Federal agencies and the Laboratory Outreach Communication System (LOCS) provide advisories, advice, and opportunities on topics ranging from monkeypox, melioidosis, and coronavirus to equipment recalls and training opportunities.
Unauthorized Viral Transport Media Containers Recalled
Haimen Shengbang Laboratory Equipment is recalling Viral Transport Media Containers because these products were distributed to U.S. customers without authorization, clearance, or approval from the U.S. Food and Drug Administration (FDA).
This means there is a risk for false negative, false positive, or misinterpretation of results from the use of these products.
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries, serious health consequences, or death.
Infection Prevention and Control of Monkeypox in Healthcare Settings
Human-to-human transmission of monkeypox in healthcare settings is rare. Still, the Centers for Disease Control and Prevention (CDC) provides infection prevention and control guidance for healthcare providers, including clinical laboratory professionals and those who collect specimens from patients. Refer to CDC guidance for information about how monkeypox spreads.
Personnel who collect specimens should use personal protective equipment (PPE) in accordance with recommendations for healthcare settings. When using proper PPE, a trained healthcare professional can safely collect specimens from patients to test for monkeypox virus or other diseases or conditions.
CDRH’s Experiential Learning Program Seeks 2023 Sites Technology is continuously evolving, and the FDA’s Center for Devices and Radiological Health (CDRH) Experiential Learning Program (ELP) provides CDRH review staff with an opportunity to visit sites and gain a better understanding of the products they review. The 2023 ELP Site Visit Proposal period is open now until 12 p.m. EST September 6, 2022.
CDRH encourages participation from medical device manufacturers, academia, and clinical facilities, medical device incubators and accelerators, health insurers, health technology assessment groups, and others, including those that have previously participated in the ELP or other FDA site visit programs.
The ELP Program:
Provides CDRH review staff with opportunities to better understand current industry policies, innovative technologies, laboratory practices, the effects of patient input on medical device development, and quality systems management.
Is a collaborative effort to close the knowledge gap between emerging and innovative technology and the pre-market review of the resulting medical devices.
Melioidosis Endemic in Areas of Mississippi Gulf Coast
On July 27, 2022, the U.S. Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory to alert clinicians and laboratory professionals in the United States to consider melioidosis in patients whose clinical presentation is compatible with signs and symptoms of the disease. The consideration should be made regardless of the patient’s travel history to international disease-endemic regions because melioidosis is now considered to be locally endemic in areas of the Gulf Coast region of Mississippi.
The HAN includes the following recommendations for laboratory professionals:
Laboratory automated identification algorithms (e.g., MALDI-TOF, 16s, VITEK-2) may misidentify pseudomallei as another bacterium. Consider re-evaluating patients with isolates identified on automated systems as Burkholderia spp. (specifically B. cepacia and B. thailandensis), Chromobacterium violaceum, Ochrobactrum anthropic, and, possibly, Pseudomonas spp., Acinetobacter spp., and Aeromonas spp.
Contact your state or local public health department immediately if you identify pseudomallei or if you suspect an organism of B. pseudomallei. The health department should forward the isolate to the closest state laboratory or to a Laboratory Response Network (LRN) laboratory for confirmation. State and LRN laboratories can send presumptive positives to CDC for confirmation as needed.
If an isolate is confirmed as pseudomallei, the state or LRN laboratory should forward the isolate to CDC for whole genome sequencing. Once isolates have been confirmed as B. pseudomallei, select agent regulations will apply.
On July 26, 2022, the U.S. Food and Drug Administration (FDA) issued a Laboratory Update for its FAQs on Testing for SARS-CoV-2 page to note that no tests remain on the commercial manufacturer serology test notification list described in FDA’s Policy for Coronavirus Disease-2019 Tests. All tests previously on the commercial manufacturer serology test notification list have either been issued an Emergency Use Authorization (EUA) or should no longer be distributed, marketed, or offered.
Ruling Affects Labs Performing Moderate- or High-Complexity Testing
For labs that perform moderate- to high-complexity texting and have enrolled in waived PT, regulations became effective August 10, 2022.
The effective date of the revisions to PT requirements (§§ 493.2 and 493.801 through 493.959) will be July 11, 2024, two years after the publication date of this final rule in the Federal Register.
The delayed effective date reflects the timeframe PT programs will need to produce or acquire PT samples to meet the revised regulations and incorporate any updates to PT reporting requirements. In addition, laboratories will need time to prepare and enroll in PT to meet the new requirements once the samples are available from the PT programs.
However, the regulations related to laboratories performing tests of moderate complexity and high complexity that also perform waived testing and proficiency testing enrollment (§§ 493.20 and 493.25) will be effective 30 days (August 10, 2022) after the publication date of this final rule.
Join us in person for another exciting ACHCU Academy. New this year: Special lab track for clinical laboratory professionals hosted by the Symposium for Clinical Laboratories, a brand of ACHCU. P.A.C.E. ® credit available.
Some content presented in “Did You Know?” may consist of timely or topical articles deemed to be of interest to the provider community. These are presented for informational purposes as a service to our readers. The views, opinions, and positions expressed by the authors are theirs alone and do not necessarily reflect the views, opinions, or positions of ACHC, its related entities, or any employee thereof.
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