CLIA flashcards

32 cards. Read the term and the definition here. The deck at the top of this page is optional.

CLIA certificate types

Certificate of Waiver, Provider-Performed Microscopy certificate, Certificate of Compliance, and Certificate of Accreditation; the certificate must match the complexity of testing performed.

CLIA-exempt states

States approved by CMS as having requirements equal to or more stringent than CLIA; Washington and New York are currently approved. Laboratories in these states follow state rules instead of CLIA.

CLIA number

The unique identifier assigned to a laboratory by CMS; required before patient testing begins and used on test reports and claims.

Laboratory director accountability

The director is responsible for overall operation and may delegate duties in writing but remains accountable for compliance with CLIA requirements.

Change notification

Laboratories must notify CMS within 30 days of changes in ownership, name, location, director, or test menu.

High complexity director qualifications

Requires a doctoral degree in a relevant field plus documented experience, or board certification, or qualifying experience under grandfather provisions.

General supervisor duties

Responsible for daily supervision of testing personnel and reporting of results; qualifications vary by complexity and specialty.

Competency assessment frequency

Semiannually during the first year and annually thereafter for each individual performing testing, including direct observation and review of results.

Testing personnel training

Documented training for each test system must be completed before an individual performs patient testing independently.

Clinical consultant role

A qualified physician or doctoral-level individual who consults on test ordering and interpretation and is available to assist with patient care decisions.

PT sample handling

PT samples must be tested like patient samples, not referred to another laboratory, and not shared with other laboratories before the due date.

PT acceptable performance

At least 80% of PT results for a test event must fall within acceptable performance limits; failure of two consecutive or two of three consecutive events is unsuccessful.

PT director review

The laboratory director must review and sign PT results before submission, and PT records must be retained for two years.

No approved PT program

For tests without a CMS-approved PT program, the laboratory must use an alternative assessment such as split-sample testing or comparison with another laboratory.

PT referral prohibition

Laboratories may not refer PT samples to another laboratory for testing, and violations can lead to sanctions including certificate revocation.

QC two levels

For many quantitative tests, at least two control levels must be tested each day of testing, or as specified by the manufacturer.

Performance specifications

Documented accuracy, precision, analytical sensitivity, analytical specificity, reportable range, and reference intervals must be established for each test system.

Quality assessment program

An ongoing program that monitors preanalytical, analytical, and postanalytical processes, reviews complaints and incidents, and documents corrective actions.

QC corrective action

When QC results are outside limits, the laboratory must repeat controls, evaluate affected patient results, and document the corrective action taken.

QC record retention

QC records must be reviewed and signed by the director or designee and retained for at least two years.

Specimen labeling

Specimens must be labeled with at least two unique patient identifiers at the time of collection, and labeling deficiencies must follow a documented rejection policy.

Critical value reporting

Critical results must be reported immediately to the responsible caregiver, and the notification must be documented with time and recipient.

Reference intervals

The laboratory must establish and document reference intervals for each test and make them available to ordering providers.

Verbal test orders

The laboratory must have a written policy for accepting and authenticating verbal orders, and the order must be documented in the medical record.

Bloodborne pathogens standard

OSHA requires an exposure control plan, hepatitis B vaccination offered to at-risk employees, universal precautions, and post-exposure follow-up.

Hand hygiene

Hand hygiene must be performed before and after patient contact and after glove removal; alcohol-based rub is acceptable when hands are not visibly soiled.

Sharps disposal

Sharps must be placed in puncture-resistant, closable containers near the point of use; recapping by hand is prohibited unless a mechanical device or single-handed technique is used.

Chemical hazard communication

Requires a chemical inventory, safety data sheets, labeling of secondary containers, and training for employees who handle hazardous chemicals.

Biennial inspection

Laboratories with a Certificate of Compliance are inspected every two years by CMS or a state agency; accredited laboratories are inspected by their accrediting organization.

Condition-level deficiency

A serious inspection finding that may result in a directed plan of correction, civil money penalties, or suspension of the certificate if not corrected.

Approved accrediting organizations

CMS-approved accrediting organizations, including CAP, The Joint Commission, and COLA, must have standards equivalent to or more stringent than CLIA.

Waived testing requirements

A Certificate of Waiver laboratory must follow manufacturer instructions, maintain training and QC records for two years, and permit inspections.