Section VI. Revenue A. The amount of application and license fee under this title shall be as follows: 1) The application fee for a clinical laboratory technologist's license is one hundred dollars. 2) The annual renewal fee for a clinical laboratory technologist's license is twenty-five dollars. 3) The application fee for a clinical laboratory technician's license is fifty dollars. 4) The annual renewal fee for a clinical laboratory technician's license is fifteen dollars. 5) The application fee for a clinical laboratory technician intern's license is twenty-five dollars. 6) The annual renewal fee for a clinical laboratory technician intern's license is ten dollars. 7) The application fee for a duplicate certificate is three dollars. B. The application fee required by this title covers the examination, the license fee and the issuance of the license valid for the remainder of the calendar year during which the license is issued. C. An application fee is returnable only when the applicant is not admitted to the examination. D. The annual renewal fee set under this title shall be paid on or before the first day of January of each calendar year. Failure to pay the annual fee in advance during the time the license remains in force shall, ipso facto, work a forfeiture of said license after a period of sixty days from the first day of January of each year, subject, however, to reinstatement under such rules and regulations as the department may make therefor. E. All fees set under this title shall be collected by and paid to the Board. All such moneys shall be deposited by the Board in the general fund in the state treasury. Section VII. Denial, revocation, and suspension of licenses and permits A. Licenses issued by the Board may be revoked or suspended after notice and hearing for each of the following reasons: 1) Conduct involving moral turpitude or dishonest reporting of tests. 2) Violation of any of the rules and regulations of the Board applicable to this title. 3) Permitting a licensed clinical laboratory technician intern to perform tests, procure specimens, or act for the director in the absence of a duly licensed clinical laboratory technician or technologist. 4) Violation of any provision of law governing the practice of medicine and surgery. 5) Proof that the holder has made false statements in material regard on his application for licensure or that he has used any degree or certificate as a means of qualifying for licensure which has been purchased or procured by barter or by any unlawful means or obtained from any institution which at the time said degree or certificate was obtained was not recognized or accredited by the Board of Education of the state where said institution is or was located to give training in the field of study in which the degree or certificate is claimed. 6) The advertising of clinical laboratory procedures to the lay public in magazines, newspapers, directories, circulars, or signs. 7) Knowingly accepting an assignment for clinical laboratory tests or specimens from and the rendering a report thereon to persons not licensed by law to submit such specimens or assignments. 8) Rendering a report on clinical laboratory work actually performed in another clinical laboratory without designating the laboratory in which the test was performed. B. The licenses or permits may be denied for any reason applicable to revocation and suspension of licenses or permits. APPROPRIATIONS The sum of dollars, or so much thereof as may be necessary, is hereby appropriated out of any moneys in the state treasury in the general fund to the credit of the state purposes fund not otherwise appropriated and made immediately available for use by the Board of including expenses of maintenance and operation and personnel service of employees in carrying out the provisions of title five of article five of the public health law, as added by this act. Such moneys shall be payable on the certificate of the commissioner of after audit by and upon the warrant of the comptroller in the manner provided by law. Mr. ROGERS. Thank you very much. Did you have a statement to make, Mr. Vander Zee? Mr. ROGERS. Mr. Stuckey? Mr. STUCKEY. I have no questions, Mr. Chairman. Thank you. Mr. ROGERS. Dr. Carter? Mr. CARTER. I am going to refer to lines 21 and 23 on page 14, and lines 1 and 2 on page 15, concerning positions of osteopaths, dentists, or podiatrists who perform laboratory tests solely as an adjunct for the treatment of their own patients. You don't want the physicians to have the right to do that? Mr. ROBINSON. Our question was that, since it was merely for their own patients, would this be interstate commerce, and would it be necessary to leave it in, since it would not be interstate commerce. Mr. CARTER. But it is not interstate commerce, is it? Mr. ROBINSON. I wouldn't think so. Mr. CARTER. But leaving it in is just a safeguard to see that they do have this right, is that not true? Mr. ROBINSON. I don't know, sir. I wouldn't be able to answer that. Mr. CARTER. I feel like they should have that safeguard. There are few practicing physicians, as I understand it, who do work for others, those who have laboratories and do laboratory work. Mr. VANDER ZEE. I think our problem, sir, was just in understanding how this would be in interstate commerce. We didn't see how it would be applicable and, therefore, question the reasons for its presence in the act. Mr. CARTER. I certainly don't think it would be in interstate commerce. Of course, it is beyond the scope of the Congress to legislate concerning private clinics within States, but it can only legislate on those in interstate commerce. Mr. VANDER ZEE. In other words, we wondered if it was some kind of a sleeper that we didn't, frankly, understand. We can see no reason for any exemptions whatever. Mr. STUCKEY (presiding). Mr. Kyros. Mr. KYROS. On page 4 of your testimony, you say that you noticed an exemption from the bill provided in lines 21 through 23 on page 14. Mr. VANDER ZEE. If the House bill has different page numbering from the Senate bill, there may be an error there. Mr. KYROS. I think it is an error. Mr. VANDER ZEE. It was drafted on the assumption that they were identical. Mr. KYROS. Secondly, as my colleague just brought out, your sole objection to the licensing of laboratories for physicians who treat their own patients, licensed physicians, osteopaths and dentists, is a question of it not being interstate commerce? Mr. ROBINSON. Where it says that the laboratories are solely as an adjunct to the treatment of his own patients, they would be exempt since this was not interstate commerce. We wondered why they would be exempted since they wouldn't be affected in the first place. Mr. KYROS. Suppose there is a doctor in a State which has a large number of summer vacationists who come from out of State whom he treats. It could well be that that could be interstate commerce. Isn't that a fact? Mr. ROBINSON. I am not qualified to answer that. Mr. KYROS. But you have no other grounds for objection to that? Mr. ROBINSON. No, sir. Mr. KYROS. No further questions, Mr. Chairman. Mr. ROGERS (presiding). How many States, if you know, have laws that license the laboratories and also the personnel? Mr. ROBINSON. There are approximately 11 States now that have some type of licensure, that presently have some types of licensure for personnel. Mr. ROGERS. Then you feel that this committee should pass the legislation? Mr. ROBINSON. Not necessarily. I think the preferable thing would be that all States have some type of licensure which would answer the problem. Mr. ROGERS. But if they don't, should this committee wait until all the States enact their licensing statutes? Mr. ROBINSON. No, sir. Mr. ROGERS. We have to consider that as an alternative. Mr. VANDER ZEE. If I may add a word, we think it would certainly be an encouraging factor to the States to pass acts as quickly as possíble if the Congress did that, providing an exemption for States that had an act that was equal to it or better. Mr. ROGERS. Thank you very much. Your testimony has been most helpful. Mr. Carter? Mr. CARTER. You are in favor of Federal licensure in the case of States that don't have the laws at the present time, do I understand correctly? You are in favor of Federal legislation concerning licensure for States which don't have State laws for licensing laboratories and so on? Mr. ROBINSON. Yes, sir. Mr. CARTER. I think that is a pretty far-reaching thing. I think it should apply only to laboratories which are in interstate commerce. Mr. VANDER ZEE. Only within the scope of this act, sir, yes. Mr. ROGERS. Are there any other questions? If not, thank you very much. We appreciate your presence here. Mr. ROBINSON. Thank you. Mr. ROGERS. The next witness is Mr. L. Davis Michel, United Medical Laboratories, Portland, Oreg., who, I understand, could not be here, but Mr. Garrett Fuller is here to present his statement to the committee. STATEMENT OF L. DAVIS MICHEL, EXECUTIVE VICE PRESIDENT, UNITED MEDICAL LABORATORIES, INC. Mr. FULLER. Thank you, Mr. Chairman. With the committee's permission, I would like to enter this statement for the record. Should there be any questions that I might be helpful on, I would be willing to try to answer them. 80-641-67-21 Mr. ROGERS. We are willing to accept the statement for the record. Thank you very much for your appearance here today. Mr. FULLER. Thank you, Mr. Chairman. (Mr. Michel's prepared statement follows:) STATEMENT OF L. DAVIS MICHEL, EXECUTIVE VICE PRESIDENT, UNITED Mr. Chairman and members of the Committee, my name is L. Davis Michel. I am Executive Vice President of United Medical Laboratories, Inc., of Portland, Oregon. In addition the laboratories identified below have authorized me to advise the Committee that they agree in principle with the following statement concerning the "Clinical Laboratories Improvement" section of H.R. 6418. We are among the larger laboratories in the country and employ over 1,000 technical and supporting personnel. Each of us has been approved for Coverage of Services of Independent Laboratories under Section 1861(s) (11) of the Social Security Act. We support the idea of Federal licensing of clinical laboratories since it appears as the most immediate and practicable means of assuring continued high quality laboratory work among laboratories engaged in interstate commerce. Furthermore, Federal licensure should also have a salutary effect on the quality of work performed by intrastate laboratories and laboratories that are excepted from the licensing requirement, since the quality and proficiency of their work will come to be measured by and compared with the federally licensed laboratory. We therefore support H.R. 6418 but wtih certain amendments which we feel are most necessary in the interest of equity and workability. Before discussing the proposed amendments, I wish to mention that we are all aware of the testimony recently given before the Senate Subcommittee on Antitrust and Monopoly to the effect that there is a need to upgrade the quality of laboratory testing throughout the United States. This need was seen to exist only as to independent laboratories but as to hospital laboratories, clinics, and laboratories in physicians' offices. Since a Federal laboratory licensing program could serve to allay the fears of the public over what has been reported in regard to poor laboratory practices, we feel that a vital part of this bill is that which brings within its purview any laboratory that reports the result of any of its tests across state lines. The fact is that most laboratories report at one time or another over state lines. We submit that none of them should be excepted from the provisions of the bill, since the minimum standards should be uniformly maintained among all laboratories that do business in interstate commerce. If exceptions were to be made, the public interest to that extent would be sacrified and the excepted laboratories would be left free to follow practices which could bring discredit to the entire industry. The clinical laboratory industry provides some of the best examples of small business with one to five employees being (with few exceptions) the size laboratory to be found everywhere. However, the advent of space age automation and computer control, combined with the use of jet airmail in transporting specimens and reports, have brought about a revolution in laboratory procedure which is adding new dimension to Medicine. Dozens of tests can be offered to the physician today which were virtually unheard of ten years ago. In fact, some laboratories find that the physician must be instructed and advised in the use and significance of new developments in laboratory testing much as the detail man for the pharmaceutical company must explain his company's new products. Not only is a broad spectrum of testing available today, but the use of sophisticated equipment, meticulously controlled by mechanical and electronic means, has made for a consistent accuracy often unobtainable in older hand-crafted methods of laboratory practice. Further, the coupling together of various items of equipment using micro-quantities of specimen material has resulted in a testing technique in which numerous reactions or results can be produced from one biological specimen within minutes. "Chemistry profile.” "Screen testing." These are part of the jargon of the new Medicine which is learning about the importance of chemical imbalance to the present and future health of the patient and the value of the annual complete laboratory analysis for comparison with past and future profiles. This type of laboratory, new to the medical scene, has resulted in a degree of laboratory specialization on the part of supervisors, technologists and technicians unforeseen even a few years ago. In the large highly automated laboratory, technical personnel are employed to perform in one laboratory specialty-for example, hematology, the study of blood. Technical personnel in hematology will have no occasion to venture into other departments of the laboratory, such as exfoliative cytology (the study of cells) or microbiology (the study of microorganisms). The degree of specialization may be even greater. The technical person may be a reader of "differentials"-one who makes a comparative analysis of certain blood components, or he may be the operator of an automatic device that counts blood cells and produces a report each 15 seconds. Such a machine can report to the computer-dominated "quality control" system as well as produce a printed tape showing the results. Personnel with such a degree of specialization become enormously expert at their task and the possibility of laboratory error becomes ever more remote. Such a testing facility as I have briefly described requires a volume of material far in excess of that needed by the laboratory which sticks with the old methods, and volume work has resulted in substantial economies. So we find in the industry that greater accuracy, greater speed, and greater economy has resulted in a vastly increased demand for laboratory work, more tests at prices people can afford to pay, and a broader spectrum of data for the inquiring physician. But this is a delicately balanced business. If such a laboratory, receiving and reporting on hundreds of specimens each day, were to be shut down for even a few days the business would be greatly jeopardized both financially and its relationship with its clientele. SEC. 353 (C). CATEGORIES We therefore look to the proceedings before the Committee for assurance that those administering the proposed law will issue licenses by category of laboratory procedure as Section 353 (c) seems to contemplate, so that if a license were to be suspended or revoked, it would not result in the laboratory's having to shut down all of its activity but only as to the procedure under question. As we view it, this does not require an amendment to the bill, but we trust these hearings will make it clear that this is what is intended under the proposed law. SEC. 353(f). SUSPENSION We are equally-if not more concerned with Section 353 (f) which provides that the license of a laboratory may be temporarily suspended without a hearing for as much as 60 days if the Secretary of Health, Education and Welfare decides that the public safety or welfare would otherwise be in imminent danger. I have previously pointed out that the business of a large, modern laboratory would be greatly jeopardized if it were to be shut down for even a few days. It could very well be out of business if the days stretched into a week or two. That such a situation could be brought about as a consequence of a statute that makes no provision for prompt notice to the licensee, without opportunity for an expedited hearing, and under delegated authority is unequitable to say the least. Yet, that is what Section 353 (f) permits. I know of no parallel in administrative law. On the contrary, the Federal Food, Drug and Cosmetic Act, for example, specifically guarantees persons in these circumstances the right of prompt notice and an expedited hearing. Similarly, the authority to suspend the application or license may not be delegated by the Secretary as the bill now before the Committee would permit. In the interest of fairness and justice we therefore strongly urge adoption of an amendment to H.R. 6418 which would assure similar guarantees for the licensed laboratory. SEC. 353 (d). STANDARDS There are also two basic objections to be noted with regard to Section 353 (d) which authorizes the Secretary to prescribe standards that must be met by a laboratory as a conditoin to its being licensed. First, as Congressman Dignell observed earlier in these hearings, the provisions of Section 353 (d) would give the Secretary unrestricted authority to |