professions, with the exception of medical technology and dental hygiene, both of which are by name in the act. There is no problem with dental hygiene, since it is already accredited professionally as a 2-year course of study.

May I repeat and make it clear that it is not our intent to bar junior college courses for medical laboratory personnel from the benefits of the act. On the contrary, such a change in Public Law 89-751 will make it a great deal easier for National Committee for Careers in Medical Technology's National Council on Medical Technology Education which has established a joint committee with the American Association of Junior Colleges to develop suitable guidelines and terminologies for 2-year courses for medical laboratory personnel to accomplish their purpose. In fact, it is anticipated by September that the American Society of Clinical Pathologists with the concurrence of the American Association of Junior Colleges will be in a position to recommend suitable terminology for junior courses as well as to provide mechanisins to enable them to make suitable arrangements for clinical training.

We very much appreciate the opportunity to recommend the above-suggested changes in section 795 (1) (A) (ii), Public Law 89-751.

Sincerely yours,

ROBERT W. COON, M.D.,

Chairman.

Mr. ROGERS. Thank you, Dr. Coon. It has been most helpful to the committee. Mr. Ottinger.

Mr. OTTINGER. No questions, Mr. Chairman.

Mr. ROGERS. Mr. Kyros.

Mr. KYROS. No questions.

Mr. ROGERS. Thank you. We certainly appreciate it.

The next witness is Mr. Bernard I. Diamond who is chairman of the Government and Professional Relations Council of the American Association of Bioanalysts.

Mr. Diamond, the committee is pleased to hear you. We will be glad to make your statement a part of the record. If you would like to just comment for us it would be helpful to the committee since the Congress is now in session. We are liable to be called to the floor at any time.

STATEMENT OF BERNARD I. DIAMOND, CHAIRMAN, COMMITTEE ON GOVERNMENTAL AND PROFESSIONAL RELATIONS, AMERICAN ASSOCIATION OF BIOANALYSTS, AND ROBERT S. BOURBON, COUNSEL

Mr. DIAMOND. Thank you very much, Mr. Chairman. I would like to introduce our counsel, Mr. Bourbon, sitting to my right, of Silver Spring, Md.

Mr. ROGERS. We are glad to have him before the committee too. Mr. DIAMOND. We do understand the problem here and although we had planned to present this committee statement in toto if you will permit me the opportunity to make a summary for a few minutes I think perhaps we can highlight the important points here.

Mr. ROGERS. Thank you.

Mr. DIAMOND. I would just like to say that I do represent the American Association of Bioanalysts, an association comprising independent clinical laboratory directors from throughout the United States. These are people who have devoted their talents to the direction and application of the life sciences to clinical laboratory analyses, those who teach such curriculums and those who hold similar commissions in the armed services or governmental laboratories.

We have since the advent of medicare supported the programs of public health and improvement of clinical laboratories and we think that the public does have a right to expect protection in the area of clinical laboratory services, and we have testified on a number of occasions before the Senate and also before the House regarding some of the issues.

However, our basic concern with H.R. 6418 in the light of our experiences under the Medicare Act is that perhaps the Secretary will receive a very broad authority in terms of licensure in interstate commerce and it is our concern that perhaps the Congress may not want to delegate that much authority in establishing regulations for laboratories in interstate commerce.

One of the important issues involves the payment of fees for issuance and renewal of licenses which is in subsection (d) (3). We are concerned here that this provision will turn what purports to be licensure into pure intimidation through selective taxation, without upper limits. Such fee should be limited as to amount absolutely and not calculated upon some arbitrary, flexible, and now unknown basis.

We think too that there should be some consideration by your committee to laboratories who perhaps do 95 percent of their work in intrastate commerce, only 5 percent in interstate commerce. Certainly provision should be made for this.

Another important consideration refers to the fact that subsections (f) and (g) provide that the license of any laboratory may be temporarily suspended without a hearing for a period of not to exceed 60 days if the Secretary determines that the public safety or welfare would be in imminent danger. We certainly have no quarrel with the concept of the public not being placed in imminent danger, but I think that you will realize that in this type of operation the closure for 60 days could really mean the ending of the operation.

We think perhaps a stay pending appeal or provision for a 2- or 3day show cause procedure might not only protect the public interest, but at the same time protect the laboratory until adjudication is made of the case.

We also want to criticize to some extent, as it appears in the bill, that the Secretary's decision as to the facts, if supported by substantial evidence, shall be conclusive. We see no reason why the findings of the Secretary should be elevated to such status, contrary to what we believe is normal administrative procedure under Federal practice.

And perhaps a summarizing statement. The bill reads that there will be excluded from the interstate licensing bill licensed physicians, ostepaths, dentists, or podiatrists, even when acting on their own patients. We submit that if the absolute standard is one of interstate service through quality control no person should be exempt.

Another question regards the Secretary's utilization of local agencies in the setting up and enforcing of the law. We ask what type of local nonprofit private agency or institution will be called upon to assist the Secretary? We think that such assistance ought to be limited to entities other than those which are comprised of individuals having an adverse economic interest to the independent laboratory; that is, professional associations or hospitals conducting laboratory tests in direct competition with independent laboratories.

I would just like to conclude. We earnestly submit that the Secretary of Health, Education, and Welfare cannot satisfactorily fulfill the intent of Congress in improvement of clinical laboratories in interstate commerce unless Congress gives him direction.

The Secretary cannot be held within reasonable bounds where the basic law provides standards which are vague or it lacks them all together. Rulemaking by Department heads should always implement legislative intent and purpose.

We therefore recommend and request your consideration of the foregoing remarks. I trust you will enter those into the hearings and very much appreciate this opportunity.

(The full statement of Mr. Diamond follows:)

STATEMENT OF BERNARD I. DIAMOND, CHAIRMAN, COMMITTEE ON GOVERNMENTAL AND PROFESSIONAL RELATIONS, AMERICAN ASSOCIATION OF BIOANALYSTS, AND ROBERT S. BOURBON, COUNSEL

Mr. Chairman and gentlemen of this committee, we are appreciative of this opportunity to express our views here today in connection with H.R. 6418.

I am Bernard I. Diamond, Director of the Diamond Laboratories, an independent bioanalytical laboratory in Philadelphia, Pennsylvania.

The American Association of Bioanalysts, of which I am Chairman of the Committee on Governmental and Professional Relations, is affiliated with the American Institute of Biological Sciences and the American Association for the Advancement of Science. I am accompanied here today by counsel, Robert S. Bourbon, Esquire, of Silver Spring, Maryland, Bernard S. Kaplan, of Morristown, New Jersey and John J. Egan, of Hartford, Connecticut, at the request of and representing State associations of bioanalysts, clinical laboratories and clinical laboratory directors in the following States:

The membership of the American Association of Bioanalysts, comprising 700 independent clinical laboratory directors, is composed of individuals who have devoted their talents to the direction and application of the life sciences to clinical laboratory analyses, those who teach such curricula and those who hold similar commissions in the armed services or governmental laboratories.

THE PUBLIC INTEREST

Without question, the public has every right to expect and receive protection in the area of laboratory services in the vital scope of interstate commerce. A great deal of information, much of it incorrect, has been brought before the Congress and carried in the press, concerning alleged deficiencies in laboratory testing. Recently, there has been substantial national publicity, on the basis of the statement of Dr. David Sencer before the Special Senate Sub-Committee, that in excess of 25% of all clinical laboratory tests in the United States are unsatisfactory. This assertion is erroneous. The basis for this data was the communicable disease center survey of 67 laboratories in federal institutions. The number of tests was not given and what was proved was the unsatisfactory performance of a certain group of federal medical laboratories. To conclude from this restricted "study" that "all laboratories in the United States" are includable within its statistics is both unwarranted and grossly unfair.

To attempt here to explain the role of competent, qualified operation of the independent clinical laboratory is at the least, a sizeable assignment in the limited time we have available. Suffice it to say, we believe the 3,000 or more independent clinical laboratories (that is, independent of a physician's office or hospital) are a valuable and irreplaceable segment of the integrated health team.

PRIOR TESTIMONY

We have testified previously, in 1965, before the Senate Finance Committee and earlier this year, on March 10, 1967, before the House Ways and Means Committee, in connection with the Social Security Amendments of 1965 and 1967. It has consistently been our position that the Medicare Program, for example, merited our support, and that reasonable regulation of the independent laboratory thereunder would be in the public interest. We have found, however, that the division of Government charged with such regulation, namely, the Department of Health, Education and Welfare, through its, "Conditions For Coverage of Services Of Independent Laboratories", has fabricated a bureaucratic crisscross of regulations which is discriminatory, ambiguous, restrictive and unrealistic.

CONCERN FOR BROADENED AUTHORITY

We are deeply concerned that the authority given to the Secretary of Health, Education and Welfare, under the laboratory licensure provisions of H.R. 6418. in light of our experiences under the Medicare Act, is far too broad and will effectively work to strangle the independent laboratory director, at a time when demand for health services is increasing, not diminishing and the availability of trained laboratory personnel diminishing, not increasing.

COMMENTS REGARDING H.R. 6418

We should like to enter the following comments regarding the Bill under discussion:

(1) Subsection (d)(1) of Section 5 of the Bill provides that a license shall not be issued for a clinical laboratory unless application therefor contain or be accompanied by such information and assurances as the Secretary finds necessary and unless the applicant agrees and the Secretary determines that such laboratory will be operated in accordance with standards found necessary by the Secretary to carry out the purposes of this Section.

EXPERIENCE UNDER MEDICARE

Our experience as laboratories regulated under Medicare is that the Secretary, even where given no authority to do so under the authorizing legislation (Title XVIII, Subparagraph 10 & 11, Section 1861 (s), Public Law 89-97) has attempted to require assurances of compliance with mandates in unrelated matters in areas where he clearly had no authority to operate. We would hope that the Congress, under this Bill, would not turn over the rule making authority completely to the Secretary, without any guidelines. Not only has the Secretary, under Medicare. adopted regulations which are grossly unbalanced in favor of hospital. pathologist and physician-directed laboratories, but these regulations are backed up by a growing body of informal rulings, of which the laboratory director learns only indirectly and whose application, we find, is being brought to bear unevenly and unfairly in the various states.

(2) Subsection (d) (3) provides for the payment of fees for issuance and renewal of licenses, subject to regulation by the Secretary. We are concerned here that this provision will turn what purports to be licensure into pure intimidation through selective taxation, without upper limits. Such fees should be limited as to amount, absolutely, and not calculated upon some arbitrary, flexible and now unknown basis. They should not be open-ended, to support what will be, we predict, a growing body of administrators.

INTRASTATE AND INTERSTATE COMMERCE

(3) Subsection (e) (2) provides for revocation, suspension or limitation of a license where an owner or operator "has engaged or attempted to engage or represented himself as entitled to perform any laboratory procedure or category of procedures not authorized in the license," notwithstanding as much as 95% of such laboratory activity apparently may be in intrastate, as opposed to interstate commerce. Subsection (e) (4) permits additional regulation by the Secretary, wherein, without guidelines or standards, he is authorized to call. at will, upon the laboratory for "any information or materials, or work on materials." Such provision should specify for what purpose these requests for information shall be made, in order to preclude harassment, invasion of privacy and abrogation of other constitutional guarantees.

"TEMPORARY SUSPENSION" AND ITS EFFECT

(4) Subsections (f) and (g) provide that the license of any laboratory may be temporarily suspended without a hearing for a period of not to exceed 60 days if the Secretary determines that the public safety or welfare would be in imminent danger. While no one can quarrel with the concept of the public not being placed in imminent danger, a temporary closure of a laboratory for 60 days or less will, by virtue of the nature of its operation, result in its being put out of business.

A stay pending appeal, or provision for a 2 or 3-day show-cause procedure, would be more equitable, protecting the public and the director from the arbitrary action of the Secretary, acting through some functionary in an area far removed, perhaps, from this seat of government, but whose action can be just as final as if the Secretary himself had nailed the door closed.

CONCLUSIVENESS OF SECRETARY'S DECISION

(5) Subsection (g) (3) provides that, in the case of an appeal to the Circuit Court of Appeals from the Secretary's decision, his findings, "as to the facts, if supported by substantial evidence, shall be conclusive."

We see no reason why the findings of the Secretary should be elevated to such status, contrary to what we believe is normal administrative procedure under federal practice.

SELECTIVE EXCLUSION

(6) Subsection (g) (1) excludes from the application of the Act the licensed physician, osteopath, dentist or podiatrist, even when acting through his employees. We respectfully submit that if the absolute standard is one of interstate service through quality control, no person should be exempt. It is doubtful whether a professional, performing infrequent testing procedures, is invariably or even regularly, capable of rendering more accurate services than an independent laboratory director who is devoted full time to such testing procedures and who may have been in the field 20 years or more competently serving his community.

It is to be noted that the language authorizing in this Subsection the performance of laboratory tests "solely as an adjunct to the treatment of his own patients," may still permit interstate testing activity on other than the professional's own patients.

UTILIZATION OF LOCAL AGENCIES

(7) Under Subsection (j), we ask what type of local "non-profit private agency or organization" will be called upon to assist the Secretary in carrying out his functions under the Act? Such assistance ought to be limited to entities other than those which are comprised of individuals having an adverse economic interest to the independent laboratory, e.g. professional associations or hospitals, conducting laboratory tests in direct competition with such independent laboratories.

UNRESTRICTED REGULATION

We view the laboratory control section of H.R. 6418 as an open invitation to the Secretary of Health, Education and Welfare, without limitation, to regulate the independent laboratory out of business, a new type of uncontrolled regulation to be superimposed over and above the over-inclusive regulations already promulgated under Medicare.

This type of federal licensure also fails to take into account those states which have regulated, or are in the process of doing so, the field of independent laboratory procedures. Pursuant to the current laboratory regulations under Medicare, the Secretary has already guaranteed the development of standardized regulation in the states. As a practical matter, the states, being local certifying agencies, must now coordinate with the Secretary.

INTENT OF CONGRESS

We earnestly submit that the Secretary of Health, Education and Welfare cannot satisfactorily fulfill the intent of Congress in improvement of clinical laboratories in interstate commerce, unless Congress gives him direction. The Secretary cannot be held within reasonable bounds, where the basic law provides