Results Worksheet

Centers for Disease Control and Prevention Performance Evaluation Program for Mycobacterium Tuberculosis/Non-tuberculosis Mycobacteria Drug Susceptibility Testing Program

0920-0600 Attachment 4c Gen Instruction and Results Worksheet (2)

MPEP for M. TB and non-tuberculous Mycobacteria Drug Susceptibility Testing Results Worksheet

OMB: 0920-0600

Document [doc]
Download: doc | pdf

U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases, Mail Stop G-25

Atlanta, Georgia 30333

OMB Approved

OMB Control No. 0920-0600

Exp. Date xx/xx/xxxx


GENERAL INSTRUCTIONS and WORKSHEET


DRUG SUSCEPTIBILITY TESTING PROGRAM FOR

MYCOBACTERIUM TUBERCULOSIS and NON-TUBERCULOUS MYCOBACTERIA


WARNING


The culture panel provided in this survey consists of viable strains of Mycobacterium tuberculosis (M. tb) only, 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

This manual recommends use of Biosafety Level 3 practices when testing M. tb cultures.


PLEASE READ ALL INSTRUCTION SHEETS COMPLETELY BEFORE PROCEEDING WITH ANY CULTURE EVALUATION.


The results must be entered on-line or postmarked not later than MM/dd/yyyy


Check the contents of your package. It should contain:


  1. Cover letter.


  1. Envelope containing:

(a) Results Worksheet for recording testing results with instructions.

  1. Laboratory Information Change Form for recording any changes to laboratory information.


Please note: All results must be entered online at http://wwwn.cdc.gov/mpep/mtbds/login.aspx


  1. Shipping container with a panel of four (4) labeled “TB Test Cultures.” The culture tubes are labeled with individual identification codes.

NOTE: Shipping containers with a panel of only four (4) cultures are provided to the laboratories that perform TB drug Susceptibility testing.


If the contents of your package are not complete, or if additional cultures are required, please call Dr. Angela Ragin, Project Coordinator at CDC at 404-498-2241 immediately.


Treat these cultures in the same manner that you routinely treat Mycobacterium tuberculosis isolates.


INSTRUCTIONS FOR ENTERING RESULTS


Please enter your results on-line data ONLY; you will need

  • your TPEP number_________

  • password___________________.

If you have forgotten or misplaced your password, contact Dr. Angela Ragin, Project Coordinator at CDC toll free at 1-888-465-6062 or 404-498-2241. Results must be entered in the on-line data entry system no later than Month/day/year.


  1. After testing your samples, enter your results at the CDC Tuberculosis Drug Susceptibility Website using the password assigned to your laboratory. The Website is located at the following HTML address:


http://wwwn.cdc.gov/mpep/mtbds/login.aspx


  1. Please verify laboratory information and make any changes on the Website or on the enclosed Laboratory Information Change Form then fax it to 404 498 2372.


  1. Only on-line results entry will be accepted.


  1. For multiple choice questions beginning on page 5 of the Results Worksheet worksheet, fully blacken the circle to the left of the appropriate answer. Please do not use checks marks () or cross marks (X) within the circles.


Do not mail the Results Worksheets. They are for your laboratory use only.

Results must be entered online on or before the specified deadline.

If you require assistance entering your data, please contact Ms. Yolanda Castillo or Dr. Angela Ragin at 1-888-465-6062 (toll-free) or 404-498-2241




U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

Coordinating Center for Infectious Diseases

Atlanta, Georgia 30333

OMB Form NO. ___________

Exp. Date ___________

CDC DRUG SUSCEPTIBILITY TESTING PROGRAM FOR MYCOBACTERIUM TUBERCULOSIS AND NON-TUBERCULOUS MYCOBACTERIA RESULTS


WORKSHEET

Month Year





Completed Results Can Be Entered at the CDC Tuberculosis Susceptibility Website:

http://wwwn.cdc.gov/mpep/mtbds/login.aspx







FAX: (404) 498 2372


Or


Mail: Angela Ragin, Ph.D.

Centers for Disease Control and Prevention

Division of Laboratory Systems

1600 Clifton Road, NE,

Mail Stop G-23

Atlanta, GA-303333


Please indicate changes to your laboratory information on the

Laboratory information Change Form and return by email or fax to project officer.


The Project Officer can be contacted at:

[email protected] or

[email protected] or 404 498-2241

FAX: 404 498-2372






Person Completing Form:


1. Name: ___________________________________________________________


2. Title: ___________________________________________________________


M. tuberculosis Results Worksheet




3. Please indicate the primary classification of your laboratory. (Please blacken only one circle.)


Hospital

[e.g., city, county, district, community, state, regional, military, Veterans Administration, Federal government

(other than military), privately-owned, university, HMO/PPO-owned and operated, religious-associated]


Health Department

[e.g., city, county, state, regional, district, national reference laboratory]


Independent

[e.g., commercial, commercial manufacturer of reagents, HMO satellite clinic, reference laboratory (non- government affiliated)]


O ther

[e.g., university-associated research, Federal government research (nonmilitary), privately-funded research]



4. In the last calendar year (January 1 - December 31, YYYY), how many Mycobacterium tuberculosis isolates (excluding quality control isolates) did your laboratory test for drug susceptibilities? (Please write the number of Mycobacterium tuberculosis isolates your laboratory tested for susceptibility in the boxes below.)







Mycobacterium tuberculosis isolates:


The following questions pertain to the receiving and testing of the culture panel. In most

cases, blacken the circle corresponding to your response in the circle provided to the left of the answer. Some questions may require more than one response; please blacken all that apply. In some cases, you will be asked to fill in the boxes to the right of the answer with an appropriate comment or number.










5. On what date was the culture panel received in your laboratory?


/



/





Month Day Year




M. tuberculosis Results Worksheet



6. What was the condition of the cultures in the panel when they arrived?

( Please blacken only one circle.)

Satisfactory

Broken

Other (please explain): _______________________________


  1. Please indicate the level of biosafety practices followed in your mycobacteriological laboratory when working with M. tb cultures. (Please blacken only one circle.)


Biosafety Level 1

Biosafety Level 2

Biosafety Level 3

Biosafety Level 2 for facilities with Level 3 containment equipment

Do not know

8. What procedure(s) was used in your laboratory to perform drug susceptibility testing on these M. tb cultures in this shipment? (Please blacken all that apply.)


Agar Proportion (Middlebrook medium)

Radiometric (BACTEC 460)

Lowenstein Jensen (LJ) proportion method

Automated MGIT 960

Other (please specify): __________________________________________


9a. Indicate the primary M. tb susceptibility test medium used by your laboratory for the cultures in this shipment. (Please blacken only one circle.)


B ACTEC 460 12B (with or without PZA media)

Middlebrook 7H10

M iddlebrook 7H11

Versa-Trek Myco

Automated MGIT 960

Other (please specify): __________________________________________


M . tuberculosis Results Worksheet



9b. If you use a rapid test method for susceptibility testing of the anti-tuberculosis drugs, do you purchase the drugs from the manufacturer? (Please blacken only one circle.)


Y es

No

Not Applicable

9c. If you use Middlebrook 7H10 or 7H11 media for any anti-tuberculosis drug susceptibility testing, your media is: (Please blacken all that apply.)


p urchased “commercially-prepared” containing anti-tuberculosis drugs

prepared in-house with disks containing anti-tuberculosis drugs

prepared in-house by reconstituting and adding anti-tuberculosis drugs

Not Applicable

Non-tuberculous mycobacteria

10. Does your laboratory perform on-site susceptibility testing of non-tuberculous mycobacteria? (Please blacken only one circle.)

Yes

No

11.For the species of NTM that you do not test in-house, do you refer (send out) these to another laboratory for drug susceptibility testing? (Please blacken only one circle.)


Y es

N o

Not applicable


12. What procedure(s) was used in your laboratory to perform drug susceptibility testing on the NTM culture in this shipment? (Please blacken all that apply.)


D o Not Perform

Agar Proportion

BACTEC 460

E-Test

Microtiter

Agar Disk Elution

Kirby Bauer

Lowenstein-Jensen

Automated MGIT 960

Other (please specify): __________________________________________


M. tuberculosis Results Form Worksheet



13. For each antimicrobial that you use routinely to determine the susceptibility of M. tb, record a test method, the concentration of the antimicrobial and a result (R=Resistant, S=Susceptible, O=Other). (Please see example 1.) If the isolates in the panel were tested using more than one concentration of an antimicrobial, record those results on lines that correspond to the antimicrobial you are testing (example 1). If you need more lines than are provided for that antimicrobial, please record results in the blank lines provided at the bottom of the result page. Do not cross out an existing antimicrobial and write another drug name over it (example 2).


If you are testing an antimicrobial not listed on the result page, record the entire drug name (no abbreviations), a concentration and a result in the blank lines provided at the bottom of the result page. Please make sure that each result is recorded on a provided line and not written in the margins outside the form. Make a copy of the result page if you do not have enough room on the provided page to record all results.


Other responses related to susceptibility results such as Borderline, Contaminated, No Growth, etc. can be abbreviated and recorded to the right of the "O" selection in the result columns (examples 1 and 3).




1. Following are examples of CORRECTLY reported M. tb results.


Isoniazid

A B C O



0

.

1


R S O

R S O

R S O

Isoniazid

A B C O



0

.

2


R S O

R S O

R S O

Isoniazid

A B C O



1

.

0


R S O

R S O

R S O NG



2. Following are examples of INCORRECTLY reported M. tb results.


Isoniazid

A B C O

1

2

-

.

-

0

R S O

R S O

R S O

Isoniazid

A B C O




.



R S O

R S O

R S O



M. tuberculosis Results Worksheet

These are the results for M. tuberculosis complex testing.

The NTM results (if applicable) will go on the next page.

**Please provide the Test Method, the Concentration, and the Test Results for each line reported.

13. (Continued) Use the blank lines provided at the end of the form for other drugs or additional concentrations.

A=Agar Proportion

B=BACTEC

C=L-J Proportion

D=MGIT

O=Other:

(Choose only one)

Please list each concentration

Culture Identification Codes

(Fill in ONE letter for each culture)

R=Resistant, S=Susceptible, O=Other

Please indicate any other responses in the space provided

For example: B=Borderline, C=Contaminated, NG=No Growth,

Antimicrobial

Test Method

Conc. μg/mL

K

L

M

N

Isoniazid

A B C D O







R S O

R S O

R S O

R S O

Isoniazid

A B C D O







R S O

R S O

R S O

R S O

Isoniazid

A B C D O







R S O

R S O

R S O

R S O

Isoniazid

A B C D O







R S O

R S O

R S O

R S O

Rifampin

A B C D O







R S O

R S O

R S O

R S O

Rifampin

A B C D O







R S O

R S O

R S O

R S O

Rifampin

A B C D O







R S O

R S O

R S O

R S O

Pyrazinamide

A B C D O







R S O

R S O

R S O

R S O

Pyrazinamide

A B C D O







R S O

R S O

R S O

R S O

Pyrazinamide

A B C D O







R S O

R S O

R S O

R S O

Ethambutol

A B C D O







R S O

R S O

R S O

R S O

Ethambutol

A B C D O







R S O

R S O

R S O

R S O

Ethambutol

A B C D O







R S O

R S O

R S O

R S O

Streptomycin

A B C D O







R S O

R S O

R S O

R S O

Streptomycin

A B C D O







R S O

R S O

R S O

R S O

Streptomycin

A B C D O







R S O

R S O

R S O

R S O

Ethionamide

A B C D O







R S O

R S O

R S O

R S O

Ethionamide

A B C D O







R S O

R S O

R S O

R S O

Kanamycin

A B C D O







R S O

R S O

R S O

R S O

Kanamycin

A B C D O







R S O

R S O

R S O

R S O

Capreomycin

A B C D O







R S O

R S O

R S O

R S O

Capreomycin

A B C D O







R S O

R S O

R S O

R S O

Cycloserine

A B C D O







R S O

R S O

R S O

R S O

Cycloserine

A B C D O







R S O

R S O

R S O

R S O

p-Aminosalicylic acid

A B C D O







R S O

R S O

R S O

R S O

p-Aminosalicylic acid

A B C D O







R S O

R S O

R S O

R S O

Amikacin

A B C D O







R S O

R S O

R S O

R S O

Amikacin

A B C D O







R S O

R S O

R S O

R S O

Ofloxacin

A B C D O







R S O

R S O

R S O

R S O

Ofloxacin

A B C D O







R S O

R S O

R S O

R S O

Ciprofloxacin

A B C D O







R S O

R S O

R S O

R S O

Ciprofloxacin

A B C D O







R S O

R S O

R S O

R S O

A B C D O







R S O

R S O

R S O

R S O


A B C D O







R S O

R S O

R S O

R S O


A B C D O







R S O

R S O

R S O

R S O


A B C D O







R S O

R S O

R S O

R S O


A B C D O







R S O

R S O

R S O

R S O

Note: Please provide the complete drug name when filling in additional spaces.


7


File Typeapplication/msword
File TitleCDC DRUG SUSCEPTIBILITY TESTING PROGRAM FOR MYCOBACTERIUM TUBERCULOSIS and NON-TUBERCULOUS MYCOBACTERIA
AuthorMichael Walsh
Last Modified Byaeo1
File Modified2009-12-11
File Created2009-12-11
© 2024 OMB.report | Privacy Policy