(a) All facilities under the jurisdiction of the Office of Mental Health will be visited and inspected by reviewers designated by the Commissioner in accordance with the provisions of this Part. Unless otherwise specifically stated in this Part, reviewers shall be personnel of the Office who are competent and qualified to conduct such inspections.
(b) This Part supersedes and replaces Part 71 of this Title with respect to facilities under the jurisdiction of the Office of Mental Health.
§ 553.2 Legal base.
(a) Section 7.09 of the Mental Hygiene Law grants the Commissioner of Mental Health the power and responsibility to adopt regulations that are necessary and proper to implement matters under his or her jurisdiction.
(b) Subdivisions (a) and (b) of Section 7.15 of the Mental Hygiene Law authorize the Commissioner of Mental Health to evaluate programs and services of prevention, diagnosis, examination, care, treatment, rehabilitation, training, and research for persons with mental illness, and permits such activities to be undertaken in cooperation and agreement with other offices of the department and with other departments or agencies of the state, local or federal government, or with other organizations and individuals.
(c) Sections 31.02 and 31.04 of the Mental Hygiene Law authorize the Commissioner of Mental Health to set standards of quality and adequacy of facilities, equipment, personnel, services, records and programs for the rendition of services for persons diagnosed with mental illness, pursuant to an operating certificate.
(d) Section 31.05 of the Mental Hygiene Law establishes criteria for the issuance of operating certificates.
(e) Section 31.07 of the Mental Hygiene law gives the Commissioner of Mental Health the power to conduct periodic investigations into the operations of providers of services which are required by Article 31 of such law to have an operating certificate and to make inspections and examine records, including, but not limited to, medical service and financial records, to determine whether such providers are complying with applicable provisions of the Mental Hygiene Law and applicable laws, rules and regulations.
(f) Section 31.08 of the Mental Hygiene Law authorizes the Commissioner of Mental Health to exempt a ward, wing, unit or other part of a hospital as defined in Article 28 of the Public Health Law, which provides services for persons with mental illness pursuant to an operating certificate issued by the Commissioner of Mental Health, from the annual inspection and visitations requirements established in Section 31.07 of the Mental Hygiene Law, under certain specified circumstances.
(g) Section 31.09 of the Mental Hygiene Law gives the Commissioner of Mental Health or his/ her authorized representative the power to inspect facilities, examine records, conduct examinations and interviews, and obtain such other information as necessary in order to carry out his/her responsibilities under Article 31 of such law. Further, all such investigations and inspections shall be made by persons competent to conduct them, and information obtained by the Commissioner or his/her authorized representative shall be kept confidential in accordance with the provisions of applicable law.
(h) Section 31.11 of the Mental Hygiene Law requires every holder of an operating certificate to assist the Office of Mental Health in carrying out its regulatory functions by cooperating with the Commissioner in any inspection or investigation, permitting the Commissioner to inspect its facility, books and records, including records of persons receiving services, and making such reports, uniform and otherwise, as are required by the Commissioner.
(i) Sections 31.13 and 31.19 of the Mental Hygiene Law further authorize the Commissioner or his or her representatives to examine and inspect such programs to determine their suitability and proper operation.
(j) Paragraphs (1) and (8) of subdivision (a) of Section 41.13 of the Mental Hygiene Law direct local governmental units to review services and local facilities for persons with mental disabilities of the area which it serves and their relationship to local need; and to make policy for and exercise general supervisory authority over or administer local services and facilities provided or supervised by it whether directly or through agreements, including responsibility for the proper performance of the services provided by other facilities of local government and by voluntary and private facilities which have been incorporated into its comprehensive program.
§ 553.3 Scope of reviews and inspections.
(a) Prior to visiting a facility, the reviewer will study reports of previous reviews and inspections and the following information submitted by the facility:
(1) clinical and statistical data, and
(2) the policies of the facility.
(b) The onsite review and inspection shall include, as appropriate:
(1) review of program operation in comparison to programs authorized;
(2) private conversation with any person receiving mental health services or employee who so desires;
(3) review of case records of persons currently or previously served;
(4) review of the legal admission documents of persons receiving services and the conformity of the facility's admission procedures with the law and regulations;
(5) review of the records of restraint and seclusion;
(6) review of the qualifications of the staff and the staffing pattern in comparison to those authorized;
(7) inspection of the records and storage of medications and procedures for prescription and dispensing of medications;
(8) review of the minutes of meetings of the governing body;
(9) inspection of the physical plant and equipment, and review of protective procedures in relation to structural and fire hazards;
(10) identification of any construction or improvements to the premises completed since the last visit; and
(11) review of written reports by local inspectors and other authorized inspection, certifying, or accrediting agencies, and review of conditions about which any recommendations for improvement have been made.
§ 553.4 Reports.
(a) Unless otherwise provided in subdivision (b) of this Section, a written report of each review and inspection shall be developed and sent to the facility by the Office and shall include, as indicated, significant findings of merit or opportunities for improvement with regard to any aspects of the facility. When required, the facility shall respond with an action plan addressing the Office's findings.
(b) For hospitals that have been granted deemed status pursuant to Section 553.5 of this Part, such hospital, or The Joint Commission or other approved accreditation agency, will provide the Office with a copy of the final accreditation report. When required, the facility shall respond to The Joint Commission and the Office with an action plan addressing The Joint Commission's findings.
(c) The Office shall make available copies of reports that it has developed and sent to facilities in accordance with subdivision (a) of this Section to the local governmental unit for facilities within such local government's jurisdiction, provided, however, for hospitals which have been granted deeming status under Section 553.5 of this Chapter, such hospitals shall provide a copy of the final report developed by The Joint Commission to the local governmental unit, upon its request.
§ 553.5 Deemed status.
(a) Applicability. For purposes of this Section, the term "hospital" shall mean a psychiatric unit of a general hospital that is certified under Article 31 of the Mental Hygiene Law and under Article 28 of the Public Health Law operating in accordance with Part 580 of this Chapter. The provisions of this section shall apply to such hospitals.
(b) Notwithstanding the provisions of Section 553.1 of this Part, reviews conducted pursuant to this Section of hospitals that have sought and obtained deemed status shall be made by personnel of a nationally accredited review organization, who possess the necessary skills and competencies in behavioral health to conduct inspections.
(c) Hospitals must comply with the operational standards set forth in Part 580 of this Title. As evidence of compliance with such Part, the Commissioner may accept accreditation by The Joint Commission or an accreditation agency to which the Centers for Medicare and Medicaid Services has granted deeming status and which the Commissioner has determined has accrediting standards sufficient to assure the Commissioner that hospitals so accredited are in compliance with such operational standards, a list of which shall be made available on the public website of the Office, provided that:
(1) the hospital has a history of compliance with applicable laws, rules, and regulations and a record of providing care of good quality, as determined by the Commissioner;
(2) a copy of the survey report and the certificate of accreditation of The Joint Commission or other approved accrediting organization is submitted by the accrediting body to the Commissioner, within 7 days of issuance to the hospital;
(3) The Joint Commission or other approved accrediting organization has agreed to, and does, evaluate, as part of its accreditation survey, any minimal operational standards established by the Commissioner which are in addition to the minimal operational standards of accreditation of The Joint Commission or other approved accrediting organization;
(4) there are no constraints placed upon access by the Commissioner to The Joint Commission or other approved accreditation organization's survey reports, plans of correction, interim self-evaluation reports, notices of noncompliance, progress reports on correction of areas of noncompliance, or any other related reports, information, communications, or materials regarding such hospital;
(5) the hospital at all times shall remain subject to inspection and visitation by the Commissioner to determine compliance with applicable law, regulations, standards, or conditions as determined to be necessary by the Commissioner; and
(6) the hospital at all times shall remain subject to the full range of licensing enforcement authority of the Commissioner.
(d) Any hospital that is under deemed status pursuant to this Section must immediately provide written notice to the Commissioner of any of the following:
(1) receipt of notice of failure to be accredited, re-accredited or the loss of accreditation by the accreditation organization;
(2) any communication the hospital has received that indicates that the accrediting organization will be recommending that such hospital not be accredited, not have its accreditation renewed, or have its accreditation terminated;
(3) receipt of notice or other communication from the Centers for Medicare and Medicaid Services regarding a determination that the hospital will be terminated from participation in the Medicare program because it is not in compliance with one or more conditions of participation in such program, or has deficiencies that either individually, or in combination with others, jeopardizes the health and safety of persons receiving services, or are of such nature as to seriously compromise the provider's ability to render adequate care;
(4) a change of the hospital's accreditation organization; or
(5) a decision by the hospital to terminate its agreement with its accrediting organization.
(e) Failure to adhere to the requirements set forth in subdivisions (c) and (d) of this Section may be grounds for revocation of deemed status.
(f) In the event that the Commissioner determines that a hospital's deemed status must be denied or revoked, the hospital may request an informal administrative review of such decision.
(1) The hospital must request such review in writing within 15 days of the date it receives notice of the denial or revocation of its deemed status by the Commissioner or designee. The request shall state specific reasons why the hospital considers the denial or revocation of deemed status incorrect and shall be accompanied by any supporting evidence or arguments.
(2) The Commissioner or designee shall notify the hospital, in writing, of the results of the informal administrative review within 20 days of receipt of the request for review. Failure of the Commissioner or designee to respond within that time shall be considered confirmation of the denial or revocation of deemed status.
(3) The Commissioner's determination after informal administrative review shall be final and not subject to further administrative review.
Text of proposed rule and any required statements and analyses may be obtained from:
Joyce Donohue, NYS Office of Mental Health, 44 Holland Avenue, Albany, NY 12229, (518) 474-1331, email: Joyce.Donohue@omh.ny.gov
Data, views or arguments may be submitted to:
Same as above.
Public comment will be received until:
45 days after publication of this notice.
Regulatory Impact Statement
1. Statutory Authority: Section 7.09 of the Mental Hygiene Law grants the Commissioner of the Office of Mental Health the authority and responsibility to adopt regulations that are necessary and proper to implement matters under his/her jurisdiction.
Sections 31.02 and 31.04 of the Mental Hygiene Law authorize the Commissioner of Mental Health to set standards of quality and adequacy of facilities, equipment, personnel, services, records and programs for the rendition of services for persons diagnosed with mental illness, pursuant to an operating certificate.
Section 31.05 of the Mental Hygiene Law establishes criteria for the issuance of operating certificates.
Section 31.07 of the Mental Hygiene law gives the Commissioner of Mental Health the power to conduct periodic investigations into the operations of providers of services which are required by Article 31 of such law to have an operating certificate and to make inspections and examine records, including, but not limited to, medical service and financial records, to determine whether such providers are complying with applicable provisions of the Mental Hygiene Law and applicable laws, rules and regulations.
Section 31.08 of the Mental Hygiene Law authorizes the Commissioner of Mental Health to exempt a ward, wing, unit or other part of a hospital as defined in Article 28 of the Public Health Law, which provides services for persons with mental illness pursuant to an operating certificate issued by the Commissioner of Mental Health, from the annual inspection and visitations requirements established in Section 31.07 of the Mental Hygiene Law, under certain specified circumstances.
Section 31.09 of the Mental Hygiene Law gives the Commissioner of Mental Health or his/ her authorized representative the power to inspect facilities, examine records, conduct examinations and interviews, and obtain such other information as necessary in order to carry out his/her responsibilities under Article 31 of such law. Further, all such investigations and inspections shall be made by persons competent to conduct them, and information obtained by the Commissioner or his/her authorized representative shall be kept confidential in accordance with the provisions of applicable law.
Section 31.11 of the Mental Hygiene Law requires every holder of an operating certificate to assist the Office of Mental Health in carrying out its regulatory functions by cooperating with the Commissioner in any inspection or investigation, permitting the Commissioner to inspect its facility, books and records, including records of persons receiving services, and making such reports, uniform and otherwise, as are required by the Commissioner.
Sections 31.13 and 31.19 of the Mental Hygiene Law further authorize the Commissioner or his or her representatives to examine and inspect such programs to determine their suitability and proper operation.
2. Legislative Objectives: Articles 7 and 31 of the Mental Hygiene Law reflect the Commissioner's authority to establish regulations regarding mental health programs. Chapter 59 (Part H, section 55) of the Laws of 2011 created a new Section 31.08 of the Mental Hygiene Law which provides for deemed status authority. In creating Section 31.08, the Legislature intended to provide authority for the Commissioner of Mental Health to accept accreditation by The Joint Commission or an accreditation agency to which the Centers for Medicare and Medicaid Services has granted deeming status and which the Commissioner has determined has accrediting standards sufficient to assure him/her that hospitals so accredited are in compliance with such operational standards, within certain parameters.
3. Needs and Benefits: The Office is required by the Mental Hygiene Law to conduct inspections of psychiatric units in general hospitals licensed under Article 28 of the Public Health Law. This authority was amended through the addition of a new Section 31.08 of the Mental Hygiene Law, which authorizes the Commissioner to exempt a ward, wing, unit or other part of a hospital licensed pursuant to Article 28 of the Public Health Law, which provides services for persons with mental illness pursuant to an operating certificate issued by the Office, from the annual inspection and visitations requirements established in Section 31.07 of the Mental Hygiene Law, under certain specified circumstances.
Current regulations do not provide for the use of secondary agents to conduct inspections on behalf of the Office. This rulemaking is therefore necessary in order to implement the authority established in Mental Hygiene Law Section 31.08. As such, it will allow the Office the flexibility to utilize the findings of nationally-recognized review organizations in lieu of the Office conducting its own inspections of psychiatric units of general hospitals in accordance with 14 NYCRR Part 580. This process is known as "deemed status."
The Office may enter into an agreement(s) with a nationally recognized accreditation organization (e.g., The Joint Commission) to conduct, as part of a hospital's regular accreditation review, a comprehensive review of the Office's licensed psychiatric inpatient units. By utilizing a review organization that already surveys a hospital, a substantial burden will be eased for those hospitals which currently must prepare for multiple reviews. In the past, the Office's on-site inspections at general hospitals took two staff two full days (on average). Inspections are very demanding on hospitals as they must ensure that key personnel from a variety of departments (medical records, nursing, maintenance, etc.) are readily available. In addition, surveys of psychiatric inpatient services conducted as part of the hospital's regularly scheduled accreditation visit should reduce redundancy and the number of disruptions that hospitals currently experience. With the elimination of the Office's survey, the amount of paperwork to be completed by hospitals would be reduced. The above-noted benefits are expected to assist hospital staff in attending to the needs of individuals receiving mental health services with limited interruption.
Lastly, deemed status will allow the Office to better utilize its limited agency resources by freeing staff to focus on quality improvement initiatives and by allowing staff additional time to work with programs that are not performing up to minimal standards. It should be noted that the amendment does not mandate deemed status. Hospitals will have the option of participating under the deemed status provision of the regulations. The Office will continue to survey hospitals that choose not to participate in the deemed status option or have compliance issues that preclude them from participating.
There are no new requirements placed on facilities as a result of this rulemaking. It is necessary to implement the new statutory authority and accurately conveys contemporary expectations of the Office regarding visitation and inspection of facilities.
4. Costs:
(a) cost to State government: These regulatory amendments will not result in any additional costs to State government.
(b) cost to local government: These regulatory amendments will not result in any additional costs to local government.
(c) cost to regulated parties: These regulatory amendments may result in an additional cost of approximately $1,000 annually paid by the hospitals to the accreditation review organization. It is anticipated that this expense will be offset by savings achieved through the reduction in costs associated with multiple reviews conducted by several surveyors. In addition, as mentioned above, deemed status participation is voluntary and is not required for licensing by the Office.
5. Local Government Mandates: These regulatory amendments will not result in any additional imposition of duties or responsibilities upon county, city, town, village, school or fire districts.
6. Paperwork: By allowing nationally recognized accreditation review organizations to conduct inspections, this rule should result in reduced paperwork for hospitals.
7. Duplication: These regulatory amendments do not duplicate existing State or federal requirements.
8. Alternatives: The only alternative to the regulatory amendment which was considered was inaction. Since the amendment updates outdated regulations, allows for a more streamlined inspection and review process, reduces redundancy, eases the burden on hospitals, and should ultimately assist hospital staff in attending to the needs of individuals receiving mental health services with limited interruption, that alternative was necessarily rejected.
9. Federal Standards: The regulatory amendments do not exceed any minimum standards of the federal government for the same or similar subject areas.
10. Compliance Schedule: The regulatory amendments are effective immediately upon adoption.
Regulatory Flexibility Analysis
A Regulatory Flexibility Analysis for Small Businesses and Local Governments is not being submitted with this notice because the rule making will not impose any new reporting, record keeping or other compliance requirements on small businesses or local governments. The proposed rule creates a new, up-to-date 14 NYCRR Part 553 that accurately reflects the expectations of the Office of Mental Health regarding visitation and inspection of facilities, and implements the statutory authority established in Mental Hygiene Law Section 31.08. There will be no adverse economic impact on small businesses or local governments.
Rural Area Flexibility Analysis
A Rural Area Flexibility Analysis is not submitted with this notice because the purpose of the rulemaking is to create a new Part 553 which accurately reflects the expectations of the Office of Mental Health and implements the statutory authority established in Mental Hygiene Law Section 31.08. This regulation will not impose any adverse economic impact on rural areas. Further, it will ease the burden on hospitals that currently experience multiple inspections of their facilities and should assist hospital staff in attending to the needs of individuals receiving mental health services with limited interruption.
Job Impact Statement
A Job Impact Statement is not submitted with this notice because its purpose is to create a new, up-to-date-Part 553 that accurately reflects the expectations of the Office of Mental Health regarding visitation and inspection of facilities. In addition, the rule making implements the statutory authority established in Mental Hygiene Law Section 31.08. There will not be a negative impact on jobs and employment opportunities as a result of this rulemaking.
