Directorship Flashcards
How much time does a laboratory have to correct a Phase __ deficiency?
A. I.
B. II.
A. By the next internal inspection.
B. 30 days.
Which agency is responsible for assigning levels of complexity to laboratory tests?
The FDA.
For proficiency testing, how long must a laboratory deal with same vendor before switching to another?
One year.
Waived tests:
A. Definition.
B. Examples.
A. Simple, relatively foolproof tests of which incorrect performance would not significantly harm the patient.
B. Urine dipstick, fecal occult blood.
Waived testing:
A. Requirement.
B. Certificate.
A. One must follow the manufacturer’s instructions.
B. Certificate of waiver.
Non-waived tests: Types.
Moderate-complexity.
High-complexity.
Moderate-complexity test:
A. Example.
B. What can make it a high-complexity test.
A. Automated procedure (most).
B. Modification.
High-complexity test: Example.
A test that has a significant manual component, e.g. identification of parasites.
Non-waived tests: Regulatory requirements.
Qualified laboratory director and testing personnel.
Written procedures for testing.
Positive and negative controls on each day of testing.
Proficiency testing.
Stipulations concerning record-keeping.
Inspection every other year.
Provider-performed microscopy: Complexity.
Moderate.
Provider-performed microscopy:
A. When?
B. Method.
C. Indication.
A. During the patient’s visit.
B. Bright-field or phase-contrast microscopy.
C. The delay of taking the specimen to the laboratory would compromise the specimen.
Provider-performed microscopy: Examples (4).
Direct wet mounts for microorganisms.
KOH preparations.
Examinations for pinworms.
Ferning tests.
Levels of review of medical devices by the FDA.
Clearance.
Approval.
Clearance of medical devices: Required form and its intent.
Premarket notification or 510(k): Filed by the manufacturer in order to document that the device is substantially equivalent to some FDA-approved device.
Approval of medical devices: Required form and its intent.
Premarket application filed by the manufacturer as a formal validation.
Requirements to be met by medical devices that are exempt from review by the FDA (4).
Proper labeling, including a statement that of device is not cleared or approved by the FDA.
Listing.
Reporting of device malfunction.
Good manufacturing practices.
The FDA’s classification of medical devices.
Based on the risk associated with use of the device:
Class I, Class II, Class III.
Branch of the FDA that regulates blood products.
Center for Biologics Evaluation and Research.
Medicare: Intended beneficiaries (3).
Those who are
Over 65 years of age, or
Permanently disabled, or
In end-stage renal disease.
Medicare: Parts that address reimbursement.
Part A: Inpatient care, home health care, and care in hospice or a skilled-nursing facility, apart from physicians’ services.
Part B: Outpatient services and inpatient physicians’ services.
Medicare, Part B: System of reimbursement.
Fee-for-service.
Medicare: Usual processors of claims.
Part A: Fiscal intermediaries.
Part B: Carriers.
ICD:
A. Basis of coding.
B. Version used in billing.
A. Diagnoses.
B. International Coding of Diseases - Clinical Modification (ICD-CM).
Health Care Procedural Coding System:
A. Basis of coding.
B. Levels.
A. Rendered services.
B. Level I consists of CPT codes, Level II is used for all other services.
Medicare: Which billing codes must be provided in order to get reimbursed?
Both ICD and HCPCS codes.
Medicare: Information required for reimbursement of pathology services.
Documentation of medical necessity in the form of an ICD code provided by the clinician.
Medicare: What is the DRG?
Diagnosis-related group: A type of reimbursement which provides a fixed payment according to the inpatient diagnosis, regardless of the length of stay.
Medicare: How different components of pathology services get reimbursed.
Professional component: Coded separately from the laboratory billing schedule.
Technical component: Covered by the DRG payment.
Medicare: What happens when a claim for an ___ laboratory test is denied?
A. outpatient
B. inpatient
A. The patient may get billed; an advanced beneficiary notice (ABN) must be filed.
B. The patient does not get billed.
Medicare: What determines payments for physicians’ services?
The Physician Fee Schedule, which is based on the Resource-Based Relative-Value Scale.
Medicare: Examples of “unbundling” of laboratory services.
Billing separately for tests in a panel.
Billing separately for the cervix and corpus of a uterus.
Medicare: Direct-billing law as it applies to laboratories.
Medicare must be billed directly by the laboratory that provides the service.
Medicare: Stark law:
A. Synonym.
B. Intent.
A. Physician-self-referral law.
B. To prevent the use of “shell laboratories” that only refer testing to real laboratories but bill Medicare directly.
Medicare: Components of the anti-kickback law.
A laboratory may not use items of value to induce clinicians to use their services.
When trying to attract non-Medicare patients, the laboratory may not charge less than the cost of the testing.
Fixed vs. variable costs: Definitions.
Fixed costs are unaffected by the total number of tests performed. However, the fixed cost per test decreases as more tests are performed.
Variable costs are affected by the total number of tests performed. However, the variable cost per test does not change.
Fixed costs: Examples.
Purchase of instruments, utilities, rent, wages.
Direct vs. indirect costs: Definitions.
Direct costs are incurred directly from the performance of tests; indirect costs are not.
Direct vs. indirect costs: Examples.
Direct costs: Purchase of instruments, reagents.
Indirect costs: Rent, utilities, custodial services, depreciation.
Over which costs does a laboratory director have the greatest control?
Over direct costs and variable costs.
Unit cost:
A. Definition.
B. Derivation.
A. The total cost per test.
B. The sum of the variable costs and fixed costs per test.
Break-even point:
A. Definition.
B. Relevance.
A. The number of tests to be performed in order for costs to balance revenue, i.e. where net income equals zero.
B. Can help determine whether to offer a test or send it out.
Break-even point: Formula.
N = FC ÷ (R − VC).
N is the number of tests performed.
FC is the fixed cost.
VC is the variable cost (per test).
Allowances and bad debt: Definitions.
Allowances: Not getting reimbursed as much as expected.
Bad debt: Not getting reimbursed at all.
Estimation of revenue based on allowances and bad debt.
Revenue = total charges − allowances − bad debt.
Budgeting: When does it begin?
About 6 months before the beginning of the budgeted year.
Budget: Components (4).
Capital budget.
Personnel budget.
Operating budget.
Allocation budget.
Capital budget:
A. Purpose.
B. How to operate when it is restricted.
A. The purchase of more expensive items such as analyzers.
B. If an analyzer is leased instead of purchased, the cost of the analyzer can be accounted for in the operating budget instead.
Personnel budget: How typically expressed.
As full-time equivalents.
Operating budget:
A. Purpose.
B. Examples of covered items.
A. To account for day-to-day operations.
B. Reagents, send-out tests, blood products.
Allocation budget: Purpose.
To account for the laboratory’s share of the hospital’s fixed costs, e.g. utilities, administration.
Gaussian distribution: Adjective used to describe it.
Parametric, i.e. expressible by a mathematical equation.
Mean, median, and mode: Definitions.
Mean: Arithmetic average of all data points.
Median: Middle value of the range of values.
Mode: Most frequently occurring value.
Mean, median, and mode:
A. In a perfect Gaussian distribution.
B. In a positively skewed distribution.
A. Mean = median = mode.
B. Mean > median > mode.
Standard deviation: Relevance to the shape of the Gaussian curve.
Narrow curve: Small standard deviation.
Wide curve: Large standard deviation.
Standard deviation: Formula.
SD = √[Σ(xi − mean)² ÷ (n − 1)]
Standard deviation: Relevance to percentiles in the Gaussian curve.
−1 SD to +1 SD: 68.2% of the population.
−2 SD to +2 SD: 95.5% of the population.
−3 SD to +3 SD: 99.7% of the population.
Analytical accuracy vs. diagnostic accuracy.
Analytic accuracy: Extent to which a test result approximates the “true value”.
Diagnostic accuracy: Ability of a test to distinguish between groups of patients.
Analytical accuracy:
A. Quantification.
B. How to control it.
A. It has no numerical value.
B. Through periodic calibration.
Precision:
A. Definition.
B. What influences it.
C. How to control it.
A. The reproducibility of a test result.
B. The random variability inherent in a process.
C. Through daily testing of QC reagents.
Precision within a run:
A. Determinant.
B. Expected value.
A. Concentration of the analyte, with low concentrations causing lower precision.
B. 1 to 10%.
Precision between runs: Determinants (2).
Changing environmental conditions.
Changing technologists (operator bias).
Coefficient of variation:
A. Purpose.
B. Formula.
A. To express the precision.
B. CV = SD/mean × 100%.
Clinical sensitivity: Formula.
Sensitivity = TP/(TP + FN).
