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American College of Rheumatology, Committee on Rheumatologic Care, Position Statement, Methodology of Testing for Antinuclear Antibodies; Feb, 2009. Available at http://www.rheumatology.org/search/search.asp accessed on June 16, 2010Anuradah V, Chopra A, Sturgess A, Edmonds J. Cost-effective screening method for antinuclear antibody detection. Asian Pacific League of Associations for Rheumatology. 2004(7):13-18.Arbuckle MR, McClain MT, Rubertone MV, et al. Development of autoantibodies before the clinical onset of systemic lupus erythematosus. N Engl J Med. Oct 16 2003;349(16):1526-1533.Bossuyt X, Frans J, Hendrickx A, Godefridis G, Westhovens R, Marien G. Detection of Anti-SSA Antibodies by Indirect Immunofluorescence. Clin Chem. 10 7 2004;50(12):2361-2369.Clinical and Laboratory Standards Institute (formerly NCCLS); Quality Assurance of Laboratory Tests for Autoantibodies to Nuclear Antigens: (1) Indirect Fluorescence Assay for Microscopy and (2) Microtiter Enzyme Immunoassay Methods; Approved Guidelines - Second Edition. CLSI I/LA2-A2. 2006;26(13).Fritzler MJ, Hanson C, Miller J, Eystathioy T. Specificity of autoantibodies to SS-A/Ro on a transfected and overexpressed human 60 kDa Ro autoantigen substrate. J.Clin.Lab.Anal. 2002;16:103-108.Fritzler MJ, Miller BJ. Detection of autoantibodies to SS-A/Ro by indirect immunofluorescence using a transfected and overexpressed human 60 kD Ro autoantigen in HEp-2 cells. J.Clin.Lab.Anal. 1995;9:218-224.Fritzler MJ, Wall W, Gohill J, Kinsella TD, Humbel RL. The Detection of Autoantibodies on HEp-2 Cells Using an Indirect Immunoperoxidase Kit (Colorzyme®). Diag Immunol. 1986;4:217-221. Keech CL, Howarth S, Coates T, Rischmueller M, McCluskey J, Gordon TP. Rapid and sensitive detection of anti-Ro (SS-A) antibodies by indirect immunofluorescence of 60kDa Ro HEp-2 transfectants. Pathology. 1996;28:54-57.Keech CL, McCluskey J, Gordon TP. Transfection and overexpression of the human 60-kDa Ro/SS-A autoantigen in HEp-2 cells. Clin.Immunol.Immunopathol. 1994;73:146-151.Kroshinsky D, Stone JH, Bloch DB, Sepehr A. Case records of the Massachusetts General Hospital. Case 5-2009. A 47-year-old woman with a rash and numbness and pain in the legs. N Engl J Med. Feb 12 2009;360(7):711-720. McCarty, G.A., Valencia, D.W., and Fritzler, M.J., Antinuclear Antibodies-Contempory Techniques and Clinical Application to Connective Tissue Disease. New York: Oxford University Press, Inc. 1984. Murray DL, Homburger HA, Horvat RT, Snyder MR, College of American Pathologists; S-C 2009: Antinuclear Antibody Screening Methods; CAP Surveys S-C Diagnostic Immunology;2009 Pollock W, Toh BH. Routine immunofluorescence detection of Ro/SS-A autoantibody using HEp-2 cells transfected with human 60 kDa Ro/SS-A. J.Clin.Pathol. 1999;52:684-687.Singer, M. and Berg, P., Genes & Genomes-A Changing Perspective. Mill Valley, CA: University Science Books. 1991.Sullivan KE. The complex Genetic Basis of Systemic Lupus Erythematosus, Reprint from 1999 and 2000; Lupus Foundation, Available at http://www.lupus.org/education/articles/geneticbasis.html Accessed June 16, 2010.Wallace DJ. New methods for antinuclear antibody testing: does it cut costs and corners without jeopardizing clinical reliability? Nat Clin Pract Rheumatol. Aug 2006;2(8):410-411.Willcocks LC, Carr EJ, Niederer HA, et al. A defunctioning polymorphism in FCGR2B is associated with protection against malaria but susceptibility to systemic lupus erythematosus. Proc Natl Acad Sci U S A. Apr 27 2010;107(17):7881-7885.

Paraffin temperatures should be maintained within 2° C to 4° C of the melting point of the paraffin. The measure and control of the temperature that the paraffin media is exposed to during its use should be recorded in the quality control records. The consistent maintenance of temperatures in a controlled range will provide the best results and performance from any paraffin formula selected; since at both on the low and high end of the recommended temperature range, problems can occur. Sectioning of blocks will be easier if the paraffin is cooled at a consistent rate for even solidification of the molten paraffin into its final crystalline structure. Controlled cooling allows the formation of a uniform and homogenous matrix of crystals. Paraffin which cools too rapidly or unevenly can cause grainy textures which interfere with sectioning and may result in artifacts in the final tissue sections. On the other hand, overheating of the paraffin can result in deterioration of the components of the paraffin mixture, and some tissue specimens may become brittle or hardened by prolonged exposure to too hot paraffin.Some technical problems, which are assumed to be microtomy issues, are really problems with media selection or embedding technique, so it is worth the time to investigate.

The flow cytometer records the interactions of individual cells that pass by the focused laser beam in a distinct fluid stream. This fluid stream is created by a sheath fluid, which is pressurized as it enters the flow cell with the patient sample. The sheath fluid utilized is isotonic, which helps to preserve cellular integrity for more accurate measurement. As the cells pass through the flow cell single file to the lasers, various measurements are taken within the instrument. These measures are based upon cellular:Light scatter – reflects intrinsic cell characteristicsEmitted fluorescence – represents extrinsic cell characteristics These processes are illustrated on next two pages.

Patient A.D., a 30 year old female, was admitted to the hospital in active labor to deliver at 37 weeks gestation. Transfusion service (TS) records showed A.D. to be group O Rh negative with no record of unexpected red cell antibodies.Maternal history showed two prior pregnancies. Her first pregnancy four years ago ended in spontaneous abortion at 9 weeks gestation and she received a mini-dose (50 µg) of RhIg.In the second pregnancy, two years ago, the infant typed as Group A Rh positive, DAT negative. Patient A.D. was injected with RhIg within 72 hours of delivery. The laboratory also confirmed that in the current pregnancy RhIg was administered at approximately 28 weeks gestation subsequent to a negative antibody screen.After many hours of non-productive labor, the physician considered that labor had stalled and decided to do a cesarian section (C-section). According to hospital policy for C-sections, a type and screen was ordered.

The Health Insurance Portability and Accountability Act (HIPAA) was enacted by Congress in 1996. There are two titles within the Act that are of importance in the clinical laboratory. Title I of the act protects insurance coverage for workers and their families if they change or lose their jobs. Title II of the act requires the establishment of national standards for electronic health care transactions as well as national identifiers for providers, health insurance plans, and employers. A very important feature of Title II is that it addresses the security and confidentiality of health data. It also entitles patients to have access to their medical records within a reasonable amount of time. Another concept worth noting within HIPAA rules is the term "covered entity". A covered entity is a term applied to a health care provider who transmits any health information in connection with a HIPAA transaction. Since substantial fines can be levied against any covered entity that does not comply with the Privacy Rule, it is important that all employees in the laboratory are fully aware of and compliant with both HIPAA and state confidentiality requirements. This should be enforced with both initial and follow-up training. The privacy of electronically transmitted personal health information (PHI) was further expanded and strengthened with the passage of the American Recovery and Reinvestment Act of 2009 (ARRA).

Phlebotomy is a skill that needs to be perfected. Because phlebotomy is an invasive procedure, it is imperative that you become and remain proficient. Many people are apprehensive when getting their blood drawn. Your professionalism will greatly decrease their fears.Individuals who collect blood specimens should be assessed for competence by a qualified mentor before being allowed to perform procedures on patients and periodically thereafter. It is important to receive feedback from the instructor/mentor so that you are ensured your phlebotomy techniques are appropriate. Any remedial training needed should be provided by qualified instructors in a controlled environment--preferably a classroom and not in the presence of patients. Training and competency assessment should again occur whenever new equipment is introduced. Training and assessment records should be kept in your employee file.Ask for assistance when unsure about a collection. Be professional at all times. You are an important part of the health care team.

After the medical director has reviewed the laboratory results from the investigation, the interpretation is recorded on the patient's permanent medical record. The transfusion service must retain the records of the test results, interpretations, and reaction classification indefinitely. In the U.S., deaths of patients resulting from a transfusion reaction must be reported to the Food and Drug Administration (FDA) by the transfusion service as soon as possible. A written report must follow within seven days. The report should contain the patient's medical records, including laboratory reports and autopsy results. Transfusion services accrediting agencies, such as AABB, the College of American Pathologists (CAP), and the Joint Commission may require reporting to them as well. All of these agencies require that transfusion services have written policies for transfusion reactions addressing the steps for detection, evaluation, and reporting.