TSRS: What is the TB Specimen Referral System ?
Smear positive sputum samples are referred from health facilities
via Posta Uganda to NTRL for culture and DST
Aim: To rule out MDR-TB
TSRS Design- Specimen & results flow
Samples
Results
9/13/2011
NTRL-NTLP
TB patients who provide specimens
. Retreatment TB cases
a. Defaulter/ Return-After-Default
b. Treatment failure
c. Relapse
d. Chronic
2. New case smear positive at 2 or 3 months of uninterrupted anti-TB treatment (follow-ups)
3. Contacts of MDR-TB patients
COMMUNICATION STRUCTURE
Figure 1. Communication structure TSRS. Left: Kampala TB zone; Right: Other TB zones
ROLES AND RESPONSIBILITIES
Clinician
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Identifies the appropriate TB patient
Makes request for TB culture and sensitivity testing and sends to laboratory
Receives the results from the NTRL and uses them for patient management
Designated Lab personnel at Health Facility
Also referred to as ‘Health Facility Focal Person (HFP)
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Collects, labels and packs the specimen safely
Transports specimen package to the local post office. For Kampala TB zone, Posta
Uganda picks the package from the health facility.
Receives the package boxes and results from the local post office
Submits the results to the clinician or patient.
Local Post office
• Receives specimen packages and transports them to Kampala main post office
• Receives empty package boxes and results from Kampala main post office
Main Post Office Kampala
• Receives and delivers specimen packages to NTRL
• Receives and delivers empty package boxes and results to local post offices
• For Kampala TB zone, delivers safety boxes and results to the source health facility
National TB Reference Laboratory
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Receives, records and analyses samples
Sends feedback through post office, phone, fax, or e-mail
Compiles results and reports
There is a Shipping Coordinator at the NTRL whose duties include:
– Coordinates all referral activities with health facility focal persons & with all
stakeholders.
– Arranges for all the necessary shipping logistics and supplies in conjunction with the
stakeholders.
– Receives a copy of the shipping forms (Pink form).
– Collects, keeps, and retrieves data on shipments done.
– Ensures that the Kampala main post office delivers the specimen packages to the
NTRL in a timely manner.
– Disinfects and takes empty package boxes to the Kampala main post office for
onward return shipping.
– Seals the results of specimen work up, in an envelop, addresses the envelope
properly and submits them to the main post office for on ward mailing to the focal
person at the source health facility.
– Ensures that the shipping activity goes on smoothly.
– Informs Central Public Health Laboratory (CPHL) on the Shipping activity.
– Verifies monthly invoices/bills from the courier company.
Examinations done at NTRL
The NTRL has capacity to perform the following test procedures or assays and NTRL
recommends you take time to request for the most suitable test for the patient or
organization. The list below gives the full name of the test/procedure and in brackets are the
most commonly used abbreviations on specimen laboratory request forms;
1. Microscopy
a. Ziehl-Neelsen Smear Microscopy (ZN Microscopy)
b. Fluorescence Microscopy (FM)
2. Culture and isolation of Mycobacterium (Culture)
a. Löweinsten-Jensen solid Media Method (LJ Culture)
b. Mycobacterial Growth Indicator Tube (MGIT) method
3. Drug susceptibility testing (DST)
a. Löweinsten-Jensen solid Media Method
b. Mycobacterial Growth Indicator Tube (MGIT) liquid culture method
c. Genomic MDRTBplus test (HAIN test)
Guide for selection of Tests and their indications
1. Microscopy
a. Ziehl-Neelsen Smear Microscopy (ZN Microscopy)
b. Fluorescence Microscopy (FM)
Indicated for the diagnosis of TB suspects, TB smear negatives by peripheral results (but
clinically suggestive of TB) and Extra-pulmonary samples (often smear negative by peripheral
results).
2. Culture and isolation of Mycobacterium (Culture)
a. Löweinsten-Jensen solid Media Method (LJ Culture)
Indicated for the diagnosis of the TB patient categories who provide samples as a prior test
to DST and follow-up test for MDR (culture conversion)
b. Mycobacterial Growth Indicator Tube (MGIT) method
Indicated as in 2-a above, for the diagnosis of NTM (Non-TB Mycobacterium), and
occasionally for Emergency cases that require a shorter Turn-around Time.
3. Drug susceptibility testing (DST)
a. Löweinsten-Jensen solid Media Method
Indicated for re-treatments (chronic, relapse, failure and defaulter patients suspected of
resistance with first line anti-TB drugs) i.e MDR and XDR
Its also used for setting second line DST (using second line drugs for MDR treatment).
b. Mycobacterial Growth Indicator Tube (MGIT) liquid culture method
Indicated for re-treatments (chronic, relapse, failure and defaulter patients suspected of
resistance with first line anti-TB drugs), MDR and XDR. Especially emergency cases that
require a shorter Turn-around time.
c. Genomic MDRTBplus test (HAIN test)
Indicated for re-treatments (chronic, relapse, failure and defaulter patients suspected of
resistance with Rifampicin and Isoniazid only), MDR and XDR. Especially emergency cases
that require a shorter Turn-around time.
Identification of the Primary Sample (Labeling)
Label/identify the sample container with at least a patient’s name and date of collection. Note that
patient’s name may be replaced by a unique numerical study or clinic Patient Identification Number
(PIN). These two parameters must at all times be 100% identical to the ones written on the
laboratory request form accordingly, the specimen may otherwise be rejected.
Laboratory Request Form and Completion
The NTRL through the National Tuberculosis and Leprosy Programme (NTLP) has its own laboratory
request form and will continue to provide them to health units that refer specimens to the NTRL
through respective TB zonal offices or precisely through the District TB and Leprosy Supervisor
(DTLS). In the event that an organization/clinic wishes to design its own request form, NTRL advises
that the facility consults the NTRL management for optimal designs.
The laboratory test request forms for referring samples to the NTRL is designed in such a way as to
capture the following information. See Appendix 1
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
The Health facility or research organization requesting examinations.
The name, sex, age of the patient from whom the sample was collected.
Address of the patient.
Clinical history of the patient (on chemotherapy or not etc)
Patient category
Reason for Request
Laboratory procedure(s) being requested for.
Type of sample collected or the site from where the sample was collected
Amount of the sample collected
Date and time of collection of sample.
Signature of person requesting for laboratory investigation and date.
A section for NTRL use only;
a. For recording initials of person receiving specimen, time and date.
b. Macroscopic quality of the specimen (e.g purulent, muco-purulent, salivary or mucosalivary)
c. A provision for inserting NTRL laboratory number
Completing the laboratory request form (See Appendix 1 Form 03)
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1. The laboratory request form (NTRL or Project-specific) must be completed fully at all times. It is
the duty of the health facility in-charges or principal investigators to ensure that personnel under
their supervision fully complete the request forms. It is important to note that all information
requested for on laboratory request forms is vital for NTRL or to the person/organization
requesting tests or both.
2. Pull out a new (blank) NTRL request form or its equivalent approved by NTRL.
3. Each specimen sent to the NTRL must have a separate request form even if the different samples
were collected from the same person. Exceptions will be accepted if the request form used has a
provision for specifying the different types of specimens and number collected from an individual
for different examinations.
4. Fill in the request form using a blue or black pen only. DO NOT USE RED PENS.
5. Fill the request form clearly in block letters avoiding abbreviations such as Mlg Hospital instead
of Mulago Hospital, Kla for Kampala etc. When filling the form, emphasis is made on the
following parts.
DATE
This is the date the request form is filled
PATIENT IDENTIFICATION
Name: Write the Patients surname and first name. AVOID writting one name
Sex: Write Male or Female
Age (years): Indicate the age of patient in years. AVOID Adult( Ad)
Patient ID: Unique number assigned to each patient at the Health unit. NOTE: For patients
under screening record Not applicable(N/A) and not new.
Contact Tel No: For the Patient
LC1/Village: The Village/LC1 where the Patient resides.
Parish/ward: The Parish/Ward where the Patient resides.
District of Residence: The district where the Patient resides.
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HEALTHY FACILITY DETAILS:
Name: Write full names of the Health Unit or Hospital. AVOID abbreviations e.g MLGH for
Mulago Hospital
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District: Write the full District name where the Health centre or Hospital is located.
TB Zone: Write the name of the TB zone where the Health Centre is located( e.g Kampala
South East, South West, East, North East, North and North West. )
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Central,
CLINICAL INFORMATION:
PATIENT CATEGORY
Tick the appropriate patient category (see section 3 definitions)
TB suspect
New Patient
Failure
Defaulter
Relapse
Chronic Case
other…
ANTI-TUBERCULOSIS DRUGS EVER BEEN USED:
Please tick the appropriate anti TB ever been used
Isoniazid
Rifampicin
Kanamycin
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Streptomycin
Amikacin
Capreomycin
Ethambutol
Ofloxacin
Pyrazinamide
Other specify……………………..
REASONS FOR REQUEST
Please tick the appropriate reason for request of the test, and specify any reason in the case of
‘other reason’ option. (Tick one)
Diagnosis
Smear positive at --------- month(s) of treatment
Culture
Initial DST
Follow Up DST at ……………………Months of TB treatment
Other reason (specify)……………………………….
SPECIMEN INFORMATION
Type of Specimen-.....e.g Sputum, BAL etc
Specimen collected at (Follow-up visit);
Please tick the appropriate box.(Tick one)
0 months
2 months
5 months
8 months
Peripheral Microscopy Results:……………………
Other specify……………………………….
Date collected:……………………………Time:………
EXAMINATION REQUESTED
Please tick the appropriate box.
MICROSCOPY:
CULTURE:
DRUG SUSCEPTIBILITY TEST:
Requested by: Name: Name of requester
Sign Signature of requester_
Phone number: of tewuester
This part of the section is reserved for use by NTRL only.
For National TB Reference Laboratory Use:
Date Received: ________________________ Time:_____________________
Appearance:__________________Volume:____________Received by (Name):________________________
Laboratory Number:______________________ Reported by: Sign__________________________________
6. Complete the request form as fully as possible.
7. Make sure that the patient names, date of collection recorded on the specimen container match
with those on the request form, otherwise specimen will be rejected.
8. In the event that the sample and the request form are in partial disagreement but there is a
single common identifier, the specimen will probationary be accepted but the request form will
be returned to the person requesting tests together with another NTRL form headed “Laboratory
Request Form Reconciliation (LRFR) form (see appendix 2). The person who completed the
request form must complete the LRFR form for results of such samples to be released as a sign of
accepting to own the discrepancy and the repercussions that might result from it.
9. The LRFR form will also be sent for completion if vital information was left out during completion
of the laboratory request form.
10. In the event that the LRFR form is not completed and returned to the NTRL, results of such
samples will be disregarded and never released.
11. In cases where the laboratory request form and the specimen identification/ label are totally
different, the specimen will be rejected totally and discarded. The request form will be labeled
“REJECTED”, a copy sent back to the clinic accompanied by a sample rejection form (Appendix 3)
that explains the reason(s) for rejection.
12. NTRL will do what it can to avert sample rejection for hard to collect specimens such as bone
marrow biopsies but this is not always guaranteed. In this case, the specimen will be processed
but results will only be released after completion of LRFR form.
13. Sign and date as a person requesting for the laboratory investigations.
Sputum collection.
Safety precautions
The shipment of diagnostics samples such as urine, sputum, tissue biopsies, blood and other body
fluids and cultures containing aetiologic agents, which includes all mycobacterium spp, is of potential
public health risk and must be done in compliance with shipment of biological specimen regulations
of the country. The National Council of Science and Technology can advise on regulations concerning
transportation of biological samples in-country and abroad. Compliance to transportation standards
is the responsibility of the shipper.
Samples must be packed using the “Tripple Packaging system”
Packaging.
After filling in the laboratory culture and DST form, the Triple packaging system is used. In
this system, the sample is physically contained in 3 receptacles ie Primary receptacle
(sputum/falcon tube), secondary receptacle (a ziplock bag) and a tertiary receptacle
(safety box).
(i) A primary receptacle(s) – The tube should be wide-mouthed, screw-capped and leakproof. A 50 ml falcon tube is thus ideal. When the sample is coughed into the tube and
after tightening the lid, label the tube with the patient name, age, sex and health facility
name, then wrap the tube with absorbent material e.g cotton in sufficient quantity to
absorb the entire contents in case of leakage.
Sputum container
Cotton wool
(ii) secondary packaging – Is the zip lock or biohazard bag. Place the wrapped tube inside
the ziplock bag and zip it up.
Zip lock Bag
(iii) Tertiary receptacle: In this manual, this is referred to as the safety box. Place the Ziploc
bag and its contents into the safety box.
Safety Box
Figure 3. Left: an open safety box; Middle: after inserting the sputum container; Right: after sealing the box.
Warnings on the safety box
Sputum and other specimens suspected to contain infectious mycobacteria or other
infectious agents are classified as ‘’Infectious substance, Category B’’. Infectious substances
in Category B are assigned to a specific UN number: UN 3373. From 1 January 2007, the
shipping name labeled on containers with such specimens is “BIOLOGICAL SUBSTANCE
CATEGORY B”. This name is already labeled on all the safety boxes as shown in figure 3.
“BIOLOGICAL SUBSTANCE
CATEGORY B”
Figure 4: Markings for infectious substances of Category B.
Maximum and minimum shipping quantity rules
For surface transport (road, rail or water) there is no maximum quantity per package.
For air transport the rules are:
• No primary receptacle shall exceed 1 L (for liquids) or 1 kg (for solids).
• The volume shipped per package shall not exceed 4L or 4 kg.
Detailed instructions are given in packing instruction P650 (see reference 1)