Medical Courier Seattle Washington:
Laboratory Services
CONTENTS
Forms Used in this Section ................10.2
Introduction ..........................................10.3
Purpose..............................................................10.3
Policy .................................................................10.3
Laboratory Contact Information..........10.4
Available Laboratory Tests..................10.8
Specimen Collection ..........................10.13
How to perform spontaneous sputum
collection at a healthcare facility ......................10.17
How to direct a patient to perform
spontaneous sputum collection at home..........10.19
Induced sputum collection at a
healthcare facility .............................................10.20
How to collect gastric aspirates ......................10.21
Bronchoscopy or collection of
extrapulmonary specimens ..............................10.22
Interferon gamma release assay (IGRA)
QuantiFERON®- TB- Gold Testing (QFT-G) ...10.23
Specimen Shipment ...........................10.24
Resources and References ...............10.27
WA State Laboratory References……10.28
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.1
UPDATED 12/11/2009
Forms Used in this Section
• MTD Request Form
• Nucleic Acid Amplification (NAA) and Mycobacterium Tuberculosis Direct Test (MTD)
Recommendations
• QFT: TB Control Guidelines for Public Health Staff (Thurston County)
• Sputum Collection (Chelan/Douglas County)
• Tuberculosis Screening Guidelines
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.2
UPDATED 12/11/2009
Introduction
Purpose
Use this section to do the following:
• Obtain contact information for laboratories
• Determine which tests are available and the turnaround times
• Identify which laboratory performs a specific test
The diagnosis of tuberculosis (TB), management of patients with the disease, and public
health TB control services rely on accurate laboratory tests. Laboratory services are an
essential component of effective TB control, providing key information to clinicians (for
patient care) and public health agencies (for control services).1
Policy
Public health laboratories should ensure that clinicians and public health agencies within
their jurisdictions have ready access to reliable laboratory tests for diagnosis and
treatment of TB.2
Effective TB control requires timely, complete, and accurate communication among the
laboratory system, TB control program, and healthcare provider.3
In the WAC, see Chapter 246-101 (Notifiable Conditions) in the Title
246 (Department of Health) at
http://apps.leg.wa.gov/wac/default.aspx?cite=246-101
Also, see the Notifiable Conditions Guidelines at,
http://www.doh.wa.gov/notify/guidelines/pdf/tuberculosis.pdf
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.3
UPDATED 12/11/2009
Laboratory Contact Information
To locate and contact a laboratory, refer to Table 1: Laboratory Contact Information.
For the list of the tests performed at each laboratory, refer to Table 2:
Available
Laboratory Tests.
TABLE 1: LABORATORY CONTACT INFORMATION
Roles and Responsibilities
Contact Information
State Laboratory
Full-service mycobacteriology laboratory. Accepts
primary specimens and referral isolates from
CoreLabs for identification and susceptibility testing of
Mycobacterium tuberculosis. Statewide coordination of
genotyping for positive cultures. Serves as a
consultant for questions involving mycobacterium
laboratory testing.
Open Monday – Friday 8am – 5
pm. Closed on national holidays.
Washington State Department of Health Public Health
Laboratories
1610 NE 150th St.
Shoreline, WA 98155
(King County)
http://www.doh.wa.gov/EHSPHL/PHL/
Supervisor: 206-418-5474
TB Lab Lead: 206-418-5473
Private and Local Public Health Laboratories
Laboratories on the following list provide primary
specimen smear and culture testing for mycobacteria.
Most refer isolates either to a CoreLab (reference Lab)
or to the Washington State Department of Health
Public Health Laboratories for identification and
susceptibility testing.
Children’s Hospital and Regional Medical Center
(Hospital)
4800 Sand Point Way NE
Seattle, WA 98105
(King County)
Ph: 206-987-2589
Fax: 206-987-3840
Deaconess Medical Center – Spokane
(Hospital)
W 800 Fifth Ave
Spokane, WA 99210
(Spokane County)
Ph: 509-473-7410
Fax: 509-473-2700
Dynacare Northwest, Inc
(Clinic)
550 17th Ave Ste 310
Seattle, WA 98122
(King County)
Ph: 206-861-7235
Fax: 206-861-7367
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.4
UPDATED 12/11/2009
Roles and Responsibilities
Contact Information
Private and Local Public Health Laboratories
Laboratories on the following list provide primary
specimen smear and culture testing for mycobacteria.
Most refer isolates either to a CoreLab (reference Lab)
or to the Washington State Department of Health
Public Health Laboratories for identification and
susceptibility testing.
Group Health ACC Lab
(HMO)
12400 E. Marginal Way S.
Tukwila, WA 98168
(King County)
Ph: 206-901-4500
Fax: 206-901-4501
Harborview Medical Center
(Hospital)
325 9th Ave
Box 259743
Seattle, WA 98104
(King County)
Ph: 206-731-3451
Fax: 206-731-8556
Molecular Epidemiology, Inc.
15300 Bothell Way N.E.
Lake Forest Park, WA 98155
206-522-0362
Multicare Medical Center Laboratories NW
(Hospital)
315 S. MLK Jr. Way
Tacoma, WA 98415
(Pierce County)
Ph: 253-403-1370
Fax: 253-403-1357
Oregon Medical Laboratory
PO Box 77003
Eugene, Oregon 97401
Ph: 541-334-8010 or
1-800-342-2971
PAML-Pathology Associates Medical Laboratories
110 W. Cliff Ave
Spokane, WA 99204
(Statewide)
Ph: PAML Client Services 800-541-7891
Bellevue/Seattle Client Services 888-472-2522
Olympia Client Services 888-910-6156
Fax: 509-924-0002
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.5
UPDATED 12/11/2009
Roles and Responsibilities
Contact Information
Private and Local Public Health Laboratories
Laboratories on the following list provide primary
specimen smear and culture testing for mycobacteria.
Most refer isolates either to a CoreLab (reference Lab)
or to the Washington State Department of Health
Public Health Laboratories for identification and
susceptibility testing.
Providence Everett Medical Center – Pacific
(Hospital)
916 Pacific Ave.
Everett, WA 98201
(Snohomish County)
Ph: 425-258-7701
Fax: 425-258-7024
Quest Diagnostics-Seattle
1737 Airport Way S
Suite 200
Seattle, WA 98134-1636
Ph: 206-623-8100
Fax: 206-224-8370
Sacred Heart Medical Center
(Hospital)
W 101 Eighth Ave.
Spokane, WA 99204
(Spokane County)
Ph: 509-474-3065
Fax: 509-474-2052
Seattle-King County Department of Public Health
Laboratory
(Health Department)
325 Ninth Ave, #359973
Seattle, WA 98104
(King County)
Ph: 206-731-8950
Fax: 206-731-8693
Roles and Responsibilities
Contact Information
Private and Local Public Health Laboratories
Laboratories on the following list provide primary
specimen smear and culture testing for mycobacteria.
Most refer isolates either to a CoreLab (reference Lab)
or to the Washington State Department of Health
Public Health Laboratories for identification and
susceptibility testing.
Spokane Regional Health District Laboratory
(Health Department)
1101 W. College Ave #210
Spokane, WA 99201
(Spokane County)
Ph: 509-324-1440
Fax: 509-324-1492
St. John’s Medical Center
(Hospital)
1615 Delaware St.
Longview, WA 98632
(Cowlitz County)
Ph: 360-636-4868
Fax: 360-636-4916
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.6
UPDATED 12/11/2009
St. Mary Medical Center
(Hospital)
401 W. Poplar
Walla Walla, WA 99362
(Walla Walla County)
Ph: 509-525-3320
Fax: 509-522-5724
Roles and Responsibilities
Contact Information
Private and Local Public Health Laboratories
Laboratories on the following list provide primary
specimen smear and culture testing for mycobacteria.
Most refer isolates either to a CoreLab (reference Lab)
or to the Washington State Department of Health
Public Health Laboratories for identification and
susceptibility testing.
Stevens Hospital Laboratory
(Hospital)
21601 76th Ave. W
Edmonds, WA 98026
(Snohomish County)
Ph: 425-640-4120
Fax: 425-640-4426
University of Washington Medical Center
(Hospital)
LAB MED BOX 357110
1959 NE Pacific St.
Seattle, WA 98195
(King County)
Ph: 206-616-8872
Fax: 206-616-8980
Virginia Mason Medical Center
(Hospital)
1100 9th Ave – C6LAB
Seattle, WA 98111
(King County)
Ph: 206-223-6850
Fax: 206-223-7540
Yakima Regional Medical Center
(Hospital)
110 S. 9th Ave
Yakima, WA 98902
(Yakima County)
Ph: 509-575-5035
Fax: 509-454-6193
Yakima Valley Memorial Hospital Laboratory
(Hospital)
2811 Tieton Dr.
Yakima, WA 98902
(Yakima County)
Ph: 509-575-8000
Fax: 509-575-8816
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.7
UPDATED 12/11/2009
Available Laboratory Tests
The laboratory tests listed below in Table 2 are available where noted.
When performing tests for the diagnosis of mycobacterial infection, acid-fast bacilli
smear and culture and sensitivities must be ordered.
At the Washington State Department of Health Public Health Laboratory, culture
identification is automatically performed on any isolate, and first-line susceptibility testing
is automatically performed on all initial Mycobacterium tuberculosis complex isolates.
Nucleic Acid Amplification (MTD) testing is done on first time smear positive specimens
and on initially smear-negative sputum specimens by special request from the local
health jurisdiction health officer.
TABLE 2: AVAILABLE LABORATORY TESTS
Test
Laboratory
Turnaround Time
Diagnosis
Interferon gamma release
assay (IGRAs) for diagnosis
latent TB infection (LTBI)
(blood test)
Evergreen PACLAB
4 locations:
1. Evergreen Hospital
12040 NE 128th St
Kirkland, WA 98034
Ph: 425-899-3900
Fax: 425-899-3901
2. PACLAB Redmond Patient Service
Center
8301 161st St. NE, Suite 104
Redmond, WA 98052
Ph: 425-869-4840
Fax: 425-869-4841
3. PACLAB Woodinville Patient Service
Center
17000 140th Ave NE
Suite E102
Woodinville, WA 98072
Ph: 425-488-4900
Fax: 425-488-4902
4. PACLAB Canyon Park Patient
Service Center
1909 214th St SE, Suite 120
Bothell, WA 98021
Ph: 425-488-4950
Fax: None
Within a week of laboratory
receipt of blood
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.8
UPDATED 12/11/2009
Test
Laboratory
Turnaround Time
Providence St. Peter Hospital
Clinical Laboratory
413 Lilly Road NE
Olympia, WA 98506
Contact: Chemistry Lab Supervisor
360-493-5181
Spokane Regional Health District
Laboratory
1101 W. College Ave
Spokane, WA 99201
Contact:
SRHD Lab Director
509-324-1450
Tacoma General Hospital
315 Martin Luther King, Jr Way
Tacoma, WA 98405
Ph: 253-403-1398 (ask for
Immunology Supervisor)
TriCities Laboratory (Kennewick,
WA)
7131 West Grandridge Blvd.
Kennewick, WA 99336
Contact:
Technical Operations Manager
509-736-0105
Within a week of laboratory
receipt of blood
Within a week of laboratory
receipt of blood
Within 4-7 days of laboratory
receipt of blood
Acid-fast bacilli (AFB) smear
Washington State Department of
Health Public Health Laboratories
Refer to list of private labs that
provide testing for mycobacteria
(Table 1)
Within 24 hours from receipt
of specimen in the laboratory• Monday through Friday• See (10.14) for sending
specimens
Culture
Washington State Department of
Health Public Health Laboratories
Refer to list of private and local public
Cultures are incubated for
up to 8 weeks before
reported as negative. Time
to detection of mycobacterial
growth is dependent on
growth rate. Ideally,
mycobacterial growth should
be detected within 14 days
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
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UPDATED 12/11/2009
Test
Laboratory
Turnaround Time
health labs that provide testing for
mycobacteria (Table 1)
of culture set up, although
this is dependent upon many
factors, including overgrowth
by other organisms, etc.
Culture identification
Washington State Department of
Health Public Health Laboratories:
Refer to list of private and local
public health labs that provide testing
for mycobacteria (Table 1)
The goal for M.tuberculosis
complex identification should
be within 21 days of culture
set up. Time to M.
tuberculosis complex
identification is dependent
upon growth rate.
Drug susceptibility
First line drugs: Isoniazid, Rifampin,
ethambutol, Streptomycin
Washington State Department of
Health Public Health Laboratories,
Harborview Medical Center, Sacred
Heart Medical Center
PZA: PHL and Sacred Heart Medical
Center
Second line drugs: PHL
Ideally, results of first-line
drugs should be available
within 30 days from
specimen receipt in the
laboratory, but this is
dependent on many factors
(for example, growth rate
and presence of other
organisms which must be
eliminated to provide a pure
culture for testing). An
additional 3-4 weeks is
needed for the confirmation
of resistance and testing for
the second line anti-TB
drugs.
Nucleic acid amplification
(NAA) test (MTD)
Manufactured by GenProbe
Washington State Department of
Health Public Health Laboratories
MTD Request Form
Within 2-3 working days
from receipt of specimen in
the laboratory.
• Tuesday and Thursday
Hepatic enzymes or up to 8
clinical, multichannel chemistry
panel (that includes aspartate
aminotransferase [AST], alanine
aminotransferase [ALT], lactate
dehydrogenase [LDH], total and
direct bilirubin, alkaline
phosphatase, uric acid, and
calcium)
Refer to list of private labs that
provide testing for mycobacteria
(Table 1) or use a local lab of your
choice
Check with Lab
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.10
UPDATED 12/11/2009
Test
Laboratory
Turnaround Time
Uric acid
Refer to list of private labs that
provide testing for mycobacteria
(Table 1) or use a local lab of your
choice
Check with Lab
Complete blood count (CBC)
and platelets
Refer to list of private labs that
provide testing for mycobacteria
(Table 1) or use a local lab of your
choice
Check with Lab
Kidney function
Refer to list of private labs that
provide testing for mycobacteria
(Table 1) or use a local lab of your
choice
Check with Lab
PCR
UW, see link
http://depts.washington.edu/molmicd
x/mdx/available_tests.shtml
Check with Lab
Epidemiologic Monitoring
Genotyping of positive cultures
for MTB.
For information on Restriction
Fragment Length
Polymorphism (RFLP) see:
http://www.cdc.gov/tb/genotypin
g/Chap5/5_Developing_3c_RF
LP.htm
Washington State Department of
Health Public Health Laboratories for
referral to the Berkeley testing site
(Referral is automatic)
Ideally 2 to 4 weeks from
receipt of specimen at the
Berkeley Laboratory
Results reported to LHJ by
WA State TB Services
See Notifiable conditions and the health care provider (WAC 246-101-101)
And Notifiable conditions and laboratories (WAC 246-101-201)
Also, see Notifiable Conditions Guidelines, at
http://www.doh.wa.gov/notify/guidelines/pdf/tuberculosis.pdf
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.11
UPDATED 12/11/2009
Table 3: Laboratory Turn Around Times for PHL
Test
Type
Results
Available
Results sent to clinician
and LHJ
Direct tests
Positive smear
24-48 hours
Phoned and faxed within
24 hours by PHL
Negative smear
24-48 hours
Faxed within 24 hours by
PHL
Amplified Mycobacterium Tuberculosis Direct
test (MTD) Note: Only the Public Health
Laboratory performs this test
Tuesday and Thursday
Positives and negatives
phoned and faxed within
24 hours by PHL,
Culture results AFB Positive Cultures
1-4 weeks, ideally within 14
days of culture set up
Result phoned, all results
faxed within 24 hours by
PHL.
AFB Negative Cultures
Up to 8 weeks
Faxed within 24 hours by
PHL.
Genetic Probe Test for MTB, MAC, M.
gordonae and M. kansasii
Done weekly on AFB
positive cultures, usually
within 21 days of culture set
up.
Phoned and faxed within
24 hours by PHL.
Biochemical analysis for mycobacteria other
than those listed above (considered atypical or
MOTT Mycobacteria Other Than Tuberculosis)
2-3 months
Faxed by PHL.
Drug
Susceptibility
Performed on confirmed MTBC cultures:
Bactec* (primary drugs)
7-10 days
Faxed within 24 hours by
PHL.
Plate method ** (second line drugs and
confirmation of resistance to primary drugs)
Up to 4 weeks
Faxed within 24 hours by
PHL.
* Bactec method: Streptomycin, Isoniazid, Rifampin, Ethambutol, Pyrazinamide
** Plate method: Streptomycin, Isoniazid, Rifampin, Ethambutol, Ethionamide, P-aminosalicylic acid, Oflaxacin and
Amikacin.
Note: Reports on specimens from Harborview Medical Center will be sent to DOH TB Services. TB Services will
ascertain the patients’ county of residence and fax to the appropriate county LHJ.
To understand the evaluation process in diagnosing TB disease and LTBI,
view the “Tuberculosis Screening Guidelines” provided on page 4.6.
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.12
UPDATED 12/11/2009
Specimen Collection
For an explanation of proper specimen collection and submission, see
instructions at the Washington State Department of Health Public Health
Laboratory Website: www.doh.wa.gov/ehsphl/phl
Sputum is phlegm from deep in the lungs. The important characteristics needed in
sputum specimens are freshness and actual sputum, rather than saliva. An early
morning specimen is best, therefore, when collecting a set of three sputum specimens,
at least one of them should be an early morning specimen.
To isolate mycobacteria from clinical materials successfully, handle specimens carefully
after collection. For optimal results, collect specimens in clean, sterile containers and
keep them in conditions (refrigeration) that inhibit the growth of contaminating
organisms, since most specimens will contain bacteria other than mycobacteria.4
Washington State Department of Health Public Health Laboratories (PHL)
At Washington State Department of Health Public Health Laboratories, culture
identification is automatically performed on all isolates, and first-line susceptibility testing
is automatically performed on all initial Mycobacterium tuberculosis complex isolates.
Nucleic Acid Amplification (MTD) testing is done on first time smear positive sputum
specimens and on initially smear-negative sputum specimens by special request from
the local health jurisdiction health officer.
(Refer to Washington State Specific References (10.26) at the end of this section for
information regarding MTD testing)
Sputum specimen kits are available from the Washington State Department of Health
Public Health Laboratories (WSPHL) by calling the PHL mailroom 206-418-5579.
Washington State Department of Health
Public Health Laboratories
Mailroom Services
1610 N.E. 150th St.
Shoreline, WA 98155
Ph: 206-418-5579
Fax: 206-418-5405
When sending the sample to WSPHL use only the unique Washington State Department
of Health Public Health Laboratories (WSPHL) sputum specimen kits distributed by
WSPHL. Keep the kits intact until used, as all necessary items are contained in the kit.
Do not use urine cups. Follow the packing instructions exactly. If the specimen leaks, it
cannot be tested and the lab area must be decontaminated. If using another lab (Table
1) contact them for collection supplies.
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.13
UPDATED 12/11/2009
If the patient or someone helping the patient will be shipping the specimen, assure that
he/she understands all of the specific steps to follow in collecting and preparing the
specimen for shipping.
Information regarding the TB Specimen Collection kits can be found at:
http://www.doh.wa.gov/ehsphl/phl/Brochures/flyerTBship.pdf (TB Specimen
Collection Kit)
For more information regarding sputum collection, please see Sputum
Collection, located in the FORMS section of the manual.
Instructions for collecting and sending specimens to PHL
1. Instruct the patient to collect the sputum specimen first thing in the morning (if
possible) after rinsing the mouth with water and spitting the water out into the sink.
2. Instruct the patient to cough deeply and spit the coughed up material into the
specimen tube.
3. Screw the cap down tightly so the specimen tube doesn’t leak.
4. Wash the outside of the specimen tube with soap and water, then dry.
5. Be sure that the specimen tube is labeled with the patient’s name and the date
(and the time the specimen was collected, if more than one specimen is collected
on the same day) .
6. Wrap absorbent material around the specimen tube.
7. Place the wrapped specimen tube in the specimen bag.
8. Seal the specimen bag with the attached “twist-tie.”
9. Place cotton or other cushioning material in the bottom of the small mailing
container.
10. Place the specimen tube (in its bag) into the small mailing container and screw the
cap on tightly.
11. Assure that all information including the patient’s address is provided on the phl
requisition form.
12. Wrap the completed laboratory requisition form around the outside of the small
mailing container and secure with a rubber band.
13. Place the small mailing container into the large mailing container and screw the
cap on tightly.
14. Ship the appropriately packaged container to the public health lab. (The address is
on the container)
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.14
UPDATED 12/11/2009
Med Ex now delivering packages from Greyhound Bus on Saturdays
PHL mailroom has made arrangements with Greyhound and Med Ex for an automatic
10:00am pickup on Saturdays. Med Ex should arrive at the lab between 10:00am-12:00
noon along with other courier deliveries.
Please encourage shippers to have their packages at the Seattle bus station no later
than 9:30am on Saturday. This will help us ensure that their packages will be delivered
to the PHL in a timely manner.
Refer to Table 4 on the following page to review the methods used to collect various
specimens and the type of specimens obtained for pulmonary tuberculosis (TB).
During procedures in which aerosols may be produced, use appropriate
respiratory protection and environmental controls. For more information, refer
to the CDC’s “Guidelines for Preventing the Transmission of Mycobacterium
tuberculosis in Health-care Settings, 2005” (MMWR 2005;54[No. RR-17]) at
http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf
Other useful links:
• WAC 246-101 Notifiable Conditions
• Also, see Notifiable Conditions Guidelines, at
http://www.doh.wa.gov/notify/guidelines/pdf/tuberculosis.pdf
• WAC 246-320-265 Hospital Infection Control Program
• WAC 296-800-160 Personal Protective Equipment
• WAC 296-842-100 through 300 Respirators
• WAC 388-97—140,147, 155 Infection Control Nursing Homes
• WRD 11.35 Tuberculosis Control in Health Care Settings
• WRD 11.36 Tuberculosis Control in Correctional Facilities
• DOC 670-030 Offender Tuberculosis Program
• DOC 670.000 Communicable Disease and Infection Control Program
(employees)
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
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UPDATED 12/11/2009
TABLE 4: SPECIMEN COLLECTION METHODS AND TYPES
FOR PULMONARY TUBERCULOSIS
Pulmonary Tuberculosis
Collection Method
Specimen Type
Spontaneous sputum collection occurs when the
patient can cough up sputum without extra assistance.
• 5–10 ml of sputum from deep in the lung
Induced sputum collection should be considered if a
patient needs assistance in bringing up sputum.*
• 5–10 ml of sputum from deep in the lung
Gastric aspirates can be submitted for the diagnosis of
pulmonary tuberculosis (TB) in persons who cannot
produce sputum. (This applies primarily to young
children.)
• 50 ml of gastric contents
Bronchoscopy can be used in the following situations:
• If a patient cannot produce sputum by the above
three methods5 or
• If a patient has a substantial risk of drug-resistant
TB and has initial routine studies that are
negative or
6
• In a patient in whom there is suspicion of
endobroncheal TB7 or
• If a variety of clinical specimens for the diagnosis
of pulmonary TB or other possible diseases need
to be obtained
• Bronchial washings
• Bronchoalveolar lavage
• Transbronchial biopsy
* It is important to specify if the sputum is induced or not, because induced sputum is “more watery” and appears to
be just saliva. Some laboratories may throw out induced sputum and report it as an inadequate specimen.
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
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UPDATED 12/11/2009
Refer to Table 5 for collection methods and specimen types for extrapulmonary TB.
TABLE 5: SPECIMEN COLLECTION METHODS AND TYPES
FOR EXTRAPULMONARY TUBERCULOSIS
Extrapulmonary Tuberculosis
Collection Method
Specimen Type
Extrapulmonary specimen collection from tissue and
other body fluids can be submitted for the diagnosis of
extrapulmonary tuberculosis.
Examples of tissues
(biopsy)*
• Lymph node
• Pleura
• Bone/joint
• Kidney
• Peritoneum
• Pericardium
Examples of
fluids
• Pleural
• Cerebrospinal
• Blood
• Urine
• Synovial
• Peritoneal
• Pericardial
* Do not place tissue specimens in formalin.
How to Perform Spontaneous Sputum Collection at a
Healthcare Facility
Refer to the Washington State Department of Health Public Health
Laboratories sub-section under “Specimen Collection” (10.13)
1. Collect the specimen in a specialized room or booth designed for cough-inducing
procedures (negative air pressure.)
2. Put a mark at the 5 ml level on the sputum tube (if not already marked) to show the
patient the minimum amount of sputum needed. (Most laboratories consider 5 to
10 ml an adequate amount.)
3. Instruct the patient on how to collect the sputum sample (Refer to detailed
instructions under Sputum Collection – PHL)
4. Before shipping, make sure the specimen container and laboratory requisition are
filled out completely, including the patient’s address. On the specimen
container, record the patient’s name and the date and time of collection. (Time of
collection is especially important when more than one sputum sample is being
collected in the same day.)
WASHINGTON STATE TUBERCULOSIS SERVICES MANUAL Laboratory Services
10.17
UPDATED 12/11/2009
5. Use the State of Washington Department of Health Public Health Laboratories
Mycobacteriology Laboratory Requisition form (or other laboratory-specific
requisition for other laboratories.) The PHL requisition is included in the sputum
collection kits which can be ordered from the PHL. An example of the requisition
can be found at http://www.doh.wa.gov/EHSPHL/PHL/Forms/MtbIsolates.pdf
Information regarding the kits can be found at:
http://www.doh.wa.gov/ehsphl/phl/Brochures/flyerTBship.pdf
(TB Specimen Collection Kit)
It is especially important to specify if the sputum is induced or not,
because an induced sputum generally is “more watery” and appears to be just
saliva. Some private laboratories may throw out the specimen and report it as
an “inadequate specimen.”
6. Make sure the specimen and laboratory requisition are packaged into appropriate
shipping containers, per laboratory instructions.
Refer to the “Specimen Collection” (10.11) topic and the “Specimen Shipment” (10.22) topic both in this section of the manual.
In the WAC, see Chapter 246-101 (Notifiable Conditions) in the Title 246
(Department of Health) at http://apps.leg.wa.gov/wac/default.aspx?cite=246-101
Also, see Notifiable Conditions Guidelines, at
http://www.doh.wa.gov/notify/guidelines/pdf/tuberculosis.pdf
7. If possible, send the specimen on the day it is collected. If this is not possible,
refrigerate the specimen until it is sent on the next day.
8. Do not save specimens to ship all three on the same day; instead, ship each one
as soon as possible after collection.
9. Use the most rapid method of shipping the specimen(s) to PHL.
Make every effort to submit specimens to PHL or other laboratory within 24
hours of collection. Normal flora can overgrow any mycobacteria in the
specimen and make it unusable. Most laboratories will not run a specimen
over five days old. Know how long it takes the specimen to arrive at PHL or
other laboratory from the time it leaves your facility, and submit specimens
accordingly.
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During procedures in which aerosols may be produced, use appropriate
respiratory protection and environmental controls. For more information, refer
to the CDC’s “Guidelines for Preventing the Transmission of Mycobacterium
tuberculosis in Health-care Settings, 2005” (MMWR 2005;54[No. RR-17]) at:
http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf.
• WAC 246-320-265 Hospital Infection Control Program
• WAC 296-800-160 Personal Protective Equipment
• WAC 296-842-100 through 300 Respirators
• WAC 388-97—140,147, 155 Infection Control Nursing Homes
• WRD 11.35 Tuberculosis Control in Health Care Settings
• WRD 11.36 Tuberculosis Control in Correctional Facilities
• DOC 670-030 Offender Tuberculosis Program
• DOC 670.000 Communicable Disease and Infection Control Program
(employees)
How to Direct a Patient to Perform Spontaneous
Sputum Collection at Home
If a patient will be collecting sputum specimens at home, provide the following guidance:
1.
Put a mark at the 5 ml level on the sputum tubes (if not already marked) to show
the patient the minimum amount of sputum needed. (Most laboratories consider 5
to 10 ml an adequate amount.)
2.
Review with the patient how to collect the sputum sample. (Refer to detailed
instructions under Sputum Collection – Washington State Department of Health
Public Health Laboratories
3.
Make arrangements for a healthcare worker to pick up the specimen or for the
patient, a family member, or a friend to drop off the specimen. If the patient or
someone helping the patient will be shipping the specimen, assure that he/she
understands all of the specific steps to follow in collecting and preparing the
specimen for shipping.
Refer to the Washington State Department of Health Public Health
Laboratories sub-section under “Specimen Collection” (10.13)
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Induced Sputum Collection at a Healthcare Facility
If the patient cannot produce sputum spontaneously, make arrangements for an induced
sputum to be collected at a facility. Facilities where sputum can be collected include the
respiratory therapy department of a local hospital, TB Clinic, or laboratory. Collect the
specimen in a specialized room or booth (negative air pressure) designed for cough-
inducing procedures.
Facilities should have appropriate respiratory protection, environmental controls, and
policies and procedures in place to prevent transmission of TB to other persons. For
further information regarding infection control during sputum collection, refer to the
Infection Control Section: environmental controls, respiratory protection and facility
requirements for infection control policies and procedures.
During procedures in which aerosols may be produced, use appropriate
respiratory protection and environmental controls. For more information, refer
to the CDC’s “Guidelines for Preventing the Transmission of Mycobacterium
tuberculosis in Health-care Settings, 2005” (MMWR 2005;54[No. RR-17]) at:
http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf
• WAC 246-320-265 Hospital Infection Control Program
• WAC 296-800-160 Personal Protective Equipment
• WAC 296-842-100 through 300 Respirators
Use the State of Washington Department of Health Public Health Laboratories
Mycobacteriology Laboratory Requisition form (or other laboratory-specific
requisition for other laboratories.) The PHL requisition is included in the
sputum collection kits which can be ordered from the PHL. An example of the
requisition can be found at :
http://www.doh.wa.gov/EHSPHL/PHL/Forms/MtbIsolates.pdf
Information regarding the PHL sputum collection kits be found at:
http://www.doh.wa.gov/ehsphl/phl/Brochures/flyerTBship.pdf
(TB Specimen Collection Kit)
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How to Collect Gastric Aspirates
Gastric aspirates are most commonly collected on children, however this procedure may
also be used in adults.
The following are basic guidelines for collecting gastric aspirates:
Patient Preparation:
4. The patient is to have nothing by mouth after midnight.
5. The family (patient) should come to the clinic first thing in the morning.
6. Place a nasal gastric tube in the patient. Do not use surgilube as it is
bacteriostatic. Use as large a bore NG tube as is comfortable (minimum 10
french). Avoid too deep a placement to prevent passage through the pylorus.
Sample Collection:
7. Aspirate the stomach contents. If less than 10 cc of mucus is aspirated, instill 20-
30 cc of sterile water into the tube and quickly withdraw. (Note: the organism is
most viable when not exposed to saline or preservatives; the kind of sterile water
used for infant feeding is fine). Reposition the tube and/or the patient to maximize
the yield of gastric contents.
8. Place the gastric aspirates in a special bicarbonate-containing gastric aspirate tube
or regular specimen cup.
9. Transport the specimen to the microbiology lab. If a special bicarbonate-containing
tube or cup is not available, the lab must neutralize the stomach acid with
bicarbonate within ½ hour.
For additional information on how to collect a gastric aspirate and prepare the specimen
for transport, see the guide and Francis J. Curry National Tuberculosis Center’s
online video Pediatric TB: A Guide to the Gastric Aspirate (GA) Procedure at:
http://www.nationaltbcenter.edu/products/product_details.cfm?productID=ONL-06
Detailed information on gastric aspirate collection is also available at the following
website:
http://www.nationaltbcenter.edu/catalogue/epub/downloads/GAP/GA_Patient_Prep.pdf
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Bronchoscopy or Collection of Extrapulmonary
Specimens
If TB staff are consulting with physicians before the specimens are collected, the
physician should be reminded to send part of the specimen (not in formalin) to the
microbiology laboratory for acid-fast bacilli (AFB) smear and culture, in addition to any
other tests or pathology examinations the physician plans to obtain. In addition, a post-
bronchoscopy sputum specimen should be sent for AFB smear and culture.
Bronchoscopy and extrapulmonary specimens will be collected by the physician and
facility performing the procedure.
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Interferon Gamma Release Assay (IGRA) QuantiFERON®-
TB- Gold In-Tube Testing (QFT-G)
The QuantiFERON®-TB Gold In-Tube Test (QFT-G) is an interferon gamma release
assay (IGRA) which tests blood for the presence of M. tuberculosis infection. For
patients with a previous positive TST reaction, an IGRA (QFT-G) can be done if there is
suspicion that the TST result was a false positive. In addition, the IGRA (QFT-G) test is
not affected by past bacille of Calmette-Guerin (BCG) vaccination and may eliminate the
unnecessary treatment of patients with BCG-related-false-positive results on a TST.
The advantages of the IGRA (QFT-G), compared with the TST, are that results can be
obtained after a single patient visit, and that, because it is a blood test performed in a
qualified laboratory using standardized analysis methods, the variability in results
associated with skin test reading can be eliminated.
However, the IGRA (QFT-G) test has practical limitations that include the need to draw
blood and to ensure its receipt in a qualified laboratory within16 hours.
CDC recommends that the IGRA (QFT-G) may be used in all circumstances in which the
TST is currently used, including contact investigations, evaluation of recent immigrants,
and sequential-testing surveillance programs for infection control (e.g., those for health-
care workers). The use of IGRA (QFT-G) in pediatric populations is still being
researched, but looks promising. The CDC guidelines can be found at
http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5415a4.htm
Guidelines for the use of the IGRA (QFT-G) test developed by Thurston County are
available in the forms section of this manual.
http://www.doh.wa.gov/cfh/TB/Manual/Forms/TBControlGuidelines.pdf
For a list of laboratories offering the IGRA (QFT-G) test in Washington State, see
Table 3
A single IGRA test is used in place of (and not in addition to) the TST in
screening of healthcare workers.
For more information regarding QFT healthcare worker guidelines see QFT:
TB Control Guidelines for Public Health Staff (Forms Section)
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Specimen Shipment
There are three main categories of transportation methods: medical couriers, ground
transportation, and air transportation. Shipment of specimens is further categorized by
their likelihood of causing infection if improperly handled. Each category requires
different packaging requirements to provide increased levels of protection against leaks
and contamination.
The following is for informational purposes:
Category A
Category A specimen handling applies only to laboratories because they deal with
pure mycobacterial cultures which are classified as “dangerous goods.” Local
Health Jurisdictions and other healthcare providers will not be handling these
specimens.
Category A: Pure mycobacterial cultures (or culture isolates suspected of being
mycobacteria) are classified as Category A Infectious Substances and can be
transported only by a medical courier or shipped by private carrier as dangerous goods.
Category A Infectious Substances cannot be mailed through the US Postal Service.
Shipment of dangerous goods by USPS is regulated by the US Department of
Transportation. Specific shipping instructions from the Centers for Disease Control and
Prevention (CDC) can be found in the publication: US Department of Health and Human
Services (DHHS) Public Health Mycobacteriology: A Guide for the Level III Laboratory.
Packaging and shipment of specimens by USPS should meet the following regulations:
• Public Health Service/CDC: 42 CFR, Part 72—Interstate Shipment of Etiologic
Agents at http://www.cdc.gov/od/ohs/biosfty/shipregs.htm
• USPS: 39 CFR and USPS Domestic Mail Manual C023.1.1, International Mail
Manual 135, and USPS Publication 52
• US Department of Transportation: 49 CFR, Parts 171–185 (August 14, 2002) at
http://www.access.gpo.gov/nara/cfr/waisidx_04/49cfrv2_04.html
• The Department of Labor, Occupational Safety and Health Administration (OSHA):
29 CFR 1910.10308
For shipments by private carriers, follow International Air Transportation Association
(IATA) instructions. Mycobacterium tuberculosis pure cultures are defined as infectious
substances/etiologic agents when shipped by private carrier and must be shipped in
packaging approved by the United Nations (UN), according to IATA Packing Instruction
602. Diagnostic specimens are defined as human or animal specimens, including
excreta, secreta, blood and its components, tissue, tissue fluids, and cultures of
nontuberculous mycobacteria being transported for diagnostic or investigational
purposes. Diagnostic specimens must be packaged according to IATA Packing
Instruction 650.9
Category B specimens are “raw” specimens which are handled by Local Health
Jurisdictions and other healthcare providers.
Category B
Category B: Infectious Substances (raw diagnostic specimens, such as sputum, blood,
or tissue) can be mailed through the US Postal Service (USPS), shipped by private
carrier (e.g., Federal Express, Airborne Express, etc.), or transported by a medical
courier, taxi or private vehicle.
For information regarding requirements for shipping, refer to the Washington State
Department of Health Public Health Laboratories website at:
http://www.doh.wa.gov/EHSPHL/PHL/packaging.htm
Shipping Training Requirements
Employers are responsible for assuring proper training for all employees with job
responsibilities which include the packaging and shipping of diagnostic (clinical)
specimens. This training may be conducted either at the job location or by sending
employees to a course presented by the Washington State Department of Health Public
Health Lab or other source for training. Documentation of training from a former
employer is also acceptable. Only the employer can certify that the training is
appropriate for each individual given their job responsibilities.
Training and certification should occur within 90 days of hire or assignment to a job
where such knowledge is needed. Retraining should occur whenever regulatory
changes indicate, or at least once every three years. Training should also be followed
by demonstration of competency, either during the training course, or by the employer at
the facility, which documents the validity of the training and the mastery of the content by
the employee. Documentation of this training and the resulting certification must be kept
throughout the entire time the individual is employed in the facility.
As part of the training process, the employer has several responsibilities:
• Training must be specific to the job duties performed by an individual.
• Retraining must be provided as needed, according to changing regulations.
• The employer must be in contact with the carrier to assure that most recent
rules are met.
• The employer must keep records of the curriculum and content of each training
session.
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• The employer must certify that the individual has been properly trained in
accordance with work responsibilities and has passed a test to assure
competency.
• The employer must maintain the documentation throughout the entire course of
employment of an individual.
For further information refer to:
• Washington State Department of Labor and Industries Enforcement
Directive: OSHA CPL 2-2.69
• Requirements for Specimen containment: WAC 296-823-14045
• Requirements for labeling: WAC 296-823-14025
• For shipping training courses, contact the Washington State Department of
Health Public Health Laboratories website at:
http://www.doh.wa.gov/ehsphl/phl/Training/train.htm
• For shipping regulations, refer to “Resources and References” at the end of
this section.
For more information regarding shipping requirements, contact the following
staff at the Washington State Department of Health Public Health
Laboratories:
• Training Program Advisor (PHL) ph: 206-418-5404 Fax: 206-418-5445
• Training Program Manager (PHL) ph: 206-418-5401 Fax: 206-418-5445
• Training Program (PHL) ph: 206-418-5402 Fax: 206-418-5445
To obtain specimen collection and transport supplies, see the topic on
“Specimen Collection” and “Specimen Shipment” in this section of the manual.
Sputum specimen kits are available from the Washington State Department of
Health Public Health Laboratories (PHL) by calling the PHL mailroom at 206-
418-5579.
Washington State Department of Health
Public Health Laboratories
Mailroom Services
1610 N.E. 150th St.
Shoreline, WA 98155
Ph: 206-418-5579
Fax: 206-418-5405
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Resources and References
Resources for Laboratory Services
Detailed descriptions of recommended laboratory tests; recommendations for their
correct use; and methods for collecting, handling, and transporting specimens have
been published.
For more information on laboratory testing for tuberculosis (TB), see the following:
• ATS, CDC, IDSA. “Controlling Tuberculosis in the United States: Recommendations
from the American Thoracic Society, CDC, and the Infectious Diseases Society of
America” (MMWR 2005;54[No. RR-12]). Available at:
http://www.cdc.gov/mmwr/PDF/rr/rr5412.pdf .
• ATS, CDC, IDSA. “Diagnostic Standards and Classification of Tuberculosis in Adults
and Children” (Am J Respir Crit Care Med 2000;161[4 Pt 1]). Available at:
http://www.cdc.gov/tb/pubs/PDF/1376.pdf .
• National Committee for Clinical Laboratory Standards. Susceptibility Testing of
Mycobacteria, Nocardiae, and Other Aerobic Actinomycetes; Approved Standard
[Document no. M24-A] (Wayne, PA; 2003).
Resources for Specimen Collection and Shipment
• CDC. “Guidelines for Preventing the Transmission of Mycobacterium tuberculosis in
Health-care Settings, 2005” (MMWR 2005;54[No. RR-17]). Available at:
http://www.cdc.gov/mmwr/pdf/rr/rr5417.pdf .
• CDC. Public Health Mycobacteriology: A Guide for the Level III Laboratory (Atlanta,
GA; 1985).
• Francis J. Curry National Tuberculosis Center. Pediatric TB: A Guide to the Gastric
Aspirate (GA) Procedure (Francis J. Curry National Tuberculosis Center Web site).
Available at:
http://www.nationaltbcenter.edu/products/product_details.cfm?productID=ONL-06 .
• International Air Transport Association (IATA). IATA Web site. Available at:
http://www.iata.org/index.htm .
• National Jewish Medical and Research Center. How to Mail Specimens and Cultures
to the National Jewish Mycobacteriology Laboratory (Denver, CO: March 2005).
• National Jewish Medical and Research Center. Instructions (for Patients) for
Collecting and Mailing Sputum Specimens (Denver, CO: March 2005).
• US Department of Transportation. Hazardous Materials: Revision to standards for
infectious substances. Part III 49 CFR Part 171. Federal Register (August 14, 2002).
• USPS. Mailing Standards of the United States Postal Service: Domestic Mail Manual
(USPS Web site). Available at: http://pe.usps.com/ .
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In the WAC, see Chapter 246-101 (Notifiable Conditions) in the Title
246 (Department of Health) at
http://apps.leg.wa.gov/wac/default.aspx?cite=246-101
Also, see Notifiable Conditions Guidelines, at
http://www.doh.wa.gov/notify/guidelines/pdf/tuberculosis.pdf
References
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1 ATS, CDC, IDSA. Controlling tuberculosis in the United States: recommendations from the American Thoracic Society,
CDC, and the Infectious Diseases Society of America. MMWR 2005;54(No. RR-12):18.
2 ATS, CDC, IDSA. Controlling tuberculosis in the United States: recommendations from the American Thoracic Society,
CDC, and the Infectious Diseases Society of America. MMWR 2005;54(No. RR-12):19.
3 Association of Public Health Laboratories. The Future of TB Laboratory Services: A framework for
integration/collaboration/leadership [Association of Public Health Laboratories Web site]. 2004. Available at:
http://www.aphl.org/Documents/Global_docs/tb_task_force_future.pdf
4 ATS, CDC, IDSA. Diagnostic standards and classification of tuberculosis in adults and children. Am J Respir Crit Care
Med. 2000;161:1376–1395.
5 Iseman, MD. A Clinician’s Guide to Tuberculosis, 2000. 1st ed. Philadelphia, PA: Williams & Wilkins; 2000:135–136.
6 Iseman, MD. A Clinician’s Guide to Tuberculosis, 2000. 1st ed. Philadelphia, PA: Williams & Wilkins; 2000:135–136.
7 Iseman, MD. A Clinician’s Guide to Tuberculosis, 2000. 1st ed. Philadelphia, PA: Williams & Wilkins; 2000:135–136.
8 National Jewish Medical and Research Center. How to Mail Specimens and Cultures to the National Jewish
Mycobacteriology Laboratory. Denver, CO; March 2005:2.
9 National Jewish Medical and Research Center. How to Mail Specimens and Cultures to the National Jewish
Mycobacteriology Laboratory. Denver, CO; March 2005:5–7.
Washington State Laboratory References
• Nucleic Acid Amplification (NAA) and Mycobacterium Tuberculosis Direct Test
(MTD) Recommendations
For more information, see Updated Guidelines for the Use of
Nucleic Acid Amplification Tests in the diagnosis of Tuberculosis at
http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5801a3.htm?s_cid=mm580
1a3_e
• Tuberculosis Screening Guidelines
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