Washington, D.C.

Legislative days:
Today we, Judy, Lindsey and I, walked the hill and talked to the Legislative Healthcare Aides for our Senators and Representatives. The issues we discussed with them are: 1) Laboratory Developed Tests (LDTs); 2) personnel shortage- reauthorization of the Workforce Investment Act; and 3) Fee Scheduling.
1) Laboratory Developed Tests:

• FDA oversight should not be initiated without continued, interactive dialogue with the clinical laboratory community and industry stakeholders
• Any new guidance or regulation should:
• 1- Be based on a better stratification of risk than is currently used for waiver test categorization;
• 2- Accommodate innovation to meet the growing needs of the clinical practices;
• 3- Avoid redundancy with current regulatory agencies and avoid adding unnecessary costs to ensure laboratory testing is affordable to patients;
• 4- Utilize a process that can be handled with staffing levels and resources the agency can prove are available, to ensure the effective and efficient oversight of LDTs;
• 5- establish a fast track process for those tests that are developed to address emergency situations, including acute public health outbreaks related to communicable diseases such as H1N1 influenza detection; and
  
• 6- Allow for provisional use of esoteric tests, with appropriate disclaimers, where there is limited access to samples for clinical validation.
• Any legislation concerning genetic testing, personalized medicine and/or LDT should not be crafted without input from clinical laboratory professionals and other stakeholders in the clinical laboratory community.

These were some of the talking points we used when telling the aides about our concerns if the FDA decides to move forward with regulating all laboratory developed tests.
More to come later....
Personnel shortage
Fee Schedule

Thanks to Kim for the easy link from the awesome new website!! Be sure to check out the new National ASCLS website and the new ASCLS-IA website!
~ Theresa