Q & A's - General
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| compare certification & accreditation | Both are voluntary non-government credentialing processes that provide recognition for acheivement of high standards. Institutions are accredited. Individuals are certified.
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| Name 2 non-governmental agencies that accredit hospitals and laboratories. | The Joint Commision on Accreditation of Health Care Organizations (JCAHO), which accredita the entire hospital. College of American Pathologists (CAP), which accredits clinical laboratories.
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| How often does CAP inspect accredited labs? | Every 2 years CAP inspections are peer reviews.
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| Name a non-governmental agency that accredits blood banks. | The American Association of Blood Banks (AABB).
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| What is the difference between certification and licensure? | certification is voluntary where a non-gov. agency grants recoginition to a person met ecucation requirements & competency by exam. Licensure is mandatory by some states to grant permission to a person or orginazation to engage in a given occupation.
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| Which states require lecensure of clinical lab personel? | California, Florida, Georgia, Hawaii, Louisiana, Montana, Nevada, North Dakota, Rhode Island, Tennessee, & West Virginia. Other states require licensure of clinical labs but not lab personnel.
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| Name several professional organizations that certify clinical lab personel. | The American Society for clinical Pathology (ASCP), the National Credentialling Agency for Laboratory Personnel (NCA), American Medical Technologists (AMT), & the American Association of Bioanalysts (AAB).
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| A Hospital ad reads "Medical Technologist, ASCP or equivalent". Which of the following credentials w/b equivalent: CLS(NCA), CLT(NCA), MLT(AMT), POLT(ISCLT), CPT(NPA)? | CLS(NCA). NCA uses the title Clinical laboratory Scientist instead of Medical Technologist & Clinical laboratory Technician instead of Medical Laboratory Technician.
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| Which federal agency issues regulations to ensure employee safety? | the Occupational Safety & Health Administration (OSHA).
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| What reporting is required for serious accidents that result in fatalities or hospitization of 3 or more employees? | they must be reported to OSHA w/i 8 hours
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| Which federal agency regulates blood banks? | The Food & Drug Administration (FDA). The FDA has authority over blood banks because blood is considered both a biologic & a drug.
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| Which agency regulates market entry of instruments & reagents? | the Food & Drug Administration (FDA)
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| Which federal agency regulates facilities that use radioisotopes? | the Nuclear Regulatory Commision (NCR)
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| which federal agency regulates packaging, labeling, & transport of biological products? | The Department of Transportation (DOT)
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| Which federal agency regulates disposal of toxic chemical & biohazardous wastes? | The Environmental Protection Agency (EPA). State or local regulations may also apply.
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| Which federal agency issues mandatory guidelines for labs performing forensic toxicology? | The Substance Abuse & Mental Health Services Administration (SAMHSA), formerly known as the Nationsl Institute on Drug Abuse (NIDA).
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| What is the federal legistationn that regulates almost all clinical labs in the US? | The Clinical Laboratory Improvement Amendments os 1988 (CLIS '88). It establishes regulations for personnel qualifications, competency assessment, patient test management, quality control, Quality assurance, and proficiency testing.
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| Which labs are subject to regulation under CLIA '88? | All labs that exam human specimens for diagnosis, prevention, or treatment of disease. there areexemptions for the Vets admin., the armed forces, & SAMHSA plus work done for legal or employment eligibility pruposes & research not used for patient care.
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| What are the levels of testing complexity under CLIA '88? | Waived, provider-performed microscopy, moderately complex, & highly complex.
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| Labs of which complexity level are required to perform QC & participate in proficiency testing? | All except waived.
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| What is the complexity level of most of the analyses performed in clinical labs? | approx. 75% are classified as moderately complex
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| What is CLSI? | The clinical & Laboratory standards Institute, an organization the issues standards of lab practice developed through a voluntary consensus process. Not a regulatory agency. Formerly known as the National Committee for Clinical Laboratory Standards (NCCLS
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| what is the role of the Centers for Disease Control & Prevention (CDC)? | It issues standards & guidelines for hospitals & labs, primarily related to infection control & safe work prices, Its role is advisory agency & does not have enforcement authority.
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