National TB Lab Services Survey - supporting statement B

Formative Research and Tool Development

National Tuberculosis (TB) Laboratory Services Survey

Supporting Statement

B. Collection of Information Employing Statistical Methods

This information collection request does not employ statistical methods.

B.1. Respondent Universe and Sampling Methods

Because a comprehensive national TB laboratory survey has not been conducted before, no statistical methods will be used to define a sample frame. Instead, a census of the entire respondent universe of all US laboratories providing some level of TB laboratory testing services will be conducted. Minimally, stratification variables will include the type of laboratory (e.g., public health, hospital-based clinical, nonhospital-based clinical, commercial, Department of Defense), geographic location, and level of services provided (e.g., microscopy, culture, identification, drug susceptibility testing).

The respondent universe was constructed from several sources by APHL. These sources included the APHL member list of public health laboratories (PHL), the CDC TB Drug Susceptibility Testing Model Performance and Evaluation Program (MPEP) participant list, a Department of Defense (DoD) laboratory list, and a directory from the Centers for Medicaid and Medicare Services (CMS) of laboratories certified to perform mycobacteriology laboratory testing. Directories from all sources were merged and crosschecked to prevent duplication. The final respondent pool consists of 1,588 entities from all regions of the U.S. including territories.

Respondent Characteristics (N= 1,588)	N (%)
Public Health Laboratory	120 (7.6)
Commercial Laboratory	50 (3.1)
Clinical Laboratory	1393 (87.7)
Department of Defense Laboratory	25 (1.6)
Total	1,588 (100)

B.2. Procedures for the Collection of Information

B.2.1. Recruitment

Respondent laboratories for this information collection include those that provide any level of TB laboratory testing service. These were identified from several sources as described in B.1. Laboratories will receive a letter of invitation to participate in the survey 1 week prior to the survey going live and then again the day before (Attachment 2).

B.2.2. Screening and Scheduling Procedures

This information collection specifically targets public health, clinical, and commercial laboratories providing TB laboratory testing services. As such, the only screening procedures utilized were the inclusion of the laboratory in the directories described in B.1. No scheduling procedures will be utilized.

B.2.3. Data Collection Methods

The National TB Laboratory Services Survey is a web-based survey designed using the MRInterview Database software package. The survey is a one-time data collection that will be utilized for program enhancement. The APHL will conduct the survey and preliminary data analyses. Laboratories identified as potential respondents will receive a letter of invitation via email from APHL which includes a link with an embedded log-in and password unique to each participant (Attachment 2). Once participants click the unique login, they will see an introductory page that includes instructions for completing the survey (Attachment 1) (test link - ). Participants will be routed to appropriate questions based on their response to one of the introductory questions aimed at determining the level of testing service provided (e.g., AFB smear microscopy, culture, identification, drug susceptibility testing). Participants will be able to save partially completed surveys and return at a later time to complete and submit the final responses. Additionally, a glossary is attached to the survey and accessible via a link on each screen for clarification of terms used in the instrument. A PDF version of the survey will be provided electronically to allow participants an opportunity to view potential questions prior to logging into the electronic survey.

B.3. Methods to Maximize Response Rates and Deal with Nonresponse

Proposed data collection does not employ statistical sampling methods. However, potential respondents will receive a reminder email at 2 and 4 weeks after the survey is distributed (Attachment 3) in an effort to ensure a high response rate. Limited phone calls may also be conducted at 5 weeks to encourage participation (Attachment 3). In addition, endorsements are being sought from several professional laboratory associations.

B.4. Tests of Procedures or Methods to be Undertaken

This submission is a request for authorization to conduct tests of procedures and methodologies typical in methods and instrument development.

B.5. Individuals Consulted on Statistical Aspects and Individuals and/or Analyzing Data

The following individuals were consulted on statistical aspects for the National TB Laboratory Services Survey:

NCHHSTP/ DTBE

Michael Chen, PhD

Math Statistician

Data Management and Statistics Branch

Corporate Square/ Bldg 11/ Room 1106

MS E10

Atlanta, Georgia 30329-1902

Phone: (404)639-6185

Fax: (404)639-8604

Email: adu3@cdc.gov

Jose Becerra, MD, MPH

Chief, Data Management and Statistics Branch

Corporate Square/ Bldg 11/ Room 1113

MS E10

Atlanta, Georgia 30329-1902

Phone: (404) 639-8498

Fax: (404) 639-8604

Email: jeb2@cdc.gov

The following individuals are responsible for design, data collection, and analysis:

CDC/ DTBE/ MLB

Angela Starks, Ph.D.

Microbiologist

Mycobacteriology Laboratory Branch

1600 Clifton Rd. NE

Bldg. 17/ Room 4028/ MS F08

Atlanta, Georgia 30333

Phone: (404) 639-3205

Fax: (404) 639-1287

Email: eog0@cdc.gov

APHL

Kelly E. Wroblewski, MPH, MT (ASCP)
Manager - HIV, STD, TB, Hepatitis Programs
Association of Public Health Laboratories
8515 Georgia Avenue, Suite 700
Silver Spring, MD 20910
P: 240.485.2728
F: 240.485.2700
kelly.wroblewski@aphl.org

Doug McNamara

Research Specialist

Association of Public Health Laboratories

8515 Georgia Avenue, Suite 700

Silver Spring, Maryland 20910

Phone: (240) 485-2735

Fax: (240) 485-2700

Email: doug.mcnamara@aphl.org

Mark Lamias

Statistical Consultant and Survey Methodologist

The Stochastic Group, Inc.

1861 Dresden Drive, NE

Atlanta, Georgia 30319

Phone: (404) 210-9018

Email: mlamias@bellsouth.net

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