(a) Each diagnostic and research clinic shall have a governing body.

1. (1) In the case of a diagnostic and research clinic operated by OPWDD as part of an established OPWDD research institute, OPWDD shall function as governing body.
2. (2) The governing body for such clinics not operated by OPWDD may be an individual or a group. For clinics operated as part of an OPWDD institute, OPWDD may appoint a director of the overall institute who shall act as OPWDD's designee and who is responsible to OPWDD.

3. (3) The governing body or the OPWDD-appointed director shall be responsible for the diagnostic and research clinic's general direction, operations policies, and shall:

   1. (i) be legally responsible for the clinic's overall operation and management;
   2. (ii) ensure that the clinic has adequate and modern administrative support to efficiently meet the needs of the individuals with developmental disabilities served by its facilities; administrative support includes clinical, communication, financial, housekeeping, laundry, personnel, physical plant safety and security, supplies, and purchasing services;
   3. (iii) ensure that the facility has a plan for a management audit, and that such audit is conducted at least annually; this audit shall determine if the clinic complies with all applicable State laws, regulations and policies;
   4. (iv) ensure that the health, safety, welfare, well-being and civil, human and legal rights of individuals with developmental disabilities served by the diagnostic and research clinic are protected, upheld and fostered;
   5. (v) ensure that agreements with other providers and with community groups have been developed to ensure that individuals with developmental disabilities receive the specialized assessments and clinical laboratory tests required to perform comprehensive diagnosis and evaluations; and assist such persons to receive the programs, treatment and care appropriate to their disabilities; and
   6. (vi) maintain minutes of its official meetings and the decisions made in relation to the operation of the diagnostic and research clinic, and maintain a record of follow-up actions accomplished based on such decisions.

(b) Each diagnostic and research clinic shall have a clinical director who is appointed by the governing body or its designee.

1. (1) The clinical director shall be responsible for the continuous day-to-day operation and control of the clinic.
2. (2) The clinical director shall be responsible for the clinical services and administrative activities of the clinic, including all outpatient diagnostic and assessment services and residential services. The clinical director shall also be responsible for ensuring that the services provided to individuals with developmental disabilities at the clinic comply with the intent and requirements of this Part and the intent and requirements of other appropriate laws and regulations.
3. (3) The clinical director shall either be certified as a clinical laboratory director, in accordance with 10 NYCRR Part 19, and thereby be responsible for the operation of the clinical laboratory, or someone else certified as a clinical laboratory director shall be designated to oversee the operation of the clinical laboratory.

4. (4) The clinical director of the diagnostic and research clinic shall:

   1. (i) designate an individual to be responsible for the administrative direction of the clinic at all times when the clinical director is absent;
   2. (ii) maintain a current table of organization which shows the diagnostic and research clinic's major programs and services, the clinic's relationship to other divisions operated by the overall facility, the administrative personnel in charge of the programs and services and the lines of authority, responsibility and communication. This table of organization shall identify the person(s) and/or divisions providing services to the individuals with developmental disabilities, including staff shared between divisions and/or the relation between the clinic and other providers of service, if applicable;

   3. (iii) ensure, in conjunction with the overall facility director, governing body or with other professionals in the field, whichever is appropriate, that standing committees are established to address issues that relate to:

      1. (a) aversive conditioning;
      2. (b) human rights;
      3. (c) incident review (including but not limited to reviewing accidents, death, abuse, mistreatment, neglect, adverse drug reactions, medication errors and the use of restraints);
      4. (d) infection control;
      5. (e) research and experimentation review and appropriate informed consents;
      6. (f) professional advisory board on clinical/research coordination;
      7. (g) admission to outpatient, laboratory and residential services; and
      8. (h) utilization review of admissions and subsequent and continued treatment review for outpatient, clinical laboratory and/or residential services;

   4. (iv) establish a manual of policies and procedures concerning the operation and administration of the diagnostic and research clinic and the well-being of the individuals served by it, and ensure that such policies and procedures are followed in topics not limited to the following:

      1. (a) the clinic's role in the State's programs for individuals with developmental disabilities;
      2. (b) the clinic's philosophy, goals and service objectives;
      3. (c) administrative organization and facility specific personnel, practices and conditions;
      4. (d) type and scope of services provided by clinic;
      5. (e) structure, functions and characteristics of services provided to individuals with developmental disabilities;
      6. (f) description of the clinic's relationships to individuals with developmental disabilities, families, community, professional committees and organizations, universities and other clinics and programs for individuals with developmental disabilities;
      7. (g) composition and activities of standing committees;
      8. (h) responsibilities of facility director;
      9. (i) responsibilities and qualifications of clinical director;
      10. (j) responsibilities and qualifications of clinical laboratory director;
      11. (k) responsibilities and qualifications of clinical and laboratory staff;
      12. (l) admission and rejection criteria and prescription for follow-up services;
      13. (m) criteria for ordering specialized services;
      14. (n) interdisciplinary team process and the development of a recommended treatment plan;
      15. (o) admission criteria for individuals authorized to receive additional medical and/or specialized clinical laboratory services during the course of an evaluation (see section 676.5[b] of this Part);
      16. (p) list of tests performed within each specialized clinical laboratory area; and
      17. (q) clinic's staffing pattern.