Don Yager DHSc, PA-C, MT(ASCP)

The art of Medicine consists of amusing the patient while nature cures the disease -Voltaire

Under the best of circumstances, no test is perfect Choice of test should be based on the prior probability of the diagnosis being sought Any particular lab result may be incorrect for many reasons regardless of the high quality of laboratory; all unexpected or suspicious results should be rechecked Consider differentials when interpreting results as certain values may fluctuate due to circadian rhythm, eating, exercise, altitude etc.

Based on the statistical definition of normal as 95% range of values, 5% of independent tests will be outside this normal range in the absence of disease Tables of reference values represent statistical data for 95% of the population. Lab values performed in a good lab tend to remain fairly constant over a period of years when performed with comparable technology

Multiple test abnormalities are more likely to be significant than single test abnormalities The degree of abnormality is useful Not all patients with same disease will have the same values Excessive repetition of tests is wastefulcost Tests should be performed only if they alter the patients diagnosis, prognosis, treatment or management Clerical errors are far more likely to cause incorrect results than are technical errors

Reference ranges may vary from one lab to another The effect of drugs on lab tests must not be overlooked.i.e. UTI drug Artifacts may cause spurious values and factitious disorders.. i.e platelet clumping bc tube isnt mixed well so CVC blood count goes up erroneously Negative lab values do not necessarily rule out a clinical diagnosisi.e. mono will be negative for 2 weeks b4 test is positive; CVC is better

Use your good clinical judgment and clinical skills to determine the best test Do not shot gun lab ordering Select and interpret diagnostic studies to evaluate the differential diagnosis, including the following for each study based on:
risks and benefits sensitivity and specificity cost effectiveness obtaining informed consent

Accreditation: The process by which an agency or organization uses predetermined standards to evaluate and recognize a program of study in an institution formed to encourage the voluntary attainment of uniformly high standards in institutional medical care facilities that are evaluated by the Joint Commission and found to be exhibiting quality care can receive accreditation in one of seven categories accreditation is granted or denied on the basis of information collected by Joint Commission staff members during unannounced surveys of the facility

Hospitals Critical Access Hospitalsrural healthcare (usually cant keep pt longer than 6-9 hrs) Ambulatory Care Centers Behavioral Health Care Laboratories Home Care Long Term Care

advocates the interests of pathologists in federal and state legislative and regulatory arenaspolicy represents pathologists interests in the private sector, working with insurers and other health care organizations to ensure the best patient care and laboratory services and to protect the ability of pathologists to practice.

The CAP Laboratory Accreditation Program is an internationally recognized program and the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors. Designed to go well beyond regulatory compliance, the program helps laboratories achieve the highest standards of excellence to positively impact patient care. The program is based on rigorous accreditation standards that are translated into detailed and focused checklist requirements. The checklists, which provide a quality practice blueprint for laboratories to follow, are used by the inspection teams as a guide to assess the overall management and operation of the laboratory.

The CAP Laboratory Accreditation Program meets the needs of a variety of laboratory settings from complex university medical centers to physician office laboratories. The program also covers a complete array of disciplines and testing procedures. Because of its comprehensive nature, CAP accreditation can help achieve a consistently high level of service throughout an institution or healthcare system.

The Centers for Medicare and Medicaid Services (CMS) has granted the CAP Laboratory Accreditation Program deeming authority. It is also recognized by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and can be used to meet many state certification requirements. The CAP also provides laboratory accreditation to forensic urine drug testing and reproductive laboratories, co-sponsored with the American Society for Reproductive Medicine (ASRM).

*Read OSHA PowerPoints on Moodle

Provides basic understanding of:

B C M

Hepatitis B & C Transmission and Exposure to HIV Hepatitis B Vaccine Standard Precautions Personal Protective Equipment Safe Work Practices Sharps Safetybe careful w/ caps, incident reporting w/in 24 hours

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA). In total, CLIA covers approximately 200,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program. The objective of the CLIA program is to ensure quality laboratory testing. Although all clinical laboratories must be properly certified to receive Medicare or Medicaid payments, CLIA has no direct Medicare or Medicaid program responsibilities.

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A laboratory is any facility that does laboratory testing on specimens derived from humans to give information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. CLIA is user fee funded; therefore, regulated facilities cover all the costs of administering the program. Centers for Medicare & Medicaid Services (CMS) assumes primary responsibility for financial management operations of the CLIA program.

The categorization of commercially marketed in vitro diagnostic tests under CLIA is the responsibility of the FDA. This categorization includes the process of assigning commercially marketed in vitro diagnostic test systems to one of three CLIA regulatory categories based on their potential for risk to public health:
waived tests tests of moderate complexity tests of high complexity

CLIA categorizations will also be announced in Federal Register Notices, which will provide opportunity for comment on the decision. FDA may reevaluate and recategorize these tests based upon the comments received in response to the Federal Register Notices. FDA will revise as necessary criteria for waivers, moderate and high complexities.

The Centers for Medicare & Medicaid Services (CMS) regulates all laboratory testing (except research) performed on humans in the U.S. through the Clinical Laboratory Improvement Amendments (CLIA) Regulations

Must have a certificate to obtain samples and perform testing Certificate renewal is every 2 years Submit to CLIA inspections of Lab and S.O.Ps with exception of those receiving certificate of waiver. Submit proficiency testing Lab personnel must be qualified & competent

Laboratory tests are categorized as one of the following:

1)Waived tests:
Criteria. Test systems are simple laboratory examinations and

1)Are cleared by FDA for home use; 2)Employ methodologies that are so simple and accurate as to render the likelihood of erroneous results negligible; or 3)Pose no reasonable risk of harm to the patient if the test is performed incorrectly. 2)Nonwaived: Tests of moderate complexity, including the subcategory of PPM procedures. 3)Nonwaived: Tests of high complexity.

procedures which

Each laboratory must be either CLIA-exempt or possess one of the following CLIA certificates:
1)Certificate of registration or registration certificate (commitment to uphold standards) 2)Certificate of waiver 3)Certificate for PPM procedures 4)Certificate of compliance 5)Certificate of accreditation

Stopper Color

Possible Additives

Yields

Red Red-Gray or Gold (SST) Green Green-Gray/Lt. Green (PST) Lavender Gray Gray Light Blue Tan Gray-Yellow or Orange Yellow Black Royal Blue Royal Blue Blue-Black Red-Green Plasma White (Pearl)

No Additive Serum Polymer Gel, Clot Activator Serum Sodium, lithium or Ammonium Heparin WB or Plasma Polymer Gel, Lithium Heparin Plasma K2EDTA or K3EDTA WB or Plasma NA Fluoride/K Oxalate NA Fluoride/Na2EDTA Plasma Sodium Fluoride/Siliceous Earth Serum Sodium Citrate/CTAD Plasma K2EDTA WB or Plasma Thrombin Serum Acid Citrate Dextrose-A (ACD-A) Acid Citrate Dextrose-B (ACD-B) Sodium Polyanetholesulfonate (SPS) WB or Plasma Sodium Citrate (Buffered) WB No Additive Serum K2EDTA Disodium EDTA WB or Plasma Sodium Citrate, Polyester Gel, Density Grad. Liquid WB or Plasma Sodium Heparin, Polyester Gel, Density Grad. Liquid WB or K2EDTA , Polyester Gel Plasma

Accuracy: when the test value approaches the absolute true value of the substance (analyte) being measured Precision: repeated analysis on the same sample give similar results time and time again

Sensitivity is the ability of a test to correctly identify individuals who have a given disease or condition. For example, a certain test may have proven to be 90% sensitive. Specificity is the ability of a test to correctly exclude individuals who do not have a given disease or condition. For example, a certain test may have proven to be 90% specific

False Negative
result or finding which suggests that the dreaded disease is not there but which, on further investigation, such disease is/was, indeed, found to be present

False Positive
test result (such as blood or finding which suggests the presence of a disease which turns out to apparently not be there. But, another disorder may be found that explains the result

CBC (RBC, WBC, H/H, MCV, PLT) PT, PTT, INR ESR, C Reactive Protein CH7 (BUN, Creatinine, Lytes, Glucose) CMP (CH7, LFTs, Amy, Uric A) D-dimer Reticulocyte count Cardiac enzymes: Troponin, CK, CKMB, Myoglobin CSF

Whole Blood

Plasma WBC Granulocytes

Agranulocytes
RBC (anucleated) Platelets
1 Monocytes 2 Lymphocytes

1 Neutrophils 2 Eosinophils 3 Basophils

Nucleated RBC s= nRBCs

Plasma (Anticoagulated)

The watery, liquid part of the blood in which the red blood cells, the white blood cells, and platelets are suspended. Clotting factors are present Pale yellowish fluid which exudes from the clot formed in the coagulation of the blood; the liquid portion of the blood, after removal of the blood corpuscles and the fibrin. Clotting factors have been consumed

Serum (Coagulated)

acute lymphocytic leukemia (ALL) - a rapidly progressing cancer

of the blood in which too many immature (not fully formed) lymphocytes, a type of white blood cell, are found in the bone marrow, blood, spleen, liver, and other organs.

acute myelogenous leukemia (AML) - a rapidly progressing cancer

of the blood in which too many immature (not fully formed) granulocytes, a type of white blood cell, are found in the bone marrow and blood. person receives stem cells from a compatible donor. chains of the hemoglobin molecule.

allogeneic bone marrow transplantation - a procedure in which a alpha thalassemia - an inherited blood disorder affecting the alpha anemia - blood disorder caused by a deficiency of red blood cells or
hemoglobin (the oxygen-carrying protein in red blood cells).

apheresis - a procedure in which blood is removed from a patient, certain fluid and cellular elements are removed, and the blood is then infused back into the patient. aplastic anemia - one type of anemia that occurs when the bone marrow produces too few of all three types of blood cells: red blood cells, white blood cells, and platelets. autologous bone marrow transplantation - a procedure in which a patient's own bone marrow is removed, treated with anticancer drugs or radiation, then returned to the patient. autosomal recessive inheritance - a gene on one of the first 22 pairs of chromosomes, which, when present in two copies, causes a trait or disease to be expressed

beta thalassemia - an inherited blood disorder affecting the beta chains of the hemoglobin molecule. biological therapy - using the body's immune system to fight cancer. blasts - immature blood cells. blood - the life-maintaining fluid which is made up of plasma, red blood cells (erythrocytes), white blood cells (leukocytes), and platelets; blood circulates through the body's heart, arteries, veins, and capillaries; it carries away waste matter and carbon dioxide, and brings nourishment, electrolytes, hormones, vitamins, antibodies, heat, and oxygen to the tissues.

blood banking - the process that takes place in the laboratory to ensure that donated blood, or blood products, are safe before they are used in blood transfusions and other medical procedures. Blood banking includes typing the blood for transfusion and testing for infectious diseases. blood plasma - the fluid part of blood that contains nutrients, glucose, proteins, minerals, enzymes, and other substances. bone marrow aspiration and biopsy - the marrow may be removed by aspiration or a needle biopsy under local anesthesia. In aspiration biopsy, a fluid specimen is removed from the bone marrow. In a needle biopsy, marrow cells (not fluid) are removed. These methods are often used together. bone marrow transplantation (BMT) - the transfusion of healthy bone marrow cells into a person after their own unhealthy bone marrow has been eliminated.

chemotherapy - treatment with drugs to destroy cancer cells.

chronic lymphocytic leukemia (CLL) - a slowly progressing cancer of the blood in which too many lymphocytes, a type of white blood cell, are produced by the bone marrow and by organs of the lymph system.
chronic myelogenous leukemia (CML) - a slowly progressing cancer of the blood in which too many white blood cells are produced in the bone marrow. coagulation disorders - problems with either the inability for blood to clot properly, resulting in excessive bleeding, or excessive clotting leading to obstruction of veins and arteries (thrombosis). complete blood count (CBC) - a measurement of size, number, and maturity of the different blood cells in a specific volume of blood.

computed tomography scan (Also called a CT or CAT scan.) - a

diagnostic imaging procedure that uses a combination of x-rays and computer technology to produce cross-sectional images (often called slices), both horizontally and vertically, of the body. A CT scan shows detailed images of any part of the body, including the bones, muscles, fat, and organs. CT scans are more detailed than general xrays.

factor - a protein in the blood that is needed to form the blood clot. factor V Leiden - an inherited mutation (change in a gene) in factor
V which increases a persons risk for venous thrombosis. the blood.

folate deficiency - the lack of folic acid (one of the B vitamins) in folic acid - a nutrient found in some green leafy vegetables, nuts,
beans, citrus fruits, fortified breakfast cereals, and some vitamin supplements. Folic acid can help reduce the risk of birth defects of the brain and spinal cord.

glucose-6-phosphate dehydrogenase deficiency (G6PD) - a deficiency of an enzyme - G6PD - in red blood cells, causing hemolytic anemia. graft-versus-host disease (GVHD) - when the donors immune system acts against the recipients tissue, after transplantation. granulocytes - a type of white blood cell. The different types of granulocytes include: basophils, eosinophils, and neutrophils hemarthrosis - bleeding into a joint. hematocrit - the measurement of the percentage of red blood cells found in a specific volume of blood.

hematologist - a physician who specializes in the functions and disorders of the blood. hematology - the scientific study of blood and blood-forming tissues. hematopoiesis - the process of producing and developing new blood cells. hemochromatosis (Also called iron overload disease.) - a metabolic disorder that causes increased absorption of iron, which is deposited in the body tissues and organs. The iron accumulates in the body where it may become toxic and cause damage. hemoglobin - substance in the red blood cells that supplies oxygen to the cells of the body.

hemolytic anemia - one type of anemia in which the red blood cells are destroyed prematurely. hemophilia (Also called coagulation disorder.) - an inherited bleeding disorder caused by low levels, or absence of, a blood protein that is essential for clotting; hemophilia A is caused by a lack of the blood clotting protein factor VIII; hemophilia B is caused by a deficiency of factor IX. Hodgkins disease - A type of lymphoma, a cancer in the lymphatic system; a rare disease, accounting for less than 1 percent of all cases of cancer in the US, and occurs most often in people between the ages of 15 and 34, and in people over age 55. Hodgkin's disease causes the cells in the lymphatic system to abnormally reproduce, eventually making the body less able to fight infection. Steady enlargement of lymph glands, spleen, and other lymphatic tissue occurs.

idiopathic thrombocytopenic purpura - a blood disorder characterized by an abnormal decrease in the number of blood platelets, which results in internal bleeding. There are two forms of idiopathic thrombocytopenic purpura: acute thrombocytopenic purpura and chronic thrombocytopenic purpura. iron-deficiency anemia - the most common type of anemia. It is characterized by a lack of iron in the blood, which is necessary to make hemoglobin leukapheresis - a procedure to remove excess lymphocytes from the body. leukemia - a cancer of the blood-forming tissue. Leukemic cells look different than normal cells and do not function properly. lymph - part of the lymphatic system; a thin, clear fluid that circulates through the lymphatic vessels and carries blood cells that fight infection and disease.

lymph node biopsy - a procedure performed to remove tissue or cells from the body for examination under a microscope. lymph nodes - part of the lymphatic system; bean-shaped organs, found in the underarm, groin, neck, and abdomen, that act as filters for the lymph fluid as it passes through them. lymph vessels - part of the lymphatic system; thin tubes that carry lymph fluid throughout the body. lymphatic system - part of the immune system; includes lymph, ducts, organs, lymph vessels, lymphocytes, and blood cells to fight disease and lymph nodes, whose function is to produce and carry white infection.

Lymphocytes - part of the lymphatic system; white blood cells that fight infection and disease. lymphocytic leukemia - a type of leukemia in which the cancer develops in the lymphocytes (lymphoid cells). magnetic resonance imaging (MRI) - a diagnostic procedure that uses a combination of large magnets, radiofrequencies, and a computer to produce detailed images of organs and structures within the body. megaloblastic anemia - a rare blood disorder caused by a deficiency of either folate (a B vitamin) or Vitamin B-12, resulting in an inadequate amount of red blood cells produced. myelogenous leukemia - a type of leukemia in which the cancer develops in the granulocytes or monocytes (myeloid cells).

myeloproliferative disorders - diseases in which the bone marrow produces too many of one of the three types of blood cells: red blood cells, which carry oxygen to all the tissues in the body; white blood cells, which fight infection; and platelets, which makes blood clot. non-Hodgkin's lymphoma - a type of lymphoma, a cancer in the lymphatic system; causes the cells in the lymphatic system to abnormally reproduce, eventually causing tumors to grow. Non-Hodgkin's lymphoma cells can also spread to other organs. Pernicious anemia - a type of megaloblastic anemia in which the body does not absorb enough Vitamin B-12 from the digestive tract. petechia - tiny red dots under the skin that are the result of very small bleeds.

phlebotomy - a procedure that involves removing blood from the body. plasma - the watery, liquid part of the blood in which the red blood cells, the white blood cells, and platelets are suspended. plateletpheresis - a procedure to remove extra platelets from the blood. platelets - cells found in the blood that are needed to control bleeding; often used in the treatment of leukemia and other forms of cancer.

pluripotent stem cell - the most primitive, undeveloped blood cell.

polycythemia vera - a blood disorder where there is an increase in all blood cells, particularly red blood cells.

radiation therapy (Also called radiotherapy.) - treatment with high-energy rays (such as x-rays or gamma rays) to kill cancer cells; may be by external radiation or by internal radiation from radioactive materials placed directly in or near the tumor. red blood cells (Also called RBCs or erythrocytes.) - main function is to transport oxygen to all the tissues in the body. sickle cell anemia - an inherited blood disorder characterized by defective hemoglobin. spinal tap (Also called lumbar puncture.) - a special needle is placed into the lower back, into the spinal canal. This is the area around the spinal cord. The pressure in the spinal canal and brain can then be measured. A small amount of cerebral spinal fluid (CSF) can be removed and sent for testing to determine if there is an infection or other problems. CSF is the fluid that bathes the brain and spinal cord.

splenectomy - surgery to remove the spleen. stem cells - the blood cells that produce other blood cells. It is the stem cells that are needed in bone marrow transplantation thalassemia - an inherited blood disorder in which the chains of the hemoglobin (a type of protein in red blood cells that carries oxygen to the tissues) molecule are abnormal; alpha thalassemia is where a mutation occurs in the alpha chain, while beta thalassemia is where the mutation occurs in the beta chain; signs and symptoms of thalassemias vary from mild (little to no symptoms) to severe (life threatening). thrombosis - excess clotting which obstructs veins (venous thrombosis) and arteries (arterial thrombosis).

transferrin saturation test (TS) - a type of iron study (blood test) that measures the percentage of transferrin and other mobile, iron-binding proteins saturated with iron. ultrasound (Also called sonography.) - a diagnostic imaging technique which uses high-frequency sound waves and a computer to create images of blood vessels, tissues, and organs. Ultrasounds are used to view internal organs as they function, and to assess blood flow through various vessels. umbilical cord blood transplant - a procedure in which stem cells are taken from an umbilical cord immediately after delivery of an infant. white blood cells (Also called WBCs or leukocytes.) - blood cells involved in the destruction of viruses, bacteria, and fungi.