What Is a Laboratory Compliance Specialist?

Laboratory Compliance Specialist

There are very strict rules and regulations in place for any business working in a lab, both to protect the healthcare professionals working in that lab and the clients and customers the lab serves.

To make sure that your company is in compliance with these laws, it is recommended to hire a laboratory compliance specialist to double check the details and make sure that all processes are up to code.

What Is Laboratory Compliance?

Laboratory compliance is an ongoing effort put forth by healthcare businesses to ensure that they are up-to-date on all licensing and regulatory requirements.

State, local, and federal agencies may require compliance with a long list of ever-changing rules and directives. It is the responsibility of the business to maintain awareness of those regulations and to ensure that they are operating according to standards and providing proof of that when necessary.

Laboratory Compliance Specialist Definition

When it comes to maintaining laboratory compliance, a laboratory compliance specialist is essential. Sometimes called compliance officers, these professionals are responsible for keeping up with the latest changes and requirements and making sure that the company is doing everything they need to do.

This doesn’t just mean coming in once a year to check that everything is in compliance or responding when there is a violation. It means creating a compliance program that includes policies, processes, and procedures that ensure continual compliance.

Additionally, if there is an audit, investigation, or suspicion of a violation, the laboratory compliance specialist will dive into the problem, handle whatever results from the audit, and adjust policies and procedures accordingly.

Does Your Healthcare Business Need a Laboratory Compliance Plan?

Learn more about how laboratory compliance can impact your healthcare business legally and create a laboratory compliance plan that will protect you in court when you call Florida Healthcare Law Firm now.

Preparing to Sell Your Laboratory

prepare a lab for sale

prepare a lab for saleBy: Dean Viskovich

COVID is front and center in all aspects of everyday life and has shined light in the strangest of places that were usually in the dark. In healthcare the laboratory space has always taken a backseat to other sectors in terms of recognition and value. The current climate in the lab space has shifted and it is not an illusion, labs are front and center.

COVID has taken its toll on areas of the economy and investors are certainly one of the first to become aware of this situation. Clinical laboratories are currently an attractive acquisition target and the reasons are numerous, sectors like retail, entertainment and travel are performing poorly and investors are shifting their investment dollars into healthcare and technology.  Investors are looking for growth and profitability and are finding it in healthcare.  Mergers and Acquisitions (M&A) is nothing new in the lab industry, but now careful consideration is required when it comes to deciding the appropriate time to sell your lab.

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A Self-Audit Checklist for Laboratories

By: Dean Viskovich

The Office of Inspector General (OIG) and other Federal agencies charged with responsibility for enforcement of Federal law have emphasized the importance of voluntarily developed and implemented compliance plans.  The government, especially the OIG, has a zero- tolerance policy towards fraud and abuse and uses its extensive statutory authority to reduce fraud in Medicare and other federally funded health care programs.  The OIG believes that through a partnership with the private sector, significant reductions in fraud and abuse can be accomplished.  Compliance plans offer a vehicle to achieve that goal.  The OIG has provided a model compliance plan for clinical laboratories to assist laboratory providers in crafting and refining their own compliance plans.

The OIG suggests that the comprehensive compliance program should include the following elements:

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The Most Important Role in the Clinical Lab Space: Lab Director

By: Dean Viskovich

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988.  CLIA established quality standards for all laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results regardless of where the test was performed.  In 2003, the Centers for Disease Control and Prevention (CDC) and the Centers for Medicare and Medicaid Services (CMS) published the CLIA Quality Systems laboratory regulations.  The quality system approach includes a laboratory’s policies, processes, procedures, and resources needed to obtain consistent, high quality testing services.

The laboratory must be under the direction of a qualified person and that person must fulfill all responsibilities of the lab director as outlined by CLIA.  CLIA prohibits a laboratory director from directing more than five non-waived laboratories.  Some states may have additional restrictions regarding the number of labs the lab director can direct. The lab director must meet education and experience requirements to hold the position and meet all requirements of the position.  The responsibilities include ensuring that there are sufficient personnel with adequate experience and training and make sure that every position in the lab is staffed by a person who is qualified to have the position and can perform all tasks required of the position.Continue reading

COVID Vaccine Administration and Billing

By: Dean Viskovich

On November 13, 2020 Centers for Medicare and Medicaid Services (CMS) announced that all Americans will have access to the COVID-19 vaccine at no cost.  CMS has clearly communicated to private insurers, Medicaid programs and Medicare that it is their responsibility to cover the vaccine at no charge to beneficiaries.  CMS states that Operation Warp Speed ensures that States, provider’s and health plans have the information and direction they need to ensure broad vaccine access and coverages for all.  As a condition of receiving free COVID-19 vaccines from the federal government, providers will be prohibited from charging consumers for administration of the vaccine.

Beneficiaries with Medicare will not pay anything for the COVID-19 vaccine and their coinsurance/copayment and deductible amounts will be waived.  In 2021, for Medicare Advantage beneficiaries, Medicare will pay directly for the vaccine and its administration for those enrolled in MA plans.  MA plans are not responsible for reimbursing providers to administer the vaccine.  MA beneficiaries do not pay for the vaccine and copayment/coinsurance and deductibles are waived.Continue reading

Laboratory Compliance Services With Expert Lab Lawyers

Contact the Florida Healthcare Law Firm today for your legal laboratory compliance questions. Initial consultations are free and we offer general counsel services on per project or a monthly basis.

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