Amy Carpenter Aquino
February 2018—Requiring strict adherence to the latest industry standard for venipuncture can go a long way to minimizing the risk of phlebotomy-related lawsuits and multimillion-dollar jury awards.
“It revolves right back to education,” says Nancy Erickson, PBT(ASCP), an expert witness in more than 30 phlebotomy-related lawsuits. She says lack of education and failure to follow the standard of care cause the two most common patient complaints that lead to phlebotomy-related litigation: nerve damage and syncope.
Updating the laboratory’s standard operating procedures to reflect the seventh edition of GP41, Collection of Diagnostic Venous Blood Specimens, and educating staff on the updates can ensure that phlebotomists avoid common mistakes that lead to injuries. The Clinical and Laboratory Standards Institute released GP41 in 2017.
The portion of the standard that addresses acceptable sites for venipuncture has been enhanced and modified. “There are sites that used to be acceptable to draw blood from that are no longer acceptable, and a facility had better put that in their manual and tell their staff,” says Dennis J. Ernst, MT(ASCP), NCPT(NCCT), director of the Center for Phlebotomy Education. “If you draw blood from a patient in an unacceptable site, you’re going to be held to today’s standard and it will be indefensible.”
The area around the basilic vein is “unfortunately where a lot of people will go because it may be something they can see,” says Erickson, product specialist for Greiner Bio-One North America. “The risks are nerve damage or an arterial nick because there is a brachial artery in that location, nearest the basilic vein.”
Ernst says the latest standard expands the area of the antecubital where nerves are at risk. “The prior version limited draws to the basilic vein unless no other vein in either antecubital is easily accessible,” he says. “Studies now show the part of the median cubital vein that approaches the basilic vein is also risky. The revision reflects those studies.”
Ernst, who chaired the revision of the standard, says his committee also found compelling evidence in the literature that the lateral wrist (thumb-side) is associated with nerve injuries during vascular-access procedures, and removed that from the list of acceptable sites for venipuncture.
When Erickson is called to be an expert witness in a phlebotomy-related lawsuit, she requests a copy of the facility’s standard operating procedures. “If they’re not up to date,”—that is, in compliance with GP41—“how can you expect your phlebotomists to perform properly?” she says.
The first action the patient’s attorney will take is to subpoena the facility’s procedure manual and compare it to the latest edition of GP41, Ernst says. If the manual does not reflect the current standards, “that facility is going to be portrayed by the patient’s attorney as completely inept.”
“We as laboratorians never want to give the attorney that kind of leverage because it’s game over at that point,” adds Ernst, who has decades of experience as a legal consultant and seen jury awards of up to $3.5 million.
At the October 2017 Global Summit on Best Practices in Preanalytics, organized by Greiner Bio-One North America, Erickson presented real cases to illustrate how failure to follow the CLSI standard can lead to patient injury and litigation.
In one case, the phlebotomist failed to follow the standard on several levels when she performed a routine blood draw on a young male patient on an exam table after a physical. Although the patient expressed unease with needles, the phlebotomist did not listen to the patient, recognize signs of imminent syncope, or tell him to move to a separate room set up with a blood-drawing chair. “She just drew him from up on top of the exam table,” Erickson says.
The blood draw was uneventful, but when the phlebotomist turned her back to the patient to label the specimen—another lapse in care—the patient fainted and fell to the floor. The patient suffered brain damage and a facial injury and is engaged in an ongoing lawsuit.
“The unfortunate thing was that he said, ‘I don’t do well with needles,’” which should have set off alarm bells and prompted the phlebotomist to consider the possibility of syncope, Erickson says.
In another case, a 24-year-old female presented to the emergency department with bleeding, bruising, tingling, and numbness in her arm after a blood draw when the phlebotomist failed to follow the standard for the insertion angle of the needle.
“The patient described the angle as closer to 45 degrees, and the standard tells us a 30-degree angle or lower,” Erickson says.
The elevated angle of the needle resulted in a transfixed vein, where the needle pierces both top and bottom vein walls, causing a compression injury, “which can be just as painful as a nerve injury,” she says. The patient also was taking an anticoagulant and continued to bleed after the blood draw. “She was a young woman, only 24, but you can’t assume that only 60-year-old people are on blood thinners,” she says.
Other examples of substandard care include not adhering to the one-minute rule with the tourniquet, slapping a patient’s arm to get a vein to swell, and shaking the specimen.
“The word ‘shake’ was used recently in a trial I went to,” Erickson says, “and the difference between ‘shake’ and ‘gently invert’ is huge.” If there is a trial, “does the staff know how to use proper terminology?” Erickson says. “It comes down to training the trainer.”
Erickson’s advice for laboratory managers is to get phlebotomists into conference rooms for continuing education.
“Quite often people will send their managers,” Erickson says. But “there are some people who have been drawing blood for 20 years and they had no idea that blood cultures were supposed to be collected first instead of last, and that’s key,” she says.
Training for all phlebotomy staff on the new edition of GP41, at a conference or in-house, will go a long way toward avoiding litigation.
“In about 70 percent of the cases I review, something was done against the standards,” Ernst says.
Amy Carpenter Aquino is CAP TODAY senior editor. A new edition of the CAP’s So You’re Going to Collect a Blood Specimen was released last year. To order (PUB225), call the CAP at 800-323-4040 option 1. For members, $28; for others, $35 ($25 at ebooks.cap.org).[hr]