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Additionally, at 419.46(e)(3), 419.95(g)(3), and 416.310(d)(3), we proposed that we may grant an ECE to one or more hospitals, REHs, or ASCs that have not requested an ECE if we determine that: a systemic problem with a CMS data collection system directly impacted the ability of the hospital, REH, or ASC to comply with a quality data reporting requirement, or that an extraordinary circumstance has affected an entire region or locale

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All products are shipped in lyophilized or powder form and must be reconstituted prior to laboratory testing, often using bacteriostatic water for laboratory reconstitution