N.Y. Comp. Codes R. & Regs. Tit. 14 §§ 635-1.2

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

Section 635-1.2 - Intent

(a) To set forth general quality control and administrative requirements with which a program, service or facility (as specified) funded or certified by OPWDD, must comply.

(b) The requirements of this Part shall be in addition to any other regulation issued by the commissioner (see glossary) and designated herein as applicable to a specific facility class, an OPWDD funded program, or an OPWDD funded service.

(c) To provide the basis for the development and implementation of written agency/facility (see glossary) specific policies/procedures (see glossary) which shall reflect compliance with this Subpart. Such policies/procedures shall become part of the agency's/facility's policy and/or procedure manual(s). Upon development, such policies/procedures shall be implemented and the facility shall have the responsibility for ensuring ongoing compliance with said policies/procedures.

(d) OPWDD expects ongoing compliance with both principles of compliance and standards of certification included in this Part. Therefore, such compliance shall be the responsibility of the agency and shall be necessary for continued participation as a certified facility or funding as an approved program or service.

(e) The OPWDD certification process defined in subdivision 635-1.2(g) of this section is superseded by requirements in Part 619 of this Title, Certification of Facilities and Home and Community Based Services (HCBS), effective on the effective date of these regulations.

(f) In every instance in this regulation, the terms, "people," "person/persons," or "individual/individuals" (see glossary) shall refer to those who have met the admission criteria for a facility and who have been admitted.

(g) In reviewing the continued eligibility of a facility for an operating certificate, OPWDD shall survey for compliance with all "standards of certification" herein, and any other regulatory requirements applicable to that class of operating certificate. OPWDD may make inquiries into and evaluate evidence of noncompliance with the "principles of compliance" applicable to that class of operating certificate. For programs or services funded by OPWDD, the OPWDD shall monitor for compliance with applicable "standards of certification" and may monitor "principles of compliance" as a condition for continued funding.

(1) Principles of compliance set forth the basic conditions for the operation of the facility. Principles of compliance identify those requirements in which the State has a substantive interest because they are the basic and necessary conditions of participation with which a facility is to comply.

(i) Principles of compliance establish basic and necessary conditions with which a facility must be in compliance in order to receive and maintain certification.

(ii) Such principles shall focus on particular service or administrative components of a facility and/or on an entire certification classification. The intent of such principles is to clearly indicate the scope and extent of the State's interest.

(iii) Unless otherwise indicated, an agency/facility shall have the authority to demonstrate through policies, procedures, other documents, or any means, the methods and practices it will utilize to establish and ensure continued compliance with such principles.

(iv) These documents and/or means shall be made available to, or verified by, OPWDD to assess compliance and to grant initial certification.

(2) OPWDD reserves the right to monitor compliance at any time pursuant to the responsibilities of the commissioner under the Mental Hygiene Law. Facilities will not be routinely examined against principles of compliance at surveys for recertification. The process whereby principles of compliance shall be reviewed and/or enforced shall be contingent upon the following premises:

(i) A mechanism for informal reconsideration or review shall be established for resolution of disputed issues relative to compliance.

(ii) Principles of compliance and standards of certification are written to stand independently of one another; however, standards may reflect and/or explicate concepts or requirements set forth in principles.

(iii) At the time of initial certification, a facility shall be examined against the concepts and requirements set forth in the principles of compliance.

(iv) After initial certification, OPWDD shall presume compliance with principles of compliance unless there is an indication of noncompliance brought to its attention. Except in the instance of those situations which pose a threat to the health and safety of the individual, noncompliance shall require more than one violation of the principle, unless the situation is pervasive, systemic, or egregious.

(v) Any person who has cause to question whether a facility is operating in conformance with required regulations has a right to bring their concern to the attention of OPWDD.

(vi) The process whereby an allegation of noncompliance with a principle of compliance will be handled shall take into consideration the orderly collection of information, evaluation of the information, determination of an appropriate course of action, and the recording of same.

(vii) "Survey" is a term that will be used only in relation to surveyor activity directly linked to determining conformity with standards of certification and other pertinent regulations.

(viii) Routine surveys for recertification shall be based solely on the requirements set forth in standards of certification and any other pertinent regulations.

(ix) The fundamental focus of surveyors when on-site at a facility for recertification purposes shall be to determine compliance with standards of certification. They are not charged with a primary responsibility of looking for indications of noncompliance in relation to principles.

(x) Surveyors visiting a facility to determine compliance with standards of certification shall not "cite" the facility for noncompliance with a principle. Whenever possible, surveyors shall bring additional matters of concern to the attention of the facility during the exit interview.

(xi) The review of and inquiry into concerns brought to the attention of OPWDD shall be done by individuals with training to understand and apply principles of compliance from a broad base of experience.

(xii) Any reviews of inquiries shall provide for the use of experiential judgment on the part of the person doing the review or inquiry.

(xiii) An inquiry into an indication of noncompliance with principles of compliance shall not be viewed as or termed a "survey".

(xiv) An inquiry into an indication of noncompliance shall be for the purpose of OPWDD ascertaining, through the collection of information, that a facility is not conforming to the principle(s) of compliance in question. It shall not be conceived as a process whereby a facility is compelled to prove compliance; rather, one whereby OPWDD substantiates that there is a violation.

(xv) When an inquiry results in the validation of an expressed concern, the facility shall be notified of the finding by way of a preliminary report. At that time the agency/facility shall be given the opportunity to respond and, if considered necessary by the facility, to access an informal reconsideration or review mechanism prior to the issuance of a formal notification of violation of a principle(s) of compliance and the request for a course of action to correct the violation.

(xvi) OPWDD shall provide an equitable mechanism, whereby there shall be an informal reconsideration or review, whenever the facility is concerned with the determination of noncompliance or the adequacy of the agency's/facility's plan of corrective action. The goal of such mechanism shall be to facilitate, whenever possible, resolution of disputes. Such mechanisms shall not neutralize or obstruct OPWDD's ability to implement article 16 actions (i.e., suspension, revocation or limitation of an operating certificate, or the imposition of penalties) at any tine subsequent to identification of a violation(s).

(xvii) Appropriate B/DDSO's (see glossary) shall be advised of actions taken relative to noncompliance issues at facilities in their service areas.

(3) "Standards of certification" are those criteria which OPWDD specifies as necessary to be met in order for a facility to demonstrate that it can and does provide the appropriate environment in which to adequately address the matters of quality of care and welfare, individual rights, safety, and/or fiscal accountability. Surveys are conducted for the purpose of documenting conformity with standards of certification. Such conformance or an acceptable plan of correction is the basis for issuing an operating certificate and/or renewing an operating certificate and constitutes one of the underlying premises justifying OPWDD's continued presumption of a facility's compliance with the principles of compliance. Standards of certification shall be surveyed contingent upon the following premises:

(i) By definition, all standards of certification shall be met for a facility to be certified/recertified. Compliance with standards of certification shall include an acceptable plan of corrective action. Except in the instance of those situations which pose a threat to the health and safety of the person, noncompliance shall require more than one violation of the standard, unless the situation is pervasive, systemic, or egregious.

(ii) In order to obtain initial certification, facilities shall be reviewed and surveyed against both principles of compliance and standards of certification to assure that the facility, its program, and physical plant are in compliance with the regulation.

(iii) Surveys for recertification will focus on determining compliance with the specified standards of certification.

(iv) As a survey for recertification focuses on standards of certification, the survey instrument shall not instruct the surveyor to review any principles of compliance.

(v) The survey shall be conducted to ensure the facility's adequacy for certification/recertification.

(vi) Surveys, or portions thereof, shall be conducted when the persons receiving services are on-site. This will enable surveyors to rely more on observation and conversation and less on written documentation as means of verification of compliance with the standards of certification.

(vii) The interpretation of a specific standard certification shall never be more restrictive than the written standard.

(viii) Only paperwork explicitly required by the standard of certification shall be included in the survey process.

(ix) The survey process shall be conducted with a maximum of efficiency and a minimum of intrusion.

(x) Prior to issuance of initial certification, the agency's/facility's policy and procedure manual shall be made available to the OPWDD Division of Quality Assurance for its discretionary review of any topics related to the principles of compliance and standards of certification, as required by applicable regulation. After initial certification, the agency's/facility's policy and/or procedure manual, and any subsequent changes thereto, will be presumed to be compliant, unless a review for cause determines that this is not so.

(xi) If the explicit condition(s) of the standard of certification are met, the surveyor shall not further evaluate the agency's/facility's means of demonstrating compliance beyond the explicit conditions.

(xii) In State-owned or State-leased buildings, where physical plant deficiencies do not place persons in imminent danger of their health or safety, the statement of deficiency shall not the noncompliance, but no plan of corrective action on the part of a facility shall be required.

(xiii) The process to be followed for certification and recertification shall not require an agency/facility to implement a plan of corrective action prior to its approval by OPWDD.

N.Y. Comp. Codes R. & Regs. Tit. 14 §§ 635-1.2

Amended New York State Register October 28, 2015/Volume XXXVII, Issue 43, eff. 11/1/2015

Amended New York State Register April 20, 2016/Volume XXXVIII, Issue 16, eff. 4/20/2016

Amended New York State Register September 21, 2016/Volume XXXVIII, Issue 38, eff. 9/21/2016

Amended New York State Register October 18, 2017/Volume XXXIX, Issue 42, eff. 10/18/2017