Connecticut Administrative Code

Regulations of Connecticut State AgenciesSec. 19a-36-D20. DefinitionsAs used in sections 19a-36-D20 through 19a-36-D39:(1) \"Advisory committee\" means a group of consultants, appointed by the commissioner and serving in a voluntary capacity, to advise the department on matters r…

Regulations of Connecticut State AgenciesSec. 19a-36-D21. Licensure requiredThe owner shall apply to the department for licensure of the laboratory or renewal thereof on forms provided for that purpose. No clinical laboratory tests or examinations shall be performed therein until…

Regulations of Connecticut State AgenciesSec. 19a-36-D22. Application for licensure(a) In applying for licensure, the applicant shall set forth the name and location of the laboratory, a complete statement of its ownership including the names and addresses of all owners and the a…

Regulations of Connecticut State AgenciesSec. 19a-36-D23. Inspection and investigationThe owner shall cause the quarters, facilities and records of the laboratory to be made immediately available for inspection upon request of a representative of the department and shall cooperat…

Regulations of Connecticut State AgenciesSec. 19a-36-D24. Terms of licensureThe duration of each license shall be set at the discretion of the department, for a period of not less than twenty-four (24) nor more than twenty-seven (27) months from its effective date. The terms of l…

Regulations of Connecticut State AgenciesSec. 19a-36-D25. Denial of licensureWhenever inspection and investigation pursuant to an application for licensure yield evidence leading to a reasonable presumption that requirements of sections 19a-36-D20 through 19a-36-D38 of the Regula…

Regulations of Connecticut State AgenciesSec. 19a-36-D26. Suspension or revocation of licensure(a) Licensure may be suspended or revoked whenever in the judgment of the commissioner any one of the following conditions exists: (1) the laboratory has operated in violation of any ap…

Regulations of Connecticut State AgenciesSec. 19a-36-D27. Connecticut license numberA Connecticut license number, which will be assigned to the laboratory by the department upon initial licensure, shall be inscribed on all reports, lists of tests, fee schedules and advertisements…

Regulations of Connecticut State AgenciesSec. 19a-36-D28. List of tests and fee schedulesA copy of each list of tests and each fee schedule issued by a laboratory shall be maintained on file at the laboratory and be available to the department upon its request. (Adopted effective…

Regulations of Connecticut State AgenciesSec. 19a-36-D29. Acceptance and collection of specimens(a) No specimen shall be accepted for analysis or collected by an owner or an employee of the laboratory except when requested by a licensed physician or other licensed person authoriz…

Regulations of Connecticut State AgenciesSec. 19a-36-D30. Identification of specimensEvery specimen received for testing shall be numbered or otherwise marked so that it may be identified definitely and related to the submitting physician and the patient from whom it was derived.…

Regulations of Connecticut State AgenciesSec. 19a-36-D31. Examination of specimens(a) No specimen shall be examined if unsuitable for testing because of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection and examination when app…

Regulations of Connecticut State AgenciesSec. 19a-36-D32. Reports of findings(a) Laboratory findings on a specimen shall be reported directly to the licensed provider who ordered the testing pursuant to authority granted to such provider by chapter 370, 372, 373, 375, 377, 378, 3…

Regulations of Connecticut State AgenciesSec. 19a-36-D33. Qualifications of directorNo person shall be the director of a clinical laboratory unless he meets the educational, training and/or experiential requirements identified in this section. (a) For laboratories performing test…

Regulations of Connecticut State AgenciesSec. 19a-36-D34. Qualifications of other personnelClinical laboratory personnel other than the director shall meet the educational, training and/or experiential requirements identified in this section. (a) For laboratories performing tests…

Regulations of Connecticut State AgenciesSec. 19a-36-D35. Responsibilities of licensee and director(a) The licensee shall ensure that the laboratory is at all times under the direction of a director who meets the qualification standards identified in Section 19a-13-D33 of the reg…

Regulations of Connecticut State AgenciesSec. 19a-36-D36. Unethical practices prohibited(a) Definitions. As used in this section: (1) \"Bribe\" means any valuable consideration given or promised by a laboratory providing service with a view to influence the behavior of a requeste…

Regulations of Connecticut State AgenciesSec. 19a-36-D37. Referral of specimens to out-of-state laboratories(a) A Connecticut licensed laboratory may refer specimens for testing to an out-of-state clinical laboratory if the out-of-state laboratory is CLIA certified and is license…

Regulations of Connecticut State AgenciesSec. 19a-36-D38. Minimum standards for the operation of private clinical laboratories(a) The laboratory shall be operated in compliance with all applicable state and federal laws and regulations, including but not necessarily limited to CL…

Regulations of Connecticut State AgenciesSec. 19a-36-E1. Definitions As used in this section, and sections 19a-36-E2 to 19a-36-E6, inclusive, of the Regulations of Connecticut State Agencies: (1) “Accreditation organization” means an entity that sets and evaluates quality and per…

Regulations of Connecticut State AgenciesSec. 19a-36-E2. Licensure Procedures(a) No person or business entity shall establish, conduct, operate or maintain a source plasma donation center unless such person or business entity holds a license issued by the department in accordance…

Regulations of Connecticut State AgenciesSec. 19a-36-E3. Minimum standards for operation(a) Source plasma donation centers licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall comply with applicable federal, state and local laws.(b) Source…

Regulations of Connecticut State AgenciesSec. 19a-36-E4. Examinations and laboratory tests(a) Source plasma donation centers licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall only perform donor eligibility tests. The performance of any …

Regulations of Connecticut State AgenciesSec. 19a-36-E5. Personnel requirements and qualifications(a) A source plasma donation center licensed pursuant to section 19a-36-E2 of the Regulations of Connecticut State Agencies shall ensure a minimum of two members of the personnel wit…

Regulations of Connecticut State AgenciesSec. 19a-36-E6. Records, data collection and reporting requirements(a) Records. Donor records shall be maintained in accordance with applicable federal and state law, including 21 CFR 606.160 and 21 CFR 640.72, as amended from time to time…

Regulations of Connecticut State AgenciesSec. 19a-36-F1. Definitions As used in this section, and sections 19a-36-F2 to 19a-36-F6, inclusive, of the Regulations of Connecticut State Agencies: (1) “Accreditation organization” means an entity that sets and evaluates quality and per…

Regulations of Connecticut State AgenciesSec. 19a-36-F2. Licensure Procedures(a) No person or business entity shall establish, conduct, operate or maintain a blood collection facility unless such person or business entity holds a license issued by the department in accordance wit…

Regulations of Connecticut State AgenciesSec. 19a-36-F3. Minimum standards for operation(a) Blood collection facilities licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall comply with applicable federal, state and local laws.(b) Blood col…

Regulations of Connecticut State AgenciesSec. 19a-36-F4. Examinations and laboratory tests(a) Blood collection facilities licensed pursuant to section 19a-36-F2 shall conduct all donor testing at a duly licensed clinical laboratory.(b) Blood and blood components collected shall b…

Regulations of Connecticut State AgenciesSec. 19a-36-F5. Personnel requirements and qualifications(a) A blood collection facility licensed pursuant to section 19a-36-F2 of the Regulations of Connecticut State Agencies shall ensure a minimum of two members of the personnel with cu…

Regulations of Connecticut State AgenciesSec. 19a-36-F6. Record and reporting requirements(a) Records. Donor records shall be maintained in accordance with applicable federal and state law, including 21 CFR 606.160 and 21 CFR 640.72, as amended from time to time. Blood collection…

Regulations of Connecticut State AgenciesSec. 19a-36h-1. Definitions.As used in Sections 19a-36h-1 to 19a-36h-7, inclusive, of the Regulations of Connecticut State Agencies: (1) “Alternate person in charge” means the person designated by the owner or manager of the food establish…

Regulations of Connecticut State AgenciesSec. 19a-36h-2. Applicability and variance.(a) Applicability. (1) All food establishments shall comply with the requirements of the food code, as amended from time to time, any food code supplement published by the United States Food and D…

Regulations of Connecticut State AgenciesSec. 19a-36h-3. Inspection observations and documentation.(a) The food inspector shall complete all sections of the commissioner’s prescribed inspection report form, as amended from time to time, to document inspection observations and oth…

Regulations of Connecticut State AgenciesSec. 19a-36h-4. Certified food protection manager and alternate person in charge.(a) Each Class 1, 2, 3, and 4 food establishment shall have a person in charge who meets the requirements of section 2-102.11 of the food code and who is on-s…

Regulations of Connecticut State AgenciesSec. 19a-36h-5. Employee health.If the owner, operator, or person in charge of a food establishment has reason to suspect that any employee has contracted any reportable diagnosis as specified in section 2-201.11(A)(2) of the food code, or…

Regulations of Connecticut State AgenciesSec. 19a-36h-6. Hold order, or destruction of food.(a) The food inspector may issue a hold order to the owner or operator of a food establishment for any food or drink suspected to be unsafe for human consumption, while verification of its…

Regulations of Connecticut State AgenciesSec. 19a-36h-7. Enforcement.(a) The director of health shall ensure all food establishments are inspected pursuant to the schedule in section 19a-36j of the Connecticut General Statutes. (b) A food inspector shall, immediately upon discove…

Regulations of Connecticut State AgenciesSec. 19a-37a-1. Notification of sprinkler installationAny person engaged in the installation or modification of an automatic fire extinguishing system in any building served by a public water system, as defined in subsection (a) of section…

Regulations of Connecticut State AgenciesSec. 19a-401-1. Definitions. As used in sections 19a-401-1 to 19a-401-6, inclusive, 19a-401-9, 19a-401-10, and 19a-401-12 to 19a-401-17, inclusive, of the Regulations of Connecticut State Agencies.(a) \"Commission\" means the Commission on…

Regulations of Connecticut State AgenciesSec. 19a-401-10. Changes in certificate of death(a) In any death subject to investigation by the chief medical examiner, the identification of the deceased or cause or manner of death, as listed on the certificate of death as initially rec…

Regulations of Connecticut State AgenciesSec. 19a-401-11. (Repealed) Repealed February 2, 2004. AUTHORITY: Conn. Gen. Stat. § 19a-401

Regulations of Connecticut State AgenciesSec. 19a-401-12. Reports and forms; inquiries; records.(a) Reports of investigations and of autopsies are prepared on standard forms issued by the Office. The original reports of investigations, reports of hospital deaths, and of authorize…

Regulations of Connecticut State AgenciesSec. 19a-401-13. Request for regulationThese rules set forth the procedure to be followed by the Commission on Medicolegal Investigations in the disposition of petitions concerning the promulgation, amendment, or repeal of a regulation gov…

Regulations of Connecticut State AgenciesSec. 19a-401-14. Form of petition.Any interested person may at any time petition the Commission to promulgate, amend, or repeal any regulation pertaining to the Office. The petition shall set forth clearly and concisely the text of the pro…

Regulations of Connecticut State AgenciesSec. 19a-401-15. Procedure after petition filed(a) Decision on petition. The Commission shall within 30 days after submission of the petition either deny the petition in writing stating its reasons for the denial or shall initiate regulati…

Regulations of Connecticut State AgenciesSec. 19a-401-16. Requests for declaratory rulings. GeneralThese rules set forth the procedure to be followed by the Commission in the disposition of requests for declaratory rulings as to the validity of any regulation, or the applicabilit…