CLC Regulatory Compliance & Safety Standards 3

Question 1

Under the CLIA regulations, which personnel qualification is required to serve as a laboratory director for a high-complexity testing laboratory?

Accepted Answer

MD, DO, or PhD with specific training/experience in high-complexity testing

Answer

42 CFR 493.1443 requires that the laboratory director for high-complexity testing hold an MD, DO, or PhD along with documented training or experience in each specialty performed.

Question 2

A laboratory is audited and found to have no documented annual competency assessments for its testing personnel. Under CLIA, this finding would be cited under which condition for coverage?

Accepted Answer

Personnel (42 CFR 493 Subpart M)

Answer

CLIA Subpart M (Personnel) requires that competency of testing personnel be assessed at least semiannually during the first year and annually thereafter.

Question 3

Which biosafety level (BSL) is required for work with agents that pose a moderate potential hazard to personnel and the environment, such as Mycobacterium tuberculosis?

Accepted Answer

BSL-3

Answer

BSL-3 is designated for work with indigenous or exotic agents that may cause serious or potentially lethal disease via inhalation, requiring special air handling and respiratory protection.

Question 4

Under OSHA's Laboratory Standard (29 CFR 1910.1450), what document must every laboratory that uses hazardous chemicals maintain?

Accepted Answer

Chemical Hygiene Plan (CHP)

Answer

The OSHA Laboratory Standard specifically requires laboratories to develop and implement a written Chemical Hygiene Plan that details protective measures for hazardous chemical exposures.

Question 5

In the context of laboratory proficiency testing (PT) under CLIA, what constitutes an 'unsuccessful' PT performance that triggers required follow-up action?

Accepted Answer

Failure to achieve a minimum score of 80% for two consecutive testing events or two of three consecutive events

Answer

CLIA defines unsuccessful PT as failing to attain the minimum satisfactory score for two consecutive events or two out of three consecutive testing events for the same analyte or test.

(CLC) Certified Laboratory Consultant Practice Test

(CLC) Certified Laboratory Consultant Practice Test

CLC Regulatory Compliance & Safety Standards 3