Lecture 1B - Professional Organizations and Lab Law Flashcards
Role of Professional Organizations
- Advocacy, education, regulation
- Membership Required
Examples of Professional Organization
ASCP & ASCLS
ASCP
American Society for Clinical Pathology
Role of ASCP
To provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals.
ASCLS
American Society for Clinical Laboratory Science
Role of ASCLS
To make a positive impact in healthcare through leadership that will assure excellence in the practice of laboratory medicine.
CLMA
Clinical Laboratory Managers Association
AABB
American Association of Blood Banks
AACC
American Association for Clinical Chemistry
ASM
American Society for Microbiology
ASH
American Society of Hematology
AMT
American Medical Technologists
-Certification Exam
Licensure is dependent on what?
State; some states require it, some don’t.
Accreditation
A Process through which an institution undergoes to ensure competency, authority, and/or credibility.
Who undergoes accreditation?
Postsecondary Education Institutions (Colleges) and Hospital Laboratories
NAACLS
National Accrediting Agency for Clinical Laboratory Sciences
Role of NAACLS
- Accrediting Agency for MLS programs (like UND MLS)
- Provides guidelines, benchmarks, and standards that must be met by the program.
TJC
The Joint Commision
Role of TJC
Accredits hospital laboratories as well as freestanding entities (whole hospitals, blood collection centers, etc.)
COLA
Commission on Laboratory Accreditation
Role of COLA
Help laboratories stay in compliance with CLIA ‘88
CAP
College of American Pathologists
CMS
Centers for Medicare and Medicaid Services
Role of CMS
Government agency that regulates all laboratory testing performed on humans in the US.
Role of CMS
Government agency that regulates all laboratory testing performed on humans in the US.
CLIA ‘88
Clinical Laboratory Improvement Amendments of 1988
Role of CLIA ‘88
To ensure that laboratory testing results that are reported are of high quality regardless of where the testing is performed.
- Proficiency programs
- QA/QC programs
- Inspection and site visits
- Personnel Requirements
Waived Testing
Simple testing that has a low probability of producing an erroneous result. Training and a high school diploma is required. (ex: POC testing)
Moderate Complexity Testing
Testing that is often ran by an MLT/MLS (or someone with military experience). (UA Microscopics, chemistry testing, etc.)
High Complexity Testing
Testing that is ONLY ran by an MLT/MLS. (Ex: PCR testing).
Provider Performed Mircoscopy
Microscopic examination generally performed by a physician in the office setting; still requires CLIA certification. (Ex: Vaginal wet prep).
SOP
Standard Operating Procedure
FDA
The Food and Drug Administration
Role of the FDA
- Categorizes tests based on complexity
- Reviews requests for Waiver by application
- Develops rules/guidance for CLIA complexity categorization
CDC
Centers for Disease Control and Prevention
Role of CDC
- Provides analysis, research, and technical assistance
- Develops technical standards and laboratory practice guidelines
- Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)
HIPAA
Health Insurance Portability and Accountability Act
Informed Consent
Legal consent granted by the patient whereby he or she is made aware of, understands, and agrees to the nature of the testing or services to be done.
Patient Access Regulations
Patients must have access to their laboratory testing results within 30 days of said test being performed.
Chain of Custody
Each step of the analysis, beginning with the collection, all the way to the analysis and reporting of results, must be documented.
