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

Form Approved
OMB No. 0920-0879
Expiration Date: 3/31/2014

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].
Please describe your role in the TB Control Program.

Has your TB program used Molecular Detection of Drug Resistance (MDDR) testing offered by the
CDC?
No, we have not used the MDDR testing.
No, we are familiar with but have not used the MDDR testing.
Yes, we have used the MDDR testing at CDC.
Who primarily initiates requests for MDDR testing offered at CDC?
TB Controller
TB Program Manager
Medical Consultant
TB Nurse Consultant
Public Health Laboratory
Healthcare Provider
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).’

If someone outside the TB program initiates a request for MDDR testing, is the program informed of
that decision?
Yes
Sometimes
No
Not applicable
Please explain your response to the question above .

If your TB program is involved in the process for submitting MDDR testing requests, what is the
program's role?
The program sends a pre-submission form directly to CDC and then contacts the public
health laboratory for sample referral.
The program consults with public health laboratory and then the program submits the presubmission form to CDC.
The program consults with public health laboratory and the laboratory submits the presubmission form to CDC.
The program consults with the healthcare provider and then the program submits the presubmission form to CDC.
Not applicable. The TB program is not involved in submitting MDDR testing requests.
Other. Please explain:

Are you satisfied with CDC’s process for submitting a request for MDDR testing?
Yes
No
Not applicable. I am not aware of CDC's process for submitting a request for MDDR testing.
Please explain how CDC could improve the process for submitting requests for MDDR testing.

Are you satisfied with CDC’s pre-submission criteria for submitting a request for MDDR testing?
Yes
No
Not applicable. I am not aware of CDC's pre-submission criteria.

Please explain how CDC could improve the pre-submission criteria.

Has your TB program initiated a request for MDDR testing to confirm results from a molecular test
performed at your local health department (e.g., GeneXpert MTB/RIF assay, HAIN MDRTBplus, or
DNA sequencing)?
Not sure
No.
Yes. Please describe:

If the molecular test results were discordant (e.g. GeneXpert indicates Rifampin resistant and the
MDDR report indicates probably Rifampin susceptible but shows a silent mutation in the rpoB
gene) what actions, if any, were initiated? (Select all that apply)
Contacted DTBE/Laboratory Branch to discuss results and take action.
Contacted DTBE/Field Services and Evaluation Branch to discuss results and take action.
Contacted public health laboratory to discuss results.
Waited for conventional DST results before initiating any action
No action initiated.
Not applicable.
Other. Please explain:
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)
Waiting for culture to grow
Culture contaminated
No growth in culture (i.e. only have specimen)
Shipping difficulties (e.g., lack of certified shipper in laboratory or paperwork issues)
Delay in obtaining specimen or isolate from another laboratory
Waiting for results from conventional growth-based drug susceptibility testing
Concern that CDC's MDDR pre-submission criteria would not be met
No submission delays experienced.
Other. Please explain:

How is your program usually notified of the molecular results from CDC's MDDR testing?
We receive a report of the molecular results directly from the CDC.
We receive a CDC report of the molecular results from the public health laboratory.
We receive the results from the public health department.
We receive the results from the healthcare provider.
We call CDC directly to obtain results.
We are generally not notified of MDDR results.
Other. Please explain

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?
within 1 business day
2-3 business days
4-5 business days
> 5 business days
Not applicable. We do not usually receive MDDR results from the public health laboratory.
Not sure. Please explain:

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 the appropriate response to the following statements regarding the report
using the scale below.
Strongly
Disagree
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.

Disagree

Agree

Strongly
Agree

N/A

If you experienced difficulty interpreting the molecular results from the MDDR testing, what
resource did you primarily use to seek additional information?
Contacted DTBE Laboratory Branch at CDC to discuss results.
Contacted DTBE Field Services and Evaluation Branch at CDC to discuss results.
Discussed the results with public health laboratory staff.
Did my own research to find information on interpretation.
Contacted RTMCC in consultation for interpreting results.
CDC website
I did not seek help for interpreting results.
I have not experienced difficulty interpreting MDDR molecular results.
Other. Please explain:
In general, does your TB Control Program communicate with healthcare providers (i.e. the person
responsible for treatment decisions) regarding MDDR molecular results?
We consult with the health care provider about MDDR molecular results most of the time.
We consult with the health care provider about MDDR molecular results only when
contacted by the provider.
We do not usually consult with health care providers about MDDR results.

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
I am comfortable
discussing the
molecular results. with
healthcare providers
I have difficulty
discussing molecular
results with healthcare
providers.

Disagree

Agree

Strongly Agree

Does anyone from your program (excluding public health laboratory staff) compare molecular
results from MDDR testing with conventional growth-based DST results?
Yes, we compare most MDDR results with conventional DST results performed at the public
health laboratory only.
Yes, we compare most MDDR results with conventional DST results performed at CDC only
as they are available.
Yes, we compare most MDDR results with conventional DST results performed at the public
health laboratory and at CDC as they are available.
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.
We do not compare MDDR results with any conventional DST results.
Other. Please explain:

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)
We consult with public health laboratory.
We request the public health laboratory to retest the isolate.
We request CDC to retest the isolate.
We request the public health laboratory to submit another isolate to CDC.
We request the public health laboratory send the isolate to another reference laboratory.
No additional actions taken.
Other. Please explain:

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

Disagree

Agree

Strongly
Agree

N/A

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 request form easy
to use.
I am satisfied with the presubmission 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 growthbased drug susceptibility test panel
for second-line drugs.
I would like training opportunities to
better understand molecular
results.

You selected that your TB Program has not used CDC's MDDR testing service. Based on your
response, please select submit to end the survey. If you feel you have selected the incorrect response
please hit the "Prev" button to return to the previous question.
If you have any questions or concerns please contact Allison McAlister at [email protected].

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