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| Acquired Immunodeficiency Syndrome |
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| College of American Pathologists |
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| Centers for Disease Control and Prevention |
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| Chemiluminescent Immunoassay |
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| Clinical Laboratory Improvement Amendments of 1988 |
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| Clinical Laboratory and Standards Institute |
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| Centers for Medicare and Medicaid Services |
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| Coagulase-negative staphylococci |
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| Diptheria, tetanus, pertussis vaccine |
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| Enzyme Linked Immunosorbent Assay |
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| Erythrocyte Sedimentation Rate |
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| Food and Drug Administration |
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| Gram Negative Coccbacilli |
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| Hepatitis B Immune Globulin |
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| Hemolytic Disease of the Fetus & Newborn |
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| Haemophilus Influenzae type b |
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| Health Insurance Portability and Accountability Act of 1996 |
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| Human Immunodeficiency Virus |
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| Indirect antiglobulin test |
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| Indirect fluorescent antibody |
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| Methicillin-resistant Stapylococcus Aureus |
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| Occupational Safety and Health Administration |
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| Polymerase Chain Reaction |
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| Polymerase Chain Reaction |
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| Protection Health Information |
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| Polymorphonuclear leukocyte, granulocyte |
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| Purified Protein Deriative |
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| Quality Assurance or Assessment |
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| Room temperature (20-24oC) |
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| Polymorphonuclear leukocyte, granulocyte |
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| Purified Protein Derivative |
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| Quality Assurance or Assessment |
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| Respiratory Tract Infection |
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| Standard Operating Procedure |
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| Vacomycin-resistant enterococci |
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Recognition granted by non-governmental agency to institutions that meet certain standards (Voluntary)
i.e AABB, CAP, JCAHO, NAACLS |
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Recognition granted by nongovernmental agency to individuals who meet education requirements & demonstrate entry-level competency by passing exam. Voluntary.
ASCP, AAB, AMT |
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| Permission granted by state to individuals/organizations to engage in certain professions/businesses. Mandatory. Illegal to practice/operate in that state without license. |
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| American Association of Blood Banks (technical standards & accreditation of blood banks) |
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| Centers for Disease Control & Prevention, Standards & Guidelines primarily related to infection control & safe work practices |
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| Clinical Laboratory & Standards Institute - Standards on all aspects of lab practice developed through voluntary consensus. |
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| International Organization for Standardization - Standards to facilitate international exchange of goods & services. Developed through voluntary worldwide consensus. ISO 15189 defines standards for management in medical labs. |
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| Centers for Medicare & Medicaid Services - Writes regulations for & enforced Clinical Laboratory Improvement Amendments of 1988 (CLIA 88) |
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| Department of Health & Human Services - Interprets & implements federal regulations related to health care. Oversees CDC, CMS, FDA, SAMSHA. |
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| Department of Transportation - Regulates packaging, labeling & transportation of |
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| Environmental Protection Agency - Regulates Disposal of Toxic Chemical & Biohazardous wastes. |
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| Food & Drug Administration - Regulates Market Entry of instruments/reagents & production of donor blood & components. Licenses blood banks. |
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| Nuclear Regulatory Commission - Licenses labs that use radionucleotides. |
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| Occupational Safety & Health Administration - Regulates employee safety in the workplace |
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| Substance Abuse and Mental Health Services Administration - Certifies laboratories to conduct forensic drug testing for federal agencies. |
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| Hazard Communication Standard (OSHA 1983) "Right-to-Know law" |
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| Requires Employers to inform employee about hazardous substances in workplace & educate them in safe handling |
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| Clinical Laboratory Improvement Amendments of 1988 "CLIA '88" |
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| Regulates all lab testing (except research) performed on humans U.S. requirements for personnel & quality assurance determined by test complexity. Administered by CMS. |
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| Occupational Exposure to Hazardous Chemicals in Laboratories (OSHA 1990) "Laboratory Standard" |
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| Requires chemical Hygiene plan to minimize personnel exposure to hazardous chemicals in labs |
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| Bloodborne Pathogens Standard (OSHA 1991) |
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| Mandates work practices & procedures to minimize worker exposure to bloodborne pathogens. |
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| Formaldehyde Standard (OSHA 1992) |
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| Requires monitoring of formaldehyde exposure. |
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| Health Insurance Portability and Accountability Act of 1996 "HIPAA" |
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| Regulates use & disclosure of protected health information (PHI) |
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Criteria - Tests cleared by FDA for home use, negligible likelihood of erroneous results, or no reasonable risk of harm to patient if performed incorrectly
QC - None required other than follow manufacturers' directions
PT - Not required
TP - None specified |
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| Provider - Performed Microscopy (PPM) |
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Criteria - Certain Microscopic exams performed by provider during patient's visits, e.g., direct wet mount, KOH prep, urine sediment
QC- Required when controls are available; otherwise, reference materials (e.g. photomicrographs) fulfill requirement
PT - not specifically required, but labs must verify accuracy of testing twice annually. Can be through PT, split sampling, or blind testing
TP - Physician, midlevel practitioner |
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Criteria - Score <= 12 on 7 criterias**
QC - 2 levels of external controls each day of testing
PT - required
TP - High School Diploma or equivalent |
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Criteria - Score of > 12 on 7 Criteria
Quality Control - 2 levels of external controls each day of testing
PT - Required
TP - Associate degree in medical laboratory technology or equivalent |
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| Bloodborne Pathogens Standard - History |
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Definition
| Published in 1991. Revised in 2001 following passage of Needlestick safety & prevention act to include stronger requirements for employers to evaluate & adopt safer medical devices |
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| Bloodborne Pathogens Standard (Purpose) |
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Definition
| To protect health-care workers from occupational exposure to bloodborne pathogens (BBP; e.g., HIV, HBV, HCV) |
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| Bloodborne Pathogens Standard (requirements |
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Definition
Exposure Control Plan
Universal Precautions
Engineering Controls
Work Practice Controls
Personal Protective Clothing & Equipment
Housekeeping
Training
Medical Surveillance
Hepatitis B Vaccine
Hazard Communication
Sharps Injury Log |
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| Potentially Infectous Agents |
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Definition
Blood
Tissue
Semen
Vaginal Secretions
Cerebrospinal Fluid
Synovial Fluid
Pleural Fluid
Peritoneal Fluid
Pericardial Fluid
Amniotic Fluid
Saliva in Dental Procedures |
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| Usually not infectous unless visibly bloodly |
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Definition
Feces
Nasal Secretions
Sputum
Sweat
Tears
Urine
Vomitus |
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| Primary Container Shipping |
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Definition
| Test tube, vial etc. containing etiologic agent. Must be securely closed, watertight, surrounded by absorbent material, & placed in secondary container. |
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| Secondary Container Shipping |
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| Must be Watertight, sealed & Placed in approved mailing container. |
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| Mailing Container Shipping |
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Definition
| Must be made of Fiberboard |
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| Biohazard label required on primary and mailing containers |
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| Employees must be trained & retrained every 2-3 yr or when regulations change. |
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