The Human Genome Where will it take us
Clinical Lab Consultants, LLC dba Ruiz & Associates are Health Care Clinical Laboratory specialist, emphasizing the implementation and compliance of all Federal and State regulations. We will help YOU to ensure Quality and Accuracy in YOUR testing either here in the United States or around the World, At the End of the day, its all about the Patient.
Who We Are
What We Do
Clinical Lab Consultants, LLC dba Ruiz & Associates over the last 15 years has helped a variety of clients for example:
• Attorney Practices
• Physician Office Laboratories (POL)
• Independent Laboratories
• Research Laboratories
• University Laboratories
• Hospital Laboratories
We work with facilities around the world to get them CLIA Certified & Accredited. Click below to see a list of who we have helped in the past.
Our specialties are the following:
We offer to advise and interpretation to Law firms on Clinical and Research Laboratories. As it relates to Plans of Correction from either CMS or any of the Accrediting bodies, along with Immediate Jeopardy issues.
We also offer help in opening laboratories. If you are going from a Research laboratory Developed Test to a Clinical Laboratory Developed Test, we can help you in getting there through the understanding of the Federal Regulations 42 title C.F.R. 493 (CLIA-88). Which will then lead to a CLIA Certificate of Compliance or a CLIA Certificate of Accreditation. Clinical Lab Consultants, LLC, dba Ruiz & Associates will help your laboratory develop:
- Policies and Procedures
- Helping you to understand the validation process of Labratory Developed Test (LDT)
- designing the flow of your laboratory
- reviewing the qualification of your Director and Testing Personnel
- Ensuring that your laboratory is compliant with all the Federal regulations and the Accrediting bodies requirements.
Clinical laboratory Consultants, LLC dba Ruiz & Associates does offer onsite audit of your laboratory to ensure that you are complying with all the regulations.
We also offer skype sessions to discuss your need or do a virtual lab tour prior to your inspections.
We can help you with your Plans of Correction or Immediate Jeopardy (IJ), If you recently have been inspected by your Accrediting body or CMS, or a Validation Inspection or even a complaint investigation inspection. Please call us, time is of the essence. We will work with your Attorney group along with you and your company. In most of the cases above, you only have 10 days to respond. The quicker we have knowledge of your citations the quicker we can help you through the process. Speed and Accuracy in your response can save you financial fines that may be imposed upon your laboratory, if citations are not corrected and non-compliance to the time line that was given to your laboratory. Clinical Lab Consultants, LLC dba Ruiz & Associates works around the clock for YOUR laboratory to ensure that Compliance to the citations is done in a timely manner and accurately.