controlled by the pathologists. The technologist level is the 4-year American Society of Clinical Pathology program, and a new category of technician was established which requires simply a 1-year AMA approved program. The technician level also includes the graduates of the Armed Forces schools of medical laboratory technologists.

"We think it is imperative that Members of Congress fully understand that the programs which have been approved by the AMA all consist of on-the-job training programs. Technologists are required to complete 3 years of college as a prerequisite, while the second category of training requires only a high school diploma. This second category is called the 'assistants program' by the ASCP, yet it is upgraded to the technician category as defined in the medicare regulations.

"It is our contention that no one should be allowed to perform laboratory tests on specimens from actual patients until he has had acceptable formal instruction and satisfactory laboratory experience. We feel that laboratory technology and techniques should be taught in institutions of learning, and that individuals who desire to work in the laboratory should be required to attend such schools. This has been the training program of the Armed Forces schools, as well as the program of the private schools of medical technology.

"We do not understand how the Department of HEW can equate a 1-year, on-the-job training program with formal courses of instruction which are the equivalent of 60 semester hours of training. We believe the inherent danger to the public is quite obvious in the on-thejob training programs, and I have personally in my private practice had some unfortunate experience because of these programs. The individuals responsible for these on-the-job training programs claim that there is always strict supervision, but I have had sufficient contact with several of these so-called schools to know that this is simply not a fact.

"We believe it is urgent that regulations be enacted controlling the activities within the clinical laboratory, but in view of the facts we have cited, we feel that such regulations must begin with the laboratory personnel, and that they should be enacted by the legislative branch of the Government rather than delegated to the executive branch. One of the fundamental concepts of licensure statutes is the historical right of the individual States to enact such legislation. We feel that the States should enact licensure statutes for clinical laboratory personnel, and that the Federal Government should encourage the States to do so. The policing of laboratories will eventually be a function of State agencies, as is now the case with the medicare regulation and we, therefore, feel that the States should be given every opportunity to exercise their rights. We know of no profession which is licensed on a national basis by the Federal Government.

"At this very moment there is intensive activity in many States to enact licensure statutes. We are proud to report that our society is playing a leading role in these activities. The most recent instance of the enactment of a statute is in the State of Nevada. In addition, there are intersociety groups meeting to draft laws in the States of Oklahoma, Missouri, Texas, Massachusetts, Florida, and Michigan. We sincerely feel that within the next 2 years a majority of States will have enacted licensure statutes. Despite this, the Department of HEW has seen fit to superimpose Federal controls on top of State controls.

"We have here a model licensure statute which was prepared by our society 3 years ago, and I respectfully request that it be made part of this testimony."

Mr. ROGERS (presiding). Without objection, it is so ordered, to be placed at the end of your testimony.

Mr. ROBINSON. Thank you.

"This is the type of legislation which we offer to this committee for its consideration as a possible alternative to proficiency testing. As we stated before, however, we feel that this committee will probably prefer proficiency testing for the reason that they would not care to go into the licensing of a profession on a national scale. However, the committee might possibly desire to pass a licensure statute which will apply only to States which do not have a licensing law. The effect of this, we feel sure, would be to encourage all the States to pass adequate licensing laws at the earliest possible time.

"We sincerely appreciate the opportunity given to us to state our position and we will always be available to work with this committee as well as other parts of the Federal Government in establishing the necessary regulations for the protection of the public." (Material furnished by the society follows:)

PROPOSED MODEL STATE LICENSURE STATUTE

(Prepared by International Society of Clinical Laboratory Technologists) AN ACT To provide for the registration and licensing of personnel working in clinical laboratories describing unlawful acts hereunder, the amount of fees for licenses, the denial, revocation and suspension of licenses and permits, and making an appropriation to the State Board of for its expenses in carrying out the provisions hereof.

VII. Denial, revocation, and suspension of licenses and permits.

Section I. Definitions.

A. "Person" includes firm, association, and corporation.

B. "Department" means the State Board of

C. "Clinical laboratory technologist" means any person licensed under this title to engage in the work and direction of a clinical laboratory.

D. "Clinical laboratory technician" means a person other than a licensed laboratory technologist who is licensed under this title to perform the technical procedures called for in a clinical laboratory under the direction of a clinical laboratory technologist or physician and surgeon.

E. "Clinical laboratory technician intern" is any person who has successfully pursued a course of study in clinical laboratory technicque for a minimum of 60 semester hours or equivalent (1550 clock hours) instruction, both theoretical and practical including, but not limited to, the following:

a. Microbiology (including parisotology).

b. Clinical Microscopy.

c. Serology.

d. Bio-chemistry.

e. Hematology.

f. Histopathological techniques.

g. Blood Banking.

F. "Student" is any person regularly matriculated in any college or university accredited by the American Association of Universities or in any legally chartered school approved by the Board and who is pursuing a course of study in clinical laboratory technique. This course shall include, but not be limited to, both theoretical and practical study in the following subjects: a) Michobiology (including parisotology); b) Clinical Microscopy; c) Serology; d) Bio-chemistry; e) Hematology; f) Histopathological techniques; g) Blood Banking.

G. "Clinical laboratory" means any place where microbiological, serological, chemical, hemotological, biophysical, cytological or pathological examinations are performed on materials derived from the human body, to obtain information for use by licensed practitioner of the healing arts in their diagnosis, prevention or treatment of a disease or assessment of a medical condition.

Section II. Administration and regulation

A. The Board may employ special examiners, and the Board may make regulations for the conduct of examinations under this title.

B. The Board may approve schools providing instruction in clinical laboratory technique which in the judgment of the Board will provide instruction adequate to prepare individuals to meet the requirements for licensure under this title. C. The Board shall make such regulations as may be necessary for the enforcement of this title which regulations shall include a provision prohibiting the employment of personnel directing or performing the technical procedures called for in a clinical laboratory who is not licensed under this title.

D. Each biennium the Board may compile and may thereafter publish and sell a directory of persons within the state licensed under the provisions of this title who hold unforfeited and unrevoked certificates. This directory is to be distributed without charge to licentiates of this title. The directory may also contain a copy of the provisions of this title and regulations relating thereto and such other information as the department may determine advisable. Each person licensed under this title shall file his address with the Board and shall report within fifteen days any change of address, giving both the old and the new address.

Section III. Application of this title

A. This title does not authorize any person to practice medicine and surgery or to furnish the services of physicians for the practice of medicine and surgery. This title does not repeal or in any manner affect any proivsions of law relating to the practice of medicine in this state.

B. This title does not apply to a clinical laboratory operated by any of the following:

1) The State of

or the United States of America, or any

department, official, or agency thereof.

C. A duly licensed clinical laboratory technologist or clinical laboratory technician may perform venipuncture or skin puncture for withdrawing for test purposes upon specific authorization from any person in accordance with the authority granted under any provision of law relating to the healing arts.

D. A student regularly matriculated in any college or university accredited by the American Association of Universities or in any legally chartered school approved by the Board or a clinical laboratory technician intern in any clinical laboratory approved by the Board may perform venipuncture and/or skin puncture as a part of the necessary training program when done under the direct and responsible supervision of a licensed clinical laboratory technologist, technician, or physician and surgeon.

E. The provisions of this title do not apply to bona fide investigational or consultative clinical laboratory procedures performed by members of the faculty in the course of their employment in institutions accredited by the American Association of Universities, or in any legally chartered school approved by the Board for the training of persons in clinical laboratory technique. Section IV. Licensing

A. The Board shall issue a clinical laboratory technologists license to each person who is a lawful holder of a degree of bachelor of arts or bachelor of science or equivalent degree issued after a full course of resident instruction in one or more established and reputable institutions maintaining standards equivalent, as determined by the Board, to those institutions accredited by the American Association of Universities with a major work for such degree in one of the

biological or chemical sciences who has had a minimum of four years' experience, at least one year of which must have been immediately antecedent to admission to the examination, either as a licensed clinical laboratory technician or its equivalent performing clinical laboratory work embracing the various fields of clinical laboratory activity in a clinical laboratory satisfactory to the Board, and whom the Board finds by written, oral, and practical examination to be properly qualified. Persons who are lawful holders of an associates art degree shall comply with the above provisions except that such persons must have a minimum of six years experience. (The Board shall establish by regulation the required courses to be included in the college, university, or junior or community college training.) The following may be accepted as equivalent of, and substituted for, experience for a maximum of three years for such experience; (1) a master's degree in fundamental medical sciences, one year; (2) a doctorate in fundamental medical sciences three years.

B. The Board shall issue a clinical laboratory technician's license to each person found by it to be properly qualified and it shall hold written, oral, or practical examinations to determine the qualifications of applicants. The examinations for license to work in a clinical laboratory as a technician shall cover the fields of microbiology (including parisotology), clinical microscopy, serology, biochemistry, hematology, histopathological techniques, and blood banking, except that the examination for a special clinical laboratory technician's license in biochemistry, microbiology (including serology and parisotology), clinical microscopy (including hematology, urine and gastric analysis), blood grouping and blood banking, and histopathological techniques shall be concerned only with the subject or subjects in which the license is to be issued. The prerequisites for entrance into the examination shall be one of the following:

1) Completion of a regular four-year college or university curriculum in medical or clinical laboratory technique with a degree of bachelor of arts or bachelor of science in a college or university approved by the Board, the last year of which course shall have been primarily clinical laboratory procedure; provided, however, that if the curriculum did not include practical clinical laboratory work, six months as a clinical laboratory technician intern or the equivalent as determined by the Board in a clinical laboratory approved by the Board shall be required; or

2) Graduation from a college or university maintaining standards equivalent, as determined by the Board, to those institutions accredited by the American Association of Universities with a bachelor of arts or bachelor of science and a major in bacteriology, biochemistry, or essentially equivalent subject or subjects as may be determined by the Board plus one year as a clinical laboratory technician intern or the equivalent as determined by the Board in a clinical laboratory approved by the Board. One year of practical experience in a public health laboratory may be accepted if such experience or if university or college courses included practical work in clinical bio-chemistry and hematology;

3) The Board shall issue a clinical laboratory technician intern's license to each person found by it to be properly qualified and it shall hold written, oral, or practical examinations to determine the qualifications of applicants. The prerequisites for entrance into the examination shall be any person who has successfully completed a course of study in clinical laboratory technique for a minimum of 60 semester hours or 1550 clock hours of formal instruction, both theoretical and practical including, but not limited to, the following: a) microbiology (including parisotology); b) clinical microscopy; c) serology; d) bio-chemistry; e) hematology; f) histopathological technique; and g) blood banking. Persons granted a license as a technician intern must perform as such for a minimum of 12 months, after which time the intern must pass such other oral or practical examinations for qualification as a technician (as the Board deems necessary or advisable). C. Persons licensed as technician interns may serve as such for no more than a maximum of 24 consecutive months from date of licensing.

D. Licenses issued under this title may cover work in any one basic science, or may cover proficiency in the entire field of clinical laboratory work.

E. Any person maintaining, conducting, or operating a clinical laboratory shall display in a prominent place in the clinical laboratory, the clinical laboratory permit, and the license or registration certificate of each person performing the technical procedures called for in a clinical laboratory.

F. A license or permit under this title may be suspended or revoked by the Board for good cause after hearing on notice.

G. Upon filing application therefor containing such information as the Board may require, and the payment of the license or certificate fee, the Board shall issue to any person duly licensed under this title a duplicate license or registration certificate for one previously issued or, where there has been a change of name, another license or registration certificate in lieu of one previously issued. H. Grandfathers clause: Persons performing clinical laboratory procedures in a clinical laboratory immediately prior to the effective date of this act shall be issued the appropriate license upon application and without examination provided that;

1) A person must have performed a minimum of 5 years as a clinical laboratory technologist with a total of 10 years experience in the clinical laboratory to qualify as such;

2) A person must have performed a minimum of 5 years as a clinical laboratory technician to qualify as such;

3) A person must have performed a minimum of 24 months as a clinical laboratory technician intern to qualify as such.

4) Each 30 semester hours of college work (or 400 clock hours) in an acceptable course of instruction, shall be credited as 2 years of experience. (Note: each college semester shall be equal to 1 year of experience).

5) The person so licensed under this provision must pay the appropriate fee as set forth above.

6) Persons otherwise qualifying under this provision must apply for the appropriate license within one year from the effective date of this act or be subject to the examination procedures set forth herein.

Section V. Offenses against this title

A. It is unlawful for any person to act as a clinical laboratory technologist unless he is licensed in that capacity under this title.

B. It is unlawful for any person to act as a clinical laboratory technician unless he is licensed in that capacity under this title.

C. It is unlawful for any person to act as a clinical laboratory technician intern unless he is licensed in that capacity under this title.

D. It is unlawful for any person to make any test or examination in a clinical laboratory unless the person is one of the following:

1) A licensed clinical laboratory technician in the subject or subjects concerned with the test or examination.

2) A licensed clinical laboratory technologist.

3) An individual licentiate of the healing arts.

4) A clinical laboratory technician intern under direct and responsible supervision.

E. It is unlawful for any person conducting, maintaining, or operating a clinical laboratory to employ any person to perform clinical laboratory procedures except a licensed physician and surgeon, a licensed clinical laboratory technologist, a licensed clinical laboratory technician, or a licensed clinical laboratory technician intern.

F. It is unlawful for a licensed clinical laboratory technician intern to work or to be employed in a clinical laboratory unless there are on active duty in the laboratory one or more licensed clinical laboratory technicians, or one or more licensed clinical laboratory technologists.

G. It is unlawful for any person to operate a school or conduct any course for the purpose of training or preparing persons for a license hereunder or to perform any of the practices or acts herein defined without having first secured the approval of the Board herein provided.

H. It is unlawful for any person conducting, maintaining, or operating a clinical laboratory to employ more than one licensed clinical laboratory technician intern for each (1) licensed laboratory technologist and (1) technician (total 2). I. Any person who violates any provision of this title is guilt of a misdemeanor. J. Any clinical laboratory may accept assignments for tests only from and make reports only to persons licensed under the provisions of law relating to the healing arts. This section does not prohibit the referral of specimens or such assignment from one clinical laboratory to another laboratory providing the reports indicates clearly the laboratory performing the test.