Proposed Laboratory Certification
Rules Revision
15A NCAC 2H .0800
Laboratory Certification
April 16, 2015
Dana Satterwhite
Gary Francies
Overview
The North Carolina Wastewater/Groundwater
Laboratory Certification (NC WW/GW LC) program is
a vital component in the effort to ensure the quality
of analytical data used to make informed regulatory
decisions by various programs within the
Department of Environment and Natural Resources
(DENR).
Applicability
The Laboratory Certification Rules apply to:
Commercial, Industrial, Municipal, Field and
Other laboratory facilities which perform
monitoring analyses that will be used to report
compliance data to the State of North Carolina.
Our program currently certifies >700 laboratories
across the United States.
Programs supported
 Groundwater
 Wastewater
 Solid and Hazardous Waste
 Surface Water
 Waste Not Discharged to Surface Waters
 Point Source Discharges to the Surface Waters
 All wastewater treatment plant laboratories having
Local Pretreatment Programs.
 Underground Storage Tank program
Revisions
We are proposing various amendments, repeals and
adoptions that would result in:
 Previous stakeholder comment inclusion
 Appending the list of certifiable parameters
 Clarifying existing legislative rules or providing additional
quality control requirements where a Rule does not exist
 Codifying current policies and providing consistency among
regulatory programs
 Improving the data quality standards for Field Labs (the
rules have not been updated since 2002)
Current Fees
No fee increases are proposed
Additional Certifiable Parameters
Non-Field labs
Inorganic parameters
Acidity
Bromide
CBOD
DOC
Enterococci
E. coli
Ignitability/Flashpoint
Paint Filter Liquids
Volatile Residue
Silica
Metals
Boron
Total Hardness
Lithium
Potassium
Phosphorous
Sodium
Strontium
Titanium
SPLP
TCLP
Organics
Explosives
Organic Halides
SPLP
TCLP
Additional Certifiable Parameters
Field labs
Free Available Chlorine
Turbidity*
Salinity
Sulfite
Vector Attraction Reduction Options 5, 6 & 12
Minor Technical Changes
 Simplify the Scope
 Update Division, Section names, etc.
 Update to current terminology used in our field (e.g.,
Class S vs. ASTM 1 and 2 weights, PE vs. PT, etc.)
Codifies PT Requirements
EPA DMR-QA PT Exemption compliance
 PTs must be analyzed in the same manner as routine
environmental samples
[.0805 (a) (2)]
 Graded PT reports must be sent to the Certification
Branch directly from the vendor
[.0805 (a) (2) (A)]
Codifies PT Requirements
 Laboratories must submit a documented root cause
analysis and corrective action report for PT failures
[.0805
(a) (2) (A)]
 Laboratories are prohibited from sharing PT results prior
to a PT study deadline
[.0807 (a) (16)]
NOTE: Up to 4 PTs per year is not new. Routine is 1 PT per
year. Additional PTs may be requested for troubleshooting
purposes.
Additional Quality Control
Legal defensibility plays a more prominent role now than it
did in 2002.
 Requires review of QAM/SOPs every 2 years and track
changes
[.0805 (a) (7)]
 Laboratories must establish acceptance criteria for QC
elements where none is prescribed [.0805 (a) (7) (A)]
 Requires that analytical data must be accurate (e.g., mg/L
vs. ug/L) [.0805 (a) (7) (B)]
Additional Quality Control*
 Codifies
that laboratories must take documented
corrective action for QC failures [.0805 (a) (7) (E)]
 Codifies additional documentation requirements for
benchsheets and support equipment logs [.0805 (a) (7) (G)]
 Allows calibration standards equal to or less than the
lab’s lowest reporting concentration [.0805 (a) (7) (H)]
Additional Quality Control
 Codifies requirements for CV/2nd source/PQL check/CCV
and CCB after every 10 samples [.0805 (a) (7) (H)]
 Codifies blank acceptance criterion [.0805 (a) (7) (H) (i)]
 Codifies verification requirements for factory-set curves
[.0805 (a) (7) (H) (iv)]
Additional Quality Control
 Codifies traceability requirements for chemicals, reagents
and standards [.0805 (a) (7) (K)]
 Codifies additional documentation requirements for
sample preservation verification and non-compliance
notifications [.0805 (a) (7) (M)]
 Adds the requirement for a documented training program
[.0805 (a) (7) (O)]
Revisions Specific to Field Labs
 Clarifies which rules pertain to Field Labs
 Adds QC and documentation requirements consistent
with Non-field Lab requirements to provide consistency
and improve data quality
Improving the Data Quality
Standards for Field Labs
 Expanded record retention requirements [.0805 (g) (1)]
 Expanded certified data documentation requirements
[.0805 (g) (2)]
 Added the requirement for SOPs [.0805 (g) (4)]
 Added the requirement for a documented training
program
[.0805 (g) (5)]
Improving the Data Quality
Standards for Field Labs
 Codified requirements for traceability management and
documentation for chemicals, standards and reagents [.0805
(g) (7)]
 Added requirements for inspections and record submission
[.0805 (g) (9)]
 Codified PT requirements [.0805 (g) (13)]
 Added requirements for written notification of changes [.0805
(g) (15)]
Miscellaneous Changes
 Allows supervisor to contact rather than visit the lab daily
[.0805 (a) (3) (C)]
 Extends substitute supervisor time to match FMLA policy
[.0805 (a) (3) (C)]
 Prohibits altering a certificate or misrepresenting the scope
of accreditation [.0807 (a) (15)]
 Requires additional subcontracting information when a lab is
decertified [.0807 (e) (3)]
Revisions with financial impact
 Increased residue standard frequency [.0805 (a) (7) (C)]
 Requirement to review QA/QC/SOPs every 2 years [.0805
(a) (7)]
 Increased frequency for multiple weight checks for
balance [.0805 (a) (7) (J)]
 Requirement that Field Labs must have SOPs [.0805 (g)(4)]
Reducing Financial Burden
 Exception to definition of Commercial Lab [.0803 (5)]
 Providing URLs where reference documents are free [.0805
(a) (1)]
 Allowing PTs analyzed in the last 6 months for initial cert
[.0805 (a) (2) (B)]
 Establishing the term Parameter Method Technology
[.0803]
Reducing Financial Burden
 Repealing submission of the application in duplicate [.0805
(a) (5)]
 Allowing the use of 3rd party assessors [.0805 (a) (5)]
 Repealing
minimum bench
requirements [.0805 (a) (6)]
space,
sink,
balance
 Expanding the allowable supervisor credentials for Field
Labs (change to “or equiv. combination of education and
work exp. And change to Physical/Chemical Operator
Certification)[.0805 (g) (8)]
Reducing Financial Burden
 Allowing the use of Approved Procedures for field
analyses [0805 (g) (4)]
 Repealing
submission
of
application
for
change
notification [.0805 (c) (8)]
 Changing pro-rating schedule to quarterly [.0806 (d)]
Reducing Financial Burden
 Reducing the minimum decertification period to 30 days
[.0807 (e) (3)]
 Allowing the use of printable benchsheets [.0805 (a) (7) (G)]
and [.0805 (g) (1)]
 Adding Turbidity to the Field Parameter definition [.0803 (10)]
Stakeholder Outreach
 Rules have been sent out electronically.
 Hard copies mailed to all labs without email.
 Proposed Rules are posted on our web site.
 Conducted stakeholder meetings.
 Will be sending a fiscal analysis survey.
Stakeholder Meetings
 We have 3 stakeholders meetings scheduled.
 Burlington
 Wilson
April 1, 2015
April 9, 2015
 Asheville
April 16, 2015
Would like comments by April 30, 2015.
Anticipated Timeline
Subject to change
 Comments on proposed revision to us by April 30, 2015
 Incorporating comments completed by June 30, 2015
 Draft rules posted to EMC website by October, 2015
 EMC Committee review in November, 2015
 EMC in January, 2016
 Public Hearings in March, 2016
 EMC for approval in September, 2016
 Implementation sometime in 2017
Submit Comments
 Dana Satterwhite
Dana.satterwhite@ncdenr.gov
 Gary Francies
Gary.francies@ncdenr.gov
 Mail to:
Dana Satterwhite
Water Sciences Section
NC Wastewater/Groundwater Laboratory Certification Branch
1623 Mail Service Center
Raleigh, North Carolina 27699-1623
Website
http://portal.ncdenr.org/web/wq/lab/cert/rulesrevision
Proposed DRAFT Rule Revision
Instructions for submitting comments
Stakeholder meeting information
Comments received – by affiliation type
Changes made based upon stakeholder comment
Questions
Any Questions or Comments?
Any Unintended Consequences?
Financial Impact?