Needle-phobic, Americans may be. But most of us probably don’t think of venipuncture as a procedure with a risk of permanent injury. And in fact, of the roughly 1 billion venipunctures performed each year in the United States, the number that cause harm to patients is exceptionally small. When injuries from phlebotomy do occur, however, they can be life-altering to patients, and onerous to health care facilities, which may face drawn-out and expensive litigation. Says Dennis Ernst, MT(ASCP), director of the Center for Phlebotomy Education in Corydon, Ind., “I refer to phlebotomy as the most underestimated procedure in health care.”
Having been a leading expert witness in phlebotomy-related legal cases for several years, Ernst devotes much of his time to communicating how hospitals and health care personnel who draw blood can keep injuries, as well as litigation, to a minimum. He and other consultants who serve as expert witnesses in phlebotomy litigation emphasize the critical need for personnel drawing blood to know the standard of care, and to strictly adhere to it.
The chairholder of the Clinical and Laboratory Standards Institute standards for venipuncture, Ernst served as an expert witness for the first time in a 1996 lawsuit, and discovered in time that the phlebotomy error at issue was far from an isolated incident. “More and more cases were brought to my attention, and I concluded that a lot of people are not taught basic information that they need to know to prevent patients from being injured, because I was seeing the same types of mistakes crop up in case after case.”
Working as an expert witness is not for the faint of heart, he says. “For every case, there’s an attorney who doesn’t like your opinion and is gunning for you. But you provide a valuable service to the legal community as to whether something was done beneath the standard of care. Because attorneys don’t have a clue, and jurors don’t have a clue.”
Most lawsuits alleging phlebotomyrelated injury name the employers. “Employers have deep pockets and the plaintiff alleges they are culpable because they are responsible for hiring, training, and managing the employees.” Of the cases he was involved in, only one charged an employee, and that was because in that state the hospital’s liability had ended under the statute of limitations.
The most common injury that leads to litigation is nerve damage, Ernst says, describing two types. “Direct nerve contact is the most obvious and usually causes the patient to experience a shooting, excruciating, electric-like pain.” The second type is an arterial nick, which creates pressure causing a compression nerve injury.
These injuries are often disabling ones that don’t resolve. When the hospital or other facility is sued, “by and large the patient is injured and the complications of the injury did not subside over time. More than likely they’ve gone through physical therapy and have been told they have complex regional pain syndrome type 2. The symptoms are tingling, numbness, lack of grip strength, limited range of motion, discoloration, and temperature sensations.” He cites many cases in which patients have settled for tens or hundreds of thousands of dollars, but the economic impact of an injury can run even higher. In one recent suit, a patient charged she had permanent nerve injury and could no longer function as a dentist. “So that’s lifetime lost wages for a dental professional.”
Unfortunately, Ernst says, lack of knowledge of anatomy is frequently a factor in lawsuits. Since phlebotomists are largely unregulated, “there are really no minimum training standards, outside of California, as to what specimen collection personnel ought to be exposed to in training.” Knowledge of the network of nerves, veins, and arteries that pass through the antecubital area is essential, but not all phlebotomists grasp it. “Most phlebotomists are taught where to expect the veins to be. They know where the brachial artery is, but I’m finding a lot who don’t know where the nerves are that run through the antecubital area—and so they don’t know how to avoid them.”
In the 16-week phlebotomist training course that The Medical Center of Central Georgia offers, Christine Presley, BS, MT(AMT), phlebotomy school technical supervisor and frequent expert witness, teaches basic anatomy and physiology, then focuses on the circulatory system and anatomy of the arm at length. However, many hospitals don’t insist that phlebotomists have this level of training. Only three states—California, Louisiana, and Nevada—spell out the requirements that phlebotomists must meet to work in the field. The others leave those decisions to the health care facilities that employ them.
One of the most common problems leading to litigation is angle-of-insertion errors. “That’s a huge area of liability,” Ernst says. “If the people drawing blood don’t know what the standards say about the limits to the angle of insertion, and a venipuncture leads to injury, they are going to have to defend themselves, because it’s so clearly established that it has to be 30 degrees or less in order to minimize the risk of going through the other side of the vein and impaling the nerve.”
Ernst has encountered several cases in which the angle-of-insertion standard was violated and the patient ended up with disabling injuries. “What I recommend to those who teach or train or perform phlebotomy is to go in at as low an angle as possible. There’s no need to carry protractors around to measure every venipuncture—it’s enough to know there is a limit, and if it exceeds 30 degrees, then you’re probably on the edge of being liable, should injury occur.” Presley agrees. “I have been on four or five cases where the phlebotomist incorrectly thought the proper angle is 45 degrees. And if you go in at that angle, you could easily provoke a nerve injury,” she says.
With patients’ variations in anatomy, the general rule on angle of insertion can become tricky to follow. For example, complications often occur with obese patients, points out Diana Mass, MT(ASCP), a consultant and expert witness who was until recently a clinical professor and program director for clinical laboratory sciences at Arizona State University, Tempe. “If there is a lot of fat on the arm, the angle may have to be slightly elevated because the vein is much deeper. But if the angle is too elevated, you might miss and go through the vein, and that’s how you might get an arterial nick or hit a nerve.”
One standard that is often disregarded is the requirement to start over when the venipuncture does not work. “Not everybody immediately accesses the vein when inserting it into the tissue. But it’s what you do when you miss that could determine your liability for injury if one occurred,” Ernst points out. “Repositioning is one thing, but blindly probing is completely different.” The CLSI standards use precise language to differentiate the two, he adds.
“You are allowed some adjustment of the needle if you don’t feel you’ve gone in far enough,” Presley says. “You can pull back a little or push in a little if you go straight forward or back, but adjustments other than that are considered probing.”
That was an issue in the first of 13 cases in which she has served as an expert witness. The case involved a woman who had received an injury after being stuck in the hand with a Vacutainer needle. “When a phlebotomist cannot access a good vein in the antecubital area, we can draw from other areas like the dorsal side of the hand. But you really should not be using a Vacutainer on the smaller veins of the hand; it should be something smaller, such as a butterfly needle.”
That recommendation is not written into the standards, but this phlebotomist’s big mistake was not anchoring the vein correctly. “So it moved, and then she went fishing for it,” Presley says. As the case heads to trial, the hospital is contending the phlebotomist did not do any probing. “So the jury will have to weigh what the patient is declaring against what the phlebotomist is saying she did or did not do.”
The only case she’s worked on so far that has been decided by a jury also involved allegations of probing. It stemmed from two unsuccessful attempts to draw blood from a female patient who was complaining of chest pain. Both the first and second phlebotomists who made the attempt to hit the patient’s basilic vein in the antecubital area were, according to the patient, “digging and gouging” in the attempt to obtain a sample. “There ended up being a nerve injury, but in addition, they sliced the brachial artery with the needle. When the needle goes from side to side, the bevel on the needle acts like a scalpel under the skin,” Presley explains.
Having developed a condition called compartment syndrome, the patient had to have surgery to treat a very large hematoma in her arm, which required a graft of her artery. The compression against the nerves from the hematoma left her unable to straighten her arm or move her hand. Presley testified that, in her opinion, the injury was most likely caused by the probing of the needle, and because the woman no longer had use of her right arm, the jury awarded $3 million to her and $500,000 to her husband who would have to care for her.
Another CLSI standard specifies how personnel performing venipuncture should prioritize veins for safety. Since the nerves in the antecubital area pass very close to the basilic vein, that vein should not be used until safer options like the medial or cephalic veins have been ruled out, Ernst says.
To his bafflement, sometimes personnel consider drawing from arteries to be an alternative to routine venipuncture. It doesn’t make sense, he says. “There is so much more pressure involved in the artery. Why would you want to put the patient through a procedure that has greater risk than venipuncture? It’s beyond me.”
Similarly, phlebotomists should not let the patient influence where the draw is made. “Patients don’t know the risks and could pick a site that is beneath the standard of care. That is specifically forbidden by the standards. We have to be very diplomatic when patients say ‘Here’s the vein to draw from,’ but we certainly don’t want to exchange their safety for customer service.”
Phlebotomists should never draw patients unless the patient is recumbent on a cot or bed, or sitting down in a chair with two armrests. When Ernst asked participants in a recent presentation how many of their facilities have chairs with two armrests, many didn’t realize that not having them is a violation of standards.
In addition, he says, phlebotomists should beware of a common practice: drawing a patient who is sitting upright on the edge of the bed. “A lot of patients are sitting upright, and the phlebotomist puts a bedside tray in front of them, resting the arm on the tray. That’s dangerous. If the patient passed out and fell forward, there would be no defending it. It’s a clear-cut violation of the standards.”
Should phlebotomists be aware that a patient is on blood thinners, is allergic to iodine or latex, or has had a mastectomy? Diana Mass says that theoretically, phlebotomists should be asking the patient those questions, but they rarely do. “When I go in for a venipuncture, they don’t ask me anything.”
However, Ernst says bringing that kind of information to the phlebotomist’s attention for every patient is not practical. “That’s why the standards—when they’re followed—protect patients against complications when phlebotomists don’t know that information.”
For example, the standards require that all patients not be bandaged until the phlebotomist has ascertained the bleeding has stopped. So it doesn’t matter if the patient is on a blood thinner or not. “You don’t do a cursory look; you actually have to stare at the site for a while,” Ernst says. He believes that patients with mastectomies, who are at risk if they’ve lost lymph nodes, are somewhat different. “They have some obligation to bring their status to the attention of whoever is drawing their blood.”
Occupational Safety and Health Administration regulations protect employees from being exposed to infection. “But there really isn’t any regulation, other than following good lab practices,” Mass says, “that protects patients from getting an infection from venipuncture.”
“Sometimes I’m amazed that phlebotomists will use alcohol to clean the skin area, and then use gauze to wipe it dry. That happens all the time, and I don’t know why. The site should be allowed to air-dry. And you shouldn’t blow on it either, which people often do because they’re rushed.”
The application of pressure following venipuncture has pitfalls. “Unfortunately, a lot of phlebotomists think it’s the patient’s responsibility,” Ernst says. “But the fact is it’s the phlebotomist’s responsibility. Patients can assist but must be monitored to make sure they are applying adequate pressure themselves. If not, the phlebotomist has to take over.” Also, he warns, the standards are clear that the patient should not be allowed to bend his or her arm up. “It must be direct pressure, applied either by the phlebotomist or a cooperative patient.”
Observing the site for at least 10 seconds to detect the formation of a hematoma is his benchmark. “Unfortunately, too many people believe if there’s no blood on the skin, it’s not bleeding. But when performing venipuncture you are doing two punctures, one in the skin and one in the vein. The skin can seal while the vein continues to leak, and unless you’re taking that extra time, you’re not going to know.”
He cites one case in which a patient came in for his monthly prothrombin time test, and after venipuncture, the hole in the patient’s vein had not sealed. The patient continued to bleed into his tissue, Ernst says. “And before he could get himself to a physician, he was black and blue from fingertip to shoulder.”
If a patient is experiencing a shooting pain, possibly signaling a nerve injury, the standard calls for the venipuncture to be terminated immediately. But experience is often the only way to develop a sense for when a nerve injury might have occurred, Mass says. “Nobody likes to have a venipuncture, and people look away. You do sometimes hit those superficial nerves right there on the skin. And if people go ‘Ow!’ and flinch a little, you’re not going to pull the needle out and stop. If that were the case, you’d never get blood from people. A phlebotomist has to learn when a person means ‘I am really in pain.’”
About two and a half percent of patients are going to faint during or immediately following a blood collection procedure, Ernst says. “The problem is, they don’t come with a label over their forehead to tell us that we need to be warned and we need to be ready.” Staying attentive and within arm’s length are two ways to make sure the patient doesn’t get hurt.
Many studies are finding that using dedicated phlebotomists for draws is more appropriate than relying on nurses to obtain samples from a central line. “There’s no law that says you have to have a dedicated phlebotomist,” Mass says. “But based on my experience looking at studies with respect to proper venipuncture, they’ve shown that dedicated phlebotomy teams give you much better results than when phlebotomy is done randomly by physicians or nurses.”
Even though the laboratory covers the extra personnel expenses, the hospital saves a lot of money overall through dedicated phlebotomists by not having repeat draws, or not having patients drawn for blood cultures that result in false-positives then being admitted, or, for patients in the hospital with false-positives, longer lengths of stay because they’re being treated unnecessarily with antibiotics, she says.
Mass has a special perspective on the value of experience in Arizona, because in that state police officers are empowered to take blood samples from drivers suspected of being drunk or impaired by drugs. “I have been totally against that, and I have been hired by defense attorneys even in cases where their clients may really have been DUI. I usually testify against the police officers doing the phlebotomy. Even though these people may be trained properly, they don’t get the orientation and supervision. You can’t just train somebody and let them loose.”
Police officers don’t perform enough draws each week to be proficient, she says. “Most people would say you need to be doing five or six draws a day to be proficient, and sometimes the police only do five or six per month. The drivers, if they really are under the influence, are often not the calmest or most comfortable of patients. And sometimes the draws are done with defendants standing up or in unsanitary situations, so there are many potential problems.”
Labeling of the specimen at the patient’s side following the draw is part of the standard of care and should be done without fail, Ernst says. “Many facilities do a great job of enforcing their policy of not labeling tubes anywhere but at the bedside. But other facilities don’t do as well. Even in good facilities, there are renegades who step out of bounds and allow circumstances to convince them that, this one time, it’s acceptable.” If the tube and the label leave the patient’s bedside unattached, he emphasizes, the specimen should be discarded and the patient redrawn. “The CLSI standards and the Joint Commission both say we have to label our tubes at the patient’s side without exception,” he says.
Labeling in advance and then drawing blood into the pre-labeled tubes was what was done many years ago, Mass notes. “Then you might accidentally use the tube on the wrong patient. There are a variety of new technologies like bar coding, armband scanners, devices to print labels right at the site, and they are supposed to be helping, yet you still hear that people are misidentifying specimens.”
“Sometimes the laboratory personnel pick up on a misidentification in the lab through a delta check—for example, when a hemoglobin from a patient on day two is really, really different from the hemoglobin on day one. A delta check is a way to trend your patient, but not every lab does it,” Mass says.
Perhaps surprisingly, the Joint Commission on Accreditation of Healthcare Organizations recently watered down a patient-identification standard, by ending the requirement that personnel performing venipuncture ask patients to state their names and dates of birth to verify their arm bracelets are correct.
“We all know that bracelets can end up on the wrong patient,” Ernst says. His Center for Phlebotomy Education, in a letter to the Joint Commission last year, pointed out that many documented errors of patient identification, some with tragic results, have occurred because the patient was not asked to give his or her name. “But the Joint Commission claims there is no way they can effectively survey compliance with the provision, and hospitals claim the mandate is ‘unnecessary and burdensome.’ So they just took away a safety net for patients.”
Presley, who has encountered serious errors in patient identification that were caught by an alert phlebotomist checking with the patient, says it’s unfortunate there are now two different standards. “I’m glad that CLSI as well as CAP are beefing up their standards, not weakening them, because the laboratory falls under CLSI standards.”
Standards matter, Ernst says. And if those who are managing, training, and performing blood collection procedures avoid the most common errors, he says, “then quite likely we could all be a little less involved in the legal aspects of what we do and more engaged in providing quality patient care.”
Anne Paxton is a writer in Seattle.