Justification for Revision 2013

Title: Laboratory Medicine Best Practices Project (LMBP^TM)

OMB Control Number: 0920-0848

Expiration Date: 3/31/2016

Rationale for Modification

The current Laboratory Medicine Best Practices LMBP^TM data collection form has been in use since May 2010. Currently, respondents are asked to register their facility or organization online and then are able to access the form and submit their information. The contractor to this project, Battelle Memorial Institute (Battelle), maintains the website and online data collection and provides support to respondents experiencing difficulty submitting their information.

The current form lists the contractor’s phone number and website information for data submission. This request for modification is to have a second version of the data collection form with alternate contact information to collect data. This is to accommodate data collection by clinical laboratory professional organizations that enter into a formal collaboration with the Centers for Disease Control and Prevention (CDC), LMBP to complete systematic reviews. With this change, there will be two versions of the form with the only changes being the contact information for data collection. No other changes are requested for this second version. The proposed changes have no effect on the burden or respondents.

With this version data will be solicited primarily through list serves and respondents will be able to submit their information by email. Professional organizations collecting data in collaboration with CDC will maintain rules of conduct pertaining to the privacy of information collected from respondents. No personal health information or patient data will be collected. Access to the information collected will be controlled by the study coordinators. Electronic transfers will be encrypted during transmission. Hard copies of data submission forms will be secured in locked storage cabinets and access limited to the study coordinators.