Clinical labs face enormous challenges, many deriving from the need to improve healthcare quality, while lowering overall cost. This means lab professionals need to develop and maintain quality standards to become and remain compliant with the multiple accrediting agencies requirements.

All clinical laboratories in the United States must be CLIA- accredited. To achieve this goal, laboratories "must establish and follow written policies and procedures for a comprehensive quality assurance program that is designed to monitor and evaluate the ongoing and overall quality of the total testing process"(American Academy of Family Physicians. CLIA and quality assurance. Available at: www.aafp.org/online/en/home/practicemgt/pt/poltopics/quality.printerview.html. Last accessed Oct. 21, 2009).

The Price of Failure

A key step in preparing for inspections and achieving accreditation is to adopt a quality system standard. If the staff members have not embraced a quality standard for their laboratory processes, preparing for laboratory inspections can be complex, time consuming and expensive. "When quality is a standard operating procedure, laboratory inspections are not an 'event,'" said Ellen Storms, product marketing manager, Beckman Coulter.

"New technologies, from lab automation to accreditation software, can help define, standardize and measure nearly every lab process and minimize the work necessary to achieve accreditation."

Laboratory administrators have already responded to today's challenges by automating instruments. What they now realize is automating information also offers undeniable benefits. Lab professionals have always had a need to establish effective policies and procedures. Now, they can rely on comprehensive software to standardize the most complex aspects of record keeping (i.e., automating information). For example, lab accreditation software can create and maintain training guidelines, select training skills, track achievement dates and manage competency assessments for all employees, based on differing and sometimes competing accreditation requirements.

It can take a laboratory staff several weeks to prepare for an inspection-collecting and validating reports, validating processes, cleaning, organizing and more; all while continuing to manage the daily

workload. Failure to achieve accreditation can be enormously expensive from the standpoints of jeopardizing reimbursement from payers and corrective action necessary to bring the laboratory up to standard. Additionally, red flags would be raised on the quality of the laboratory services, discrediting the hardworking technologists and placing the reputation of the hospital at risk.

Improving Service

CLSI Consensus Guidelines recommend laboratory staffs apply quality systems essentials (QSEs) to all operations in the workflow path, to help ensure they achieve and maintain accreditation. QSEs address each step in the workflow path: pre-analytical, analytical, post-analytical and information management.

"The number of agencies and accrediting organizations that impact laboratory operations can be overwhelming. But with the correct software solution, documentation can be leveraged to ease meeting the requirements of multiple accreditation organizations," Storms noted.

Using lab accreditation software to standardize laboratory operations:

• minimizes the preparation time for each inspection;

• allows the laboratory staff to identify non-compliant elements during self-inspections, so they can be corrected before an inspection takes place; and

• ensures the laboratory is consistently compliant with all required standards.

Ultimately, by meeting the requirements for accreditation, the overall productivity and efficiency of laboratory operations is increased, therefore improving the quality of services and lowering costs.

Compliance Tools

Comprehensive laboratory accreditation software allows labs to standardize and automate procedures, testing and performance criteria needed to meet legal and regulatory requirements. Because not all lab techs are computer whizzes, having easy-to-use software makes all the difference. Lab accreditation software should be based on a familiar format, like Microsoft's Outlook, Word or Excel, making it easy for users to customize key elements of the record keeping processes.

Beckman Coulter's Quality Link 6 software and Lab Accelerator, for example, is a lab accreditation software application tailored for the clinical lab built under ISO standards. The design enhances a laboratory's ability to plan for inspections, and to meet varying accreditation requirements, without disruption.

It can flag and capture the two patient identifiers associated with each test or related service, to make sure they are used consistently. It can also automatically track turnaround time for all tests and reporting. This is helpful in identifying and correcting workflow bottlenecks. The software system can also allow users to view, sort, store and nest documents for the laboratory's entire quality manual.

Maintenance is a critical aspect of quality, and lab software can provide practical tools, such as an easy way to identify each instrument's model, serial number and location. It can track both in-house and outside maintenance and calibration records across multiple department disciplines; and it can hold all vendor contact information, set vendor criteria, track evaluations and store results.

Inspection software can help laboratories manage the highly inter-related QSE areas of information management, occurrence management, assessment and process improvement. Having built-in security levels can help protect the staff when reading and editing documents, as can the ability to store audit results separately. Pre-defined, customizable master category lists allow a lab professional to identify and store deviations, as well as unusual occurrences and outcomes. These lists can also help identify and store corrective actions, non-compliant sources and root cause information.

To lab staff members documenting and reporting to various accrediting bodies, laboratory software can provide items such as audit details, schedules and category definitions. These save time, allowing each staff to collect and compare its own internal audit information and prepare a full range of reports.

Laboratory scientists face enormous challenges today, but using the full range of capabilities provided with lab accreditation software allows them to operate in a high quality, consistent manner and increases the probability of achieving full compliance during an on-site inspection. If areas of non-compliance are identified, the software's built-in tools and capabilities provide a way to clearly document progress toward compliance, and reduce the cost to reach and maintain compliance.

Chris Neary is vice president, Clinical IT Business Center, Beckman Coulter.