Record Keeping
Emergency
Reviews/Assessments
SOPs
PPE
100
Earlier editions of this, including entries, revisions, dates of implementation and discontinuance should be archived and kept for at least 2 years
What is SOPs??
100
Fire extinguishing method (no acronyms please)
What is Pull Aim Squeeze Sweep?
100
Managers and supervisors along with all other testing personnel must undergo one of these the first six months, 12 months, and annually thereafter.
What is Competency Assessments?
100
List the different imaging techniques in the PCR Product Visualization SOP.
What is QIAxcel, Flash Gel, and PAGE gel photography?
100
Employee's first responsibility in the event of exposure to potentially infections materials
What is administer first aid?
200
There is explicit documented policies that specify who may use the computer system to enter or access this type of data.
What is patient data?
200
These type of spills should be cleaned immediately with appropriate disinfectant. It should also be reported to the laboratory director, documented, investigated and addressed with corrective action as necessary.
What is blood and bodily fluid spills?
200
This section is included in every competency assessment.
What is the QA/QC section?
200
Name three major steps in the summary of PCR Amplification.
What is DNA strand separation, primer hybridization, and DNA synthesis?
200
GeneDx approved germicide
What is Caltech Dispatch?
300
In the event an "out of range" temperature is recorded, these sections must always be filled out.
What is Corrective Action and Follow-Up sections on the temperature log
300
The emergency plan, contained in a bright yellow binder can be located here.
Where is the quality programs office?
300
These two reviews are not a company wide requirement
What is 90-day and mid-year reviews?
300
The re-array program is able to prioritize STAT samples based on this key difference.
What is the "s" prefix?
300
Evidence that GeneDx complies with PPE regulations
What are training records and written procedures?
400
Material Safety Data Sheets which contain information on chemicals used at GeneDx are stored here. (Name 3 places)
What is Outside Katie's office, Alger's office, and in the Quality Systems Office
400
This emergency station is required in all GeneDx laboratories where hazardous chemicals are used and must be within a 10 second travel distance.
What is Eyewash stations?
400
Name four of the six processes used to evaluate competency.
What is Direct Observation, Record Review, Test performance, problem solving skills, compliance, communication, allocation, leadership and personnel management?
400
Each exon must be set up with no DNA template blank. Blanks for exons can be shared by up to ....... tests (one set of blanks for every .... patients for the same test)
What is three tests?
400
The single most important means of preventing infection
What is hand washing?
500
Daily Double. Documentation is required this often for evaluation of instrument maintenance and function, including temperature of refrigerators/freezer in which reagents or patient specimens are kept.
What is monthly or more often as required by manufacturer
500
4 response steps in an emergency
What does Rescue, Alert, Confine, and Escape refer to?
500
Name the criteria used to score employee's on competency assessments.
What is 1-Advanced/Trainer level, 2-Skilled/minor-suggestions given, and 3-Unacceptable/Re-training/Re-testing?
500
Always check volume of DNA first. If less than this volume will remain after usage, inform the test manager before starting the test.
What is 20 micro-liters of DNA?
500
GeneDx employees that should be trained on the potential of hazardous materials
Who are all?