Ssb- Nears Sid

SSB- NEARS SID .docx

National Environmental Assessment Reporting System (NEARS)

OMB: 0920-0980

Document [docx]
Download: docx | pdf

Supporting Statement B



National Environmental Assessment Reporting System (NEARS)


(formerly National Voluntary Environmental Assessment Information System [NVEAIS])



OMB Control No. 0920-0980 (Expiration Date: 08/31/2016)


REVISION



April 2016
























Erik W. Coleman, MPH

Centers for Disease Control and Prevention

National Center for Environmental Health

Emergency and Environmental Health Services

Environmental Health Services Branch

4770 Buford Highway, NE MS: F 58

Atlanta, GA 30341-3724

[email protected]

770-488-3438


Table of Contents


B. Collection of Information Employing Statistical Methods

1. Respondent Universe and Sampling Methods

2. Procedures for the Collection of Information

3. Methods to Maximize Response Rates and Deal with Nonresponse

4. Test of Procedures or Methods to be Undertaken

5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data





















List of Attachments


Att 1. Regulation Authorizing Data Collection- Public Health Service Act and Food Safety Modernization Act

Att 2. NEARS 60-Day FRN

Att 3. Definition of Contributing Factors to Foodborne Illness Outbreaks

Att 4. NEARS Food Safety Program Training

Att 5. NEARS e-Learning on Environmental Assessment Food borne Illness Outbreaks (screenshots)

Att 6. NEARS Data Recording Instrument (Word)

Att 7. NEARS Data Recording and Manager Interview Web Entry (screenshots)

Att 8. NEARS Manager Interview

Att 9. NEARS NCEH Research Determination



B. Collection of Information Employing Statistical Methods


Statistical methods will not be used to select respondents for this data collection. All food safety programs in the United States will be invited to participate; however, participation is voluntary. Programs that participate in NEARS will report data on all outbreaks occurring in their jurisdictions. We expect that program participation will increase over time. However, until all eligible programs are participating, a limitation of our data will be that it applies to only those jurisdictions participating in NEARS. We will use this section of the supporting statement to describe data collection procedures.


B.1. Respondent Universe and Sampling Methods


State, local, tribal, and territorial food safety programs will report data into NEARS. There are approximately 3,000 such food safety programs in the United States.


Although the data reported through this system are collected by food safety programs; they are not collected on food safety programs or personnel. Instead, they are collected primarily on foodborne illness outbreaks. Specifically, data collected by food safety programs during their investigation of foodborne illness outbreaks will be reported into NEARS. These data will provide information on environmental factors associated with outbreaks.


Data on all outbreaks occurring in the jurisdictions of participating food safety programs (the NEARS ‘catchment area’) will be reported to NEARS. Thus, we will be utilizing a convenience sample of voluntary participating programs and not obtaining a statistical sample. In the future, should a nationally representative program evolve, we may be able to generalize our data. Currently, we will describe the population of outbreaks solely in the NEARS catchment area and the environmental factors associated with them, and not generalize the data as nationally representative.


B.2. Procedures for the Collection of Information


Data Collection


Prior to collecting data, all food safety program personnel participating in NEARS will be encouraged to attend training for NEARS. These staff will be encouraged to attend a Lync Meeting (i.e., webinar) training session conducted by CDC staff (Attachment 4). This training is voluntary and will cover identifying environmental factors, logging in and entering data into the web-based NEARS data entry system, and troubleshooting problems. There will be no website, form, or presentation document associated with this training. Instead, CDC personnel will be guiding participants through the NEARS data entry system. Attachment 4 contains a brief description of the training.


Although not a requirement food safety program personnel participating in NEARS will also be encouraged to complete CDC’s e-Learning on Environmental Assessment of Foodborne Illness Outbreaks (Attachment 5). This e-Learning course provides training on how to use a systems approach in foodborne illness outbreak environmental assessments. Participants acquire in-depth skills and knowledge to investigate foodborne illness outbreaks as a member of a larger outbreak response team, identify an outbreak’s environmental causes, and recommend appropriate control measures. The course is presented in the context of a simulated virtual environment where participants can interact and practice the skills being learned. Attachment 5 contains a brief description of the training.


There are two data collection activities. For the first activity, participating food safety programs will record all their environmental assessment data by pen-and -paper form (Attachment 6) and then enter all their data into the secure NEARS web-based system (Attachment 7), which is designed to make data entry easy for respondents. The respondents for this activity are the food safety program personnel participating in NEARS. This will be done once for each outbreak.


The second activity is the manager interview that will be conducted at each establishment associated with an outbreak (Attachment 8). The respondents for this activity are the retail food managers of the outbreak establishments. Manager interviews are a routine part of outbreak investigations; however, food safety program personnel participating in NEARS conducts a structured interview, and will thus conduct their interviews slightly differently than they would if they were not participating in NEARS.


Data analysis results will be shared informally with participating sites through annual data summary reports and presentations during NEARS quarterly webinars. Results will also be shared with other stakeholders (e.g. NORS Team) and the food safety and environmental public health community through presentations at meetings and conferences, peer-reviewed publications in scientific journals, and possibly ‘plain language’ summaries on the CDC website. Results will be presented in aggregate form.


The results will be used to develop recommendations for food safety and environmental public health programs and the retail food industry. For example, if data collection identifies specific environmental antecedents are associated with certain foodborne outbreaks, CDC can develop recommendations that address these unsafe polices and/or practices and disseminate the information to environmental public health programs and the retail food industry.

Quality Control Procedures


CDC personnel will periodically review the data from each site, and perform quality assurance procedures to check for data entry errors. They will provide reports to each program about the quality of their data. CDC personnel will use these reports to highlight weaknesses in data and recommend ways to improve the quality of the data.


Potential Biases


The act of observing workers during environmental assessments may influence their performance and behavior on work-related tasks. In other words, the workers may not respond naturally when they know they are being observed. However, for the most part, those collecting these data will be experienced and will take measures (such as remaining unobtrusive and engaging in activities that will place workers more at ease) to minimize this bias when possible.


The manager interview data may be influenced by social desirability bias - the tendency for people to report greater levels of socially desirable behavior (such as safe food preparation practices) than they actually engage in, or to report their best behavior rather than their typical or worst behavior.


Any presentation of these data will acknowledge these potential biases and include a discussion of how they impact data interpretation.


B.3. Methods to Maximize Response Rates and Deal with Nonresponse


Program Response


We have been and will continue to engage in activities to promote and encourage food safety program participation in NEARS. We have presented at multiple conferences attended by those responsible for outbreak investigation (e.g., National Environmental Health Association, Council to Improve Foodborne Outbreak Response etc.). We will hold informational conference calls with programs interested in NEARS. During these calls, we will attempt to identify barriers to NEARS participation and address those barriers. Our goal is to achieve close to 100% participation in NEARS.



B.4. Test of Procedures or Methods to be Undertaken


The data collection instrument to be used for the NEARS was previously developed by the Environmental Health Specialists Network (EHS-Net) (See Attachments 6, 7, and 8). As food safety programs beyond the EHS-Net participants continue using the instrument, we expect that they will identify some components of the instrument that need revision. We expect these revisions to be minor. We plan to annually review respondents’ revision comments and questions to determine the nature and scope of requested revisions. Annual review of data may also reveal minor needed changes. Should we identify the need for changes to the data collection instruments, we will submit a nonmaterial or non-substantive change request to OMB for approval. For major changes to the instruments or methods, a full revision ICR will be submitted for Paperwork Reduction Act (PRA) clearance.


Data Analysis Plan


The three main goals of this data collection are to:

  1. Describe foodborne illness outbreaks and outbreak responses.

  2. Describe environmental factors (environmental antecedents and contributing factors) associated with outbreaks.

  3. Describe the associations between environmental antecedents and contributing factors to outbreaks.


To address the first goal of this data collection, describe outbreaks and outbreak responses, we will conduct descriptive analyses (frequencies, means, etc.) to describe:

  • outbreaks (Table B.4.1 contains the variables included in these descriptive analyses)

  • outbreak responses (Table B.4.2 contains the variables included in these descriptive analyses).


Table B.4.1. Variables included in descriptive analyses of outbreaks

Question

Number

Question

Justification

I_1

Did the exposure(s) take place in a single or multiple locations, for example a single restaurant or two or more restaurants, a single school or two or more schools or a combination of establishments, etc.?

Describe whether single or multiple establishments were involved in the outbreak.

I_2

Did the exposure(s) happen in a single County/Township / Parish or multiple Counties / Townships / Parishes in your state?

Describe whether single or multiple jurisdictions were involved in the outbreak.

I_3

Did the exposure(s) occur in a single state or multiple states?

Describe whether single or multiple states were involved in the outbreak.

I_4

How many food service establishment locations within your jurisdiction were associated with this outbreak?

Describe how many food service establishments were associated with the outbreak.

I_5

Were any environmental assessments conducted at foodservice establishments in your jurisdiction as part of this outbreak

Describe whether environmental assessments were conducted.

I_5a

Briefly, describe the reason(s) why environmental assessments were conducted in your jurisdiction as a part of this outbreak?

Describe why and when environmental assessments were conducted.

I_5b

How many environmental assessments were conducted at foodservice establishments in your jurisdiction as part of this outbreak?

Describe how many environmental assessments where conducted in the reporting jurisdiction.

I_5c

Why were no environmental assessments conducted at foodservice establishments in your jurisdiction as part of this outbreak investigation

Describe why environmental assessments were not conducted.

I_6

Were any non-food service establishment locations within your jurisdiction were associated with this outbreak?

Describe whether any non-food service establishments were associated with the outbreak.

I_6a

How many non-food service establishment locations within your jurisdiction were associated with this outbreak?

Describe how many non-food service establishment locations were associated with the outbreak.

I_6b

How many environmental assessments were conducted at non-food service establishments in your jurisdiction as part of this outbreak?

Describe how many environmental assessments were conducted in non food service establishments.

I_7

Was a primary agent identified in this outbreak?

Describe the agent.


I_7a

What was the identified agent?

Was the identified agent suspect or confirmed?

I_7b

Was a serotype identified in this outbreak?

Describe the serotype.

I_7c

What was the identified serotype?    

I_8

Was this outbreak reported to a state or local Communicable Disease Surveillance Program?

This information will be used to help connect the NEARS data to existing epidemiological and laboratory data reported to the state.

I_8a

Select the state or local surveillance system(s) where this outbreak was reported.

I_9

Was this outbreak reported to a national surveillance system?

This information will be used to help connect the NEARS data to existing epidemiological and laboratory data reported to other national surveillance systems.

I_9a

Select the national surveillance system(s) where this outbreak was reported and record the corresponding reporting number.

V_1

Was a specific ingredient or multi-ingredient food suspected or confirmed in this outbreak?

Describe ingredients and foods associated with the outbreak.

V_1a

If No, explain why food was the suspected vehicle in this outbreak.

V_2

Is this food a single specific ingredient or multi-ingredient?

V_3

What is the name of the suspected or confirmed ingredient / food vehicle?

V_4

Select the reason that best describes how this single specific ingredient or multi ingredient food was implicated in the outbreak.

Describes the type of information used to determine the food associated with the outbreak.

VI_3a

Where was the sample taken from?

Describe where environmental samples were taken.

VI_3

What type of sample was taken?

Describe if food sample is a single ingredient, multi ingredient food item or environmental.

VI_5

Was an agent identified in this sample?

Describe if an agent was found in sample.

VI_6

What was the identified agent?

Describe agent found in sample.

VI_6a

Was a serotype of the agent identified?

Describe if a serotype was found in sample.

VII_1

Were any contributing factors identified in this outbreak?

Describe if contributing factors where identified in an outbreak investigation.



Table B.4.2. Variables included in descriptive analyses of outbreak responses

Question Number

Question

Justification

II_1

Date the establishment was identified for an environmental assessment

Describe how long it takes to respond to outbreaks with an environmental assessment.

II_2

Date of first contact with establishment management

II_3

Number of visits to the establishment to complete this environmental assessment

Describe environmental assessment responses.

II_4

Number of contacts with the establishment other than visits, (ex. phone calls, phone interviews with staff, faxes, etc.) to complete this environmental assessment

II_9

Was a translator needed to communicate with the kitchen manager during the environmental assessment?

Describe whether language and communication are issues in collecting information for environmental assessments.

II_9a

Was a translator used to communicate with the kitchen manager?

II_10

Was a translator needed to communicate with the food workers during the environmental assessment?

II_10a

Was a translator used to communicate with the food workers?

III_1

Date the manager interview was conducted

Describe the time from identification/contact until specific environmental assessment activities are conducted.

IV_1

Date observations were made

VI_1

Were any samples taken?

Describe how many samples and what type are taken during environmental assessments.

VI_2

How many samples were taken?

VI_3

What type of sample was taken?

VII_2

During the outbreak investigation, what activities were used to try to identify the contributing factors?

Describe outbreak responses.

VII_3

Please rate the quality of communication between the food regulatory program and the communicable disease control program during this outbreak investigation.

Describe outbreak responses.


To address the second goal of this data collection, describe environmental factors associated with outbreaks, we will conduct descriptive analyses (frequencies, means, etc.) to describe

  • environmental antecedents (see Table B.4.3 for the variables included in these descriptive analyses and their environmental antecedent classifications [economics, equipment, food, people, processes])

  • contributing factors (examined by category: contamination, proliferation, and survival; see Table B.4.4 for the variables included in these descriptive analyses).


The list and descriptions of all contributing factors can be found in Attachment 3.


NEARS collects data on a number of environmental antecedent variables. These variables were chosen for inclusion in NEARS because existing hypotheses, theories or data suggest that they may be related to food safety and/or foodborne illness outbreaks.



Table B.4.3. Variables included in descriptive analyses of environmental antecedents

Question Number

Question

Justification

Classification

Part II: Establishment description, categorization and menu review

II_5

Facility type

Describe facility type.

Process

II_6

How many critical violations were noted during the last routine inspection?

Describe critical violations.

Equipment, People, Process

II_7

What is the establishment’s source of potable water?

Describe water source.

Equipment

II_8

What is the establishment’s sewage disposal method?

Describe sewage disposal method.

Equipment

II_11

Establishment Type

Describe establishment type.

Process

II_12

Do customers have direct access to unpackaged food such as a buffet line or salad bar in this establishment?

Describe customer access to unpackaged food.

People

II_13

Does the establishment serve raw or undercooked animal products (example, oysters or raw shell eggs) in any menu item?

Describe whether this food safety risk exists and whether customers are notified of this risk.

Food, Process

II_13a

Is a consumer advisory regarding the risk of consuming raw or undercooked animal products provided?

People

II_13b

Where is the consumer advisory located? (Check all that apply)


People

II_14

Which one of the options below best describes the menu for this establishment?

Describe the establishment menu.

Food, Process

Part III: Manager Interview

III_2

Is this an independent establishment or a chain establishment?

Describe establishment ownership.

People, Process

III_3

Approximately how many meals are served here daily?

Describe volume of business.

Economics, People, Process

III_4

What is the establishment’s busiest day, in terms of number of meals served?

III_5

Are any foods prepared or partially prepared at a commissary or other location?

Describe whether foods are prepared at commissaries.

Process

III_6

Other than daily specials, when was the last time food items were added to your menu(s)?

Describe whether food items have been added to the menu.

Food, People, Process

III_7

Where does the establishment purchase or acquire its food?

Describe establishment food sources.

Process

III_8

In total how long have you worked as a kitchen manager?

Describe manager experience.


People, Process

III_9

Approximately how long have you been employed as a kitchen manager in this establishment?

III_10

How many kitchen managers, including you, are currently employed in this establishment?

Describe ratio of managers to workers (measure of worker supervision).

People

III_11

What language(s) do you and other managers in this establishment speak fluently? (Check all that apply)

Describe manager/worker communication/language barriers.


People

III_12

What languages do you and other managers speak at work? (Check all that apply

III_13

In your opinion, how well do you communicate verbally with your food workers, very well, somewhat well or not well at all?

III_14

Do any kitchen managers receive food safety training?

Describe manager food safety training.

People

III_14a

How many kitchen managers have had food safety training?

III_14b

What type of food safety training do kitchen managers (you) receive?

III_15

Does this establishment require that kitchen managers have a food safety certification?

Describe food safety certification.

People

III_16

Are any kitchen managers, including you, food safety certified?

III_16a

How many kitchen managers in this establishment, including yourself, are food safety certified by an ANSI accredited program such as ServSafe National Registry of Food Safety Professionals/Environmental Health Testing or Thomson Prometric?

III_17

How many food workers do you have?

Describe staff size.

People, Process

III_18

What language(s) do food workers in this establishment speak fluently

Describe manager/worker communication/language barriers.


People

III_19

What languages do food workers speak at work?


III_20

Do any food workers receive food safety training?

Describe food worker food safety training.

People

III_20a

How many food workers have had food safety training?

III_20b

What type of food safety training do food workers receive?

III_21

Does this establishment have a cleaning policy or schedule for the kitchen floor?

Describe cleaning policies.

Process

III_21a

Is this policy written?

III_22

Does this establishment have a cleaning policy or schedule for the refrigerator units, such as a walk-in or reach-in?

III_22a

Is this policy written?

III_23

Does this establishment have a cleaning policy or schedule for the cutting boards?

III_24

Does this establishment have a cleaning policy or schedule for the food slicers?

III_24a

Is this policy written?

III_25

Does this establishment have a cleaning policy or schedule for the food preparation tables?

III_25a

Is this policy written?

III_26

Does this establishment have a policy concerning disposable glove use?

Describe glove use policies.

Process

III_27

Does the glove policy require that food workers wear gloves:

III_27a

at all times while working in the kitchen?

III_27b

when handling ready-to-eat foods?

III_27c

when handling raw meat or poultry?

III_27d

when they have cuts or other skin injuries?

III_28

Does this establishment have a policy to take the temperature of any incoming food products?

Describe temperature taking and recording policies/practices.

Process

III_28a

Are temperatures of incoming products recorded?

People

III_29

Excluding incoming products, does this establishment have a policy to take food temperatures?

Process

III_29a

Are these food temperatures recorded?

People

III_30

Does this establishment have a policy or procedure that requires food workers to tell a manager when they are ill?

Describe ill worker policies.

People

III_30a

Is this policy in writing?

III_30b

Does this policy require ill workers to tell managers what their symptoms are?

III_30c

Does this policy specify certain symptoms that ill workers are required to tell managers about?

III_30c1

What are those symptoms? (Check all that apply)

III_30d

Does this policy apply to kitchen managers as well as food workers?

III_31

When food workers say they are ill, do you typically ask if they are experiencing certain symptoms?

III_31a

What are those symptoms? (Check all that apply)

III_32

Does this establishment have a policy or procedure to restrict or exclude ill workers from working?

III_32a

Is this policy in writing?

III_32b

Does this policy specify the specific symptoms that would prompt excluding or restricting ill workers from working?

III_32b1

What are those symptoms? (Check all that apply)

III_32c

Does this policy apply to kitchen managers as well as food workers?

III_33

Do any kitchen managers (you) ever get paid when they miss work because they are ill?

Describe paid sick leave policies.

People

III_33a

How many kitchen managers get paid when they miss work because they are ill?

III_34

Do any food workers ever get paid when work is missed because they are ill?

III_34a

How many food workers get paid when they miss work because they are ill?



Part IV: Establishment Observation


IV_2

Are hand sinks available in the employee restroom(s)?

Describe availability of handwashing sinks, supplies and equipment.

Equipment


IV_2a

How many hand sinks are in the employee restrooms?


IV_2b

Is warm water (minimum 100°F) available at all employee restroom hand sinks?


IV_2c

Is soap available at (or near) all employee restroom hand sinks?


IV_2d

Are paper or cloth drying towels available at (or near) all employee restroom hand sinks?


IV_3

Is a hand sink available in the work area(s)?


IV_3a

How many hand sinks are located in the work area(s)?


IV_3b

Is warm water (minimum 100°F) available at all hand sinks in the work area?


IV_3c

Is soap available at (or near) all hand sinks in the work area?


IV_3d

Are paper or cloth drying towels available at (or near) all hand sinks in the work area?


IV_4

Are there cold storage units in the establishment?

Describe cold storage units and their temperatures.

Equipment


IV_4a

How many cold storage units are in the establishment?


IV_4b

Which types of units did you observe?


IV_5

Are all cold storage areas maintained at a temperature of 41°F or below?


IV_5a

How many cold storage units are above 41°F?


IV_6

Are any food workers using gloves while handling food?

Describe glove practices.

Equipment


IV_7

Is there a supply of disposable gloves available in the establishment?

Describe glove availability.

Economics, Equipment


IV_8

Are any food workers handling RTE foods with bare hands?

Describe bare hand contact practices.

People


IV_9

Are there records to indicate that the temperatures of incoming ingredients are being taken and recorded?

Describe temperature taking and recording practices.

People


IV_10

Are there records to indicate that the temperatures of foods, excluding incoming ingredients, are being taken and recorded?


IV_11

Is there any evidence of direct cross contamination of raw animal products with ready to eat foods?

Describe practices that could lead to cross contamination.

People, Process


IV_12

Is there cooling of hot foods in this establishment?

Describe food cooling practices.

Process


IV_12a

What cooling method(s) are used?



IV_13

Were any foods observed in hot holding?

Describe food holding practices.

People, Process

IV_13a

Were the temperatures of any foods in hot holding measured?

IV_13b

Were the temperatures of all foods measured in hot holding at 135°F or above?

IV_14

Were any foods observed in cold holding?

IV_14a

Were the temperatures of any foods in cold holding measured?

IV_14b

Were the temperatures of all foods measured in cold holding at 41°F or below?

IV_15

Were any foods observed during cooking?

Describe cooking practices.

People, Process

IV_15a

Were the temperatures of any foods being cooked measured?

IV_15b

Were the temperatures of all foods measured during cooking at the recommended temperatures?

IV_16

Are wiping cloths used in the establishment?

Describe wiping cloth practices.

Equipment, Process

IV_16a

Are all wiping cloths stored in a sanitizer solution between uses?

IV_17

Are there mechanical washing machines for dishes, utensils, or other equipment?

Describe dishwashing practices.

Equipment, Process

IV_17a

Does the wash cycle reach the temperatures recommended for that washing machine?

IV_17b

Does the sanitizing cycle reach the temperatures recommended for sanitization?

IV_17c

Is chemical sanitizing used?

IV_17d

Did the chemical sanitizing cycle have the required levels of chemical sanitizer recommended for the machine?

IV_18

Are there any hand washed dishes, utensils or other equipment?

IV_18a

Are hand washed dishes, utensils or other equipment washed and sanitized (either with heat or chemical)?

IV_18b

Is the sanitizing method (heat or chemical) properly implemented?

IV_19

Did you observe signs and instructions posted in the establishment?

Describe signs.


People, Process

IV_19a

Did any signs or posted instructions use pictures or symbols to communicate a message?

IV_19b

What languages did you observe on signs or instructions posted for food workers?


Part V: Suspected/Confirmed Food


V_5

Which of the following best describes the food preparation process used for this specific ingredient or multi-ingredient food before consumption?

Describe and classify the food prep processes that the establishment used to prepare the suspected/confirmed vehicle.

Process

V_6

During the likely time the ingredient / food was prepared, were any events noted that appeared to be different from the ordinary operating circumstances or procedures as described by managers and / or workers?

Out-of-the ordinary events can lead to potential food safety risks. These data will identify and describe these events.

Process

V_6a

If yes, how would they be best characterized

V_7

Name of the single specific ingredient

Describe and classify food ingredients linked with the outbreak.


Food

V_8

Is the ingredient an animal product?

V_8a

Select the type of animal product

V_8b

If Poultry, select the type

V_8c

If Seafood, select the type

V_8d

For beef, poultry, pork, lamb, and seafood products select the best description of the product upon arrival at the foodservice establishment

V_8e

For dairy, select the best description of the product upon arrival at the foodservice establishment

V_8f

For eggs, select the best description of the product upon arrival at the foodservice establishment

V_9

Is this ingredient a plant or plant product?

V_9a

Select the type of plant product

V_9b

If Produce, select type (Select only one

V_9c

Provide the best description of the plant product upon arrival of the product to the foodservice establishment

V_10

Was the ingredient described in question 8 or 9?

V_10a

Please describe the ingredient class/category?

V_11

Is any information present (product manifests, records, tags, etc.) that shows ingredient is an imported food item?

Describe the origin of the food.

Food















Table B.4.4. Variables included in descriptive analyses of contributing factors

Number

Question

Justification

VII_1

Were any contributing factors identified in this outbreak?

Describe whether contributing factors where identified.

VII_4

Were any Contamination Factors identified in this foodborne illness outbreak?

Describe whether contamination factors were identified.

VII_4a

How many Contamination Factors were identified in this outbreak?

Describe how many contamination factors were identified.

VII_5

Were any Proliferation/Amplification Factors identified in this foodborne illness outbreak?

Describe whether proliferation factors were identified.

VII_5a

How many Proliferation/Amplification Factors were identified in this outbreak?

Describe how many proliferation factors were identified.

VII_6

Were any Survival Factors identified in this foodborne illness outbreak?

Describe whether survival factors were identified.

VII_6a

How many Survival Factors were identified in this outbreak?

Describe how many survival factors were identified.

VII_7

Which Contributing Factor was identified?

Describe the specific contributing factors identified in the outbreak.

VII_8

In your judgment, was this the primary contributing factor for this outbreak?

Describe whether the contributing factors were primary contributing factors.

VII_8a

Briefly explain why this is a contributing factor in this outbreak.

Describe how contributing factors are identified.

VII_10

When did this factor most likely occur?

Describe when the contributing factors occurred.


To address the third goal of this data collection, describe the associations between environmental antecedents and contributing factors, we will conduct tests for association and logistic regression models.


Analysis will involve bivariate tests for association between individual environmental antecedent (explanatory) variables and the contributing factor (outcome) variables. Odds ratios will be calculated to assess the strength and direction of the bivariate relationships. For those bivariate associations found to be statistically significant at p<.30, the environmental antecedent variables will be used as candidate “predictors” to examine their multivariate relationships with the contributing factor variables. Multivariable logistic regression will be used to model for the effects that these environmental antecedent variables have in explaining the variations observed in the contributing factor variables. This type of analysis allows us to determine which environmental antecedents contribute to the presence of the contributing factor, and the relative degree of impact that each environmental antecedent has in the presence of that contributing factor. A separate model will be developed for each contributing factor analyzed.


Table B.4.5 describes the study questions designed to address this third goal of this data collection and the data collection variables designed to answer those questions. Note that we will likely create composite environmental antecedent variables based on the individual variables listed in the table.


Table B.4.5. Study questions and the data collection variables designed to answer those questions

Study Question

Environmental Antecedent Variables

Contributing Factors

How are specific environmental antecedents related to contamination contributing factors?

II_5, II_6, II_7, II_8, II_11, II_12, II_13, II_14, III_2, III_3, III_4, III_5, III_7, III_8, III_9, III_10, III_11, III_12, III_13, III_14 (a, b), III_15, III_16 (a), III_17, III_18, III_19, III_20 (a, b), III_21 (a), III_22 (a), III_23 (a), III_24 (a), III_25 (a), III_26 (a), III_27 (a,b,c,d), III_30 (a,b,c,d), III_31 (a), III_32 (a, b, c), III_33 (a), III_34 (a), IV_2 (a, b, c, d), IV_3 (a, b, c, d), IV_6, IV_7, IV_8, IV_11, IV_16 (a), IV_17 (a, b, c, d), IV_18 (a, b), IV_19 (a,b), IV_20, V_1 (a), V_2, V_3, V_4, V_5, V_6 (a), V_7 , V_8 (a,b,c,d,e,f), V_9 (a,b,c), V_10 (a), V_11

C1-C15


How are specific environmental antecedents related to proliferation contributing factors?

II_5, II_6, II_11, II_13, II_14, III_2, III_3, III_4, III_5, III_6, III_8, III_9, III_10, III_11, III_12, III_13, III_14 (a, b), III_15, III_16 (a), III_17, III_18, III_19, III_20 (a, b), III_28 (a), III_29 (a), IV_4 (a, b), IV_5 (a, b), IV_12 (a), IV_13 (a), IV_14 (a)

P1-P12

How are specific environmental antecedents related to survival contributing factors?

II_5, II_6, II_13, II_14, III_2, III_3, III_4, III_5, III_6, III_8, III_9, III_10, III_11, III_12, III_13, III_14 (a, b), III_15, III_16 (a), III_17, III_18, III_19, III_20 (a, b), III_29 (a), IV_15 (a)

S1-S5


Table B.4.6 is a table shell that illustrates how we might analyze and present the data examining the bivariate relationships between specific environmental antecedents and the contributing factor of bare-hand contact with ready-to-eat food by a food worker who is suspected to be infectious (contributing factor C10).


Table B.4.6. Example Table Shell: Environmental antecedent variables associated with the outcome variable of whether the contributing factor of bare-hand contact with ready-to-eat food by an infectious food worker was identified, bivariate analyses

Environmental antecedent variables

Bare hand contact with food by infectious food worker (C10) identified as a contributing factor


OR (95% CI)

P

Number of meals served daily (III_3)



<300

x.xx (ref)

.xxx

>300

x.xx


Food worker training provided (III_20)



No

x.xx (ref)

.xxx

Yes

x.xx


Paid sick leave provided (III_34)



No

x.xx (ref)

.xxx

Yes

x.xx


Establishment has ill worker policy (III_30)



No

x.xx (ref)

.xxx

Yes

x.xx


Disposable gloves are available in establishment (IV_7)



No

x.xx (ref)

.xxx

Yes

x.xx


Hand sink is available in work area (IV_3)



No

x.xx (ref)

.xxx

Yes

x.xx


OR=Odds Ratio, P=probability level


Below is an example figure demonstrating results from a multivariate analysis of the associations between environmental antecedents and the contributing factor of bare-hand contact with ready-to-eat food by an infectious food worker. This type of analysis allows us to determine the relationships among environmental antecedents and between environmental antecedents and contributing factors. It allows us to determine the direct and indirect effects of each environmental antecedent on the contributing factor. A separate model would be developed for each contributing factor analyzed.



Table B.4.7. Example Table Shell- Environmental antecedent variables associated with the outcome variable of whether the contributing factor of bare-hand contact with ready-to-eat food by an infectious worker was identified, multivariate analyses

Shape1

Bare-hand contact with food by infectious worker (C10)

Shape2

B.5. Individuals Consulted on Statistical Aspects and Individuals Collecting and/or Analyzing Data


The following persons were primarily responsible for designing the instrument however, Laura Brown, Erik Coleman, and Vince Radke will be primarily responsible for analyzing data.


Data Collection Designers and Analysts


Laura Green Brown, PHD

Behavioral Scientist

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Emergency and Environmental Health Services

Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-4332

[email protected]


Carol Selman, MPH (Retired)

Senior Public Health Advisor

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Emergency and Environmental Health Services

Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-4352

[email protected]


Erik W. Coleman, MPH

Health Scientist (Informatics)

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Emergency and Environmental Health Services

Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-3438

[email protected]


Kristin C. Delea MPH, REHS

Health Scientist/Epidemiologist

Centers for Disease Control and Prevention

Center for Global Health

Division of Global Health Protection

Center for Global Health Country Implementation and Strategy Branch (Proposed)

1600 Clifton Road (A06)

Atlanta, GA 30333

770-488-7065

[email protected]


Brenda Le, MS

Statistician

Centers for Disease Control and Prevention

National Center for Chronic Disease Prevention & Health Promotion Environmental Health

Division of Reproductive Health

Applied Sciences Branch

4770 Buford Hwy, NE (F74)

Atlanta, GA 30341

770-488-3756

[email protected]

Vince Radke, MPH

Sanitarian

Centers for Disease Control and Prevention

National Center for Environmental Health

Division of Emergency and Environmental Health Services

Environmental Health Services Branch

4770 Buford Hwy, NE (F58)

Atlanta, GA 30341

770-488-4352

[email protected]








31


File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorBrown, Laura (CDC/ONDIEH/NCEH)
File Modified0000-00-00
File Created2021-01-24

© 2024 OMB.report | Privacy Policy