So, multiphasic screening, in my opinion, is not a futuristic dream. It is here now.

There are two other technical problems, which have recently been solved, which make it feasible. One is sample identification. When you start doing a thousand determinations, an hour or 2,000, it is awfully hard to keep the patients straight.

As Dr. Slack pointed out, the patients sometimes even come into the hospital under one name and go out under another. In fact, we have on one occasion had two patients in the same room with the unusual name of Heatherborough and the same first initial. So, patient identification is a difficult problem. But computers have solved this, in two different fashions. The IBM Co. has just put out a new "1080" system, in which by redesign of the punchcard and the development of some special hardware, the blood sample is identified as soon as it comes out of the patient's arm and that identity is maintained automatically until the results are printed. It is important, in my opinion, to realize that in the most elegant way of handling multiphasic screening, the results for ECG, spirogram, history, and everything, could come out ready for the doctor in integrated form on the same sheet, all with automatic identification and collation.

Another problem is sample stability. Both the identification of samples and the sample stability problem have been solved by the King County's Research Laboratory of New York City in a rather different fashion. This laboratory is one of the pioneers in providing low-cost, automated data to physicians in that area. The problem with blood stability is that the minute you take blood from an arm, the cells and the plasma begin to react together to change the composition. You can separate the two by centrifugation, as shown here, and pouring off the upper layer, which is the part we are always interested in analyzing. But the minute you open the tube, you get problems with the fact that there is loss of some parts of the sample to the open air. Bacterial contamination is also a risk. So that stability is a problem.

A technique has been developed, which uses a sealed system. By using a vacuum tube, which has a preservative in it, and a doubleended needle, one can take the clear plasma off the top of the cells. (It is not as clear as it should be, because I carried it up here in my pocket and it got slightly mixed again.) But you see the principle.

Everything is disposable except what you want a sealed sample of stabilized plasma. Tests have shown that this can be shipped through the mail, and 7 or 9 days later the most sensitive constituents are still there, in the original concentration. So that the geographical problem has been solved. Blood can be kept stable for clinical chemical analysis.

There is no other "fundamental technical problem" that I can see. We should be using mutiphasic screening far more than we are today. Multiphasic screening is at its best when it is most widely used. I think multiphasic screening centers, such as we have been talking about, should apply not only to the elderly, but to hospital in-patients, outpatients, and to the normal person, young or old. If so, why then do we find it in places like King's County Research Laboratory (an independent laboratory which is not in the best reputation among certain physicians, although among those I have met, who have checked its

accuracy, it has a very high reputation), Permanente Foundation, another independent institution, Technicon Corp., the Swedish Government-why are American hospitals and medical centers not leading the way?

There are a number of problems, two of them most serious. These are subtle problems, and in my opinion they stand squarely across the path of success in multiphasic screening.

The costs I was talking about in the previous flip chart were the real costs. Unlike them the charges to patients have not fallen dramatically with time.

This is a pattern which has had serious effects on the laboratory for many years and now stands in the way of multiphasic screening. Think of it a moment. If someone is being charged $5 for a laboratory determination that really costs 50 cents, and if the difference is not going to the support of the laboratory, then there is no motivation for improving the services of the laboratory. Why? Because if you improve the services; there is no reason, and no excuse for increasing charges; they are already too high. Then there is no motivation for improving the services in the laboratory except the dedication of those right on the firing line in the laboratory. What effect has this on the laboratory? Well, the technicians and people right on the firing line, who have a great deal of dedication, find that that dedication wears very thin after the hospital has added 10 percent more beds without changing the size of the laboratory, or its budget-for about the fifth time.

The net result of this and I can't state this too strongly-is that, at least with respect to clinical chemistry which I know best, the laboratory work done for patients today is mediocre to poor, in a country where the technology can provide excellent services. This statement may not apply to any service except chemistry; I don't know. Application of the "Rule of 13" makes one suspect that it does apply in other services. You know the rule, "If a clock strikes 13 times, the 13th chime is not only incorrect; it casts doubt on the other 12. So it may be a wider pattern than just chemistry."

A second thing standing in the way of multiphasic screening is the confusion on the part of many people, including the medical profession, between quantitative data and qualitative data. I say Mr. Smith weighs 270 pounds and is 5 feet 2 inches tall. That is a quantitative statement. It is expressed in numbers. If I say Mr. Smith is overweight, that is a qualitative statement. The latter statement is a clinical judgment. It can properly be made only by a physician.

The former statement, "the man weighs 270 pounds and is 5 feet 2 inches tall," is a quantitative statement. It can be made best by the person who did the weighing. Of course, the physician is perfectly capable of making an accurate weighing, but in all honesty physicians are not trained and are not interested in operating equipment like the complex gear we see here today.

If the physician does operate this equipment, he is wasting his training. But the American Medical Association has passed a resolution, saying that the conduct of laboratory examinations is the proper responsibility of physicians, and implying strongly that it is the practice of medicine.

Physicians are not trained in medical school to perform careful quantitative determinations. This is the area of chemists, physicists,

engineers, et cetera. If a physician insists on operating these instruments, he is wasting his training. If he insists on supervising that operation, he will not get top-flight chemists, engineers, or physicists to work under him. They won't work under that kind of supervisor. The result is that the excellent chemists, physicists, et cetera, being produced by our universities of today, have for many years kept away from the clinical service field and by now have forgotten it. They are asleep to their responsibilities in this area.

Unless they are made to understand these responsibilities, and unless the confusion between quantitative and qualitative which has produced this unreasonable attitude is changed, they will remain asleep. I think training programs are in order for chemists, physicists, engineers, to wake them up to their responsibilities in this area and to teach them best how to discharge them.

In spite of these and other serious problems, which explain the reasons that multiphasic screening is seen in independent laboratories, et cetera, instead of where one would expect to see it, in large medical centers in spite of these difficulties-I think multiphasic screening will go ahead and break down these barriers. It must. It is logical.

But we must understand that the real motivation for multiphasic screening is not that it is less expensive, because it will not cost less. It will just increase the service. The manpower required will not decrease. The service will increase tremendously. But the goal, I think, will be reached and reached very shortly; namely, the goal of providing to the physician, by the most competent people to do it, all of the information that can possibly be obtained for him in the analytical part of the procedure. I believe this will lead us to a new era in medicine where the physicians can concentrate on those parts of the field that are most rewarding to them and best fit their training-diagnosis, and treatment-which is the goal of it all.

I would like to discuss the two instruments on the right-hand side of the room, and if the member of the committee who is here would like to come down closer to it, we can do it far more easily.

Senator NEUBERGER. Í keep worrying that a bell will ring any moment and we don't want to interrupt.

Now, what are all of these (pointing to lights on the control board)? Dr. THIERS. This indicates which of the steps is in process at any given time. All systems are "go," as they say, as indicated by the bottom series of lights. This shows how quickly an analysis can be made. In this case it is 30 seconds.

This is the machine I have spoken about, which is today's ultimate in multichannel, continuous-flow analysis. You are pointing to the heart of the system now. Under your hand is a pump which moves the liquids through the various tubes. The samples are actually being picked behind you, here. Each of these is from a different patient. The sample moves through this tube, and then divides into different streams at this point. There are more than a dozen reagents involved in these 12 tests, and a wide variety of different procedures is being carried out. For example, this device removes interfering substances from the samples, things that make the tests impossible. And all of these streams then converge on the measuring device, a colorimeter, after having been treated, and passing through coils which time the reaction. Each of these different colors is a different reagent producing a color which can be measured later on and which indicates the concentration.

Senator NEUBERGER. How much blood serum does it use? Dr. Thiers. The amount of blood used can be seen by the amount, a little less than a teaspoonful.

All of these then pass into that device, which measures the results of the reaction.

Senator NEUBERGER. Like telephone wires in a dial system.

Dr. THIERS. There are real analogies to what you see here and the wires of telephone exchanges.

The results are printed up as a line, here, across a chart.

example of this chart.

The chart is as follows:

Here is an

This can be sent directly to a physician, and the horizontal position at which a line crosses the calcium scale, for example, tells the physician that the calcium value in the blood of this patient is 9.8. The gray area indicates the normal range, so that, as you can see, this calcium is in normal range.

The inorganic phosphorus is also in normal range, but uric acid is not, and is quite high, as you can see. There are 12 different important chemical determinations being made here. All 12 come out on this one sheet.

They are then printed out here in a form suitable for putting into a computer.

Thank you, Senator Neuberger.

Senator NEUBERGER. We have certainly appreciated the wonderful demonstrations we have just seen.

We are trying to keep the program on schedule, and we have a number of witnesses yet.

I believe Dr. Lester Goodman is here and will be our next witness. Dr. Goodman is Chief of the Biomedical Engineering and Instrumentation Branch, Division of Research Services, National Institutes of Health, here in Bethesda, Md.

Dr. Goodman will be the last witness before we recess for lunch, and I would like to resume the committee as early as possible after just an hour's recess, and plan to come back about 1 o'clock, because the Senate will be having a number of votes this afternoon, and it may be necessary for us to interrupt.

So, after Dr. Goodman we will take a brief recess until 1 o'clock and we can pick up with the scheduled witnesses.

STATEMENT OF LESTER GOODMAN, PH. D., CHIEF, BIOMEDICAL ENGINEERING AND INSTRUMENTATION BRANCH, DIVISION OF RESEARCH SERVICES, NATIONAL INSTITUTES OF HEALTH, BETHESDA, MD.

Dr. GOODMAN. Madam Chairman, the testimony presented this morning and yesterday has discussed the problems of medical diagnosis and prevention. The needs of multiphasic screening and early detection of disease have been well stated. Certainly the need has been justified and estimates of the ultimate benefits have been made. It has been reiterated in the comments and vividly displayed by demonstrations that technology has a very important key role to play, not only in multiphasic screening and diagnosis, but in the entire practice of medicine.

What I would like to attempt here is a brief description and characterization of technology, in some basic, somewhat abstract terms, and to examine its interrelationships with the field of medicine. Comments pertinent to fields of medicine, such as surgery, therapy, and diagnosis, certainly have great bearing on our immediate focus on multiphasic screening.

The format that I have adopted is illustrated by table 1 of my prepared statement.

The purpose of technology in medicine is to provide tools to perform medical tasks. For sake of brief perspective, I have arbitrarily parti