Conn. Agencies Regs. § 19a-36-A33 - Requirements and standards for approval

Current through March 4, 2022

(a) The department of Public Health will approve registered laboratories only under the following circumstances:
(1) When such approval is sought in order to comply with provisions of the general statutes or the public health code of Connecticut making approval a prerequisite for the performance of laboratory tests for the purposes specified therein;
(2) When laboratory tests for the diagnosis of reportable diseases of man are to be made in a laboratory serving a hospital, or
(3) Whenever the department of Public Health deems that the application of standards for approval of a laboratory would be in the interests of the public health. When any of the foregoing conditions exist, the person in whose name a laboratory is registered may apply to the department of Public Health for approval of such laboratory to perform one or more examinations, determinations or tests specified in section 19a-36 -A26 of the Regulations of Connecticut State Agencies. If after inspection and investigation such laboratory is found to conform to the requirements and standards for approval that are required by said department, the laboratory may be designated as an approved laboratory to perform examinations, determinations or tests specified. In recognition thereof the department shall issue a certificate of approval in the name of the individual who is designated by the owner of the laboratory, or by his authorized agent, to be the individual in charge of the work for which approval is requested.
(b) Requirements and standards for approval of laboratories shall be based upon the ability and qualifications, as determined by investigation or examination, of the individual designated by the owner to be in charge of the laboratory and to the extent deemed necessary at any time of persons performing the examinations, determinations or tests; upon the standards and agreements set forth in section 19-4-1 of the Regulations of Connecticut State Agencies; and upon agreement on the part of the individual in charge to adhere to the standards upon which approval is based for making the specified examinations, determinations or tests. Approval shall lapse at any time that registration has expired or approval may be revoked or suspended at the discretion of the department of Public Health if at any time the standards of performance are found to be below that required. Certificates of approval shall expire at the end of each registration period and shall be returned at any time if revoked or suspended.
(c) Environmental laboratories, as defined in section 19a-29a(a) of the Connecticut General Statutes, located outside of the geographical boundaries of Connecticut must be approved to test samples that have originated in the state of Connecticut. For the purposes of this section:
(1) "Matrix" means the component or substrate (e.g. drinking water, wastewater, soil) which contains the analyte of interest.
(2) "Analyte" means the substance being measured in an analytical procedure.
(3) "Primary accrediting authority" means the agency or department designated at the Territory, State or Federal level as the recognized authority with responsibility and accountability for granting approval for determination of a given analyte in a given matrix for an environmental laboratory.
(A) In order to obtain approval, an applicant shall complete an application for registration in accordance with section 19a-36 -A27 of the Regulations of Connecticut State Agencies, remit a biennial fee of $1000.00 as specified in section 19a-29a(c) of the Connecticut General Statutes, and it must be established that:
(i) The laboratory is certified or approved by its primary accrediting authority for the analytes and matrices for which approval is requested, and the certification standards of the primary accrediting authority are equivalent to or exceed Connecticut's standards, and;
(ii) The requirements of section 19a-36 -A62 of the Regulations of Connecticut State Agencies regarding qualifications of the director are complied with.
(B) For analytes and/or matrices for which the primary accrediting authority does not have a Connecticut equivalent certification, the Department of Public Health may approve the laboratory based on its certification or approval in a Territory, Federal, State or other nationally recognized program whose standards are equivalent to, or exceed Connecticut's standards, such as, but not limited to, the National Environmental Laboratory Accreditation Program.
(C) An approval shall automatically expire:
(i) Upon a change in the ownership of the laboratory, unless 30 days in advance of the transfer, a new completed application is received by the department. In such case the Department of Public Health shall grant conditional permission to operate the laboratory for 30 days or until the department either approves or disapproves the new application, whichever is sooner, in accordance with section 19a-36 -A28 of the Regulations of Connecticut State Agencies.
(ii) Upon any change in the information in the laboratory application, unless within two weeks of said change, a new appropriately updated application is received by the department. In such case the department shall grant the laboratory conditional permission to operate for 30 days or until the department either approves or disapproves the new application, whichever is sooner, in accordance with section 19a-36 -A28 of the Regulations of Connecticut State Agencies.
(iii) Upon a change in the director of the laboratory, unless a new director is hired by the laboratory owner and approved by the department within 30 days after the termination of the previous director.
(D) If the certification of the laboratory, upon which the department bases its approval, is suspended or revoked, the approval of the department is automatically and immediately likewise suspended or revoked. An out of state laboratory must notify the department in writing of any changes in its certification within 14 days of said change.
(E) The owner shall maintain the current address of its laboratory with the department. Any notice with respect to the operation of the laboratory sent to the owner at the laboratory address on file is effective notice. Service of process by the department upon the owner shall be effective when made on the Connecticut Secretary of State's Office.

Notes

Conn. Agencies Regs. § 19a-36-A33
Effective October 25, 1989; Amended October 10, 2006

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