The location of all Microarray specific policies, SOPs, and methods can be found here.
Where is on the Intranet and in the Array lab in the cabinets.
100
The time interval at which each technician should be tested for their competency in a particular skill.
What is semiannually (at 6 months and at 12 months) 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 it 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
Scanners, Beckmans, ABIs and Stratagenes perform this testing twice a year.
What are Inter-Instrument Comparisons?
200
The location where 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 colors of the Pre and Post Lab designated material.
What are white (Pre) and blue (Post).
200
TRUE/FALSE
The person who witnessed DNA addition may also lab check.
Why?
What is false. This is to limit mistakes during setup. If the same person witnesses and lab checks, it is easier for them to miss the same mistake twice.
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 dedicated CAP telephone line for GeneDx employees to communicate concerns about quality and safety management.
Candy Bonus: What is the phone number for the Compliance Department?
300
The best practice for when there is a gender discrepancy for a sample being analyzed.
What is check the setup sheet and tracking sheet to ensure genders match. The tech should then check LIMS and if the genders still match, the tech should pull in the remaining samples from the slide to check genders and spike-ins. The tech should also notify a supervisor.
300
These pipette tips are used to prevent contamination. They are recommended as part of contamination prevention protocols.
What are aerosol barrier pipette tips (also called filtered tips)?
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
Bi-Annually the water quality is tested for.
What are silicates and bacteria contamination?
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 or gender discrepancy, 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. They also should check that the gender on the setup sheet matches the gender (or karyotype) on the tracking sheet.
400
This helps to monitor sample to sample contamination in array setup.
What is a Spike-in?
Candy Bonus: Name all 16 in order
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 best practice during scanning when a PDF has a DLR of 0.00
What is tell your supervisor and then crop and re-extract?
500
Name a way that contamination can be found for each type of testing technology.
What is multiple spike-ins being found on the same array, the NTC showing sample peaks, and the NTC having a CT value? You could also have problems with genders.
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, running an undigested array on a digested slide, running a sample of unknown gender with a female reference, or not adding water due to a low concentration.