Clia and fda regulations - Study guides, Class notes & Summaries

What is accreditation recognition granted by non governmental agency to institutions that meet certain standard (voluntary) What is certification recognition granted by nongovernmental agency to individuals who meet education requirements and demonstrate entry-level competency by assessing exam. (voluntary) What is Licensure permission granted by state to individuates/organizations to engage in certain professions/businesses. (Mandatory) Illegal to practice/operate in that state...

What agency approves new test methodologies, instruments, and reagents before they are available for purchase by consumers? FDA How often should biological safety hoods be inspected? Annually What is the minimum number of standards required for a standard curve? 3 What is the maximum magnification using a brightfield microscope? 1000X What is the most accurate pipette for reconstituting control material? Glass volumetric pipettes Which unit of measure refe...

AABB - Answers American Association of Blood Banks; one of six CMS- approved accreditation organizations Abuse - Answers Improperly, and often unknowingly, violating regulations ALJ hearing - Answers The third level of Medicare appeal; the amount in controversy threshold for 2012 is $130 American Association of Blood Banks - Answers AABB; one of six CMS - approved accreditation organizations. American Osteopathic Association - Answers AOA; one of six CMS - approved accreditation orga...

Laboratory Management: Regulation and Compliance VERIFIED SOLUTIONS Clinical Laboratory Improvement Amendments of 1988 Regulates all clinical laboratory testing regardless of where it is performed. All laboratory testing must be performed under an approved CLIA certificate. CLIA Agency Administration Responsibilities CMS - Approves private accreditation organizations FDA - Categorizes tests based on complexity Test Site Neutrality All sites handling materials derived form the...

Social Security Act of 1965 It was signed into law by President Johnson on July 30, 1965. The law established both Medicare, the health insurance program for Americans over 65 and Medicaid, the health insurance program for low-income Americans. Health Care Financing Administration (HCFA) Created in 1977 to combine, under one administration, the oversight of Medicare and Medicaid under the HCFA (the predecessor of CMS). Medicare Signed into law in 1965, Medicare is a Health...

Pharmacy Law, Exam Questions and answers, Rated A+ ____ are passed by federal, state, and local legislatures statutes ____ clarify and explain statutes regulations ____ is the legal interpretation of the law and is determined by judges in a case law legislative intent ___ enforces regulations (board of medicine, department of health) regulatory agency What happens when federal and state laws cover the same issue? The most stringent of the two applies ____ refine laws and regulations...

Clinical Laboratory Improvement Amendments (CLIA) Exam Questions With Verified Answers. CLIA - answerstandards of quality, proficiency testing, and competency in the lab- 1967 CLIA standard - answeridentifies specific, essential requirements for materials, methods, or practices CLIA '88 - answerexpanded the scope of CLIA '67; labs are required to submit to routine periodic inspections; law requirements for staffing, management, procedures, and oversight of US labs that perform testing ...

Chapter 01: Fundamentals of the Clinical Laboratory Turgeon: Linné & Ringsrud’s Clinical Laboratory Science, 7th Edition MULTIPLE CHOICE 1. The ASCLS professional Code of Ethics states that all laboratory professionals have a responsibility for proper conduct toward: a. the patient. b. colleagues and the profession. c. society. d. all of the above. ANS: D The Code of Ethics sets forth the principles and standards by which clinical laboratory professionals practice their profession....

Laboratories performing which of the following types of test need to be enrolled in a CLIA approved proficiency testing program? a. waived b. moderately complex c. highly complex d. both b & c - ANSWER-d. both b & c Departments of the clinical laboratory includes all except- a. clinical chemistry b. coagulation c. blood bank d. radioloy - ANSWER-d. radiology Which statement/s is/are true about CLIA'88? a. CLIA'88 specifies the minimum performance standards for government laborat...

Social Security Act of 1965 - Answer- It was signed into law by President Johnson on July 30, 1965. The law established both Medicare, the health insurance program for Americans over 65 and Medicaid, the health insurance program for low-income Americans. Health Care Financing Administration (HCFA) - Answer- Created in 1977 to combine, under one administration, the oversight of Medicare and Medicaid under the HCFA (the predecessor of CMS). Medicare - Answer- Signed into law in 1965, Medicar...