Chapter 1: Introduction to Blood Collection
Clinical Laboratory Improvement Amendments (CLIA) - Answer- Federal regulations governing laboratories that test human samples
Clinical and Laboratory Standards Institute (CLSI) - Answer- Nonprofit organization that publishes standards and guideline...
Chapter 1: Introduction to Blood
Collection
Clinical Laboratory Improvement Amendments (CLIA) - Answer- Federal regulations
governing laboratories that test human samples
Clinical and Laboratory Standards Institute (CLSI) - Answer- Nonprofit organization
that publishes standards and guidelines for clinical laboratory procedures
Health Insurance Portability and Accountability Act (HIPAA) - Answer- Legislation
that guarantees the privacy of individual information
Procedures are written in accordance with the current standards of - Answer- CLSI
OSHA
CDC
Specimen - Answer- Portion of bodily fluid or tissue taken for examination
Pre-examination errors - Answer- Monitoring of sample ordering
Correct patient information
Patient communication and safety
Timing of collections
Phlebotomy equipment
Collection technique
Sample labeling
Sample handling, transportation, processing
Laboratories charged with the responsibility for reliable and timely test results by -
Answer- CLIA
CLIA administered by: - Answer- CMS
FDA
CLIA classifies test as: - Answer- Waived
Moderate complexity
High complexity
, Provider performed microscopy procedures
All laboratories performing tests on human species for the purpose of diagnosing,
prevention, treatment, monitoring must be licensed and obtain a certificate by -
Answer- Centers for Medicare & Medicaid Services (CMS)
Laboratories are subject to inspection every 2 years by - Answer- CMS
CAP
TJC
COLA
COLA - Answer- Commission on Laboratory Assessment
All laboratory procedures are written in accordance with the current standards of -
Answer- CLSI
Example of a waived test - Answer- Pregnancy test
Easy to perform following manufacturer's instruction
PPMP can be preformed by - Answer- Physician
Dentist
Midlevel practitioner
Require documental of training in test principles, instrument calibration, periodic
proficiency testing, competency assessment, on-site inspections - Answer- Moderare
complexity
Require sophisticated instrumentation and a high degree of interpretation
Proficiency testing and on-site inspections required - Answer- High complexity tests
Consists of representatives from labs, industry, and government - Answer- CLSI
Moderate complexity testing can be performed by - Answer- Person with high school
dipolma
Example of moderate complexity test - Answer- CBC
High complexity test can be performed by - Answer- Person with clinical lab science
degree
Example of high complexity test - Answer- Urine culture and sensitivity
Accrediting Agencies - Answer- TJC
CAP
COLA
TJC (3) - Answer- Independent
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