To achieve quality care, labs must exist between the information they use to define and implement good practices and successful laboratory inspection.
Vol. 24 • Issue 5 • Page 14
For clinical laboratorians, the delivery of quality laboratory medicine and quality patient care is at the heart of what they do. To achieve this goal, alignment must exist between the plethora of information laboratories use to define and implement Good Laboratory Practices (GLP), and a successful laboratory inspection.
The lab inspection is designed, in essence, to measure compliance with the expectations set forth by local, state and federal organizations. These organizations can include, but are not limited to, federal (e.g., Food and Drug Administration [FDA], CMS/CLIA, Occupational Safety and Health Administration [OSHA]), state (e.g., laboratory, public health, medical waste management), and professional (e.g., College of American Pathologists [CAP] and AABB). To ensure all regulatory compliance is achieved, the laboratory must inevitably “survive” an inspection by a laboratory accreditation organization.
Who Performs Today’s Laboratory Inspections?
Inspections are performed by an outside agency that has accredited the laboratory to perform clinical diagnostic testing. The laboratory will either be surveyed by CMS/CLIA or by an accrediting organization (AO) that has been granted deeming authority by CMS. There are currently seven CMS-approved accreditation organizations: AABB, American Association for Laboratory Accreditation (A2LA), American Osteopathic Association (AOA), American Society of Histocompatibility and Immunogenetics (ASHI), COLA, CAP, and Joint Commission on Accreditation of Healthcare Organizations (JCAHO). If a laboratory applies for accreditation by one of the CMS-approved accreditation organizations, the application process begins by first submitting an application to CMS for a COA (Certificate of Accreditation) concurrently. The CLIA program utilizes state agencies to conduct surveys, and the private organizations have trained surveyors that may work by region or nationwide.
Inspections are often announced in advance either via email, postal mail, telephone or fax to the laboratory. Inspection schedules are subject to the time frames of the AO. CLIA follows a biennial schedule. Some private AO’s follow an 18-24 month schedule, so it would be prudent for laboratories to be additionally vigilant during these time frames. It should be noted that if there has been a complaint against a laboratory, the inspection/survey may be unannounced.
Below are eight key steps the laboratory can follow that may minimize the anxiety and anticipation of an inspection.
- Step 1: Determine the laboratory requirements that apply to your laboratory, based on your selected test menu. What is the level of testing complexity (waived, moderate or high complexity?)
- Step 2: Assign qualified individuals to complete the CLIA requirements. Are the laboratory personnel qualified or have the credentials necessary to perform the testing?
- Step 3: Select a Proficiency Testing (PT) program that meets your needs.
- Step 4: Establish and maintain written policies, processes, and procedures manuals. These documents must outline the procedure for the three phases of testing for each test performed by the laboratory; a quality management plan and laboratory safety procedures that align with OSHA requirements are critical.
- Step 5: Train and perform competency assessments on all laboratory personnel. This is an ongoing, documented process.
- Step 6: Document and perform Quality Control (QC) and achieve acceptable results for all tests performed.
- Step 7: Incorporate quality assessment activities into the daily routine of the laboratory. This includes assessing the quality throughout the testing process; taking corrective actions when needed; and following up on the effectiveness of corrective actions.
- Step 8: Maintain thorough documentation for future inspections.
Often times the question arises, “Should the laboratory develop a checklist or a self-assessment document prior to inspection day?” For some laboratories, a checklist or as described by some AOs a “self assessment,” may serve as a tool to help guide the laboratory through the inspection process, allowing the lab to identify areas of weakness in processes and identify ways to improve overall operational efficiencies. The ultimate decision rests with the laboratory.
Once the inspection is completed and an exit conference or interview has occurred with the inspector or surveyor, the laboratory director should share all findings with the laboratory personnel. Sharing the information in a timely fashion will allow the laboratory the opportunity to begin addressing deficiencies immediately, and prepare for subsequent inspections.
Preparing for a laboratory inspection is a journey, one that brings a level of anxiety and stress above and beyond the levels faced every day. However, laboratorians are not alone on this journey. Extensive resources are available to help make the process rewarding, one that brings a sense of accomplishment. Optimizing quality laboratory medicine and quality patient care may be compulsory for clinical laboratories, but surviving a laboratory inspection should also bring a special sense of satisfaction to these professionals.