Laboratory
Consulting Services
Laboratories are required to comply with law regulations, this is a condition to maintain CLIA certification.
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The failure to comply with the law and the recurrence of deficiencies may lead to the suspension, limitation, and/or revocation of your CLIA certificate and the consequent cancellation of your Medicare Provider Number.
Click On Laboratory Consultant Group will help you resolve your inspection problem and respond to your non-compliance letter with acceptable and pertinent evidence that will show the CLIA inspection team that you and your laboratory are committed to complying with the law, doing the corrections and monitor each of the questioned processes.
We are committed to excellence and good customer service to solve these problems in the shortest possible time. We have worked for 4 years with different laboratories and medical offices in the resolution of their compliance and personnel problems.
Consulting Services
Initial Consultation
Are you a medical office or an independent laboratory?
For a medical office, we will assess the laboratory performance to improve the use of your resources. The laboratory analyzers or equipment must be appropriate to the lab test menu and volume, this will depend on the office’s specialty. Also, as a consultant group we can offer assistance with staff training including laboratory policies and test processes.
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Are you an independent laboratory?
In an initial survey we can evaluate and get a complete report of the laboratory performance and detect deficiencies and strengths as well as staff training needs.
Compliance
The CLIA protocols and guidelines clarify and explain the Federal requirements for laboratories and are required for use by all Federal or State surveyors assessing laboratory performance based on these requirements. The focus of the CLIA, COLA, CAP, JC survey is to assess how the laboratory monitors its operations and ensures the quality of testing as well as assure patient care. We can help you to follow all requirements of law.
Laboratory Set up
Do you want to open a new laboratory service?
We can help you create a test menu, choose the appropriate equipment, internal laboratory systems or software and the right supplies for your laboratory necessities. Our staff is prepared to build your procedures, laboratory quality control and maintenance log forms for all equipment and test methods to be used by the lab. We can do CLIA application (CMS-116) to request the CLIA Certificate as well as Medicare/Medicaid and private insurance applications to get a provider number.
Inspection Prep
We will provide laboratory inspection services to clients in Miami-Dade
and Broward County area. Our cost-effective laboratory inspections are the perfect way to identify issues prior to a federal inspection. Our services include instructions to correct any deficiencies found during the survey.
Your lab can handle the accreditation inspection with confidence.
Test Validation
We will assist with written Standard Operation Procedures (SOPs) for all test methods processed by the lab, a complete test validation protocol is used by Click on Laboratory Consultant Group, ensuring the quality of test processes. We can work on the instrument validation and staff training.
POCT
For medical offices using point of care analyzers and methods to get results as soon as possible, the Quality Control is an important aspect. Our services allow you to ensure compliance with the POCT QC requirements. We will ensure that proper documentation for your laboratory will be
ready for inspection.