With two new publications, CLSI resets the bar for phlebotomy procedures
4月底，临床和实验室标准研究所（CLSI）发布了与收集患者血液标本的设施和人员的两份重要文件，与诊断测试结合。Collection of Diagnostic Venous Blood Specimens是已久的第7版的CLSI静脉正版标准。静脉曲张训练计划的基本要素是医疗保健专业人士和教育工作者的资源，寻求开发和实施校准培训计划和课程。1,2
- A comprehensive literature review of more than 400 articles and studies
- 56 new references
- A new reader-friendly design in full color, with more images, tables, and graphic elements
- Complete reorganization as a quality management systems document
The committee also added new appendices that provide detailed guidance on maximum blood volumes to be collected from patients susceptible to iatrogenic anemia; drawing from pediatric, elderly, obese, oncology, needle-phobic, cognitively impaired, and combative patients; and preventing syncope.
“Any facility that isn’t using this as a basis of their procedure manual is putting themselves at risk of operating beneath the standard of care,” says Ernst. “Users of GP41 are more likely to provide patients with a standardized phlebotomy experience, maintain sample quality, prevent patient injury, and release test results that accurately reflect the patient’s health status. Not only that, but they have the confidence their procedure manual is based on a standard established by the consensus of highly respected authorities from some of the most prestigious organizations on the planet.”
The new guideline lays out everything educators need to create or redesign their training program to include all aspects of preanalytics, including the collection of blood and non-blood samples, general and technical course content, and clinical and remedial training. In addition, the standard’s appendices are a rich resource containing a wealth of supplementary information, including an expansive list of questions every educator should ask when assessing the caliber of their existing programs.
要了解有关这些新出版物的更多信息，CLP.recently spoke with Dennis J. Ernst, MT(ASCP), NCPT(NCCT), director of the Center for Phlebotomy Education, who chaired the committees that wrote the two new documents.
Dennis J. Ernst, MT(ASCP), NCPT(NCCT):我很久以前就会得出结论，生活中的一切都比你想象的要长。这种修订肯定是真实的。其中一个原因是参与本文件的个人是曾经组装过的最热情和最有意义的预审当局。他们的集体经验的深度及其掌握了这一修订的批判将是每个患者的批判都是前所未有的。这是一个真正的梦想团队。每当你组装一组这个口径时，放心就没有石头留下了多次。
Having been involved in the previous two revisions, I can tell you this standard has never been subjected to such scrutiny. Updating the references alone took 6 months and required the creation of a special task force within the committee. We read more than 400 published studies and abstracts, and made sure every reference earned its place.
We had our share of obstacles and delays, make no mistake. But developing industry standards is one of those things that can be done either well or quickly—but not both. My committee opted for the former.
CLP.:The medical community has learned a lot about almost everything in the decade since the previous edition of this standard. What new understandings were hardest to accommodate in the revised standard?
Since the previous revision, however, instruments that label tubes in advance have come into use in some parts of the world. Additionally, we found some countries label tubes in advance as a matter of tradition. However, it was the consensus of the committee that the standards should dictate practice, not the other way around. The overriding concern among members was that if a prelabeled tube wasn’t filled during the draw for any reason, and not discarded, it could be used for another patient. We weren’t comfortable with that potential. That issue took about 10 months to resolve, but the decision was unanimous among committee members.
CLP.:The revised standard includes a lit review of more than 400 sources on venous blood collection. What were the most surprising trends revealed in that review?
恩斯特：We reviewed a College of American Pathologists Q-Probe study that found the healthcare sector’s use of barcoded bands to identify patients increased from 8% to 38% between 2007 and 2015. But what was surprising is that the incidence of wrong-blood-in-tube errors did not change. That and other studies reminded the committee how critical it was that we get the passage on patient identification right.
其他要求是新发展的结果and studies. For example, when blood pressure cuffs were used in place of a tourniquet, the prior version of the standard said to limit inflation to 40 mm of mercury. In our literature review we found that might not be sufficient for all patients, so we changed the inflation limit to just below the patient’s diastolic blood pressure. We also dispensed with the practice of circular cleansing for venipuncture sites. Several sources revealed it’s not evidence-based and unnecessary for blood cultures and routine labs. Friction, yes; but circular cleansing is old school.
CLP.:The revised standard has adopted a quality systems approach to phlebotomy processes. What kinds of changes in the standard resulted from this approach, and how have they affected the shape of the standard’s requirements?
恩斯特：Establishing this standard as a quality management system document didn’t change how blood should be drawn, but it organized the material in a much more logical and user-friendly format. It put the process of how blood is drawn front and center where it should be, and moved other essential but not sequential information later in the document under the section on quality system essentials. Users will find this structure vastly more functional, as well as easier to follow and implement.
The other thing I’m crazy about with this revision is how CLSI has made its documents more graphically appealing. The font is vastly more readable, the infusion of graphic elements really enhances the visual appeal of the publications, and the use of images and color throughout give the look and feel some real pizazz.
恩斯特：The documents that will be addressing those developments will be CLSI’s skin puncture standard, which is currently under revision, and sample handling guideline, which is not due for revision for another year or so. Point-of-care testing developments required only minor consideration in the revision of the venipuncture standard. Alternative site testing didn’t play into it at all, since the standard doesn’t discuss transportation, processing, or handling aspects of the preanalytical phase.
CLP.:Of the current challenges faced by phlebotomists, which do you think are most likely to still be problematic when the next update of this standard is produced?
恩斯特：None of it will be problematic if managers do two things: infuse every provision of the standard into their policies and procedures, and discipline deviations consistently. Everything my dream team accomplished with this document—all the time, toil, and tears—will be a complete waste if facilities decide to continue doing things the way they’ve always done them.
But here’s the nightmare scenario that those labs would be bringing on themselves. Not a month goes by when I don’t hear from two or three attorneys wanting me to review a case in which a patient was allegedly injured during a ‘simple’ blood draw. And, of course, the document they use to establish the standard of care is GP41. Any facility that doesn’t implement every provision of this revision puts itself at risk of legal liability. All it takes is for one nurse or phlebotomist to draw from an unacceptable site or vein, position the patient improperly, or take shortcuts in patient identification or sample labeling, and the lab’s directors will one day wake up to a legal firestorm that will destroy their productivity for months, if not years.
几乎所有的预期错误都是可预防的 - 但它们都是行为。我们将永远不会自动化静脉散，因此为了“工程师出来”错误，我们必须积极主动，不断教育，并为与标准实践的偏差提供后果。吸血的人是患者的患者最后的防线与许多灾难性的医疗错误。管理者和教育工作者必须为其设施的政策和自己的领导地位灌输对标准的健康尊重。这是三足粪便，以坐落在一起。
恩斯特：With the release of GP48,静脉曲张训练计划的基本要素,每个教育家现在都有一个高效计划的模板，这些计划将出现高口径静脉瘤。实验室教育者不再猜测他们的计划中应包括什么，或者怀疑他们的计划是否与应全面。参与发展本文件的人受到高度尊重，并来自地球上的一些最着名的机构。
Infusing the recommendations of this guideline into an in-house or academic training program gives the educator and faculty confidence that their program is well established and capable of producing high-powered talent for the laboratory workforce. Phlebotomists are the backbone of the laboratory. Programs that are missing key components are like a spine missing a few vertebrae. It just doesn’t work right, and causes a lot of pain and suffering.
- Ernst Dj，Martel Am，Arbique，JC等。诊断静脉血液标本的集合。7th ed. CLSI standard GP41. Wayne, Pa: Clinical and Laboratory Standards Institute, 2017.
- Ernst DJ, Berte LM, Blake C, et al.静脉曲张训练计划的基本要素。CLSI标准GP48。韦恩，帕：2017年临床和实验室标准研究所。