Worried That Your Laboratory Doesn't Measure Up?

Let's face it, many laboratorians are simply not comfortable using third-party job aids and applications such as Microsoft Excel for operational issues beyond budgeting and administrative reports. A common reaction to using spreadsheets in the laboratory may be something along the lines of “my staff already has too much to do … I can't think of adding another thing for them to learn … besides, they do not even like spreadsheets and can perform the calculations just fine by using a calculator….” The author of the report cited previously1 demonstrates quite effectively that the last point is not entirely correct. How many more laboratories would have failed to appropriately calculate RhIG doses if every staff member had been asked to perform the calculations?

Laboratory staff members are required to learn all manner of new techniques, technologies, and computer systems to keep up with changing processes and technologic advances. They can learn to use any tool, if properly trained. A mini-tutorial or job aid that gives a “walk-through” of the tool's application would be very helpful. Administration of RhIG is relatively safe, but not without side effects.15 Accounting for the number of vials of RhIG, the dollars saved per year, and the number of patients receiving correct dosages should be enough to convince your administrative office to purchase outside training software if none is available inside your institution. If not, the needs of a whole laboratory, seeking cost- or time-saving measures, can be used to justify your request.

Do not underestimate the power of the spreadsheet alone in making an impact on your laboratory's operations. After being exposed to the use of spreadsheets, the laboratory staff can use other published spreadsheet tools16 or create its own tools to perform additional tasks, such as standardizing repetitive calculations or scanning bar code blood unit numbers to prevent typographic errors. Spreadsheets also have more advanced features, which can be set up to flag suspect entries or abnormal results. The use of spreadsheets as part of general operations, and not just as a budgeting tool, has had a very positive impact in the authors' institution, eliminating variation in approaches to calculation, greatly reducing errors, speeding up the analysis of data, and enhancing the appearance and clarity of the resulting records. The investment in technology, training, and validation is easily justified.

A laboratory without a PC made readily accessible to the staff will find it difficult to implement software-based tools that are not already part of its hospital or laboratory information systems. Institutional policies may also make it difficult to get access to the appropriate software tools. While staff may not have access to PCs at their workstation, one PC could be placed in a readily accessible part of the laboratory. Such access is increasingly necessary to use corporate applications such as e-mail and electronic medical records. Hopefully, the lack of a computer is no longer an obstacle to using PC-based or Internet-based tools. In the authors' opinion, restricting frontline staff from accessing a PC because of perceived concerns about computer viruses, the viewing of unacceptable Web sites, or the potential for playing online games, undervalues laboratory professionals and will hinder efforts to retain Internet-savvy, younger staff members who have grown up learning about and working with computers.

You validated your new piece of automated testing equipment and your new refrigerator and temperature monitoring system, and you did so successfully. But a third-party software solution such as a spreadsheet? The validation process is straightforward. Validation is essentially a confidence-building exercise, but its formal definition can be found in a number of resources.17 Other resources discuss the validation processes in much greater detail.18,19 There can be a number of reasons for performing a validation, driven by regulatory, business, legal, or clinical requirements. Transfusion Services should be familiar with Clinical Laboratory Improvement Amendments, CAP, and US Food and Drug Administration expectations for validation, just to name a few. At the 50 000-foot level of commitment, a validation consists of the following:

• A description of the intended use of the item

• An inventory of requirements

• A list of tasks that will establish if the item performs as expected

• An analysis of things that might go wrong with the use of the item and how to mitigate or control these risks

As an example, consider the CAP's RhIG dose calculator. An individual should take no more than 2 to 4 hours to complete the validation, including finding cases to help validate the calculations. After applying some critical thinking to the problem, the authors of this editorial rapidly assembled a straightforward approach for validating this simple spreadsheet tool. The basic tasks needed to establish the validity of this tool can be broken down into 4 steps.

• Have someone familiar with Excel review the formulas in the spreadsheet against the calculations in the technical manual. A quick review will confirm that they match.

• Pick a few sets of data, real or artificial, and show that the application gives the same result as a correctly performed manual calculation.

• Verify that the spreadsheet is locked and protected (it is), such that formulas cannot be changed without unprotecting the spreadsheet. For greater protection, you might consider adding a password that would be required to unprotect the worksheet.

• To mitigate input error potential, consider establishing a standard procedure requiring personnel to print and verify their entries with each use.

Laboratory managers and supervisors commonly complain that they lack the additional resources to implement changes or new technologies, yet are increasingly required to justify dollars spent on health care.20 Publications, including the Institute of Medicine's To Err is Human,21 point out the preventable errors in the health care system that impact patient safety. To improve patient safety, some system-wide changes will be required to how health care is currently delivered. Not all fixes, however, will require such drastic changes.22 Third-party, PC-based software solutions provide simple, inexpensive tools that can improve accuracy, tracking/trending, and consistency while decreasing manual calculations, preventable errors, and procedural complexity when local information systems lack the necessary functionality. Tools such as the CAP's RhIG dose calculator would appear to offer a pragmatic solution, offering uniform interpretation, accurate calculation, and readily printable or electronic documentation of the input data and results.