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As a regulatory compliance inspector, I have noticed through the years a recurring theme of errors and deficiencies when conducting audits on policies and procedures (P&Ps) in standard operations procedures (SOP) manuals. Deficiencies are defined as a departure or deviation from required quality assurance and control standards or regulations.
Additionally, deficiencies are classified as documents that are incomplete due to inadequate and insufficient content necessary for meeting compliance with accreditation, licensure or regulatory agencies.
Laboratory P&Ps should consistently meet the requirements of the Joint Commission on Accreditation of Healthcare Organizations, the Clinical Laboratory Improvement Amendments (CLIA), the Food and Drug Administration (FDA) and other regulatory authorities.
 Well-written P&Ps allow employees to understand their roles and responsibilities within predefined limits. Additionally, P&Ps should provide clarity to any the auditor reading them, and that accountability issues and activities critical to the laboratory department are addressed in accurate, safe and effective methods.
A few signs your P&Ps need to be reviewed and/or updated would include, but are not limited to, an increase in deficiency rates from inspectors and an increase in the number of accidents and costly overruns. Also, laboratory employees can provide important hints it is time to review P&Ps, like when their questions on "normal operations" increase or when they exhibit confused behavior regarding a laboratory process or display poor technique when operating a new piece of equipment.
Finally, increases in complaints from patients and other departments is another vital sign you need to revisit your documents.
There are basic four steps to developing P&Ps. They are planning, designing, implementation and evaluation. Problematic issues and deficiencies arising during these steps will be discussed in this article.
The following lists are some common recurring deficiencies with suggested corrective action steps. Ongoing scheduled internal reviews of the deficiencies outlined can be a beneficial tool for maintaining readiness for external inspections and audits.
Planning
The planning step consists of the activities for determining the department's goals, then identifying the best approach for achieving them. This step requires precise goal definitions at the start of your policy and procedures development project.
No. 1 Deficiency:
Writing unnecessary P&Ps.
Corrective Action:
Not all processes require P&Ps. Keep in mind, the more P&Ps you write, the more documents you will have to edit, implement, train on, audit and review. Only P&Ps required by standards, regulations or department functioning (i.e., new equipment added) must be developed. Scrutinize carefully when you get the urge to create P&Ps for each and every departmental activity.
No. 2 Deficiency:
Missing documents for key activities and/or requirements.
Corrective Action:
You need to review the various accreditation, licensure, regulatory and contracts to ensure you address all mandatory requirements. Core processes greatly impacting your day-to-day functions, involve safety or are risk-related activities are where you want to put your energies. Develop a checklist of these critical tasks to ensure none of these topics are overlooked during your development activities.
Designing
During the design step, I would recommend you make a short statement of intent. First, write in draft form the specifications or the requirements "needing" to be addressed. Then write the "means" (or the "how to") for solving these needs.
No.1 Deficiency:
Unclear differentiation between the P&Ps.
Corrective Action:
Rules, regulations and standards talk all the time about P&Ps. It is important at the onset of the design step to ensure you and your document writing team understand how a policy differs from a procedure. Often times, I see procedure statements which were meant to be policy statements and vice versa.
- A policy is a written guiding principle used to set direction in the laboratory department. It should read like a mini-mission statement.
- Procedure: The procedures are written steps explaining a particular way of accomplishing the tasks and end results stated in the policy statement.
No. 2 Deficiency: Lack of useful, meaningful information is a serious problem and perhaps it is one of the larger impediments to successful P&Ps.
Corrective Action: Incoherent and meaningless information leads to expensive waste and rework, as well as to unproductive scrambling. First, identify and collect all of the process information (i.e., supportive documents). Once the gathering is complete, use tools such as flow charts, process maps and outlines for your next step of clarification. Charts and maps "illuminate" and clearly highlight the various processes, steps and information flow for the narrative portion of the documents being created.
No. 3 Deficiency: Purchasing off-the-shelf (cookie-cutter) P&Ps and then not taking the time to redesign these documents to address the department's unique needs.
Corrective Action: I am not suggesting you reinvent the wheel. But keep in mind off-the-shelf P&Ps are templates for you to purchase and then further develop them by incorporating your department's specific needs and goals. The software developer does not know your exact layout, staffing pattern and equipment setup. So, if you are going to use "purchased" P&Ps, you should revise the templates accordingly to match your own individual department's setup and resources. (This suggestion also applies to times when you "rework" borrowed P&Ps from other companies and from the Internet.)
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