By Ana Cristina Magalhães

The Food and Drug Administration (FDA) rule and Joint Commission on Accreditation of Healthcare Organizations (JCAHO) recommendations for patient safety in diagnostic testing are prompting hospitals to re-evaluate sample and patient-identification processes, and manufacturers are helping them find ways to eliminate errors.

 On Radiometer’s ABL800 FLEX, users can queue up to three samples.

With more than seven billion lab tests being performed annually, the potential for human error is vast. In 2004, both the FDA and JCAHO focused strongly on error reduction and patient safety in diagnostic testing. The 2004 FDA rule urged the use of bar codes on drug and biological products. JCAHO’s 2005 National Safety Goals include a goal to improve the accuracy of patient identification by using at least two patient identifiers when administering medication or blood products, taking blood samples or other specimens for clinical testing, or providing any other treatment or procedure.

As the regulatory climate changes, how are hospitals and manufacturers working to solve the identity crisis in diagnostic testing?

A Pressing Issue
Regulatory demands for better sample and patient identification may be on the rise, but hospitals are still struggling to implement the technology necessary to do just that. According to a March 2004 article on, in early 2004, only about 150 hospitals in the United States had “installed the scanning systems throughout their facilities.” The modest adoption was linked to the fact that then only about one-third of pharmaceuticals were bar-coded.

 With the FLEXLINK software, sampler and patient identification are linked at the bedside and sent to the analyzer.

However, this scenario is changing. Changes in the regulatory climate, and ongoing discussions about error reduction and patient safety are prompting an increasing number of hospitals to take a hard look at their sample- and patient-identification processes, and how they can be improved. In many cases, incorrect sample and patient identification are due to honest human mistakes made by staff trying to do more with less. The good news is that automation of the testing process can not only unburden staff, but also reduce errors.

An Automated Blood Gas Analysis System
Manufacturers are also reacting to the change in the regulatory climate. Radiometer, a manufacturer of blood gas equipment, is supporting the FDA rule and JCAHO recommendations by incorporating automation features into its instrumentation. The company is scheduled to introduce the world’s first automated blood gas analysis system during the American Association for Clinical Chemistry annual meeting this month in Orlando, Fla.

The new system has three elements:
1) safePICO: a prebar-coded arterial sampler;
2) FLEXLINK(510(k) approval pending: software that links patient, sample, and operator information at the bedside; and
3) ABL800 FLEX with FLEXQ: a blood gas analyzer that provides automated identification, mixing, and measurement of up to three samples in a queue.

The system, “1st automatic,” automates many manual steps in blood gas testing, ensuring not only faster testing, but also correct sample and patient identification.

Typical Errors
The starting point for developing the new system was identifying the current practices in blood gas testing and the errors associated with them. This involved discussions with dozens of customers during the past 2 years.

Most errors occur in the pre- and postanalytical phases of testing. For example, a physician will order a blood gas test for a patient, either verbally or by entering the request on the patient chart. The nurse will then draw the blood sample from the patient. Note that the time the sample is taken may not be recorded. The nurse will then remove the needle from the syringe, risking needle-stick injury. The nurse will expel any air bubbles and cap the sampler for anaerobic transport. The sample is manually mixed to ensure that the heparin is dissolved throughout the sample, and the sample is then taken to the nearest blood gas analyzer. Before the nurse places the sample in the analyzer inlet, he or she mixes it again to ensure a homogenous sample. As the tip cap is removed and the sampler is placed into the analyzer inlet, the nurse must take care not to come in contact with the patient’s blood.

While the measurement gets under way, the nurse enters the patient ID, typically from memory, increasing the possibility of sample mix-ups. Other sample-related information, such as ventilator settings, is entered. The sample is removed from the analyzer, and the nurse waits for the result. Once it is available, the nurse tears off the printed result and carries it back to the patient bedside, where it is manually transcribed into the patient’s notes.

What is wrong with these steps? In an ideal world, where blood gas testing would only be performed by recently trained professionals with all the time in the world and no other responsibility than to run these tests, probably nothing. However, in the real world, where blood gas testing is often performed by understaffed caregivers under great time pressure, it can be made both safer and faster.

Sample, Scan, and Go
When developing 1st automatic, Radiometer wanted to reduce and automate as many manual steps associated with blood gas testing as possible. The idea was not only to make blood gas testing faster and safer, but to make it as simple as sample, scan, and go.

One goal was to remove the risk of needle-stick injuries and contact with patient blood, as well as to make sample preparation as fast and simple as possible. That is why Radiometer developed the arterial safePICO sampler. The sampler is prebar-coded and self-filling. It has a needle shield device, which can be activated with one hand, so operators can easily remove needles without the risk of injury. To ensure proper mixing, safePICO has an integrated mixing device in the form of a metal ball that improves and shortens the mixing process. The sampler also has a special tip cap. By pressing the plunger, the tip cap easily removes all air bubbles. Once they have been removed, the sampler becomes a closed system, so the operator is never in contact with patient blood.

Ensuring correct patient and sample identification was also a crucial requirement. In addition to prebar coding safePICO, Radiometer developed the FLEXLINK software module, which is both PDA- and PC-compatible. With FLEXLINK, operators can scan or enter their operator ID, the prebarcoded safePICO sampler, and the patient ID. FLEXLINK links and stores these three critical identifiers, providing 100% data capture and ensuring 100% data accuracy within seconds at the bedside.

Once the sampler is placed on the analyzer’s queue module, it is automatically identified using the safePICO’s sampler bar code to retrieve all linked information. Up to three samples can be placed on the analyzer’s queue module. One by one, each sample is identified, mixed, and measured, enabling caregivers to return to their patients. Once the sample is measured, the result can be automatically made available to caregivers wherever they need it: on their FLEXLINK PDAs, patient monitors, information systems or the analyzer itself.

Together, IT, sampler, and instrumentation provide a greater degree of safety—for patients as well as operators—and speed in blood gas testing.

Automation Is Key
Better sample and patient identification is highly dependent on bar coding and on the automation of certain testing procedures. Honest human mistakes can and will continue to occur, as long as caregivers continue to take on an increasing number of tasks that go beyond actual patient care. But the more blood gas and other types of testing becomes automated, the more time staff will have for patient care, and the better—and safer—patient care will be.

Ana Cristina Magalhães is a science writer for Radiometer.