quite a problem. Federal regulation and Federal licensing of such groups may cause some difficulty. I thank you for your wonderful statement. You are a master of the King's English. I yield back the balance of my time, Mr. Chairman. Mr. STUCKEY. Mr. Ennes, thank you again for your statement. Mr. STUCKEY. The next witness will be Mr. Tom Robinson, who is accompanied by Mr. Vander Zee. STATEMENT OF TOM ROBINSON, PRESIDENT, INTERNATIONAL SOCIETY OF CLINICAL LABORATORY TECHNOLOGISTS; ACCOMPANIED BY REIN J. VANDER ZEE, ATTORNEY Mr. ROBINSON. Mr. Chairman and members of the Interstate and Foreign Commerce Committee. I would like to introduce Mr. Rein J. Vander Zee, our counsel. My name is Tom Robinson, and I am the president of the International Society of Clinical Laboratory Technologists, an organization of clinical laboratory personnel with almost 3,000 members residing in all 50 of the United States. My home is in Tulsa, Okla., where I direct a clinical laboratory. Our society maintains its administrative offices at 805 Ambassador Building, St. Louis, Mo. Dr. Stanley Reitman, a practicing physician and a member of the accrediting commission of our society, who was to testify with me, had to return to St. Louis, Mo., and consequently will not be here today. I have been personally active in the clinical laboratory as a technologist and a laboratory director for over 16 years and I was for 6 years chief laboratory technologist at the Oklahoma Osteopathic Hospital, Tulsa. Since 1957, I have operated the Robinson Laboratories in Tulsa. Dr. Reitman has been most active in the field of laboratory medicine for the past 12 years and has won international recognition as the codeveloper of one of the most widely used laboratory techniques, the Reitman-Franekl transaminase procedure. In addition, Dr. Reitman has been active in the training of laboratory personnel as the director of one of the oldest schools of medical laboratory technology in the United States, the Gradwohl School in St. Louis. This afternoon we wish to testify on House bill No. 6418, limiting our testimony to that portion of the bill which pertains to clinical laboratory improvement. I am quite sure that you are all aware of the news stories of the past few months which point out the need for regulation in this vital health service field. However, we believe that certain fundamental concepts should be carefully considered by this committee so that the legislation which is enacted shall be meaningful and designed to provide a high degree of protection to the patient public. We feel we must be frank with the committee in recognizing that a chaotic situation exists today in the clinical laboratory. We regretfully report that a great deal of this unfortunate situation has been financially motivated. In fact, the U.S. Department of Justice presently has an antitrust suit pending against the College of American Pathologists. We earnestly recommend that this committee secure a copy of the Department of Justice's complaint in that case so that it might be studied in connection with this and other legislation which comes before you. Our society has made every effort to work with representatives of organized medicine and the Department of HEW and yet, whenever we have asked the organized medical groups to establish standards and permit us to work with them in upgrading the profession, they have issued a blanket refusal. We feel that it is only through the efforts of the representatives of the public, such as the members of this committee and your counterparts in the various State legislatures, that we will begin to make the necessary improvements in the laboratory field. First, we wish to emphasize that any regulations which cover the clinical laboratory (the four walls or physical plant), and perhaps the laboratory director, are entirely inadequate. It is the official policy of our organization, and my own personal conviction, that such limited regulations are not only insufficient but ineffective and that the only true public safeguard exists in insuring that the laboratory personnel at all levels are competent to do the work required of them. To achieve this, we recommend one of two alternatives, the first being the licensing of laboratory personnel, that is, all individuals who perform work in the laboratory, or, No. 2, to provide for the proficiency testing of laboratories as a unit. Since we are discussing here today Federal legislation and since the Federal Government would probably be hesitant to go into licensing activities, we believe the second alternative would be the preferable in this situation. Furthermore, we feel that the legislation presently before you should not be passed merely as a type of enabling legislation but rather should establish specific qualifications and standards with specific provisions for their enforcement. Enabling legislation which leaves it to an executive agency of the Government to establish qualifications can many times frustrate the original intention of the Congress or other legislative body. As a recent example of what can happen in this manner, we would point to the regulations propounded by the Department of HEW pursuant to the Medicare Act. As we pointed out before, the Department of Justice has an antitrust suit pending against the College of American Pathologists which alleges that the pathologists have created a monopoly in the clinical laboratory field. Despite the pending suit, we find that members of the defendant organization apparently enjoy a high degree of influence with the Department of HEW and when HEW drew up its regulations pursuant to medicare, these regulations actually assisted in perpetuating the monopoly that the Justice Department is attempting to break. Therefore, we would most urgently ask this committee that no exemptions or exceptions be provided in this legislation and that all laboratories which come within the legislative scope of this proposed act be treated equally. We notice that an exception from this bill is provided in lines 21 through 23 on page 14 and lines 1 and 2 on page 15 for physicians, osteopaths, dentists, or podiatrists who perform laboratory tests "solely as an adjunct to the treatment of his own patients." We would ask the committee to reconsider the basis for this exemption since it would appear that such laboratory operations would not in any event be in interstate commerce. Therefore, we would question the reason for such exemption. Finally, to conclude my portion of this statement, I would like to reiterate to this committee that while is sounds good in theory to establish personnel standards for laboratory directors and thereby feel that this guarantees the quality of the performance of that laboratory, it simply does not happen in actual practice, particularly when there is no counterbalancing limitation placed on the number of laboratories to be supervised by that director. The remainder of the testimony is Dr. Reitman's. I would like to read it. "Mr. Chairman and members of this committee, I may add to what Mr. Robinson has stated pertaining to qualifications of directors of laboratories. As a physician with a special interest in the laboratory, I would like to emphasize that there are many laboratory disciplines where scientists who are not physicians are, in my opinion, eminently more qualified than physicians, including most pathologists. These scientists are highly qualified to be laboratory directors and should be recognized as such. In this connection, a provision in this legislation requiring proficiency testing of the laboratories without setting standards for laboratory directors and personnel would permit this recognition. "Under the medicare regulations previously mentioned, there is a provision which allows an individual to direct as many laboratories as he can possibly put under his control. The provisions for private laboratories establish that a full-time director is limited to three laboratories unless he has an assistant director. An assistant director is likewise limited to three laboratories. Therefore, based upon these regulations, the laboratory director's only limitation on the number of laboratories he may direct is simply three times the number of assistant directors that he will be able to find, plus three. "One of the most indefensible practices that we can cite is the itinerant or circuit riding director. We submit that it is physically impossible for any director to competently direct the activites of more than two or, at the most, three laboratores. Despite this fact, the medicare regulations just described perpetuate this loose practice which presents a greater danger to the health and welfare of the patient public. "The city of New York has recognized this danger and has limited a director to two laboratories. Even so limited, a laboratory director cannot supervise each and every test performed in the laboratory. We think this fact, more than anything else, establishes the absolute necessity for requiring that the competence of laboratory personnel be established either, as we have said, through proficiency testing or individual licensing as the first step in assuring competent performance in the clinical laboratory. In other words, it is our feeling that in order to safeguard the public welfare, standards for laboratory personnel, as in almost all areas of human endeavor, must be built from the bottom up rather than from the top down. "The medicare regulations established two categories of laboratory workers, technologists and technicians, and anyone who has had experience in this field will find that the qualifications established for those two categories are identical to the training programs which are 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. |