State laws and regulations that affect your medical practice
1. What are the requirements for forensic chemical testing of blood, breath or urine related to motor vehicle violations?
(a) Requirements for blood collection:
(1) Blood shall be withdrawn by a person licensed to practice medicine and surgery in this state, a licensed phlebotomist, a qualified laboratory technician, an emergency medical technician II, a registered nurse or such other occupational classification as the commissioner determines may competently and safely withdraw blood.
(3) Containers and other equipment for sample collection shall be of a type that will preserve the integrity and suitability of the sample from the time of collection until analysis. Following collection, the container for each sample shall be sealed and labeled. Only those samples that have been properly sealed shall be analyzed.
(b) Requirements for urine testing:
(1) The police officer collecting the sample shall monitor the collection of the sample to ensure that adulteration or misidentification does not occur. Collections shall be monitored by a police officer of the same gender as the individual from whom the sample is obtained.
(2) Containers and other equipment for sample collection shall be of a type that will preserve the integrity and suitability of the sample from the time of collection until it is analyzed. Following collection, the container for each sample shall be sealed and labeled. Only those samples that have been properly sealed shall be analyzed.
( c ) Requirements for blood and urine tests:
(1) No analysis result may be reported, unless the method or methods used to conduct the analysis have been approved by the commissioner and such analysis is performed by an analyst.
(2) In conducting the analysis, the analyst shall use standards and controls approved by the commissioner.
(3) All tests shall be performed in duplicate. Alcohol test results shall be reported to the requesting agency only when the duplicate results correspond to each other within 5 percent of the mean value. Drug test results shall be reported to the requesting agency only when the duplicate results correspond to each other within 20 percent of the mean value.
(4) All reports, written and oral, shall indicate the determined or equivalent blood alcohol content in terms of hundredths of a percent. When determinations are made to the nearest thousandth of a percent, results shall be truncated to the first two digits after the decimal point. For example, a determination of 0.149 percent shall be reported as 0.14 percent.
CT ADC § 14-227a-9b
2. May radiographers and radiologic technologists perform venipuncture?
In any hospital, a radiologic technologist licensed by the Department of Public Health who (1) has completed a course of study in radiologic technology in a program accredited by the Committee on Allied Health Education and Accreditation of the American Medical Association or its successor organization, or a course or study deemed equivalent to such accredited program by the American Registry of Radiologic Technologists and has passed an examination prescribed by the department and administered by the American Registry of Radiologic Technologists or (2) is registered by the American Registry of Radiologic Technologists and has performed venipuncture in the course of his employment for at least three years may perform venipuncture and administer intravenous medication for diagnostic procedures.
C.G.S.A. § 20-74dd
3. What are the regulations governing acceptance and collection of specimens?
(a) No specimen shall be accepted for analysis or collected by an owner or an employee of a 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 authorized person.
( 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 licensed health care facility, no specimen requiring venipuncture shall be accepted for analysis unless taken by an employee of a licensed laboratory. 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 statutory requirements and shall possess, at 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 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 specimen. 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 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. Blood collection facilities shall receive written approval from the department before any specimens are collected. Said approval may be revoked at any time by the department.
CT ADC § 19a-36-D29
4. How is a plasmapheresis center and/or blood collection facility registered?
(a) The owner or duly designated registrant shall apply to the department for registration of the center or renewal thereof on forms provided for that purpose by the department. No procedures shall be performed therein until the registrant has been notified by the department that registration is in effect. No such procedures shall be performed after registration has expired or has been suspended or revoked as provided herein until such registration is renewed or reinstated.
(b) In applying for registration, the applicant shall set forth the name and location of the center, a complete statement of its ownership, the name and qualifications of the director, the procedures for which registration is sought and such other information as to quarters, facilities, personnel and proposed operations as the department may require. In the application for registration or renewal thereof, the registrant and director shall agree to abide by all general statutes, regulations and administrative directives pursuant thereto.
( c ) Prior to registration, the owner shall cause the quarters, facilities and records of the center to be made available for inspection upon request of a representative of the department and shall cooperate with such representative by furnishing information in any pertinent investigation or inspection. The commissioner or his designee shall inspect each center at least once every twelve months unless the commissioner elects to accept an inspection report from the American Association of Blood Banks in lieu of one annual departmental inspection during any two year period. For the purpose of this subsection, representatives of the department shall have the right of entry into the premises of the center at any time during the hours of operation.
(d) The duration of each registration shall be set at the discretion of the department but no longer than two years from its effective date. The terms of registration or renewal thereof may restrict the scope of operations or establish a time limit for the owner to carry out recommendations based upon inspection or investigation. In all cases, application for renewal of registration shall be made as follows:
(1) Within thirty calendar days prior to the expiration of the registration, then current;
(2) Before any change in ownership or change in director is made;
(3) Prior to any major expansion or alteration in quarters in an existing location; and
(4) Prior to removal of the center to new quarters. Registration or renewal thereof shall not be effective until the registrant is so notified.
(e) A Connecticut registration number will be assigned to the center by the department upon initial registration.
(f) A mobile or temporary blood collection facility shall not require registration provided that the person or organization conducting said facility is otherwise registered in this state in accordance with these regulations.
(g) Additional blood collection facilities shall not require separate registration provided that the person or organization conducting such facilities is otherwise registered in accordance with these regulations and has filed with the department a list of all permanent locations.
CT ADC § 19a-36-A48
5. For what reasons will registration of a center be denied, suspended or revoked?
(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 of 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.
(b) At the discretion of the commissioner of health, the registrant may be directed by written notice to appear not less than ten days after receipt of such notice at a hearing before said commissioner or his agent to show cause why registration should not be denied, suspended, or revoked. When in the judgment of the commissioner of health, conditions so warrant, suspension of the registration may be invoked without prior hearing if the continued operation is prejudicial to the public health. Revocation of a suspended registration will become effective within thirty days after suspension unless otherwise ordered by the commissioner of health. Prior to revocation, the registrant may request a hearing before the commissioner of health or his agent to petition for reconsideration stating upon what grounds such petition is based.
CT ADC § 19a-36-A49
6. Who is qualified to be a director of a blood collection facility?
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.
CT ADC § 19a-36-A50
7. What are the responsibilities of the registrant and director?
(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. 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 and with any 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.
CT ADC § 19a-36-A51
8. What are the minimum standards for operation of plasmapheresis centers and blood collection facilities?
(a) The center shall be operated in compliance with all applicable laws, ordinances and regulations and with all administrative directives 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 work and shall be free from unnecessary safety hazards.
( c ) Equipment shall be adequate and in food 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.
CT ADC § 19a-36-A52
9. What sort of standards must be established in blood collection facilities?
Standards include but are not 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.
CT ADC § 19a-36-A53
10. What records and reports must be maintained in blood collection facilities?
(a) The medical history and a written record of weight, blood pressure, hemoglobin level (or acceptable alternate test), temperature, pulse, and such 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.
CT ADC § 19a-36-A54
Copyright Kern Augustine Conroy and Schoppmann, P.C. Used with permission.