CEO SUMMARY: Here’s a prediction that automation of work processes for phlebotomy, specimen collection, and specimen transport may be the next trend. Unfolding developments in the United States are creating a situation parallel to what was seen in Japanese hospital laboratories more than two decades ago—and led to the world’s first automated solutions for clinical laboratories. Another factor to enable this trend are recent advances in technology and miniaturization.
IS PHLEBOTOMY AND SPECIMEN COLLECTION the next area of laboratory work flow to undergo automation? There are several reasons why one can answer this question with a “yes.”
First, one consequence of the use of automation, particularly in accessioning/pre-analytical and in the high volume core lab, is recognition of how automation contributes to reducing variation in outcomes, including more consistent turn-around times as well as overall improved quality.
Second, once laboratory staff has used automation to improve work flow in both the pre-analytical stage and the analytical stage, they want to identify other sources of errors in the laboratory work flow. This sets up the use of automation as a tool to reduce these errors.
Third, the growing use of Lean, Six Sigma, and similar process improvement methods reinforces an operating mind set of continuous improvement. Staff in Lean labs constantly seek ways to reduce the source of errors and identify opportunities to lessen variability produced by individual work processes.
THE DARK REPORT believes that each of these three factors, as they become rooted in an increased number of clinical laboratories here in the United States, will collectively act to create a demand for products that automate specific work processes in phlebotomy, specimen collection, and transport of specimens into the laboratory.
Automation Path Of Labs
This is a natural outcome from the automation path most laboratories have taken. Typically, the first automation solution implemented involved the high volume core laboratory. Often it was creating an automated track to transport specimens from one instrument to another. Another approach was use of a consolidated analyzer that put chemistry and immunochemistry into an integrated instrument system.
Whatever specific automation solution was used in the high volume core laboratory, two improvements were quickly confirmed by data. One, the automation reduced errors often related to manual handling of individual specimens. Two, there was a notable reduction in variability of quality and turnaround times.
It is a similar story for laboratories that next used automation in accessioning and pre-analytical work flow. Again, automation contributed to fewer errors and less variability in how each specimen was handled and processed.
Demand For Automation
Here is where the future of the lab industry becomes interesting and leads to a demand for automated phlebotomy and specimen collection solutions. What does a laboratory do next to improve quality if it has already installed automation in both accessioning/pre-analytical and the high volume core laboratory?
To continuously improve, this lab must next identify the largest source of errors. Invariably, the process improvement teams look at the work steps upstream of accessioning. This puts phlebotomy, specimen collection, and specimen transport on the radar screen. Because these work processes remain manual and few phlebotomists adhere to standard work, data on the existing state generally reveal that errors and variability in outcomes typically fall far short of a Six Sigma level of performance (only 3.4 million errors per million events).
Going Upstream To Improve
This sequence of developments, as it occurs in the United States, supports the prediction that a demand for automated phlebotomy and specimen collection solutions is likely to emerge. How many years are required for an active market to develop is uncertain. What can be said, with a high degree of confidence, is that laboratories—using process improvement methods in tandem with automation solutions—will eventually go upstream in the pre-analytical work flow. They will identify phlebotomy and specimen collection as having high potential for improvement.
Of course, some of this is happening already. Automated systems to aid in patient identification and to help phlebotomists produce labels for specimen containers are already in the marketplace. But the level of phlebotomy automation that is typical in Japan, Korea, Taiwan, and other Asian countries has yet to occur in the United States.
Following trips to Korea (2006) and Japan (2008), THE DARK REPORT has alerted clients and regular readers to the rather remarkable and widespread use of automated phlebotomy systems in hospital laboratories. (See TDRs, May 5, 2008, and May 1, 2006.) In fact, this extensive use of automated phlebotomy systems by hospital labs in Japan and Korea is one aspect that makes them different from hospital labs in the United States.
Differences In Japan
As I puzzled over why this difference exists during this year’s trip to Japan, I recognized two reasons why—in this operational aspect—labs in Japan have evolved differently from labs in the United States. One reason has to do with mind set. The other reason has to do with volume. Both reasons worked together in Japan to create an opportunity to improve laboratory operations in ways that have not existed in our country.
Reason One: Japanese people understand and respect the concept of “kaizen”, loosely translated as “continuous improvement.” This is the reason why, when several innovative pathologists began to develop the world’s first laboratory automation systems early in the 1980s, they were inspired and guided by the continuous improvement mind set. This caused these pathologists to constantly look for the next source of improvement in their labs’ workflow and individual work processes.
For example, once they had designed automated solutions for the analytical stage in their laboratories, they quickly looked upstream in the work flow and saw the improvement opportunities that existed in accession and specimen processing. Once those improvements were harvested, these pathologists looked further upstream and recognized that phlebotomy, specimen collection, and specimen transport—if automated properly—could deliver further improvements in quality, turnaround time, productivity, decreased variation, and reduced costs.
Reason Two: Phlebotomy automation has flourished in Japan and is non-existent in this country because of a characteristic of laboratories in larger Japanese hospitals. The size of these laboratories generates economies of scale not seen in hospital laboratories in the United States.
Many hospitals in Japan are larger than the largest hospitals in the United States. For example, only a handful of hospitals in the United States exceed 1,500 beds. Japan has many hospitals larger than 1,500 beds. This means the large Japanese hospital laboratory tests large numbers of patients daily. This volume of specimens triggers economies of scale that make it easier to realize benefits from using automation in many work flow steps within the laboratory.
Another difference in Japan from the United States is that the larger hospitals commonly have an outpatient clinic attached to the hospital building. This outpatient clinic may see between 2,000 and 5,000 patients per day. Specimens from these patients are often drawn by the hospital lab at a central patient service center that is located next to the core laboratory.
Automation Adoption Curve
This means that a hospital laboratory in Japan may draw blood from 1,000 to 2,000 patients per day—with a large number performed at the single draw site next to the core laboratory. Such large volumes of specimens contribute to economies of scale that are difficult to match for an American hospital laboratory.
Not only did Japanese pathologists have the mind set of continuous improvement, they had economies of scale to support automation solutions that did not exist in the United States or countries in Europe. It was only natural that, as these pathologists first automated the high volume laboratory, and next, accessioning and specimen processing, they would then look upstream in the work flow and apply the same continuous improvement techniques to phlebotomy and specimen collection.
Labs In Japan And The U.S.
Simply said, one major difference between hospitals laboratories in Japan and hospital laboratories in the United States is the daily volume of patients serviced and specimens collected. The combination of a large hospital—of greater than 1,500 beds—with a large outpatient clinic next to the hospital, handling several thousand outpatients daily, creates a volume of specimens not seen by large hospital labs in this country.
Despite the fact that Japanese labs dived into automation in the 1980s, and notwithstanding the significantly fewer specimens handled daily by hospital labs in this country versus their counterparts in Japan, the adoption of laboratory automation has strong parallels. Labs in both countries began by using automation in the analytical stage. They then went upstream in the work flow and began using automation in accessioning and specimen processing.
Thus, just as Japanese labs next looked upstream in work flow and applied automation to phlebotomy and specimen transport work processes, it is reasonable to expect that American laboratories will start to do the same. Lacking the daily specimen volume common to labs in Japan, Korea, and other Asian countries, laboratories here will likely struggle to find cost-effective approaches to phlebotomy automation. But creativity and innovation are likely to resolve those issues. As that occurs, it will trigger a growing use of automated phlebotomy by hospital labs in the United States.
Labs in Japan and South Korea Take Two Paths To Automate Phlebotomy & Specimen Collection
DURING VISITS TO HOSPITAL LABORATORIES in Korea (2006) and Japan (2008), I saw automated phlebotomy/specimen collection systems being used in two ways.
The first approach was automation in the patient service center. When a patient presented at reception with the test request, this information was either entered into the information system, or, if an electronic test order, confirmed against that order in the computer.
Here is where the automated phlebotomy system takes over. That patient’s order is received by an automated system that selects the collection materials and evacuated blood collection tubes needed, prepares and applies the correct identification labels, then assembles these items into a small collection tray.
Next, this collection tray is sent out, via a transport line, to the phlebotomist’s work station where the specimen collection will take place. Commonly, the transport line runs under the bench tops of the draw stations.
Once the collection is completed, the phlebotomist puts the collection materials back in the collection tray and places the tray on a different transport line. This transport line takes the specimens directly into the laboratory, where automated systems process the specimens, then send the specimens to the correct analyzers.
Two comments about this arrangement. First, in sites where I observed this method of phlebotomy/specimen collection automation, the hospital stood next door to a large outpatient clinic. The patient service center was a central site and was often drawing between one and two thousand patients each day. That volume helps generate a return on investment from this automation solution. Also, by collecting specimens directly next to the central laboratory, it is possible to utilize an automated transport line that takes specimens directly into the laboratory and supports automation in pre-analytical and analytical stages.
During a Korean hospital laboratory site visit, the automated phlebotomy equipment in use for this type of arrangement was manufactured by Astech Corporation of Osaka, Japan. Its products can be found at: https://www.astech.co.jp/e/products/index.html.
The second approach involved an automated phlebotomy unit that stands in the central laboratory. When a test request is received, it is entered in the automated system. The automated system then selects the correct collection materials and evacuated blood collection tubes. These are labeled and inserted into a collection tray. This collection tray is transported to the correct location in the hospital by a pneumatic tube or other automated system. The phlebotomist uses these collection materials with the patient, then sends the collection tray back to the laboratory using the same transport system. Upon arrival back at the laboratory, the specimens go right on the pre-analytical line.
Our Japanese and Korean laboratory hosts, in discussing these automation solutions in phlebotomy and specimen collection, pointed out how automation reduced manual handling errors and reduced the chance of the phlebotomist selecting the wrong collection supplies. Automation of the labels eliminated the possibility that the phlebotomist would either use the wrong patient label or apply the labels incorrectly, leading to problems on the automated line in the laboratory.
One system used in this arrangement that I saw on my lab tours is made by Techno Medica Co., Ltd of Yokohama, Japan. Its phlebotomy automation solutions can be viewed at: https://www.technomedica.co.jp/t02/en/product s/bc-robo.htm.