reglab/statecodes huggingface dataset:
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A26 - Registration required when. Exemptions

Current through July 10, 2024
(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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A27 - Application for registration or reregistration

Current through July 10, 2024
(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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A28 - Conditional permission to operate laboratory

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A29 - Granting of registration

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A30 - Suspension or revocation of registration

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A31 - Inspections and investigation by state department of health

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A32 - Prohibition of transmission of material to unregistered laboratory

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A33 - Requirements and standards for approval

Current through July 10, 2024
(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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A34 - Serologists to be certified

Current through July 10, 2024
Before any serological test for syphilis may be reported for
				use or used as an aid to the diagnosis or the exclusion of syphilis, any person
				performing such test shall have demonstrated a standard of proficiency in
				performing such test which will fulfill the requirements of the state
				department of health and such person shall hold an unexpired certificate to
				perform such test which shall be issued by the state department of health
				subject to revocation for cause and to annual renewal. Serological tests
				performed entirely for instructional, research or experimental purposes and
				serological tests performed by a physician for use only in his private practice
				are exempted from this requirement.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A35 - Standard tests for syphilis

Current through July 10, 2024
A standard laboratory blood test or a standard serological test
				for syphilis as required under the provisions of the general statutes or the
				public acts shall be a serological test approved by, and performed in a manner
				that meets the approval of the state department of health. The following types
				of tests are so approved: VDRL slide flocculation, fluorescent treponemal
				antibody absorption (FTA-ABS), automated reagin (ART) and rapid plasma reagin
				(RPR) circle card tests.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A36 - Funeral directors to report deaths of reportable communicable diseases

Current through July 10, 2024
Within twelve hours after being called to take charge of a
				human body dead of a communicable disease listed pursuant to section
				19a-36
				-A2, the funeral director shall report the case to the local director of health
				and the body shall be prepared for burial in accordance with section
				19a-36
				-A39.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A37 - Funerals of persons dead of reportable communicable diseases

Current through July 10, 2024
Funerals of persons dead of any communicable disease listed
				pursuant to section
				19a-36
				-A2 shall be conducted in such a manner that the family and public shall have
				no opportunity to come into contact with the body.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A38 - Definitions

Current through July 10, 2024
The intent and meaning of certain words and phrases as used in
				sections
				19a-36
				-A39,
				19a-36
				-A40, 19a-36-A41 and 19a-36-A42 are as follows:
(a)
Washed.
A dead human body
			 shall be considered as washed when the entire surface of the body has been
			 bathed with a disinfecting solution.
(b)
Embalmed.
A body shall be
			 considered embalmed when it has had injected into the circulatory system
			 embalming fluid in an amount not less than five per cent of the body weight and
			 when such cavities have been injected as may be necessary to properly preserve
			 the body and render it sanitary.
(c)
Wrapped.
A body shall be
			 considered as wrapped when it has been bandaged with five thicknesses of cloth
			 saturated with a disinfecting solution, provided, when a body has been
			 embalmed, the face, arms and hands need not be so bandaged.
(d)
Embalming fluid.
For the
			 purposes mentioned in section 19a-36-A40, an embalming fluid shall be a fluid
			 containing not less than four per cent formaldehyde gas by weight.
(e)
Disinfecting solution.
A
			 disinfecting solution shall be an aqueous solution containing not less than
			 five per cent of phenol by weight, a 1-500 solution of bichloride of mercury or
			 such other solution as shall be equivalent to five per cent phenol in
			 germicidal action when tested in the presence of organic matter by a method and
			 in a laboratory that has met the approval of the state department of health for
			 that purpose, provided such other solution shall have been approved in writing
			 by the commissioner of health. The active ingredients shall be named on the
			 label of any package or container in which a disinfecting solution is offered
			 for sale.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A39 - Preparation for burial of persons dead of reportable communicable diseases

Current through July 10, 2024
Human bodies dead of any communicable disease listed pursuant
				to section
				19a-36
				-A2 shall be prepared for burial by being washed with a disinfecting solution
				or embalmed or wrapped.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A40 - Transportation of dead bodies

Current through July 10, 2024
(a) Dead human
			 bodies to be transported by common carrier shall be embalmed or wrapped and
			 then enclosed in a casket, and outside box or, in lieu of such double
			 container, be enclosed in an impervious container acceptable to the
			 commissioner of health.
(b) Dead
			 human bodies to be removed from the place of death to another location for
			 preparation shall be temporarily prepared by enclosing in an impervious
			 container. The licensed embalmer having charge of such a body may sign the
			 certificate required in section
			 7-62 of the general
			 statutes, but in so doing, such licensed embalmer obligates himself to further
			 prepare the body as required by section
			 19a-36
			 -A39 as soon as practicable after arrival at his regular place of
			 business.
(c) The impervious
			 containers mentioned in subsections (a) and (b) of this section shall be
			 cleansed and washed with a disinfecting solution after each use.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A41 - Disinterment permits

Current through July 10, 2024
Embalmed bodies which have been placed in receiving vaults
				shall not be regarded the same as disinterred bodies until after the expiration
				of thirty days. All bodies remaining in a receiving vault over thirty days
				shall be treated the same as disinterred bodies. The above shall not apply
				during winter months to embalmed bodies which are to be buried in any cemetery
				in Connecticut before the first of June following the date in which they are
				placed in such receiving vault, but permits may be granted for removal and
				burial the same as if burial were made immediately after
				death.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A42 - Care in handling bodies dead of a communicable disease

Current through July 10, 2024
Any licensed embalmer who has in charge the preparation of a
				body dead of a communicable disease shall take the necessary precautions to
				prevent the spread of infection, and such licensed embalmer shall instruct the
				owner of the building or the family in which the death occurs, or both, that it
				is unlawful to remove any infectious material, clothing, instrument or thing
				until thoroughly disinfected by combustion, by boiling for at least ten minutes
				or by thorough saturation or immersion in a disinfecting solution for at least
				two hours.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A43 - Sanitation of buildings, equipment and instruments

Current through July 10, 2024
All buildings occupied or used and all equipment and
				instruments used or owned by funeral directors or licensed embalmers shall be
				kept in a sanitary condition acceptable to the state department of
				health.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A44 - Inspection of buildings, equipment and instruments

Current through July 10, 2024
The state department of health may, at any time, make an
				inspection of the buildings occupied or used or the equipment or instruments
				owned or used by funeral directors or licensed embalmers in the discharge of
				their business. When such buildings, equipment or instruments are found to be
				in such an insanitary condition as to be detrimental to the public health, and
				when it also is found that such buildings, equipment or instruments are owned
				or used by a licensed embalmer, such fact shall be reported to the state board
				of examiners of embalmers and funeral directors with the recommendation that
				the license be not renewed to the licensed embalmer who owns or operates such
				insanitary place of business.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A46 - Sale of turtles

Current through July 10, 2024
(1) No live turtle
			 shall be sold in Connecticut until examination in the laboratory of the state
			 department of health of three specimens of water from the tank in which the
			 turtle is kept, taken not less than forty-eight hours apart by a representative
			 of either a local health department or state department of health fails to show
			 the presence of salmonella organisms.
(2) Should a single such examination show the
			 presence of salmonella organisms all turtles in the tank shall be destroyed.
(3) Persons who import, purchase,
			 sell, exchange, barter, give away or otherwise deal in turtles shall keep
			 records of such transactions embodying information required by the state
			 department of health for a mininum period of two years, which records shall be
			 open for inspection by a representative of the local director of health or the
			 state department of health.
(4) In
			 any location where turtles are offered for sale the vendor shall post warnings
			 which adequately inform the public that the transmission of salmonella disease
			 by turtles is possible.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A49 - Denial, suspension or revocation of registration

Current through July 10, 2024
(a) Registration of a center shall be denied,
			 revoked, suspended, limited, or renewal thereof denied for knowingly:
(1) making false statements of material
			 information on an application for registration or renewal thereof or any other
			 documents required by the department;
(2) permitting unauthorized persons to
			 perform any medical or technical procedure such as but not necessarily limited
			 to: plasmapheresis, phlebotomies, and medical history interviews;
(3) demonstrating incompetence in the
			 performance of any procedure;
(4)
			 performing a procedure for which registration has not been granted;
(5) lending the use of the name of the
			 registered center or its personnel to an unregistered center;
(6) operating a program of mobile or
			 permanently fixed collection stations without prior written approval from the
			 department; and
(7) operating the
			 center in a manner which is deemed prejudicial to the public health.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A50 - Qualifications of director

Current through July 10, 2024
No person shall be the director of a center unless said person
				is a physician licensed to practice in Connecticut who is board-certified in
				clinical pathology or blood banking by the American Board of Pathology, or has
				received a minimum of one year of specialized training in blood banking, or has
				equivalent experience and training acceptable to the
				department.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A51 - Responsibilities of registrant and director

Current through July 10, 2024
(a) The registrant
			 shall be responsible to ensure that the center is at all times under the
			 direction of a director acceptable to the department as set forth in section
			 19a-36
			 -A50. Whenever the designated director is to be on leave from his duties for
			 more than thirty calendar days, the registrant shall so notify the department
			 in advance in writing and shall designate, subject to departmental approval, an
			 interim director of the center. The registrant shall notify the department in
			 advance whenever the designated director is about to sever connection with the
			 center.
(b) The registrant and
			 director shall, if different persons, be jointly and severally responsible for
			 the operation of the center in compliance with sections
			 19a-36
			 -A47 to 19a-36-A55 inclusive, and with any other pertinent regulatory and
			 statutory requirements.
(c) The
			 director shall be responsible for the proper performance of all procedures
			 including phlebotomies, plasmapheresis and all procedures performed by
			 subordinates. He shall be responsible for the continuous application of quality
			 control procedures to the work in accordance with recommendations and
			 directives of the department.
(d)
			 Except for illness, vacation, or other justifiable leave, the director shall be
			 present and in active direction of the center during at least one-half of its
			 normal working hours each week. When the total normal working hours of a center
			 exceed thirty hours weekly, a total of fifteen working hours shall satisfy the
			 requirements of this subsection.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A52 - Minimum standards for operation of centers

Current through July 10, 2024
(a) The
			 center shall be operated in compliance with all applicable laws, ordinances,
			 and regulations and with all administrative directives pursuant thereto that
			 shall be issued by the department.
(b) Quarters in which any procedures are
			 performed or specimens collected shall be kept free from filth, excessive dirt
			 or other objectionable conditions, shall be adequately lighted and ventilated,
			 shall be of adequate size and arrangement for the proper conduct of the work
			 and shall be free from unnecessary safety hazards.
(c) Equipment shall be adequate and in good
			 order at all times as considered necessary for the proper handling of
			 procedures for which registration may be granted.
(d) All persons engaged in the performance of
			 any procedures in the center shall be qualified to do the work in the opinion
			 of the director subject to appraisal by the state department of
			 health.
(e) No misrepresentation of
			 the scope of the procedures performed by the center, or of the qualifications
			 or special abilities of persons associated with the center, shall be
			 permitted.
(f) No person shall be
			 subjected to plasmapheresis except when a physician licensed to practice in
			 Connecticut is on the premises.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A53 - Standards for plasmapheresis and blood collection

Current through July 10, 2024
The department shall, upon recommendation of the Advisory
				Committee, establish such standards as it deems necessary for the performance
				of plasmapheresis and phlebotomies. Such standards shall include but may not be
				limited to: donor selection requirements, blood container and pilot tube
				identification, donor arm preparation, phlebotomy, collection of blood,
				plasmapheresis, availability of equipment in the event of donor reaction,
				processing requirements for donor blood, space and ventilation requirements,
				and equipment maintenance.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A54 - Maintenance of records and reports

Current through July 10, 2024
(a) The medical
			 history and a written record of weight, blood pressure, hemoglobin level (or
			 acceptable alternate test), temperature, pulse, and such other tests as shall
			 be required shall be maintained for a minimum of one year.
(b) Prior to plasmapheresis, each center
			 shall require positive identification of the donor.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Section 19a-36-A55 - Laboratory tests

Current through July 10, 2024
Such laboratory tests as deemed necessary in any standards as
				may be established pursuant to section
				19a-36
				-A53 shall be performed in a laboratory approved in accordance with section
				19a-36
				-A33.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Environmental Laboratories › Section 19a-36-A57 - Definitions

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Environmental Laboratories › Section 19a-36-A58 - Identification and tracking of samples

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Environmental Laboratories › Section 19a-36-A59 - Examination of samples

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Environmental Laboratories › Section 19a-36-A60 - Referral of samples

Current through July 10, 2024
(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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Environmental Laboratories › Section 19a-36-A61 - Proficiency testing

Current through July 10, 2024
(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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Environmental Laboratories › Section 19a-36-A62 - Qualifications of director

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Environmental Laboratories › Section 19a-36-A63 - Advisory committee

Current through July 10, 2024
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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Public Swimming Areas › Section 19a-36-B61 - Public swimming areas

Current through July 10, 2024
(a)
Definitions.
As used in this section:
(1) "Public swimming area" means a designated
				location, together with any buildings, toilet facilities, the water and the
				land area used in connection therewith, at any natural or artificial pond,
				lake, stream, tidal water or other body of fresh or salt water that is
				advertised as a place for swimming and is accessible to the public. Public
				swimming area does not include:
(A) swimming
				areas in connection with or appurtenant to single family dwellings and used
				solely by persons residing in such dwellings and such person's guests,
				including but not limited to those swimming areas accessible only as part of a
				lake association, beach association or condominium;
(B) any state owned or operated swimming areas;
				and,
(C) public swimming pools that
				are regulated under Section
				19-13-B33b of the Regulations of
				Connecticut State Agencies.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D21 - Licensure required

Current through July 10, 2024
The 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 the licensee
				  has been notified by the department that licensure is in effect. No such tests
				  or examinations shall be made after licensure has been suspended or revoked as
				  provided in section
				  19a-36
				  -D26 of the regulations of Connecticut State Agencies or after the licensee has
				  voluntarily surrendered its license, until such licensure is renewed or
				  reinstated.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D22 - Application for licensure

Current through July 10, 2024
(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 agent for service of process and the agent's
				address, the name of the director, a list of laboratory tests and examinations
				for which licensure is sought and such other information as to ownership,
				quarters, facilities, personnel and proposed operations as the department may
				require. Application for renewal of licensure shall delineate changes made in
				the preceding licensure period. When applying for renewal of licensure under
				this section, the applicant shall simultaneously apply for renewal of any
				additional registration required by sections
				19a-36
				-A25 through
				19a-36
				-A33 of the regulations of Connecticut State Agencies, and such renewal, when
				granted, shall be considered to be in force for the issuance of such
				certificates of approval as are required by section 19a-36-A33 of the
				regulations of Connecticut State Agencies. The applicant shall, as part of each
				application, agree to abide by such standards of operation as are made a part
				thereof.
(b) The following clinical
				laboratories are exempt from licensure:
(1)
				laboratories owned and operated by the United States or any agency of the
				federal government;
(2)
				laboratories that perform tests or examinations for research purposes
				only;
(3) laboratories that perform
				tests or examinations for forensic purposes only; and
(4) laboratories that perform tests or
				examinations that are exempt for CLIA purposes.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D23 - Inspection and investigation

Current through July 10, 2024
The 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 cooperate with such representative
				  by furnishing information in any pertinent investigation. Failure to allow the
				  Department to inspect constitutes cause for revocation of the laboratory's
				  license.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D24 - Terms of licensure

Current through July 10, 2024
The 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 licensure or
				  renewal thereof may restrict the scope of laboratory operations or establish a
				  time limit for the owner to carry out recommendations based upon inspection and
				  investigation. Initial licensure shall not be in force until notice of its
				  effective date and term has been sent to the applicant. Application for renewal
				  of licensure shall be made as follows:
(a) biennially within thirty calendar days
				prior to expiration of the license then current;
(b) thirty (30) days before any change in
				ownership that will result in an actual change of the licensee of the
				laboratory or a planned change of director is made; or
(c) thirty (30) days prior to any major
				expansion or alteration in quarters, which includes expanding the quarters
				through construction or relocating the laboratory testing area to another
				floor, building or location.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D25 - Denial of licensure

Current through July 10, 2024
Whenever 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 Regulations of Connecticut State Agencies, or of
				  any applicable statute would not or could not be fulfilled, licensure shall be
				  denied.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D26 - Suspension or revocation of licensure

Current through July 10, 2024
(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 applicable statute or regulation or
				has failed to implement a plan of correction as submitted to the
				department;
(2) the findings of the
				laboratory are found, after investigation, to be inaccurate or unreliable
				beyond the limits of error inherent in the method and such condition is not
				corrected forthwith;
(3) findings
				have been reported on specimens that were not tested or examined;
(4) the owner has failed to comply with
				instructions from the commissioner for the correction of conditions adversely
				affecting the quality of work;
(5)
				CLIA certification has been suspended or revoked; or
(6) any other condition of the laboratory
				that is deemed prejudicial to the public health.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D27 - Connecticut license number

Current through July 10, 2024
A 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 of the
				  laboratory.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D28 - List of tests and fee schedules

Current through July 10, 2024
A 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.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D30 - Identification of specimens

Current through July 10, 2024
Every 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. An appropriate,
				  dated record of its receipt, disposition and examination and of the findings
				  obtained shall be made and kept on file for a minimum of one (1) year after
				  receipt or in accordance with the CLIA regulations, Title 42 part 493 of the
				  code of federal regulations, whichever is more stringent.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D32 - Reports of findings

Current through July 10, 2024
(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, 379, 380 or 400j of the Connecticut General
				Statutes, and may be provided by laboratories other than the department's
				laboratory to lay persons upon the written request of the provider who ordered
				the testing. Laboratories other than the department's laboratory may also
				provide findings upon the written request of providers who did not order the
				testing, so long as the requesting provider is also statutorily authorized to
				order such testing pursuant to chapter 370, 372, 373, 375, 377, 378, 379, 380
				or 400j of the Connecticut General Statutes, and is providing care to the
				patient who is the subject of the testing. Nothing in this section shall
				prohibit the issuance of reports of laboratory findings to town, city or state
				health officials as required by the Regulations of Connecticut State Agencies
				or the inspection or impounding of records of such reports by a representative
				of the department.
(b) No report
				shall be worded to convey or simulate a diagnosis or prognosis or to specify or
				suggest specific medication, surgical manipulation or other form of treatment
				unless signed by a physician licensed to practice in Connecticut or in the
				state in which the laboratory performing the examinations is located. This
				subsection shall not prohibit the laboratory from furnishing the normal ranges
				for the methods of analysis employed in such laboratory nor shall it prohibit
				the laboratory from identifying patient values that are outside the normal
				ranges for the methods of analysis employed. When the specimen has been
				referred for examination to an out-of-state laboratory, the report shall bear
				or be accompanied by a clear statement that such findings were obtained in such
				laboratory and shall specify its name and location.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D33 - Qualifications of director

Current through July 10, 2024
No 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 tests categorized as high complexity, the director
				shall:
(1) be a physician licensed to practice
				medicine in Connecticut who is certified in anatomic and/or clinical pathology
				by the American Board of Pathology or the American Osteopathic Board of
				Pathology or meets all of the education, training or experience requirements to
				take the examination but has not actually taken and successfully completed the
				examination; or
(2) hold an earned
				doctoral degree in a chemical, physical, biological or clinical laboratory
				science from an accredited institution and:
(A) be certified by the American Board of
				Medical Microbiology, the American Board of Clinical Chemistry, the American
				Board of Bioanalysis, the American Board of Medical Laboratory Immunology or
				other board deemed comparable by the Commissioner; or
(B) have at least two (2) years of laboratory
				training or experience, or both, and at least two (2) years of experience
				directing or supervising high complexity testing; or
(3) have a combination of education, training
				and experience in the clinical laboratory specialty, which, in the judgment of
				the commissioner, qualifies the individual to direct a laboratory whose
				services are limited to that specialty.
Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D34 - Qualifications of other personnel

Current through July 10, 2024
Clinical laboratory personnel other than the director shall
				  meet the educational, training and/or experiential requirements identified in
				  this section.
(a) For laboratories
				performing tests categorized as moderate complexity, personnel shall meet the
				following requirements.
(1) A technical
				consultant shall:
(A) be a physician licensed
				to practice medicine in Connecticut who is certified in anatomic and/or
				clinical pathology by the Board of Pathology or the American Osteopathic Board
				of Pathology or meets all of the education, training or experience requirements
				to take the examination but has not actually taken and successfully completed
				the examination; or
(B) hold an
				earned doctoral or master's degree in a chemical, physical, biological or
				clinical laboratory science or medical technology from an accredited
				institution and have at least one (1) year of laboratory training or
				experience, or both in non-waived testing, in the designated specialty areas of
				service for which the technical consultant is responsible; or
(C) have earned a bachelor's degree in
				chemical, physical or biological science or medical technology from an
				accredited institution and have at least two (2) years of laboratory training
				or experience, or both in the designated specialty or sub-specialty areas of
				services for which the technical consultant is responsible.