New York Codes, Rules and Regulations › Title 10 - DEPARTMENT OF HEALTH › Chapter V - Medical Facilities › Subchapter A - Medical Facilities-minimum Standards › Article 1 - General › Part 404 - INTEGRATED OUTPATIENT SERVICES › Section 404.15 - Inspection

Current through Register Vol. 46, No. 28, July 10, 2024
(a) The state
					 licensing agency with authority for the host clinic shall have ongoing
					 inspection responsibility for the integrated services clinic, pursuant to this
					 Part. The purpose of the inspection is to ensure compliance with all applicable
					 laws, rules, and regulations, as well as to determine the renewal term of the
					 operating certificate or license, as applicable. Inspection activities shall
					 not be duplicated.
(b) The host
					 state licensing agency shall consult with the adjunct state licensing agency on
					 matters specific to the provision of such add-on services, as may be necessary
					 to assure patient health and safety. Any significant deficiencies will
					 immediately be referred for enforcement to the responsible state licensing
					 agency. If at any point during the inspection, findings are identified that
					 suggest imminent risk of serious harm or injury to patients, the inspector(s)
					 will immediately contact their supervisor, who will consult with the adjunct
					 state licensing agency, as applicable.
(c) Inspections shall be conducted utilizing
					 a joint-licensing instrument, developed collaboratively by the three state
					 licensing agencies. This standardized procedure will ensure consistency of the
					 inspection process throughout the State and provide standardized reviews of the
					 operations and services at each integrated services clinic. All deficiencies
					 and/or corrective action will be overseen by the monitoring state licensing
					 agency with notice to the adjunct state licensing agency or agencies, as
					 applicable.
(d) Each integrated
					 services provider shall undergo an unannounced inspection which will occur
					 prior to renewal of the Operating Certificate or License.
(1) At the start of the inspection, the
					 inspector(s) will meet with integrated services clinic administrative staff to
					 explain the purpose and scope of the inspection and request any documentation
					 (e.g., policies; staffing information; etc.) that may be needed to facilitate
					 the review.
(2) The inspection will
					 include, but not be limited to, the following areas of review:
(a) on-site inspection of clinic appearance,
					 conditions and general safety;
(b)
					 evaluation of the sponsor, its management systems, and procedures;
(c) patient case record review;
(d) interviews of staff and
					 patients;
(e) examination of
					 staffing patterns and staff qualifications;
(f) analysis of statistical information
					 contained in reports required to be submitted by the clinic;
(g) compliance with the reporting
					 requirements;
(h) verification of
					 staff credentials, as applicable;
(i) incident reporting requirements;
					 and
(j) such other operating areas
					 of activities as may be necessary or appropriate to determine compliance with
					 applicable laws and regulations.
(3) At the conclusion of the inspection, the
					 inspector(s) will meet with the integrated services clinic administrative staff
					 to discuss all deficiencies identified during the
					 inspection.