When you get your blood drawn, the person who tells you to roll up your sleeve and make a fist may have a professional manner and be dressed in medical scrubs. That doesn't mean he's been to medical school or nursing school . . . or any school at all. In most parts of the country, including the Washington area, phlebotomists -- workers who take blood in a medical setting -- are governed by few rules or none at all.
Unlike your hairdresser, your cosmetologist and even the aromatherapist down the street -- most of whom are licensed by some authority -- the person probing for a vein may have only a few days of on-the-job training.
"Most patients don't realize that the person sticking the needle in their arm today could have been flipping burgers last week," said Dennis Ernst, a veteran phlebotomist who runs a phlebotomy resource center in Ramey, Ind. The consequences -- in mistakes made and injuries to patients -- can be dire: contaminated samples that have to be redrawn, false positive results, incorrect medication doses, fractures, nerve damage and worse. And while the great majority of us will never face a blood-draw injury worse than a sore arm, the potential for harm has proven real.
The virtual absence of regulation for this field often comes as news even to people knowledgeable about the medical field. "I was a little surprised to hear [from a reporter] that phlebotomists have not been required to be licensed by states," said Carnegie Mellon University health care economist Martin Gaynor. "My impression was that most folks practicing in the health area have been required to be licensed a long time ago."
Phlebotomy -- the word is derived from the Greek for "vein cutting" -- matters because blood matters, in some ways more than it used to. The list of problems that can be identified by analyzing blood is amazingly long: cancer, diabetes, cholesterol, high lead levels, infections, anemia, kidney failure and heart attacks, for starters.
According to the American Society for Clinical Pathology, "an estimated 80 percent of physicians' decisions are based on laboratory test results," most of these involving blood tests. By one estimate, Americans underwent more than 1 billion blood draws last year.
That is why 58-year-old Ken Peloquin of Reston went back to school to learn to draw blood after being downsized out of middle management at a Virginia medical supply firm. And why he expects no trouble finding work, and why so many job-seekers are likely to follow him.
Said Frankie Harris-Lyne, who runs the medical lab technician and phlebotomy programs at Northern Virginia Community College Medical Education Center, where Peloquin is a student: "We can only accommodate 15 students per class, or 30 per year," she said. "Currently we have approximately 50 students placed in the major, and that number continues to grow."
Peloquin and his classmates will have an edge over the competition in that they have actually gone to school to learn their profession. Most phlebotomists don't. Only California and Louisiana have training and monitoring standards for phlebotomists.
Ernst knows the harm an unskilled phlebotomist can do, having served as an expert witness at dozens of lawsuits involving phlebotomy injuries. "There's a repeating pattern of errors that inflict permanent injuries," he said.
The biggest problem is nerve injuries: The needle sticks a nerve, not a vein, which can lead to chronic pain, sometimes severe, that can lead to disability or paralysis. But Ernst said he also sees punctured arteries, lacerations and serious bleeding and bruising. Poorly trained phlebotomists can also make simpler, but still devastating mistakes, such as turning their backs on a patient at the wrong time.
"I see a fair amount of injuries, including paralysis from patients who pass out during or immediately following the procedure and fall and fracture bones," he said. "One of them, in fact, was a lady who fell out of a chair in her home. She was being drawn for an insurance examination. The medical assistant turned his back on the woman and she fell out of her kitchen chair, fractured her vertebrae, and she is now paralyzed. [Passing out] is something that happens quite commonly. . . . They're not taught that passing out is a risk of the procedure, and they turn their back on the patient."
Then there is the case that brought sweeping changes in California, after a phlebotomist's felony conviction for assault with a deadly weapon: a phlebotomy needle.
It was 1999 when the phlebotomist, working at a Palo Alto lab, was found to be using the same needle on multiple patients in thousands of cases over a period of four years. When the investigation ended, more than 3,000 patients had to be tested for HIV and hepatitis.
Soon after, California passed a law that set new standards for phlebotomy. One requirement is that phlebotomists train for a minimum of 80 hours and be tested and certified before they approaching their first patient.
But except for California and Louisiana, which took similar steps in 1993, phlebotomy training varies widely, ranging from 10-hour crash courses -- in some places, said Ernst, even that is considered a lot -- to a 200-hour program. As a rule, phlebotomists are trained on the job, not in programs like Peloquin's. So standards are set by the clinic, hospital or doctor's office that has hired the individual. Almost by definition, said Ernst, a phlebotomist trained this way is going to get the basics and not much more: Where does the needle go in, how deep, and at what angle? How much blood is too much, too little? How do you label and sort the vials?
In the three-month program at Northern Virginia Community College (NVCC), phlebotomy students learn basic anatomy. They are also exposed to physiology, medical terminology, medico-legal issues and patient communications.
Peloquin was surprised at how much psychology was involved. "Every patient is different," he explained, "so you never know what you're going to get with your next stick. . . ." Some patients, he said, are afraid of needles; others, anxious about the purpose of the test. "Depending on each individual patient, you have to adapt to the patient's moods and dislikes."
For April Wharton, one of Peloquin's classmates, the surprise was the complexity of the paraphernalia. "There are so many different kinds of anticoagulant stuff, so many different tubes," she said. "You have to know what every test does and is."
When NVCC students finally begin sticking needles in arms, they aren't the arms of patients.
"We practiced on each other," explained Wharton -- something she called critical to building confidence . . . and technique. "The first time I stuck one of my classmates I was terrified. I was shaking. It was very hard. If a patient were to see me doing that, they probably would have gone crazy."
Getting the needle in is only half of the job. Handling the blood sample to avoid contamination or mix-ups is the next challenge. The goal, said Harris-Lyne, is to get a quality blood sample: the right amount of blood, drawn the right way; properly labeled, sealed and preserved; and delivered to the appropriate address for the appropriate test.
The National Committee for Clinical Laboratory Standards (NCCLS) lists 32 steps that, if followed, almost guarantee a successful blood draw. But skip a step or two, even accidentally, and bad things can happen, said Ernst.
An imperfect draw, for example, can result in a specimen that isn't sterile. This can happen if a patient is not adequately "prepped" -- if the site where the needle goes in is not properly cleaned in advance. An unsterile sample can result in a false positive for certain conditions, meaning a healthy patient may think he is sick. Or a doctor may prescribe medication for a patient based on an incorrect blood test result. "That," Ernst said, "can have life-threatening consequences."
This was the concern a few years ago at the Alameda Country Medical Center in California, where a lab manager noticed an unusually high rate of contaminated blood cultures. Senior lab staff members recognized the problem and brought in trained phlebotomists to take over.
They recruited new people and trained them beyond what was considered "routine." Within two years, the contamination rate for blood cultures in the lab had dropped 70 percent. With fewer false positives triggering unneeded treatment, the hospital's costs went down, too.
Under-trained phlebotomists can also be a hazard to themselves. When a phlebotomist accidentally jabs himself, or has contact with blood and other bodily fluids, he can be exposed to HIV, hepatitis or other pathogens.
The Mayo Clinic in Rochester, Minn., takes such risks very seriously. A training program that was begun there in 1994 reduced "occupational exposures" for phlebotomists from a high of 1.5 exposures per 10,000 sticks, to 0.2 per 10,000.
Consumers have a right to demand that a qualified professional draw their blood, said Ernst. But how to know when you've found one?
A diploma hanging on the clinic wall is no guarantee. In an unregulated field, said Ernst, "there are some entities that claim to certify phlebotomists" but have substandard eligibility requirements. "It is one thing to mandate certification," he explained, "but without minimum standards for what that certification entails, it's just window dressing."
The only alternative may be to ask the phlebotomist, point blank, about her credentials. "That way," said Ernst, "the patient can protect themselves from the unskilled until the legislators make it a given that all specimens are drawn by qualified personnel."
At NVCC, Harris-Lyne discourages students from seeking certification by any but the most highly regarded and widely accepted certifying bodies. The American Certification Agency, for example, requires applicants to have completed either a year of on-the-job training or an accredited training program, to have documented at least 100 successful venipunctures and to have passed a two-hour written and practical test.
In California, where certification has been required since last spring, consumers appear to be benefiting. According to Robert Miller of the California Department of Health, the number of phlebotomy complaints has decreased "from 17 percent of the total [number of medical complaints of all kinds] we receive each year to about 5 percent of the total" since the new regulations went into effect.
Why don't more states follow California's example? Gaynor thinks the reason is simple: Quality costs money. Phlebotomists are generally paid from $8 to $12 an hour, depending on location, demand and training. Higher personnel costs for well-trained workers are eventually borne by the consumer in terms of higher prices or less covered care.
But Ernst thinks there's another reason the field remains so unchecked: People either don't know or don't care who is sticking needles in their arms, and governments reflect that complacency.
"Does every state have to have a phlebotomist caught reusing needles in order for them to act and implement legislation?" he asked. "Of course, the answer should be no."
Ranit Mishori, a family-practice resident at Georgetown University Medical Center, last wrote for the Health section about aichmophobia, the fear of needles.