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Impact Health - FAQs
 

 

Selecting a company to provide on-site laboratory testing? Know the FACTS!

Regulatory FAQs

Impact Health Image Impact Health - Apple Bullet What is CLIA?

  • The Clinical Laboratory Improvement Act (CLIA) is a federal mandate written with the objective of standardizing clinical laboratory testing.


  • CLIA established a list of "waived" tests that were determined to be easy to perform and interpret.
    Personnel and quality control standards are less stringent with these tests.
Impact Health - Apple Bullet Does that mean that physicians, nurses and other staff can perform "waived" tests?
  • Not necessarily. Many states have established regulatory guidelines that override the CLIA guidelines. In those jurisdictions, "waived" tests are not allowed unless you hold a laboratory license or permit.


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  • Physicians and nurses must work under the auspices of a CLIA certificate or laboratory license.
Impact Health - Apple Bullet What is the difference between CLIA certification and a laboratory classified as "moderately complex?”
  • A laboratory approved to do "moderately complex" testing must adhere to more stringent standards for personnel, quality control and proficiency testing.
  • A license as a “moderately complex” laboratory is necessary to perform testing in jurisdictions that do not accept the CLIA certification; examples include NY, NJ, PA, FL, CA and more.

Impact Health - Apple Bullet What is the difference between Quality Control and Quality Assurance in a Clinical Laboratory?

  • Quality Control (QC) refers to the routine analysis of control samples with known results (normal and abnormal) to test the optics of each system, reagents and instrumentation. A Clinical Pathologist or designee then reviews these results.

  • Quality Assurance (QA) is the process of evaluating other pre-analytical and post-analytical aspects of the testing process that can, and will affect results. These include sample collection, data collection and reporting.
Impact Health - Apple Bullet What is Proficiency Testing (PT)?
  • A PT program refers to samples with unknown results that are analyzed and submitted for comparison. The results are compared to known values and to other laboratories using the same technology and methodology.

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  • Some states mandate PT programs. The laboratory may voluntarily select other programs in order to monitor performance and quality of testing.
Impact Health - Apple Bullet What training and personnel standards are appropriate for clinical laboratory testing?
  • Licensed laboratories will have a Director, usually a Clinical Pathologist and a Clinical Supervisor. The Director approves all procedures and the Supervisor monitors adherence to protocols.

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  • Training includes review of all protocols for testing SOPM, quality control, OSHA Blood-Borne Pathogens, counseling and more.

Impact Health - Apple Bullet What documentation should be requested when selecting a laboratory for on-site testing?

  • A copy of a CLIA certificate as well as state license or permit where required.


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  • Certificate of insurance.
Impact Health - Apple Bullet Are all Medical Professional Liability policies the same?
  • Medical Professional Liability varies from one policy to another.


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  • Not all Medical Professional Liability policies provide coverage for the delivery of healthcare services.


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  • A Healthcare Medical Professional Liability Policy will provide necessary protection.

Impact Health - Apple Bullet How do HIPAA regulations affect clinical screening programs?
  • HIPAA (Health Insurance Portability and Accountability Act) regulations do apply to clinical screening results.

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  • Under HIPAA, providers must utilize approved documents for informed consent,
    a privacy protection notice and a process for allowing participants to opt in to receive additional information
  
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Impact Health
1040 First Avenue • King of Prussia, PA 19406 • 1.800.470.4439