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Accreditation Of Laboratories


Published: 2015

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The Oregon Administrative Rules contain OARs filed through November 15, 2015

 

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OREGON HEALTH AUTHORITY,

PUBLIC HEALTH DIVISION

 

DIVISION 64
ACCREDITATION OF LABORATORIES

333-064-0005
Purpose
These rules are
for the purpose of implementing Oregon Revised Statutes (ORS) 438.605 to
438.620, 448.280 and the Oregon Drinking Water Quality Act of 1981. ORS 438.610
states that the Oregon Health Authority shall by adopting standards in concurrence
with the accrediting body, implement an environmental laboratory accreditation program
hereafter referred to as the Oregon Environmental Laboratory Accreditation Program
(ORELAP). These rules establish requirements for the accreditation of laboratories
analyzing environmental samples under the guidance of the Clean Air Act (CAA), Clean
Water Act (CWA), Safe Drinking Water Act (SDWA), and the Resource, Conservation
and Recovery Act (RCRA). The Oregon Health Authority shall accept ORELAP accreditation
for 448.150(1) that states that water samples from public water systems shall be
analyzed in a laboratory approved by the Oregon Health Authority.
Stat. Auth.:
ORS 448.150(1), 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 &
438.620

Stats.
Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 16-2002, f. & cert. ef. 10-10-02;
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03,
cert. ef. 12-08-03; PH 6-2011, f. & cert. ef. 8-9-11
333-064-0010
Scope
(1) These rules
apply to environmental laboratories seeking accreditation and performing environmental
testing.
(2) Accreditation
as described in these rules is required for all environmental laboratories reporting
drinking water analysis results to the Oregon Health Authority except for Oregon
Department of Agriculture Laboratory, Oregon Department of Environmental Quality
Laboratory and the Oregon State Public Health Laboratory which must be certified
by the United States Environmental Protection Agency for drinking water analysis.
Stat. Auth.:
ORS 448.150(1), 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 &
438.620

Stats.
Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 16-2002, f. & cert. ef. 10-10-02;
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03,
cert. ef. 12-08-03; PH 6-2011, f. & cert. ef. 8-9-11
333-064-0015
Adoption
by Reference
All standards,
listings and publications referred to in these rules are, by those references, made
a part of these rules as though fully set forth. Copies are available through the
Oregon Health Authority, Oregon State Public Health Laboratory.
Stat. Auth.:
ORS 448.150(1), 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 &
438.620

Stats.
Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 16-2002, f. & cert. ef. 10-10-02;
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03,
cert. ef. 12-08-03; PH 6-2011, f. & cert. ef. 8-9-11
333-064-0020
Severability
These rules are severable. If any rule or part thereof or the application of such rule to any person or circumstance is declared invalid, that invalidity shall not affect the validity of any remaining portion of these rules.
Stat. Auth.: ORS 448.150(1) & 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Stats. Implemented: ORS 448.280(1)(b)(2), 438.605, 438.610, 438.615 & 438.620

Hist.: OHD 7-1999, f. & cert. ef. 10-26-99
333-064-0025
Definitions
As used in these
rules, unless the context indicates otherwise:
(1) "Accrediting
Body" means the official accrediting authority for the Oregon Environmental Laboratory
Accreditation Program comprised of the Administrator of the Oregon State Public
Health Laboratory or designee, the Laboratory Administrator of the Department of
Environmental Quality or designee and the Laboratory Administrator of the Department
of Agriculture or designee.
(2) “Air”
as matrix means air samples, which are analyzed for possible contaminants under
the guidance of the Clean Air Act.
(3) “Authority”
means the Oregon Health Authority.
(4) “Biological
Tissue” as matrix means samples of biological tissue, excluding those of human
origin, which are analyzed for the presence of possible environmental contamination.
(5) "Clean
Air Act (CAA)" means the enabling legislation, 42 U.S.C. 7401 et seq. (1974),
Public Law 91-604, 84 Stat. 1676 Public Law 95-95, 91 Stat., 685 and Public Law
95-190, 91 Stat., 1399, that empowers the EPA to promulgate air quality standards,
monitor and enforce them.
(6) "Clean
Water Act (CWA)" means the enabling legislation under 33 U.S.C. 1251 et seq.,
Public Law 92-50086, Stat. 816 that empowers the EPA to set discharge limitations,
write discharge permits, monitor and bring enforcement action for non-compliance.
(7) “Drinking
Water” as matrix means samples of presumed potable water and source water,
which are analyzed for possible contaminants under the guidance of the Safe Drinking
Water Act.
(8) "Environmental
laboratory" means a fixed location or mobile facility that analyzes environmental
samples in a controlled and scientific manner.
(9) “Fields
of Accreditation” means those matrix, technology/method, and analyte combinations
for which ORELAP offers accreditation.
(10) “Fields
of Testing” means those technologies for which ORELAP offers accreditation.
(11)(a)
“Mobile Category 1 Laboratory” means any facility, deployed for no more
than six consecutive months and no more than six months during a calendar year,
that:
(A) Analyzes
environmental samples utilizing the staff and equipment from the parent fixed laboratory;
(B) Operates
under the quality system of its parent fixed laboratory;
(C) Is
capable of moving or being moved from site to site, such as but not limited to vans,
trailers and motor coaches; and
(D) May
operate under the fixed laboratory’s accreditation.
(12)(a)
“Mobile Category 2 Laboratory” means any facility that:
(A) Analyzes
environmental samples;
(B) Operates
under its own quality system;
(C) Is
capable of moving or being moved from site to site, such as but not limited to vans,
trailers and motor coaches; and
(D) Issues
the final reports or is a mobile laboratory operating with a fixed laboratory’s
quality system, but is deployed for more than six consecutive months or more than
six months in a calendar year.
(b) Mobile
category 2 laboratories require separate accreditation and are accredited to their
vehicle identification numbers (VIN).
(13) "National
Environmental Laboratory Accreditation Program (NELAP)" means the program established
to oversee the implementation of the TNI Standards.
(14) "NELAP
approved accrediting body" means a state or federal department/agency that has been
approved by NELAP as being an entity whose accreditation and assessment program
meets all of the requirements of the TNI Standards.
(15) “Non-Potable
Water” as matrix means aqueous samples, which are analyzed under the guidance
of the Clean Water Act or the Resource, Conservation and Recovery Act.
(16) "On-site
assessment" means an on-site visit to the environmental laboratory to verify items
addressed in the ORELAP application and to evaluate the facility and analytical
performance for conformance with the TNI Standards.
(17) "ORELAP approved assessor" means an assessor
whose qualification has been evaluated by ORELAP and found to meet TNI Standards
for laboratory on-site assessors.
(18) "Primary Accreditation"
means accreditation by a NELAP approved accrediting body based on a laboratory's
compliance to TNI Standards after a review of the laboratory's application, quality
manual, PT results and on-site assessment results as described in the TNI Standards.
(19) "Proficiency
testing (PT)" means the analysis of samples obtained from providers that meet the
TNI standards for PT providers. The composition of the sample is unknown to the
laboratory performing the analysis, and is used in part to evaluate the ability
of the laboratory to produce precise and accurate results.
(20) "Public
water system" means a water system as defined in OAR 333-061-0010.
(21) "Quality
Manual (QM)" means a document stating the management policies, objectives, principles,
organizational structure and authority, responsibilities, accountability, and implementation
of a laboratory to ensure the quality of its product and the utility of its product
to its users.
(22) "Resource
Conservation and Recovery Act (RCRA)" means the enabling legislation, 42 U.S.C.
section 6901 et seq. (1976), that requires the EPA to protect human health and protecting
and monitoring the environment by regulating hazardous waste disposal practices.
(23) "Safe
Drinking Water Act (SDWA)" means the SDWA enacted in 1974 and the Safe Drinking
Water Amendments of 1986, 42 U.S.C. 300f et seq., Public Law 93-523, that is the
enabling legislation that requires the EPA to protect the quality of drinking water
in the U.S. by setting maximum allowable contaminant levels, monitoring, and enforcing
violations.
(24) "Secondary
Accreditation" means the recognition by reciprocity for the fields of accreditation,
methods and analytes for which the laboratory holds current primary accreditation
by another NELAP recognized accrediting body.
(25) “Solids”
as a matrix means samples of soil, sludge and other non-aqueous compounds analyzed
under the guidance of the Resource, Conservation and Recovery Act.
(26) “TNI”
means the NELAC (National Environmental Laboratory Accreditation Conference) Institute.
TNI is a voluntary organization of state and federal environmental officials and
interest groups purposed primarily to establish mutually acceptable standards for
accrediting environmental laboratories.
(27) “TNI
Standards” means the adopted 2009 TNI Standards (© 2009 The NELAC Institute),
which are documents describing the elements of laboratory accreditation that was
developed and established by the consensus principles of TNI and meets the approval
requirements of TNI procedures and policies.
(28) "These
rules" means the Oregon Administrative Rules encompassed by OAR 333-064-0005 through
333-064-0065.
(29) "Third
party assessor" means an ORELAP approved assessor who has a current contract with
the Oregon Health Authority to perform on-site assessments of laboratories for ORELAP
and is not employed by the state agencies comprising ORELAP's accrediting body.
(30) "United
States Environmental Protection Agency (EPA)" means the federal government agency
with the responsibility for protecting public health and safeguarding and improving
the natural environment (i.e., air, water, and land) upon which human life depends.
[Publications:
Publications referenced are available from the agency.]
Stat.
Auth.: ORS 184, 438.605, 438.610, 438.615, 438.620, 448.131, 448.150(1), 448.280(1)(b)
& (2)

Stats.
Implemented: ORS 438.605, 438.610, 438.615, 438.620, 448.280(1)(b) & (2)

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 1-2001, f. & cert. ef. 1-17-01;
OHD 16-2002, f. & cert. ef. 10-10-02; PH 5-2003, f. 5-15-03, cert. ef. 7-1-03;
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03,
cert. ef. 12-08-03; PH 23-2004, f. & cert. ef. 7-1-04; PH 8-2005, f. 6-1-05,
cert. ef. 7-1-05; PH 6-2011, f. & cert. ef. 8-9-11
333-064-0030
Schedule
for Requesting Accreditation, Period of Accreditation
(1) Laboratories
in Oregon will be considered to be accredited by ORELAP after the laboratory has
requested accreditation, been evaluated by ORELAP and has met all criteria in accordance
with OAR 333-064-0035.
(2) The
accreditation period for each laboratory is for one year with subsequent accreditation
periods beginning from the first day the laboratory is granted accreditation.
(3) Laboratories
must reapply for ORELAP approval annually, with the application to be received by
ORELAP 120 calendar days prior to the expiration of the current accreditation period
and with all appropriate fees paid no less than 60 days prior to the expiration
of their current certificate of accreditation.
(4) ORELAP-accredited
laboratories may apply for accreditation of additional parameters (analytes, methods,
matrices) at any time during their accreditation period with accreditation for such
parameters expiring with the current accreditation period.
Stat. Auth.:
ORS 448.150(1), 448.131, 448.280(1)(b) & (2), 438.610 & 438.615

Stats. Implemented:
ORS 438.605, 438.610 & 438.615

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 1-2001, f. & cert. ef. 1-17-01;
OHD 16-2002, f. & cert. ef. 10-10-02; PH 13-2003(Temp), f. & cert. ef. 9-22-03
thru 3-20-04; PH 20-2003, f. 12-02-03, cert. ef. 12-08-03; PH 6-2011, f. & cert.
ef. 8-9-11
333-064-0035
Approval
Requirements
(1) This rule
and the TNI Standards describe the procedure for obtaining and maintaining accreditation.
(2) ORELAP
accreditation can be granted, denied, suspended, or revoked in total or in part
as described in the TNI Standards.
(3) In
no case shall a laboratory be accredited that does not comply with the TNI Standards
as specified in this rule.
(4) The
elements for accreditation shall include but are not restricted to:
(a) Application
for accreditation:
(A) ORELAP
will make online, electronic applications available to all laboratories requesting
an application.
(B) The
laboratory must request ORELAP accreditation by completing and submitting to ORELAP
an acceptable application that includes all elements as required by the TNI Standards.
For primary accreditation this includes a completed application with all required
documents. For secondary accreditation this includes a completed application with
all of the required documents plus proof of accreditation from a primary accrediting
body.
(b) Laboratory's
participation in a biennial on-site assessment(s) as required by the TNI Standards.
Environmental testing laboratories seeking initial, primary ORELAP accreditation
shall not be granted accreditation prior to an acceptable on-site assessment;
(c) Laboratory's
participation in proficiency testing (PT) and the obtaining of acceptable PT results
according to the TNI Standards;
(d) A
quality manual (QM) that includes all elements as set forth in the TNI Standards;
(e) Laboratory
staff members that meet the TNI Standards for training and experience for their
responsibilities within the environmental laboratory;
(f) Creation
and retention of all records pertaining to samples and analyses, including chain
of custody documents, log books, work sheets, raw data, calculations, quality assurance
data, and reports according to TNI Standards;
(g) Laboratory's
full payment of all appropriate fees as described in OAR 333-064-0060.
Stat. Auth.:
ORS 448.150(1), 448.131, 448.280(1)(b)(2), 438.605, 438.610, 438.615 & 438.620

Stats.
Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 1-2001, f. & cert. ef. 1-17-01;
OHD 16-2002, f. & cert. ef. 10-10-02; PH 13-2003(Temp), f. & cert. ef. 9-22-03
thru 3-20-04; PH 20-2003, f. 12-02-03, cert. ef. 12-08-03; PH 8-2005, f. 6-1-05,
cert. ef. 7-1-05; PH 6-2011, f. & cert. ef. 8-9-11
333-064-0040
Action Response for Laboratory Drinking Water Analysis Results
(1) If an accredited laboratory is authorized by the water supplier to report results of analyses required by OAR 333-061-0036 and performed by the laboratory directly to the Oregon Health Authority (Authority), then it must do so within 10 days after the end of the month, or within 10 days after the end of the monitoring period.
(2) If a result exceeds the maximum contaminant level (MCL) specified in OAR 333-061-0030:
(a) The accredited lab that issues the final test report must:
(A) Validate the results of any sample analysis and report that analysis directly to the Authority and to the water supplier within 48 hours or two business days of completing the analytical run if the sample analysis:
(i) Exceeds the MCL for nitrate as specified in OAR 333-061-0030(1); or
(ii) Is positive for coliform bacteria.
(B) Report any sample analysis directly to the Authority and to the water supplier within 24 hours or on the next business day after validating a sample result that exceeds the MCL for any chemical analyte specified in OAR 333-061-0030 other than nitrate.
(C) Report any sample analysis directly to the Authority and to the water supplier within 24 hours or on the next business day after obtaining a sample result from a subcontracted laboratory, if the sample analysis:
(i) Exceeds the MCL for nitrate as specified in OAR 333-061-0030(1) or is positive for coliform bacteria; or
(ii) Exceeds the MCL for any chemical analyte specified in OAR 333-061-0030 other than nitrate upon validating the sample analysis.
(b) Accredited, subcontracted laboratories must:
(A) Validate the results of any sample analysis and report that analysis to their client laboratory within 48 hours or two business days of completing the analytical run if the analysis:
(i) Exceeds the MCL for nitrate as specified in OAR 333-061-0030(1); or
(ii) Is positive for coliform bacteria.
(B) Report any sample analysis to their client laboratory within 24 hours or on the next business day after validating a sample result that exceeds the MCL for any chemical analyte specified in OAR 333-061-0030 other than nitrate.
(3) The laboratory must notify the public water system and, if authorized by the water system, the Authority of all unregulated contaminants detected and their concentrations from each specific method used to measure the regulated contaminants.
(4) The laboratory must use report forms that have been approved by the Authority for reporting drinking water test results to the Authority.
Stat. Auth.: ORS 448.150(1) & 448.131

Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.: OHD 7-1999, f. & cert. ef. 10-26-99; OHD 16-2002, f. & cert. ef. 10-10-02; PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03, cert. ef. 12-08-03; PH 3-2011, f. & cert. ef. 4-21-11
333-064-0045
Procedure for Contesting Actions of ORELAP
The procedure for contesting the actions of ORELAP regarding denial, suspension and revocation of accreditation, or other changes in accreditation status is in accordance with the Administrative Procedures Act, ORS 183.
Stat. Auth.: ORS 448.150(1), 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.: OHD 7-1999, f. & cert. ef. 10-26-99
333-064-0050
Accreditation
of Out-of-State and Mobile Category 2 Laboratories
(1) ORELAP shall
accredit out-of-state laboratories that are eligible for reciprocal accreditation
provided:
(a) The
laboratory is accredited by a state recognized as a NELAP accrediting body for those
fields of testing (analytes, methods, matrices) in which the laboratory is requesting
accreditation pursuant to this rule.
(b) The
laboratory submits to ORELAP an acceptable application as described in OAR 333-064-0035(4).
(c) The
laboratory pays all appropriate fees as described in OAR 333-064-0060.
(2) ORELAP
may accredit out-of-state laboratories that are located in states that do not have
a NELAP approved accrediting body for the fields of testing and matrices in which
the laboratory desires accreditation provided that the laboratory complies with
all the requirements in OAR 333-064-0035.
(3) ORELAP
may accredit mobile category 2 laboratories that do not operate as an entity of
an Oregon fixed base facility as out-of-state laboratories. Such laboratories must
meet all of the requirements for out-of-state laboratories pursuant to these rules.
Stat. Auth.:
ORS 448.150(1) & 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615
& 438.620

Stats.
Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; PH 6-2011, f. & cert. ef. 8-9-11
333-064-0055
Display of Certificate
Accredited environmental laboratories shall post or display their most recent ORELAP accreditation certificate and their ORELAP-accredited fields of testing in a prominent place in the laboratory facility.
Stat. Auth.: ORS 448.150(1) & 448.131, 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Stats. Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.: OHD 7-1999, f. & cert. ef. 10-26-99
333-064-0060
Fee Schedule
Fees will be
charged to Oregon in-state and out-of-state environmental laboratories according
to the following schedule. A mobile category 2 laboratory that operates as an entity
of an Oregon fixed base facility will be considered an in-state laboratory, and
one that does not operate as an entity of an Oregon fixed base facility will be
considered an out-of-state laboratory. Mobile category 1 laboratories are covered
under the parent fixed laboratory’s accreditation and are not required to
pay an additional fee.
(1) A
non-refundable application fee must be paid for each application requesting accreditation
for methods.
(a) For
laboratories located in Oregon, one of three levels of fees, Tier 1 at $450, Tier
2 at $900 and Tier 3 at $1,600 will be charged. The Tiers will be determined by
the total number of points derived from the number of fields of testing requested
for accreditation listed in subsections (2)(a) through (c) of this rule.
(A) Each
Basic Field of Testing has a multiplier of 1.
(B) Each
Moderate Field of Testing has a multiplier of 3.
(C) Each
Complex Field of Testing has a multiplier of 5.
(D) The
total number of points is determined by first summing the number of fields of testing
within each category (Basic, Moderate or Complex) and then multiplying the sums
by their appropriate multiplier as given in this rule. The sum of these results
determines the total number of points for each laboratory. Laboratories with a total
of 1 to 10 points are to be considered Tier 1 laboratories, 11 to 25 points are
Tier 2 laboratories and 26 or more points are Tier 3 laboratories.
(b) For
each out-of-state laboratory requesting primary or secondary accreditation through
ORELAP, one of three levels of fees, Tier 1 at $1,375, Tier 2 at $2,200 and Tier
3 at $3,300 will be charged with each Tier determined according to subsection (1)(a)
of this rule.
(c) If
a new owner acquires the laboratory and wishes the laboratory to remain accredited,
the laboratory must submit a new owner application, and may be required to pay the
application fee and
be subject to a new on-site assessment and payment of on-site assessment fees as
described in this rule.
(2) Upon ORELAP's review
of a laboratory's application, each laboratory requesting primary accreditation
through ORELAP, when ORELAP personnel will be used for the assessment, the laboratory
will be charged an assessment fee based on the number fields of testing and matrices
as follows:
(a) Oregon
laboratories will be charged $90 and out-of-state laboratories will be charged $100
for each of the following Basic Fields of Testing requested for accreditation:
(A) Chromofluorogenic
(Microbiology);
(B) Membrane
Filter and/or Heterotrophic Plate Count (Microbiology);
(C) Multiple
Tube Fermentation/Most Probable Number (MPN) (Microbiology);
(D) Gravimetric;
(E) Physical;
(F) Probe.
(b) Oregon
laboratories will be charged $350 and out-of-state laboratories will be charged
$385 for each of the following Moderate Fields of Testing requested for accreditation:
(A) Inorganic
Atomic absorption spectrometry;
(B) Inorganic
Atomic fluorescence spectrometry;
(C) Inorganic-non-metals
automated colorimetric;
(D) Inorganic-non-metals
manual colorimetric;
(E) Inorganic-ion
chromatography (IC);
(F) Organic-liquid
chromatography (LC);
(G) Organic-gas
chromatography (GC) — volatiles;
(H) Organic-gas
chromatography (GC) — extractables;
(I) Whole
Effluent Toxicity Immunoassay;
(J) Asbestos
(bulk);
(K) Asbestos
— electron microscopy
(L) Radiochemistry.
(c) Oregon
laboratories will be charged $500 and out-of-state laboratories will be charged
$550 for each of the following Complex Fields of Testing requested for accreditation:
(A) Organic
— gas chromatography/mass spectrometry (GC/MS) — volatiles;
(B) Organic
— gas chromatography/mass spectrometry (GC/MS) — extractables;
(C) Organic
— liquid chromatography/mass spectrometry (LC/MS);
(D) Organic
— gas chromatography/tandem mass spectrometry (GC/MS/MS);
(E) Organic
— gas chromatography/high resolution mass spectrometry (GC/HRMS);
(F) Inorganic
— metals — inductively coupled plasma (ICP);
(G) Inorganic
— metals — inductively coupled plasma/mass spectrometry (ICP/MS);
(H) Inorganic
— ion chromatography/mass spectrometry (IC/MS);
(I) X-ray.
(d) An
additional fee of $10 for Basic Fields of Testing, $40 for Moderate Fields of Testing
and $75 for Complex Fields of Testing will be charged to Oregon laboratories, and
an additional fee of $11 for Basic Fields of Testing, $44 for Moderate Fields of
Testing and $83 for Complex Fields of Testing will be charged to out-of-state laboratories
for each additional matrix per field of testing for which the laboratory has requested
accreditation. The matrices are:
(A) Air;
(B) Biological
tissue;
(C) Drinking
water;
(D) Non-potable
water;
(E) Solids.
(e) Assessment
fees must be paid before a routine on-site assessment will be performed.
(f) All
laboratories must pay the appropriate on-site assessment fee per on-site assessment
performed due to just cause according to TNI Standards.
(3) All
Oregon environmental laboratories requesting primary accreditation through ORELAP
where Oregon state assessor(s) will perform the on-site assessment must pay an on-site
trip fee for each on-site assessment. For a mobile category 2 laboratory, the trip
fees are waived if it is moved to the Oregon State Public Health Laboratory for
the on-site assessment, and reduced to the amount in excess of its fixed base facility
when moved to the fixed base facility if both are to be assessed at the same time.
(a) On-site
trip fees are $350 for Tier 1, $500 for Tier 2 and $1,000 for Tier 3 laboratories
with the Tiers determined according to subsection (1)(a) of this rule.
(b) All
laboratories must pay the appropriate on-site trip fee for performing each required
on-site assessment and additional assessments as requested by the laboratory for
accreditation for additional fields of testing and matrices.
(c) All
laboratories must pay the appropriate on-site trip fee per on-site assessment performed
due to just cause according to TNI Standards.
(4) All
environmental laboratories located in Oregon requesting primary accreditation through
ORELAP where ORELAP has determined that third party assessors will be used, must
pay ORELAP application assessment fees plus all third party assessors costs. ORELAP
may require the laboratory to pay the on-site assessment costs directly to the third
party assessor according to the schedule of the assessor for all required on-site
assessments.
(5) All
out of-state environmental laboratories must pay all on-site assessment costs incurred
by ORELAP approved assessors to perform the on-site assessment including but not
limited to transportation, per diem and wages during travel. For a mobile category
2 laboratory, the travel costs are waived if it is moved to the Oregon State Public
Health Laboratory for the on-site assessment, and reduced to the amount in excess
of its fixed base facility when moved to the fixed base facility if both are to
be assessed at the same time. The excess amount is to be determined by those fields
of testing and matrices requested for accreditation by the mobile lab that have
not been requested by its fixed based facility. If third party assessors are used,
ORELAP may require the lab to pay the on-site assessment costs directly to the assessor
according to the schedule of the assessor for all required inspections.
(6) Accredited
laboratories requesting additions to their fields of accreditation during the accreditation
period must pay:
(a) The
difference in cost of the application fee with a minimum fee of $200;
(b) The
difference in cost of the assessment fee;
(c) An
on-site trip fee, as described in subsection (3)(a) and section (5) of this rule,
based only on the additional parameters if ORELAP determines that an on-site assessment
is required.
Stat. Auth.:
ORS 438.605 - 438.620 & 448.280(1)(b) & (2)

Stats.
Implemented: ORS 438.605 - 438.620

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 1-2001, f. & cert. ef. 1-17-01;
OHD 16-2002, f. & cert. ef. 10-10-02; PH 13-2003(Temp), f. & cert. ef. 9-22-03
thru 3-20-04; PH 20-2003, f. 12-02-03, cert. ef. 12-08-03; PH 3-2006(Temp), f. &
cert. ef. 2-8-06 thru 7-30-06; PH 5-2006, f. & cert. ef. 4-6-06; PH 6-2011,
f. & cert. ef. 8-9-11
333-064-0065
Civil
Penalties
(1) In addition
to any other penalty provided by law, the Oregon Health Authority, in collaboration
with the accrediting body, may impose a civil penalty not to exceed $500 per day
per violation upon any and all laboratories that willfully or negligently commit
any of the following:
(a) Falsely
purport to be ORELAP accredited;
(b) Improperly
use their ORELAP accreditation status in order to mislead;
(c) Use
the TNI\NELAP logo in catalogs, advertisements, business solicitations, proposals,
quotations, laboratory reports and other materials without proper authorization.
(2) The
Oregon Health Authority reserves the right to pursue other remedies and may take
any other disciplinary action against alleged violators.
(3) In establishing the amount of the penalty
for each violation, the Oregon Health Authority will consider, but not be limited
to the following factors:
(a) The gravity and magnitude
of the violation;
(b) The
laboratory's previous record of complying or failing to comply with this rule.
(c) The
laboratory's history in taking all feasible steps or in following all procedures
necessary or appropriate to correct the violation; and,
(d) Such
other considerations as the Oregon Health Authority may consider appropriate.
(4) The
Oregon Health Authority in collaboration the accrediting body may deny, suspend
or revoke accreditation of any laboratory that fails to pay on demand a civil penalty
that has become due and payable, provided that it first gives the laboratory an
opportunity for a hearing as outlined in ORS Chapter 183.
Stat. Auth.:
ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Stats.
Implemented: ORS 448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620

Hist.:
OHD 7-1999, f. & cert. ef. 10-26-99; OHD 16-2002, f. & cert. ef. 10-10-02;
PH 13-2003(Temp), f. & cert. ef. 9-22-03 thru 3-20-04; PH 20-2003, f. 12-02-03,
cert. ef. 12-08-03; PH 6-2011, f. & cert. ef. 8-9-11
Oregon Environmental Laboratory
Accreditation Program (ORELAP)
333-064-0100
Marijuana Item Sampling Procedures
and Testing
(1) Sampling.
(a) A laboratory must prepare
sampling policies and procedures that contain all of the information necessary for
collecting and transporting samples in a manner that does not endanger the integrity
of the sample for any analysis required by this rule. These procedures must be appropriate
to the matrix being sampled.
(b) Sampling policies and procedures
must be submitted to the accrediting body for approval prior to any marijuana samples
being taken.
(c) Care should be taken while
sampling to avoid contamination of the non-sampled material. Sample containers must
be free of analytes of interest and appropriate for the analyses requested.
(d) A sufficient sample size
must be taken for analysis of all requested tests, quality control, and for a re-test
of sample if necessary.
(2) Sample identification.
(a) Records must contain the
location of each sample and subsample taken.
(b) The samples, subsamples
and field duplicates must be assigned a field identification number the field identification
numbers must have an unequivocal link to the laboratory analysis identification.
(c) The test batch must be assigned
a unique identifier in accordance with TNI standard V1M2 5.8.5 and that information
must be provided to the licensee or registrant.
(d) The following must be entered
into the Commission’s seed to sale tracking system or the Authority’s
database under the licensee or registrant number:
(A) The sample test batch numbers;
(B) Date and time samples were
received; and
(C) A description of the marijuana
item being tested.
(3) Combining subsamples.
(a) Subsamples collected from
the same batch must be combined into a single sample by a laboratory prior to testing.
(b) Subsamples and samples collected
from different batches may not be combined.
(c) Field duplicates may not
be combined with the other samples.
(4) THC and CBD testing validity.
When testing a sample for THC and CBD a laboratory must comply with additional method
validation as follows:
(a) Run a laboratory control
standard in accordance with TNI standards requirements within passing control limits
of 70 percent to 130 percent recovery.
(b) Analyze field duplicates
of samples within precision control limits of plus or minus 30 percent relative
percent difference.
(5) Calculating total THC and
total CBD.
(a) Total THC must be calculated
as follows, where M is the mass or mass fraction of delta-9 THC or delta-9 THCA:
M total delta-9
THC = M delta-9 THC + 0.877 x M delta-9 THCA.
(b) Total CBD must be calculated as follows,
where M is the mass or mass fraction of CBD and CBDA:
M total CBD = M CBD + 0.877 x M CBDA.
(c) Each test report must include the total
THC and total CBD.
(6) Report total THC and total
CBD as Dry Weight. A laboratory must report total THC and Total CBD content by dry
weight calculated as follows:
P total THC(dry) = P total THC(wet) / [1-(P moisture/100)]
P total CBD(dry) = P total CBD(wet) / [1-(P moisture/100)]
(7) Tentative Identification of Compounds
(TIC).
(a) When testing cannabinoid
concentrates or extracts, if a laboratory determines that a sample may contain compounds
that are not included in the list of analytes the laboratory is testing for the
laboratory must attempt to achieve tentative identification.
(b) Tentative identification
is achieved by searching NIST 2014 (>250,000 compounds) or an equivalent database.
Match scores for background subtracted or deconvoluted spectra must exceed 90 percent
compared to library spectrum. The top five matches over 90 percent should be considered
by the analyst for reporting.
(c) TIC quantitation is estimated
by comparing analyte area to closest internal standard area. All chromatographic
peaks from total (reconstructed) ion chromatogram estimated to have a concentration
greater than 1ppm should have representative spectra (background subtraction or
deconvolution) searched for possible library matches and tentative identification
or quantitation.
(d) A laboratory shall report
to the licensee or registrant and the Authority or the Commission, depending on
which agency has jurisdiction, up to five tentatively identified compounds (TICS)
that have the greatest apparent concentration using the response factor (RF) = 1.
(8) A laboratory must provide
a sample or a portion of a sample to the Department of Agriculture upon that agency’s
request, document the chain of custody from the laboratory to the Department, and
document that the sample or portion of the sample was provided to the Department
in the Commission’s seed to sale tracking system.
Stat. Auth.: ORS 448.150(1), 448.131,
448.280(1)(b) & (2), 438.605, 438.610, 438.615 & 438.620, Sec. 92 &
94, ch. 614, OL 2015
Stats. Implemented: ORS 448.280(1)(b)
& (2), 438.605, 438.610, 438.615 & 438.620, Sec. 92 & 94, ch. 614, OL
2015
Hist.: PH 22-2015(Temp),
f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16
333-064-0110
Reporting Marijuana Test Results
(1) A laboratory must report all required
test results within 24 hours of completion of validation:
(a) Into the Commission’s
seed to sale tracking system; and
(b) To the licensee or registrant.
(2) A laboratory must determine
and include on each test report its limit of quantification (LOQ) for each analyte.
(3) When reporting pesticide
testing results the laboratory must report any target compound that falls below
the LOQ that has a signal to noise ratio of greater than 3:1 and meets identification
criteria with a result of “detected".
(4) A test report must include
any associated test batch numbers and the date each test was completed.
Stat. Auth.: Sec. 91 and 92, ch. 614,
OL 2015
Stats. Implemented: Sec.
91 and 92, ch. 614, OL 2015
Hist.: PH 22-2015(Temp),
f. 11-13-15, cert. ef. 1-1-16 thru 6-28-16

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