The saga of “The Tube” began for me in 1957. At that time, I was the House Physician to Sir James Paterson-Ross and Sir Eric Scowen on the Professorial Unit of St. ’Bartholomew’s Hospital in London, England.
I was paid 400 pounds per year with room and board, for 24-hour, 365-day duty, while living in the hospital. One hundred pounds was withdrawn for food, but our shoes were cleaned! The job was considered an honor and allowed you to learn of the natural history of disease in the patients under your care. It certainly did this, but in the process you became a sleep-deprived autonomous robot — neither desirable nor safe.
One day in the long ward I cared for, I looked at a laboratory hematology report and said to myself, “How do I know that this slip bears any relationship to the blood sample I sent?” I also noted the equipment for collecting a blood sample and the makeshift system by which it got to the laboratory. Similarly at that time, as we gowned and masked to perform a lumbar puncture, the cerebrospinal fluid samples went to the laboratory in six 10-mL test tubes in a wooden test tube rack, with each tube having a cotton wool plug. This cavalier attitude toward a sample that had come from a patient’s spinal canal was deplorable!
I started to think of a new tube for collecting blood samples. A friend of my wife-to-be was the daughter of a Knight of the realm who ran a huge industrial enterprise. He kindly took my idea and produced a plastic tube with an attached stopper that would plug the tube. This was created by the relatively new wonder of injection molding of plastic. I put some blood into one of these tubes and placed it in my back trouser pocket for three days. It did not leak, so I felt I had something.
After my year at Bart’s, I was fortunate to be asked to travel north to be the clinical assistant to Sir Stanley Davidson in Edinburgh. He was a Professor of Medicine and a hematologist. He was having a problem in his emergency department with an unreliable method of estimating the erythrocyte sedimentation rate (ESR), which a registrar had brought back from a visit to Professor Maxwell Wintrobe in Utah. I was given the charge to resolve the problem. I was offered little finance, and I “borrowed” my equipment from the hospital. I retired, part-time, to the rafters of the attic over the medical wards of this ancient university hospital built with massive granite blocks. After about a year, I found the solution and explained it to Sir Stanley.
He then asked me to report to his office at 5 p.m. for three days in succession, where he trained me on how to present my findings to the Pathology Society of Edinburgh. He streamlined my talk to a 15-minute presentation for which the comment at the meeting was, “You went too fast.” I then had the help of a colleague, Dr. Howard Davies, who edited the write-up of this research, and we shipped it off to the British Medical Journal.
Back in Edinburgh, I was reading The Times when I noticed an advertisement for a paid fellowship post at the Australian National University (ANU) in Canberra to work in virology. En route to Sydney, Australia, during a five-week trip on a P&O liner, I received a telegram from Moscow inviting me to join the International Committee on Standardization in Hematology (ICSH) as part of a committee to standardize the ESR. Swedish internist Alf Westergren was sitting on this committee; he had used the ESR as a pregnancy test. The committee was a part of the International Society of Hematology, which was planning to standardize hemoglobin and the ESR, two commonly used blood indices considered somewhat messy in the practical world.
While in virology at the ANU, I developed a reproducible mouse fibroblast system that cell biologists found useful. During this work, I noticed that a solution containing a pH indicator would change color when pipetted through soda glass, but not through Pyrex. It became obvious that the type of glass to be used for hematology was crucial. I was in Australia for five years in Canberra and later in Melbourne at the Baker Institute of Medical Research. Here I was working on ion-specific electrodes. One of my colleagues acted as a way station for blood samples arriving in modified evacuated tubes from Dr. Carleton Gajdusek in New Guinea on their way to the National Institutes of Health (NIH). He was working with Kuru in the Fore tribe, and developed his concept of “Prions,” for which he was awarded the Nobel Prize in 1976. It became clear at this point that a blood sample had to survive any environmental conditions and had to be able to travel by air.
Requirements of an Evacuated Tube
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After five years in Australia, I traveled to the United States, where the space age had produced a gadget that would transform the charge on my ion-specific electrode. This would give the connecting cable a resistance of 1,000 Ω instead of 1,000,000 Ω, which permitted the meter to be gloriously stable. I was just in time to join the ICSH in their standardization efforts for hemoglobin and ESR. Dr. Russell Eiters who was, at that time, a member of ICSH, was also a leader in the U.S. National Committee for Standardization of Clinical Laboratory Standards (NCCLS), now the Clinical and Laboratory Standards Institute (CLSI) in Wayne, Pennsylvania. He saw my BMJ paper on the ESR and invited me to visit him at his laboratory in Kansas. He gave me a very good lunch at the top of a high building and suggested I chair an NCCLS committee to work on a standard evacuated tube. It was obvious that such a tube was necessary, because apart from hematologic needs, no laboratory equipment could be designed until the size and nature of the tubes was fixed.
Our inaugural committee met in November 1974 at the Key Bridge Marriott in Arlington, Virginia and initially gathered every three months. I had roughly 14 core members and 14 visitor members, plus welcome guests such as Dr. Lewis from Hammersmith, London, who represented Dr. Sacker from the British equivalent team. Together, our team members represented an extraordinary level of expertise from national organizations such as the NIH, Centers for Disease Control and Prevention, airlines, the military, and multiple industries. This meant that my duties were only to corral, chivy, and direct. Some had their egos, rivalries, and proprietary differences, but they all agreed to work together-- and work they did. They would start Friday evening in three groups dealing with different parts of the whole. On Saturday morning, there was more of the same to include late arrivals, and then on Saturday afternoons we would all gather as a core cohesive large body and amalgamate progress, swap ideas, and generally move things forward. Sundays were for more of the same and to prepare for the next gathering.
As we progressed with the tube, other priorities appeared, and we continued to meet as a core group, while individual members took up the reins for four more hematology standards. Skin puncture for hematology specimens, especially from infant heels, was started by Dr. Tom Blumenfeld of Columbia University. He carried out autopsy measurements of heel skin depth and what lay underneath in 13 dead children. This practice enabled him to arrive at safe spots around the heel of the foot for lancet puncture to obtain maximal blood without damaging the underlying calcaneus and other structures. This beginning blossomed into consideration for skin puncture for obtaining blood samples from 1) the severely burned; 2) the extremely obese; 3) patients with severe malignancies in which veins are, for example, saved for chemotherapy; 4) geriatric patients with fragile veins; and 5) individual patients who, for example, test at home for glucose.
While Tom was doing his superb work, core members were beginning to generate ideas for blood collection, transportation, and laboratory acceptance. Next came the venipuncture standard, which was led by Dr. Jean Slockbower of the Mayo Clinic. This important and detailed standard was so popular that it spawned the American Phlebotomy Association. The transport standard brought all kinds of informed and varied expertise to consider: the response to heat, light, cold, trauma, vibration, storage, and the effects of shipping and handling, especially by that of aircraft shipments. Polypropylene and Pyrex containers seemed to be the most practical for diagnostic and ecological specimens, and it was hoped that their use would stop the 20-percent loss of hematology specimen en route from the African continent to the CDC. These four standards were designed for the safe transport of specimens from the individual to the laboratory (refer to online supplement, ‘Requirements of an Evacuated Tube’). We were now all confounded as to what to do with specimens after laboratory acceptance until Dr. Roger Calam developed his subcommittee to solve the multitude of problems within the modern laboratory.
Thus, we now had five basic standardized procedures for the USA which I then took to my subcommittee of the ICSH, which included a dozen of the best international hematologists at that time from the United States, United Kingdom, Israel, Russia, Thailand, China, Australia, Canada, Germany, Sweden, and other nations. We met in Montreal and approved the five NCCLS hematology standards for international acceptance, only to find that Dr. S.M. Lewis (London), the Secretary of the ICSH, was not about to let a bunch of American standards become international. He canceled our international subcommittee and thereby its conclusions. His Dutch secretary supported his decision. Such is international politics.
I believe our NCCLS committee for hematology succeeded in creating five badly needed standards, which expanded in time to further standardize requirements for toxicology, heparin, and many others. I now feel that the results on laboratory reports really do represent the blood specimens submitted. In this regard, the U.S. Joint Commission on Accreditation of Hospitals (now the Joint Commission) felt the same way and ruled in our favor such that hospitals not using our standards would not be accredited.
Dawson extract 8/18/15
Those interested in standardization within medicine in general, and in the NCCLS in particular, can contact CLSI to become a member, to order individual documents, or for their catalog of hundreds of standards. Similarly, membership in bodies such as the ISH and ICSH, which meet every two years, is ideal for CME. Their meetings are exciting, interesting, and provide opportunities for long-lasting overseas friends.
