Corrective / Preventive Actions in a Health Care System

The anacroym CAPA is a familiar one for those responsible for quality assurance in manufacturing facilities and particularly in the medical device and pharmaceutical industries. CAPA signifies Corrective/Preventive Action and is the formal process of resolving existing problems and preventing potential problems. Establishing an effective CAPA system is aproven management tool that can help assure continuous quality improvement and customer satisfaction.

In the world of regulatory affairs CAPA is essential. Both the FDA and ISO requirements demand the implementation of a well documented, risk-based CAPA system. In fact, the CAPA subsystem of an organization’s quality system is nearly always examined during FDA and ISO regulatory compliance audits. Evaluating the implementation and effectiveness of the CAPA system has become one of the primary measurements of regulatory compliance. They have recognized that how a quality system is maintained and monitored is critical to its effectiveness. With the introduction of a new accreditation process the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is establishing a similar approach for evaluating continuing certification of health care organizations. R. M. Baldwin, Inc. already serves the needs of the medical device community by offering the CAPA Facilitator™ program to help manage corrective and preventive actions. The company is now working with several large health care organizations to extend the capabilities of that software to help such institutions comply with the new JCAHO requirements.*

In January 2004 JCAHO initiated a new accreditation process called Shared Visions – New Pathways. The current accreditation process to this point has allowed organizations to focus on survey preparation and organization-specific accreditation scores. Under the Shared Visions – New Pathways accreditation process, there will be more emphasis on continuous standards compliance and less emphasis placed on specific preparation for a survey. The approach will be to have Joint Commission staff work with health care organizations to continually improve their systems and operations. Corrective and preventive actions are an important part of this approach.

Our approach to CAPA is a seven step process which includes:

1. Identification of the problem or potential problem.
2. Evaluation of the seriousness and risk associated with the problem.
3. Investigation into the events and root cause of the problem
4. Analysis of the data and results of the investigation.
5. Action Plan for correcting the problem and preventing a recurrence.
6. Implementation of the action plan
7. Follow Up to determine the success and effectiveness of the action.

The Shared Visions—New Pathways initiative incorporates many of these same components as part of their guidelines for continuous compliance and standards. A few quotes from the JCAHO guidelines for accreditation illustrate this: The guidelines require that health care organizations establish “clear systems for internal and external reporting of information about system or process failures.” They must, “proactively identify potential risks to safety, find the underlying cause, and make the necessary improvements to reduce these risks.” In addition, “the hospital uses the information from data analysis to identify changes that will improve patient safety,” and “changes made to improve processes or outcomes are evaluated to ensure that they achieve the expected results.”

There are other specific references to corrective/preventive activities including Periodic Performance Reviews and specific adverse events referred to as Sentinel Events. Periodic Performance Reviews promote continuous standards compliance through ongoing, internal monitoring. Any problems discovered during these internal reviews require a corrective action plan be submitted to JCAHO. For Sentinel events the policy requires organizations to investigate the root causes of adverse events, implement appropriate strategies to prevent the reoccurrence of such events in the future, and monitor the effectiveness of these strategies. Health care organizations must report their root cause analyses and corrective action plan to JCAHO.

Shared Visions- New Pathways shifts the focus of the accreditation process from survey preparation to continuous improvement of the operations and internal systems that directly impact the quality and safety of care. The corrective/preventive action process will play an important role in realizing these goals. Based on the CAPA Facilitator™ program, which offers a comprehensive CAPA system for industry, the new software package will serve as an internal tool for describing, tracking, and documenting incidents and situations that occur within a health care system. This program will help health care organizations reach the goal of continuous system improvements and ultimately improved patient care.

* JCAHO - 2004 CAHM (Comprehensive Accreditation Manual for Hospitals)