Transitioning from offering waived testing to moderately complex laboratory testing involves a shift in perspective, transforming from merely providing a service to effectively managing a business within your primary operation. This transition is motivated by the potential operational efficiencies and value generated by moderately complex testing, particularly beneficial for high-volume practices.
This decision often stems from the realization that testing volumes have reached a point where conducting tests in batches using advanced and costly equipment becomes justifiable. However, one drawback of this transition is the shift in result turnaround time, from real-time or within hours to within days. To mitigate delays, a combination of waived and moderately complex testing can be employed based on the specific requirements of the practice.
Determining the necessary analyzers, test systems, and kits is guided by patient volumes and testing menus. Factors such as laboratory license level, technical expertise of staff, and available space and specifications also influence equipment selection. When choosing laboratory test systems, considerations include capturing the test menu, cost per test, space requirements, compliance with specifications, ease of use, minimal startup and maintenance time, warranty options, service contracts, reagent costs and integration with instruments or electronic medical records (EMR).
Upon selecting an analyzer, contractual agreements cover terms and conditions, reagent pricing, service, leasing, and warranties. Subsequently, vendor-provided training prepares staff for equipment operation, followed by the practice’s responsibility for validation, laboratory information system (LIS) integration, and review of policies, procedures, and quality assessment plans to ensure testing quality and documentation completeness.
Transitioning from CLIA waived procedures to moderately complex testing involves staffing considerations, as personnel requirements vary with testing complexity. Key positions include:
Lab Director: Often filled by physicians or practice owners, qualification requires completion of online lab director courses meeting CLIA requirements, typically yielding 20 or more CME credits. The certificate is submitted to CLIA and the state agency.
Lab Supervisor: While not mandatory, having a lab supervisor with strong analytical skills can enhance operations. The role operates under the lab director’s oversight.
Technical Consultant: Required for new lab setups if the lab director lacks prior experience overseeing a moderately complex lab for at least a year. The consultant provides regulatory guidance and oversight, requiring a Bachelor of Science degree with coursework in relevant fields and expertise in CLIA compliance and state regulations.
Physicians often seek guidance from technical consultants, such as our partner company IncMD, healthcare and laboratory consults, or utilize national accreditation organizations, local accrediting bodies, like the College of American Pathologists (CAP), or CLIA surveyors, to find suitable consultants knowledgeable about state regulations.
Our moderate complexity laboratory equipment is all state-of-the art and manufactured by industry leaders, like Siemens, Beckmann Coulter, Horiba, and Shimadzu. With more than 55 years of combined clinical laboratory experience, our team is current with the regulatory standards and has consulted on dozens of Physician Owned Laboratories (POL’s) across the country.
Shop our line of hematology analyzers, immunoassays and other CLIA and N0n-CLIA waived tests at Shop Laboratory
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