PROCESS IMPROVEMENT, LEAN AND SIX SIGMA THROUGH LABORATORY AUTOMATION

PROCESS IMPROVEMENT, LEAN AND SIX SIGMA THROUGH LABORATORY AUTOMATION

These terms have received considerable popularity in improving clinical laboratory work flow leading to improved efficiency. The application of such “management methods” in planning for laboratory automation is important in developing the best plan and the most effective use of resources. Simplistically, Lean refers to improvement of work flow by “identification and elimination of waste.” This approach has been known for years as re-engineering and emphasizes smoothness of work flow with the elimination of “unevenness” in work processes.

Six Sigma is another tool of improving efficiency and basically is defined as variance reduction and is most applicable to manufacturing processes. However any sequence of steps or processes is a candidate for reduction of errors and improving the process using the statistical tools of Six Sigma.

There has been a great deal written about how to apply these theories to clinical laboratory automation. As a starting point these definitions will be helpful;

Ø  Understanding and documenting current processes from phlebotomy to report generation.

Ø  Defining the end points you are attempting to achieve (safety, reduction of staff, TAT’s for stats and routine testing, etc.)

Ø  Determine the resources available to reach your goals including finances, internal and external consultants, etc.

Ø  Assessment of your clinical laboratory’s physical plant.

From these evaluations, the start of a plan for total laboratory automation can be initiated using the principles of Lean and Six Sigma. The contribution of automation is that it eliminates many of the repetitive and wasteful motions and activities that characterized the clinical laboratory in the past. However, in improving workflow and efficiencies one must plan for a system that is understood and controlled by the technologist.

Process Improvement

Process improvement can be delved into with great depth; what's discussed here is a glimpse. Any given laboratory has their processes, from sample receipt, analysis and post-analysis tracking to instrument maintenance and utilization. If you look at the areas that can provide the most room for improving efficiencies and therefore having a more significant impact on the bottom line of the lab itself, then that is where the starting point should be.

Ten Reasons Why Automation Projects are Not Successful

Ø  Incomplete understanding of current environment...processes, costs, customer expectations

Ø  Loss in flexibility due to fixed processes and limited throughput

Ø  Unrealistic expectations of system...cost reduction, throughput, return on investment

Ø  Unplanned and poorly developed ‘workarounds’ required to interface automation with manual processes

Ø  Unclear expectations of system functionality

Ø  Overbuilt and unnecessarily complicated system design

Ø  Inadequate technical support

Ø  Credible and realistic impact analysis never conducted

Ø  Hidden costs...labor, supplies, maintenance

Ø  Failure to optimize current processes prior to automation→never automate a poor process!

Systematic Approach to Automation

Ø  Evaluation of needs (move current state to desired state)

Ø  Logistics and handling issues

Ø  Facilities and space considerations

Ø  Temperature considerations

Ø  Mapping workflow, timing workflow

Ø  Finding bottlenecks and time wasters

Ø  Identify possible solutions to meet needs

Ø  Evaluation of alternatives

Ø  Progress measures

Ø  Cost justification

Lab Automation

The first step in laboratory automation is the laboratory information system (LIS). The capabilities of the LIS that a laboratory implements are really what determines the parameters for what is possible in all other types of automation and how well you are able to leverage that automation throughout every process within a given laboratory and its associated facilities.

The main areas of automation include:

Instruments

Automated instruments can communicate with an LIS either uni- or bi-directionally. Some instruments only need to be uni-directional, such as a urine dipstick analyzer, whereas others are far more effective with a bi-directional interface, such as immunoassay or special chemistry analyzers. Taking advantage of the correct interface for the specific instrument with your LIS is what will determine the amount of efficiency from which your lab will benefit.

Interfacing your instruments directly to your LIS is a simple task for an experienced LIS vendor. Some of the benefits include the reduction in time for manual processes (that include not only placing orders to the instrument but also receiving results back directly from the instrument); the ability to see where in the queue the test is or where in the process of testing if there are multiple steps; ability to run and analyze QC; and having a common user interface and robust set of rules-based configuration tools at hand. Autoverification processes are key in instrument automation. To truly leverage automated instruments though, having the ability to configure and manage complex rules and filters is also key.

Batch Laboratory Automation

In high volume clinical laboratories — especially some of the commercial labs — batch testing is effectively used to move large numbers of specimens. There are “integrated pre-analytic” instruments that have been developed to perform the de-capping, centrifugation, sorting and preparing aliquots of the original patient specimen. The sorted specimens and aliquots are then transferred to the racks destined for the analyzer that has the capability to perform the test(s) ordered. The initial specimen processing and aliquots remains a critical function of batch testing. Some high volume labs continue to use manual centrifugation as it has a higher throughput and has been determined to be cost effective. One of the draw backs of the batch approach to automation is that preparation of numerous aliquots is required in the processing or pre-analytical steps. This results in the aliquot moving to the testing instrument without any efficient method to retrieve the aliquot sample for additional testing. Numerous aliquots may lead to QNS situations especially in short draws and pediatric specimens.

Continuous Flow Automation

Continuous Flow Automation in which the individual patient specimen is placed on a continuous conveyor belt and the tube circulates, stopping at individual analyzers where a patient specimen, usually serum, may be sampled to perform the appropriate clinical tests. Continuous flow systems allow for a variety of analytic instruments, including duplicate analyzers. This allows high volume clinical laboratories to install appropriate redundancies in case of instrument down time, loading of reagents, or other scheduled maintenance. This permits single analyzers to be bypassed without disrupting the flow and productivity of the clinical laboratory’s automated system.

This approach essentially results in the aliquot functions to occur after all of the tests on the automation line have been completed and not in the pre-analytic process. By doing aliquots after testing in the automated line this approach conserves serum and decreases the number of aliquots requires to perform all of the patient’s tests. Sorting of specimens can be performed in the pre-analytical or by the exit robot.

Human Transaction Automation (e.g., the automatic accessioning of cases).

Using barcode technology for patient accessioning, ordering histology blocks, printing labels or specimen tracking when a specimen is ordered not only cuts down significantly on manual entry errors, but also speeds the entire process through the lab and eases reporting as well as future retrieval and analysis, if necessary. Billing charges can be automatically associated with tests and special stains at the time the test order is placed.

Transcription also can be automated utilizing voice-activated applications to free the hands of your staff. The time spent going back and forth between slides, microscopes, images and a keyboard is costly and can create duplicated work and errors. Transcriptionists can simply dictate what they are seeing directly into the case record, which saves time and reduces error.

As well, digital cameras and high-resolution images are able to be -automatically stored directly with a patient's case and shared electronically with other facilities and between pathologists for review or referral between colleagues.

Sample Transporting

Two major methods of transporting patient specimens within the laboratory have evolved. The first is the manual transport of specimens, usually in racks of multiple specimens (batch transfer) to individual analyzers where the tubes are automatically sampled and processed by the analyzer. This is essentially an extension from the traditional method of transporting single samples to testing instruments to racks of multiple patient samples. The second method is the continuous feed of single specimens by conveyor to a variety of analyzers (continuous flow) in which sequential sampling and testing of patient specimens in different and separate analyzers occur.

Pre-Analytical:

Open LAS systems such as ILAS have the capacity and experience to extend automation to incorporate all these steps required in specimen reception. There are three major approaches to the pre-analytic preparation of specimen containers.

The first is the use of integrated instruments that have the capability to de-cap, centrifuge, sort and aliquot specimens. In continuous flow automation, the de-capping and centrifugation become the most important steps prior to placing the specimen on the automated track.

The second approach is the use of modular components including de-cappers, automated centrifugation units and free standing aliquot system modules as part of the continuous automation line. The latter usually is most efficiently performed in the post analytic phase.

The third approach is to perform some or all of theses processes manually. Manual de-capping may be difficult and may lead to carpal tunnel injury to personnel, it is not recommended. Automated centrifugation of specimens may be a rate-limiting step in preanalytical processing. Most automated centrifuges can process up to 400 specimens per hour and in laboratories with peak loads greater than this will require either multiple automated centrifuges or a manual system to supplement automated centrifugation during periods of peak volumes. However the combined analyzer through put is most often the rate limiting step in clinical laboratory automation, and all of these functions need to be in balance to plan a “lean” LAS system.

Post analytical:

Post analytical instrumentation incorporates a number of processes depending on the design and work flow of the laboratory. An exit robot is integral to all systems. Removing a sample to a holding area that allows retrieval of the specimen if additional testing is required is standard. Exit robots can sort specimens for distribution to specialty labs which may include an aliquot module and for long term storage. The latter invariably incorporates a memory system for locating patient specimens needed to be retrieved at a later date. Manual transfer of trays of specimen tubes into refrigerators or direct storage in refrigerated exit robot modules remain the

Types of Automation Systems

 - Open system

 - Closed System

Open systems are defined as automation lines that both the hardware and software can incorporate all types of analyzers, as well as a variety of pre-analytical and post analytical instruments. Essentially this allows the medical laboratory the freedom to decide which vendors’ instrumentation will be used in their laboratory. As a result it has focused on the integration and interfacing of a variety of analyzers and other complementary pre and post automation instrumentation to the LAS design.

Advantages of Open System -

1)     Flexibility in designing the physical track lay out,

2)     The modular design allows customizing the clinical laboratory’s workflow using the modules that work best for each operation.

3)     Incorporation of specimen processing modules including automated centrifugation

4)     Units provides the laboratory with a variety of options.

5)     “Open” systems have greater flexibility for adding modules or making other changes in the composition of the system both initially and with time as the needs of the lab change.

6)     With the “open” ILAS system analyzers and modules may be changed, added or removed at minimal cost and effort allowing maximum flexibility and efficiency for laboratory over time.

7)     Open total laboratory automation systems allow the clinical laboratory to pick and choose which instruments and analyzers incorporated into the workflow. In some instances this allows optimum competition in the bidding process for both analyzers and consumables.

8)     In addition, an open total laboratory automation system allows the laboratory to control the processes used to produce its results and of how the institution plans for the future.

Closed systems are generally defined as packages of pre-analytic, automation lines, analyzers, and post analytic instruments from a single vendor. Not only is the hardware specific to only the vendors products, but the software is designed specifically to interact with the vendor’s analyzers and instruments that makes adaption of another vendor’s instrument difficult at best. Closed total laboratory automation systems are more difficult and costly to modify after installation and do not offer the flexibility of an open system.

Summary

Clinical laboratories clearly profit from total laboratory automation with reduced handling of specimens, avoidance of mislabeling, and the ability to relieve medical technologist and medical laboratory technicians from repetitive activities such as transporting specimens and loading analyzers. The laboratory with smaller work loads is also a prime candidate for automation, especially when automated pre-analytical instrumentation is available to load patient specimens on the automation line. In summary, the size and volume of the clinical laboratory dictates the design of the automation process, but all medical laboratories of all sizes can improve efficiency with automation.

The design of the total laboratory automation line also needs to consider the physical layout of the laboratory. This will include site of specimen processing/reception the location of storage facilities. Other factors, such as walls, support pillars, fire lanes, etc., need a flexible design that turns corners and adjusts to the physical facility. The integration of specimen processing into the automated testing line is an often overlooked but important feature of total laboratory automation. In clinical laboratories that require extensive inputting of billing information, test ordering and other IT input, the connection of this function to the pre-analytical portion of the automated laboratory becomes an extremely important, but often overlooked, factor in efficient designs.

The key to successful clinical laboratory automation is to understand work flow and to design a system that provides optimum efficiencies. Each lab’s personnel must be involved in the process, regardless of the consultant’s experience. This involvement will result in a system the laboratory team understands and will allow for adaption of continuous improvement and “lean” processes. Lastly it is extremely important to visit other clinical laboratories that have been through the installation of total laboratory automation systems. One can learn from others experiences and sort out the sales “promises” from the deliverables.

The increase in clinical lab efficiency and flexibility dictate that medical laboratories will need to automate to achieve the cost savings, elimination of labeling errors and optimize use and safety of skilled medical technologists. Steps that are recommended for choosing an automation system include;

1)     A thorough evaluation of your laboratory work flow to understand each step of your current processes.

2)     Evaluate each vendors approach to provide the optimum most efficient solution to satisfy your laboratories needs.

3)     Determine whether an open or closed system provides the best solution for decreasing costs and improving efficiency including flexibility for future expansion or other changes.

4)     Evaluate the role of the technologist and their ability to manage the system so they can gain “ownership” and continue to contribute to process improvement.

5)     Visit vendor installations to determine the level of satisfaction of laboratories that are operating a vendors LAS. This differentiates sales enthusiasm from actual operator experience and is critical in making the best decision for your labs future.