Vol. 10 Issue 8
Phlebotomy Meets the Law
Most phlebotomists don't think that a venipuncture can land them in the witness chair desperately defending their technique; most phlebotomy supervisors don't realize they can be called as the next witness to defend their hiring and training practices. In today's litigious society, it would be easy to discount phlebotomy-related lawsuits as the frivolous pursuit of ill-gotten gains. Many patients, however, are suffering and suing with just cause.
Phlebotomy is one of the most underestimated procedures in health care. It's a heavily detailed invasive procedure requiring the collector to perform a complex sequence of maneuvers to be performed properly and safely.
In addition to technical expertise, phlebotomy demands a great deal of professional judgment. But it's not just the actions of the phlebotomist that bring liability on a facility; administrative errors can come to light during legal proceedings, putting phlebotomy supervisors on the defensive. To protect your facility from phlebotomy-related lawsuits, it's important to know the types of injuries patients most commonly suffer and the errors collectors typically make that inflict them. But first, a little basic information on legal proceedings is necessary to put this information in context.
Standard of Care
Typically, once a patient retains an attorney to seek compensation for an injury allegedly inflicted during a venipuncture, a fairly standard sequence of events is set into motion. This sequence seeks the answers to two important questions:
1. Did an injury actually occur? From the attorney's standpoint, it's important to have proof of an injury beyond the patient's own claim of pain and suffering. Fortunately, many injuries can be proven by a wide variety of clinical measurements and/or medical examinations. That's not to say a case cannot proceed without it, but it's much more inviting for the attorney to accept the case if there is documented evidence that an injury occurred. Documented evidence can substantiate an injury, but the lack of it may not close the case.
2. Did the collector deviate from the "standard of care" for the procedure? The standard of care is loosely defined as the sequence of events that, when followed according to established and accepted standards for the procedure, will prevent injury or complications under normal circumstances. To find out what the standard of care is for phlebotomy, the attorney must rely on published material and other sources detailing how the procedure should be performed. Textbooks, authorities, the facility's procedure manual and the standards as established by the National Committee for Clinical Laboratory Standards (NCCLS) constitute the body of knowledge on the subject from which the standard of care can be derived.
While researching the standard for phlebotomy, the attorney will try to reconstruct the sequence of events that led up to the alleged injury and look for deviations from the standards in an attempt to link any deviations to the injury. Reconstructing the circumstances surrounding the venipuncture requires a series of interviews, either informally with their own client, or formally by interviewing any or all of those involved in the incident in a deposition. A deposition is a question/answer session conducted in the presence of a court reporter for the purpose of setting down an account under oath of the events leading up to and surrounding the venipuncture. The statements taken during a deposition constitute evidence that will be scrutinized to answer the question about the violation of the prevailing standard of care. Not only can the phlebotomist be deposed, but the supervisor(s) responsible for the phlebotomist's training and evaluation can be called upon as well.
The case will ultimately hinge upon unearthing evidence in either the performance of the procedure or the hiring, training or evaluation of the phlebotomist involved that is irrefutable proof that the facility put the patient at undo risk. Even if there is documented evidence of an injury, it must be shown that the injury occurred as a direct result of an incorrectly performed procedure or practice. This is because, as with any invasive procedure, phlebotomy carries with it an inherent risk that cannot be completely eliminated by adherence to the standard of care. When the needle enters the flesh, the structures it may come in contact with cannot be seen. The best that phlebotomists and their supervisors can do is to minimize the risk of injury by being knowledgeable of the procedure and of proper employment practices and not deviate from them.
However, the risk of injury can never completely be eliminated. When an injury occurs, therefore, the onus for establishing liability for that injury rests on the plaintiff's attorney to find an error in the way the procedure was performed or in the hiring, training and/or evaluation of the individual who performed it.
Who's to Blame?
What follows are case studies of actual phlebotomy-related lawsuits. To minimize your risk of being embroiled in gut-wrenching legal proceedings, make sure that you and your staff are well-versed on the errors that have dragged others through the anxiety of a phlebotomy-related lawsuit.
A nurse was attempting to collect a unit of blood from the basilic vein. When she saw there was no initial blood flow, she began probing the area. Her patient felt shooting pain from his fingertips to his shoulder and into his chest. The nurse removed the needle and found it plugged with flesh. The patient suffered a median nerve injury causing permanent damage and sought compensation.
The most common phlebotomy-related injury is nerve damage. Aggravation of the nerves during a venipuncture often results in sudden, shooting pains that extend down to the fingertips and up toward the shoulder, even into the chest. Keep in mind that just because a patient experiences this pain doesn't mean that you've just inflicted permanent nerve injury, only that you've provoked the underlying nerve. In most cases, the pain is temporary. When it's permanent, the results are often verifiable by neurological studies such as conduction measurements and clinical presentation. When patients experience shooting pain, the venipuncture should be terminated and attempted elsewhere.
Nerves traversing the antecubital area are neither visible nor palpable. It's critical, therefore, that those performing venipunctures know the anatomy of the antecubital area. In particular, health care professionals performing venipunctures need to know where the nerves and brachial artery lie in relation to the three acceptable veins for venipuncture in the antecubital area.
The basilic vein's close proximity to these structures makes attempts at puncturing it riskier than punctures to either the medial or cephalic vein. The basilic vein is a perfectly acceptable vein to puncture and in many cases is the prominent vein in the antecubital area. However, blind probing for this vein puts the patient at risk. The NCCLS limits the extent of needle relocation to a forward or backward adjustment. Side-to-side manipulation, therefore, constitutes a deviation from the standard of care. When choosing the basilic vein, be aware that it is more likely to result in injury if your technique is flawed or if probing is attempted to salvage the puncture. If the patient experiences a shooting pain sensation, do not attempt to salvage the venipuncture. Terminate it immediately and attempt a puncture in another area.
A patient received a permanent nerve injury during an attempted puncture of the basilic vein. During her deposition, the patient claimed the phlebotomist performed the venipuncture at about a 70-degree angle. According to the phlebotomist, the angle was closer to 40 degrees. The jury found the facility at fault and awarded damages to the patient.
A phlebotomist attempted to draw an outpatient twice and was unsuccessful. On third attempt, she entered the skin at a 90-degree angle and injured a nerve. The patient sued the hospital for violating the standard of care.
The attorney in the former case found that many phlebotomy texts, even the lab's own procedure manual, state the proper angle of insertion for a venipuncture is less than 30 degrees. Unaware of the standard of care in regard to the angle of insertion, the phlebotomist's supervisor testified that the 40-degree angle was acceptable. By his supervisor's own unknowing testimony, the phlebotomist not only violated the standard of care according to the literature, but also went against the lab's own policy. To the jury it appeared as if the facility exempted itself from the prevailing standard of care. Testifying against the literature and one's own procedure manual is futile. Insert the needle at the lowest possible angle.
A phlebotomist was presented with the option of puncturing the medial vein or the basilic vein; both appeared to be accessible. She chose the basilic vein and, because of poor technique, injured a nerve that resulted in permanent injury to the patient.
This was a judgmental error. The medial vein is considered in the literature as the vein of choice for several reasons, not the least of which is that there are fewer underlying structures around the medial vein that, if punctured, can result in injury than there are around the basilic vein. Selecting the basilic vein when the medial vein is prominent increases the risk to the patient. Whenever the medial vein is available, therefore, it should be chosen for the venipuncture for the same reason as the previous case: The medial vein is more forgiving should the phlebotomist miss the mark. Punctures to the cephalic vein are also more forgiving and should be considered after the medial vein. In this case, partly because the phlebotomist chose the basilic vein when the medial vein was a well-defined option, the jury found the phlebotomist in error.
It is important to understand that the basilic vein should not be excluded as an acceptable puncture site. In many patients, it is the most prominent vein and is more easily accessed than any other vein. Phlebotomists must puncture the vein that gives them the greatest degree of confidence that the vein will be accessed successfully. Punctures to the basilic vein that bring injury usually occur when the collector blindly probes for a vein that is not visible and/or barely palpable. Check both arms of the patient for the medial and cephalic veins before considering the basilic vein.
A nurse at a blood donor station attempted to obtain a unit of blood from a basilic vein that was palpable, but not visible. She was initially unsuccessful and attempted to manipulate the needle into the vein. The donor involved and an adjacent donor testified that bright red blood entered the line momentarily and appeared to pulse. Unable to achieve an adequate flow, the nurse ended her attempts to locate a vein and sent the patient home without recognizing or treating the arterial nick. Later in the day, the donor's arm swelled and became so painful that she went to the emergency room where she was diagnosed with a compression nerve injury secondary to an arterial nick from the attempted donation. The lingering nerve injury brought a lawsuit against the facility.
In this case, the nurse clearly failed to recognize the signs of an arterial nick. When drawing blood from the vein near the brachial artery, collectors need to be aware of the potential for injury. Palpation should reveal the location of the artery in relation to the basilic vein and if it cannot be distinguished, a vein should be located elsewhere. If excessive bleeding after the puncture occurs or if a hematoma develops, pressure should be applied immediately for several minutes until the collector is confident that the puncture has sealed. Watch for the signs of an arterial nick when puncturing near the brachial artery and be prepared to apply additional pressure as needed.
An outpatient was collected in the antecubital area for his monthly protime. Upon completion, the phlebotomist checked the site, saw that there was no visible bleeding and released the patient. The patient continued to bleed subcutaneously, resulting in a complete infiltration of the entire arm. Because of the complications, it almost became necessary to amputate the extremity.
Another risk of subcutaneous hemorrhage exists if the patient is taking aspirin or is on anticoagulant therapy. Realize that checking for bleeding on the surface puncture isn't enough. Phlebotomists don't always know if the patient is taking aspirin or anticoagulants or has conditions that compromise hemostasis. One must be assured that the hole in the vein has sealed as well as the puncture through the skin. Before bandaging, in addition to checking for surface bleeding, watch the insertion point around the site for any raising or mounding that would indicate that the vein is leaking into the surrounding tissue. If you suspect the vein has not sealed, reapply pressure for several more minutes and check again. Under no circumstances should you leave a patient–or allow a patient to leave you–if you are not 100 percent certain the puncture has been sealed superficially and subcutaneously. Observe the puncture site for several seconds after pressure is removed and check for the signs that the puncture in the vein has not sealed.
A woman was admitted to the hospital and informed the nurse that she had undergone a mastectomy several years earlier and requested that the affected arm not be used for IVs. The nurse disregarded the patient's concerns and inserted an IV into the arm on the affected side. The patient experienced a fluid imbalance in the limb resulting in excruciating pain and discomfort for months. The patient sued the facility that employed the nurse for violations against the standard of care.
This is another case of judgmental error. It is well established in the literature that drawing from the same side as a prior mastectomy is not an acceptable practice. In this case, the nurse was made aware of the mastectomy and still started an IV in the affected limb. Performing a venipuncture would have brought the same liability. If the patient is a difficult draw and no other site is available, physician's permission should be obtained in writing. Some physicians are less concerned about punctures to the affected side in older mastectomies than in recent mastectomies and may allow it. Should a lawsuit follow, however, the facility may still be liable, but the onus lies on the physician, not the phlebotomist or laboratory. The lesson here is to not draw blood from the same side on which a mastectomy had been performed.
A hospital hired a phlebotomist who had recently completed a six-month phlebotomy training program at a local vocational school. According to the hospital's own policies, her technique was to be observed for 40 hours before being allowed to perform venipunctures unsupervised. After only two-and-a-half hours of supervision, she was allowed to draw blood on her own. Two months later she inflicted permanent nerve damage on a patient during a venipuncture. The hospital was sued for negligence.
This is a case in which an administrative error brought liability upon the facility. Clearly, the phlebotomy supervisor violated the laboratory's own policy by clearing the new phlebotomist prematurely. No employee should be considered exempt from a policy the facility has established for the protection of the patients and the assurance of quality care. There is little defense for a randomly implemented policy.
It's one thing to train your staff, but don't assume that their skills will not erode as time goes by. Making sure phlebotomists maintain their skills takes diligence and a well-designed evaluation protocol. Evaluate skills of all those performing punctures on a regular basis. Regular can be anything you define it to be, but three to six months after their initial training and annually thereafter as part of the individual's annual skills assessment is adequate. The best evaluation protocol is useless if it can't be proven on paper. As far as the court is concerned, if it isn't documented, it isn't done. Establish and stick to a well-defined phlebotomy training policy and evaluation protocol. Make sure no employee is exempt and that documentation is complete.
Two days after surgery, a woman experienced seizures and subsequently died. Her physician accused the phlebotomist of drawing blood above the IV site. According to the physician, the laboratory results were so far from the expected values that he was forced to disregard them as being diluted by IV fluids. He claimed that had the phlebotomist drawn from an acceptable site, he would have had reliable information with which to save the patient's life. In the wrongful death suit that followed, the phlebotomist was implicated in the patient's death.
In this case, the phlebotomist was exonerated when it was shown that the laboratory results were not consistent with IV fluid contamination. Nevertheless, it demonstrates the kind of accusations phlebotomists and their supervisors have to defend themselves against. Never draw blood above an IV site even if it has been temporarily discontinued.
A patient with a known history of passing out during blood draws was brought to the facility's laboratory for blood work by attendants who then left the area. The phlebotomist drew the blood without incident. Because the attendants didn't return to escort the patient back to his room, he left the laboratory and immediately passed out, falling to the floor and breaking his jaw in two places. The patient sought damages for the injuries claiming that he should not have been allowed to leave the area unattended.
The safety of the patient is the phlebotomist's responsibility while the patient is in the phlebotomist's care. Health care professionals should always be watching for signs of vertigo and imminent syncope. Pallor, perspiration, anxiety, lightheadedness, hyperventilation, nausea, etc. can precede a loss of consciousness. Make it a habit to ask patients if they feel all right, but don't rely on their answers completely, especially in the presence of any of the above symptoms. Facilities should have a procedure for reacting to patients who become lightheaded or lose consciousness during or after a blood draw and all phlebotomists should be aware of its provisions.
The fault here rests more on the attendants who failed to escort the patient back to his room than on the phlebotomist since the fall occurred outside the area in which the phlebotomist was responsible for the patient. Had the patient collapsed while still in the drawing area, the phlebotomist may have had some liability. Take all precautions to protect patients who become lightheaded or appear to be on the verge of fainting. Recognize the symptoms of vertigo and syncope and respond according to the facility's procedure for such events.
At a small Midwestern hospital, a lab tech drew a specimen of blood to determine the blood type of a patient. She left the room without properly labeling the specimen, drew two more patients, then returned to the lab and sat down to apply the labels. She was momentarily called away and when she returned to her workstation, she misidentified the specimens and typed the patients incorrectly. One patient, a 31-year-old wife and mother of four, received incompatible blood and subsequently died.
There is no defense for not completely labeling a specimen at the bedside. Laboratories should adopt a zero tolerance policy for accepting unlabeled specimens and should refuse to label specimens that have been drawn by other departments. The bottom line is without exception: Label the specimen completely at the bedside. In addition, never label specimens you do not draw unless you witness the collection and can verify that the specimen is from the intended patient. Often, laboratories receive unlabeled specimens in a clear biohazard bag with the patient's labels present but unattached or with a label attached to the bag. These specimens should be returned to the individual who collected the specimen and labeled properly.
Additionally, an armband attached to the bedrail identifies the bedrail, not the patient. Inpatients who are not identified by an armband attached to their person should be able to give their full name and other unique identifying information before they are drawn. Patients who are unconscious or who otherwise cannot provide this information should be identified by a caregiver who will take responsibility for verifying their identification. The name of the verifier should be documented. Label all specimens at the bedside; do not label blood you did not draw; do not draw blood from patients who are not properly identified.
A phlebotomist attempted to draw a blood gas from the radial artery on an ER patient. After an unsuccessful attempt, he drew from the brachial artery and nerve injury ensued. The patient sued for damages.
In this case, no procedural errors were uncovered. Because the radial artery was initially considered and attempted, the attorney was advised that no violations of the standard of care were committed. If, however, the phlebotomist attempted to draw from the brachial artery without considering a radial draw, it could be argued that the phlebotomist put the patient at risk of an injury. The brachial artery, although larger than the radial artery, is much deeper and, hence, more difficult to puncture. Because of this difficulty, brachial attempts are more likely to require needle manipulation, a dangerous maneuver because of the proximity of the branches of the median nerve to the brachial artery as already discussed. Therefore, radial punctures should always be considered before brachial punctures when a blood gas analysis is ordered. Always consider, by palpation, drawing arterial blood gases from the radial artery before the brachial artery.
For those who perform phlebotomy, the only way to avoid the high anxiety and gut-wrenching sleepless nights that come with being named in a phlebotomy-related lawsuit is to know what the standard of care is for venipunctures and apply this knowledge every time. A regular review of the NCCLS standards and of textbooks on the subject as well as strict adherence to a good training and evaluation protocol are the best ways to immunize yourself, your facility and your patients from the pain and suffering of poorly performed venipunctures. n
Dennis J.Ernst is the director of the Center for Phlebotomy Education Inc. and author of Phlebotomy for Nurses and Nursing Personnel. He teaches phlebotomy at the University of Louisville School of Allied Health and is the editor of Phlebotomy Today, an online newsletter accessible at www.phlebotomy.com
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