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17 Cards in this Set

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What does CLIA67 and CLIA88 stand for?
CLIA67: Clinical Laboratory Improvement Act of 1967

CLIA88: Clinical Laboratory Improvement Amendments of 1988

Who administers CLIA? What are the 3 classifications of testing under CLIA?
Who administers CLIA?
Center for Medicare and Medicaid Services (CMS). All laboratories performing laboratory testing on patients are required to register with CMS and obtain a certificate.

What are the 3 classifications of testing under CLIA?
- Provider performed microscopic procedures
- Waived tests
- Non-waived tests
Are proficiency tests required for waived tests?
No

Are waived test laboratories subject to random inspections? If so, how often?
Yes. About 2% of labs are inspected. There are 100,000 waived test labs.
How often are non-waived test labs subjected to formal inspection?
Every 2 years.

By what organization?
CMS or a deemed provider (CAP, Joint Commission, COLA).
How often is proficiency testing performed for moderate or high complexity (i.e. non-waived) tests?
Require proficiency testing 3 times a year with 5 samples for testing. If proficiency testing doesn't exist for the test, the lab must develop some method to assess performance at least 2 times per year.
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
What does HIPAA stand for?
Health Insurance Portability and Accountability Act
In a Joint commission inspection, what is meant by Requirements for Improvement (RFI)?
RFI: serious deficiency requiring the lab to correct the deficiency and submit a report termed Evidence of Standards Compliance (ESC) within 45 days.
Note: supplemental findings are suggestions only.

For CAP, what is meant by Phase I and Phase II deficiencies? What about Recommendations?
Phase I: minor defect, should be corrected if possible

Phase II: serious defect, must document corrective action

Recommendations: suggestions only
For techs doing high complexity testing before 2/28/92, what are they grandfathered for?
The grandfathered techs can only have high school diploma and on the job training. For those after 2/28/92, they need at minimum an associate degree in science w/ minimal science and math.

What are the minimal requirements for a person to be a lab director of a non-waived test lab as of 2/24/03?
Must be an MD with lab training or PhD with board certification.
How long do most material (including instrument printouts, quality control ) need to be retained?
2 years

How long do cytology slides and SP slides and blocks need to be retained?
10 years.
How long does blood bank QC need to be kept?
5 years

What about other blood bank records?
10 years. Deferred donor records are indefinite.
Define productivity.
Productivity: number of results produced per hour per technologist.
One byte is how many bits?

One kilobyte (KB) is how many bytes?
1 byte = 8 bits

1 KB = 1024 bytes
What do the following stand for?
LIS
HIS
CPOE
LOINC
SNOMED
ICD
LIS: Laboratory Information System
HIS: Hospital Information System
CPOE: Computerized Physician Order Entry
LOINC: Logical Obstervation Identifiers Names and Codes (a database and universal standard for identifying medical laboratory observations)
SNOMED: Systematized Nomenclature of Medicine (codes for classification of diagnoses)
ICD: International Classification of Disease (codes for diagnosis; ICD10 takes effect 10/1/13)
What is HL-7?
Common protocol for communicating data between computers (i.e. LIS and computers on laboratory instruments). It provides a framework for the exchange, integration, sharing, and retrieval of electronic health information.
List Maslow's hierarchy of needs.
Physical (food, clothing, shelter)
Security (safety)
Being loved
Ego (need to feel important)
Self-Actualization (developing abilities)
In theory X and Y, who is the "micromanager" boss and who is manager concerned about workers achieving Maslow hierarchy of needs (ego and self-actualization) to improve outcomes?
X = micromanager

Y = Maslow, participatory, delegates responsibility, seeks involvement by and feedback from employees
If your current test costs $100 to send out but you can purchase the instrument which lasts for 5 years for $50,000 and performance of each test is $10, what annual test volume would be needed to break even?
100x = 50,000 + 10x
x = 556 for 5 years

Would need 111 to 112 tests per year to break even.