University of Pennsylvania School of Medicine s2

Policy No. : AA-HBOD-001 Page 1 of 9 ______

University of Pennsylvania School of Medicine Policy & Procedure Manual

MANAGEMENT OF DECEASED HUMAN BODIES AND RECOGNIZABLE PARTS OF HUMAN BODIES ACADEMIC ADMINISTRATION Policy Number: AA-HBOD-001 Date Approved: 12/05/08

I. PURPOSE

The purpose of this policy is to provide guidelines and assign responsibility for oversight of the appropriate management of deceased human bodies and recognizable parts of human bodies.

II. POLICY STATEMENT

The University of Pennsylvania School of Medicine (SOM) recognizes that clinical services and biomedical education and research require the use of deceased human bodies and recognizable parts of human bodies. The SOM obliges its employees to obey and to uphold all legal, public health, and ethical standards associated with the handling of human cadavers and recognizable parts of human bodies. The SOM is committed to the dignified and respectful treatment of human remains.

III. SCOPE

This policy applies to all deceased human bodies and recognizable parts of human bodies, including surgical and autopsy specimens recognizable as parts of human bodies, whether provided to the SOM by the Humanity Gifts Registry or other source. This policy applies to deceased human bodies and recognizable parts of human bodies which are sent to the Morgue of the School of Medicine administered by the Department of Pathology and Laboratory Medicine. This policy is consistent with UPMC policy #x-xx-xx, which governs the activities of the Anatomic Pathology Division and the Morgue of the Hospital of the University of Pennsylvania.

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 2 of 9 ______IV.IMPLEMENTATION

The Chief Executive Officer of the Health System/Dean of the School of Medicine delegates authority for managing deceased human bodies and recognizable parts thereof to the senior executive responsible for School of Medicine operations. He/she may, in turn, assign management supervision to the persons bearing responsibility for the Morgue of the School of Medicine and Department of Pathology and Laboratory Medicine. It is expected that day to day monitoring of morgue activity may be delegated, in part, by the Chair of the responsible department.

Persons with delegated responsibilities shall be notified in writing of the nature and term of such responsibility; copies of these letters shall be placed on file with Chief Executive Officer of the Health System/Dean of the School of Medicine together with copies of written acceptances.

Annually, a report of all anatomic and morgue related activity of the Department of Pathology and Laboratory Medicine shall be made to the Chief Executive Officer of the Health System/Dean of the School of Medicine.

The Chief Executive Officer of the Health System/Dean of the School of Medicine or his/her designee will schedule unannounced visits to the Morgue to ensure that policies and procedures are being followed. Findings should be reported to the CEO/Dean.

V. DEFINITIONS AND EXCLUSIONS

"Extramural Individuals and Institutions" Individuals, schools, and centers of the University not subsumed within the SOM or the University of Pennsylvania Health System and any individual or institution not a part of the University of Pennsylvania. Faculty located at other institutions must receive institutional approval both from their institution and the University of Pennsylvania.

” Institutional Approval,” as used in this document, means formal and written approval of a program or protocol by the official group or committee of the University of Pennsylvania (e.g. Director of the SOM Morgue or Institutional Review Board Committee on Studies involving Human Beings) appropriate to that activity.

“Recognizable Parts of Human Bodies” refers to whole bones or whole viscera and external members recognizable to the lay person. Small quantities of tissue or sections of bone or viscera

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 3 of 9 ______are not considered recognizable parts of human bodies. Recognizable and viable parts of human bodies designated and actually used for clinical transplantation (for example, heart, liver, and kidney) are not included in the policies set forth in this document. This policy applies solely to human cadavers and recognizable parts of human bodies. This policy is intended to be consistent with, and to supplement the laws and guidelines of The Humanity Gifts Registry of the Commonwealth of Pennsylvania.

The SOM recognizes that the clinical services of its hospital and the hospitals of the Health System involve death and dying and work regularly with deceased human bodies and recognizable parts of human bodies. This policy does not address such clinical services.

VI.WHO SHOULD KNOW THIS POLICY?

 Deans / Department Chairs / Division Chiefs  School of Medicine Faculty  School of Medicine Administrators  Employees of the Department of Pathology and Laboratory Medicine and of the Morgue of the School of Medicine  Employees of the Division of Anatomic Pathology and of the Morgue of the Hospital of the University of Pennsylvania  Medical Students / Graduate Students / Postdoctoral Fellows / Residents  School of Dental Medicine (Gross Anatomy Teaching Faculty and Students)  Related Course Directors / Teaching Faculty / Assistants  Office of Regulatory Affairs (University of Pennsylvania)

VII. PROCEDURES

RESPONSIBLE PROCEDURE PERSON / DEPT

A. Institutional Approval

Responsible Faculty The School of Medicine of the University of Pennsylvania Medical Member Center requires that all deceased human bodies and recognizable parts of human bodies entering and leaving the School of Medicine do so as Anatomy Course part of a program or protocol which has written institutional approval.

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 4 of 9 ______Director Changes in use subsequent to original approval require additional approval. All deceased human bodies and recognizable parts of human Manager, School of bodies entering the School of Medicine for educational or research Medicine Morgue purposes must have approval from the Director, School of Medicine Morgue prior to any use or activity. Senior Business Administrator, The SOM prohibits any individual or unit from providing any Pathology and deceased human bodies or recognizable parts of human bodies except Laboratory Medicine through programs or protocols approved by the Director, School of Medicine Morgue to receive such materials. Any such approved Chair, Department of materials of this kind to be sent outside the Commonwealth of Pathology and Pennsylvania as permitted by applicable anatomical and transportation Laboratory Medicine laws requires written notification to the Humanity Gifts Registry. Any questions regarding whether a particular activity requires IRB University approval shall be directed to the Institutional Review Board. Institutional Review Board

B. Entry and Disposition

Responsible Faculty The SOM requires that all deceased human bodies or recognizable Member parts thereof that enter or leave the School of Medicine do so through the Morgue of the School of Medicine administered by the Manager, School of Department of Pathology and Laboratory Medicine (the recipient of Medicine Morgue bodies donated through the Humanity Gifts Registry, and body parts obtained through pre-approved programs on behalf of specific Morgue Attendant departments such as the departments of Otorhinolaryngology-Head and Neck Surgery and Orthopaedic Surgery). The Departmental Senior Business Procedural Manual details the methods of recording transactions. Administrator, Pathology and Laboratory Medicine

Responsible Faculty C. Transport Member The SOM requires that all deceased human bodies or recognizable Chair, Department of parts thereof used for research and educational purposes that must Pathology and leave the premises of the University of Pennsylvania do so through the

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 5 of 9 ______Laboratory Medicine Department of Pathology and Laboratory Medicine and by transportation methods approved under applicable state and federal Senior Business law. This includes, but is not limited to, using a reliable transportation Administrator, or shipping service and including a letter with any transported Pathology and materials describing the materials, the purpose of the transportation, Laboratory Medicine and the expected date of return of the materials. The Procedural Manual for the Department of Cell and Developmental Biology Manager, School of outlines in detail all procedures to be followed in order to transport Medicine Morgue any recognizable bodies or parts thereof beyond the premises of the University of Pennsylvania. Transportation out of the Commonwealth Morgue Attendant may only occur for the express purpose of a specific activity, such as plastination, demonstration models for CME courses, education use or Humanity Gifts preparation, research, clinical, or other pre-approved purposes, and Registry must follow the approved transportation methods and all procedures outlined in the Procedural Manual of the Department of Cell and Developmental Biology. In addition, a copy of the letter accompanying the material must be sent to the Humanity Gifts Registry notifying it of the activity. Such processes must allow for the return of materials to the Commonwealth of Pennsylvania. When applicable, the immediate return of all said parts to the Department of Pathology and Laboratory Medicine upon completion of the specific activity is required. The individual responsible for sending the material is directly responsible for following up with its return, if applicable.

Responsible Faculty D. Record Keeping Member The SOM requires that all departments making use of deceased human Course Director bodies or recognizable parts thereof register, record, and monitor the location, movement, and use of such items, as outlined in the Manager, School of Departmental Procedural Manual, from the time of their arrival at the Medicine Morgue SOM until the time of their final disposition by the SOM, including internal transfer among investigators. The office within the SOM Morgue Attendant which initially receives the materials is designated the party responsible for the maintenance of all subsequent records relating to Senior Business such materials until their final disposition. Administrator, Cell and Developmental A detailed system for monitoring the location of specific bodies and

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 6 of 9 ______Biology recognizable parts at any time together with the purpose(s) for which they are being used must be strictly adhered to by the Department of Pathology and Laboratory Medicine. This process is outlined in the Departmental Procedural Manual.

A record of research protocols approved by the Director, School of Medicine Morgue, and educational curricula reviewed by the Director, must be kept on file in the Department of Pathology and Laboratory Medicine so that recognizable parts of human bodies or whole bodies are distributed only for approved purposes to authorized individuals.

Recognizable parts of a human body transferred to the School of Medicine from the Morgue of the Hospital of the University of Pennsylvania for teaching purposes shall be transferred to the Department of Pathology and Laboratory Medicine. Such parts then enter the records of that Department and shall be tracked through that Department’s System.

E. Cremation and Burial Course Director The SOM requires that all deceased human bodies or recognizable Manager, School of parts thereof used for research or educational purposes be kept intact Medicine Morgue as much as possible for the purpose of cremation and burial. When processes including, but not limited to, prosection and plastination are Morgue Attendant used, which enable portions of the deceased human body to be maintained indefinitely for teaching purposes, the deceased human Senior Business body may be cremated in an incomplete state. All parts not cremated Administrator, Cell with the body must be properly tagged and identified for the duration and Developmental of their use. Future cremation of the part must be properly recorded. Biology Cremations will take place at an off-site crematorium. If cremation is to occur at an off-site facility, the University of Pennsylvania requires that each human cadaver be cremated individually and placed in a container to be returned to the University of Pennsylvania or be designated for burial, as specified by the University of Pennsylvania. The crematorium is required to provide an assigned cremation number along with the date and time of cremation, which will be logged into the permanent records of the crematorium. In addition, all cadavers

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 7 of 9 ______removed from the University of Pennsylvania by the crematorium will have a number assigned to them by the University of Pennsylvania or Humanity Gifts Registry. All dissected material and other human components will be cremated and placed in a container designated for the University of Pennsylvania and returned to the University of Pennsylvania or prepared for burial, as specified by the University of Pennsylvania. All dissected material boxes will also be assigned a cremation number along with the date and time of cremation and filed into the permanent records of the crematorium.

F. Employees with Morgue Duties

Morgue attendants shall have an embalmer’s license and a high school Manager, School of diploma, or equivalent experience. A valid funeral director license at Medicine Morgue the time of hire is preferred for the Attendant of the Teaching Morgue. For newly employed personnel, a training period shall be established Senior Business and during this period the individual shall be formally instructed in the Administrator, procedures to be followed in the Morgue and shall be made thoroughly Pathology and familiar with the Departmental Procedural Manual. Laboratory Medicine

G. Manual of Procedures for the Handling of Human Bodies and Their Parts

Manager, School of The Departmental Procedural Manual is located in the departmental Medicine Morgue chair’s office of the Department of Cell and Developmental Biology.

Senior Business The Departmental Procedural Manual details the duties and Administrator, Cell responsibilities of all who have assignments related to the Morgue. and Developmental The development and updating of the Departmental Procedural Biology Manual is the responsibility of the Chairperson of the Department of Cell and Developmental Biology. Chair, Department of Cell and The Departmental Procedural Manual presents organizational charts Developmental and a schedule and format for periodic written reports of Morgue Biology activities with respect to the management of deceased human bodies and recognizable parts of human bodies.

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 8 of 9 ______Expectations regarding compliance with the legal, ethical, and public health aspects of managing human bodies and recognizable parts of human bodies, as well as the sanctions for misconduct, shall be explicitly detailed in the Departmental Procedural Manual.

H. Financial Aspects

Vice Dean, The policy: 1) prohibits any and all commercial trafficking in Administration and deceased human bodies and recognizable parts of human bodies; 2) Finance realizes that provision must be made for legitimate study and research activities; and 3) recognizes that departments must be able to recover Chair, Department of real and verifiable expenses incurred by providing deceased human Cell and bodies and parts of human bodies for study. All transactions must Developmental flow through established institutional channels, and complete financial Biology records must be maintained and are subject to audit. No investigator, other staff, or personnel is to charge or receive remuneration for Senior Business provision of deceased human bodies or parts of human bodies, nor are Administrator, Cell departments, except to cover actual operating costs. and Developmental Biology

Manager, School of Medicine Morgue I. Individual Responsibilities

The senior executive responsible for School of Medicine operations is Dean, Vice Deans, responsible for informing faculty and employees of the content of this Administration and policy. Further, it should be emphasized that: 1) all faculty, students, Finance / Education / staff and employees must comply with this policy, and 2) all faculty Research and employees must obtain the necessary approval from the Director, School of Medicine Morgue, for all educational or research programs Responsible Faculty involving the use of deceased human bodies and recognizable parts of and Staff human bodies.

J. Sanctions

Each manager, department director, and department chair has the Dean, Vice Deans, responsibility to ensure that all departmental staff practice in

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00 Policy No. : AA-HBOD-001 Page 9 of 9 ______Administration and compliance with the policy. The manager, department director, or Finance / Education / department chair may impose appropriate measures for failure to Research comply. If a faculty member refuses to comply, the department chair will consult with the CEO/Dean as to imposition of further sanctions Department Chairs as appropriate. Violation of these procedures or protocols with respect to deceased human bodies or recognizable parts of human bodies is Directors / Managers subject to disciplinary action, up to and including dismissal.

VIII. CONTACTS

Office of the CEO/Dean, School of Medicine Phone: (215) 898-5181 FAX: (215) 898-5607

Vice Dean, Administration and Finance, School of Medicine Phone: (215) 898-3655 FAX: (215) 898-0994

Executive Director, School of Medicine Administration Phone: (215) 573-0681 FAX: (215) 898-0994

Manager, School of Medicine Morgue Phone: (215) 898-4450 FAX: (215) 898-9871

Morgue Attendant Phone: (215) 898-8054 FAX: (215) 898-9871

SUPERSEDES: University of Pennsylvania Medical ISSUED BY: Center Policy for the Management of Deceased Human Bodies and Recognizable Parts of Human bodies Dean, School of Medicine Date --11/6/87 and 9/28/00