Instructions to Participants

CDC Model Performance Evaluation Program (MPEP) for Mycobacterium tuberculosis Drug Susceptibility Testing

Attachment 6

Instructions to Participants

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop F08

Atlanta, Georgia 30333

OMB Form NO. __0920-0600_

Exp. Date 03/31/2019

CDC Model Performance Evaluation Program (MPEP)

for Mycobacterium tuberculosis Drug Susceptibility Testing

WARNING: The panel provided in this survey consists of viable cultures of Mycobacterium tuberculosis complex, some of which are drug resistant. The cultures in the panel should be considered hazardous and capable of transmitting infection. Testing should only be done if the recommended safety procedures are followed as described in the Centers for Disease Control and Prevention's Biosafety in Microbiological and Biomedical Laboratories, 2007, 5th Edition.
This manual can be accessed at http://www.cdc.gov/od/ohs/biosfty/bmbl5/BMBL_5th_Edition.pdf.
Biosafety Level 3 practices should be used when testing MTBC cultures.

Check the contents of your package. It should contain:

1. This cover letter with instructions

2. Shipping container with five (5) M. tuberculosis isolates. The isolate tubes are labeled with individual identification codes.

3. MPEP Results Worksheet for recording results prior to online data entry.

Please contact us at TBMPEP@CDC.GOV or call 404-639-4013 immediately if:

1. Your package is not complete.

2. You need replacement subcultures due to problems with the isolates (e.g., subculture contaminated, non-viable).

3. If you are not able to participate in this cycle. Please discard your shipment as biohazardous waste.

4. If you have any questions or comments.

For maximum benefit, please consider testing these isolates by ALL drug susceptibility methods and antituberculosis drugs used in your laboratory.

Results must be entered in the online data entry system at the link below no later than MM/DD/YYYY.

http://MPEP.formstack.com/forms/mpep_1

Instructions for online data entry:

1. Your MPEP number must be entered.

2. A separate survey should be filled out for each conventional drug susceptibility method used (e.g., one survey for MGIT, one survey for agar proportion, and one survey for Sensititre). This can be done by using the same web link. Submit one for the first method, then click on the same webpage and a fresh survey will open for the second submission.

3. Molecular results, if performed, should be only entered with the first survey completed.

4. Please note the order of the antituberculosis drugs on the enclosed worksheet and online data system have changed.

5. As you may notice, there is a new online data entry system, but the functionality is very similar to the previous program. Please contact TBMPEP@CDC.GOV with any questions.

6. All results for a survey must be entered at one time.

   1. For corrections after submission, please contact TBMPEP@CDC.GOV.

7. Although the on-line system does not have the option to print prior to submission, a printer-friendly copy of the results will be emailed to the submitter automatically.

We appreciate your continued interest and participation in the Model Performance Evaluation Prog