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GeneDx General
QA/QC
Clinical Applications
Contamination
Controls
100
The location of all Microarray specific policies, SOPs, and methods can be found here.
Where is on the Intranet and in the Array labs.
100
The time interval at which each technician should be tested for their competency in a particular skill.
What is semiannually in the first year following training and then annually thereafter.
100
Name at least 2 of the 4 unique identifiers that are acceptable for labeling all specimen samples.
What are Patient Name, Date of Birth, Social Security Number, Accession Number/Requisition Number. LIMS Barcode is also an acceptable answer.
100
TRUE/FALSE Samples, equipment, and PPE can be transported back and forth between Pre- and Post- Laboratories as needed.
What is False. Workflow should remain from Pre to Post and never the reverse. PPE is to remain in the laboratory they originated in.
100
TRUE/FALSE Control samples can be processed before, along side, and/or following their associated Clinical Samples.
What is False. Control Samples are to be processed at the same time, by the same technician, with the same reagents/equipment as the Clinical Samples.
200
This document contains quality goals, objectives, performance measures, and quality improvement initiatives.
What is the Quality Manual.
200
Bi-Annually the water quality is tested for.
What is silicates and bacteria contamination?
200
The location you can find step-by-step guidelines and procedures for what to do next while you are working in the laboratory.
What is the SOP.
200
The color of the PostLab designated material.
What is blue.
200
TRUE/FALSE The person who witnessed DNA addition may not lab check.
What is true.
300
The system of recording of lot numbers, expiration dates, date received, and date placed into service, so that the labs are sufficiently stocked.
What is the inventory control system?
300
(Daily Double) 866-236-7212 (US) 847-832-7533 (International)
What is the dedicated CAP telephone line for GeneDx employees to communicate concerns about quality and safety management.
300
The best practice for when there is an error in patient identification or other information on a specimen label.
What is recollect the specimen? If that is not possible, label correction should be documented and a Corrective Action put into place.
300
Separate rooms or a separation barrier has been implemented to prevent contamination and is mandatory for successful test results.
What is Pre and Post PCR areas?
300
The control that monitors specifically for contamination within the method's reagents.
What is a Non-Template Control, a Water Blank, a Negative Control, or a 'No DNA' Control.
400
The interval of time earlier editions of all SOPs, including entries, revisions, dates of implementation, and discontinuance, should be archived and maintained.
What is at least two years.
400
Beckman and Stratagene instruments perform this testing twice a year.
What is Inter-Instrument Comparisons?
400
The procedure when patient test results cannot be reported out within established time frames.
What is GeneDx is obliged to notify the appropriate individual/client that there will be a delay of testing.
400
In order to reduce the possibility of a sample switch, a DNA addition witness must check what?
What is the witness must check that the accession number on the DNA tube (top and side) matches the setup sheet and the tracking sheet.
400
This helps to monitor sample to sample contamination in array setup.
What is a Spike-in?
500
In order to assure all copies of a policy/procedure are up to date, personnel have read those policies, and that all policies have been authorized by the lab director prior to implementation, this system was put into place.
What is the Document Control System?
500
Studies that specifically test for process accuracy, analytical sensitivity, analytical specificity, and precision.
What are Validation Studies?
500
(Daily Double) The TAT (turn-around-time) for following Microarray tests: Exon/Genome NDD Panels/Mito Panels
What are 3 weeks and 6 weeks?
500
These pipette tips are used to prevent contamination. They are recommended as part of contamination prevention protocols.
What is aerosol barrier pipette tips (also called filtered tips)?
500
When is it necessary to get a supervisor's signature on an array setup sheet?
What is when the tech does anything that deviates from protocol. Examples of this would be running a full rxn in an 8x array or running an undigested array on a digested slide.