Ohio Admin. Code 3745-89-06 - [Effective until 7/7/2025] Director's actions for laboratory certification
(A) The director
shall issue or renew a laboratory certification provided the laboratory has met
the laboratory certification requirements as described in this chapter of the
Administrative Code.(2)
(3)
The period and provisions of each laboratory certification are summarized on a
laboratory certificate, which is issued to the laboratory as a record of the
certification and its details.
(1) Laboratory
certification shall expire within three years from the effective date of
certification. Laboratory certification shall expire within one year from the
effective date of certification if the laboratory certification meets one of
the following:
(a) Is an initial
certification under rule
3745-89-03 of the Administrative
Code.
(b) Directly follows a period
of revocation or denial of a former certification under this
rule.
(2)
Acceptance of any certification of a laboratory under
rule 3745-89-12 of the Administrative
Code shall expire on the earlier of the following dates:
(a)
The date of
expiration of the certification submitted in accordance with 3745-89-12 of the
Administrative Code.
(b)
Within three years of the date acceptance was granted
pursuant to 3745-89-12 of the Administrative Code.
(B) The director may deny, suspend or revoke
a laboratory certification, or all such certifications issued to a laboratory
under this chapter, in accordance with Chapters 3745-47 and 3745-49 of the
Administrative Code, upon any finding of the following:
(1) The laboratory or any laboratory
personnel has falsified laboratory data.
(2) The laboratory failed to meet laboratory
certification requirements as described in rules
3745-89-03 to
3745-89-05 of the Administrative
Code or submitted unacceptable data.
(3) The laboratory failed to meet the
reporting requirements in rule
3745-89-08 of the Administrative
Code.
(4) The laboratory has
submitted unacceptable data.
(5)
The laboratory has submitted a proficiency test sample to another laboratory
for analysis and reported the data as its own.
(6) A person not named on a valid laboratory
certificate performed analysis of a water proficiency test sample for purposes
of retaining a valid laboratory certification.
(7) The laboratory or any laboratory
personnel has performed, reported, or failed to report drinking water analyses
in such a manner as to threaten public health or welfare.
(8) The laboratory failed to satisfactorily
correct deviations
violations.
(9)
A laboratory
certified under paragraph (C) of rule
3745-89-03 of the Administrative
Code had the laboratory's certification suspended or revoked by the recognized
accreditation body which issued the certification.
(C) The director may deny, suspend or revoke
an individual's certification to perform laboratory analyses issued under this
chapter if the individual is an operator certified under Chapter 3745-7 of the
Administrative Code and said certification is suspended or revoked for any
reason other than falsification.
(D) The director shall revoke an individual's
certification to perform laboratory analyses issued under this chapter if the
individual is an operator certified under Chapter 3745-7 of the Administrative
Code and said certification is suspended or revoked for actions related to
falsification.
(E) During the
pendency of an action to suspend or revoke a laboratory certification, the
results of performances on a proficiency test shall not be considered by the
director in making a determination to suspend or revoke the
certification.
(F) The results of
drinking water analyses shall not be acceptable for determining compliance with
Chapters 3745-81, 3745-82 and 3745-90, and rules
3745-91-06 and 3745-9-09, or as
specified by paragraph (B) of rule
3745-83-01 of the Administrative
Code, or for other analyses required by the director, if the results are
obtained in violation of rule
3745-81-27 of the Administrative
Code or this chapter during the pendency of an action to suspend or revoke a
laboratory certification.
(G)
Suspension of a laboratory certification shall be for a time period specified
by the director, but no less than thirty days and no more than six months,
provided a correction statement is submitted in writing to the director
addressing each individual deviation
violation within the time period specified by the
director and is acceptable to the director in accordance with paragraph (I) of
this rule.
(H) The director may
notify or require a laboratory to notify customers, within a specific period of
time, of the suspended or revoked certification.
(I) The laboratory shall demonstrate in a
manner acceptable to the director that deviations
violations have been addressed to cease
suspended certification. The demonstration shall be in writing and may include,
but not be limited to, on-site surveys or other means as determined by the
director. If the deviations
violations are not satisfactorily addressed
within the specified time period, the certificate may remain suspended or be
revoked.
(J) Revocation or denial
of a new or renewed laboratory certification shall remain in effect for a time
period specified by the director of not less than ninety days and not more than
one year. Laboratories shall not reapply for certification until the period of
denial or revocation expires. After such time, the laboratory may apply for
certification as specified in rule
3745-89-03 of the Administrative
Code.
(K) All actions under this
rule affecting the status of a laboratory's certification shall be in
accordance with Chapters 3745-47 and 3745-49 of the Administrative Code. The
director shall notify the laboratory of any action to deny, suspend or revoke
certification. An action taken by the director under this rule does not
preclude the director from pursuing additional civil or criminal enforcement.
Suspension or revocation may include any or all laboratory certifications
issued by the director under this chapter.
Notes
Promulgated Under: 119.03
Statutory Authority: 6109.04
Rule Amplifies: 6109.04, 3745.50
Prior Effective Dates: 11/26/1980, 04/09/1990, 04/01/1999, 06/18/2004, 09/14/2009, 05/04/2015, 06/01/2016
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(A) The director shall issue or renew a laboratory certification provided the laboratory has met the laboratory certification requirements as described in this chapter of the Administrative Code.(2) (3) The period and provisions of each laboratory certification are summarized on a laboratory certificate , which is issued to the laboratory as a record of the certification and its details.
(1) Laboratory certification shall expire within three years from the effective date of certification. Laboratory certification shall expire within one year from the effective date of certification if the laboratory certification meets one of the following:
(a) Is an initial certification under rule 3745-89-03 of the Administrative Code.
(b) Directly follows a period of revocation or denial of a former certification under this rule.
(2) Acceptance of any certification of a laboratory under rule 3745-89-12 of the Administrative Code shall expire on the earlier of the following dates:
(a) The date of expiration of the certification submitted in accordance with 3745-89-12 of the Administrative Code.
(b) Within three years of the date acceptance was granted pursuant to 3745-89-12 of the Administrative Code.
(B) The director may deny, suspend or revoke a laboratory certification, or all such certifications issued to a laboratory under this chapter, in accordance with Chapters 3745-47 and 3745-49 of the Administrative Code, upon any finding of the following:
(1) The laboratory or any laboratory personnel has falsified laboratory data.
(2) The laboratory failed to meet laboratory certification requirements as described in rules 3745-89-03 to 3745-89-05 of the Administrative Code or submitted unacceptable data .
(3) The laboratory failed to meet the reporting requirements in rule 3745-89-08 of the Administrative Code.
(4) The laboratory has submitted unacceptable data .
(5) The laboratory has submitted a proficiency test sample to another laboratory for analysis and reported the data as its own.
(6) A person not named on a valid laboratory certificate performed analysis of a water proficiency test sample for purposes of retaining a valid laboratory certification.
(7) The laboratory or any laboratory personnel has performed, reported, or failed to report drinking water analyses in such a manner as to threaten public health or welfare.
(8) The laboratory failed to satisfactorily correct deviations violation s.
(9) A laboratory certified under paragraph (C) of rule 3745-89-03 of the Administrative Code had the laboratory's certification suspended or revoked by the recognized accreditation body which issued the certification.
(C) The director may deny, suspend or revoke an individual's certification to perform laboratory analyses issued under this chapter if the individual is an operator certified under Chapter 3745-7 of the Administrative Code and said certification is suspended or revoked for any reason other than falsification.
(D) The director shall revoke an individual's certification to perform laboratory analyses issued under this chapter if the individual is an operator certified under Chapter 3745-7 of the Administrative Code and said certification is suspended or revoked for actions related to falsification.
(E) During the pendency of an action to suspend or revoke a laboratory certification, the results of performances on a proficiency test shall not be considered by the director in making a determination to suspend or revoke the certification.
(F) The results of drinking water analyses shall not be acceptable for determining compliance with Chapters 3745-81, 3745-82 and 3745-90, and rules 3745-91-06 and 3745-9-09, or as specified by paragraph (B) of rule 3745-83-01 of the Administrative Code, or for other analyses required by the director, if the results are obtained in violation of rule 3745-81-27 of the Administrative Code or this chapter during the pendency of an action to suspend or revoke a laboratory certification.
(G) Suspension of a laboratory certification shall be for a time period specified by the director, but no less than thirty days and no more than six months, provided a correction statement is submitted in writing to the director addressing each individual deviation violation within the time period specified by the director and is acceptable to the director in accordance with paragraph (I) of this rule.
(H) The director may notify or require a laboratory to notify customers, within a specific period of time, of the suspended or revoked certification.
(I) The laboratory shall demonstrate in a manner acceptable to the director that deviations violation s have been addressed to cease suspended certification. The demonstration shall be in writing and may include, but not be limited to, on-site surveys or other means as determined by the director. If the deviations violation s are not satisfactorily addressed within the specified time period, the certificate may remain suspended or be revoked.
(J) Revocation or denial of a new or renewed laboratory certification shall remain in effect for a time period specified by the director of not less than ninety days and not more than one year. Laboratories shall not reapply for certification until the period of denial or revocation expires. After such time, the laboratory may apply for certification as specified in rule 3745-89-03 of the Administrative Code.
(K) All actions under this rule affecting the status of a laboratory's certification shall be in accordance with Chapters 3745-47 and 3745-49 of the Administrative Code. The director shall notify the laboratory of any action to deny, suspend or revoke certification. An action taken by the director under this rule does not preclude the director from pursuing additional civil or criminal enforcement. Suspension or revocation may include any or all laboratory certifications issued by the director under this chapter.
Notes
Promulgated Under: 119.03
Statutory Authority: 6109.04
Rule Amplifies: 6109.04, 3745.50
Prior Effective Dates: 11/26/1980, 04/09/1990, 04/01/1999, 06/18/2004, 09/14/2009, 05/04/2015, 06/01/2016