Laboratory Accountability Program for Certified Laboratories

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Laboratory Accountability Program(for Certified
Laboratories)

• Presentation to KWWOA
• April 2, 2008
• Department for Environmental ProtectionEnvironmen
  tal Public Protection Cabinet

To Protect and Enhance Kentuckys Environment
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Laboratory Accountability Program

• OVERVIEW
• Began January 1, 2008
• Warning Letter Notice of Deficiency
• Program Utilizes EPA Manual for Laboratories
  Analyzing Drinking Water Samples 5th Edition
• 401 KAR 8040 incorporates EPA Manual and 40 CFR
  141 by reference

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Purpose of Lab Accountability Program

• The primary reason for DOW undertaking the
  laboratory accountability program is to
• Add structure to procedures already used
• Minimize/eliminate reporting errors
• Identify and track source(s) of reporting errors,
  document errors, and institute corrective actions
  (with consequences)
• Prevent repetitive errors over long periods of
  time
• Provide feedback and technical assistance and
• Properly place the responsibility of quality
  checks.

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EPA - State PWS Lab Interactions
Sample Information and Results
Certified Laboratory (40 CFR 141) (EPA Manual 5th
Ed.)
PWS (40 CFR 141)
B-2-B Agreement
EPA
Regulated Entity
Regulated Entity
Primacy State KY Drinking Water Program 401 KAR
Chapter 8 (40 CFR 141 and 142) (EPA Drinking
Water Manual 5th Ed.)
Sample Results
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Lab Accountability Flowchart
Each Lab report with errors resulting in a
possible PWSs noncompliance will result in a
warning letter issued to Lab
Three (3) Lab errors resulting in any PWSs
noncompliance or any single lab error resulting
in ten (10) PWSs noncompliance in a compliance
quarter
Microbiology
VOC
SOC
IOC
Pb / Cu
DBP
6 Lab Errors Effecting 20 PWS
Unannounced On-site Lab Audit
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Lab Accountability Flowchart (cont)
Unannounced On-site Lab Audit
Deficiencies found resulting in downgrading to
provisional Certification through next quarter
If audit reveals NO deficiencies lab
certification status remains intact
Following quarter without three (3) lab errors
resulting in any PWSs noncompliance or any single
lab error resulting in ten (10) possible PWSs
noncompliance and meets all required remedial
recommendations from the on-site audit
Following quarter with three (3) lab errors
resulting in any PWSs noncompliance or any single
lab error resulting in ten (10) possible PWSs
noncompliance and meets all required remedial
recommendations from the on-site audit
Lab Certification Revoked for six (6) months
Lab Certification Restored
After two (2) quarters the Lab may re-apply for
certification. Certification will be restored
after the following has been successfully
completed all certification requirements and fees
have been paid.
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What Triggers a Notice of Deficiency?

• 1st Written NOD - any reporting error within each
  report form group.
• 2nd Written NOD a second reporting error within
  the same report form group.
• 3rd Written NOD a third reporting error within
  the same report form group.

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Notice of Deficiency

• 1st NOD Signed by Certification Officer
• 2nd NOD Signed by Certification Program Manager
• 3rd NOD Signed by Certification Authority
• Copies of NOD letters also sent to all PWSs
  effected

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Common Lab Errors Red Flags

• Late report submission
• Incomplete report
• Incorrect information (e.g. PWSID )
• Missed and/or incorrect holding times used
• Incorrect dates
• Incorrect method/analyte reference codes

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Red Flags (cont)

• Missing analyte codes
• Incorrect method reporting limits (MRL)
• Incorrect nomenclature (e.g. lt )
• Maximum Contaminant Level (MCL) violations
• Incorrect reporting units
• False positives / negatives.

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Potential Trends in Analytical Results

• DOW utilizing a database format to log, track and
  review reporting errors.
• Trends that have been identified since 1/2008
• Consistently submit reports with errors
• Same analyst involvement
• High bias / low bias
• False positives / negatives

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Laboratory Audit

• On-site audit to review laboratory procedures,
  records, etc
• Announced or unannounced
• Possible downgrade of certification status
• Possible revocation of certification

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Laboratory Services

• Primary Laboratory
• Certified laboratory contracted by a PWS
• Subcontracted (Secondary) Laboratory
• Certified laboratory contracted by primary
  laboratory

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Primary Laboratory

• The Primary laboratory is responsible for
  ensuring that subcontracted laboratories meets
  all of the requirements of 401 KAR 8040 40 CFR
  141 SDWA and EPA Drinking Water Manual 5th.

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Primary Lab and Secondary Lab Results

• Primary lab may submit results generated by a
  secondary lab only if they acknowledge the
  secondary lab by name, lab code and applicable
  results by using separate form and unique sample
  identification number.
• Primary lab must not take credit for another labs
  work product, not even by omission. Possible
  fines and/or penalties.
• Primary lab must not add any information to a
  secondary labs report form without their
  permission (e.g. print analyst name, supervisor
  name, etc)

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Data Retention Subcontracting

• The PWS is responsible for maintaining compliance
  sample results for the required period of time.
• The Laboratory is responsible for maintaining
  compliance sample raw data for the required
  period of time. Raw data is defined as the data
  necessary to reconstruct the sample results.

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PWS Primary Lab Subcontracted Lab

• Primary laboratories do subcontract various
  analyte/method analysis for a variety of reasons
  to other certified drinking water labs.
• PWS should be made aware that their contracted
  laboratory is subcontracting some or all of the
  analysis required to completely report a
  compliance sample result (on time).

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PWS Primary Lab Subcontracted Lab

• Steps should be taken to ensure that the data are
  retained in the event
• Primary lab suffers a catastrophic event (fire)
  or goes out of business
• Subcontracted (or secondary) lab suffers a
  catastrophic event (fire) or goes out of business
• The secondary lab is not under contractual
  agreement with the PWS, they are the
  subcontractor to the primary lab.

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Detection Limits

• MDL minimum detection limit for an analyte
  (should be updated at least annually)
• IDC initial demonstration of capability must be
  initially performed for each analyte/method
  and/or instrument
• MRL minimum reporting limit for a drinking
  water analyte
• MCL maximum contaminant level for an analyte

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MDL MRL MCL Discussion
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Minimum Reporting Limit (MRL)

• Updated MRLs are currently on Website
• KY does require MRL at or just above Federal
  Detection Level
• Calibration standard must be at or below the MRL
• KY utilizes EPA Memo for SOC use of a 2.2
  multiplier in calculating MRL
• DOW expects every laboratory to make a concerted
  effort to achieve KY MRL requirement

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Questions

• ?

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Contact Information

• Patrick J. Garrity
• Certification Officer Division of Water14
  Reilly Road
• Frankfort, KY 40601
• Phone [phone] ext. 574
• Fax [phone]
• Email patrick.garrity_at_ky.gov