SIP

Olla to all you med techs out there! So i am here, assignned to share my SIP experience with you for the first week. Background information here, I am attached to a private laboratory. I'm fortunate 'cause I get to rotate among the different sections. And for my first couple of weeks, I am attached to the immunology department.

In this department, it's mostly automated. But it uses only one machine, the great ADVIA Centaur Immunoassay System, by Bayer HealthCare.


Subject title: Immunology
Topic: ADVIA Centaur

Taken from http://www.blockscientific.com/advia-centaur-chemistry-analyzer.htm

The Centaur, as it is affectionately known to all my collegues, is an automated immunoassay analyzer which uses direct chemiluminescence as its principle technique. Chemiluminescence is actually a term to describe the emission of light from a chemical reaction in the sample that is being analyzed.

In the Centaur, acridinium ester (AE) is used as the chemiluminescence label. It was found out that AE is preffered and used as it does not require any addition of catalyst or substrate. It also cause the reaction to occur more rapidly, increase assay sensitivity and allow a longer reagent shelf life due to its dimethyl form.

OK, so in the Centaur, the AE is oxidized by hydrogen peroxide. The acidic environment is changed to basic in order to maximise the amount of light emitted. In this case, oxidation occurs super fast with its peak amount emitted in less than a second. This light is then measured to give the results for the sample that is being analyzed.

The Centaur can analyze for many constituents found in the blood, such as tumour markers ( CA 125, CA 199 ), thyroid stimulating hormone, Hepatitis A & B surface antigens or antibodies, cortisol, ferritin, testosterone, folate, vitamin B12, and many more. The most which is tested is for HIV.

The blood received from various clinics are centrifuged for 10minutes before they are labelled and barcoded. The tests to be done on the sample can either be pre-specified by the LIS or done manually.

Once the tests are selected, they are put in test-tube racks before they are inserted into the machine. Once all the samples are taken, the completed test-tube rack are pushed out while the samples are incubated and undergo the various tests. Its as simple as that, and that is done manually.

Those which are controlled by the LIS are just placed in the Sample Manager. The rest are fully automated, from selecting the right test-tube, to allocating the test-tube to the correct Centaur by the transportation track, to doing the various tests on its own, to going back into the Sample Manager after its all done. All the med techs have to do is to make sure everything runs smoothly, and validate the results.

Fantastic machine ain't it?

So that's all for now. Another week to get fully acquainted with the Centaur before I'm posted to another department.

Have fun for all your SIP!!!!

Name: Mayafirhana

Class: TG02

Laboratory Management and Quality Assurance

Name: Raihana Binte Zainalabidin
Subject title: Laboratory Management and Quality Assurance
Topic: Organization of regulatory bodies that regulate the operations of clinical laboratories in Singapore

Clinical Trials Resource Centre

Established in May 1999, the Clinical Trials Resource Centre (CTRC) helps promote and co-ordinate high quality clinical trials in SGH. CTRC provides advice to Principal Investigators and their Sponsors on the policies and guidelines for conducting clinical trials.

Apart from maintaining database for SGH, CTRC keeps record of the progress and status of the trials and helps trains Principle investigators and study co-ordinators
Services CTRC provides includes provision of CGP trained co-ordinators, monitoring sites, carrying out audits and assist in collection and preliminary processing of samples at the laboratory to ensure quality samples to be sent to the central laboratory(Clinical Trials Resource Centre, Singapore General Hospital, 2008).

References:
Singapore General Hospital (2008). Division of Reseach: Clinical Trials Resource Centre, Retrieved on 15 June 2008 from http://www.sgh.com.sg/ForDoctorsnHealthcareProfessionals/Research/ClinicalTrialsResourceCentre/

Laboratory Management and Quality Assurance

Name: Mayafirhana Bte Hairulhassan
Subject title: Laboratory Management and Quality Assurance
Topic: Organization of regulatory bodies that regulate the operations of clinical laboratories in Singapore

The Institutional Review Board (IRB) is formed mainly to ensure the rights, safety and privacy of the subjects in any Human Biomedical Research (HBR) projects that is to be conducted1,2. The IRB must contain at least five members who have the knowledge of the types of research that is usually done in the institution1.

Other obligations of the IRB include:
- The education of research investigators regarding the human subjects2
- Review and approval of HBR projects1,2
- Controlling of the approved HBR project1,2
- Report any unforeseen activities to their respective institutions1,2

1. Operational Guidelines for Institutional review Boards. (2007). Retrieved 16th June, 2008, from http://www.moh.gov.sg/mohcorp/uploadedFiles/Publications/Guidelines/IRB%20Operational%20Guidelines_14-12-07_formatted.pdf

2. Institutional Review Board. (2007). Retrieved 16th June, 2008, from http://www.smu.edu.sg/research/IRB.asp

Laboratory Management and Quality Assurance

Name: Mohammad Amir bin Mohammad Arshad
Subject Title: Laboratory Management and Quality Assurance
Topic: Organization or regulatory bodies that regulate the operations of clinical laboratories in Singapore

Singapore Good Clinical Practice Guidelines is launched by the Ministry of Health and the Asia Pacific Economic Co-operation (APEC) for GCP in Singapore in August 1998, together with Medicines (Clinical Trials) Amended Regulations 1998 regulates clinical trials.1 This allows APEC countries to form a regulatory framework in producing quality and efficient drug, attracting overseas companies to invest in Singapore.2

Principles
- Guarantees qualified investigators reporting information accurately.1
- Ensures safety and less risk to the trial subjects, by obtaining their consent.1
- Have sufficient data to support proposed trials.1
- Safe keeping of confidential records.1
- Follow closely to protocols.1

1. Conducting Clinical Trials in Singapore (1998). Retrieved June 16, 2008 from: http://www.sma.org.sg/smj/4004/articles/4004ra4.html

2. Active Promotion of Good Clinical Practice and Bio-Safety(2007). Retrieved June 16, 2008 from: http://www.biomed-singapore.com/bms/sg/en_uk/index/about_biomedical_sciences/regulatory_framework/research.html

Laboratory Management and Quality Assurance

Name: Rusydiana binte Kusni
Subject Title: Laboratory Management and Quality Assurance
Topic: Organization or regulatory bodies that regulate the operations of clinical laboratories in Singapore

The Centre for Transfusion Medicine (CTM) is an internationally acclaimed organization for blood banking1. In addition to assisting World Health Organization (WHO) with promoting blood safety and quality, it is also responsible for the efficient processing of blood and blood components from point of collection to distribution to external bodies1. In order to maintain its quality, Health Sciences Authority (HSA) a regulatory body, overlooks the activities of CTM. It regulates the health products, in this case, blood, and ensures that Singapore does not lack in blood supply for any emergencies2. By doing this, HSA is responsible for safeguarding public health2.

1. (2007). About Centre for Transfusion Medicine. Retrieved June 16, 2008, from Health Sciences Authority. Website: http://www.hsa.gov.sg/publish/hsaportal/en/health_services/about_ctm.html
2. (2007). Mission and Vision. Retrieved June 16, 2008, from Health Sciences Authority. Website: http://www.hsa.gov.sg/publish/hsaportal/en/about_us/mission_and_vision.html

Laboratory Management and Quality Assurance

Name: Nur Sofieyana Bte Muhammad Ismaeil
Subject: Laboratory Management and Quality Assurance
Title: Organization or regulatory bodies that regulate the operations of clinical laboratories in Singapore



SPRING Singapore is one of the member bodies of the International Organization of Standardization (ISO). It is the national standard authority that is accountable for the consistency of Singapore’s industry activities. 1, 3

The national Standard Council that supervises the country consistency program in areas, like biotechnology, will guide SPRING Singapore in ensuring that Singapore standards tally with international standards. 2, 3

Partly and fully automated machines are commonly used in laboratories particularly in the Clinical Chemistry section. For this reason, the application of ISO will guarantee that the laboratories operations are accurate and thus producing a good quality results.


1. International Standards Bodies/Regional Standards & Conformance Fora (2007). Retrieved 16 June, 2008, from Spring Singapore. Website: http://www.standards.org.sg/AboutUs.cfm?id=AU1001

2. The Singapore Standard Programme (2007). Retrieved 16 June, 2008, from Spring Singapore. Website: http://www.standards.org.sg/

3. National Standard Body (2007). Retrieved 16 June, 2008, from Spring Singapore. Website: http://www.spring.gov.sg/Content/WebPageleft.aspx?id=e6ff85fa-58ad-4dd3-b307-92efe370d03c