Understanding CLIA Compliance
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.
Generally speaking, 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. Examples of waived tests can include a simple urinalysis or urine pregnancy test. Office staff must follow the manufacturer’s instructions for performing the test, handling the specimen, storing the test kits, and many other requirements.
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. Therefore, following all CMS regulations and maintaining compliance with said regulations is imperative.
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 laboratory, including processing, storage and testing spaces
- Ask for copies of all laboratory records and data
Our Laboratory Compliance Services (CLIA)
Meeting laboratory compliance regulations is a necessity, but that doesn’t mean it’s easy when you have other things to think about, like patient care. When you engage the services of DoctorsManagement, you’re collaborating with a team of experienced professionals who study compliance for a living. We are prepared to work with your specific needs and develop a personalized compliance plan that meets all CLIA regulations without negatively impacting your existing processes.
Our services cover the documentation and evaluation you need to maintain CLIA guidelines. We are here to assist you with:
- Application assistance (Federal, State and Accreditation)
- Customized procedure and quality assessment manuals, including the forms required for documentation to ensure compliance
- 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
