With two new publications, CLSI resets the bar for phlebotomy procedures
Interview by Steve Halasey
At the end of April, the Clinical and Laboratory Standards Institute (CLSI) released two documents of importance to facilities and personnel that collect patient blood specimens in conjunction with diagnostic testing. Collection of Diagnostic Venous Blood Specimens is the long-awaited 7th edition of the CLSI venipuncture standard. Essential Elements of a Phlebotomy Training Program is a resource for healthcare professionals and educators seeking to develop and implement phlebotomy training programs and courses.1,2
Updating of the CLSI venipuncture standard has been in progress for a number of years. “This revision is the most comprehensive in the document’s history,” says Dennis J. Ernst, MT(ASCP), NCPT(NCCT), director of the Center for Phlebotomy Education, Corydon, Ind, who chaired the committee that revised the standard. “Four years in the making, every passage was intensely scrutinized by some of the most highly respected authorities in the industry. I had a real dream team working on this document.” Features of the revision include:
- A comprehensive literature review of more than 400 articles and studies
- 56 new references
- 149 new mandatory requirements for phlebotomy procedures
- 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.”
CLSI simultaneously released Essential Elements of a Phlebotomy Training Program, a guideline for educators also written by a CLSI committee chaired by Ernst. This new publication provides a comprehensive outline for a world-class phlebotomy training program, saving educators at healthcare facilities and academic institutions many hours of research and curriculum development.
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.
To find out more about these new publications, 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.
CLP: The previous edition of CLSI’s new standard on venous blood collection was issued in 2007. Why was the updated edition so long in coming?
Dennis J. Ernst, MT(ASCP), NCPT(NCCT): I’ve come to the conclusion long ago that everything in life takes longer than you think it should. That’s certainly true with this revision. One of the reasons is that the individuals who participated in this document were some of the most passionate and accomplished preanalytical authorities that have ever been assembled. The depth of their collective experience and their grasp of just how critical this revision was going to be to every patient was unprecedented. It was a real dream team. Whenever you assemble a group of this caliber, rest assured no stone will be left unturned multiple times.
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?
Ernst: Vein selection and tube labeling. The prior version of the standard cautioned against drawing blood from the basilic vein, which passes through the antecubital area medially, due to the close proximity of the median antebrachial cutaneous nerves. In reviewing studies published since the last revision, we found ample evidence to suggest that patient risk attaches not just to the basilic vein, but also to the medial aspect of the median cubital vein, where it connects to the basilic vein. What that meant was that we had to recommend avoiding an area, not just a vein. Defining and articulating the at-risk area was far more complicated, and required new, highly detailed illustrations.
One of the things we were asked to consider was permitting those who draw blood samples to label the tubes before filling them. The committee really struggled with this, since the standard has not permitted precollection labeling since 1991, and no studies have been published that show that practice reduces labeling errors.
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?
Ernst: 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.
So we made the protocol more stringent by requiring patients to state their full name and birthdate, and to spell their first and last names. We also require outpatients without identification bands to present some form of identification as an additional form of verification. Since labeling errors can be so catastrophic to the patient, we’re also requiring all labeled tubes to be compared against the patient’s identification band to confirm they were properly labeled, or to have the patient confirm the labeling is correct. The prior standard recommended it whenever possible, but we felt that wasn’t strong enough.
CLP: How have the technologies associated with venipuncture changed since the previous edition of this standard, and what did the committee do to make the revised standard reflect those changes?
Ernst: Besides the emergence of prelabeling hardware, there was only one other advance in technology that resulted in a change. The previous version of the standard recommended avoiding 25-gauge needles, as they can be a source of hemolysis. However, the introduction of red-cell-friendly 25-gauge needles, which have thinner walls and larger interior diameters, led us to mention the potential for hemolysis with some needles rather than to discourage their use across the board.
CLP: The revised standard describes 149 new mandatory requirements for phlebotomy procedures. Are there certain areas or types of procedures that have undergone significant change, leading to this large number of new requirements?
Ernst: Many of the additional mandates were not the result of changes in the healthcare sector or newly published studies. Rather, they were important provisions that belonged in the standard all along. They include practices such as using safety transfer devices when evacuating a syringe, not drawing specimens from patients who are sitting upright on the side of the bed or an exam table, not placing phlebotomy trays on patient surfaces, not preassembling needles prior to greeting the patient, and so on. These practices were never in the standard before, but really belong there. By adding them, managers have more backing when trying to enforce their policies.
Other mandates were the result of new developments 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?
Ernst: 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.
CLP: Point-of-care and alternate site testing have increased significantly since the previous edition of the standard. How does the revision address issues related to blood collection in such settings?
Ernst: 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?
Ernst: 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.
I have personally observed phlebotomy supervisors ripped to shreds on the witness stand because they didn’t know what the standards specified, and wound up offering testimony that undermined their own professional standing. I left the bench in 1998, and made it my job to see that no patient would be injured at the hands of the unskilled, and no manager would have to deal with the nightmare of litigation that comes from deviating from the standards and permitting lax discipline. I have a long way to go, but until attorneys stop calling me to review their cases, I won’t be satisfied.
Almost every preanalytic error is preventable—but they’re all behavioral. We will never automate phlebotomy, so in order to ‘engineer out’ error we have to be proactive, educate unceasingly, and provide consequences for deviations from standard practice. Those who draw blood and manage specimen collection personnel are the patients’ last line of defense against many catastrophic medical mistakes. Managers and educators have to instill a healthy respect for the standards, for their facilities’ policies, and for their own leadership. This is the three-legged stool that preanalytical quality sits on.
CLP: The venipuncture standard was issued together with a new guidance on phlebotomy training. What is your key hope for the benefits that this companion guidance may produce?
Ernst: With the release of GP48, Essential Elements of a Phlebotomy Training Program, every educator now has a template for a highly effective program that will turn out high-caliber phlebotomists. No longer will laboratory educators have to guess at what should be included in their programs, or wonder if their programs are as comprehensive as they should be. Those who participated in developing this document are highly respected, and come from some of the most prestigious institutions on the planet.
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.
Steve Halasey is chief editor of CLP.
- Ernst DJ, Martel AM, Arbique, JC, et al. Collection of Diagnostic Venous Blood Specimens. 7th ed. CLSI standard GP41. Wayne, Pa: Clinical and Laboratory Standards Institute, 2017.
- Ernst DJ, Berte LM, Blake C, et al. Essential Elements of a Phlebotomy Training Program. CLSI standard GP48. Wayne, Pa: Clinical and Laboratory Standards Institute, 2017.