CLIA '88 Flashcards Preview

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Flashcards in CLIA '88 Deck (55):
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)

31

Under Pathology, what is the annual testing structure for cytology?

90% passing on a 10 slide test

32

If one fails the cytology PT, what is the next step?

The next PT must be rescheduled within 45 days, 90% passing on a 10-slide set.

33

What happens with the cytology PT if the 10 slide test is failed twice?

documented remedial training and education in the area of failure, reexamination of slides must be documented, and a third tests of 20 slides must be scheduled. passing rate is 90%.

34

What is the passing rate required in cytology on the 3rd try 20 slide test?

90%

35

What happens in the cytology PT if the individual fails the 3rd attempt (20 slide test)?

35 hours of documented remedial training and education followed by repeating the 20 slide test with a 90% passing score

36

As part of Subpart K (Quality Systems), what must the laboratory have in place for complaint investigation?

A documentation system for all complaints and problems received by the laboratory. Documentation must also exist of any investigations or corrective actions, when necessary.

37

As part of Subpart K (Quality Systems), what must the laboratory do to establish systems assessment?

Lab must establish and follow written policies and procedures for ongoing mechanisms to monitor, assess, and when indicated, correct problems identified. A review of effectiveness of corrective actions. Document all general laboratory systems assessment activities.

38

What is the proper laboratory procedure when an oral request for a test is received?

Oral tests are permitted only if they are followed by a written authorization within 30 days.

39

How long is the laboratory required to keep records of the test requisitions?

minimum of 2 years

40

In a procedure manual, is it appropriate to use a textbook or part of a textbook in lieu of a written procedure?

no; textbooks may be used to supplement the procedure, but cannot serve as a replacement for a written procedure

41

How long is the laboratory required to store discontinued procedures?

minimum of 2 years - not stored with active procedures

42

Should both discontinued and current procedures be stored together?

Discontinued procedures should be filed separately from active procedures

43

What signature is required on all new procedures and all modifications of procedures?

The laboratory director

44

What four components are required for every method validation or verification?

1. accuracy and precision
2. analytical sensitivity/specificity
3. reportable range of patient test results
4. reference range of normal values

45

What must the laboratory have for every piece of equipment in use in the laboratory?

a maintenance protocol, documentation of performed maintenance, documented function checks

46

Prior to what date are laboratories not required to establish performance characteristics of moderate or high complexity testing?

April 24, 2003

47

Every how many months are you required to perform instrument calibration at a minimum?

6 months

48

What other four instances would warrant an instrument calibration?

1. lot change in reagents
2. PM or part replacement
3. a shift or trend in control results
4. the lab schedules more frequent calibration

49

Reportable range controls for quantitative assays require how many levels?

1. not detected
2. LOW, which should be near the lower limit
3. HIGH, which should be near the upper limit

50

What controls are required for a qualitative assay?

Positive and Negative

51

What type of testing is used to determine the mean and standard deviation of either calibrator or control material?

repetitive testing

52

What big change happened within CLIA in October of 2014?

CLIA allows HIPAA covered entities to provide results to patients

53

According to HIPAA Privacy Rule, if a patient requests a result, when should they be delivered?

Within 30 days of patient request

54

What records should be retained when there is an error in reporting?

The problem should be documented (e.g. PI form), and records should be maintained in duplicate of the original and corrected reports.

55

When were the CLIA '88 regulations published?

in 2003