MEG CORE FACILITY National Institute of Mental Health Bethesda, MD 20892-1059 VARIANCE / PROCESS IMPROVEMENT REPORT	Variance Reporting: To be filled out within 24 hours by the person(s) witnessing an event to report the occurrence(s) or variance(s) to normal operations, policies, procedures, and practices involving any users, subjects / patients and / or equipment. If any injury involved notify Lab Director immediately. QA/QI Instructions: To make recommendation(s) for quality assurance / improvement indicate details of the proposed improvement in the description section. Check all that apply; Fill out sections A-N; where not applicable indicate N/A.
Section I.
A. Variance QA/QI
B. Status: ( all that apply) 1. Subject 2. Patient 3. Equipment 3. Other ________	C. Variance Date: _____/ ____/ _____ Variance Time: ________ am / pm Witnessed by: ______________________________________________ Witnessed by: ______________________________________________ Witnessed by: ______________________________________________
D. Description of Variance / Description of Improvement: (attach another page if necessary)
E. Injury To Person: *Report all subject, patient or staff injuries to the MEG Core Director immediately. N/A No Injury Inconsequential injury or effect Consequential (Possible temporary injury or effect) Serious / (Possible minor permanent injury or effect) Severe / (Possible major permanent injury or effect) Seizure / Possible Seizure Medical Emergency:___________________	F. Damage to Equipment: If any damage has been sustained discontinue use. Place an “Out of Service/Do not use” sticker on the equipment. N/A None Minor Damage / Inconsequential damage Consequential (Possible temporary damage) Serious / (Possible minor permanent damage) Severe / (Possible major permanent damage) Other ___________________________
G. Equipment Malfunction: * Discontinue use and place an “Out of Service” sticker on the equipment. If there is an injury contact the Lab Director immediately. N/A Unknown Malfunction Malfunction with injury Other ___________________________	H. Use Related: If there is an injury contact the Lab Director immediately. N/A Unknown Not clean Improper use Not properly maintained Previous user changed settings With injury Other ___________________________
I. Electronics Problem: N/A DSQ Electronics command failure No LEDs Slow Boot Flashing yellow LED Fails to boot DSQ Configuration read error Other ______________________________________________	J. Acq Problem: N/A Failure to start / launch Acq During localization at beginning of collection During localization at end of collection During collection Other ___________________________
K. Maintenance Related: N/A Unknown Maintenance not done Other ___________________________	L. Other: N/A Unknown Policy/procedure/practice variance _______________________________
M. Whom Notified: Director Staff Scientist System Analyst Research Asst. Lab Manager / Tech No one available Other _____________________________________________________________________________________ Reported by: __________________________ Phone Number: _______________ Date Reported: __________ Over
Variance / Process Improvement Report
N. Action:
Section II. (To be complete by MEG Staff)
Priority: Urgent Important Routine
Outcome / Result of Investigation:
Recommendations / Possible Solutions:
Process Improvement / Measures Implemented To Prevent Reoccurrence:
Investigator: ________________________________________________ Date: __________________________ Classification Code (Check all that apply): Acq / Electronics / Equipment / Damage / Injury / Maintenance / User / Other

1/04; Revised: 9/06