Webinar Quiz: IHC Quality Management Program - Where Do I Start? -Sakura Finetek USA

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What is the standard type of specimen used for IHC staining(Required)

Frozen sections

Air-dried smears

Formalin-fixed, paraffin-embedded tissue (FFPE)

Decalcified tissues

Which of the below should be included in a function verification plan for IHC instruments?(Required)

Plan to verify performance prior to initial use, after major service, or after relocation

Written procedures for start-up, operation, and shutdown

Guidance for troubleshooting and repairs

All of the above

When should pH buffers be tested?(Required)

When a new batch is prepared or received

For every test ran using that buffer

Only if the pH is suspected to be off

Never, pH buffers do not require testing

Which of the below is NOT true about reagent handling with IHC?(Required)

Reagents must be stored and handled as per manufacturer’s instructions

Expired reagents can be used after proper validation

Reagents must be labeled appropriately

Reagents that are part of a “kit” are only to be used within the same lot unless otherwise specified by the manufacturer

What is important to consider when it comes to positive controls?(Required)

Maintaining a bank of positive controls is acceptable

The ideal method is to include a positive control on the same slide as the patient tissue, but a separate positive control slide/run/antibody may also be acceptable

Take caution in using only normal tissue as positive controls

All of the above

What is considered a non-predictive marker?(Required)

Markers that are used as negative controls

Markers used to predict responsiveness to a specific treatment

Markers used for routine staining to confirm a specific diagnosis

Used to determine responsiveness to targeted therapies like hormonal treatments for breast carcinomas

Which of the below is a fixation requirement for HER2 and ER?(Required)

10% neutral buffered formalin should be used

Immersion in fixative should occur within 1 hour of the biopsy of resection

Fixation time should be at least 6 hours and up to 72 hours

All of the above

Which of the below is NOT a general component of written IHC procedures?(Required)

Which type tissue processor was used to process the tissue

Validation/verification of new antibodies

Process for lot-to-lot comparisons

Correlation of IHC results

Which of the below is true about CAP Surveys or CAP-accepted PT programs for predictive markers?(Required)

HER2 PT for breast predictive marker testing is method specific

IHC slides may be sent to another facility for staining only and be interpreted at the originating laboratory

Semi-annual alternative performance assessment is required for other predictive marker tests for which CAP does not require proficiency testing

All of the above

What must be stated on the patient report as it pertains to Class I ASR antibodies?(Required)

A disclaimer that results may be influenced because of the use of decal solutions in the standard process

A disclaimer indicating that the test was developed and its performance characteristics have been determined by the facility and has not been cleared or approved by the FDA

A disclaimer that the process has been cleared and approved by CAP

No special disclaimers are required for Class I ASR antibodies

Webinar Quiz: IHC Quality Management Program – Where Do I Start?

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