2016 TNI Standard
Ensures proper documentation in the process of the sample going from the client to the lab
WHAT ISSSS THEEEE CHAIN OF CUSTODY
A successful score of two of these studies allows us to report analytes
What is a Proficiency Test
Where all things QA reside currently
What is the QA Shared folder
Report integrity issues to
Your manager/QA/anonymous hotline
Travis receives a non-potable total coliform water sample from a client for a membrane filter method test at 9:45am. The only sample information on the chain of custody is the collection date, location, sampler’s name, and sample ID. He fills in the collection time as 9:45am and gives the sample to Cindy Lou who preps the sample and places the sample in the incubator at 5:30pm.
•The actual collection time is unknown and cannot be entered without client feedback
•Non-potable water samples have a maximum holding time of 8 hours which includes the time elapsed from collection of the sample to placement into the incubator
Documents the regular calibration and maintenance of instruments.
What is a maintenance log
Obtaining this allows for someone to report data validly
What is an Initial Demonstration of Compentency
Name a record that must be maintained per the TNI standard for each item of equipment
A reason why Unethical behavior occurs
Pressure/Lack of ethics/Lack of understanding/Lack of knowledge or confidence/Ineffective oversight/Focus on production/Unrealistic expectations/Lack of fortitude or personnel standards
Cindy Lou a sales person has a big quote and she knows that location ABC doesn’t have certification for Alachlor but she knows they will receive it in 3 months. The work will arrive in 4 months so she indicates that the location ABC has certification.
•YES!- We must provide a fair representation in all dealings including Quotes, Invoices, etc.
•Cindy Lou should say that we are in the process of obtaining certification and we expect to have it by the time your samples arrive. If we don’t she will let the client know.
An agency that issues our certification through NELAP
What is an accrediting body
THTAP? (You can miss ONE)
Trust/Honesty/Transparency/Accountability/Principals
The study QA provides to an agency upon request that has 2 samples quarterly
What is an MDL study
A reason to behave ethically
You have integrity/JAIL/etc.
Travis never sees changes in the refrigerator’s temperature. It is always 4°C. He reads a thermometer that does not have a correction factor indicated and is divided into 2°C. He decides to fill out the temperature log sheet for the entire month of April on April 1st. Name 2 issues
•Refrigerator temperatures must be checked each workday
•The correction factor for the thermometer used to take the temperature is not incorporated
•Observations must be recorded in Real Time
•Refrigerator thermometers must have graduations of no greater than 1°C
Calibrations are required at this frequency for dispensettes and pipettes
What is quarterly
This agency released a 2016 Standard that dictates what is required for our lab.
The NELAP Institute
The means of going "off-road" your SOP
What is an SOP Deviation
The name for faking lab results
What is dry labbing
Travis's SOP says that samples must dry for one hour. Travis always takes the samples out after his 30 minute lunch, because that's how time works best for him and they get the same results anyway. He still reports the time drying as an hour on the prep sheet, because that's how it automatically populates.
•Travis needed to follow his SOP
•Travis didn't submit a request with QA to change his SOP and see if it's allowed
•Travis didn't submit an SOP deviation to cover his back
•Travis is reporting incorrect/inaccurate information on his prep log.
Name one of the Four Data Integrity Procedures
NELAP stands for this
What is the National Environmental Laboratory Accreditation Program
Study that documents the range of concentrations where the signals are directly proportional to the concentration of the analyte OR the study documenting time an analyte spends on a chromatography column between injection and detection
Linear Range Study or Retention Time Window Study
FIVE consequences of data fraud
Firing/Probation/Loss of responsibility/RETRAINING?Criminal penalties/Revocation of Certs/Suspension/Fines/Imprisonment/Death (JK)
Travis had a really hard first day on a new method. He's never done it before, but his coworker didn't show up so his manager, Big Travis, told him to cover the test. His curve didn't pass the first time. Travis doesn't have time to recalibrate again, and the samples go out of hold today. Travis tells his manager, Big Travis, and Big Travis says to "figure it out". Travis keeps messing with the curve and manually integrating things different ways until it passes. This took Travis so long, his last sample went out of hold and it's outside the 12 hour tune time by just 30 seconds. Travis edits the report to "round down" and be within the time frame.
•Data manipulation/Misrepresenting QC results
•Time travel
•Should have called the anonymous hotline/told QA on Big Travis
•Didn't have IDCs