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

Universal Citation: 14 NY Comp Codes Rules and Regs ยง 676.3

Current through Register Vol. 46, No. 39, September 25, 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.

(l) The certified diagnostic and research clinic shall obtain prior approval from OPWDD to:

(1) change the address or physical location of the diagnostic and research clinic or to utilize additional physical locations or premises or parts of premises;

(2) initiate any changes in the overall provision of services to the individuals with developmental disabilities served by the clinic;

(3) change the powers or purposes set forth in any certificate of incorporation or partnership agreement or New York State statute pertaining to its designation, certification, operation or administration; or

(4) become affiliated with another institution(s).

(m) The certified diagnostic and research clinic shall obtain the informed consent of the person with a disability if possible, and/or the correspondent of the person with a disability, before conducting diagnostic or evaluation procedures or experimental diagnostic, evaluation and treatment procedures for an individual.

(n) The certified diagnostic and research clinic shall notify the commissioner of OPWDD within 90 days of any intention to voluntarily terminate its operation or any part of its operation. This notice of intention shall include a statement of the actions that will be taken by the clinic's administrative and clinical staff to ensure:

(1) appropriate continued service for individuals with developmental disabilities being served by the diagnostic and research clinic;

(2) the confidentiality of records; and

(3) that outstanding obligations, debts and accounts receivable are settled according to the requirements established in particular agreements and contracts.

(o) Nothing in this Part shall prevent the diagnostic and research clinic from establishing provider agreements with certified generic or specialized community providers or from affiliating itself with accredited universities or teaching hospitals, or with departments in such universities or teaching hospitals; or to prevent the free exchange and communication between researchers and clinicians in the health and/or human sciences.

(p) Operating certificates issued under this Part are not transferable.

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