Ohio Admin. Code 3745-89-12 - [Effective 7/7/2025] Alternate acceptance of laboratory certification

(A) Acceptance of certification. Unless otherwise specified in this paragraph in this paragraph, in lieu of complying with the requirements of rule 3745-89-03 of the Administrative Code, laboratories may apply for acceptance of certification to perform analyses to determine compliance with Chapters 3745-81 and 3745-82, and rules 3745-91-06 and 3745-9-09, and as specified by paragraph (B) of rule 3745-83-01 of the Administrative Code by meeting the following requirements:

(1) The laboratory is certified by the United States environmental protection agency (USEPA), the national environmental laboratory accreditation program (NELAP), or by another environmental laboratory accreditation program acceptable to the director to perform required analyses for those Fields of Accreditation in which the laboratory is requesting acceptance of certification pursuant to this rule, with the exception of those analytes required in Chapter 3745-90 of the Administrative Code. The field of accreditation shall be for drinking water.

(2) The laboratory submits an application on a form acceptable to the director.

(3) The laboratory submits a copy of the most recent certificate and field of accreditation issued by an acceptable accrediting body for the USEPA approved drinking water methods which acceptance is sought.

(4) The laboratory submits evaluations of the two most recent proficiency test (PT) sample studies. A provider of PT samples shall be accredited by a proficiency testing provider accreditor that meets the national environmental laboratory accreditation conference requirements per paragraph (A)(3)(d) of rule 3745-89-03 of the Administrative Code.

(5) The laboratory submits evaluations of any PT sample studies within the previous five years that have resulted in an evaluation of "Unacceptable" and the subsequent make-up PT sample evaluation.

(6) The laboratory submits reports from the most recent survey by the accrediting body issuing the certification. The inspection shall be completed by a program acceptable to the agency.

(7) The laboratory shall submit all correspondence, documents or other communications between the laboratory and the accrediting body which may affect the laboratory's accreditation within thirty days. Failure to submit these articles may result in loss of agency acceptance of certification.

(8) For out of state laboratories, a certification that one of the conditions listed in paragraph (D) of rule 3745-89-02 of the Administrative Code exists at the time of application. Any acceptance of certification for an out of state laboratory shall only remain effective so long as one of the conditions listed in paragraph (D) of rule 3745-89-02 of the Administrative Code continues to exist.

(B) Renewal of acceptance of certification. For acceptance of certifications issued in accordance with paragraph (A) of this rule, the director may renew an acceptance of certification in accordance with paragraph (D) of this rule upon the laboratory's successful completion of the following:

(1) The laboratory shall maintain a valid and unexpired laboratory certification issued by an accreditation program approved under paragraph (A)(1) of this rule for the analyses for which renewal is sought.

(2) The laboratory shall submit to the director for a completed application for renewal, including the information required under paragraph (A) of this rule, with the exception of paragraph (A)(4) of this rule, no sooner than one hundred twenty days and no later than thirty days prior to the expiration of the currently valid certification. When applications are submitted in accordance with this rule and deemed complete, the laboratory acceptance of certification will be extended until the earlier of three years from the date of renewal or the expiration of certification issued by an accreditation program approved under paragraph (A)(1) of this rule.

(3) The laboratory submits evaluations of the most recent proficiency test (PT) sample studies. A provider of PT samples shall be accredited by a proficiency testing provider accreditor that meets the national environmental laboratory accreditation conference requirements per paragraph (A)(3)(d) of the Administrative Code.

(C) Maintenance of acceptance of certification. To maintain an acceptance of certification a laboratory shall comply with the requirements of paragraphs (A)(11), (A)(12) and (A)(14) of rule 3745-89-05 and rule 3745-89-08 of the Administrative Code.

(D) Director's actions.

(1) The director may issue or renew an acceptance of certification provided the laboratory has met the requirements for acceptance as described in this rule.

(2) The period and provisions of each acceptance of certification are summarized on a laboratory acceptance, which is issued to the laboratory as a record of the acceptance and certification details.

(3) The director may deny, suspend or revoke an acceptance of certification in accordance with Chapters 3745-47 and 3745-49 of the Administrative Code upon a finding of any of the criteria under paragraph (B) or (C) of rule 3745-89-06 of the Administrative Code or upon a finding that the laboratory no longer holds a valid unexpired certification from an accreditation program approved under paragraph (A)(1) of this rule.

(4) During the pendency of an action to suspend or revoke an acceptance of 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 acceptance of certification.

(5) The results of drinking water analyses shall not be acceptable for determining compliance with Chapter 3745-81 or 3745-82, 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 an acceptance of certification.

(6) Suspension of an acceptance of 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 violation within the time period specified by the director and is acceptable to the director.

(7) The director may notify or require a laboratory to notify customers, within a specific period of time, of the suspended or revoked acceptance of certification.

(8) The laboratory shall demonstrate in a manner acceptable to the director that violations have been addressed to cease suspended acceptance of certifications. The demonstration shall be in writing and may include, but not be limited to, surveys or other means as determined by the director. If the violations are not satisfactorily addressed within the specified time period, the acceptance of certification may remain suspended or be revoked.

(9) Revocation or denial of a new or renewed acceptance of 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 acceptance of certification until the period of denial or revocation expires. After such time, the laboratory may apply for acceptance of certification as specified in this rule.

(10) 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 acceptance of certifications issued by the director under this chapter.

(E) An acceptance of certification issued under this rule remains the property of the state and shall be surrendered to the director upon revocation.

Notes

Ohio Admin. Code 3745-89-12

Effective: 7/7/2025
Five Year Review (FYR) Dates: 4/2/2025 and 04/02/2030
Promulgated Under: 119.03
Statutory Authority: 6109.04
Rule Amplifies: 3745.50, 6109.03, 6109.04
Prior Effective Dates: 10/26/2020