What is so important about assessment audits?

Assessment, a principal element of the 12 quality system essentials, is the means for determining the effectiveness of a quality management system through internal and external audits; it also provides evaluation of performance in an external quality assessment program. Why, though, are assessments so crucial?

The basics of assessment audits

An assessment is the systematic examination of some or all parts of the quality management system to demonstrate that the facility meets regulatory, accreditation and physician and patient expectation requirements.

The International Organization for Standardization (ISO) standards define assessment, or audit, as an “independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which required criteria are fulfilled.”

When conducting an assessment, you ask the following questions:

• What procedures and processes are being followed, and what exactly is being done?
• Are there written policies and procedures for all the processes being performed, and do the current processes comply with those written policies and procedures?
• Do the written policies and procedures comply with standards, regulations and requirements?

An assessment allows your facility to understand how well it performs when compared to a standard or benchmark. Any gaps or non-conformances noted on an assessment can show you where you need revisions to procedures or processes or if you should reemphasize staff education.

You’ll use assessment information about performance for:

• Planning and implementing a quality system
• Monitoring effectiveness of the quality system
• Correcting any deficiencies that are identified
• Working toward continuous improvement

The value of a well-designed audit is to reveal weaknesses in the pre-analytic, analytic and post-analytic phases of testing. During an audit, you gather and evaluate information regarding:

• Processes and standard operating procedures
• Staff competencies and training
• Equipment
• Environment
• Handling of samples
• Quality control and verification of results
• Recording and reporting practices

Once you have the information, compare the findings of the audit to written policies and standards or benchmarks to identify any breakdown in the system or departure from procedures.

Internal and external assessment options

You might conduct your assessments as internal audits, where staff from one department or area assesses another department or area of the same facility for compliance with policy requirements. Or you might make use of external audits, where groups or agencies from outside assess for accreditation, certification or licensure.

Regardless of which type you use, all audits should include the evaluation of steps in the whole path of workflow to detect problems throughout the entire process.

Why would my facility take part in external audits?

You may perform external audits to ensure compliance with licensing requirements and national regulations, to obtain or retain accreditation or certification, to evaluate compliance with standards or to demonstrate that quality standards are being met and that quality practices are in place for funding agencies.

In conducting external audits, assessors verify that policies, processes and procedures are documented and comply with designated standards, which may range from international standards to locally developed checklists.

If you are management, it is your responsibility to demonstrate to the assessment team that all requirements for the standard being utilized are being followed.

After an audit, the findings and recommendations of the assessors are presented in a verbal summary and followed up with a thorough written report. You as management should use these findings to investigate where benchmarks and standards were not fully met, plan to correct all non-conformities and record all results and actions taken to preserve information.

What are the benefits of internal audits?

Internal audits will be helpful for your facility for a number of reasons. Not only do they allow you to look at your own processes, but they can be conducted as frequently as needed and performed at little to no cost. Internal audits should be part of every quality system to:

• Prepare for external audits
• Increase staff awareness of quality system requirements
• Identify gaps or non-conformities (opportunities for improvement)
• Understand where preventive or corrective action is needed
• Identify areas where education and training need to occur
• Determine if the facility meets self-identified quality standards

Your quality manager is responsible for organizing and managing the internal audit program, including setting a timeframe, choosing and training auditors, coordinating the auditing process, managing all corrective action efforts and informing management and staff about all outcomes of the audits.

The quality manager should organize the process by:

• Developing a formal plan
• Preparing a checklist based on guidelines or standards
• Meeting with staff and explain the audit process
• Selecting staff to serve as auditors
• Collecting and analyze information
• Sharing results with staff
• Preparing a report
• Presenting that report to management
• Retaining the report as permanent record

In partnership, your director is responsible for setting overall policies for the internal audit program and supporting any corrective action measures. The commitment of management and the quality manager will be key to successfully establishing a process for internal audits.

“The main elements of the quality management system should normally be subject to internal audit once every twelve months,” according to ISO regulations. This requirement does not mean that a complete audit needs to be done annually. Rather, over a period of a year, every part of your facility should have at least one inspection. Doing a few small, bench-specific or section-specific audits is much easier than trying to do them all at the same time.

When developing checklists for internal audits, keep several elements in mind. You want to reflect established national policies and standards, ensure checklists are easy to use and include areas for recording information, and focus on specific tests or processes addressing all areas of the quality system.

In choosing your auditor, know that any knowledgeable person in the facility can perform internal audits, not just the manager or supervisor. A good auditor will pay attention to details and be able to communicate effectively and diplomatically. Diplomacy is an important skill since it is easy to imply criticism during an audit process.

The auditors chosen must also have the technical skills needed to evaluate the area being audited and have a good understanding of the quality management system.

Next steps once the audit is complete

Audits should lead to actions to further the process of continual improvement. Make both preventive and corrective actions to improve a process or to correct a problem. Sometimes the cause of a problem is not obvious or easily found; in such cases, form a problem-solving team to:

• Look for root causes
• Recommend appropriate corrective action
• Implement actions decided upon
• Check to see if corrective actions are effective
• Monitor the procedures over time.

So, what is so important about assessment audits?

Assessment is important in monitoring the effectiveness of your quality management system. If you don’t continually check that your facility is in line with policies and procedures, you might miss when those practices fall by the wayside.

Audits identify problems you might otherwise never know about and to improve your facility’s processes and procedures. An outcome of assessment is finding root causes of problems and taking corrective actions, part of the process of continual improvement that results in better patient care.