DPH: Laws and Regulations

Laws and Regulations

Sec. 19a-29a. Environmental laboratories.

(a) As used in this section:

(1) “Environmental laboratory” means any facility or other area, including, but not limited to, an outdoor area where testing occurs, used for microbiological, chemical, radiological or other analyte testing of drinking waters, ground waters, sea waters, rivers, streams and surface waters, recreational waters, fresh water sources, wastewaters, swimming pools, construction, renovation and demolition building materials, soil, solid waste, animal and plant tissues, sewage, sewage effluent, sewage sludge or any other matrix for the purpose of providing information on the sanitary quality or the amount of pollution or any substance prejudicial to health or the environment. “Environmental laboratory” does not include a publicly-owned treatment works, as defined in section 22a-521, that performs only physical, residue, microbiological and biological oxygen demand tests for its own facility for which results are required by or submitted to the Department of Energy and Environmental Protection to comply with permits or authorizations issued pursuant to section 22a-6k, 22a-430 or 22a-430b, or a pollution abatement facility, as defined in either section 22a-423 or 22a-475, that tests for pH, turbidity, conductivity, salinity and oxidation-reduction potential, and tests for residual chlorine for its own facility for which results are required by or submitted to the Department of Energy and Environmental Protection to comply with permits or authorizations issued pursuant to section 22a-6k, 22a-430 or 22a-430b;

(2) “Analyte” means a microbiological, chemical, radiological or other component of a matrix being measured by an analytical test; and

(3) “Matrix” means the substance or medium in which an analyte is contained, that may include drinking water or wastewater.

(b) The Department of Public Health shall (1) adopt regulations, in accordance with the provisions of chapter 54, to establish reasonable standards governing environmental laboratory operations and facilities, personnel qualifications, certification for testing, levels of acceptable proficiency in testing programs approved by the department, the collection, acceptance and suitability of samples for analysis and such other pertinent laboratory functions, including the establishment of advisory committees, as may be necessary to ensure environmental quality, public health and safety, and (2) establish one or more schedules of the amounts of civil penalties that may be imposed under this section. Each registered environmental laboratory shall comply with all standards for environmental laboratories established by the department and shall be subject to inspection by said department, including inspection of all records necessary to carry out the purposes of this section. The Commissioner of Public Health may revoke or otherwise limit the license of any environmental laboratory that fails to comply with the provisions of this section or regulations adopted under this section.

(c) The Commissioner of Public Health shall determine whether it is necessary for the protection of the public health or the environment for an environmental laboratory to be registered and to have certification to conduct a test for an analyte in a matrix. If the commissioner determines that it is necessary for the environmental laboratory to be registered, such environmental laboratory shall obtain from the commissioner a certification to conduct such tests for analytes. No person shall operate, manage or control an environmental laboratory that tests for analytes for the purpose of providing information on the sanitary quality or the amount of pollution of any substance prejudicial to health or the environment for which the commissioner has determined registration and certification is required without having first registered and obtained such certification.

(d) The commissioner shall, annually, publish a list setting forth all analytes and matrices for which a certification for testing is required.

(e) Each application for registration of an environmental laboratory and for certification for testing any analyte shall be made on forms provided by said department, shall be accompanied by a fee of one thousand two hundred fifty dollars and shall be executed by the owner or owners or by a responsible officer authorized to do so by the agency, firm or corporation owning the environmental laboratory. Upon receipt of any such application, the department shall make such inspections and investigations as are necessary and shall deny registration when operation of the environmental laboratory would be prejudicial to the health of the public. Registration shall not be in force until notice of its effective date and term has been sent to the applicant.

(f) Each registration or certification shall be issued for a period of not less than twenty-four or more than twenty-seven months from any deadline for applications established by the commissioner. Renewal applications shall be made (1) biennially within the twenty-fourth month of the current registration; (2) before any change in ownership is made; and (3) prior to any major expansion or alteration in, or changing of, quarters.

(g) This section shall not apply to any environmental laboratory that only provides laboratory services or information for the agency, person, firm or corporation which owns or operates such laboratory.

(h) If, upon review, investigation or inspection, the Commissioner of Public Health determines an environmental laboratory has violated any provision of this section or regulations adopted under this section, the commissioner may impose a civil penalty not to exceed five thousand dollars per violation per day and issue such other orders as the commissioner determines necessary to protect the public health. Upon notice of imposition of the civil penalty, the commissioner shall provide the environmental laboratory with an opportunity for a hearing. Governmental immunity shall not be a defense against the imposition of any civil penalty imposed pursuant to this section. In determining the amount of the civil penalty to be imposed on an environmental laboratory, the commissioner shall consider the degree of the threat to public health or the environment, the amount necessary to achieve compliance, and the history of compliance of the environmental laboratory. Any order issued under this provision may be appealed in accordance with the provisions of section 4-183.

(i) The failure of an environmental laboratory to pay a civil penalty imposed by the commissioner shall be grounds for revocation of the environmental laboratory’s registration and certification for testing.

(j) The commissioner may order an unregistered environmental laboratory to cease operations.

(k) The commissioner may request the Attorney General to petition the Superior Court for an order to aid in enforcement of any provision of this section.

 


 Sec. 25-40. Analysis of water. Schedule of fees, when applicable.

Town, city and borough directors of health shall, when in their judgment health may be menaced or impaired through a water supply, send, subject to the approval of the Department of Public Health, samples of such water to said department for examination and analysis. Said department shall perform such examination and analysis without charge unless such town, city or borough is to be reimbursed for the expense of any such examination and analysis, and in such event a fee shall be charged in accordance with a schedule of fees directly related to operating costs to be established by the Commissioner of Public Health. Any person, firm or corporation which operates or maintains a laboratory in which any determination, examination or analysis is made of any sample of water or sewage as a basis for advice as to the sanitary quality of such water or sewage or as to any possible danger to health involved, unless such laboratory has been approved specifically for that purpose by the Department of Public Health, after meeting the requirements established by said department, shall be fined not more than one hundred dollars.


Minimum Standards for Approval of Public Health Laboratories

19-4-1. Minimum standards

Section 19a-36-A33 provides that a registered laboratory may be given a certificate of approval for making certain specified public health laboratory examinations, determinations or tests in a manner conforming with the requirements and standards required by the state department of health. In accepting approval, heads of laboratories shall agree to abide by these minimum standards upon which approval of public health laboratories is based, as follows:

(1)            Adequate housing of the laboratory as determined by inspection before the certificate of approval is issued and by reinspection at any time.

(2)            Equipment complete and in good order at all times as considered necessary for making each examination, determination or test for which approval is extended according to the method or methods which the person in charge has agreed to follow under subparagraph (b) of subdivision (4).

(3)            Operation of the laboratory under the direct supervision of an individual designated by the owner of the laboratory to be in charge of the work for which approval is extended.

(4)               Agreement on the part of the person, firm or corporation operating or maintaining the laboratory, or of the duly authorized agent thereof, that the individual designated by the owner to be in charge of the laboratory shall:

(a)              Conduct the laboratory strictly in accordance with recognized standards and to carry out the provisions of the general statutes and of the public health code pertaining to the performance and reporting of the examinations, determinations or tests for which approval has been extended;

(b)              report no public health laboratory examination, determination or test unless based upon a method or procedure which meets the approval of the state department of health and, upon request, to furnish the state department of health with a complete description of any method used in making any specified examination, determination or test for which approval is extended or requested;

(c)               notify the state department of health before undertaking any new type of public health laboratory examination, determination or test not already included in the list for which approval has been extended;

(d)              assume responsibility for the reliability of the laboratory findings made by any person employed in the laboratory, and for any interpretation based upon those findings.

(5)               Agreement on the part of the person, firm or corporation operating or maintaining the laboratory, or of the duly authorized agent thereof:

(a)              To notify the state department of health in writing without delay if the person designated by the owner to be in charge of the laboratory severs or is about to sever connection with the laboratory and to surrender the certificate of approval on or before the day such person leaves; to give notice in writing prior to the taking of a leave-of-absence of more than four weeks' duration by such person; if approval has been conditioned upon the performance of a given type of test by a specified person, to give prompt notice in writing when the specified person severs or is about to sever connection with the laboratory;

(b)              to inform the state department of health without delay and in writing;

                    (i)         of any change in the amount of time given to his
                                   position by the person designated by the owner to be
                                   in charge of the laboratory

(ii)        of any contemplated removal of the laboratory to new quarters;

(iii)        of any major changes, alterations or additions to the laboratory  quarters;

(iv)        of any change in ownership of the laboratory;

(v)         of any changes in personnel of the laboratory;

(c)        to permit the use of no statement, made orally or appearing on any advertising or laboratory forms, which expresses or implies that approval of the state department of health is extended beyond that specified on the certificate of approval.

            (Effective October 25, 1989.)


19a-36-A25. Laboratories to register

Any person, firm or corporation, or the duly authorized agent thereof, operating or maintaining a laboratory in which there is made any examination, determination or test specified in section 19a-36-A26, shall register such laboratory with the state department of health before any such examination, determination or test is made. The carrying on of any of the examinations, determinations or tests specified in said section shall be deemed the operating or maintaining of a laboratory.

            (Effective October 25, 1989.)

 

19a-36-A26. Registration required when. Exemptions

(a)        Except for laboratory work of the types hereinafter exempted, registration is required for any of the following laboratory procedures:

(1)       Those which utilize any living agent capable of causing human infections or reportable disease of man, or which are used to secure evidence bearing upon the presence or absence of such living agents or the illnesses caused;

(2)       those used to determine the sanitary quality of water or the amount of pollution therein or to control and evaluate the effectiveness of water treatment

(3)       those performed on sewage, sewage effluent or sewage sludge in connection with investigation of sources of pollution, problems of sewage disposal or effectiveness of sewage treatment;

(4)       any examination, determination or test performed on any sample of milk, cream, frozen dessert, milk product or milk beverage or of any container or package used or intended to be used for holding any such product;

(5)       those used to determine the sanitary quality of any substance used as a food, or as an ingredient of food or as a container for food, or to determine whether or not such substance may be harmful to health;

(6)       those performed on any material or substance for the purpose of determining the effectiveness of sanitation in the establishment serving food or beverages to the public;

(7)       those performed on air or materials contributing substances to the air which may be prejudicial to health, except those performed for routine operational control or maintenance purposes.

(b)            Laboratories performing any of the work specified above shall be exempt from the requirements of this section only when all such work is done under one or more of the following conditions:

(1)       When laboratory findings are obtained in a laboratory facility and service maintained by a licensed practitioner of a healing art exclusively for the examination of his own patients within the scope of his license to practice;

(2)       when the laboratory has been established as an agency of the state or federal government for the purpose of providing data for state or federal officials in the enforcement of the dairy and pure food and drug laws;

(3)       when laboratory work is confined to butter fat tests on milk and cream for use in determining payment to producers of such products under provisions of the general statutes;

(4)            repealed, March 23, 1976;

(5)       when laboratory findings are obtained on materials derived from animals in a laboratory facility and service maintained by a Veterinarian licensed to practice in Connecticut performing laboratory examinations exclusively on animals under his or her care and treatment.

(c)        When the laboratory work consists solely of those tests necessary to control the operation of water treatment plants under the supervision of operators whose qualifications have been approved by the state department of health or of sewage treatment plants under the supervision of operators whose qualifications have been approved by the state department of environmental protection, upon recommendation of the division of environmental health services in the former case or the state department of environmental protection in the latter case, the department shall grant registration without approval as provided in section 19a-36-A33 solely for the purpose of allowing such operators to perform those tests as shall be required for the control of treatment. Such granting of limited registration or renewal thereof may be made by the department without prior inspection or investigation of facilities, personnel, equipment and proficiency.

          (Effective October 25, 1989.) 

19a-36-A27. Application for registration or reregistration

(a)            Application for registration shall be made on forms provided for the purpose by the state department of health and shall set forth clearly essential information concerning the laboratory, including its name, its location, the name of the person, firm or corporation owning or operating it, and such additional information as the state department of health may at any time deem necessary regarding the tests to be made, the housing, equipment and personnel of the laboratory. As part of the application for registration, the owner of the laboratory, or his duly authorized agent, shall designate a person to be in charge of the laboratory and shall agree to notify the state department of health in writing before any change in status of the person in charge or removal of the laboratory to new quarters is made.

(b)           In a similar manner, application for reregistration of such laboratory shall be made

(1)        biennially within thirty calendar days prior to expiration of the registration then current,

(2)        before the laboratory is moved to new quarters,

(3)        whenever a change in status of the person designated to be in charge is about to be made or

(4)         whenever registration has lapsed for any cause.

          (Effective October 25, 1989.)

 

19a-36-A28. Conditional permission to operate laboratory

The state department of health may extend conditional permission to operate an unregistered laboratory for a period not to exceed thirty days pending completion of investigation or carrying out of conditions imposed prior to registration or reregistration.

            (Effective October 25, 1989.)

 

19a-36-A29. Granting of registration

Registration or reregistration of a laboratory will be granted only after the state department of health has determined by inspection and investigation that no condition or circumstance exists which would, in the opinion of the state department of health, cause the laboratory to be operated in a manner prejudicial to the health of the public.

            (Effective October 25, 1989.)

 

19a-36-A30. Suspension or revocation of registration

Registration of a laboratory may be suspended at any time when investigation has shown that the registration agreement has been violated or that the laboratory is being operated in a manner which may be prejudicial to the health of the public. Registration may be revoked for such cause after notice to and hearing of the parties interested.

(Effective October 25, 1989.)

 

19a-36-A31. Inspections and investigation by state department of health

Representatives of the state department of health shall be granted reasonable access to laboratory quarters and records for inspection and investigation. Whenever necessary to evaluate the accuracy of any type of laboratory work done in a laboratory which is registered or has applied for registration, said department will require technical reviews of procedures used or submit a reasonable number of suitable specimens or samples and require reports thereon.

            (Effective October 25, 1989.)

 

19a-36-A32. Prohibition of transmission of material to unregistered laboratory

No person, firm or corporation shall, without approval in writing from the state department of health, maintain, conduct or operate a station or office for the reception from the public of materials to be transmitted to a laboratory for the making of any clinical, medical, or sanitary laboratory examination, determination or test except when the laboratory in which the work is to be done is currently registered with the state department of health or is exempt from registration requirements, as provided for in section 19a-36-A26.

            (Effective October 25, 1989.)

        19a-36-A33. Requirements and standards for approval

(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 $1250.00 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.

 

                          (Effective Oct. 2006)


Environmental Laboratories

19a-36-A57. Definitions

As used in sections 19a-36-A57 through 19a-36-A63:

(1)        "Advisory committee" means a group of consultants, appointed by the commissioner and serving in a voluntary capacity, to advise the commissioner on matters relating to the regulation of environmental laboratories.

(2)        "Commissioner" means the Commissioner of Public Health.

(3)        "Department" means the Connecticut Department of Public Health.

(4)        "Environmental laboratory" means any facility or other area defined in subsection (a) of Section 19a-29a of the Connecticut General Statutes.

(Effective November 28, 1995.)

 

19a-36-A58. Identification and tracking of samples

Every sample received in an environmental laboratory for testing shall be numbered or otherwise marked so that it may be identified and related to the source from which it was derived. A dated record of its receipt, disposition and examination and of the findings obtained shall be made and kept on file for a minimum of two (2) years after receipt.

(Effective November 28, 1995.)

 

19a-36-A59. Examination of samples

An environmental laboratory shall have available at all times in the immediate bench area of personnel engaged in examining samples and performing related procedures within a speciality (e.g., minerals, nutrients, volatile organics, trace metals) current laboratory manuals or other complete written descriptions and instructions related to the analytical methods used by those personnel, designated and dated to reflect the most recent supervisory review. Such manuals shall also contain information concerning preparation and storage or reagents, standards and calibration procedures, and pertinent literature references.

(Effective November 28, 1995.)

 

19a-36-A60. Referral of samples

(a)         An environmental laboratory shall refer samples for testing only to an environmental laboratory that is registered or approved by the department.

(b)         An environmental laboratory shall perform at least seventy (70) percent of those tests for which it has approval and refer out those tests for which approval has not been granted.

(c)         When samples have been referred, reports shall be done by one of the following:

(1) The testing environmental laboratory, with permission from the referring environmental laboratory, may send test results directly to the person who ordered the tests.

(2) The referring environmental laboratory shall indicate on the report to the person who ordered the test the name and address of each environmental laboratory at which a test was performed.

(Effective November 28, 1995.)

 

19a-36-A61. Proficiency testing

(a)         An environmental laboratory shall enroll in a proficiency testing program approved by the department.

(b)         An environmental laboratory shall successfully participate in an approved program for each analyte or test for which it has approval.

(c)        The proficiency testing samples shall be examined or tested with the environmental laboratory's regular workload by personnel who routinely perform the testing in the environmental laboratory, using methods approved by the department.

(Effective November 28, 1995.)

 

19a-36-A62. Qualifications of director

No person shall be a director of an environmental laboratory unless one (1) of the following qualifications are met.

(a)       When microbiology is performed, the director shall have at least:

(1) a baccalaureate degree from an accredited institution including a minimum of eight (8) semester hours of microbiology; and

(2) a minimum of one (1) year of pertinent experience in environmental microbiology.

(b)        When chemical analyses are performed, the director shall have at least:

(1) a baccalaureate degree from an accredited institution including a minimum of eight (8) semester hours of inorganic and/or organic chemistry; and

(2) a minimum of one (1) year of pertinent experience in environmental chemistry.

(Effective November 28, 1995.)

 

19a-36-A63. Advisory committee

The advisory committee shall consist of:

(a)        two (2) private environmental laboratory directors;

(b)        two (2) public environment laboratory directors;

(c)        two (2) members from public water utilities;

(d)        one (1) specialist in microbiology from a registered or approved environmental laboratory;

(e)        one (1) specialist in inorganic chemistry from a registered or approved environmental laboratory;

(f)         one (1) specialist in organic chemistry from a registered or approved environmental laboratory;

(g)        one (1) person who is not a laboratory director and has no financial interest in any laboratory registered with the department; and

(h)        one (1) person who is the owner of an environmental laboratory.

(Effective November 28, 1995.)





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