Compliance is the clinical lab’s ongoing resolve to perform medical testing according to stipulations by multiple governmental agencies.¹ Over time, the process has become more complicated and consequently more stringent, as the body of test types grows, reimbursement schemes evolve, and laws governing lab safety issues are updated to be more inclusive and clear. Indeed, comprehensive, up-to-date regulatory compliance in the clinical lab is a daunting challenge.

The purpose of enforcing compliance standards include the establishment of standard operating procedures, a system to monitor compliance, the establishment of associate performance standards, and a system to monitor variances and deficiencies, including documentation of corrective actions.¹

There are three general areas of lab medicine that require evidence of ongoing compliance; the quality of specimen testing, legitimate billing for those tests, and performing safely within that testing environment.

Regarding testing quality, the Clinical Laboratory Improvement Amendments (CLIA) requires that labs provide testing services in the context of demonstrable Quality Assurance (QA) measures in areas such as:

• Qualifications of Testing Personnel

• Quality Control

• Proficiency

• Communications

• Staff Review and Proficiency Testing

• Patient Test Management

While CLIA governs the analytical and quality issues of lab tests, the Office of the Inspector General (OIG) has created a set of guidelines pertaining to proper billing of and ethical considerations around medical testing. Specific areas addressed are:

• A code of ethical, compliant conduct for associates

• The establishment of compliance oversight, including a Compliance Committee with a charter and appointment of a Compliance Officer

• Creating protocols for ongoing auditing

• Establishing protocols to detect violations of policy and impose progressive disciplinary actions²

A third area of the lab impacted by evolving compliance requirements is safety. The Occupational Safety and Health Administration (OSHA) creates standards of workplace safety for the lab and all industries. Their goal is to create a clear, universally-accepted standard for communication of chemical and other workplace hazards.

Toward this end, OSHA has created a number of their own workplace standards, which the clinical lab, again, must demonstrate compliance, such as:

• The requirement for employers to be compliant with the current Hazard Communication Standards (HCS)

• Completion of GHS Compliance Training for new employees

• Standardizing "hazard" definitions and labelage

• Standardizing Safety Data Sheets (STS) to a defined 16-section format

Don't go down the path of Compliance alone. Let Ektelligen® guide you through the ever-changing maze of Compliance. Ektelligen® can help you feel confident that your lab is well-positioned to determine and execute current Compliance requirements pertaining to your laboratory. Contact an Ektelligen® representative today!