1_Intro to CLM

8/13/2019 1_Intro to CLM

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


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The art of Medicine consists of amusing thepatient while nature cures the disease

-Voltaire


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Under the best of circumstances, no test isperfectChoice of test should be based on the priorprobability of the diagnosis being soughtAny particular lab result may be incorrect formany reasons regardless of the high qualityof laboratory; all unexpected or suspiciousresults should be rechecked

Consider differentials when interpretingresults as certain values may fluctuate due tocircadian rhythm, eating, exercise, altitudeetc.


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Based on the statistical definition of normalas 95% range of values, 5% of independenttests will be outside this normal range in theabsence of diseaseTables of reference values representstatistical data for 95% of the population.Lab values performed in a good lab tend to

remain fairly constant over a period of yearswhen performed with comparable technology


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Multiple test abnormalities are more likely tobe significant than single test abnormalitiesThe degree of abnormality is usefulNot all patients with same disease will havethe same valuesExcessive repetition of tests is wastefulcost Tests should be performed only if they alterthe patients diagnosis, prognosis, treatmentor managementClerical errors are far more likely to causeincorrect results than are technical errors


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Reference ranges may vary from one lab toanotherThe effect of drugs on lab tests must not beoverlooked.i.e. UTI drugArtifacts may cause spurious values andfactitious disorders.. i.e platelet clumping bctube isnt mixed well so CVC blood count goesup erroneously

Negative lab values do not necessarily rule out aclinical diagnosisi.e. mono will be negative for2 weeks b4 test is positive; CVC is better


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Use your good clinical judgment and clinicalskills to determine the best testDo not shot gun lab ordering

Select and interpret diagnostic studies toevaluate the differential diagnosis, includingthe following for each study based on: risks and benefits

sensitivity and specificity cost effectiveness obtaining informed consent


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Accreditation: The process by which an agency ororganization uses predetermined standards toevaluate and recognize a program of study in aninstitutionformed to encourage the voluntary attainment ofuniformly high standards in institutional medical carefacilities that are evaluated by the Joint Commissionand found to be exhibiting quality care can receiveaccreditation in one of seven categoriesaccreditation is granted or denied on the basis ofinformation collected by Joint Commission staffmembers during unannounced surveys of the facility


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HospitalsCritical Access Hospitalsrural healthcare(usually cant keep pt longer than 6 -9 hrs)

Ambulatory Care CentersBehavioral Health CareLaboratoriesHome Care

Long Term Care


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advocates the interests of pathologists infederal and state legislative and regulatoryarenaspolicyrepresents pathologists interests in theprivate sector, working with insurers andother health care organizations to ensure thebest patient care and laboratory services andto protect the ability of pathologists topractice.


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The CAP Laboratory Accreditation Program is aninternationally recognized program and the only oneof its kind that utilizes teams of practicing laboratoryprofessionals as inspectors. Designed to go wellbeyond regulatory compliance, the program helpslaboratories achieve the highest standards ofexcellence to positively impact patient care.

The program is based on rigorous accreditationstandards that are translated into detailed andfocused checklist requirements. The checklists, whichprovide a quality practice blueprint for laboratories tofollow, are used by the inspection teams as a guide toassess the overall management and operation of thelaboratory.


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The CAP Laboratory Accreditation Program meets the needs of avariety of laboratory settings from complex university medicalcenters to physician office laboratories. The program also coversa complete array of disciplines and testing procedures. Becauseof its comprehensive nature, CAP accreditation can help achievea consistently high level of service throughout an institution orhealthcare system.

The Centers for Medicare and Medicaid Services (CMS) hasgranted the CAP Laboratory Accreditation Program deemingauthority. It is also recognized by the Joint Commission onAccreditation of Healthcare Organizations (JCAHO), and can beused to meet many state certification requirements. The CAP also

provides laboratory accreditation to forensic urine drug testingand reproductive laboratories, co-sponsored with the AmericanSociety for Reproductive Medicine (ASRM).


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*Read OSHA PowerPoints on Moodle


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Provides basic understanding of: B C MHepatitis B & CTransmission and Exposure to HIVHepatitis B VaccineStandard PrecautionsPersonal Protective EquipmentSafe Work PracticesSharps Safetybe careful w/ caps, incidentreporting w/in 24 hours


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Congress passed the Clinical Laboratory ImprovementAmendments (CLIA) in 1988 establishing qualitystandards for all laboratory testing to ensure theaccuracy, reliability and timeliness of patient testresults regardless of where the test was performed.A laboratory is any facility that does laboratorytesting on specimens derived from humans to giveinformation for the diagnosis, prevention, treatmentof disease, or impairment of, or assessment ofhealth.CLIA is user fee funded; therefore, regulated facilitiescover all the costs of administering the program.Centers for Medicare & Medicaid Services (CMS)assumes primary responsibility for financialmanagement operations of the CLIA program.


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The categorization of commercially marketed in vitrodiagnostic tests under CLIA is the responsibility of theFDA. This categorization includes the process of assigningcommercially marketed in vitro diagnostic test systems toone of three CLIA regulatory categories based on theirpotential for risk to public health:

waived tests tests of moderate complexity tests of high complexityCLIA categorizations will also be announced in FederalRegister Notices, which will provide opportunity forcomment on the decision. FDA may reevaluate and re-

categorize these tests based upon the comments receivedin response to the Federal Register Notices.FDA will revise as necessary criteria for waivers, moderateand high complexities.


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The Centers for Medicare & Medicaid Services(CMS) regulates all laboratory testing (exceptresearch) performed on humans in the U.S.

through the Clinical Laboratory ImprovementAmendments (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


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Laboratory tests are categorized as one of thefollowing: 1)Waived tests:

Criteria Test systems are simple laboratory examinations andprocedures which 1)Are cleared by FDA for home use;2)Employ methodologies that are so simple and accurateas to render the likelihood of erroneous resultsnegligible; or

3)Pose no reasonable risk of harm to the patient if thetest is performed incorrectly. 2)Nonwaived: Tests of moderate complexity, including

the subcategory of PPM procedures. 3)Nonwaived: Tests of high complexity.


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Each laboratory must be either CLIA-exemptor possess one of the following CLIAcertificates: 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


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Stopper Color Possible Additives Yields

Red No Additive SerumRed- Gray or Gold (SST) Polymer Gel, Clot Activator SerumGreen Sodium, lithium or Ammonium Heparin WB or PlasmaGreen- Gray/Lt. Green (PST) Polymer Gel, Lithium Heparin PlasmaLavender K2EDTA or K3EDTA WB or PlasmaGray NA Fluoride/K Oxalate

NA Fluoride/Na2EDTA PlasmaGray Sodium Fluoride/Siliceous Earth SerumLight Blue Sodium Citrate/CTAD PlasmaTan K2EDTA WB or PlasmaGray-Yellow or Orange Thrombin SerumYellow Acid Citrate Dextrose-A (ACD-A)

Acid Citrate Dextrose-B (ACD-B)Sodium Polyanetholesulfonate (SPS) WB or Plasma

Black Sodium Citrate (Buffered) WBRoyal Blue No Additive SerumRoyal Blue K2EDTA

Disodium EDTA WB or PlasmaBlue-Black Sodium Citrate, Polyester Gel, Density Grad. Liquid WB or PlasmaRed-Green Sodium Heparin, Polyester Gel, Density Grad. Liquid WB orPlasmaWhite (Pearl) K2EDTA , Polyester Gel Plasma


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Accuracy: when the test value approachesthe absolute true value of the substance(analyte) being measured

Precision: repeated analysis on the samesample give similar results time and timeagain


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Sensitivity is the ability of a test to correctlyidentify individuals who have a given diseaseor condition. For example, a certain test mayhave proven to be 90% sensitive.

Specificity is the ability of a test to correctlyexclude individuals who do not have a given

disease or condition. For example, a certaintest may have proven to be 90% specific


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False Negative result or finding which suggests that the dreaded

disease is not there but which, on furtherinvestigation, 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 toapparently not be there. But, another disorder maybe found that explains the result


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CBC (RBC, WBC, H/H, MCV, PLT)PT, PTT, INRESR, C Reactive ProteinCH7 (BUN, Creatinine, Lytes,Glucose)CMP (CH7, LFTs, Amy, Uric A)D-dimer

Reticulocyte countCardiac enzymes: Troponin, CK, CK-MB, MyoglobinCSF


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Whole Blood Plasma WBC

Granulocytes1 Neutrophils2 Eosinophils3 Basophils

Agranulocytes1 Monocytes2 Lymphocytes

RBC (anucleated)Nucleated RBC s= nRBCs

Platelets


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Plasma (Anticoagulated) The watery, liquid part of the blood in which

the red blood cells, the white blood cells,and platelets are suspended. Clottingfactors are present

Serum (Coagulated) Pale yellowish fluid which exudes from the

clot formed in the coagulation of the blood;

the liquid portion of the blood, after removalof the blood corpuscles and the fibrin.Clotting factors have been consumed


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acute lymphocytic leukemia (ALL) - a rapidly progressing cancerof the blood in which too many immature (not fully formed)lymphocytes, a type of white blood cell, are found in the bonemarrow, blood, spleen, liver, and other organs.

acute myelogenous leukemia (AML) - a rapidly progressing cancerof the blood in which too many immature (not fully formed)granulocytes, a type of white blood cell, are found in the bonemarrow and blood.

allogeneic bone marrow transplantation - a procedure in which aperson receives stem cells from a compatible donor.

alpha thalassemia - an inherited blood disorder affecting the alphachains of the hemoglobin molecule.

anemia - blood disorder caused by a deficiency of red blood cells orhemoglobin (the oxygen-carrying protein in red blood cells).


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apheresis - a procedure in which blood is removed from apatient, certain fluid and cellular elements are removed, andthe blood is then infused back into the patient.

aplastic anemia - one type of anemia that occurs when thebone 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 inwhich a patient's own bone marrow is removed, treated withanticancer drugs or radiation, then returned to the patient.

autosomal recessive inheritance - a gene on one of the first22 pairs of chromosomes, which, when present in two copies,causes a trait or disease to be expressed


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beta thalassemia - an inherited blood disorder affecting thebeta chains of the hemoglobin molecule.

biological therapy - using the body's immune system to fightcancer.

blasts - immature blood cells.

blood - the life-maintaining fluid which is made up ofplasma, red blood cells (erythrocytes), white blood cells(leukocytes), and platelets; blood circulates through thebody's heart, arteries, veins, and capillaries; it carries awaywaste matter and carbon dioxide, and brings nourishment,electrolytes, hormones, vitamins, antibodies, heat, andoxygen to the tissues.


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blood banking - the process that takes place in the laboratoryto ensure that donated blood, or blood products, are safebefore they are used in blood transfusions and other medicalprocedures. Blood banking includes typing the blood fortransfusion 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 beremoved by aspiration or a needle biopsy under localanesthesia. In aspiration biopsy, a fluid specimen is removedfrom the bone marrow. In a needle biopsy, marrow cells (notfluid) are removed. These methods are often used together.

bone marrow transplantation (BMT) - the transfusion ofhealthy bone marrow cells into a person after their ownunhealthy bone marrow has been eliminated.


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chemotherapy - treatment with drugs to destroy cancer cells.

chronic lymphocytic leukemia (CLL) - a slowly progressingcancer of the blood in which too many lymphocytes, a type ofwhite blood cell, are produced by the bone marrow and byorgans of the lymph system.

chronic myelogenous leukemia (CML) - a slowly progressingcancer of the blood in which too many white blood cells areproduced in the bone marrow.

coagulation disorders - problems with either the inability forblood 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 volumeof blood.


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computed tomography scan (Also called a CT or CAT scan.) - adiagnostic imaging procedure that uses a combination of x-rays andcomputer technology to produce cross-sectional images (often calledslices), both horizontally and vertically, of the body. A CT scan showsdetailed images of any part of the body, including the bones,muscles, fat, and organs. CT scans are more detailed than general x-rays.

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 factorV which increases a persons risk for venous thrombosis.

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


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glucose-6-phosphate dehydrogenase deficiency (G6PD) - adeficiency of an enzyme - G6PD - in red blood cells, causinghemolytic anemia.

graft-versus-host disease (GVHD) - when the donors immunesystem acts against the recipients tissue, aftertransplantation.

granulocytes - a type of white blood cell. The different typesof granulocytes include: basophils, eosinophils, andneutrophils

hemarthrosis - bleeding into a joint.

hematocrit - the measurement of the percentage of red bloodcells found in a specific volume of blood.


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hematologist - a physician who specializes in the functionsand disorders of the blood.

hematology - the scientific study of blood and blood-formingtissues.

hematopoiesis - the process of producing and developing newblood cells.

hemochromatosis (Also called iron overload disease.) - ametabolic disorder that causes increased absorption of iron,which is deposited in the body tissues and organs. The ironaccumulates in the body where it may become toxic and causedamage.

hemoglobin - substance in the red blood cells that suppliesoxygen to the cells of the body.


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hemolytic anemia - one type of anemia in which the redblood cells are destroyed prematurely.

hemophilia (Also called coagulation disorder.) - an inheritedbleeding disorder caused by low levels, or absence of, ablood protein that is essential for clotting; hemophilia A iscaused 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 thelymphatic system; a rare disease, accounting for less than 1percent of all cases of cancer in the US, and occurs mostoften in people between the ages of 15 and 34, and in peopleover age 55. Hodgkin's disease causes the cells in thelymphatic system to abnormally reproduce, eventually makingthe body less able to fight infection. Steady enlargement oflymph glands, spleen, and other lymphatic tissue occurs.


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idiopathic thrombocytopenic purpura - a blood disordercharacterized by an abnormal decrease in the number ofblood platelets, which results in internal bleeding. There aretwo forms of idiopathic thrombocytopenic purpura: acutethrombocytopenic purpura and chronic thrombocytopenicpurpura.

iron-deficiency anemia - the most common type of anemia.It is characterized by a lack of iron in the blood, which isnecessary to make hemoglobin

leukapheresis - a procedure to remove excess lymphocytesfrom the body.

leukemia - a cancer of the blood-forming tissue. Leukemiccells look different than normal cells and do not functionproperly.

lymph - part of the lymphatic system; a thin, clear fluid thatcirculates through the lymphatic vessels and carries bloodcells that fight infection and disease.


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lymph node biopsy - a procedure performed to remove tissueor cells from the body for examination under a microscope.

lymph nodes - part of the lymphatic system; bean-shapedorgans, 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 thatcarry lymph fluid throughout the body.

lymphatic system - part of the immune system; includeslymph, ducts, organs, lymph vessels, lymphocytes, and bloodcells to fight disease and lymph nodes, whose function is toproduce and carry white infection.


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Lymphocytes - part of the lymphatic system; white bloodcells that fight infection and disease.

lymphocytic leukemia - a type of leukemia in which thecancer develops in the lymphocytes (lymphoid cells).

magnetic resonance imaging (MRI) - a diagnostic procedurethat uses a combination of large magnets, radiofrequencies,and a computer to produce detailed images of organs andstructures within the body.

megaloblastic anemia - a rare blood disorder caused by adeficiency of either folate (a B vitamin) or Vitamin B-12,

resulting in an inadequate amount of red blood cellsproduced.

myelogenous leukemia - a type of leukemia in which thecancer develops in the granulocytes or monocytes (myeloidcells).


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myeloproliferative disorders - diseases in which the bonemarrow produces too many of one of the three types of bloodcells: red blood cells, which carry oxygen to all the tissues inthe body; white blood cells, which fight infection; andplatelets, which makes blood clot.

non-Hodgkin s lymphoma - a type of lymphoma, a cancer inthe lymphatic system; causes the cells in the lymphatic systemto abnormally reproduce, eventually causing tumors to grow.Non-Hodgkin's lymphoma cells can also spread to otherorgans.

Pernicious anemia - a type of megaloblastic anemia in whichthe body does not absorb enough Vitamin B-12 from thedigestive tract.

petechia - tiny red dots under the skin that are the result ofvery small bleeds.


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phlebotomy - a procedure that involves removing blood fromthe body.

plasma - the watery, liquid part of the blood in which the redblood cells, the white blood cells, and platelets aresuspended.

plateletpheresis - a procedure to remove extra platelets fromthe blood.

platelets - cells found in the blood that are needed to controlbleeding; often used in the treatment of leukemia and otherforms of cancer.

pluripotent stem cell - the most primitive, undeveloped bloodcell.

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


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radiation therapy (Also called radiotherapy.) - treatment withhigh-energy rays (such as x-rays or gamma rays) to killcancer cells; may be by external radiation or by internalradiation from radioactive materials placed directly in or nearthe tumor.

red blood cells (Also called RBCs or erythrocytes.) - mainfunction is to transport oxygen to all the tissues in the body.

sickle cell anemia - an inherited blood disorder characterizedby defective hemoglobin.

spinal tap (Also called lumbar puncture.) - a special needle is

placed into the lower back, into the spinal canal. This is thearea around the spinal cord. The pressure in the spinal canaland brain can then be measured. A small amount of cerebralspinal fluid (CSF) can be removed and sent for testing todetermine if there is an infection or other problems. CSF is thefluid that bathes the brain and spinal cord.


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splenectomy - surgery to remove the spleen.

stem cells - the blood cells that produce other blood cells. Itis the stem cells that are needed in bone marrowtransplantation

thalassemia - an inherited blood disorder in which the chainsof the hemoglobin (a type of protein in red blood cells thatcarries oxygen to the tissues) molecule are abnormal; alphathalassemia is where a mutation occurs in the alpha chain,while beta thalassemia is where the mutation occurs in thebeta chain; signs and symptoms of thalassemias vary frommild (little to no symptoms) to severe (life threatening).

thrombosis - excess clotting which obstructs veins (venousthrombosis) and arteries (arterial thrombosis).


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transferrin saturation test (TS) - a type of iron study (bloodtest) that measures the percentage of transferrin and othermobile, iron-binding proteins saturated with iron.

ultrasound (Also called sonography.) - a diagnostic imagingtechnique which uses high-frequency sound waves and acomputer to create images of blood vessels, tissues, andorgans. Ultrasounds are used to view internal organs as theyfunction, and to assess blood flow through various vessels.

umbilical cord blood transplant - a procedure in which stemcells are taken from an umbilical cord immediately afterdelivery of an infant.

white blood cells (Also called WBCs or leukocytes.) - bloodcells involved in the destruction of viruses, bacteria, andfungi.


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