Phlebotomy on trial.

Collecting blood specimens can carry an element of risk for your laboratory - errors in judgment and technique may cause injuries that leave you vulnerable to litigation. In this article, an expert witness discusses six ways to protect your lab from phlebotomy liability.

Picture this: The worst day of your life as a laboratory professional starts routinely. You're well into your daily work when you are summoned into your manager's office to learn that a patient, whose blood you had drawn months ago, is taking you to court, claiming that your careless phlebotomy technique resulted in a permanent and disabling nerve injury. Your nightmare has officially begun.

Over the next 18 months, you meet many times with your manager and the facility's risk manager and its attorney to discuss the case. You rack your brain trying to remember facts and pressure others for more details of an event long faded from their memories as well. You struggle to assemble a paper trail in a frantic attempt to document every precise detail. You spend your days distracted from your daily duties and your nights lying in bed with your mind racing, unable to rest. The process is lengthy and gut wrenching. In time, you may uncover procedural errors, administrative oversights, gaps in your own documentation, or perhaps a combination of all three. All hope of immunity is gone. You fear for your job.

The entire, anxiety-producing ordeal consumes large quantities of time, attention, money, and peace of mind. And in the end, one ill-fated venipuncture ends up costing you and your facility hundreds of thousands of dollars in legal defense, damages, and lost productivity. The human cost to everyone involved is incalculable.

Not entirely fiction

Unfortunately, this scenario plays out more often than you might think. Hospitals, physicians' offices, blood donor centers, long-term care facilities, or anywhere a caregiver uses a needle to access a vein in the name of healthcare puts patients at risk if those doing the punctures don't completely understand the finer points of phlebotomy technique. As an expert witness, I am frequently called by attorneys to evaluate and testify in cases involving permanent injuries allegedly inflicted during phlebotomy.

Because phlebotomy skills are being diluted in healthcare settings through the implementation of multiskilled staffing strategies, an industry-wide decrease in phlebotomy expertise is exposing an increasing number of facilities to a dangerously high risk of phlebotomy liability. In your facility, are you or those who perform phlebotomy flirting with a legal nightmare? If the healthcare workers who draw blood and their supervisors do not adhere to what attorneys refer to as "the prevailing standard of care" for phlebotomy, the previously described scenario could become your reality overnight. The rest of this article lists six tests that every laboratory should run on itself to assess its risk of phlebotomy liability.

1. Test for documentation. When it comes to proving that you maintain the standard of care, nothing closes a case like thorough documentation. This includes putting the proper information on every tube of blood, including the time and date of collection and the phlebotomist's initials. If another healthcare professional has to verify an unidentified, unresponsive patient, documentation should include the name of the individual who verifies the patient's identification as well.

Documentation is also critical when maintaining employee records: Can you prove that your phlebotomists are sufficiently trained? Can you prove that your phlebotomists' skills are regularly evaluated? Do you document any unusual reactions during a venipuncture when they happen?

It is best to assume that, should a case come to trial, if it wasn't documented, it wasn't done. Every risk manager and most laboratorians know this. Making sure that your phlebotomists know this and that they consistently practice complete documentation makes risk significantly easier to manage.

2. Test the angle. When a vein is punctured at an angle greater than 30 degrees, the possibility of passing through the vein into the underlying structures increases the risk of permanent injury. The consensus in the literature on the angle of insertion is undeniably clear. Every phlebotomy textbook sets a range between 15 and 30 degrees for the angle of needle insertion [ILLUSTRATION FOR FIGURE 1 OMITTED]. With such an overwhelming consensus, it would be difficult for you to effectively argue that your facility or any specific case should be an exception. I have seen cases in which the estimated angle of insertion was 40, 70, even 90 degrees. All have resulted in damages paid to the patient. In light of the body of evidence in the literature, no testimony that condones an angle greater than 30 degrees can be expected to contribute to a plausible defense. Arguing against the literature is futile.

3. Test your training practices. Phlebotomy supervisors should follow conservative timetables of supervision, regardless of an employee's experience. Whether your laboratory has hired an unskilled new employee or an experienced registered nurse, an uncompromising adherence to a conservative protocol is essential. With apologies to a well-known shoe company, you can't send new phlebotomists into your patient population and tell them to "just do it." Even if that individual is a nurse with years of experience starting IVs, phlebotomy takes a different approach. The only thing IVs and phlebotomy have in common is that, in both cases, a needle is accessing a vein. The techniques are completely different-assuming the skills overlap is a common, yet dangerous mistake.

There are no national standards or requirements dictating how a laboratory should train staff members to perform phlebotomy. Rather, the Joint Commission on Accreditation of Healthcare Organizations states that hospitals "define the qualifications and job expectations for their staff, and establish a system for evaluating job performance."[1(HR.1)] In addition, hospitals are to assure that "new staff orientation provides initial job training and information, and assesses capability to perform job responsibilities.[1(HR.4)]

Because the Clinical Laboratory Improvement Amendments of 1988 deemed that the laboratory is ultimately responsible for the integrity of the blood specimens it analyzes, a seasoned phlebotomist should train and observe the work of new phlebotomists for an extended period of time. Therefore, in the absence of formal phlebotomy training or experience, those new to the procedure should undergo a well-structured course in blood collection, followed by extensive supervision. For those specializing in phlebotomy, I recommend a comprehensive didactic session in addition to 40 hours of observed venipunctures. For nurses and multiskilled healthcare technicians whose roles are being modified to include phlebotomy responsibilities, 40 hours of observation is not a practical requirement because only a fraction of their time will involve venipunctures. In these cases, I recommend the didactic session in addition to 40 supervised punctures before allowing unobserved collections.

These numbers may seem unreasonably demanding to administrators or to those who are involved in training and evaluating phlebotomists. However, managers and supervisors should consider that the importance of training and evaluation cannot be overemphasized when it comes to legal liability. No case illustrates this more than the one in which a patient sued a hospital for damages that resulted from a venipuncture performed by a newly trained phlebotomist who wasn't well supervised. The policy of the laboratory involved in this case clearly stated that all new employees were to receive 40 hours of supervised venipunctures. However, because this phlebotomist had recently completed a phlebotomy course at a technical school, the employee received only 2 1/2 hours of supervised punctures, which was clearly a deviation from the lab's own procedures. This and other indefensible deviations from the standard of care sealed the case in favor of the patient. There is no effective defense against violating your own policies when an injury has resulted from a randomly implemented policy.

Realize, too, that not everyone can learn to draw blood effectively. Those who perform poorly during their training and evaluations should be given every opportunity to perfect the technique. When all avenues have been tried with unsuccessful results, supervisors might want to consider prohibiting these employees from drawing blood to prevent putting a questionable or poor performance record before a jury.

4. Test your evaluation protocol. In addition to completing a well-organized and well-implemented orientation program, those who perform phlebotomy should be evaluated regularly on use of the proper technique. "Regularly" is whatever the individual's supervisor defines it to be, but an evaluation 3 to 6 months after the individual has been performing unsupervised punctures, and annually thereafter, is standard. This is the only practical way to keep new phlebotomists from slipping into harmful or sloppy habits. Without regular evaluations, it will happen. Of course, even if your phlebotomy trainers adhere to a well-rounded phlebotomy training and evaluation program, the effort is wasted without thorough documentation.

5. Test vein selection practices. According to the literature, three veins exist in the antecubital area that are acceptable puncture sites for phlebotomy [ILLUSTRATION FOR FIGURE 2 OMITTED]. One of these, however, puts the patient at an inordinately high risk compared with the others. The vein of choice is the medial vein, which typically lies in a slight depression in the center of the antecubital area. This vein is usually larger, more stationary, less painful to puncture, closer to the surface of the skin, and more isolated from other underlying structures than the others. Phlebotomists should inspect the medial veins of both arms before considering one of the other acceptable veins.

The cephalic vein lies on the lateral or outside aspect of the arm and provides the second choice if the patient's medial vein is inaccessible in either arm. The basilic vein, however, should be approached with trepidation. Positioned on the medial or inside aspect of the arm, its close proximity to the median nerve and brachial artery puts the patient at risk of injury should the phlebotomist's technique lack precision.

In one recent case, a phlebotomist chose the basilic vein when the medial was clearly an option and subsequently injured the median nerve. Because so many textbooks, publications, and even the laboratory's own procedure manual stated that the medial vein is the vein of choice for punctures, the phlebotomist's choice was indefensible. In conjunction with an excessive angle of insertion and other errors in supervision and documentation, the jury found that the hospital violated the prevailing standard of care for phlebotomy and then awarded the patient $47,600.

Sometimes, however, the basilic vein is the best or only choice because of its prominence or accessibility. Nevertheless, it is important to make sure that those who perform phlebotomy understand the risks involved and use this vein as a last resort.

6. Test for proper identification. Few errors are more indefensible for a hospital than misidentifying a patient. Treating a patient based on another patient's lab work may have devastating effects. The window of vulnerability can be opened wide in all three areas where blood collection takes place: the emergency department, the inpatient floors, and the outpatient collection areas. With carefully constructed policies and adherence to them, however, these windows can be narrowed or closed completely.

The risk is highest in emergency departments, where a flurry of activity descends on traumatized patients. Hospitals at greatest risk are those in which blood collection may be done before concrete patient identification is in place in the form of an arm bracelet or identification tag. In such cases, pragmatism urges phlebotomists to rely on verbal identification from the ED team until such devices can be applied. Even more vulnerable are hospitals that accept specimens collected in the field or en route to the facility by paramedics and emergency medical technicians. Should either of these scenarios exist in your facility, the window of vulnerability is officially open.

Closing this window involves putting some form of identification on every patient as soon as he or she enters your facility and not accepting specimens drawn in the field. For patients who are unresponsive and whose names are unknown when they enter your facility, this means assigning a temporary identifier and amending it as soon as complete identification is available. Establish a policy that blood is not to be collected on patients who are unable to identify themselves or who have no permanent or temporary identifier attached to them. This policy will encourage the ED to affix a temporary or permanent identifier on every patient moments after arrival rather than to contend with delays in triage and will virtually eliminate the risk of patient misidentification during triage.

What are your policies for accepting blood collected in the field or en route to your facility? If your laboratory accepts them, it may be putting your patients and your hospital at great risk According to CLIA '88, the laboratory is ultimately responsible for the integrity of the specimens it analyzes. If the specimens were collected off site by nonhospital employees, your laboratory has no assurance that the collector properly identified the patient or the specimen. Collecting blood in the field or en route to your facility saves little time. Because the process can be so quickly accomplished once the patient arrives, the benefits of an internally collected specimen outweigh the risks of accepting a specimen with potentially compromised identification.

If a field specimen is collected by members of your hospital's own staff of paramedics or EMTs, your laboratory has control over the integrity of the specimen only if it trains them in phlebotomy and evaluates their technique regularly with documentation. It would be reasonable, therefore, to accept such specimens as correctly drawn if they are labeled with the standard information: patient name, the date, the time, and the initials of the individual who drew it. Under no circumstances, however, should your laboratory accept an unlabeled specimen from any source.

Inpatient identification presents its own risks. There are only three acceptable ways a phlebotomist can be assured of an inpatient's identification: check the identification bracelet, ask the patient to state his or her name, or ask a member of the patient's care team to verify the patient's identification. Phlebotomists rarely find patients without properly affixed identification bracelets, but it happens. When it does, the phlebotomist is challenged to ensure that the specimen drawn will be from the intended patient.

Water pitchers, bed tags, or posted charts and forms do not guarantee positive patient identification and cannot be trusted. The phlebotomist must ask the lucid patient to state his or her name in full. Asking a patient to affirm his name as in "Are you John Smith?" is not acceptable. If the patient is unidentified and unresponsive, it is the phlebotomist's duty to find someone responsible for the patient and to ask for verification of the patient's identity. The verifier's name must be documented in the event that the patient is misidentified.

As for outpatients, phlebotomists can't rely solely on the forms patients bring with them to the draw station. Because outpatients are usually not identified with hard forms of identification, verbal inquiries are the only guarantee of accuracy.

To close the window of vulnerability to patient misidentification in your facility, take steps to ensure that (1) your emergency department quickly assigns a hard form of identification to its patients; (2) your laboratory doesn't accept specimens of questionable integrity; and (3) your phlebotomists know the three acceptable methods of positive patient identification.

Collecting blood specimens can be somewhat like walking through a mine field. Arteries, tendons, nerves, and bone are all in close proximity to veins - one error in judgment or technique may result in an injury serious enough to bring an explosion of legal proceedings. Making sure that blood collectors and those responsible for training and evaluating them are aware of the technical and administrative errors of phlebotomy will significantly reduce a lab's exposure to phlebotomy liability. Walking through a mine field is that much easier if you know where the mines are.

References

1. Joint Commission on Accreditation of Healthcare Organizations. Accreditation Manual for Pathology and Clinical Laboratory Services. 1996:HR. 1,HR.4.

Suggested reading

Becan-McBride K. Collection, Professionalism and QA. In: Phlebotomy. ASCP Press; 1993.

Garza D, Becan-McBride K. Phlebotomy Handbook. 2nd ed. Appleton and Lange; 1989.

National Committee for Clinical Laboratory Standards. Procedures for the Collection of Diagnostic Blood Specimens by Venipuncture. 4th ed. 1998.

Phelan S. Phlebotomy Techniques: A Laboratory Workshop. ASCP Press; 1993.

Prendergraph G. Handbook of Phlebotomy. 3rd ed. Lea and Febiger; 1992.

Slockbower J, Blumenfeld T. Collection and Handling of Laboratory Specimens: A Practical Guide. Lippincott Company; 1983.

Dennis Ernst is the founder and president of The Center for Phlebotomy Education, New Salisbury, IN.