Corrective and Preventive Actions

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Implementing a Corrective and Preventive Action (CAPA) system can help overcome operational risks by realigning data and obviating errors but it will go only to the extent to which it has been integrated with the rest of the support systems and policies of the hospital. If integrated diligently, CAPA goes beyond regulatory compliance and quality benchmarks to give an organization the ability to deliver the best and stay ahead in the competition.

This white paper gives a clear understanding of the challenges being faced by the healthcare providers today, how CAPA processes and systems can provide a solution and the features that a best-in-class CAPA solution must provide

According to the FDA, disoriented CAPA systems lead to over 50% FDA citations6.

Challenges Faced by Hospitals
The health care industry is under severe pressure as it struggles to keep its operating process in sync with rising demand and increasing costs, maintain quality benchmarks and customer expectations, comply with many regulations and standards. All of these translate into complex challenges especially affecting financial sustenance and reputation management. A best in class CAPA solution can form the core of an organization by providing a systematized approach to managing challenges and effecting improvements.

Healthcare services work in a 24x7 environment where data flows from all directions and needs to be assimilated and evaluated in real time. Also, with emergencies occurring more frequently in the hospitals’ operations than in any other industry, healthcare sector demands an incessant watch on its workflow and poses various challenges in the process – operational and legal among others.

• Operational Challenges: The hospitals face constraints initiated and heightened by data overload and critical emergencies. They can be described as:
• Excessive Data: One of the most overwhelming challenges facing this industry today is the sheer volume of data confronting it on a daily basis. It gets difficult to cleanse, evaluate and synchronize data in real time, leading to erroneous decisions.
• Poor data quality costs 1 percent to 4 percent of the average hospital’s expense stream
• Increased Maintenance Cost: From using more sophisticated, costly technologies and expensive drugs to dealing with rampant errors and overheads, maintenance costs in healthcare industry are continuously following an upward trend, further adding to the worries of the hospital administration.
• Legal Challenges: Given the high risk and unpredictable environment of healthcare industry, legal issues arising out of non-conformance with regulations, audits, etc. are frequent. They can be described as:
• Non-conformance with Regulations: Healthcare administrators find themselves in a catch 22 situation attempting to ensure a tightly managed and conforming process and dealing with high costs.
• Audits: Increasing business complexity, rising number of audits and stringent audit regulations are forcing healthcare auditors to look at their processes more deeply.
• Customer Litigation: Medical errors are one of the nation’s primary causes of death and injury leading to as many litigations and complaint redressals.
• As many as 98,000 people die in U.S. hospitals each year as the result of medical errors2.
• Other Challenges: Healthcare industry faces high operational costs due to demand supply gap and insufficient manpower.
• Growing Customer Expectations: The expectations of the customers have grown in proportion to the improving technology. Also, with rising costs of healthcare facilities customers demand value for every dollar spent. Any dissatisfaction on customers’ end can lead to complex legal issues.
• U.S. spends about a third of its health care dollar on hospital care3.
• Inadequate Manpower: Apart from expertise in vigilance and ability to work under high pressures, a hospital administrator’s profile demands special skill sets which are not suitable to many candidates. As a result, manpower shortage coexists with excessive workload.
• Demand Supply Gap: High probability of emergencies, heavy inflow of data and ensuring all inputs conform to quality standards together cause a severe gap between demand of a product and its supply, leading to quiet a few undesirable situations and/or high costs.
• Once confronted with such critical and escalating challenges, a healthcare provider needs to address them in totality and without delay.

• Identification of deviation/nonconformity/problem
• Implementation of corrective action
• Evaluation/Analysis of the impact
• Implementation of precautionary/preventive measure

An enterprise-wide, well integrated CAPA system can help find a solution to these challenges.

• Managing data: CAPA helps assimilate, evaluate and synchronize data coming from all sources in real time and provides automatic updates and reports to be sent to required personnel thereby enabling proactive management in a timely manner.
• Optimizing costs: CAPA enables rapid entry of new complaints and corrective/preventive actions for the same thus greatly reducing the probability of critical errors and preventing unnecessary losses borne at time of recovery.
• Health care spending per privately insured person increased 7.4 percent in 20055.
• Conformance with Regulations: Evaluating the implementation and effectiveness of the CAPA system has become one of the primary measurements of regulatory compliance. Regulators have recognized that how a quality system is maintained and monitored is critical to its effectiveness. With the introduction of the accreditation process the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) is establishing a similar approach for evaluating continuing certification of health care organizations.
• Audits: Exact records with proper tracking of all the events updated in real time help make the task of audit fairly simple and organized.
• Customer Complaints: CAPA greatly reduces the probability of errors by evaluating the root cause and then implementing appropriate action, thereby reducing chances of error, helping give better services to the patients/customers.
• Automation of Work: CAPA system provides automated data update in real time which manages itself and connects with relevant systems and personnel, designing actions that can be assigned to appropriate staff thereby reducing the dependence on human checks and leveraging the existing manpower more efficiently.

Corrective and Preventive Action helps hospitals overcome risks, conform to regulations and optimize costs. If used properly it can serve as a catalyst in providing steady growth to a hospital.

CAPA, An Imperative for Healthcare Providers
Healthcare industry requires ever more sophisticated technology and tools to support its mounting operations, share data across the organization and successfully steer through the stringent regulatory compliance. A CAPA enabled system helps achieve all this and more. The primary benefits include:

• Prioritization of resources
• Identification and rectification of errors before they become critical
• Prevent and Reduce accidents
• Reduction in workload of already overburdened manpower
• Equivocation of rampant and repetitive wastage
• Standardization of quality of inputs, critical in case of hospitals
• Making available data across departments for smoother operations.

• In-built reporting system: The system should be able to assimilate and analyze and report data as soon as an update occurs. For instance, in a hospital the supply of a critical drug is less than the demand. The CAPA system should immediately detect this ‘deviation’, evaluate how its going to effect the workflow and send a report to the personnel in-charge of stocking so that adequate arrangements can be made in.
• Browser Based: The System should be browser based enabling personnel to view dashboards of information as per their requirement from anywhere in the hospital.
• Automated Data Evaluation: Automatic data evaluation should be available to make necessary updates in the given records. In the example given in first point, a deviation report is sent to the manager, giving detail of the deviation, its impact on the business and a comparison chart of drug suppliers. Such a report will reduce the work of the manager by 50%.
• Audit Trail: The system should have a secure, accountable, dated audit trail of all changes made to the data and should be easily accessible to the appropriate users and departments.
• Automatic Alerts: Automatic real-time alerts should be generated and sent to the required personnel. This obviates the need for human interference and brings efficiency.
• Security: The System although available for use and data interpretation by everybody in the organization should ensure fortification of data from unauthorized access. Automatic time-out options, appropriate password settings, intruder login detections etc should be an inherent part of the security system.
• Communication Across Channels: In order to deliver best results, the CAPA system should allow data sharing both vertically and horizontally across the organization while also integrating with other support systems and departments of the organization.
• Flexible and Scalable: The System should be flexible to allow manual use together with automated assimilation of data and should easily grow with the needs of the organization in a cost effective manner.

It is critical that the CAPA system be connected with company’s policies and support systems and features detailed above are key to this integration;

Conclusion
Extensive regulations, escalating costs and stringent quality controls are few conspicuous features of the prevalent healthcare scenario. Most of these challenges can be addressed through enhanced use of resources—specifically, data information resources. Substantial progress can be made in delivery of services and overall management of a hospital by implementing a CAPA system. A well integrated CAPA system can go beyond providing corrective and preventive action to give a holistic approach to quality by streamlining operations, reducing costs and asserting more accountability to employees.

MetricStream Offering
MetricStream offers an integrated regulatory compliance solution for the healthcare industry for successfully meeting these requirements while lowering the associated costs that can otherwise be substantial. MetricStream Compliance Platform, a proven infrastructure for building compliance application, provides core modules and services to automate and streamline compliance processes.

By improving operational efficiencies in quality systems, MetricStream lowers the cost of regulatory compliance and creates a transparent environment for proactively identifying, tracking and resolving quality issues.

By leveraging MetricStream’s flexible control-hierarchy, organizations can define and maintain a centralized compliance structure with processes, risks, and controls documented for SOx compliance, IT governance, and other risk management frameworks. Assessments can be scheduled and assigned to test and document the effectiveness of controls.

Role-based dashboards, control diagrams, and scorecards provide visibility into the ongoing compliance efforts and bring high-risk areas into focus. The solution has the ability to track process ownership, assessment plans, remediation status, etc., on graphical charts with real-time information that can be accessed globally.

References:

• A study conducted by data management company, Perigon LLC
• A report by the Institute of Medicine
• Centers for Medicare and Medicaid
• Gene Bellinger, Systems-Thinking.org
• Health Affairs 2006
• FDA-QSIT Workshop