SISTEMA bio~SIGNA

Laboratory Precision

 - At one time or another, we hear or say, “with laboratory precision.” Depending on the image we see on hearing the phrase, we conjure up ideas on what a lab does, and does not do. Whoever reads this blog post would have had prior experience in a certain environment that required utmost diligence, accuracy and mental concentration. And let’s not forget the long white coats. At that point, we still have to describe the actual environment inside the lab: whether particle physics with an accelerator, or even a kitchen responsible for preparing specially packed savory meals to be “shipped” to the International Space Station.

 - Since we are dealing with a medical environment, we’ll devote the next words to the biochemistry lab, or a physiology lab. Of course, now with the ubiquity of computing resources, the lab has already adopted the laptop, desktop, and now, the mobile device. Amidst the seeming clutter of equipment and lab paraphernalia, we can notice that there is actually order in procedure and function. With order comes accuracy. Of course, to be able to perform an experiment in several iterations, one will exercise exceptional concentration and diligence. That’s not to say that the setting is cold and calculated. There is actually an aura of camaraderie (more or less) and mutual respect, and the occasional jest.

Procedure and Structure

 - Planning: Laboratory work encompasses a spectrum of activity and detail. To have things clearly in mind, the laboratory scientist must start off with the clear vision of the prime purpose of the job on hand, like any competent project manager will have. In the course of the experiment, several issues may come up, some expectedly, while others not. The worker must likewise be flexible enough to allow for dynamic alterations in the project course. But, at the same time he should not waver from the goal. There are interesting programs that involve brainstorming, or mind-mapping. The chief study scientist can make use of this software, of which there are paid versions, and free ones. The brainstorming can start off with the study head, then eventually include members of staff. This way, there is a sense of cooperation and one-mindedness

 - Safety: Safety is a top priority in chemical and biological laboratories. The lab can, and oftentimes will carry hazardous materials that can cause quite a problem if not properly handled. Thus, we need to comply with safety standards of the highest order. The OSHA (Occupational Safety and Health Administration) in the United States, and in European Countries (check out the European lasboratory safety standards documentation here)

is responsible for formulating and enforcing safety standards, so as to safeguard the worker and his workplace. Each lab has its pockets of danger and due precautions must be maintained rigorously. 

 - It is necessary to understand the requirements of the lab and the safety protocols. The standards of chemical laboratory protocol (of OSHA) require that a lab produce a Chemical Hygiene Plan (CHP) which addresses the specific hazards found in its environment, and its approach to them. Then they could work on the Chemical Hygiene Plan and stick to that plan, not just to satisfy the OSHA, but to make reasonably sure and feasible that the lab is a safe place to spend most of the working day in. In addition to safety standards, the lab also has to keep its books straight in terms of recording expenditures and inventory of each material used in the lab. This is business management, laboratory style. It has to be managed with care because the materials are not only expensive, but it is part of the stakeholders’ investment. Since haste makes waste, a modicum of entrepreneurial zeal and accounting savvy will set the lab in its precision in all areas of its activity. And necessarily so because the lab is the heart of research and development, that which makes the way for a cure, or even the Higg’s Boson.

 - Documentation and the Electronic Notebook: Habits don’t go away easily. There is a point where the pocket notebook has to give way to the ELN (Electronic Laboratory Notebook). While it may be pure habit of scribbling notes on a small lab pocket notebook, the lab scientist now deals with the computer technology that has fostered the new paradigm of recording on a virtual device, which is part of the new Laboratory Information System. We have to budge out of our comfort zones so as to grow along the lines of forward thinking. Does one port his or her own mental recording system to the ELN? There is a place for both ELN and paper notebook. The problem is that going back and forth consumes time which could be spent doing the experiment. But if the lab and its crew work on optimal procedures, they will be even more productive. It’s a matter of organizational management, whether human or material resources. Many scientists are reluctant to rely on commercial software be­cause it can require them to adapt their processes to conform to out-of-the-box functionality. For example, with an ELN, the reviewer simply opens the record for that solu­tion and reviews the usage log.  This then shows every instance where the specific solution was used, either as a reagent in an experiment or as a component in another solution. This would be impossible with a paper notebook system. Some will definitely calculate the cost of the e-notebook system and shy away from its true value. There are commercial electronic lab recording software packages with robust features that may outshine free open source software (FOSS). This “disadvantage” of free software may not hold for long because there are already software systems that can cater to the science group.

 - Workflow: A current study or experiment must adhere to a type of hierarchy of workflow.  One would do well to use a model or template for the record. There is a record for materials and one for lab process per se, and so on. Once we have formulated the workflow, one must record the names and numbers of the materials (like the chemical name and stock number). So, inventory must start in point zero, log the materials, proceed with care. Because bioanalytical labs operate in a collaborative fashion, the project or study chief will have had a lab organization, each devoted to specific work. It would be most practical to have a template of recording and sub-planning. A “dry run” is carried out to evaluate the efficiency of the template and the workflow embedded therein. Such a sample analysis, and the calculations that are vital, can be served up for all to give their feedback on. Computations done on a computer must be tested for accuracy, thereby reducing the cumulative errors in calculations. The scientist has the option to make a change, but if they proceed, the exception will be logged in the audit trail along with a mandatory annotation from the scientist.

 - Since documentation is vital to the quality of the study, teams of analysts and editors may devote their time on auditing the study’s records’ to spot any errors as they come. While redundancy of recording can provide a better degree of accuracy, one must make sure there is no haphazard and inadvertent duplication in different database records pointing to the same variable.  The Quality Assurance reviewers can scan lab notebooks, instrument log books and archived instrument data files. This adds a certain degree of confidence that, because there is cross-referencing in different record devices, one can double check all the data for errors to a certain degree of accuracy. If the data is not subjected to this scrutiny, errors will multiply and in the end, the work is found inaccurate and of little value.

 - Thus far, we have scanned the operations of a laboratory, regardless of type of science. There may be differences in scope of work but they entail the same working principle. As technology grows, the devices and techniques will change, and the laboratory has to match it. 

 - Begin with the end in mind; work with others in mind; Finish with everybody in mind.

 - 'Til another iteration...

 - Fernando Yaakov Lalana, M.D.