Laboratory Testing

Question 1

T/F majority of all medical decisions are based on laboratory data

Answer 1

True (75%)

Question 2

T/F Physicians, dentists, mid level practitioners but not osteopaths can order lab tests

Answer 2

False - all, including osteopaths can order lab tests

Question 3

The law enacted in 1988 that specifies that all labs performing tests on which patient decisions will be made must be certified and licensed is _ . Who issues these certificates?

Answer 3

CLIA (clinical laboratory Improvement amendment) - Certified by Centers for medicaid and medicare services (CMS)

Question 4

T/F A facility that does only one waived test does not require a CLIA license

Answer 4

False - all patient assoc testing requires CLIA

Question 5

T/F Labs that perform research on unidentified patient samples, labs that do forensic testing and substance abuse testing labs must all have a CLIA license

Answer 5

False - these are all exceptions to CLIA

Question 6

A test that has been cleared by the CDC and FDA for home use and have an insignificant risk of erroneous results are classified as _

Answer 6

Waived tests

Question 7

The fastest growing segment of lab testing performed “near the patient” and not in a hospital or reference laboratory is _

Answer 7

Point of care testing

Question 8

T/F Point of care testing must only be performed using unprocessed human specimens

Answer 8

True

Question 9

What type of testing has the following 2 advantages?

• Rapid testing
• Source of revenue for physician’s offices?

Answer 9

Point of care testing

Question 10

What are the 2 types of non-waived testing?

Answer 10

Moderately complex and highly complex

Question 11

T/F Both moderately and highly complex non-waived testing requires no expertise beyond automation to interpret

Answer 11

False. That only applies to moderately complex non-waived testing

Question 12

What are the 2 types of CLIA certificates that can be obtained for waived testing? These tests can be done in physician offices

Answer 12

1) Certificate of waiver and 2) certificate of provider performed microscopy

Question 13

What are the 3 types of CLIA certificates that apply to non-waived testing? These tests are done in hospital and reference labs

Answer 13

Certificate of registration, certificate of compliance, certificate of accreditation

Question 14

T/F CLIA specifically outlines the requirements to be a lab director in a physician’s office?

Answer 14

False - But at least 1 person must be designated for oversight and decision making

Question 15

T/F only pathologist can be lab directors of highly complex labs

Answer 15

False - a non-pathologist can, has to meet 1 of the following
• One year lab training or
• Two years experience directing or supervising highly
complex testing

Question 16

What is the organization that accredits many physician offices and focuses a lot on laboratory education?

Answer 16

COLA

Question 17

T/F Provider performed microscopy can only be performed by physicians and dentists

Answer 17

False - mid level providers can also perform this testing

Question 18

T/F A major advantage of waived testing is that they are usually cheaper than using a hospital chemistry laboratory

Answer 18

False - these tests are usually more expensive

Question 19

T/F Waived testing is performed only on whole blood or urine samples that don’t require processing

Answer 19

True - this is a requirement

Question 20

T/F - Dialysis centers, cancer centers, patient transport services, family medicine clinics all use point of care testing

Answer 20

True

Question 21

T/F Lyme disease, HIV and Hep C are all examples of diseases where point of care testing is used

Answer 21

True

Question 22

T/F Because of complexity of point of care testing, patient misidentification is a major problem

Answer 22

False - since done while the patient is

there, reduces misidentification of samples, or inappropriate sampling

Question 23

T/F CLIA allows physician offices to alter manufacturer’s instructions provided that they document the changes for inspection

Answer 23

False - No changes are allowed to test instructions as provided by the manufacturer

Question 24

T/F CLIA non compliance can be punished by hefty fines, suspensions and license revocation, but not imprisonment

Answer 24

False - Any person convicted of intentional violation may be imprisoned

Question 25

What should be done when point of care testing devices give abnormal results?

Answer 25

Need to verify with reference or hospital laboratory

Question 26

T/F Point of care testing devices can be used to measure HbA1C levels and diagnose diabetes

Answer 26

False - There are currently no Hb A1c POC
instruments which have the analytical
sensitivity needed for diagnosis

Question 27

T/F Because of the ease of use of point of care testing devices, these devices are essentially fool proof and don’t suffer from “user error”

Answer 27

False - User error still a problem, devices not fool proof