User:Apamahu888/sandbox

TUD Background
Working closely with Malaysia SMECorp, awarded by the only Malaysia government affirmative brand award – Malaysia Brand. TUD expanded the business from its Malaysia until many countries including China, Hong Kong and United Kingdom by filling up of reliable and quality consistency products to its existing potential market. TUD has attested by ISO13485 due to its diligent and conscious for blood collection tubes in manufacturing, design, development and etc. TUD develop oriented social integrity of return by forming a great management team with 3 values : Tactful, Unique and Dynamic; actively participate in corporate social responsibility have earn unanimously praised and gain the local respect. TUD have formed a global distribution channel in globalize by working hand in hand in order to explore the existing potential market. We do believing that TUD shall be one of the leading player in IVD industry which could equal the global market share with western country from practice in very soon future.

Common Technical Issue
Blood collection tubes are usually at the bottom part of medical chain for IVD industry, but it play more important role for today. Routine and simple in early but DNA/RNA/viral study for current era. This has highlight the positioning of blood tube value in modern medical era. However, technical issues insist happening, its occurrence is usually established in human negligence or during in transit, such as temperature, exposure under sunlight, humidity and so on.

1.Haemolysis
a. What is haemolysis:- rupturing of RBC and the release of their contents (hemoglobin) into surrounding fluids. The release of hemoglobin causes the serum or plasma to appear pale red to cherry in color

b.Factors:-
 * shaking the tube filled with sample
 * incorrect needle size
 * excessive suction
 * pressure
 * prolonged storage or incorrect condition (too cold or hot)
 * centrifuge or re-centrifuge
 * patient condition- infection with bacteria - autoimmune disorder - genetic disorder (sickle-cell)

c.To prevent haemolysis during venipuncture:-
 * Do not shake, invert tube slowly
 * Use correct needle size
 * Never draw blood through a hematoma
 * Do not force / push the syringe to draw blood into the tube

2.Fibrin strand or fibrin mass formation
a.What is Fibrin strand/fibrin mass:- protein strands which can entrap red blood cells, white blood cells and platelets b.Factor:- fibrin can present due to poor mixing, short clot time, or patient condition. c.Consequences:- physical obstruction of the probe, failure to provide test results, or incorrect test results. d.Prevention:- Properly mix tubes, allow adequate clotting time

3.Gel globules or oil droplets formation / Gel Smearing
a.What happen:- spherical drops of fluid resembling a fat droplet floating in the serum

b.Factors:- arise from material expressed from the gel resin, certain patient conditions, high temperature in storage or handling process

c.Consequences:- Gel globules or oil droplets can coat or occlude instrument probes, leading to erroneous results or instrument down time.

d.Prevention:- Use product within the shelf life, store tubes between 4-25 °C. Exposure to high temperature prior to use and during centrifugation may lead to the formation of gel globules or oil droplets in the serum

4.Gel failed to form a barrier
a.What happen:- gel could not go up after centrifugation

b.Factors:- unsuitable usage speed & time of spinning

c.Consequences:- Separation is not complete

d.Prevention:- Regular check on the centrifuge machine. Sufficient spinning time

5.Analyser randomly give 0 result
a.Factors:
 * Insufficient volume of samples are use whereby the probe unreachable to the samples
 * Probe was being stucked by the residual of protein or gel

b.Prevention:
 * Make sure the volume of the samples is reach at least the minimum volume.
 * Regularly clean the probes.
 * Alignment of the probes are in right place

6.Over-filling or Under-filling
a.Factors:
 * Tubes containminated due to expiry or improper storage
 * Tube manufacturing defeat due to improper measurement & calibration of the tube cap & vacuum pressure
 * +/- 10% from actual sample volume are acceptable under ISO 6710 & EN 14820 for blood collection tubes

b.Prevention:
 * Do not open the cap when blood drawing from patient.
 * Do not use expiry tubes
 * Do not purchase with non international recognize supplier or manufacturer

7.Backflow
a.What is backflow : Since tubes contain a chemical additive, it is important to avoid possible backflow from the tube when blood collection

b.Factor : With the possibility of adverse patient reactions or sample drawing process

c.Consequence :- The sample is contaminated

d.Prevention :-
 * Place patient's arm in a downward position.
 * Hold tube with the stopper uppermost.
 * Release tourniquet as soon as blood starts to flow into tube.

e.Make sure tube additives do not touch stopper or end of the needle during venipuncture.