CLIA '88 Flashcards Preview

Study Materials > CLIA '88 > Flashcards

Flashcards in CLIA '88 Deck (55)
Loading flashcards...
1

What does CLIA stand for?

Clinical Laboratory Improvement Amendments

2

What does Subpart M in CLIA '88 cover?

Personnel

3

What does Subpart H in CLIA '88 cover?

Participation in Proficiency Testing

4

What does Subpart T in CLIA '88 cover?

Consultations

5

What does Subpart K in CLIA '88 cover?

Quality Systems for Non-Waived Tests

6

What changes have to reported to CMS within 30 days?

change in:
Ownership
Name
Location
Director or Technical Supervisor

7

What changes have to be reported to CMS within 6 months?

1. performing a test not included in your certification specialty
2. any deletions or changes in tests in a specialty or sub-specialty included on the certification of compliance.

8

Name the three categories of tests described by CLIA '88?

1. waived tests
2. tests of moderate complexity
3. tests of high complexity

9

What type of CLIA issued certificate is required for laboratories performing tests of moderate or high complexity as an initial certificate before the lab applies for the next level of certificate?

Certificate of Registration

10

What type of CLIA issued certificate is required for laboratories performing waived tests only?

Certificate of Waiver

11

What type of CLIA issued certificate is required for laboratories performing PPM tests only?

Certificate for PPM procedures

12

What type of CLIA issued certificate is given to laboratories that meet all requirements?

Certificate of Compliance

13

What CLIA issued certificate replaces the Certificate of Registration?

Certificate of Compliance

14

What CLIA issued certificate suggests that your laboratory will be inspected by State CMA inspectors?

Certificate of Compliance

15

If your laboratory has a Certificate of Compliance, who is likely to inspect your laboratory?

State CMA inspectors

16

What CLIA issued certificate states your laboratory meets the standards of private non-profit accreditation programs?

Certificate of Accreditation

17

What two CLIA issued certificates are essentially the same, but just recognize two different inspection methods?

Certificate of Compliance (state CMA) and Certificate of Accreditation (private HHS approved accreditation programs)

18

How long is a CLIA issued certificate valid?

2 years

19

For waived testing, test system instructions must be written at what level?

no higher than 7th grade

20

PPM

Provider Performed Microscopy

21

Name a few examples of PPM procedures. (9)

1. wet mounts (vaginal, cervical, skin)
2. potassium hydroxide (KOH) preparations
3. pinworm
4. fern test
5. post-coital direct
6. urinanalysis
7. fecal leukocyte exam
8. semen analysis
9. nasal smears for eosinophils

22

Successful participation in PT is considered what percentage passing?

80%

23

The subspecialties that require 100% passing results on PT include what two groups in immunohematology?

1. ABO grouping and Rho typing
2. Compatibility Testing

24

What four specialties are defined for PT testing?

1. Microbiology
2. Diagnostic immunology
3. Chemistry
4. Hematology

25

What are the three subspecialties of chemistry?

1. routine chemistry
2. endocrinology
3. toxicology

26

What are the two subspecialties of diagnostic immunology?

1. syphilis serology
2. general immunology

27

What are the five subspecialties of microbiology?

1. bacteriology
2. mycobacteriology
3. mycology
4. parasitology
5. virology

28

For almost all subspecialty PT challenges, what is the number of samples per testing event?

5 per testing event

29

How many times a year should one receive a PT challenge?

3 times a year

30

Failure to return PT results is considered what type of performance?

an unsatisfactory performance with a score of 0 (failure)