Laboratory Compliance (CLIA)
Bringing a new laboratory to life in your office is exciting. Our specialized CLIA experts assist new and seasoned physician office laboratories with all aspects of inspection success and quality laboratory results.
Reach Out for CLIA Assistance
Inspection Success and Quality Lab Results
The right laboratory setup enables you to care for your patients with accuracy and cuts down processing times so you can deliver results while your patient is still in the office. However, before you can open your laboratory, there are a number of compliance regulations you must meet.
At DoctorsManagement, our team works with laboratory compliance concerns every day. Our specialized team assists new and seasoned physician office laboratories with all aspects of the laboratory. Our experienced CLIA experts provide that extra boost to ensure inspection success and quality laboratory results.
What CLIA Compliance Means for Your Practice
If you examine human samples to accompany patient care, you must comply with the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The Centers for Medicare and Medicaid Services (CMS) performs laboratory inspections to enforce CLIA compliance.
The applicable CLIA regulations depend on the type of tests you perform. Most physicians who test human samples in the office have a Certificate of Waiver (COW). With a COW, healthcare staff can only perform waived tests like a simple urinalysis or urine pregnancy test.
Even though CMS will not routinely inspect your laboratory if you have a COW, they can still conduct an inspection at any time. Furthermore, CMS may survey your laboratory if a complaint is filed or if they suspect you're performing non-waived tests.
What Happens During an Inspection
- Observe staff performing procedures and examining samples
- Interview personnel about compliance regulations
- Access processing, storage and testing spaces
- Request copies of all laboratory records and data
Comprehensive Laboratory Compliance Support
We work with your specific needs and develop a personalized compliance plan that meets all CLIA regulations without negatively impacting your existing processes.
Application assistance (Federal, State, and Accreditation)
Customized procedure and quality assessment manuals
Quality assessment plan development
Proficiency testing enrollment
Regulatory training (onsite or remote)
Inspection preparation and response
Documentation forms and templates
Competency assessments for personnel
Mock audits and corrective actions
Monthly consulting and data review
Telephone consultation
Forms required for ongoing documentation
The Benefits of Working With CLIA Experts
CLIA encourages every laboratory performing moderate complexity testing to have a qualified Technical Consultant (TC). The CLIA Department of DoctorsManagement has licensed Technical Consultants who can serve in that TC role indefinitely or until you or your physicians become qualified.
Our consultants analyze laboratory data monthly and provide detailed written reports with findings and recommendations.
Survey Assistance
Your assigned TC will assist with surveys, provide required corrective actions, and ensure your manuals are always up to date.
Personnel Competencies
We perform testing personnel competencies and monitor all quality systems in your laboratory.
Reliable Test Results
Continuous monitoring ensures reliable test results and ongoing regulatory compliance for your facility.
Training & Manuals
Our CLIA professional staff provides training and manuals to assist your team in laboratory preparation and management.
CLIA Technical Consulting & Training Resources
From dedicated technical consultants to ready-to-use training materials, we offer flexible solutions for laboratories of all sizes.
CLIA Technical Consulting
The CLIA Compliance division of DoctorsManagement has licensed laboratory consultants who can serve in the Technical Consultant role indefinitely or until you or your physicians become qualified. Our consultants review laboratory data monthly and provide detailed written reports.
Engage a Technical ConsultantTraining Videos and Manuals
Our CLIA professional staff has developed training videos and manuals to assist your team in the preparation and management of the many aspects of running a laboratory. Visit our online store for CLIA compliance manuals, study guides, webinars and more.
Visit the Online StoreFrequently Asked Questions
Meeting all laboratory compliance regulations is essential for all facilities. Learn more about CLIA and how our technical consulting can help.
What Is CLIA?
The Clinical Laboratory Improvement Amendments, more commonly known as CLIA, is a federal law that Congress passed in 1988. This document established the standards which more than 320,000 laboratories across the United States use to ensure quality testing results for urine samples, blood tests, tissue collections, and more. Maintaining laboratory compliance through CLIA requires certification every two years.
Who Must Comply With CLIA?
If you examine human samples to accompany patient care, you must comply with the Clinical Laboratory Improvement Amendments (CLIA) of 1988. The Centers for Medicare and Medicaid Services (CMS) performs laboratory inspections in order to enforce CLIA compliance.
Do I Need CLIA Certification for My Practice?
CLIA laboratory compliance is required for any facility that accepts and analyzes human specimens. Failure to adhere to all regulations can result in extensive fines and serious repercussions, especially for repeat offenders.
How Does CLIA Technical Consulting Help?
At the end of the day, medical practices are focused on one thing, helping patients. With CLIA services from DoctorsManagement, your staff can continue doing their important work without compromising your compliance. We will manage the paperwork from initial certification through inspection responses, and together we can bring your practice to the next level of quality patient care.
Schedule a CLIA Consultation
Connect with our team of laboratory compliance experts to discuss your needs and learn how we can help your practice maintain regulatory compliance.
Reach Out for CLIA Assistance
DoctorsManagement does not work with patients. We offer support to medical practices.
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