N.Y. Comp. Codes R. & Regs. tit. 10 § 703.6

Current through Register Vol. 46, No. 45, November 2, 2024

Section 703.6 - Part-time clinics

(a) Applicability. In lieu of Parts 702, 711, 712 and 715 of this Title, this section shall apply to part-time clinic sites, except for those operated by the State Department of Health (other than those part-time clinics which are operated as an extension of article 28 hospitals operated by the State Department of Health) or by the health department of a city or county as such terms are defined in section 614 of the Public Health Law. Such cities and counties shall submit to the State Department of Health information which lists the location(s), hours of operation and services offered at each part-time clinic operated by or under the authority of the city or county health department. This information shall be submitted annually, by January 30th of each year, as an update to the Municipal Public Health Services Plan (MPHSP) submitted by the city or county pursuant to section 602 of the Public Health Law, and shall provide such information for each part-time clinic operated by or under the authority of the city or county health department in the previous calendar year. Consistent with the definition of part-time clinic site in section 700.2(a)(22) of this Title, a part-time clinic shall:

(1) provide services which shall be limited to low-risk (as determined by prevailing standards of care and services) procedures and examinations which do not normally require backup and support from the primary delivery site of the operator or other medical facility. Such services may include health screening (such as blood pressure and HIV screening), preventive health care and other public health initiatives (such as HIV services), procedures and examinations (such as well child care, the provision of immunizations and screening for chronic or communicable conditions which are treatable or preventable by early detection or which are of public health significance);

(2) be located at a site that has adequate and appropriate space and resources to provide the intended services safely and effectively and is located in proximity to the primary delivery site to ensure that supervision and quality assurance are not compromised; and

(3) not be located at a private residence or apartment, an intermediate care facility, an individualized residential alternative, congregate living arrangements (not including a shelter for adults or other group shelter operated by governmental or other organizations to provide temporary housing accommodations in a safe environment to at-risk populations), an area within an adult home, a residence for adults or enriched housing program as defined in section 2 of the Social Services Law, unless the part-time clinic is operated as part of an approved State Department of Health public health initiative. A part-time clinic also shall not be located in space which is part of another facility licensed under article 28 of the Public Health Law, unless such part-time clinic is operated as part of an approved State Department of Health public health initiative, or in space which is part of the private office of a health care practitioner or group of practitioners licensed by the State Education Department.

(b) Department approval and/or notification.

(1) An operator of part-time clinics may initiate patient care services at a specific site only upon written approval from the department in accordance with the department's limited review process set forth at section 710.1(c)(5)(iv)(e) of this Title. To request such approval, the operator shall submit to the department, for each such site, information and documentation in a format acceptable to the department and in sufficient detail to enable the commissioner to make a decision, including the following:

(i) the location, type and nature of the building, days and hours of operation, expected duration of operation (specified limited period of time, for example, seasonally), staffing patterns and objectives of the part-time clinic;

(ii) the leasing or other arrangement for gaining access to the site's real property, (including a copy of the agreement which grants the applicant the right to use and occupy the space for the part-time clinic site);

(iii) the plans and strategies for meeting the operational standards set forth in this section and an explanation of how the operator will provide adequate supervision and ensure quality of care;

(iv) a listing of all part-time clinic sites already operated by the applicant;

(v) a description of the services to be provided and the populations to be served;

(vi) procedures or strategies for advising patients on making arrangements for follow-up care; and

(vii) the annual aggregate number of part-time clinic services (based on the number of visits) already provided by the applicant and the percentage such visits represent of all outpatient visits provided by the applicant, the number of visits anticipated to be provided at the new part-time clinic and the impact such new site will have on the percentage of the applicant's total annual outpatient visits that will be part-time clinic visits.

(2) After initiating patient care services, an operator of part-time clinics may relocate a part-time clinic or change a category of service only upon written approval from the department in accordance with the department's limited review process as set forth in section 710.1(c)(5)(iv)(e) of this Title. To request approval, the operator shall submit to the department, for the site of relocation, change in hours of operation or change in services, information concerning:

(i) the location, type and nature of the building, days and hours of operation, and expected duration of operation (specified limited period of time, for example, seasonally);

(ii) the leasing or other arrangement for gaining access to the site's real property (including a copy of the agreement which grants the applicant the right to use and occupy the space for the part-time clinic site);

(iii) a description of the services to be provided and the populations to be served; and

(iv) the type of information concerning the volume of visits as required under subparagraph (i)(vii) of this subdivision.

(3) After initiating patient care services, the operator shall give written notification, including a closure plan acceptable to the department, to the Director of the Bureau of Hospital and Primary Care Services of the department at least 15 days prior to the discontinuance of a part-time clinic site other than a scheduled discontinuance as indicated in accordance with subparagraph (1)(i) of this subdivision. No part-time clinic site shall discontinue operation without first obtaining written approval from the department.

(4)

(i) The operator of any part-time clinic that was in operation on August 15, 2000, and in conformance with all pertinent statutes and regulations in effect prior to that date, and has submitted request(s) to the department for approval to continue providing services for each such site by November 13, 2000, in accordance with requirements in effect at that time shall be permitted to operate until and unless the department issues a written denial of approval to continue operation. If a request to continue operation of a part-time clinic site is denied, the operator shall, within 30 days of receipt of such denial submit to the department and obtain written approval of a closure plan consistent with the provisions of paragraph (3) of this subdivision for the expeditious termination of services at the site. Notwithstanding any other provision of this section, the operator of such part-time clinic site shall cease providing services at and close such site within 60 days of receipt of the notice of denial to continue operation regardless of whether a plan of closure has been approved by the department.

(ii) The operator of any part-time clinic site for which an application to continue providing services at such site was not submitted to the department by November 13, 2000, shall cease operations by December 31, 2000.

(c) Policies and Procedures.

(1) The operator shall ensure the development and implementation of written policies and procedures specific to each part-time clinic site, which shall include, but need not be limited to:

(i) security, confidentiality, maintenance, access to and storage of medical records for each patient, including documentation of any diagnoses or treatments;

(ii) handling and storage of drugs in accordance with state law and regulation;

(iii) standards for maintaining asceptic conditions including the provision and storage of sterile supplies; sterilization equipment as necessary; disposal of contaminated supplies, equipment and medical waste; sharps disposal; and hand washing;

(iv) the prohibition of smoking within the facility;

(v) handling of patient emergencies, including written transfer agreements with hospitals within the service area;

(vi) a fire plan consistent with local laws;

(vii) training and education of staff in fire safety, evacuation and emergency procedures specific to each site, including those policies established by the building owner or operator;

(viii) credentialing of staff by the governing authority of the operator and assurance that only appropriately licensed and/or certified staff perform functions that require such licensure or certification;

(ix) quality assurance/improvement initiatives coordinated with such activities at the operator's primary delivery site(s);

(x) utilization review;

(xi) community outreach efforts designed to ensure that community members are aware of the availability of and the range of clinic services and hours of operation; and

(xii) assurance that patients can access necessary services without regard to source of payment.

(2) The following services shall not be provided at a part-time clinic site:

(i) services that require specialized equipment such as radiographic equipment, computerized axial tomography, magnetic resonance imaging or that required for renal dialysis;

(ii) services that involve invasion or invasive treatment procedures or disruption of the integrity of the body that normally require a surgical operative environment; and

(iii) services other than those available at the primary delivery site(s) listed on the primary facility's operating certificate.

(d) Services and personnel. The operator shall ensure that all health care services and personnel provided at the part-time clinic site shall conform with generally accepted standards of care and practice and with the following:

(1) part-time clinics operated by hospitals shall comply with pertinent standards established in Part 405 of this Title including, but not limited to, sections 405.7 (Patients' rights) and 405.20 (Outpatient services), which cross-references the outpatient care provisions of sections 752.1 and 753.1 of this Title; and

(2) part-time clinics operated by diagnostic and treatment centers shall comply with the pertinent provisions of Parts 750, 751, 752 and 753 of this Title including, but not limited to, section 751.9 (Patients' rights).

(e) Environment. The operator shall ensure that:

(1) the site is located in a building that complies with all applicable building construction and fire safety regulations and is acceptable to the local authority having jurisdiction, as evidenced by a valid certificate of occupancy or other written documentation;

(2) exits and access routes to exits are readily identified and accessible to patients and staff during all hours of occupancy or operation;

(3) continuous lighting, including provisions for emergency lighting in the event of electrical power interruptions, is provided for all exit route components and signage, during all hours of occupancy or operation;

(4) passageways, corridors, doorways and other means of exit are kept unobstructed; and

(5) all water used at the part-time clinic site is provided from a water supply which meets all applicable standards set forth in Part 5 of this Title.

(f) Limitation on the size of part-time clinic programs. An operator of part-time clinic sites shall limit the size and scope of its total part-time clinic program and operations so that the annual aggregate number or amount of outpatient services (based on the number of visits) provided by an operator at all of its part-time clinic sites in the aggregate does not exceed 20 percent of all outpatient services visits provided by such operator at all of its article 28 sites, so that at least 80 percent of all outpatient visit services provided by such operator must be provided at its main site of operation and/or approved extension clinics. Operators of part-time clinics who are not in compliance with the requirements of this subdivision on the effective date of this subdivision shall have 90 days from such effective date within which to come into full compliance with such requirements.

(g) Waivers. The commissioner, upon a request from the operator, may waive one or more provisions of this section upon a finding that such waiver would:

(1) enable at risk or medically underserved patients to obtain needed care and services, which are otherwise unavailable or difficult to access;

(2) contribute to attaining a generally recognized public health goal;

(3) not jeopardize the health or safety of patients or clinic staff; and

(4) not conflict with existing Federal or State law or regulation.

N.Y. Comp. Codes R. & Regs. Tit. 10 § 703.6