Intro to Phlebotomy Part 2

• American Association of Blood Banks- Accredits blood banks and develops standards for blood donor, blood product, and blood recipient safety
• American Society for Histocompatibility and Immunogenetics- Inspects and accredits laboratories that perform histocompatibility testing
• Centers for Disease Control and Prevention- Categorizes newly developed laboratory tests
• Centers for Medicare & Medicaid Services- The agency that established regulations to implement CLIA '88
• Clinical and Laboratory Standards Institute- Sets standards for clinical laboratory testing procedures
• College of American Pathologists- Accredits hospital and reference laboratories
• Commission on Office Laboratory Accreditation- Accredits physician office laboratories
• Department of Health and Human Services- Oversees the operations of the CMS
• Department of Transportation- Sets requirements for safe packaging and transport of HAZMATs
• Environmental Protection Agency- Ensures correct disposal of medical waste
• Food and Drug Administration- Approves medical equipment, pharmaceuticals, reagents, and diagnostic tests before use-laboratory-issued pharmaceuticals include blood products
• National Accrediting Agency for Clinical Laboratory Sciences- Approves phlebotomy training programs
• Nuclear Regulatory Commission- Regulates handling and disposal of radioactive materials
• Occupational Safety and Health Administration- Regulates practices to ensure worker safety in the workplace
• The Joint Commission- Accredits healthcare facilities to ensure high standards of patient care
• Professionalism includes a sincere interest in providing health- care, a standard of excellence, training, accountability, and pride in your work.
• Regulatory agencies routinely visit and inspect laboratories and medical offices to evaluate quality control and quality assurance.
• Laboratory facilities must have quality assurance programs in place to ensure that tests are effective and accurate.
• The 1988 Clinical Laboratory Improvement Amendments (CLIA ’88), a revision of CLIA ’67, were established to ensure that all laboratories receiv- ing federal funds, regardless of size, type, or location, would meet the same standards and be certified by the federal government.
• Centers for Medicare & Medicaid Services (CMS) is the main regulatory body for all laboratories and established qualifications for phlebotomists.
• Classifications of laboratories are based on the complexity of testing performed and the associated patient risks if the tests are not performed properly.
• Waived are not subject to inspections because they perform only simple tests that have minimal associated patient risks, such as dipstick urine testing.
• Moderately Complex tests are simple tests but still requires skills. An example is fecalysis.
• Highly Complex are complicated tests. An example is HIV Testing.
• CLIA was established on 1967 and was revised on 1988.
• The Joint Commission- Accredits healthcare facilities to

  ensure high standards of patient care. It focuses on hospitals.
• College of American Pathologists- Accredits hospital and reference laboratories. It focuses on medical laboratories.
• Clinical Laboratory Standards Institute- Develops and publishes national and international standards for

  clinical testing procedures. Standards in developing the

  laboratory’s procedures and policies.
• CLSI have three phases. Before 2010, it was called pre-analytical, analytical, and post-analytical. After 2010, it is called pre-examination! examination, and post-examination.
• Centers for Disease Control and Prevention- Implements public health regulations and reporting requirements. Categorize newly developed laboratory tests as waived,

  moderately complex, or highly complex
• Occupational Safety and Health Administration- Regulates concerns over worker safety for the clinical laboratory
• Environmental Protection Agency- Ensures that healthcare providers follow Medical Waste Tracking Act, Department of

  Transportation, and Nuclear Regulatory Commission
• Food and Drug Administration- Approves medical and diagnostic equipment, pharmaceuticals, reagents, and

  diagnostic tests before these can be marketed. Regulates content-labeling requirements
• Attitudes of a Professional:

  Integrity

  Compassion

  Motivation

  Work Ethic

  Diplomacy

  Dependability
• LEGAL ISSUES:

  Confidentiality

  Battery

  Negligence

  Malpractice
• The Medical Waste Tracking Act- defines medical waste (laboratory specimens and items contaminated by blood or body fluids) and establishes acceptable practices for treatment and disposal of this waste.
• Department of Transportation (DOT) establishes requirements for safe packaging and transport of biologically hazardous and other hazardous materials (HAZMATs), such as used or expired laboratory chemicals.
• The Nuclear Regulatory Commission (NRC) regulates handling and disposal of radioactive materials (radionuclides used in therapy).
• There may be times when the blood bank needs to irradiate blood products for transfusion. This may occur when patients need blood in which the white blood cells have been deactivated.
• Filters or barriers —pain, fear, visitors, or the television—may be present and can interfere with a receiver decoding a message.