An analysis of how well-informed laboratorians can make intelligent compliance decisions based upon their understanding of procedural practices
Being knowledgeable can help us make informed decisions. Work-related knowledge is collected from regulatory books, inspection experiences and sometimes from just watching other healthcare providers undergo audit activities. British philosopher Francis Bacon once stated, “The more one knows; the more one will be able to control events.” In other words, as the French say, savoir faire (know-how) is power, because knowledge truly empowers us.
There is not a grain of doubt that knowledge of compliance expectations is powerful. Fear and powerlessness exists when there is lack of knowledge. However, well-informed laboratorians can make intelligent decisions based upon their understanding of procedural practices. The byproduct of information is the courage to overcome difficult tasks.
P&Ps versus SOPs
Labs set rules on how the work gets done. Lab workers will use standard operating procedures (SOPs) as well as a set of policies and procedures (P&Ps) to accomplish work predictably and efficiently. However, I have found from time to time there is confusion about the difference between P&Ps versus SOPs. There are significant differences between the two. P&Ps give an overview of a company’s activities. SOPs are documents that are written with the intent to perform strictly by the book.
Policies and Procedures: Defining the term “policy” is very simple. A policy is a written/non-written piece of information that shows the intention to do something. For example, a quality control policy with procedures shows the intent and directions of the lab with respect to quality.
Standard Operations Procedures: Standard Operating Procedures are written documents or instructions detailing all steps and activities of a specific operation, process or part of a system. It is customary to have these documents for clearly illustrating how to operate a machine; clean and sanitize work areas; and for the testing specimens and releasing the results.
Compare and Contrast
To further illustrate the differences between P&Ps and SOPs, it is necessary to conduct a brief compare and contrast exercise. For example, P&Ps describe the generalized view of a job without getting into the major specifics and often remain the same within a lab. SOPs often govern “who” does “what” and “how” (the specific steps) on the job.
Other examples include:
- SOPs get down to specifics of how a task is to be accomplished. SOPs work to fulfill policy and procedures.
- SOPs look more toward identical methods to get work done, while P&Ps allow more room for a worker to improvise.
- SOPs take a process and break it down step by step. This may include anything from how to thoroughly clean a bench station to the sequence of assembling specimens.
- Finally, the SOP manual(s) is generally larger than the P&Ps manual. In other words, since SOPs contains many what, who and how steps, SOPs may consist of many manuals and will most likely take up more shelf space than the P&P manual.
There are several benefits to standardizing on paper all its processes and procedures. These documents will pave a way to ensure uniformity for all lab tasks, which will be beneficial to all concerned. Benefits of uniformity, reduction in errors and, finally, safety controls are just a few of the benefits derived from accurate and complete SOPs.
Work Task Consistency
For example, one benefit is that, when a laboratory documents all its operating procedures, it is able to enforce consistency for all tasks. In addition, it will ensure consistency. In other words, whenever a key employee leaves the organization the work does not get halted. The productivity levels remain standard and constant because of the availability of SOPS.
Reduction in Error Rates
Every lab’s quest is to reduce error rates. So another benefit of SOPS is that errors have been shown via research to be minimized due to clear and specific steps in work processes. Whenever in doubt, the laboratorians can refer to the SOPs for clarifications.
Finally, as we all know, lab safety is an ongoing concern for both management and line staff. SOPs are very essential in maintaining safe and habitable working conditions for all the employees. The SOPs should list out all the safety precautions that the worker must take to perform his job without injuring himself. The SOPs should also list out all the measures that the institution must take to protect its employees. The lab may need to buy specialized protective gear and masks for lab workers involved in unique processes.
In addition to the above mentioned benefits as valid reasons to design SOPs, several governmental agencies, including accreditation, certification and regulatory agencies, require SOPs to be in place. In addition to the procedures, forms to accompany the steps should be included. Full compliance with FDA and CLIA regulations, CAPS requirements, and the latest Joint Commission Laboratory standards will ensure effective functioning specific to your lab setting.
SOPs cover a wide variety of topics, including but not limited to: documents control (i.e. preparation of SOPS), quality control (i.e. reagent and test kits, retention samples), equipment and chemicals use (i.e. QC & maintenance, equipment use), documentation (i.e. reporting procedures, control and use of lab notebooks, lot release), safety (i.e. lab safety, biohazard materials), specimen collection (i.e. ordering, labeling) and operation of gas chromatography.
How to Write an SOP
Again, SOPS give instructions on how to complete a task. There are several simple steps to designing an SOP that is unique to your lab. The following some writing tips:
- First, you might do this by consulting regulatory guidelines and interviewing the lab staff members who actually do the job, reading their job descriptions and talking with end users. If it’s possible, perform the task yourself to see what it is really like.
- Next, in draft format, write down each step clearly and concisely. Be sure to keep the process divided into individual steps to make them easily understood.
- After the draft of steps has been steps have been documented, have someone go through the procedure, following the steps as written. This will allow for corrections and additions.
- Next, complete a final document with revisions. Be sure there are no gaps or overlap.
- Finally, obtain support from stakeholders by conducting training and periodic reviews during staff meetings on the SOP.
But of utmost importance, it is critical before putting pen to paper that there is a thorough understanding each specific lab job task at hand.
Generally, approved SOPs are good for a number of years. However, the lab should make modifications to these procedures when needed. Believe it or not, out-of-date SOPs are the number one deficiency that leads to many citations on inspections reports.
- Najera, Rene F. “Standard Operating Procedures for a Medical Microbiology Lab”, www.ehow.com/way_5965774_standard-procedures-medical microbiology lab/. Accessed October 15, 2014.