Lab management, Statistics Flashcards by Timothy Carll

PPM

Must be performed by a provider. May have competency assessments but proficiency testing is not required.

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DOT categories

A - Pathogens, high biological risk

B - Routine biological specimens, some risk

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HIPAA exceptions

Can send information to insurance groups and other providers without express consent.

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Inspections: JCO, CAP, COLA

JCO: q3yr hospital, q2yr labs.
CAP: q2yr, off-year self-inspection. Phase 2 worse than 1.
COLA: q2yr, voluntary. For smaller labs

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Medical director requirements

Mod/High complex: Doctorate with 1+yr experience, or PhD with boarding.
Waived testing: None required.

Director can delegate roles. May cover max of 5 labs.

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Competency testing

Annual (or q6mo if new hire)

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Material retention

Most CP things - 2yrs
Cyto slides - 5yrs
AP materials - 10yrs
Forensics - Forever

Suggested cytogenetics and flow 10+ yrs.

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Productivity

Tests (or product) per tech (or labor).

Higher with automated testing and SMALLER labs?

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Lean

Toyota method

Identify and remove wasteful steps.

Use physical maps, spaghetti diagrams.

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Three day stay

Outpatient lab services occurring up to 3 days prior to admission are billed to the admission

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AHRQ

Agency that examines effectiveness of new treatments

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Analytical sensitivity

Analytical specificity

A. sens: Ability to detect analyte at low concentrations

A. spec: Ability to detect analyte with interferants

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Calibration verification vs assay calibration

Calibration verification: Test known concentrates throughout the RR.
Assay calibration: Adjust instrument output to match known concentrates.

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Validating FDA-approved assays

Need accuracy, precision, RR. Confirmation of manufacturer RR (20-40 cohort OK)

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Frequency of QC checking

q24hrs (exception: blood gas q8hr or per run)

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CLIA certificates

Waiver - Most common. For labs that only do waived tests.

Registration - Allows for complex testing to proceed until inspection

FMLA

12 weeks
Unpaid, job-secure
no gender/sex difference

ISO Standard 15189:2007

International standard for medical lab quality and competence.

Voluntary. Has no legal authority.

Levey Jennings plot

Bland-altman plot

Levey-Jennings: Graphs Mean+/- SD over runs or time.

Bland-Altman: Compares % difference to average values

PT testing: Unsuccessful, unsatisfactoryu

Unsatisfactory: Failed to attain adequate result on an assay
Unsuccessful: Unsatisfactory result on 2+ consecutive attempts.

PT testing: Send-outs

NEVER DO IT, just specify that you would normally.

Root cause analysis

Factor mapping
Tree diagrams
Ishikawa fishbone
Pareto analysis
Fishbone analysis

Seeks to identify many factors in a blameless fashion. Results in an actionabl solution

Six Sigma

Aims to minimize product defects. Uses “Black belts” and “green belts”…

MBA rubbish.

Sec 1877 of SSA (42 USC 1395)

Stark low. No referrals for financial benefit (including to family members, etc).

Westgard rules

``` 1(2S) - Warning 1(3S) 2(2S) 4(1S) R(4S) 10(x) ```

SD containers

1SD: 68% 2SD: 95% 3SD: 99%

Tests to compare datasets

If parametric, use student's T-test. | If non-parametric, use Mann-Whitney.

How is efficiency calculated?

TP + TN / All outcomes

Reagent lease

Pay for reagents and depreciation of instrument. Manufacturer retains ownership of instrument.

Semi-variable costs

"Step variable", increases with testing volume but not linearly. eg. Supervisors.

Turnover rate

departures / total staff in a given time period. Address these with exit interviews.

DRGs

Only reimburse HOSPITALS for inpatient services (eg, Medicare part A). Adjustments exist for geographic location, setting, hospital type, and patient demography?

SSTs

Separates cells and serum. Not good for drug or immunoassay testing (adsorption)

Effect of standing, tourniquets

Both: Third-spacing (hemoconcentration) Tourniquets: Lactic acidosis, maybe hyperkalemia (fist clenching)

Optical interferants

Bilirubin: 340-500 nm Heme: 412 nm ("Soret band") Lipids: Scatters, doesn't absorb.

Likelihood ratio

Sens / 1 - spec Refers to the odds of a positive result in a disease patient relative to non-diseased.

CV%

SD / Mean

How is post-test probability counted?

Multiply the pre-test ODDS RATIO by the LR. Then convert back to probability. Eg: 25% population diseased, test with 5x LR 25% >> 33% pre-test odds ratio. 166% post-test odds ratio 166/266 or 62.4% post-test probability