National TB Services Survey Report - APHL

NatioNal tB ServiceS Survey report

APHL Report

Diagnosing TB JUNE 201 2

© Copyright 2012, Association of Public Health Laboratories. All Rights Reserved.

The Association of Public Health Laboratories (APHL) is a national non-profit organization dedi-cated 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.

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 laborato-ries 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 Fu-ture of TB Laboratory Services to develop recommendations to assure continued availability of high-quality, 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 Labo-ratory Services Survey in 2010. The purpose of the survey was to assess the overall ability of com-mercial, 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 labo-ratories. 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 method-ologies and volume; referral strategies; specimen collection, handling and transport; turnaround-times; 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 Depart-ment 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.

6 Association of Public Health Laboratories

RESuLTS

Table 1

In-house service

performed

No. of laboratories by type Total (% )Hospital-based

Clinical Commercial State Public Health

Local Public Health Other

AFB-smear Microscopy 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)

Figure 1: Respondents by Laboratory Type (n=580)

466 (80%)

25 (4%)

51 (9%)

15 (3%)

23 (4%)

State Public Health Laboratory

Commercial Laboratory

Other

Hospital-based Clinical

Local Public Health Laboratory

Survey Summary report 7

Results

Table 2

No. of afb smears processed per week

No. of laboratories by type

Total (% )Hospital-based Clinical

Commercial State Public Health


<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

Figure 2: Primary AFB Staining Method (n=575)

Ziehl-Neelsen

Fluorochrom-auromine/rhodamine

Kinyoun

Fluorochrome-Auromine O

Other

200 (35%)

79 (14%)

20 (3%)

14 (2%)

262 (46%

)


Results

Figure 3: Primary direct detection Method of MTBC from Clinical Specimen (n=85)

Other

LDT real-time PCR

LDT conventional PCR

Direct HPLC

Cepheid GeneXpert

Innogenetics INNOLiPA

Gen-Probe MTD

56 (66%)

1 (1%)

4 (5%)

13 (15%)

2 (2%)

4 (5%)

5 (6%)

56 (665 (66666 (656

(1%%)%)%)%)%)))(1

)))%%)%)%))))(1

5%%%%%)%)))5%%%%)))5%

5%)%)5%)%))

2%)2%2%

5 (66%%%)%)%)%)%)%5

%%%%)%)%)%%%%)(6%

5 (

Figure 4: Primary Broth-based Culture System (n=466)

Other

Exclusive Use of non-broth based culture

Manual MGIT

Manual 7H9

BACTEC MGIT-960

Versa TREK

MB/BacT-Alert72 (15%)

14 (3%)

11 (2%)

13 (3%)

12 (3%)33 (7%)

149 (32%)

162 (35%)

Bactec 460 TB

)( ))

3%%)))))3

( ))

(33%%))%%3%

%%%%%%%)%%%%%%%)%%%)

162 2 (33333(35%5%5%5%5%5%5%5 )))))))1 2 ( %%%%%%5%%)335%62

149 (32%1 (332%49


Results

Table 3

No. of afb cultures inoculated per week

No. of laboratories by type

Total (% )Hospital-based Clinical Commercial State Public

HealthLocal Public

Health Other

<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)

177(83.1%)

1 (0.5%)

4 (1.9%)

21 (9.9%)

1 (0.5%)1 (0.5%)1 (0.5%)2 (0.9%)4 (1.9%)1 (0.5%)

LDT- conventional PCR

Other

NAP test

Innogenetics INNOLiPA Mycobacteria

PRA (PCR/RFLP)

Genetic Sequencing

LDT-real-time PCR

Gen-Probe - AccuProbe

HPLC

Biochemicals

55

5%)%)5%5%%)555%)%)55%%5%%55555%%)%)

555595

)55%%)%)55

))5555%%)%)55%%

999995595

)55%%55%%%9

%%)%%%5%)%)%%%%

000

%%%%9999999%%55%%)5%)%)%9

0.55%%0. %55%%

%)%%)00 55%0 550 5

%%)%%99%)%%)9%)

))%)%%%%)

))

177(83.1%)%)

1773.1%%)%).1%

(8377(8

17

1 (9.9%%))

(9 9%1 (9.9%))

%%)%))%%))


Results

Figure 6: Culture Positivity for MTBC (n=212)

0

20

40

60

80

100

Less than1%

1-5%

Percent of cultures postive for MTBC within the last year

Num

ber

of

Lab

ora

tori

es

6-10% 11-25% 26-40% 41-50% Greater than60%

10

30

50

70

90

72

87

31

17

2 1 2

Figure 7: Culture Positivity for NTM (n=212)

Percent of cultures postive for NTM within the last year

Num

ber

of

Lab

ora

tori

es

8

51

67

46

26

3

11

0

10

20

30

40

50

60

70

80

Less than1%

1-3% 4-6% 7-10% 11-20% 21-30% Greater than30%


Results

Figure 8: Primary Method for First-line drug Susceptibility Testing (n=91)

60 (66%)

22 (24%)

6 (7%)

3 (3%)

Versa TREK

BACTEC MGIT 960

BACTEC 460 TB

Agar Proportion

22 (24%)%)

22 (224%)

22 (24%))

3%%%%%)%)%)%)%)))%%%%)%)%)%)%)%)%))))

(77%%%%%)%)%)%%%%%%)%)%%)(7%

%%%%)%%%

66

Figure 9: Average Volume of First-line dST Per Month (n=91)

DST Performed Per Month

Num

ber

of

Lab

ora

tori

es

0

12

14

16

18

20

22

24

26

<1 1-5 6-10 11-15 16-20

Local PHL

State PHL

Commercial

Hospital-based clinical

21-25 26-30 31-40 51-100 >100

2

4

6

8

10


Results

Table 4

availability of mol-Dr for MtbC

No. of laboratories by type Total (% )Hospital-based



Performed In-house 3 0 5 2 0 10 (1.8)

Clinical specimens referred 83 3 2 2 1 91 (16.4)

Culture isolates referred 96 6 15 7 5 129

(23.2)Both clinical specimens and isolates referred

135 7 19 7 3 171 (30.8)

No availability of this service 128 7 9 5 6 155

(27.9)Total 445 23 50 23 15 556

Figure 10: Reference Services by Laboratory Type

Testing Service Provided

200

225

AFB S

mea

r

AFB C

ultu

re

Direct

Det

ectio

n

MTB

C ID

NTM ID

ID o

f all

Myc

obac

teria

Firs

t-lin

e DST

Seco

nd-li

ne D

ST

Mol

-DR

Genot

ypin

g175

150

125

100

75

50

25

0

Local Public Health

State Public Health

Commercial


Other

Num

ber

of

Lab

ora

tori

es


Results

Table 5

testing service

No. of laboratories by type referriNg for serviCes Total (% )Hospital-based



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 453 21 31 21 15 541 (93.3)

Direct Detection 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)

Hospital-basedClinical

StatePublicHealth

Commercial

Per

cent

of L

abor

ator

ies

OtherLocal Public Health

80%

100%

90%

70%

0%

30%

20%

10%

40%

50%

60% 94.9

100

75.5

94.5

88.9


Results

*includes TAT for in-house and referred testing


Figure 12: Laboratories with ≥80% of MTBC direct detection Results Reported within 48 and 72 hours of Specimen (n=98)*

Hours from Specimen Receipt to Report of MTBC

Num

ber

of

Lab

ora

tori

es

Local Public Health (n=8)

State Public Health (n=37)

Commercial (n=5)

Hospital-based clinical (n=47)

Other (n=1)

90

100

48 hours 72 hours

80

70

60

50

40

30

10

20

072727272 hhhhouoursrshho ssshhhoo77

Figure 13: Laboratories with ≥80% of MTBC Id within 14, 21 and 28 days of Specimen Receipt (n=149)*

Days from Specimen Receipt to Report of MTBC ID

Num

ber

of

Lab

ora

tori

es



Commercial (n=5)

Hospital-based Clinical (n=81)

Other (n=3)

14 Days 21 Days 28 Days

140

120

100

80

40

60

0

20


Results


Figure 14: L boratories with ≥80% of First-line dST within 28 and 35 days of Specimen Receipt (n=145)*

Days from Specimen Receipt to Report of DST

Num

ber

of

Lab

ora

tori

es



Commercial (n=6)

Hospital-based clinical (n=83)

Other (n=1)

28 Days 35 Days

140

120

100

80

40

60

0

20

Figure 15: Maximum Specimen Transport Time Allowed (n=561)

Num

ber

of

Lab

ora

tori

es

Local Public Health

State Public Health

Commercial


Other

24-48hours

0-24hours

48-72hours

3 days-1week

No transporttime policy

8 days-1 month

140

200

180

160

120

100

80

40

60

0

20

00-0-2242400 4400

00

0

00

0

00

000

0

0000

00

0

2424 4-488242 848822 33 dadaysys-dad yy33 88 dadaysys-aaaayy88 NNo ttranspNN aaNN4848 7-72288 772244


Results

Figure 16: Barriers to Timely Transport of Specimens (n=310)

Local Public Health

State Public Health

Commercial


Other

Num

ber

of

Lab

ora

tori

es

Frequency of

courier pick-up

Lack ofcourier service

Cost of Courier

UnreliableCourier

OtherBatchingof

specimens

90

120

100110

80

7060

20

40

30

50

010

Figure 17: State Requirement for Submission of MTBC Isolate to Public Health Laboratory (n=548)

Local Public Health

State Public Health

Commercial


Other

Num

ber

of

Lab

ora

tori

es

Yes No N/A accept frommultiple states

Unsure

225

300

325

250

275

200

175

150

50

100

75

125

0

25


Results

Figure 18: Laboratory Capability for Electronic Reporting (n=557)

Local Public Health

State Public Health

Commercial


OtherN

umb

er o

f La

bo

rato

ries

Health DepartmentOnly

Clinical CareProvider Only

No ElectronicReporting Capability

Both

175

225

200

150

125

50

75

100

0

25

Figure 19: Experienced Staff Shortages for Mycobacteriology within the Last Year

Yes

No

Num

ber

of

Lab

ora

tori

es

Hospital-basedClinical (n=442)

StatePublic Health

(n=50)

Commercial(n=23)

Other(n=15)

Local Public Health

(n=23)

80%

100%

90%

70%

60%

50%

20%

30%

40%

0%

10%


Results

Figure 20: Have Staff Shortages Resulted in a decrease in Services or an Increase in Turnaround Times

Yes

No

Unsure


StatePublic Health

(n=34)

Commercial(n=10)

Other(n=5)

Local Public Health

(n=9)

80%

100%

90%

70%

60%

50%

20%

30%

40%

0%

10%

Figure 21: Experienced Obstacles Recruiting Qualified Staff for Testing

Yes

No


StatePublic Health

(n=50)

Commercial(n=23)

Other(n=15)

Local Public Health

(n=23)

80%

100%

90%

70%

60%

50%

20%

30%

40%

0%

10%

H it l b dl St ttC i lC OthOtL lLL


Results

*Respondents could select up to three recruitment obstacles

Figure 22: Obstacles to Recruiting Qualified Staff

Shortages of MTs/CLSs

Lack of Certificatio

Salary

Resistance to Working with Mycobacteria

Resistance to Work Needed Shifts

State Licensing Requirement

Difficulty in Hiring Process

Hiring Freeze

Other

Lack of Professional Experience

6

34

15

5

8

12

42

10

65

0 10 20 30 40 50 60 70 80 90 100

Percent of Laboratories

54

eerrrerr

zzeeeeze

151555

zeezeee

ssssss

5555

ssssss

nntttnntt

r

tstsstsst

riiaaariiriaaiaa

o

ryryyyyy

10100010

ryy

onnoonn

SSsssSSsSssS

ceeeeceeceeec

Figure 23: Anticipate Change in Workload in Next Year (n=545)

Local Public Health

State Public Health

Commercial


Num

ber

of

Lab

ora

tori

es

Other

200

250275300325350375400

225

175150125

5075

100

025

DecreaseDecreasecr seereDe UnsureUnsurens eurUNo Major ChangeNo Major ChangM or hahaorMNIncreaseIncreasec sanc


Results

Figure 24: Service Consolidation as Reason for Change in Workload (n=114)

No

Unsure

Yes

400

500

600

300

100

200

0

Decrease Due to Service ConsolidationIncrease Due to Service Consolidation

40

50

60

30

10

20

0

Decrease Due to Service ConsolidationIncrease Due to Service Consolidation

Num

ber

of

Lab

ora

tori

es

Figure 25: Plans to Add or Eliminate Mycobacteriology Laboratory Services

No

Unsure

Yes

400

500

600

300

100

200

0

Plans to Eliminate ServicesPlans to Add Services

Nu

mb

er

of

La

bo

rato

rie

s

400

500

600

300

100

200

0

Plans to Eliminate ServicesPlans to Add Services

Nu

mb

er

of

La

bo

rato

rie

s

PlPPlans to AAdddd SSer iivicela t AAdd SS v eervdd SAAs tlla Plans to Eliminate SerPl s E mi te eSeatemiEs tla


Results

*Respondents could select multiple responses

*Respondents could select multiple responses

Figure 26: Additional Services under Consideration (n=545)*

AFB Culture

MTB Identification

NTM Identification

NAAT for Direct Detection

Traditional DST

Mol-DR

Second DST Method for Confirmation

Second-line DST

IGRA

Other

378Not adding new service

AFB Smear

13

44

8

9

42

12

66

9

19

0 50 100 150 200 250 300 350 400

Number of Laboratories

6

3

eee

nn

nnnn

nn

TT

RRRR

nn

TT

AAAA

erre

eeee

arrrr

131313

4444

888

99

4242

121212

66666

999

1919

66

333

Figure 27: Training Topics Most Relevant for those Performing Mycobacteriology Testing (n=552)*

Other

TB Epidemiology/ Public Health Issues

QA/ QMS/ Laboratory Management

Molecular Diagnostics

IGRA

DST for MTBC

AFB Identification

AFB Culture

Direct Detection

AFB Smear Microscopy

Biosafety

16

1

14

30

12

18

24

43

16

0 10 20 30 40 50 60 70 80 90 100

Percent of Laboratories

54

53

errererr

sssss 11

nttntt

AAAAAA

CCCC

nnn

eeeee

nnn

yyy

yyyy

sssss


Results

Figure 28: Laboratories With Continuity of Operations Plan for TB Laboratory Services (n=538)

Yes

No

Unsure


StatePublic Health

(n=50)

Commercial(n=22)

Other(n=14)

Local Public Health

(n=22)

80%

100%

90%

70%

60%

50%

20%

30%

40%

0%

10%


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.

Interniche.B

Typewritten Text


• 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.


RESOuRCES

APHL TB Laboratory Assessment ToolLaboratories 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 PageThis 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


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


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


APPENdIx

Survey Questions and Corresponding FigureFigure 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?


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 TableTable 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: Approximately how many smears per week does your laboratory process?

Table 3: What is the average number or specimens per week that are set up for culture of AFB in your laboratory?

Table 4: Does your laboratory perform testing for the molecular detection of mutations associated with drug resistance (mol-DR) for M. tuberculosis complex?

Table 5: 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?

Appendix


ACkNOWLEdgEMENTS

APHL/ CDC National TB Laboratory Services Survey Workgroup

Kathleen Beavis, MD, PhD, FCAPJohn H. Stroger Jr. Hospital of Cook CountyChicago, IL

John Bernardo, MDBoston University School of Medicine

Barbara Body, PhD, D(ABMM)Laboratory Corporation of America

Tracy Dalton, PhDCDC Division of TB Elimination

Denise DunbarLaboratory Services SectionTexas Department of State Health Services

Rosemary Humes, MS, MT(ASCP)SMBARDA, formerly Association of Public Health Laboratories

Ken Jost, Jr., MT(ASCP)Laboratory Services SectionTexas Department of State Health Services

Billie Ann Juni, MSMinnesota Public Health Laboratory Division

Raymond Kaplan, PhDQuest Diagnostics

Mark LamiasStochastic Group

Yvette McCarter, PhDShands HospitalJacksonville, FL

Doug McNamaraAssociation of Public Health Laboratories

Beverly Metchock, DrPH, D(ABMM)CDC Division of TB Elimination

Angela Starks, PhD CDC Division of TB Elimination Becky TempleVermont Department of Health Laboratory

Frances Tyrrell, MPH, MT(ASCP), SMCDC Division of TB Elimination

David Warshauer, PhD, D(ABMM)Wisconsin State Laboratory of Hygiene

Kelly Wroblewski, MPH, MT(ASCP)Association of Public Health Laboratories

Mitch Yakrus, MS, MPHCDC Division of TB Elimination

Susanne Zanto, BS, CLS(NCA)Montana Laboratory Services Bureau

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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