The Clinical Laboratory Evaluation Program (CLEP) within the Wadsworth Center has taken an important step to support the expansion of Hospital at Home (HaH) services in New York State. CLEP, which has regulatory oversight authority for all clinical laboratories under Article 5, Title 5 of the New York State Public Health Law (PHL), ensures that any facility performing tests on human-derived materials meets state standards for quality and safety. This authority applies not only to hospital-based laboratories but wherever testing is performed – including at home.
Under current law and regulation, each physical location where testing occurs must hold a laboratory permit. As a result, hospitals planning to provide HaH services could not perform point-of-care testing in patients’ homes because their clinical laboratory permit authorizes testing at a single, fixed location.
Several New York hospitals are preparing to launch or expand HaH programs, an increasingly important and effective model of acute patient care. To avoid delaying access to diagnostic testing essential for these programs while formal regulatory revisions are pursued – a process that can take considerable time – CLEP has developed and adopted an interim policy allowing hospitals to conduct limited point-of-care testing in patient homes under specific conditions. This temporary policy enables HaH programs to operate safely while the Department undertakes the longer regulatory update necessary to permanently support this model of care.
CLEP is pleased to announce the first approval under this interim policy: NewYork-Presbyterian has launched its Hospital at Home program, which will include point-of-care clinical testing conducted in accordance with the new policy. (www.nyp.org/news/nyp-launches-hospital-at-home-to-deliver-care-in-the-comfort-of-home) This action reflects the Wadsworth Center’s commitment to modernizing clinical laboratory oversight in ways that protect patient safety while enabling innovative care models across New York State.