Disposition of Unclaimed Tissue Policy

INTRODUCTION

Embryo, eggs, sperm and tissue (together, “tissue”) left unclaimed can raise ethical and logistical concerns regarding if, how, and when abandoned tissue might be disposed if individuals or couples (“patients”) fall out of contact and have not provided written instruction concerning the disposition of their tissue. Patient choice is important and therefore Inception Intermediate Holdings and its affiliated providers (together, “Inception”) seek to respect patients’ choices about the disposition of their tissue if practical and consistent with prevailing legal and ethical requirements and Inception’s policies and procedures. Inception has developed procedures to establish and document patients’ instructions regarding their tissue disposition. However, Inception is not responsible for the indefinite storage of unclaimed tissue in circumstances when attempts to contact patients are not successful and patients do not continue to pay storage fees. The purpose of this policy is to describe Inception’s designation, retention, and disposal of unclaimed tissue.

This policy applies to Inception patients, including patients of practices since acquired by Inception whose tissue is currently preserved by Inception.

DEFINITIONS

Delinquent The status of tissue when a patient with dispositional control has not paid applicable storage fees to Inception for at least 24 months after reasonable efforts by Inception to contact the patient; or a patient with dispositional control has not paid applicable storage fees to Inception for at least 24 months in circumstances where Inception does not have any contact information on file.

Dispositional Control The individual with the authority to make decisions about the tissue, often the patient and/or couple.

Patient The individual or couple with dispositional control as documented by Inception.

Reasonable Effort The attempts undertaken by Inception to make contact with a patient. Reasonable effort includes at least one attempt to contact the patient regarding this policy and/or a patient’s tissue using any of the following communication channels (e.g., phone, mobile, mail, email). When a patient has not been in contact with Inception for five (5) or more years, and the patient’s contact information on file is no longer valid, Inception may, but is not required to, conduct independent research or engage third parties to attempt to find current contact information for the patient, and attempted contact using contact information on file is sufficient.

Reasonable Period of Time The period of time from which Inception first attempts to contact a patient regarding this policy and/or the disposition of a patient’s tissue using reasonable efforts and/or the date which the patient ceases to pay storage fees until Inception determines the tissue is unclaimed for lack of response from the patient. For the purposes of this policy, such time is considered to be five (5) years or more.

Unclaimed The status of tissue when a patient with dispositional control (1) cannot be contacted within a reasonable period of time after reasonable efforts by Inception, or (2) clearly indicates either: (i) in writing or (ii) verbally to Inception that the patient does not wish to have further dispositional control of the patient’s tissue.

POLICY

General

This policy describes the criteria by which Inception determines tissue’s status as delinquent or unclaimed and provides the conditions under which Inception may transfer delinquent tissue to long term storage or dispose of unclaimed tissue. This policy does not require Inception to dispose of unclaimed tissue if these conditions are met. Rather, Inception may deem the tissue unclaimed and subject to destruction, but choose to preserve unclaimed tissue based on individual circumstances. During the pendency of the reasonable period of time, Inception may, but is not required to, transfer delinquent tissue subject to this policy (including but not limited to unclaimed tissue) to one or more long-term storage facilities. Inception’s transfer procedures may take into account the fact that certain tissue is unclaimed at the time of transfer. Inception will only destroy unclaimed tissue consistent with this policy.

Inception understands that patients’ disposition decisions may change over time. In circumstances of unclaimed tissue, Inception shall refer to a patient’s most recent documented disposition instructions on file.

Should local law require additional or more stringent requirements than described in this policy, Inception shall comply with such law.

Inception’s communication attempts pursuant to this policy shall comply with relevant privacy laws and Inception’s own privacy policies.

Disposition Process

As part of Inception’s current standard informed consent and contracting procedures, patients shall indicate their intentions regarding the future disposition of tissue in writing prior to cryopreservation. However, where historical practice did not require such written instruction, Inception shall use best efforts to notify applicable patients about this policy and encourage patients to create written disposition instructions.

Inception shall not consider tissue unclaimed when a patient responds to reasonable efforts from Inception and provides written instructions regarding disposition and promptly pays storage fees within thirty (30) days. If a patient (1) acknowledges Inception’s contact and does not pay storage fees within thirty (30) days of the acknowledgement or (2) states that the individual does not wish to be responsible for their tissue, the individual shall be deemed to have delegated dispositional control to Inception and Inception shall deem the associated tissue unclaimed with respect to that individual.

Patients’ associated medical records shall be maintained consistent with Inception’s policy regarding medical record retention.

No Contact With Clear Written Disposition

If a patient has provided written instructions regarding the patient’s wishes for the destruction of tissue, yet Inception is subsequently unable to contact the patient because the patient has not provided Inception with current contact information, Inception shall not be obligated to re-contact the patient. Inception may adhere to the patient’s last written disposition instructions and need not receive further contemporaneous consent before following the patient’s disposition instructions to destroy tissue. Inception may transfer the unclaimed tissue to long-term storage or destroy the unclaimed tissue at Inception’s discretion.

No Contact Without Clear Written or Verbal Disposition

If a patient has not provided disposition instructions and reasonable efforts to contact the patient over a reasonable period of time have been unsuccessful, Inception may transfer the unclaimed tissue to long-term storage or destroy the unclaimed tissue at Inception’s discretion. Before Inception may commence destruction of unclaimed tissue, Inception shall confirm and document the following:

The patient has not provided written instructions regarding tissue disposition
The patient has not been in contact with Inception for a reasonable period of time
The patient has not paid or has ceased paying storage fees
The patient cannot be reached after Inception’s reasonable efforts

Inception may only destroy the unclaimed tissue in such circumstances and may not provide or utilize the unclaimed tissue for research or reproductive purposes without a patient’s express written instruction.

No Contact and Written Disposition Indicates Do Not Discard

If a patient has provided “do not discard” instructions and reasonable efforts to contact the patient over a reasonable period of time have been unsuccessful, Inception may transfer the unclaimed tissue to long-term storage or destroy the unclaimed tissue at Inception’s discretion. Before Inception may commence destruction of unclaimed tissue, Inception shall confirm and document the following:

The patient’s written “do not discard” tissue disposition instructions were provided prior to this policy’s creation
The patient has not been in contact with Inception for a reasonable period of time
The patient has not paid or has ceased paying storage fees
The patient cannot be reached after Inception’s reasonable efforts

If the patient has provided “do not discard” disposition instructions after this policy’s creation, Inception shall follow the terms of the patient’s written instructions, subject to the patient’s payment of storage fees.

No Contact and Written Disposition Abdicates Responsibility for Tissue

If a patient provided clear disposition instructions consistent with Inception’s informed consent and contracting process that the patient does not wish to maintain future responsibility for the patient’s tissue, thereby effectively delegating dispositional control to Inception, Inception shall not be obligated to re-contact the patient before making disposition decisions. Inception may transfer the unclaimed tissue to long-term storage or destroy the unclaimed tissue at Inception’s sole discretion.

If More Than One Individual Has Dispositional Control

If more than one individual has dispositional control over the cryopreserved tissue, the tissue may be deemed unclaimed with respect to one individual and not the other. Inception’s calculation of a reasonable amount of time shall be determined independently for each individual with dispositional control.

If individuals with dispositional control over tissue notify Inception of a dispute between them with respect to disposition, Inception shall comply with any dispositional instructions developed after the date of the notice of dispute and agreed in writing by the individuals, or in accordance with a court order. If no such agreement or court order is provided to Inception in a reasonable period of time after the individuals provided notice of the dispute to Inception, Inception may deem the tissue unclaimed with respect to all interested individuals.

Communication of Policy

Inception shall make this policy available to all new patients prior to retrieval as well as to all established patients with cryopreserved tissue for which Inception has the ability to contact.

Inception may update this policy from time to time to respond to evolving laws, guidance, or Inception procedures. Material changes to this policy shall be communicated.