New York Codes, Rules and Regulations › Title 14 - DEPARTMENT OF MENTAL HYGIENE › Chapter XIV - Office for People With Developmental Disabilities › Part 676 - Diagnostic and Research Clinics › Section 676.3 - Certification

Current through Register Vol. 46, No. 28, July 10, 2024
(a) Each diagnostic
				and research clinic shall have a current operating certificate issued by
				OPWDD.
(b) A diagnostic and
				research clinic shall either be a distinct part of a general hospital
				accredited by the Joint Commission of Accreditation of Hospitals (JCAH) and
				certified under article 28 of the New York State Public Health Law or shall be
				part of an established research institute operated by OPWDD.
(c) A diagnostic and research clinic shall
				only be operated by New York State Office for People With Developmental
				Disabilities unless otherwise specified by the commissioner.
(d) Each diagnostic and research clinic
				certified under this Part shall operate a clinical laboratory as part of its
				facility, for the examination of microbiological, serological, chemical,
				hematological, biophysical, cytological or pathological materials derived from
				the human body, for the purpose of obtaining information for the diagnosis,
				evaluation, prevention or treatment of a disease and/or disability. Such
				clinics shall be required to have a valid clinic laboratory permit issued in
				accordance with section 574 of the New York State Public Health Law to perform
				such laboratory procedures. This provision shall be recommended but not
				mandated for clinical laboratories operated by diagnostic and research clinics
				that are themselves part of an established research institute operated by
				OPWDD.
(e) A certified diagnostic
				and research clinic which is part of an OPWDD operated research institute, but
				is not part of an article 28 certified hospital, (see subdivision [b] of this
				section) shall have on its premises an intermediate care facility for persons
				with developmental disabilities certified by OPWDD to provide residential care
				for those persons with developmental disabilities who are required to stay at
				the clinic for more than one day for diagnosis, evaluation, and, if
				appropriate, for approved and/or approvable experimental treatment. Persons
				with developmental disabilities staying in the clinic's ICF/DD residence shall
				be cared for according to the standards specified in this Part and in Part 681
				of this Chapter.
(f) An initial
				application to certify the operation of a diagnostic and research clinic or an
				application for the renewal of an existing operating certificate shall be
				submitted to the commissioner of OPWDD in the format specified by OPWDD and be
				subject to its review and approval procedures.
(g) Each operating certificate shall be valid
				for two years after the day of its issuance, and shall be issued to a
				diagnostic and research clinic which, after appropriate inspections, has been
				deemed to comply with the requirements stated herein and other applicable State
				and Federal requirements.
(h)
				Diagnostic and research clinics shall only be certified to bill for services
				specified in this Part. Such clinics shall be required to receive
				certification, pursuant to Part 679 of this Chapter, or the certification of
				another appropriate program, in the event that the clinic elects to provide
				treatment and active programming to individuals with developmental disabilities
				in addition to the provision of the clinical services stated herein or the
				services required by its ICF/DD.
(i) The certificate issued under this Part,
				and all other certificates required by this Part or other State and Federal
				standards, shall be displayed in a conspicuous place in the clinic so that it
				can be seen by anyone wishing to see it.
(j) All operating certificates shall remain
				the property of OPWDD and shall be returned to OPWDD upon request.
(k) The operating certificate may be
				suspended, revoked or limited as follows:
(1)
				The commissioner may revoke, suspend or limit the operating certificate upon
				his finding that a diagnostic and research clinic has failed to comply with the
				terms of the operating certificate or with the provisions of any applicable
				statute, rule or regulation. The director of the diagnostic and research clinic
				shall be given notice that such an action is pending and be given an
				opportunity to be heard prior to such action.
(2) Pending a determination pursuant to
				paragraph (1) of this subdivision, the commissioner may, upon written notice to
				the director of the diagnostic and research clinic, suspend the certificate
				upon his or her finding that the continued operation of the diagnostic and
				research clinic presents an immediate danger to the health and welfare of any
				of the individuals with developmental disabilities being served by the clinic
				or any of its related facilities such as the clinical laboratory and/or the
				ICF/DD.