CLIA

Question 1

What is Clinical Laboratory Improvement Amendments (CLIA)?

Answer 1

• federal regulation (law)
• regulates all laboratory testing (except research) on human samples
• established quality standards

Question 2

T/F Only some labs need CLIA licenses.

Answer 2

FALSE

ALL labs must have CLIA license to do business of laboratory testing (except research) on human specimens

Question 3

CLIA regulations are site _________.

Answer 3

Neutral

All regulations are the same no matter the location, size of location or type of laboratory.

Question 4

Are CLIA licenses facility or personnel based?

Answer 4

Facility

Question 5

The laboratory is issued a certificate in which categories (4)?

Answer 5

Waived
PPM
Moderate
High
categories are based on complexity of testing method/instrument and how complex it is for the person to perform the test.

Question 6

T/F testing personnel are responsible for all aspects of the lab operation.

Answer 6

FALSE
Director: responsible for all aspects of lab operation (MD, CLS)
Testing personnel: education, on-site training, yearly competency assessment

Question 7

Procedure Manual Requirements are:
A) Specific guidelines for each test performed
B) Must be approved and signed/dated by lab director initially, then yearly, and with each change
C) Available to all testing personnel
D) Provide procedural steps to perform the test
E) All of the above

Answer 7

E) All of the above

It also provides information about:

• specimen collection, handling, processing
• instrumentation calibration, verification, maintenance
• quality control requirements, frequency, evaluation

Question 8

What are quality control requirements? How long are records maintained?

Answer 8

How often must quality control must be tested and how to determine the validity.
Must be maintained for at least 2 years.
-5years immunohematology
-10 years pathology

Question 9

Accuracy, Precision, Sensitivity, Specificity, Linearity, Reportable Range, and Reference Range are examples of:

Answer 9

Method Verification Requirements

Question 10

T/F In order to maintain CLIA certification (moderate-high complexity) proficiency testing is performed periodically.

Answer 10

True
Lab enrolls in a approved testing program. The PT program sends lab ‘unknown’ specimen, lab runs the tests, sends the results back, and must PASS to maintain certification.

Question 11

Quality assurance program evaluates the ongoing and overall of the total testing process through:
A) Error detection
B) Corrective actions
C) Incorporating future improvements
D) all of the above

Answer 11

D) All of the above

Question 12

Patient test management requirements: Lab must define specific policies to ensure maintaining sample integrity and _______ _________ identification throughout the testing process.

Answer 12

Positive patient

Question 13

T/F laboratories must be accredited once every 10 years.

Answer 13

FALSE - every 2 years by: CMS or CMS approved organization JCAHO, CAP, COLA

Question 14

What is waived testing?

Answer 14

simple laboratory examinations and procedures, little risk of error
pose no reasonable risk of harm to the patient if the test is performed inaccurately

Question 15

Which of the following is NOT an example of waived testing?
A) Dipstick UA
B) Hemoglobin (hemacue)
C) Complete Blood Count
D) Strep A
E) Blood Glucose
F) Fecal occult blood
G) Urine pregnancy
H) Non-automated ESR
I) Spun hematocrit

Answer 15

C) Complete Blood Count is NOT waived testing
others include:
FDA approved for home use: glucose self-monitoring, pregnancy, ovulation
Fecal occult blood
Urine pregnancy
Non-automated ESR
Spun hematocrit

Question 16

Chemistry, lipid, hepatitis panels; Microscopic evaluation of urine and complete blood counts are examples of ______ _______ testing?

Answer 16

Moderate Complexity Testing

Question 17

What are High Complexity Testing Methods?

Answer 17

Microbiology
Immunohematology
Molecular Diagnostics
Tissue Typing

Question 18

What type of testing are physicians, mid-level practitioners, or dentists allowed to perform? Are they required to meet the same proficiency testing?

Answer 18

Provider Performed Microscopy - (MD, PA, APRN, DDS)

Yes are required to meet the same proficiency testing, quality control, and quality assurance testing.

Question 19

Which of the following are PPM tests?
A) direct wet mount examination
B) KOH prep
C) pin worm exams
D) qualitative semen analysis
E) all of the above

Answer 19

E
Other PPM tests are:
Waived testing category +
urine microscopic exam
fern test
post-coital direct qualitative exam of vaginal mucus
fecal leukocyte exam
nasal smear of granulocytes