# Presentation: 862014

## United States Department of Agriculture  Food Safety Inspection Service

*LCDR Kimberly Elenberg, HHSD*

-     Consumer Complaint
-       Monitoring System

**Notes:**
Good afternoon. We are honored to present to you updates on the United States Department of Agriculture’s, FSIS Consumer Complaint Monitoring System. 

## Consumer Complaint Monitoring System

- An electronic database
- record, triage, coordinate, and track all consumer complaints reported to FSIS
- Implemented Nov. 2001.
- Goals of CCMS
**Protection of public health by identifying food hazards**
**Support and augment homeland security**

**Notes:**
The Food Safety Inspection Service centralized this function through the Consumer Complaint Monitoring System (CCMS). The Consumer Complaint Monitoring System is an electronic database used to record, evaluate and track consumer complaints related to agency regulated foods. 

	The protection of the public’s health is a fundamental obligation of the Food Safety Inspection Service.  Major threats to the food chain include naturally occurring phenomena and accidental or intentional acts. Prompt response and mitigation of damage requires that threats be detected as early and specifically as possible. 

## CCMS Provides Agency Wide Support

- Health and Human Sciences Division
- Identifies potential food hazards, initiates investigations
- Office of Field Operations
- Compliance Officers/Enforcement Investigations Analysis Officers conduct investigations
- Technical Center
- Linking trends to establishments, improving programs

**Notes:**
The database  helps the Health and Human Sciences Division (HHSD), which houses and runs the Consumer Complaint Monitoring System, to identify and evaluate potential food-borne hazards, estimates of risk to human health, and respond to recognized, emerging, or potential threats to the food supply through the initiation of further investigations. 

The database must collect enough information for the Office of Field Operations to assist with trace back or trace forward investigations to identify product disposition and/or the origin of hazards. The information gathered during this investigation is  used verify Hazard analysis and critical control procedures in an establishment and to coordinate the recall of products when there is reason to believe they are adulterated or unwholesome. 

## CCMS Provides Agency Wide Support

- School Lunch Program
- Complaints involving FSIS Regulated product entered into CCMS
- Work in conjunction with the outbreak branch and state/county health officials
- Provide service to FNS and AMS
- Example: identified area in contract related to bone size that could be altered to prevent injury to students
- Analyzing data elements/systems utilized by FNS/AMS
- Establish bi—directional flow in communication
- Collect information that will aid in trace-back investigations

## CCMS Data

- Data Enters CCMS Primarily through OFO and Hotline
- CO/EIAO’s are ultimately responsible for clarifying data
- SOP’s for following through complaints
- located on the CCMS tool bar
- HHSD controls access to the CCMS
- Increases security

**Notes:**
There are multiple data entry points for data into the CCMS.  We are looking to increase this by adding a web portal this year.  However, the ultimate collection and clarification of data rests with the CO’s and the EIAO’s.  

To assist with communication and understanding, SOP’s for triaging and initiating investigations has been posted on the tool bar of the CCMS database.  

Access to CCMS and its information content is provided on a need to know basis and is controlled by HHSD. Each user is identified and given access appropriate to their role and responsibility.  For example, the Tech center may read data but they may not alter case notes.  Likewise, District 5 may read and write data for cases in their district but they may not alter data on cases outside that do not involve their district.

## Current Consumer Complaint Monitoring System

- Successful tool in the coordination of case investigations throughout the United States and its’ territories
- Current search capabilities allow identification of similar complaints through: product brand, product name, and establishment number

**Notes:**
Decisions to investigate cases are made in accordance with public health practice.  A steering committee representing multiple scientific areas of expertise developed algorithms that act as a guide in making decisions. Current search capabilities allow nurses to identify other cases that may be similar in nature through establishment number, product brand and product name search strings. Results of these searches have led to investigations.  These Investigation findings have been used to verify establishments hazard controls and critical control points.  Results also have augmented the recall process helping mitigate food hazards found in commerce..

## Case Study

- Three complaints received in the CCMS
- Within three days
- Est. XYZ
- Same product, Same Lot
- Illness, not lab confirmed
- Onset time and symptoms same
- Ready to Eat Product
- Consult with Micro, product tested for LM
- Product positive for LM
- Product Recalled

## What have we learned? The Value of Time in Epidemics

- Under the right circumstances, epidemics can spread quickly
- The world is smaller as we become more global
- Traditional surveillance depends on lab confirmation

**Notes:**
The recent SARS epidemic, while it is not food-borne, clearly demonstrates how rapidly pathogens can spread.  This can be applied to pathogens occurring naturally as well as to those pathogens, chemicals, and other possible food hazards that may be introduced intentionally.

Solely depending on traditional surveillance of lab confirmed illnesses assumes many things: 1) people went to the doctor 2) the doctor drew labs 3) people were able to provide a specimen 4) the time it takes to grow a culture averaging 24-72 hours and 5) that results are reported in a timely matter to the state and CDC
We do not dispute the value of traditional data.  At the same time, however,
we believe that collecting non-traditional data from consumer complaints helps to capture data that might not traditionally get reported.  This data is not clean data but it has already demonstrated its ability to identify possible trends and food hazards that have led to further investigations.  Results of these investigations have led to program changes in producing establishments and mitigation of hazardous product.

At this time, this process is done primarily by hand on an average of 15 cases per a week.  It is time consuming and vulnerable to mistakes.

## DARPAhttp://www.darpa.mil/iao/BSS.htm

**Notes:**
To improve these capabilities and decrease the chances of error, The Consumer Complaint Monitoring System must incorporate the necessary information technologies capable of detecting food hazards automatically. The Consumer Complaint Monitoring Program is looking to dramatically increase the number of cases reported to the agency and our ability to detect food hazards in commerce and so avoid unknown numbers of casualties.  The key to mitigating an outbreak or food hazard is early detection.   For contagious biological agents, early detection is paramount. 

## Legal Mandate for Surveillance

***Guidance from CDC and the U.S. Department of Health and Human Services***
***MMWR  April 11, 2003 / 52;1-12***

**Notes:**
Public health practice often requires the acquisition, use, and exchange of protected health information to perform public health activities (e.g., public health surveillance, terrorism preparedness, outbreak investigations, and public health research). Balancing the protection of individual health information with the need to protect public health, the Privacy Rule expressly permits disclosures without individual authorization to public health authorities authorized by law to collect or receive the information for the purpose of preventing or controlling disease, injury, or disability, including but not limited to public health surveillance, investigation, and intervention. 
 National health information privacy standards have been issued by the U.S. Department of Health and Human Services, pursuant to the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The regulations provide protection for the privacy of certain individually identifiable health data. 

## The “Act”

- The tragic events of September 11, 2001 forever changed the way we look at the world around us.
- The Consumer Complaint Monitoring System will support title III of the Bioterrorism Act which President Bush signed into law on June 12, 2002.

**Notes:**
The tragic events of September 11, 2001 forever changed the way we look at the world around us and alerted us to the enormous responsibilities we face in protecting the public’s health. Since September 11th, 2001, it has become necessary to re-align the goals of CCMS with a nationwide heightened awareness of potential terrorist attacks. A primary goal of the CCMS is to support and augment homeland security in accordance with the FSIS 2000-2005 strategic plan and Title III of the 2002 Bioterrorism Act by implementing a robust information system that will aid the food safety inspection service in identifying unsafe meat, poultry and egg products quickly and thoroughly.

##  Informatics Challenges of the Current Consumer Complaint Monitoring System

- Multiplicity of database systems that do not communicate at all or not well
- Receipt of data from states and laboratories is not timely
- Cumbersome navigation overwhelming
- System not using state-of -the -art technology

**Notes:**
The CCMS database is currently housed within a Microsoft Access program that is inadequate to satisfy our strategic goals. We is in need of state-of-the-art technology that can handle a planned nationwide initiative. The lack of interoperability with other systems (i.e. states, laboratories) leads to double data entry of consumer complaints. When a consumer files a complaint with the CCMS via the 1- 800 telephone number, the screener, after confirming the complaint meets criteria for a valid consumer complaint, automatically forwards the information onward to a repository. Personnel must remember to trigger this connection several times a day to upload new cases. Many fields do not match, and thus, much of the text arrives in a free text box and must be re-entered into the appropriate fields. Often, the receipt of data is not timely. This is particularly important for time sensitive lab-confirmed reports of positive identifiable food-borne organisms. 
With the current database, case investigation is a time-consuming process. In order to thoroughly review an individual case and initiate the necessary follow-up, the public health officer must navigate through several cumbersome user screens. This process involves numerous passes in and out of the database in order to comprehensively scrutinize each consumer complaint.

In addition, due to the lack of analytical models, data analysis and investigation initiation are limited to the officer’s individual interpretation of data and CCMS guidelines. 

## System Goals 

*Increase* the ability to harness relevant information from complaints
*Provide* graphical pictures of analysis and interpretation of data
*Support* the FSIS district offices’ local response
*Disseminate* information between FSIS, State Health Departments, Tech Center and the CDC
*Collaboration* with e-Health initiative

**Notes:**
The system needs to address two areas of concern: Natural outbreaks which cause approximately 76 million illnesses,325,000 hospitalizations, and 5,000 deaths
The consequences of Bioterrorisim ????? Are unknown.  The Consumer Complaint Monitoring System is a tool to be used by our agency to Increase the ability to harness relevant information from complaints. Provide graphical pictures of analysis and interpretation of data. Support the FSIS district offices local response and
Disseminate information between FSIS, State Health Departments, and the CDC in
Collaboration with  the e-Health initiative

An enhanced system will increase the ability to tease out relevant information from complaints. It will provide epidemiologists with graphical pictures of analysis using created algorithms. Information will be transmitted in a timely manner from all possible sources to the FSIS experts for investigation and follow-up. A legal mandate issued by Harrell and Baker of the US Public Health Service further emphasized the importance of this mission.

## Information System Functions Necessary for Public Health Preparedness and Response

- Preparedness requires that all partners are part of systems
- Surveillance data analysis--event detection and management
- Notification--rapid alerting
- Communication- information sharing (State Health Departments, Laboratories, CDC, Recall)

**Notes:**
Information System Functions Necessary for Public Health Preparedness and Response
Preparedness requires that all partners are part of systems
Surveillance data analysis--event detection and management
Notification--rapid alerting
Communication- information sharing (State Health Departments, Laboratories, CDC, Recall)

## System Platform will be Based on NEDSS

- NEDSS is a CDC initiative that uses national data and information system standards
- _[http://www.cdc.gov/nedss](http://www.cdc.gov/nedss)_
- NEDSS provides tools that can provide for the electronic data transfer between state health departments and Consumer Complaint Monitoring System
- Security standards (HIPAA compliant)

**Notes:**
The ability to share data with public health entities and the National Electronic Disease Surveillance System (NEDSS) will be critical to interoperability between agencies. Each state or agency is considered as a potential voluntary client and USDA as a central server, the components of which are fully integrated and interoperable with CCMS through NEDSS. The integrity of the CCMS will allow USDA, CDC and FDA, as well as states and local health agencies/departments to access and share the information about food born illness outbreaks and the critical need for timely reporting for the detection of bioterrorist events 24 hours a day, 7 days a week. Additionally, an interconnected computer network (Intranet) among USDA labs, Recall Management Division (RMD), Health and Human Sciences Division (HHSD), Office of Field Operations (OFO), Meat and Poultry Hotline (the Hotline), the Office of Policy, Program Development, Labeling and Consumer Protection Staff (OPPD/LCPS) is critical for the timely flow of information.

## Once We Collect Data, What to Do With It?

- Detect abnormalities
- Gain actionable intelligence
**What models are needed to harness intelligence?**
**Time Series Modeling**
**Spatial/Geo-temporal Modeling**
**Bayesian Modeling**
**Active learning model**
**ARMIA models**
- http://www.biomedcentral.com/1472-6947/3/2

**Notes:**
In order to facilitate a decision support system we must be able to gain actionable intelligence from our data.  Time series models will help us identify changes in data over time. Spatial/geotemporal modeling will increase the specificity and sensitivity of our data by alerting us to clusters of complaints by either establishment number or zip code.  If complaints have the same establishment number, we now have a a suspect establishment. If we have multiple complaints from the same zip code without matching establishment numbers, it is possible the symptoms are not related to a particular establishment but instead, are related to the environment (i.e. water, etc.). Bayesian modeling will help integrate multiple sets of data, and ARMIA models will correct for trends in the data. 
At this point, alarm thresholds need to be set. The particular alarm strategy chosen affects the detection specificity and sensitivity of the detection system as a whole. 
Because our database is largely passive, it is possible that our denominator is low, meaning that we are only seeing the tip of the iceberg. Therefore, the alarm threshold will be low. 

## How will we eliminate noise?

- Train field officers on collecting clean data
- Use exponential, linear, and moving average filters
- Identify confounders and noise

**Notes:**
One of our biggest challenges we face is grouping data.  The cleaner the data collected by field officers, the easier it will be to group that data and therefore will help with the elimination of noise.  Much of the data coming in from the hotline is in free text. A natural language processor will also help group that data. Through filters, we can use the element of time to decrease noise. Lastly, quality controls on our data sets will need to be examined for confounders.

## In Conclusion

- The Consumer Complaints Monitoring System will adopt and implement standards-based, integrated, interoperable information technology to enhance public health practice
- Computational and detection algorithms will contribute intelligence to a decision support system
- This will result in progress towards identifying food hazards in commerce

**Notes:**
The Consumer Complaints Monitoring System will adopt and implement standards-based, integrated, interoperable information technology to enhance public health practice.  Computational and detection algorithms will contribute actionable intelligence to a decision support system. This will result in progress towards identifying food hazards in commerce in a more timely manner.

## A Hopeful Future

**Notes:**
This slide is an illustration of the projected outcome we believe will result from the enhancements made to the consumer complaint monitoring system.  An important aspect of our program is communicating with the public to increase their awareness of how to submit concerns to our agency.  Without the proposed enhancements, this increased case load would make data analysis much more difficult, leaving gaps where human errors could occur. Implementation of the enhancements will do the opposite, leading to statistically more significant signals as the data, or number of concerns logged, increases. Overall, Consumer Complaint Monitoring Systems bioterrorism alert capacity will increase.

## Thank you

**Thank you**
**Questions?**

**Notes:**
This concludes our presentation. We want to thank you for your time. It has been our pleasure to present to you the current status of the CCMS. Are there any questions?