Test Volume Determination for CLIA

Each laboratory completes the Centers for Medicare & Medicaid Services’ CMS 116 application form as part of the process to obtain a Clinical Laboratory Improvement Amendment (CLIA) certificate. Data collected on this document includes the annual test volume for each specialty and subspecialty. This annual test volume is used by CMS for the calculation of applicable fees.

As part of the accreditation reapplication process, each laboratory is required to provide its annual test volume for non-waived tests conducted in each specialty and subspecialty. The test volume provided by your organization will be compared to previously reported volume and verified in the application process. If there is a significant change in test volume, we will contact you to verify that test volume was accurately counted.

Calculating Test Volumes

CLIA has published guidelines for the proper calculations of test volumes. Do not count calculations (e.g., A/G ratio, MCH, T7, etc.), quality control, quality assurance, or proficiency testing assays.

The table below outlines specific counting instructions for those tests commonly performed.

SARS-CoV-2 Information

SARS-CoV-2: Packaging and Shipping

Do you pack and ship specimens for SARS-CoV-2 testing? Check out CDC’s quick reference guide (available in PDF and PowerPoint versions) adapted from the CDC Laboratory Training course, Packing and Shipping Dangerous Goods: What the Laboratory Staff Must Know.  

Quidel Recalls Lyra SARS-CoV-2 Assay (M120) Due to Risk of False Negative Results

Quidel is recalling its Lyra SARS-CoV-2 Assay (M120) due to a significant risk of false negative results for patients with relatively high amounts of SARS‐CoV‐2 virus. False negative results may lead to delayed diagnosis or treatment of SARS-CoV-2, which may cause patient harm including serious illness and death. Read the full recall notice here.

Updates from CDC

Changes to CDC RT-PCR for SARS-CoV-2 Testing

After December 31, 2021, CDC will withdraw the request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel, the assay first introduced in February 2020 for detection of SARS-CoV-2 only.

CDC is providing this advance notice for clinical laboratories to have adequate time to select and implement one of the many FDA-authorized alternatives. Visit the FDA website for a list of authorized COVID-19 diagnostic methods. For a summary of the performance of FDA-authorized molecular methods with an FDA reference panel, visit this page.

SARS-CoV-2 Variant Classification Updates

On July 20, 2021, CDC announced that SARS-CoV-2 variant AY.3 is now aggregated with Delta variant B.1.617.2. As new data become available, CDC will continue to evaluate the independent classifications of AY.1, AY.2, and AY.3.

Additionally, SARS-CoV-2 variant P.2 (Zeta) is no longer classified as a variant of interest due to declining prevalence and very few detections in recent months. CDC continues to monitor all variants circulating within the United States.

For more information, visit the SARS-CoV-2 Variant Classifications and Definitions page and the COVID Data Tracker.

FDA Revokes EUA for Curative SARS-CoV-2 Assay

On July 15, 2021, the U.S. Food and Drug Administration (FDA) revoked the emergency use authorization (EUA) for the Curative SARS-CoV-2 Assay. Effective immediately, laboratories and testing sites should discontinue use of the Curative test. Refer to the FDA Letter of Revocation for more information.

CDC Health Advisory

This information is being provided at the request of the CDC subject-matter experts for Burkholderia pseudomallei.

The Georgia Department of Public Health, with assistance from the U.S. Centers for Disease Control and Prevention (CDC), is investigating a fatal case of Burkholderia pseudomallei infection (i.e., melioidosis) identified in late July 2021. Based on genomic analysis, this case in Georgia closely matches the three cases previously identified in Kansas, Minnesota, and Texas in 2021, indicating that all four cases most likely share a common source of exposure.

The Kansas Department of Health and Environment, the Minnesota Department of Health, and the Texas Department of State Health Services continue to investigate the three previous cases with assistance from CDC. This Lab Alert serves as an update to the previous Lab Alert issued on July 1, 2021.

What Laboratories Should Know 

• Culture of B. pseudomallei from any clinical specimen is considered diagnostic for melioidosis. Ideal specimens for culture include blood, urine, throat swab, and, when relevant, respiratory specimens, abscesses, or wound swabs.
• Because cultures may grow B. pseudomallei, it’s important for laboratory personnel to observe appropriate laboratory safety precautions. 
• Laboratory testing involving automated identification algorithms (e.g., MALDI-TOF, 16s, VITEK-2) may misidentify B. pseudomallei as another bacterium. The isolate from the Texas case was initially misidentified as B. thailandensis by MALDI-TOF. 
• If B. pseudomallei is identified or an organism is suspicious for B. pseudomallei, contact your state or local public health laboratory or Laboratory Response Network (LRN) Reference Laboratory immediately.

CDC has also issued a health alert notification (HAN) to inform physicians about this situation and provide recommendations. 

Any questions or comments regarding this message should be directed to your state or local public health laboratory.

Meeting the Challenge

This year's HFAP Quality Review, Meeting the Challenge, examines the most frequent deficiencies cited in 2020 across hospital, clinical laboratory, and ambulatory surgery center surveys. 

Want to learn more about ACHC Clinical Laboratory Accreditation?
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Latest ACHC Podcast Examines the Value of Asking What Matters

In ACHC's latest podcast, we speak with Dr. Alice Bonner of the Institute for Healthcare Improvement about the benefits of building a deeper personal connection between clinicians, patients, and patients' families. Listen now to Episode 4: What Matters to You?