Quality Audits

In the context of healthcare, quality audit can be defined as a systematic, critical analysis of the quality of patient care and resulting outcomes as well as planned, independent and documented assessment of a process, product, or quality management system to determine whether requirements are being met. Quality audits enable organizations to systematically review their activities, practices and results referenced against accepted standards of practice, government regulations, guidelines, quality management system requirements, or organizational policies and procedures. A disciplined approach to quality audits helps organizations improve systems and processes, promote a culture of continual quality improvement, enhance teamwork, and provide learning opportunities. As an integral component of the risk management program, quality audits are used to identify, analyze and minimize loss exposures, develop appropriate risk response strategies and reduce the effects of undesirable events. Depending on the area of interest and purpose of the audit, organizations tend to use different names for quality audits. For example, some of the commonly used terms include compliance audit, clinical audit, medical audit, HR audit, safety audit, product quality audit, process quality audit, quality system audit, management system audit, and blitz audit. In general, quality audits are classified based on the possible interrelationships among key audit participants that include the auditor, client and organization being audited.


Quality Audits


Healthcare providers will likely get involved only in internal audits as a part of their effort to increase effectiveness of work processes, enhance patient safety and provide added benefits to the patients, families and community. Internal audit teams should always maintain independence, objectivity, and ability to reach sound judgments based on objective evidence. Internal quality audits have to be carefully prioritized, planned and scheduled while taking into consideration the following decision factors:

  • Severity and likelihood of risks
  • Observed patient care outcomes
  • Criticality and complexity of processes
  • The number of people impacted by the processes
  • Frequency of tasks and related activities
  • Legal and regulatory framework
  • Availability of qualified human resources
  • Strategic goals and objectives
  • Incident reporting trends
  • Evidence-based practices
  • Patient satisfaction survey results
  • The nature and frequency of complaints
  • The degree of variation in performance

The number of audit team members should be determined based on the size and complexity of the area being audited and the scope of the planned internal audit. It is common to establish small audit teams with two to three members, but at least one team member should bring a “fresh pair of eyes” to the process. Well-prepared audit checklists are essential for carrying out successful quality audits because they provide structure, consistency and continuity to the audit. Checklists can help the audit team follow the defined scope of the audit and obtain necessary evidence. The audit checklists capture the essence of accepted standard of practice or requirements defined in the selected quality management system elements, government regulations, or organizational policies and procedures. To remain valid and appropriate, audit checklists need to be reviewed and updated as necessary for each quality audit. The audit team should be flexible and also look for other significant issues that may not be the part of the checklist. The primary sources of evidence in internal quality audits include examination of data, documents and records, observations of actual activities and conditions, and staff interviews. The process for data collection must be robust to ensure that the data are complete, representative, relevant, and valid. Data can be collected prospectively over a specified period of time, or retrospectively from existing information sources within the organization. There must be sufficient evidence to support and justify each improvement opportunity or finding. Upon completion of the audit, the audit team needs to achieve consensus with unit representatives, and document both improvement opportunities and strengths in a formal audit report. Improvement opportunities should be clearly defined, succinct and focused on systems and processes, not individuals. The unit leaders assume ownership for performing root cause analysis, leading practice change and implementing corrective and preventive actions. In order to be effective, the quality audit has to be repeated within specified timeframe to ensure that implemented changes have produced desired outcomes. Whenever possible, the same audit team should perform the follow-up audit and focus on seeking objective evidence that corrective and preventive actions are implemented and effective. If the corrective and preventive actions are not effective, the audit team will further clarify requirements and set up a new follow-up audit date.


Auditing Cycle