What's New?
This workflow was recently introduced to the QIAxcel process to transfer No Template Controls (NTCs) and gel-based tests from robotic PCR source plates to consolidated 96-well plates for product visualization.
What is Rearray for Product Check (RPC)?
Manual PCR exceptions. Panels with controls which can set-up to 3 patients, plus the 2 controls for these panels (Name Three).
What is CYP27B1, FKTN, HEAR-GEL-CORE: GJB6 MPXA & MPXB, HPS3 DEL/NODEL, IKBKG T1, MSH2 MPXA, NEB DEL/NODEL, and SRY 1A and 1B?
CLRW stands for ______________________________
What is Clinical Laboratory Reagent Water?
An Inspector asks for a list of individuals who can use Megaman during a walk-through. Refer them to this log.
What is Equipment User Log?
Proper method to operate a portable fire extinguisher.
What is the PASS method? P-pull the pin A-aim the nozzle S-squeeze the lever S-sweep back and forth
This mutliplex assay was the last test which utilized the Lonza FlashGel system before being optimized to transfer to the QIAxcel Advanced System.
What is MSH2?
Equipment preventative maintenance, calibrations, and functional checks last and next dates can be verified by evaluating.
What is the inspection tag, EquipmentDx, or assessing documentation filed in Equipment Binders?
_________ ________ tips are used to prevent contamination prior to amplification.
What is aerosol barrier?
Reagent validations must be performed upon receipt and during discovery of Freezer/Fridge/Room-Temperature incidents which fall outside of this acceptance/rejection criteria.
What is equal to or exceeding 2 hours for incidents ≤5 degree's Celsius out of range or exceeding 1 hour for incidents above 5 degree's Celsius out of range?
Name one instrument and two processes that utilize UV light.
What is UV decontamination of Post Hamilton instruments before performing RFN, RFS, or Post-PCR_Setup program?
DAILY DOUBLE. The Agilent PlateLoc Sealer monthly air line check was recently added as a maintenance requirement in E-26_General Equipment policy to ensure......
What is to ensure that the air coming into the PlateLoc Sealer is properly filtered from moisture or aerosolized impurities?
Defined pre and post areas are indicated by the following (Name three).
What is pre/post labeled signs, color coding scheme (white designated for pre coats/tags and blue designations for post coats/tags), and separate spaces with closed doors ?
The GeneDx approved germicide, ____, is a ____ dilution of _______ ______.
What is CALTECH dispatch,1:10, sodium hypochlorite?
If an inspector asks where do you find the SDS for the reagent being used refer them to the following.
What is Sharepoint>Quality Systems>Safety>Core Sequencing Safety Data Sheets?
GeneDx maintains this plan to help identify and address activities that put workers at risk for occupational and/or repetitive motion injuries.
What is the Ergonomics Plan?
Cyclers now have __________ wells verified during ___________ testing.
What is all 96 wells wells by Driftcon testing?
This is the pipette calibration schedule.
What is calibrations performed in June and December every year.
_____________ and _____________ are both examples of cleaning logs used in lab.
What is Daily Decontamination and Weekly Cleaning Logs?
Hardware errors, software errors, and scheduled/unscheduled maintenance of an instrument is recorded on this log.
What is maintenance log?
Used during annual fire drill and in the event of an actual fire/emergency evacuation. HINT: Acroynm
What is RACE, Rescue-remove employees and vistors, Alarm-activate the nearest fire alarm, Contain-confine the fire/smoke by closing doors and windows, Extinguish/Evacuate-escape the area of the fire?
Any plates that do not meet the expected threshold for Avg Length, Avg QV, or Pass % will be flagged as ____________ in CoreDx and placed on ____________. All plates flagged as such will be evaluated by ABI leadership and Lab Supervisors to determine the following __________________________________.
What is "False/Fail" and placed on "Hold"? And What is if plates should proceed through provisional processing or if plates will be repeated at the ABI plate setup step to produce additional data?
CLRW should be pure enough to satisfy the requirements of most routine clinical laboratory testing. This is the maximum microbial content allowed before demarcating water out of usage.
What is 10 CFU/mL (Colony Forming Units)?
_______/________ temperature is required on manual logs if there is a 15 hour period between shifts, technician failed to clear temps the night before, or after returning from a holiday.
What is Min and Max?
Instruments verified during comparability testing is as follows.
QIAxcel, FlashGel, and ABI Sequencers.
This should be performed at all times when Pre-PCR is transferred into Post cyclers.
What is 1) With white coat and gloves from Pre transfer PCR into post WITHOUT touching door, table, etc. in post to be sure not to cross-contaminate PPE. Set down on table adjacent to cyclers, 2) Without touching anything in Post go back into Pre and DOFF, 3) Go back into Post and DON, 4) Load strips/plates into cyclers with Post Coat + Gloves, AND 5) Rinse previously soaked PCR tray and Soak PCR Tray just used to load PCR in 10% bleach for a minimum of 30 minutes.