(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 governmental unit'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) 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.
Final rule as compared with last published rule:
Nonsubstantive changes were made in sections 553.4(c) and 553.5(b).
Text of 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
Revised Regulatory Impact Statement
A revised regulatory impact statement is not submitted with this notice because the changes to the final version of the rule making are non-substantive. The changes improve readability by correcting a typographical error and eliminating an unnecessary clause.
Revised Regulatory Flexibility Analysis
A revised Regulatory Flexibility Analysis for Small Businesses and Local Governments is not being submitted with this notice because the changes to the final version of the rule making are non-substantive. The changes improve readability by correcting a typographical error and eliminating an unnecessary clause. The amendments to 14 NYCRR Part 553 will not have an adverse economic impact upon small businesses or local governments.
Revised Rural Area Flexibility Analysis
A revised Rural Area Flexibility Analysis is not submitted with this notice because the changes to the final version of the rulemaking are non-substantive. The changes improve readability by correcting a typographical error and eliminating an unnecessary clause. The amendments to 14 NYCRR Part 553 will not impose any adverse economic impact on rural areas.
Revised Job Impact Statement
A revised Job Impact Statement is not submitted with this notice because the changes to the final version of the rulemaking are non-substantive. The changes improve readability by correcting a typographical error and eliminating an unnecessary clause. There will be no adverse impact on jobs and employment opportunities as a result of these changes.
Assessment of Public Comment
The agency received two comment letters with respect to the new 14 NYCRR Part 553, "Visitation and Inspection of Facilities".
One commenter expressed strong support for the proposed rule, which enables the Commissioner of the New York State Office of Mental Health to accept accreditation by The Joint Commission or other accreditation agency to which the Centers for Medicare and Medicaid Services has granted deeming status, as evidence of compliance with the Office's inpatient operation standards, rather than requiring a separate visit and inspection by personnel of the Office of Mental Health (Office). The writer believes this provision is consistent with the Governor's priorities to streamline government operations, eliminate duplicative provider requirements, and reduce costs to the Medicaid program, while ensuring the highest quality care for persons with mental illness.
The second commenter raised several concerns regarding the proposed rule that appear to be grounded in the mistaken belief that the Commissioner's authority would be diminished by the regulation as it pertains to deemed status. It is important to note that the Office maintains the authority to conduct its own reviews, and to "look behind" the reviews conducted by the accrediting organization. The Commissioner has full access to any of the accreditation organization's survey reports, information, communications, or materials regarding the hospital. Deemed status is not a right. To be considered for deemed status, hospitals must have a history of compliance with applicable laws, rules and regulations and have a record of providing good quality care, as determined by the Commissioner. In addition, the Commissioner has the authority to deny or revoke a hospital's deemed status if the hospital fails to adhere to the requirements in Section 553.5 of Title 14 NYCRR.
The writer questioned the issue of confidentiality and legality with respect to the accrediting body having access to confidential materials such as incident reports and investigations. The writer further expressed concern with the fact that surveys would be completed by individuals with limited knowledge of the local service system.
Response: Section 31.09 of the Mental Hygiene Law gives the Commissioner or his 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 responsibilities under Article 31. All investigations and inspections must be made by persons competent to conduct them, and information obtained by the Commissioner or his authorized representative must be kept confidential in accordance with law. The use of secondary agents in the performance of certification inspections is not new. The Department of Health and The Joint Commission have participated in a collaborative agreement for the surveillance of hospitals and diagnostic and treatment centers since 1996. In addition, the Federal government, through the Centers for Medicare and Medicaid Services, provides for deeming authority.
The writer expressed concern about the potential for a conflict of interest since hospitals would pay an annual fee to the accrediting organization, and that accrediting body would determine if the hospital's performance is sufficient to warrant continued certification/licensure.
Response: While it is true that in the case of The Joint Commission a hospital is required to pay a yearly fee of approximately $1,000 to the accreditation review organization, and other organizations may similarly require the payment of a fee, in order for an accrediting organization to be granted deeming status, it will be required to review the operational standards set forth in 14 NYCRR Part 580 in the performance of their reviews. It is believed that the ability of the Office to independently review licensed programs and the discretionary nature of the granting of deeming authority provides a far greater incentive for accrediting organizations to diligently perform their functions than the minimal incentive created by the receipt by the organization of a fee from the hospital to be less than rigorous in such reviews.
The writer believes the expense paid by hospitals to accrediting agencies could be passed on to the public, and suggests that the Office complete a fiscal analysis based on the number of hospitals anticipated to participate in the deeming process.
Response: As mentioned above, the cost to a hospital wishing to participate in deemed status is anticipated to be approximately $1,000 annually. This cost is minimal, compared to the savings achieved through the reduction in costs associated with multiple reviews conducted by several surveyors. Inspections are very demanding on hospitals as they must ensure that key personnel from a variety of departments are readily available. 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. This will allow for hospital staff to attend to the needs of individuals receiving mental health services with limited interruption. Hospitals that will participate in deemed status have yet to be determined; therefore, the Office has no means to develop the fiscal comparison as suggested by the writer.
The writer claims that the deeming proposal will create a barrier to transparency.
Response: The Joint Commission maintains a website that provides a list of all hospitals and programs that have been accredited by that body (www.jointcommission.org). Accreditation Quality Reports by facility as available on that website as well. Final reports developed by the accreditation agency shall be provided by the hospital to the local governmental unit upon request.
The writer questioned the "Job Impact Statement" in the regulatory filing paperwork which stated that there will not be a negative impact on jobs and employment opportunities as a result of the proposed rule.
Response: The Office has already addressed this issue in its Regulatory Impact Statement. Deemed status will enable 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. Further, as the proposed rule does not mandate deemed status, the Office will continue to survey hospitals that choose not to participate in the deemed status option or those hospitals that have compliance issues that prevent them from participating.
