Att. 6-Instructions for 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 30329

OMB Form No. 0920-0600

Exp. Date 02/20/2022

CDC Model Performance Evaluation Program (MPEP)

for Mycobacterium tuberculosis Drug Susceptibility Testing

WARNING: The panel provided in this survey consists of viable isolates of Mycobacterium tuberculosis complex, some of which are drug resistant. The isolates in the panel should be considered hazardous and capable of transmitting infection. Testing should only be performed if the recommended safety procedures are followed as described in the Centers for Disease Control and Prevention's Biosafety in Microbiological and Biomedical Laboratories, 2020, 6th Edition.
This manual can be accessed at https://www.cdc.gov/labs/pdf/CDC-BiosafetyMicrobiologicalBiomedicalLaboratories-2020-P.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.

4. Material Transfer Certificate for this shipment

Please contact 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 upon arrival (e.g., subculture contaminated, damaged).

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

4. 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 5/7/2021.

https://rdcp.cdc.gov/surveys/?s=TMKFCMRNW4

Instructions for online data entry:

1. Your MPEP number must be entered. Please contact TBMPEP@CDC.GOV if this is unknown.

2. A new online data entry system will be used, but the functionality is very similar to the previous program. Please contact TBMPEP@CDC.GOV with any questions.

3. For each survey submitted, two growth-based drug susceptibility test methods and one molecular test method can be entered.

   1. Sensititre, if performed, must be entered as the first method.

4. For laboratories performing Sensititre, MIC results should be entered within the online system.

5. Please note additional antituberculosis drugs have been added to the enclosed worksheet and online data system.

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

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

7. Upon submission, a pdf copy of results will be available for download and by email.

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