NIST Clinical Reference Materials Survey

OMB Control No. 0693-0033 – NIST Generic Clearance for Program Evaluation Data Collections

NIST Reference Materials Survey

FOUR STANDARD SURVEY QUESTIONS

1. Explain who will be surveyed and why the group is appropriate to survey.

The Biomolecular Measurements Division, from the Materials Measurement Laboratory (MML), at the National Institute of Standards and Technology (NIST) proposes to survey scientists in the clinical community, which includes clinicians, researchers, manufacturers, and laboratory directors. This group of attendees is appropriate to survey, as they are currently practicing clinicians, perform clinical research, or make diagnostic assays for accurately measuring disease states. Currently, two Standard Reference Materials (SRMs) undergoing production and characterization within the Applied Genetics Group at NIST are for cytomegalovirus (CMV) and BK virus, however, in order to prioritize our next materials, surveying the clinical community for feedback is appropriate.

2. Explain how the survey was developed including consultation with interested parties, pre-testing, and responses to suggestions for improvement.

The survey was developed by Jo Lynne Harenza following attendance at the 2014 Clinical Virology Symposium and Standardisation of Genomic Amplification Techniques Meetings. In addition, discussion with scientists within industry, government, and academia made clear the need for increased and improved market research prior to SRM development. No consultation or pre-testing was performed. Suggestions for question improvement were received from members of the Applied Genetics Group.

3. Explain how the survey will be conducted, how customers will be sampled if fewer than all customers will be surveyed, expected response rate, and actions your agency plans to take to improve the response rate.

The survey link (https://docs.google.com/forms/d/1gj9UauOBGZFmiOn0YCSQY4co84ILNFENA_OsGwINHfg/viewform) will be distributed via email by either Dr. Jo Lynne Harenza, professional clinical, cancer, and/or genetics societies, or via social media (to include Twitter, Facebook, and/or LinkedIn). The expected response rate for an online survey is 30-50%, but we hope to improve this response rate by clearly communicating to the customers how this survey will benefit them as well as the entire clinical community. In addition to email and social media distribution, we will also post a link to the survey on our Clinical DNA Information Resource (http://www.nist.gov/mml/bmd/genetics/clinical_dna.cfm). In our email, on the website, and on our survey, we will use the following invitation to notifiy respondents:

“The mission of the National Institute of Standards and Technology (NIST) is to serve the clinical and industrial community by advancing measurement science, standards, and technology. One way we do so is by providing primary reference materials, which are defined as materials that are certified to be traceable to the international system of units (SI). In an effort to evaluate and prioritize which materials are needed within the clinical community, we have designed a reference materials survey. We value your input, so please take a few minutes to answer the questions below.”

We are asking to include social media because we do not feel we will reach our goal response rate simply through email. Previously, we have contacted the following professional organizations and gotten the following responses:

Pan-Atlantic Society for Clinical Virology - administered the survey twice, but will not send more emails in an effort to circumvent spamming the membership

Clinical Virology Symposium - will not allow outside surveys

American Society for Microbiology - will not allow outside surveys

Association for Molecular Pathology - emailed twice, with no response

American Association for Clinical Chemistry - emailed once, with no response (will be attending the meeting in July, so will discuss in person)

American Society of Clinical Oncology - emailed twice, with no response

American Association for Cancer Research - emailed and responded that our survey does not match the needs of their membership

American Society of Human Genetics - require a 2-page proposal to survey membership; submitted to them 6/27/14.

Genetic Testing Reference Materials Coordination Program, under Clinical Laboratory Improvement Amendments - emailed once (7/1/14), got a response from the Program Coordinator – follow-up discussion on 7/9/14

For social media outlets, we use short messages such as those below, containing the link to the survey:

• “Quantitating viruses in patient samples? Making new viral detection assays? Please take our new clinical reference material survey here.”

• “Need reference materials in the clinic? Tell us! Please take our new clinical reference material survey here.”

• “Need reference materials for cancer? Tell us! Please take our new clinical reference materials survey here.”

• “Need reference materials for genetic testing? Tell us! Please take our new clinical reference materials survey here.”

Since emailing a single organization yielded only 29 responses, we don’t forsee surpassing the originally estimated 500 respondants. If we reach our goal of 500 respondants, we will turn off the survey.

4. Describe how the results of the survey will be analyzed and used to generalize the results to the entire customer population.

The results of the survey will be analyzed internally and used to assess and prioritize current and future standard reference materials needs. If we reach our goal response rate and have sufficient samples from each academia, industry, government, and clinical laboratories, we feel confident that we can then generalize the results to the entire customer population. We will present the results of our survey at clinical reference materials meetings and/or post them to our Clinical DNA information resource website.

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