect on July 1, 2000. It required vaccination against “hepatitis A for food handlers. As cited in the ordinance “A “food handler” shall mean a person who is employed by any person or entity in any capacity which requires the preparation, handling or touching of any food (except uncut produce), utensils, serving items or kitchen or serving area surfaces or materials, in a place where food that is intended for individual service and consumption is routinely provided completely prepared, regardless of whether consumption is on or off the premises and regardless of whether there is a charge for the food. Such places include restaurants, hospital cafeterias, school and nursing home kitchens, day care facilities, residential group homes, caterers, banquet facilities, coffee shops, cafeterias, short order cafes, luncheonettes, taverns, sandwich stands, soda fountains, food vending carts and all other eating or drinking establishments, as well as kitchens, commissaries or other places in which food or drink is prepared for individual sale elsewhere”. The ordinance also specified three categories that are exempt: pregnant women, daycare centers with fewer than 10 children, and benevolent groups e.g. churches that host barbecues and other social events at which food is served.
The practice is new to the field of public healthProcess used to determine that the practice is new to the field of public healthThe practice was new to the field of public health at the time the ordinance was passed in 1999. St Louis County was the first jurisdiction in the state of Missouri to mandate hepatitis A vaccine for food handlers. St Louis County was categorized as high rate community with more than 20 cases per 100,000 in 1993 based on Advisory Committee on Immunization Practices (ACIP) guidelines for classifying areas with epidemics of Hepatitis A. ACIP recommended routine vaccination of children in those areas, as in most cases children were the most likely source of transmission and spread. Case rates declined in many communities in 1999, after ACIP recommended Hepatitis A vaccine for children.
In St Louis County all three community wide outbreaks involved major food establishments, and were linked to infected food handlers. Infected food handlers, in particular, represent an extremely high risk for the transmission of pathogens to others through food when bare hand contact with ready-to-eat foods and poor hand washing are present. According to Allen et al study 2006, 31% of all outbreaks reported to the CDC between 1994 through 1999 were foodborne. (n=80). Of these 66% were restaurant or food service related with unknown source (n=53) and 21% involved an infected food handler (n=17).The vaccine, which has been used in the US since 1995, has fewer side effects. Mandatory immunization for food handlers ensured vaccination uptake.
How this practice differs from other approaches used to address the public health issueACIP recommends vaccinating high risk individuals against Hepatitis A, which include children, adults working in day cares, travelers, men having sex with men, IV drug users, people at risk of occupational exposure such as non human primate handlers or people working with Hepatitis A virus in research labs. Routine vaccination is not recommended for food handlers. Most of the outbreaks during 1994 through 1999 were reported in daycares and children were cited as major source of transmission. Targeted vaccination of children in areas with high case rates and outbreaks was considered an effective control strategy. Case rates declined in many communities in 1999, after ACIP recommended Hepatitis A vaccine for children. St Louis County was unique that all major outbreaks occurred at major food establishments and involved infected food handlers, who were most likely, the source of transmission and spread of Hepatitis A. During epidemics, best preventative measures include hand hygiene, safe food handling, maintaining proper food temperatures as well as getting a vaccine before the infection. In rare cases Hepatitis A causes acute liver failure in individuals with underlying risk factors such as immunocompromised, old age or other chronic conditions. This can lead to hospitalization and requires liver transplant. Between 1993 through 1999 St Louis County reported one case of Hepatitis A with acute liver failure, requiring liver transplant. The unique aspect of this practice was mandatory Hepatitis A vaccination for food handlers, which ensured high uptake, ultimately led to lower morbidity and reduced economic burden due to illness.
Primary stakeholdersGeneral public, STLCODOH, food handlers, food servicing facilities, St. Louis Chapter of the Restaurant Association, major food chain and catering services owners, owners of places in which food or drink is prepared for individual sale e.g. daycare, schools, hospital cafeteria, nursing homes, residential group homes, gas stations were the key stake holders.
LHD's role Broadly speaking the practice incorporates all three fundamental roles pertaining to any public health practice: Assessment/Assurance: The STLCODOH took the lead in research, development and implementation of this ordinance. CDCS nurses led case investigations during outbreaks, implemented standard control measures, and offered prophylactic IG to close contacts. The DEP at the health department carried out food facility inspections, reviewed food handling and storage protocols, provided safe food handling education to the staff at food establishments. No major violations were noted, except for low or occasionally no proof of hepatitis A vaccination among food handlers.
The two divisions worked closely, exchanging research information. This successful collaboration led to the proposed ordinance. The bill was forwarded to the County Council. The County Council scheduled public hearings. Policy development: Findings led to the development of mandating hepatitis A vaccine to food handlers.
Stakeholders/partnersThe general public, the St. Louis Chapter of the Restaurant Association, major food chain owners, and other key stakeholders participated in the discussions. Some of the major concerns rose during the hearings were fear of side effects of vaccine. Others pointed out that mandatory vaccination of food handlers will give them a false sense of security, which will jeopardize hand hygiene and safe food handling practices. It was also noted if the law would apply to a food handler at a day care facility with less than 10 kids, or a person who volunteers as a food handler. Religious and health exemptions were also discussed. Question about businesses should self regulate safe food handling and vaccination of their employees was also brought up during hearings. After several meetings, St. Louis County Council passed the bill into an ordinance on December 16, 1999. The ordinance addresses the key concerns raised during public hearings.
STLCODOH continuously monitors number of hepatitis A cases reported, through routine surveillance. Weekly and monthly reports are generated and disseminated to general public, infection prevention staff and area physicians via website and email.
Routine inspections are carried out by the DEP staff. Any violations if noted are rectified through education, follow up inspections and face to face meetings with the environmental program manager.
Lessons learned Immunization is an effective way to control recurring epidemics for vaccine preventable illnesses. Building effective intra and interagency relationships is essential to address issues of public health importance and establish new policies that will ultimately benefit communities. Implementing the code, placing primary responsibility for compliance on the permit holder combined with the protocol requiring environmental staff to conduct a 10 day follow up inspection for noncompliance, is an effective enforcement tool to ensure compliance. Some of the barriers to developing collaboration especially with the permit holder are, withholding employee`s immunization records by some employers, when paid for by employer, poor immunization record keeping by some employers for new versus old hires delays compliance and the implementation process. Need for two shots also pose a challenge. Employees often miss the second shot. There are no processes or systems in place by the employers for alerting employees when the second shot is due. High job turnover between inspections especially for facilities where inspections are done yearly such as convenience stores and gas stations also delays compliance.
Tasks taken that achieve each goal and objective of the practiceTasks can be broadly divided into following categories:
1- Funds: Arranging funds for initial vaccine purchase, printers/scanners and to hire staff.
2- Education/Training: Developing flyers and other educational materials for the target audience. Spreading the word this included, education about the ordinance and the vaccine to key stake holders. Training the DEP staff i.e. introducing the new ordinance
3- Tools/Record Keeping: Developing electronic tools to capture immunization information including the number of shot received, and compliance information by food handlers and permit holders.
Time frameOrdinance was passed in Dec of 1999, and went into effect within 6 months on July 1 2000.
Implementation- On Dec 1999, the ordinance was also added to the St. Louis County Food Code section 8-501.11. A copy of ordinance was also available on the county`s website for public access.
On May 16, 2000, the Saint Louis County Department of Health sent informational brochures to all licensed foodservice establishments to remind them of the new requirement. Environmental Representatives/Specialists began enforcing the new law in Saint Louis County beginning July 1, 2000.-
On June 8, 2000, the Council approved a revision extending the grace period to thirty days for new hires to get the first shot. The St Louis County Council funded the initial purchase of vaccine and the cost of new staff. Detailed information on vaccine and locations where vaccine is offered was posted on the health department’s website. Electronic databases and other tools to capture immunization information were developed and were available for use in July 2000.The vaccine was offered at the health department’s South County and the John C. Murphy Health Centers for $25 per dose for those 19 years of age and older, and $18 per shot for those under 19 years old. Additionally, it was also being offered through various other health organizations such as the Visiting Nurse Association and corporate health providers.
Lessons learnedDuring implementation process the need for additional sites providing vaccination was identified. Furthermore, electronic systems and reports were put in place to set up reminders for the second shot.
Cost of implementationSt. Louis County Council funded the project. Money was used to purchase initial batch of vaccines. Nurses and additional staff were hired for vaccine administration. Consent form scanners and printers were purchased with the funds.
Objective 1: Monitoring hepatitis A vaccination compliance and non-compliance at food servicing facilities Monthly and year to date comparison of number of hepatitis A compliance versus non compliance food servicing facilities is the performance measure. Primary data source is the food servicing facilities inspection reports. DEP staff does routine inspections at food servicing facilities. Data is entered by the DEP staff into an in house data collection system. This tool was developed five years ago, to monitor any increase in non – compliance or a sudden decline in compliance. Based on 2012 YTD data 5937 food servicing facilities were inspected, of those 85% were hepatitis A compliant.DEP is working with the staff to add these findings to the annual Community Environmental Health Profile report for dissemination to general public. This report will be available in electronic and paper format. DEP is also planning to modify data capturing and analysis tools to further improve the process.
Objective 2: Enhance routine surveillance and active surveillance. Performance measure: Changes in trends or a sudden rise in number of cases above the expected threshold (previous 5 year median) is the performance measure. Primary data source is the hepatitis A disease case report received via fax from physicians office, laboratories, or hospitals or the state lab. The CDCS nurses investigate the case using enteric disease questionnaire. This form enables STLCODOH to gather key epidemiologic data by person, place and time. The nurses enter this information in a web based data capture system developed by the state of Missouri, called “Websurv”. Data is downloadable in easy format and readily available for analysis and surveillance.
STLCODOH developed surveillance tools to monitor changes in trends and or detect hepatitis A outbreaks. This system is successfully in place since the last 10 years. The rates have been steady in the last decade and no outbreaks have been detected. On average the CDCS division receives 2 -3 cases per month, the incidence rate is <1 per 100,000. STLCODOH disseminates the surveillance findings via weekly report that is posted on the DOH website, available for viewing by the general public and all key stakeholders. Additionally a monthly report summarizing major enteric diseases is emailed back to the hospitals, Infection Control Departments. As ongoing feedback and communication. All of the feedback is positive and no modifications were made.
Objective 3: Monitoring hepatitis A cases by occupation. Performance measure: Descriptive analysis of number of hepatitis A by occupation especially food handlers versus non food handlers and other high risk occupation is the performance measure.
The CDCS nurses investigate the case using enteric disease questionnaire, which includes questions pertaining to high risk occupation such as food handler, day care workers, and health care. Information on family members working in high risk occupation is also captured.
The nurses enter this information in a web based data capture system developed by the state of Missouri, called “Websurv”. Data is downloadable in easy format and readily available for analysis and surveillance. This system is successfully in place since the last 10 years. Occupation specific disease rates have been steady in the last decade and no outbreaks have been detected. On average the CDCS division receives 0-1 case per month among food handlers versus 2 in non food handlers. STLCODOH reviews the information weekly and monthly. Any increase or change in trend is communicated to the DEP. If need arises any abnormal trend is disseminated via monthly report to the hospitals, Infection Control Departments. All of the feedback is positive and no modifications were made.
Stakeholder CommitmentThe STLCODOH continues to offer hepatitis A vaccine at its three community health centers during business hours. There has been an increase in the cost of vaccine during the last 10 years (between 2000 to 2011) from $25 to $37 for those 19 years of age and older and from $18 to $27 for those under 19 years old. In 2005, the County Council expanded the number of authorized facilities offering hepatitis A vaccine to include other entities such as not-for-profit corporations, public school districts, fire protection districts, the State of Missouri and any political subdivisions besides St. Louis County.
For new hires, as cited in the ordinance “a two week grace period is allowed to provide written documentation or certification by a health care provider that:1. the person is immune from hepatitis A; or 2. the person has been vaccinated against hepatitis A, including a booster shot within six (6) to twelve (12) months of the original vaccination; or• the person has received the initial vaccination against hepatitis A; however, said person must then provide the restaurant owner(s) a health care provider's certification of the required booster shot within one year of the date of the original vaccination.(source: Section 1 of Ordinance # 19,770 - 807.305)”(4) Following the law is the primary responsibility of a food handler, but ensuring compliance is the primary responsibility of permit holder.
According to the St. Louis County Food Code, lack of hepatitis A vaccination is considered a critical violation. This means that if an employer fails to show proof of vaccination for his employees, a 10 day follow up inspection is conducted. If not corrected at time of follow up, a Notice of Violation is issued. It explains that the permit holder is required to comply within 10 days following receipt of the notice. After that, if employers are still in violation, they are required to attend an administrative conference with the DEP Environmental Administrator to set up a compliance schedule. Continued violation results in fines.
SustainabilityRoutine inspections of food servicing facilities are done annually. According to the St. Louis County Food Code, lack of hepatitis A vaccination is considered a critical violation. This constitutes failure by an employer to reveal proof of vaccination for his employees. A ten day follow up inspection is conducted. If not corrected at the time of follow up, a Notice of Violation is issued. It explains that the permit holder is required to comply within 10 days following receipt of the notice. After that, if employers are still in violation, they are required to attend an administrative conference with the DEP Environmental Administrator to set up a compliance schedule. Continued violation results in fines. Food handlers can now get vaccination at numerous locations throughout the county and also through their health care providers.