quality assurance and quality control

Question 1

improving the accuracy and reliability of testing; ensure that reported laboratory results are of the highest quality

Answer 1

quality assurance (QA) programs and quality control (QC)

Question 2

_____ established a minimum threshold for all aspects of clinical laboratory testing

Answer 2

CLIA

Question 3

____________ was passed in response to the concerns about laboratory testing errors

Answer 3

Clinical Laboratory Improvement Amendments of 1988 (CLIA ’88)

Question 4

_____, ______, _______ : also established standards

Answer 4

The Joint Commission (TJC), the Commission on Office Laboratory Accreditation (COLA), and the College of American Pathologists (CAP)

Question 5

• voluntary accreditation aimed at improving quality
• world’s largest nongovernmental developer and publisher of international standards

Answer 5

International Organization for Standardization (ISO)

Question 6

_______ has now been formulated for clinical laboratories

Answer 6

ISO 15189

Question 7

NONANALYTICAL FACTORS RELATED TO TESTING ACCURACY

Answer 7

1. Qualified Personnel
2. Established Laboratory Policies
3. Laboratory Procedure Manual
4. Test Requisitioning
5. Patient Identification, Specimen Procurement, and Labeling
6. Preventive Maintenance of Equipment
7. Appropriate Testing Methods
8. Inaccurate Results

Question 8

(1) Laboratory policies should be included in a _________.

Answer 8

Laboratory reference manual

Question 9

and (Lab policies) must have up-to-date ________

Answer 9

Safety Manual

Question 10

(2) this manual (safety manual) contains a comprehensive listing of _______, ________, and ________, ____________

Answer 10

approved policies, acceptable practices, precautions, Occupational Safety and Health Administration (OSHA) regulations

Question 11

(3) manual for all analytical procedures performed in the laboratory reviewed _________

Answer 11

regularly/ annually

Question 12

(4) laboratory test request must include the following:

Answer 12

(1) patient identification data;
(2) time and date of specimen collection;
(3) source of the specimen;
(4) test to be performed

Question 13

(5) _______ can only be as good as the specimen

Answer 13

analytical result

Question 14

(6) Microscopes, centrifuges, and other pieces of equipment need to be _____ and ________

Answer 14

cleaned ; checked for accuracy

Question 15

(7) must have an assessment routine for all procedures, performed on a daily, weekly, or monthly basis, to detect problems

Answer 15

Appropriate Testing Methods

Question 16

(8) eliminated by a program that monitors equipment, reagents, and other supplies

Answer 16

Systematic errors

Question 17

(8) produce false-positive and false-negative results, depending on the technique used for testing

Answer 17

Sporadic or isolated errors in technique