About CLIA

Posted on February 21, 2008 by Dr. David Edward Marcinko MBA MEd CMP™

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Clinical Laboratory Improvement Amendments

 By Patricia A. Trites; PhD, MPA, CHBC, CMP™ (Hon)

trites

The Clinical Laboratory Improvement Amendment (CLIA) was passed in 1988 and pertains to any healthcare provider or entity that performs any laboratory test.   

A Series of Acts 

This legislation is actually a series of acts that established quality standards for laboratory testing in order to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.   

Certification Types 

Providers must register with the Centers for Medicare and Medicaid Services (CMS) by filling out an application and paying the required fees. These fees vary upon the type or complexity of certificate requested. After completing all of the requirements, the provider will receive a CLIA Certificate.   

The four types of CLIA certificates are:  

  1. Waived Complexity
  2. Provider Performed Microscopy [sub-group of moderate complexity]
  3. Moderate Complexity
  4. High Complexity 

Revised Regulations 

In 1997 CMS enacted a new regulation that requires providers to include their CLIA number on all claim forms (ex: HCFA/CMS 1500) that contain requests for payment for clinical laboratory services.  

This is to insure that: (1) the provider has a current CLIA certificate and, (2) that the provider is performing only the laboratory tests that are allowed for the particular level of certificate. There are specific regulations and documentation requirements for the different levels of service.

Compliance Issues 

A recent study in 2001 found that a large percentage of clinical laboratories were not in compliance.  It has been recommended that increased inspection, both announced and unannounced, be instituted to better insure the quality of laboratory services.  

The CLIA requirements can be found at: http://www.cms.gov/clia. 

Assessment 

What has been your experience with CLIA?

Conclusion

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5 Responses

  1. Betty, on October 20, 2009 at 10:32 AM said:

    Pati

    Unintended Consequences

    In 2003, the Office of Civil Rights at HHS wrote the HIPAA Privacy Rule regulations allowed consumers to access a copy of their own protected health information. But, they carved out lab data as a special case. Lab data (CLIA) was to be governed under CMS regulations that stated that lab test results could only be delivered to “Authorized Persons”, defined as “an individual authorized under state law to order tests or receive test results, or both.”

    Only a few states have passed laws stating that the individual subject of the test is considered authorized to receive test results, so in almost all states consumers are not able to do so. They can only legally get test results from their ordering provider … Imagine that!

    Betty

    Like

  2. Linda, on April 7, 2011 at 2:01 PM said:

    Medicare Lab Signature Rule Delayed Again

    Pati – The Centers for Medicare & Medicaid Services (CMS) again delayed enforcement of a new Medicare rule requiring physicians to sign-off on laboratory test requests, as the agency continues to come under pressure from physicians groups and lawmakers.

    http://www.physiciansmoneydigest.com/your-practice/Medicare-Lab-Signature-Rule-Delayed-Again

    Linda

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  3. Hope R. Hetico RN MHA, on February 3, 2014 at 9:37 PM said:

    How New Amendment To The Clinical Laboratory Improvement Amendments of 1988 (CLIA) Effects Patients

    1. Allows laboratories to give a patient/person designated by the patient, his or her “personal representative,” access to the patient’s completed test reports on the patient’s / representative’s request.

    2. Eliminates exception under the HIPAA Privacy Rule to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory.

    3. Gives patients a new option to obtain their test reports directly from the laboratory while maintaining strong protections for patients’ privacy

    Source: U.S. Department of Health and Human Services

    Like

  4. Sam, on February 4, 2014 at 3:58 PM said:

    Patients can now get lab results without doc

    Pati and Hope – I understand that patients can now get their own test results directly from the lab.

    IOW: No more calls to the doctor’s office, waiting on hold with the front desk, or arguing with the office staff.

    http://www.govhealthit.com/news/feds-update-clia-gives-patients-access-lab-results?topic=18

    The new rule, which was first proposed by President Obama in 2011, is part of an ongoing effort to give patients more control of their own health care information and maintenance.

    Samantha

    Like

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