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Online compliance and continuing education courses for clinical laboratories

Health Information and Courses from MediaLab, Inc.

These are the MediaLab courses that cover Health and links to relevant pages within the course.

Learn more about laboratory continuing education for medical technologists to earn CE credit for AMT, ASCP, NCA, and state license renewal and recertification. Or get information about laboratory safety and compliance courses that deliver cost-effective OSHA safety training and continuing education to your laboratory's employees.

Laboratories Individuals

Alpha Thalassemia
References

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.

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Antibody Detection and Identification
References

Alba MA. Clinical Immunohematology Laboratory Manual. Albuquerque, NM: UNM Health Sciences Center; 2008.Brecher MF, Leger RM, Linden JV, Roseff SD, eds. Technical Manual 15th ed. Bethesda, Md. AABB; 2005.Harmening DM. Modern Blood Banking and Transfusion Practices. 5th ed. Philadelphia, Pa: F.A. Davis Company; 2005.

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Cerebrospinal Fluid

Chemical Screening of Urine by Reagent Strip

CLIA General Laboratory Review
In what section of the MSDS manual would you find information on which chemical might affect your health:View Page
Which one of the following does not directly regulate clinical laboratories:View Page
Which of the following infectious agents represent the greatest risk to the laboratory worker:View Page
Which section of the MSDS would provide information on chemical hazards that might affect your health:View Page

Confirmatory and Secondary Urinalysis Screening Tests

Current Topics in Clinical Microbiology
Review 2

Griego RD. Rosen T. Orengo IF. Wolf JE.: Dog, cat, and human bites: a review. Journal of the American Academy of Dermatology. 33:1019-29, 1995It is estimated that half of all Americans will be bitten by an animal or another human being during their lifetimes. The vast majority of the estimated 2 million annual mammalian bite wounds are minor, and the victims never seek medical attention. Nonetheless, bite wounds account for approximately 1% of all emergency department visits and more than $30 million in annual health care costs.Infection is the most common bite-associated complication; the relative risk is determined by the species of the inflicting animal, bite location, host factors, and local wound care. Most infections caused by mammalian bites are polymicrobial, with mixed aerobic and anaerobic species.The clinical presentation and appropriate treatment of infected bite wounds vary according to the causative organisms. Human bite wounds have long had a bad reputation for severe infection and frequent complication. However, recent data demonstrate that human bites occurring anywhere other than the hand present no more of a risk for infection than any other type of mammalian bite.The increased incidence of serious infections and complications associated with human bites to the hand warrants their consideration and management in three different categories: occlusional/simple, clenched fist injuries, and occlusional bites to the hand. This article reviews dogs, cat, and human bite wounds, risk factors for complications, evaluation components, bacteriology, antimicrobial susceptibility patterns, and recommended treatments. Epidemiology, clinical presentation, and treatment of infections caused by Pasteurella multocida, Capnocytophaga canimorsus, Eikenella corrodens, and rhabdovirus (rabies only) receive particular emphasis.

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Department of Transportation (DOT) & Federally Regulated Urine Specimen Collection Training
Monitored collection

For monitored collections, the Department of Transportation classifies the following as health professionals: Physician Medical Technologist Medical Laboratory Technician Nurse (RN/LPN) Physician's Assistant/Nurse Practitioner Medical Technician (A medical technician is anyone who is licensed or certified to practice in the institution where the collection is being done. For example, a phlebotomist, EMT, or medical assistant.)

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Monitored collection

Another type of collection is the monitored collection. Monitored collections occur where the collection must take place in a multi-stall restroom with partial length doors.The collector enters the restroom with the donor, but the donor goes into the stall alone and closes the door. It is preferred that the collector be the same sex as the donor, but it is not required so long as the collector is classified as a health professional.

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In both the monitored and observed collections, the collector MUST be the same gender as the donor.View Page

Descriptive Statistics

Emerging Cardiovascular Risk Markers
Introduction

We are all aware of the clinical laboratory's role in assessing overall health and we are also aware that measuring a patient's serum lipids will provide some insight into their cardiovascular health. The traditional measurements of low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and triglycerides are the 'classic' cardiovascular risk markers.Laboratorians, and even the general public are now well-aware that LDL-C ('bad' cholesterol) concentrations should be low while HDL-C ('good' cholesterol) concentrations should be high. Triglycerides should be kept in check as well. Optimal levels are shown in the table below. So what is the risk if these values are not within optimal ranges?Cardiovascular risk can be simply defined as increasing the odds of having a pathology which affects blood flow and/or the heart. The most common cardiovascular pathology is atherosclerosis. Other cardiovascular pathologies whose odds increase as serum lipids and other cardiovascular markers become suboptimal are myocardial infarction (heart attack), stroke, congestive heart disease and coronary artery disease. Other diseases such as diabetes and the metabolic syndrome are also strongly associated with the classic cardiovascular risk markers LDL-C, HDL-C and triglycerides.

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References

Atherosclerosis. U.S. Department of Health & Human Services National Institutes of Health. Available at http://www.nhlbi.nih.gov/health/dci/Diseases/Atherosclerosis/Atherosclerosis_WhatIs.htmlAccessed June 23, 2009.Daniels LB, Barrett-Connor E, Sarno M, Laughlin GA,Bettencourt R, Wolfert RL. Lipoprotein-associated phospholipase A2 (Lp-PLA2) independently predicts incident coronary heart disease (CHD) in an apparently healthy older population: The Rancho Bernardo study. J Am Coll Cardiol. 2008;51:913-919.Executive Summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001; 285:2486-2497. Frostegard, J, Wu R, Lemne C, Thulin T, Witztum JL and de Faire U. Circulating oxidized low-density lipoprotein is increased in hypertension, Clin Sci 2003; 105, 615.Garza CA, Montoir VM, McConnell JP, et al. Association between lipoprotein-associated phospholipase A2 and cardiovascular disease: a systematic review. Mayo Clin Proc. 2007;82(2):159-165.Interpretive Handbook, (MC0440rev0407) Mayo Clinic, Rochester MN;2007. Maksimowicz-McKinnon K, Bhatt DL, Calabrese LH: Recent advances in vascular inflammation: C-reactive protein and other inflammatory biomarkers. Curr Opin Rheumatol. 2004;16:18-24.Mora S, Szklo M, Otvos JD, et al. LDL particle subclasses, LDL particle size, and carotid atherosclerosis in the multi-ethnic study of atherosclerosis. Atherosclerosis. 2007;192:211-217.NACB Laboratory Medicine Practice Guidelines. Emerging biomarkers of cardiovascular disease and stroke. National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines. 2006.PLACtest animation, diaDexus. http://www.plactest.com/laboratorians/action.php Accessed June 23, 2009.Rifai N, Warnick GR. Lipids, lipoproteins, apolipoproteins, and other cardiovascular risk factors. In: Burtis CA, Ashwood ER. Bruns DE. Tietz Textbook of Clinical Chemistry and Molecular Diagnostics. 4th ed. St. Louis, MO: Elsevier Saunders: 2006; chap. 26.Ridker PM, Rifai N, Rose L, et al. Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med. 2002;347:1557-1565.Sniderman AD. Differential response of cholesterol and particle measures of atherogenic lipoproteins to LDL-lowering therapy: Implications for clinical practice. J Clin Lipidol 2008;2:36-42.Tsimikas, S, Brilakis ES, Miller ER, et al. Oxidized phospholipids, Lp(a) lipoprotein, and coronary artery disease, N Engl J Med: 2005;353:46.Tsimikas S, Bergmark C, Beyer RW, et al. Temporal increases in plasma markers of oxidized low-density lipoprotein strongly reflect the presence of acute coronary syndromes. J Am Coll Cardiol. 2003; 41: 360.Tsimikas, S, Lau HK, Han KR, et al. Percutaneous coronary intervention results in acute increases in oxidized phospholipids and lipoprotein(a): Short-term and long-term immunologic responses to oxidized low-density lipoprotein. Circulation. 2004;109, 3164.Tsimikas S, Witztum JL, Miller ER, Sasiela WJ, et al. High-dose atorvastatin reduces total plasma levels of oxidized phospholipids and immune complexes present on apolipoprotein B-100 in patients with acute coronary syndromes in the MIRACL trial, Circulation: 2004;110, 1406. Walldius G, Jungner I, Holme I, et al. High apolipoprotein B, low apolipoprotein A-I, and improvement in the prediction of fatal myocardial infarction (AMORIS study): a prospective study. Lancet. 2001;358:2026-2033.Yusuf S, Hawken S, Ounpuu S, et al. Effect of potentially modifiable risk factors associated with myocardial infarction in 52 countries (the INTERHEART study): case-control study. Lancet. 2004;364:937-952.

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Erythrocyte Inclusions - Wright Stained Smears

Fundamentals of Hemostasis

Fundamentals of Molecular Diagnostics
Infectious Diseases

Molecular methodologies can be useful in the detection of a variety of diseases that are important public health issues such as:Chlamydia trachomatis (CT) Neisseria gonorrhoeae (GC)Human papillomavirus (HPV)Human Immunodeficiency Virus (HIV)Herpes Simplex Virus (HSV)Cytomegalovirus (CMV)In many clinical laboratories, traditional methods have been replaced by molecular methodologies because testing can occur for several pathogens in a single specimen. This is termed multiplex testing.

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Hereditary Hemochromatosis
Introduction

Hereditary hemochromatosis (HH) is a disorder of iron regulation that results in excessive dietary iron absorption through the gastrointestinal tract. Over time, the resultant iron overload and its deposition in tissue may lead to widespread organ damage, a variety of chronic disorders, and even death. Although it is a genetic disorder, clinical symptoms most typically become apparent in middle aged adults. Iron overload occurs in a variety of hereditary and acquired forms, known as iron storage diseases. HH is the most common cause of inherited iron overload. (1) Due to lack of awareness, HH often goes undetected or unrecognized by health care providers. Early detection to prevent the serious complications associated with iron overload has important consequences for reducing morbidity and mortality. Laboratory tests that assess iron levels and molecular assays for genetic mutatations are essential for both its detection and diagnosis.

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General Clinical Considerations

Hereditary hemochromatosis (HH) is frequently discovered only during management of associated illness or routine health evaluations. It has been estimated that only a small percentage of all affected persons are actually diagnosed. Individuals with HH may be symptomatic for several years prior to diagnosis and may have consulted multiple health care providers.Under-diagnosis of HH is thought to occur due to:• Lack of specificity of early signs and symptoms• Asymptomatic status of some patients until damage to organs and tissues has occurred• Confusion with liver disease due to other causes• Insufficient awareness and knowledge of HHEarly identification of persons with HH is essential to prevent serious and irreversible complications associated with severe iron overload. A classic triad of skin hyperpigmentation (bronzing), type 2 diabetes, and hepatic cirrhosis has long been recognized as evidence of advanced iron overload. However, persons with HH may present with a much wider variety of signs and symptoms, particularly if they are seen before significant iron accumulation has occurred. Age of presentation and disease severity are highly variable. A diagnosis of HH is based on laboratory evidence of iron overload, genetic mutations associated with HH, and presence of clinical signs and symptoms consistent with HH.(10)

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Screening Controversies

The subject of screening for hereditary hemochromatosis (HH) is controversial and is currently being debated in the medical literature. Using laboratory tests to screen the asymptomatic general population is currently not recommended due to issues of testing costs, low genetic penetrance, and the possible risk of discrimination. Targeted case finding in select high risk populations such as men of Northern European ancestry may be a better approach to screening. (12)Molecular-based (DNA) assays required for confirmation of HH are costly when used for general population screening. Because recent studies have shown that a high percentage of persons with C282Y mutations do not develop iron overload or HH-related clinical conditions, screening for these mutations may falsely label an individual with a disease diagnosis. At the present time, it is impossible to determine which homozygotes or heterozygotes for HFE mutations will eventually develop iron overload. Furthermore, there is potential risk of discrimination in obtaining health insurance for persons identified as having genetic disorders.In contrast, some experts do advocate for screening the general population. Mutations associated with HH are very common in Caucasians in the US. Individuals who know they carry mutations associated with HH may benefit from periodic testing for iron overload. Finally, laboratory tests that assess iron status are relatively inexpensive, widely available, and offer one approach to screening for phenotypic expression of HH. Screening first-degree family members of a person with documented HH is generally considered to be worthwhile. Early detection of HH in relatives with common mutations may permit treatment before the development of substantial iron overload and related disease due to organ damage.

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Molecular Tests

DNA tests for HFE mutations associated with hereditary hemochromatosis (HH) are available in some clinical laboratories and reference laboratories. Testing for the presence of the C282Y is essential, although most labs also test for H63D and S65C mutations. Molecular testing is most appropriate for confirmatory testing of symptomatic individuals with altered iron studies (increased TS and SF), in pre-symptomatic individuals (increased TS, normal SF and liver function tests), and in family members of individuals diagnosed with HH. The use of genetic tests alone for routine screening of asymptomatic persons is not recommended for several reasons. A positive test indicating the presence of HFE mutations does not guarantee that an individual will develop clinically significant iron overload or predict severity of symptoms. A negative result (no HFE mutations present) does not rule out a diagnosis of iron overload because of genetic heterogeneity. Compared to biochemical analyses for iron, molecular assays are expensive. Finally, molecular testing may result in the diagnosis of a genetic disease, thus opening up the possibility for discrimination in health insurance coverage. Using molecular methods, DNA is extracted from leukocytes in whole blood samples or from buccal cells and analyzed for specific HFE mutations using polymerase chain reaction (PCR) with melt curve analysis. Currently there are no FDA-cleared products for HFE testing, and testing laboratories are using "home brew" reagents. This situation is expected to change as manufacturers submit products for FDA approval.

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HIPAA Privacy and Security Regulations
What is the HIPAA Security Regulation?

The HIPAA Security Regulation: Defines how to protect electronic health information. Went into effect April 20,2005

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Case Study: Physical SafeguardsYou are a supervisor of a health clinic. During orientation of a new employee, you instruct him to keep the door leading from a patient area to a computer work area locked at all times. On several occasions, he forgets to make sure the door is locked as he leaves. Which of the following are true regarding this situation?View Page
What is the HIPAA Privacy Regulation:

The HIPAA Privacy Regulation went into effect April 14, 2003. It protects the confidentiality of individuals' health data by:Regulating how Protected Health Information (PHI) is used, whom it is disclosed to, and how and where it is maintained. The HIPAA Privacy Regulation:Requires reasonable security measures to protect individuals' health information. Establishes accountability for use and release of this information. Gives individuals rights regarding their health information.

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What Information is Protected?

HIPAA protects ALL information related to an individual's physical or mental health, including demographic and payment information, whether oral, written, or in computer format. All such information is referred to as Protected Health Information or PHI.

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Limiting Use and Disclosure of PHI

A covered entity may use or disclose PHI, without getting an individual's authorization, in order to:Perform requested tests and treatments.Bill for the services performed.Perform essential operations, including quality assessment, accreditation, and compliance.Meet legal reporting requirements, including those mandated by public health departments, workers' compensation, law enforcement agencies, and the US Department of Health and Human Services. Other uses and disclosures require written authorization.

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De-Identified Health Information

Health information is considered de-identified, if it cannot be used to identify an individual. Other terms for de-identified health information are: Anonymous, Aggregated, and Scrubbed.The Privacy Regulation details the specific individual information which needs to be removed from PHI for it to qualify as de-identified.When PHI is de-identified, it is no longer considered protected.De-identified health information should be used whenever individual patient identification is unnecessary.

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Case Study: Minimum Necessary Use & Disclosure You are a phlebotomist at a specimen collection center. A patient arrives with an order for a blood glucose test, and a lipid profile. You get the patient's address, phone number, health insurance coverage, and ask how long ago he ate his most recent meal. You then ask him about his recent auto accident, his wound infection, and his family. You write down all the extra information. Under the HIPAA Privacy Regulations, which of the following information requests is acceptable?View Page
Authorization

The privacy regulations give covered entities permission to use and disclose PHI for treatment, payment, and health care operations (TPO), without obtaining specific authorization.A covered entity may disclose PHI to other covered entities such as reference laboratories, and homecare services, which are providing services to the primary covered entity.The service that the other covered entity is providing must fall within treatment, payment or health care operations (TPO).If the service being provided does not fall within TPO, an authorization is generally required.An authorization form must state the specific disclosures of PHI to be made, what the information will be used for, and must be signed and dated by the patient.

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Case Study: De-identified Health Information. You work in a laboratory microbiology department which provides a local nursing home with information about the effectiveness of various antibiotics it uses to treat infections. You print the requested information, including complete patient identification, bacterial organisms identified, and their sensitivity to various antibiotics. What information should you provide to the nursing home?View Page
Business Associate Agreement

A Business Associate is a separate organization, providing services to a covered entity, which require the exchange of PHI.An agreement must be in place between covered entities and their business associates.This agreement defines the processes that will be implemented to ensure the privacy and security of PHI.Examples of Business Associates may include collection agencies, attorneys, consultants, and accountants, requiring access to PHI.Business Associate agreements are not generally required between two covered entities involved in treatment, payment, or health care operations.

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Privacy is Your Responsibility.

As a health care worker, you are required by HIPAA to protect the privacy and security of the personal health information to which you have access.

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HIPAA Enforcement

Failure to comply with HIPAA can result in substantial civil and criminal penalties.Civil Penalties Violations of the "Administrative Simplification Regulations" can result in civil monetary penalties of $100 per violation, up to $25,000 per year. Stated in these regulations is a requirement to protect the confidentiality of individually identifiable health information.Criminal PenaltiesIn June 2005, the U.S. Department of Justice (DOJ) clarified who can be held criminally liable under HIPAA. Covered entities and specified individuals who "knowingly" obtain or disclose individually identifiable health information in violation of the Administrative Simplification Regulations face a fine of up to $50,000, as well as imprisonment up to one year. Offenses committed under false pretenses allow penalties to be increased to a $100,000 fine, with up to five years in prison. Finally, offenses committed with the intent to sell, transfer, or use individually identifiable health information for commercial advantage, personal gain or malicious harm permit fines of $250,000, and imprisonment for up to ten years.

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Which of the following entities are covered by HIPAA?View Page
Importance of Privacy - An Example

You will have many opportunities to avoid disclosing protected health information. Here is one simple example: Your best friend asks you to look up her mother's laboratory results. Knowing the HIPAA privacy regulation and your own departmental policies and procedures, you do not disclose the protected health information which she is requesting. You politely tell your friend that your are not allowed to give her the laboratory results.

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What is HIPAA?

HIPAA is a federal law passed by Congress in 1996 to help protect the privacy and security of health information. It is short for Health Insurance Portability and Accountability Act.

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Who does HIPAA apply to?

HIPAA applies to: Health Plans (such as health insurance companies) Healthcare Clearinghouses (such as billing companies), and Healthcare Providers (including doctors, hospitals, laboratories, and pharmacies). HIPAA refers to these 3 groups as covered entities.

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HIV Safety for Florida
A person commits a misdemeanor of the first degree by:View Page
Informed Consent

Informed consent must be obtained first before a HIV antigen or antibody test can be ordered.Informed consent must be preceded by: Explanation of the test subject's right of confidentiality. Notification that a positive HIV test result will be reported to county health department with enough information to possibly identify the test subject. Availability and location of sites where anonymous testing is performedInformed consent can be given by a legal guardian or other person authorized by law when the test subject is: not competent incapacitated a minor

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Reporting results

Each laboratory that performs a test indicative of HIV or AIDS shall report to the county health department in less than 2 weeks.To assure the confidentiality of the patient, reporting of HIV infection and AIDS must be conducted using a system developed by CDC or equivalent system.Each person who violates reporting rules may be fined $500 per offense.

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Legislative Intent

The Florida Legislature finds that the public health will be served by facilitating informed, voluntary, and confidential use of tests designed to detect HIV infection.

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References

Panlilo AI, Cardo DM, Grohskopf LA, Heneine W, Ross, CS. Updated U.S. Public Health Service Guidelines for the Management of Occupational Exposures to HIV and Recommendations for Postexposure Prophylaxis, 2005. MMWR Recomm Rep 2005 Sep 30; 54:RR-9.The 2005 Florida Statutes, Chapters 381, 384,456. Available at www.leg.state.fl.us.MediaLab Course "HIV: Structure and Replication," Garland Pendergraph.MediaLab Course "OSHA Blodborne Pathogens," Terry Jo Gile MT(ASCP),Ma Ed.

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Introduction to Bioterrorism
Category A

Those agents in Category A are highest-priority because they: Can be easily disseminated or transmitted person-to-person Cause high mortality, with potential for major public health impact Might cause public panic and social disruption Require special action for public health preparedness

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Category C

Agents in the third highest priority, Category C, include emerging pathogens that could be engineered for mass dissemination at some future date because of: Availability Ease of production and dissemination Potential for high morbidity and mortality and major health impact

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Biological agents that are the easiest to disseminate, or that pass most easily from person to person are found in Category:View Page
Disadvantages of using Biological Agents

They are not immediate. The delayed effect, for example, the long incubation period for some agents, may detract and limit their tactful usefulness as a political statement.They are hazardous to all who come in contact.There is the possibility that the biological agents could also affect the health of the aggressor forces. They are hard to control.The dependence of prevailing winds and other weather conditions such as temperature, sunlight, and desiccation may make it difficult to control distribution of the biological agent.  Potential long term effects beyond the initial attack.The persistence of some agents such as spore-forming anthrax in the environment may make an area uninhabitable to aggressor forces for long periods. Results are unpredictable.Morbidity secondary to a biological attack is unpredictable since casualties will be related to the quantity and manner of exposure plus the preventive and treatment measures available.

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Laboratory Response

The broad base of clinical laboratories in this country is an essential component of our nation’s public health and healthcare system and is an essential link in addressing biological and chemical terrorism. In 1999 the Centers for Disease Control and Prevention (CDC) initiated the concept of a Laboratory Response Network (LRN).  The LRN is a network of local, state, federal, and military laboratories across the United States and internationally which work together in an integrated and coordinated way for a rapid response to public health emergencies. The LRN concept of operations is based on a system of safety and proficiency.

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The LRN Pyramid

The LRN is a multilevel system designed to link frontline clinical microbiology laboratories and hospitals and other institutions to state and local public health laboratories in supporting advanced capacity public health, military, veterinary, agricultural, water and food testing laboratories at the federal level. Laboratories within the LRN are divided into 3 levels: Sentinel Labs, Reference Labs, and National Labs.

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Laboratory Response - Chemical

Currently there are over 60 territorial and metropolitan public health laboratories that are members of the chemical component of the LRN. A designation of Level 1, 2, or 3 defines their network participation.

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Laboratory Response - Chemical, Level 3

Level 3 laboratories are responsible for: Working with hospitals and private laboratories in their jurisdiction Knowing how to properly collect and ship clinical specimens Ensuring that specimens, which can be used as evidence in a criminal investigation, are properly handled and that chain-of-custody procedures are followed Being familiar with chemical agents and how they can affect health and well-being Training on anticipated clinical sample flow and shipping regulations Working to develop a coordinated response plan for their respective state and jurisdiction

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Sentinel Labs

The frontline clinical microbiology laboratories are known as “sentinel laboratories”. The sentinel laboratories play a key role in the nation’s preparedness efforts. These laboratories perform the initial screening of clinical specimens for potential pathogens (rule-out) and refer specimens or isolates to a state or local public health laboratory at the reference level of the LRN. There are two kinds of sentinel laboratories: advanced and basic. Classification depends on their biological safety level and analytical capability.

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Introduction to Bone Marrow

Introduction to Quality Control
Federal Regulations

The importance of quality control is recognized by the federal government. Federal regulations, such as the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88), require successful participation in external quality control programs for clinical laboratories, regardless of size. These regulations are aimed at providing all citizens with the highest quality of health care and at the same time controlling costs.

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Introduction to the ABO Blood Group System

Laboratory Ergonomics
References

Centers for Disease Control and Prevention. Laboratory ergonomics. Available at: http://www.cdc.gov/od/ohs/Ergonomics/labergo.htm. Accessed July 6, 2009.Cornell University. CUErgo. Available at: http://ergo.human.cornell.edu/ Accessed July 6, 2009.National Institute for Occupational Safety and Health. Ergonomics and musculoskeletal disorders. Available at: http://www.cdc.gov/niosh/topics/ergonomics/ Accessed July 6, 2009.UCLA Ergonomics. Musculoskeletal disorders: Anatomy of an injury. Available at: http://ergonomics.ucla.edu/MSD_Anatomy.html. Accessed July 6, 2009.US Department of Labor. Healthcare wide hazards module: Ergonomics. Available at: http://www.osha.gov/SLTC/etools/hospital/hazards/ergo/ergo.html Accessed July 6, 2009.

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Laws and Rules of the Florida Board of Clinical Laboratory Personnel
Your Role

As a clinical laboratory worker, your role is vital in the health care process. You provide information to doctors, nurses, and healthcare organizations that is vital to proper patient care. Because your role is so important, you must be properly qualified, trained, and licensed for your position. You must also keep up with the latest laboratory techniques and developments by fulfilling continuing education requirements; and you are bound by a code of ethics, which ensures that patient results are accurate, reliable, and free from error and bias.

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Public health laboratory scientists

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.

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CEBroker

CEBroker is the Florida Department of Health's online system for tracking continuing education requirements. Companies and colleges that provide continuing education, whether through online programs, lectures, seminars, or other methods, will report your completed credits to CEBroker. All courses you complete through MediaLab that carry Florida credit will be reported to CEBroker and automatically credited to your license. For that reason, make sure you keep your license number up-to-date with MediaLab. Even though CEBroker tracks your credits, keep copies of all Certificates of Completion that you receive in case of an audit. You are responsible for maintaining proper documentation of your completed courses. CEBroker's website is www.cebroker.com.

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Kickback and Inducement Violations

Offering or taking a bribe, kickback, bonus, commission, or inducement is against the rules of the Board and against the law. Many companies give away small promotional items, such as pens or note pads, to promote their products. This is legal, but be cautious about accepting more valuable items. This could be seen as a bribe. All of the following are serious violations of Board, state, and federal rules:Participating in any commissions, bonuses, kickbacks, inducements, or split-fee arrangements from physicians, health care providers, suppliers, hospitals, nursing homes, other clinical laboratories, pharmacies, and other facilities.Exploiting or influencing a patient for financial gain, including promoting, selling, or withholding services, drugs, or referrals.

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Linear Regression Analysis

Medical Error Prevention
Which statement describes an Adverse Event?View Page
Medical Errors in the United States

Most medical interventions produce positive outcomes. Everyone expects to give and receive effective medical care. These expectations are routinely met by the healthcare community. However, a 2000 publication from the Institute of Medicine, the IOM, To err is human: Building a safer health system, reports that medical errors cause as many as 98,000 deaths every year in the United States.

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Joint Commission Patient Safety Goals Joint Commission adopted national patient safety goals for healthcare organizations, including specific goals for laboratories. 2009 Laboratory Services National Patient Safety Goals These goals are directly quoted.View Page
Improving Patient Safety Many other organizations strive to improve patient safety. These dedicated groups promote current information about their goals, projects, progress, publications, tools, and educational offerings in their Internet Websites.View Page
American Society for Clinical Laboratory ScienceThe American Society for Clinical Laboratory Science, ASCLS, joins the leadership effort to prevent medical errors and increase patient safety.View Page
Public Responsibility for Safety

People can help prevent errors in their medical care by understanding their treatment, keeping organized health records, and asking questions. They should feel comfortable talking with medical professionals when things do not seem right.

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Medical Errors

The health community describes medical errors several ways: Failures of planned actions Mistakes of execution Use of wrong plans to achieve outcomesSometimes peoples' plans and actions fail, causing medical errors. Sometimes people make mistakes performing their duties, and this causes medical errors. Sometimes people use wrong plans and actions, and this creates medical errors. Medical errors are mistakes medical professionals make in patient testing, care, or treatment.

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Adverse Events

Medical errors lead to adverse events--unintended injuries or other negative health consequences. These unfortunate events are caused by medical mismanagement, not underlying patient diseases or conditions. Adverse events may or may not be preventable.

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Medicare Compliance for Clinical Laboratories
Introduction

The government believes that fraud, abuse and waste exist in the healthcare industry today because of cases it has settled and prosecuted.All healthcare providers, including laboratories, make billing errors.The Office of Inspector General (OIG) believes that honest members of the healthcare community can police themselves if they receive guidance.The OIG has published Compliance Program Guidance documents for health care providers, including laboratories.

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Element 5

Element 5: Every employee must understand that the standards, policies and procedures associated with the compliance program must be adhered to at all times. Employee will be disciplined up to terminations for violations. Employee can be disciplined or terminated for failing to report a problem or suspect activity. All employees are screened prior to being hired for previous actions against them by any law enforcement or government agency regarding any health care prosecution or exclusion from the Medicare or Medicaid program. Adherence to the compliance program's policies and procedures will be a component of every employees annual evaluation and performance review.

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Laws and regulations that govern laboratories

Social Security Act: Medicare and Medicaid laws are in this act. Medicare rules and regulations come under this act. Antikickback laws: Provide criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive money or favors for referrals of tests or services that will be paid for by the Medicare or Medicaid programs. False Claims Act: Provides criminal penalties for knowingly or willingly filing a false claim to a government program. Self Referral (Stark) laws and regulations: Identify financial relationships that have the potential to result in directed referral to one or both of the individuals or entities involved. Prohibit the referral of patients or tests between related entities unless certain conditions are met. Health Insurance Portability and Accountability Act (HIPAA) Prohibits health care providers and payers from improper or inappropriate use of a patient's confidential health information Requires health care providers to insure that a patient's confidential information is kept secure Provides for standardized electronic formats for all health care transactions

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HCPCS and CPT coding

The HCFA (Health Care Financing Administration) Common Procedural Coding System (HCPCS) and the CPT (Current Procedural Terminology) codes are used to describe specific tests or services. The amount of payment for a test is dependent on the HCPCS or CPT code. HCPCS or CPT codes should be assigned under the supervision of the laboratory technical staff. Billing department employees should never change a HCPCS or CPT code without the approval of a manager or compliance officer. If a billing department clerk notices that a particular HCPCS or CPT code is being rejected by a payer they should report it to their manager. It is against the law to use the wrong HCPCS or CPT code for the purpose of causing or increasing payment for a test.

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Communication with physicians and patients

It is important that billing department employees are clear and accurate when communicating with physician office personnel and patients. Never guess at the answer to a question; ask if you are unsure. Do not speculate or express personal opinions. When requesting diagnosis information from the physician office staff be careful to not lead them to give a billable code: The code must come from the patient's medical record. There is an incentive program for patients to find and report fraud and abuse by health care providers, including laboratories, so: Billing department employees must accurately state laboratory policies and procedures, or forward the call to a supervisor to avoid misstatements and misunderstandings.

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Client contracts

A laboratory that receives referrals from a nursing home or Skilled Nursing Facility (SNF) should have a written agreement with that facility: The Agreement should define billing and documentation responsibilities. The facility should be responsible for determining the payment status of its patients and is liable for submitting incorrect payment information to the laboratory. Fees should be consistent with other similar customers. A laboratory that provides services to a Home Health Agency treating Medicare/Medicaid beneficiaries should have a written agreement with that agency: The Agreement should define billing and documentation responsibilities. The Agreement should place the responsibility on the Home Health Agency to establish that all patients receiving laboratory services are "homebound" as defined by Medicare. Fees should be consistent with other similar customers.

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Medicare Compliance for Clinical Laboratories (updated 2009)
Laws and Regulations Applicable to Medicare

Social Security Act: Medicare and Medicaid laws are in this act. Medicare rules and regulations come under this act. Antikickback laws: Provide criminal penalties for individuals or entities that knowingly and willfully offer, pay, solicit or receive money or favors for referrals of tests or services that will be paid for by the Medicare or Medicaid programs. False Claims Act: Provides criminal penalties for knowingly or willingly filing a false Medicare claim to a government program. Self Referral (Stark) laws and regulations: Identify financial relationships that have the potential to result in directed referral to one or both of the individuals or entities involved. Prohibit the referral of patients or tests between related entities unless certain conditions are met. Health Insurance Portability and Accountability Act (HIPAA) Prohibits health care providers and payers from improperly or inappropriately using a patient's confidential health information Requires health care providers to keep a patient's confidential information secure Provides for standardized electronic formats for all health care transactions

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Element 5

Every employee must understand that the standards, policies and procedures associated with the compliance program must be adhered to at all times. An employee will be disciplined up to termination for violations. An employee can be disciplined or terminated for failing to report a problem or suspect activity. All employees are screened prior to being hired for previous actions against them by any law enforcement or government agency regarding any health care prosecution or exclusion from the Medicare or Medicaid program. Adherence to the compliance program's policies and procedures will be a component of every employee's annual evaluation and performance review.

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Client contracts

A laboratory that receives referrals from a nursing home or Skilled Nursing Facility (SNF) should have a written agreement with that facility: The Agreement should define billing and documentation responsibilities. The facility should be responsible for determining the payment status of its patients and is liable for submitting incorrect payment information to the laboratory. Fees should be consistent with other similar customers. A laboratory that provides services to a Home Health Agency treating Medicare/Medicaid beneficiaries should have a written agreement with that agency: The Agreement should define billing and documentation responsibilities. The Agreement should place the responsibility on the Home Health Agency to establish that all patients receiving laboratory services are "homebound" as defined by Medicare. Fees should be consistent with other similar customers.

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Normal Peripheral Blood Cells

OSHA Electrical Safety (updated 2007)

OSHA Formaldehyde
A Potential Carcinogen

More importantly, the National Institute for Occupational Safety and Health (NIOSH) has labeled formaldehyde a potential human carcinogen.

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OSHA Formaldehyde (updated 2009)
A Potential Carcinogen

More importantly, the National Institute for Occupational Safety and Health (NIOSH) has labeled formaldehyde a potential human carcinogen.

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Packaging and Shipping Infectious Materials
Categories of Division 6.2 Infectious Substances

Hazardous material classifications are consistent across all agencies who regulate commercial shipping and are based on criteria developed by the United Nations (UN) Committee of Experts working with the World Health Organization (WHO), the Centers for Disease Control and Prevention (CDC), medical professionals, microbiologists, transportation professionals, and packaging technical experts. These requirements can be found in the 13th and 14th editions of the United Nations Recommendations for the Transport of Dangerous Goods, the 2005 - 2006 edition of the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO Technical Instructions), and the International Maritime Organization (IMO) Dangerous Goods Code. The classification system for Division 6.2 Infectious Substances includes two catergories, known simply as Category A and Category B.

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Classification Scenario 4

A culture of Mycobacterium tuberculosis is to be sent by commercial carrier to the Public Health Laboratory. What classification should be used for appropriate packaging and labeling? Work through the Classification Decision Tree.

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Labeling a Package Containing a Category A Substance

Packages that contain category A substances must exhibit these labels.Proper shipping name and UN number(Category A label) or Hazard class 6 infectious substance label that includes this statement:In case of damage or leakage, immediately notify public health authority. In the US, notify the CDC 1-800-232-0124 UN package certification markOrientation arrows (if greater than 50 mL)Contact information (Shipper or Consignee Identification)The contact person (usually the shipper), referred to as the "responsible person" by IATA, must be someone who can be reached 24 hours a day, seven days a week (24/7) and can answer questions about the content of the package. The 24/7 number must reach that person directly and not a pager or answering machine/service. If the contact person that you are listing is the person receiving the specimen, be certain that the person is aware you are listing him/her as the contact person and has consented to it.

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Security Awareness

A category A infectious substance is in a form that is capable of causing permanent disability or life-threatening or fatal disease in otherwise healthy humans or animals when exposure to it occurs. Exposure would occur if the substance were released from its protective packaging and a human or animal came into contact with it. Therefore, it is critical that a category A infectious substance does not end up in the hands of an unauthorized individual who may purposely or unknowingly release the substance from its protective packaging and endanger humans or animals. Being aware of the people that you interact with in the process of packaging and sending category A substances is vital to the safety of the transport and prevention of a health disaster. An outsider with limited access and system knowledge could constitute a threat, but be aware that insiders could also be a threat, e.g., a disgruntled employee or a person who is angry with his or her supervisor or job or the government. Anyone desiring to do harm could potentially seize the opportunity to steal a hazardous material.Follow these precautionary procedures: When you are questioned about an infectious substance that you are packaging for shipment, it is important that you know the person that is asking AND that he or she has a need to know. If you do not know the person and if you are not aware that the person needs to know about the substance that is being shipped, do not answer the questions. You could refer him or her to your supervisor. Watch for unusual behavior. Secure the package until it is picked up. Check the identification of the courier who will be picking up the package. Use an intralaboratory chain of custody procedure if the specimens are tranferred within the facility or system. Track the package once it has been sent to be sure it arrives safely. Notify the Responsible Official or federal authority if the package does not arrive at its destination.

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Security Plan for Category A Infectious Substances

Each facility that stores and transports hazardous materials must have a written, detailed security plan. The Select Agents and Toxins Security Information Document that was prepared by the Centers for Disease Control and Prevention (CDC) and the U.S. Department of Agriculture, Animal and Plant Health Inspection Service (APHIS) is an excellent resource to use for developing a security plan that would apply to category A infectious substances. This document can be found at http://www.selectagents.gov/resources%5CSecurity%20Information%20Document.pdfThe current version, dated March 8, 2007, is available in this course as a resource. However, because the document does undergo revisions, it is recommended that the URL given above be checked periodically for document updates.

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References

International Civil Aviation Organization. Technical instructions for the safe transport of dangerous goods by air. Doc 9284; 2005 - 2006 ed with amendment. National Laboratory Training Network. Packaging and shipping Division 6.2 materials. Georgia Public Health Laboratory; 2008. Sentinel Laboratory Guidelines for Suspected Agents of Bioterrorism. Available at: http://www.asm.org/ASM/files/LeftMarginHeaderList/DOWNLOADFILENAME/000000001202/Packing&Shipping11-18-05.pdf Accessed on February 13, 2009.US Department of Transportation Pipeline and Hazardous Materials Safety Administration. Transporting Infectious Substances Safely. Guide to changes effective October 1, 2006. Washington, DC; 2006.

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Parasitology Review
A 27 year old male was seen in the emergency room complaining of diarrhea. He had no other symptoms and was in very good health. The doctor ordered a stool for culture and parasite study. The culture revealed no enteric pathogens. This suspicious form was seen on the wet preparations and the permanent stain. It measured 16 µm. With which of the following parasites is this patient most likely infected?View Page
An 18 year old female athlete, who recently competed in a barefoot run for charity in Southern Georgia, presented to her doctor for a routine check-up. Other than complaining of being exhausted and having occasional diarrhea, she was in good health. The doctor ordered a stool for culture and parasite examination. The culture was negative. Numerous suspicious forms, as that shown here, were seen upon microscopic examination of the stool. The name of this suspicious form is:View Page
A 12 year old female went to her doctor for her yearly back-to-school check-up. She was in good health and was asymptomatic at the time of the examination. Due to the increased incidence of parasites in the area, the doctor ordered a stool for parasite examination as part of the routine physical testing. Multiple suspicious forms, measuring approximately 9 µm each were seen. Which of the following is most likely the identification of these forms?View Page
A 45 year old mother of two went to her physician because her children were recently diagnosed with ascariasis and she was concerned that she had also contracted the disease. Other than complaining of recent sporadic diarrhea, she was in overall good health. The doctor ordered a stool for ova & parasite examination. This suspicious form, measuring 55 µm was seen throughout the sample. This form is most likely:View Page
A 17 year old female went to her doctor complaining of diarrhea. With the exception of seasonal allergies, she was in relatively good health. Patient history was unremarkable. A stool was submitted for culture and parasite examination. The culture was reported out as "no enteric pathogens isolated." This suspicious form was seen on wet preparation and permanent stain. It measures 27 µm. This patient is most likely suffering from which of the following conditions:View Page

Pharmacology in the Clinical Lab: Therapeutic Drug Monitoring and Pharmacogenomics
Bioavailability

Bioavailability refers to the amount of drug that actually reaches the circulation. It is calculated by comparing (in the same subjects) the area under the serum concentration - time curve (AUC) of an equivalent dose of the intravenous form and oral form. This is illustrated in the diagram on the right.For IV drugs, the bioavailability is 100%For oral medications, the bioavailability will be less than 100%, due in part to any of these reasons:* Oral drugs take longer to enter the circulation.* Oral drugs have slower absorption and distribution than IV drugs.* The amount of drug that is absorbed can depend on the status of the GI tract (stomach pH, presence of food, integrity/health of the intestines, speed of the GI tract, etc.)For oral drugs to be effective, bioavailability typically should be greater than 70%.Not all of a drug taken orally is able to have a pharmacologic effect; the dose would need to be higher than an IV dose.Since the absorption of an oral drug is slower than an IV drug and the drug takes longer to enter the circulation, clearing the drug will also most likely take a longer time.

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Phlebotomy
What is a phlebotomist’s role in a health care facility?

The phlebotomist collects blood & other specimens which ultimately provide doctors and nurses with laboratory test information critical to patient care.He or she therefore plays a vital role in any health care system.

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What is a phlebotomist’s role in health care facility? [continued]

Phlebotomists work in a variety of settings including: Hospitals Physician Offices Nursing Homes Home Health Care Clinics, and Military facilities. A well trained phlebotomist will therefore have a variety of job opportunities available.Other medical professionals, including nurses, respiratory therapists, and medical assistants may also be trained to collect blood specimens.

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What is a phlebotomist?

A phlebotomist is a medical professional who:Collects blood and other specimens.Prepares specimens for testing. Interacts with patients & health care professionals.

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OSHA bloodborne pathogens standard

The Occupational Health and Safety Administration (OSHA), of the federal government has mandated bloodborne pathogen training for all US workers who are at risk of exposure. The next few slides cover a few highlights of this training. You will receive complete OSHA bloodborne pathogens training before you begin work.

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Needlestick safety and prevention act

The Needlestick Safety and Prevention Act was passed by Congress in November 2000. This law modifies the OSHA Bloodborne Pathogens Standard to require that health-care institutions use only needles and other sharps which have engineering controls and design features to help prevent accidental sharps injury. Health care institutions must update their exposure control plans to reflect these changes.

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Reading Gram Stained Direct Smears

Reading Gram Stained Smears From Cultures

Red Cell Disorders: Peripheral Blood Clues to Nonneoplastic Conditions

Red Cell Morphology

Routine Venipuncture
Vein Palpation

Before attempting a venipuncture, the phlebotomist should assess a vein by palpation. Palpating the vein increases the chance of a successful venipuncture. Use the index or middle finger to palpate the vein following this procedure: Align your finger in the direction of the vein Press on top of the vein with enough pressure to depress the skin Keep your finger in contact with the skin so that you may feel the "bounce back" of a resilient, healthy vein. The phlebotomist uses palpation to assess the depth, width, direction and health (resilience) of a vein. When determining a vein suitable for venipuncture, the skilled phlebotomist relies more on touch or feel than on sight. Looking away from the vein while palpating will help the phlebotomist perfect the skill of palpation leading to good vein assessment. The image on the following page illustrates the considerations for vein assessment.

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Semen Analysis
Sperm count: Normal values

A sperm count is considered normal if it is over 20 million sperm/ml. Although lower counts are considered abnormal by World Health Organization (WHO) standards (see the WHO manual, 1999), it is sometimes possible for men with significantly reduced counts to father a pregnancy.

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The Urine Microscopic: Microscopic Analysis of Urine Sediment

Tuberculosis Awareness for Healthcare Workers
Records and Results

Skin tests are read 48-72 hours after injection by a trained health-care worker such as a physician or nurse.The diameter of any induration is measured in millimeters.Records of the test are kept in the individual's health record for future reference.

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Fundamentals of TB infection control

TB infection controls include: standardized anti-tuberculosis treatment regimens in the initial phase of therapy; rapid drug susceptibility testing; directly observed therapy in which a health professional watches a patient swallow each dose of medication and records the date that the administration was observed; improved infection control practices.

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Biosafety Levels

Laboratory workers who handle infectious materials in the microbiology laboratory should be aware of the work practices, safety equipment, and barriers that will protect them and others in the area from infectious agents. The Centers for Disease Control and Prevention (CDC) and the National Institutes of Health (NIH) created guidelines to assist laboratories in developing safe practices based on the infectious agents that are handled. These guidelines are referred to as Biosafety Levels 1 through 4. Each increasing number represents increased risk, requiring more stringent work practice and increasingly protective safety equipment and barriers. A copy of the Guidelines can be obtained from the CDC or accessed online at:http://www.cdc.gov/OD/ohs/biosfty/bmbl5/bmbl5toc.htm

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Variations in White Cell Morphology - Granulocytes

White Cell and Platelet Disorders: Peripheral Blood Clues to Nonneoplastic Conditions
WBC inclusions: summary

The presence of atypical inclusions within the cytoplasm of neutrophils and other leukocytes should lead to a clinical investigation of the setting for these findings.Atypical neutrophil inclusions may be seen in the following disorders: Chediak-Higashi syndrome, May-Hegglin anomaly, Alder-Reilly anomaly, Fechtner , Sebastian, Epstein and Alport-like syndromes and in infectious and toxic conditions (in the form of Doehle bodies).Although a specific entity may not be evident from examination of the peripheral blood alone, it is important that hematology technologists include a comment reporting on the presence of these inclusions or granules. A clinical investigation with further hematologic and genetic studies may then appropriately be considered.Many of the disorders with atypical neutrophil cytoplasmic granules are also associated with platelet abnormalities, particularly giant platelets (lower photograph).Therefore, when atypical granules are recognized, scanning of the peripheral blood smear for atypical platelets may be revealing. These observations serve as readily identifiable markers for acquired and genetic human maladies, and as a guide for unraveling the reasons for a patient's suffering and impaired health.

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