Att D_Burden of Canine Brucellosis Information Collection Insrument

Form Approved

OMB No. 0920-xxxx

Expires xx/xx/xxxx

Attachment D_ Data Collection Instrument

B urden of Canine Brucellosis Information Collection

Welcome! Thanks for taking the time to participate in this information collection. Below you will find a brief description of the project. Please review this description before proceeding through the information collection instrument.

Project Title: Burden of Canine Brucellosis
Investigators: Rita Traxler, Dr. Marta Guerra, Centers for Disease Control and Prevention
Protocol and Consent Title: Burden of Canine Brucellosis Information Collection

You are being asked to volunteer in an information collection. This information collection will ask about Brucella canis lab results from dogs. It will also identify lab tests used, lab exposure policies, and state reporting policies. Average time for completion should not exceed one hour. Information collected through this process will be kept secure, and will be presented in aggregate form, so as not to include any individually identifiable information.

Purpose: To assist in estimating the burden of canine brucellosis in the United States.

Requirements: You must be over the age of 18 years to participate in this information collection.

Procedures: Some of the information collection questions will require review of your records. To save time, we recommend printing a copy of the PDF information collection instrument attached to the email you received, then entering the data into the online information collection instrument. Please click on “Next” to participate in the online information collection instrument. There are 22 questions. You will need to look up data in your results database. Please click “Submit” when you reach the end of the information collection instrument. If your lab does not conduct any testing on dogs, please start the information collection instrument and complete the first 4 questions, then submit the information collection instrument on the final page.

Confidentiality: No identifying information will be gathered. All responses will remain secure between the respondent and the project administrators. Responses will be aggregated in future publications.

Participant Rights: Your participation in this information collection is voluntary. You do not have to complete the information collection instrument if you don't want to. You have the right to change your mind and exit the information collection instrument at any time without giving any reason and without penalty.

Questions about the Information collection instrument: If you have any questions about the information collection instrument, you may contact Rita Traxler (rtraxler@cdc.gov) at (404) 639-0265.

Next

Participant Agreement: By participating in the information collection instrument, it means that you have read (or have had read to you) the information given in this consent form, and you would like to be a volunteer in this information collection.

Form Approved

OMB No. 0920-xxxx

Expires xx/xx/xxxx

Burden of Canine Brucellosis Information Collection Instrument

1. Laboratory Name ____________________________________

2. Laboratory State _______ [drop down list of states]

3. Describe your laboratory (check all that apply):

State university-based laboratory

State government facility (e.g., Dept. of Agriculture lab)

Federal facility

National Animal Health Laboratory Network lab

Other, Specify:_________________________

4. Has your lab conducted any laboratory testing on dogs since January 1, 2010?

Yes No Unknown

5. Do you have an electronic database for specimen information and data storage?

Yes No Unknown

6. If yes, how many years has this or another compatible electronic system been in place in your laboratory?

<1 year 1-<3 3-5 >5, but less than 10 ≥10

a. How many full years of relatively complete data for your facility are contained in your database?

____years (if less than 5, provide data using this number of years for those questions that request data for a given time period)

Laboratory Results

7. Of the canine samples received by your lab during the last __ years (January 1, 2010- December 31, 2014 or calculated date range):

   1. Did you outsource testing for any of these samples?

Yes No Unknown

2. If yes, what percentage of testing did you outsource?

1-25% 26-50% 51-75% 76-100%

3. To whichWhat type of laboratory(s) did you outsource testing during the above-stated time frame to?

Lab Name City State

__________________ ________________ _____

__________________ ________________ _____

__________________ ________________ _____

Local commercial laboratory

National commercial laboratory (e.g., IDEXX)

Government laboratory—State

Government laboratory—Federal (e.g., NVSL)

Other

8. Of the canine samples processed in your lab during the last __ years (January 1, 2010- December 31, 2014 or calculated date range)::

   1. What types of specimens are submitted to your laboratory requesting culture?

(give the number of each sample type, if available)

____ Blood ____ Fluid specify: _______________

____ Vaginal swab ____ Other specify: _______________

____ Semen ____ Other specify: _______________

____ Tissue ____ Unknown type

____ Urine

Unknown number of samples

2. How many samples were culture positive for Brucella canis?

_______ Unknown

3. How many dogs have you reported out as culture positive for Brucella canis?

_______ Unknown

4. Have any dogs been culture positive for other Brucella species?

Yes No Unknown

1. If yes, which Brucella species were identified, how many samples, and how many dogs were positive?

Species _________________ No. of Samples ___________ No. of Dogs ________

Species _________________ No. of Samples ___________ No. of Dogs ________

Species _________________ No. of Samples ___________ No. of Dogs ________

9. When your lab obtains a positive Brucella spp. culture, what do you do with the isolate?

Transfer to another lab

Retain in inventory

Destroy/discard

Other, specify _______________________________

1. If your lab retains isolates in your inventory, would you consider allowing CDC access to some isolates for assay development?

Yes No Maybe, please contact us to discuss Unknown

10. Of the canine samples processed in your lab during the last __ years (January 1, 2010- December 31, 2014 or calculated date range):

    1. What types of specimens are submitted to your laboratory requesting PCR for bacterial agents?

(give the number of each sample type, if available)

____ Blood ____ Fluid specify: _______________

____ Vaginal swab ____ Other specify: _______________

____ Semen ____ Other specify: _______________

____ Tissue ____ Unknown type

____ Urine

Unknown number of samples

Not applicable

2. How many samples were PCR-positive for Brucella canis?

_______ Unknown Not applicable

3. How many dogs were considered PCR-positive for Brucella canis?

_______ Unknown Not applicable

4. Have any dogs been PCR-positive for other Brucella species?

Yes No Unknown Not applicable

1. If yes, which Brucella species were identified, how many samples, and how many dogs were positive?

Species _________________ No. of Samples ___________ No. of Dogs ________

Species _________________ No. of Samples ___________ No. of Dogs ________

Species _________________ No. of Samples ___________ No. of Dogs ________

11. Of the canine samples processed in your lab during the last __ years (January 1, 2010- December 31, 2014 or calculated date range)::

1. What types of specimens were submitted to your laboratory requesting serology for bacterial agents? (give the number of each sample type, if available)

____ Serum ____ CSF

____ Unknown type Unknown number of samples

1. Does this include paired samples?

Yes No Unknown

2. How many samples were sero-positive for rough Brucella species (i.e. B. canis)?

_______ Unknown

3. How many dogs were considered sero-positive for Brucella canis?

_______ Unknown

4. Have any dogs been sero-positive for smooth Brucella species (e.g., Brucella suis)?

Yes No Unknown Not applicable

1. If yes, how many samples, and how many dogs were positive?

No. of Samples ___________ No. of Dogs ________

12. If your lab obtains a positive serology result, what do you do with the sera?

Transfer to another lab

Retain in inventory

Destroy/discard

Other, specify _______________________________

1. If your lab retains serum in your inventory, would you consider allowing CDC access to sera for assay development?

Yes No Maybe, please contact us to discuss Unknown

13. Of the canine serum specimens received and tested in-house for Brucella spp. testing, estimate the number submitted for each the following reasons (if possible):

___ Suspicion of illness ___ Import/Export/Travel (interstate or international)

___ Regulatory ___ Other specify:­­­­­­ _______________________

___ Kennel ___ Don’t know

___ Sale of animal

14. For the Brucella canis-specific test(s) used in your lab in the past _years, select how each is used (select all that apply):

		Tests used from (January 1, 2010- December 31, 2014 or (calculated date range):
Test		Screening	Confirmatory	Experimental	Diagnostic
Rapid Slide Agglutination Test (RSAT)
2ME-RSAT
Card test
Tube Agglutination (TAT)
Agar Gel Immunodiffusion Test (AGID)
Indirect Fluorescent Antibody Test (IFAT or IFA)
ELISA
PCR
Other, Specify:
Other, Specify:
Other, Specify:

15. If you have more details that you would like to share about the laboratory results section, please comment here: ______________________________________________________________________

______________________________________________________________________

Policy & Exposures

16. Is Brucella canis infection a reportable disease in your state?

    1. In dogs? Yes No Unknown

1. If yes, to whom do you report a positive result?

State Dept. of Agriculture

State Bureau of Animal Health

US Dept. of Agriculture

Other (please specify) ____________________________

2. In humans? Yes No Unknown

17. Estimate the number of lab workers exposed to B. canis in your lab in the last __ years (January 1, 2010- December 31, 2014 or calculated date range). CDC defines a laboratory exposure to Brucella spp. as the following:

• Manipulation of a Brucella isolate OR

• Handling animal tissues that have a high concentration of Brucella organisms (reproductive tissues and products of parturition)

• on an open bench or in a class II biosafety cabinet without using biosafety level 3 practices or safety equipment.

• Presence in a laboratory room during any of the above activities.

0 11-15 26-30

1-5 16-20 31+

6-10 21-25 Unknown

Other/specific number:

18. Does your lab have a written policy regarding human Brucella spp. exposures?

Yes Not written, but do have an informal plan No

1. [If yes or Informal plan] Select the components of your written or informal policy:

Symptom monitoring Serological monitoring

Prophylactic antibiotics Risk evaluation/classification

Consult occupational health Other _______________________

19. Does your lab have a written policy specific to human B. canis exposures?

Yes Not written, but do have an informal plan No

1. [If yes or Informal plan] Select the components of your written or informal policy:

Symptom monitoring Serological monitoring

Prophylactic antibiotics Risk evaluation/classification

Consult occupational health Other _______________________

The same as for Brucella spp. (#18a)

20. Who would you contact for information if a person was exposed to B. canis in your lab (select all that apply)?

Local Health Department

State Health Department

Occupational Health/Infection Control Officer

Centers for Disease Control and Prevention

US Dept. of Agriculture

Other ______________________________

21. Would your lab be willing to participate in future studies related to B. canis in humans or dogs?

Yes No Maybe, please contact us to discuss

Unknown

22. If you have more details that you would like to share about the policy and exposures section, please comment here: ________________________________________________________________ ______________________________________________________________________________

Thank you for your participation! <SUBMIT>

Public reporting burden of this collection of information is estimated to average 1 hour per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.  Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74,  Atlanta, Georgia 30333; ATTN:  PRA (0920-xxxx).