CLIA Waived Testing Quality Control Procedures Quiz

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Questions and Answers

What samples are NOT recommended for use with the OSOM Strep A Test?

Sputum

Saliva

Throat swabs

Urine (correct)

Why is it important to obtain proper throat swab specimens for the OSOM Strep A Test?

To prevent pharyngitis

To ensure the test quality (correct)

To confirm the presence of Group A Streptococcus

To differentiate between carriers and acute infection

What does a negative result on the OSOM Strep A Test indicate?

The test is functioning properly

An acute infection is present

The antigen concentration is high

The specimen is inadequate (correct)

When should external positive and negative controls be run for the OSOM Strep A Test?

With each new lot and each newly trained operator Signup and view all the answers

Which virus does the BD Veritor Influenza test detect?

Both Influenza A and B Signup and view all the answers

What organism does the OSOM/HS Mono test detect?

Mononucleosis virus Signup and view all the answers

What is a limitation of the OSOM Strep A Test?

It is not specific to Group A Streptococcus Signup and view all the answers

What should be done with control solution bottle before running external controls for the OSOM Strep A Test?

Vigorously mix Signup and view all the answers

What should be done if the control line does not appear or the background is not clear during quality control testing with BD Veritor Flu A+B test?

The test is invalid and needs to be rerun. Signup and view all the answers

What should be done if no new lot of BD Veritor Flu A+B test is received in a given month?

Record 'No new lot, no new shipment' and continue testing as usual. Signup and view all the answers

What is the purpose of applying a pink sticker on the box after running quality control for BD Veritor Flu A+B test?

To mark the box with the date it was opened. Signup and view all the answers

What does the red control line represent in BD Veritor Flu A+B test?

Internal positive control Signup and view all the answers

When is a patient sample considered valid for testing with BD Veritor Flu A+B?

Only if external positive and negative controls run successfully. Signup and view all the answers

Why is it important to document quality control per manufacturer’s instructions on Exhibit 800.7A Mono Quality Control Log?

To ensure proper functioning of the test kit. Signup and view all the answers

What happens if multiple boxes of the same lot are received for BD Veritor Flu A+B?

A pink received sticker is placed on each box. Signup and view all the answers

Which action should be taken if proper controls were not run or found to be invalid before testing patient samples with BD Veritor Influenza A+B?

'Invalid controls' require rerunning controls and verifying their validity. Signup and view all the answers

What should be done if the background is not clear during quality control for BD Veritor Flu A+B?

'Repeat testing with new control drop' and properly document the result. Signup and view all the answers

What information should be recorded if no new lot is received in a given month for BD Veritor Flu A+B?

Box lot number, expiration date, and 'No new lot, no new shipment'. Signup and view all the answers

Study Notes

CLIA Overview

OSOM Strep A Test does not differentiate between viable and nonviable Group A Streptococci
The test should only be used with throat swabs, and not with other samples such as saliva, sputum, or urine
The quality of the test depends on the quality of the sample, and proper throat swab specimens must be obtained

Controls to be Performed

External Positive and Negative Controls:
- Must be run with each new lot and each newly trained operator
- Mix control solution bottle, and add three drops of Reagent 1 and three drops of Reagent 2 in a test tube
- Add one drop of positive or negative control into the Reagent 1 + Reagent 2 solution
External Positive and Negative Swab Controls:
- Must be run for each new lot, each newly trained operator, and each new shipment
- Insert the swab into the appropriately labeled reagent tube and plunge the swab up and down in the fluid for a minimum of 15 seconds
- Continue processing the swab according to the test procedure for nasal swabs
- Apply pink sticker and mark box with date opened/QC completed

Internal Controls

Evaluated by the BD Veritor System Reader after the insertion of each test device
Failure of the internal/procedural controls will generate an invalid test result
Internal control must be noted whenever external positive and negative swab control is run

Documentation

Monthly Quality Control Procedure:
- Document or verify quality control per manufacturer's instructions on BD Veritor SARS-CoV-2 Quality Control Log
- If no new lot is opened or shipment received in a given month, document such by recording box lot number and expiration date and "No new lot, no new shipment"

CardioChek Plus Quality Control Guidance

Quality Control for CardioChek Plus must be run per manufacturer's recommendations to assure the most accurate test results and quality of care
Before performing test on patients, review the package insert, run the Optics Check, and review Exhibit 800.14A CardioChekPlus Quality Control Log to assure proper controls were run and are valid

Mono Quality Control Guidance

Quality Control for Mono must be run per manufacturer's recommendations to assure the most accurate test results and quality of care
Before performing test on patients, review the package insert and Exhibit 800.7A Mono Quality Control Log to assure proper controls were run and are valid

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Description

Test your knowledge on CLIA waived testing quality control procedures including controls for various tests like Strep A, Influenza, Mono, and COVID Antigen. Learn about the specific controls that need to be performed for different tests and scenarios.