Name: Mawuenyegah Benjamin Sena

School: Accra Technical University

Index number: 01201141B

Course: Medical Laboratory Science

Level 400 Group B Weekend

Quality Assurance in the laboratory ensures that the result a laboratory generates and reports is

accurate, precise and specific. External quality assurance (EQA) is an important component of

the total quality assurance program of a clinical haemostasis laboratory. The same test,

performed on the same specimen, should give the same answer wherever and by whoever it is

carried out. In practice, of course, coagulation tests are biological-tests performed on blood

samples and there will always be a certain amount of variation, but any individual test result

should be similar to everyone else's. Internal Quality Control [IQC] and EQA [when available]

should be a fundamental part of any test that a laboratory offers.

Standardisation: A material standard or reference preparation is used to calibrate analytic

instruments and to assign a quantitative value to calibrators. In some cases this can also refer to

reference method which is an defined technique which provides sufficiently accurate and precise

data for it to be used to assess the validity of other methods. These are often referred to as the

'Gold Standard' method.

Laboratory Controls: These are commonly commercial rather than 'in house' pooled plasma

samples and are used to check for accuracy.

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Any test/assay should include controls of normal, high and low values in addition to including a

calibrator.

Ensuring quality has become a daily requirement in laboratories. In haemostasis, even more than

in other disciplines of biology, quality is determined by a pre-analytical step that encompasses all

procedures, starting with the formulation of the medical question, and includes patient

preparation, sample collection, handling, transportation, processing, and storage until time of

analysis. This step, based on a variety of manual activities, is the most vulnerable part of the total

testing process and is a major component of the reliability and validity of results in haemostasis

and constitutes the most important source of erroneous or un-interpretable results.

Pre-analytical errors may occur throughout the testing process and arise from unsuitable,

inappropriate or wrongly handled procedures. Problems may arise during the collection of blood

specimens such as misidentification of the sample, use of inadequate devices or needles,

incorrect order of draw, prolonged tourniquet placing, unsuccessful attempts to locate the vein,

incorrect use of additive tubes, collection of unsuitable samples for quality or quantity,

inappropriate mixing of a sample, etc. Some factors can alter the result of a sample constituent

after collection during transportation, preparation and storage.

Laboratory errors can often have serious adverse consequences. Lack of standardized procedures

for sample collection accounts for most of the errors encountered within the total testing process.

They can also have clinical consequences as well as a significant impact on patient care,

especially those related to specialized tests as these are often considered as “diagnostic”.

Controlling pre-analytical variables is critical since this has a direct influence on the quality of

results and on their clinical reliability. The accurate standardization of the pre-analytical phase is

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of pivotal importance for achieving reliable results of coagulation tests and should reduce the

side effects of the influence factors.

Homeostasis: A property of cells, tissues, and organisms that allows the maintenance and

regulation of the stability and constancy needed to function properly.

In case of acquired haemostatic disorders, family history can be seen as a family tree of the types

of haemorrhage observed as well as their spontaneous or provoked features. As far as a person’s

bleeding history is concerned, it is important to know the terms of appearance of haemorrhages,

their frequency and their source, and whether bleeding is aggravated after taking aspirin and/or

other medications like antiplatelet therapy, NSAIDs, etc. Regarding the surgical and obstetrical

history, it is important to note the number of interventions that resulted in bleeding complications

(new intervention due to complication).

In order to prevent disturbing pre-analytical influences, any interfering drugs should be

administered after collecting a blood sample. A record of all the drugs that the subject took

during the week prior to testing should be collected. Treatment with desmopressin, in treating or

preventing bleeding episodes in patients with von Willebrand disease, haemophilia A and

platelet function defects, should be noted. It is important to know if the patient is pregnant.

Pregnancy is associated with increase in fibrinogen, factors VII, VIII, X, VWF, D-dimer

concentration and with increase in levels of prothrombin fragments 1 + 2 and thrombin-

antithrombin III complexes. There is a decrease in physiological anticoagulants manifested by

acquired activated protein C (APC) resistance

Hormonal contraceptives can be responsible for interferences in coagulation testing and may lead

to increased concentrations of fibrinogen, prothrombin and factors VII, VIII and X, and

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reduction in coagulation inhibitors, such as antithrombin (AT), protein S and tissue factor

pathway inhibitor.The coagulation laboratory plays an important role in the diagnosis

and treatment of individuals with bleeding or clotting (i.e., thrombotic) disorders.

Test methodologies used to assess common disorders or diseases of haemostasis

are reviewed as well as the clinical relevance of each assay. The preanalytical

phase of testing offers the greatest opportunity for introducing result error in the

haemostasis laboratory and it is therefore imperative that samples are properly

collected, transported and stored. Samples for haemostasis testing should be

collected in 3.2% sodium citrate at a 9:1 blood to anticoagulant ratio and

maintained at room temperature until processed. Some test processes such as

platelet function testing have special processing and testing requirements. For

plasma-based tests, centrifugation to obtain platelet poor plasma and testing should

ideally be completed within 4 hours or the plasma frozen. IQC must be performed

with each assay, at appropriate levels of the analyte and at appropriate time

intervals as a means for assessing ongoing assay performance.

Internal quality control is used to establish whether a series of techniques and

procedures are performing consistently over a period of time. The expression

“quality control” is commonly used to describe the set of procedures used to check

that the results of laboratory investigations are reliable enough to be released to

assist clinical decision making, monitoring of therapy, and diagnosis of hemostatic

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abnormalities. Quality control procedures should be applied in a way that ensures

immediate and constant control of result generation.

Within a laboratory setting, the quality of results obtained is influenced by many

factors, including:

appropriate sample collection and handling

selection of suitable techniques and maintenance of an up-to-date manual of

standard operational procedures

use of reliable reagents and reference materials

selection of suitable automation and adequate maintenance

adequate records

reporting system for results

In addition, the quality of results obtained in routine practice is highly dependent

on the selection, training, and motivation of an appropriate complement of suitable

personnel.

Internal quality control is particularly useful to identify the degree of precision of a

particular technique — precision being the degree of agreement among repeat

measurements on one sample.

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It is important to recognize that a precise technique is not necessarily accurate,

accuracy being a measure of the closeness of an estimated value to the true value.

To assess the precision of a particular method, it is necessary to perform repeated

analyses of aliquots of the same sample. It is important to include Quality control

(QC) samples with normal and abnormal values to ensure that a method is under

control at different levels of a particular analyte, since relatively minor changes in

an analytical process may be more apparent when testing an abnormal control.

The control material should be similar in properties to test samples and be analysed

concurrently. Quality control materials of human origin are more likely to closely

resemble human test samples. All vials or aliquots of the control material should be

practically identical, so that any variation in test results is not a consequence of

vial-to-vial variation.

The QC material should also be stable for its intended period of use. In respect of

hemostatic tests and assays, plasma samples have to be deep frozen (preferably at -

35°C or lower) or lyophilized in order ensure adequate stability for use as QC

material. For reconstitution of lyophilized samples, it is important to use distilled

water with pH 6.8–7.2 and to allow at least five minutes for reconstitution.

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If commercial QC material is used, this should be reconstituted according to

manufacturer’s instructions using an accurate pipetting system. If deep frozen QC

material is used, this should be thawed rapidly at 37°C for five minutes.

In the selection of QC material, the risk of transmission of blood-borne viruses

should be considered. High-risk material should not be used. At least one QC

material should be included with each group of screening tests or assays. For

screening tests, it may be most appropriate to include a normal QC in this way and

to test abnormal QC materials once per day or shift, or when doubt exists about

whether a method is under control.