A technologist gets an unexpected result on a proficiency testing sample. She wants to send part of it to the hospital's reference laboratory to confirm before submitting. This is:

Prohibited: PT samples must not be sent to another lab

Allowed if her own result is the one submitted

Allowed if the referral is recorded in the QA log

Allowed if the reference lab is CAP accredited

A laboratory's potassium PT scores in three consecutive events are 60%, 100% and 60%. Satisfactory performance needs at least 80%. Under CLIA, its status for potassium is:

Unsuccessful: failed two of three consecutive events

Unsuccessful only if the next event also fails

Satisfactory: no two consecutive events were failed

Acceptable once corrective action for event 3 is filed

CAP accreditation requires an on-site inspection of the laboratory every:

2 years, with a self-inspection in between

3 years, with a self-inspection in between

5 years, with self-inspections each year

Year, with no self-inspection required

Which federal agency issues CLIA certificates and enforces CLIA rules for US clinical laboratories?

Centers for Medicare & Medicaid Services

Centers for Disease Control and Prevention

Occupational Safety and Health Administration

Compliance and regulation (proficiency testing, competency, accreditation)

7 ASCP MLS practice questions on Compliance and regulation (proficiency testing, competency, accreditation), part of Laboratory Operations. The first 7 are below; the first 5 with answers and explanations (tap Show answer after you have chosen), the rest in Learn with a free account.

Question 1 · Medium
A technologist gets an unexpected result on a proficiency testing sample. She wants to send part of it to the hospital's reference laboratory to confirm before submitting. This is:
1. AProhibited: PT samples must not be sent to another lab
2. BAllowed if her own result is the one submitted
3. CAllowed if the referral is recorded in the QA log
4. DAllowed if the reference lab is CAP accredited
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Answer: A · Prohibited: PT samples must not be sent to another lab
CLIA forbids sending PT samples, or any part of them, to another laboratory for testing, even when the laboratory reports its own result. It also forbids discussing PT results with other laboratories before the reporting deadline. Intentional referral can lead to revocation of the CLIA certificate for at least a year. An unexpected result is investigated within the laboratory, and the sample is handled exactly as a patient sample would be.
- B: Referral is prohibited even when the laboratory submits its own result.
- C: Documenting a referral does not make it permitted.
- D: Accreditation of the other laboratory does not make referral allowed.
Question 2 · Medium
A family practice runs urine dipsticks and rapid strep tests, and its physicians examine their own patients' vaginal wet mounts and KOH preparations. Which is the most limited CLIA certificate that covers all of this?
1. ACertificate for PPM Procedures
2. BCertificate of Registration
3. CCertificate of Waiver
4. DCertificate of Compliance
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Answer: A · Certificate for PPM Procedures
Provider-performed microscopy (PPM) procedures, such as wet mounts, KOH preparations and urine sediment exams, are moderate-complexity tests done by a physician, midlevel practitioner or dentist during the patient's visit. A Certificate for PPM Procedures covers these plus waived tests, such as dipsticks and rapid strep tests. A Certificate of Waiver does not cover microscopy. A Certificate of Compliance would cover them but brings routine surveys and more than this practice needs.
- B: A Certificate of Registration only allows testing until a compliance or accreditation survey.
- C: A Certificate of Waiver covers only waived tests, not microscopy.
- D: A Certificate of Compliance covers this testing but is far more than needed.
Question 3 · Hard
A laboratory's potassium PT scores in three consecutive events are 60%, 100% and 60%. Satisfactory performance needs at least 80%. Under CLIA, its status for potassium is:
1. AUnsuccessful only if the next event also fails
2. BUnsuccessful: failed two of three consecutive events
3. CSatisfactory: no two consecutive events were failed
4. DAcceptable once corrective action for event 3 is filed
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Answer: B · Unsuccessful: failed two of three consecutive events
A score below 80% in an event is unsatisfactory performance for that analyte. Unsatisfactory performance in two consecutive events, or in two of three consecutive events, is unsuccessful participation. Here events 1 and 3 were failed, so performance is unsuccessful even though event 2 was perfect. CMS can then require training and corrective action and may stop the laboratory from testing potassium until it shows satisfactory performance.
- A: The status is already unsuccessful after events 1 and 3.
- C: Failing two of three consecutive events also counts, not only two in a row.
- D: Corrective action is required, but it does not change the status.
Question 4 · Easy
CAP accreditation requires an on-site inspection of the laboratory every:
1. A3 years, with a self-inspection in between
2. B5 years, with self-inspections each year
3. CYear, with no self-inspection required
4. D2 years, with a self-inspection in between
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Answer: D · 2 years, with a self-inspection in between
CAP inspects accredited laboratories on site every two years, using peer inspectors and its accreditation checklists. In the year between, the laboratory completes a self-inspection against the same checklists and corrects any deficiencies. CAP has deemed status from CMS, so a CAP-accredited laboratory meets CLIA through this process. The laboratory must also take part in proficiency testing for its tests.
- A: Three years is longer than CAP's cycle.
- B: Five years is far longer than CAP's cycle.
- C: CAP inspects every two years, not every year.
Question 5 · Easy
Which federal agency issues CLIA certificates and enforces CLIA rules for US clinical laboratories?
1. ACenters for Disease Control and Prevention
2. BOccupational Safety and Health Administration
3. CFood and Drug Administration
4. DCenters for Medicare & Medicaid Services
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Answer: D · Centers for Medicare & Medicaid Services
CMS runs the CLIA program: it registers laboratories, issues certificates, collects fees, carries out surveys and enforces the rules. The FDA categorizes commercial tests by complexity, and the CDC supports CLIA with research, guidance and its advisory committee. OSHA regulates worker safety, such as bloodborne pathogen exposure, not test quality. Two states with approved programs, New York and Washington, are exempt from CLIA.
- A: The CDC gives scientific support and guidance, not enforcement.
- B: OSHA covers worker safety, not laboratory test quality.
- C: The FDA categorizes test complexity but does not certify laboratories.
Question 6 · Easy
Under CLIA, a proficiency testing program for a regulated analyte must provide:
1. ATwo events a year, three samples each
2. BOne event a year, ten samples each
3. CThree events a year, five samples each
4. DFour events a year, two samples each
Answer and explanation in LearnFree account
Question 7 · Medium
A technologist starts high-complexity testing in January. Under CLIA, her competency must be assessed:
1. AOnce only, at the end of her training
2. BOnce a year, starting 12 months after hire
3. CEvery 2 years, at each inspection
4. DAt 6 and 12 months, then at least yearly
Answer and explanation in LearnFree account

Compliance and regulation (proficiency testing, competency, accreditation)

A technologist gets an unexpected result on a proficiency testing sample. She wants to send part of it to the hospital's reference laboratory to confirm before submitting. This is:

A family practice runs urine dipsticks and rapid strep tests, and its physicians examine their own patients' vaginal wet mounts and KOH preparations. Which is the most limited CLIA certificate that covers all of this?

A laboratory's potassium PT scores in three consecutive events are 60%, 100% and 60%. Satisfactory performance needs at least 80%. Under CLIA, its status for potassium is:

CAP accreditation requires an on-site inspection of the laboratory every:

Which federal agency issues CLIA certificates and enforces CLIA rules for US clinical laboratories?

Under CLIA, a proficiency testing program for a regulated analyte must provide:

A technologist starts high-complexity testing in January. Under CLIA, her competency must be assessed: