Laboratory Accountability Program for Public Water Systems

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Laboratory Accountability Program(for Public
Water Systems)

• Presentation to KWWOA
• March 31, 2008
• Department for Environmental ProtectionEnvironmen
  tal Public Protection Cabinet

To Protect and Enhance Kentuckys Environment
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Laboratory Certification Program

• OVERVIEW
• DOW began administrative responsibilities on
  January 1, 2008
• EPA has approved the updated structure
• Program will continue to utilize the use of
  third-party auditors
• KY currently has Primacy for chemistry and
  microbiology only, not radionuclides

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Organizational Chart
EPA Administrator
KY Certification Authority - CA Donna Marlin
may designate to DOW Director
Certification Program Manager - CPM Frank Hall
Third-party Auditors
Certification Officer CO Patrick Garrity
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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 by reference

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Purpose of Lab Accountability Program

• The primary reason for DOW undertaking the
  laboratory accountability program is to
• 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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Lab Accountability In Addition

• REMEMBER !!!
• PWSs are ultimately responsibility for reporting
  errors!
• The laboratory accountability program is intended
  to hold laboratories accountable
• in addition to PWSs

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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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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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Types Laboratory Errors

• Clerical error
• Typos
• Incorrect information
• Technical errors
• Timeliness of report
• Incomplete
• Improper sub-contracting / reporting

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Common Lab Errors Red Flags

• Late
• Reporting errors
• Incomplete
• Lack of attention to detail
• Incorrect information
• Missed and/or incorrect holding times used
• Incorrect dates

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Red Flags (cont)

• Incorrect method/analyte reference codes
• Missing analyte codes
• Incorrect method reporting limits (MRL)
• Incorrect nomenclature
• Maximum Contaminant Level (MCL) violations
• Incorrect reporting units
• False positives

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Potential Trends in Analytical Results

• Consistently submit reports with errors
• Same analyst(s) 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
• Possible fines / penalties

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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.
• Primary lab must not take credit for another labs
  work product, not even by omission.
• Primary lab must not add any information to a
  secondary labs report form, including 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
• PWS Note that the secondary lab is not under
  contractual agreement with you, they are the
  subcontractor to the primary lab.

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Example Compliance Report
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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