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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.
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.
How often does CAP inspect accredited labs? Every 2 years CAP inspections are peer reviews.
Name a non-governmental agency that accredits blood banks. The American Association of Blood Banks (AABB).
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.
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.
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).
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.
Which federal agency issues regulations to ensure employee safety? the Occupational Safety & Health Administration (OSHA).
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
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.
Which agency regulates market entry of instruments & reagents? the Food & Drug Administration (FDA)
Which federal agency regulates facilities that use radioisotopes? the Nuclear Regulatory Commision (NCR)
which federal agency regulates packaging, labeling, & transport of biological products? The Department of Transportation (DOT)
Which federal agency regulates disposal of toxic chemical & biohazardous wastes? The Environmental Protection Agency (EPA). State or local regulations may also apply.
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).
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.
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.
What are the levels of testing complexity under CLIA '88? Waived, provider-performed microscopy, moderately complex, & highly complex.
Labs of which complexity level are required to perform QC & participate in proficiency testing? All except waived.
What is the complexity level of most of the analyses performed in clinical labs? approx. 75% are classified as moderately complex
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
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.
Created by: dayzemai
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