Directorship Flashcards
1
Q
How much time does a laboratory have to correct a Phase __ deficiency?
A. I.
B. II.
A
A. By the next internal inspection.
B. 30 days.
2
Q
For proficiency testing, how long must a laboratory deal with same vendor before switching to another?
A
One year.
3
Q
Waived tests:
A. Definition.
B. Examples.
A
A. Simple, relatively foolproof tests of which incorrect performance would not significantly harm the patient.
B. Urine dipstick, fecal occult blood.
4
Q
Waived testing:
A. Requirement.
B. Certificate.
A
A. One must follow the manufacturer’s instructions.
B. Certificate of waiver.
5
Q
Non-waived tests: Types.
A
Moderate-complexity.
High-complexity.
6
Q
Moderate-complexity test:
A. Example.
B. What can make it a high-complexity test.
A
A. Automated procedure (most).
B. Modification.
7
Q
High-complexity test: Example.
A
A test that has a significant manual component, e.g. identification of parasites.
8
Q
Non-waived tests: Regulatory requirements.
A
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.
9
Q
Provider-performed microscopy: Complexity.
A
Moderate.
10
Q
Provider-performed microscopy:
A. When?
B. Method.
C. Indication.
A
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.
11
Q
Provider-performed microscopy: Examples (4).
A
Direct wet mounts for microorganisms.
KOH preparations.
Examinations for pinworms.
Ferning tests.
12
Q
Levels of review of medical devices by the FDA.
A
Clearance.
Approval.
13
Q
Clearance of medical devices: Required form and its intent.
A
Premarket notification or 510(k): Filed by the manufacturer in order to document that the device is substantially equivalent to some FDA-approved device.
14
Q
Approval of medical devices: Required form and its intent.
A
Premarket application filed by the manufacturer as a formal validation.
15
Q
Requirements to be met by medical devices that are exempt from review by the FDA (4).
A
Proper labeling, including a statement that of device is not cleared or approved by the FDA.
Listing.
Reporting of device malfunction.
Good manufacturing practices.
16
Q
The FDA’s classification of medical devices.
A
Based on the risk associated with use of the device:
Class I, Class II, Class III.
17
Q
Branch of the FDA that regulates blood products.
A
Center for Biologics Evaluation and Research.
18
Q
Medicare: Intended beneficiaries (3).
A
Those who are
Over 65 years of age, or
Permanently disabled, or
In end-stage renal disease.
19
Q
Medicare: Parts that address reimbursement.
A
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.
20
Q
Medicare, Part B: System of reimbursement.
A
Fee-for-service.
21
Q
Medicare: Usual processors of claims.
A
Part A: Fiscal intermediaries.
Part B: Carriers.
22
Q
ICD:
A. Basis of coding.
B. Version used in billing.
A
A. Diagnoses.
B. International Coding of Diseases - Clinical Modification (ICD-CM).
23
Q
Health Care Procedural Coding System:
A. Basis of coding.
B. Levels.
A
A. Rendered services.
B. Level I consists of CPT codes, Level II is used for all other services.
24
Q
Medicare: Which billing codes must be provided in order to get reimbursed?
A
Both ICD and HCPCS codes.
25
Medicare: Information required for reimbursement of pathology services.
Documentation of medical necessity in the form of an ICD code provided by the clinician.
26
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.
27
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.
28
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.
29
Medicare: What determines payments for physicians' services?
The Physician Fee Schedule, which is based on the Resource-Based Relative-Value Scale.
30
Medicare: Examples of "unbundling" of laboratory services.
Billing separately for tests in a panel.
Billing separately for the cervix and corpus of a uterus.
31
Medicare: Direct-billing law as it applies to laboratories.
Medicare must be billed directly by the laboratory that provides the service.
32
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.
33
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.
34
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.
35
Fixed costs: Examples.
Purchase of instruments, utilities, rent, wages.
36
Direct vs. indirect costs: Definitions.
Direct costs are incurred directly from the performance of tests; indirect costs are not.
37
Direct vs. indirect costs: Examples.
Direct costs: Purchase of instruments, reagents.
Indirect costs: Rent, utilities, custodial services, depreciation.
38
Over which costs does a laboratory director have the greatest control?
Over direct costs and variable costs.
39
Unit cost:
A. Definition.
B. Derivation.
A. The total cost per test.
B. The sum of the variable costs and fixed costs per test.
40
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.
41
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).
42
Allowances and bad debt: Definitions.
Allowances: Not getting reimbursed as much as expected.
Bad debt: Not getting reimbursed at all.
43
Estimation of revenue based on allowances and bad debt.
Revenue = total charges − allowances − bad debt.
44
Budgeting: When does it begin?
About 6 months before the beginning of the budgeted year.
45
Budget: Components (4).
Capital budget.
Personnel budget.
Operating budget.
Allocation budget.
46
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.
47
Personnel budget: How typically expressed.
As full-time equivalents.
48
Operating budget:
A. Purpose.
B. Examples of covered items.
A. To account for day-to-day operations.
B. Reagents, send-out tests, blood products.
49
Allocation budget: Purpose.
To account for the laboratory's share of the hospital's fixed costs, e.g. utilities, administration.
50
Gaussian distribution: Adjective used to describe it.
Parametric, i.e. expressible by a mathematical equation.
51
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.
52
Mean, median, and mode:
A. In a perfect Gaussian distribution.
B. In a positively skewed distribution.
A. Mean = median = mode.
B. Mean > median > mode.
53
Standard deviation: Relevance to the shape of the Gaussian curve.
Narrow curve: Small standard deviation.
Wide curve: Large standard deviation.
54
Standard deviation: Formula.
SD = √[Σ(xi − mean)² ÷ (n − 1)]
55
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.
56
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.
57
Analytical accuracy:
A. Quantification.
B. How to control it.
A. It has no numerical value.
B. Through periodic calibration.
58
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.
59
Precision within a run:
A. Determinant.
B. Expected value.
A. Concentration of the analyte, with low concentrations causing lower precision.
B. 1 to 10%.
60
Precision between runs: Determinants (2).
Changing environmental conditions.
Changing technologists (operator bias).
61
Coefficient of variation:
A. Purpose.
B. Formula.
A. To express the precision.
B. CV = SD/mean × 100%.
62
Clinical sensitivity: Formula.
Sensitivity = TP/(TP + FN).
63
Clinical specificity: Formula.
Specificity = TN / (TN + FP).
64
Analytical sensitivity:
A. Synonym.
B. Definition.
A. Limit of detection.
B. The lowest detectable concentration of analyte.
65
Analytical specificity: Definition.
Ability of the assay to detect a certain analyte in the presence of many other substances.
66
Positive predictive value:
A. Definition.
B. Formula.
A. The percentage of positive results that actually indicate disease.
B. PPV = TP / (TP + FP).
67
Negative predictive value:
A. Definition.
B. Formula.
A. The probability of no disease when the test is negative.
B. NPV = TN / (TN + FN).
68
Prevalence:
A. Effect on PPV and NPV.
B. Effect on sensitivity and specificity.
A. A low prevalence decreases PPV and increases NPV; the converse is also true.
B. No effect.
69
Relative risk: Definition.
The ratio of the risk, in the presence of a risk factor, to the baseline risk.
70
Relative risk: Formula.
RR =
(Number with X who develop Y ÷ Number with X) / (Number in population who develop Y ÷ Number in population).
71
Scales:
A. Interval.
B. Ordinal.
C. Nominal.
A. The numbers have their usual mathematical values, e.g. 135 mg/dL.
B. The numbers have assigned values, e.g. 1+, 4+.
C. Categories are used, e.g. positive, negative.
72
Graphs used for illustrating diagnostic accuracy (2).
Receiver-operating-characteristic curve.
Dot diagram.
73
ROC curve: Axes.
Y-axis: Sensitivity.
X-axis: 1 − specificity.
74
ROC curve: How it is used (2).
Points along the curve: Estimation of diagnostic accuracy (sensitivity and specificity) at different cutoffs.
Area under the curve (the c statistic): Quantitation of diagnostic accuracy.
75
ROC curve: Slope and area under curve of a ___.
A. test with perfect discrimination.
B. test with no discrimination.
A. Infinity; 1.0.
B. 1.0; 0.5.
76
Dot diagram: How constructed.
Quantitative results are expressed as dots, each of which is placed in one of two columns: "disease" or "no disease".
One can then see how well the test distinguishes at various cutoffs (horizontal lines).
77
Reference intervals: Number of values required.
The minimum number required for 90% confidence at the limits of the 95th percentile (2.5% of individuals will be below this range, 2.5% above it).
In practice, at least 20 healthy individuals who are representative of the population being tested.
78
How a laboratory can obtain a reference interval for an analyte (2).
Establish its own reference interval.
Take a published or manufacturer's recommended reference interval and verify it for that particular laboratory.
79
Examples of tests for which population-based reference intervals are not useful (2).
Serum lipid levels: Range is based on medical decision-points.
MCV: Varies much between individuals but little within an individual.
80
How new methods or instruments are evaluated before implementation (2).
FDA-approved test: Verification.
Non-approved: Validation.
81
Method verification: Requirements (3).
The laboratory must
Verify that it can reproduce manufacturer's claims for precision, accuracy, and reportable range.
Verify reference intervals.
Establish parameters for calibration and QC.
82
Method verification: How the laboratory might go about meeting the requirements (2).
Correlation study between the new instrument and an existing one or an outside reference laboratory.
Correlation between new instruments of the same model.
83
Method validation: Requirements (2).
The laboratory must
Meet all the requirements of method verification.
Assess sensitivity, specificity, and PPV.
84
Parts of a complete validation plan (3).
Validation elements.
Number of specimens to suffice for each element.
Predetermined points of passing or failing.
85
Calibration:
A. Definition.
B. When performed.
A. Adjusting the instrument to report the known concentration of analyte in a calibrator.
B. At least every 6 months.
86
Calibrators: Examples (4).
Samples from patients.
Commercial calibrators.
Samples from proficiency tests.
Controls.
87
Accuracy: How assessed?
By comparison with a previously validated method or with a reference method.
88
Bias: Definition.
The difference between the measured value and the "true" value.
89
Proportional bias:
A. Appearance on a correlation study.
B. Relevance to values of analyte.
A. The y-intercept is the same as that of the reference method, but the slope is different.
B. Bias is clinically less significant at lower values.
90
Types of method validation.
Primary: Based on a previously validated assay or a reference method.
Secondary: Validation between instruments.
91
Analytic specificity: How to test it.
Perform a "recovery" experiment, in which a known quantity of analyte must be detected in the presence of interfering substances such as bilirubin, lipids, free hemoglobin.
92
Analytical sensitivity: Determination.
Measure a blank sample (no analyte) 20 times.
Calculate the mean and the SD.
The value at 2-3 standard deviations above zero is considered the analytical sensitivity.
93
Functional sensitivity:
A. Synonym.
B. Definition.
A. Limit of quantitation.
B. The lowest reliably quantified concentration of analyte, reliability being determined by the CV (often 20%).
94
Carryover studies: When performed.
When the analyte has a wide range of concentration, e.g. β-hCG.
95
Carryover studies: How performed.
Six samples are used, four of low concentration (samples 1, 2, 3, and 6) and two of high concentration (samples 4 and 5).
Carryover = result of sample 6 − (average of results of 1, 2, and 3 ÷ average of results of 4 and 5).
96
Carryover studies: Desirable result.
A carryover of <0.015 (1.5%).
97
Analytical measuring range:
A. Synonym.
B. Definition.
A. Linear range.
B. The range over which reliable measurements can be obtained.
98
Analytical measurement range: Determination.
Measuring serially diluted samples that contain the analyte of interest.
99
Clinical reportable range:
A. Definition.
B. Relationship to the AMR.
A. The highest and lowest values that can be reported accurately.
B. CRR and AMR typically have the same lower limit, but the CRR may have a higher upper value, depending on the feasibility of dilution of samples.
100
Specimen stability: Definition.
How long a stored specimen continues to produce reliable results.
101
How often must the medical director review procedures (3)?
Initially.
With each change.
Annually.
102
Reagents for quality control:
A. Where obtained?
B. How designed?
A. From the manufacturer.
B. They are directed to values at or near the cutoffs.
103
Quality control: What is done when a new lot of control reagents is received (4)?
It is reconstituted.
It is run at least 20 times on the instrument.
The results are used to calculate mean and SD.
The mean and the SD are used to make a Levey-Jennings chart.
104
Quality control: Commutable reagents.
Those that are biologically similar to patients' samples.
Most QC reagents are non-commutable.
105
Quality control: According to the CLIA, how often must it be performed in the laboratory?
Two levels of QC every 24 hours, or more often if recommended by the manufacturer.
106
Quality control:
A. When is a result considered in control?
B. What is done with other results?
A. When it falls within 2 SD of the mean.
B. Westgard's rules are applied in order to determine whether the result is in control.
107
The 1:3s rule:
A. Definition.
B. Purpose.
A. One value is found to be 3 SD from the mean.
B. To detect imprecision.
108
The 2:2s rule:
A. Definition.
B. Purpose.
A. Two consecutive values are found to be >2 SD from the mean, on the same side of it.
B. To detect imprecision and systematic bias.
109
The R:4s rule:
A. Definition.
B. Purpose.
A. Two values are separated by >4 SD.
B. To detect random error.
110
The 4:1s rule:
A. Definition.
B. Purpose.
A. Four consecutive values are found at >1 SD from the mean, on the same side of it.
B. To detect systematic bias.
111
The 10:mean rule:
A. Definition.
B. Purpose.
A. Ten consecutive values are found to be on the same side of the mean.
B. To detect systematic bias.
112
Causes of error: Systematic (4).
Poor calibration.
Defective blanks.
Degraded reagents or instrument components.
113
Causes of error: Random (4).
Bubbles.
Under-filled tubes.
Error by technologist.
114
Addressing results that are out of control: First two steps.
1. Check the reagents and the instrument.
2. Repeat testing on a new aliquot of QC reagent. Significant correction suggests deterioration of the previously used QC reagent.
115
Addressing results that are out of control: Next three steps.
Thorough recheck of instrument and reagents and correction of problems.
Retesting of QC reagents.
Retesting of patients' samples before reporting.
116
Addressing results that are out of control: What to do if all troubleshooting fails.
Take the instrument offline and call for formal maintenance.
117
Constant bias:
A. Appearance on a correlation study.
B. Relevance to values of analyte.
A. The slope is the same as that of the reference method, but the y-intercept is different.
B. Bias is clinically less significant at higher values.
118
Type of error that corresponds with
A. A widening distribution of results.
B. A shift of drift of results.
A. Random error or imprecision.
B. Systematic bias.
119
Proficiency testing:
A. How many times a year?
B. How many samples per survey?
C. Passing score.
A. Three.
B. Five.
C. 80%.
120
Proficiency testing: What happens if the laboratory fails a survey (2)?
The laboratory must exceed 80% on the next 2 surveys or face possible suspension of certification.
The cause of the failure must be found and corrected.
121
Proficiency testing: Possible causes of failure (2).
Problems with reagents: Check reagent logs.
Problems with instrument: Check calibration and maintenance log.
122
Standard deviation index: Formula.
SDI = (laboratory's result − mean for peer group) ÷ SD for peer group.
123
Proficiency testing: Screening rule.
A. Question.
B. Implication.
A. Do 2 or more of the 5 results exceed 1 SDI?
B. Proceed to evaluate the data according to the remaining rules.
124
Proficiency testing: Mean rule.
A. Question.
B. Implication.
A. Does the average of the 5 SDIs exceed 1.5?
B. Systematic error is significant.
125
Proficiency testing: 3 SDI rule.
A. Question.
B. Implication.
A. Is any result beyond 3 SDIs?
B. Random error is significant.
126
Proficiency testing: 4 SDI rule.
A. Question.
B. Implication.
A. Are any 2 results >4 SDI apart?
B. Random error is significant.
127
Proficiency testing: What is a "split" sample?
A patient's sample that is divided between two laboratories as an alternative means of proficiency testing.
128
Proficiency testing: How are target ranges assigned for ___ samples?
A. commutable
B. non-commutable
A. Based on a reference method.
B. Based on the mean and SD of data from the peer group, using the SD index.
129
Which phase of testing accounts for most of the errors in laboratory medicine?
The pre-analytical phase.
130
Pre-analytical errors: Examples (5).
Patient's age.
Selection of test.
Identification of patient.
Collection of specimen.
Integrity of sample.
131
How often does a patient's test tube contain a sample from a different patient?
About 1 time in 2500.
132
What should be done with a sample when a plasma-based test cannot be performed within 1-2 hours?
It should be centrifuged within 1 hour and stored at 4-6 degrees.
133
Why must serum or plasma be separated from red cells for many tests?
To prevent spurious results due to continued metabolism, e.g. low glucose, high lactate.
134
Red-top tube:
A. Additive.
B. Purpose.
A. Silica (plastic tubes) or none (glass tubes).
B. Serum chemistry, serology.
135
Green-top tube:
A. Additive.
B. Purpose.
A. Heparin.
B. Plasma chemistry (e.g. CK, troponin).
136
Blue-top tube:
A. Additive.
B. Purpose.
A. Citrate.
B. Coagulation tests.
137
Black-top tube:
A. Additive.
B. Purpose.
A. Citrate.
B. Erythrocyte-sedimentation rate.
138
Lavender-top tube:
A. Additive.
B. Purpose.
A. EDTA.
B. Cell counts.
139
Yellow-top tube:
A. Additive.
B. Purpose.
A. Citrate and dextrose.
B. Blood-bank tests, HLA typing.
140
Gray-top tube:
A. Additive.
B. Purpose.
A. Sodium fluoride.
B. Glucose, lactate.
141
Order of draw: Plastic tubes (5).
1. Culture.
2. Blue-top.
3. Red-top.
4. Serum-separator tube.
5. Additive tubes: Green, lavender, gray.
142
Order of draw: Glass tubes (5).
Same as for plastic tubes, except that red-top precedes blue-top.
143
Analyte that can seem alarmingly high in healthy adolescents.
Alkaline phosphatase.
144
Changes in analytes that come with advanced age (4).
Decreased creatinine clearance.
Decreased glucose tolerance.
Increased lipids.
Increased releasing hormones.
145
Analytes that are affected by eating (5).
Glucose.
Triglycerides.
Bilirubin.
Gastrin, insulin.
146
Changes in analytes that are brought about by prolonged fasting.
Increased: Ketones, bilirubin.
Decreased: Albumin, potassium, magnesium.
147
Analytes that may be increased by ___ exercise.
A. Recent (3).
B. Vigorous.
A. CK, LDH, AST.
B. Neutrophil count.
148
Types of analyte that increase when the patient is standing (3).
Proteins.
Substances bound to proteins, e.g. calcium.
Formed elements, e.g. red blood cells.
149
Analytes that are affected by fist-clenching or prolonged tourniquet time (2).
Potassium, lactate.
150
Analytes that are increased in ___.
A. Serum (4).
B. Plasma.
A. Calcium, magnesium, LDH, potassium.
B. Plasma proteins, esp. fibrinogen.
All of these occur secondary to clotting.
151
Analytes whose concentrations may be factitiously changed by paraproteinemia (5).
Decreased: Bilirubin, albumin, uric acid, sodium.
Increased: Calcium.
152
How paraproteinemia may lead to hypercalcemia (3).
Factitious hypercalcemia due to the turbidity of the paraprotein.
True total hypercalcemia due to increased transport of calcium by the paraprotein (ionized calcium remains normal).
True total and ionized hypercalcemia due to the myeloma itself.
153
Factitious hyperkalemia caused by leukocytosis or thrombocytosis: Serum vs. plasma.
Potassium is significantly higher in the serum.
With true hyperkalemia, there should be little or no difference.
154
Chemical analyte that is increased with CML.
B₁₂.
155
Post-analytical errors: Examples (4).
Errors in
Issuing the report.
Reading (or hearing) the report.
Interpreting the report.
Responding to the report.
156
Estimation of body surface area: Formula.
BSA ≈ √(height × weight ÷ 3600).
157
β₂
β₂
158
Which agency is responsible for assigning levels of complexity to laboratory tests?
The FDA.
