CHAPTER IV
Administrative Considerations in the Zone of Interior
The blood and plasma program of the U.S. ArmyMedical Department in World War II involved the cooperation of a number ofagencies, both in and out of the Department, including the Army Medical School;NRC (National Research Council); the Office of The Surgeon General; the NationalInstitute of Health; the U.S. Navy; the American Red Cross; and the millions ofdonors who gave their blood to supply blood, plasma, and byproducts of blood forthe Army, including the Army Air Forces, and the Navy. It was amagnificent national endeavor, and it saved countless lives.
The activities of these various agenciesoccurred, for the most part, at the same time, but they are most convenientlydescribed under special headings (1).
ARMY MEDICAL SCHOOL
Organization of the Blood Research Branch
The first steps in the plasma andblood program in World War II were taken early in 1940 by Col. (laterBrig. Gen.) Charles C. Hillman, MC, Chief, Professional Services Division,Office of The Surgeon General (fig. 6). His first action was to request Col.(later Brig. Gen.) George R. Callender, MC, Commandant, Army Medical School(fig. 7), to organize a blood research branch in the Division of SurgicalPhysiology at the school.
At the same time that Colonel Hillman made thisrequest, he, acting for The Surgeon General, also requested the Division ofMedical Sciences, NRC, to assemble a civilian committee to act informally, in anadvisory capacity to the Surgeons General of the Army and the Navy. TheCommittee on Transfusions (p. 73) was appointed in response to this request.
The Division of Surgical Physiology at theArmy Medical School had been set up in 1936, by Capt. (later Col.) Sam Seeley,MC, but it had ceased to function in 1938, after 2 years of very activeoperation, when he was transferred elsewhere. When it was reactivated in thespring of 1940, Capt. (later
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Col.) Douglas B. Kendrick, MC, was selected tohead it, because of his earlier training and experience.1
Personnel
The original personnel of the division consistedof Captain Kendrick (fig. 8) and an enlisted man who served as technicalassistant. The number of its personnel varied from time to time, but the listfor July 1944 may be taken as typical of the roster for the greater part of thewar:
Officers:
One lieutenant colonel, MC, whose chief duties were administrative.
Two captains, MC, whose chief duties concerned production and research.
One captain, SnC, whose chief duty was research.1During a civilian surgical residency at Grady Hospital, in Atlanta, under Dr. Daniel C. Elkin, Captain Kendrick had a considerable experience in traumatic surgery, with its attendant problems, including shock. He also served under Dr. Fred Rudder, who was greatly interested in the use of whole blood in shock and who devised an ingenious apparatus for direct transfusion.
After his service at Grady Hospital, Captain Kendrick entered the Army Medical Corps and, because of his previous experience, he was sent for a year to the Institute of Experimental Medicine at the Mayo Clinic, Rochester, Minn., where he worked on gas gangrene; the special uses of the sulfonamides; anesthesia (under Dr. John S. Lundy); shock; and replacement fluids. The plan had been that on his return to the Army Medical School, Captain Kendrick should continue Captain Seeley's work. Funds for research, however, proved so inadequate that this plan could not be carried out. Captain Kendrick was therefore assigned to the orthopedic service, Walter Reed General Hospital, Washington, D.C., and he was transferred from it when, at Colonel Hillman's request, the Department of Surgical Physiology, Army Medical School, was reactivated, with research in blood and blood substitutes as its chief objective.-J. B. C., Jr.
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FIGURE 7.-Col. (later Brig. Gen.) George R.Callender, MC, Commandant, Army Medical School.
Enlisted male personnel:
One technical sergeant; one technician, fourth grade; one technician, fifth grade; one private, first class. Three-quarters of the time of these enlisted personnel was spent on production and the remainder on research.
Enlisted female personnel:
One technician, fifth grade, and four privates, first class, whose time was similarly divided.
Civilian personnel:
One laboratory technician, P-2, used for research.
Two clerk-typists, CAF-4, used for office work.
One laboratory helper, SP-1, used for utility purposes.
Liaison
As long as he was connected with the bloodprogram (from 1940 until 18 November 1944), Colonel Kendrick served as chief ofthe research program at the Army Medical School. Even when he was givenadditional duty in the Office of The Surgeon General, in 1943, as SpecialRepresentative on Blood and Plasma Transfusions, it seemed wiser for him tocontinue to operate under the table of allowances at the School, so that hemight continue to have free access to the research facilities needed in theprogram. Policies for the blood and plasma program were established in theOffice of The Surgeon General, but all operations were conducted at the ArmyMedical School. The arrangement proved highly efficient.
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During Colonel Kendrick's connection withthe blood program, there was always the closest possible cooperation between theArmy Medical School and the Office of The Surgeon General. Colonel Callender atthe School, General Hillman in the Office of The Surgeon General, and Col.(later Brig. Gen.) Fred W. Rankin, MC, Chief Surgical Consultant, Office of TheSurgeon General, and his staff gave unlimited support to him in all hisactivities, and all matters concerned with blood, shock, and resuscitation werereferred to him as a matter of routine. From the beginning of the blood program,although he was not officially appointed in that capacity until late in 1943,Colonel Kendrick, for all practical purposes, served as consultant to TheSurgeon General in these matters.
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Development of the Program
The first activity of the blood researchprogram was a survey and analysis of the relevant literature and the building upof a large reprint file. At this time, the literature on shock was voluminous(and confusing), but the literature on plasma and other blood substitutes wasrather scanty, and contributions on liquid plasma were just beginning to appear.
Information on these subjects was alsocollected, by personal visits, from the following sources:
Mr. (later Captain SnC) John Elliott, Chief ofLaboratory at the Rowan Memorial Hospital, Salisbury, N.C., who had developed atechnique of processing sterile, pyrogen-free plasma in liquid form. When Mr.Elliott later entered the U.S. Army, he was assigned to the Army MedicalSchool, where he instructed personnel in the processing of the liquid plasmaused in Zone of Interior hospitals. He also contributed to the development ofthe vacuum bottle manufactured by the Baxter Co. and used, with certainmodifications, for both plasma and whole blood during the war.
Dr. Max M. Strumia, pathologist at the BrynMawr Hospital, who had done special work on dried plasma.
Dr. John Reichel, of the Reichel Laboratories,Kimberton, Pa., who had worked with Dr. Strumia on the development of equipmentfor drying plasma.
Dr. Stuart Mudd, Professor of Bacteriology,University of Pennsylvania School of Medicine, Philadelphia, Pa., and Dr. EarlW. Flosdorf, an experienced refrigeration engineer, who had worked with Dr. Muddas his research assistant in freezing and drying plasma and in the preparationof serum.
Information was also secured from Sharp &Dohme, a firm which had long been interested in the preparation of antisera andother immunizing agents. This company had done considerable work with typhoidand other vaccines, and, with the help of Dr. Reichel, had pioneered in thedevelopment of vacuum- drying equipment.
The activities of the Division of SurgicalPhysiology (fig. 9) included, in addition to the blood research program, studieson, or supervision of studies on, dried and liquid plasma and its production foruse in the Zone of Interior (fig. 10); studies on human serum albumin and onbovine albumin; studies on various proposed blood substitutes, such as gelatin,pectin, synthetic plasma, and globin; studies on group O blood; studies on theRh factor; studies on typing sera; and studies on blood preservatives. Thedesign and testing of plasma and transfusion equipment were also part of thework of the division. These various activities are described under appropriateheadings.
One of the functions of the Division ofSurgical Physiology was the review of manuscripts and the evaluation ofsuggestions submitted by interested lay persons as well as by medical personnel.For various reasons, many papers were not considered suitable for publication intheir current form. The suggestions covered a wide range: one physiciansuggested the treatment of shock by ultraviolet therapy. Another declared thatif the technique he
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proposed for the surgical treatment of anuriaresulting from transfusion incompatibility were not adopted, there would bethousands of deaths from uremia in crushing injuries and from the transfusionkidney during the invasion of the Continent. One manuscript was chieflyconcerned with condemnation of the apparatus that had been used with greatsatisfaction for indirect transfusions for almost 3 years. Another was based onthe false premise that the treatment of shock would be carried out by untrainedenlisted personnel; the adoption of the apparatus described by the author forentering the veins would, in his opinion, solve this problem.
The interest behind these suggestions wasgreatly appreciated, but most of them were entirely impractical and quiteunsuited for field use. They were always acknowledged, and in these letters itwas pointed out to the physicians and others who had made the suggestions thatthe circumstances of warfare permitted the use of only simple, proved, andaccepted methods of treatment.
Personnel of the Division of SurgicalPhysiology during the course of the war prepared and published a large number ofpapers on the various phases of the blood and plasma program. They are cited inappropriate places in this volume.
The training courses conducted at the ArmyMedical School are described elsewhere (p. 86).
OFFICE OF THE SURGEON GENERAL
In 1939, before the outbreak of WorldWar II, a blood transfusion service was organized in the British Army, headed byBrigadier (later Sir) Lionel E. H. Whitby, RAMC (p. 15). In sharp contrast, theOffice of The Surgeon General did not organize a section devoted to thisspecialty until November 1943, and never, during the entire war, was there asingle medical officer in the office whose entire time was devoted to mattersconcerned with blood and plasma transfusion (2). It is true that, for abrief period in 1943, Col. Charles F. Shook, MC, served as SpecialRepresentative of The Surgeon General for the Blood Plasma Program. His servicein this capacity, however, did not parallel that of Brigadier Whitby; it waschiefly concerned with production and supply and not with the professionalaspects of the problem.
The initial responsibility for the blood andplasma program, as just described, was given to the Division of SurgicalPhysiology, Army Medical School. In late 1942, it was transferred to the Surgery(later the Surgical Consultants) Division, Office of The Surgeon General, andLt. Col. (later Col.) B. Noland Carter, MC (fig. 11), was made responsible, inaddition to his other duties, for all matters connected with fluid replacementtherapy in shocked casualties.
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Establishment of the Transfusion Branch
On 24 November 1943, a Transfusion Branch wascreated in the Surgery Division, Office of The Surgeon General, with ColonelCarter serving as Chief, again in addition to his other duties in the division,and Maj. Frederic N. Schwartz, MAC, as Operations Officer. The establishment ofthis branch was the outgrowth of a memorandum from General Rankin to The SurgeonGeneral on 5 July 1943, in which General Rankin pointed out the necessity forsuch a branch because of the tremendous growth of the plasma and albuminprograms and their increasing complexity(3).
Shortly after this branch was established,Colonel Kendrick was appointed Special Representative toThe Surgeon General on Blood and Plasma Transfusion. On 18 November 1944, whenColonel Kendrick left the Zone of Interior on permanent change of station (p.603), he was succeeded by Maj. John J. McGraw, Jr., MC,who had had a wide experience in this field in the Mediterraneantheater (p. 402).
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Functions
The Transfusion Branch eventually carried theentire responsibility for the blood procurement program from the collection ofthe blood to the point at which it was placed on planes for oversea shipment(chart 1). Major Schwartz had performed many of the same functions in hisprevious assignment in the Supply Division, Office of The Surgeon General.
The functions of the chief of the TransfusionBranch were as follows (4):
1. To act as liaison officer with the AmericanRed Cross and as adviser to the director of its blood donor program, includingthe publicity and recruiting phases of the program and changes in donor quotasto fulfill existing contracts.
2. To provide and maintain a force of 60medical officers for duty in the blood donor centers.
3. To assist in procurement of equipment andsupplies for the blood donor centers and the processing laboratories.
4. To maintain contact with Selective Service,so as to secure deferment and retention of essential technical personnel.
5. To maintain data on bleedings, finishedunits, issues, and stocks.
6. To act as liaison officer between theOffice of The Surgeon General and the Blood Substitutes Subcommittee, NRC; theNational Institute of Health; the representative of
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CHART 1.-Finalevolution of organization chart, Transfusion Branch, Surgical Consultants Division, Office of The Surgeon General, July 1944
the Navy on blood, plasma, albumin, and byproducts; and thealbumin pilot laboratory at the Harvard Medical School under Dr. Edwin J. Cohn.
7. To coordinate with the commercial biological laboratoriesall technical matters pertaining to the production of plasma, albumin,byproducts, and intravenous solutions, and, by repeated inspection of theselaboratories and testing of their products, to insure adequate production ofacceptable material for the Armed Forces.
8. To secure from the Legal Division, Office of The SurgeonGeneral, advice on any legal questions that might arise in connection with thecontrol and use of plasma, albumin, and byproducts processed from bloodcollected by the American Red Cross and turned over to the Army for its use.
9. To coordinate action in the various divisions of the Officeof The Surgeon General on all matters pertaining to plasma, albumin, bloodsubstitutes, and intravenous solutions.
10. To represent The Surgeon General in transactions withmilitary missions and purchasing agencies concerned with plasma and otherproducts.
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The Transfusion Branch was also responsible for thepreparation of circular letters and other publications concerned with blood,plasma, albumin, and byproducts. Among these publications were:
1. Circular Letter No. 108, Office of The Surgeon General, 27May 1943, subject: Transfusion of Whole Blood in the Theaters of Operations (5)(p. 463).
2. War Department Technical Bulletin (TB MED) 204, 24 Oct.1945, subject: Complications of Blood Transfusion (6).
3. A laboratory manual of technical procedures, standard atall blood centers, and issued in March 1945 by the Army Whole Blood ProcurementService (7).
Liaison With the Navy
In April 1940, shortly after Captain Kendrickhad been assigned to the Division of Surgical Physiology, Army Medical School,Lt. Cdr. (later Capt.) Lloyd R. Newhouser, MC, USN, was assigned, withcomparable duties, to the National Naval Medical Center, Washington, D.C. (fig.12). They encountered each other in the course of their work, and, since bothwere trying to accomplish the same purposes, it seemed only sensible to pooltheir efforts. This they did from 1940 until late in 1944, when both wereassigned to oversea duty. Their collaboration, while entirely unofficial, wasapproved and encouraged by their superior officers in both services.
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This association proved extremely fruitful.From the beginning, Captain Kendrick and Commander Newhouser kept each otherclosely informed of their plans and their projects, and this exchange ofinformation eliminated many duplicating and overlappingactivities. Many items were standardized jointly by the Army and the Navy, andmost orders could be placed with a consideration of joint needs. The intimateliaison was an important factor in the maintenance of a smoothly running programfor the procurement of plasma, albumin, and, finally, whole blood. It was out ofthis informal arrangement that formal plans were eventually consummated for theNavy to assume the responsibility of flying blood to the Pacific (p. 599), sincethe Army was already occupied with the task of flying blood to Europe (p. 494).
NATIONAL RESEARCH COUNCIL
Historical Note
In 1916, when U.S. involvement inWorld War I began to seem imminent, the National Academy of Sciences offered itsservices to the Government (8). The offer was immediately accepted byPresident Wilson, who requested the academy to organize the scientific agenciesof the country, not only in the interests of national defense but with theultimate object of advancing scientific and industrial progress. The NationalResearch Council was accordingly constituted by the academy and renderednoteworthy service in various fields during World War I.
In 1918, President Wilson, by Executive order,requested the academy to take the necessary steps to perpetuate the council, sothat its services could be utilized in time of peace. This was done. As aresult, when World War II broke out, the council was already organized forimmediate action, and it did much useful work before the United States enteredthe war in December 1941. In fact, the activities of the council before thisdate furnished one more piece of evidence that the President and his adviserswere aware that, for all practical purposes, the country was already at war.
Organization of Committees
Committee on Transfusions.-The Committeeon Transfusions, Division of Medical Sciences, NRC, which held its first meetingon 31 May 1940 (9)2consisted of:
Dr. Walter B. Cannon, Chairman, Professor ofPhysiology, Harvard Medical School.
2It is impossible to overemphasize the importance of the establishment of this committee at this time, 18 months before the United States was precipitated into World War II. It meant that significant advances could be made in the blood and plasma programs before the actual need for them arose. This committee and its subcommittees, as already noted, were established at the request of The Surgeon General (Maj. Gen. James C. Magee), and representatives of the Army and the Navy were present at all meetings to present the needs and interests of the services.
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Dr. Alfred Blalock, Professor of Surgery, VanderbiltUniversity School of Medicine.
Dr. Everett D. Plass, Professor of Obstetrics and Gynecology,State University of Iowa College of Medicine.
Dr. Strumia, Assistant Professor of Pathology, University ofPennsylvania Graduate School of Medicine.
Dr. Cyrus C. Sturgis, Professor of Internal Medicine,University of Michigan Medical School.
Subcommittee on Shock.-At its initial meeting on 31May 1940, the Committee on Transfusions appointed a Subcommittee on Anesthesiaand Shock (usually called the Subcommittee on Shock), consisting of:
Dr. Blalock, Chairman.
Dr. Henry K. Beecher, Professor of Anesthesia, Harvard MedicalSchool.
Dr. Norman E. Freeman, Assistant Professor of ResearchSurgery, University of Pennsylvania School of Medicine.
Dr. Paul D. Lamson, Professor of Pharmacology, VanderbiltUniversity School of Medicine.
Dr. John S. Lundy, Professor of Anesthesia, University ofMinnesota Graduate School of Medicine.
Dr. Leo Eloesser, Clinical Professor of Surgery, LelandStanford University School of Medicine.
Dr. Ralph M. Waters, Professor of Anesthesia, University ofWisconsin School of Medicine.
Dr. John Scudder, Instructor in Surgery, Columbia UniversityCollege of Physicians and Surgeons.
Subcommittee on Blood Substitutes-TheSubcommittee on Blood Substitutes appointed by the Committee on Transfusions atits initial meeting consisted of Dr. Sturgis, chairman, Dr. Plass, Dr. Strumia,and Dr. Oswald H. Robertson, Professor of Medicine, University of Chicago Schoolof Medicine.
Dr. Sturgis and Dr. Plass resigned from this subcommittee on19 April 1941 but continued to serve on the Committee on Transfusions. TheSubcommittee on Blood Substitutes finally consisted, in addition to Dr.Robertson, Dr. Scudder (secretary), and Dr. Strumia, of the following:
Dr. Robert F. Loeb, Chairman, Professor of Medicine, ColumbiaUniversity College of Physicians and Surgeons, who served until 2 June 1944,when he was succeeded by Dr. Joseph T. Wearn (10).
Dr. Edwin J. Cohn, Professor of Biological Chemistry, HarvardUniversity Medical School.
Dr. Elmer L. DeGowin, Associate Professor of InternalMedicine, State University of Iowa College of Medicine.
Dr. Cornelius P. Rhoads, Director, Memorial Hospital, NewYork, N.Y.
Dr. Owen H. Wangensteen, Professor of Surgery, University ofMinnesota Medical School.
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Subcommittee on Blood Procurement.-The Subcommitteeon Blood Procurement appointed by the Committee onTransfusions consisted, in addition to Drs. Rhoads and Strumia, of:
Dr. Warfield M. Firor, Associate Professor ofSurgery, Johns Hopkins University School of Medicine.
Dr. Carl W. Walter, Associate Professor ofSurgery, Harvard Medical School.
Ad hoc committees-TheSubcommittee on Blood Substitutes, like other NRC committees, promptly realizedthe impracticability of committee action on matters of detail and delegated theresponsibility for special projects to individual members or ad hoc committees.
All of the members of these NRC committees, itshould be noted, were experienced clinicians or had played an active part in theinvestigation of blood and plasma or had figured in both roles.
Functions and Activities
Although the Subcommittee on Blood Substituteshad come into existence at the request of The Surgeon General, almost a yearearlier, it was not until 19 April 1941 that its functions were formallyoutlined, as follows (11):
1. To continue research work on the variousblood substitutes and to establish their relative merits by clinical trials.
2. To determine the best techniques ofpreparing the various blood substitutes.
3. To standardize the best techniques ofcollecting and dispensing plasma and serum.
4. To select the type of container(containers) for preserving and dispensing plasma and serum.
All the emphasis at this time, it should benoted, was on blood plasma and so-called blood substitutes. Nothing was saidabout the possible functions of the committee in connection with blood. At themeeting of the subcommittee on 18 July 1941 (12), however, it wasrecommended that an adequate study of blood substitutes, especially humanalbumin, be made by a member of the Army Medical Corps at an institution atwhich an adequate number of cases would be treated to permit definiteconclusions as to the efficacy of these substitutes in the prevention andtreatment of shock. No action was taken officially on this recommendation of thesubcommittee.
Summary of activities to 24 February 1943-Asa matter of convenience, the actions of the Subcommittee on Blood Substitutes onsuch matters as whole blood, plasma, albumin, bovine albumin, and byproducts arediscussed in detail under appropriate headings. The summarized report of thesubcommittee, however, of 24 February 1943, on its activities during the first 2
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years of its existence is worth citing as anindication of the far-reaching scope of its activities and accomplishments (13).They included:
1. A study of the relative merits of thevarious preparations of human plasma and serum, with a recommendation to theArmed Forces that dried plasma be used.
2. Development of packaging and dispensingequipment for dried plasma.
3. Improvements in the methods of dryingplasma, a study of the effects of these methods upon the products obtained, thedevelopment of equipment for drying plasma for use by hospitals as well as bylarge processors, and the recommendation to the Armed Forces that 0.1-percentcitric acid be used as the diluent for dried plasma.
4. Recommendations to the American Red Crosscovering: (a) the control of blood procurement centers by professionalpersonnel, (b) techniques for blood procurement, (c) standardization ofequipment at these centers, and (d) blood grouping.
5. Recommendations to the Surgeons General,Army and Navy, for the establishment of sections on shock and transfusion intheir medical departments.
6. Preparation of a concentrated solution ofhuman serum albumin which was stable over a wide range of conditions; whichoccupied little space in packaged form; which could be given with facility andwithout diluent; and which had been prepared to meet certain specificrequirements of the Armed Forces, particularly the Navy. This product had beenrecommended to the Armed Forces and was then in preparation in large amounts fortheir use.
7. A study, thenin progress, of the possible use of globulin byproducts of human albuminproduction for the control of measles, mumps, and other diseases, which gavehope of widespread practical application in the Armed Forces.
8. A study of the possible use of humanfibrinogen and thrombin, also byproducts of albumin production, in the localtreatment of burns.
9. Studies, still in progress, on the possibleuse of blood substitutes of other than human origin, including bovine albumin,gelatin, pectin, aldobionic acid, and glutamyl polypeptide.
10. Conferences to consider progress in thesevarious studies and to examine their extension to various groups of workers.
11. Preparation of manuals on bloodtransfusion and blood plasma for the Office of Civilian Defense (p. 93).
As time passed, work on various aspects ofthese projects was extended, but the really important investigations to whichthe Subcommittee on Blood Substitutes devoted its major efforts are included inthis 1943 summary.
Proposal for Intravenous Therapy Service forArmed Forces
At the Conference on Transfusion Equipment andProcedure on 25 August 1942 (14), it was the sense of the meeting thatthe question of using preserved blood for the Armed Forces was primarily one offeasibility. Dr. DeGowin was requested to draw up a statement and propose a planfor an intravenous therapy service which could be submitted to the SurgeonsGeneral of the Army and the Navy for their consideration. These proposals, whichwere drawn up in collaboration with Colonel Kendrick and Commander Newhouser,were handed to the membership of the Subcommittee on Blood Substitutes at themeeting on 10 November 1942 (15), and it was requested that comments andsuggestions concerning them be sent to Dr. DeGowin by mail.
At the meeting of the subcommittee on 15December 1942 (16), Dr. DeGowin reported that favorable comment on theproposals had been received
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from all the members. It was voted that thememorandum containing the proposal and the justificationsfor it be included in the minutes of the meeting and submitted to the SurgeonsGeneral of the Army and the Navy through channels. This was done on 20 January1943.
Although the recommendation for a separateintravenous therapy service in the Armed Forces was never acted upon during WorldWar II, the arguments for it were entirely valid and are worth recording. Insubstance, they were as follows:
1. Intravenous therapy is a medical specialty,training in which is not provided in a routine medical education. The complexityof the problems involved in the manufacture, processing, and preservation ofblood, blood substitutes, and other parenteral fluids is little known to theaverage physician, nor has he acquired the knowledge to design equipment and totest it for efficiency in the collection and administration of these fluids. Healso does not understand the techniques of typing and crossmatching of blood.
2. The average physician is not a specialistin intravenous therapy. When he orders infusions and transfusions in a civilianhospital, he trusts to the special knowledge of experts in the field tomanufacture pyrogen-free solutions. He accepts apparatus designed and tested bypersons with special knowledge. He relies on a special department for propercleansing and sterilization of the apparatus used. He depends on the laboratoryfor the typing and cross-matching of blood. The discussion of transfusionreactions in medical textbooks is inadequate, and the civilian physician, if allgoes smoothly, is completely unaware of the organization and painstaking controlthat make the use of parenteral fluids safe. When, however, he enters theMedical Corps, he is called upon to practice more intravenous therapy than heemployed in civilian life. He will be unable to perform this work satisfactorilywithout personal instruction in the procedures involved and the apparatusrequired for them.
3. Military medicine presents special problemsin intravenous therapy as compared with civilian practice: the incidence ofshock, hemorrhage, and burns is many times greater, as is their severity. Intheir treatment, the methods of civilian medicine must be modified byconsiderations of transport, equipment, and environment. Determination of theblood group of an occasional civilian patient is far removed from the masstyping of thousands of men entering the Armed Forces. Special techniques must bedevised that are both rapid and accurate. Only specialists are logicallyqualified to evaluate and select them. The testing and procurement of propertyping sera is a major procedure in itself.
4. If a medical officer were to attempt toaccumulate a store of whole blood, he would find that none of the methods in usein civilian practice could be applied directly to his military problem withoutmodifications in equipment and technique.
5. Commercially available transfusion andinfusion equipment is designed for civilian use. Military equipment must bedesigned with emphasis on portability, compactness, expendability, andconservation of critical material,
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already in increasingly short supply. Thereare no textbooks to serve as guides, and few medical menin the country are qualified in this field. The development and testingof suitable plastics and synthetics to replace rubber tubing and stoppersrequire the combined knowledge of the chemist, the production engineer, and themedical expert in intravenous therapy.
6. A global war requires the adaptation ofmedical equipment and techniques in many situations and environments. The onlypractical methods of treating shock may be, variously, plasma or serum albumin,fresh blood, or banked blood. The procedures for their administration, however,are sufficiently simple to permit the average medical officer, with properinstruction, to become proficient in them. The issuance of directives is onlysupplementary to specific personal instruction, not a substitute for it.
Great progress, the subcommittee memorandumcontinued, had been made in the development of blood substitutes by thecooperation of appropriate committees of the National Research Council and byliaison with Army and Navy officers, but many delays could have been eliminated,and much more could have been accomplished before the United States entered thewar, if the armed services had had well-organized sections on shock andtransfusion, composed of experts in the field, with authority to act on problemsof equipment, products, and procedures. With the rapid expansion of personnel inthe military organization, the needs in the future would be even greater thanthey had been in the past.
In view of these considerations, it was therecommendation of the Subcommittee on Blood Substitutes that the Army and theNavy Medical Corps should recognize, as the Royal Army Medical Corps hadrecognized, that intravenous therapy is a medical specialty and that they shouldorganize, as the British had organized, sections composed of experts in thefield who were to be charged with the responsibility, and endowed with theauthority, to act on:
1. Devising, testing, and authorizingtechniques in this field.
2. Training medical personnel in intravenoustherapy in the most practical possible manner.
3. Designing, and authorizing the productionof, equipment and apparatus.
4. Supervising the procurement and processingof blood substitutes.
5. Participating in research in the field ofintravenous therapy and cooperating with NRC in appropriate studies.
It is unfortunate that the recommendations ofthe Subcommittee on Blood Substitutes, NRC, for a separate transfusion servicewere not adopted. Both medical officers and technicians trained in the handlingand care of whole blood continued in short supply throughout the war. As late asJanuary 1945, officers and men necessary to handle the blood supply for thePacific had to be trained on an emergency basis and used as cadres for thetransfusion teams to be sent to that theater (p. 605).
To the end of the war, those in charge of theprogram continued to hold the view that blood banks should be operated only byspecially trained personnel, who had a profound respect for the potential risksof blood transfusion and who
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believed that the careless submission of a wounded man to theinherent dangers of this form of therapy was totally unwarranted (1).
Dissemination of Information
At a meeting of the Subcommittee on Blood Substitutes on 19April 1941 (11), arrangements were made for the subcommittee to issue amonthly bulletin for its own information as well as that of others with aconcern in the blood program. This proved a very useful plan.
Limitations on the use of paper during the war sometimes madethe publicizing of the results of various investigations sponsored by theNational Research Council a good deal of a problem. In March 1944, for instance,such a shortage delayed the publicizing of important recent developments on thepreparation and use of byproducts of human blood plasma. It was essential thatmedical officers be familiar with this work, and in the course of several weeksthe dispute was resolved favorably, but it was not the first time suchdifficulties had developed, nor was it to be the last.
At a meeting of the Subcommittee on Blood Substitutes on 20October 1942 (17), there was a considerable discussion on an editorial onthe toxicity of plasma that had appeared in the Journal of the AmericanMedical Association for 19 September 1942 (18) and that was based onan article by Levine and State (19), which appeared in the same journalthe following week. Dr. Strumia's extensive experience, reported at thismeeting, was in sharp contrast to these authors' observations; he had had onlyfive reactions in 2,200 transfusions with human plasma. It was agreed that theeditorial contained numerous errors of fact, and a communication was sent to theeditor of the Journal, asking for a retraction and pointing out that thepublication of such data might cause serious difficulties in the bloodprocurement program. Dr. William Thalhimer had already prepared an article inwhich the misstatements concerning the supposed toxicity of plasma were refuted.
As had been feared, the editorial in the Journal madeserious trouble for the Blood Plasma Section, Office of Civilian Defense, andalso interfered with blood procurement by the American Red Cross. At the meetingof the subcommittee on 23 March 1943 (20), galley proof of the retractionrequested was available and it was agreed to take no further action in thematter, though the statement was not considered entirely satisfactory.
This experience, like others related elsewhere, is indicativeof the highly sensitive character of the blood and plasma program and of thematters with which the Subcommittee on Blood Substitutes had to concern itself.
Proposed Field Investigations
It has already been mentioned that nothing ever came of theproposal made at the first meeting of the Subcommittee on Blood Substitutes on31 May 1940, that a group of physicians be allowed to work in the Army, freed
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from any of the obligations of Army officers, to investigateshock on a large scale (p. 41). The matter was brought up again at the meetingof the Subcommittee on Blood Substitutes on 30 November 1940 (21), by Dr.Sturgis, who proposed that a team, financed by the Red Cross, be sent to studytransfusion in England. Dr. Lewis H. Weed did not think that the proposal wasfeasible at this time, because of the situation abroad, but stated that it wouldbe discussed with British authorities.
There was no further discussion of a fieldinvestigation until the meeting of 9 April 1943 (22), at which it wasdecided that the subcommittee had reached a point at which it could no longerfunction effectively without more precise information concerning field problemsand the conditions imposed on therapy by the military requirements of the war.
A considerable portion of the presentknowledge of the mechanism of shock and its treatment had come about through thephysiologic studies of specially qualified and completely integrated groups ofinvestigators in the field (Cannon, for instance, Bayliss, Keith, and Robertson,among others). The Medical Research Council of Great Britain had continued tosupport this policy. The National Research Council had not.
It was therefore the unanimous recommendationof the Subcommittee on Blood Substitutes, to be transmitted to Dr. Weed forsubmission to The Surgeon General, that a qualified fact-finding group beappointed, without special function of command, which should report its findingsthrough official channels, these findings to be transmitted subsequently to thesubcommittee, to serve as a basis for continued investigation. It was furtherrecommended that the research group in the field should receive, throughofficial channels, reports of recent significant developments in Zone ofInterior research and should transmit this information, through officialchannels, to medical officers in the field.
The study which the subcommittee proposed wasto cover plasma, albumin, crystalloid solutions, and whole blood, with respectto their requirements, use, effectiveness, and limitations.
The subcommittee specified that professionalpersonnel for the proposed investigative group should be chosen from the bestinformed and best qualified personnel, irrespective of their present military orcivilian status.
This recommendation was duly transmitted tothe Surgeons General of the Army and the Navy, through channels, and wasrepeated at the meeting of the Subcommittee on Blood Substitutes on 24 September1943 (23), when it was found that no action had been taken on it. At thesame time, the subcommittee reiterated its recommendation that intravenoustherapy be considered as a special branch of military medicine (p. 76).
These recommendations, as such, were neveracted upon. The recommendation that replacement therapy be studied in the fieldwas, however, implemented to some extent in June 1944, when General Rankin,Chief Surgical Consultant, Office of The Surgeon General, arranged for ColonelKendrick to
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visit the Pacific areas and study shock, transfusion, supply,and all other phases of replacement therapy (p. 590).
Both during and after the war, comments were frequently heardto the effect that the studies of NRC committees and subcommittees wereconducted from an ivory tower and in a sort of nonmilitary vacuum. The criticismis not justified in view of the repeated endeavors of the Subcommittee on BloodSubstitutes to secure its information at first hand and to base itsrecommendations on the information thus secured. The subcommittee was frustratedin its endeavors, and DeBakey (24), in 1946, wrote quite correctly of"the barrier between military surgeons and civilian investigators that wasnever completely crossed on either side."
NATIONAL INSTITUTE OF HEALTH
The NIH (National Institute of Health) played little part inthe blood and plasma program until 1941, when Dr. Cohn, at the Harvard MedicalSchool, succeeded in fractionating plasma protein and, at about the same time,dried plasma was prepared successfully. No question of interstate commerce hadpreviously been involved. With these achievements, the products, under strictinterpretation of the law, became biologicals, with whose manufacture, storage,and utilization NIH was intimately concerned. It was unlawful to produce andsell biologicals, which included serum, albumin, dried plasma, and byproducts ofplasma, without a license from this agency.
Throughout the war, close liaison was maintained by the Army,the Navy, and the Subcommittee on Blood Substitutes, NRC, with Dr. Milton V.Veldee, Chief, Laboratory of Biologics Control, National Institute of Health.The excellent cooperation between NIH and the Army, the Navy, and NRC offers onemore explanation of the success of the blood-plasma program.
Minimum specifications were prepared by Dr. Veldee and hisassociates for the processing and packaging of plasma and the products of plasmafractionation (25). Later modifications in both apparatus and techniquesfor the program were made only after consultation with, and approval by, Dr.Veldee, Captain Newhouser, and Colonel Kendrick. Representatives ofNIH frequently visited the commercial laboratories producing plasma and otherblood derivatives, aiding them in the establishment of techniques and assistingthem in the solution of special problems.
LEGAL ASPECTS OF THE BLOOD AND PLASMAPROGRAM
Ownership of Blood and Its Components
The matter of ownership of the blood donated for use of theArmed Forces at the Red Cross blood donor centers seems to have been handled bydefault until the meeting of the Subcommittee on Blood Substitutes on 23 June1942 (26), when the proposal to release a certain amount of plasma to OCD(Office
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of Civilian Defense) came up for discussion(p. 92). It was the sense of the meeting that the responsibility of the RedCross for the blood collected ceased as soon as the blood was delivered to theprocessing laboratories. It was also brought out that, at this time, none of theinterested parties (American Red Cross, Army, Navy) exercised any supervisionover losses in the plant. While it was not clear who owned the material from thetime the blood was delivered to the processing laboratories by the Red Crossuntil the laboratories delivered it to the Armed Forces as dried plasma, theassumption was, since the laboratories could not hold title to it, that it mustindeed be the property of the Armed Forces.
A formal resolution was passed at this meeting to the effectthat the blood collected by the Red Cross should "become as heretofore theproperty of the armed forces from the time it enters the processing plant."It was further resolved that the Armed Forces assume responsibility andauthority for the processing, preparation, and disposition of the blood andplasma as "safe and effective therapeutic material."
Before the legal aspects of the disposition and ownership ofred blood cells and other byproducts of the plasma program became an issue, thepolicy had been to permit commercial processing houses to furnish red bloodcells to adjacent hospitals, with the specification that the Office of TheSurgeon General be furnished reports of the studies made with them. It wasfurther understood that the laboratories should not charge the hospitals; thatthe hospitals should not charge the patients treated, who, preferably would bethose unable to pay; and that the hospitals should agree to indemnify theGovernment for any claims which might arise out of the use of the red bloodcells.
At the Conference on Blood Grouping on 23 March 1943 (27), itwas agreed that the arrangements made up to this time were no more thantemporary expedients, that the question of charges and other problems wouldrecur as other byproducts were developed, and that a group of experts mustformulate a policy that would be legal and that would meet the obligations tothe donors of the blood. It was the sense of the meeting that Dr. Weed call aconference on the subject, to be attended by representatives of the Army, theNavy, and American Red Cross, as well as by Dr. Cohn, Dr. Rhoads, and Dr. Veldee.
Statement of the Problem
On 6 April 1943, Dr. Cohn, in whose laboratory at the HarvardMedical School most of the work on byproducts had been done, prepared astatement of the problem for Dr. Weed, as follows (28):
1. Clearly, these byproducts could not become a source ofprofit to commercial houses. At the present time, these substances, which wereconsidered the property of the Government, were being retained "in thecold," under the most favorable conditions to permit the preservation, forprotracted periods
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of time, of some-though not all-of their properties. Allof these byproducts (red cells, fibrinogen, thrombin, isohemagglutinins, measlesprotective antibodies) could be brought into more stable states, including thedry state, although additional processing would be required.
2. The present problem was more clearly exemplified inconnection with fraction II, which contained the highly promising measlesantibodies. Under optimum circumstances, the amounts which could be processedwould presumably be greatly in excess of any needs the Armed Forces might havefor this byproduct. The results of tests with small amounts released on theauthorization of The Surgeon General, Navy, for experimental purposes tocommercial laboratories, under controlled conditions, had been hopeful. Thematerial must not be allowed to deteriorate, and the excess, beyond what wasneeded for the Armed Forces, should be used for "social value." TheRed Cross, Dr. Cohn thought, might well be put in the position of making "apublic restitution" of the byproducts not needed by the Armed Forces.
Recommendations
Dr. Cohn's letter was read at the Conference on Albumin andBy-Products called by Dr. Weed on 10 May 1943 (28). In the discussion, itwas brought out that the largest byproduct of plasma processing, in point ofbulk, was the red blood cells, but that the globulin fractions would probablyprove to be of greater importance. The problem was financial as well as legal:the Red Cross considered it better that it should take title to the byproductsthan have another agency do it; but the estimated cost, on the assumption thatthe entire quantity of globulin now available would be worked up into formssuitable for military and civilian use, would be about $1? million.
At the meeting of the Subcommittee on Blood Substitutes on 13May 1943 (29), it was reported that the Red Cross Medical and HealthAdvisory Committee had met since the conference on 10 May and had requested thatthe subcommittee make specific recommendations concerning the ownership of thebyproducts of the blood and plasma program. The organization was willing toexercise ownership, supervise the processing of the byproducts under conditionswhich "would give prior lien" on all material to the Armed Forces, andarrange for the financing and distribution "for the public good" ofthe material not required by the Armed Forces.
Although some doubt was expressed as to the legality of theproposed arrangements, the following recommendations were made:
1. Title to the byproducts of the blood procurement programshall be transferred from the Army and the Navy to the American Red Cross ifthere are no legal impediments to this arrangement
2. The Red Cross shall assume responsibility for financing theprogram and for the processing, control, and redistribution of these byproducts
3. To carry out the program, the Red Cross, acting on theadvice of its National Medical and Health Advisory Committee, shall appoint asmall group of representative technical
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experts (Army, Navy, Public Health Service, National ResearchCouncil, Committee on Medical Research) to supervise and control the processingof these byproducts by contract with university or pharmaceutical laboratories.
4. The Army and the Navy shall have priorityin requisitioning such quantities of these byproducts as they may need. Theexcess shall be used for civilian purposes, foreign relief, or such experimentalprocedures as may be considered essential by the supervisory group. The RedCross (or some other designated agency) shall arrange the best method ofdistribution of the excess.
5. As the value of each new byproduct isestablished, subordinate groups shall be appointed, of not more than threemembers each, representing, respectively, the National Institute of Health, theNational Research Council, and the Armed Forces.
Dr. Cohn stated that he had already asked foran appraisal group for each byproduct of the albumin program.
Further Actions
The ownership of these byproducts was discussedby letters and at meetings during the remainder of 1943 from all points of view.One of the principal objections to the proposed plan was that the Red Crossmight not be able to obtain the necessary equipment for processing thebyproducts.
The Navy believed that all contracts forbyproducts from the albumin program should be let by the Navy, which was alreadyhandling all albumin contracts. Dr. Cohn agreed, on the ground that plasmafractionating is an integrated process. At the meeting of the Albumin andBy-Products Group on 28 July 1943 (30), he pointed out that thesettlement of the issue was pressing, since measles antibodies (fraction II),thrombin, and fibrin film had been thoroughly tested and were ready forappraisal. At the meeting of the Subcommittee on Blood Substitutes on 24September 1943 (23), Captain Newhouser reported requests from civilianphysicians for allocation of serum albumin for the treatment of their patients.
At the meeting of the subcommittee on 6October 1943 (31), it was announced that a red blood cell suspensionservice had been set up at Halloran General Hospital, Staten Island, N.Y., andthe recommendation was made that, for administrative purposes, it would be agood idea to give the Red Cross ownership of red blood cells, since similarservices would shortly be set up in other cities. On 7 January 1944, Maj. Gen.George F. Lull, Deputy Surgeon General, approved this arrangement (32). Thisinformation was duly conveyed to the processing laboratories, which weredirected to release the cells at the times and in the amounts specified by theRed Cross. These laboratories had previously been reminded (27 August 1943) thatall blood received from the Red Cross and all plasma processed from it remainedthe property of the Government and none of its byproducts should be releasedwithout written authorization by responsible authorities.
On 27 May 1944, Maj. Gen. Norman T. Kirknotified the Director, Medical and Health Service, American Red Cross, that theNavy had agreed to turn
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over to it all immune serum globulin in excessof requirements of the Armed Forces, to be distributed to the civilianpopulation through the state health agencies designated by the Red Cross.General Kirk gladly concurred in this arrangement (33).
Note-As a matter of convenience,certain other legal aspects of the blood program are discussed elsewhere in thisvolume. The accounting problems of the processing laboratories are discussed inconnection with the plasma program.
TRAINING
In any consideration of the training of medicalofficers and enlisted men in the handling and use of plasma and blood, it mustbe borne in mind that when time United States entered World War II, plasma wasan almost unknown agent and the use of blood transfusion was far from general.Both theory and demonstration were therefore equally important phases of alltraining programs.
National Research Council
The Subcommittee on Blood Substitutes recognizedthe importance of training in intravenous therapy by suggesting at its firstmeeting on 31 May 1940 (9) that (1) there should be some center in everyArmy organization at which men would receive training in caring for shockedcasualties, and (2) there should also be centers in which men could be trainedin all aspects of intravenous therapy. At a later meeting, on 9 April 1943 (22),a visitor from the Canadian Army who was present pointed out that theBritish had found it necessary to have medical officers with specializedtraining in charge of transfusions. Colonel Kendrick made the same point at themeeting of the subcommittee on 17 November 1943 (34), when he stated, inreply to an inquiry concerning oversea training, that the Office of The SurgeonGeneral would issue a memorandum on the technique of transfusion and on methodsof preserving blood but had no authority to recommend techniques to surgeons intheaters of operations.
Questions concerning training were also raisedat the meeting of the subcommittee on 19 April 1941 (11) and at theConference on Transfusion Equipment on 25 August 1942 (14). Some medicalofficers, it was stated, had not yet even seen dried plasma, let alone havinghad any instruction in its use. Dr. Cannon, basing his remarks on his ownobservations, stated that it was more important to teach men to needle veinsthan to provide them with blood substitutes, since the substitutes could not beused without training in venipuncture. It was reported that, in the summer of1940, Dr. (later Major, MC) Robert C. Hardin had taken several enlisted men of aNational Guard unit to the State University of Iowa Hospital and instructed themin this procedure. Although they had had no previous medical training, they alllearned readily.
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FIGURE 13.-Laboratory technicians intraining, Army Medical School, Walter Reed Army Medical Center.
Army Medical School
Two formal training courses (fig. 13) wereconducted at the Army Medical School, listed in Army Service Forces Manual M3for November 1944 (35) as:
1. Course MO-20, Red Cross Blood Donor Center,Operation of. This course lasted for 2 weeks and was intended for medicalofficers who were to be sent to liquid plasma processing centers in Zone ofInterior hospitals (p. 274). Instructions included (a) general plans oforganization and operation and (b) techniques of bleeding donors. The course wasconcluded with several days of supervised practice at the Washington, D.C., RedCross Blood Donor Center.
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2. Course ME-12, Blood Plasma Bank Technique.This course lasted 4 weeks and was planned for medical technicians who hadalready had some portion, or all, of the Army basic course for technicians andwho were to be sent to the liquid plasma processing centers. The materialincluded the technical procedures used in the operation of a blood donor centerand methods of preparing and storing liquid plasma.
In all, 23 officers completed Course MO-20 and15 spent at least a month of temporary duty learning to operate liquid plasmacenters, each of which eventually had 3 officers assigned to it. Forty-threetechnicians completed Course ME-12.
In addition to the supervision of these formalcourses, Captain Kendrick taught the principles and practices of resuscitation,along with the management of war wounds, to the classes of officers who attendedthe Army Medical and Dental Schools. He also lectured on the same subjects atthe Medical Field Service School at Carlisle Barracks, Pa.
Field Training
Training in the use of plasma was also conductedduring maneuvers before the United States entered the war and in the Zone ofInterior during the war (figs. 14, 15, and 16).
Training Aids
A training film (FS 8-51), with appropriatecomments, was prepared at Carlisle Barracks by Major Kendrick in January 1942.In February 1943, a manual was prepared to be used in conjunction with it. Itcontained a statement of general principles and a detailed, fully illustrated,description of each step of the use of the plasma package and the administrationof the plasma (p. 698). The material was essentially the same as that containedon the instruction sheet enclosed in all plasma packages except for those issuedat the very beginning of the program. When demonstration packages of plasmabecame available, they were distributed with each copy of the film.
Demonstration Packages of Plasma
Practically all of the packages of driedplasma distributed in the United States were for training purposes only (36).The question of providing them came to a head in October 1942, when theDirector, Biological Division, Lilly Research Laboratories, wrote GeneralHillman that he had received a number of requests from medical officers,particularly those in charge of replacement training centers, for demonstrationpackages of the standard Army-Navy dried plasma. Up to this time, he had simplysent dummy packages, filled with contaminated plasma and marked Not for humanuse. A recent request for 12 packages for a single installation, however,indicated that such an informal method of supply could no longer be used; if allcamps were to make such requests, the number of packages necessary would runinto the hundreds.
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This letter was the beginning of acorrespondence, chiefly with Colonel Carter in the Surgery Division, Office ofThe Surgeon General, which continued until July 1943.
There was complete agreement on the part ofall concerned that in the program of instruction being planned for medicalofficers in station and general hospitals in the Zone of Interior and for thoseattached to Ground Forces, it was imperative that there be actual demonstrationsof the reconstitution of plasma, which was, as already pointed out, a newtechnique. There were, however, a number of problems to be solved.
Form of package-Thefirst problem was what to use in the plasma bottle. Theuse of contaminated plasma was not desirable, partly because it might, throughsome mischance, be used clinically and partly because research had shown that itcould be safely converted into albumin (p. 303). The use of any colored materialwould destroy the realism of the demonstration. Horse serum had obvious risks.Shell-frozen dextrose became so powdered when it was dried that it collapsed inthe bottle and did not look like plasma. Also, it tended to clump when waterwas introduced and did not go into solution readily.
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The addition of dextran made it possible toshell-freeze glucose and the final demonstration package, prepared in thismanner, contained 25 gm. of glucose and 3 gm. of dextran. In solution, thiscombined material had the approximate color and haziness characteristic ofnormal human plasma. If it were inadvertently used clinically, it would cause noreactions, especially as it was decided that, for added safety (though at anincreased cost), all packages must be sterilized.
All labels used were marked in red Notfor human use. For demonstration use only.
The Red Cross was supplied with a number ofthese demonstration packages for display at blood procurement centers and formobile units.
Procurement-Whenthe form of the demonstration package had been settled, problems of procurementarose. Army rules did not permit the acceptance of the offer of Eli Lilly andCo. to make up a number of packages at once, without waiting for bids. Instead,it was necessary to set up separate contracts for them. When bids wererequested, in July 1943, for 10,000 demonstration packages, seven of the ninelaboratories then processing plasma were not interested because they werechanging over to the 500-cc. plasma
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package within the next 3-4 weeks and they had no excessequipment to make up the smaller demonstration package. In addition, cans couldbe ordered only in 25,000 lots. The necessary number of demonstration sets wasfinally produced by Eli Lilly and Co., which continued to make the smallerpackage of plasma.
Instructions for use-CircularLetter No. 55, Office of The Surgeon General, Services of Supply, WarDepartment, 22 February 1943 (37), was entitled "Instruction ofmedical officers in the reconstitution and use of the Standard Army-NavyPackage of Normal Human Plasma, Dried." It explained that the demonstrationpackages (which were not then available for distribution) were designed toaccompany Film Strip 8-51, dealing with the same subject. After it had beenshown, the instructor should demonstrate the reconstitution and use of onepackage and then distribute others to small groups of students, so that theymight become familiar, individually, with the technique of reconstitutingplasma.
OFFICE OF CIVILIAN DEFENSE
Planning
Provision of blood and plasma for the Office of CivilianDefense was not the responsibility of the Armed Forces program, but, as wasinevitable, there was some cooperation between the two programs, and it isremarkable that there was so little conflict.
The question was first brought up at the Blood ProcurementConference on 14 February 1942 (38), at which it was pointed out thatthroughout the country there were feelings of restlessness and anxiety lestblood or a blood substitute be needed for a civilian catastrophe arising fromenemy action or accidents in industrial plants and there be no provision for thecare of casualties.
At this conference, Dr. (later Major, MC) Earl S. Taylor,Technical Director, American Red Cross, reported that on a recent trip to thePacific coast, he had found a disturbing situation, apparently related to thissense of apprehension: Blood and plasma banks were being set up without theaffiliation of either the Red Cross or the Office of Civilian Defense. Thedirectors of some of these banks clearly lacked the qualifications necessary forthe preparation of safe products, and he feared that their continued growthwould lead to great waste of blood or serious accidents.
On 11 April 1942, the sum of $292,500 was allotted to theU.S. Public Health Service, from an emergency fund controlled by the President,to be expended in emergencies affecting the national security and defense andfor setting up reserves of liquid, frozen, or dried blood plasma or serumalbumin for the treatment of casualties from enemy action. These grants were tobe made to public or private hospitals located not more than 300 miles from theoceans or the gulf coast. On 17 April 1942, the Federal Security Agency set upregulations governing these grants (39).
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Provision of Plasma
The question of plasma for the Office of Civilian Defense cameup again at the meeting of the Subcommittee on Blood Substitutes on 23 June 1942(26). Dr. G. Canby Robinson, National Director, American Red CrossBlood Donor Service, speaking for the Red Cross, proposed that letters bewritten to The Surgeon General, U.S. Army, from his agency, the U.S. PublicHealth Service, and the Office of Civilian Defense asking that the limits of theprograms of the Red Cross and the Office of Civilian Defense be clarified inrespect to blood donors. He made the suggestion because, since the Japaneseattack on Dutch Harbor in the Aleutians earlier this year, a number ofcommunities had attempted to collect blood for local use, and their efforts hadinterfered with the Red Cross National Blood Procurement Program to obtain bloodfor the Armed Forces.
It was proposed that 55,000 of the 96,762 units ofplasma then held in the frozen state in various processing plants be releasedand distributed as follows:
25,000 units to be transferred to the Red Cross, for deliveryto the Office of Civilian Defense for distribution to suitable civilianhospitals in exposed areas, with the understanding that cities in which the RedCross had blood donor centers would all be protected in this manner.
30,000 units to be placed at the disposal of the chief medicalofficer, OCD, or one of the regional medical officers, to be used ingrave emergencies, with the understanding that the Office of Civilian Defensewould thereafter refrain from collecting blood within a radius of 75 miles fromthe (seven) Red Cross blood donor centers presently in operation.
The considerable discussion that followed the introduction of these proposals covered the mechanics of such a transfer and the legal aspects of ownership of the plasma (p. 81). A motion was finally passed, as already noted, to the effect that the blood collected by the American Red Cross remained "as heretofore the property of the armed forces from the time it entered the processing plant." A second motion was then passed requesting The Surgeon General, U.S. Army, to release 55,000 units of frozen plasma to the Office of Civilian Defense for the allocation and use just specified. It was hoped that the announcement of the release of such a large amount of frozen plasma to OCD would relieve public apprehension caused by fears of inadequate supplies in case of an enemy attack and would enable the Red Cross to continue to concentrate on the needs of the Armed Forces, which might be tripled within the coming year.
Some anxiety was expressed over the actions taken: Dr. Loeb, chairman of the subcommittee, pointed out that OCD was undertaking a grave responsibility in assuming control of a large amount of frozen plasma, with its problems of supervision, storage, and administration. If, through lack of proper controls, unfortunate accidents should occur, they might, entirely unjustifiably,
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reflect on the Red Cross procurement program. Fortunately, no such accidents occurred.
It should be noted that the distribution of plasma proposed at this time was possible only because the Red Cross was collecting blood equal to, or in excess of, the current combined drying facilities of the processing laboratories (p. 120).
Of the 88,000 donations procured by the Red Cross and used for plasma made available to the Office of Civilian Defense, 29,000 units were secured from the backlog of frozen plasma held in processing laboratories (40). Another 50,000 units were processed for this special purpose, most of it in a processing laboratory equipped for this type of work but not yet in production for the Army. The balance was provided by the Army from reserve stocks late in 1942. Some of this lot was returned to the Army later, to meet potential emergency needs in the Pacific.
As a result of these arrangements, the initial confusion,that could have had rather serious consequences, was completely eliminatedearly in the war. Fortunately, it was never necessary to use OCD supplies ofplasma for casualties from enemy action. At the end of the war, by act ofCongress, the U.S. Public Health Service was authorized to make OCD stocksavailable for civilian use. And so, to quote Dr. Robinson, "It waseventually returned to the American public who had donated it"(40).
Preparation of Manuals
The only other activity of the Office of Civilian Defensethat concerned the blood-plasma program dealt with the preparation of manualsfor OCD use by members of the Subcommittee on Blood Substitutes. The manual onplasma (38, 41) was the responsibility of Dr. Strumia and the manual onblood banks (41) of Dr. DeGowin (42). The subcommittee informedresponsible OCD authorities that these manuals represented the best practice atthe time they were prepared (1942) but warned that the procedures described inthem should be undertaken only by technically qualified and adequately trainedpersonnel.
PLASMA FOR ALLIED NATIONS
There was never any question about the emergency use ofplasma provided by the Red Cross for soldiers of other nations. When it came toproviding a stockpile for troops of Allied nations, however, generous instinctscame into conflict with the realities of the situation (4, 43,44). For one thing, supplies of plasma, particularly early in the war, werenot inexhaustible, and they had to be kept for the needs of the U.S. ArmedForces. More important, the blood from which the plasma was made had beendonated for that special purpose. The legal as well as the moral right of theRed Cross and the Armed Forces to utilize it for other purposes, however worthythey might be, was
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limited by the representations made to thepublic when the donations were secured and the releases signed by the donors,which included the statement that the blood was to be used for the Armed Forces.
There could be no legitimate criticism of thetransfer of certain amounts of plasma to the British for use in their hospitals,since many U.S. soldiers were cared for in them. Later in the war, arrangementswere made for the British to purchase plasma from one of the commerciallaboratories which had excess capacity after fulfilling its Army contracts. Theblood was procured from professional donors, without newspaper advertising orany other solicitation that would interfere with the Red Cross program.
The British needs were always small, fortheir own fine blood transfusion service furnished almost all of the blood andplasma needed for their own casualties. The supply of plasma for the Free French was another and more difficult problem.
The Free French, up to the liberation ofParis, at least, had no home population from which to procure blood. The idea ofthe French Military Medical Mission to the United States that they shouldprocess their own plasma in North Africa was discouraged by those in charge ofthe blood program in the Office of The Surgeon General, because of the cost, thelack of trained personnel, and the delay that would be inevitable in trainingpersonnel and procuring equipment.
The first plasma supplied to the Free Frenchwas delivered under Lend-Lease arrangements and made from blood purchased fromprofessional donors, as just described. When the U.S. Army supply program beganto include medical equipment and supplies for the French Army, the plasmaincluded in U.S. supplies was removed from the maintenance units. It wasrealized, however, that the U.S. Army and the Red Cross would be open toserious criticism if an agent publicly proclaimed as lifesaving were withheldfrom Allied troops, even though the blood from which the plasma was made hadbeen donated specifically for U.S. Armed Forces.
The whole subject was discussed at aconference in the Office of The Surgeon General on 8 June 1943 (45), andtwo plans were considered:
1. That the Red Cross ask for blood donations designated for the Free French, with the donors asked to sign a special release to that effect. If the blood were treated as fungible, it would not be necessary to segregate these particular donations but merely to make sure that the amount of plasma given to the Free French did not exceed the amount of blood donated for it.
2. That the plasma, as previously, be made from blood purchased in commercial channels. Procurement of blood in this way would not interfere with the Red Cross Blood Donor Program, and two commercial laboratories were then in a position to undertake the processing of the necessary amounts of plasma without interference with their contracts for plasma for the U.S. Armed Forces.
The latter plan was eventually put into effect, with the assistance of the Armed Services Medical Procurement Agency, Brooklyn, N.Y.
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A number of the countries in South America were desirous of making dried plasma for their own use and consulted the personnel of the U.S. blood program about their plans. They were always advised to use liquid plasma: The U.S. experience had shown that the production of dried plasma was an onerous and complex problem, quite aside from the difficulty of procuring equipment and the length of time it took to procure it.
The Russian experience illustrates the procurement difficulties just mentioned (46). In September 1943, at the request of the Russian Red Cross, an outline of current methods of drying plasma was drawn up, and, a little later, Soviet Red Cross representatives were shown the various drying equipment in use in Zone of Interior commercial laboratories.
When the Soviet authorities decided to proceed with the drying of plasma, all possible cooperation was given to them by the Office of The Surgeon General, through Colonel Kendrick, the Special Representative on Blood and Plasma Transfusions; the American Red Cross; and the National Research Corp. of Boston, through which the equipment was ordered. The equipment was not completed, however, and the necessary testing was not carried out, until the spring of 1945. The war in Europe was over before the departure date of Capt. (later Maj.) John Reichel, Jr., MC, who had been designated to supervise the equipment in the Soviet Union and instruct medical officers and technicians in its use. Later, he spent several weeks in the Soviet Union on this mission.
OFFERS FROM OTHER COUNTRIES
During the war, a number of friendly nations conceived theidea of setting up projects for the collection of blood and the processing ofplasma, some or all of which they would make available to the United States (47).The stumbling block to the acceptance of these offers was always the same:Scarcities of essential materials and high priorities of other branches of theArmed Forces were making it difficult for the U.S. blood and plasma program toprocure equipment for its own needs. Moreover, the processing of plasma wassuch a delicate operation and required such careful supervision that, until alaboratory was well equipped with apparatus and operated by trained personnel,satisfactory qualitative and quantitative results were impossible.
SUPPLIES OF PLASMA FOR ZONE OF INTERIOR HOSPITALS
Liquid Plasma
The details of the program by which liquid plasma wassupplied to Zone of Interior hospitals during the war is part of the story ofplasma and is related under that heading (p. 274). The Blood Research Division,Army Medical School, acted as the Blood Plasma Coordinating Center; itexercised general control of the program, and after March 1944, onrequisition from the surgeons
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of the various service commands, it supplied all the plasmaused in Zone of Interior hospitals.
This was a highly successful program from every standpoint (40).Of the 310,135 blood donations delivered to military hospitals in the Zoneof Interior from the blood donor centers, 295,200 were used for liquid plasma.The Washington center, which continuously used some of its donations for thispurpose, devoted 88,387 bloods to this program. The Denver center, which opened14 September 1942, delivered its entire output to Fitzsimons General Hospital,Denver, Colo. When this center was closed on 15 September 1945, it had deliveredto the hospital 150,880 donations, 140,578 of which were processed into liquidplasma.
There were no confirmed reports of the distribution ofcontaminated plasma, and the incidence of posttransfusion reactions was verysmall, probably because of continuous policing of every phase of the program.
No special training was required for the administration ofliquid plasma. When bulk was undesirable, it could be given undiluted. In thesecircumstances, the ordinary rate of 8 to 10 cc. per minute was reduced to 5cc. or less per minute until it was found that so-called speed shock did notreally exist and that the rate of administration made no difference unlessthere were clinical contraindications to fluid administration.
Liquid plasma contained Merthiolate 1:10,000 or phenylmercuricborate 1:25,000 as a preservative. For this reason, it was the practice to limitthe quantity given over a 24-hour period to 2,000 cc. When dried plasma wasemployed, quantities up to 4,000 cc. per 24-hour period could be used, since theconcentrations of Merthiolate or phenylmercuric nitrate in it were,respectively, 1:35,000 and 1:50,000.
The safety and efficiency of liquid plasma were evident almost as soon as the program was started. Also, it soon became evident that original dating periods had been set much too low and that, if liquid plasma were prepared under proper conditions of sterility and kept in the frozen state, it would last almost indefinitely. The inconvenience, expense, and personnel required for the production of dried plasma for Zone of Interior hospitals therefore did not seem justified.
Dried Plasma
Dried plasma prepared at the Army Medical School was, however,given to smaller hospitals, whose needs were limited, and in which the turnoverof liquid plasma would be very slow. In April 1945, the amounts of liquid plasmabeing requisitioned by Zone of Interior hospitals exceeded the amounts beingproduced with current facilities. At the same time, the quantity of driedplasma on hand exceeded oversea requirements. When stocks of liquid plasma wereexhausted, therefore, dried plasma was supplied to the hospitals in theUnited States, which were informed at the same time that one form of plasma wasno more useful than the other (48).
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PROVISION OF WHOLE BLOOD IN ZONE OF INTERIOR HOSPITALS
Until well into 1944, all hospitals in theZone of Interior were responsible for the collection of their own supplies ofwhole blood. By that time, however, it became apparent that certain hospitalswere located in areas so sparsely populated, and had so few service troopsattached to them, that it was impractical for them to maintain donor lists tomeet even their limited requirements. In March 1944, therefore, by agreementwith the American Red Cross and with the concurrence of the TransfusionBranch, Office of The Surgeon General, arrangements were made to supply blood tosuch hospitals when the location of bleeding centers made this plan practicable(49). It was possible for 23 hospitals to take advantage of thisplan, their supply coming from 16 of the 35 blood donor centers then inoperation.
Only type O blood was supplied, in 500 cc.amounts, and it was supplied only as oversea surpluses permitted (50). Thetransportation of the blood and equipment between the centers and thereceiving hospitals, as well as the return of all equipment sent to thehospitals, was the responsibility of the receiving hospitals. The receivinghospitals were also responsible for retyping and crossmatching of the blood,for its serologic investigation, for reporting all unsatisfactory (that is,positive) tests, for the administration of time blood, and for the recording ofclinical results. The blood was furnished according to a prearranged schedule,running parallel with the delivery of red blood cells (p. 313). Emergencyneeds were not supplied.
In June 1945, 556 pints of O blood wereshipped to Halloran, England (Atlantic City, N.J.), Tilton (Fort Dix, N.J.),Lovell (Ayer, Mass.), and Torney (Palm Springs, Calif.) General Hospitals andto the Chelsea Naval Hospital, Chelsea, Mass. In August 1945, 804 pints weredelivered to these and other hospitals and to the Philadelphia NavalHospital. Once the availability of this service was realized, there werenumerous requests for it from hospitals all over the country. The reply wasalways the same, that other hospitals would be included in the distribution assoon as possible if demands from overseas were not too heavy. The end of thewar, with the termination of the Red Cross blood collection program, ended thisparticular service.
RECOMMENDATIONS
Basic Recommendations
In his formal report at the end of the waron the blood-plasma program (1), Colonel Kendrick made the followingrecommendations:
1. The Transfusion Branch, SurgicalConsultants Division, Office of The Surgeon General, should be discontinued asnot necessary in peacetime. In the light of postwar events, his opinion at thepresent time (1962) is that even
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in peacetime, there should be a knowledgeable consultant ontransfusion and allied matters in this office.
2. The position of Special Representative to The SurgeonGeneral on Blood and Plasma Transfusions should be retained, but with a lesscumbersome title, perhaps Transfusion Consultant or Transfusion ServiceConsultant.
3. This consultant should be responsible for providing theMedical Department with the most recent information on advances in fluidreplacement therapy.
4. In the event of future mobilization, a transfusion branchshould at once be established in the Office of The Surgeon General, the chiefof the branch to serve as Transfusion Consultant, with the rank of colonel,and to have an adequate staff for the functions assigned to him.
References
1. Kendrick, D. B.: History of Blood and Plasma Program,United States Army During World War II, 1 Aug. 1952.
2. Annual Report of the Activities of the Transfusion Branch,Surgical Consultants Division, Office of The Surgeon General, fiscal year 1945.
3. Memorandum, Brig. Gen. Fred W. Rankin for Maj. Gen. NormanT. Kirk, 5 July 1943, subject: Establishment of a Transfusion and IntravenousSolutions Branch of the Surgery Division of the Surgeon General's Office.
4. Memorandum, Col. Tracy S. Voorhees, JAGD, for Maj. Gen.Norman T. Kirk, 23 Oct. 1943, subject: Use for the Armed Forces of our Alliesof Plasma from Donated Blood, and Use of By-Products of Plasma and AlbuminPrograms.
5. Circular Letter No. 108, Officeof The Surgeon General, U.S. Army, 27 May 1943, subject: Transfusion of WholeBlood in the Theaters of Operations.
6. War Department Technical Bulletin (TB MED) 204, 24 Oct.1945, subject: Complications of Blood Transfusion.
7. Army Whole Blood Procurement Service. Laboratory Manual,March 1945.
8. National Research Council. In The Surgeon General'sOffice, The Medical Department of the United States Army in the World War.Washington: Government Printing Office, 1923, vol. I, pp. 566-573.
9. Minutes, meeting of Committee on Transfusions, Division ofMedical Sciences, NRC, 31 May 1940.
10. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 2 June 1944.
11. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 19 Apr. 1941.
12. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 18 July 1941.
13. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 24 Feb. 1943.
14. Minutes, Conference on Transfusion Equipment andProcedure, Division of Medical Sciences, NRC, 25 Aug. 1942.
15. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 10 Nov. 1942.
16. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 15 Dec. 1942.
17. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 20 Oct. 1942.
18. Editorial, Toxicity of Human Plasma. J.A.M.A. 120: 206-207,19 Sept. 1942.
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19. Levine, M., and State, D.: A and B Substances as a Causeof Reactions Following Human Plasma Transfusions. J.A.M.A. 120: 275-277, 26Sept. 1942.
20. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 23 Mar. 1943.
21. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 30 Nov. 1940.
22. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 9 Apr. 1943.
23. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 24 Sept. 1943.
24. DeBakey, M. E.: Military Surgery in World War II. ABackward Glance and a Forward Look. New England J. Med. 236: 341-350, 6 Mar.1947.
25. Minimum Requirements for Unfiltered Normal Human Plasma,NIH, 20 Feb. 1941.
26. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 23 June 1942.
27. Minutes, Conference on Blood Grouping, Division ofMedical Sciences, NRC, 23 Mar. 1943.
28. Minutes, meeting of the Albumin and By-Products Group,Division of Medical Sciences, NRC, 10 May 1943.
29. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 13 May 1943.
30. Minutes, Conference of Albumin and By-Products Group,Division of Medical Sciences, NRC, 28 July 1943.
31. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 6 Oct. 1943.
32. Letter, Lt. Col. Douglas B. Kendrick, MC, to The SurgeonGeneral, 7 Jan. 1944, subject: Release of Red Blood Cells to American Red Crossfor Transfusions. Approved Maj. Gen. George F. Lull, Deputy Surgeon General.
33. Letter, Maj. Gen. Norman T. Kirk to Dr. G. Foard McGinnes,27 May 1944, subject: Use of By-Products of Plasma by Civilian Population.
34. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 17 Nov. 1943.
35. Army Service Forces Manual M3, Courses of InstructionGiven in Schools of Army Service Forces. Headquarters, Army Service Forces,November 1944.
36. Correspondence concerning demonstration packages ofplasma, 22 Oct. 1942-16 July 1943. [On file, General Reference and ResearchBranch, Historical Unit, AMEDS, Walter Reed Army Medical Center, Washington,D.C.]
37. Circular Letter No. 55, Office of The Surgeon General,Services of Supply, War Department, 22 Feb. 1943, subject: Instruction ofMedical Officers in the Reconstitution and Use of the Standard Army-NavyPackage of Normal Human Plasma, Dried.
38. Minutes, Blood Procurement Conference, Division ofMedical Sciences, NRC, 14 Feb. 1942.
39. Regulations Governing Grants to Hospitals for EstablishingReserves of Blood Plasma. Federal Security Agency, U.S. Public Health Service,17 Apr. 1942.
40. Robinson, G. C.: American Red Cross Blood Donor ServiceDuring World War II. Its Organization and Operation. Washington: The AmericanNational Red Cross, 1 July 1946.
41. A Technical Manual on Citrated Human Blood PlasmaDetailing Its Procurement, Processing, and Use. Washington: U.S. Office ofCivilian Defense, November 1942.
42. The Operation of a Hospital Transfusion Service. ATechnical Manual. Washington: Medical Division, Office of Civilian Defense,March 1944.
43. Minutes, meeting of Subcommittee on Blood Substitutes,Division of Medical Sciences, NRC, 10 Mar. 1942.
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44. Correspondence and memorandumsconcerning supply of plasma to Allied nations, 25 Nov. 1942-31 Jan. 1944. [On file, General Reference andResearch Branch, Historical Unit, AMEDS, Walter Reed Army Medical Center,Washington, D.C.]
45. Memorandum re Conference at Surgeon General's Office, 8 June 1943, concerning Useof Plasma and Albumin for Other United Nations, andDisposition of By-Products from Plasma and Albumin Processing, 8 June 1943.
46. Correspondence and memorandums concerning supply ofplasma-drying equipment to Russia, September 1943-June 1944. [On file, GeneralReference and Research Branch, Historical Unit, AMEDS, Walter Reed Army MedicalCenter, Washington, D.C.]
47. Correspondence and memorandums concerning Cuban proposalto supply dried plasma for Allied use, 18 Sept. 1942-31 Oct. 1945. [On file,General Reference and Research Branch, Historical Unit, AMEDS, Walter Reed ArmyMedical Center, Washington, D.C.]
48. Letters, Maj. Gen. Norman T. Kirk and Brig. Gen. Fred W.Rankin to Commanding Generals, all Service Commands, 27 Apr. 1945, subject:Dried Plasma for Hospitals in Zone of Interior.
49. Letter, Lt. Col. Douglas B. Kendrick, MC, to Dr. G. CanbyRobinson, 11 Mar. 1944.
50. Memorandum, Maj. Earl S. Taylor, MC, subject: The Methodsto be Employed in Furnishing Whole Blood to Military Hospitals.
