CLIA study plan

Map the CLIA regulatory hierarchy from statute to CMS interpretive guidelines, distinguishing what Congress, CMS, CDC, and FDA each control

Classify each test category (waived, moderate complexity, high complexity, PPM) using the seven criteria that drive categorization decisions

Explain the certificate types (waiver, PPM, compliance, accreditation) and the conditions a laboratory must meet to hold and maintain each

Summarize the 42 CFR Part 493 subparts by letter and the subject each subpart governs

Draft a one-page comparison of the three CLIA certificate fee schedules and what triggers a fee increase

Differentiate PT enrollment obligations for regulated analytes versus non-regulated analytes and the minimum testing events per year

Explain the PT referral prohibition and the consequences of interlaboratory communication on PT samples

Work through PT evaluation math: scoring by analyte, the 80% satisfactory performance threshold, and the cumulative two-of-three rule for unsuccessful performance

Identify the actions a laboratory must take after an unsuccessful PT event, including the plan of correction timeline

Distinguish PT failure from PT non-participation and describe the sanction pathway for each

Compare PT performance with alternative assessment for analytes lacking PT, including split-sample and accuracy-based approaches

Calculate quality control statistics from raw data: mean, standard deviation, coefficient of variation, and control limits

Apply Westgard multirule logic to Levey-Jennings plots and identify which rule fired in each example

Explain calibration verification, method validation, and verification of performance specifications for unmodified and modified FDA-cleared tests

Describe the elements of a quality assessment program, including the annual review of QC and PT records

List qualification requirements for each personnel role (laboratory director, technical consultant, clinical consultant, technical supervisor, general supervisor, testing personnel) by test complexity

Match education, certification, and experience pathways to each role and identify which requirements differ between moderate and high complexity

Outline director responsibilities that cannot be delegated versus those that can be assigned in writing

Describe competency assessment requirements, including the six evaluation elements and the annual and semiannual timing rules

Identify documentation a surveyor would request to verify personnel qualifications and competency

Trace a specimen from order through report, listing the required elements of a test requisition and the conditions under which a laboratory may accept an oral request

Explain specimen rejection criteria, stability limits, and the documentation required when a specimen is compromised

Describe critical value reporting, reflex and add-on testing rules, and requirements for amended reports

Apply the Bloodborne Pathogens standard to a clinical laboratory: exposure control plan, engineering controls, PPE, and post-exposure evaluation

Outline chemical hygiene, hazardous waste segregation, and tuberculosis and respiratory protection requirements for laboratory staff

Sequence the survey and certification process from application through certificate issuance, including announced versus unannounced inspections

Distinguish the accreditation option from state-exempt oversight and explain how deemed status works

Classify deficiencies as condition-level versus standard-level and predict the enforcement consequence of each

Describe the range of enforcement remedies: directed plans of correction, civil money penalties, suspension, revocation, and exclusion

Explain the appeal process and the role of the hearing before an administrative law judge

Define waived testing, list the criteria a test must meet, and explain the manufacturer's responsibility for obtaining waiver status

Describe the minimal CLIA requirements that still apply to waived laboratories: certificate maintenance, adherence to instructions, and notification of changes

Explain the Certificate of Waiver project and the consequences of a waived laboratory failing to follow manufacturer instructions

Compare point-of-care testing oversight in waived, moderate complexity, and high complexity settings, including operator training and competency

Revisit regulatory framework gaps identified in weeks 1 through 6 and close them with targeted review

Complete a full-length timed practice exam and score it by domain to identify the weakest two areas

Re-drill PT evaluation and enforcement scenarios until every miss is explained with a citation

Recite the personnel qualification requirements and competency timing rules from memory

Build a one-page formula and threshold sheet covering PT scoring, QC statistics, and enforcement timelines

Simulate a survey interview by writing answers to 15 likely inspector questions