TPT Global Tech Inc (TPTW)

[MadBrewer]

"The agreement includes EPIC's current CLIA certificate of registration that enables TPT MedTech's Mobile QuikLABs to operate in 46 US States

Clinical Laboratory Improvement Amendments (CLIA);
Diagnostic testing helps health care providers screen for or monitor specific diseases or conditions. It also helps assess patient health to make clinical decisions for patient care. The Clinical Laboratory Improvement Amendments (CLIA) regulate laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.

Three federal agencies are responsible for CLIA: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS), and the Centers for Disease Control and Prevention (CDC). Each agency has a unique role in assuring quality laboratory testing.

FDA

Categorizes tests based on complexity
Reviews requests for Waiver by Application
Develops rules/guidance for CLIA complexity categorization
CMS

Issues laboratory certificates
Collects user fees
Conducts inspections and enforces regulatory compliance
Approves private accreditation organizations for performing
inspections, and approves state exemptions
Monitors laboratory performance on Proficiency Testing (PT)
and approves PT programs
Publishes CLIA rules and regulations
CDC

Provides analysis, research, and technical assistance
Develops technical standards and laboratory practice
guidelines, including standards and guidelines for cytology
Conducts laboratory quality improvement studies
Monitors proficiency testing practices
Develops and distributes professional information and
educational resources
Manages the Clinical Laboratory Improvement Advisory
Committee (CLIAC)
https://www.fda.gov/medical-devices/ivd-regulatory-assistance/clinical-laboratory-improvement-amendments-clia

Certificate of Registration

The Certificate of Registration is the certificate that is initially issued to a laboratory that has applied for a Certificate of Compliance or a Certificate of Accreditation. This certificate enables the laboratory to conduct moderate and/or high complexity laboratory testing until the survey is performed and the laboratory found to be in compliance with the CLIA regulations.

The Certificate of Registration includes PPM and waived testing as well as all moderate and high complexity testing.

Inspections are required for all Certificate of Registration laboratories. The inspection will be conducted between 90 days and 12 months after the effective date of the certificate in order to permit observation of actual testing during the survey.
https://ldh.la.gov/index.cfm/page/777


https://www.cdc.gov/clia/LabSearch.html

Been connecting dots,
Been saying FEMA/. gov

This is our hold up for QuikLAB testing.
TPTW is dotting "i's" & crossing "t's" on this one!!

Cheers