Health Department Use and Application of CDC Drug Resistant TB Laboratory Services

Form Approved

OMB No. 0920-0879

Expiration Date 03/31/2014

ATTACHMENT – C: Data Collection Instrument (Word Version)

Thank you for your participation. Completion of the assessment is entirely voluntary and your responses will not be shared in an identifiable form. Information from the survey will aid in clarifying reporting language and focusing training and educational efforts to improve understanding of the MDDR service and molecular results. Please contact Allison McAlister if you have questions or concerns at 404-639-4925 or at [email protected].

1. Please describe your role in the TB Control Program

2. Has your TB program utilized the Molecular Detection of Drug Resistance (MDDR) Service offered by the CDC?

1. No, we have not utilized the MDDR service. [If selected, survey ends]

2. No, we are familiar with but have not utilized the MDDR service. [If selected, survey ends]

3. Yes, we have utilized the MDDR service at CDC.

3. Who primarily initiates requests for MDDR testing service at CDC?

1. TB Controller

2. Medical Consultant

3. TB Program Manager

4. Public Health Laboratory

5. Healthcare provider

6. Other. Please Explain:

Public reporting burden of this collection of information is estimated to average 15 minutes 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 (0920-0879).

4. If someone outside the TB program initiates a request for MDDR testing, is the program informed of that decision?

1. Yes. Please explain:

2. Sometimes. Please explain:

3. No. Please explain:

4. Not applicable.

5. If your TB program is involved in the process for submitting MDDR testing requests, what is the program’s role?

1. The program sends a pre-submission form directly to CDC and then contacts the public health laboratory for sample referral.

2. The program consults with public health laboratory and then the program submits the pre-submission form to CDC.

3. The program consults with public health laboratory and the laboratory submits the pre-submission form to CDC.

4. The program consults with the health care provider and then the program submits the pre-submission form to CDC.

5. Not applicable. The TB program is not involved in submitting MDDR testing requests.

6. Other. Please explain:

6. Are you satisfied with CDC’s process for submitting a request for MDDR testing?

1. Yes

2. No. Please explain how CDC could improve the process for submitting MDDR requests.

3. I am not aware of CDC’s process for submitting a request for MDDR testing.

7. Are you satisfied with CDC’s pre-submission criteria for submitting a request for MDDR testing?

1. Yes

2. No. Please explain how CDC could improve the pre-submission criteria for submitting MDDR requests.

3. I am not aware of CDC’s pre-submission criteria for submitting a request for MDDR testing.

8. Has your TB program initiated a request for MDDR testing to confirm results from a molecular test performed locally (e.g., GeneXpert MTB/RIF assay, HAIN MDRTBplus, or DNA sequencing)?

1. Yes. Please describe. (Go to question 9)

2. No (Go to question 10)

3. Not sure (Go to question 10)

9. If the molecular test results were discordant (e.g. GeneXpert indicates Rif-R and the MDDR indicates probably Rif-S but shows a silent mutation in the rpoB gene) what actions, if any, were initiated? (Select all that apply)

1. Contacted DTBE/Laboratory Branch to discuss results and take appropriate action.

2. Contacted DTBE/Field Services and Evaluation Branch to discuss results and appropriate action.

3. Contacted and consulted with another public health official outside DTBE.

4. Contacted local public health laboratory to discuss results.

5. Waited for conventional DST results before initiating any action.

6. No action initiated.

7. Other. Please explain.

10. Has your program experienced a delay in submission of a sample for MDDR testing due to any of the following reasons? (Select all that apply)

1. Waiting for an isolate of M. tuberculosis to grow

2. Culture contaminated

3. Culture did not grow

4. Shipping difficulties (e.g., lack of certified shipper in laboratory or paperwork issues)

5. Delay in obtaining isolate or specimen from another laboratory

6. Waiting for results from local conventional growth-based drug susceptibility testing

7. Concern that MDDR pre-submission criteria would not be met

8. Have not experienced any submission delays

9. Other. Please explain.

11. How is your program usually notified of the molecular results from the MDDR testing service?

1. We receive a report of the molecular results directly from CDC.

2. We receive a CDC report of the molecular results from public health laboratory.

3. We receive the results from a local health department. [Go to question 13]

4. We receive the results from the healthcare provider. [Go to question 13]

5. We call CDC directly to obtain results. [Go to question 13]

6. We are generally not notified of MDDR results. [Go to question 13]

7. Other, please explain. [Go to question 13]

12. CDC issues an interim report describing the molecular results while growth-based drug susceptibility test results are pending. If you have received an interim report describing molecular results, please select your appropriate response to the following statements regarding the report using the scale below.

Strongly Disagree	Disagree		Agree	Strongly Agree	N/A
The format of the interim report of molecular results is easy to interpret
I usually read all the interpretive comments on the interim report.
The interim report does not provide enough information.
The interim report is formatted well and easy to read.

The interpretation provided on the interim report is helpful for understanding the results.

The interpretation provided on the interim report is difficult to understand.

The inclusion of the nucleotide change (e.g. TCGTTG) is necessary for interpretation of the report.

The inclusion of the amino acid change (e.g. Ser531Leu) is necessary for interpretation of the report.

Further interpretive comments are needed for less common mutations.

13. Once the public health laboratory receives the MDDR results from CDC, how quickly does the public health laboratory usually report the results to the program?

A. Within 1 business day

B. 2-3 business days

C. 4-5 business days

D. > 5 business day

E. Not applicable. The TB program is not usually notified of MDDR testing results.

F. Other. Please explain:

14. If you experienced difficulty interpreting the molecular results from the MDDR testing service, what resource did you primarily use to seek additional information?

1. Contacted DTBE Laboratory Branch at CDC to discuss results.

2. Contacted DTBE Field Services and Evaluation Branch at CDC to discuss results.

3. Discussed the results with local public health laboratory staff.

4. Did my own research to find information on interpretation.

5. Contacted RTMCC in consultation for interpreting results.

6. CDC Website.

7. I did not seek help for interpreting results.

8. Other, please explain.

15. In general, does your TB Control Program communicate with healthcare providers (i.e. the person responsible for treatment decisions) regarding MDDR molecular results?

1. We consult with the health care provider about MDDR molecular results most of the time.

2. We consult with the health care provider about MDDR molecular results only when contacted by the provider.

3. We do not usually consult with health care providers about MDDR results. [Go to question 17]

16. For the following statements, please select the appropriate response in regards to discussing molecular results with healthcare providers (i.e. the person responsible for treatment decisions) using the scale below.

.

Strongly Disagree	Disagree		Agree	Strongly Agree N/A
I am comfortable discussing the molecular results with healthcare providers.
I have difficulty discussing molecular results with healthcare providers.

17. Does anyone from your program (excluding public health laboratory staff) compare molecular results from MDDR testing with conventional growth-based DST results?

1. Yes, we compare most MDDR results with conventional DST results performed locally only.

2. Yes, we compare most MDDR results with conventional DST results performed at CDC only as they are available.

3. Yes, we compare most MDDR results with conventional DST results performed locally and at CDC as they are available.

4. We compare results from MDDR with conventional DST results only when we suspect a problem or when MDDR was requested based on conventional DST results.

5. We do not compare MDDR results with any conventional DST results.

6. Other. Please explain.

18. If you find discordance between the molecular results from the MDDR service and conventional growth-based DST performed at the public health laboratory or at CDC, what actions, if any, are taken by your TB Control Program? (Select all that apply)

1. We request the public health laboratory to retest the isolate.

2. We request CDC to retest the isolate.

3. We request the public health laboratory to submit another isolate to CDC.

4. We request the public health laboratory send the isolate to another reference laboratory.

5. No additional actions taken.

6. Other. Please explain:

19. For the following statements, please select the appropriate response regarding the use of MDDR results in guiding public health or clinical decision making using the scale below.

Strongly Disagree	Disagree		Agree	Strongly Agree N/A
MDDR molecular results are useful when deciding how to treat contacts to a MDR-TB case. MDDR molecular results are useful when deciding how to treat contacts to a drug-susceptible TB case. Growth-based drug susceptibility test results are essential for guiding treatment of contacts. The program is confident about treatment decisions for TB cases based primarily on molecular results. The program advises waiting for growth-based drug susceptibility test results before making treating decisions for TB cases.
MDDR results have been useful in decision making with high profile situations (e.g., daycare, nursing home, corrections, or healthcare settings, homeless shelters, etc.)

20. For the following statements, please select the appropriate response regarding customer satisfaction with the MDDR testing service using the scale below.

Strongly Disagree	Disagree	Agree	Strongly Agree	N/A
I find the MDDR pre-submission request form easy to use. I am satisfied with pre-submission criteria for submitting a sample for MDDR testing.
I am satisfied with the turnaround time of the molecular results. I am satisfied with the turnaround time of the growth-based drug susceptibility test results. The DTBE Laboratory Branch is available when I need consultation. I have found the information from the CDC website to be useful.
I am satisfied with CDC’s growth-based drug susceptibility test panel for second-line drugs. I would like training opportunities to better understand molecular results.

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