All Common
Labs are required to perform PT/AAP, at minimum, this many times a year.
What is 2 times a year.
Analytical measurement range (AMR) verification must be performed for these type of test systems.
AIL's scope of service (document describing tests offered, hours of operation, turn-around-times) is captured in this type of document.
What is the lab test catelog
Instruments/Equipment Record Review must occur at this frequency.
What is at least monthly.
If a result is greater than or less than the AMR, a numeric result is not reported unless the sample is processed by dilution. TRYPT>200 results are performed at this maximum dilution factor to obtain numeric results.
What is 1:10 dilution factor.
The system that AIL uses to document non-confirming events.
What is the Laboratory Event Management System (LEMS).
In AIL, expired thermometric standard devices and timers are sent to this location.
What is the Recycling Center, South Warehouse.
These 2 types of controls must be included in fluorescent antibody testing.
Whare are positive and negative controls.
Quality control records must be kept for this many years before their discard.
What is 2 years.
All Primary specimen containers must be labeled with at least 2 patient-specific Identifiers. What are the acceptable patient-specific Identifiers?
What are patient name, date of birth, hospital number, social security number, requisition number, accession number, or unique random number.
What is before the next dose of drug administration.
Specimen material packaging and shipping must be in accordance with national, federal, state and local laws and regulations. AIL uses this group to handle the packaging and shipping of specimens.
What is QMS (Quality Management Services)
All technical policies and procedures must be reviewed at this frequency.
What is at least every 2 years.
The calibration procedure for FDA approved methods must include at minimum these 4 components.
What are the number, type, concentration of calibration materials, frequency of calibration and criteria for acceptable performance.
Corrections made to laboratory records must be ______ and ________.
What is legible and indelible.