Connecticut Administrative Code › Title 19a - Public Health and Well-being › 36 - Reportable Diseases and Laboratory Findings › Clinical Laboratories › Section 19a-36-D29 - Acceptance and collection of specimens

Current through July 10, 2024
(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 authorized by law to make diagnoses.
(b) No person shall be given any parenteral
				injection for the collection of a specimen except by a licensed physician or
				other person so authorized by the Connecticut General Statutes.
(c) This section shall not prohibit the
				transmission of specimens collected as specified in subsection (a) to another
				licensed laboratory or to a qualified laboratory exempt from licensure
				requirements nor shall it prohibit the acceptance of specimens submitted by a
				representative of the department for evaluation of testing
				procedures.
(d) Except for
				specimens collected by a practitioner of the healing arts or an employee
				working under such practitioner's direction or by an employee of a hospital or
				other health care facility licensed in accordance with chapter 368v of the
				Connecticut General Statutes, no specimen requiring venipuncture shall be
				accepted for analysis unless taken by an employee of a laboratory licensed in
				accordance with sections
				19a-36
				-D20 through
				19a-36
				-D38 of the regulations of Connecticut State Agencies. Any blood collection
				facility other than the actual laboratory facility that is used for the
				collection of specimens by venipuncture shall be inspected prior to use and a
				written certificate of approval shall be issued by the department. The licensee
				or director of a laboratory shall notify the department in writing immediately
				when the operations of an approved blood collection facility are about to
				terminate.
(e) An approved blood
				collection facility shall meet all the requirements set forth in subsection (b)
				of section
				19a-36
				-D38 and shall possess as a minimum, a blood drawing chair or cot acceptable to
				the department, a telephone, adequate hand washing and toilet facilities for
				employees and patients located on the same floor as the blood drawing facility
				and a written procedure manual detailing the steps to be followed in the event
				of any emergency. Approved blood collection facilities shall be identified by
				signs and advertising in a manner which will not suggest that the facility is a
				laboratory. No laboratory examinations shall be performed in a blood collection
				facility other than the separation of plasma and serum and the preparative
				procedures necessary for the blood collection.
(f) The director of the laboratory of which
				the approved blood collection facility is a part shall be responsible for all
				aspects of the blood collection facility, including without limitation,
				physical plant, personnel and processing and transporting specimens. The
				director or supervisor of the laboratory of which the approved blood collection
				facility is a part shall be available to blood collection facility personnel at
				all times during operation of the facility for personal or telephone
				consultation and shall make on-site monthly inspections of the facility to
				ensure suitable handling of patients and specimens and to instruct the
				employees in such matters and in the most recent improvements. The director of
				the laboratory of which the approved blood collection facility is a part shall
				establish a protocol for action in cases of emergency which shall include,
				without limitation, the immediate availability of a physician or emergency
				medical service. Any technical employee of a blood collection facility shall be
				proficient in venipuncture, specimen processing as limited by sections
				19a-36
				-D20 through 19a-36-D38 of the regulations of Connecticut State Agencies, and
				emergency procedures required to aid a distressed patient. Each licensed
				laboratory shall be limited to six (6) blood collection facilities.
(g) Out-of-state laboratories obtaining
				specimens in blood collection facilities located in Connecticut shall meet all
				applicable requirements in this section. In accordance with Sections 19a-36-A25
				through 19a-36-A33 of the regulations of Connecticut State Agencies, blood
				collection facilities shall receive written approval from the department before
				any specimens are collected. Said approval may be revoked by the department at
				any time in accordance with Section
				19a-36
				-D26 of the regulations of Connecticut State Agencies.