Title: Section 404.15 - Inspection

404.15 Inspection

(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.

(e) Upon completion of the inspection, a written report will be provided to the integrated services clinic which describes the results of the inspection, including each regulatory deficiency identified, if any. The provider of services shall take all actions necessary to correct all deficiencies reported. The provider of services shall submit a plan of correction to the state licensing agency with authority for the host clinic within 30 days, which states the specific actions taken or planned to achieve compliance with identified requirements. Any planned actions described in the plan of correction must be accompanied with a timetable for their implementation.

(f) If the provider of services fails, within the specified or an otherwise reasonable time, to correct any reported deficiencies, or fails to maintain satisfactory compliance with applicable laws, rules and regulations, the commissioner of the state licensing agency with authority for the host clinic may revoke, suspend or limit the operating certificate or license or levy a civil fine for such failures, in accordance with applicable regulations.

(g) Concurrently, each integrated services clinic shall undergo a fiscal viability review which will include an assessment of the financial information of the provider of services. Such information shall be submitted in intervals and in a form prescribed by the state licensing agency with authority for the host clinic, for compliance with minimum standards established by the state licensing agency, in order to determine the provider's fiscal capability to effectively support the authorized services.

(h) Providers of services that fail to meet the minimum standards of the state licensing agency with authority for the host clinic shall be required to submit a corrective action plan setting forth the specific actions to be taken to meet the minimum standards within a reasonable time frame.