Vol. 10 •Issue 10 • Page 22
Transfusion Service Automation
The implementation of automation encourages streamlined and standardized processes with resultant increase in speed, efficiency and lowered cost.
The 21st century may be described in history as the century of “artificial intelligence.” Nearly every industry has sought to capitalize on the efficiencies and cost savings of automation. Clinical laboratories have long been utilizing automation to produce well-controlled, high volumes of test results with fewer, sometimes less educated technical staff. Today, in part due to increased regulatory scrutiny, competition and a shortage of qualified blood bank personnel, transfusion services are similarly being forced to adapt to an increasingly demanding environment while simultaneously increasing productivity, reducing operating costs and remaining compliant with current good manufacturing practices (c GMPs). Automating routine processes will help many laboratories achieve these goals.
Rapidly changing medical technologies are revolutionizing the health care environment and increasing specialized treatment options for an aging patient population. The escalating treatment needs continuously challenge transfusion services to rapidly and accurately provide blood products, while adhering steadfastly to regulations. The demand to enhance the level of services offered yet continue to lower costs and “do more with less” necessitates that transfusion services seek alternatives.
Nationally, fewer technical personnel are available than ever before, probably due to a combination of the reduction in medical laboratory technician (MLT) and medical technologist (MT) programs as well as competition from other industries. According to the U.S. Bureau of Labor Statistics, 5,300 new MT and MLT positions will be created annually through 2008. However, the National Accrediting Agency for Clinical Laboratory Sciences reported that only 2,491 MTs and 2,381 MLTs graduated last year. Additionally, MT programs dropped by nearly two-thirds in the past 15 years.1
The recognized shortage of personnel often requires transfusion services to utilize personnel with minimal technical expertise. Some laboratories routinely rotate these personnel through other laboratory areas, eliminating the blood bank specialist whose expertise could be relied upon by other, less experienced staff. This uncomfortable reality has some managers looking to automation for answers.
Automation for transfusion services exists in all shapes and sizes. Many instrument configurations are available and can be adapted to all sizes of transfusion services. Some target a small, crosstrained lab environment with little in-house transfusion expertise; others are designed for large transfusion services that may also provide reference and donor unit testing.
Automation configurations include both semi-automated and fully automated walkaway systems. Systems marketed toward transfusion services are primarily manufactured and supported by Immucor, Norcross, GA, and Ortho-Clinical Diagnostics, Raritan, NJ.
The introduction of automation into the transfusion service will almost uniformly create an atmosphere of “horror” among those career blood bankers who had never imagined automation would encroach into their world. Managers can calm these staff members by assuring them that the automation will completely conform to, if not actually enhance, the objectives that are most important to transfusion services’ culture. Highlight objectives that illustrate this conformance by discussing the ability to streamline processes without sacrificing quality while increasing the testing throughput and efficiency.
The inclusion of an automated reader almost eliminates subjectivity when interpreting results, thereby reducing the usual time-intensive training period for test interpretation. This, combined with the assurance of positive sample identification (ID) throughout the testing process, will ensure the reporting of quality results on a consistent basis. Additionally, the implementation of a laboratory information system (LIS) interface reduces the opportunity for clerical error, further ensuring accurate results. Attaining these goals effectively reduces stress and potential burnout of new and existing staff members.
When evaluating and selecting a system that best suits a transfusion service’s needs, include an assessment of current and projected workload, different staffing configurations (include retention and recruiting history) and the anticipated test mix. Analyze the laboratory’s current workflow and consider functions that might be done by less technical staff. A MLT may be allowed to perform testing using the automated process, freeing the MT for the more complex, problem-solving tasks. Depending on licensure issues, this technologist may be asked to verify any work performed by the technician via the automated method. Much of the cost savings realized by the implementation of automation are associated with change in the technical mix as well as the number of personnel now required to complete the necessary tasks.
Consider the testing methodology already in place at the transfusion service environment. A transfusion service that tests with a test system similar to that used by the proposed automated methodology will have an easier time transitioning. However, it is more important to look at the big picture and choose the system that will best fit the laboratory’s needs. In time, the transfusion staff will adapt to the automation. Remind staff that there is no “one best test method” for immunohematology testing. Review the pros and cons of the new system, as well as the pros and cons of the system currently in use.
Once the automation system has been chosen, the real work begins. The excitement experienced during the arrival of the equipment is quickly muted by the realization that it can’t be used until a validation plan and all associated procedures are written. (The procedures will be validated during the performance of the validation plan.)
Additionally, a training plan must be written. Training should occur early in the implementation so that staff can help with the performance of the validation process. This involvement may increase staff buy-in of the new process and make them feel a part of the implementation process.
Take advantage of any customer referrals the vendor may offer. These customers may be willing to share their protocols and procedures.
Developing a Validation Plan
Success depends on the development and subsequent completion of a detailed validation plan. The purpose of the validation is to establish documented evidence that provides a high degree of assurance that a specific process consistently produces a product that meets its predetermined specifications and quality attributes. Additionally, a validation plan is best developed after obtaining a good understanding of the system.
In May 1987, the Food and Drug Administration (FDA) published the “Guideline on General Principles of Process Validation” to explain the basics of process validation as an elaboration of the GMP requirement. However, a description of how the FDA would like the process performed is not provided. The guideline refers to three key components of equipment validation qualification:
•operational qualification and
An example of a validation plan can include the following key components:
•Purpose: Describes the reason for writing the plan as well as the components of the automated system that the plan pertains to.
•Background: Details the dates of installation as well as the details surrounding the setup of the system. Each of the system components should be described.
•Responsibilities: Identifies whose responsibility it is to create and approve the initial and completed validation protocols. For example, this section will describe who will write the protocol, who will approve the protocol, who will perform the validation as written in the protocol and who will approve the completed protocol.
•Installation Qualification: Details all aspects of the installation process, including the identification and installation information pertaining to each component of the system. Include documentation regarding the identification of the equipment vendor and technical support contact information–this information is helpful when troubleshooting during the validation process. Record references to the appropriate equipment procedures and maintenance sheets.
•Operational Qualification: Documents that the equipment operates as intended within the established limits and tolerances. This section should detail the expectations of the equipment function and include guidance for the operator to be able to qualify whether the equipment functioned as intended.
•Product Qualification: Verifies that the equipment consistently and accurately performs each task required of it during consecutive cycles and that for each test system implemented, the sensitivity and specificity as compared to the current systems is acceptable. Evaluate discrepancies for potential method or automation failure. Record investigation results for inclusion in the final validation summary report.
•Process Description: Provides the documentation and references for the completed operating instructions, including instructions for handling downtime situations. This is a great place to document the completion of the preventive maintenance instructions as well as the acquisition of MSDS sheets.
•Revalidation: Lists for future reference of the conditions that will require revalidation of affected system components, which may include the replacement of existing equipment, changes resulting from regulatory changes, process and/or procedure changes, software updates or relocation of the equipment system.
•References: Refers to any references that may have been used during the development of the validation plan and may include training manuals, product inserts or other miscellaneous instruction manuals.
The procedures associated with the equipment operations and test systems must be written concurrently with those sections of the validation protocol. Once this is accomplished, a key user performs the validation as written, subsequently validating the procedures as well. While the validation protocol performance is being completed, development of the associated training protocols may begin, followed by the training of the remaining staff.
Developing a Training Program
The automation training program fits within an already established training program. The key difference is the lack of automation experience that is inherent in any transfusion service.
Typically, transfusion personnel have had limited automation experience. Employees are often drawn to immunohematology because of its lack of automation. Ironically, the utilization of crosstrained personnel or those without strong blood bank backgrounds may actually provide the laboratory with exactly the sort of staff member who will almost certainly approve of the changes implemented with the adoption of automation. This staff member will be particularly adept at performing the validation protocol and troubleshooting any subsequent equipment failure. Ideally, there will be a more experienced (traditional) blood bank staff member who supports the change and can mentor others on the nuances of any new test methodology associated with the automated process.
Establish specific training objectives during this process such as:
•Evaluate the trainee’s prior experience to establish the appropriate level required. For example, a trainee may be very comfortable with the use of automation, but not as comfortable working with the methodology related to the testing. Or, the trainee may be an expert using the methodology, but very intimidated by the concept of automation. Trainees may need more training in one area than another.
•Review all applicable procedures with the trainee, tailoring the review to the previously established level of knowledge. Include a comprehensive review (or training) of the specific procedural steps required to perform testing appropriately.
•Review all test methods employed by the automation. Accomplish this review by asking questions requiring detailed answers pertaining to the methodology involved.
•Observe the trainee’s performance once their level of understanding meets the established objectives.
•Develop a detailed observation checklist for each stated objective.
•Highlight critical control points in each process to ensure the trainee’s level of awareness and understanding. (This checklist serves to remind the trainer of the critical steps as well, ensuring that complete training is accomplished each time it is performed.) The observation should only be performed when the trainee feels confident enough to perform the task without guidance.
After completing all observations, the employee must demonstrate a synthesis of all completed training by passing a comprehensive, open book, training assessment quiz. Develop questions requiring the formulation of an answer and a clear demonstration of subject knowledge. If the trainee fails the quiz, retrain and administer a retest, focusing on the weak performance areas of the original quiz.
Upon completion of the training, the trainer should include a declaration of competence for the trainee and sign the attestation for the department’s training records.
Other issues associated with the promotion of automation in a transfusion service include:
•Computer (LIS) considerations:
The LIS interface is now a common expectation for transfusion services. Several LIS vendors have already met this demand; however, if an interface for the instrument has not been written, the LIS vendor and the transfusion service’s Information Systems department will have to work closely together while scripting, installing and implementing the interface. Accomplishing the interface completes the loop in the positive patient ID process, ensuring the accurate entry of results for the associated patient sample. Depending on the facility, the LIS may also eliminate redundancies built into testing/result entry processes designed to ensure accuracy of result reporting when using manual processes.
Duplicate computer test profiles may need to be built if a facility wishes to perform both manual and automated testing. Differences in methodology result entry or even collection of statistics may drive the need for dissimilar test codes.
Sample requirements may change with the automation. The collection staff, including phlebotomy and other hospital collection personnel, may need training as to the appropriate collection tube. Ample notice must be given to the hospital supply department so that patient care units are stocked with the required sample tubes. Facilitate acceptance when requesting the changes by explaining that the alternate sample tubes will allow for the use of automation, subsequently providing faster turnaround times, improved patient care and hospital cost reduction.
•Transfusion service mindset changes:
Staff will be accustomed to responding to all samples as if they were stat. Evaluate workflow and create algorithms for performing tests in batches at specified time intervals. Continuously emphasize to the staff that it is acceptable to leave a sample in the automation rack until the next run time. Educate the medical staff that because most work will be performed in these batches, the processes will become more efficient, thereby decreasing the turnaround time in most cases.
Increased workload and the decreasing number of technical staff have forced the need for automation in many workplaces. The implementation of automation encourages streamlined and standardized processes with resulting increase in speed and efficiency and lowered cost. The implementation of automated processes, including computer interfaces, drastically reduces the opportunity for clerical or other testing error. Implementing automation in the transfusion service provides a less stressful environment for staff, management and transfusion service customers.
Dina M. Hannah is assistant director of Quality and Compliance, ARUP Laboratories, Salt Lake City.
Foubister V. Bench press: The technologist/technician shortfall is putting the squeeze on laboratories nationwide. CAP Today September 2000.