Management and Technical Requirements
What must be evaluated for subcontracted testing?
Technical competence
V1M2 §4.5.2
What must an individual successfully perform prior to using any method?
Initial DOC
V1M4 §1.6.2
How often must initial calibration be verified?
At the beginning and end of each batch (with exceptions)
V1M4 §1.7.1.2d
What is the federal agency of the US Department of Commerce's Technology Administration that is designed as the United States national metrology institute?
National Institute of Standards and Technology (NIST)
V1M2 §3.1
How often must PT samples be analyzed?
Twice yearly
V1M1 §5.1.1
What term describes laboratory's management system policies related to quality, including a quality policy statement?
Quality Manual
V1M2 §4.2.2
What is used within a batch to evaluate the performance of the total analytical system, including all preparation and analysis steps?
Laboratory Control Sample (LCS)
V1M4 §1.7.2.2.1
What acronym describes the verification standard that is equal to or less than half of the highest level in the calibration?
CCV (Continuing Calibration Verification)
V1M4 §1.7.1.2c
What position includes 8 explicit duties, one of them being to "arrange for or conduct internal audits as per §4.14 annually"?
Quality Manager
V1M2 §4.1.7.1f
Who is the person or organization that operates a TNI-compliant PT program?
PT provider
V1M1 §3.6
What document records the client/project name, date and time samples are delivered to the lab, unique lab ID, and initials of the person making entries?
Sample receipt log
V1M2 §5.8.7.3a
When required, what are chosen to reflect the chemistries of the targeted components of the method and are added prior to sample preparation / extraction?
Surrogate spikes
V1M4 §1.7.2.3.3
What is the minimum number of calibration standards for a Quadratic Fit calibration curve?
6
V1M4 §1.7.1.1f
What is the term for specified limits placed on characteristics of an item, process, or service, defined in requirement documents?
Acceptance Criteria
V1M2 §3.1
What is the calendar date by which all participating labs must submit results for a PT sample to a PT provider?
Closing Date
V1M1 §3.10
Who is responsible for implementing the quality system?
Quality manager
V1M2 §4.1.13
What QC sample tests for contamination in the lab environment, and is processed along with and under the same conditions as the associated samples to include all steps of the analytical procedure?
Method blank
V1M4 §1.7.2.1
How frequently must a calibration using a linear range with only a zero point and a single calibration standard be performed?
Daily or at the beginning of each analytical batch
V1M4 §1.7.1.1li
1 of 18 explicit requirement of this document includes "all maintenance, calibration and verification procedures used by the laboratory in conducting tests"?
Quality Manual
V1M2 §4.2.8.4a
How long shall a lab retain all records necessary to facilitate the reconstruction of the preparation, processing, and reporting of results for PT samples?
minimum of 5 years
V1M1 §4.4.1
What is the frequency that internal audits are scheduled?
Annually
V1M2 §4.14.5c
What acronym stands for the lowest level an analyte can be reliably measured?
Limit of Quantitation (LOQ or LOD)
V1M4 §1.5.2.1
What must be the requirement of the ICV of a standard to verify the accuracy of the initial calibration?
Second source
V1M4 §1.7.1.1n
What is the policy that asks for "proper sample labeling to include unique identification and a labeling system for the samples with requirements concerning the durability of the labels and the use of indelible ink" as part of the 7 requirements for it?
Sample Acceptance Policy
V1M2 §5.8.6
The two things a lab must do if they fail to successfully analyze a PT study?
Determine root cause of the failure and take corrective action
V1M1 §6.1