Phlebotomy Regulatory Agencies

OSHA (Occupational Safety and Health Administration) main role.

Enforces workplace safety standards, Blood Borne Pathogens Standard, requires use of PPE, sharps containers, and exposure control plans, mandates Hepatitis B vaccination be offered to healthcare workers.

OSHA Bloodborne Pathogens Standard is designed to

protect healthcare workers from the risk of exposure to bloodborne pathogens such as HIV, Hepatitis B (HBV), and Hepatitis C (HCV).

CLIA (Clinical Laboratory Improvement Amendments) mai role.

Federal regulatory program overseen by the Centers for Medicare & Medicaid Services (CMS) in the United States. Regulates laboratory testing quality in the U.S.

CLIA defines what testing complexity levels?

Waived, moderate, high

Phlebotomy practices in clinical laboratories must comply with what regulations?

CLIA regulations to ensure accurate and reliable test results.

What is a CLIA waived test?

A simple laboratory test that has been designated as having low risk for error and can be safely performed at the point of care (POC) by trained non-laboratory personnel.

What is Quality assurance (QA)?

A broad, system-wide plan of actions, policies, and procedures designed to ensure quality throughout the entire healthcare process, from patient prep to specimen delivery and test reporting.

What is Quality Control (QC)?

The specific, measurable procedures and checks that ensure lab tests and equipment are working accurately and reliably.

What are examples of Quality Control (QC)?

Running control samples with each test batch, calibrating equipment (centrifuges, glucose meters), checking expiration dates on tubes and reagents, recording daily temps of refrigerators, and documenting lot numbers and results off control checks.

How is Quality control for glucometers done?

Use control solutions to check the meter: when opening a new strip bottle, if results seem off, and daily, or per facility policy.

A coded glucometer requires you to do what before every use?

To enter a new code or confirm it to match the test strip give every use.

Centers for Disease Control and Prevention (CDC) main role.

Develops guidelines for infection control and public health

Centers for Disease Control and Prevention (CDC) phlebotomy relevance.

Creates Standard Precautions and hand hygiene protocols, provides recommendations handling and disease prevention.

The Joint Commission (TJC) main role.

Accredits healthcare organizations and ensures quality of care.

The Joint Commission (TJC) phlebotomy relevance.

Monitors patient safety practices, reviews compliance with proper patient identification before specimen collection, TJC requires phlebotomists to use at least two patient identifiers before collecting blood specimens or performing any invasive procedures.

HIPPA (Health Insurance Portability and Accountability Act) main role.

Protects patient privacy and health information.

HIPPA (Health Insurance Portability and Accountability Act) phlebotomy relevance.

Phlebotomists must keep patient data confidential, must not discuss lab or patient info in public areas.

National Institute for Occupational Safety and Health (NIOSH) main role.

A federal research agency focused on worker safety and health, it makes recommendations (not laws) to prevent workplace injuries and illnesses.

National Insitute for Occupational Safety and Health (NIOSH) phlebotomy relevance.

Provides guidelines and recommendations for the safe handling and disposing of sharps, recommends that sharps containers be disposed of when they are three-quarters full.

Clinical and Laboratory Standards Institute (CLSI) main role.

Is a nonprofit organization that sets standards and guidelines for laboratory procedures, including specimen collection and handling.

Clinical and Laboratory Standards Institute (CLSI) phlebotomy relevance.

Establishes the Order of Draw, sets protocols for blood culture collection, tube inversion, and specimen handling, provides best practices to ensure accuracy, safety, and consistency in lab testing