MT 1A: Introduction to Medical Technology with Science, Technology and Society

Report on Clinical Laboratory Section Hematology Section

Clinical Laboratory Section Hematology Section

1EMT - Group #4 Aquitania, Mary Christelle

Donato, Anna Katrina Galope, Jerrica Charlene

Leachon, Sofia Marie Manalastas, Keen

Mendoza, Jose Paulo Nabong, Krizel Ann Therese

Samorano, Kathryn Chemaine Whaley, Kristen Therese

Prof. Ron Christian G. Sison, RMT, AMT, MPH University of Santo Tomas

Faculty of Pharmacy Department of Medical Technology

September 2008

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Table of Contents I. Introduction .......................................................................................................................................... 3

II. Definition of Terms ............................................................................................................................... 4

III. Function of the Section ......................................................................................................................... 6

Laboratory Floor Plan of Hematology Section .......................................................................................... 7

IV. Lists of Tests .......................................................................................................................................... 8

1. Routine Tests..................................................................................................................................... 8

COMPLETE BLOOD COUNT (CBC) .................................................................................................. 8

About MANUAL DIFFERENTIAL COUNT ...................................................................................... 19

2. Special Tests .................................................................................................................................... 20

Prothombin Time (PT) ................................................................................................................. 20

Partial Thromboplastin Time (PTT) ............................................................................................. 20

Diascopy ...................................................................................................................................... 21

D-dimer ....................................................................................................................................... 21

V. Flow of Specimen ................................................................................................................................ 22

VI. Quality Assurance & Quality Control .................................................................................................. 23

VII. Updates & Automation ....................................................................................................................... 25

References ................................................................................................................................................. 27

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I. Introduction Blood is the most important fluid in our body which is being pumped by the heart through a

network of arteries and veins. It transports nutrients and oxygen throughout our body, removes waste materials such as carbon dioxide, urea and lactic acid, regulates pH and body temperature. Furthermore, and provides immunological, messenger and hydraulic functions.

Hematology is a part of the clinical laboratory which studies the blood, blood-forming organs and the diseases related to it. It is a unique subdivision of internal medicine. This department is both completely different but at the same time actually overlapping with the subspecialty, medical oncology. The study of etiology, diagnosis, treatment, prognosis, and prevention of blood diseases are also included in this division.

The physicians assigned to this section of clinical laboratory are called hematologists. These physicians are usually board-certified interns who have managed to complete additional years of training in hematology. Their work basically includes caring and treating patients with hematological diseases. They are the ones assigned to view blood films and bone marrow slides under the microscope, and then interpret the various hematological test results.

There are also physicians that are referred to as hemapathologists. These are pathologists who specialize in diagnosing diseases that are related to hematology. Almost similar to a hematologist, they manage and work in the hematology laboratory. Both physicians work closely together in order to draw out an accurate diagnosis and dispatch the most appropriate treatment or therapy required.

Figure 1 Complete Blood Count by a hematologist in East Avenue Hospital (From left to right)

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II. Definition of Terms

1. Acanthocytes – A crenated red cell which has a distinctive spiky outline.

2. Accuracy – It is defined as the best estimate of the result to the true value.

3. Analyte – A substance or chemical constituent that is undergoing analysis

4. Anticoagulant – A substance that prevents the clotting of blood.

5. Biopsy – The surgical removal of tissue

from a living body for examination and diagnosis. It is also a medical examination of this tissue.

6. Blood – The fluid consisting of plasma, blood cells, and platelets that is circulated by the heart through the vertebrate vascular system, carrying oxygen and nutrients to and waste materials away from all body tissues.

7. Chemiluminescent – Emission of light as a result of a chemical reaction at environmental temperatures.

8. Coagulation – Process of forming a blood clot to prevent blood loss from a ruptured vessel. A damaged blood vessel stimulates activation of clotting factors, eventually leading to the formation of long, sticky threads of fibrin.

9. Controls (Control Materials) – These are used to monitor the performance of a method after calibration.

10. EDTA - Abbreviation for ethylenediaminetetraacetic acid, used for anticoagulation. 11. Erythrocytes – A type of Blood Cell that distributes oxygen throughout the body tissues.

Also known as red blood cells. 12. Erythropoietin – It is a medicine used to treat a low red blood cell count. (Also refers to

Epoetin alfa, a recombinant preparation of human erythropoietin used to treat some forms of anemia.)

13. Extravasate – To force the flow of blood or lymph from a vessel out into surrounding tissue

14. Exudate – A fluid with a high content of protein and cellular debris which has escaped from blood vessels and has been deposited in tissues or on tissue surfaces, usually as a result of inflammation

15. Hematocrit – The proportion of the blood volume that is occupied by the red blood cells.

16. Hematopoiesis – The formation of blood or blood cells in the body. Also refers to erythropoiesis.

17. Hemostasis - The stoppage of bleeding or hemorrhage; the stoppage of blood flow through a blood vessel or body part.

18. Ischemia – An insufficient supply of blood to an organ, usually due to a blocked artery.

Figure 2 Acanthocytes

Figure 3 Erythrocytes and a Leukocyte

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19. Leukocytes – A type of Blood Cell that defend the body against both infectious disease and foreign material. Also known as white blood cells.

20. Magtration – A simple, patented separation method in which magnetic particles on the inner wall of the pipette tip are washed and separated.

21. Mean – It is the arithmetic average of a group of data points.

22. Median – It is the middle value of a dataset. 23. Mode – It is the value occurring most frequently. 24. Precision – This relates to reproducibility and repeatability of test samples using the

same methodology. 25. PRP - A special blood concentrate known as platelet-rich plasma (PRP) that can promote

healing in different aspects of medical and surgical situations. 26. Reticulocytes – Immature red blood cells. These are non-nucleated and that contain

remnant RNA material, reticulum. 27. Rouleaux – The stacking up of red blood cells, caused by extra or abnormal proteins in

the blood that decrease the normal distance red cells maintain between each other. 28. Smear - A blood sample or specimen spread on a slide for microscopic examination or

on the surface of a culture medium 29. Spherocytes – A spherical red blood cell. 30. Thrombocytes – A small cytoplasmic bodies derived from cells. They circulate in the

blood of mammals and are involved in homeostasis. Also known as platelets. 31. Transudate – A fluid substance that has passed through a membrane or has been

extruded from a tissue; it is characterized by high fluidity and a low content of protein, cells or solid matter derived from cells.

32. Trephine Biopsy – Removal of a small core of bone marrow under local anesthetic. It is used to assess bone marrow structure, the number and distribution of all the blood cell types.

Figure 4 Spherocytes

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III. Function of the Section

A clinical laboratory functions as an information center for each of the departments and programs that provide services within the Health Department. The staff performs a multitude of test, providing virtually immediate results for requests as basic as a urinalysis to those as complicated as HDL Cholesterol. The laboratory also oversees tests that are outside of the parameters of the laboratory’s certifications, and are performed at several in-state and out-of-state facilities. The results of the tests are critical for the individual departments and programs to be able to provide accurate information and advice to their clients as it relates to each individual’s medical concerns.

The laboratory is staffed with Medical Laboratory Technicians who are individually certified by the American Society of Clinical Pathologists (ASCP). All of the technicians are trained to operate all of the testing equipment employed by the laboratory, and are evaluated for proficiency on a regular basis. Each technician receives continuing education (as required by laboratory policy) in order to maintain and improve current knowledge and to be able to continue to provide SCHD programs with test results reflecting the most recent technical training.

The hematology section is a section of a clinical laboratory which applies molecular, cellular and morphological techniques to the study of blood, blood-forming tissues, and blood diseases. This section of the laboratory is particularly involved in areas such as hemostasis, thrombosis, metabolism, and morphology, and concentrated on the study of blood coagulation, fibrinolysis and the use of hemostatic tests as markers of diseases. It performs routine and special tests on blood such as complete blood count (CBC), peripheral smear and malarial parasite examination, and tests for hemostasis and coagulation studies. The section also performs cell counts and microscopic examination of cerebrospinal fluid (CSF) and other body fluids. The Hematology section counts and differentiates the types of cells in blood. Tests performed in this area are used to check for anemia, leukemia, mononucleosis and indications of viral or bacterial infection. They also observe the cells in other body fluids, such as synovial (joint) fluid or spinal fluid, examine bone marrow aspirations and perform semen analyses.

Figure 6 Hematology laboratory: Test result analyzing

Figure 7 CBC test using hematology analyzer

Figure 5 Hematologist performing differential blood count.

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Laboratory Floor Plan of Hematology Section Courtesy of East Avenue Medical Center

Image 1 Hematology Section - Laboratory Floor Plan

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IV. Lists of Tests

1. Routine Tests

COMPLETE BLOOD COUNT (CBC)

CBC is a series of tests used to evaluate the composition and

concentration of the cellular constituents of blood. The nine components of the CBC are the white blood cell count (WBC), red blood cell count (RBC), Hgb, hematocrit (Hct), mean corpuscular volume (MCV), mean corpuscular Hgb (MCH), eancorpuscular Hgb content (MCHC), platelet count, and red cell distribution width (RDW). It provides information about the size and shape, hemoglobin content of RBCs, percentage and absolute number determination of the types of WBCs and identifies cell abnormalities. This will determine the presence of infections and chronic disorders for diagnosis, preoperative test and monitoring treatments, and ascertain the effects of chemotherapy and radiation therapy on blood cell production. These tests are performed using an automated hematology analyzer. This test is also known as Full Blood Count (FBC) and hemogram.

Table 1 Nine Blood Components and other routine tests

Component Description Reference Ranges Relevance

Red Blood Cell Count

The number of red blood cells in 1 mm3 of blood; a useful diagnostic tool in the determination of several kinds of anemia.

Male: 4.3 – 5.9 x1012/L [1] 4.3 – 6.2 x1012/L [2] Female: 3.5 – 5.5 x1012/L [1] 3.8 – 5.5 x1012/L [2] Infant/Child: 3.8 – 5.5 x1012/L [2]

Diagnose for anemia (low hemoglobin)

Figure 9 Erythrocytes (RBC)

White Blood Cell Count (Refer to Table 3: Type of WBC) (See image next page)

It determine the number of white blood cells and the percentage of each type of white blood cell in a person's blood

4,300 - 10,800 cells/µL/cu mm

Detection of bacterial/parasitic infection in the blood

Diagnose for leukemia and other bone marrow related conditions

Figure 8 Human Red Blood Cells

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Figure 10 White Blood Cell

Hemoglobin (Hgb) Measures the constituent of iron-containing respiratory pigment in red blood cells of vertebrates, consisting of about 6 percent heme and 94 percent globin.

Male: 13 – 18 gm/dL 2.1 – 2.7 mmol/L[1] 132 – 162 g/L[2] 135 – 175 g/L[1] Female: 12 – 16 gm/dL 1.9 – 2.5 mmol/L[1] 120 – 160 g/L

Diagnose for anemia (low hemoglobin)

Figure 11 Hemoglobin

Hematocrit (Hct) Measures how much space in the blood is occupied by red blood cells.

Male: 0.41 – 0.53 [1] 0 – 15 mm/hr Female: 0.36 – 0.46 [1]

0 – 20 mm/hr Child: 0.31 – 43 [2]

Very useful in diagnose for anemia

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Figure 12 Hematocrit of the Blood Sample

Mean Corpuscular Volume (MCV)

The average volume of red cells in erythrocyte indices, calculated from the hematocrit and the red blood cell count.

Male: 82 – 102 fL Female: 78 – 101 fL Normal RBC Indices Value: 80 – 96 fL

Detection in deficiency in vitamin B12

Detecting hemochromatosis

Useful diagnostic haematological parameter for detection of α-thalassaemia at birth

Mean Corpuscular Hgb (MCH)

A measure of the weight of hemoglobin in a single red blood cell.

27 - 32 pg/cell 0.39 – 0.54

fmol/cell[1]

Detection in deficiency in vitamin B12

Detecting hemochromatosis

Eancorpuscular Hgb content (MCHC)

Mean cell hemoglobin concentration. The average hemoglobin concentration in a given volume of packed red blood cells.

31 – 35 g/dL[2] Increased hyperchromic cells Determination

Platelet count (See image next page)

A diagnostic test that determines the number of platelets in the patient's blood

150,000 - 350,000/mL Determine stable hemostasis process

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Figure 13 Platelets in 100x magnification (pointed by the arrow)

Red blood cell Distribution Width (RDW)

Measure of the variation of red blood cell volume

11.5 – 14.5 % (coefficient of variation)

Diagnose for anemia (low hemoglobin)

Figure 14 Representative of Red Blood Cell, Morphology

Reticulocyte Count (See image next page)

A blood test performed to assess the body's production of immature red blood cells (reticulocytes). Sometimes it is called retic count.

Adult: 0.5 – 1.5 % of RBC [1] [2] Newborn: 1.1 – 4.5 % of RBC [2] Infant: 0.5 – 3.1 % of RBC [2]

Diagnose and treatment for anemia

Reflection of bone marrow health or injury

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Figure 15 Reticulocyte in peripheral smear

Erythrocytes Sedimentation Rate (ESR)

A nonspecific screening test indicative of inflammation which is used as an initial screening tool and follow-up test to monitor therapy and progression or remission of disease. This test is reported in millimeters.

Male: 1 - 13 mm/hr Female: 1 - 20 mm/hr Hemoglobin in plasma: 0.16 – 0.62 μmol/L 1 – 4 mg/dL

Used to assess blood content through blood sedimentation

Figure 16 Actual Blood Sedimentation and Constituents

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Figure 17 Rouleaux Formation of RBC

Any condition that will increase rouleaux formation will usually increase the settling of red cells.

Bone Marrow Examination (See image in Figure 19)

This test refers to pathologic analysis of bone marrow samples obtained by trephine biopsy and bone marrow aspiration. It is sometimes necessary to examine the source of blood in the bone marrow to obtain information about hematopoiesis.

(refer to the Normal Range of the 9 Components of

CBC)

Used in the diagnosis a number of conditions, including leukemia, anemia, multiple myeloma and pancytopenia

Figure 18 Normal Bone Marrow at medium magnification

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Figure 19 Bone Marrow Examination

Table 2 Factors in Erythrocyte Sedimentation Rate, from Practice in Hematology by Ciesla, B., page 300-301

Factors Affecting ESR

Red cell shape and size: Specimens containing sickle cells, acanthocytes, or spherocytes will settle slowly and give a decreased ESR

Plasma fibrinogen and globulin levels: o Increased fibrinogen or globulin levels will cause increased settling and give an

increased ESR

Mechanical and technical conditions: Surfaces that are not level will influence red cell settling. Specimens that are not properly anticoagulated will also affect red cell settling. EDTA is the recommended anticoagulant.

Blood Fluid Cell Count/Cerebrospinal Fluid Cell Count (CSF) (See image in Figure 20)

A CSF cell count is a test to measure the number of red and white blood cells that are in CSF. CSF is a clear fluid that circulates in the space surrounding the spinal cord and brain.It is used to evaluate body fluids, differential diagnosis of exudates and transudate. Cell counts and cell morphology (refer to Figure

14) are key elements in identifying abnormalities within each of these systems.

Normal white blood cells: 0 and 5. Normal red blood cell count: 0

Increase of white blood cells indicates infection, inflammation or bleeding into the cerebrospinal fluid that may cause, such Abscess, Acute infection, Encephalitis, Hemorrhage, Meningitis, Multiple sclerosis, Stroke and Tumor.

Red blood cells may indicate a sign of bleeding

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Figure 20 CSF (cerebrospinal fluid) is a clear fluid that circulates in the space surrounding the spinal cord and

brain.

Differential Count A test based on the percentage of each variety of leukocytes in the blood, usually based on counting 100 leukocytes. Also known as leukocyte count. (Refer to Table 4: Peripheral Smear Preparation)

4.3-10.8 × 103/mm3 Differentiate the different types of leukocytes and infection involve due to varied results

Diagnose viral and parasitological infection in blood

Figure 21 White Blood Cell Differentiation: Granulocytes and Agranulocytes

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Table 3 Leukocyte Count Identification

WBC Components Type

Assessment

Normal Range

Image

Neutrophils Can increase in response to

bacterial infection or inflammatory disease

Severe elevations in

neutrophils may be caused by various bone marrow disorders, such as chronic

myelogenous leukemia Decreased neutrophil levels

may be the result of severe infection or other conditions,

such as responses to various medications, particularly chemotherapy.

Adults: 50% to 70% Infants: 37% to 67%

Eosinophil Can increase in response to allergic disorders,

inflammation of the skin, and parasitic infections.

Can increase in response to

some infections or to various bone marrow disorders

Decreased levels can occur as a result of infection.

Adults: 0% to 4% Infants: 1% to 4%

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Basophils Can increase in cases of

leukemia, chronic inflammation, the presence

of a hypersensitivity reaction to food, or radiation therapy

Adults: 0% to 2% Infants: 0% to 2%

Lymphocytes Can increase in cases of viral infection, leukemia, cancer of

the bone marrow, or radiation therapy

Decreased lymphocyte levels indicate diseases that affect the immune system, such as lupus, and the later stages of HIV infection.

Adults: 20% to 44% Infants: 18% to 38%

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Monocyte Can increase in response to all kinds of infection as well

as to inflammatory disorders Increases in certain

malignant disorders, including leukemia.

Decreases monocyte levels indicate bone marrow injury

or failure and some forms of leukemia.

Adults: 4% to 10% Infants: 1% to 12%

Band Cells (Stab Cells)

Indicates early response to infections that forms immature neutrophils

Earliest sign of WBC

response, even before the WBC becomes elevated

Adults: 1% to 10% Infants: 4% to 14%

Note 1 Reference Range Based on Three Different Sources:

1. Last page of Deepak A. Rao; Le, Tao; Bhushan, Vikas (2007). First Aid for the USMLE Step 1 2008 (First Aid for the Usmle Step 1). McGraw-Hill Medical. ISBN 0-07-149868-0.

2. Normal Reference Range Table from The University of Texas Southwestern Medical Center at Dallas. Used in Interactive Case Study Companion to PATHOLOGIC BASIS of DISEASE.

3. "Hematology in Practice" by Betty Ciela

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About MANUAL DIFFERENTIAL COUNT

When automated differentials do not meet specified criteria programmed into the automated hematology instrument, the technologist/technician must perform a manual differential count from a prepared smear. There are two types of blood smears: the wedge smear and the spun smear. Usually, wedge smear is done because it is easy to prepare and more reliable in terms of cell counting. A good counting area is an essential ingredient in a peripheral smear for evaluating the numbers of and types of white cells present and evaluating red cell and platelet morphology.

Table 4 Preparation of a Blood Smear through Wedge Smear

How To Prepare a Peripheral Blood Smear

Step 1. Placing a small drop (2 - 3 mm drop approximately 1/4" from the frosted slide) of venous blood on a glass microscope slide, using a glass capillary pipette. A wooden applicator stick can also be used for this purpose.

Step 4. The spreader slide is further pulled out, leaving a thin layer of blood behind.

Step 2. A spreader slide has been positioned at an angle and slowly drawn toward the drop of blood.

Step 5. The blood smear is nearly complete.

Step 3. The spreader slide has been brought in contact with the drop of blood and is being drawn away. Note layer of blood at the edge of the spreader slide.

Step 6. End result. A glass slide with a well-formed blood film. After drying for about 10 minutes, the slide can be stained manually or placed on an automated slide stainer.

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2. Special Tests

Prothombin Time (PT)

Prothrombin time (PT) is a blood test that measures how long it takes blood to clot which aids in checking bleeding problems. Generally, it measures the integrity of the extrinsic and common pathways of coagulation. About 12 blood clotting factors are needed for blood to clot (coagulation). Prothrombin, or factor II, is one of the clotting factors made by the liver. Vitamin K is needed to make prothrombin and other clotting factors. It is an important test because it checks to see if five different blood clotting factors (factors I, II, V, VII, and X) are present.

The normal range in Prothrombin Time is between 25 to 24 seconds of coagulation.

Table 5 Prothrombin Time extends time due to different factors listed below.

Delaying Factors in Prothrombin Time

Blood-thinning medicine, such as heparin

Low levels of blood clotting factors.

A change in the activity of any of the clotting factors.

The absence of any of the clotting factors.

Other substances, called inhibitors that affect the clotting factors.

An increase in the use of the clotting factors.

Prothrombin time abnormality is often caused by liver disease or injury or by treatment with blood thinners.

Partial Thromboplastin Time (PTT)

The activated partial thromboplastin time (PTT) measures the clotting time from the activation of factor XII, through the formation of fibrin clot. This measures the integrity of the intrinsic and common pathways of coagulation. PTT prolongations are caused by either factor deficiencies (especially of factors VIII, IX, XI, and/or XII), or inhibitors (most commonly, lupus anticoagulants, or therapeutic anticoagulants such as heparin, hirudin, or argatroban).

Table 6 Obtain information from Practice in Hematology by Ciesla, B., page 315

Principle behind PT ant (a)PTT Coagulation instruments, most of which are capable of analyzing samples through the use of clotting, chromogenic or immunoassay methods, are currently fully automated to analyze larger volume of samples with high degree of accuracy. Clot method of photodetection uses light transmission (optical detection method) to determine prothrombin (PT) and activated partial thromboplastin time (aPTT) times. Meanwhile, The optical detection method detects the change in absorbance as a light-emitting diode recognized fibrin or clot formation. Then, a sensor picks up the light beam and converts into an electrical signal. A microcomputer signals and calculates the electrical power to determine the coagulation time. Presently, some automated coagulation testing are now able to identify variables such as lipemia and hemolysis and yet still able to present accurate clotting times.present accurate clotting times.

Figure 22 A Wright's stained bone marrow aspirate smear of patient with precursor B-cell acute lymphoblastic leukemia.

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Diascopy

Diascopy is a medical approach used to differentiate between certain types of hematologic lesions. This is divided in two general types of hematologic lesions: Vascular and Non-vascular lesions. This test relies on the principle, difference in which it entails through the use of a thin plate of transparent to depress a hematologic lesion. If the lesion blanches and no longer appears with the same bloodlike color, the lesion is deemed vascular, as the glass or plastic has effectively blocked the circulatory flow of or about the lesion, causing a momentary ischemia or the lesion. If the lesion is non-vascular, pressing it with the plate will merely press on the collection of blood, but the area will not blanch.

Table 7 General Types of Hematologic Lesions

Vascular Lesions Non-vascular Lesions

It exists as pathologic formations of blood vessels, such as telangectasias and hemangiolas.

This are the result extravasated blood collected below the surface of the skin or trapped between layers of tissue, such as a hematoma.

D-dimer

D-dimer is a performed test to diagnose thrombosis. Its primary objective is to exclude thromboembolic disease where the probability is low. This use when there is a suspicion of deep venous thrombosis (DVT) or pulmonary embolism (PE). In its range reference, values exceeding 250-500 ng/ml and above are considered positive.

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V. Flow of Specimen Blood samples undergo series of procedure that ensures the accuracy and precision of results. The Hematology section follows standardization and quality assurance for a quality service. The figure below shows a step-by-step method on how blood samples are process within the premises of the laboratory.

Figure 23 Specimen Flow in Hematology Section

BLOOD SPECIMEN taken from the

patient

Record information of

the patient

Label the test tube in Number

BLOOD

CBCReticulocyte

CountDifferential CountCSF

Test is repeated until it satisfies

the requirement

Test Result Clarification

Chief MT checks the results

Pathologist supervise and

checks the results for finalization

RELEASE OF RESULT

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VI. Quality Assurance & Quality

Control

Quality assurance is a comprehensive and systematic process that strives to ensure valid and reliable patient results. This process includes every level of laboratory operation. Phlebotomy services, competency testing, error analysis, standard protocols, PPE, quality control, and turnaround time are each a key factor in the quality assurance system. From the time a sample arrives in the laboratory until the results are reported, an accurate quality assurance system is the key feature in ensuring quality results. Each part of the quality assurance plan or process should be analyzed, monitored, and reconfigured as necessary to emphasize excellence at every outcome. Although many hospitals and research facilities have “quality” professionals who provide oversight for quality assurance plans for their facilities, an elemental understanding of terms related to the total quality assurance plan is required of all staff technologists and students. Quality control plays a large part in quality assurance program at most facilities.

In maintaining quality assurance, a medical technologist notes important information to be obtained

about the patient. Specimens of blood are labeled and each undergoes a certain procedures. The determination of results is recorded in a logged book or in a data sheet. Several repetition of procedure is necessary to achieve the normal value needed, or in other cases are the abnormalities of the patient’s blood result. All information is documented; this is to be signed by the medical technologist in the laboratory. Released output is under the supervision and administration of the pathologist, or head medical technologist of the section.

Table 8 Quality Assurance Indicators, from Practice in Hematology by Ciesla, B., page 8

Short List of Quality Assurance Indicators

• Number of patient redraws • Labeling errors • Patient and specimens properly identified • Critical values called • Pass rate on competency testing • Test cancellation • Integrity of send-out samples • Employee productivity • Errors in data entry • Testing turnaround times • Delays due to equipment failures or maintenance • Performance on proficiency testing

Figure 24 Evacuated tubes and micro-collection tubes. (From left to right: EDTA, Na Citrate, SST, Plain, Na Citrate, Na Heparin, EDTA, Acid Solution A, EDTA, and SST). The sample volumes of these tubes range from 250 microliters to 10 milliliters

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The analytical component (actual measurement of the analyte in body fluids) is monitored in the laboratory by quality control, a component of the laboratory quality assurance plan. Control materials are assayed concurrently with patient samples, and the analyte value for the controls is calculated from the calibration data in the same manner as the unknown or patient’s results are calculated. Control materials are commercially available as stable or liquid materials that are analyzed concurrently with the unknown samples. The control material measured values are compared with their expected values or target range.

A statistical quality control system is used to

establish the target range. The procedure involves obtaining at least 20 control values for the analyte to be measured. Ideally, the repeated control results should be the same; however, there will always be variability in the assay. The concept of clustering of the data points about one value is known as central tendency. The mean, mode, and median are statistical parameters used to measure the central tendency. If the mean, mode, and the median are nearly the same for the control values, the data have a normal distribution.

Clarifying accuracy and precision is usually a troublesome task as these terms are often used interchangeably. When a test result is accurate, it means that it has come closest to the correct value if the reference or correct value is known. Theoretically, patient results should be repeatable if analyzed a number of times using the same method. If there is great variability of results around a target value, then the precision is compromised.

Table 9 Specimen Time Frame Requirment

Specimen Time Frame Requirement for Examination

All peripheral smears (and body fluid cytospin) Kept for only one month

ESR Within 4 hours of collection

CBC Within 24 hours of collection

Differential Within 8 hours of collection

PT/PTT Within 4 hours of collection

Fibrinogen Within 4 hours of collection

Urinalysis Within 2 hours of collection

Figure 25 Evacuated tubes and micro-collection tubes.

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VII. Updates & Automation Retacrit is a biosimilar erythropoietin

approved in Europe3 for subcutaneous

administration in the treatment of anemia

associated with chemotherapy. Efficacy,

safety and tolerability in this indication

were evaluated from an open-label Phase III

trial involving 216 patients with solid

tumors, malignant lymphoma or multiple

myeloma who were undergoing

chemotherapy. Analysis of the safety of the

data showed that, in almost all cases,

patients and investigators reported tolerability as good or excellent.

"This study confirms that treatment with Retacrit has real benefits for cancer patients with anemia, a common side-effect of chemotherapy. The data showed a high hemoglobin response rate, which means a reduced need for blood transfusions during treatment and an improvement in patients' quality of life", commented principal study investigator Valentina Tzekova, University Hospital Queen Joanna, Sofia, Bulgaria. There is a study in the September/October 2005 issue of The Journal of Craniofacial Surgery presents accurate approach to measure platelet count in PRP preparation through using standard hematology analyzer to automate the time-consuming manual platelet count technique. This analyzer can measure platelets, in PRP preparation, up to 2 million platelets per microliter-relatively high. Results in automated count were highly accurate, even though it was beyond the limits of typical hematology equipment. However, studies of PRP have yielded varying results, which is seen in differing platelet concentration. ‘Intelligent’ molecules are the new discovery of Professor A. Prasanna de Silva, a scientist from Queen’s University. The discovery is based on previous pioneering research by Professor De Silva and his colleagues at Queen's, which created 'Catch and tell' sensor molecules that send out light signals when they catch chemicals in blood. This technology help create blood diagnostic cassettes, which are being used in hospitals, ambulances, and veterinary offices nowadays to quickly monitor blood for levels of common salt components such as sodium, potassium and calcium. The new research at Queen's also shows as feasible 'ID tags' for very small objects the size of biological cells. It enables the on-the-spot analysis of salt levels and blood type during accidents. Such ID tags can also help track infection and highlight vulnerable people during disease outbreaks. An extension of the same design has also developed molecules which can act as simple 'logic gates': more complex versions of which what drive current computers.

Figure 27 PRP Treatment.

Figure 26 Hematology-Analyzer-URIT-3300 used in CBC and other blood examinations

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The Cedars-Sinai Medical Center recently purchased a blood mobile, which helps to keep a steady and sufficient supply of blood and blood products on hand. The blood mobile functions to transport all of the equipment necessary to hold an off-site blood drive involving up to 120 donors. The blood mobile is about the size of a city bus, equipped with donor beds, two private screening rooms, automated red-cell collection capabilities and a comfortable refreshment area where donors can relax after giving blood. Designed to handle smaller blood drives or locations that lack set-up space, the blood mobile can accommodate up to 50 donors in one day.

The PATHFAST is an immunoanalyzer used for measuring emergency parameters in 17 minutes from whole blood at the same quality as produced in a central laboratory. Measuring W14.7" x D22.4" x H20.0", it is easily contain in the laboratory. Its user friendly methods allow the technician to simply add blood to the cartridges, place them on the system then to press the start button is easily stored and fits on a laboratory. It utilizes a chemiluminescent technology combined with a unique magtration separation method that allows this system to report highly accurate results that compare to large platform instruments. The system occupies individual cartridge-

based technology utilizing a whole blood sample which can handle six samples in batch or random access mode and report these six results in 17 minutes. This sensitive technology will allow the laboratory to report NTproBNP results from 15-30,000 pg/mL.

Von Willebrand disease is a bleeding disorder caused by a defect or deficiency of a blood clotting protein called von Willebrand factor. Von Willebrand factor is a protein necessary in the initial stages of blood clotting. Through Alphanate(R), which is the first and only dual inactivated (solvent detergent and heat treatment) and affinity chromatography purified antihemophilic factor/von Willebrand factor complex VWD can be treated. This has been proven safe and effective for the treatment of hemophilia

Figure 28 Example of Blood Mobile from Oklahoma Blood Institute

Figure 29 PATHFAST immunoassay analyzer

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