Form 0920-1067 Att C - IHC Telephone Interview Contacted

CAP IHC Telephone Interview Contacted Attachment C

Form Approved

OMB No. 0920-1067

Exp. Date: xx/xx/20xx

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Hello,

• I’m Ron Brooks calling on behalf of the College of American Pathologists (the CAP) in collaboration with the Centers for Disease Control and Prevention (the CDC) to assess the status of our cooperative agreement for improving the impact of laboratory practice guidelines. The CAP is one of three organizations that are working with the CDC on this continuing initiative.

• In 2013, the CAP published a study that identified a gap in practice consistency across laboratories when validating and re-validating immunohistochemistry (IHC) assays.

• In 2014, the CAP published a new evidence-based guideline, “Principles of Analytic Validation of Immunohistochemical Assays,” which was designed to support accurate and consistent validation and re-validation of IHC assays and addresses diagnostic markers and predictive markers other than ER (Estrogen Receptor)/PR (Progesterone Receptor) and HER2 (human epidermal growth factor receptor 2 for breast cancer).

• Note: IF the individual requests additional information about the guideline, Mr. Brooks will provide the 2014 press release summary and a copy of the guideline summary at time of call or afterwards depending on the individual’s preference (attachments Ci and Cii). Mr. Brooks will also offer to have CAP Center Director to follow up with them on any issue, question or concern the individual may have.

• In 2015, the CAP together with the CDC distributed a questionnaire to collect current IHC validation practice data and your laboratory returned the completed survey. We thank you for your responses.

• Would you be willing to participate in a short, follow-up telephone interview designed to be completed within 15 minutes? Is this a good time or would it be better to reschedule this for another time? Our focus is to understand if and how the IHC evidence-based guideline has impacted your laboratory and what additional support from CAP might be helpful.

• Please note that this initiative and telephone interview revolve around evidence-based guidelines and is not associated with the CAP Laboratory Accreditation Program (LAP). Your participation is completely voluntary and we respect the value of your time. No individual laboratory responses will be shared with the CDC and CAP. Your responses will be recorded in an anonymous way and no individual will be identified in any resulting report or publication.

CDC estimates the average public reporting burden for this collection of information as 1 minute per response, including the time for reviewing instructions, searching existing data/information sources, gathering and maintaining the data/information needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden to CDC/ATSDR Information Collection Review Office, 1600 Clifton Road NE, MS D-74, Atlanta, Georgia 30333; ATTN: PRA (0920-1067)

CAP/CDC: Improving the Impact of Laboratory Practice Guidelines: A New Paradigm for Metrics