Quality Control Method. All clinical data and samples collected will be carefully labeled so that it can be established to which patient the information relates. When available, replicate blood/DNA samples and specimens from family members will be tested/retested to confirm new findings and control for possible sample mix-ups. All identified disease-causing alterations will be confirmed in a patient at least twice prior to contacting the referring physician/patient to inform him/her of the progress. Clinical data will be confirmed from the original paper source whenever possible before being included in any scientific presentation/report. Specific results will not be shared with participants or their healthcare providers without first being confirmed in a CLIA-certified Laboratory. We recognize that there could be potential conflicts of interest given the relationship between the investigators, Challengers, and judges. The investigators will not participate in the Challenge or help any Challengers with their analysis or submissions. All Challengers who meet the guidelines put forth in the Participant Agreement will be considered for participation – one of the conditions of participation is a assurance that the Challenger Institution, Principal Investigator and Team Members do not have any conflicts of interest related to the Challenge. Any Challengers who are not approved for participation or who are disqualified will be agreed upon by the Principal Investigator, Co-investigator, and Xx. Xxxxxx Xxxx, a physician in the Program in Genomics at Children’s Hospital Boston who is not directly involved in the protocol and therefore can serve as a non-biased party. Requiring the agreement of all three individuals will help ensure that decisions about challengers are fair. In order to guarantee that judging is impartial, judges will not know which individual Challengers have submitted which data for judging and will not have a known financial relationship with any of the participating Challengers. Further, a condition of participation as a judge will require an assurance that the judge does not have any conflicts of interest related to the Challenge.
Quality Control Method a. Describe your methodology for assuring quality control. This includes the tools or processes that are available for reporting and tracking issues or work orders. Also explain the process for escalation of issues.
