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Flashcards in Laboratory Management Deck (120)
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What is the primary legislation enacted by the US Department of Health and Human Services to ensure minimum quality of laboratory services? How is it enforced?

CLIA '88, enforced by CMS (or usually their deemed accrediting agencies) which perform inspections on labs.


What are the different degrees of test complexity?


Note that labs are classified according to the highest complexity of testing it performs.


What are the required qualifications of a medical director?

May be an MD, DO, DPM, or PhD. Need not be board certified or eligible, but must hold license in the state where the lab is located.

Individual requirements may vary further by state.


What is "provider performed microscopy"?

A microscopic method (usually bright field or phase contrast) performed by clinicians for specimens that usually cannot be delayed by sending to the lab. Examples include direct wet mounts and pinworm examinations.


Who is the certificate holder for a lab? Are there any restrictions on these certificates?

The laboratory director, who may hold no more than 5 certificates at any given time. Certificates last for 2 years.


What are the requirements for labs with regards to inspections?

They must undergo inspection every 2 years and must also participate in internal inspection during the off-year.


What are the types of citations that may be issued under a CAP inspection?

Phase II - Severe, require immediate correction (30d)
Phase I - Minor, must be corrected before next inspeciton
Phase 0 - Unofficial, items under development.


What are the CLIA (or CAP) requirements for slide retention duration?

Histology: 10 years
Cytology: 5 years (CAP requires 10 years)
Autopsy: 10 years (nonforensic) or indefinite (forensic)


What are the CLIA (or CAP) requirements for tissue block and wet tissue retention duration?

Tissue block: 2 years (CAP requires 10 years) for nonforensic, indefinite for forensic

Wet tissue: Until report is completed (CAP requires 2 weeks after report completed)


What are the CLIA (or CAP) requirements for documents and reports retention duration?

All reports (simple reports, test requisitions, proficiency testing, old SOPs) must be kept for 2 years, except for pathology final reports which must be kept for 10 years (including flow cytometry reports).


What are the CLIA (or CAP) requirements for smear and microbiology slide retention?

7 days


What are the CLIA (or CAP) requirements for blood bank record retention duration?

QC records: 5 years
Donor and recipient records: 10 years


What defines a lab's productivity?

Productivity is testing output divided by resources. Note that this only applies to billable testing output...


What is a "reagent lease"?

A model in which a lab receives an instrument on loan from a vendor and pays for reagents as well as for incremental depreciation of the instrument. At the end of the lease, the vendor still owns the instrument.


What is the difference between fixed, semi-variable, and variable costs?

Fixed - Cost does not change with testing volume (eg, overhead)
Semi-variable - Cost changes nonproportionally with testing volume (eg, supervisor oversight)
Variable - Cost changes proportionally with testing volume (eg, reagents)


What measures can be used to reduce employee turnover?

Identify problems with exit interviews. Address problems relating to compensation, hours, conditions, and other worker complaints.


What are the component costs of testing?

Indirect (eg, overhead)


What does true total turnaround time reflect?

Time from point of order to time of physician notification (includes pre-analytic, analytic, and post-analytic intervals)


What is the largest part of a lab's budget?

Salaries / labor costs


What is a CPT code? An ICD code?

A code that identifies a test (or bundle of tests). An ICD code identifies a diagnosis (and has implications for the necessity of a test)


What defines a capital item?

Any lab resource that has a lifetime of greater than one production cycle (usually 1yr), and often meets a minimum cost. Classic example would be a lab analyzer.


What are RVUs?

Relative value units, valuations assigned by CMS to pay physicians for a particular CPT code. Each code has a physician work RVU, a practice expense RVU, and a malpractice RVU, each of which are adjusted by geographic area and then adjusted by a conversion factor (to limit costs to CMS).


What is an advance beneficiary notice?

An acknowledgement for patients who will not receive Medicare coverage that they understand they will be billed directly.


How often should QC be performed for a given test?

Most tests offered continuously should be QC'd every 24 hours and following calibrations. Tests ran less frequently should be QC'd every run. Some tests (blood gas) should be QC'd even more often.


What is a certificate of registration, and what is it for?

A certificate of registration REGISTERS you with CLIA so you may begin performing lab testing until you undergo regular inspection--no need to wait for inspection to start.


What do delta checks flag and detect?

Delta checks flag when a sample yields a drastically differ from that of the same test performed previously on a patient. This should identify pre-analytic and analytic errors.


What is FMLA?

Government-mandated unpaid but protected leave. 12 weeks for men and women. Health insurance is maintained. Need 1yr working first.


How are LDTs regulated?

As medical devices, they should fall under FDA jurisdiction, but the FDA does not actively regulate them. CLIA does require that internal validations be performed and report the common performance metrics.


How is FDA approval normally sought for medical devices?

FDA can provide clearance (510k process) for devices that are equivalent to another approved devices, or else undergo a rigorous premarket approval (PMA) process.


What medical devices are exempt from FDA review?

Those labeled with the statement that it is not FDA approved
Grandfathered devices
Humanitarian-use devices (rare usage)
Other specific exemptions (microscopes)