Conn. Agencies Regs. § 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.
Notes
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