CHAPTER
Env-C 300 N.H. ENVIRONMENTAL LABORATORY
ACCREDITATION PROGRAM
Statutory
Authority: RSA 485:46, I; RSA 485:47,
I-X
REVISION NOTE:
Document
#12065, effective 1-1-17, readopted with amendments Env-C 300 titled
“Laboratory Accreditation” and re-titled the chapt er
as “N.H. Environmental Accreditation Program.”
Document #12065 also made extensive changes to the wording and numbering
of rules within the former Env-C 300.
Document #12065 replaces all prior filings for rules in the former
Chapter Env-C 300. The prior filings for
the former Chapter Env-C 300 include the following documents:
#4861,
eff 7-6-90
#5564,
eff 1-28-93, EXPIRED 1-28-99 if not amended by #5871
or #6305
#5871,
eff 7-19-94
#6305,
eff 7-26-96
#7035,
INTERIM, eff 6-25-99, EXPIRED 10-23-99
#7126.
eff 10-29-99
#9009,
INTERIM, eff 10-19-07
#9134,
eff 4-19-08
The rules in the former
Env-C 300 which had last been filed under Document #9134 did not expire on
4-19-16 since they were extended pursuant to RSA 541-A:14-a until replaced by
the rules in Document #12065, effective 1-1-17.
PART
Env-C 301 PURPOSE; APPLICABILITY;
INCORPORATED REFERENCE
Env-C 301.01 Purpose. The purpose of the rules in this chapter is
to implement RSA 485:44 and RSA 485:46 relative to establishing an
environmental laboratory accreditation program.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 301.02 Applicability. The rules in this chapter shall apply to:
(a)
Any laboratory that is required to be accredited to perform laboratory
analyses that will be accepted by regulatory agencies for compliance purposes;
(b)
Any laboratory that voluntarily desires to be accredited to perform
laboratory analyses that will be accepted by regulatory agencies for compliance
purposes and used for non-regulatory purposes; and
(c)
Any third party assessor organization (TPAO)
that seeks approval to conduct accreditation assessments under these rules.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 301.03 Incorporated Reference. For the purpose of
this chapter, unless otherwise specified all references to the laboratory
accreditation standards of The NELAC Institute (TNI standards) shall be to the 2016 edition,
available as noted in Appendix B.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C
302.01 “Accreditation body” means
“accreditation body” as defined in the TNI standards, Volume 1, as reprinted in
Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.02 “Analyte list” means a list of the matrix,
method, and analyte combinations that a laboratory has been accredited to
perform.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.03 “Applicant” means the entity seeking
accreditation for a laboratory.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.04 “Assessor” means an
individual who performs an assessment of a laboratory’s capability and capacity
for meeting the TNI standards by examining the
records and other physical evidence for each one of the tests for which accreditation
has been requested.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 302.05 “Assessment” means “assessment” as defined in
the TNI standards, Volume 1, as reprinted in Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.06 “Authorized agent” means the individual,
regardless of title, who is responsible for supervising overall laboratory procedures and test result reporting for the
laboratory as a whole.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.07 “Business entity” means any for-profit or
non-profit organization. The term does
not include any government or government agency.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.08 “Demonstration of capability” means
“demonstration of capability” as defined in the TNI standards, Volume 1, as
reprinted in Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.09 “Department” means department of
environmental services.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.10
“Denial”
means the accreditation body’s refusal to accredit, in total or in part, a
laboratory applying for initial or renewal accreditation.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.11 “Extraordinary assessments” means those
assessments conducted as a result of complaints or
changes in ownership, key personnel, location, scope of accreditation, or other
matters that may affect the ability of a laboratory to meet applicable
accreditation requirements.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.12 “Field of accreditation” means “field of
accreditation” as defined in the TNI standards, Volume 1, as reprinted in
Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.13 “Follow-up assessment” means a type of
assessment undertaken to verify effective implementation of corrective actions
employed in response to an assessment.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.14 “Initial assessment” means a type of
assessment that is comprehensive and involves reviewing all key activities
performed by a laboratory applying for accreditation for the first time.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.15 “Limited inorganic chemistry” means 6 or
fewer matrix,
method, and analyte combination analyses for inorganic analytes other than
metals.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C
302.16 “Limited organic chemistry” means 6 or fewer matrix,
method, and analyte combination analyses for organic analytes.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.17 “Limit of
quantitation (LOQ)” means the lowest concentration of a target variable that
can be reported with a specific degree of confidence.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.18 “Method detection limit (MDL)” means the
minimum measured concentration of a substance that can be reported with 99%
confidence that the measured concentration is distinguishable from method blank
results.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.19 “New Hampshire
Environmental Laboratory Accreditation Program (NH ELAP)” means the program
implemented by the department pursuant to RSA 485:44 to accredit laboratories
in conformance with and consistent with TNI accreditation standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.20 “National
Environmental Laboratory Accreditation Program (NELAP)” means the program
established by TNI for the accreditation of environmental laboratories.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 302.21 “Person” means “person” as defined in RSA
485:1-a, XIII, as reprinted in Appendix C.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.22 “Primary accreditation body” means the agency or department designated at the territory,
provincial, state, or federal level as the authority recognized by the NELAP
with responsibility and accountability for granting
NELAP accreditation for a specific field of testing.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.23 “Program manager”
means the department employee who is responsible for implementing the NH ELAP.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.24 “Proficiency testing (PT)” means “proficiency
testing” as defined in the TNI standards, Volume 1, as reprinted in Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.25 “Proficiency testing provider (PT provider)”
means “proficiency testing provider” as defined in the TNI standards, Volume 1,
as reprinted in Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 302.26 “Proficiency testing provider accreditor”
means an organization that is approved by TNI to accredit and monitor the
performance of proficiency testing providers.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.27 “Quality system” means “quality system” as
defined in the TNI Standards Volume 1, Module 2, reprinted in Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.28 “Reassessment” means a type of biennial assessment
similar in scope to an initial assessments.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.29 “Revocation”
means “revocation” as defined in the TNI standards, Volume 1, as reprinted in
Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 302.30 “Secondary accreditation body” means an
entity that grants accreditation to laboratories on the basis
of accreditation granted by a primary accreditation body.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.31 “Successful participation” and any other verb
form of the term such as “successfully participate” or “successfully
participated” means receiving a score of “acceptable” or “check for error” on:
(a) All available concentrations, for analyses
accredited on an analyte-by-analyte basis; or
(b) The entire group, for analytes accredited as
a group of interdependent analytes as described in Volume 1, Module 1 of the
TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.32 “Successor in interest” means any laboratory
that is owned or controlled by an entity in which the majority of officials
also owned or controlled the laboratory accredited under a previously-issued
certificate.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.33 “Surveillance assessment” means a type of
assessment that is less comprehensive than an initial assessment or reassessment, and occurs as-needed between an initial
assessment and a reassessment.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.34 “Suspension”
means “suspension” as defined in the TNI standards, Volume 1, as reprinted in
Appendix D.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.35 “Technical manager” means an individual,
regardless of title, who is responsible for supervising laboratory procedures
and test result reporting for a particular area of the laboratory.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.36 “Third party assessor (TPA)” means an
assessor who is not affiliated with the department.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.37 “Third party assessor organization (TPAO)”
means an organization that employs one or more assessors.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.38 “Unit cost” means the hourly rate of the
department employee who conducts the work plus employee benefits and overhead.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 302.39 “Written notice” means a communication sent:
(a)
On paper via U.S. Postal Service first class mail or via private
delivery service;
(b)
On paper sent by fax; or
(c)
Electronically via email.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART
Env-C 303 APPLICATIONS FOR ACCREDITATION
Env-C 303.01 Application for
Primary Accreditation.
(a)
In order to request initial or renewed primary
accreditation pursuant to RSA 485:44, the applicant shall submit a
complete application as specified in (b), below, to the department:
(1) Electronically; or
(2) In hard copy, by mailing or otherwise
delivering the application to:
NH Department of
Environmental Services
Attn: Program Manager, NH ELAP
29 Hazen Drive
P.O. Box 95
Concord, N.H. 03302-0095.
(b)
A complete application for primary accreditation shall include:
(1) The information specified in Env-C 303.03 on
an “Application For Laboratory Accreditation with NH ELAP as a Primary
Accreditation Body” form, NHDES-W-03-199, dated 12-17-2019 and available at https://onlineforms.nh.gov/?FormTag=NHDES-W-03-199, that has been
signed and dated as specified in Env-C 303.02;
(2) Information detailing each method, matrix,
and analyte combination for which accreditation is requested;
(3)
The results of successful participation in a proficiency test (PT) study as
specified in Volume 1, Module 1 of the TNI standards, submitted by the PT
provider; and
(4) The fee specified in Env-C 303.08.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.02 Signatures
Required.
(a)
The application form shall be signed and dated by the individual
designated by the applicant pursuant to Env-C 303.04(c).
(b)
The signature shall constitute certification that:
(1) The information provided is true, complete,
and not misleading to the knowledge and belief of the signer; and
(2) The signer understands that:
a. Any accreditation issued
based on false, incomplete, or misleading information shall be subject to
denial, suspension, or revocation; and
b. The signer is subject to the penalties
specified in New Hampshire law, currently RSA 641:3, for making unsworn false
statements.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C
303.03 Information for Primary
Accreditation. An applicant for
primary accreditation shall provide the following information:
(a)
Whether the application is for a new laboratory, an update of a laboratory
currently in the NH ELAP, or a renewal of a laboratory currently in the NH ELAP;
(b) For a renewal or
update application, the laboratory identification
number previously assigned by the department and the EPA laboratory
identification number;
(c)
The contact information specified in Env-C 303.04;
(d)
The ownership information specified in Env-C 303.05;
(e)
The laboratory operational information specified in Env-C 303.06; and
(f)
The additional information specified in Env-C 303.07.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.04 Required Contact Information. The contact information required by Env-Dw 303.03(c) shall be as follows:
(a)
The legal name, mailing address, street address, billing address,
daytime telephone number, and fax number of the laboratory and, if available,
the e-mail address and web site address of the laboratory;
(b)
The name, daytime telephone number, extension number, if applicable, and
e-mail address of the individual at the laboratory who is the contact for
purposes of the application;
(c)
The name and title of the individual authorized by the laboratory to
sign the application form;
(d)
The name and daytime telephone number including extension, if
applicable, of the authorized agent;
(e)
The name and daytime telephone number including extension, if
applicable, of the quality assurance officer; and
(f)
The name and daytime telephone number including extension, if
applicable, of the lead technical manager and of each additional technical
manager.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.05 Required Ownership Information. The ownership information required by Env-Dw 303.03(d) shall be as follows:
(a)
Whether the laboratory seeking
accreditation is owned by a business entity or a government entity;
(b)
If the laboratory is owned by a
business entity, the following:
(1) The type of business entity, such as corporation,
a limited liability corporation, a partnership, a sole proprietorship, or
another type, which shall be identified;
(2) The legal name of the business entity, if
other than the legal name of the laboratory;
(3) The date the laboratory registered with the
New Hampshire secretary of state;
(4) If the owner is a corporation, the date and
state of incorporation; and
(5) The name and title of each principal official
of the business entity, such as corporate officers or general partners; and
(c)
If the laboratory is owned by a governmental entity, the name and
primary mailing address of the federal, state, or local agency that owns the
laboratory, if different from the information provided pursuant to Env-C
303.04(a).
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.06 Required Laboratory Operation Information. The laboratory operational information
required by Env-C 303.03(e) shall be as follows:
(a)
The type of laboratory, type of building housing the laboratory, floor plan space, utilities, and computer systems,
including software;
(b)
A list of all general use laboratory equipment, including the name and
description of the equipment, the manufacturer, the manufacturer’s make and
model, and the age and year purchased;
(c)
Each matrix, method, and
analyte combination for which accreditation is
being sought;
(d)
The analytical methodology and equipment used for each analyte, matrix,
and method combination for which accreditation is being sought;
(e)
For a mobile laboratory, the vehicle identification number (VIN) or serial
number;
(f)
Laboratory hours of operation; and
(g) A demonstration of capability data
for each new matrix, method, and analyte combination for which accreditation is
sought.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.07 Additional Information Required for
Primary Accreditation. The
additional information required by Env-C 303.03(e) shall be as follows:
(a)
The amount of fees due, calculated in accordance with Env-C 303.08;
(b)
The education and experience background of each technical manager;
(c)
Transcripts of all college courses completed by each technical manager,
including graduate courses if applicable;
(d)
A resume for each technical manager that documents analytical laboratory
experience;
(e)
A paper copy and an electronic copy of
the quality system manual (QSM) and standard operating procedures (SOPs) as
specified in Env-C 308.02 and Env-C 308.03;
(f)
Information regarding which of the methods allowed by Env-C 304.07 the
laboratory intends to use to inform all prospective, current, and repeat New
Hampshire clients of which analytes or categories it is accredited by NH ELAP to test; and
(g)
A “NH ELAP Certificate of Compliance” form, NHDES-W-03-265, dated 11/25/2020,
available at https://onlineforms.nh.gov/?FormTag=NHDES-W-03-265 that has been signed
and dated by the authorized agent, each quality assurance officer, each
technical manager, and the laboratory director, each of whom shall also type or
print his or her name on the form, to constitute certification that each signer
acknowledges that the laboratory is legally bound to:
(1) Fully comply with all applicable requirements
of these rules and the TNI standards as incorporated into these rules;
(2) Provide NH ELAP administrative staff and
assessors access to laboratory staff and to information, documents, and records
as necessary for the assessment and maintenance of accreditation;
(3) Arrange the witnessing of laboratory services
if requested in accordance with NH ELAP rules and the TNI standards;
(4) Claim accreditation only with respect to the latest
scope of accreditation granted; and
(5) Pay fees as specified in Env-C 303.08, Env-C
303.09, and Env-C 303.10, as authorized by RSA 485:46, I.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.08 Fees for New or Renewal Applications.
(a) A
nonrefundable application fee shall accompany each application for a new or
renewal accreditation for drinking water matrix
methods, non-potable water matrix methods, solid and chemical materials matrix
methods, tissue matrix methods, or air matrix methods, or any combination
thereof.
(b) The application fee required by (a), above,
shall be the sum of:
(1) A $225 base fee;
(2) A sample preparation method fee of $28 per
method;
(3) An additional fee for each non-standard performance-based
or laboratory-developed method, as follows:
a. If column A applies, $112;
b. If column B applies, $135; and
c. If column C applies, $168; and
(4) All applicable amounts listed in Table 300-1
below, subject to the explanatory notes in (c), below:
Table 300-1: Additional Fees
Included in Nonrefundable Fee
Accreditation Requested |
A |
B |
C |
Microbiology |
$168 |
$197 |
$253 |
Pathogen
analysis |
$168 |
$197 |
$253 |
Limited
inorganic chemistry only |
$281 |
$309 |
$365 |
Limited
organic chemistry only |
$281 |
$309 |
$365 |
Limited
inorganic chemistry |
$168 |
$197 |
$253 |
Limited
organic chemistry |
$168 |
$197 |
$253 |
One
or 2 metals |
$168 |
$197 |
$253 |
Microbiology
and limited inorganic chemistry |
$225 |
$253 |
$337 |
Microbiology
and one or 2 metals |
$225 |
$253 |
$337 |
Microbiology,
limited inorganic chemistry, and |
$337 |
$365 |
$506 |
Metals |
$478 |
$568 |
$731 |
Inorganic
chemistry |
$478 |
$568 |
$731 |
Metals
and Inorganic chemistry |
$562 |
$675 |
$815 |
Organic
chemistry |
$562 |
$675 |
$815 |
Radiological
chemistry |
$337 |
$365 |
$506 |
Whole
Effluent or Sediment Toxicity Testing |
$337 |
|
|
Whole
Effluent and Sediment Toxicity Testing |
|
$506 |
|
Radon
in Water analysis |
$168 |
|
|
(c)
The following explanatory notes shall apply to Table 300-1:
(1) Column A shall
apply to laboratories seeking accreditation for:
a. Drinking water matrix methods only;
b. Non-potable water matrix methods other than
SW-846 methods (non-SW-846 methods) only;
c. Non-potable
water matrix SW-846 methods only;
d. Tissue matrix methods only;
e. Air matrix methods
only; or
f. Solid and chemical materials matrix
methods only.
(2) Column B shall
apply to laboratories seeking accreditation for any 2 matrix methods
combinations listed in (1), above; and
(3) Column C shall
apply to laboratories seeking accreditation for any combination of 3 or more
matrix or methods combinations from (1), above.
(d) Accreditation shall not be granted if the
correct application fee is not received by the department.
(e) The individual fees listed in Table 300-1
shall increase by 4%, rounded to the nearest whole dollar, on July 1 of each
biennium beginning July 1, 2023.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.09 Fees to Modify Existing Accreditations.
(a) The fee to modify either
a primary accreditation or a secondary accreditation at a
laboratory’s request or based on a primary accreditation
body’s accreditation requirements shall be the sum of all applicable
amounts listed in Table 300-2, below, or $337, whichever is less:
Table 300-2: Fees for Requests
to Modify Existing Accreditation
Reason for
Request: |
Fee |
Update to latest
revision or edition, Primary or Secondary Accredited Laboratories, one method;
previous accreditation remains. |
|
Method with 1 to 5 analytes |
$28 |
Method with 6 to20 analytes |
$38 |
Method with ≥ 21 analytes |
$51 |
Update to latest
revision or edition, Primary or Secondary Accredited Laboratories, multiple
methods; previous accreditation remains. |
|
Method with 1 to 5 analytes |
$18 |
Method with 6 to20 analytes |
$28 |
Method with ≥ 21 analytes |
$38 |
Additional new
accreditation per method per request, Secondary Accredited Laboratories |
|
Method with 1 to 5 analytes |
$18 |
Method with 6 to20 analytes |
$28 |
Method with ≥ 21 analytes |
$46 |
Additional new
accreditation per method per request, Primary Accredited Laboratories |
|
Method with 1 to 5 analytes |
$33 |
Method with 6 to20 analytes |
$56 |
Method with ≥ 21 analytes |
$89 |
Additional same-technology same-matrix
accreditation per method per request, Primary or Secondary Accredited
Laboratories |
|
Method with 1 to 5 analytes |
$18 |
Method with 6 to 20 analytes |
$28 |
Method with ≥ 21 analytes |
$38 |
Drop accreditation per
method per request, Primary or Secondary Accredited Laboratories |
|
1 single Analyte Method |
$11 |
2 – 10 single Analyte Methods |
$18 |
≥ 11 single Analyte Methods |
$28 |
Multi-Analyte Method |
$18 |
(b) The individual fees listed in Table 300-2
shall increase by 4%, rounded to the nearest whole dollar, on July 1 of each
biennium beginning July 1, 2023.
(c)
Fees for additional or updated accreditation shall be paid at the time
of the request.
(d)
Additional or updated accreditation requests shall not be processed
until the applicable fee is received by the department.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.10 Reimbursable Expenses for Department
Assessors.
(a)
In addition to the nonrefundable application fee, the laboratory shall reimburse
the department in accordance with (d) through (h), below, for the following
costs associated with the department’s primary accreditation assessments, as
applicable:
(1) Department staff
expenses, calculated as the time needed to perform the tasks listed in a.
through h., below, multiplied by the unit cost:
a. Completeness review of the application and
documents supplied with the application;
b. Study of documents in preparation for the assessment;
c. Preparation of the checklists used for the assessment;
d. Communications with the applicant related to
the assessment;
e. Travel to and from the laboratory;
f. Assessment of the
laboratory;
g. Preparation of the assessment
report(s); and
h. Review of any corrective action report(s) submitted
per Env-C 309.04;
(2) Meals and lodging while on out-of-state
assessments or in-state assessments that require an overnight stay; and
(3)
Costs of transportation, which for public transportation shall include all
fares and which for non-public transportation shall include:
a. Mileage;
b. Tolls paid, if any; and
c. Parking fees, if any.
(b) In addition to the nonrefundable application
fee, the laboratory shall reimburse the department in accordance with (d)
through (h), below, for the following costs associated with secondary
assessments, calculated as the time needed to perform the tasks listed in (1)
and (2), below, multiplied by the unit cost:
(1) Review of supporting documents related to
additional or updated accreditation requests supplied by a laboratory; and
(2) Communications with the secondary accredited
laboratory.
(c)
In addition to the nonrefundable application fee, the laboratory shall
reimburse the department in accordance with (d) through (h), below, for the
following costs associated with the department’s review of TPAO assessment
procedures and documentation, calculated as the time needed to perform the
tasks listed in (1) through (5), below, multiplied by the unit cost:
(1) Review of supporting documents supplied by
the applicant;
(2) Review of the draft checklist(s) and
supporting documents supplied by a TPAO;
(3) Review of the draft and final assessment reports and any corrective action
report(s);
(4) Communications with the applicant or the
TPAO, or both, related to the assessment; and
(5) Quality control observations of TPAs
performing on-site assessments, provided that if travel is required, the costs
shall include costs identified in (a)(2) and (3), above, as applicable.
(d)
The department shall inform the laboratory of the costs associated with
the assessment with the assessment report.
(e)
If accreditation is denied, revoked, or suspended based on the assessment,
or if the laboratory withdraws its request for accreditation, the laboratory
shall pay the costs of the assessment within 30 days of receiving the
assessment report.
(f)
If accreditation is granted or renewed, the laboratory shall pay the
costs of the assessment prior to receiving its accreditation certificate and analyte list.
(g) Accreditation
shall be denied, revoked, or suspended if the laboratory fails to pay the costs
associated with any of the events covered by (a) through (c), above, within 30
days of receiving the assessment report.
(h) If payment is made by check or money order,
the instrument shall be made payable to “Treasurer – State of New Hampshire”.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.11 Mobile Laboratories; Individual or Remote
Sites.
(a)
A mobile laboratory owned by an accredited fixed-based laboratory shall
be considered an extension of the parent laboratory and shall not require separate
accreditation if it:
(1) Operates under the same quality system as the
fixed-based laboratory;
(2) Performs a subset of analyses for which the
parent laboratory is accredited; and
(3) Analyzes samples exclusively from within the
state in which the parent fixed-base laboratory is located.
(b)
A mobile laboratory owned by an accredited fixed-base laboratory shall
be considered a separate laboratory requiring separate accreditation,
subject to the same application process, fees, assessments, and other
requirements as any other environmental laboratory, if it:
(1) Does not operate under the same quality
system as the fixed-based laboratory;
(2) Performs analyses for which the fixed-base
laboratory is not accredited; or
(3) Analyzes samples from outside of the state in
which the parent fixed-base laboratory is located.
(c)
Individual or remote sites shall be subject to the same application
process, fees, assessments, and other requirements as other environmental
laboratories, subject to the following:
(1) A part of a laboratory that is in a building
in proximity to the laboratory shall not be considered an individual or remote
site; and
(2) A location that is only a sample collection
site shall not be considered an environmental laboratory that is subject to the
requirements of this chapter.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 303.12 Application for Secondary Accreditation.
(a) In order to request initial or renewal
secondary accreditation, the applicant shall submit a complete application as
specified in (b), below, to the department:
(1) Electronically; or
(2)
In hard copy, by mailing or otherwise delivering the application to:
NH Department of
Environmental Services
Attn: Program Manager, NH ELAP
29 Hazen Drive
P.O. Box 95
Concord, N.H. 03302-0095
(b) A complete application for secondary
accreditation shall include:
(1) The information
specified in Env-C 303.13 on an “Application For Laboratory Accreditation with
NH ELAP as a Secondary Accreditation Body” form, NHDES-W-03-200,
dated 12-17-2019 and available at https://onlineforms.nh.gov/?FormTag=NHDES-W-03-200, that has been signed and dated as specified in Env-C
303.02;
(2) Information detailing each method, matrix,
and analyte combination for which accreditation is requested; and
(3) The fee specified in
Env-C 303.08.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.13 Application Information for Secondary
Accreditation. An applicant for
secondary accreditation shall provide the following information:
(a) All information required by Env-C 303.03(a) -
(d) and Env-C 303.06(c);
(b) For the applicant’s primary accreditation body, the following:
(1) The name, mailing address, and main telephone number of the
primary accreditation body;
(2) The name, mailing address, and daytime telephone number and,
if available, an e-mail address, of an individual at the primary accreditation
body who can be contacted relative to the applicant;
and
(3) The date the applicant’s current primary accreditation will
expire; and
(c) For each other accreditation body that has accredited the applicant, the following:
(1) The name, mailing
address, and main telephone number of the accreditation body;
(2) The name, mailing address, and daytime telephone number and,
if available, an e-mail address, of an individual at the accreditation
body who can be contacted relative to the applicant;
and
(3) The date the applicant’s current accreditation from that accreditation body will expire.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.14 Additional Information Required for
Secondary Accreditation Applications.
The applicant shall provide the following to the department with the
completed application:
(a) All information required by Env-C 303.07;
(b) A copy of the most recent and valid
certificate and analyte list from the primary accreditation body or accreditation bodies;
(c) A certificate of compliance as required by
Env-C 303.07(g); and
(d) Additional supporting documentation as necessary
to verify laboratory compliance with applicable method, standard, or regulatory
requirements.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.15 Out-of-state Laboratories Applying for
Accreditation with NH ELAP as a Secondary Accreditation Body.
(a)
Any laboratory located outside of New Hampshire applying for
accreditation with the department as a secondary
accreditation body shall submit a complete application as specified in Env-C
303.12.
(b)
The laboratory shall also submit the following with the application:
(1) A copy of the certificate and analyte list(s)
from its primary accreditation body with each accredited method, matrix, and
analyte combination noted and the expiration date clearly indicated;
(2) A copy of any assessment report not more than
2 years old that was used to obtain the accreditation for each area
accreditation is requested or was based on a complaint investigation;
(3) A copy of the response to each assessment
report provided pursuant to (2), above, as applicable; and
(4) Copies of results from participation in
proficiency test (PT) studies.
(c)
The department shall recognize the accreditation granted by another
primary accreditation body for the same matrix, method, and analyte combination
that the department accredits laboratories as a primary accreditation body.
(d)
The department shall recognize the accreditation for groups of analytes
granted by another primary accreditation body only if the group is identical to
a group that would be accredited by the department as the primary accreditation
body.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.16 Out-of-state Laboratories Applying for
Accreditation with NH as a Primary
Accreditation Body.
(a)
An out-of-state laboratory may request the department to be a primary accreditation body only if:
(1) There is no NELAP-approved accreditation body
in the state or province in which the laboratory is located; or
(2) The primary accreditation
body in the state or province in which the laboratory
is located does not offer the fields of accreditation sought by the laboratory.
(b)
Any laboratory located outside of New Hampshire applying for
accreditation with the department as a primary accreditation body shall apply as
specified in Env-C 303.01.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.17 Application Processing.
(a)
The department shall not process an application until a complete
application is received.
(b)
Subject to (e) and (f), below, if the application is not complete when
filed, the department shall send the applicant written notice of what is needed
to complete the application.
(c)
Upon notifying an applicant that the application is incomplete, the
department shall suspend further processing of the application pending receipt
of the information needed to complete the application.
(d)
No portion of the time between the date a notice of incompleteness is
provided and the date the applicant responds shall be included in computing the
time limits for processing the application specified in RSA 541-A:29.
(e)
The department shall notify the applicant by telephone in lieu of
providing a written notice of incompleteness if:
(1) The anticipated time required of the
applicant to correct the deficiency is less than the anticipated time required
of the department to notify the applicant in writing; and
(2) The department is able to
contact the applicant by telephone.
(f)
If the department provides notice of incompleteness pursuant to (e),
above, the department shall specify a reasonable time period
for completing the application in the telephone notice, after which time
written notice will be sent by the department in accordance with (b), above, if
no response from the applicant is received by the department.
(g)
Upon determining that an application is complete, the department shall
review it and shall
act on the application.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.18 Decision on Application. The department shall approve an application
and grant accreditation only if:
(a) The applicant has submitted a
complete application as specified in Env-C 303.01 through Env-C 303.11 and
Env-C 303.16, as applicable, for primary accreditation or Env-C 303.12 through
Env-C 303.15 for secondary accreditation, as applicable;
(b)
The applicant has paid all additional reimbursable expenses pursuant to
Env-C 303.10;
(c)
The criteria listed in Env-C 303.19 for primary accreditation or Env-C
303.21 for secondary accreditation, as applicable, have been met; and
(d)
No grounds exist on which the accreditation would be denied, suspended,
or revoked.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.19 Basis for Granting
Primary Accreditation.
(a)
In determining whether to approve an application for primary accreditation, the department shall consider:
(1) The results of successful participation in a
PT study as specified in Volume 1, Module 1 of the TNI standards;
(2)
The results of an initial assessment, a reassessment, a surveillance, an
extraordinary assessment, or a follow-up assessment, as applicable; and
(3) The results of the review of documentation
submitted as part of the application process.
(b) Accreditation status shall be either
“Accredited” for a laboratory meeting the TNI
standards, or “Not Accredited” for a laboratory not meeting the TNI standards,
based upon the criteria specified in (a), above, and Env-C 303.18.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.20 Interim Status.
(a)
If a laboratory completes all of the
requirements for accreditation except for the on-site component of the
assessment because the department is unable to schedule the on-site assessment
and a third-party assessor is not available, the department shall issue an interim
accreditation upon request by the laboratory.
(b) Interim status accreditation shall
allow the laboratory to perform analyses and report results with the same
status as an accredited laboratory until the on-site component of the
assessment requirements have been completed, provided that interim
accreditation status shall not exceed 12 months.
(c) Interim accreditation status may be denied,
suspended, or revoked for just cause as described in Env-C 311.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.21 Basis
for Granting Secondary Accreditation.
(a) In determining whether to approve an
application for secondary accreditation, the department shall consider:
(1) The matrix, method, and analyte combination listed on the
analyte list of the primary accreditation body;
(2) The matrix, method, and
analyte combination available in the department’s fields of accreditation;
(3) The accreditation status information from the primary accreditation
body; and
(4) The results of the review of documentation submitted as part
of the application process.
(b) Accreditation status shall be either
“Accredited” for a laboratory meeting the TNI standards,
or “Not Accredited” for a laboratory not meeting the TNI standards, based upon the criteria specified in (a), above, and
Env-C 303.18.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 303.22 Application for Renewal.
(a)
Any accredited laboratory wishing to renew its accreditation shall submit an application for renewal to the department in
accordance with this section.
(b)
The application for renewal of primary accreditation shall:
(1) Comply with Env-C 303.01; and
(2) Be submitted to the department prior to the
expiration date of the current accreditation.
(c)
The application for renewal of secondary accreditation shall:
(1) Comply with Env-C 303.11 through Env-C
303.15; and
(2) Be submitted to the department prior to the
expiration date of the current accreditation.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART Env-C
304 ACCREDITATION
ISSUANCE AND TRANSFERAL
Env-C 304.01 Issuance of Certificates and Analyte Lists.
(a)
Any accreditation issued by the department pursuant to Env-C 303 shall
be valid for one year from the date of initial issuance unless sooner suspended
or revoked in accordance with Env-C 311.
(b)
A certificate or analyte list issued as a
replacement for an existing certificate or analyte list shall be valid until
the expiration date of the certificate or analyte list that it is replacing.
(c)
Each certificate shall include the following:
(1) The name and address of the laboratory;
(2) A statement that continued accreditation
depends on compliance with these rules;
(3) A statement requesting that customers verify
the laboratory’s accreditation status with the department;
(4) A NH ELAP
identification number; and
(5) An effective date and
expiration date of the certificate.
(d) The certificate shall be accompanied
by the laboratory’s analyte list.
(e)
The department shall issue a new analyte list whenever any change in the
laboratory’s fields of accreditation is approved.
(f)
The analyte list shall:
(1) List the name, address, and telephone number
of the laboratory;
(2) Have each page numbered with the total number
of pages indicated;
(3) Specify a unique analyte
list number;
(4) List the effective date and expiration date
of the analyte list; and
(5) List each matrix, method, and analyte
combination for which the laboratory has been accredited.
(g) The laboratory shall post or display its most
recent certificate and analyte list in a location within the laboratory where
clients or potential clients visiting the laboratory would be most likely to
see them.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 304.02 Withdrawal from
Accreditation; Return of Certificate and Analyte Lists.
(a) An accredited laboratory that wishes to
withdraw from the NH ELAP shall so inform the department in writing no later
than 30 days prior to the end of the laboratory’s accreditation year.
(b)
A laboratory accredited by the department shall return its original
certificate and analyte list(s) to the department if:
(1)
Accreditation is totally suspended, revoked, or denied;
(2) The request for
accreditation is voluntarily withdrawn; or
(3)
When a new analyte list is issued by another primary accreditation body.
(c)
A laboratory accredited by the department shall return its original
analyte list(s) to the department if:
(1) Accreditation
is partially suspended, revoked, or denied; or
(2) Accreditation
status is updated as a result of PT results.
(d) The laboratory shall not return to
the department expired certificate(s) or analyte list(s).
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 304.03 Notification of Changes Required.
(a) As required by RSA 485:44, X, a laboratory
shall provide written notice to the department of any changes in ownership,
location, personnel, methodology, or other factors significantly affecting the
performance of analyses for which it is accredited within 5 business days of
the change.
(b) For purposes of this section, “other factors
significantly affecting the performance of analyses for which it is accredited”
means any circumstances that impede the performance of the analyses, including
but not limited to damage to the laboratory’s office(s) or equipment, or both,
from fire or natural disasters.
(c) A notification
submitted pursuant to (a), above, for changes to the authorized agent,
laboratory director, quality assurance officer, or technical manager positions
shall include an updated application and certificate of compliance.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 304.04 Transferring Accreditation: Name Change
Only.
(a) If a laboratory changes its name but does not
make any change identified in Env-C 304.05(a), the laboratory director shall:
(1) Inform the department in writing of the new name within 30 calendar
days of the change of name; and
(2) Certify under penalties
of false swearing that none of the changes identified in Env-C 304.05(a) are
also being made.
(b) Within 10 business days of receipt of a
notice pursuant to (a), above, the department shall issue a replacement
certificate in the new name of the laboratory, provided it has no credible
basis to believe that additional changes are being made.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 304.05 Transferring Accreditation: Changes
Related To Capabilities.
(a) A laboratory’s accreditation shall not be
directly transferable when the ownership, the location, the analytical
instrumentation, the principal officers, or the local
management of the laboratory changes.
(b)
The laboratory director shall provide written notice to the department
as required by Env-C 303.03 of any change related to the laboratory’s
capabilities, as specified in Volume 2, Module 3, Section 7.0 of the TNI
standards.
(c)
The laboratory shall submit updated application information as specified
in Env-C 303 for each change with the written notice required by (b), above.
(d)
The department shall issue a new certificate and
analyte list within 14 calendar days of
receiving the application if there is a change in location. The expiration date of the new certificate
and analyte list shall be the same as the expiration date on the certificate
and analyte list being replaced.
(e)
If the department is the primary accreditation body, the department
shall conduct an assessment of
the laboratory within 60 calendar days if changes reported by the laboratory
affect the day-to-day operations of the laboratory.
(f)
If a laboratory determines that it will be appointing a new technical
manager, the laboratory shall inform the department in writing of its intent
within 30 calendar days of making its determination.
(g)
The proposed technical manager shall meet the educational and experience
requirement of Volume 1, Module 2, Section 5.2.6 of the TNI standards.
(h)
The notice provided pursuant to (e), above, shall include a copy of the
college transcript and resume of the proposed new technical manager, if the
individual has been selected at the time the notice is provided.
(i) If a technical manager is
appointed by the laboratory without approval by the department and it is
determined that the new technical manager does
not meet the requirements of Volume 1, Module 2, Section 5.2.6 of the TNI standards, accreditation of the affected
area(s) shall be suspended in accordance with Env-C 311.02.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 304.06 Use of NH ELAP Name and TNI/NELAP Logo.
(a)
For purposes of this section, “business materials” means any written,
printed, or electronic document, including but not limited to laboratory test
reports, catalogs, advertising, business solicitations, quotations, or
contracts, and any information provided on a website.
(b) An accredited laboratory shall provide only
true, complete, and not misleading information regarding its NH ELAP fields of
accreditation, methods, analytes, or accreditation status on any business
materials.
(c)
When an accredited laboratory uses the NH ELAP name or the TNI/NELAP
logo on any business materials, the laboratory shall include the laboratory’s NH ELAP assigned 4-digit laboratory identification
number.
(d)
The accredited laboratory shall use its department certificate and analyte list, department
accreditation status, and the TNI/NELAP logo only to show compliance with the TNI
standards.
(e)
A laboratory accredited by the department shall not use its certificate,
analyte list, accreditation status, or the TNI/NELAP logo to imply endorsement by the accreditation body or
bring the accreditation body into disrepute.
(f)
If accreditation is denied, suspended, revoked, or withdrawn, the laboratory
shall:
(1) Discontinue the use of all business materials
that contain any reference to the laboratory’s past NH ELAP accreditation for
the affected analyses; and
(2) Delete any reference to the past NH ELAP accreditation
for the affected analyses from its website.
(g)
If accreditation is denied, suspended, revoked, or withdrawn,
the laboratory shall return all copies and original certificates and analyte
lists to the department as specified in Env-C 304.02(b) and (c).
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C
304.07 Providing Information on
Accreditation Status.
(a)
A laboratory shall inform all prospective New Hampshire clients of which
matrix, method, and analyte combination(s) it is accredited by the department
to test using one of the following methods:
(1) Providing a copy of the laboratory’s current
certificate and analyte list to prospective clients with all sample kits;
(2) Providing a list of tests for which the
laboratory is accredited with all sample kits;
(3) Using an asterisk or other mark with the
appropriate legend to indicate accreditation status next to the test on a price
list or other literature supplied with all sample kits; or
(4) Providing the address of a website where the
accreditation information is located.
(b)
The list of tests for which the laboratory is accredited by the department to perform shall be indicated on or with
the test report by one of the following methods:
(1) Using an asterisk or other mark next to the
result or the name of the test with the appropriate legend to indicate
accreditation status on the face of the report;
(2) Providing a copy of the laboratory’s current
certificate and analyte list with all test results;
(3) Providing a list of tests for which the
laboratory is accredited with all test results; or
(4) Providing the address of a website where the
accreditation information is located.
(c)
A laboratory may choose to inform repeat clients of changes in
accreditation status by:
(1) Sending a written notice;
(2) Sending a copy of the new certificate or
analyte list, or both, at the time of the change instead of informing the
client each time a sample kit is sent; or
(3) Providing the address of a website where the
new accreditation information is located.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART Env-C
305 GENERAL REQUIREMENTS FOR
ACCREDITATION
Env-C 305.01 Accreditation Requirements. To be accredited for specific analytes, the
laboratory shall meet all requirements specified in Env-C 305.02 through Env-C
305.14, and the applicable educational requirements in Env-C 306.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.02 Personnel.
(a)
The laboratory shall have an authorized agent.
(b) The laboratory shall have at least one
technical manager who meets the educational requirements in Env-C 306 for each specific
matrix, method, and analyte combination of accreditation.
(c)
The laboratory shall have a quality assurance officer or individual
designated as accountable for data quality as specified in Volume 1, Module 2,
Section 4.1.7.1 of the TNI standards.
(d)
The laboratory also shall meet:
(1) All organizational and management
requirements specified in Volume 1, Module 2, Section 4.0 of the TNI standards;
and
(2) All organizational and personnel requirements
specified in Volume 1, Module 2, Section 5.2 of the TNI standards.
(e)
The laboratory analytical staff shall:
(1) Successfully perform an initial demonstration
of capability for each matrix, method, and analyte combination prior to using
any method, and any time there is a change in instrument type, or method,
or any time that a method has not been performed by the analyst in a 12-month
period; and
(2) Once the initial demonstration of capability
has been passed, successfully perform an ongoing demonstration of capability
for each matrix, method, and analyte combination on an annual basis.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.03 Technical Manager Responsibilities and
Qualifications.
(a)
A technical manager shall be a full-time laboratory staff member who conducts actual day-to-day supervision of laboratory
procedures and test result reporting.
(b)
The duties of a technical manager shall include, but not necessarily be
limited to:
(1) Monitoring standards of performance in
quality control and quality assurance;
(2) Monitoring the validity of the analyses
performed and data generated in the laboratory to assure reliable data;
(3) Ensuring that sufficient
numbers of qualified personnel are employed to supervise and perform the
work of the laboratory; and
(4) Providing educational direction to laboratory
staff.
(c)
An individual shall not be the technical manager of more than one
NELAP-accredited environmental laboratory without providing written
notification to the primary accreditation body.
(d)
A technical manager who is absent for more than 15 consecutive calendar
days shall designate another full-time staff member meeting the qualifications
of technical manager to temporarily perform this function.
(e)
If a technical manager is absent for more than 65 consecutive calendar
days, the quality assurance officer or the staff member temporarily performing
the technical manager’s functions shall notify the accreditation body in
writing, by mail, or electronically.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.04 Exceptions to Technical Manager
Qualifications.
(a)
In lieu of the educational requirements in the applicable sections of
Env-C 306, the technical manager of an environmental laboratory for a drinking
water or wastewater treatment facility may be a full-time employee of the
facility who:
(1) Holds a valid operator’s certificate
appropriate to the nature and size of such facility within the scope of that
facility’s regulatory permit; and
(2) Has not less than 2 years of experience
testing the kind of samples required by the facility’s permit.
(b)
In lieu of the educational requirements in the applicable sections of
Env-C 306, the technical manager of an environmental laboratory for an
industrial waste treatment facility may be a full-time employee of the facility
who has not less than 2 years of supervised experience testing the kind of
samples required by that facility’s permit.
(c)
Any individual who does not meet the applicable education requirements
specified in Env-C 306 but who possesses the requisite experience shall qualify
as a technical manager subject to the conditions specified in Volume 1, Module
2, Section 5.2.6.2(c) of the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.05 Laboratory Facilities. The laboratory facilities shall meet the
requirements as specified in Volume 1, Module 2, Section 5.3 of the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.06 Laboratory Equipment, Calibration, and Measurement
Traceability.
(a) The laboratory equipment, including support
equipment, shall meet the requirements as specified in Volume 1, Module
2, Section 5.5 of the TNI standards.
(b) The laboratory
shall have reference standards and reference materials that meet requirements
relative to measurement traceability as specified in Volume 1, Module 2,
Section 5.6 of the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.07 Analytical Methodology. The laboratory shall meet the analytical methodology
requirements as specified in Volume 1, Module 2, Section 5.4 of the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.08 Sample Collection, Handling, and
Preservation. The laboratory shall
meet the sample collection, handling and preservation requirements as specified in
Volume 1, Module 2, 5.7 and Module 2, Section 5.8 of the
TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.09 Quality Assurance Requirements.
(a) The laboratory shall develop and implement a
quality system in accordance with Volume 1, Module 2
of the TNI standards that incorporates the essential quality control
requirements specified in Volume 1, Modules 3 through 7 of the TNI standards.
(b) If the quality control requirements of Volume 1,
Modules 2 through 7 of the TNI standards and the
requirements in an approved method differ, the laboratory shall use the
requirements that result in a higher level of confidence in testing results.
(c) The laboratory shall analyze laboratory control
samples whenever whole volume material, concentrated material, or spiking
solution material is available to create or otherwise prepare laboratory control
samples.
(d)
An appropriate clean matrix material shall be used in laboratory reagent
blank and laboratory control sample preparation associated with solid and
chemical materials and biological tissue analytical procedures.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.10 Calibration of Instruments.
(a) The laboratory shall meet the instrument
calibration requirements specified in Volume 1, Module 2, Section 5.5 of the TNI standards.
(b) If the requirements in Volume 1, Module 2, Section 5.5 of the TNI standards and the requirements in an
approved method differ, the laboratory shall use the requirements that result in a higher level of confidence in testing
results.
(c) Prior to
analyzing any samples, the laboratory shall verify all
initial instrument calibrations with:
(1) A standard obtained from a manufacturer other
than the one that produced the calibration standards used by the laboratory; or
(2) A standard obtained from the same
manufacturer that produced the calibration standards but from a different lot
that was independently prepared from different source materials.
(d) If option (c)(2) is used, the laboratory
shall maintain records from the manufacturer to document that the 2 lots were
prepared independently from different source materials.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.11 Records and Data Reporting.
(a) The laboratory
shall meet the records and data reporting requirements specified in Volume 1,
Module 2, Section 4.13 and 5.10 of the TNI standards.
(b)
All quality control and sample analytical results shall include the
appropriate unit of measure.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.12 Response to Laboratory Results for
Compliance Purpose Samples. When a
response required by Env-Dw 719.02 is a designated
laboratory responsibility, the laboratory shall promptly notify the department
of:
(a)
Exceedance results as required by Env-Dw
719.02(c); and
(b)
All other results in the time frame and format designated in Env-Dw 719.02.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.13 Outside Support Services and Supplies.
(a) The laboratory shall meet the outside support
and supplies requirements as specified in Volume 1, Module 2, Section 4.6 of the TNI standards.
(b) The laboratory shall meet the subcontracting
of environmental tests requirements as specified in Volume 1 Module 2 Section
4.5 of the TNI standards.
(c) When a laboratory subcontracts environmental
tests, the laboratory shall:
(1) Be responsible to the customer for the subcontractor’s work;
and
(2) Communicate to the
client any failure to meet the client’s data quality objectives.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 305.14 Complaints. The laboratory shall meet the requirements
for handling complaints as specified in Volume 1, Module 2, Sections 4.8 and 4.11
of the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART Env-C 306 SPECIFIC EDUCATION REQUIREMENTS FOR
CATEGORIES OF TESTING
Env-C 306.01 Educational Requirement for Microbiology.
(a) To be accredited
for microbiological or pathogen analysis, the
technical manager shall have:
(1) A bachelor’s degree in microbiology, biology,
chemistry, environmental sciences, physical sciences, or engineering, with a
minimum of 16 college semester credit hours in general microbiology and
biology; and
(2) At least 2 years of experience in the
environmental analysis of representative analytes for which the laboratory is
seeking approval, provided that a master’s degree or doctoral degree in one of
the disciplines listed in (1), above, may be substituted for one year of
experience.
(b)
Subject to (c), below, an employee of a laboratory engaged in
microbiological analyses limited to total coliform, fecal coliform, E. coli,
and standard plate count who has an associate’s degree in an appropriate field
of the sciences or applied sciences, with a minimum of 4 college semester
credit hours in general microbiology and one year experience, shall be deemed
to meet the educational and experience requirements for a technical manager for
microbiology.
(c)
College education that includes at least 2 years of equivalent and
successful education, including the microbiology requirement, may be
substituted for the associate’s degree.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 306.02 Educational Requirement for Radiology.
To be accredited for
radiological analysis, the technical manager shall
have:
(a)
A bachelor’s degree in chemistry, engineering, or environmental, biological,
or physical sciences with at least 24 college semester credit hours in
chemistry; and
(b)
At least 2 years of experience in the radiological analysis of
environmental samples, provided that a master’s or doctoral degree in one of
the disciplines listed in (a), above, may be substituted for one year of
experience.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 306.03 Educational Requirement for Radon Testing.
To be accredited for
radon analysis, the technical manager shall have:
(a)
An associate’s degree or 2 years of college;
and
(b)
At least one year of experience in the measurement of radon or radon
progeny, or both.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 306.04 Educational Requirement for Toxicity
Analysis. To be accredited for
toxicity analysis, the technical manager shall
have:
(a) A bachelor’s degree in microbiology, biology,
chemistry, environmental sciences, physical sciences, or engineering, with a
minimum of 16 college semester credit hours in general microbiology and
biology; and
(b) At least 2 years of experience in the
environmental analysis of representative biological, physical science,
inorganic or organic analytes for which the laboratory is seeking approval,
provided that a master’s or doctoral degree in one of the above disciplines may
be substituted for one year of experience.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 306.05 Educational Requirement for Chemical
Analysis. To be accredited for chemical analysis, the technical manager
shall meet the following qualifications:
(a)
A bachelor’s degree in chemistry, environmental sciences, biological
sciences, physical sciences, or engineering, with at least 24 college semester
credit hours in chemistry; and
(b)
At least 2 years of experience in the environmental analysis of
representative inorganic and organic analytes for which the laboratory is
seeking approval, provided that a master’s degree or doctoral degree in one of
the disciplines listed in (a), above, may be substituted for one year of
experience.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 306.06 Educational Requirement for Asbestos
Analysis. To be accredited for
microscopic examination of asbestos or airborne fibers, the technical manager
shall have:
(a)
For procedures requiring the use of a transmission electron microscope:
(1) A bachelor’s degree in chemistry, environmental
sciences, biological sciences, physical sciences, or engineering;
(2) Successful completion of a course in the use
of the instrument; and
(3) One year of supervised experience in the use
of the instrument.
(b)
For procedures requiring the use of a polarized light microscope:
(1) An associate’s
degree or 2 years of college study in any of the areas listed in (a)(1), above;
(2) Successful completion of a formal course in
polarized light microscopy; and
(3) One year of supervised experience in the use
of the instrument, which shall include experience in the identification of
minerals.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART
Env-C 307 PROFICIENCY TESTING (PT)
Env-C 307.01 Participation in Scheduled and
Supplemental Proficiency Testing.
(a) Laboratories shall use proficiency testing
(PT) providers approved by:
(1) TNI;
(2) The U.S. Environmental
Protection Agency (EPA);
(3) Other proficiency test providers that are
also accreditation bodies; or
(4) A proficiency testing provider accreditor.
(b) Laboratories
seeking to become accredited or to maintain accreditation shall perform
analyses of PT samples for each field of accreditation for which NH ELAP
accreditation is sought, as described in Volume 1, Module 1 of the TNI standards.
(c) Prior to requesting PT samples or otherwise
participating in a PT study, a laboratory shall obtain an EPA laboratory identification
code, where applicable, which is the EPA identification code the laboratory
uses when reporting results to an approved PT provider.
(d)
The laboratory seeking or maintaining accreditation shall obtain
scheduled and supplemental PT samples that meet the requirements of Volume 1, Module 1 of the TNI standards from any PT provider as required by Volume 1, Module 1 of
the TNI standards.
(e) Subject to (h), below, each laboratory
seeking to become accredited or to maintain accreditation shall participate in
at least 2 PT studies per year provided by a PT Provider as required by Volume
1, Module 1 of the TNI
standards.
(f) In addition to (e) above, the laboratory
shall successfully participate annually in at least one PT study for each
drinking water method and analyte for which accreditation is sought.
(g)
Subsequent PT studies for initial or continuing accreditation shall be
conducted in accordance with Volume 1, Module 1 of
the TNI standards.
(h) Any laboratory seeking to obtain initial
accreditation for whole effluent toxicity or to
maintain such accreditation shall successfully participate in at least one discharge monitoring report-quality
assurance (DMR-QA) study per year provided by
a PT provider.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 307.02 PT Sampling Handling.
(a) The laboratory shall analyze PT samples in
the same manner as is used for routine environmental samples using the same
staff, sample tracking, sample preparation and analysis methods, standard
operating procedures, calibration techniques, quality control procedures, and
acceptance criteria.
(b)
There shall be at least 7 calendar days between the closing date(s) of
PT samples that resulted in not-acceptable results and the opening date(s) of
subsequent PT samples.
(c) A laboratory shall
analyze:
(1) Low level PT samples for low level method
accreditation; and
(2) Medium level PT samples for regular or standard
method accreditation.
(d) A laboratory shall
analyze a DMR-QA PT sample in place of a non-potable water PT when required by
a wastewater program standard or a TNI standard. If this substitution is made, the quality
control and corrective action requirements of the DMR-QA shall be met.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 307.03 PT Study Deemed Not Acceptable.
(a)
Failure to meet the schedule specified in Env-307.01 shall be regarded
as a not-acceptable study.
(b)
A laboratory may participate in a supplemental study for not-acceptable
analyses, for missed analyses, or for meeting the PT requirements for a new analysis
as allowed in Volume 1 Module 1, of the TNI
standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 307.04 Employees and PT Sample Security.
(a) An analyst employed at more than one
laboratory shall:
(1) Before analyzing
any PT sample, inform the department, in writing, that the analyst is employed
at more than one laboratory;
(2) Declare to the department the date on which each laboratory plans
to analyze the PT sample;
(3) Analyze the PT sample in only one laboratory; and
(4) Not analyze any PT sample for that round of
testing after analyzing the first PT sample.
(b) Laboratory personnel, including corporate
personnel, shall meet the PT sample security requirements of Volume 1, Module
1, Section 4.1.5 of the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C
307.05 Initial and Continued Accreditation
PT Samples.
(a)
A laboratory that seeks accreditation for a
field of accreditation for which it has not been previously accredited shall:
(1) Successfully complete 2 PT studies for each
requested field of accreditation out of the
most recent 3 rounds attempted within the 18 months preceding the application; and
(2) Maintain a PT study history for initial
accreditation in accordance with Volume 1, Module 1 of
the TNI standards during the application and accreditation process.
(b) In order to maintain accreditation, an
accredited laboratory shall maintain a history of at least 2 successful PT
studies out of the most recent 3 PT studies attempted.
(c) A
laboratory may withdraw from a PT study for one or more analytes or for the
entire study if the laboratory notifies both the PT provider and the primary
accreditation body before the closing date of the PT study.
(d) Withdrawal from a
PT study shall not exempt the laboratory from participating in the semiannual
schedule required by Env-C 307.01(e).
(e) Failure to meet the PT requirements shall
result in a suspension of accreditation of the affected fields of accreditation
following the procedures established in Env-C 311.02.
(f) Failure
to take the appropriate corrective action to address suspended accreditation
due to PT failures shall result in a revocation of the affected fields of
accreditation following the procedures established in Env-C 311.03.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 307.06 Reporting PT Study Results.
(a) After analyzing the PT samples, the
laboratory shall:
(1) Return the results to the PT study provider
for scoring no later than 45 calendar days from the date of sample receipt;
(2) Accurately and
completely report the required matrix, technology key, method code, analyte
code, and result information for each PT sample; and
(3) Authorize the PT provider to release all
accreditation and remediation results and acceptable/not acceptable status directly
to the primary accreditation body, the proficiency test provider accreditor, and the laboratory.
(b) Errors in reporting the proper matrix, the
method used, or the tested analytes in the PT study by the laboratory shall be
graded as “not acceptable”.
(c)
The department shall evaluate only results received directly from the PT
provider as specified in Volume 1, Module 1 of
the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C
307.07 PT Study Record Retention.
(a)
The laboratory shall maintain copies of all written, printed, and
electronic records pertaining to PT sample analyses for 5 years or for as long
as is required by the applicable regulatory program, whichever is greater.
(b)
Records retained pursuant to (a), above, shall include, but not be limited
to:
(1) Bench sheets;
(2) Instrument strip charts or printouts;
(3) Data calculations;
(4) Data reports;
(5) The PT study report forms used by the
laboratory to record PT results; and
(6) The PT study report form that documents the submitted
results.
(c)
The laboratory shall make all records retained available to assessors
during on-site assessments of the laboratory.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 307.08 Proficiency Testing Study
Results Review. If a laboratory
receives a “not acceptable” result for any PT sample, the laboratory shall:
(a)
Review each “not acceptable” result to
determine:
(1) What caused the error; and
(2) What corrective action(s) the laboratory
needs to take to correct the problem;
(b)
Document in its own records the cause(s) and corrective action(s) the
laboratory has taken to correct each problem that caused or contributed to the
“not acceptable” result;
(c)
Submit the results of its own investigation and a corrective action
report to the department within 30 calendar days of receiving the results; and
(d)
Initiate corrective action that is documented in a corrective action
report submitted to the department before requesting a supplemental PT study.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART Env-C 308 QUALITY SYSTEMS MANUAL AND STANDARD OPERATING
PROCEDURES MANUAL
Env-C 308.01 Establishing and Documenting Quality
Systems.
(a)
The laboratory shall define and document its policies and objectives
for, and its commitment to, accepted laboratory practices and quality of
testing services in a quality system that is:
(1) Based on the required elements found in
Volume 1, Module 2 of the TNI standards;
(2) Appropriate to the type, range, and volume of
environmental testing activities it undertakes; and
(3) Documented in the organization’s quality
systems manual as specified in Env-C 308.02.
(b)
The laboratory’s quality assurance officer shall maintain the quality
systems manual to ensure that it remains accurate and up-to-date.
(c)
The quality systems manual shall be available for use by all laboratory
personnel.
(d)
Laboratory management shall ensure that the laboratory’s policies and
objectives are communicated to, understood by, and implemented by all
laboratory personnel, by conducting:
(1) Internal audits as specified in Volume 1,
Module 2, 4.14 of the TNI standards;
(2) Managerial reviews as specified in Volume 1, Module 2, 4.15 of the TNI
standards; and
(3) Data integrity investigations as specified in Volume 1, Module
2, 4.16 of the TNI standards.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 308.02 Quality Systems Manual.
(a)
The laboratory shall prepare and maintain a quality systems manual that
meet the requirements specified in Volume 1, Module 2, Sections 4.2.8.3 and
4.2.8.4 of the TNI standards.
(b)
The quality systems manual shall:
(1) Represent the laboratory’s normal day to day
operating procedures and policies;
(2) State that all laboratory staff must follow
all specified procedures and policies;
(3) Describe or reference the procedures for the
development of in-house limits for analytical method quality control standards
when not defined by the reference method; and
(4) Describe or reference the procedures for
reviewing and validating analytical method support activities, analytical
results, and reported analytical results.
(c)
The quality systems manual shall either include the standard operating
procedures (SOPs) or reference where the SOPs are maintained.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 308.03 Documenting Standard Operating Procedures
(SOPs).
(a) The laboratory shall prepare:
(1) An SOP for preparing and implementing SOPs
for laboratory activities, which shall include identifying the title of each
position responsible for approving each SOP, known as the approving authority(ies);
(2) An accurate written SOP
for each laboratory administrative activity, including but not limited to
sampling, sample receiving, employee training, reporting analytical results,
verification of analytical results, internal audits, and corrective actions;
and
(3) An accurate written SOP
for each laboratory analytical activity, including but not limited to test
methods, instrument operation, data generation and quality control sample analysis; and corrective actions.
(b)
The analytical SOPs shall meet the
requirements specified in Volume 1, Module 2, Section 4.2.8.5 of the TNI
standards. If the method allows
modifications, the modification used by the laboratory shall be documented in
the SOPs.
(c)
The laboratory shall maintain a copy of each SOP and a record of SOP
effective dates for the same period of time that records
of the data generated by those procedures are required to be maintained.
(d) Copies of each current SOP shall be made
available to all personnel engaged in laboratory activities to
which a particular SOP applies.
(e) Each official
version of a SOP shall bear the signature(s) of the approving authority(ies).
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 308.04 Implementing SOPs.
(a) The analyst shall use only the official version of the
applicable laboratory SOP or a controlled copy of the official version
of the SOP for all laboratory activities related to
the analysis of compliance samples and any
other sample analyses for which
accreditation is required.
(b) The laboratory shall maintain a record of
each sample that is not analyzed as required by the SOPs.
(c)
The records required by (b), above, shall include:
(1) Laboratory sample identification;
(2)
For each deviation from the SOP, the following:
a. A
description of the deviation;
b. The
reason(s) for the deviation; and
c. Client
authorization or acknowledgment of the deviation; and
(3) An analytical report that identifies all
quality control failure qualifiers.
(d) In order to be properly evaluated against
quality control limits, each analytical SOP shall require that:
(1) Quality control standard results are
calculated and recorded as percent recovery or other applicable and valid
statistical technique; and
(2) Duplicate samples are calculated and recorded
as a relative percent difference or other applicable and valid statistical
technique.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 308.05 Corrective Actions.
(a)
The laboratory shall implement general procedures to be followed when
departures from documented policies, procedures, and quality control (QC) measures
have occurred.
(b)
The laboratory shall document departures from documented policies,
procedures, and QC measures and the corrective actions taken as specified in
Volume 1, Module 2, Sections 4.9 and 4.11 of the TNI standards.
(c)
The laboratory’s documented corrective action shall include a
description of the nonconforming work or departure from a policy or procedure,
a root cause analysis, a selection of corrective action, an implementation of
corrective action, monitoring of corrective action, additional audits
performed, and signed and dated approval of laboratory management.
(d)
Where possible, the laboratory shall report data only if all laboratory
policies and procedures have been followed and QC measures are acceptable.
(e)
If a QC measure is found to be a departure from documented policies,
procedures, and QC measures and the data is to be reported, all samples
associated with the failed QC measure shall be reported with appropriate data
qualifier(s).
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 308.06 Essential Quality Control Procedures.
(a)
All laboratories shall:
(1) Develop and
implement protocols to monitor QC measures as specified in Volume 1,
Module 2, Section 5.9 of the TNI standards;
(2) Assess and evaluate all QC measures on an
on-going basis;
(3) Use the laboratory’s documented QC acceptance
criteria to determine the usability of the data; and
(4) Develop and
implement procedures for the development of QC sample
acceptance/rejection criteria where no method, data quality objective, or
regulatory criteria exist.
(b)
QC requirements for specific analytes shall be as specified in the TNI
standard identified in table 300-3, below, and the reference method(s) upon
which accreditation has been granted:
Table 300-3: Applicable QC Requirements
Type of Testing |
TNI Standard |
Asbestos |
Volume
1, Module 3, Section 1.7.2 |
Chemical |
Volume
1, Module 4, Section 1.7.3 |
Microbiology |
Volume
1, Module 5, Section 1.7.3 |
Radiochemical |
Volume
1, Module 6, Section 1.7.2 |
Toxicity |
Volume
1, Module 7, Section 1.7.1 |
Pathogens |
Volume
1, Module 5, Section 1.7.3 |
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART Env-C
309 ASSESSMENTS
Env-C 309.01 Initial Assessments, Reassessments, and
Surveillance Assessments.
(a) When serving as the primary accreditation body, the department shall not issue an accreditation
prior to completion of an assessment in accordance with Volume 2, Module 3,
Section 6.0 of the TNI standards.
(b)
In order to maintain NH ELAP accreditation, a laboratory for which the
department is the primary accreditation body shall be assessed
for all fields of accreditation on a frequency of at least once every 18
to 30 months.
(c)
An initial assessment or reassessment shall
include an administrative review of the application for completeness and
a technical review of the application, quality
systems manual, SOPs, and any other document submitted with the application.
(d)
Surveillance assessments shall be performed to monitor a laboratory’s
ability to meet requirements of accreditation between an initial assessment or
reassessment and a scheduled reassessment.
(e)
Laboratory personnel shall allow duly-authorized
employees of the department or an approved TPAO to enter the premises of any
laboratory accredited under these rules during the laboratory’s normal business
hours to determine compliance with the department’s rules
and with applicable TNI standards.
(f) Assessors shall have access to interview any and all staff engaged in activities related to the areas for which
the laboratory requests accreditation.
(g)
Arrangements for an assessment shall be made between the program manager
or TPAO and the laboratory’s authorized agent or
contact person.
(h)
If a laboratory refuses to allow a scheduled assessment, the department
shall:
(1) Deny initial accreditation; or
(2) Initiate revocation proceedings to revoke or
refuse to renew an existing accreditation.
(i) The assessment team shall use the TNI quality
systems checklist(s) and technical checklists prepared by the department to
conduct the assessment.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 309.02 Extraordinary Assessments.
(a)
The department or TPAO shall conduct an
extraordinary assessment of a laboratory for which the department is the
primary accreditation body if the program
manager receives a written complaint or other credible information indicating
that:
(1) The laboratory is not
meeting the requirements of its accreditation under these rules or the TNI
standards; or
(2) The laboratory is engaged in an improper, illegal, or deceptive
practice.
(b) An extraordinary assessment shall be
unannounced if laboratory
records could be destroyed or altered if prior notice is given.
(c) An
extraordinary assessment shall be conducted during the laboratory’s normal
business hours, to:
(1) Confirm that corrective actions were
implemented after a previous assessment; or
(2) To determine whether reported changes in the
laboratory’s ownership, key personnel, location, scope of accreditation, or
other matters have affected the ability of a laboratory to fulfill
accreditation requirements.
(d) The assessor shall use either a TNI quality
systems checklist or a checklist prepared by the department to evaluate the
merits of the information or complaints received by
the program manager that were relied upon to justify an extraordinary
assessment.
Source.
(See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 309.03 Follow-up Assessments.
(a)
The department or TPAO shall conduct a follow-up
assessment if:
(1) The deficiencies
noted during any assessment are so numerous or serious that the laboratory no
longer meets the requirements for accreditation of the laboratory in part or in
whole;
(2) The laboratory’s responses to a previous assessment report and the
follow-up assessment report were inadequate; or
(3) Any deficiency noted during an initial
assessment or any deficiency identified during a reassessment was the same as a deficiency identified during any
previous assessment.
(b)
The follow-up assessment shall be completed and reported within 30
calendar days after receipt of the laboratory’s corrective action plan if the
deficiencies are of such severity as to possibly warrant revoking, suspending, or
withholding of the laboratory’s accreditation.
(c)
If the department issues a decision to suspend, revoke, or refuse to renew
an accreditation that the laboratory appeals, the department shall conduct a
follow-up assessment to examine the laboratory’s facilities, records, and
personnel to determine the merits of the appeal.
(d)
The assessor shall use the TNI quality systems
checklist(s) and technical checklists prepared by the department to
conduct the follow-up assessment.
(e)
The laboratory may request the follow-up assessment to be canceled by
withdrawing the request for accreditation for the affected field of accreditation
or the appeal, as applicable.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 309.04 Assessment Report; Corrective Action
Report.
(a)
The department or TPAO shall issue a
written assessment report electronically to the laboratory within 30 calendar
days of any assessment.
(b)
If deficiencies are identified in the assessment report, the laboratory
shall, within 30 calendar days of receiving the
assessment report, prepare and submit, to the
department or TPAO as applicable based on who provided the assessment report to
the laboratory, a corrective action report that:
(1) Explains how
each deficiency has been corrected or will be
corrected; and
(2) Includes supporting
documentation, where possible, to show how each deficiency was corrected or
will be corrected.
(c)
The laboratory shall submit the
corrective action report required by (b), above, electronically, using a format that is compatible with that of the department or
TPAO, as applicable based on who provided the assessment report to the
laboratory.
(d)
If the laboratory wants additional time to submit the report required by
(b), above, the laboratory shall:
(1) Submit a written request to the department,
on paper or electronically, prior to the original deadline, which explains why
additional time is needed; and
(2) Negotiate in good faith to establish a new
deadline.
(e)
Within 30 calendar days of receipt of the corrective action report, the
department or TPAO, as applicable, shall:
(1) Determine whether the submitted corrective
actions are acceptable based on the applicable TNI standard(s), reference
method(s), state rule(s), or federal regulation(s); and
(2) Notify the laboratory in writing of its
determination, by sending:
a. A letter, if the submitted corrective actions
are acceptable; or
b. A follow-up report, if the submitted
corrective actions are not acceptable.
(f)
If the notice provided pursuant to (e), above, identifies any
deficiency(ies) in the corrective action report, the
laboratory shall submit a revised corrective action report, with supporting
documentation as provided in (b), above, electronically within 30 calendar days
of the date of the notice.
(g)
Within 30 calendar days of receipt of the revised corrective action
report, the department or TPAO, as applicable, shall inform the laboratory in
writing if the submitted revised corrective actions are acceptable or not based
on the applicable TNI standard(s), reference method(s), state rule(s), or
federal regulation(s).
(h)
The department shall base its decision to grant or deny initial
accreditation or to suspend, revoke, or refuse to renew an existing
accreditation based on its evaluation of the corrective action report, the
revised corrective action report, if any, and PT sample results and information
submitted with the application.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART Env-C 310 THIRD PARTY
ASSESSOR ORGANIZATIONS; THIRD PARTY ASSESSORS
Env-C 310.01 Mandatory Use of Third
Party Assessor Organization (TPAO).
(a) The department shall require an in-state or
out-of-state laboratory to use a TPAO for part or all of an assessment if:
(1) Based on available
resources, the department will not be able to perform an on-site assessment
within the required on-site time frame, for example because of the number and complexity of the field(s) of
accreditation for which accreditation is sought;
(2) Based on available resources, the department
will not be able to perform an initial or reassessment within the required 2
year plus or minus 6 months time frame; or
(3) The department staff lacks expertise in a field of accreditation
requested by the laboratory.
(b)
The department shall notify the
laboratory, in writing, of the need to use a TPAO within 30 days of receiving a
laboratory’s application for initial accreditation or at the time an
accreditation renewal application is sent to a laboratory, as applicable.
(c)
The authorized agent for a laboratory that receives a notice pursuant to
(b), above, shall:
(1) Choose the TPAO to conduct the assessment
from the list of approved TPAOs prepared by the department pursuant to Env-C
310.05(d); and
(2) Not later than one month prior to the
scheduled onsite assessment, inform the department in writing of which TPAO the laboratory has contracted with.
(d) If the authorized agent
fails to comply with (c), above, the department shall inform the authorized
agent, in writing, that accreditation shall not be
granted or renewed until the requirements of (c), above, have been met.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-Dw 310.02 Optional Use of TPAO.
(a)
A laboratory may request the department to allow the use of a TPAO to
conduct the assessment in lieu of the department by submitting a written
request that:
(1) Identifies the TPAO the laboratory wishes to use;
(2) Explains why the laboratory wishes to have
the TPAO conduct the assessment in lieu of the department; and
(3) Provides sufficient information and
documentation, which may take the form of a sworn affidavit
from the laboratory director, that the criteria specified in (b), below, are
met.
(b)
The department shall approve a request to use a TPAO submitted pursuant
to (a), above, if:
(1) The TPAO chosen by the laboratory is on the
list of approved TPAOs prepared by the department pursuant to Env-C 310.05(d);
(2)
The department is not aware of any complaints pending against the laboratory;
(3) The laboratory has not made any changes in
key personnel, major equipment, or laboratory location within the previous 6
months; and
(4) If applicable, the laboratory has completed
all corrective actions needed as a result of any prior
assessment(s).
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 310.03 Payment For TPAO
Assessments.
(a)
The laboratory shall pay all costs associated with a third
party assessment directly to the TPAO.
(b)
The laboratory shall pay all department expenses related to the review
and processing of TPAO assessment support documentation, quality control
observations, report(s), and laboratory corrective actions to the department
per the fee schedule specified in Env-C 303.10.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 310.04 Application for Initial or Renewal
Approval of TPAOs.
(a)
In order to be approved by the department,
a TPAO shall submit the information specified in (b), below, on a “Third Party
Assessor Organization Application (TPAO) for Approval” form, NHDES-W-03-201, dated 12-17-2019 and available at https://onlineforms.nh.gov/?FormTag=NHDES-W-03-201, to the
department electronically.
(b)
A complete application for TPAO approval shall include the following:
(1) The legal name, mailing address, street
address, billing address, daytime telephone number, and fax number of the TPAO
and, if available, the e-mail address and website address of the TPAO;
(2) Whether the TPAO is a business entity or a
government entity;
(3) If the TPAO is a business entity, the
following:
a. The type of business entity, such as
corporation, general or limited partnership, sole proprietorship, or limited
liability company, and the legal name of the business entity, if other than the
legal name of the TPAO;
b. The date the TPAO registered with the New
Hampshire secretary of state and the business identification number assigned by
the secretary of state’s office;
c. If the TPAO is a corporation, the date and state
of incorporation; and
d. The name and title of each principal official
of the business entity, such as corporate officers or general partners;
(4) If the TPAO is a federal, state, county, or
local agency, the name and primary mailing address of the agency, if different
from the information provided pursuant to (b)(1), above;
(5) The name, daytime telephone number, extension
number, if applicable, and e-mail address of the individual at the TPAO who is the contact for purposes of the application;
(6) The name and title of the individual
authorized by the TPAO to sign the application;
(7) The full legal name of each current and
former affiliated and parent organization;
(8) The geographic area(s) in which the TPAO
provides service, both domestic and foreign;
(9) The name, title, and qualifications of each
individual TPA employed or otherwise used by the TPAO for laboratory
accreditation assessments;
(10) Documentation that the TPAO meets the
criteria specified in Env-C 310.05(a);
(11) An affidavit signed as specified in (12),
below, that the TPAO:
a. Certifies that the statements regarding the
TPAO’s qualifications, systems, approved assessor lists, and supporting
documentation provided on or with the application are true, complete, and not
misleading to the best of the applicant’s knowledge and belief;
b. Understands that application forms and
supplemental application documentation and materials are considered public data;
c. Acknowledges
receipt of a copy of the Tennessen Warnings provided with the application
package and has read and understands the contents;
d. Acknowledges that all current or former
relationships, associations, or investments that may influence or appear to
influence the applicant’s judgment, discretion, or impartiality with
laboratories applying to or accredited by the program have been disclosed, and
that if a conflict of interest is confirmed, the TPAO will not knowingly access
records of those laboratories for personal gain and will again declare the
conflict of interest to the department if is the applicant assigned
duties where a conflict may be perceived to affect the applicant’s judgment;
and
e. Agrees to comply with all applicable
requirements of the state of New Hampshire and the NH ELAP related to assessment of
environmental laboratories and protection of the data obtained while preparing,
performing, or supervising the assessment activities; and
(12) The affidavit required by (10), above, shall
be:
a. Signed by the individual authorized by the
TPAO to sign the application; and
b. Notarized by a notary public in the
jurisdiction in which the affidavit is executed.
(c) The TPAO shall submit a renewal application
prior to expiration of its existing approval.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 310.05 Approval of TPAOs.
(a) The department shall approve a TPAO
to conduct assessments if the TPAO:
(1) Submits all information required by Env-C 310.04;
(2) Documents that each of its TPAs meets the
requirements specified in:
a. Volume 2, Module 1, Sections 6.1.4 and 6.2.4
of the TNI standards; and
b. Volume 2, Module 3, Sections 4.2 through 4.4
of the TNI standards;
(3) Submits copies of quality system
documentation that describes the TPAO operations related to on-site assessments;
(4) Agrees to conduct assessments that meet the
assessment procedures specified in Volume 2, Module 3, Section 6.0 of the TNI standards;
(5) Agrees to use the quality
systems checklist and technical checklists prepared by the department,
or approved by the department as being equivalent to the department-prepared
checklists, when conducting assessments;
(6) Agrees to provide to the department a copy of
the checklists used for an assessment with all findings recorded in hard copy
or electronic copy within one calendar week of the assessment closing conference;
(7) Agrees to provide a hard copy or electronic
copy of all handwritten notes and documents used to prepare the checklists
described in (6), above, to the department; and
(8) Agrees to provide a draft of the assessment report to the department within 7 business days of the assessment closing
conference.
(b)
The department shall notify an applicant for approval as a TPAO in
writing of the approval or denial of its application. If the application is denied, the notice
shall specify the reason(s) for the denial.
(c) Upon being notified of its approval,
the TPAO shall enter into a written agreement with the department by which it
commits to meet the requirements of (a)(4) through (7),
above, prior to conducting an assessment pursuant to Env-C 310.01 or Env-C
310.02.
(d) The department shall maintain
a list of approved TPAOs on its website.
(e)
TPAO approvals shall be valid for one year unless sooner suspended or
revoked per Env-C 311.03.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 310.06 Review of TPAO Work.
(a)
The department shall review all work performed by a TPAO to determine
compliance with Env-C 300 and the TNI standards.
(b) Disputes between a laboratory and a TPAO
concerning issues raised during the assessment process shall be brought to the
attention of the program manager.
(c) If the work performed by a TPAO does not comply with Env-C 300 and the TNI standards, the department shall reject the work and:
(1) Return any work not in
compliance to the TPAO
with a written notice identifying the work that is
not acceptable;
(2) Send written notice to
each laboratory whose pending accreditation review relies on the assessment
performed by the TPAO
of any unacceptable work performed by the TPAO; and
(3) Provide the TPAO an opportunity
to correct the unacceptable work within 30 days.
(d)
If the TPAO wishes to correct the unacceptable work, the TPAO shall
resubmit its work to the department within 30 days of the date of the written
notice provided pursuant to (c)(2), above.
(e) The department shall review any resubmitted
work from a TPAO
in accordance with this section.
(f) The department shall suspend the approval of
a TPAO
for any field of accreditation for which the work of
the TPAO has been rejected and not corrected within 30 days.
(g) The department shall not grant accreditation
to a laboratory for any field of accreditation for which the work of the TPAO has been rejected and not corrected.
(h)
Department staff shall:
(1) Observe the physical on-site assessment
procedure of the TPAO on an annual basis;
(2) Notify a TPAO of any failure to meet the
requirements of Env-C 310; and
(3) Provide the
TPAO an opportunity to correct any failure to meet the applicable regulation.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
PART Env-C
311 DENIAL, SUSPENSION, OR REVOCATION OF
ACCREDITATION
Env-C 311.01 Denial.
(a)
Reasons for the department to deny a primary accreditation application
for initial or renewal accreditation shall include:
(1) Failure to submit a completed application
within 60 days after notification of apparent errors or omissions;
(2) Failure of laboratory staff to meet the personnel
qualifications as required by the TNI
standards including those related to education, training, and experience;
(3) Failure to successfully analyze and report
proficiency testing samples as required by Volume 1, Module 1 of the TNI standards;
(4) Failure to respond to an assessment report
with a corrective action report within the required 30 calendar days after
receipt of the assessment report, as required by Env-C 309.04(b);
(5) Failure to implement the corrective actions
detailed in the corrective action report as required by Env-C 309.04;
(6) Failure to pay required fees;
(7) Misrepresentation of any material fact
pertinent to receiving or maintaining accreditation;
(8) Refusal to allow an assessor to enter during
normal business hours for an assessment; and
(9) Failure to implement a quality system as
required by the applicable provision(s) of Env-C 308.
(b)
Reasons for the department to deny a secondary accreditation application
for initial or renewal accreditation shall include:
(1) Accreditation has been denied by the primary
accreditation body;
(2) Failure to submit a completed application
within 60 days after notification of apparent errors or omissions;
(3) Failure to pay required fees; and
(4) Misrepresentation of any material fact
pertinent to receiving or maintaining accreditation.
(c)
A laboratory shall have 2 opportunities to correct the deficient area(s)
that resulted in a denial of accreditation.
(d) If the laboratory is not successful in
correcting the deficiencies, the laboratory shall wait at least 6 months before
reapplying for accreditation.
(e)
Upon reapplication, the laboratory shall be responsible for all of the fees incurred as part of the application for
accreditation.
(f)
A laboratory whose application for initial accreditation has been denied
may request reconsideration. Any
reconsideration request shall be filed in accordance with Env-C 206.
(g)
No laboratory’s application for renewal accreditation shall be denied
without opportunity for a hearing in accordance with Env-C 311.04.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 311.02 Suspension.
(a)
Reasons for the department to suspend a primary accreditation shall
include:
(1) The primary accreditation body finds during
the assessment that emergency action is needed to protect public health or safety;
(2) Failure to notify the primary accreditation
body within 30 calendar days of major changes in:
a. Laboratory ownership;
b. Location;
c. Key personnel named on the application; or
d. Analytical instrumentation;
(3) Failure to maintain a quality system as defined in Volume 1,
Module 2 of the TNI standards; and
(4) Failure of laboratory
to employ staff that meet the personnel qualifications for education, training,
and experience as required by the TNI standards.
(b)
The department shall send written notice to the laboratory of the
department’s intent to suspend the laboratory’s accreditation.
(c)
The notice sent pursuant to (b), above, shall:
(1) Identify each reason for the proposed
suspension and each field of accreditation that is proposed to be suspended;
and
(2) Inform the laboratory that:
a. Its accreditation shall be suspended 10 days
from the date of the written notice unless the laboratory sends a written
request for a hearing to the department that is received by the department
prior to the expiration of that time period;
b. The accreditation shall remain suspended
until the laboratory takes all corrective actions needed to address the reasons
for suspension and submits proof that the corrective actions have been
completed to the department; and
c. If the laboratory does not take all
corrective actions needed to address the reason(s) for suspension and submit
proof that the corrective actions have been completed to the department within
6 months of the effective date of the suspension, the accreditation shall be
revoked.
(d)
Except as provided in (e), below, if a laboratory submits a request for
a hearing as specified in (c)(2)a., above, then the laboratory’s accreditation
shall remain in effect until a decision is issued after a hearing is conducted
in accordance with Env-C 200 as applicable to adjudicative proceedings.
(e)
Accreditation shall be suspended for each
affected field of accreditation where the laboratory fails 2 out of the most
recent 3 PT studies. The suspension
shall remain in effect until the laboratory has successfully
participated in 2 out of the 3 most recent PT studies. The laboratory shall not be required to
reapply for accreditation if the suspension is for failure on PT studies. The suspension shall take effect upon the
primary accrediting body’s processing of the PT results.
(f)
After a laboratory’s accreditation has been suspended, the laboratory
shall not continue to analyze samples for clients who need analytical results
from an accredited laboratory in the field(s) of testing for which the laboratory’s
accreditation has been suspended.
(g) A laboratory shall not need to reapply for
accreditation if the cause(s) for suspension are corrected within 6 months of
the effective date of the suspension.
(h)
If the laboratory does not correct each basis for suspension within 6
months of the effective date of the suspension, the accreditation that had been
suspended shall be revoked.
(i) The laboratory shall retain accreditation for
the fields of accreditation in which it continues to meet the requirements of the TNI standards.
(j) The laboratory’s suspended accreditation
status shall be changed to accredited when the laboratory demonstrates to the
department that the laboratory has corrected the cause of the suspension.
(k)
Secondary accreditation shall:
(1) Be suspended by the department if the
accreditation granted by the primary accreditation body has been suspended; and
(2) Remain suspended until accreditation is
reinstated by the primary accreditation body.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff 11-23-21
Env-C 311.03 Revocation.
(a) Reasons for the department to revoke a
primary accreditation, including an interim status accreditation, shall
include:
(1) Failure to submit an acceptable corrective action plan in response
to an assessment report;
(2) Failure to implement
corrective action(s) related to any deficiencies found during an assessment
after submitting 2 corrective action plans as specified in Env-C 309.04;
(3) Failure to respond to an assessment report with a corrective
action plan within 30 calendar days of the assessment report date;
(4) Failure to participate in the proficiency
testing program as required by Volume 1, Module 1 of
the TNI standards;
(5) Submittal of proficiency test sample results
generated by another laboratory as its own;
(6) Misrepresentation of any material fact
pertinent to receiving or maintaining accreditation;
(7) Refusal to allow an assessor to enter during
normal business hours for an assessment;
(8) Determination of civil or criminal liability
by a court of competent jurisdiction for falsifying any report:
a. Relating to a laboratory analysis; or
b. Submitted to any government entity for an
official purpose.;
(9) Failure to remit accreditation fees within
the time limit established by the department; or
(10) Failure to implement corrective actions to correct deficiencies
within the time period specified in the laboratory’s
corrective action plan.
(b)
After correcting the cause(s) for revocation, the laboratory may reapply
for accreditation no sooner than 6 months from the effective date of the
revocation.
(c)
No laboratory’s accreditation shall be revoked without the opportunity
for a hearing as set forth Env-C 311.04.
(d)
Secondary accreditation shall:
(1) Be revoked by the department if the
accreditation granted by the primary accreditation body has been revoked; and
(2) Remain revoked until accreditation is
reinstated by the primary accreditation body.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 311.04 Action to Deny Application for Renewal
Accreditation or to Revoke Accreditation.
(a)
Whenever the department has reason to consider denial of an application
for renewal accreditation or revocation of a laboratory’s accreditation, it
shall initiate an adjudicative proceeding in accordance with the applicable
provisions of Env-C 200.
(b)
The laboratory shall be given an opportunity to be heard as provided in
Env-C 200 prior to any final action being taken.
(c)
The department shall notify the laboratory of its decision in writing by
certified mail, return receipt requested.
If renewal accreditation is denied or if accreditation is revoked, the
written decision shall specify the reason(s) for the decision.
(d)
The laboratory shall remain accredited with continued successful PT
participation until the department has issued a decision to revoke or refuse to
renew the accreditation.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 311.05 Reconsideration
of Accreditation Status.
(a) A laboratory whose accreditation has been
revoked or refused renewal may request reconsideration of the decision.
(b) Any request for reconsideration shall be made
in accordance with Env-C 206.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Env-C 311.06 Successor in
Interest Applying for Reaccreditation.
The revocation or suspension of accreditation shall operate to prohibit
any successor in interest from applying for reaccreditation from NH ELAP until
the end of the term for which the accreditation was revoked or suspended.
Source. (See Revision Note at chapter heading for
Env-C 300) #12065, eff 1-1-17; ss by #13291, eff
11-23-21
Appendix A: State Statutes
Implemented
Rule |
State Statute(s)
Implemented |
Env-C
301, Env-C 302 |
RSA
485:44, II; RSA 485:47, I |
Env-C
303 |
RSA
485:44, I; RSA 485:44, VII; RSA 485:46; RSA 485:47 |
Env-C
304 |
RSA
485:44, II; RSA 485:44 VII; RSA 485:44, X |
Env-C
305, Env-C 306 |
RSA
485:44, II; RSA 485:44 III; RSA 485:47 |
Env-C
307 |
RSA
485:44, II; RSA 485:44, III; RSA 485:47, I |
Env-C
308 |
RSA
485:44, II; RSA 485:47, I |
Env-C
309, Env-C 310 |
RSA
485:44, II, RSA 485:47, I |
Env-C
311 |
RSA
485:44, IX, RSA 485:47, III; RSA 541-A:16, I |
Appendix B: Incorporated
Reference
Rule
(Env-C) |
Reference
(Date/Edition) |
Obtain
From (Cost) |
301.03;
303.01(b)(3); 303.19(a)(1); 304.05(g)&(i);
305.02(c)&(d)(1)-(2); 305.05; 305.06; 305.07; 305.08; 305.09(a)&(b);
305.10(a)&(b); 305.11; 305.13; 305.14; 307.01(b), (d), (e), & (g);
307.03(b); 307.05(a)(2); 307.06(c); 308.01(a)(1)&(d)(1)-(3); 308.02; 308.03(b);
308.05(b); 308.06(a)&(e); 309.01(e); 311.01(a)(3); 311.02(a)(3);
311.03(a)(4) |
Laboratory
Accreditation Standards, Volume 1: Management and Technical Requirements for
Laboratories Performing Environmental Analysis (2016) |
The NELAC Institute P.O.
Box 2439 Weatherford,
TX 76096 817-598-1624 Cost
for Single Use version Volume 1: $290 and Volume 2: $250; TNI members can
receive a discount based on the membership level (member, patron, sponsor,
partner) Order
on-line at: |
301.03;
304.05(b); 309.01(a)&(e); 310.05(a)(2)&(3) |
Laboratory
Accreditation Standards, Volume 2: General Requirements for Accreditation
Bodies Accrediting Environmental Laboratories (2016) |
Appendix C: Statutory Definitions
RSA
485:1-a:
XIII.
“Person” means any individual,
partnership, company, public or private corporation, political subdivision or
agency of the state, department, agency or instrumentality of the United
States, or any other legal entity.”
Appendix
D: The NELAC Institute Volume 1, Module
1 & 2 Definitions
“Accreditation
body” means the territorial, state or federal agency
having responsibility and accountability for environmental laboratory
accreditation and which grants accreditation”.
“Assessment”
means the evaluation process used to measure or establish the performance,
effectiveness, and conformance of an organization and/or its systems to defined
criteria (to the standards and requirements of laboratory accreditation).
“Demonstration of
Capability” means a procedure to establish the ability of the analyst to
generate analytical results of acceptable accuracy and precision.
“Field of Accreditation”
means those matrix, technology/method, and analyte combinations for which the
accreditation body offers accreditation.
“Proficiency
Testing (PT)” means a means of evaluating a laboratory’s performance under
controlled conditions relative to a given set of criteria through analysis of
unknown samples provided by an external source.
“Proficiency
Testing Provider (PTP)” means a person or organization accredited by the
TNI-approved Proficiency Testing Provider Accreditor to operate a TNI-compliant
PT program.
“Quality System”
means a structured and documented management system describing the policies,
objectives, principles, organizational authority, responsibilities,
accountability, and implementation plan of an organization for ensuring quality
in its work processes, products (items), and services. The quality system provides the framework for
planning, implementing, and assessing work performed by the organization and
for carrying out required quality assurance (QA) and quality control (QC) activities.
“Revocation”
means the total or partial withdrawal of a laboratory’s accreditation by an
accreditation body.
“Suspension”
means the temporary removal of a laboratory’s accreditation for a defined period of time, which shall not exceed six (6) months or the
period of accreditation, whichever is longer, in order to allow the laboratory
time to correct deficiencies or area of non-conformance with the Standard.