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Elevated Risk Plan

State: CA Type: Promising Practice Year: 2019

San Bernardino County is the largest county in the contiguous United States. It covers over 20,000 square miles of land, and is located in southeastern California, with Inyo and Tulare Counties to the north, Kern and Los Angeles Counties to the west, and Orange and Riverside Counties to the south. San Bernardino County is bordered on the east by the states of Nevada and Arizona. San Bernardino County is racially and ethnically diverse. Ethnicities include, but are not limited to Latino, White, African American, Asian or Pacific Island, and American Indian/Alaska Native. Approximately 21% of the population was born outside of the U.S., and approximately 42% of the population speak a language other than English at home.

The County of San Bernardino, Department of Public Health, Division of Environmental Health Services (EHS) regulates all food facilities within the county, and evaluates their food safety practices through inspections. Upon multiple self-assessments of the Food Protection program, EHS found that many food facilities habitually present a higher risk to the public due to multiple and/or repeating critical violations that could cause a foodborne illness (FBI). A FBI is a very serious and costly, yet preventable issue that is caused by consuming contaminated food or beverages. According to the Centers for Disease Control and Prevention (CDC), 128,000 are hospitalized and 3,000 die from FBIs each year in the United States. One lapse in food safety practices can potentially cause many people to become ill.

From July 2013 to June 2014, approximately 981 inspections were conducted at presumed high risk facilities, and only 53% of those facilities shown improvement at subsequent inspections that means 47% of those facilities continuously posed a high or elevated risk of causing a FBI. To overcome this, EHS implemented the Elevated Risk Plan. The Elevated Risk Plan is a step by step strategy that is based on a set of performance criteria. It focuses on improving food facilities that present a higher risk of causing FBIs and provides the operators with the tools and resources necessary to gain and retain food safety knowledge and achieve long-term compliance.

The development of the Elevated Risk Plan began in February 2015. The initial goal was to align with FDA's Standard 3 of the Voluntary National Retail Food Regulatory Program Standards by basing our food protection program on Hazard Analysis and Critical Control Point (HACCP) principles and the Centers for Disease Control and Prevention (CDC) risk factors. The initial objectives were to:

  • Establish a process that groups food facilities into 3 categories based on potential and inherent food safety risk, and
  • Assign an inspection frequency based on the risk categories to focus on food facilities that pose the greatest risk of causing a FBI.

    To implement the Elevated Risk Plan, community meetings were held with the food industry to obtain feedback and to inform them of the upcoming changes, including, but not limited to: the frequency of inspections on food facilities, the permit fees and fee structure, and the way compliance and enforcement is handled. Also, EHS trained staff on the new elements of the Elevated Risk Plan. It was officially launched on July 1st, 2016.

    Using a quality improvement model, the Plan Do Study Act (PDSA), the Elevated Risk Plan has been monitored and fine-tuned throughout the years to ensure its efficiency and effectiveness. From July 2017 to June 2018, 437 inspections were conducted at presumed high risk facilities, and the results show that the Elevated Risk Plan is a very effective practice. Approximately 80% of those facilities have improved. Interdepartmental collaboration and several PDSA cycles have helped EHS meet all of the objectives, and made the Elevated Risk Plan a successful practice. The Elevated Risk Plan ultimately protects Public Health by purposefully and continuously improving food safety practices at food facilities that pose a high risk of causing a FBI. Website for Program:  www.sbcounty.gov/dph/dehs.

A FBI is a very serious and costly, yet preventable issue that is caused by consuming contaminated food or beverages. Well known FBIs like Campylobacter, Hepatitis A, Salmonella, E. coli, Listeria, Norovirus and botulism can lead to blindness, kidney failure, hearing impairment, paralysis, and permanent neurological damage, and even death. These sort of illness causes the U.S. an economic burden of approximately $77.7 billion each year in medical expenses, quality of life adjustments, and illness-related death, with an average cost of $1,068 per case. These substantial numbers do not include costs related to the food industry or the public health agencies.

Due to the high volume of food served, a food facility faces hygiene and sanitation challenges every day. One lapse in food safety practices can potentially cause many people to become ill. According to the CDC, 1 in 6 people become ill, approximately 128,000 people are hospitalized, and 3,000 die from FBIs each year in the United States. San Bernardino County has the fifth largest population in California, and is the twelfth most populous county in the nation. In 2017, San Bernardino County's population was estimated at over two million (2,160,256). That means potentially 360,043 residents in the county could potentially become ill from a FBI each year – that does not even include people that visit the county. San Bernardino County is also racially and ethnically diverse. Half (50%) of San Bernardino County residents are Latino. Among the remaining non-Latino residents, 32% are White, 8% are Black or African American, 7% are Asian or Pacific Islander, and 3% report two or more races. Less than one percent of residents are American Indian/Alaska Native (0.6%). A FBI can affect anyone, and EHS works to protect all patrons of San Bernardino County food facilities.

In the past, routine food facility inspections were conducted twice a year, regardless of historical data or performance risks. A grading system based on the varying degrees of risk was used as an indicator of compliance just for these type inspections. Each food facility routine inspection would begin with 100 points. The point value from each marked violation is summed and this total is then deducted from the initial 100 points, where critical violations range from a 2 to 4 point deduction each. The grading scale is as follows: 100 to 90 points (A), 89 to 80 points (B), 79 to 70 points (C), and 69 or below is a closure.  Follow-up inspections, complaint inspections, and closures occurred as necessary. However, there wasn't a performance management system in place. Therefore, many food facilities continuously had repeat critical violations at subsequent inspections, thus presenting a higher risk of causing a FBI.

Upon doing self-assessments of the food facility Food Protection program for fiscal year 2013/2014 (July 2013 – June 2014), we found that approximately 981 inspections were conducted at presumed high risk facilities, and only 53% of those facilities shown improvement at subsequent inspections. That means 47% of those facilities continuously posed a high or elevated risk of causing a FBI.

The Elevated Risk Plan is an innovative and a much better approach because it is a performance based strategy. It zeros in on a food facility's historical data, patterns, and critical factors that are highly associated with causing a FBI. The Elevated Risk Plan consists of 8 steps that provides operators with ample opportunities to learn, develop, and implement their own food safety procedures and ultimately comply with food safety regulations. This strategy includes, but is not limited to 2 scored routine (non-billable) and 2 scored elevated risk (billable) inspections; a custom 5 minute educational video known as the Preliminary Education Presentation (PEP) talk that is given during routine and elevated risk inspections if facilities meet high risk criteria; a one-on-one onsite consultation completed by the Food Safety Health Education Liaison Program (HELP); a risk review meeting to verify food facility operators meet the terms of the compliance agreement made during the HELP consultation; and a comprehensive class known as Liaison Education and Review Network (LEARN) where Active Managerial Control (AMC) is emphasized. The Elevated Risk Plan is a sustainable practice that allows EHS to direct personnel and financial resources on the food facilities that need the most help.

The development of the Elevated Risk Plan began in February 2015. The initial goal was to align with FDA's Standard 3 of the Voluntary National Retail Food Regulatory Program Standards by basing our food protection program on Hazard Analysis and Critical Control Point (HACCP) principles and the Centers for Disease Control and Prevention (CDC) risk factors. The initial objectives were to:

  • Establish a process that groups food facilities into 3 categories based on potential and inherent food safety risk, and
  • Assign an inspection frequency based on the risk categories to focus on food facilities that pose the greatest risk of causing a FBI.

The three categories/tiers that were established are shown below.

  • Tier 1: This includes facilities that only serve prepackaged food. They receive 1 routine, scored inspection a year.
  • Tier 2: This includes facilities with limited food handling or open food preparation. They receive 2 routine, scored inspections a year.
  • Tier 3: This includes food facilities from Tier 1 and Tier 2 which met one or more of the following 5 criteria:
  • A score letter of (C) or lower in one of the last two graded inspections,
  • A score letter of (B) on two of the three last graded inspections,
  • Repeated four-point violation risk factors on the last two graded inspections,
  • Four or more critical violations noted during the last graded inspection, or
  • A closure for cause.

Facilities that fall into this tier receive an additional scored inspection that is billed at the hourly rate. This inspection is called an elevated risk inspection.

EHS initially conducted a soft launch of the Elevated Risk Plan. Community meetings were conducted with the food industry to obtain feedback and to inform them of the upcoming changes, including, but not limited to: the frequency of inspections on food facilities, the permit fees and fee structure, and the way compliance and enforcement is handled. It was officially implemented on July 1st, 2016, and the first elevated inspection was conducted in September 21st, 2016.

The first 6 months of implementation was focused on training staff, continuing to educate food facility operators, and ensuring consistent application of this plan. Afterwards, the data that was collected during that timeframe was evaluated. We found that from January 2017 to June 2017, 216 elevated risk inspections were conducted – approximately 73% of these facilities showed improvement. Although this was a great accomplishment, EHS felt that more could be done. Therefore, it was decided to create and implement an intervention that would occur before the elevated risk inspection.

Our Division worked with the Performance and Quality Management Committee (PQMC) within the San Bernardino County's Public Health Department to develop an intervention to increase the percentage of improvement among identified high risk facilities. The PQMC consists of staff from a variety of Public Health programs including, but not limited to Nutrition, Compliance, Administration, Communicable Disease, and Emergency Preparedness. Working with the PQMC helped EHS come up with an intervention that occurs early in the Elevated Risk Plan in order to immediately address the facilities that met high risk criteria. It was decided to develop educational materials to give to all operators at food facilities that met any of the high risk criteria at the conclusion of their routine inspection. The materials that were developed and used for this intervention include a handout on the CDC risk factors and a short video called the Preliminary Education Presentation (PEP) Talk. The PEP Talk is a 5 minute video that contains information on the factors that are most commonly associated with FBIs, and how to correctly address them to prevent a FBI from occurring. This step/intervention was implemented August 2017. The goal for this new step/intervention was to have the number of elevated risk facilities that show improvement be increased from the baseline of 73% to 76% by the end of November 2017. From September 1st, 2017 to November 30th, 2017, EHS was already at 79% improvement.

In addition to PEP Talks, EHS has implemented additional sequential steps in the Elevated Risk Plan to continue to assist the high risk facilities that did not show improvement during the elevated risk inspection. If a food facility did not improve after an elevated risk inspection, the next step is to offer them an on-site consultation – a HELP consultation. This one on one consultation with food facility operators provides EHS the opportunity to teach effective strategies on how to raise food safety standards, strengthen managerial control measures, and ultimately achieve long-term compliance and improve inspection scores. It helps operators understand the underlying causes of the violations and commit to a specific correction plan. A risk review meeting is conducted on-site 1 week after this consultation to verify systems are in place to reduce the FBI contributing risk factors.

Last, but not least, one additional step was recently implemented into the Elevated Risk Plan in November 2018. It is a monthly comprehensive classroom training that focuses on regaining control of the food facility known as LEARN. It is geared towards food facilities that have been elevated after receiving an on-site consultation. However, it is open to any food operator that would like to attend. It is an interactive approach to learning Active Managerial Control (AMC) practices, and provides the operators the tools necessary to take control of their facility, their employees, and practice safe food handling. During this class, they are instructed on how to develop their own policies that will address their specific issues, and how to monitor and verify that their policies are working. We will also explain the importance of food safety and its relevance to FBIs. We hope that this final step of the Elevated Risk Plan will empower them to take ownership of their facility.

The onetime expenses incurred were from the development and implementation of PEP Talks, and the reports used to track and monitor the progression of the food facilities. This cost was approximately $5,240 in staff time. By using existing technology, such as EnvisionConnect, Microsoft Video Editor, and an iPhone, there was no additional technological operating costs. Also, no additional personnel cost were included to maintain the Elevated Risk Plan, since all the positions involved were incorporated into the annual budget. Inspectors are an integral part of the Elevated Risk Plan. All 27 district inspectors conduct the routine and elevated risk inspections, and provide the PEP Talks as needed. Currently, there is 1 inspector designated to provide the specialized phases of the Elevated Risk Plan: the HELP consultations, the risk review meetings, and the LEARN class. In addition, 1 Public Service Employee dedicates 15 hours per week to schedule the HELP consultations, and 1 EHS Supervisor spends approximately 10% of his/her time evaluating and monitoring the reports. Lastly, the Elevated Risk Plan is partially funded from the elevated risks inspections. EHS invoiced $30,210.56 at the end of June 2017, and by the end of June 2018, we invoiced approximately $35,000.

Environmental Health Services persistently look for ways to improve the Food Protection program. We recognize that resources are limited, yet aspire to make the biggest impact on food safety. With the Elevated Risk Plan, EHS has implemented various reports and tracking mechanisms to monitor the results of each step of the plan, including the PEP Talks given, elevated risk inspections, and the food facilities that were offered and received an on-site consultation.

As previously mentioned, the initial goal was to align with FDA's Standard 3 of the Voluntary National Retail Food Regulatory Program Standards by basing our food protection program on Hazard Analysis and Critical Control Point (HACCP) principles and the Centers for Disease Control and Prevention (CDC) risk factors. The initial objectives were to:

  • Establish a process that groups food facilities into 3 categories based on potential and inherent food safety risk, and
  • Assign an inspection frequency based on the risk categories to focus on food facilities that pose the greatest risk of causing a FBI.

Once those objectives were met, EHS began working with of the members of San Bernardino County's Public Health Department's PQMC, to implement a true performance management system that ensured that data was collected, evaluated, and used to improve the quality of the Elevated Risk Plan. Thus, EHS set an additional short-term goal of having the percentage of elevated risk facilities that show improvement increase from the baseline of 73% to 76% by the end of November 2017.

By using existing technology, EnvisionConnect, EHS was able to easily collect and analyze primary data. To do this, EHS created a service code to track all the PEP Talks given. Reports were also developed in EnvisionConnect to confirm if PEP Talks were completed, and to summarize the outcomes of the elevated risk inspections.

Environmental Health Services met with PQMC at least monthly to discuss what worked and what didn't work.  A variety of PSDA cycles were attempted to ensure that the Elevated Risk Plan is effective and efficient. Some of the PDSA cycles included, but was not limited to:

  • Decreasing the amount of time inspectors spend on conducting PEP Talks,
  • Decreasing the time it takes to analyze data, and
  • Ensuring consistency of PEP talk delivery.

These PDSA cycles really modified and shaped the Elevated Risk Plan to what it is today a very effective model practice. Environmental Health Services was able to exceed the short-term goal of 76% by 3% in November 2017. Recent data shows that from July 2017 to June 2018, 437 inspections were conducted at presumed high risk facilities, and 80% of those food facilities have improved.

This Elevated Risk Plan is a sustainable practice. However, it didn't become sustainable overnight. Though data collection and much evaluation, EHS has learned that it's critical to think big, but start small. By collaborating with members of San Bernardino County's Public Health Department's PQMC, EHS was able to focus on projects that could be completed in a short period of time with the staffing that was available. By doing this, EHS was able to meet the objectives and ultimately meet the goal. Collaboration with interdepartmental programs and communication with industry has been crucial part of this process.


A cost benefit analysis was conducted and it was found that the bulk of the expenses that have been incurred were from the development and implementation of PEP Talks and the reports used to track and monitor the PEP Talks and the progression of the food facilities. By using existing technology, EHS is able to keep technological operating costs to a minimum. Also, no additional personnel cost is incurred since all positions are budgeted.  Lastly, since billable inspections are built into the plan, the revenue generated allows EHS to develop and tailor educational materials (i.e. multilingual handouts, videos, etc.) for the operators. There is no sufficient stakeholder commitment to sustain this practice. Ultimately, the Elevated Risk Plan was easy to implement, has proven to be effective, and has become sustainable.

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