College of American Pathologists
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  Patient ID systems offer smart


cap today

October 2005
Feature Story

Karen Lusky

If Hippocrates were to write his oath today, he might well advise healers to use the power of technology to end an entirely preventable cause of harm: misidentifying patients at the point of care.

As Denise Driscoll, MS, MT(ASCP), SBB, director of the CAP’s Laboratory Accreditation Program, puts it: “The hospital laboratory can, for example, do everything right in identifying atypical antibodies and ensuring compatibility, but if someone misidentifies the patient and administers the wrong blood or other treatment, nothing else matters.”

The promise of machine-readable systems to prevent misidentification lies in the nature of such errors, which are known as “lapse” or “slip-up errors,” says Walter Dzik, MD, co-director of Massachusetts General Hospital blood transfusion services, Boston. Health care personnel who make such errors know full well how to identify the patient properly, but they get distracted, hurried, fatigued, or overextended.

“And repetitive functions, such as labeling a patient specimen tube or checking the patient’s identification before a blood transfusion, are highly prone to people making errors,” which can be deadly, Dr. Dzik says. By contrast, “machines performing patient ID functions have the distinct advantage of not getting distracted, hurried, or tired and subject to slip-up errors.”
Laboratories, along with radiology departments, have already learned that lesson and are among the first in hospitals to use computer technology to identify specimens and tests, Dr. Dzik notes. “The challenge for hospitals now is to extend the patient-safety advantages of machine-readable information systems to the bedside,” he says.

Companies are working mightily to make that possible.

Each vendor’s system for positive patient ID offers its own set of safety features and bells and whistles, including being able to generate reports for management and quality assurance purposes. Some of the large vendors also offer Lean and Six Sigma consultation to help hospitals improve not only safety but also workflow, cost savings, and employee satisfaction.

Becton Dickinson and Company’s Patient Identification System for Specimen Management, for one, prevents phlebotomists or nurses from printing labels before they complete the specimen collection. “The system also helps nurses who aren’t familiar with which tubes are required for certain tests,” says BD’s Beth DiLauri, senior marketing manager for Systems for specimen collection management, Franklin Lakes, NJ.

Here’s how the system works:

  • The person who is going to collect the specimen scans his or her ID badge to log onto the computerized system. Next the user scans the patient’s bar-coded wristband, which calls up the specimen collection list on a handheld computerized device.
  • The system displays the number and type of tubes to be collected, which are sorted according to the order of the draw recommended by the Clinical and Laboratory Standards Institute.
  • The collector performs the phlebotomy procedure to obtain a specimen.
  • The collector scans the first tube specified by the order of the draw, which links the BD Vacutainer Plus plastic tube bar code to the patient order. The system verifies the tube is correct and then prints an instrument-readable label for the tube. Thus “the person doing the collection doesn’t have the opportunity to make sorting mistakes by grabbing the label for the wrong patient or putting the wrong label on the tube for another test that should go in a different tube,” DiLauri says.

The approach fits the Lean management principle of single-piece flow, she says. “The user handles each tube, applies the label, and then moves to the next tube rather than batching.”

The labels printed at the bedside have a notch cut out that the phlebotomist or nurse matches to black triangles on the specimen collection tubes. This helps ensure that the nurse or phlebotomist properly positions the label on the tubes. That way, laboratory personnel don’t have to reapply labels so that the lab’s automated equipment can read the bar codes. Relabeling leaves tubes without an identifier for a period, which is as dangerous as a patient without a wristband.

Then there is Cerner Bridge Medical’s MedPoint-Specimen system. The nurse or phlebotomist scans his or her ID badge and then the patient’s bar-coded wristband, which displays the patient’s demographics on the computerized device (a handheld, laptop, or hardwired device). “This allows the caregiver to ensure the patient’s identity electronically and visually with multiple patient data elements on the screen,” says Joseph Stabile, MT (ASCP), solution manager for Cerner Bridge Medical, Solano Beach, Calif. Scanning the wristband also pulls up a computerized list of collection orders from the lab information system.

The user prints separate labels for each container (on a portable printer), does the lab draw, attaches the labels to the tubes, and then confirms that he or she has collected the sample by clicking on the “confirm” button. The system produces a management report that measures the time from when the user printed the label to when the process was completed. “If that time is less than a minute, the manager knows something is wrong because you can’t do a lab draw in less than a minute,” Stabile says. “The report would also flag users who take too much time to complete the process.”

The software solutions for administering blood are limited because some patient ID vendors have put their blood transfusion applications on hold until they obtain 510(k) approval from the Food and Drug Administration.

“FDA approval is required for software devices, applications, and interfaces that verify the patient’s identity and that the correct blood unit is being administered to that patient,” explains Robert Finizio, vice president of sales for McLean, Va.-based Care Fusion. The company offers several patient ID modular systems, including ones for specimen collection and a 510(k)-cleared application for blood transfusion.

“The FDA changed its position on the issue [of whether software used for blood transfusions requires clearance] last December,” Finizio says.

Whether a system requires clearance depends on how the manufacturer describes its intended use, says Sheryl Kochman, chief of the Devices Review Branch in the Division of Blood Applications, FDA Center for Biologics Evaluation and Research. A system that is labeled as just ensuring proper sample identification doesn’t require a 510(k), Kochman says. But if the system will generate labels for samples for crossmatching and units for transfusion, then it would require clearance, she says.

Korchek Technologies’ CareChek Tx, which just received a 510(k) as a software device for blood transfusions, allows the nurse to match the patient to the unit of blood at the bedside before administering a transfusion. The Care Chek system uses whatever bar-coding system the hospital has in place, says Gregory Francis, president of the Shelton, Conn.-based company.

“For blood, however, hospitals should be transitioning from Code 39 to ISBT 128, the international [symbology] standard, which will incorporate more information with one bar code,” he adds. The CareChek software, which goes on handheld devices or a laptop, can read ISBT 128.

Using CareChek, the nurse administering the blood first scans the patient’s wristband followed by his or her ID badge, and then the unit number placed on the blood bag by the American Red Cross or other supplier. “There has to be a match there—if not, the system throws up an error message that says ‘doesn’t match,’” Francis says.

Once the nurse obtains a match, he or she uses the computerized device to record some of the AABB requirements, for example, visual inspection, validation of informed consent, the blood’s expiration date, and the crossmatch tag (the blood bank, too, checks the latter). “All of that is one large category with the requirements itemized and checked off separately,” Francis says.

Next the nurse takes the first set of the patient’s vital signs and records those using the handheld device or laptop, and then starts the blood transfusion. “Fifteen minutes later, the nurse goes back and repeats the process: IDs the user, the patient, the blood unit, and that brings up the second set of vitals, which the nurse records.” When the transfusion is over, the nurse repeats the process to record the post-transfusion vitals.

The system generates a report that can identify instances in which nurses recorded patients’ vital signs late, which may indicate, for example, that the nurse jotted down the vitals on a piece of paper and entered them later, defeating the purpose of the point-of-care documentation system. Or late vital signs could signal that the nurse performed the vital signs behind schedule, which may represent a time-management problem for a particular nurse—or a nurse staff shortage, Francis adds.

For just about any system, how well it works starts—and can end—with the machine-readable patient wristband.

Massachusetts General Hospital’s Dr. Dzik says the wristband is being viewed more and more as the starting point for any infrastructure to improve safety through better patient identification. “Wristbands need to be machine readable as well as eye readable,” he says.

For manufacturers, making userfriendly wristbands that scan throughout a patient’s hospital stay has been a challenge. Bar-coded wristbands that scan at a quick clip promote optimal workflow for busy nurses dispensing medications or for phlebotomists and nurses drawing lab specimens. They also encourage staff to champion rather than reject or circumvent automated patient ID systems.

“Bar coding medications or lab specimens typically helps improve nursing work flow, giving nurses more time for patient care, but not if you throw a difficult-to-use, time-intensive product on top of a nursing shortage,” says Care Fusion’s Fin izio.

Cerner Bridge Medical uses a process re-engineering approach to get a bar-coded wristband that will work 99.99 percent of the time, Stabile says. “We have an employee wear [the wristband] for two weeks, take a shower with it on, go to the gym, sleep in it, etc.,” he says.

Many of the positive patient ID vendors that offer complete systems resell or recommend wristbands made by Zebra Technologies Inc., Vernon Hills, Ill., a company that also sells desktop printers and mobile wireless label printers that can print one- and two-dimensional bar codes.

Zebra’s Z-Band durable thermal wristband has been through substantial testing and can be scan ned and read when patients wear it for several days—even if the band comes into contact with water, blood, foam soaps, and more, says Debbie Murphy, Zebra’s global practice leader for life sciences.

The way in which a hospital bar codes wristbands also determines how easily they scan and how much information they can pack. For example, many hospitals use a one-dimensional or linear bar code that contains a single set of numeric numbers that sometimes curve around the wristband, disappearing from the scanner’s line of sight.

By contrast, “a two-dimensional bar code the size of a postage stamp could encode the entire Gettysburg address on it,” says John Kling, national account manager for Digi-Trax Corp., Lincolnshire, Ill., which sells HemaTrax ID for Transfusion.

Being smaller and denser, two-dimensional bar codes are easier to scan than linear bar codes. “Two-dimensional bar codes work especially well for pediatric patients, because you can point the scanner in any direction to read the bar code, and the curvature of the ID band isn’t such an issue,” says Su zanne Duncan, MT(ASCP), senior solution manager for Cerner Corp., Kansas City, Mo., which provides Bridge Medical’s specimen collection solution.

Most printers on the market can print a two-dimensional bar code for wristbands, Zebra’s Murphy says. But to make the switch to two-dimensional bar codes, a hospital that is using linear bar-code scanners would have to purchase dual scanners.

In lieu of two-dimensional bar codes, some hospitals choose to print a “picket fence” linear bar code that runs across the width of the band rather than the length, says Murphy. “The picket fence orientation allows for a better scan. You can also print the picket-fence bar code a couple of times on the band, so as the wristband turns on the patient’s arm, the scanner has a better chance that one of the bar codes will be in the line of sight.”

Radio-frequency identification, or RFID, technology, which many of the vendors’ IDsystems support, is another way to make wristbands scan easily. Still in its infancy, RFID for patient identification uses very low frequency radio signals that allow users to read and write to a chip on a patient’s wristband or other devices. RFID scanners don’t require a direct line of sight to scan an RFID tag on a wristband or employee ID badge; in fact, the scanner can read the RFID tags through a patient’s bedclothes or in an employee’s pocket. But because RFID for patient ID uses a very low radio frequency, the health care provider has to place the scanner in close proximity to the wristband and actively obtain the reading. That safety feature prevents the scanner from inadvertently picking up an adjacent patient’s identifying information.

“RFID tags scan faster than bar codes, so they are easier and less stressful for nurses to use in capturing the correct patient identification,” says Irwin Thall, RFID manager for health care at Precision Dynamics Corp., San Fernando, Calif. Precision Dynamics sells “smart” patient identification wristbands that include human-readable print, a bar code, and RFID tag. In July, the company also introduced a dual RFID and bar-code reader, the DR1000, which connects to POC mobile carts and other devices.

Yet RFID technology costs a lot more than bar coding. “The disposable chips for the wristbands, specimen tubes, and blood bags are the high-price item,” rather than the dual bar-code and RFID scanners, according to Finizio, of Care Fusion, whose specimen-collection and blood-transfusion modules support RFID. “For example, the RFID wristband costs between 80 cents and a dollar, whereas a hospital can generate bar-coded wristbands for about a penny each, depending on how they do it,” he says.

Precision Dynamics is banking on the cost of RFID technology coming down in three to five years as major users, such as Wal-Mart and the Department of Defense, deploy the technology more widely. But even with the higher cost associated with RFID, some applications for bedside patient ID may pay off for hospitals now. For example, RFID wristbands would make it possible for OR staff to identify patients whose arms are under surgical drapes before administering blood transfusions, BD’s DiLauri says.

Of course, any machine-readable wristband is useless if personnel don’t use it consistently to identify patients. And busy nurses and phlebotomists trying to save time have been known to scan patients’ bar codes on the chart or other locations rather than on the patient’s wristband.

Some positive patient ID systems have features to prevent staff from using work-arounds. For example, Lattice’s Medi Copia, a computerized patient ID system for lab specimen collection and other applications, distinguishes between different bar codes printed on various records. “So if someone scans a bar code on anything but the wristband, the computerized system won’t provide the collection list of lab orders for the patient,” says Peter Muzzy, president of the Wheaton, Ill.-based company.

St. John/Bio-Logics, a maker of patient ID systems based in Valencia, Calif., addresses one of the most common threats to the effectiveness of automated patient ID systems—clinicians with scissors. The banding system allows nurses to quickly reband a patient when they have to cut an ID bracelet that has become too tight or stained with blood, or to start an IV in the arm, as examples. In such cases, the nurse can simply reattach Bio-Logics’ proprietary “tag” containing the bar code and primary information to a new vinyl bracelet and immediately snap it on the patient. While the company’s product literature doesn’t tout that rebanding feature, some of its customers have said that’s why they like the wristband, says St. John/ Bio-Logics’ Steve McDermott. Some of them have “shown that they have been able to maintain a higher population of patients identified than they did before using the wristband,” he adds.

The Bio-Logics ID band contains, in a single bracelet, all of the patient-specific alerts—allergy, fall precautions, mother-baby, blood bank labeling—that ordinarily require multiple brace lets. The band contains little pockets and pouches where the alert labels can be added as needed. Bio-Logics provides about 70 different alert tags, and they come in four sizes so they can fit into one of the multiple pouches on the ID band. “All alerts have two parts; one is inserted into a pouch on the bracelet and the other functions as the chart label,” McDermott explains. One major medical center prints two bar codes on a single bracelet—one used by the lab for specimen collection and another for nursing documentation and pharmacy solutions. “The lab prefers the medical record number because it is used to keep a history of the patient’s past lab work,” McDermott says.

Hospitals have to decide what hardware to use with their patient identification systems, a decision driven in part by whether they have implemented wireless connectivity or plan to do so.

Computerized patient identification systems receive physician orders and information about specimen collection and other data from users who enter it on handheld computers or laptops over a wireless network—or in batch mode, where the user docks a handheld computer in a cradle. A few hospitals sidestep the need for wireless capability or batch mode updates by equipping every patient’s room with hardwired PCs with scanners attached.

Hospitals are moving toward using pocket-sized computers for point-of-care applications that don’t involve a fair amount of text documentation requiring a keyboard. On the specimen collection side, for example, many of the major vendors of positive patient ID systems use the Symbol PPT8800, a pocket-sized computer with an integral bar-code scanner made by Symbol Technologies, Holtsville, NY. Most often, the Symbol device is used wirelessly, with the only connection being to the wireless network.

McKesson uses the Symbol device for its wireless Horizon Mobile Care Phlebotomy, which phlebotomists use to ensure and document positive patient and specimen ID. Horizon MobileCare Phle bot o my provides three-way, bar-coded positive ID, positively identifying and matching the patient, specimen, and test request. The application also automatically identifies and tracks the phle bot o mist through bar-code scanning.

It frees the phlebotomist from manual specimen logging and transport by wirelessly sending positive ID and collection information to Horizon Lab, McKesson’s laboratory information system, which makes it possible for the lab to monitor the specimen-collection process. McKesson’s Mark Spencer, vice president and general manager, calls this integration with Horizon Lab one of the application’s unique features. “Being an integrated part of the whole laboratory information system, rather than being an independent application that has to interface to an LIS, Horizon MobileCare Phlebotomy enhances patient safety through real-time information delivery from point of care to the lab and enables the lab to conduct real-time lab surveillance.” To provide cost savings for customers and deliver efficiency at the bedside, the application can reside on the same handheld device as McKesson’s Horizon MobileCare Transfusion and Horizon Admin-Rx.

Unlike personal digital assistants that physicians use to manage their calendars and run clinical applications, the Symbol handheld devices are sealed, which is important from an infection control standpoint, says Jeff Schou, Symbol Technologies’ director of health care industry solutions. For example, if blood comes into contact with a sealed device, the blood can’t infiltrate the unit and render it unusable. The hospital staff can simply wipe the Symbol unit clean with whatever disinfectant the hospital uses to clean other medical equipment in a patient’s room, Schou says.

For infection control purposes, some hospitals require staff to slip the sealed handheld device into a plastic bag that they discard after leaving a patient’s room.

Yet “with the focus on super bugs in hospitals,” Schou says, “one can argue that there are more important targets as vectors for transporting those bugs, such as doctors’ cell phones and neckties.”

The Symbol device is also “rug gedized” to withstand breakage if a user drops it. The Symbol handheld computers are priced from $500 to $2,000 per device, depending on how many options are added, including the amount of memory, Schou says.

Hospitals that haven’t implemented wireless networks have to ensure that staff cradle or dock their handheld computers to update the devices and the server before and after obtaining specimens or dispensing medications. Otherwise, nurses and phlebotomists will work using outdated information, which can lead to duplicate care.

Lattice’s Muzzy recommends hospitals put cradles in convenient locations on the nursing units so staff develop a habit of docking their handheld computers before and after using them.

Muzzy says even hospitals with wireless capability might consider choosing products that can work in wireless and nonwireless environments because all wireless settings have dead zones where the wireless system doesn’t function. And the wireless network can go down temporarily. “Using a browser-based system that requires a wireless network to access data that resides on a server [either in the hospital or maintained off site by the vendor], the hospital is out of luck when the wireless connectivity is disrupted,” Muzzy says.

In hospitals that buy patient ID solutions from various vendors, nurses can end up strapped with multiple handheld devices: a blue one for lab, red for meds, and others for blood transfusion, nursing documentation, or oncology. That’s because “some vendors try to make their devices proprietary so the hospital can’t run competitors’ applications on them, which almost forces a situation where the hospital ends up with multiple handheld devices,” says BD’s DiLauri. By contrast, BD’s system allows hospitals to choose best-in-class applications for lab, pharmacy, and so on, she adds.

What might the future be technologically for positive patient ID systems? Korchek’s Francis predicts that within a decade, all labs will have electronic systems to ensure the right patients receive the right lab test results and blood transfusions. “Keep in mind that 10 to 15 years ago, most labs didn’t have an LIS, but now virtually all of them do,” he says. “I predict we will see the same shift in use of technology from just a small percentage now to the technology becoming standard in labs and hospitals.”

Precision Dynamics’ Thall foresees RFID being used in a growing number of applications, though he views it as complementary to bar coding because the latter will always be more cost-effective.

But “in blood transfusion scenarios, for example, one could write the patient’s type and crossmatch data to the RFID tag on his wristband,” Thall says. “That way, if the blood bank’s computer system goes down, you have that basic data. In most instances, the data shelf-life is pretty much indefinite once it’s stored on the RFID tag.”

University hospitals and large, privately funded hospitals are looking to be on the cutting edge of RFID and are sponsoring pilots, Thall says. “That’s where you will find the breakthrough results with RFID for patient identification and care.”

Karen Lusky is a writer in Brentwood, Tenn.