National TB Services Survey Report

National TB Services Survey Report APHL Report Diagnosing TB JUNE 2012

The Association of Public Health Laboratories (APHL) is a national non-profit organization dedicated to working with members to strengthen governmental laboratories that perform testing of public health significance. By promoting effective programs and public policy, APHL strives to provide member laboratories with the resources and infrastructure needed to protect the health of US residents and to prevent and control disease globally. Copyright 2012, Association of Public Health Laboratories. All Rights Reserved.

TABLE OF CONTENTS Background and Purpose... 4 Method... 5 Results... 6-22 Summary of Major Findings...23-24 Resources... 25 Glossary of Terms... 26 References...27 Appendix...28-29 Acknowledgements... 30

Background and Purpose Diagnosis of tuberculosis (TB) in the United States involves a network of private and public laboratories with different levels of service. As a result, specimens from a single patient may be referred to several laboratories for more complex tests including drug susceptibility testing. Without excellent coordination and communication between public and private sector laboratories, diagnosis and treatment of TB patients may be delayed. As the number of TB cases in the US has fallen, the number of laboratories offering the full menu of TB diagnostic services has eroded. In 2002, the Association of Public Health Laboratories (APHL) and the US Centers for Disease Control and Prevention (CDC) convened the Task Force on the Future of TB Laboratory Services to develop recommendations to assure continued availability of highquality, cost-effective TB laboratory services. The Task Force formulated three principle benchmarks of which one was a comprehensive assessment of available TB laboratory services in the public and private sector to fill gaps in knowledge about the capabilities and capacities of US laboratories and the structure of jurisdictional laboratory networks. In response to that recommendation, APHL and CDC developed and launched the National TB Laboratory Services Survey in 2010. The purpose of the survey was to assess the overall ability of commercial, clinical, and public health laboratories in the United States to provide quality TB diagnostic services. The results will be used to identify gaps in the capabilities and capacities of TB testing services and identify opportunities to strengthen laboratory systems.

Method The National TB Laboratory Services Survey was developed by an APHL-led workgroup that consisted of representatives from CDC s Division of Tuberculosis Elimination (DTBE) and public health laboratories. The final product was reviewed by a larger workgroup that included representatives from clinical and commercial laboratories. The 118-question survey was launched September 7, 2010, and officially closed in February 2011. The questions were divided into 11 different categories, including: demographics; testing methodologies and volume; referral strategies; specimen collection, handling and transport; turnaroundtimes; reporting practices; laboratory staff and training; safety practices; proficiency testing and quality assurance; public health and epidemiology; and planning for the future. The survey was distributed electronically to 1,444 clinical, commercial, public health, and Department of Defense laboratories via MRInterview, a web-based survey instrument. The survey participants were identified based on a list of laboratories enrolled in a mycobacteriology proficiency testing program in 2009. The list was quality-checked by APHL, and points of contact were identified for each laboratory. The point of contact for each laboratory received a link to an electronic version of the survey as well as a PDF file on September 7, 2010. Reminders were sent out on September 14 and twice more, biweekly. Of the 1,444 laboratories receiving the survey, 656 (45%) responded. Of those that responded, 580 (88%) performed some level of TB service in-house and were included in the analysis for this first of a series of issue briefs describing the survey results.

Results Figure 1: Respondents by Laboratory Type (n=580) 25 (4%) 51 (9%) 466 (80%) 15 (3%) 23 (4%) Hospital-based Clinical Laboratory State Public Health Laboratory Local Public Health Laboratory Table 1 In-house service performed AFB-smear Microscopy Hospital-based Clinical No. of laboratories by type State Public Health Local Public Health Total (% ) 466 23 51 25 15 580 (100) AFB Culture 364 23 50 25 12 474 (81.7) MTBC Identification 121 19 50 21 4 215 (37.1) First-line DST 26 8 44 16 0 94 (16.2) Second-line DST 4 2 19 4 0 29 ( 5.0) Direct Detection 33 6 37 11 0 87 (15.0) IGRA 35 8 17 14 5 79 (13.6) 6 Association of Public Health Laboratories

79 (14%) Results Figure 2: Primary AFB Staining Method (n=575) 20 (3%) 14 (2%) 200 (35%) Fluorochrome- Auromine O Fluorochromauromine/rhodamine Kinyoun 262 (46%) Ziehl-Neelsen Table 2 No. of AFB smears processed per week Hospitalbased Clinical No. of laboratories by type State Public Health Local Public Health Total (% ) <5 93 0 1 1 2 97 (16.8) 6-14 115 0 4 4 4 127 (22.0) 15-25 80 3 7 6 4 100 (17.3) 26-50 87 4 9 9 3 112 (19.4) 51-100 60 5 15 0 1 81 (14.0) >100 28 11 15 5 1 60 (10.4) Total 463 23 51 25 15 577 Survey Summary Report 7

Results Figure 3: Primary Direct Detection Method of MTBC from Clinical Specimen (n=85) 2( 2% ) 4( 5% ) ) 66% ( 6 5 13 (1 5%) Gen-Probe MTD Cepheid GeneXpert Innogenetics INNOLiPA 5%) 4 (5 %) 1 (1 5 Direct HPLC LDT real-time PCR ) (6% LDT conventional PCR Figure 4: Primary Broth-based Culture System (n=466) 12 (3%) 33 (7%) ( ) 13 (3%) 149 (32%) (3 (32% 32% 149 ( ) 11 (2%) (3 3%) 3% 14 (3%) Bactec 460 TB Versa TREK MB/BacT-Alert 72 (15%) %) BACTEC MGIT-960 Manual MGIT Manual 7H9 162 2 (35%) ((35% (3 35% 5%) 162 8 Association of Public Health Laboratories Exclusive Use of non-broth based culture

Results Table 3 No. of AFB cultures inoculated per week Hospital-based Clinical No. of laboratories by type State Public Health Local Public Health Total (% ) <5 29 0 0 0 0 29 (6.3) 5-9 46 0 3 2 1 52 (11.2) 10-15 54 1 2 3 2 62 (13.4) 16-20 34 1 2 3 2 42 (9.1) 21-30 52 3 6 3 2 66 (14.2) 31-40 34 2 3 4 1 44 (9.5) 41-100 81 5 20 3 3 112 (24.1) 101-250 23 6 11 3 0 43 (9.3) 251-500 3 2 3 2 1 11 (2.4) >500 0 3 0 0 0 3 (0.7) Total 356 23 50 23 12 464 Figure 5: Primary Method for ID of MTBC from Culture (n=213) 4 (1.9%) 1 (0.5%) 1 (0.5%) ) 1 (0.5%) % ) 1 (0.5%) % ) 2 (0.9%) 9 4 (1.9%) ) 1 (0.5%) 0 5 % 21 1 (9.9%) 9% 177(83.1%) Biochemicals HPLC Gen-Probe - AccuProbe Genetic Sequencing LDT-real-time PCR PRA (PCR/RFLP) NAP test Innogenetics INNOLiPA Mycobacteria LDT- conventional PCR Survey Summary Report 9

Results Figure 6: Culture Positivity for MTBC (n=212) 100 90 87 Number of Laboratories 80 70 60 50 40 30 72 31 20 10 0 Less than 1% 17 2 1 2 1-5% 6-10% 11-25% 26-40% 41-50% Greater than 60% Percent of cultures postive for MTBC within the last year Figure 7: Culture Positivity for NTM (n=212) 80 70 67 60 Number of Laboratories 50 40 30 20 10 8 51 46 26 3 11 0 Less than 1% 1-3% 4-6% 7-10% 11-20% 21-30% Greater than 30% Percent of cultures postive for NTM within the last year 10 Association of Public Health Laboratories

Results Figure 8: Primary Method for First-line Drug Susceptibility Testing (n=91) 22 (24%) 60 (66%) 3 (3%) 6 (7%) Agar Proportion BACTEC 460 TB BACTEC MGIT 960 Versa TREK Figure 9: Average Volume of First-line DST Per Month (n=91) Number of Laboratories 26 24 22 20 18 16 14 12 10 8 6 4 2 Local PHL State PHL Hospital-based clinical 0 <1 1-5 6-10 11-15 16-20 DST Performed Per Month 21-25 26-30 31-40 51-100 >100 Survey Summary Report 11

Results Table 4 Availability of mol-dr for MTBC Performed In-house Clinical specimens referred Culture isolates referred Both clinical specimens and isolates referred No availability of this service Hospital-based Clinical No. of laboratories by type State Public Health Local Public Health Total (% ) 3 0 5 2 0 10 (1.8) 83 3 2 2 1 91 (16.4) 96 6 15 7 5 135 7 19 7 3 128 7 9 5 6 129 (23.2) 171 (30.8) 155 (27.9) Total 445 23 50 23 15 556 Figure 10: Reference Services by Laboratory Type 225 Number of Laboratories 200 175 150 125 100 75 50 Local Public Health State Public Health Hospital-based clinical 25 0 AFB Smear Direct Detection AFB Culture MTBC ID NTM ID ID of all Mycobacteria First-line DST Testing Service Provided Second-line DST Mol-DR Genotyping 12 Association of Public Health Laboratories

Results Table 5 Testing Service No. of laboratories by type referring for services Hospital-based Clinical State Public Health Local Public Health Total (% ) AFB Culture 100 0 1 0 3 104 (17.9) MTBC Identification 342 4 1 4 11 362 (62.4) First-line DST 431 15 7 9 15 477 (82.2) Second-line DST Direct Detection 453 21 31 21 15 541 (93.3) 418 17 13 13 15 476 (82.1) IGRA 314 10 7 7 7 345 (59.5) Figure 11: Laboratories with 80% of AFB Smear Results Reported within 24 Hours of Speicmen Receipt (n=329) 100% 90% 80% Percent of Laboratories 70% 60% 94.9 50% 40% 30% 20% 10% 100 75.5 94.5 88.9 0% Hospital-based Clinical State PublicHealth Local Public Health Survey Summary Report 13

Results Figure 12: Laboratories with 80% of MTBC Direct Detection Results Reported within 48 and 72 hours of Specimen (n=98)* Number of Laboratories 100 90 80 70 60 50 40 (n=1) Local Public Health (n=8) State Public Health (n=37) (n=5) Hospital-based clinical (n=47) 30 20 10 0 48 hours 72 hours Hours from Specimen Receipt to Report of MTBC *includes TAT for in-house and referred testing Figure 13: Laboratories with 80% of MTBC ID within 14, 21 and 28 Days of Specimen Receipt (n=149)* 140 (n=3) Local Public Health (n=14) State Public Health (n=46) (n=5) Hospital-based Clinical (n=81) Number of Laboratories 120 100 80 60 40 20 0 14 Days 21 Days 28 Days Days from Specimen Receipt to Report of MTBC ID *includes TAT for in-house and referred testing 14 Association of Public Health Laboratories

Results Figure 14: L boratories with 80% of First-line DST within 28 and 35 Days of Specimen Receipt (n=145)* 140 120 (n=1) Local Public Health (n=10) State Public Health (n=45) (n=6) Hospital-based clinical (n=83) Number of Laboratories 100 80 60 40 20 0 28 Days 35 Days Days from Specimen Receipt to Report of DST *includes TAT for in-house and referred testing Figure 15: Maximum Specimen Transport Time Allowed (n=561) 200 180 160 Local Public Health State Public Health Hospital-based clinical 140 Number of Laboratories 120 1000 80 60 40 20 0 0-24 hours 24-48 48 48-72 3 days- 8 days- No transport hours hours 1week 1 month time policy Survey Summary Report 15

Results Figure 16: Barriers to Timely Transport of Specimens (n=310) Number of Laboratories 120 110 100 90 80 70 60 50 40 30 20 10 0 Lack of Frequency courier service of courier pick-up Cost of Courier Unreliable Courier Local Public Health State Public Health Hospital-based clinical Batching of specimens Figure 17: State Requirement for Submission of MTBC Isolate to Public Health Laboratory (n=548) Number of Laboratories 325 300 275 250 225 200 175 150 125 100 75 50 25 0 Local Public Health State Public Health Hospital-based clinical Yes No Unsure N/A accept from multiple states 16 Association of Public Health Laboratories

Results Figure 18: Laboratory Capability for Electronic Reporting (n=557) 225 Local Public Health State Public Health Hospital-based clinical 200 Number of Laboratories 175 150 125 100 75 50 25 0 Health Department Only Clinical Care Provider Only Both No Electronic Reporting Capability Figure 19: Experienced Staff Shortages for Mycobacteriology within the Last Year No Yes 100% Number of Laboratories 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Hospital-based Clinical (n=442) (n=23) State Public Health (n=50) Local Public Health (n=23) (n=15) Survey Summary Report 17

Results Figure 20: Have Staff Shortages Resulted in a Decrease in Services or an Increase in Turnaround Times No Yes Unsure 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Hospital-based Clinical (n=124) (n=10) State Public Health (n=34) Local Public Health (n=9) (n=5) Figure 21: Experienced Obstacles Recruiting Qualified Staff for Testing No Yes 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% 0% Hospital-based Clinical (n=441) (n=23) State t Public Health (n=50) Local Public Health (n=23) (n=15) 18 Association of Public Health Laboratories

Results Figure 22: Obstacles to Recruiting Qualified Staff 6 Hiring Freeze 34 Difficulty in Hiring Process 15 State Licensing Requirement 5 Resistance to Work Needed Shifts 8 Resistance to Working with Mycobacteria 12 Salary 42 Lack of Certificatio on 10 Shortages of MTs/CLSs 54 Lack of Professional Experience 65 0 10 20 30 40 50 60 70 80 90 100 Percent of Laboratories *Respondents could select up to three recruitment obstacles Figure 23: Anticipate Change in Workload in Next Year (n=545) Local Public Health State Public Health Hospital-based clinical Number of Laboratories 400 375 350 325 300 275 250 225 200 175 150 125 100 75 50 25 0 Increase Decrease No Major Change Unsure Survey Summary Report 19

Results Figure 24: Service Consolidation as Reason for Change in Workload (n=114) Number of Laboratories 60 50 40 30 20 10 Yes No Unsure 0 Increase Due to Service Consolidation Decrease Due to Service Consolidation Figure 25: Plans to Add or Eliminate Mycobacteriology Laboratory Services Yes No Unsure 600 Number of Laboratories 500 400 300 200 100 0 Plans to Add d Services e Plans to Eliminate Servicese 20 Association of Public Health Laboratories

Results Figure 26: Additional Services Under Consideration (n=545)* Not adding new servicee IGRA Second-line DST Second DST Method for Confirmationn Mol-DR Traditional DST NAAT for Direct Detection NTM Identificationn MTB Identificationn AFB Culture AFB Smear 13 8 9 12 9 6 3 19 44 42 66 378 0 50 100 150 200 250 300 350 400 Number of Laboratories *Respondents could select multiple responses Figure 27: Training Topics Most Relevant for those Performing Mycobacteriology Testing (n=552)* 1 TB Epidemiology/ Public Health Issuess QA/ QMS/ Laboratory Management nt 16 14 Molecular Diagnosticss IGRA 12 DST for MTBC 18 AFB Identificationn 24 AFB Culture Direct Detection 16 AFB Smear Microscopy Biosafety 30 43 54 53 0 10 20 30 40 50 60 70 80 90 100 Percent of Laboratories *Respondents could select multiple responses Survey Summary Report 21

Results Figure 28: Laboratories With Continuity of Operations Plan for TB Laboratory Services (n=538) 100% 90% 80% 70% 60% 50% 40% 30% 20% 10% No Yes Unsure 0% Hospital-based Clinical (n=430) (n=22) State Public Health (n=50) Local Public Health (n=22) (n=14) 22 Association of Public Health Laboratories

Summary of Major Findings Survey responses were obtained from 45% of all US laboratories enrolled in a mycobacteriology proficiency testing program in 2009. Of the 580 laboratories performing AFB-smear microscopy, 82% also performed AFB culture. Most laboratories performing culture refer isolates for MTBC identification, first and second-line DST, and direct detection. 81% of laboratories use a fluorescent stain as a primary staining method for AFB-smear microscopy, consistent with CDC recommendations (1, 2). 39% of laboratories perform fewer than 15 AFB smears per week. The current ATS and CDC recommendation specifies preparation and examination of at least 15 specimens per week for each microscopist to maintain proficiency (1). 15% of laboratories perform direct detection for rapid identification of MTBC from a clinical specimen. Of these, 55% were public health laboratories. Current CDC recommendations encourage the use of nucleic acid amplification testing on at least one respiratory specimen from each patient with signs and symptoms of pulmonary TB for whom a diagnosis of TB is being considered but has not yet been established, and for whom the test results would alter case management or TB control activities (3). Of those laboratories performing AFB culture, 40% inoculate fewer than 20 AFB cultures per week. To maintain proficiency in culture and identification of MTBC, it is recommended that laboratories process a minimum of 20 specimens per week (4). In 75% of laboratories performing identification in-house, 5% or less of mycobacterial cultures processed within the last year were positive for MTBC. In 72% of laboratories performing identification in-house, 4% or more of mycobacterial cultures processed within the last year were positive for nontuberculous mycobacteria. 42% of laboratories performing first-line DST perform testing for five or fewer MTBC isolates per month. The current APHL recommendation is referral if performing DST for less than 50 isolates per year (5). 72% of laboratories reported access, primarily through referral, for the molecular detection of mutations associated with drug resistance for MTBC. Survey Summary Report 23

The majority of laboratories reported that greater than 80% of AFB-smear results are reported within 24 hours of specimen receipt. However, only 54% of laboratories performing direct detection reported rapid reporting of 80% of results within the recommended 48 hours of specimen receipt (3). Meeting the recommended turnaround times for identification of MTBC within 21 days and DST within 28 days of specimen receipt was problematic for many laboratories with only 71 of 149 (48%) reporting 80% of ID within 21 days and 57 of 145 (39%) reporting 80% of DST results within 28 days. 250 of 560 (44%) respondents indicated no obstacles to timely transport of specimens. 37% of laboratories have electronic reporting capability for providing results to both the health department and clinical care provider. 34% of public health laboratories have no electronic reporting capability, including 38% of State Public Health Laboratories. Most laboratories anticipate no major change in workload during the next year but are considering adding additional services. The three top selections for additional services under consideration include nucleic acid amplification tests for direct detection of MTBC, molecular detection of mutations associated with drug resistance, and IGRA. 24 Association of Public Health Laboratories

Resources APHL TB Laboratory Assessment Tool Laboratories are encouraged to incorporate the use of this tool into their current Quality Assurance practices as a means to determine the existence of areas within individual laboratories that may be in need of improvement. http://www.aphl.org/aphlprograms/infectious/tuberculosis/pages/tbtool.aspx APHL TB Resource Page This webpage provide access to reports, tools and guidelines developed by APHL s TB Steering Committee. http://www.aphl.org/aphlprograms/infectious/tuberculosis/pages/tbresources.aspx Survey Summary Report 25

Glossary of Terms AFB: Acid fast bacilli Direct detection: Test performed directly from patient specimen (e.g., sputum or bronchial alveolar lavage) for the detection of Mycobacterium tuberculosis complex. Tests may include nucleic acid amplification or direct HPLC. DST: Drug susceptibility test (i.e., antimicrobial susceptibility test) HPLC: High performance liquid chromatography ID: Identification IGRA: Interferon gamma release assay LDT: Laboratory developed test Mol-DR: Molecular detection of mutations associated with drug resistance MTBC: Mycobacterium tuberculosis complex QMS: Quality management system NTM: Nontuberculous mycobacteria TAT: Turnaround time 26 Association of Public Health Laboratories

References 1. American Thoracic Society; Centers for Disease Control and Prevention; Council of the Infectious Disease Society of America. (2000). Diagnostic standards and classification of tuberculosis in adults and children. American Journal of Respiratory and Critical Care Medicine. 161:1376 1395. 2. Tenover, F.C., J.T. Crawford, R.E. Huebner, L.J. Geiter, C.R. Horsburg Jr., and R.C. Good. (1993). The resurgence of tuberculosis: is your laboratory ready? Journal of Clinical Microbiology. 31: 767-770. 3. Centers for Disease Control and Prevention. (2009). Updated Guidelines for the Use of Nucleic Acid Amplification Tests in the Diagnosis of Tuberculosis. MMWR. 58(01); 7-10. 4. Clinical and Laboratory Standards Institute. Laboratory detection and identification of mycobacteria; approved guideline. CLSI Document M48-A. Wayne, PA: CLSI; 2008. 5. Association of Public Health Laboratories (2007). TB Drug-Susceptibility Testing Expert Panel Meeting. Retrieved August 30, 2011, from http://www.aphl.org/aphlprograms/infectious/ tuberculosis/documents/tb_dst_report.pdf Survey Summary Report 27

Appendix Survey Questions and Corresponding Figure Figure 1: Which laboratory type best describes your facility? Figure 2: What primary staining method is used for acid-fast smear microscopy of clinical specimens? Figure 3: What is the primary direct detection method performed by your laboratory? Figure 4: Which broth-based culture system is primarily used in your laboratory for the isolation of mycobacteria from respiratory specimens? Figure 5: What is the primary method used to identify isolates of Mycobacterium tuberculosis complex in your laboratory? Figure 6: In your laboratory, approximately what percentage of mycobacterial cultures processed within the last year were positive for M. tuberculosis complex? Figure 7: In your laboratory, approximately what percentage of mycobacterial cultures processed within the last year were positive for NTM? Figure 8: What is the primary method for first-line drug susceptibility testing? Figure 9: In the last year, what was the average number of M. tuberculosis isolates set up for first-line drug susceptibility testing each month? Figure 10: What Mycobacteriology reference services do you provide for other laboratories in-house? Figure 11: In your laboratory, what percentage of AFB-smear microscopy results are reported to the provider within 24 hours of specimen receipt? Figure 12: In your laboratory, what percentage of M. tuberculosis complex direct detection results are reported to the provider within 48 hours and 72 hours of specimen receipt? Figure 13: What percent of M. tuberculosis complex does your laboratory identify from culture of clinical specimens (e.g., sputum) within 14, 21, and 28 days of specimen receipt? Figure 14: What percent of M. tuberculosis complex first-line drug susceptibility testing results does your laboratory report from clinical specimens (e.g., sputum) within 28 and 35 days of specimen receipt? Figure 15: What is the maximum transport time that your laboratory allows before a specimen will be rejected (date of collection to date of receipt)? Figure 16: What is the single biggest obstacle to the timely transport of specimens to your laboratory? Figure 17: Does your state legally require the submission of an isolate of M. tuberculosis complex from all new TB cases to your state and/or local public health laboratory? 28 Association of Public Health Laboratories

Appendix Figure 18: Does your laboratory have the capability to report results electronically to the state or local public health department only, clinical care provider only, both, or your laboratory does not have electronic reporting capability? Figure 19: Have you experienced staff shortages for Mycobacteriology within the last 12 months? Figure 20: Have those shortages resulted in a decrease in AFB services or an increase in turnaround times? Figure 21: Has your laboratory experienced any obstacles in recruiting qualified staff to perform Mycobacteriology testing? Figure 22: What are the biggest obstacles in recruiting qualified staff to perform Mycobacteriology testing? Figure 23: Over the next 12 months, does your laboratory plan (or anticipate) changes in the volume of testing performed in house? Figure 24: You indicated your laboratory is anticipating an increase or decrease in workload. Is this increase due to service consolidation within your network or geographic region? Figure 25: Does your laboratory have any plans to eliminate Mycobacteriology services within the next 12 months or has your laboratory decreased services within the last 12 months? Figure 26: Which of the following Mycobacteriology services is your laboratory considering adding? Figure 27: What training topics are most relevant to those performing Mycobacteriology testing in your laboratory? Figure 28: Does your laboratory have a Continuity of Operations plan to ensure the uninterrupted provision of TB laboratory services in the event of any unforeseen event that affects laboratory testing capability? Survey Question and Corresponding Table Table 1: Does your laboratory perform or refer for the following AFB services: AFB-smear microscopy, direct detection, AFB culture, MTBC identification, first-line DST, second-line DST, and IGRA? Table 2: Table 3: Table 4: Table 5: Approximately how many smears per week does your laboratory process? What is the average number or specimens per week that are set up for culture of AFB in your laboratory? Does your laboratory perform testing for the molecular detection of mutations associated with drug resistance (mol-dr) for M. tuberculosis complex? Does your laboratory perform or refer for the following AFB services: AFB-smear microscopy, direct detection, AFB culture, MTBC identification, first-line DST, second-line DST, and IGRA? Survey Summary Report 29

Acknowledgements APHL/ CDC National TB Laboratory Services Survey Workgroup Kathleen Beavis, MD, PhD, FCAP John H. Stroger Jr. Hospital of Cook County Chicago, IL John Bernardo, MD Boston University School of Medicine Mark Lamias Stochastic Group Yvette McCarter, PhD Shands Hospital Jacksonville, FL Barbara Body, PhD, D(ABMM) Laboratory Corporation of America Doug McNamara Association of Public Health Laboratories Tracy Dalton, PhD CDC Division of TB Elimination Beverly Metchock, DrPH, D(ABMM) CDC Division of TB Elimination Denise Dunbar Laboratory Services Section Texas Department of State Health Services Rosemary Humes, MS, MT(ASCP)SM BARDA, formerly Association of Public Health Laboratories Ken Jost, Jr., MT(ASCP) Laboratory Services Section Texas Department of State Health Services Angela Starks, PhD CDC Division of TB Elimination Becky Temple Vermont Department of Health Laboratory Frances Tyrrell, MPH, MT(ASCP), SM CDC Division of TB Elimination David Warshauer, PhD, D(ABMM) Wisconsin State Laboratory of Hygiene Billie Ann Juni, MS Minnesota Public Health Laboratory Division Kelly Wroblewski, MPH, MT(ASCP) Association of Public Health Laboratories Raymond Kaplan, PhD Quest Diagnostics Mitch Yakrus, MS, MPH CDC Division of TB Elimination Susanne Zanto, BS, CLS(NCA) Montana Laboratory Services Bureau 30 Association of Public Health Laboratories

This publication was supported by Cooperative Agreement Number #1U60HM000803 from Centers for Disease Control and Prevention ( CDC ). Its contents are solely the responsibility of the authors and do not necessarily represent the official views of CDC. Funding support for this publication was provided by National Center for Environmental Health (NCEH); National Center for Zoonotic, Vector-borne, and Enteric Diseases (CK); National Center for Immunization and Respiratory Diseases (IP); National Center for HIV, Viral Hepatitis, STDS and TB Prevention (PS); National Center for Infectious Diseases (NCID) (CID); Office of the Director, Centers for Disease Control & Prevention (ODCDC); National Center for Health Marketing (HM). The National TB Laboratory Services Survey was financed 100% by Federal funds. The total cost of the project was $120,000.

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