The focuses are on errors and automation


     Radiometer safePICO_AspiratorRadiometer’s pre-bar coded safePICO is designed to reduce preanalytical errors, incorporating a vented tip cap, integrated mixing device, and electrolyte-balance heparin.  Preanalytical errors are often fingered as the culprit for up to 60% of all errors in laboratory medicine.
Diagnostic consequences of these errors depend on the magnitude of the mistake. In the worst case, errors may lead to mistreatment of patients. In all cases, these errors create extra work for the hospital staff involved.
       The preanalytical phase of lab workflow encompasses every step from the time a diagnostic test is ordered to the point of analysis. Despite technological advances, the preanalytical phase is still primarily a manual process. The highest percentage of lab errors occur during this phase, which includes issues such as hemolysis, quantity not sufficient, incorrect order of draw—each of which can potentially impact analytical testing.
       Preanalytical errors are a concern for clinical labs, not only from a patient care perspective, but financially as well, says Michelle McLean, MS, MT(ASCP), product and clinical applications manager, preanalytics, Greiner Bio-One North America, Preanalytics, Monroe, NC.
       As hospitals wrestle with the requirements of the Affordable Care Act, it is increasingly important to reduce testing errors, according to Alan Beder, senior product manager, Radiometer America, Westlake, Ohio. Accurate, error-free testing reduces the need for retesting, and ensures that patient-treatment decisions are well-informed, supporting favorable outcomes and reducing readmissions.

The critical role of sample quality

       Preanalytical errors may be related to specimen quality, as well as to its identification. Its integrity may be compromised by improper mixing and room air contamination—the presence of clots and air bubbles within the sample, Beder says. The clinical impact of an improperly mixed sample may be an inaccurate hemoglobin result, which may lead to costly and unnecessary blood transfusions.
       Radiometer’s analyzers and blood collection products automate many of the manual processes that contribute to errors in the preanalytical phase, and its analyzers, blood samplers, and software work together synergistically to reduce errors and ensure sample quality.
       Radiometer offers a proprietary safety-engineered ABG sampler designed to be used with the company’s ABL analyzers. The safePICO incorporates a vented tip cap to expel air bubbles, an integrated mixing ball in the barrel of the sampler, and electrolyte-balanced dry heparin to reduce clotting. When placed in the tray of the ABL800 FLEX or ABL90 FLEX analyzer, the mixing ball is activated. Automated mixing eliminates user-variability, a possible source of preanalytical error.

The importance of proper sample identification

       Improperly identified samples are another source of preanalytical errors, and an issue taken seriously by The Joint Commission (JCAHO), Beder notes. A principal National Patient Safety Goal of the JCAHO is to improve the accuracy of patient identification. In addition to the obvious risks of improper treatment, lost or mislabeled samples may mean lost billing (revenue) opportunities for the hospital.
       Radiometer automates the process of specimen identification by enabling automatic sample registration at the bedside, eliminating the possibility of transcription error. The pre-bar coded safePICO sampler and patient wristband may be scanned at the bedside and then again at the analyzer, relating the specimen to the patient and the result.

Radiometer Fig_1_1stAutoDiagramRadiometer’s 1st Automatic system integrates samplers, analyzers and data management to ensure the right results for the right patient.The synergy of 1st Automatic

       The company’s system approach noted above—or 1st Automatic—combines analyzers, samplers, and data management to ensure the right results for the right patient at the right time. Figure 1 shows each step in the blood gas testing process using a 1st Automatic implementation.

Big changes in microbiology labs demand automation

       Microbiology labs are undergoing dramatic changes. At the same time testing demands are on the rise, the pool of qualified lab professionals on hand to perform these tests is growing smaller, says Annette Allaire, manager, microbiology products, US M&M business management, Siemens Healthcare Diagnostics, Tarrytown, NY.
       These challenges help illustrate why standardized sample collection and automated preanalytical sample management is critical to increasing the efficiency and productivity of the microbiology lab workflow. “Unlike the clinical chemistry lab where automation was introduced more than a decade ago, the microbiology workflow is not as easily automated,” Allaire says. “Microbiology samples come in a variety of shapes and forms, making automation of specimen processing a significant challenge until now.”
       By using liquid-based collection systems, such as ESwab™, SL Solution, and Cary-Blair transport media, labs are able to implement automation solutions that were previously unavailable. Automation not only addresses anticipated staffing shortages, but improves lab quality by standardizing a manual process with inherent variability. Automation solutions will play an increasingly important role in microbiology testing in the future, Allaire says.

The lure of the WASP
Radiometer FLEXQThe ABL800 FLEX analyzer from Radiometer incorporates a sample-handling feature that automatically scans, mixes, and aspirates the specimen.
       Many microbiology labs are seeking complete microbiology solutions, not just stand-alone products. “At Siemens, we are working to meet the needs of our customers by seamlessly integrating the
microbiology laboratory workflow by offering innovative solutions for preanalytical, analytical, and postanalytical identification and antibiotic susceptibility testing (ID/AST) testing and management, Allaire says.
       “With regard to preanalytical sample management, the Siemens solution is the Copan WASP® (Walkaway Specimen Processor), which can automate over 90% of the non-blood culture microbiology
specimens,” she says. “This fully automated preanalytical sample processing system standardizes inoculation and streaking, decreases errors, and increases efficiency and productivity.”
       The WASP, from Copan, Murietta, Calif, is the only system that automatically prepares and labels gram slides and broths, and its design helps ensure accurate plating and minimizes the risk of cross contamination, Allaire says. This frees up technicians to accomplish other tasks. The WASP System is designed as a modular, open platform for the seamless addition of new features and capabilities, allowing labs to easily adapt to changing needs in the future, Allaire says.
       Soon, Siemens plans to make the Copan WASPLab™ System available in the United States. WASPLab is a tracked system that moves plates from the Copan WASP to automated incubators, or what are called smart incubators. It is here that digital images are shot of the plates (which can be reviewed by a lab technologist without needing to remove plates from the incubator), helping to significantly boost productivity. Labs that have adopted WASPLab have reported as much as a four-fold decrease in the time it takes to read and process culture plates—based on customer feedback, Allaire says. “Given the staffing challenges experienced by many labs, this increased efficiency can help laboratories to grow without adding new staff, or to adapt to anticipated staffing shortages,” she says.

Addressing need for compatibility with lab automation

       A number of variables affect the preanalytical or pre-examination phase of diagnostic testing. Here, Michelle McLean, Greiner Bio-One North America, narrows down the possibilities to three issues of importance to the clinical lab: prevention of needlesticks, collection of high-quality patient samples, and the need for products that are compatible with lab automation.

Prevention of Needlestick Injuries

• It has been well documented that needlestick injuries (NSI) are costly for health care facilities. Greiner Bio-One offers a range of VACUETTE® safety products that help minimize the risk of accidental exposure due to needlesticks.
• The QUICKSHIELD Complete PLUS, which is a preassembled Safety Tube Holder with Visio Needle that allows visual confirmation of venous access with a flash window, and the Safety Tube Holder both have a safety shield that moves over the needle to contain splatter and aerosols. The safety shield is activated on a solid surface or by using the thumb, so the users’ hands are always behind or away from the needle. The needle is locked in the shield after activation.
• The VACUETTE Safety Blood Collection Set is a winged collection device that provides in-vein activation of the safety mechanism so healthcare workers are protected from NSI as the venipuncture is terminated (which is the time they are most vulnerable to injury, according to published statistics).
• The most recent addition to the product line is the TUBE-TOUCH, which is a passive, preassembled medical device that is activated as the tube is inserted into the holder and shields the needle automatically as it is removed from the vein.

High-Quality Patient Samples

• Lab results are only as good as the sample provided and how accurately it reflects the health status of the patient from whom it was collected. These products are from the VACUETTE line:
• Blood Collection Tubes, ideally used as a system with Safety Products, are designed for optimal specimen quality. They are manufactured from polyethylene terephthalate plastic, which delivers a highly transparent, virtually unbreakable tube for improved safety. Most Tubes have a shelf life of 18 months (with the exception of coagulation tubes, which have a 12-month shelf life) for improved utilization. If expired product is used for collection, there is an increased risk of sample quantity being insufficient for the amount of additive in the tube, potentially impacting analysis.
• All Tubes have safety caps to minimize aerosols as the cap is removed for processing. The caps also have a recessed stopper to reduce the potential for exposure to any blood that may be present following collection. The caps feature color-coded rings for easy recognition of tube type, which also helps prevent inadvertent selection of the wrong tube for the testing ordered and helps minimize sample rejection and the need to re-collect.
• All tube labels have an optimal fill mark. Coagulation tubes have a fill range for easy recognition of the acceptable ±10% fill tolerance to achieve the 9:1 blood to additive ratio required for routine coagulation testing. This allows for easy determination of sufficient sample quantity for the amount of additive in the tube during collection so that patients are not subjected to a second venipuncture.

Lab Automation-Ready Products

• McLean says that the shortage of medical technologists and technicians in US healthcare, combined with the increased need to provide high-quality patient care at a lower cost, has necessitated that labs turn to automation for sample receiving, processing, and distribution throughout the lab as well as sample analysis.
• VACUETTE Blood Collection Tubes are validated with all commonly used automation platforms, including stand-alone systems, in-line systems, as well as instrumentation for analysis. Greiner Bio-One works closely with all automation and instrument manufacturers to help ensure compatibility of these products.
• As automation expands and includes more preanalytical processes, the company works to ensure that current products, as well as those in development, meet the needs of the lab to reduce manual methods and opportunities for error.
“Preanalytic factors will continue to be a focus for clinical laboratories as the effort to reduce biohazardous exposure and laboratory errors progresses,” McLean says.

Educational Resources
 on Reducing Preanalytical Errors in Blood Gas Testing
Radiometer helps lab and clinical personnel reduce preanalytical errors in blood gas testing. Among its educational resources are:


AlphaTec ATS_gram_slides
Alpha-Tec Systems Inc
, Vancouver, Wash, Offers Preanalytic Products for the Clinical Lab 

  • Gram Slides
    Gram-stain quality control slides validate routine Gram-staining protocols. Each slide contains a known positive and negative control in clearly designated areas. Options include slides with areas for up to three clinical specimens, which are useful for swing or night shifts where review of the staining procedures may be required by lab supervisors or senior technologists. 

AlphaTec EA3

  • NAC-PAC™ ea3
    NAC-PAC ea3 includes a combination of reagents for AFB specimen preparation that will decontaminate the sample, provide visual confirmation of a neutral pH, generate effective neutralization without titration, create ideal final sample characteristics, and with individual patient test packaging, alleviate cross-contamination concerns. These measures of control allow for greater recovery of mycobacteria and increased diagnostic accuracy.


Gary Tufel is a contributing writer for CLP. For more information, contact Chief Editor Judy O’Rourke, [email protected].