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Lab Management Questions and Answers
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Lab Management Questions and Answers CLIA-88 1) Whats the purpose?Administered by who? Why have it? 2) Test categories 3) Which are the only tests that need proficiency testing (for lab, not individual)? What kind of testing? 1)- purpose to improve quality and reduce errors -CMS (Center for...

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  • December 25, 2024
  • 22
  • 2024/2025
  • Exam (elaborations)
  • Questions & answers

Subjects

  • lab management questions and answers
  • clia 88 4 which are the only tests subjected to
  • clia 88 laboratory proficiency testing 1 for whi

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  • Laboratory management
  • Laboratory management

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Lab Management Questions and
Answers
CLIA-88

1) Whats the purpose? Administered by who? Why have it?
2) Test categories
3) Which are the only tests that need proficiency testing (for lab, not individual)? What
kind of testing? - answer 1)- purpose to improve quality and reduce errors
-CMS (Center for MediCARE and MediCAID services) or Deemed provider (CAP,
JCAHO)
- required to receive federal payments

2) WAIVED
- simple tests (BGT, dipstick, fecal occult, urine preg)

MOD and HIGH COMPLEXITY
- need knowledge/training required to perform

PROVIDER PERFORMED MICROSCOPY
- physician/PA/nurse as part of PE
- labile specimen and delay will impact accuracy
-vag wet prep, KOH, UNSTAINED slides

3) Mod and high complexity
- Regulated tests require proficiency testing 3x/yr with 5 samples per test
- for tests with no regulation available, must have some way to assess performance at
least 2x/yr

CLIA-88

4) Which are the only tests subjected to inspection? How long?
5) Which tests make up most tests in lab? - answer 4) Moderate and high complexity
tests; subject to inspection every 2 years by CMS or deemed provider

5) Waived and Provider performed microscopy make up together 80% of tests

CLIA-88 Laboratory Proficiency Testing

1) For which tests
2) When is it a successful proficiency test?
3) Define failed proficiency test
4) What happens if fail proficiency test?

,5) What if there is no proficiency test available for analyte? - answer 1) Mod high
complexity tests

2) meet target value >80% of time for each analyte in challenge

3) defined as unsatisfactory performance in 2 consecutive or 2 of 3 challenges

4) lab may not report patient results for any analyte that has failed and must develop
remedial action plan

5) Lab must demonstrate proficiency by internally developed system

What are the CLIA-88 certificates and when are they issued and who surveys them? (4)
- answer Waiver
- issued to testing sites that perform waived tests
-not surveyed

Provider Performed Microscopy
- issued to testing sites that only perform testing as part of patient examination (these
providers can also perform waived tests)
-not surveyed

Compliance
- issued to testing sites that perform mod or high complex tests
- are surveyed by CMS or state health agency

Accreditation
- issued to testing sites that perform mod or high complex tests
- surveyed by org with CMS deemed status (aka CAP or JCAHO) (not CMS or state
agency)

What are the 6 CMS (Center for MEdicare and MEdicaid Services) approved
accreditation agencies - answer -AABB
-American Osteopathic Assoc
-American Society for histocompaitiblity and immunogenetics
-COLA
-CAP
-The Joint Commission (JCAHO)

CLIA-88 Personnel Requirements

1) What positions are required to perform moderate and complex testing? (4)

2) What are the required credentials for a lab director? - answer 1) Lab Director
Technical Consultant
General Supervisor

, Testing Personnel

2) Must be MD with lab/training experience OR PhD with board certification (serving as
a lab director before 2/24/03 OR masters and PhD with experience)

CLIA-88 Personnel requirement

1) What are minimum requirements for an employee to perform a waived tests?

2) What are the minimum requirement for an employee to perform a Non-Waived test
(mod to high compelxity) - answer 1) No requirements

2) At least a minimum hrs of science or math OR have been doing high complexity
testing before 2/28/1992

CLIA personnel requirements and histology

1) what are requirements

2) special? Thus what? - answer 1) histology is NOT covered by CLIA personnel

2) many procedures performed in histology labs are classified as high complexity
(grossing, processing of specimen, ISH, immuno)
- thus, personnel performing these must meet standards for high complexity testing!

CLIA-88 Inspections

1) How often must you get them
2) Performed by whom? - answer 1) must have routine inspections every 2 years

2) CMS, state or agency with deemed status from CMS (CAP, JCAHO)

1) Equal employment opportunity (EEO) act covers what

2) American disability (AD) act says what

3) If you ask questions that may appear discriminatory, what will happen? - answer
1) discrim in hiring/PROMOTION based on age, gender, ethnic background, sexual
orientation

2) employer must make reasonable accomodations to job requirements for persons with
disabilities

3) MAy lead to EEO actions

CLIA and Training

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