Laboratory practices questionnaire

Form Approved

OMB Control No. 0920-0600

Exp. Date. xx/xx/xxxx

Form Approved

Model Performance Evaluation Program for Mycobacterium tuberculosis complex (MTBC) and Non-tuberculous Mycobacterium (NTM) Drug Susceptibility Testing

Laboratory Practices Questionnaire (LPQ) for 2010

Worksheet---Online submission only at:

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

Do not mail the LPQ Worksheet Worksheets. It is for your laboratory use only.

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

If you require assistance entering your data, please contact

Dr. Angela Ragin at 1-888-465-6062 (toll-free) or 404-498-2241.

Public reporting of this collection of information is estimated to average 30 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 Reports Clearance Officer; 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-XXX)

1.    What is your laboratory’s classification?  (Check only one.)

           

О Hospital

О Independent
О Other Public Health Laboratory
О State Public Health Laboratory

О Other (specify)________________

2.  On what isolates does your laboratory perform susceptibility testing?

            О MTBC, only

            О NTM, only

            О Both MTBC and NTM

3.  What method(s) does your laboratory use to perform susceptibility testing on MTBC?

      (Check all that apply)

           

О Agar Proportion (AP) w/Middlebrook 7H10

О AP w/Middlebrook 7H11

О Radiometric (BACTEC)

О MGIT (B-D)

О TREK

О Molecular methods

О Other (specify)________________

4.  How frequently is MTBC susceptibility testing performed in your laboratory? 

      (Check only one)

О <1x per month

О <1x per week

О 1x per week

О 2x per week
О As positive TB isolates become ready to test

5.  If your laboratory used the broth DST method for TB susceptibility testing, what is your primary testing schedule?

О Do not use broth DST methods

О Set-up on Friday test Monday-Friday

О Test on weekend

6.  What was the approximate number of MTBC isolates tested in your laboratory for drug susceptibilities in calendar year YYYY (January 1– December 31)?   

________________________

7.  Of the MTBC isolates tested for drug susceptibilities in calendar year YYYY

(January 1--December 31), what percent were from patient specimens decontaminated and concentrated in your laboratory?
     

            _______________%

8.  What criteria does your laboratory use to determine when to perform drug susceptibility testing for primary (first-line) anti-tuberculosis drugs on MTBC isolates?  (Check all that apply)

О First culture isolate from a new TB case

О Every culture isolate

О Repeat on positive after 1 month on treatment

О Repeat on positive after 2 months on treatment

О Repeat on positive after 3 months on treatment

О Repeat by physician’s request

О Other (Specify)___________________________

9. If the agar proportion method is used in your laboratory, what are the criteria for performing this method? (Check all that apply)

О AP on all patient isolates

О Questionable results obtained with broth culture

О Resistance to a first line drug by broth culture

О Physician’s request

О Other (Specify)________________

10a. What is the primary method(s) (not confirmatory method) used for testing first-line drugs for MTBC susceptibility testing in your laboratory? (Check all that apply)

О Agar Proportion

О MGIT, manual

О MGIT 960

            О BACTEC 460

О BACTEC 960

О TREK

О Molecular Method

О Other (Specify)____________

10b. What anti-tuberculosis drugs and concentrations are initially tested as the primary panel on MTBC isolates? __________Will add drop-down list online______________

11.  Does your laboratory perform susceptibility testing for any second line anti-tuberculosis drugs? 

О Yes, List (Will add drop-down list online)
О No

12.  What second line anti-tuberculosis drugs and concentrations are tested on MTBC isolates in your laboratory?

_____________________________(Drop-down list?) plus a text box for additional drugs

13.  What percentage of MTBC isolates in your laboratory was tested against any second line anti-tuberculosis drug in the calendar year YYYY (January 1 – December 31)? 

________________________________%

14.  What criteria does your laboratory use to determine when to perform second-line

 anti-tuberculosis drug susceptibility testing?  (Check all that apply)

О Physician’s request

О Resistance to any one of the first line drugs (SIRE or PZA)

О Resistance to any two of the first line drugs (SIRE or PZA)

О Resistance to Rifampin

О Resistance to Isoniazid

О Other (Specify) ________________

15.  If your laboratory does not perform second-line anti-tuberculosis drug susceptibility testing, where do you refer secondary drug susceptibility testing? (Check all that apply)

О CDC laboratory

О State public health laboratory

О Other public health laboratory

О Hospital laboratory

О Commercial laboratory

О Reference laboratory

О Independent laboratory

О Other (Specify)________________

16.  If your laboratory receives referred isolates, on what media are isolates sent for testing? (Check all that apply)

О Commercial Broth Media (BACTEC, MGIT, TREK)

О Lowenstein-Jenson slants

О Middlebrook 7H9 Broth

О Middlebrook 7H10/7H11 plates/slants

О Other (Specify)________________

17.  When MTBC susceptibility test results are complete, how soon do you report the results to the ordering clinician/laboratory/TB Control program or agency?
(Check only one)

О 1-2 days
О 3-4 days

О 5-7 days

О Do not know

О Other (specify)_____________

18.  How does your laboratory initially report MTBC susceptibility test results to the ordering clinician or laboratory?  (Check all that apply)

О Email

О Fax

О Telephone

О Hard copy delivered by courier

О Hard copy delivered by mail

О Other (specify)________________

19.  Please indicate what is included in your laboratory’s report of MTBC susceptibility test results.  (Check all that apply)

О Drug, concentration tested and interpretation

О Drug and Interpretation

О Recommend further consultation

О Test Method

О AP percentage of resistant colonies

О Other (Specify)______________

20. How often are quality control MTBC strain(s) run in conjunction with susceptibility tests?  (Check all that apply)

О Each Run

О Once a week

О With a new lot of drugs

О With a new lot of media

О Other (Specify)__________________

21.  Do you perform quality control tests with strains of MTBC that are resistant to one

           or more primary drugs? 

 

О Yes

О No

22.  If your laboratory uses a broth based susceptibility method (e.g., BACTEC, MGIT, or TREK), what procedure is used to check the purity of the broth inoculum used for the susceptibility test?  (Check all that apply.)

О Culture to blood or chocolate agar plates

О Culture to Middlebrook agar tube/plate

О Acid-fast smear

О Other (Specify)________________________________

О None

23.  If you detected resistance to rifampin, would you

О Issue a report; do not confirm

О Repeat the test

О Issue a preliminary report and set up or
    send out for confirmatory testing by a different method

О Set up confirmatory testing by different method;
    do not report until confirmed

О Other (Specify)________________________________

Thank you for your participation!

7

CDC Model Performance Evaluation Program for MTB/NTM DST

Laboratory Practices Questionnaire