MLT 131 Laboratory Techniques – Regulatory, Credentialing and Ethics Flashcards

A set of practice flashcards covering CLIA regulations, accreditation bodies, hospital lab departments, credentialing, allied personnel, medical-legal issues, ethics, and related regulatory concepts from the notes.

What is CLIA '88 and what does it regulate?

Clinical Laboratory Improvement Amendments of 1988; sets minimum required standards for clinical laboratory testing, including proficiency testing, quality assessment and QC, personnel requirements, and inspections.

What are the minimum standards required by CLIA '88?

Proficiency testing (PT), quality assessment and quality control (QC) systems, personnel requirements (education, training, and experience), and inspections/site visits.

What criteria does CLIA use to classify the levels of testing?

Risk of harm to the patient; risk of erroneous result; type of testing method; degree of independent judgment and interpretation; availability of the test for home use.

What are the levels of testing under CLIA?

Waived, Moderate complexity, High complexity, and Provider-Performed Microscopy (PPM).

Which agency regulates laboratory testing on human body materials for diagnosis, prevention, and treatment?

Centers for Medicare and Medicaid Services (CMS).

Name the top three healthcare accrediting agencies.

College of American Pathologists (CAP), COLA, and The Joint Commission (TJC).

What is CAP known for?

Largest accreditation program; internationally recognized; strict, specialty-specific standards.

What is COLA known for regarding CMS status?

First organization to receive deemed status by CMS; cost-effective; physician-directed.

What is The Joint Commission's focus?

Concentrates on operational systems.

List the major hospital laboratory departments.

Immunohematology; Chemistry; Hematology; Hemostasis; Immunology/Serology; Microbiology; Urinalysis.

What alternate sites of testing are mentioned?

Physician Office Laboratories (POL); Reference Laboratories; Government laboratories (State and Federal).

Name credentialed professionals in the clinical laboratory.

Medical Laboratory Assistant (MLA/CA), Medical Laboratory Technician (MLT/CLT), Medical Laboratory Technologist (MLS/MT), Specialist Certified Phlebotomy Technicians (PT), Pathologists’ Assistant (PA), Diplomat in Laboratory Management (DLM).

Which organizations govern credentialing and professional standards?

American Society of Clinical Pathologists (ASCP), American Society of Clinical Laboratory Science (ASCLS), National Accrediting Agency for Clinical Laboratory Sciences (NAACLS), American Medical Technologists (AMT).

What are continuing education requirements to maintain national certification?

36 hours of documented professional development (PD) every 3 years (as per ASCP).

Who are the other allied health personnel in the clinical laboratory?

Certified medical assistant/registered medical assistant; Physician office laboratory technician; Diagnostic molecular scientist; Point-of-care technician; Paramedics; Nursing staff.

What are the educational and licensing considerations for laboratory personnel?

Educational programs and accrediting agencies; Educational requirements; Areas of specialization; Credentialing and certification; Licensing of laboratory professionals.

What are the medical-legal issues in clinical laboratory practice?

Informed consent; HIPAA; New patient access regulations; Chain of Custody; Other legal considerations.

What are the ASCLS Code of Ethics duties?

Duty to patient; Duty to colleagues and the profession; Duty to society.

What actions can result from legal action in lab settings?

Criminal or civil prosecution; Local, State, and Federal actions initiated by patients or family.

What is HIPAA and what does it regulate?

Health Insurance Portability and Accountability Act; governs patient privacy and access to health information.

How is accreditation related to Medicare/Medicaid reimbursement?

Labs must be in good standing with an accrediting agency approved by the federal government to receive Medicare/Medicaid reimbursement; CLIA oversight can be satisfied via accreditation.

What is Provider-Performed Microscopy (PPM)?

A CLIA category of testing involving microscopy.

What is proficiency testing (PT) under CLIA used for?

To evaluate the laboratory's testing accuracy by comparing results with known standards.

What does 'deemed status' mean in the CMS context and which organization achieved it first?

CMS recognition of an accrediting body's ability to regulate labs; COLA was the first organization to receive deemed status by CMS.