Whether at a physician’s office or a large hospital, we have the consultant for you.
- CLIA, COLA, CAP, Joint Commission
- Opening a New Lab
- Assisting with Validation Protocols
- Adding New Tests to Existing Platforms
- Developing an Individualized Quality Control Plan
- Support with all Laboratory Operations
- Creation or Implementation of Policies and Procedures
- Team Management, Trainings, Assessments
- Hiring a Laboratory Director, or Become One Yourself
- Proficiency Testing, Surveys, Point of Care
Consultants at The National Network have free access to the tools they need to serve you, the client. We provide services for clinical specialties according to your needs, and in every region of the United States.
Lab Specialties:
- Hematology
- Mass Spectrometry
- Microbiology
- Molecular Diagnostics
- List Item
- Anatomic Pathology
- Molecular Pathology
- Cytogenetics
- Cytopathology
- Flow Cytometry
- Immunology
- Toxicology
- Transfusion Medicine
- Urinalysis
Areas of Support:
- Oncology practices
- Behavioral Health facilities
- Gastroenterology practices
- Cardiology
- Urology
- Ambulatory Surgery Centers
- Large and small clinics
- Psychiatry
- Urgent Care facilities
- Primary Care facilities
- Long-Term care facilities
- Mobile Services
- Correctional Centers
- OB/GYN
- Pediatric Facilities
Packages through the National Network
Policy & Procedures Complete Package
Quality Assurance & Control Package with Written Programs
Lab Director Recruitment
National Network will help you navigate through all testing requirements and best practices to maintain state and federal compliance.
Clinical Laboratory Improvement Amendments consist of federal standards overseen by three Federal agencies: The US Food and Drug Administration (FDA), Centers for Medicare and Medicaid (CMS), and The Centers for Disease Control and Prevention (CDC).
Any testing performed that yields results for the direct care of a patient must comply with all CLIA standards. Each of these agencies perform independently and specific oversight for the accuracy of patient testing performed in a Physician’s Office, Hospital system or Reference Laboratories.
The FDA categorizes tests submitted through a 510K process and are classified as either waived, moderate, or highly complex based on seven categorization criteria which determine their application CLIA requirements. Laboratory Developed Tests (LDT) have not been approved by the FDA and are required to go through an extensive validation process.
CMS enforces CLIA compliance. CLIA Amendments were approved in 1988 by the House of Representatives in Washington DC that ensures basic CLIA requirements for all laboratories operating and performing testing on human samples in all 50 states.
The CDC manages the Clinical Laboratory Improvement Advisory Committee (CLIAC), which supports the CLIA program through the development of lab standards and guidelines, quality improvement studies and Proficiency testing.
RESOURCES
CLIA Proficiency Testing and PT Refferal Dos and Don’ts
Authored by Clinical Laboratory Improvement Amendments (CLIA)
Considerations When Deciding to Develop an IQCP
Authored by Clinical Laboratory Improvement Amendments (CLIA)
