The QM program is appraised for its effectiveness at this frequency.
What is annually
100
Studies that document test accuracy, analytical sensitivity, analytical specificity, and precision
What are validation studies?
100
This is done to ensure the accuracy and quality of patient results by ensuring that all temperature sensitive materials are monitored daily.
What is recording the temperature?
100
This type of testing, in which a laboratory is in direct contact with a patient, is not offered by GeneDx
What is Direct-To-Consumer testing?
100
These must be checked for temperature accuracy before being placed into use and at least annually thereafter
What are thermocyclers?
200
SOP's, quality management policies, forms, records, tables, lists, cheatsheets and the like can all be found here
What is document control?
200
Reagents that are manufactured as this, must be validated and used together unless otherwise determined fit by GeneDX
What is a kit?
200
An "X" on a temperature log
What is temp not taken due to a weekend or a holiday?
200
It is implicit in quality to test these two types of specimens in the same manner
What are patient samples and controls?
200
We are required to keep this type of equipment cleaned and properly maintained at all times even though they are in constant use. (An alliterative acronym reminds us of the proper orientation).
What are electrophoretic instruments? (Run to red)
300
The quality management system(QMS) is required to support all lab personnel by providing resources to for them to carry out their duties. Personnel are encouraged to report any concerns about lab practices or behaviors to QMS or this program
What is the Clinical Laboratory Evaluation Program?
300
This classification or reagent must be validated with each new shipment/and or lot
What is critical non exempt?
300
"N/A" on a temperature log
What is day of the month not valid for given month?
300
(Daily Double) The Health Information Portability and Accountability Act (HIPAA) is a federal law requiring the protection of patient's health care information. GeneDx has a HIPAA policy that includes these two things.
What are annual training and document shredding?
300
Pipettes are calibrated this often
What is every 6 months?
400
(Daily Double) This federal law requires protection of patient's health care information. GeneDx remains compliant to this law by documenting annual training and shredding. (No acronyms please)
What is the Health Information Portability and Accountability Act
400
GeneDx uses more than one instrument/method to test for given analytes. These methods are checked against each other this many times a year.
What is twice?
400
Done every monday or after every 24 hour gap in readings
What is min/max recording?
400
These types of testing can identify an individual or a family member by use of genetic material. GeneDx does not offer these.
What are parentage and forensic identity testing?
400
BigBird, Foghorn, and Duck Dodgers are an example of this instrument requirement.
What is a unique label, or other ID between identical or congruent instruments to for proper reference in records.
500
There are 5 key indicator of quality that are monitored by the quality management program. Name 4 of them.
What are patient specimen ID, Test order accuracy, Critical value reporting, Specimen acceptability, and Corrected reports.
500
These checks are performed on each instrument prior to putting them in use.
What are function checks?
500
(Daily Double) Cap does not allow this on any temperature log, or any other log in the lab.
What is a blank space?
500
Preanalytic, Analytic, and Post-Analytic
What is the report phase of testing?
500
The laboratory should have an organized system for monitoring and maintaining all instruments as specified by the manufacturer. Since some equipment has no standard frequency or extent of maintenance, a schedule will be established based on this