ABI Sequencers, Nanodrops, Hamilton Robots (Thunder-blast and Johnny 5), and QIAxcel instruments performs this twice a year.
What is Inter-Instrument Comparisons?
100
Bi-Annually the water quality is tested for.
What is silicates and bacteria contamination?
100
Xterminator Solution, BigDye Terminator v3.1 Ready Reaction mix, Taq, dNTP, Kappa, and deaza are all defined as.
What is critical non-exempt reagents?
100
ONLY on inspection day your required to do the following.
What is wear pants and NO personal devices in the lab:phones, earbuds, ipods, pagers, etc.?
100
A test report must contain the original report date and the report date of the amended tests results.
When GeneDx documents a change in a report?
200
Representative wells of this instrument are tested when originally placed into service and annually thereafter to check for temperature accuracy.
What is thermocyclers?
200
This log is filled out before and after using work surfaces to indicate that CALTech Dispatch was used to eliminate potentially infectious materials.
What is the Daily Decontamination Log?
200
Critical Non-Exempt reagents require this type of validation.
What is Parallel Lot to Lot testing.
200
Politely ask them to put on a coat and gloves before continuing if you see.
What is ANYONE (including an inspector) not wearing gloves and a coat in a gloved only area.
200
This system is in place for supplies, recording of lot numbers, expiration dates, dates received and placed in service.
What is Inventory control system?
300
This instrument is NOT calibrated since it's only used to collect liquid to the bottom of tubes, not to form pellets.
What is mini-centrifuges?
300
This separation barrier has been implemented to prevent contamination and is mandatory for successful test results.
What is Pre and Post PCR areas?
300
Master mix requires the following labeling requirements.
What is Identity of Reagent, Storage Conditions, Preparation Date, Initials of preparer, and expiration date.
300
Know the various locations of.
What is MSDS, Fire Extinguishers, First aid kits, biological clean up kit, and fire meet area?
300
Protection from electrical surges and interruptions must be adequate to prevent loss of data to this system.
What is the GeneDx computer system?
400
Calibration of our pipettes occurs.
What is Every 6 months?
400
This control is used to look for contamination?
What is "no DNA" controls (blanks)
400
This category of reagents are NOT tested against current lot. New lots are subject to documentation of satisfactory performance upon first use of the reagent only; not lot to lot comparisons.
What is Critical Exempt reagents?
400
Two or Three most commonly seen reagents used beyond their expiration dates. (NO REAGENTS ARE TO BE USED BEYOND THEIR EXPIRATION DATE, unless manufacturer has provided written authorization to do so)
What is Master Mix, Water Aliquots at personal benches, and AS Buffer (beyond 7 days from open date in the fridge).
400
These records should maintain manufacturer, serial number, date and place of service, equipment performance, maintenance logs, and damage/malfunction/repair reports.
What is equipment records?
500
(Daily Double) Performance records shall be maintained and readily available for this time frame.
What is the life span of the equipment plus two years thereafter (including electronic records)?
500
(Daily Double). These pipette tips are used to prevent contamination. They are recommended as part of contamination prevention protocols.
What is aerosol barrier pipette tips?
500
Small aliquots of this is stored to minimize the number of freeze thaw cycles.
What is stocks of primers?
500
Rather than defaulting to "I don't know ask my supervisor" when asked a question you should.
What is Take your time and answer in your own words, ask for clarification, or if the question is about a task you don't normally do refer them to someone responsible.
500
Name two or three records required to be maintained for each item of equipment.
What is reports/certificates of all calibrations, adjustments, acceptance criteria, date due of next inspection?