Automation in specimen handling is an idea whose time has finally begun to arrive, but for some labs, widespread automation is still in the future. One big reason: the wide variety of specimens and containers that come into labs for handling. That’s slowing the progress of total automation.

Specimen handling can be an error-prone process because often, specimens are collected at the bedside and then labeled later at the nursing station, says John Van Blaricum, Mediware Information Systems vice president, marketing and communications. “This leaves open the very real opportunity that specimens will be mislabeled, resulting in the test attributes being applied to the wrong patient. Transfusion cross matches and other therapies based on these results will then be given in error, which could result in extended stay or even death.”

Mary Ann Silvius, director of new product and business development for Microbiology North America, Thermo Fisher Scientific, says most labs still handle specimens manually but larger labs may automate their chemistry lines and urine processing. In microbiology, most labs are very manual, with the exception of automated urine plating in large labs and automated extraction in labs with a significant molecular menu.

But labs want automation. “Take the process and automate the accessioning, labeling, processing, and plating. However, due to the variety of specimens this will be very difficult,” she says.

Peter Rumswinkel, vice president/general manager, Sarstedt Inc, says automation is increasingly used for analytical processes and some specimen-preparation steps. He says Sarstedt’s new bulk loader module for its preanalytical automation systems allows lab techs to input tubes by simply dumping them into a hopper rather than manually placing them into racks. The system then places each tube onto a track system for identification and further preparation for analysis steps such as decapping, aliquoting, and sorting as defined by the laboratory. The amount of automation varies by facility and is dependent on throughput, workforce, and budget. Rumswinkel says many preanalytical processes, such as patient preparation and ID, specimen collection, labeling, and mixing, are still manually accomplished by collectors and lab techs.

Microbiology in Need of Advances

“Microbiology is crying out for advances in sample handling, which is not as streamlined as in the other disciplines, adds Norman Sharples, Copan Diagnostics Inc executive vice president. “For example, some labs receive urine samples in three different types of containers. That’s where Copan and few other companies come in. Copan lives and dies by innovation in the preanalytical phase of microbiology, specifically on specimen collection and transport systems.”

“Specimen collection and transport systems is a niche that has been overlooked and underappreciated,” adds Gabriela Powers, marketing manager, Copan Diagnostics Inc.

Copan specializes in manufacturing devices specializing in the collection and transport of specimens in the preanalytical area of microbiology, she says, adding that other manufacturing companies produce transport systems only as a small part of a larger portfolio. “We are totally focused on the areas of bacteriology and virology collection swabs and transport media,” Powers notes.

“Copan’s commitment to collection and transport systems has been evident with the recent swine flu outbreak, where we decided to triple our daily production of Flocked Swabs and Universal Transport Medium overnight to accommodate the worldwide demand for viral sample collection system, and we are working closely with our distributors and communicating with governmental institutions to ensure proper supply.”

Most labs handle blood, sterile body fluids, respiratory, urine, stool, and tissue specimens, and smaller labs see the same types of specimens as larger labs but may send more tests out than larger labs do, Silvius says. Large commercial labs will process many more urine and blood samples versus more invasive specimens based on the client type. The main aspects of the process and current challenges are accessioning, processing, smear and stain, plating, broth inoculation (if appropriate), incubation and plate reading, she says. Most blood specimens arrive in the lab in the tube from which they are drawn; sterile body fluids usually arrive in a sterile cup or come preinoculated into a blood culture bottle, which is not always optimal. Tissue comes in a sterile cup with sterile saline, and stool or urine will arrive either in a sterile container or in a container containing transport media (boric acid for urine, Cary Blair for stool), Silvius says.

Challenges in Managing the Workflow

According to Rumswinkel, test ordering, patient identification and preparation, sample collection and identification, sample transport and handling, analysis, result reporting, and sample archiving are the primary processes in diagnostic testing. “A key challenge is managing the staff, processes, and costs involved, as the path of workflow often involves various departments and employees. Maintaining high quality standards while improving efficiency and safety in light of ubiquitous workforce shortages and reduced budgets is another serious challenge,” he says.

The types of specimens handled most frequently by labs varies significantly by the type of hospital, but blood samples are most prominent, Van Blaricum says. The types of specimens handled by smaller labs, larger commercial labs, and hospital labs might result from the types of treatments that are managed. Hospitals or labs that are not equipped to handle more complicated testing need to rely on outside expertise, he says.

But for microbiology, although the challenges in labeling, handling, transporting, and tracking lab test specimens can be similar to those presented in hematology and chemistry, they are fundamentally different. In microbiology, most specimens are either urine, swabs, fecal, or sputum samples, and there are differences in handling each—and thus, challenges, Sharples says.

“That’s because other disciplines deal with liquid samples such as blood and plasma, while microbiology samples, except for urine, aren’t liquid. Therefore, hematology and chemistry have had the luxury of using automation to process samples for quite some time, while the specimen-receiving area of microbiology has not had that privilege because of the buffet of specimen types and transport container size. With liquid samples analyzers, handling, preparation, and the containers used can be standardized. Containers can be color-coded by caps that have meaning to doctors, nurses, and lab techs,” Sharples says.

Substances other than liquids present special challenges that hamper automation in microbiology sample testing, he says.

Containers differ for every type of specimen collected. For example, although urine is liquid, the containers for collection and transport of urines are yet to be standardized. Fecal samples, swabs, sputum, and solids come in all kinds of containers. Because of the nature of the specimens collected, “It’s impossible to standardize these containers, which has been a big roadblock to development of automation for the receiving end of microbiology, while automation in diagnostics has proceeded by leaps and bounds,” Sharples says.

And because hospital-acquired infections like VRE and MRSA are increasing, labs are required to do more testing on admitted patients. In addition, staff shortages of medical technologists are creating additional burdens on laboratories everywhere. “There should be plenty of people available for lab tech jobs under the current economic situation, but in fact there’s a shortage,” Sharples says. And using qualified med techs for sample ascension is a misuse of their time and capabilities because repetitive planting and streaking tasks are very laborious and time-intensive, causing a loss of availability of high-value staff.

In bacteriology, Copan developed ESwab, the only liquid transport swab system for automation, and with that innovation, automation in the front end of microbiology is now possible. Sharples says Copan’s Walk-Away Specimen Processor (WASP) automatically plants and streaks samples and draws down patient information and, using bar code scanners, selects the appropriate culture plates for the appropriate investigation as is done in hematology and chemistry sample handling.

The first installation of the WASP in Canada was recently done at Vancouver General Hospital. Diane Roscoe, MD, head of the hospital’s Medical Microbiology and Infection Control Division, says WASP enables the microbiology lab to provide excellent service by improving throughput capacity while maintaining consistency.

Automation Coming to the Front End

WASP can automate tasks at the front end but does not provide interpretation; med techs are still needed to interpret results by looking at what’s on the plates. “We’ll still need techs, because their expertise and interpretative abilities are invaluable and can’t be automated. But their skills shouldn’t be used in specimen ascension. This permits techs to perform more highly skilled tasks,” Powers says.

Using WASP, a swab is converted into liquid form in a test tube; previously, a tech had to pull the swab and roll it onto a plate, which was almost impossible to automate. (With urine, the procedure is much easier because of the nature of the specimen.)

Copan developed a flocked swab that has been sprayed with nylon fibers. Due to the flocked swab design, when one is placed into liquid, it drains the sample from the swab into the transport medium, which can then be loaded onto the instrument for planting. One platform manages both liquid and swab specimens, Powers says.

Prior to the introduction of ESwab with Flocked Swabs, the problem of converting swab samples to liquid had not been cracked, Sharples says. This advance offers many opportunities and benefits for hospitals in the area of specimen handling and opens the opportunity to automate the front end of microbiology, which offers cost savings for hospitals. “There are lots of upsides to this process,” he concludes.

There are an almost overwhelming number of devices designed for blood collection, and they are typically categorized by the blood-sample type they collect: venous, arterial, or capillary, Rumswinkel says. “A typical venous collection setup includes prepared evacuated tubes and corresponding needles and holders. Unfortunately, the vacuum force exerted upon a vein during collection can be too great for some patients, resulting in a vein collapse and subsequent restick. Other devices are therefore required for fragile veins. Many times evacuated tubes are coupled with collection sets, also known as butterfly needles, which typically combine small-bore needles and tubing to reduce the pressure on a vein.

“However, butterfly needles are usually expensive, pose a greater safety risk, and can affect sample quality when cells have difficulty passing through small needle bores. Sometimes syringes are used to collect blood when collection is difficult, as the user controls the pressure and can manually slow down the process. However, different needles are required and blood must be transferred out of the syringes and into treated blood tubes. Such sample transfers require additional devices and steps, increase exposure risk, and can result in premature clotting and hemolysis,” he says.

In traditional processes, clinicians will draw samples based on hospital orders, then label the group of samples for delivery to the lab. Errors result from mislabeling. Van Blaricum says using Mediware Information Systems’ PathCollect, clinicians manage their workflow to draw the appropriate samples.

Using handheld technologies and bar codes, the clinician verifies patient ID at the time of sample collection, then prints the appropriate labels at the bedside to ensure the risk of error is minimized. As samples are collected, lab professionals are notified that samples are being transported to allow them the opportunity to monitor and adjust their workflow as necessary.

The extension of technology to the bedside allows hospitals to decrease the opportunity for error but also improve the communication and workflow between the lab and clinicians on the ward floor.

PathCollect does not automate the testing process but supports the workflow of sample management. Orders for collections are communicated to clinicians, enabling them to better manage their rounds and workflow. Patient ID is verified, and the samples are accurately labeled at the bedside. Upon collection, the lab is aware of the pending delivery and can manage its workflow to ensure that priority orders are processed expeditiously and that results are delivered in a timely fashion, Van Blaricum says.

Van Blaricum says bringing clinicians and the lab closer together through information and workflow is an important safety concern that PathCollect addresses. PathCollect can work with all types of samples, though the samples with the greatest patient-safety risks are the blood samples for patients who may receive transfusions. PathCollect can also work with any sample-collection container. Once the software recognizes the patient and the tech indicates the sample collected, it prints a bar code label with patient information so that the samples/results are not lost, mishandled, or attributed to the wrong patient. Labels can be generic relating to the type of sample, Van Blaricum says.

Two key advantages are safety and efficiency. PathCollect acts as a workflow manager between the lab and hospital floor, and takes labeling to the bedside. Clinicians know what they are to collect/draw through the tools provided. Patient ID is verified using the system, and the sample labels are printed at the time of collection so there is very little chance of error. And PathCollect, which is essentially a software product, uses industry-standard handheld devices that many hospitals already own.

Sarstedt’s Rumswinkel says his company’s S-Monovette® venous blood collection system allows greater flexibility for difficult draws without compromising safety or sample quality and meets Lean and green initiatives.

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S-Monovette tubes provide users with a choice of collection technique based on the patient’s vein condition. For fragile veins, the user can pull back on the tube’s plunger to collect blood directly into the prepared S-Monovette. No sample transfer is required as with a traditional syringe. For more robust veins, S-Monovette tubes can be evacuated by the user at the point of collection. Regardless of the technique employed, the same compact Safety Needle is used for collection. With the S-Monovette system, fewer components are used, fewer steps are required, and less waste is generated than with traditional collection products, Rumswinkel says.

Gary Tufel is a contributing writer for CLP.