Start up a laboratory
- We can help you build a new laboratory or help with an upgrade to your current laboratory.
- If you need help setting up a new laboratory, we can help you. We can complete your initial laboratory application (CMS- 116) to CMS.
- If you decide your laboratory will be accredited by an Accreditation Organization, we will also complete that application.
- We can serve as your laboratory Technical Consultants for routine oversight of moderate complexity testing.
- We can also serve as your Laboratory Director.
Pre-inspection evaluations
- As a qualified Technical Consultants (based on CMS educational requirements and work experience) we can help your laboratory with CLIA or your accreditation organization inspection to ensure a stress-free experience.
Post inspection corrections and follow up
- We can also help your laboratory with any corrective actions that may need addressed after an inspection/survey.
- We can write a Plan of Correction (POC) for CLIA or a Plan of Required Improvements (PRI) for COLA following an unsuccessful survey.
- After we submit your POC or PRI, if desired, we can continue to help keep your laboratory in compliance by serving as your technical consultants.
Simplified management plan and monthly visits to ensure compliance
- A simplified management plan can turn your laboratory into an efficient, motivated, and well-operated laboratory.
- We can provide the required technical oversight for your laboratory. From the physician office laboratory to a large hospital laboratory, we've got you covered.
- We will review your laboratory personnel records to ensure all laboratory personnel are qualified to perform moderate complexity testing.
- We will provide laboratory personnel competency evaluations and documentation to ensure that your staff is conforming to standard polices and procedures in accordance with CLIA and/or your accreditation organization.
- We will develop and maintain a comprehensive quality control (QC) program for your laboratory.
- We will assist your laboratory with QC issues. We will work with your laboratory personnel to troubleshoot any test system that may be having QC issues.
- We will review proficiency testing (PT) records to ensure your laboratory is currently enrolled in all required testing.
- If you are starting a new laboratory, we can enroll your laboratory in the proper PT program.
- We will assist your laboratory personnel with the investigation of any PT failures.
- We will review your laboratory policy and procedure manuals (SOP) and update as needed.
- If you are starting a new laboratory we can write your policy and procedure manuals.
- We will provide a comprehensive quality assessment (QA) plan.
- We also provide monthly visits to review laboratory records, and ensure your laboratory is in compliance with all regulatory agencies.