Sec.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 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.

(Adopted effective June 4, 1996)