NY_mortlaws by James Syrett

MortSci 2012

New York Funeral Law

Disclaimer: While every effort was made to ensure the accuracy and completeness of the Funeral Laws and regulations available on the Stateâ&#x20AC;&#x2122;s website, the documents are not official, and the state agencies preparing this website and the Compiler are not responsible for any errors or omissions which may occur in these files. Only the current published volumes of the States Laws are considered valid

New York Codes, Rules and Regulations, Title 10 The information contained on this Web site is not the official version of the Compilation of the Rules and Regulations of the State of New York (NYCRR). No representation is made as to its accuracy. To ensure accuracy and for evidentiary purposes, reference should be made to the Official Compilation of the Rules and Regulations of the State of New York, available from West Publishing at 1-800-344-5009 1-800-344-5009. For questions related to the compilation of the rules and regulations published on this Web site, you may write to regsqna@health.state.ny.us. An unofficial version of the NYCRR is also available on the Department of State's Web site at www.dos.state.ny.us.

Title: Section 77.5 - Funeral establishments 77.5 Funeral establishments. (a) The business and practice of funeral directing shall be conducted and registered only from a fixed funeral establishment. (b) Separate buildings or portions thereof connected by a private passageway, walk or driveway shall constitute a single funeral establishment. (c) After February 28, 1974, all funeral firms and their funeral establishments shall comply and conform as follows: (1) Embalming. No embalming of a body of a deceased person shall be performed in a funeral establishment except in a room set aside exclusively for embalming or other preparation of a body of a deceased person. Such room shall be maintained and kept in a clean and sanitary condition. (2) Embalming and preparation room. Every embalming and preparation room shall be constructed, equipped and maintained as follows: (i) the surfaces of the floor, walls and ceiling shall be covered with tile or other hard, smooth, impervious washable material; (ii) the room shall be adequately lighted and adequately ventilated. The ventilation shall be provided by an exhaust fan or by an appropriate air-conditioning unit which will completely remove objectionable fumes; (iii) the room shall be equipped and provided with hot and cold running water, a utility sink, and cabinets, closets or shelves for instruments and supplies; (iv) the room shall be equipped with adequate sewage and waste disposal and drainage facilities and systems; (v) the doors shall be tight-closing and rigid, and any windows of the room shall be so maintained as to obstruct any view into such room;

(vi) the embalming or preparation table shall be nonporous; and (vii) the room shall be equipped with proper and convenient receptacles for refuse, bandages, cotton and other waste materials. (3) Business telephone. Every registered funeral firm shall have, listed and in working order, at its registered address a business telephone, the number of which shall be indicated as the business telephone number. Any other telephone number also listed for the funeral firm shall be specifically designated as "residence telephone number," "number to call if no answer," or otherwise identified. (4) Display of signs. Every registered funeral firm shall display a sign indicating the true funeral firm name as registered with the department. Such sign shall be conspicuously located at or near the main entrance and shall be visible from the exterior of the building. The lettering of the funeral firm name shall be legible and shall have a minimum height of 1-1/2 inches. Wherever the name of the funeral firm appears on a sign indicating the location or presence of an establishment, only the funeral firm name registered with the department shall be used. A change in a funeral firm's registered name shall be indicated on any and all signs. Signs shall conform with all local laws, ordinances and regulations. (5) Listings, publications and advertising. Only true funeral firm names and addresses, as registered with the department, shall appear in telephone listings or other publications and in advertising by any media whatsoever of funeral firms. This paragraph shall not apply to the listing or advertising of funeral firms outside the State. (6) Food and beverages. The provision of space, facilities, equipment, accommodations or supplies for, or the preparation, sale, service or distribution of, food or beverages in any part of a funeral establishment to or by friends, relatives, mourners, family, visitors or next of kin of any deceased person in the funeral establishment is prohibited. (d) A funeral establishment of a funeral firm registering after February 28, 1974 shall, in addition to the provisions of subdivision (c) of this section, contain at least one of each of the following: (1) a chapel or reposing room, containing at least 300 square feet of floor space, to be used exclusively for the conduct of funeral services; (2) an arrangement office, to be used exclusively for making funeral arrangements and for other related business matters; and (3) a preparation room, containing at least 120 square feet of floor space. The preparation, disinfection, embalming, washing, dressing and casketing or other care of a body of a deceased person shall take place only in such room, which room shall contain only articles and equipment necessary for such preparation. Such room and equipment, instruments and articles contained therein shall be maintained and kept in a clean and sanitary condition. Temporary storage of an uncasketed body of a deceased person awaiting burial or other final disposition shall take place only in such preparation room or in a storage room in a manner acceptable to the commissioner.

(e) No change in name or transfer of title or interest to a successor entity or transfer of title to or leasehold of real property wherein a funeral establishment is located by a firm registered prior to March 1, 1974, and continuing thereafter to operate from such funeral establishment, shall require compliance with the provisions of subdivision (d) of this section.

Volume: A-1a Title: Section 77.1 - Academic requirements for funeral director examination 77.1 Academic requirements for funeral director examination. (a) Applicants for examination pursuant to section 3421(1) of the Public Health Law shall submit evidence of satisfactory completion of a course of collegiate-level study in funeral service, as required by section 3421(2)(b) of the Public Health Law, consisting of not less than 60 semester credits or 90 quarter credits in an institution or institutions approved by the department or approved by an accrediting agency recognized by the department. The approved course of study shall consist of the following curriculum: Area of study

Hours

Examples of courses (illustrative only)

Mortuary Arts & Sciences and Related Academic Disciplines

22 semester credit or 33 quarter credit

Embalming, Restorative Art, Anatomy, Chemistry, Microbiology, Pathology, Personal and Public Health, Biology, Practicum.

Funeral Service Education and Related Academic Disciplines

22 semester credit or 33 quarter credit

Funeral Service Orientation, Funeral Counseling, Funeral Directing, Funeral Home Management, Funeral Merchandising, Funeral Home Accounting, Business and Mortuary Law, Practicum.

Electives (Institutional Requirements)

16 semester credit or 24 quarter credit

(b) The department shall accept, in lieu of completion of a course of collegiate-level study in funeral service as described in subdivision (a) of this section, satisfactory evidence that the applicant possesses an Associate or higher degree in funeral service awarded by an institution approved by the department or approved by an accrediting agency recognized by the department. (c) Any applicant for examination pursuant to section 3421(1) of the Public Health Law may submit evidence that:

(1) prior to October 17, 1983, he/she was enrolled in a college or university approved by the State Education Department or approved by an accrediting organization recognized by the department; (2) he/she completed a general course of study consisting of not less than 30 semester credits; (3) such general course of study was completed by October 17, 1987; and (4) he/she began funeral service study within one year of completion of such general college study. (d) Upon submission of the evidence contained in subdivision (c) of this section, the department shall, whenever it benefits the applicant, substitute, in lieu of completion of a course of collegiate-level study in funeral service as described in subdivision (a) of this section, the satisfactory completion of the following course of study consisting of 42-2/3, semester credits or 64 quarter credits in an institution or institutions approved by the department or approved by an accrediting agency recognized by the department.

Area of study

Hours

Examples of courses (illustrative only)

Mortuary Arts & Sciences and Related Academic Disciplines

22 1/3 semester credit or 32 quarter credit

Embalming, Restorative Art, Anatomy, Chemistry, Microbiology, Pathology, Personal and Public Health, Biology, Practicum.

Funeral Service Education and Related Academic Disciplines

16 semester credit or 24 quarter credit

Funeral Service Orientation, Funeral Counseling, Funeral Directing, Funeral Home Management, Funeral Merchandising, Funeral Home Accounting, Business and Mortuary Law, Practicum.

Electives (Institutional Requirements)

5 1/3 semester credit or 8 quarter credit

Volume: A-1a PART 77 PRACTICE OF FUNERAL DIRECTING (Statutory authority: Public Health Law, Sections 3400(k), 3401(1)) Title: Section 77.0 - Definitions Section 77.0 Definitions. The following words and phrases as used in this Part shall have the following meanings, unless the context otherwise requires:

(a) Department means the New York State Department of Health. (b) Commissioner means the Commissioner of Health of the State of New York. (c) School means any educational institution wherein funeral directing, embalming and related subjects are taught for the purpose of preparing students for licensing and practice as funeral directors. (d) Curriculum means the complete program of instruction in funeral service education. (e) Accrediting agency means a duly constituted and departmentally recognized agency which evaluates and accredits curricula in funeral service education. (f) Common carrier is defined, for the purposes of this Part and Part 13 of this Title, as a carrier licensed or authorized to transport cargo by any of the following: (1) New York State Department of Transportation; (2) Interstate Commerce Commission; (3) Federal Aviation Administration; or (4) United States Coast Guard. (g) Customer means the person making arrangements, or the customer's designee, to whom a written statement showing thereon the price of the funeral, including an itemized list of the services and merchandise to be furnished for such price, shall be furnished at the time funeral arrangements are made. (h) Customer's designee means the person whom the funeral director reasonably believes to be acting on behalf of a customer. (i) Casket includes coffin and means a rigid container designed for the encasement of human remains and customarily ornamented and lined with fabric. (j) Outer interment receptacle means any container or enclosure which is placed in the grave around the casket to prevent the collapse of the grave and/or to protect the casket, including but not limited to receptacles commonly known as burial vaults, grave boxes or grave liners. (k) Actual retail price is the price for which a funeral director regularly sells an item of merchandise to customers. (l) Direct cremation is the disposition of human remains by cremation, without a formal viewing, visitation or ceremony with the body present. (m) Direct burial is the disposition of human remains by burial, without formal viewing, visitation or ceremony with the body present, except for a graveside service.

(n) Unfinished wooden box is an unornamented casket made of wood which does not have a fixed interior lining. (o) Alternative container is a nonmetal receptacle or enclosure, without ornamentation or a fixed interior lining, which is designed for the encasement of human remains and which is made of cardboard, pressed wood, composition materials (with or without an outside covering) or pouches of canvas or other materials. Section 77.1 - Academic requirements for funeral director examination 77.1 Academic requirements for funeral director examination. (a) Applicants for examination pursuant to section 3421(1) of the Public Health Law shall submit evidence of satisfactory completion of a course of collegiate-level study in funeral service, as required by section 3421(2)(b) of the Public Health Law, consisting of not less than 60 semester credits or 90 quarter credits in an institution or institutions approved by the department or approved by an accrediting agency recognized by the department. The approved course of study shall consist of the following curriculum: Area of study

Hours

Examples of courses (illustrative only)

Mortuary Arts & Sciences and Related Academic Disciplines

22 semester credit or 33 quarter credit

Embalming, Restorative Art, Anatomy, Chemistry, Microbiology, Pathology, Personal and Public Health, Biology, Practicum.

Funeral Service Education and Related Academic Disciplines

22 semester credit or 33 quarter credit

Funeral Service Orientation, Funeral Counseling, Funeral Directing, Funeral Home Management, Funeral Merchandising, Funeral Home Accounting, Business and Mortuary Law, Practicum.

Electives (Institutional Requirements)

16 semester credit or 24 quarter credit

Department or approved by an accrediting organization recognized by the department; (2) he/she completed a general course of study consisting of not less than 30 semester credits; (3) such general course of study was completed by October 17, 1987; and (4) he/she began funeral service study within one year of completion of such general college study. (d) Upon submission of the evidence contained in subdivision (c) of this section, the department shall, whenever it benefits the applicant, substitute, in lieu of completion of a course of collegiate-level study in funeral service as described in subdivision (a) of this section, the satisfactory completion of the following course of study consisting of 42-2/3, semester credits or 64 quarter credits in an institution or institutions approved by the department or approved by an accrediting agency recognized by the department.

Area of study

Hours

Examples of courses (illustrative only)

Mortuary Arts & Sciences and Related Academic Disciplines

22 1/3 semester credit or 32 quarter credit

Embalming, Restorative Art, Anatomy, Chemistry, Microbiology, Pathology, Personal and Public Health, Biology, Practicum.

Funeral Service Education and Related Academic Disciplines

16 semester credit or 24 quarter credit

Funeral Service Orientation, Funeral Counseling, Funeral Directing, Funeral Home Management, Funeral Merchandising, Funeral Home Accounting, Business and Mortuary Law, Practicum.

Electives (Institutional Requirements)

5 1/3 semester credit or 8 quarter credit

Section 77.2 - Examinations 77.2 Examinations. (a) A candidate for examination shall submit evidence satisfactory to the department that such applicant: (1) has met the academic requirements for funeral director examination contained in section 77.1 of this Part; and (2) is a citizen of the United States at the time of filing such application, or an alien lawfully admitted for permanent residence.

(b) An applicant for examination, who has been convicted of a felony (by any court in this State or by any court of the United States or by any court of any other state of the United States, or of any crime of which such applicant shall have been convicted, by any court of the United States or of any other state, which is not a felony in the jurisdiction in which the conviction is had, but is a felony in the State of New York) or a misdemeanor, shall submit such documentation as the department may require to make a determination as to whether there is satisfactory evidence of the applicant's good moral character as required by section 3421(1) of the Public Health Law. (c) Where applicable, an applicant for examination shall submit supporting documentation of a change in name, such as a photocopy of a judicial order from a court of legal jurisdiction or a marriage certificate. (d) An applicant for examination who is a veteran of the Armed Forces of the United States shall submit a photocopy of an official United States Armed Forces Certificate of Discharge and/or an official Report of Transfer or Discharge. (e) Examinations for funeral director license may include the following subjects: (1) the law; (2) the State Sanitary Code (Chapter I of this Title); (3) rules and regulations of the commissioner; (4) tests for death; (5) hygiene and sanitary science; (6) disinfection; (7) mortuary law; (8) pathology; (9) bacteriology; (10) anatomy; (11) applied chemistry; (12) practical embalming; (13) restorative art; (14) funeral management; (15) care and preparation of the human dead for final disposition;

(16) ethics; (17) accounting; (18) psychology; (19) business English; and (20) speech. (f) Every candidate for a funeral director license shall pass such an examination with a grade of not less than 75. (g) Gradings need not represent arithmetic percentages, but may, in the department's discretion, be higher than percentage ratings and be computed on the basis of either an arithmetic addition of a certain number of points to the percentage rating of each candidate, or an arithmetic adjustment of deductions for errors or of credits for correct answers obtained by each candidate. (h) The department shall determine the method of grading each examination separately, and shall apply the method uniformly to all candidates taking that examination. The department shall not disclose the percentage ratings of candidates by individual identity to any of its officers or employees responsible for determining the final grading of an examination until such determination has been made. (i) In determining the method to be used in grading an examination, the department shall take into consideration: (1) the advice and judgment of department officers, employees and consultants regarding the difficulty of the examination in relation to the minimum requirements for satisfactory performance as a funeral director; and (2) the results of any studies conducted regarding the difficulty of the examination. (j) The department may conditionally admit to examination for licensure an applicant who, on the date of a scheduled examination for licensure, has not fully established his qualifications, if, in the judgment of the department, it appears that such qualifications will be fully completed within 45 days after the date of such examination. Unless such applicant submits satisfactory evidence of such completion of qualifications within 45 days following the date of the examination, the department shall notify the applicant that he is not qualified for licensure. (k) The department shall accept, in lieu of an applicant's passing with acceptable scores its own examination, certification from The Conference of Funeral Service Examining Boards of the United States, granted on the basis of an applicant's passing with acceptable scores an approved National Board Examination taken after August 31, 1973. For acceptance of such certification, an applicant must meet all the requirements for admission to the New York State funeral director licensing examination. However,

such certification shall not be applicable to the department examination required by section 3421(4)(d) of the Public Heath Law. Section 77.3 - Registered residents 77.3 Registered residents. (a) Every candidate for funeral director licensure, upon entering employment as a registered resident as required by the provisions of the Public Health Law, shall register with the department, within two weeks from the date of the beginning of such employment, on a form prescribed by the department. (b) No funeral firm shall be approved to employ a registered resident unless the manager, or sponsor designated by the manager, submits satisfactory evidence and a signed statement, on a form provided by the department, that: (1) the residence shall be under the supervision of a manager or sponsor designated by the manager, who is licensed and registered as a funeral director or undertaker and embalmer, and who is regularly employed by the funeral firm; (2) during the 12 months immediately preceding the date of beginning of the proposed residency period of the applicant, the funeral firm in which the registered resident is to be employed has had, and has serviced or handled, at least 40 cases directly for, and pursuant to engagement by, the respective families or friends of the decedent, exclusive of cases of stillborn children and exclusive of cases serviced or handled for and on behalf of, or in conjunction with, other funeral firms. These 40 cases may be a total of all cases done by branches and/or affiliate funeral firms; (3) the funeral establishment in which the registered resident is to be employed contains adequate facilities for embalming as required by the department pursuant to its rules and regulations; and (4) residence practice in connection with funeral arrangements shall consist of observing, instruction, taking of preliminary information and exposure to the sale of service and merchandise. (c) The registered residency shall be of a grade and character satisfactory to the department and, in addition thereto: (1) the registered resident shall serve for not less than the period required by law; (2) the registered resident shall serve on a full-time work schedule which shall be of sufficient scope to include training in all aspects of funeral service; (3) the registered resident and the manager or the sponsor designated by the manager shall jointly file quarterly reports with the department, on forms provided by the department. Reports are due immediately after the end of each quarter, and shall be signed and mailed to the Albany office of the department with a copy sent to the appropriate department area office representative within 10 days following the end of the quarter. Reports mailed thereafter may be accepted if, in the judgment of the department, a justifiable cause existed for delay;

(4) the registered resident, manager or sponsor designated by the manager shall report to the department, on a form provided by the department, any change in manager or sponsor or discontinuance or completion of residency within 10 days after such occurrence; (5) the registered resident shall carry with him at all times while engaged in activities relative to the residency, a pocket card issued to him by the department. In the event of loss or destruction thereof, a duplicate pocket card shall be issued by the department; and (6) the registered resident shall be subject to all provisions of article 34 of the Public Health Law, the administrative rules and regulations, and other laws relating to funeral directing. (d) If the employer funeral firm fails to comply with the provisions of the law and with these regulations to the satisfaction of the department, the department may refuse to register registered residents from such funeral firm for such period as the department may prescribe. (e) After or during the serving of a one-year period as a registered resident, the department may direct either or both the registered resident, the manager or the sponsor, to appear, at a time and place designated by the department, for an oral interview to determine the resident's qualifications for full licensure. (f) After or during the serving of a one-year period as a registered resident, the resident shall appear for an examination on New York State laws, rules and regulations relating to funeral directing as provided for in section 3421(4) (d) of the Public Health Law. Section 77.4 - Funeral service schools 77.4 Funeral service schools. (a) Approval procedure. (1) Any school offering a curriculum in funeral service education may make application for approval on a form provided by the department and shall remit the fee prescribed by law. (2) Any school applying for approval shall supply all data necessary for a complete evaluation of its administration, curriculum, physical facilities, faculty, and such other information as the department may require. (3) A certificate of approval shall be issued to a school maintaining standards satisfactory to the department. (4) The department may grant full approval, provisional approval, limited approval or conditional approval. (5) Approval shall be on a fiscal-year basis, starting April 1st of each year and terminating the following March 31st. The certificate of approval issued to any school by the department during a fiscal year shall expire at the end of that fiscal year. Application for renewal of approval in any year shall be made not later than 60 days prior to the beginning of the new fiscal year. Each school shall remit with the renewal application such fee as is prescribed by law. (6) The department may, in lieu of the approval procedures contained in paragraphs (1)-(3) and (5) of this subdivision, accept the certification of accreditation issued by an accrediting organization recognized by the

department, or the department may conduct its own examination and evaluation to determine the degree of compliance by the school of the rules, regulations and standards of the accrediting agency. (7) Approval of a school for funeral service education may be withdrawn by the department for any violation of this Part or of the provisions of the Public Health Law or other statutes pertaining to funeral directing, or the rules, regulations and standards of the accrediting agency. When charges of violation are brought to the attention of the department, the affected school shall be notified in writing of the alleged violations, and shall be given an opportunity to be heard on the charges. If, after hearing, the school shall be found guilty of the violations, the certificate of approval may be withdrawn by order of the commissioner served personally or by mail on the school. (8)(i) A school whose approval has been withdrawn shall not be eligible for a new approval until such time as the school has corrected all conditions specified in the withdrawal order. (ii) Reports. Each approved school shall report in writing to the department the name and address of each student enrolled in the funeral service course who has expressed an intention to apply for a funeral director license in the State of New York. Upon graduation, a certification of graduation, together with a transcript of grades and attendance records, shall be forwarded by the school to the department within 20 days after graduation. (iii) Students. A student, enrolled in the funeral service course of an approved school, who enters active service in the Armed Forces of the United States of America, may continue his academic studies, provided such student registers within one year after the date of the honorable termination of his initial term of such active service, but credit for studies prior to his entry therein shall be at the discretion of the school administrator. Section 77.5 - Funeral establishments 77.5 Funeral establishments. (a) The business and practice of funeral directing shall be conducted and registered only from a fixed funeral establishment. (b) Separate buildings or portions thereof connected by a private passageway, walk or driveway shall constitute a single funeral establishment. (c) After February 28, 1974, all funeral firms and their funeral establishments shall comply and conform as follows: (1) Embalming. No embalming of a body of a deceased person shall be performed in a funeral establishment except in a room set aside exclusively for embalming or other preparation of a body of a deceased person. Such room shall be maintained and kept in a clean and sanitary condition. (2) Embalming and preparation room. Every embalming and preparation room shall be constructed, equipped and maintained as follows:

(i) the surfaces of the floor, walls and ceiling shall be covered with tile or other hard, smooth, impervious washable material; (ii) the room shall be adequately lighted and adequately ventilated. The ventilation shall be provided by an exhaust fan or by an appropriate air-conditioning unit which will completely remove objectionable fumes; (iii) the room shall be equipped and provided with hot and cold running water, a utility sink, and cabinets, closets or shelves for instruments and supplies; (iv) the room shall be equipped with adequate sewage and waste disposal and drainage facilities and systems; (v) the doors shall be tight-closing and rigid, and any windows of the room shall be so maintained as to obstruct any view into such room; (vi) the embalming or preparation table shall be nonporous; and (vii) the room shall be equipped with proper and convenient receptacles for refuse, bandages, cotton and other waste materials. (3) Business telephone. Every registered funeral firm shall have, listed and in working order, at its registered address a business telephone, the number of which shall be indicated as the business telephone number. Any other telephone number also listed for the funeral firm shall be specifically designated as "residence telephone number," "number to call if no answer," or otherwise identified. (4) Display of signs. Every registered funeral firm shall display a sign indicating the true funeral firm name as registered with the department. Such sign shall be conspicuously located at or near the main entrance and shall be visible from the exterior of the building. The lettering of the funeral firm name shall be legible and shall have a minimum height of 1-1/2 inches. Wherever the name of the funeral firm appears on a sign indicating the location or presence of an establishment, only the funeral firm name registered with the department shall be used. A change in a funeral firm's registered name shall be indicated on any and all signs. Signs shall conform with all local laws, ordinances and regulations. (5) Listings, publications and advertising. Only true funeral firm names and addresses, as registered with the department, shall appear in telephone listings or other publications and in advertising by any media whatsoever of funeral firms. This paragraph shall not apply to the listing or advertising of funeral firms outside the State. (6) Food and beverages. The provision of space, facilities, equipment, accommodations or supplies for, or the preparation, sale, service or distribution of, food or beverages in any part of a funeral establishment to or by friends, relatives, mourners, family, visitors or next of kin of any deceased person in the funeral establishment is prohibited. (d) A funeral establishment of a funeral firm registering after February 28, 1974 shall, in addition to the provisions of subdivision (c) of this section, contain at least one of each of the following:

(1) a chapel or reposing room, containing at least 300 square feet of floor space, to be used exclusively for the conduct of funeral services; (2) an arrangement office, to be used exclusively for making funeral arrangements and for other related business matters; and (3) a preparation room, containing at least 120 square feet of floor space. The preparation, disinfection, embalming, washing, dressing and casketing or other care of a body of a deceased person shall take place only in such room, which room shall contain only articles and equipment necessary for such preparation. Such room and equipment, instruments and articles contained therein shall be maintained and kept in a clean and sanitary condition. Temporary storage of an uncasketed body of a deceased person awaiting burial or other final disposition shall take place only in such preparation room or in a storage room in a manner acceptable to the commissioner. (e) No change in name or transfer of title or interest to a successor entity or transfer of title to or leasehold of real property wherein a funeral establishment is located by a firm registered prior to March 1, 1974, and continuing thereafter to operate from such funeral establishment, shall require compliance with the provisions of subdivision (d) of this section. Section 77.6 - Registrations 77.6 Registrations. (a) Funeral firm registrations. No funeral firm shall be registered from a funeral establishment that is not in compliance with section 77.5 of this Part, provided that nothing herein contained shall be construed or interpreted to prohibit the practice of funeral directing by more than one registered funeral firm from the same funeral establishment. (b) Corporations. Application for registration of a new corporate funeral firm must be accompanied by a true copy of the certificate of incorporation as filed with the Secretary of State; a copy of the notice from the Secretary of State showing that the corporation has been duly incorporated; the name, residence address and title of each of its officers and directors; the name and residence address of each stockholder and other person, firm and corporation having a 10 per centum or greater proprietary, beneficial, equitable or credit interest; and the designation of a manager, which shall, unless otherwise acceptable to the department, be in the form of a certified copy of a resolution of the board of directors appointing such manager. A corporation which changes its name shall file with the Department of Health true copies of the amended corporate name certificate and filing receipt from the Secretary of State. (c) Individual proprietor. Application for registration of a funeral firm to be operated under the individual name of the applicant must be accompanied by a certificate executed under penalty of perjury by the applicant certifying that he is the only person having a proprietary or financial interest in the business. (d) Estates. Application for registration of a funeral firm operated by the estate of a deceased funeral director or undertaker shall be accompanied by an administrator's or executor's certificate, the names and addresses of all executors or administrators, and a certified copy of the assumed business name certificate as filed in the county clerk's office. Such duly appointed estate representatives, subject to the provisions of the Estates, Powers and Trusts Law and the Surrogate's Court Procedure Act, may operate the funeral firm for a period of not more than 30 months from the date of death of the funeral director, provided the estate

representative files a designation of, and registers, a licensed manager. In the event the funeral director or undertaker conducted 50 or fewer funerals during the 12 months immediately preceding his death, the estate representative may temporarily appoint any funeral director or undertaker to act as manager for the first six months following the death of the funeral director or undertaker, after which period a new manager shall be designated and registered with the department as hereinabove provided. (e) Partnerships. Application for registration of a funeral firm operated by a partnership shall be signed by all partners and shall be accompanied by a certified copy of the certificate of assumed business name, as filed in the office of the county clerk, and by a certificate executed under penalty of perjury by the applicants certifying that they are the only persons having a proprietary or financial interest in the business. (f) Assumed name. Application for registration of a funeral firm under a new assumed business name must be accompanied by a certified copy of the assumed business name certificate as filed in a county clerk's office. (g) Changes. The individual, partnership or corporate owner or estate representative of a funeral firm operating from a funeral establishment shall notify the department in writing within 10 days of any change in name, address, ownership or other legal status. A change in ownership shall be considered a first registration for fee purposes under section 3428 of the Public Health Law. (h) Individual licensee registration; special provisions. (1) The department shall issue a single certificate of biennial registration to any person who holds and registers both an undertaker and embalmer license, upon payment of the fees required for such license by the Public Health Law. (2) Every person entitled to engage in the business and practice of funeral directing, undertaking or embalming shall at all times while actively so engaged or while on the premises of any funeral establishment, carry on his person a current certificate of biennial registration duly issued to him by the department. He shall exhibit such certificate when so requested by any of the following: (i) a representative of the State or municipal government engaged in the administration or enforcement of law; (ii) a representative of a cemetery, crematory, hospital, common carrier or casket showroom; (iii) a person having lawful possession of a dead human body, the release of which is sought by such licensee. (3) Every registrant shall give notice in writing to the department of any change of his residence address within 10 days after such change of residence. (i) Registration periods. (1) The biennial registration of licensed funeral directors, embalmers and undertakers shall be renewable July first of each even year. (2) The biennial registration of funeral firms shall be renewable July first of each odd year.

Section 77.7 - Funeral directing 77.7 Funeral directing. (a) A funeral director, undertaker or embalmer shall not permit any unlicensed person to engage in or take charge of the activities for which a license to engage in the business or practice of funeral directing, undertaking or embalming is required by the provisions of the Public Health Law. (1) A licensed and registered funeral director or undertaker or a registered resident shall be present and personally supervise and arrange for the removal or transfer of each dead human body from the place where death occurs, or from the place where it is released to him/her by the family or other legal authority. (2) A licensed and registered funeral director or undertaker or a registered resident shall be present and personally supervise the conduct of each funeral service. (3) Nothing herein shall be construed as prohibiting religious supervision of the funeral service by a member or members of the clergy designated by the family of the deceased person. (4) A licensed and registered funeral director or undertaker or a registered resident shall, unless prevented by the rules or documented practices of the cemetery, be present and personally supervise the interment, delivery to and acceptance by crematory personnel at the crematory, or the pickup from or the delivery to a common carrier, of a dead human body. (5) No person other than a duly licensed and registered funeral director or undertaker shall make or be permitted to make arrangements on behalf of any funeral director, undertaker or funeral firm with a customer or customer's designee: (i) for temporary or final entombment, or cremation, disinterment, reinterment or other lawful disposition of a dead human body; (ii) for the care, preparation, shipment or transportation of a dead human body; or (iii) for the purchase, sale or rental of funeral merchandise, services or paraphernalia. The taking of preliminary information over the telephone by an unlicensed person shall not be construed as the making of funeral arrangements under this section. (b) (1) In no case shall a dead human body be released from any hospital, institution or other place where the death occurred or from the place where the body is held by legal authority to any person not a duly licensed and registered funeral director or undertaker or a registered resident. (2) Every person, including, although not limited to, a person in charge of a hospital, institution, or place where a person has died, having lawful possession, charge, custody or control of a dead human body, shall request the person seeking to obtain the release of said body and acting as, for, or in behalf of a funeral director or funeral firm, to produce his/her current certificate of registration, showing that he/she is personally entitled to practice as a funeral director, undertaker or registered resident. (c) Every person, including a person acting lawfully in an emergency, in charge of a cemetery, crematory,

vault or other place to which a dead human body is brought for temporary or permanent disposition shall require the person in charge of such body to identify himself /herself as a duly licensed and registered funeral director or undertaker or as a registered resident and to produce his/her current certificate of registration as such. . (d) In the event such burial or other disposition is not in the charge of a duly licensed and registered funeral director or undertaker or a registered resident, the person in charge of the cemetery, crematory, vault or other place where dead human bodies are brought for temporary or permanent disposition shall immediately submit to the Department of Health the name and address of the person who had charge of the body at the time of burial or other disposition and the name and address of the funeral director, undertaker, registered resident or funeral firm for which such person was acting. (e) In the event that a person other than a duly licensed and registered funeral director or undertaker shall make any arrangements for the purchase, sale or rental of funeral merchandise, services or paraphernalia accompanied by the representative of a decedent at a casket showroom, display room or other facility, the owner or manager of such facility shall immediately notify the Department of Health of the name and address of the person and of the funeral director, undertaker or funeral firm for which such person was acting. (f) Nothing contained in this section shall be deemed to require that a mere transporter, to whom or to which a dead human body has been duly released for the sole purpose of transportation or transfer, shall be a duly licensed and registered funeral director or undertaker or a registered resident. (g) A funeral director, undertaker or funeral firm entering another state or a province of the Dominion of Canada, personally or by an agent or employee, pursuant to a reciprocal agreement between the State Commissioner of Health and such state or province, shall not violate any statute, code, rule or regulation of such state or province relating to the practice of funeral directing, undertaking or the equivalent thereof. (h) A registered resident may only render the services described in this section under the supervision of the sponsor for his/her registration. A registered resident shall not have the authority to sign any form or document required by law which requires the signature of a licensed funeral director, or to make funeral arrangements or to own or manage a funeral firm. Section 77.8 - Managers 77.8 Managers. (a) The manager of each funeral firm shall be a funeral director or undertaker duly licensed as such under and pursuant to the laws of the State of New York and shall be duly registered with the department as such manager. (b) A funeral director or undertaker shall not serve and shall not be registered as a manager of more than one funeral firm. (c) When a funeral firm owned and operated by a corporation organized under and pursuant to the laws of the State of New York for such purpose, the board of directors of such corporation shall designate an employee as manager. Such employee shall be a duly licensed and registered funeral director or undertaker of the funeral firm and his/her designation as manager shall be filed with the department.

(d) When a funeral firm is owned and operated by the estate of a deceased funeral director or undertaker, the duly appointed representative of the estate shall designate a duly licensed and registered funeral director or undertaker as manager, and his/her designation as manager shall be filed with the department. (e) The funeral establishment of a funeral firm shall be under the immediate and personal supervision, direction, management and control of the manager, and his/her failure to exercise such supervision, direction, management and control adequately, shall constitute a violation of the rules and regulations of the State Commissioner of Health. Any violation of the provisions of article 34 of the Public Health Law, the Sanitary Code, the rules and regulations of the commissioner or of any statute, code, rule or regulation relating to the practice of funeral directing, embalming or vital statistics by the funeral firm or its personnel shall constitute a violation of the rules and regulations of the commissioner by the manager unless he/she exercised adequate supervision, management, direction and control to prevent said violation. (f) If the manager is unable, for any reason, to exercise adequate supervision, direction, management and control of the funeral establishment, the manager, owner, board of directors or the representative of the estate, as the case may be, shall designate any funeral director or undertaker to serve as temporary manager and notify the department thereof in writing. If such inability of the manager exceeds 90 days or is expected to exceed 90 days, a new manager shall be designated and registered with the department as hereinbefore provided. (g) The owner and operator or estate representative of a funeral firm shall notify the department in writing within 10 days of any change of manager of any funeral firm and shall file designation of the new manager as herein provided. In the case of a corporation, the designation of a new manager shall, unless otherwise acceptable to the department, be in the form of a resolution of the board of directors appointing such manager and a certified copy of such resolution shall be filed with the department.

Section 77.9 - Tests prescribed by the commissioner for signs of death 77.9 Tests prescribed by the commissioner for signs of death. The embalmer or funeral director, before proceeding either to embalm, remove, cremate or bury the body, shall determine that life is extinct by ascertaining that: (a) pulsation has ceased in the radial or other arteries; (b) heart and respiratory sounds are not heard with the use of a stethoscope or with the ear applied directly over the heart.

Section 77.10 - Embalming procedure 77.10 Embalming procedure. (a) The preparation for burial or other disposition of all dead human bodies shall be performed in privacy. No one shall be permitted to be present in the embalming, operating or preparation room while a dead human body is being embalmed, washed or otherwise prepared for burial or

other disposition, except the following: (1) licensed funeral directors or embalmers and their employees; (2) duly registered funeral director students and trainees; (3) duly authorized instructors of funeral directing schools; (4) public officials or representatives in the discharge of their duties; (5) duly accredited doctors or nurses; (6) members of the immediate family of the deceased and their designated representatives. (b) The use of any fluid or compound which contains arsenic, lead, mercury, zinc, silver, antimony or chloral or any poisonous alkaloid in the embalming of a dead human body is prohibited. (c) All blood and excretions of a dead human body shall be disposed of in a sanitary manner. (d) All receptacles containing embalming fluid or any poisonous or dangerous substances shall be plainly marked to indicate the contents thereof. (e) No embalmer or funeral director shall embalm, nor shall any funeral director, undertaker or embalmer permit the embalming of a dead human body when he has information reasonably indicating that death occurred as a result of accidental, homicidal or suicidal means or other suspicious or unnatural circumstances, until the body has been duly released to him for embalming or other preparation by the proper authority. (f) A funeral director trainee may not embalm or perform any part of embalming procedure on a dead human body unless such activity is performed under the personal supervision and instruction of a New York State licensed and registered funeral director or a New York State licensed and registered embalmer.

Section 77.11 - Funeral director business practices 77.11 Funeral director business practices. Every funeral director, undertaker or funeral firm shall give customers, unless otherwise agreed upon in writing at the time arrangements are made, documents which have been procured for or supplied by the customer within one week after the funeral. If the funeral director, undertaker or funeral firm does not have possession of such documents within that time, he shall give them to the customer when he obtains possession of them.

Section 77.12 - Misconduct 77.12 Misconduct. Misconduct in the business and practice of funeral directing within the meaning of paragraph (f) of subdivision (1) of section 3450 of the Public Health Law, shall include, but is not limited to,

the following: (a) failing to comply with the provisions of law, rules and regulations relating to the funeral directing, undertaking and embalming; (b) exercising undue influence on a customer, misleading a customer, or misrepresenting to a customer the sale of services or merchandise and thereby taking unfair advantage of the customer, under the circumstances which existed during the course of the sale; (c) (1) making or filing a false report or inducing another person to do so; or (2) failing to file a report required by law, rules and regulations relating to funeral directing, undertaking and embalming, or willfully obstructing such filing or inducing another person to do so; (d) revealing the personally identifiable facts, data or information about a decedent or customer, obtained in the business or practice of funeral directing without the prior consent of the customer, except as: (1) authorized and/or required by law or regulation; or (2) as necessary to complete the performance of the contract between the customer and the funeral director; (e) delegating funeral directing responsibilities to a person when the licensee delegating such responsibilities knows, or has reason to know, that such person is not qualified by training, experience or licensure, to perform them; (f) harassing, abusing, intimidating or otherwise threatening a customer; (g) abandoning, neglecting, abusing or failing to treat with dignity and respect, a dead human body entrusted to the licensee; (h) charging for services not contracted for or failing to provide or making substitution for services contracted for without the authorization of the customer; (i) charging for any item of merchandise: (1) not required by law, which is not authorized by the customer; or (2) which is not actually furnished; (j) making a substitution for merchandise arranged and contracted for when such substitution is not authorized by the customer; (k) charging in excess of the amount advanced, paid or owed to third parties on behalf of the customers, or not passing along to the customer any discount, rebate or other benefit received from third parties for any items of service or merchandise described as cash advances. Cash advances shall include, but are not limited to the following services or merchandise:

(1) cemetery or crematory charges; (2) clergy honoraria; (3) death certificate transcripts; (4) escorts; (5) chevra kadisha (Tahara); (6) public transportation (common carrier); (7) gratuities; (8) bridge and road tolls; and (9) telephone and telegraph charges; (l) suggesting, or implying in any manner, that the customer's expressed concern about prices, inexpensive services or merchandise, or desire to save money, is improper or inappropriate; (m) verbally disparaging to a customer the quality or appearance of merchandise or services which the licensee or funeral firm has advertised or offered for sale; (n) failing to display the less expensive items of merchandise advertised or offered for sale in the same manner and condition as the more expensive items of merchandise; (o) (1) misrepresenting the law or public health necessity, including but not limited to representing that State or local law requires that a deceased person be embalmed, or that a casket is required for direct cremations, or that outer interment receptacles are required, or that any purchase of goods or services is required when such is not the case; or (2) misrepresenting cemetery or crematory regulations or requirements, including but not limited to representing that such regulations or requirements require that a deceased person be embalmed, or that a casket is required for direct cremations, or that outer interment receptacles are required when such is not the case, or that any purchase of goods or services is required when such is not the case; or (3) misrepresenting religious requirements; however, this shall not include differences in interpretation of religious requirements when due diligence has been exercised to determine those requirements on behalf of the customer; or (4) misrepresenting that a deceased person is required to be embalmed for direct cremation, for direct burial, for a funeral using a sealed casket or for a funeral without viewing or visitation when there is to be a closed casket and refrigeration is available; or

(5) misrepresenting that a casket (other than an unfinished wooden box) is required for direct cremation, or misrepresenting that any other container is required by the crematory when such is not the case; (p) obtaining custody of a deceased human body without having first received from a customer explicit written or oral authorization; (q) failing to promptly release a body and/or give information in regard to the release, care and whereabouts of a body upon the request of a customer; (r) embalming or furnishing other services or merchandise, without having first obtained from the customer explicit written or oral authorization; (s) making false, misleading or unsubstantiated claims directly, or by implication, as to the benefits or quality of funeral merchandise or services, including but not limited to: (1) misrepresenting that funeral merchandise or services will delay the natural decomposition of human remains for a long-term or indefinite time; or (2) misrepresenting that funeral goods have protective features or will protect the body from gravesite substances, when such is not the case; (t) indicating interest charges or finance charges unless written disclosure is contained in the statement of itemization. Such disclosure shall include the payment due date after which interest charges or finance charges will be assessed, and the annual percentage rate of interest or charge, and, where repayment is on the basis of a fixed periodic repayment schedule, such disclosure shall include the interest or finance charge in dollars; (u) (1) failing to conspicuously and legibly display the actual retail price on each casket, outer interment or entombment receptacle, or other item of funeral merchandise offered for sale (in regard to the particular items of casket and outer interment receptacle, the actual retail price printed in half-inch numbers or larger will be considered as legible); or (2) failing to legibly display the actual retail price with each picture, when pictures are used for the presentation of merchandise for sale; (v) displaying with caskets, outer interment or entombment receptacles, or any other funeral merchandise, any price other than the actual retail price of that particular item; (w) inducing the customer to consent to delay or otherwise change the desired day or time of the funeral by misstating facts or circumstances relating to such funeral, burial or cremation: (1) resulting in an increase in charges for the funeral to the customer; or (2) depriving the customer of his desire to have the funeral at a particular time, when such particular time has been expressed by the customer as an essential element of the funeral;

(x) procuring or soliciting, or attempting to procure or solicit, funeral patronage through the use of door-todoor or telephone solicitation methods unless specifically requested by a potential customer; (y) representing, permitting a representative to be made, or describing any funeral firm or entity as a society, fund, trust, or in any other way which might indicate that such funeral firm or entity is not-for-profit, unless such funeral firm or entity is not-for-profit, or unless such description includes a statement that such funeral firm or entity is for-profit; (z) requiring that a casket other than an unfinished wooden box be purchased for direct cremations or failing to make an unfinished wooden box or alternative container available for direct cremations if direct cremations are arranged; (aa) conditioning the furnishing of any funeral merchandise or services to a person arranging a funeral upon the purchase of any other funeral merchandise or services, except as required by law or as permitted by this Part. Failing to comply with a request for a combination of merchandise or services that would be impossible, impractical or excessively burdensome to provide or not regularly offered by the funeral firm shall not be misconduct. (bb) (1) charging additional fees for topical disinfection when embalming was selected or necessary because of other selections made as set out in Item 1-C of section 78.2 of this Title. (2) charging additional fees for custodial care for a time period during which a charge was incurred for embalming, or for other preparation, or for visitation or for the funeral service.

(5) No person other than a duly licensed and registered funeral director or undertaker shall make or be permitted to make arrangements on behalf of any funeral director, undertaker or funeral firm with a customer or customer's designee: (i) for temporary or final entombment, or cremation, disinterment, reinterment or other lawful disposition of a dead human body; (ii) for the care, preparation, shipment or transportation of a dead human body; or (iii) for the purchase, sale or rental of funeral merchandise, services or paraphernalia. The taking of preliminary information over the telephone by an unlicensed person shall not be construed as the making of funeral arrangements under this section. (b) (1) In no case shall a dead human body be released from any hospital, institution or other place where the death occurred or from the place where the body is held by legal authority to any person not a duly licensed and registered funeral director or undertaker or a registered resident. (2) Every person, including, although not limited to, a person in charge of a hospital, institution, or place where a person has died, having lawful possession, charge, custody or control of a dead human body, shall request the person seeking to obtain the release of said body and acting as, for, or in behalf of a funeral director or funeral firm, to produce his/her current certificate of registration, showing that he/she is personally entitled to practice as a funeral director, undertaker or registered resident. (c) Every person, including a person acting lawfully in an emergency, in charge of a cemetery, crematory, vault or other place to which a dead human body is brought for temporary or permanent disposition shall require the person in charge of such body to identify himself /herself as a duly licensed and registered funeral director or undertaker or as a registered resident and to produce his/her current certificate of registration as such. . (d) In the event such burial or other disposition is not in the charge of a duly licensed and registered funeral director or undertaker or a registered resident, the person in charge of the cemetery, crematory, vault or other place where dead human bodies are brought for temporary or permanent disposition shall immediately submit to the Department of Health the name and address of the person who had charge of the body at the time of burial or other disposition and the name and address of the funeral director, undertaker, registered resident or funeral firm for which such person was acting. (e) In the event that a person other than a duly licensed and registered funeral director or undertaker shall make any arrangements for the purchase, sale or rental of funeral merchandise, services or paraphernalia accompanied by the representative of a decedent at a casket showroom, display room or other facility, the owner or manager of such facility shall immediately notify the Department of Health of the name and address of the person and of the funeral director, undertaker or funeral firm for which such person was acting. (f) Nothing contained in this section shall be deemed to require that a mere transporter, to whom or to which a dead human body has been duly released for the sole purpose of transportation or transfer, shall be a duly

licensed and registered funeral director or undertaker or a registered resident. (g) A funeral director, undertaker or funeral firm entering another state or a province of the Dominion of Canada, personally or by an agent or employee, pursuant to a reciprocal agreement between the State Commissioner of Health and such state or province, shall not violate any statute, code, rule or regulation of such state or province relating to the practice of funeral directing, undertaking or the equivalent thereof. (h) A registered resident may only render the services described in this section under the supervision of the sponsor for his/her registration. A registered resident shall not have the authority to sign any form or document required by law which requires the signature of a licensed funeral director, or to make funeral arrangements or to own or manage a funeral firm. Section 77.6 - Registrations 77.6 Registrations. (a) Funeral firm registrations. No funeral firm shall be registered from a funeral establishment that is not in compliance with section 77.5 of this Part, provided that nothing herein contained shall be construed or interpreted to prohibit the practice of funeral directing by more than one registered funeral firm from the same funeral establishment. (b) Corporations. Application for registration of a new corporate funeral firm must be accompanied by a true copy of the certificate of incorporation as filed with the Secretary of State; a copy of the notice from the Secretary of State showing that the corporation has been duly incorporated; the name, residence address and title of each of its officers and directors; the name and residence address of each stockholder and other person, firm and corporation having a 10 per centum or greater proprietary, beneficial, equitable or credit interest; and the designation of a manager, which shall, unless otherwise acceptable to the department, be in the form of a certified copy of a resolution of the board of directors appointing such manager. A corporation which changes its name shall file with the Department of Health true copies of the amended corporate name certificate and filing receipt from the Secretary of State. (c) Individual proprietor. Application for registration of a funeral firm to be operated under the individual name of the applicant must be accompanied by a certificate executed under penalty of perjury by the applicant certifying that he is the only person having a proprietary or financial interest in the business. (d) Estates. Application for registration of a funeral firm operated by the estate of a deceased funeral director or undertaker shall be accompanied by an administrator's or executor's certificate, the names and addresses of all executors or administrators, and a certified copy of the assumed business name certificate as filed in the county clerk's office. Such duly appointed estate representatives, subject to the provisions of the Estates, Powers and Trusts Law and the Surrogate's Court Procedure Act, may operate the funeral firm for a period of not more than 30 months from the date of death of the funeral director, provided the estate representative files a designation of, and registers, a licensed manager. In the event the funeral director or undertaker conducted 50 or fewer funerals during the 12 months immediately preceding his death, the estate representative may temporarily appoint any funeral director or undertaker to act as manager for the first six months following the death of the funeral director or undertaker, after which period a new manager shall be designated and registered with the department as hereinabove provided. (e) Partnerships. Application for registration of a funeral firm operated by a partnership shall be signed by

all partners and shall be accompanied by a certified copy of the certificate of assumed business name, as filed in the office of the county clerk, and by a certificate executed under penalty of perjury by the applicants certifying that they are the only persons having a proprietary or financial interest in the business. (f) Assumed name. Application for registration of a funeral firm under a new assumed business name must be accompanied by a certified copy of the assumed business name certificate as filed in a county clerk's office. (g) Changes. The individual, partnership or corporate owner or estate representative of a funeral firm operating from a funeral establishment shall notify the department in writing within 10 days of any change in name, address, ownership or other legal status. A change in ownership shall be considered a first registration for fee purposes under section 3428 of the Public Health Law. (h) Individual licensee registration; special provisions. (1) The department shall issue a single certificate of biennial registration to any person who holds and registers both an undertaker and embalmer license, upon payment of the fees required for such license by the Public Health Law. (2) Every person entitled to engage in the business and practice of funeral directing, undertaking or embalming shall at all times while actively so engaged or while on the premises of any funeral establishment, carry on his person a current certificate of biennial registration duly issued to him by the department. He shall exhibit such certificate when so requested by any of the following: (i) a representative of the State or municipal government engaged in the administration or enforcement of law; (ii) a representative of a cemetery, crematory, hospital, common carrier or casket showroom; (iii) a person having lawful possession of a dead human body, the release of which is sought by such licensee. (3) Every registrant shall give notice in writing to the department of any change of his residence address within 10 days after such change of residence. (i) Registration periods. (1) The biennial registration of licensed funeral directors, embalmers and undertakers shall be renewable July first of each even year. (2) The biennial registration of funeral firms shall be renewable July first of each odd year.

SUBCHAPTER J Funeral Directing, Undertaking and Embalming PART 78 STATEMENT TO BE FURNISHED BY EVERY PERSON LICENSED PURSUANT TO ARTICLE 34 OF THE PUBLIC HEALTH LAW (Statutory authority: Public Health Law, Sections 3401,3440-a, 4202)

Section 78.1 - Contents of statement Section 78.1 Contents of statement. (a) Every person licensed pursuant to article 34 of the Public Health Law, including funeral directors and funeral firms, shall furnish at the time funeral arrangements are made for the care and disposition of the body of a deceased person, to the person or persons making such arrangements, a written statement which shall include, but not be limited to, the price of the funeral, including an itemized list of the services and merchandise to be furnished for such price, as required by paragraph (b)(4) of this section. No reference to the Public Health Law or administrative rules and regulations promulgated pursuant thereto shall appear on the front or back of such statement except as required by the public notice in section 78.2 of this Part. (b) Such statement shall include the following: (1) true firm name and address as registered with the department; (2) the signature and printed or typed name of the funeral director or undertaker making funeral arrangements and the date such statement was furnished to the customer; (3) name of deceased together with the place and date of death; (4) the price of the funeral together with the price of each item of service and merchandise actually to be furnished. The itemization of prices shall be contained in a written statement similar in form to that contained in section 78.2 of this Part, and shall be limited to the statements, language, titles, and the numerical order contained in said section. The itemization shall be completed as follows: (i) The charging of expenses related to the overall cost of doing business under "overhead", "administrative costs" or any similar title, is prohibited. (ii) The statement of "cash advances" shall be in compliance with subdivision (k) of section 77.12 of this Title in regard to those services or merchandise required to be listed as cash advances. (iii) Charges for additional services and merchandise selected by the customer, which the funeral firm purchases for the customer, such as hairdressing, flowers, death notices, pallbearers, clothing or burial garments, musicians and watcher shall be specifically described and may be made either as a "Funeral Home Charge" under the section "Additional Services and Merchandise Selected," if the funeral firm charges for its services in purchasing these items, or as a "Cash Advance," if the funeral home does not charge the customer in excess of the amount advanced to a third party. If the funeral firm charges more than it advances to a third party or receives and retains a rebate, commission, trade or volume discount or other benefit, the items must be listed under the heading "Additional Services and Merchandise Selected." (iv) Under the heading "Cash Advances," the price for each cash advance item selected shall be listed to the extent known or ascertainable at the time the itemization form is completed. If prices are not known or ascertainable, a good faith estimate shall be listed. The actual charges for any estimated prices shall be provided in writing to the person making the arrangements before the final bill is paid.

(v) Items listed under the heading "Additional Services and Merchandise Selected" shall be the actual charge and shall not be an estimate even when the item is to be purchased by the funeral firm from a third party. (vi) Charges for preparation of the remains. The charge for embalming shall include all items of service incidental to the disinfection and preservation of the remains. Charges for "other preparation (excluding embalming)," that is cosmetology, dressing/casketing and restoration, shall be listed if selected. If a charge is incurred for "other," the service provided must be specifically listed. A charge for topical disinfection may only be listed when the remains are not to be embalmed and this service is selected. The charge for "custodial care" shall be listed, if applicable. A separate charge for the use of the preparation room shall not be listed as the use of this facility is incidental to the "preparation of remains." A separate charge for "hairdressing" may be made under either the heading "Additional Services and Merchandise Selected," if it is a "Funeral Home Charge," or under the heading "Cash Advances," if the funeral director does not charge the customer in excess of the amount advanced to a third party. (vii) Items listed under "Funeral Home Charges" shall not be estimated and the term estimate shall only appear on the statement in reference to cash advance items. (5) Under the heading "Explanation of Charges," a clear, concise written description of the reasons for an embalming charge or any other charge made necessary by cemetery requirements, crematory requirements or other selections made by the person making arrangements. (6) The dated signature of the person making arrangements acknowledging receipt of the itemization statement. This must be signed unless the person making arrangements refuses to sign it or signs and dates a contractual statement on the same form. (c) Nothing contained herein shall be interpreted to prohibit the addition of legal contractual language on the itemized statement form provided that no such additional language, if any, shall be inconsistent with the provisions of this Part. Such language shall appear after the required information in section 78.2 of this Part. The customer shall be required to sign either the acknowledgment required by this section or a binding contractual agreement, which includes the itemized statement, proposed by the funeral director. (d) (1) True copies of the statement required by this Part shall be consecutively numbered and maintained in numerical order at the funeral establishment. (2) The following documents shall be retained at the funeral home for a period of not less than four years following the funeral and shall, during normal business hours within such period, be open to inspection by the commissioner or his representatives: (i) itemized statements; (ii) funeral bills rendered to customers indicating funeral charges and service/ merchandise provided. Bills for past due balances need not be retained; (iii) casket invoices or delivery copies; (iv) outer interment receptacle invoices or delivery copies;

(v) receipts or cancelled checks for cash advance items, except for gratuities paid in cash. Wholesale prices of funeral home merchandise need not appear on casket and/or outer interment receptacle invoices; and (vi) customer's designation of intentions. (e) Itemization of social services and other governmental cases shall be in compliance with the rules of the department or agency having jurisdiction; provided, however, that the requirements of this Part are also met. True copies of documents pertaining to all such cases shall be consecutively numbered and maintained at the funeral establishment for a period not less than four years following the funeral and shall during normal hours within such period be open to inspection by the commissioner or his representatives. Where any portion of the payment for such cases is not provided for by such department or agency, itemization shall be governed by this Part. Section 78.2 - Format for statement of goods and services selected 78.2 Format for statement of goods and services selected. The statement of goods and services selected shall be in the following format: ITEMIZATION OF FUNERAL SERVICES AND MERCHANDISE SELECTED The following are the charges for the services, merchandise and livery you have selected. You will not be charged for any item you do not choose unless it is necessary because of other selections you have made. Any such charges are explained below. I. FUNERAL HOME CHARGES (Indicate N/A for items of service and/or merchandise that are not provided.) A. Alternative Services 1. Direct Cremation $_______ 2. Direct Burial $_______ B. Transfer of remains to the funeral establishment, including personnel, equipment and vehicle. $_______ C. Preparation of Remains 1. Embalming (including use of preparation room) $_______ If you select a funeral for which this firm requires embalming, such as a funeral with viewing, you may have to pay for embalming. You do not have to pay

for embalming you do not approve if you select ar rangements such as direct cremation or direct burial. If we charge for embalming, we will explain why below. 2. Other preparation (including use of preparation room but excluding embalming) a. Topical Disinfection $_______ b. Custodial Care $_______ c. Dressing/Casketing $_______ d. Cosmetology $_______ e. Restoration $_______ f. Other (specify) ______________________________ $_______ _______________________________________________ D. Arrangements $_______ Basic arrangements: including funeral director, other staff, equipment and facilities to respond to initial request for service, the arrangement conference, securing of necessary authorizations and coordination of service plans with parties involved in the final disposition of the deceased. E. Supervision (funeral director and staff) $_______ 1. Supervision for visitation $_______ 2. Supervision for funeral service $_______

3. Other supervision (specify) ___________________ ________________________________________________ F. Use of the Facilities Use of the facilties for visitation $_______ Use of facilities for funeral service $_______ Other use of facilities (specify) _______________ $_______ _________________________________________________ G. Livery a. Hearse or $_______ b. Alternative vehicle $_______ (Specify type: ______________________________) Flower vehicle $_______ Limousine(s) $_______ (Specify number:______ @ $_____ /limousine) $_______ Passenger car(s) $_______ (Specify number:______ @ $_____ /car) H. Merchandise $_______ 1. Casket or Alternative Container $_______ a. Supplier _____________________________________ b. Model name or number _________________________ c. Material: Species of wood ____________________ or kind of metal _____________________________ weight or gauge _____ or alternative container

(describe)____________________________________ d. Interior _____________________________________ 2. Outer Interment Receptacle $_______ Supplier_____________________________________ Model name or number ________________________ Material ____________________________________ I. Additional Services and Merchandise Selected (Describe and show price) 1. ________________________________________________ $_______ 2. ________________________________________________ $_______ 3. ________________________________________________ $_______ 4. ________________________________________________ $_______ J. Limited Services 1. Forwarding remains to __________________________ $_______ 2. Receiving remains from _________________________ $_______ TOTAL OF FUNERAL HOME CHARGES $_______ II. CASH ADVANCES These are estimated charges for items to be paid to others. We will charge you no more for these items than is actually paid the third parties. (Describe and show estimated charges.) 1. ________________________________________________ $_______ 2. ________________________________________________ $_______ 3. ________________________________________________ $_______ 4. ________________________________________________ $_______ ESTIMATED TOTAL OF CASH ADVANCES $_______ III. SUMMARY OF CHARGES 1. Funeral Home Charges $_______

2. Cash Advances $_______ TOTAL FUNERAL CHARGES $_______ IV. EXPLANATION OF CHARGES charges for embalming and for any items that are not required by law may be necessary because of cemetery requirements, crematory or other selections made. ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ ___________________________________________________________________________ Signature of Licensed Funeral Director Date ___________________________________________________________________________ Printed or Typed Name of Funeral Director ACKNOWLEDGMENT OF RECEIPT I have received this itemization of funeral services and merchandise selected. ___________________________________________________________________________ Signature Date PUBLIC NOTICE The New York State Department of Health is responsible for licensing and regulating New York State funeral directing under the Public Health Law. You may contact the Department at: Bureau of Funeral Directing New York State Department of Health Corning Tower, Empire State Plaza

Albany, NY 12237

Section 78.3 - Customer's designation of intentions 78.3 Customer's designation of intentions. (a) Every person licensed pursuant to article 34 of the Public Health Law, including funeral directors and funeral firms, shall furnish at the time funeral arrangements are made for the cremation of the body of a deceased person, to the person or persons making arrangements, a written statement which shall include the following: (1) true firm name and address as registered with the department; (2) the signature and printed or typed name of the funeral director or undertaker making funeral arrangements, and the date such statement was furnished to the customer; (3) name of deceased, together with the place and scheduled date of cremation; (4) a statement, by the person making the arrangements, indicating the manner of disposition of the cremains; (5) the dated signature, address and phone number of the person making the arrangements;and (6) a disclosure statement by the funeral director or undertaker making the arrangements, indicating the manner of disposition of the cremains if unclaimed after 120 days from the date of cremation. (b) The funeral firm's copy of the customer's designation of intentions shall include the following: (1) the actual date of cremation, and the name and location of crematory; (2) the date, location and manner of disposition of cremains; and (3) the dated signature and printed or typed name of person making disposition of cremains.

PART 79 PRICE INFORMATION (Statutory authority: Public Health Law, Section 3401(1) Section 79.1 - Telephone price disclosure Section 79.1 Telephone price disclosure. A funeral firm shall inform persons who call the firm's place of business and inquire about the terms, conditions or prices at which funeral goods or funeral services are offered, that price information is available over the telephone. A firm shall also inform such persons, who ask by telephone about the offerings or prices, of any accurate information from the price lists (general,

casket or outer interment receptacle) or other readily available source which reasonably answers the question.

Section 79.2 - Casket price list 79.2 Casket price list. A funeral firm shall present for information and review a printed or typewritten price list to individuals who inquire in person about caskets or alternative containers. The funeral firm may neither discuss nor show caskets or alternative containers until a casket price list is offered to the customer. The list must contain at least the retail price of each casket and alternative container offered which does not require special ordering; supplier name; model name or number; species of wood, kind and gauge of metal or other construction material; description of the interior; and the effective date of the price list. The list must contain the true funeral firm name and address as registered with the department and a caption describing the list as a "Casket Price List." In lieu of a written list, other formats, such as notebooks, brochures or charts may be used if they contain the same information as required in a printed or typewritten list and are displayed in a clear and conspicuous manner Section 79.3 - Outer interment receptacle price list 79.3 Outer interment receptacle price list. A funeral firm shall present for information and review a printed or typewritten price list to individuals who inquire in person about outer interment receptacles. The funeral firm may neither discuss nor show outer interment receptacles until an outer interment receptacle price list is offered to the customer. The list must contain at least the retail price of each outer interment receptacle which does not require special ordering; supplier name; model name or number; description of construction material; and the effective date of the prices listed. In immediate conjunction with the prices must be the following statement: "No New York State or local law requires you to buy a receptacle to surround the casket in the grave. However, many cemeteries require that you have such a receptacle so that the grave will not sink. Either a burial vault or grave liner will satisfy these requirements." The list must contain the true funeral firm name and address as registered with the department and a caption describing the list as an "Outer Interment Receptacle Price List." In lieu of a written list, the firm may use other formats, such as notebooks, brochures or charts, if they contain the same information as required in a printed or typewritten list and are displayed in a clear and conspicuous manner.

Section 79.4 - General price list 79.4 General price list. A funeral firm shall present a printed or typewritten price list for retention to the individuals who inquire in person about funeral arrangements or the prices and availability of funeral services and merchandise offered. When individuals inquire in person about funeral arrangements or the prices of funeral services or merchandise, the funeral firm must offer them the list upon beginning discussion either of funeral arrangements or of the selection of any funeral services or merchandise. This list must contain at least the following information: (a) The true funeral firm name, address and telephone number as registered with the department; (b) A caption describing the list as a "General Price List";

(c) The effective date of the price list; and (d) Immediately above the price disclosures required by this section, the list shall contain the statements: (1) "The goods and services shown below are those we can provide to our customers. You may choose only the items you desire. If legal or other requirements mean you must buy any items you did not specifically ask for, we will explain the reason in writing on the statement we provide describing the funeral services and merchandise you selected." (2) "This list may not include prices for certain items that you select, such as cemetery charges or crematory services, flowers and newspaper notices. The estimated or final prices for those items will be shown on the itemized statement describing the funeral services and merchandise you selected." (3) If the services of the funeral director and staff cannot be declined by the purchaser, the following sentence must be inserted between the second and third sentences of the required statement in paragraph (1) of this subdivision: "However, any funeral arrangements you select will include a charge for our services." (4) For some items that the funeral firm buys for the customer such as flowers and newspaper notices, if the firm charges more than the cost or receives and retains a rebate, commission or trade or volume discount, a sentence must be added at the end of the statement required by paragraph (2) of this subdivision, "We charge you for our services in buying certain items." (e) The list shall include funeral home charges in the following order with the retail prices (expressed either as a flat fee or as the price per hour, mile or other unit of computation) and the other information below for each service regularly offered for sale. If any of the services or merchandise are not regularly offered by the funeral firm, they do not have to appear on the general price list. (1) Alternative services. (i) Direct cremations. The price range for direct cremations offered by the funeral firm must be listed. In addition, at least two package prices must be listed: for direct cremation where the purchaser provides the container and for direct cremation using an alternative container or an unfinished wooden box. The services and the container (where applicable) included in each package price must be described. Each package price must include at least the transfer of remains, services of the funeral director and staff, necessary authorizations, the transportation of the remains by livery to the crematorium and the return of the cremains to the funeral firm. In immediate conjunction with the prices for direct cremations, there must be the statement, "If you want to arrange a direct cremation, you may use an unfinished wooden box or an alternative container. Alternative containers can be made of heavy cardboard, pressed wood or composition materials (with or without an outside covering), or may be pouches of canvas or other materials." A second statement must also be included that, "The direct cremation prices do not include the crematory charge." (ii) Direct burials. The price range for direct burials offered by the funeral firm must be listed. In addition, at least two package prices must be listed: for direct burial where the purchaser provides the casket and for direct burial using an alternative container or unfinished wooden box. Other package prices for direct burials using caskets may also be listed. The services and the container (where applicable) included in each package price must be described. Each package price must include the transfer of remains, services of the funeral

director and staff, necessary authorizations, and the transportation of the remains to the cemetery by livery. The statement "The direct burial prices do not include cemetery charges" must be included. (2) Transfer of remains to the funeral establishment. The price for transfer of remains must include personnel, equipment and vehicle. (3) Preparation of remains. (i) Embalming. The price must include use of the preparation room. In immediate conjunction with the price for embalming there must be the statement, "In New York State, embalming is not required by law. If you do not want embalming, you have the right to choose an arrangement which does not require you to pay for embalming such as direct cremation or direct burial. If you select certain funeral arrangements, such as viewing or an open casket funeral, embalming may be required by the funeral firm." (ii) Other preparation of remains (excluding embalming). The price for topical disinfection (when there is no embalming), custodial care, dressing/casketing, cosmetology and restoration must be listed. The charges for other services regularly offered as "other" shall be specifically listed. If the firm intends to charge for custodial care, a specific time interval must be listed after which a charge is incurred and the statement must be included next to that item on the price list. "Custodial care will not be charged on the days when embalming or other preparation of the remains occurs, visitation is held or a funeral service is conducted." In immediate conjunction with the heading "Other Preparation of Remains" the statement "Preparation of the remains, unless selected, is not required for direct cremation or for direct burial" must appear. (4) Arrangements. The charge for basic arrangements shall include the services of the funeral director, other staff, equipment and facilities to respond to the initial request for service, the arrangement conference, securing of necessity authorizations and coordination of service plans with parties involved in the final disposition of the deceased. The charge for these services may not be included in the casket prices and are already included in the quoted prices for direct cremation, direct burial, forwarding of remains or receiving of remains. For other types of funeral arrangements, the funeral firm may require that a charge for arrangements be added to the cost of the services provided. If the funeral firm has this requirement, it must place in immediate conjunction with the price for arrangements the statement, "The charge for our services will be added to the total cost of the funeral arrangements you select. However, this charge will not be added to the cost for direct cremation, direct burial, forwarding of remains or receiving of remains because the prices for those services include this charge." (5) Supervision. The charges for supervision by the funeral director and support staff for visitation and for the funeral service must be listed. Other supervision charges, if any, must be specifically listed. These charges may not be added to the cost for direct cremation, direct burial, forwarding of remains or receiving of remains. (6) Use of the facilities. Separate prices must be listed for use of facilities for visitation, use of facilities for funeral service, and other use of facilities, if any. Each of the prices must include the equipment used. Any price for "other use of the facilities" must clearly identify what the price is for and what facilities are included. No charges may be made under this paragraph for the use of facilities included under the paragraphs of this subdivision. For example, no charge can made for the use of the preparation room because its use is included in paragraph (3) of this subdivision. A separate charge may not be listed for parking facilities, lounges, storage rooms or other common facilities.

(7) Livery. Separate prices must be listed along with description of the equipment for each of the livery services offered by the funeral firm: a hearse, alternative vehicle with identification of the alternative vehicle, limousine, passenger car, flower vehicle and/or other livery service. (8) Merchandise. (i) Casket or alternative container. The price range for caskets and alternative containers offered by the funeral firm must be stated together with the statement "A complete price list will be provided at the funeral home." As an alternative, the funeral firm may include in the general price list all of the casket price information required by section 79.2 of this Part. (ii) Outer interment receptacle. The price range for outer interment receptacles offered by the funeral firm must be stated together with the statement "A complete price list will be provided at the funeral home." As an alternative, the funeral firm may include in the general price list all of the outer interment receptacle price information required by section 79.3 of this Part. (9) Additional services and merchandise. The price of acknowledgment cards and any additional services and merchandise routinely offered by the funeral firm must be stated with an explanation of what is included. If the funeral firm offers to purchase additional merchandise or services and charges more than the actual cost or receives and retains a rebate, commission, trade or volume discount or other benefit, the firm must include a statement under this heading that it will purchase additional merchandise and services for the customer. In immediate conjunction with this statement must be the sentence, "The prices in this section include a charge for our services in buying these items." (10) Limited services. (i) Forwarding of remains. Prices must be listed for the services of the funeral firm for forwarding remains to another funeral firm together with a list of services provided for any quoted price. A package price must be listed that includes transfer of remains to funeral establishment, securing necessary authorizations, the services of the funeral director and staff and local transportation of the remains to point of shipment. In addition, a statement must be included indicating how other means of transportation will be charged beyond the local point of shipment. Public transportation (by common carrier) may only be charged as a "cash advance." (ii) Receiving of remains. Prices must be listed for the services of the funeral firm for receiving remains from another funeral firm together with a list of services provided for any quoted price. A package price must be listed that includes transfer of remains to funeral establishment and/or place of local disposition, securing necessary authorizations, the services of the funeral director and staff. In addition a statement must be included indicating how other means of transportation will be charged. Public transportation (by common carrier) may only be charged as a "cash advance." (f) The list shall include items of service and merchandise which are routinely available as cash advances. (1) Cash advances. A listing must be placed on the general price list indicating what items of service and merchandise are routinely available as cash advances. If the funeral firm is willing to purchase other cash advance items, it may include a statement to that effect. A statement must be included in immediate conjunction with the cash advance information that "Services and merchandise provided as cash advance items will be billed at the same amount paid by the funeral firm." The funeral firm may not charge the customer any more than the actual cost for cash advance items and must deduct from the charge to the customer any rebate, commission, trade or volume discount or other benefit received. Cash advance items shall include, but are not limited to the following services or merchandise: cemetery or crematory charges;

clergy honoraria; certified copies of the death certificate or transcripts; escorts; chevra kadisha (Tahara); public transportation (common carrier); gratuities; bridge and road tolls; and telephone and telegraph charges. (g) Each price for transfer of remains or for other transportation by livery included in the general price list must be stated as a flat fee for a specified number of miles from the funeral firm or for a geographical zone. The number of miles or the boundaries of the geographical zone included in the flat fee must be stated next to the price. If the firm charges for additional mileage beyond the specified distance or geographical zone, the additional mileage charge must be stated in immediate conjunction with the flat fee.

Section 79.5 - Alternative pricing methods 79.5 Alternative pricing methods. Alternative pricing methods are not permitted except for package prices which are agreed upon between the funeral firm and a governmental agency, or between the funeral firm and a not-for-profit corporation for members of the corporation or other persons whose interests are represented by the corporation. The itemization requirements of Part 78 of this Title must be complied with and if an alternative pricing method is selected by the person making arrangements, the charges must be listed and provided to the person on an itemization statement which complies with Part 78. Package prices must be broken down and listed by their component parts on the itemization statement except for the "Alternative Services" and the "Limited Services" in section 79.4(e)(1) and (10) of this Part. Section 79.6 - Alternative containers 79.6 Alternative containers. Funeral firms must make an unfinished wooden box or alternative container available for direct cremations, if they arrange direct cremations.

Section 79.7 - Retention of price lists 79.7 Retention of price lists. Copies of all price lists shall be retained on file at the funeral firm for a period of at least four years from the date of their last distribution to customers and shall be available for review during normal business hours by the designated representative of the commissioner.

Section 79.8 - Comprehension of disclosure 79.8 Comprehension of disclosure. All disclosures required by this Part shall be in a clear and conspicuous manner

Section 415.19 - Infection control 415.19 Infection control. The facility shall establish and maintain an infection control program designed to provide a safe, sanitary, and comfortable environment in which residents reside and to help prevent the development and transmission of disease and infection.

(a) Infection control program. The facility shall establish an infection control program with written policies and procedures under which it: (1) Investigates, controls and takes action to prevent infections in the facility; (2) Determines what procedures such as isolation and universal precautions should be utilized for an individual resident and implements the appropriate procedures; and (3) Maintains a record of incidence and corrective actions related to infections. (b) Preventing spread of infection. (1) When the infection control program determines that isolation is needed to prevent the spread of infection, the facility shall isolate the resident. (2) The facility shall assure that all equipment and supplies are cleaned and properly sterilized where necessary and are stored in a manner that will not violate the integrity of the sterilization. (3) The facility shall prohibit persons, including but not limited to, staff, volunteers, and visitors known to have a communicable disease or infected skin lesions from direct contact with residents or their food, if direct contact will transmit the disease. (4) The facility shall require physicians and staff to wash their hands after each direct resident contact for which handwashing is indicated by accepted professional practice. (c) Linens. Personnel shall handle, store, process, and transport linens so as to prevent the spread of infection. (d) Reporting. The facility shall report increased incidence of infections, including nosocomial infections as defined in Section 2.2 of this Title, to the appropriate area office of the Office of Health Systems Management and shall report, immediately, the presence of any communicable disease as defined in section 2.1 of Part 2 of this Title to the city, county or district health officer. (e) Notice to Funeral Director. If, at the time of death, a resident was diagnosed as having a specific communicable disease designated in Part 2 of this Title or an infectious disease, a written report of such disease shall accompany the body when it is released to the funeral director or his or her agent, except that no HIV-related information shall be disclosed to the funeral director unless the funeral director has access in the ordinary course of business to HIV-related information on the death certificate of the deceased individual. Section 52-11.4 - Retrieval and acquisition of nontransplant anatomic parts

Section 52-11.4 Retrieval and acquisition of nontransplant anatomic parts. (a) The retrieval of nontransplant anatomic parts shall only be performed on: (1) the premises of a general hospital; (2) the premises of a whole body acquisition service licensed in accordance with this Subpart; or (3) for nontransplant anatomic parts other than whole bodies and body segments, the premises of a comprehensive tissue procurement service licensed in accordance with Subpart 52-2 of this Part.

(b) No body, body segment, or other nontransplant anatomic part shall be retrieved, acquired, distributed, transported, or used for a purpose not authorized by Public Health Law section 4302. For the purposes of this Subpart, the term â&#x20AC;&#x153;researchâ&#x20AC;? as used in Public Health Law section 4302 shall be limited to research conducted in accordance with accepted research protocols designed to improve the public health, safety and welfare. (c) Whole body acquisition services. (1) A whole body acquisition service shall employ the following staff: (i) a nontransplant anatomic bank director who holds a graduate degree in anatomy or the health sciences, or who has been serving as director of a nontransplant anatomic bank licensed by the department prior to the adoption of this provision; (ii) an appropriately trained technician, morgue attendant, diener, or licensed funeral director responsible for the preparation, care and maintenance of whole bodies and body segments; and (iii) at least one support staff person, other than the nontransplant anatomic bank director, but who may be the technician, morgue attendant, diener, or licensed funeral director, who shall be responsible for record keeping. (2) Facilities requirements. A whole body acquisition service shall have a dedicated, secure and restricted space for preparation of whole bodies and body segments for research and/or education purposes. Access to such space shall be limited to individuals directly associated with receipt and preparation of whole bodies or body segments. Preparation and storage space shall include: (i) a working sink and adequate counter space for preparation of whole bodies or body segments; (ii) suitable space for storage of chemicals/materials used in preparation of whole bodies or body segments, as applicable; (iii) counters, tables, and cabinetry built of material that may be easily disinfected and cleaned; (iv) a refrigerated storage room, walk-in cooler, or cadaver drawer cooler, dedicated solely to storage of whole bodies or body segments. Such storage areas shall have lockable access doors, and alarms to signal intrusion or unacceptable temperature deviation; (v) a U.S. Occupational Safety and Health Administration (OSHA)-approved device for handling, lifting, and internal transportation of whole bodies or body segments; (vi) OSHA-approved eye wash stations; (vii) if embalming is performed, a morgue compliant with federal and state standards; and (viii) if cremation is performed, a crematory compliant with federal and state standards. (3) Records. In addition to the records required in section 52-2.9(i) of this Subpart,

a whole body acquisition service shall maintain complete and accurate records of all donations, including: (i) identification of the whole body, and, in the case of a body segment, a description and source of the body segment; (ii) documentation of unclaimed acquisitions, death certificates, and burial transit permits associated with receipt and use of whole bodies or body segments; (iii) facilities/institutions to which the whole bodies or body segments are transferred, or documentation of any other disposition; and (iv) a copy of any contract or letter of agreement between the whole body acquisition service and the whole body user, and documentation of the method of intended final disposition of the whole body or body segment. (d) Transfer. (1) Any transfer of whole bodies, body segments or other nontransplant anatomic parts shall be conducted in compliance with existing state standards for such transfer. The burial transit permit(s) issued by the registrar of vital statistics (in the case of a whole body transfer), or written documentation of the source and a description of the body segment(s) or anatomic parts, shall accompany whole bodies, body segments, or nontransplant anatomic parts. (2) In the case of a whole body transfer, a copy of the properly executed burial transit permit shall be maintained by the whole body acquisition service. Section 16.9 - Professional practitioners and related provisions 16.9 Professional practitioners and related provisions. (a) Nothing in sections 16.6 through 16.16 shall limit any human use of radiation in diagnostic or therapeutic procedures pursuant to section 16.19 provided that with respect to use on humans of radioactive material, such use is in accordance with a specific or general license issued under this Part, or an exemption therefrom. (b) Each professional practitioner who administers, or implants an amount of radioactive material into a patient in such quantities as to require such patient to be confined for radiation protection purposes pursuant to section 16.123 of this Part shall require that such patients wear a wrist band. The wrist band shall bear the radiation symbol, the quantity and type of radioactive material administered, inserted or implanted and the date on which such quantity was measured. (c) Radioactive cadavers. (1) If any patient containing radioactive material, which was administered for therapeutic purposes, dies it shall be the responsibility of the doctor who pronounces such patient as dead to notify immediately the physician in charge of the case or his/her designated representative. (2) No person shall commence any autopsy on any cadaver that contains radioactive material in a quantity that exceeds five millicuries, which was administered for therapeutic purposes, without first having consulted with and being advised by the radiation safety officer of the hospital or, if he/she is not available, the physician responsible for the administration of the radioactive material. If neither is available, their

designated representative may serve. (3) A radioactivity report on every cadaver containing more than five millicuries of radioactive material which was administered for therapeutic purposes, shall be completed by the radiation safety officer or the physician responsible for the administration of the radioactive material or their designated representatives. The report must include: the name and address of the hospital; the name of the deceased; the name, address and telephone number of the next of kin; the name, address and telephone number of the funeral home to which the deceased will be sent; the radionuclide involved, the approximate activity on the day of the report and the physical form; the location of the radioactive materials in the body and the external rate at the body surface closest to the source; the precautions to be observed during autopsy or handling of the body by the funeral director; and the name of the person who prepared the form. This report shall accompany the body (whether autopsied or not) when it is surrendered to the funeral director. The department shall be notified in person, or by telephone, mailgram or facsimile within 24 hours of the death and a copy of the radioactivity report shall be sent to the department within 15 days of the death.

Section 13.3 - Disinterments 13.3 Disinterments. (a) No dead human bodies shall be disinterred for transportation and/or removal to another cemetery or crematory without a permit from the registrar of vital statistics having jurisdiction at the place of disinterment. No permit is necessary for removal within the same cemetery. (b) The funeral director or undertaker shall make a request to disinter the body on a form provided by the commissioner. Upon receipt of such request, the local registrar shall issue a permit as required by subdivision (a) of section 13.1 of this Part. (c) If the original burial container has not retained its integrity, transfer to another container shall be required if transportation of the body is necessary. If the remains are to be transported by common carrier, the provisions of subdivision (b) of section 13.1 shall apply. Chapter II - Administrative Rules And Regulations CHAPTER II Administrative Rules and Regulations PART VOLUME A Subchapter A Vital Records and Personal Information 35 Subchapter B State Aid and Funding 39 Subchapter C Access to Records 50 Subchapter D Laboratories 55 VOLUME A-1 Subchapter E Food and Drug Products; Research 60 Subchapter F Disease Registry 62 Subchapter G Communicable Diseases and Poisoning 64

Subchapter H Maternal and Child Health 69 Subchapter I Environmental Health 70 Subchapter J Funeral Directing, Undertaking and Embalming 77 Subchapter K Controlled Substances 80 Subchapter L Hospitals and Related Facilities 81 Subchapter M X-ray Technology and Chiropractic Use of X-ray 89 Subchapter N Professional Medical and Dental Services 91 Subchapter O Physician's Assistants; Prohibited Discrimination in 94 Hospital Staff Appointments and Privileges Subchapter P Licensure and Practice of Nursing Home Administration 96 Subchapter Q State Environmental Quality Review 97 Subchapter R Health Maintenance Organizations 98 Subchapter S Land Acquisition 99

Section 13.2 - Transportation of dead human bodies by other than common carrier 13.2 Transportation of dead human bodies by other than common carrier. In the transportation of dead human bodies by every mode of transportation including air, other than by common carrier in the State of New York, and including such transportation which originates outside the State of New York, the dead body shall be encased in a casket or container or shall be enclosed in a waterproof pouch and secured in a rigid litter or stretcher, and however encased or enclosed, the dead body shall be obscured from public view and: (1) the funeral director or his agent assuming responsibility for the transportation of the dead body must take the steps necessary to prevent leakage of body fluids from the container in which the remains are encased; and (2) the interior of the vehicle and equipment used for transportation must be maintained in a clean and sanitary manner.

458.2 Salaries and wages. (a) General. (1) If management is to have maximum control over labor costs, close control of the number of man-hours paid is essential. Man-hours are a more stable measure of labor utilization than dollars, because man-hours are not affected by inflation. Also, when man-hours are compared to units of service, they can provide management with information that is useful both for internal control and external comparisons. (2) A record of man-hours paid that exactly parallels the record of salaries and wages paid by department must be maintained. This requires that the residential health care facility establish a record of paid manhours by department for all personnel whose compensation is included on the payroll, including exempt personnel. These man-hours must include separate records of worked man-hours and nonworked man-hours. Worked man-hours should include regular hours worked, overtime hours worked, hours worked when on call or on standby, hours spent in in-service education, orientation, breaks, paid social functions (such as Christmas parties), and so forth. Nonworked man-hours should include paid vacations, holidays, sick pay, military leave, educational leave, (including continuing education) bereavement or funeral leave, jury duty, benefit hours paid for but not taken as leave, and so forth. (3) Overtime hours are hours for which an overtime pay rate is used. The actual overtime hours are not treated differently from regular worked hours; it is the rate that changes. This is preferable to the common but undesirable practice of adding additional hours to the records when calculating the payroll so that the regular pay rate can be used instead of the overtime rate. (4) On-call and/or standby pay is compensation to an employee for being available to work. During the period when the employee is on call or on standby, he might or might not actually perform work. The Fair Labor Standards Act differentiates between restricted and unrestricted on-call situations. All restricted oncall hours are compensable and contribute to the total hours used for determining overtime pay. Unrestricted on-call hours do not contribute to total hours, but unrestricted on-call compensation does contribute to the salary base used for calculating overtime premiums only. Thus all restricted on-call hours must be accounted for, but only those hours worked need be accounted for when employees are on unrestricted oncall duty. (5) Salaries and wages are defined as all remuneration, payable in cash, for services performed by an employee for the residential health care facility, and the fair market value of services donated to the facility by persons performing in an employee relationship. Reimbursement of independent contractors, such as private duty nurses, should be excluded. (b) Specific classifications of salaries and wages follow: (1) Management and supervision. Employees included in this classification are primarily involved in the direction, supervision and coordination of residential health care facility activities. Salaries and wages for this classification would usually include, but are not limited to, the following job titles: president, chief executive officer; administrator; manager; department head; supervisor; director; and foreman. These employees may be exempt from Federal wage and hour laws. Lead positions of chief, head, and so forth must be classified as Management and Supervision if they provide direct supervision to five or more other employees, except for Registered Nurses and Licensed Practical Nurses which must be classified as detailed in paragraphs (b)(3) and (b)(4) of this section. Positions supervising fewer than five employees may be

classified as Management and Supervision if the activities performed otherwise meet the Management and Supervision criteria. (2) Technicians, specialists and non-physician medical practitioners. Employees included in this classification usually perform activities of a creative or complex nature. Also included are those employed to consult, diagnose and prescribe and provide treatment to patients under the direction of a physician. Salaries and wages for this classification would usually include, but are not limited to, the following job titles: coordinator; chef; programmer; technologist; technician; therapist; instructor; nurse practitioner; physician assistant; clinical specialist and accountant. These employees are often licensed or registered. Some of these positions are exempt from Federal wage and hour laws because they are administrative or professional in nature. Lead positions of chief, head, and so forth must be classified as Management and Supervision if they provide direct supervision to five or more other employees. Positions supervising fewer than five employees may be classified as Management and Supervision if the activities performed otherwise meet the Management and Supervision criteria. (3) Registered nurses. This classification includes all registered nurses employed to provide direct nursing care to patients except the following specific job titles: RN - Supervisor (supervising two or more units), Health Services Supervisor, Director of Nursing Services and Assistant Director of Nursing Services. These specific job titles are to be reported under the classification Management and Supervision in accordance with paragraph (b)(1) of this section. (4) Licensed practical nurses. This classification includes all licensed practical nurses employed to provide direct nursing care to patients except the following specific job titles: RN - Supervisor (supervising two or more units), Health Services Supervisor, Director of Nursing Services and Assistant Director of Nursing Services. These specific job titles are to be reported under the classification Management and Supervision in accordance with paragraph (b)(1) of this section. Employees in this classification are subject to Federal wage and hour laws. (5) Aides, orderlies and assistants. Included in this classification are nontechnical personnel employed to provide direct nursing care to patients. Salaries and wages for this classification would usually include, but are not limited to, the following job titles; aide; orderly; and nurse assistant. These employees are subject to Federal wage and hour laws. (6) Clerical and other administrative employees. Included in this classification are nontechnical personnel employed in the performance of recordkeeping, communication and other administrative functions, who are subject to Federal wage and hour laws. Salaries and wages for this classification would usually include, but are not limited to the following job titles: accounting clerk; admitting clerk; messenger; keypunch operator; secretary; telephone operator; clerk-typist; cashier; and receptionist. (7) Environment, hotel and food service employees. This classification includes personnel employed to provide basic services related to food and accommodations. They perform routine work of a nontechnical nature and are subject to Federal wage and hour laws. Salaries and wages for this classification would usually include, but are not limited to, the following job titles: maintenance man; housekeeping aide; cook's helper; flatwork finisher; guard; food service worker; wall washer; washperson; carpenter and plumber. (8) Physicians salaries. Employees included in this classification are employed to consult, diagnose, and prescribe and provide treatment for patients. Physicians are also employed to provide education. These employees must possess Doctor of Medicine or Doctor of Osteopathy degrees and be licensed to practice

medicine. (9) Interns, residents and fellows. Employees included in this classification are employed to consult, diagnose, and prescribe and provide treatment for patients. Salaries and wages for this classification would usually include, but are not limited to, the following job titles: intern; resident and fellow.

Section 52-2.2 - Provisional licensure 52-2.2 Provisional licensure. (a) The department may issue a provisional license which shall be valid for a period determined by the department to be sufficient to enable the department to assess the compliance of the tissue bank or nontransplant anatomic bank with this Part. The provisional license may be renewed pending issuance or denial of a license. (b) Except for a limited tissue procurement service, a tissue bank initially applying for a license may be issued a provisional license provided it meets the following conditions: (1) a valid and complete license application has been filed; (2) unless the site is a tissue transplantation facility or insemination/implantation site or a tissue storage facility whose tissue storage activity is limited to virally inactivated tissue, a medical advisory committee, consisting of at least five individuals with experience in tissue banking and/or transplantation medicine, including at least one member with expertise in infectious diseases, has been designated; (3) if the tissue bank has been inspected by the department, the tissue bank has provided satisfactory evidence of correction of any deficiencies found; and (4) the owners and/or persons with a controlling interest, tissue bank director, medical director, tissue bank compliance officer and transplantation service director, as required, meet the requirements of this Part and possess the education and experience necessary to ensure that the bank is operated in substantial compliance with this Part. (c) A nontransplant anatomic bank or a limited tissue procurement service initially applying for a license may be issued a provisional license provided it submits a complete application. (d) A provisional license may be withheld if the director, medical director, tissue bank compliance officer, any owner, or any person with a controlling interest applying for a provisional license has ever directed, owned or controlled a health care facility, laboratory, tissue bank, funeral directing firm, or nontransplant anatomic bank which has had its permit or license denied, revoked, suspended, limited or annulled, or which has an enforcement proceeding against it pending at the time of application for a provisional license. (e) A provisional license may be denied or terminated, without a hearing, if the department finds that the tissue bank or nontransplant anatomic bank is not operated in substantial compliance with the applicable provisions of section 52-2.5 of this Subpart. (f) The valid provisional license shall be conspicuously posted within the facility

Section 63.6 - Confidentiality and disclosure 63.6 Confidentiality and disclosure. (a) No person who obtains confidential HIV-related information in the course of providing any health or social service or pursuant to a release of confidential HIV-related information may disclose or be compelled to disclose such information, except to the following: (1) the protected individual or, when the protected individual lacks capacity to consent, a person authorized pursuant to law to consent to health care for the individual; (2) any person to whom disclosure is authorized pursuant to a release of confidential HIV-related information in accordance with section 63.5(a); (3) an agent or employee of a health facility or health care provider if (i) the agent or employee is authorized to access medical records; (ii) the health facility or health care provider itself is authorized to obtain the HIV-related information; and (iii) the agent or employee provides health care to the protected individual, or maintains or processes medical records for billing or reimbursement; (4)(i) a health care provider or health facility when knowledge of the HIV-related information is necessary to provide appropriate care or treatment to the protected individual or a child of the individual; (ii) a health care provider or health facility when knowledge of HIV-related information is necessary to provide appropriate care or treatment to a contact, provided the requirements in subdivision (m) of section 63.8 are followed for disclosures involving exposures in risk situations; (iii) in circumstances when consent for health care is necessary, disclosure may also be made to a person authorized to consent to health care for such contact or for such protected individual, provided that if disclosure is to a person authorized to consent to the health care of a contact or to a contact when such contact has been exposed to HIV under circumstances which present a risk of transmission, the requirements in subdivision (m) of section 63.8 must be followed; (5) a health facility or health care provider, in relation to the procurement, processing, distributing or use of a human body or a human body part, including organs, tissues, blood, semen, or other body fluids, for use in medical education, research, therapy, or for transplantation to individuals; (6) health facility staff committees, or accreditation or oversight review organizations authorized to access medical records, provided that such committees or organizations may only disclose confidential HIV-related information: (i) back to the facility or provider of a health or social service; (ii) to carry out the monitoring, evaluation, or service review for whcih it was obtained; or (iii) to a federal, state or local government agency for the purposes of and subject to the conditions provided in paragraph (e) of this section;

(7) a federal, state, county or local health officer when such disclosure is mandated by federal or state law, including reporting and contact notification processes authorized pursuant to Article 21, Title III, or pursuant to Article 27-F; (8) authorized agencies as defined by Social Services Law, Section 371 and corporations incorporated or organized to receive children for adoption or foster care, in connection with foster care or adoption of a child. Such agency shall be authorized to redisclose such information only pursuant to the provisions of Article 27-F of the Public Health Law or in accordance with the provisions of Social Services Law Section 373-A and regulations promulgated thereunder; (9) third party reimbursers or their agents to the extent necessary to reimburse health care providers, including health facilities, for health services, provided that, an otherwise appropriate authorization for such disclosure has been secured; (10) an insurance institution, for other than the purpose set forth in paragraph (9) of this subdivision, provided the insurance institution secures a dated and written authorization that indicates that health care providers, health facilities, insurance institutions, and other persons are authorized to disclose information about the protected individual, the nature of the information to be disclosed, the purposes for which the information is to be disclosed and which is signed by: (i) the protected individual; (ii) if the protected individual lacks the capacity to consent, such other person authorized pursuant to law to consent for such individual; or (iii) if the protected individual is deceased, the beneficiary or claimant for benefits under an insurance policy, a health services plan, or an employee welfare benefit plan as authorized in Article 27-F of the Public Health Law; (11) to a funeral director upon taking charge of the remains of a deceased person when such funeral director has access in the ordinary course of business to HIV-related information on the death certificate of the deceased individual, as authorized by Public Health Law Section 4142; (12) any person to whom disclosure is ordered by a court of competent jurisdiction pursuant to Public Health Law Section 2785; (13) an employee or agent of the Division of Probation and Correctional Alternatives, Division of Parole, Commission of Correction, or any local probation department, to the extent the employee or agent is authorized to access records containing such information in order to carry out functions, powers and duties with respect to the protected person and in accordance with regulations promulgated pursuant to Public Health Law Article 27-F; (14) a medical director of a local correctional facility in accordance with regulations promulgated pursuant to Article 27-F to the extent the medical director is authorized to access records to carry out his/her functions relating to the protected person. Redisclosure by the medical director is prohibited except as

permitted under Public Health Law Article 27-F, Article 21, Title III and implementing regulations; (15) an employee or agent of the New York City Board of Corrections so that the board may continue to access records of inmates who die while in the custody of the New York City Department of Corrections when necessary for the board to carry out its duties, functions, and powers with respect to the protected individual, pursuant to the New York City charter; or (16) a law guardian, appointed to represent a minor pursuant to the social services law or the family court act, for the purpose of representing that minor. If the minor has the capacity to consent, the law guardian may not redisclose confidential HIV related information without the minor's permission. If the minor lacks capacity to consent, the law guardian may redisclose confidential HIV-related information for the purpose of representing the minor. (b) A state, county or local health officer may disclose confidential HIV-related information when: (1) disclosure is specifically authorized or required by federal or state law including, but not limited to Public Health Law, Article 21, Title III and Public Health Law, Article 27-F; or (2) disclosure is made pursuant to a release of confidential HIV related information; or (3) disclosure of information regarding a contact is requested by a physician pursuant to section 63.8 of this Part; or if the contact resides outside the jurisdiction of the authorized public health official, the official shall inform the public health official in the contact's jurisdiction in order to confidentially inform such contact; or (4) disclosure is authorized by court order pursuant to the provisions of Public Health Law Section 2785. (c) A physician or his/her agent may disclose the confidential HIV-related information to a contact and to a public health officer for the purpose of making a disclosure to the contact. (d) A physician or his/her agent may, upon the consent of a parent or guardian, disclose confidential HIVrelated information to a state, county, or local health officer for the purpose of reviewing the medical history of a child to determine the fitness of the child to attend school. (e) Confidential HIV-related information of a protected person may be disclosed to authorized employees or agents of a governmental agency pursuant to the regulations of the governmental agency when the person providing health or social services is regulated, supervised or monitored by the governmental agency or when the governmental agency administers the health program or a social service program and when such employees or agents have access to records in the ordinary course of business and when access is reasonably necessary for regulation, supervision, monitoring, administration or provision of services. Such authorized employees or agents may include attorneys authorized by a government agency when access occurs in the ordinary course of providing legal services and is reasonably necessary for supervision, monitoring, administration or provision of services. Such authorized employees or agents may also include public health officers as required for conducting epidemiological or surveillance investigations pursuant to the State Sanitary Code or this Part. Such surveillance or investigational data shall also be disclosed by the public health officer to the State Department of Health as required by the State Sanitary Code or this Part .

(f) Confidential HIV-related information of a protected person may be disclosed to authorized employees or agents of a provider of health or social services when such provider is either regulated, supervised or monitored by a governmental agency or when a governmental agency administers the provider's health or social service program, and when such employees or agents have access to records in the ordinary course of business and when access is reasonably necessary for regulation, supervision, monitoring, administration or provision of services. Such authorized employees or agents may include attorneys authorized by persons providing health services when access occurs in the ordinary course of providing legal services and is reasonably necessary for supervision, monitoring, administration or provision of services. (g) A physician or his/her agent may disclose confidential HIV-related information pertaining to a protected individual to a person, known to the physician or his/her agent , authorized pursuant to law to consent to the health care for the protected individual when the physician reasonably believes that: (1) disclosure is medically necessary in order to provide timely care and treatment for the protected individual; and (2) after appropriate counseling as to the need for such disclosure the protected individual will not inform a person authorized by law to consent to health care; provided, however, that the physician shall not make such disclosure if, in the judgment of the physician: (i) the disclosure would not be in the best interest of the protected individual; or (ii) the protected individual is authorized pursuant to law to consent to such care and treatment. A physician's decision to disclose pursuant to this paragraph, and the basis for that decision shall be recorded in the medical record. (h) No person to whom confidential HIV information has been disclosed shall disclose the information to another person except as authorized by law, (including, but not limited to, disclosure authorized by PHL Article 21, Title III), except that this provision shall not apply to: (1) the protected individual; (2) a natural person who is authorized pursuant to law to consent to health care for the protected individual; (3) a protected individual's foster parent, subject to Department of Social Services regulations, for the purpose of providing care, treatment or supervision to the protected individual; or (4) a prospective adoptive parent, subject to Department of Social Services regulations, with whom a child has been placed for adoption. (i) Nothing in this section shall limit a person's or agency's responsibility or authority to report, investigate, or redisclose child protective and adult protective services information in accordance with title six of article six and titles one and two of article nine-b of the Social Services Law, or to provide or monitor the provision of child and adult protective or preventive services.

(j) Confidential HIV-related information shall not be disclosed to a health care provider or health care facility for the sole purpose of implementing infection control precautions when such provider or facility is regulated under the Public Health Law and required to implement such precautions with all individuals pursuant to this Title. This restriction shall not limit access to HIV-related information by a facility's infection control personnel for purposes of fulfilling their designated responsibilities in the facility. (k) Confidential HIV-related information shall not be released pursuant to a subpoena. A court order pursuant to Public Health Law section 2785 is required for release of confidential HIV-related information. (l) Confidential HIV related information shall be disclosed upon the request of the Health Care Worker HIV/HBV Advisory Panel (see Public Health Law Article 27-DD) to the Panel or its designee(s) only when the Panel considers the information reasonably necessary for the evaluation and monitoring of a worker who has voluntarily sought the Panel's review.

Section 52-2.1 - Licensure Section 52-2.1 Licensure. (a) Any person who plans to operate a tissue bank or non-transplant anatomic bank or distribute tissue or non-transplant anatomic parts in New York State shall submit a completed, signed application to the department and obtain a license from the department prior to the operation of such a tissue bank or non-transplant anatomic bank, or conduct of such activity, unless otherwise specified in this Part. (b) The department shall provide, upon request, an application for licensure as a tissue bank which may require information including, but not limited to, the following: (1) the name, address and telephone number of the bank; (2) the days and hours of bank operation; (3) the type of organization sponsoring the bank, i.e., proprietary, municipal or non-profit; (4) the type of ownership, i.e., individual, partnership, corporation or government; (5) if ownership is individual, corporation or partnership: the name and principal office address of the entity, and the name, title, home address and Social Security number and Federal employer identification number, if any, of the owner, officers of the corporation or the partners; (6) if government-operated: the name, principal office address of the government entity, and the name(s), title(s) and addresses of the administrator responsible for the operation of the bank in conjunction with the director; (7) except for facilities established pursuant to Public Health Law, Article 28, for any person or entity with a direct or indirect ownership interest in the tissue bank of five percent or more, or any owner who is a licensed health professional and is authorized by law to prescribe tissue services and/or perform transplantation services, or principal stockholder or any person or entity with a controlling interest:

(i) name, home address and Social Security number and employer identification number, if any, of such persons, or for a corporation, the corporate name, principal place of business, corporate executive office address and employer identification number; (ii) the manner in which the person or entity has an ownership interest or a controlling interest, and the percentage of such ownership interest; (iii) any existing or prior direct or indirect ownership interest or status as a person or entity with a controlling interest in any other tissue bank, laboratory, funeral firm or health care facility holding a New York State or New York City license, permit or certificate of operation, and the name and address of such bank, laboratory, firm or facility, and whether such bank, laboratory, firm or facility has had its permit or license denied, revoked, suspended, limited or annulled, or currently has an enforcement proceeding pending against it; and (iv) whether the person or entity has been convicted of, or pled guilty to, a criminal offense related to the operation of a bank, laboratory or health care facility, or of any programs established pursuant to Titles XVIII, XIX, or XX of the Federal Social Security Act; and (8) the category or categories of tissue, and the type or types of tissue services to be provided; (9) a description of the tissue bank premises and equipment; (10) any other employment of the tissue bank director and/or medical director, including the position and number of hours worked; (11) the name, position, qualifications, duties and work schedule of all technical personnel; (12) a copy of all existing tissue acquisition and/or processing agreements; (13) a description of the tissue bank's proposed or existing service area for acquisition and/or distribution of tissue; (14) a description of educational programs, including those programs designed to encourage tissue donation; (15) donor and recipient selection and testing criteria; (16) a copy of each protocol or procedure required in this Subpart and in the Subpart for each category of tissue; (17) any information required in the Subpart for each category of tissue; (18) for a corporation: a copy of the existing certificate of incorporation, by-laws and any certificates of doing business under an assumed name, or for a partnership: a copy of the partnership agreement and any certificates of doing business under an assumed name;

(19) for the tissue bank director and medical director, if applicable, the following information: (i) name; (ii) work and home addresses and work telephone number; (iii) educational background; and (iv) work experience, including all places of employment and positions held for the ten years immediately preceding the date of the application; and (20) the name, title, work address and telephone number of the tissue bank compliance officer and tissue transplantation service director(s), if such personnel are required pursuant to this Part. (c) An application for licensure as a limited tissue procurement service shall require the information specified in paragraphs (1) through (8) of subdivision (b) above, and: (1) a list of all tissue banks performing tissue acquisition activities on the premises of a limited tissue procurement service; and (2) the name, title and business telephone number of the person with primary responsibility for compliance with Public Health Law Article 43-B. (d) An application for licensure as a nontransplant anatomic bank shall require the information specified in paragraphs (b) (1) through (8) of this section, and: (1) a list of all the types of nontransplant anatomic parts banked; (2) a list of all facilities that provide nontransplant anatomic parts to the nontransplant anatomic bank; (3) a list of all facilities in New York State to which nontransplant anatomic parts are distributed; (4) the name, title and business telephone number of the person with primary responsibility for compliance with Public Health Law article 43-B; and (5) an affirmation that the tissue will be distributed only to a legal donee as designated in Public Health Law section 4302 and will only be used by the bank for the purposes authorized by Public Health Law section 4302. (e) Any dentist or physician whose use of tissue is limited to virally inactivated tissue shall not be required to be separately licensed pursuant to this Part, provided he or she is licensed by, and currently registered with, the State Education Department. (f) Shipping of any tissue from an out-of-state facility shall constitute distribution and shall require a license, unless the tissue is:

(1) avascular eye tissue or hematopoietic progenitor cells shipped to a licensed comprehensive tissue procurement service, provided the licensed comprehensive tissue procurement service shall be responsible for: (i) the safety and appropriateness of the imported tissue as specified in Subparts 52-3 and 52-7 of this Part, and Subpart 58-5 of this Title; and (ii) obtaining documentation that valuable consideration has not been paid to the out-of-state facility transferring the tissue. Documentation that the transferring out-of-state facility is a nonprofit organization shall create a presumption that valuable consideration has not been paid. (2) subjected to viral inactivation by a process accepted by leading authorities in the field of transplantation medicine and a written exception to the requirements of this subdivision has been granted by the department on the basis of documentation submitted by the applicant, including a detailed description of the viral inactivation methodology and procedure, and data showing the amount of virus introduced and the effectiveness of the method in destroying the virus; or (3) from fully screened and tested donors; has been extensively processed and altered by such means as culturing over many generations, and combined with nontissue components, so that the original human tissue constitutes a small percentage of the final product; and a written exception to the requirements of this section has been granted by the department on the basis of documentation submitted by the applicant. Such documentation shall include a detailed description of the processing and donor screening performed to ensure that the tissue is free of pathogens listed in sections 52-3.4(c)(4), 52-4.7(a), 52-5.7(a), 52-6.7(a) and 52-7.7(a), as applicable to the type of tissue procured. (g) All changes in the tissue bank director, medical director, owner or persons with a controlling interest shall be reported as specified in section 52-2.3(a) and (b) of this Subpart.

Section 52-2.5 - License issuance and denial 52-2.5 License issuance and denial. (a) A tissue bank, other than a tissue transplantation facility, tissue storage facility, or a limited tissue procurement service, shall be issued a license for one or more tissue categories, provided that: (1) the owner(s) and/or an authorized representative have submitted a license application pursuant to this Subpart; (2) a tissue bank director has been appointed who: (i) is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices, and has at least two years' training or experience in the category or categories of tissue, or in a related field, as determined by the department; or (ii) is a person with a doctoral degree in an appropriate biological science, and has a minimum of two years' tissue banking experience in the category or categories of tissue, or in a closely related field, as determined

by the department; or (iii) is a person with a master's degree in an appropriate biological science, and has a minimum of four years' tissue banking experience in the category or categories of tissue, or in a closely related field, as determined by the department; or (iv) is a person with a bachelor's degree in an appropriate biological science, and has a minimum of six years' tissue banking experience in the category or categories of tissue, or in a closely related field, as determined by the department; and (v) holds a current certificate of qualification from the department, in the category or categories of testing, if laboratory testing is performed by the tissue bank; (3) the medical director is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices. The tissue bank director may serve as the medical director if he or she is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices; (4) for tissue banks other than insemination/implantation sites, the medical advisory committee is found acceptable by the department; (5) the department has found that the tissue bank owners, any parties with a controlling interest, medical director and tissue bank director have the character and competence to ensure that the tissue bank is competently staffed, properly equipped, and operated in accordance with the law, and that such tissue bank will be so operated. In making such a determination, the department shall consider the factors listed in subdivision (e) of this section with respect to the tissue bank, the director, medical director and owner(s) of the tissue bank, and any affiliated person, including parties with a controlling interest; and (6) the tissue bank has corrected deficiencies found on any inspection conducted by the department and any deficiencies noted by the department in the standard operating procedures manual submitted with the application. (b) A tissue transplantation facility shall be issued a license for one or more tissue categories, provided that: (1) the owner(s) and/or authorized representative have submitted a license application pursuant to this Subpart; (2) a tissue bank compliance officer has been appointed; (3) a director who is a physician licensed and currently registered to practice medicine in New York State is appointed for each tissue transplantation service within the tissue transplantation facility; (4) the tissue transplantation facility is established pursuant to Public Health Law, Article 28, or is the private office of a physician licensed and currently registered to practice medicine in New York State; (5) the department has found no evidence that the tissue bank compliance officer and director of each tissue

transplantation service within the tissue transplantation facility lack the character and competence to ensure that the tissue transplantation facility is competently staffed, properly equipped and operated in accordance with the law, and that such tissue transplantation facility will be so operated. In making such a determination, the department shall consider the factors listed in subdivision (e) of this section with respect to the tissue transplantation facility, the tissue bank compliance officer and the director of each tissue transplantation service within the tissue transplantation facility; and (6) the tissue transplantation facility has corrected any deficiencies noted by the department in the written standard operating procedure manual or records of tissue issuance and, if inspected, the tissue transplantation facility has corrected any deficiencies found. (c) A tissue storage facility shall be issued a license provided: (1) the owner(s) and/or authorized representative(s) have submitted a license application pursuant to this Subpart; (2) a director has been appointed who has at least two years' experience in the storage of tissue or in a related field, as determined by the department; (3) the medical director is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices. The tissue storage facility director may serve as the medical director only if he or she is a physician licensed and currently registered to practice medicine in New York State or in the state in which he or she practices; (4) if inspected, the facility has corrected any deficiencies found; and (5) the department has found that the tissue bank owners and any parties with a controlling interest, medical director and tissue bank director have the character and competence to ensure that the facility is competently staffed, properly equipped and operated in accordance with the law, and that such tissue bank will be so operated. In making such a determination, the department shall consider the factors listed in subdivision (e) of this section with respect to the facility, the director(s) and owner(s) of the facility, and any affiliated person, including parties with a controlling interest. (d) A nontransplant anatomic bank or limited tissue procurement service shall be issued a license provided: (1) the owner(s) and/or authorized representative(s) have submitted a license application pursuant to this Subpart; (2) if inspected, the bank has corrected any deficiencies found; and (3) the bank is competently staffed, properly equipped and operated in accordance with the law. In making such a determination, the department may consider the factors listed in subdivision (e) of this section with respect to the bank, the director(s) and owner(s) of the bank, and any affiliated person, including parties with a controlling interest. (e) In determining whether to deny a license, the department may consider the following factors with respect

to the tissue bank or nontransplant anatomic bank director(s) and owner(s), and any affiliated person, including parties with a controlling interest: (1) false representation or omission of a material fact in filing the license application or during inspection; (2) failure to supply further information necessary to process the license application, within three months of the department's written request, without satisfactory explanation; (3) conviction of any crime or sustained charges of administrative violations of state or federal laws, rules and regulations, related to the operation of a site performing health care services or a funeral directing firm, including, but not limited to, the Public Health Law or related statutes; (4) the employment of unqualified technical personnel or an insufficient number of such personnel or support personnel; (5) a pattern of deficiencies on onsite inspection, especially in areas of quality assurance, management and handling of regulated medical waste and radioactive materials, including: (i) refusal or inability to produce records or reports as requested by department employees; (ii) failure to correct deficiencies from inspection to inspection; (iii) deviation from regulations and/or accepted standards so as to jeopardize the quality of tissue services provided or pose a hazard to employees, donors, recipients or the public; and (iv) refusal to provide department employees with access to the premises; (6) knowing acceptance of tissue requisitions from or provision of tissue services or tissue to a person or persons not authorized by law to provide such services, or possess or use such tissue; (7) failure of the director to be on the premises for an adequate amount of time and adequately supervise technical personnel to ensure the proper performance of all tissue services provided; (8) failure to establish and follow procedures for disposal or handling of tissue or infectious or radioactive medical waste, as determined by the governing state and federal agencies, or disposal in a manner which endangers the public, the employees or the environment; and (9) whether the bank is in compliance with the technical requirements specified in this Subpart, Subpart 523 of this Part and/or the Subpart specific to each category of tissue. (f) License denial. (1) If the department proposes to deny a license to a tissue bank or nontransplant anatomic bank, the bank shall be given written notice of the proposed denial, stating the reason or reasons for the denial. Such notice shall be sent by certified mail and shall be a final determination to be effective thirty (30) days from the date of the notice unless reconsideration is requested pursuant to paragraphs (3), (4) and (5) of this subdivision.

(2) Denial of a license shall preclude the applicant from operating a tissue bank or nontransplant anatomic bank in New York State, either directly or indirectly through any other person. (3) If the department gives notice of proposed denial of a license, the applicant may request reconsideration of the proposed denial by submitting a written request for reconsideration to the department within thirty (30) days of the date of the notice. Submission of a request for reconsideration within thirty (30) days shall stay any action to deny a license, pending the department's decision regarding such reconsideration. (4) The written request for reconsideration shall include all information the applicant wishes to be considered, including any written documentation which would controvert the reason for the denial or disclose that the denial was based upon a mistake of fact. (5) Within ninety (90) days of receipt of the request for reconsideration, the department shall review its initial determination to deny a license and shall issue a written determination after reconsideration. The determination after reconsideration may affirm, revoke, or modify the proposed denial, allow issuance of a license conditional on maintenance of corrective action, or require that the applicant take corrective action. Such determination shall be the final decision of the department. (6) No license application shall be considered for any applicant who is substantially the same as an applicant who has been denied a license within six (6) months of the final determination of the department denying such application. In the event an applicant has received two successive license denials, no license application shall be considered for that applicant within two (2) years of the last final determination of the department denying a previous application. (7) In addition to any penalties provided under the Public Health Law and Penal Law, falsification or failure to make full disclosure on a license application shall be deemed to constitute, in itself, a bar to obtaining a tissue bank or nontransplant anatomic bank license in New York State. (g) A tissue bank license shall list the categories of tissue and types of tissue services offered, as defined in section 52-1.1(aa) and (ad) of this Subpart, respectively. Such license shall be conspicuously posted on the premises of the bank. Section 52-2.9 - Required records 52-2.9 Required records. (a) Complete and accurate records of tissue and nontransplant anatomic parts released shall be kept by the tissue banks or nontransplant anatomic banks distributing the tissue. Such records shall be open to inspection by the department. For all donated tissue and nontransplant anatomic parts, the donor's name, address and any other information which would directly or indirectly identify the donor shall not be disclosed or released by the bank to any person or entity, except upon the written consent of the donor or the person authorized by law to make the donation, or to authorized employees of the department, or as permitted by law. The recipient's name, address and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the tissue bank to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law. (b) Complete and accurate records of tissue and nontransplant anatomic parts released for transplantation,

transfer, artificial insemination, implantation, research and education shall be kept by the tissue transplantation facility or insemination/implantation site. Such records shall be open to inspection by the department and shall be kept for at least seven (7) years after transplantation or six (6) months after the expiration date of the tissue, whichever is longer. In cases of reproductive tissue transfer/artificial insemination/implantation, records shall be kept for at least seven (7) years after the release of tissue not resulting in live births and twenty-five (25) years for tissue resulting in live births. Nontransplant anatomic banks shall retain records for five (5) years after release of nontransplant anatomic parts for research or education purposes. The recipient's name, address, and any other information which would directly or indirectly identify the recipient shall not be disclosed or released by the tissue transplantation facility or insemination/implantation site to any person or entity, except upon the written consent of the recipient, or except to authorized employees of the department, or as permitted by law. (c) The following donation records shall be kept by each comprehensive tissue procurement service: (1) donor's full name, address at time of donation, identification code, date of birth or age, and date and time of death, if a cadaveric donor; (2) documentation of evaluations of physical condition, if a cadaveric donor; (3) pertinent donor medical history, including, but not limited to, autopsy reports, donation questionnaires and other donor solicitation materials; (4) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address, unless this record is retained by a limited tissue procurement service; (5) date and time of collection, and description and quantity of tissue retrieved; (6) any reported changes in donor health status, if applicable; (7) outcome of transplantation, transfer, artificial insemination and implantation procedures, if known, and any reports from facilities using the tissue, which would affect the donor's acceptability; (8) records specified in the Subpart specific to each category of tissue; and (9) documentation of staff training, certification and continuing education. (d) The following records shall be kept by each limited tissue procurement service: (1) a record of each referral to a comprehensive tissue procurement service, including the donor's name or other identification, the date and time of referral, the name of the person making the referral, the name of the comprehensive tissue procurement service, and whether the records specified in paragraphs (2) and (3) of this subdivision have been transferred to the comprehensive tissue procurement service; (2) medical and social history information obtained from the donor, donor's family, and other individuals, including the names of the persons obtaining and giving the information, unless this record is transferred to

a comprehensive tissue procurement service; and (3) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address, unless the record is transferred to a comprehensive tissue procurement service. (e) The following records shall be kept by each tissue processing facility: (1) an acquisition log or other similar record indicating: (i) donor's identification code and/or unique tissue product number; (ii) name and address of the tissue bank from which the tissue was acquired; (iii) date of receipt of the tissue; and (iv) tissue location in the storage chamber; (2) description of tissue received for processing; (3) methods used for acquisition, processing, distribution and storage of the tissue; (4) air quality measurements for critical and controlled work areas, if applicable; (5) disposition of the tissue, including, but not limited to, distribution records, destruction logs, and autoclaving or incineration records; (6) results of all laboratory tests performed on donors and donated tissue, including documentation of review of test results prior to release of the tissue; (7) documentation of labeling and packaging inspection prior to tissue transport to a tissue transplantation facility or release for transplantation, transfer, artificial insemination or implantation; (8) records specified in the Subpart specific to each category of tissue; and (9) documentation of staff training, certification and continuing education. (f) The following records shall be kept by each tissue storage facility: (1) an acquisition log or other similar record indicating: (i) donor's identification code and/or unique tissue product number; (ii) date of receipt of tissue; (iii) name and address of tissue bank providing the tissue; and

(iv) location of the tissue in the storage chamber; and (2) a record of the disposition of the tissue, including, but not limited to, distribution records, destruction logs, and autoclave or incineration records. (g) The following records shall be kept by each tissue transplantation facility or insemination/implantation site: (1) the name of the tissue bank providing the tissue, and unique tissue product number; (2) a description of the tissue; (3) results of any laboratory tests performed; (4) a log of the disposition of the tissue, including, but not limited to, name or identification code of recipient, tissue product return records, destruction logs and autoclaving or incineration records; (5) condition of the tissue upon receipt, including any loss noted of liquid nitrogen, dry ice, or other coolant; (6) date of transplant, transfer, artificial insemination or implantation; (7) quantity of tissue used; (8) outcome of the tranplantation, artificial insemination, transfer or implantation procedure, including, but not limited to, any adverse outcome or infectious disease in the recipient, which shall be reported to the tissue bank from which the tissue was obtained; and (9) record specified in the Subpart specific to each category of tissue. (h) Records shall be kept in insemination/implantation sites as specified in Subpart 52-8. (i) Nontransplant anatomic banks which solicit, retrieve, release or store nontransplant anatomic parts shall keep the following information: (1) if known, donor's full name, address at the time of donation, identification code, date of birth or age, and date and time of death if a cadaveric donor; (2) documentation of donor informed consent or consent of the person authorized by law to consent to the donation, if applicable, including such person's address; (3) records of distribution of all nontransplant anatomic parts; (4) if applicable, name and address of the nontransplant anatomic bank from which the nontransplant anatomic part was acquired;

(5) if applicable, date of receipt of the nontransplant anatomic part from the nontransplant anatomic bank; (6) location of nontransplant parts in storage, including documentation tracing nontransplant anatomic parts to specific donors; and (7) if known, disposition of the nontransplant anatomic parts once their use in education or research is ended, including the names of the funeral directors, cemeteries or crematories involved in disposition.