Laboratory Compliance (CLIA)
So, you’d like to start an in-office laboratory — the American Academy of Provider Offices and Laboratories (AAPOL), a division of DoctorsManagement, can help! We work with new and seasoned physician office laboratory professionals by assisting them with all aspects of the laboratory, from initial certification through inspection responses. Our experienced team provides that extra boost to ensure inspection success and quality laboratory results.
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.
What Are Laboratory Compliance Regulations?
Generally speaking, 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. Examples of waived tests can include a simple urinalysis or urine pregnancy test. Office staff must follow the manufacturer’s instructions for performing, handling and storing these tests, among other requirements.
While CMS will not routinely inspect your laboratory if you have a CoW, they can still conduct an inspection at any time. In addition, CMS may survey your laboratory if a complaint is filed or if they suspect you’re performing non-waived tests. While operating a laboratory, the office will be required to meet all the regulations referenced in Subpart A of the Code of Federal Regulations if you perform tests of moderate complexity and have a Certificate of Compliance (CoC) or Certificate of Accreditation (CoA).
Laboratories with a CoC or CoA are inspected every two years to ensure compliance. However, we encourage all laboratories to be “inspection ready” in order to prevent potential certification or reimbursement issues.
You can find the general inspection requirements in Subpart Q of the Code of Federal Regulations. As you’ll see, an inspector will do the following during a survey:
- Observe staff performing procedures and examining samples
- Interview personnel, asking questions about compliance regulations
- Access any area in the lab, including processing, storage and testing spaces
- Ask for copies of all laboratory records or data
Our CLIA Services
Our team will develop a customized laboratory compliance program that meets all CLIA regulations.
Our services include the following:
- Application assistance
- Customized procedure manual, including the forms required for documentation
- Quality assessment plan
- Proficiency testing enrollment
- Regulatory training onsite or remote
- Inspection preparation
- Inspection response
- Documentation forms
- Competency assessments
- Mock audits
- Corrective actions
- Monthly consulting to review all laboratory data and ensure compliance
- Telephone consultation
CLIA Technical Consulting
CLIA requires every laboratory performing moderate complexity testing to have a qualified technical consultant (TC). The AAPOL division of DoctorsManagement has BS, MT (ASCP) consultants who can serve in the TC role indefinitely or until you or your physicians become qualified.
Our consultants review laboratory data monthly and provide detailed written reports with findings and recommendations. The assigned TC will assist with the survey, provide any required corrective actions, ensure manuals are up-to-date, perform testing personnel competencies, and monitor all quality systems in the laboratory to ensure reliable test results and regulatory compliance.
CLIA Training 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 the laboratory. Visit our online store for CLIA compliance manuals, study guides, webinars and more.
Need a Laboratory Compliance Consultant?
If you need assistance with CLIA compliance, let us help. Please contact us today to speak with a laboratory consulting specialist or learn more about our CLIA compliance services.