Lecture 1B - Professional Organizations and Lab Law

Question 1

Role of Professional Organizations

Answer 1

• Advocacy, education, regulation

- Membership Required

Question 2

Examples of Professional Organization

Answer 2

ASCP & ASCLS

Question 3

ASCP

Answer 3

American Society for Clinical Pathology

Question 4

Role of ASCP

Answer 4

To provide excellence in education, certification, and advocacy on behalf of patients, pathologists, and laboratory professionals.

Question 5

ASCLS

Answer 5

American Society for Clinical Laboratory Science

Question 6

Role of ASCLS

Answer 6

To make a positive impact in healthcare through leadership that will assure excellence in the practice of laboratory medicine.

Question 7

CLMA

Answer 7

Clinical Laboratory Managers Association

Question 8

AABB

Answer 8

American Association of Blood Banks

Question 9

AACC

Answer 9

American Association for Clinical Chemistry

Question 10

ASM

Answer 10

American Society for Microbiology

Question 11

ASH

Answer 11

American Society of Hematology

Question 12

AMT

Answer 12

American Medical Technologists

-Certification Exam

Question 13

Licensure is dependent on what?

Answer 13

State; some states require it, some don’t.

Question 14

Accreditation

Answer 14

A Process through which an institution undergoes to ensure competency, authority, and/or credibility.

Question 15

Who undergoes accreditation?

Answer 15

Postsecondary Education Institutions (Colleges) and Hospital Laboratories

Question 16

NAACLS

Answer 16

National Accrediting Agency for Clinical Laboratory Sciences

Question 17

Role of NAACLS

Answer 17

• Accrediting Agency for MLS programs (like UND MLS)

- Provides guidelines, benchmarks, and standards that must be met by the program.

Question 18

TJC

Answer 18

The Joint Commision

Question 19

Role of TJC

Answer 19

Accredits hospital laboratories as well as freestanding entities (whole hospitals, blood collection centers, etc.)

Question 20

COLA

Answer 20

Commission on Laboratory Accreditation

Question 21

Role of COLA

Answer 21

Help laboratories stay in compliance with CLIA ‘88

Question 22

CAP

Answer 22

College of American Pathologists

Question 23

CMS

Answer 23

Centers for Medicare and Medicaid Services

Question 24

Role of CMS

Answer 24

Government agency that regulates all laboratory testing performed on humans in the US.

Question 25

Role of CMS

Answer 25

Government agency that regulates all laboratory testing performed on humans in the US.

Question 26

CLIA ‘88

Answer 26

Clinical Laboratory Improvement Amendments of 1988

Question 27

Role of CLIA ‘88

Answer 27

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

Question 28

Waived Testing

Answer 28

Simple testing that has a low probability of producing an erroneous result. Training and a high school diploma is required. (ex: POC testing)

Question 29

Moderate Complexity Testing

Answer 29

Testing that is often ran by an MLT/MLS (or someone with military experience). (UA Microscopics, chemistry testing, etc.)

Question 30

High Complexity Testing

Answer 30

Testing that is ONLY ran by an MLT/MLS. (Ex: PCR testing).

Question 31

Provider Performed Mircoscopy

Answer 31

Microscopic examination generally performed by a physician in the office setting; still requires CLIA certification. (Ex: Vaginal wet prep).

Question 32

SOP

Answer 32

Standard Operating Procedure

Question 33

FDA

Answer 33

The Food and Drug Administration

Question 34

Role of the FDA

Answer 34

• Categorizes tests based on complexity
• Reviews requests for Waiver by application
• Develops rules/guidance for CLIA complexity categorization

Question 35

CDC

Answer 35

Centers for Disease Control and Prevention

Question 36

Role of CDC

Answer 36

• Provides analysis, research, and technical assistance
• Develops technical standards and laboratory practice guidelines
• Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)

Question 37

HIPAA

Answer 37

Health Insurance Portability and Accountability Act

Question 38

Informed Consent

Answer 38

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.

Question 39

Patient Access Regulations

Answer 39

Patients must have access to their laboratory testing results within 30 days of said test being performed.

Question 40

Chain of Custody

Answer 40

Each step of the analysis, beginning with the collection, all the way to the analysis and reporting of results, must be documented.