College of American Pathologists
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Safety net: juggling the gains, losses of phlebotomy routines

June 2004
Karen Lusky

The "butterfly effect" holds that a butterfly flaps its wings in Rio de Janeiro and affects the weather in Chicago. Sounds far-fetched, of course, but the underlying concept describes what safety experts well know: Even a tiny change in a system can lead to unintended and bigger effects elsewhere. That’s certainly true in phlebotomy and laboratory practice where patient and employee safety improvements tend to create new risks and problems that health care organizations have to predict and fix.

For example, manufacturers and laboratories are tackling the last bastion of sharps-related injuries by making the transition to plastic specimen collection tubes. Plastic is less likely than glass to break during centrifugation and lab accidents. "And glass exposures to blood pose more of a risk than needlestick injuries because usually broken glass results in exposure to significantly more volume of blood," says Dennis Ernst, MT (ASCP), director of the Center for Phlebotomy Education, Ramsey, Ind. Plastic is also lighter and easier to dispose of than glass, and once manufacturers complete the switch from glass to plastic tubes, the latter should cost less.

Thus, switching to plastic specimen collection tubes sounds like a relatively simple, commonsense safety move. Yet this ostensibly small change can affect the adequacy and integrity of specimens, and it even has the potential to produce different lab test results.

"Regulations require that when switching tube types, for example from glass to plastic, the new tube does not contribute to analytic interference. Sometimes people phrase this as ’The test results need to be clinically equivalent in both tube types,’" says Ana Stankovic, MD, PhD, MSPH, formerly with the Centers for Disease Control and Prevention and now worldwide medical director of BD Diagnostics, Preanalytical Systems, Becton, Dickinson and Company, Franklin Lakes, NJ. "But glass and plastic tubes don’t have the same mechanical characteristics," she says. For starters, a plastic tube may not hold the vacuum as long as a glass-evacuated tube does, so its shelf life may be shorter.

In switching to plastic tubes, LDS Hospital, Salt Lake City, found that altitude affected the vacuum in the plastic tubes. "As a result, phlebotomists were getting short draws with the smaller plastic tube," says Doyle Harcrow, CPT, ASPT, phlebotomy education supervisor and instructor for Intermountain Health Care, Salt Lake City, which owns LDS Hospital. To solve the problem, the lab stopped using the lower-volume (1.8 mL) tubes and went to the larger ones (4.5 mL), according to Leslie Jones, urban central regional phlebotomy supervisor for Intermountain.

When using plastic tubes, it’s important to mix the additive and the specimen well, by totally inverting the specimen immediately after collection a correct amount of times, which varies by tube type, says Dr. Stankovic. Most additives in plastic tubes are in dry form, she explains, to address concerns about the evaporation of liquid additives, such as anticoagulants, in a plastic tube throughout its shelf life. "In addition, glass is viewed as a better activator of the clotting system than is plastic," she says, "so in order to obtain optimal coagulation of blood in a plastic tube, a ’clot activator’ must be added during the manufacturing process that will allow fast blood clotting."

So, for example, with coagulation tubes, the phlebotomist should do about four inversions to mix the specimen properly, and for plasma tubes, eight inversions, says Dr. Stankovic. "The person doing the blood draw really has to adhere to the manufacturer’s guidelines in mixing the specimen by inverting it the required number of times," she says.

When transitioning to plastic tubes, labs also have to ensure that they will get the same test results from various analytes. "There is a CAP Lab Accreditation Program question relating to specimen containers that asks if the lab has evaluated specimen containers to ensure they do not contribute to analyte interference in assays to be performed by the lab," says Thomas Merrick, MD, chair of the CAP Safety Committee and director of the clinical microbiology lab at Presbyterian St. Luke’s Medical Center, Denver.

To satisfy that accreditation requirement, Dr. Stankovic adds, "a lab needs to have documentation to show that it has reviewed the manufacturer’s data, other people’s data, data in the literature, or its own data as part of the validation of the tube’s performance." Yet the way the regulations and accreditation standards are written, labs don’t have to do their own in-house validation studies when switching from glass to plastic tubes. But in Dr. Merrick’s opinion, labs should be doing in-house validation studies, a viewpoint Dr. Stankovic shares.

"Most people feel there are some [correlation studies] that labs should do in-house; these include your most common tests, the critical tests used for diagnosis, your most sensitive tests, etc.," says Dr. Stankovic. "A good example would be critical tests used for diagnosis of serious diseases, such as heart attacks, for example CK-MB and troponin I."

LDS Hospital is doing correlation studies now to compare glass and plastic coagulation tubes by drawing and testing blood in both types on about 40 patients to compare the test results, says Sterling Bennett, MD, director of clinical pathology at the hospital. Due to the potential differences in the tubes’ activation of the clotting system, Dr. Bennett was uneasy about relying on the manufacturer’s claims about how plastic tubes perform.

Increased use of chronic warfarin and other anticoagulant therapy is another double-edged patient safety improvement in the phlebotomy setting. Patients who have therapeutic levels of anticoagulation are at risk for developing a debilitating venipuncture-related complication called compartment syndrome. The condition occurs when the venipuncture site in the skin seals over but active venous bleeding continues subcutaneously.

"This problem is not common but is becoming more so due to the increasing number of elderly people receiving Coumadin," says Frederick Kiechle, MD, PhD, chair of the Department of Clinical Pathology at William Beaumont Hospital, Royal Oak, Mich. And when compartment syndrome occurs, "treatment must be aggressive, requiring a cut-down to drain the area and allow it to heal," he adds.

Compartment syndrome can be prevented, however, if phlebotomists adhere to revised NCCLS standards that direct them to follow a two-step process, according to Ernst. They must check the venipuncture site for superficial bleeding and hematoma formation before bandaging the site, he says. "If discoloration or swelling appears, the phlebotomist should apply additional pressure and be prepared to call the physician to evaluate the patient if necessary," Ernst adds. At LDS Hospital, for example, the pathologist examines patients thought to be having a problem related to the phlebotomy procedure, according to Barbara Bagley, manager of phlebotomy at LDS.

The consequences of not detecting subcutaneous bleeding after simple venipuncture can be devastating for the patient. Ernst recalls one case where a patient injured during a simple blood specimen collection developed compartment syndrome and had to have an emergency fasciotomy in which muscles of his forearm were removed. "The risk is real," he says.

Dr. Kiechle adds, "Phlebotomists should routinely ask patients if they are taking anticoagulants—Coumadin, heparin, aspirin therapy, Plavix—and, if so, apply pressure to the venipuncture site for at least two minutes and assess the area to make sure clotting is complete."

To reduce the likelihood of causing uncontrolled bleeding at a venipuncture site, phlebotomists might also consider following a "two strikes and you’re out" rule where they switch to the patient’s other arm if they don’t complete a successful blood draw on the second attempt. "Ideally, the person should get someone else to do the venipuncture at that point," says Dr. Kiechle, editor of the CAP’s phlebotomy manual, So You’re Going to Collect a Blood Specimen. He reviewed cases where the person drawing a blood specimen attempted to do so more than twice and finally damaged the area to the extent that the bleeding didn’t stop until it had accumulated between the muscles and fascia.

Compartment syndrome can also develop if the phlebotomist nicks the patient’s artery accidentally during venipuncture. If that happens, the discoloration and swelling will develop rapidly. "A general surgeon would have to go in and repair the artery surgically," Dr. Kiechle says.

As for their own safety, phlebotomists have come a long way since the Needlestick Safety and Prevention Act went into effect in April 2001. Yet moving to the high ground with safety needle devices has produced unexpected product development and compliance issues. For example, some settings are still grappling with the "you can lead a horse to water but can’t make him drink" phenomenon in getting phlebotomists to activate the safety devices before disposing of a needle, given it takes only one lapse to contract hepatitis C from an exposed needle. Reports continue to circulate about how some hospital departments maintain secret caches of the "good stuff," that is, conventional needles for difficult sticks.

Yet the cost of noncompliance is multifold, including hefty Occupational Safety and Health Administration fines. "Here’s the deal with safety needles: If you’re not using one, you’re in violation of OSHA and can be fined up to $7,000 per incident," says Terry Jo Gile, MT (ASCP), a laboratory safety consultant in St. Louis. "And if the facility provides safety needles, but the phlebotomist or other person using the needle doesn’t activate the safety device before disposing of the needle, that may be an OSHA violation, too," Gile says.

Dionne Williams, MPH, senior industrial hygienist with OSHA, agrees that the agency could cite an employer if phlebotomists are not activating the safety device before disposing of the needle. In such cases, OSHA encourages employers to retrain employees who are not adhering to their policy and procedure. And OSHA would especially have an issue with a health care organization that knew its employees weren’t activating the devices and took no action, Williams adds.

Given the dangers of bloodborne pathogen exposures, why would someone not activate the safety device? For one, old habits die hard, and phlebotomists in the Baby Boomer demographic bulge used conventional needles for decades. In addition, some health care employees claim that the new devices aren’t as nimble as the conventional needles. "For example, there are devices that retract the needle and lock into the body of the device, while on other devices a shield is locked into place over the needle. Many of these devices depend on manual activation by the health care worker," says Dr. Stankovic. "Some employees skip that safety step."

That’s why OSHA directs health care employers to solicit input from frontline staff in selecting safety devices. "Staff should actually use various products when making a decision about a product," says Dr. Stankovic. For example, in selecting safety products, Intermountain Health Care did a systemwide study and selected people who had used different products from various vendors and then chose a vendor based on that. "So the staff provided input," says Intermountain’s Jones. "And we just evaluated that again last year."

OSHA requires employers to evaluate annually what’s on the market to see if a product might work better for employees, a requirement that Dr. Merrick suspects some institutions are not following. What happens, he says, is that staff report they are happy with a product so the institution doesn’t look for an alternative. "But there might be something available that would do a better job in preventing injuries," he says.

Knowing what’s on the market and providing feedback to manufacturers about their products helps the companies invent better mousetraps. For example, BD heard health care providers say its earlier product versions did not allow the person doing a venipuncture to easily perceive the "flash" that appears when the blood enters the transparent end of the needle, which lets phlebotomists know they are in the vein. "BD took that kind of feedback very seriously and changed the indicator button on the BD Vacutainer PushButton blood collection set to draw the eye toward the place where the flashback occurs," says Dr. Stankovic. "Like other manufacturers, BD strives to make products as user friendly as possible without sacrificing safety."

Manufacturers can also use suggestions from pediatric health care providers on how to improve safety devices for children and small adults, says Deborah Perry, MD, director of the Department of Pathology at Children’s Hospital, Omaha, Neb. "For example, there are butterfly needles with safety features, but these could be improved for easier use in children," she says.

Training staff in how to use new safety devices is also essential to prevent exposures to bloodborne pathogens born more out of ignorance than resistance to the unfamiliar. "Changing from one device to another is like changing a routine and requires a bit of practice," says Dr. Stankovic. For example, on BD’s Vacutainer Safety-Lok blood collection set, she says, "once you learn how to activate the safety feature, it becomes part of your normal routine." It’s equally important for facilities to put work practice controls in place (providing training materials, posting instructions for use, and so on) to help employees remember to take the necessary steps to stay safe.

LDS Hospital and many others have eliminated nonsafety sharps, so employees have no other options. "Staff have to use the safety products because they don’t have anything else available," Harcrow says. Health care institutions have also gotten tough on phlebotomists and other employees who don’t activate the safety devices. For example, Intermountain-owned hospitals make it a requirement of employment for phlebotomists to use the safety products as directed, Jones says. "Staff are evaluated on their performance in that regard quarterly."

Phlebotomists face special safety challenges in doing pediatric blood draws. "Children are unpredictable: They move, they kick, they bite, and because of that, they can hurt themselves as well as the person performing venipuncture," says Karen Butler, laboratory manager at Omaha’s Children’s Hospital.

Children’s Hospital phlebotomists wear a full array of personal protective equipment when drawing blood, including glasses or goggles and a facemask, as well as fluid-resistant lab coats with knit cuffs that are snapped all the way up, though this isn’t an OSHA mandate. The hospital began to require it when a safety analysis found that its phlebotomists were encountering an increased rate of blood aerosol and splashes during venipuncture. "For whatever reason, we were having blood splashes up toward the phlebotomist’s face," Butler says.

Yet phlebotomists have to balance the potential dangers of blood exposures with the fact that the sight of someone in a mask and goggles can further frighten children and cause them to become more combative. Protective gear can also suggest to parents that the laboratory staff views their child as contaminated, Butler says.

To allay parents’ concerns in that regard, phlebotomists simply tell them that they wear the mask and goggles as a safety precaution in every case to protect themselves from a splash, says Butler, who has found parents generally accept the matter-of-fact explanation. In addition, the phlebotomist greets the child before donning protective gear to allow the child to see him or her without it.

To prevent backsplash, phlebotomists at Intermountain-owned hospitals have someone stabilize the child’s hand or arm, depending on the age of the child, how much blood they have to draw, and whether the phlebotomist knows the child. LDS Hospital enlists parents’ assistance in helping to secure small children who are battling a venipuncture. Harcrow explains: "One procedure we use for children under three or four years of age is to lay them down on a table like a big bed and ask the parent to lay across the child and hold the child’s shoulders. The parent’s presence or contact seems to comfort most children and leaves an arm free for the phlebotomist."

On some children, Children’s Hospital uses EMLA, a local anesthetic cream applied to the venipuncture site before the procedure. "There are certain ’frequent flyers’ and their families who have found that really helps to calm the child," Butler says. There are limitations to using EMLA, however, because it has to be applied one hour before the procedure, which knocks it out of the running for stat lab work. Yet Butler reports one case where parents applied hand lotion to their child’s venipuncture site as a placebo right before stat lab work and that seemed to work for the child.

Teaching older children about the venipuncture can help ensure their cooperation. Phlebotomists at both LDS and Children’s hospitals are taught how to provide age-appropriate instructions. "Once a child gets to be about four or five, you can talk to them about what is happening," Butler says. Harcrow tells children who can comprehend what’s going on that the venipuncture will hurt a little; he then cautions the child that if he or she moves during the procedure, it will make it start hurting. He’s found that this strategy motivates the older child to hold still. It also gives the child a sense of control.

With younger children, the idea is to distract them from what’s going on rather than talk about it, Butler says. What distractions work best, in her experience? At one point, Children’s Hospital had success with plastic wands filled with glitter or little objects that a child or parent can tilt back and forth. "Those worked well until a child hit the phlebotomist over the head with one," says Butler. Next the hospital staff tried blowing bubbles and providing children small stuffed animals to hold, until infection control concerns halted the latter.

Now the phlebotomists leave the distraction technique to a child-life specialist who provides age-appropriate toys and gadgets for children to hold or look at using their free hand, such as key chain mobiles. "Our child-life staff are social work specialists who know how to help entertain children and distract them for a variety of procedures, including radiology," says Dr. Perry.

Children’s Hospital also had to educate phlebotomists about the need to suit up to protect themselves from the documented risk of backsplashes. "We have a huge educational push for the phlebotomists, emphasizing that we are doing all of these things to protect them," says Butler. "When we began to ask them to wear the goggles and masks, we showed them the data about how facial splashes had increased. They really take it to heart, and they police each other."

Customer satisfaction surveys help monitor phlebotomists’ compliance with the bloodborne pathogen standards. "On the survey, we ask parents if the phlebotomist used all the safety precautions," Butler says. "And we find that the parents notice right away if phlebotomist No. 1 comes in and does something that phlebotomist No. 2 doesn’t do," she says.

In Ernst’s view, the biggest safety worry with pediatric patients or in any setting is complacency toward compliance with the bloodborne pathogen standards. And even when you prepare children so they know what to expect and the child appears calm, "chaos can be lurking just under the surface," he says. "You never know how the child will react during the actual procedure."

The same holds true for doing venipuncture on an adult with a potentially altered mental status caused by dementia, medication, delirium, or mental illness, Ernst adds. "The phlebotomist has to anticipate that anything can happen and be prepared to prevent it by stabilizing the patient and the arm—and wearing protective equipment to protect him—or herself from exposures."

Karen Lusky is a writer in Brentwood, Tenn.