Chemistry Information and Courses from MediaLab, Inc.

Burtis, CA. & Ashwood, ER. Tietz Textbook of Clinical Chemistry 2nd ed. W. B. Saunders. 1994.Harmening, DM. Clinical Hematology and Fundamentals of Hemostatis 5th ed., F.A. Davis, 2008Lotspeich-Steininger, Stiene-Martin and Koepke, Clinical Hematology Principles, Procedures, Correlations, Lippincott 1992McKenzie, SB., Textbook of Hematology 2nd ed., Williams and Wilkins 1996.Miale, JB, Laboratory Medicine Hematology 6th ed., Mosby 1982.Nouwens, J and Spahn, M. Hemoglobin H Disease: A self-instructional unit 3rd ed., Educational Materials for Health Professionals, Inc. 1991.Doig, K. Rodak's Diagnostic Hematology 3rd ed. W.B.Sunders Co., 2007.

Burtis CA, Ashwood ER. Tietz Textbook of Clinical Chemistry 2nd ed. WB Saunders; 1994.Doig, K. Rodak's Diagnostic Hematology. 3rd ed. WB Saunders Co; 2007.Harmening DM. Clinical Hematology and Fundamentals of Hemostatis. 5th ed. FA Davis; 2008Hoffman R, Benz EJ Jr., Shattil SJ, Furie B, Cohen HJ, Silberstein LE. Hematology Basic Principles and Practice, 2nd ed. Churchill Livingstone; 1995.McKenzie SB. Textbook of Hematology, 2nd ed. Williams and Wilkins; 1996.Miale JB, Laboratory Medicine Hematology, 6th ed. Mosby; 1982.Stiene-Martin EA, Lotspeich-Steininger CA, Koepke JA, Clinical Hematology Principles, Procedures, Correlations, 2nd ed. Lippincott; 1998.

Each specimen tube is used for a different purpose:first tube - chemistry/serologysecond tube - microbiologythird tube - hematologyfourth tube - cytology/miscellaneous

Clinical Chemistry Concepts and Applications. Shauna C. Anderson and Susan Cockayne. Long Grove, Illinois: Waveland Press, Inc, 2003.Clinical Laboratory Instrumentation and Automation Principles, Applications, and Selection. Kory M. Ward, Craig A. Lehmann, Alan M. Leiken. Philadelphia: WB Saunders Company, 1994.Laboratory Instrumentation, 4th Edition. Mary C. Haven, Gregory A. Tetrault, Jerald R. Schenken, eds. New York: Van Nostrand Reinhold, 1995.Molecular Diagnostics Fundamentals, Methods, and Clinical Applications. Lela Buckingham and Maribeth L. Flaws. Philadelphia: FA Davis Company, 2007.Principles of Gel Electrophoresis. Available at http://www.vivo.colostate.edu/hbooks/genetics/biotech/gels/principles.html accessed 9/29/08.Tietz Textbook of Clinical Chemistry and Molecular Diagnostics, 4th Edition. Carl A. Burtis, Edward R. Ashwood, David E. Burns, eds. Philadelphia: Elsevier Saunders, 2005.

Measuring ApoB and ApoA1 can be performed using standard immunoassay techniques. Nephelometry is popular, as are ELISA-based methods that are performed on automated chemistry analyzer platforms. The power of the ApoB/ApoA1 ratio as a cardiovascular risk marker is getting widespread attention. An individual with seemingly normal LDL-C may in fact have high ApoB concentrations. When this individual has his or her ApoB/ApoA1 ratio calculated, the risk is evident. Studies have also shown that patients with metabolic syndrome and type-2 diabetes can also easily be identified with the ApoB/ApoA1 ratio, whereas these patients cannot always be identified by measuring LDL-C and HDL-C.In 2004, the global INTERHEART study of risk factors for acute myocardial infarction concluded that the ApoB/ApoA1 ratio was the most important risk factor in all geographic regions. The ApoB/ApoA1 ratio is easy to use because the risk is integrated into a single number that indicates the balance between atherogenic and antiatherogenic particles.There have been many studies concerning the predictive power of the ApoB/ApoA1 ratio. One study, which involved thousands of patients who were followed for an average of 10 years, showed that the ApoB/ApoA1 ratio was a strong predictor of stroke in addition to other cardiovascular events. Due to the evidence presented in studies like these, the National Academy of Clinical Biochemistry (NACB) has recommended that the ApoB/ApoA1 ratio be used as an alternative to the usual total cholesterol (TC)/HDL cholesterol ratio when determining lipoprotein-related risk for cardiovascular disease. Some believe that ApoB/ApoA1 testing will eventually replace traditional LDL-C and HDL-C measurements.

Burtis CA, Ashwood ER, Bruns DE, eds. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. St. Louis, MO: Elsevier Inc; 2006.Clinical and Laboratory Standards Institute (CLSI). Collection, Transport, Preparation, and Storage of Specimens for Molecular Methods; Approved Guideline. CLSI document MM13-A. NCCLS. Wayne, PA: 2005.Clinical and Laboratory Standards Institute (CLSI). Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline. Second ed. CLSI document MM3-A2. NCCLS. Wayne, PA: 2006.

1. Beutler E. Iron storage disease: Facts, fiction and progress. Blood Cells Mol Dis. 2007;39:140-7.2. Higgins T, Beutler E, Doumas BT. Hemoglobin, iron, and bilirubin. In: Burtis CA, editor. Teitz Fundamentals of Clinical Chemistry. 6th ed. Saunders Elsevier, 2008.3. Ganz T. Hepcidin, a key regulator of iron metabolism and mediator of anemia and inflammation. Blood 2003;102(3):78-8.4. Andrews NC, Schmidt PJ. Iron homeostasis. Annu Rev Physiolo. 2007;69:69-85.5. Murtagh LJ, Whiley M, Wilson S, et al. Unsaturated iron binding capacity and transferrin saturation are equally reliable in detection of HFE hemochromatosis. Am J Gastroenterol. 2002;97(8):2093-9.6. Haddy TB, Castro OL, Rana SR. Hereditary hemochromatosis in children, adolescents, and young adults. Am J Pediatr Hematol Oncol 1988;10:23-4.7. Edwards CQ, Ajoika RS, Kushner JP. Hemochromatosis: A genetic definition. In Barton JC, Edwards CQ, eds. Hemochromatosis: Genetics, Pathophysiology, Diagnosis and Treatment. Cambridge, UK:Cambridge Univ Pr 2000:8-11.8. Whitlock EP, Garlitz BA, Harris EL , et al. Screening for Hereditary Hemochromatosis: A Systematic Review for the U.S. Preventive Services Task Force. Ann Intern Med. 2006; 145: 209-23.9. Wallace DF, Subramaniam VN. Non-HFE haemaochromatosis. World J Gastroenterol. 2007;13(35):4690-8.10. Tavill AS. Diagnosis and management of hemochromatosis. Hepatology. 2001;33:1321-811. Qaseem A, Aronson M, Fitterman N, Snow V, Weiss KB, Owens DK, et al. Screening for hereditary hemochromatosis: a clinical practice guideline from the American College of Physicians. Ann Intern Med. 2005;143:517-21.12. Phatak PD, Bonkovsky HL, and Kowdley KV. Hereditary Hemochromatosis: time for targeted screening. Ann Intern Med. 2008; 149(4): 270 – 2.13. Brissot P, deBels F. Current approaches to the management of hemochromatosis. Hematology Am Soc Hematol Educ Program. 2006:36-41. 14. Guidance for industry: Variances for blood collection from individuals with hereditary hemochromatosis. http://www.fda.gov/cber/gdlns/hemchrom.htm Accessed 12/17/08.

External quality control is performed to ensure the reliability of test results between different laboratories. It is also required by CLIA for laboratory accreditation. External quality control is generally accomplished through proficiency testing (PT). In proficiency testing, simulated patient samples are sent out to laboratories for testing. The CLIA standards for handling proficiency testing specimens are as follows: PT samples must be tested with the laboratory's regular patient load. PT samples must be tested the same number of times that patients' samples are tested routinely. Laboratories participating in PT programs must not engage in interlaboratory comparison of PT sample results. Laboratories may not send PT samples to another laboratory for analysis. Laboratories must document all steps of processing for PT samples. PT is required for only the primary method used for testing of analytes in patients' samples during the period covered by the PT event.In return for their participation, the laboratory will receive the following information: results for each analyte sample mean result for each analyte standard deviation of results by the comparative method number of laboratories using the same method standard deviation index (SDI) lower and upper limits of acceptability of resultsPT results that are between the lower and upper limits of acceptability are considered satisfactory. For chemistry, 80% of samples must test within the acceptable range for the PT to be considered successful. External quality control serves several purposes, including: providing a check on internal quality control detecting errors in a lab's methods providing a comparison of testing methods, which is useful in selecting new methods

Public health laboratory scientists are also regulated by the Board. The table below outlines the various requirements for applicants to receive licensure for a public health laboratory. Public Health Laboratory RequirementsDirectorFulfill the same requirements as a clinical laboratory directorSupervisorBe certified by National Registry in Clinical Chemistry or American Society for MicrobiologyBe licensed as a technologistHave five year's relevant experiencePass the state examTechnician (microbiology)Have a Bachelor's degree in one of the biological sciencesObtain American Society for Microbiology or the National Registry in Microbiology Certification in Public Health Microbiology Technician (chemistry)Have a Bachelor's degree in one of the chemical, biological, or physical sciencesObtain National Registry of Clinical Chemistry Certification in Public Health ChemistryTechnician (conditional)Have a Bachelor's degree in one of the chemical or biological sciencesPerform tests only under the direct supervision of a licensed pathologist, director, supervisor, or technologist.Receives a conditional two-year license, which may be renewed only once A license from the Board of Clinical Laboratory Personnel allows you to work in a public health laboratory at the same level and specialty.

Specialists in immunohematology perform all testing prior to blood transfusions and work to prevent transfusion infections. They also investigate any post-transfusion reactions. This specialty includes all lab procedures performed in the specialty of histocompatibility. Specialists in clinical chemistry analyze body fluids such as blood, urine, and spinal fluid to determine the chemical makeup, including the amount of carbohydrates, proteins, enzymes, and trace elements. The special covers urine microscopics and chemical evaluation of the liver, kidneys, lungs, heart, and other vital organ systems. This specialty also covers all testing performed in the specialties of radioassay and blood gas analysis. Specialists in blood banking can perform all immunohematology testing as well as testing from the specialties of clinical chemistry, hematology and serology/immunology that relates to donor blood. Clinical laboratory personnel who are licensed in the specialties of immunohematology, clinical chemistry, hematology, and serology / immunology may perform all tests in the blood banking specialty.

The setting is automated chemistry department, night shift, busy core laboratory for a hospital based outreach laboratory. A medical technologist who operates the automated chemistry analyzer on third shift encounters short samples a couple of times a night. When this happens, he runs as many of the ordered tests as he can and fills in the blank results with a comment indicating that a short sample occurred. As far as he knows there isn't a policy that addresses this problem directly.The test reports out with the results and the comments. The technologist does not have to change the physician order in any way and is providing the maximum results that can be reported for the specimen in a timely fashion. This is done as a matter of patient care and quality service. There has not ever been a complaint about this practice as far as he knows. Are there any additional steps this technologist should be taking?Correct Answer: The technologist should follow the procedures that the laboratory has in place for testing and billing samples for which there is no order or for ambiguous orders. If the policies do not seem to address his particular situation, he thinks there should be a separate policy to cover this situation or has a question about it, he should talk to his supervisor or to the laboratory compliance officerDiscussion: This choice addresses the problem in the most complete manner, in that the employee fulfills his responsibility to take action when he thinks there is a problem.

It is 11:00 PM and the specimen processing department is finishing up the night's accessioning and test order entry. A specimen processor is working on a requisition that has an order for a Hepatic Profile but there are two tubes of blood with the order, one of which is a lavender top tube. This is the fourth requisition from this same doctor's office and all of them have had a lavender top tube and serum tube with an order for a chemistry test and a CBC. No CBC is marked on the requisition or written on the tube. The specimen processor figures the office just forgot to mark the test and knows that the results will be delayed and the sample might not be any good if he doesn't order the CBC now. He is also under pressure from the technical departments to finish processing on time so they can get their work done on time for result printing in the morning. What should the processor do?Correct Answer: Look up the laboratory's policy for handling such a situation and follow the policy.Discussion: The laboratory is not permitted to change a doctor's order in any way. By ordering the CBC the processor is ordering a test that the doctor did not specifically order and therefore makes the laboratory subject to a violation of the False Claims Act. By reviewing and following the laboratory policy the processor assures that the laboratory, the physician and the patient's best interests are met.

Therapeutic Drug Monitoring (TDM) is a branch of clinical chemistry that specializes in the measurement of medication levels in serum. TDM requires quantitative measurements of drugs and/or their metabolites.

Marcie Moore was a phlebotomist at a community hospital in Atlanta. It was her week to collect the pediatric unit and she was on her way to the room of a newborn for which she had just received orders to draw a STAT BMP (chem-7) and bilirubin. After informing the mother of the baby about the test she needed to perform, Marcie set up to perform a heel stick on the baby. Marcie chose a site on the outer edge of the heel on the bottom of the baby’s foot ( the correct area for a heel stick) and made a small incision with a Tenderfoot lancet after cleaning the site well with alcohol.She immediately began collecting the blood in the correct tube for the BMP and bilirubin. Blood flow was not strong so Marcie squeezed the baby’s foot a little to help the blood come out faster – the newborn was screaming and Marcie could tell it was making the mother uncomfortable. She wanted to hurry and get done so the mother could hold the baby.After the chemistry tech ran the blood tests on the tube, she informed Marcie that the newborn had a panic potassium level which did not coincide with the previous blood work on the newborn. Also the chemistry instrument could not perform the bilirubin due to hemolysis. Marcie was asked to recollect the specimen.

Validated material for the different testing areas in a laboratory (such as chemistry, hematology, and microbiology) are provided several times a year. Participating laboratories test the specimens and return results to the proficiency testing source. The laboratory’s performance is then evaluated using the comparative method mean as the target value plus or minus a defined limit. In general, the evaluation report will show: number of laboratories comprising the peer groupcomparative mean of the group for that particular analyte the laboratory’s performance compared to the peer group whether the performance was satisfactory or unsatisfactory.

Most blood collection tubes contain an additive that either accelerates clotting of the blood (clot activator) or prevents the blood from clotting (anticoagulant). A tube that contains a clot activator will produce a serum sample when the blood is separated by centrifugation and a tube that contains an anticoagulant will produce a plasma sample after centrifugation. Some tests require the use of serum, some require plasma, and other tests require anticoagulated whole blood. The table below lists the most commonly used blood collection tubes. Tube cap color Additive Function of Additive Common laboratory tests Light-blue 3.2% Sodium citrate Prevents blood from clotting by binding calcium Coagulation Red or gold (mottled or "tiger" top used with some tubes is not shown) Serum tube with or without clot activator or gel Clot activator promotes blood clotting with glass or silica particles. Gel separates serum from cells. Chemistry, serology, immunology Green Sodium or lithium heparin with or without gel Prevents clotting by inhibiting thrombin and thromboplastin Stat and routine chemistry Lavender or pink Potassium EDTA Prevents clotting by binding calcium Hematology and blood bank Gray Sodium fluoride, and sodium or potassium oxalate Fluoride inhibits glycolysis, and oxalate prevents clotting by precipitating calcium. Glucose (especially when testing will be delayed), blood alcohol, lactic acid