14 CRR-NY 633.99NY-CRR

OFFICIAL COMPILATION OF CODES, RULES AND REGULATIONS OF THE STATE OF NEW YORK
TITLE 14. DEPARTMENT OF MENTAL HYGIENE
CHAPTER XIV. OFFICE FOR PEOPLE WITH DEVELOPMENTAL DISABILITIES
PART 633. PROTECTION OF INDIVIDUALS RECEIVING SERVICES IN FACILITIES OPERATED AND/OR CERTIFIED BY OPWDD
14 CRR-NY 633.99
14 CRR-NY 633.99
633.99 Glossary.
(a) Account, burial reserve.
An account which is established for the express purpose of reserving an amount of money to be set aside for the burial of the individual names on the account. The account shall be separate and distinct from an agency bank account and a training bank account. The maximum dollar amount may not exceed that established by section 131-n of the Social Services Law. Any account or money which is held in trust by a funeral director, funeral firm or other person, firm or corporation under General Business Law, section 453 shall not be considered a burial reserve account under this regulation and is not governed by this regulation.
(b) Administrator, program.
That party, by whatever title known, designated in an agency's administrative structure with responsibility for the day-to-day operation of one or more facilities of a particular class operated by an agency. This may be someone who has the responsibilities of the chief executive officer, or someone designated as staff to the chief executive officer.
(c) Adult.
Anyone who is 18 years of age or older, or is the parent of a child, or has married.
(d) Adult, competent.
In relation to a health care proxy only (as used in sections 633.4 and 633.20 of this Part), every person who is 18 years of age or older, or is the parent of a child, or has married, and who is residing in a residential facility operated or certified by OPWDD, is presumed to be able to understand the meaning of the delegation of authority and is thereby able to execute a health care proxy unless such person has had a prior court determination that he or she is not capable of making health care decisions or that he or she is not capable of appointing a health care agent or unless a committee has been appointed for the person pursuant to article 78 of the Mental Hygiene Law or unless a guardian has been appointed for the person pursuant to article 17-A of the Surrogate's Court Procedure Act. However, a determination that a principal lacks the capacity to make a health care decision empowering an agent in a health care proxy is made in conformance with section 633.20(a)(9) of this Part.
(e) Advocate.
This term shall have the same meaning as in section 635-99.1 of this Title.
(f) Agency.
The operator of a facility, program or service operated, certified, authorized (see glossary), or funded through contract by OPWDD. In the case of State-operated facilities, the DDSO (see glossary) is considered to be the agency. Family care providers are not considered to be an agency (also see “agency, sponsoring”).
(g) Agency/facility.
As used in this Part, a term used to indicate that the stated requirement needs to be considered in relation to the administrative structure of both the agency (see glossary) and the site-specific facility (see glossary) and acted upon accordingly. In the case of HCBS waiver and other non-certified services, the stated requirement needs to be considered in relation to the administrative structure of the agency only.
(h) Agency, sponsoring.
The administrator of one or more family care homes. In the case of family homes operated under State auspice, the DDSO is considered to be the sponsoring agency.
(i) Agent, health care.
An adult to whom authority to make health care decisions is delegated pursuant to a health care proxy written in accordance with section 633.20 of this Part and article 29-C of the Public Health Law.
(j) AIDS.
Acquired immune deficiency syndrome, as may be defined from time to time by the centers for disease control of the United States Public Health Service.
(k) Assent.
For the purposes of section 633.13 of this Part only, an affirmative agreement by a minor to participate in research. Mere failure to object shall not, absent affirmative agreement, be construed as assent.
(l) Authorized.
Having the formal approval to provide HCBS waiver services pursuant to Subpart 635-10 of this Title or other services through the Medical Assistance Program whereby the provider agreement with the Department of Health requires OPWDD approval of the provider.
(m) Available, reasonably.
A surrogate to be contacted can be contacted with diligent efforts within a reasonable time by an attending physician or other party seeking to obtain either informed consent for the purposes of section 633.11 or 633.16 of this Part, or a DNR decision pursuant to section 633.18 of this Part.
(n) Board, consumer advisory.
A seven-member board established in conformance with the requirements of the Willowbrook Consent Judgement.
(o) Board, institutional review (IRB).
For the purposes of section 633.13 of this Part only, a committee meeting the membership requirements of 45 CFR 46.107. It is established for the purpose of reviewing and monitoring research involving human subjects, in accordance with the provisions of 45 CFR 46. Facilities or entities may establish their own IRB or may contract to use an IRB, meeting these requirements, which has been established by another facility or entity.
(p) Capacity.
The ability to adequately understand and appreciate the nature and consequences of professional medical treatment (see glossary), behavior support plans, pursuant to section 633.16 of this Part and DNR orders (see glossary), including the benefits and significant risks and alternatives to such treatment/plans so as to be capable of making a decision thereto in a knowing and voluntary manner. A person's decision relative to the proposed professional medical treatment, proposed plan or proposed DNR order shall not, in and of itself, be the exclusive basis for the determination of capacity.
(q) Care, health.
Any treatment, service or procedure to diagnose or treat an individual's physical or mental condition.
(r) Center, developmental.
A school for the care and treatment of persons (q.v.) with developmental disabilities, as designated in article 13.17 of the Mental Hygiene Law. A developmental center may be referred to as an ICF/IID.
(s) Certification, standards of.
See standards of certification.
(t) Commissioner.
The commissioner of the New York State Office for People With Developmental Disabilities, or his or her designee.
(u) Committee, surrogate decisionmaking.
A committee of at least 12 persons established pursuant to section 80.05 of the Mental Hygiene Law that, for a person receiving services determined to be in need of surrogate decisionmaking, and in accordance with the provisions of article 80 of the Mental Hygiene Law, can make a determination as to whether proposed professional medical treatment is or is not in the best interest of the person receiving services, and provide consent for such treatment.
(v) Compliance, principles of.
See principles of compliance.
(w) Condition, terminal.
The circumstance of an illness or injury from which there is no recovery, and which reasonably can be expected to cause death within one year.
(x) Consent, a person's capacity to.
For the purposes of section 633.13 of this Part only, a person's ability to understand the purpose, nature, risks, benefits and, where appropriate, alternatives of the research, to make a decision about participation, and to understand that the decision about participation in the research will involve no penalty or loss of rights to which the person is otherwise entitled.
(y) Consent, informed.
(1) For the purposes of this Part, informed consent shall mean the effective knowing consent by a person (or his/her legally empowered surrogate, parent or adult child) with sufficient capacity to consent and so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion. Such consent shall be in writing, except in the case of:
(i) consent for research involving no more than minimal risk where there is a waiver of consent; or
(ii) a waiver of the need for written consent as allowed in 45 CFR 46.117(c) to ensure confidentiality; or
(iii) the use of short-term medication pursuant to section 633.16(j)(5)(v) of this Part (with limitations); or
(iv) the use of restrictive/intrusive interventions or rights limitations pursuant to section 633.16(g)(1) of this Part (with limitations).
(2) The basic elements of information necessary to such informed consent include:
(i) a fair explanation to the person of the procedures to be followed, and their purposes, including identification of any procedures which are experimental;
(ii) a description of any attendant discomforts and risks reasonably to be expected;
(iii) a description of any benefits to the participant or others which may reasonably be expected;
(iv) a disclosure of any appropriate alternative procedures or courses of treatment, if any; and
(v) an instruction that the person or surrogate is free to withdraw his or her consent at any time without prejudice.
(3) No informed consent shall include any language through which the person or surrogate waives, or appears to waive, any legal right, including the release of any party, institution, agency, or any agents thereof, from liability from negligence.
(4) Information must be presented in a manner permitting a knowledgeable evaluation and decision to be made. It must be presented in whatever language the party giving informed consent reads or understands most easily and clearly (e.g., English, Spanish, Mandarin) and in whatever manner he or she understands most easily and clearly (e.g., sign language, communications board, computer assisted technology, Braille). Consent, when given by a surrogate, should only be given if, in doing so, this will be in the person's best interest and takes into consideration, to the extent possible, the person's opinions, beliefs, and wishes.
(5) This definition does not apply to informed consent obtained by a subject party (see section 633.22 of this Part) related to criminal history record checks, as such consent is required pursuant to section 633.22 of this Part.
(z) Contact.
An identified spouse or sex partner of a person being served or someone proposed for admission, or a party identified as having shared hypodermic needles or syringes with said person or party proposed for admission.
(aa) Coordination, service.
The active assistance offered persons as they access and negotiate with the various service systems and the community in pursuit of the necessary and desired services and supports to achieve or maintain their personal goals.
(ab) Coordinator, service.
An employee of an agency, or an independent contractor or other party, so designated, who provides service coordination (see glossary). A service coordinator may also be referred to as a case manager.
(ac) Correspondent.
Someone (not on the staff of the facility) who assists an individual to obtain necessary services, participates as a member of that person's program planning process, and who receives notification of certain significant events in the life of that person. The fact that someone is providing advocacy for an individual as a correspondent does not endow that party with any legal authority over the person's affairs.
(ad) Custodian.
For the purposes of section 633.7 only, a party that meets one of the following criteria:
(1) a director, operator, employee or volunteer of a facility or program which is certified or operated by OPWDD; or
(2) a consultant or an employee or volunteer of a corporation, partnership, organization or governmental entity which provides goods or services to such facility or program pursuant to contract or other arrangement that permits such party to have regular and substantial contact with individuals receiving services from the facility or program; or
(3) a family care provider; or
(4) a family care respite/substitute provider.
(ae) Day(s).
This term shall mean calendar day(s). Unless otherwise stated, the computation of a period of days shall be in accordance with sections 20 and 25-a of the General Construction Law.
(af) DDSO.
The Developmental Disabilities Services Office is the local administrative unit of OPWDD. The governing body of a DDSO is the central office administration of OPWDD. The DDSO director is its chief executive officer.
(ag) Decision, health care.
Any decision to consent or refuse to consent to health care.
(ah) Decision, capacity to make health care.
In relation to section 633.20 of this Part, the ability to understand and appreciate the nature and consequences of health care decisions, including the benefits and risks of, and alternatives to, any proposed health care, and to reach an informed decision.
(ai) Disability, developmental.
A developmental disability as defined in section 1.03(22) of the Mental Hygiene Law.
(aj) Discharge.
By regulation, most facilities are required to have admission and discharge policies. As used in that context, means the release of a person from a facility and the termination of programs/services at the facility. In the context of section 633.12 of this Part, discharge does not include the administrative process that takes place to remove a person's name from the records when that person, who has undergone the placement process, takes up residence in another facility. However, discharge also takes place when a residential or day program facility determines, in conformance with its policies/procedures, that it can no longer provide programming/services, even if it has been incapable of make alternative provisions for programs or services. In this instance, objection to discharge shall be processed pursuant to section 633.12 of this Part. In a developmental center, discharge (and conditional release) must also comply with the legal requirements of article 29 of the Mental Hygiene Law, thereby terminating a person's inpatient status. Community based facilities, whether State or voluntary operated, do not come under the requirements of article 29 relative to legal admission or discharge and can, therefore, establish their own criteria in conformance with applicable laws and regulations.
(ak) Entity(ies).
For the purposes of section 633.13 of this Part only, entities are those organizational structures such as universities, hospitals and research organizations that may seek to conduct research.
(al) Facility.
Unless otherwise defined or modified, facility means any place operated or certified by OPWDD in which either residential or nonresidential services are provided to persons with developmental disabilities.
(1) Facility, health care. For the purposes of section 633.19 of this Part, any provider of comprehensive residential program or day program or specific health services which holds an operating certificate from OPWDD, holds a contract with OPWDD or a certified provider to provide services to persons with developmental disabilities.
(2) Facility, residential. Any place certified or operated by OPWDD in which residential services are provided to persons with a developmental disability.
(3) Facility, residential health care. A nursing home or a facility providing health related services, operated in conformance with the requirements of article 28 of the Public Health Law.
(am) Friend, close.
For purposes of section 633.18 of this Part, any party, 18 years of age or older, who presents an affidavit to an attending physician stating that he or she is a close friend of the person and that he or she has maintained such regular contact with the person as to be familiar with the person's activities, health, and religious or moral beliefs and stating the facts and circumstances that demonstrate such familiarity. The person's program planning team must be able to validate the information presented in the affidavit. Neither a chief executive officer, program administrator, nor medical director of a developmental center or DDSO may serve as a close friend for the purpose of making a decision regarding CPR for the person. Other staff may submit an affidavit as a close friend, if appropriate.
(an) Futile, medically.
That situation in which cardiopulmonary resuscitation will be unsuccessful in registering cardiac and pulmonary function or the person will experience repeated arrests in a short time before death occurs.
(ao) Governing body.
The policymaking authority, whether an individual or a group, that exercises general direction over the affairs of one or more certified facilities in the same class, and establishes policies concerning the operation of such facility or facilities for the welfare of the persons served. In State-operated facilities, the governing body is the central office administration of OPWDD.
(ap) Hospital.
A medical facility as defined in section 2801 of the Public Health Law.
(aq) Illness, HIV-related.
Any illness that may result from or be associated with HIV infection.
(ar) Illness, mental.
An affliction with a mental disease or mental condition which is manifested by a disorder or disturbance in behavior, feeling, thinking, or judgment to such an extent that the person afflicted requires care, treatment and rehabilitation.
(as) Indicated.
That term, as used in title 6 of New York State Social Services Law governing child protective services, that establishes that investigation has determined that some credible evidence of child abuse exists.
(at) Individual/individuals.
For the purpose of this Part, a child or adult with a diagnosis of developmental disability, who has been or is being served by a State, private or voluntary operating facility certified by OPWDD. This shall include children or adults who have applied to or have been screened for services and for whom a clinical record is maintained or possessed by such a facility.
(au) Infection, HIV.
An infection with the human immunodeficiency virus or any other related virus identified as a probable causative agent of acquired immune deficiency syndrome (AIDS).
(av) Information, HIV-related.
Any information concerning whether the person being served or any party being considered for admission has been the subject of an HIV-related test, or has HIV infection, HIV-related illness or AIDS, or information which identifies or reasonably could identify such person or parties as having one or more of such conditions, including information indicating a person's potential exposure to HIV.
(aw) Interest, best.
Best interest shall mean promoting the person’s well-being by evaluating the risks, benefits and alternatives to the person of a proposed treatment or intervention. Such a determination takes into account several factors including but not limited to the relief of suffering, the preservation or restoration of functioning, improvement in the quality of the person’s life with and without the proposed treatment or intervention, and consistency with the personal beliefs and values known to be held by the person.
(ax) Involved, actively.
Significant and ongoing involvement in a person's life so as to have sufficient knowledge of the person's needs.
(ay) IRB.
See Board, Institutional Review.
(az) Justice Center for the Protection of People with Special Needs (Justice Center).
An entity established by article 20 of the Executive Law for the protection of people who are vulnerable because of their reliance on professional caregivers to help them overcome physical, cognitive and other challenges. The Justice Center contains the Vulnerable Persons’ Central Register as established by article 11 of the Social Services Law and receives requests for criminal history record checks pursuant to section 16.33 of the Mental Hygiene Law.
(ba) List, surrogate.
The list set forth in section 633.18(a)(8)(iv) of this Part.
(bb) Medication.
A medicinal substance, whether prescribed or obtained over-the-counter. For purposes of this Part, unless otherwise excepted, “medication” shall also include vitamins.
(bc) Medication, over-the-counter.
A medicinal substance or vitamin for which, by Federal or State law, a written prescription is not required.
(bd) Medication, prescribed.
A medicinal substance or vitamin for which, by Federal or State with a written prescription is required.
(be) Medication, self-administration of.
The act of taking the right medication at the right time, in the right dosage and manner. This includes the ability to recognize the time medication is to be taken; to identify the container; to open the correct container; to remove the correct dosage and close the container; to obtain appropriate fluids or materials needs to ingest, apply, inject or use as ordered; and to return medication to the appropriate storage area.
(1) Independent self-administration of medication. To consistently self-administer medication in accordance with all of the above criteria. Supervision and/or assistance is needed in exceptional circumstances only.
(2) Self-administration of medication with supervision. To self-administer medication with occasional verbal prompting and/or instructions and/or monitoring by a health care professional (q.v.) or approved medication administration staff.
(3) Self-administration of medication with assistance. To self-administer medication with frequent or regular verbal prompting and/or instructions and/or frequent or regular physical aid by a health care professional or approved medication administration staff.
(bf) Member, family.
Any party related by blood, marriage or legal adoption.
(bg) Mental Hygiene Legal Service (MHLS).
An agency of the appellate division of the State Supreme Court established pursuant to article 47 of the Mental Hygiene Law, and which provides protective legal services, advice and assistance to persons with developmental disabilities who reside in developmental centers or in the community on conditional release from a developmental center.
(bh) Minor.
Anyone who does not meet the definition of adult.
(bi) Officer, chief executive.
Someone designated by the governing body (see glossary) with overall and ultimate responsibility for the operation of services certified, authorized, approved or funded through contract by OPWDD, or his other designee for specific responsibilities and/or equipment as specified in written agency/facility policy, including but not limited to requirements related to criminal history record checks. In a DDSO, this party is referred to as the director.
(bj) OPWDD.
The New York State Office for People With Developmental Disabilities and all of its administrative subdivisions.
(bk) Order, do not resuscitate (DNR).
Instructions not to attempt cardiopulmonary resuscitation in the event a person suffers cardiac or respiratory arrest. Such instructions may cover any cardiopulmonary resuscitation measures or may be limited depending on the scope of the consent.
(bl) Order, nonhospital DNR.
A do not resuscitate instruction issued for a person who is not a resident of a developmental center; or instructions issued for a person in a developmental center, hospital, psychiatric center or residential health care facility which is to take effect only after the person leaves such a facility.
(bm) Parent.
A biological or legally adoptive mother or father.
(bn) Participant(s).
For the purposes of section 633.13 of this Part only, a person(s) (see definition) or any other party with developmental disabilities receiving services from the facility (e.g., those occupying respite or temporary use beds) and who are involved in any research project.
(bo) Party, qualified.
For the purposes of this Part, any properly identified person; committee for an incompetent person appointed pursuant to article 78 of the Mental Hygiene Law; guardian appointed pursuant to article 81 of the Mental Hygiene Law; or a parent or guardian of a person under the age of 18 appointed pursuant to article 17 of the Surrogate's Court Procedure Act, or other legally appointed guardian of a person under the age of 18; or a guardian of a person appointed pursuant to article 17-A of the Surrogate's Court Procedure Act; or a parent, spouse, adult child, or adult sibling of an adult person who may be qualified to request access because the parent, spouse, adult child, or adult sibling is authorized pursuant to law, rule or regulation to provide consent and has consented, or is being requested to provide consent for care and treatment.
(bp) Person, capable adult.
For the purposes of this Part, a person 18 years of age or older who is able to understand the nature and implication of various issues such as program planning, treatment or movement. The assessment of capability in relation to each issue as it arises will be made by the person's program planning team. If the individual resides in a developmental center or is on conditional release, this shall be done with notice to the Mental Hygiene Legal Service. Capability as stipulated by this definition does not mean legal competency; or does it necessarily relate to a person's capability to independently handle his or her own financial affairs; nor does it relate to the person's capacity to understand appropriate disclosures regarding proposed professional medical treatment, which must be evaluated independently. Thus, an individual may be capable of participation in planning for his or her services and programs but still requires assistance in the management of financial matters. Whenever there is doubt on the part of other party interested in the welfare of the individual as to that person's ability to make decisions, as ascertained by the program planning team, a determination of capability is to be made by an external Capability Review Board, designated by the commissioner. A capable adult persons cannot override the authority of a guardian appointed in accordance with the Surrogate Court Procedure Act, or of a conservator, or of a committee.
(bq) Person/persons.
For purposes of this Part, a child or adult with a diagnosis of developmental disability, who has been or is being served by a state, private or voluntary operated facility certified by OPWDD. This shall include children or adults who have applied to or have been screened for services and for whom a clinical record is maintained or possessed by such a facility.
(br) Physician, attending.
As used in sections 633.18 and 633.20 of this Part, the physician selected by, or assigned to, a person in a developmental center, hospital, psychiatric center, residential health care facility, or any facility certified or operated by OPWDD who has primary responsibility for the treatment and care of that person. Where more than one physician shares such responsibility, any such physician may act as the attending physician pursuant to these sections.
(bs) Placement.
The relocation (change of address) of a person from an OPWDD-operated or certified residential facility to another residential setting as proposed and planned by the person's program planning team; or relocation to another OPWDD-operated or certified residential facility as requested by a capable adult person or someone acting on behalf of a person. Placement as used in the Part does not include the admission of someone residing in another type of non-OPWDD operated or certified residential setting in the community to an OPWDD operated or certified facility (e.g., someone is admitted to a facility from the parent's home). Nor does it include the termination of programs/services to a person (e.g., when the person or the person's correspondent chooses to terminate such services; the person will reside out-of-state; the person chooses to live independently; a determination is made by the facility that it will not longer provide programming/services). Time limited moves are not placement; nor are hospital stays, vacations at camps, and visits with families.
(bt) Plan, individualized service (ISP).
This term shall have the same meaning as defined in section 635-99.1 of this Title.
(bu) Policies/procedures or policy/procedure.
As used in this Part, the term indicating the need for appropriate written guidance for staff, whether such guidance is in the form of a policy statement, a policy statement with accompanying procedures, or procedures only. Determination of the nature of the material is that of the agency/facility.
(bv) Practitioner.
For purposes of section 633.17 of this Part, that person, who by State law, is authorized to designate for use, any medication needed by a person (whether designated on a required prescription order form or, for over-the-counter medications, in another acceptable manner).
(bw) Principal.
For purposes of section 633.20 of this Part, a person residing in an OPWDD operated or certified facility who has executed a health care proxy.
(bx) Principles of compliance.
Those requirements with which an agency/facility must comply, but against which the facility will not be surveyed for certification or recertification purposes. However, evidence of failure to comply with the principles may be the basis for decertification in accordance with article 16 of the Mental Hygiene Law.
(by) Professional.
For the purposes of section 633.19 of this Part, anyone who, by virtue of training, licensure, certification and/or applicable State law and/or regulation, has the authority to perform those activities granted or assumed by that profession.
(bz) Professional, health care.
For the purpose of clarity in relation to section 633.17 of this Part, one of the following holding current licensure: a physician, dentist, podiatrist, physician's assistant, registered nurse, or licensed practical nurse.
(ca) Provider, health care.
For the purposes of this Part, except for section 633.20 of this Part, any party in the employ of a health care facility, or an authorized volunteer who, as part of their training and assigned responsibilities, would, in the course of carrying out said responsibilities, have access to a person's clinical record. For purposes of section 633.20 of this Part, a health care provider is a facility or a party licensed, certified, or otherwise authorized or permitted by law to administer health care in the ordinary course of business or professional practice.
(cb) Proxy, health care.
A document delegating the authority to make health care decisions, executed in accordance with the requirements of article 29-C of the Public Health Law and section 633.20 of this Part.
(cc) Punishment, corporal.
The use of physical force upon a person for the purpose of disciplining or chastising that person.
(cd) Research.
A systematic investigation designed to contribute to generalizable knowledge. Some “demonstration” and “service” programs may include research activities.
(ce) Resuscitate, order not to (DNR orders).
Instructions not to attempt cardiopulmonary resuscitation in the event a person suffers cardiac or respiratory arrest. Such instructions may cover any cardiopulmonary resuscitation measures or may be limited depending on the scope of the consent.
(cf) Resuscitation, cardiopulmonary (CPR).
Any measures to restore cardiac function or pulmonary function in the event of a cardiac or respiratory arrest such as manual chest compression, mouth-to-mouth rescue breathing, intubation, direct cardiac injection, intravenous medications, electrical defibrillation, and open chest cardiac massage. For purposes of section 633.18 of this Part, cardiopulmonary resuscitation shall also include the transfer of a person to another facility if solely for the purpose of providing cardiopulmonary resuscitation. Cardiopulmonary resuscitation shall not include measures to improve pulmonary and cardiac function in the absence of an arrest.
(cg) Risk, minimal.
For the purposes of section 633.13 of this Part only, and as defined in 45 CFR 46.102(g), minimal risk “means that the risk of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”
(ch) Risk, significant.
Circumstances which constitute significant risk of transmitting or contracting HIV infection are:
(1) sexual intercourse (vaginal, anal, oral) which exposes a noninfected individual to blood, semen or vaginal secretions of an infected individual;
(2) sharing of needles and other paraphernalia used for preparing and injecting drugs between infected and noninfected individuals;
(3) the gestation, birthing or breastfeeding of an infant when the mother is infected with HIV;
(4) transfusion or transplantation of blood, organs, or other tissues from an infected individual to an uninfected individual, provided such blood, organs or other tissues have not tested negatively for antibody or antigen and have not been rendered noninfective by heat or chemical treatment;
(5) other circumstances not identified in paragraphs (1)-(4) of this subdivision during which a significant risk body substance (other than breast milk) of an infected individual contacts mucous membranes (e.g., eyes, nose, mouth), nonintact skin (e.g., open wound, skin with a dermatitis condition, abraded areas) or the vascular system of a noninfected person. Some circumstances include, but are not limited to needle-stick or puncture wound injuries and direct saturation or permeation of these body surfaces by the infectious body substance;
(6) circumstances that involve significant risk shall not include:
(i) exposure to urine, feces, sputum, nasal secretions, saliva, sweat, tears or vomitus that does not contain blood that is visible to the naked eye;
(ii) human bites where there is not direct blood to blood, or blood to mucous membrane contact;
(iii) exposure of intact skin to blood or any other body substance; and
(iv) occupational settings where individuals use scientifically accepted barrier techniques and preventive practices in circumstances which would otherwise pose a significant risk.
(ci) Risk, undue.
A level of risk that may affect a person’s wellbeing, may involve a physical effect that changes the person’s normal functional status or might be considered excessive by some third parties.
(cj) Service, Mental Hygiene Legal (MHLS).
See Mental Hygiene Legal Service.
(ck) Services, home and community-based (HCBS) waiver.
This term shall include those services provided in conformance with Subpart 635-10 of this Title.
(cl) Services, plan of.
A records system, by whatever name known, maintained in accordance with the regulations applicable to the facility class in question, which documents the process of developing, implementing, coordinating, reviewing, and modifying the plan developed for a specific person. It is maintained as the functional record indicating all planning as well as all services and interventions provided to that person. It contains, at a minimum, identification data, assessment information, service plans, appropriate health information, a general description of activities, program planning team minutes and reports, staff action records, and information on efforts to place people in a less restrictive level of programming.
(cm) Services, staff providing direct care.
For purposes of medication administration, an employee who, by job description, is responsible for providing the day-to-day hands-on care, training, guidance, direction, assistance, support, etc. to persons in a facility. Employees hired to provide professional or any other services cannot be designated as providing “direct care services.”
(cn) Sibling.
One of two or more parties having at least one common parent.
(co) Staff.
Personnel of an OPWDD certified, operated, or contractor agency, hired for the express purpose of carrying out various tasks to facilitate the functioning of the establishment, under the direction of an overall director or head.
(cp) Standards of certification.
Those criteria which specify the basis for documenting compliance for the purposes of issuing an operating certificate. The basis of documentation may include facility specific record; specified forms or reports; specified contents of records, reports, or forms; and/or other means of assessing compliance such as interviews with persons receiving services at the facility, employees, volunteers, and/or onsite observation of activities and the environment.
(cq) Status, involuntary admission.
That designation ascribed to persons with a developmental disability who has been admitted to a developmental center or private school (for persons with a developmental disability) for the residential care and treatment essential to his or her welfare, based on medical or psychological certification, due to the fact that his or her judgement is so impaired as to be unable to understand the need for such care and treatment.
(cr) Sterilization.
Any procedure or operation, the primary purpose of which is to render one permanently incapable of reproducing and which is not a necessary part of the treatment of a physical illness or injury.
(cs) Subjects, assurance of compliance with regulations for the protection of human.
For the purposes of section 633.13 of this Part, a written assurance, satisfactory to the Secretary of the Federal Department of Health and Human Services, certifying that the facility or entity will comply with the provisions of 45 CFR 46 and containing the elements specified in 45 CFR 46.103.
(ct) Substances, significant risk body fluids.
Any body fluid or substance which has been epidemiologically implicated in the transmission of HIV including blood, semen, vaginal secretions, breast milk, cerebrospinal fluid, amniotic fluid; peritoneal fluid, synovial fluid, pericardial fluid, pleural fluid and body tissues.
(cu) Surrogate.
For the purposes of sections 633.11, 633.16 and 633.18 of this Part, a party designated to act in the place of a person receiving services by the provisions of the respective regulations. For the purposes of section 633.13 of this Part only, someone designated to advocate on behalf of a person who may be/who will be the subject of research. Designation is made in conformance with section 633.13(a)(3)(ii)(b) of this Part.
(cv) System, dispute, mediation.
A process whereby disputes over DNR orders in developmental centers, hospitals, psychiatric centers and residential health care facilities (see definition) can be resolved.
(cw) Team, program planning.
Members of a group of persons, acting as a unit, responsible for identifying an individual's needs; for developing, implementing and evaluating the plan of services for that person; and ensuring that he or she is appropriate to remain in the current setting. Regulations for a specific class of facility are to be referenced for specific details. For those persons enrolled in the home and community-based services waiver (HCBS), the program planning team is defined as the person and the waiver case manager, and the advocate (if appropriate) as well as any other party or parties considered, at any given time, as being appropriate for participation by the individual, the waiver case manager, and, if appropriate, the advocate.
(cx) Test, HIV-related.
Any laboratory test or series of tests for any virus, antibody, antigen or etiologic agent whatsoever thought to cause or to indicate the presence of HIV infection.
(cy) Training.
As used in this Part, training refers to the dissemination of information to employees, volunteers, family care providers, members of board of directors, or persons receiving services by any appropriate method and which is documented to have taken place. Thus, training may include, but is not limited to, orientation (formal or informal), instruction sessions (formal or informal), self- instruction, onsite instruction, formal training or educational activities at a facility or elsewhere, and field trips.
(cz) Treatment, capacity to understand appropriate disclosures regarding proposed professional medical.
The ability to adequately understand and appreciate the nature and consequences of such professional medical treatment (see subdivision [df] of this section), including the benefits and significant risks and alternatives to such treatment so as to be capable of making a decision thereto in a knowing and voluntary manner. A person's decision relative to the proposed professional medical treatment shall not, in and of itself, be the exclusive basis for the determination of capacity.
(da) Treatment, professional medical.
A medical, dental, surgical or diagnostic intervention or procedure in which a general anesthetic is used or which involves a significant invasion of bodily integrity requiring an incision or producing substantial pain, discomfort, debilitation or having a significant recovery period, or any professional diagnosis or treatment to which informed consent is required by law.
(db) Verify.
Any means including, but not limited to, observation, interview, and the written word that provides OPWDD with a basis for being reasonably assured that a requirement has been met.
(dc) Volunteer.
For the purposes of this Part, someone who applies to and is accepted by an agency to participate, under the supervision of agency staff or management, in activities with or for the benefit of the persons receiving services operated, certified, authorized, approved or funded through contract by OPWDD, and for which he or she receives no salary or remuneration.
14 CRR-NY 633.99
Current through March 15, 2020
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