Follow Guidance on Lab Information Change Form

Laboratory administrators see a lot of forms. Becoming familiar with the latest procedural guidance can help administrators avoid confusion and delays when a lab must notify a state agency of certain changes.

The Centers for Medicare & Medicaid Services (CMS) Central Office is providing additional guidance specific to laboratory changes that require a new Form CMS-116 and changes that require only written notification.

Titled Procedural Guidance for Clinical Laboratory Improvement Amendments (CLIA) Form CMS-116 Changes that Require a New Form CMS-116 or Written Notification (UPDATED), the memorandum summarizes when laboratory changes require a new Form CMS-116 to be completed and when written notification of a change is sufficient.

Each Form CMS-116 must be retained for at least seven years.

Some changes that require a new Form CMS-116 include an initial application; an initial or recertification survey; reinstatement of a CLIA certificate; exceptions for multiple or temporary sites; and change in director or ownership.

Some changes that would require written notification include name or location of lab; telephone number or email address; tax ID; specialty or subspecialty change; total test volume change; change in accreditation organization; reinstatement; multiple-site information; voluntary closure or termination; or technical supervisor.

No More Waiting for a Paper Envelope

Clinical laboratories that achieve Clinical Laboratory Improvement Amendments (CLIA) certification now can receive their certificates electronically.

The Centers for Medicare & Medicaid Services (CMS) on March 23 announced the launch of electronic certificates for laboratories that opt in to receive notifications by email on their CLIA application forms CMS-116.

As of late March, a lab can receive an email from the Division of Clinical Laboratory Improvement and Quality (DCLIQ) with a link to its CLIA certificate. The lab can print its own hard copy of the certificate. Labs also will continue to receive paper copies via mail until paper certificates are phased out.

A lab that wishes to opt in for email notifications can contact its state agency.

Join the Monthly Laboratory Systems Call

Block off time on the third Monday of each month to join the Division of Laboratory Systems for a one-hour call on topics such as recent discussions of emergency preparedness and response and the Food and Drug Administration’s resiliency program. The next call is scheduled for Monday, April 17, from 3 to 4 p.m. ET.

Attendance for the call is limited to 5,000 participants, but audio, transcripts, and slides will be posted online by the following Monday in the LOCS Calls Archive.

To submit a question, email [email protected] in advance or use the Question & Answer (Q&A) function in Zoom during the call.

Watch this page for each month’s Latest News from LOCS post, including the Zoom link or telephone numbers. If you plan to join by phone, install the Zoom App for Android or for iOS for the best experience. For questions, contact [email protected].

To receive emails from the Centers for Disease Control and Prevention (CDC) Laboratory Outreach Communication System (LOCS), opt in.

Authorization: FDA Allows Traditional Premarket Review

The U.S. Food and Drug Administration (FDA) has granted marketing authorization of Quidel’s Sofia 2 SARS Antigen+ FIA, Sofia SARS Antigen FIA Control Swab Set.

The set is intended for prescription use only for the detection of the COVID-19 virus within six days of symptom onset and can be used in a point-of-care setting. The test aids in the diagnosis of COVID-19 for people experiencing symptoms and is to be repeated twice over three days with at least 48 hours between tests.

“Marketing authorization of the first COVID-19 antigen test underscores our ongoing commitment to maintain access to testing long-term,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “We look forward to working with developers of all test types who are interested in moving their products through our traditional review pathways and encourage those who are ready to do so as soon as possible.”

Along with this De Novo request authorization, the FDA is establishing criteria called “special controls” that define certain requirements including required labeling and performance testing to help provide a reasonable assurance of safety and effectiveness for tests of this type. This action also creates a new, Class II regulatory classification for simple devices to directly detect SARS-CoV-2 viral targets from clinical specimens in point-of-care settings or at home use, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) pathway.

Authorization: First OTC At-Home Test Detects Flu and COVID-19

The U.S. Food and Drug Administration has issued an emergency use authorization (EUA) for the first over-the-counter (OTC) at-home diagnostic test that can identify and tell the difference between influenza A and B, commonly known as the flu, and SARS-CoV-2, the virus that causes COVID-19.  

The Lucira COVID-19 & Flu Home Test is a single-use test for individuals with signs and symptoms consistent with a respiratory tract infection, including COVID-19.  

This test can be used for people ages 14 years or older with a self-collected nasal swab sample or ages 2 and older when an adult collects the nasal swab sample. Results are provided in 30 minutes or less.

Recall: Universal Meditech’s Skippack Medical Lab Rapid Test

Universal Meditech Inc. has underway a nationwide recall of 56,300 Skippack Medical Lab SARS-CoV-2 Antigen Rapid Test Kits. The kits were distributed without premarket clearance or approval, which potentially could result in inaccurate test results due to lack of performance evaluation by the FDA.

A recall of the same device has been previously conducted by SML Distribution LLC.

Consumers should stop using the test kits immediately and contact the distributor for product return.

Recalled products were manufactured from October 2021 to December 2021 and distributed in January 2022. The recall was initiated in December 2022.

Here to Help

Accreditation Commission for Health Care (ACHC) supports your efforts to deliver safe, high-quality patient care and appreciates hearing from you. Email [email protected] or call (855) 937-2242.