Current through Register Vol. 48, No. 39, March 25, 2024
Subpart
1.
Base certification requirements.
A. A laboratory may request to be certified
by the commissioner for the use of methods to test the analytes eligible for
certification.
B. A laboratory
must specify the fields of testing for which it seeks certification. No
certification shall be awarded for any field of testing without the laboratory
meeting base certification requirements. No laboratory may receive base
certification without approval of at least one field of testing.
C. A laboratory must apply on a form that is
provided by the commissioner.
D.
Applications for renewal of certification must be received no later than 90
days before the expiration of certification. The application must meet the
criteria of this subpart. If a laboratory fails to submit a renewal application
within 90 days before the expiration of certification, the commissioner must
notify the regulatory authorities that receive data that the laboratory did not
apply to renew its certification. The laboratory must not report results as
certified after its certification expires.
Subp. 2.
Requirements for mobile
laboratories.
A. A mobile laboratory is
considered a separate laboratory and is subject to all requirements, including
application requirements, of parts
4740.2010 to
4740.2120.
B. In addition to the requirements under
subpart
1, a mobile laboratory must
submit a vehicle identification number, license plate number, or other uniquely
identifying information.
C. A
mobile laboratory must designate which fields of testing, equipment, and
personnel are associated with the mobile laboratory. Changes to the numbers and
types of equipment within the mobile laboratory may require reapplication
according to subpart 1.
Subp. 3. [Repealed, 44
SR 371]
Subp. 4.
Changes in
scope of certification.
A. The
commissioner shall approve a laboratory's application to add a field of testing
at any time other than the time of renewal if the laboratory meets the criteria
in parts
4740.2010 to
4740.2120 and submits the
applicable fees.
B. Requests to add
fields of testing for new analytes in response to a notice of availability do
not require payment of additional fees if the laboratory holds a certification
for that test category and applies for additional analytes within the same test
category. Applications for fields of testing for new analytes in response to a
notice of availability must meet the requirements of subpart
1 and must be received by the
commissioner no later than 180 days after the notice of availability is
posted.
C. Requests for the
addition of fields of testing received more than 180 days after the notice of
availability is posted are subject to fees according to subpart
16.
Subp. 5.
Review of application.
After receiving the application and information required in
subpart
1, the commissioner
shall:
A. notify the laboratory in
writing of any omission or error in the application;
B. deny certification for an initial
application or revoke certification for a renewal application if the laboratory
does not submit to the commissioner the required information within 15 days
after receiving an error notice under item A;
C. award certification according to subpart
7 if the laboratory's
application meets the applicable standards of parts
4740.2010 to
4740.2120; or
D. notify the laboratory that its current
certification for fields of testing shall be continued until the commissioner
fully reviews all documentation for compliance with parts
4740.2010 to
4740.2120.
Subp. 6.
Laboratory inspection.
A. The commissioner may conduct inspections
of certified laboratories or laboratories applying for certification.
B. The commissioner may notify the laboratory
prior to arrival at the facility or may conduct an inspection without prior
notice at any time during normal business hours to verify compliance with parts
4740.2010 to
4740.2120. When the commissioner
provides notification, the notification may be written or oral.
C. When the commissioner determines after
inspection that a certified laboratory does not comply with applicable
provisions of parts
4740.2010 to
4740.2120, the commissioner shall
notify the laboratory of the deficiencies in writing.
D. A laboratory must remedy any deficiencies
and provide documentation of the correction to the commissioner. Within 30 days
of receiving the report of deficiencies, the laboratory must submit
documentation of corrective actions planned and taken. If the laboratory does
not provide acceptable documentation of corrective actions or corrective action
plans within 30 days, the commissioner shall notify the laboratory that its
certification may be suspended in total or in part according to subpart
9. If the laboratory does not
provide any documentation of deficiency corrections within 30 days, the
commissioner shall notify the laboratory that its certification is revoked in
total according to subpart
10.
E. A laboratory may not reapply for
certification after suspension or revocation until it has corrected all
deficiencies. After all deficiencies are corrected, the laboratory may apply
for certification according to subpart
1. With its new application,
the laboratory must submit written documentation of the steps taken to correct
the deficiencies.
Subp.
7.
Awarding certification.
A. Documentation of a laboratory's
certification must include:
(1) a certificate
acknowledging the laboratory's compliance with base certification requirements;
and
(2) the scope of certification
for the laboratory.
B. If a laboratory's
scope of certification changes, the commissioner shall issue a new certificate
and scope of certification.
C. A
laboratory must return its certificate to the commissioner upon suspension or
revocation of certification.
D. A certified
laboratory must not misrepresent its certification on any document, including
laboratory reports, catalogs, advertising, business solicitations, proposals,
quotations, or other materials.
E. A laboratory must
make available its current certificate and corresponding scope of certification
upon the request of a client, certification authority, or regulatory agency.
The laboratory must not supply a copy of its current certificate without the
accompanying copy of its scope of certification.
Subp. 8.
Denial.
A. The commissioner shall deny certification
if a laboratory's initial or renewal application does not meet the requirements
of subpart
1 or if a laboratory's
request for variance does not satisfactorily address all items in subpart
13.
B. A laboratory that has had its request for
certification denied may reapply according to subpart
1. The application and all
required documentation must be accompanied by repayment of applicable
fees.
C. The commissioner shall not
refund fees if an application is denied.
Subp. 9.
Suspension.
A. When the commissioner determines that
there are grounds for suspension, the commissioner must notify the laboratory
in writing. A laboratory's certification may be suspended in total or in part
for a period not to exceed 180 days and not to extend beyond the expiration
date of the current certification. If a laboratory takes corrective action
before the end of the suspension period, certification for the suspended fields
of testing or for the base certification and fields of testing must be restored
if the corrective actions satisfactorily address the deficiencies cited in the
notice of suspension, except when contrary to an applicable reciprocity
agreement. The laboratory shall retain certification for the fields of testing
for which it continues to meet the requirements of parts
4740.2010 to
4740.2120.
B. Grounds for suspension of certification
are:
(1) failure to produce acceptable
results in two consecutive proficiency testing studies for the same field of
testing;
(2) failure to use an
approved method or to follow the method in sample analysis;
(3) failure to submit an acceptable
corrective action report in response to an inspection or unacceptable
proficiency testing results;
(4)
failure to notify the commissioner of any changes according to subpart
15;
(5) failure of the laboratory to maintain
records that demonstrate the capability of laboratory staff as required by part
4740.2099; or
(6) suspension of certification by a
certifying authority with which the commissioner has a reciprocity
agreement.
C. The
effective date of suspension is the date that the laboratory receives the
suspension notice from the commissioner. Upon receiving the notice, the
laboratory must notify all clients whose samples have been received or analyzed
within 30 days prior to the notification or back to the date at which the
laboratory was in compliance, whichever is greater. Notification is required
for all fields of testing for which the laboratory's certification has been
suspended. The notification from the laboratory must be in writing. The
laboratory must submit copies of each notification to the commissioner at the
time that the notification is sent to the client.
D. A laboratory that has had its
certification suspended may reapply according to subpart
1. Repayment of fees is not
required for reinstatement if the laboratory corrects the deficiencies within
the time frame required by the commissioner, not to exceed 180 days or the
expiration date of the current certification, whichever is sooner. If the
laboratory fails to correct the causes of suspension within the specified time
frame, the commissioner shall revoke in total or in part the laboratory's
certification according to subpart
10, item A.
E. A laboratory that has had its
certification suspended due to unacceptable proficiency testing results must
submit acceptable proficiency testing results for the fields of testing from
two successive studies to restore certification.
Subp. 10.
Revocation.
A. When the commissioner determines that
there are grounds for partial or total revocation of a laboratory
certification, the commissioner must notify the laboratory in writing. The
laboratory shall retain certification for the fields of testing for which it
continues to meet the requirements of parts
4740.2010 to
4740.2120.
B. Grounds for partial or total revocation of
certification are:
(1) failure to respond to
deficiencies according to subpart
6;
(2) failure to correct the deficiencies cited
in a notice of suspension within the time frame specified by the
commissioner;
(3) failure to
implement corrective action related to any deficiencies found during a
laboratory inspection;
(4) failure
to implement corrective action in response to an unacceptable proficiency
testing result;
(5) failure to
complete proficiency testing studies and maintain a history of successful
proficiency testing studies;
(6)
revocation of certification by a certifying authority with which the
commissioner has a reciprocity agreement; or
(7) failure to comply with applicable
standards of parts
4740.2010 to
4740.2120.
C. Grounds for total revocation of a
laboratory's certification are:
(1) failure to
respond with a report of corrective actions or corrective action plans for
deficiencies identified during an on-site inspection within 30 days of
receiving the inspection notice of deficiencies;
(2) submittal of proficiency test sample
results generated by another laboratory as its own;
(3) reporting sample results without
qualification or notation for fields of testing for which the laboratory's
certification has been suspended or for which the laboratory has not requested
or received certification;
(4)
misrepresentation of any material fact pertinent to receiving and maintaining
certification;
(5) denial of entry
during normal business hours for an inspection as required under subpart
6, unless circumstances
endangering safety or welfare prohibit entry;
(6) failure to send written notification of
revocation or suspension to clients within the time frame specified in this
subpart;
(7) conviction of charges
relating to the falsification of any report relating to a laboratory analysis;
or
(8) for laboratories certified
through reciprocal agreements, failure to notify the commissioner within 30
days after any enforcement action is taken by the reciprocal certifying
authority.
D. The
effective date of revocation is the date that the laboratory receives the
revocation notice from the commissioner. Upon receiving the notice, the
laboratory must notify all clients whose samples have been received or analyzed
within 30 days prior to the notification or back to the date at which the
laboratory was in compliance, whichever is greater. Notification is required
for all fields of testing for which the laboratory's certification has been
revoked. The notification from the laboratory must be in writing. The
laboratory must submit a copy of each notification to the commissioner at the
time that the notification is sent to the client.
E. A laboratory that has had its
certification revoked must not advertise itself as certified and, when
possible, must remove or replace any advertisements that indicate that the
laboratory is certified.
F. A
laboratory that has had its certification revoked may not reapply for
certification until it has corrected all deficiencies. The laboratory may
reapply according to subpart
1 and, with the application,
must provide documentation of the steps taken to correct the
deficiencies.
Subp. 11.
Successor in interest; recertification.
A successor in interest of a laboratory that has had its
certification revoked or suspended may not apply for recertification until the
end of the term for which the certification was suspended or until all
conditions for reapplication after revocation are met.
Subp. 12.
Reciprocity and laboratories
in other states.
A. A laboratory in
another state may request certification in Minnesota. In addition to following
the application process under subpart
1, the laboratory must submit
the appropriate fees with its application.
B. The commissioner may enter into agreements
with certifying authorities of federal agencies and agencies of other states
for reciprocal recognition of laboratory certification programs or portions of
programs that are substantially equivalent.
C. When a reciprocal
agreement exists, the commissioner shall certify an out-of-state laboratory
that:
(1) submits an application meeting the
requirements of subpart
1;
(2) submits the appropriate fees
(3) provides a copy of current certification
from the reciprocal state or private or federal agency; and
(4) provides a copy of the certifying
authority's most recent inspection report.
D. A
laboratory certified under this subpart must notify the commissioner within 30
days after any enforcement action is taken by the reciprocal certifying
authority.
E. Laboratories certified under reciprocity agreements
are subject to parts 4740.2010 to
4740.2120.
F. The
commissioner shall provide a list of reciprocity agreements upon
request.
Subp. 13.
Request for variance.
A. The
commissioner may grant a variance from parts
4740.2010 to
4740.2120. Variances from the use
of an approved method may be granted according to part
4740.2060. To request a variance,
a laboratory must pay the appropriate variance fee and must indicate in
writing:
(1) the rule part and language for
which the variance is sought;
(2)
reasons for the request;
(3)
alternate measures that will be taken if the request for a variance is
granted;
(4) the length of time of
the variance; and
(5) data to
ensure analytical results of equal or better reliability.
B. The commissioner shall review information
submitted with the variance request. If the laboratory proposes alternatives
equivalent or superior to those requirements in the rule, shows that strict
enforcement of the rule would cause undue hardship, and shows that the variance
will not adversely affect the reliability of the data produced by the
laboratory, the commissioner shall grant the variance provided the variance
does not conflict with statutory provisions. The commissioner shall grant or
deny the variance within 60 days after receipt of the request, giving the
laboratory written justification for the decision. The commissioner must
specify an expiration date for the variances the commissioner issues.
Subp. 14.
Voluntary
withdrawal of certification.
A. If a
laboratory chooses to withdraw its application for certification or its current
certification in total or in part, the laboratory must notify the commissioner
in writing and specify the effective date of withdrawal.
B. The commissioner shall consider that a
laboratory has chosen to voluntarily withdraw its certification if the
laboratory has not submitted a complete renewal application within 90 days
before the expiration date of its current certification. In this situation, the
effective date is the expiration date of the laboratory's current
certification.
C. By the effective
date of the withdrawal of certification, in total or in part, the laboratory
must notify current clients and regulatory agencies of its intent to withdraw
its certification and must indicate the effective date of the withdrawal.
Notification is required for all fields of testing for which the laboratory has
chosen to voluntarily withdraw certification. The notification from the
laboratory must be in writing. The laboratory must submit a copy of each
notification to the commissioner at the time that the notification is sent to
the client.
D. The commissioner
shall not refund fees if a current certification is voluntarily withdrawn by
the laboratory.
Subp.
15.
Duty to notify.
A. A laboratory must notify the commissioner
in writing within 30 days of a change in:
(1)
the name of the laboratory;
(2) the
physical location, postal mailing address, and electronic mailing address of
the laboratory;
(3) the owner of
the laboratory;
(4) the names and
telephone numbers of a designated contact person and the laboratory
director;
(5) the name of at least
one managing agent with signature attested by a notarial officer;
(6) the names of supervisory professional
staff responsible for the analyses;
(7) major analytical equipment; or
(8) test methods.
B. With the notification, a laboratory must
provide results of proficiency testing samples, or a demonstration of
capability, analyzed in the new laboratory location or analyzed under the
change in laboratory owner, instrumentation, or methods.
Subp. 16.
Payment of fees.
A. All applications or requests to change the
scope of certification submitted to the commissioner for approval must be
accompanied by the fee specified in Minnesota Statutes, section
144.98.
B. When a laboratory requests
certification for additional fields of testing at any time other than the time
of initial or renewal application, the laboratory must submit fees equal to the
fees for the test category in which the method or analyte is requested. The fee
also applies to the addition of methods or analytes for reinstatement after
revocation or denial of certification. No fee shall be assessed for the
addition of fields of testing in response to a notice of availability when an
application is submitted under the conditions specified in subpart
4.
C. When a laboratory requests a variance
according to subpart 13,
the request must be accompanied by applicable fees according to Minnesota
Statutes, section
144.98.
D. Payment of fees must
be in the form of a check, money order, or electronic transfer of funds. When
payment is in the form of an electronic transfer of funds, proof of deposit
must be verifiable before the date the fees are due to the
commissioner.
Subp. 17.
Appeal of administrative decision.
A. The commissioner shall notify a laboratory
in writing of the reasons for a decision to suspend or revoke a
certification.
B. A laboratory has
30 days from the date of receiving the decision to appeal the decision. A
request to appeal the decision must:
(1) be in
writing;
(2) indicate the facts the
laboratory disputes;
(3) be signed
by the laboratory director; and
(4)
be sent to the commissioner.
C. Upon receipt of an appeal request, the
commissioner shall initiate the procedure for a contested case hearing
according to Minnesota Statutes, chapter 14, and rules of the Office of
Administrative Hearings.
Statutory Authority: MS s
144.97;
144.98