By Laura Fusco

At one time, blood banking standards, in general, were considered little more than a “good idea,” just a few measures to make sure donors did not suffer from ailments such as “bizarre skin diseases” or rheumatic fever, and had not had any tooth extractions. Infectious disease screening was not nearly as extensive it is today; after all, bacteriologic cultures were only conducted every three months, screening just 1 percent of the blood collected that month, according to a historical vignette published in TRANSFUSION by AABB historian Paul Schmidt, MD.

Many years ago, the general consensus was that written and explicit standards were not necessary to guide practices in blood banking and transfusion medicine. “Back in the day there was more of a sense that ‘we don’t need to write it down … people know what to do,’” explained Frances Widman, MD, an AABB member since the mid-1960s.

In the early years of AABB, the focus was on technical methods rather than published, standardized processes and procedures. It was the Technical Manual — formerly titled Technical Methods and Procedures — that ultimately drove the development of standards, or, as Schmidt explained, “it was agreed that standards for ‘what to do’ were needed to supplement the Technical Manual’s guidelines for ‘how to do it.’” At that time, it was understood that standards would be necessary to carry out the wishes of the AABB Board of Directors to begin accrediting members by inspection. “They said, we can’t accredit people on the basis of the Technical Manual; we have to tell them what to do,” Schmidt said. “So they decided to write standards.”

Vintage Standards

According to Schmidt’s 1997 vignette, a document called the “Minimum Standards for Blood Transfusion” was developed in 1956 by an AABB committee aiming to reflect and promote ideal medical practice. A second draft, “Standards for Accreditation of a Blood Transfusion Service,” was prepared by the Joint Blood Council Inc. and circulated to the AABB Board of Directors for comment — the booklet was considered a preliminary product of both the Joint Blood Council and AABB and was only distributed in limited numbers for suggestions and corrections.

Existing copies of this 1957 version of Standards, which predates “the true first edition of 1958,” Schmidt said, are now collectors’ items. The first, second and third editions of Standards were released as the combined efforts of AABB and the Joint Blood Council. It was not until the fourth edition that the development of Standards became the sole responsibility of AABB.

The Authors

When evaluating each edition of Standards published during this 50-year time period, it is clear that each successive standards committee was thoughtful and careful in writing the principles that would guide the community to carry out its work with regard to quality and safety. “Words and phrases were fine-tuned continually to reflect improvements in the art and the science,” Schmidt wrote.

The standards committee was originally composed of 16 individuals, representing AABB and the Joint Blood Council. In the 1970s, AABB sought the expertise and review of its partners in the medical field to enhance its standards-setting activities, inviting representatives from the Food and Drug Administration and the Centers for Disease Control and Prevention to serve on its standards committee. A decade later, liaisons from the American Red Cross, the College of American Pathologists and the U.S. Department of Defense joined its ranks. An international perspective was gained with the input and review of a representative from the Canadian Red Cross, beginning in 1994. Today, the number of people serving on the committee has doubled and, at 32 people strong, also includes voting members, two public members, liaisons from other AABB committees, and representatives from even more organizations, including the American Association of Tissue Banks, the American Society for Apheresis, the Armed Services Blood Program, the Centers for Medicare and Medicaid Services, ICCBBA, the Plasma Protein Therapeutics Association and the state of California.

Widman — who worked for the transfusion service at the VA Medical Center in Durham, N.C., before she retired — served as a public member of the standards committee from 1977 to 1985, subsequently serving as chair of the Technical Manual Committee. She was named chair of the standards committee in 1989, at a time when “the association was turning its attention to procedures, techniques and specifics.” She remembered that it was a challenge for the committee to ensure that all of the individuals in the group were closely aligned. “We recognized the value of having all of these people at the table, but there were a lot of fierce arguments about how explicit the standards and the Tech Manual should be,” she said.

Adapting to New Ways

This independent thinking, combined with a shared desire to continuously improve practices in the field and member services, led to a number of positive changes. In the early days of the association, there was minimal infrastructure. As AABB grew, it added processes for granting variances, began providing interpretations of the standards, developed member guidance, and took the opportunity to gain and share insight from the regulatory affairs, accreditation and legal departments.

Herbert Perkins, MD, served as chair of the committee when the fifth edition was released in 1970. At the time he worked for Irwin Blood Center, now called Blood Centers of the Pacific, where he still works on a part-time basis. One of the most significant developments Perkins said he has observed throughout the years with regard to standards-setting was the introduction of planned comment periods. “It was a big change to make sure that the membership had adequate time to comment on things,” he said. “There’s a lot of value in gathering this feedback because while the committee might think something sounds logical, there might be implications that they didn’t think of, or that might make [a particular standard] unwise.” Since the 1984 edition of Standards for Blood Banks and Transfusion Services, proposals for revisions have been published for comment before new and modified standards are formalized.

Changing Philosophy

Five decades ago, the standards-setting process allowed for a mix of requirements, recommendations and educational statements. Today, the association promotes a strict separation of standards from recommendations. Schmidt believes that this evolution reflects modern society. “The atmosphere has changed,” he said. “We have a very litigious culture these days, and it’s necessary to make the distinction between a recommendation and a requirement. This is an issue for FDA as well.”

Recognizing and emphasizing the difference between standards and recommendations has been a positive change for AABB and its membership, according to Widman. “It improved things,” she said. “When you have a strict set of standards you may not like it, but at least you know where you stand.” In her opinion, there will always be controversy, but having clarified “the circumstances in which the topic at hand is up for debate (recommendations) or simply what is necessary (standards)” has been an important aspect of the standards-setting history.

While AABB’s standards program has grown and evolved, some critical elements have remained constant. “To work with standards and to put them into effect you have to understand the whole chain of activity from donor to patient — or vein to vein,” said Schmidt, who serves as a consultant to Florida Blood Services in Tampa. “And now, so much of the activity between the donor and the patient is done by machines that it’s possible for a person to sort of be uninvolved. Kind of like, ‘buy the right machines, set them up, and turn them on.’ But that’s how things go wrong.” He went on to explain that the evolution from total manual processes — “where everyone knew what each step meant for the next step” — to a system where machines conduct each step, requires that there be standards “for what the machines will be doing for you.”

Whether it is a machine or a human accomplishing each step between collection and transfusion, standards always will have an integral role. Along with the requirements detailed in the Accreditation Information Manual, the standards have promoted quality and safety for hundreds of facilities and thousands of individuals during the past 50 years. “AABB standards have always been the most detailed set of requirements for the practice of transfusion medicine,” Perkins said. “They’ve covered areas that are not even included in FDA requirements, and we need them.” 

Early federal regulations — administered by the National Institutes of Health — applied only to the blood product itself and only when it was transported across state lines. “Before we had standards, every organization could do what it thought was best based on the opinions of individuals and based on what they read in the medical literature,” Schmidt added. “FDA was not involved until 1972, so everything was governed by state or city laws, with different sorts of legal codes covering how transfusion should be done.”

Now, as AABB commemorates 50 years of standards-setting history, it is clear that much has changed since that first 19-page booklet was introduced. The standards have been translated and adapted into many languages and, in more than a few cases, have been incorporated verbatim or by reference into state and even country laws.

As Harvey Klein, MD, who was chair of the standards committee during the release of the 17th edition of Standards, noted in his preface, standards are the result of a “remarkable process involving diligence and dedication on the part of many people; the blending of current contributions into the collective wisdom of the past; the insights, analysis and spirited exchanges that have led to the production of remarkable documents. The standards contain the essence of our knowledge of blood banking.” 

This article was published in the current issue of AABB News.