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TRANSCRIPT
The CILM’s Sampling Manual Version 1.0 January 2017
[Written by the Quality Committee]
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Table of content
Table of Contents
Information 4 Introducing the CILM 4 Timetable, access and contacts 4
Timetable 4 Access and contact 5
Pre-analytical phase 6 Completion of request form 7 List of analysis performed at the CILM 10
For HIV 10 For Tuberculosis 10 For Hepatitis C 10 For Hepatitis B 10
List of material for the samplers 10 Tubes for blood draws 10 Pots for sputum sampling 10 Expired material 10
When to request those tests? 11 For HIV 11 For Hepatitis C 11 For Hepatitis B 11 For Tuberculosis 12
The request forms and the sampling data sheet 12 The request forms 12 The sampling data sheets 12
Blood draws 12 Patient preparedness for blood draw 12 Performing the venepuncture 12 Labelling the tubes 13
Hygiene and security 13 Blood exposure accident 13 Disposal of the material 13
Transportation and storage before the testing 14 Storage before sending the sample 14 Packing 14 Transportation 14
Urgent examination 14
Analytical phase 15 Turnaround time for routine analysis. 15
Post-analytical phase 15 Report of the result(s) 15
Routine report of results 15 Urgent report of results 15 Additional testing. 15
Storage, archives and complaints 16 Privacy and protection of the patient information 16 Complaint procedure 16
Appendixes 16
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The CILM’s Sampling Manual
PROCESS – PRE EXAMINATION
VERSION 1.1 APPLICATION DATE: January 17
th 2017
Activity Name Position Signature
Author Mixivang XAYAOVONG Quality Officer
Reader Philavanh SITBOUNLANG Lab Manager
Validator Laurent MALATO Scientific responsible FM
History of modifications:
Version Date Comments
1.0 16.01.2017 Initial version
1.1 29.05.2017 Add the section of completing request form (page: 7-9)
Next revision planned: 29
th May 2019
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Information The CILM is proud to present you this sampling manual that has been elaborated to offer you a better service when taking care of your patients. The aim of such a sampling manual is to give you the list of all the exams that are performed within our lab, and to explain you what are the different information we require for the pre-analytical phase according to the norm ISO 15189. Among those requisites, the way the samples have been obtained and transmitted are important steps that require a good collaboration between the clinical services and our laboratory. Respecting those rules is a must to guarantee trustworthy results. Your involvement and participation in this pre-analytical phase allow us to better take care and serve your patients. We really hope that this sampling manual will provide you some precious help in your daily sampling activity. We are at your disposal and looking forward to any comments or suggestion that may lead to the improvement of this handbook.
Introducing the CILM The CILM belongs to the Ministry of Health of Lao PDR. This centre includes a BSL2+ medical laboratory (LRM) in charge of specialised biology assays in the field of HIV, Hepatitis and tuberculosis. This laboratory is the only one in the whole country with the capacity to perform viral load testing (HIV, HBV, HCV), early infant diagnosis for HIV and drug susceptibility test for ARVs. Samples for HIV come from all over the country. The CILM works in close relationship with the CHAS (National Program for HIV/AIDS) and NTC the National Program for Tuberculosis.
Timetable, access and contacts
Timetable The CILM is opened from Monday to Friday, 8am to 5pm. Sampling hours at the laboratory are from Monday to Friday: 9am to 3pm. The CILM is located in the centre of Vientiane at the following address:
Centre d’Infectiologie Lao Christophe Mérieux BP 3888 Samsenthai Road-Kaoyot Village-Sisathanak District,
Vientiane Capital Lao P.D.R
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The processing of a biological sample from the collection to the delivery of the results is split between 3 phases known as:
Pre-analytical stage
Analytical stage
Post analytical stage Each step is important for the diagnosis provided by the CILM to its customers. The recommendations, given in this manual, aim at providing the clinical services with all information and tips related to the performance of the biological test to ensure the trustfulness and robustness of the diagnosis.
Pre-analytical phase The pre-analytical phase is under the responsibility of the clinical service asking for the realisation of a test for one of its patient. In this section, we provide details and information to ensure that the sample sent to the CILM has been obtained under the adequate conditions for testing and that all information required for the processing of the biological specimen are present.
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Completion of request form
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Picture 1: Completed HIV request form (Annex 1: Request forms)
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(Picture 2: File maker database)
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List of analysis performed at the CILM This is the list of tests that can be performed at the CILM:
For HIV
HIV RNA viral load on plasma from EDTA K3 tubes; 6mL at least
HIV early infant diagnosis on Dry Blood Spot
HIV drug resistance on plasma from EDTA K3 tubes; 6mL at least
For Tuberculosis
Molecular assessment of TB with the GeneXpert on sputum and other specimens (CSF, pleural fluid, lymph nodes, biopsy…)
Second line treatment susceptibility testing on sputum culture
Common Mycobacterium treatment susceptibility testing on sputum culture
For Hepatitis C
HCV RNA viral load on plasma from EDTA K3 tubes; 6mL at least
HCV genotyping on plasma from EDTA K3 tubes; 6mL at least
For Hepatitis B
HBV DNA viral load on plasma from EDTA K3 tubes; 6mL at least
HBV serology markers o Qualitative HBs Antigen on serum tubes or EDTA K3; 6mL at least o Qualitative or Quantitative HBs Antibody on serum tubes or EDTA K3;
6mL at least o Qualitative HBc Antibody on serum tubes or EDTA K3; 6mL at least o Qualitative HBe Antigen on serum tubes or EDTA K3; 6mL at least o Qualitative HBe Antibody on serum tubes or EDTA K3; 6mL at least
List of material for the samplers
Tubes for blood draws The tubes that are compatible will all the molecular biology tests or even for serology markers at the CILM are the EDTA K3 tubes. For the serology markers, in the case of Hepatitis B diagnosis, serum tubes might also be accepted. Note: samples drawn on Lithium heparin tubes will be rejected and will be considered as Non Conform because heparin is a potent inhibitor of the PCR reaction.
Pots for sputum sampling Pots for sputum collection should be sterile with a screw cap for tight and leak-proof closing. They should be labelled correctly according to the requirements of the norm ISO 15189. (Please refer to the labelling section below in this manual)
Expired material
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The sampling material that is sent to your place has a long shelf life, in the case of a low turnover rate it might happen that the expiration date is passed. We remind that it is your responsibility to check and make sure that the material is not expired when using it.
When to request those tests?
For HIV
HIV viral load
HIV viral load testing is supposed to be performed once per year for patient under ARV treatment. Ideally the viral load determination or evaluation is linked to a CD4 count when available. HIV viral load can also be performed for naïve patients as a baseline assessment of the replication.
HIV early infant diagnosis
This test concerns infants born from HIV infected women. This test is meant to detect whether or not the newborn has been infected by HIV. In the case of a first positive sample, a confirmatory test must be done on a second specimen.
HIV drug resistance
This test is requested for patient diagnosed with HIV and treated with ARV and who would exhibit a detectable viral load. This test can also be requested for naïve patients prior the initiation of ARV treatment to ensure they are infected with a wild-type HIV virus and not exhibiting any primary drug resistance.
For Hepatitis C
HCV viral load
This test is requested for patient diagnosed with HCV and followed or treated for their infection. This test is meant to detect the circulation of HCV in the bloodstream and assess the replication of the virus.
For Hepatitis B
HBV viral load
This test is requested for patient diagnosed with HBV and followed or treated for their infection. This test is meant to detect the circulation of HBV in the bloodstream and assess the replication of the virus.
HBV serology markers
This series of tests is meant to understand the status of a patient regarding HBV (current or past infection, immunization yes/no, prognosis). To better understand those tests and their interpretation, please contact the CILM (phone number mentioned above)
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For Tuberculosis
GeneXpert
GeneXpert is requested for patients who are suspected with MTB. This test is meant to detect MTB Rifampicin resistance.
The request forms and the sampling data sheet
The request forms The requests forms are enclosed as annexes to this manual. In the case you do not have any request form anymore, please contact the CILM (T: 21 260 357).
The sampling data sheets
Identifying the samples
Every sample sent to the CILM must be correctly identified and must clearly indicate the following information on a label stuck on the tube:
Name
Last Name
Maiden name for women
Birth Date
Gender
Date of sampling
Exception for HIV samples:
In the particular case of HIV samples, the tubes must be labelled with the Patient ID given by the CHAS/ARV sites.
Patient ID (CHAS)
Birth Date
Gender
Date of sampling Any ambiguity when identifying the primary sample would trigger a non-conformity and the non realization of the test.
Blood draws
Patient preparedness for blood draw None of the tests performed at the CILM require special preparation for the patient, no fasting or any other state.
Performing the venepuncture Discretion and confidentiality are mandatory when performing the blood draw; the patient has to be installed comfortably.
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Introduce yourself to the patient and ask the patient to state their full name.
Check that the form matches patient’s identity.
Wear coats and goggles
Put on well-fitting, non-sterile gloves
Label / write down the name of the patient on the blood collection tubes. Labels should carry the name, the last name, and the type of tests requested. Date of writing should be clearly legible.
Disinfect largely (from the inside to the outside) the area to be punctured
Blood draw has to be quick and without excessive pain
Make sure that the tube are correctly filled (check volume indicators)
Place the collection tube on a rack to prevent needle stick injury when filling it
with blood
In case any incident occurred during the blood draw, please fill in the report form.
Labelling the tubes
It’s very important that the tubes are labelled correctly with all the information (mentioned on the example above) written clearly and in a legible way.
Hygiene and security
Blood exposure accident In case of blood exposure accident, the victim has to be addressed immediately to the competent service. Reporting of the accident should be written without delay indicating the serological status of both the victim and the source patient. The accident should then be thoroughly investigated by the Quality Management to mitigate the risk of new occurrence.
Disposal of the material According to the regulation the disposal the infectious material used for the blood draw is upon the responsibility of the sampler and the sampling service. Sharps and needles should be collected in appropriate containers and discarded ensuring that there is no risk of propagation or contamination for the staff and the population or environment.
Name Last name
Date of birth Gender
Sampling date
EDTA K3 tubes
Example of labelling
Test
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Any defect in the correct elimination of infectious material would expose the staff to blood exposure accidents.
Transportation and storage before the testing
Storage before sending the sample The viral load tests performed at the CILM require the use of plasma as the 1st choice matrix: Plasma must be prepared from EDTA anticoagulated–whole blood (venous) within six hours of blood collection (if left at room temperature), 24 hours at 2–8°C or according to the manufacturer’s instructions. Prepared plasma can be stored at room temperature for up to 24 hours, at 2–8°C for up to 5 days and –20°C to –80°C for longer periods
Packing The minimum requirement is triple packaging system: primary box (plasma tube/EDTA tube), secondary box (Lio-box/bottle) and outer box (Styrofoam). A box (polystyrene or ice box) with the address of the CILM, a contact number and the name of the shipper inclusive of a phone number also.
Transportation The transportation of the specimens should comply with rules that ensure sample’s integrity and its good quality that is a must for confidence in the result of the test afterwards. Those rules also ensure the safety of the staff that will take care of this specimen in the laboratory. For HIV samples, the CILM has provided all ARV sites with monitoring temperatures devices that have to be activated and sent to the CILM with the batch of samples to test for viral load. Upon arrival at the CILM, we check that the temperature during the transportation of the samples stayed within the acceptance range and that the specimen can be used for examination.
Urgent examination None of the test performed at the CILM is supposed to be urgent. Anyway in the case where you need an urgent result, please clearly mention the special nature of your sample on the examination sheet with the following information in addition to the regular information required:
Name of the Practitioner
Reason(s) for an urgent result
Contact information for the result (e-mail, fax, phone)
It is also recommended to directly contact the laboratory to confirm that this particular demand can be processed on a shorter time.
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Analytical phase
Turnaround time for routine analysis. Here is the (maximum) turnaround time chart for the tests done at the CILM.
Type of test performed at the CILM Maximum turnaround time
HIV viral load testing 14 days
Early infant diagnosis 20 days
HIV drug resistance 1 month
HCV viral load testing 16 days
HBV viral load testing 9 days
HBV serological markers by ELISA 20 days
GeneXpert testing for Tuberculosis 2 days (as soon as possible)
Post-analytical phase Post analytical relates to every aspect concerning the patient after the sample is processed at the laboratory. This phase encompasses the reporting of the result, archiving and eventually dealing with additional requests or complaints.
Report of the result(s)
Routine report of results You might expect to obtain the results for your patient according to the table mentioned above. Reporting of the result is sent to the clinician through different methods (fax, mail, e-mail). Reporting of the result by the phone is not done anymore for privacy and confidentiality reasons.
Urgent report of results In the case you requested an urgent report of the result(s) for your patient, the CILM can, on an exceptional basis, report the result by the phone. But please keep in mind the exceptional nature of this method.
Additional testing. In the case you would need an additional test on the same specimen for your patient, please contact the CILM for practical modalities and to make sure that it is possible to do so.
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Storage, archives and complaints
Privacy and protection of the patient information The CILM has committed to protect privacy and all the data concerning patient from unauthorized access. Only the staffs that have been granted permission have access to the information concerning your patients after signing a confidentiality agreement. All data are stored on a protected server. Paper-based versions of the reports for patient are kept in a lockable cabinet. Protection of the privacy is one of the main concerns of the CILM and this is why reporting of the results by the phone has been abandoned.
Complaint procedure In the case you were not entirely satisfied with the way CILM has taken care of your patient, feel free to contact us (+856 (0) 21 260 357). Please keep in mind that continuous improvement is an important part of our Quality Management System and that customer satisfaction is also very important for us.
Appendixes Please find as appendixes the different request and report forms corresponding to the different types of test offered by the CILM.