Legal Defensibility in the Laboratory

To Protect and Enhance Kentucky’s Environment

KWWOA

April 17, 2013

Definition

An organization must proactively build a case that can withstand legal scrutiny. It should operate under the assumptions that it will be subject to legal proceedings (civil or criminal) that challenge whether or not what it did

what was necessary, adequate and reasonable.

Definition

An organization must proactively build a case that can withstand legal scrutiny. It should operate under the assumptions that it will be subject to legal proceedings (civil or criminal) that challenge whether or not what it did

what was necessary, adequate and reasonable.

Main obstacles to achieving legally defensible data:

• Lack of QA/QC – Inappropriate/missing QC

– Missed hold times

– Unethical behavior

• Inadequate Documentation

Just Remember…

If you did not write it down,

YOU DID NOT DO IT!

QAP/SOP• Laboratories must document all procedures in

a Quality Assurance Plan and/or Standard Operating Procedures– Must include policies on record integrity, record

retention and storage

– Maintain ALL QAP/SOPs including old revisions

Chain of Custody• Date, Location (including name of utility and PWSID#), site within

the system, time of sampling, name/organization/phone number of sampler, and analyses required (IV; 8.3.1)

• ID of the sample (routine distribution, check sample, raw or finished, repeat or confirmation or other special purpose) (IV; 8.3.2)

• Date of receipt of sample in the laboratory (IV; 8.3.3)

• Sample volume/weight, container type, preservation and holding time and condition on receipt (IV; 8.3.4)

• pH and disinfectant residual at time of sampling (if required)(IV; 8.3.5)

• Transportation and delivery of sample (person/carrier, conditions) (IV; 8.3.6)

Chain of Custody• Relinquish/Received Signatures

– Samples must be relinquished and received at the SAME TIME—NO GAPS when sample is out of custody

– If samples are put in a refrigerator, relinquish them to the refrigerator! Make sure that refrigerator is secure and has a temperature log.

CoC Signature Examples

• What’s wrong with this picture?– Where is the sample from 8:30am until 9:45am?

CoC Signature Examples

• This shows the whole story– Relinquish/Received times match up

– No question as to sample location

– Make sure if relinquishing to a refrigerator that it’s SECURE and has a TEMPERATURE LOG

CoC Continued• If refrigerator is NOT secure, use custody

seals on sample bottles

• Once in the laboratory, maintain internal tracking to show sample’s location

Log Books• Temperature logs for EACH oven,

refrigerator, incubator, water bath, etc.– If more than one, use a unique identifier for the

log and equipment (ie: Oven 1, Oven 2). These identifiers must be plainly visible.

– Thermometers must have a unique identifier or serial number traceable back to calibration against a NIST thermometer. Clearly indicate a correction factor and expiration of calibration on the thermometer.

Log Books• Thermometer Calibration Logs

– Serial number of lab thermometer being calibrated– Serial number of NIST thermometer used– Temperature of lab thermometer – Temperature of NIST thermometer– Correction factor– Date/Initials

• Calibration must be performed at the temperature at which the thermometer will be used!

Log Books• Reagent/Standards Log

– Include Lot #, Expiration Dates– When making a working standard, include how much of

which stock standard is used and what it was diluted with. Give this working standard an identifier and expiration date. Whoever made it must indicate date/time made and initial the log. Label the working standard as well.

– Log must contain sufficient information to get any working standards used back to a Certificate of Authenticity

Log Books• Maintenance Logs

– Any instrument/equipment requiring maintenance MUST have a log book.

• Balance Verification Log– Document which weights are being used and when their

certification expires. – Place a copy of that weight set’s acceptance criteria in

the log book. – Document weight used, weight read, and whether or not

that weight read is acceptable according to the CofA.

Log Books• Water Quality

– Document water source tested, which parameters are tested, QC acceptance for those parameters.

• Calibration Logs– Standard Lot #, Expiration date, Slope and any QC

acceptance criteria

Log Books

Log Books

• DATE, TIME, INITIALS

• Line Downs and Ditto marks are NOT acceptable for most logs

• Write-overs are NOT acceptable.

Log Books

Bench Sheets

Bench sheets must contain ALL information necessary to recreate an analysis and result!

Bench Sheets• Information to record includes:

– Standard # (must get back to CoA eventually)

– Expiration dates

– Analyst’s initials

– Analysis dates and times (including extraction info)

– Instrument ID

– Acceptance criteria• %RSD, Duplicate, Weight Differences, ICAL/CCV etc.

Bench Sheets• More info to include:

– Final results AND units of measurement

– Unique sample ID #

– Specific method utilized

– Manual adjustments/justifications

– All QC associated with that batch, including closing QC!

Documentation• Items to consider:

– Did calibrations bracket the results?

– Were hold times met?

– Did all QC pass?

Just Remember…

If you did not write it down,

YOU DID NOT DO IT!

Questions?

Contact InformationArianna LagemanDivision of Water

200 Fair Oaks Lane; 4th Floor

Frankfort, KY 40601

Phone: (502) 564-3410 Email: Arianna.Lageman@ky.gov