Standard/Guideline - Organ and Tissue Donation Program



|Standard/Guideline – effective January 2009 |

|14.00.01 Organ/Tissue Donation and Transplantation. |

|The hospital must have and implement written protocols that incorporate an agreement with an Organ Procurement Organization (OPO), under part 486 of this chapter, to timely notify the OPO or a third party |

|designated by the OPO about deaths or imminent deaths. The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital the OPO determines medical |

|suitability for tissue and eye donation, using the definition of potential tissue and eye donor and the notification protocol developed in consultation with the tissue and eye banks identified by the |

|hospital for this purpose. Effective 2009 |

|CMS 482.45; 482.45(a); 482.45(a)(1) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|The regulation applies to all Medicare-certified hospitals including psychiatric hospitals, rehabilitation hospitals, cancer centers, small | | | |

|rural hospitals, patients receiving swing services, and long-term acute-care hospitals. (The regulation does not apply to critical access | | | |

|hospitals, which are a separate provider type.) It also applies to Indian Health Service hospitals. | | | |

|The regulation does not apply to Veterans Administration hospitals, military hospitals or prison hospitals because they are not Medicare | | | |

|hospitals. The regulation does not cover hospices, skilled nursing facilities, nursing facilities (Intermediate Care), or home health | | | |

|agencies, even if they are located within a Medicare-certified hospital. | | | |

|If a patient is transferred from one hospital to another the receiving hospital is responsible for notification of the OPO. | | | |

|The OPO determines medical suitability for organ donation and, in the absence of alternative arrangements by the hospital, the OPO | | | |

|determines medical suitability for tissue and eye donation, using the definition of a potential tissue and eye donor and the notification | | | |

|protocol developed in consultation with the tissue and eye banks identified by the hospital for this purpose. | | | |

|DOCUMENT REVIEW: Review hospital documents. Verify the following are in place: | | | |

|A written protocol that incorporates the agreement with the OPO designated by the secretary of HHS. | | | |

|An agreement with an OPO indicating that the hospital will notify the OPO, in a timely manner, about individuals who have died or when a | | | |

|death is imminent. | | | |

|Notes: |

|Standard/Guideline |

|14.00.02 OPO Waiver Requests. |

|A hospital may request and CMS may grant a waiver permitting the hospital to have an agreement with a designated OPO other than the OPO designated for the service area in which the hospital is located. |

|CMS 486.316(e) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|A waiver would allow the hospital to have an agreement with an “out-of-the-areas” OPO if it meets the following criteria in the statute | | | |

|(Section 1138(a)(2)(a)(i)(ii). | | | |

|To qualify for a waiver, the hospital must submit data to CMS establishing that: | | | |

|The waiver is expected to increase organ donations; and | | | |

|The waiver will ensure equitable treatment of patients referred for transplants within the area served by the hospital's designated OPO and | | | |

|within the area served by the OPO with which the hospital seeks to enter into an agreement. | | | |

|DOCUMENT REVIEW: | | | |

|Review the waiver agreement from the secretary of HHS to determine when, and why, it was issued and the time period for which it was | | | |

|granted. | | | |

|Notes: |

|Standard/Guideline |

|14.00.03 Tissue and Eye Bank Agreements. |

|The hospital must have and implement a written protocol that incorporates an agreement with at least one tissue bank and at least one eye bank to cooperate in the retrieval, processing, preservation, |

|storage, and distribution of tissues and eyes, as may be appropriate to assure that all usable tissues and eyes are obtained from potential donors, insofar as such agreement does not interfere with organ |

|procurement. |

|CMS 482.45(a)(2) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|The regulation requires hospitals to have an agreement with at least one tissue bank and one eye bank. The OPO many serve as a gatekeeper | | | |

|receiving notification about every hospital death and shall notify the tissue and eye banks chosen by the hospital about potential tissue | | | |

|and eye donors. | | | |

|It is not necessary for a hospital to have a separate agreement with a tissue bank if it has an agreement with its OPO to provide | | | |

|tissue-procurement services nor is it necessary for a hospital to have a separate agreement with an eye bank if its OPO provides | | | |

|eye-procurement services. | | | |

|DOCUMENT REVIEW: | | | |

|Review hospital documents to assure that the hospital has an agreement with at least one tissue bank and one eye bank. | | | |

|Review for the specifications / responsibilities of each party. | | | |

|Is the agreement operational? | | | |

|Notes: |

|Standard/Guideline |

|14.00.04 Informed Consent Requirements. |

|The hospital must have and implement a written protocol to ensure, in collaboration with the designated OPO, that the family of each potential donor is informed of its option to donate organs, tissue or |

|eyes, or to decline to donate. |

|CMS 482.45(a)(3) |

|Explanation/Proof of Compliance Available? |Y |N |Document Title, Person Responsible |

|It is the responsibility of the OPO to screen for medical suitability to select potential donors. Once the OPO has selected a potential | | | |

|donor, that person’s family must be informed of the family’s donation options. | | | |

|Ideally, the OPO and the hospital will decide together how and by whom the family will be approached. | | | |

|DOCUMENT REVIEW: | | | |

|Verify that the hospital ensures that the family of each potential donor is informed of its options to donate organs, tissue or eyes, | | | |

|including the option to decline to donate. | | | |

|Verify that the hospital has QAPI mechanisms in place to ensure that the families of all potential donors are informed of their options to | | | |

|donate organs, tissue or eyes, or to decline to donate? | | | |

|Notes: |

|Standard/Guideline |

|14.00.05 Designated Requestors. |

|The individual designated by the hospital to initiate the request to the family must be an organ procurement representative or a designated requestor. |

|CMS 482.45(a)(3) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|Ideally, the OPO and the hospital will decide together how and by whom the family will be approached. If possible, the OPO representative | | | |

|and a designated requestor should approach the family together. | | | |

|A designated requestor is defined in the regulation as an individual who has completed a course offered or approved by the OPO and | | | |

|designated in conjunction with the tissue and eye bank community. | | | |

|Research has shown that the highest consent rates occur when the OPO and hospital staff approach the family together. In the event that | | | |

|collaboration is not possible, the hospital decides who approaches the family to provide information, discuss the family’s options, and | | | |

|request donation. The hospital may have chosen to have an organ procurement coordinator from the OPO approach the family or may choose to | | | |

|have a designated requestor approach the family. | | | |

|DOCUMENT REVIEW: Review hospital records to determine whether hospital staff member requested organ donation. If so, was he or she trained | | | |

|as a designated requestor? | | | |

|FILE REVIEW: Review employee records to determine if individuals involved in organ, tissue or eye donation have received formal training in | | | |

|the consent process for donation. | | | |

|INTERVIEW: How does the hospital ensure that only OPO, tissue bank, or eye bank staff or designated requestors are approaching families to | | | |

|ask them to donate? | | | |

|(Does hospital staff know if there has been an improvement in donations?) | | | |

|Notes: |

|Standard/Guideline |

|14.00.06 Sensitivity Training. |

|The hospital must have and implement a protocol that encourages discretion and sensitivity with respect to the circumstances, views and beliefs of the families of potential donors. |

|CMS 482.45(a)(4) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|Using discretion does not mean a judgment can be made that certain families should not be approached about donation. | | | |

|DOCUMENT REVIEW: | | | |

|Review training plans and ensure they encourage discretion. | | | |

|INTERVIEW: | | | |

|Verify through staff interviews that there has been sensitivity training regarding the process. | | | |

|Notes: |

|Standard/Guideline |

|14.00.07 OPO Responsibilities. |

|The hospital must have and implement a protocol that ensures that the hospital works cooperatively with the designated OPO, tissue bank and eye bank in: |

|Educating staff on donation issues |

|Reviewing death records to improve identification of potential donors |

|Maintaining potential donors while necessary testing and placement of potential donated organs, tissue and eyes take place. |

|CMS 482.45(a)(5) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|The education requirement is based on research that shows that families of potential organ donors are more likely to consent to donation | | | |

|when best practices are used to initiate the request for donation. Therefore, the regulation requires that the individual who initiates the | | | |

|request shall be an organ procurement representative or designated requestor, i.e., an individual who has been trained in best practices for| | | |

|obtaining consent donation. (Most of the OPOs want to do the training themselves.) | | | |

|Any individuals involved in a request for organ donation shall be formally trained in the consent process for organ donation and designated | | | |

|requestors. | | | |

|Any individuals involved in the request for tissue and eye donation shall be formally trained in the consent process for tissue and eye | | | |

|donation and designated requestors. | | | |

|DOCUMENT REVIEW: | | | |

|Review staff training schedules and attendance sheets. | | | |

|Request protocols related to death record review. (Who reviews the records and how often are reviews done?) | | | |

|Request recorded examples of maintaining potential donors. | | | |

|Notes: |

|Standard/Guideline |

|14.00.08 Organ Transplant Facilities. |

|A hospital in which organ transplants are performed must be a member of the Organ Procurement and Transplantation Network (OPTN). |

|CMS 482.45(b)(1) |

|For the purpose of these standards, the term “organ” means a human kidney, liver, heart, lung, or pancreas. |

|CMS 482.45(b)(2) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|Review of death records enables facilities to recognize missed opportunities for organ donation and to identify the hospital, OPO and | | | |

|recovery staff that may need additional education. | | | |

|The term “rules of the OPTN” means those rules provided for in regulations issued by the secretary (of HHS) in accordance with section 372 | | | |

|of the PHS Act which are enforceable under 42 CFR 121.10. No hospital is considered to be out of compliance with section 1138 (a)(1)(B) of | | | |

|the Act, or with the requirements of this paragraph, unless the secretary of HHS has given the OPTN formal notice that he or she approves | | | |

|the decision to exclude the hospital from the OPTN and has notified the hospital in writing. For purposes of these standards, the term | | | |

|“organ” means a kidney, liver, heart, lung or pancreas. | | | |

|As a member of an OPTN, the hospital conforms to all federal requirements regarding these activities. | | | |

|CMS 482.12(5)(ii) | | | |

|A qualified OPTN operates under a grant made under Section 371(a) of the Public Services (PHS) Act. The hospital maintains copies of, and | | | |

|adheres to, the most recent additions or amendments to these standards and regulations. | | | |

|DOCUMENT REVIW: | | | |

|Determine that the hospital is an active OPO member of a regional affiliate of an OPTN by reviewing documentation. | | | |

|Determine that there are current copies of all communications from the OPTN regarding standards and regulations impacting procurement and | | | |

|transplant activities. | | | |

|Notes: |

|Standard/Guideline |

|14.00.09 Data Collection and Reporting. |

|If a hospital performs any type of transplants, it must provide organ transplant related data, as requested by the OPTN, the Scientific Registry, or the OPOs. The hospital must also provide data directly |

|to the Department of Health and Human Services when requested by the secretary. |

|CMS 482.45(b)(3) |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|DOCUMENT REVIEW: | | | |

|Review reports of the past 12 months. Verify: | | | |

|The facility submits reports to the OPTN, the Scientific Registry, and the OPOs. | | | |

|The facility submits data, as requested, to CMS. | | | |

|Notes: |

|Standard/Guideline |

|14.00.10 Confidentiality of Patient Records. |

|Hospitals and OPOs must have procedures for ensuring the confidentiality of patient records and information. |

|CMS 482.24(b)(3); 486.306(o) |

|Explanation/Proof of Compliance Available? |Y |N |Document Title, Person Responsible |

|Processes are in place to insure the patient records and information exchanged between the hospitals and OPOs shall remain confidential and | | | |

|is not accessed by unauthorized individuals. | | | |

|Unauthorized individuals are those individuals not directly involved as employees of the hospital or OPO in facilitating organ donation or | | | |

|transplantation. | | | |

|DOCUMENT REVIEW: | | | |

|Review reports of the past 12 months. Verify: | | | |

|A process is in place for ensuring confidentiality of patient records exchanged with the OPO. | | | |

|INTERVIEW: | | | |

|Interview staff for how information is shared and protected. | | | |

|Check for complaints about any lack of confidentiality. | | | |

|Notes: |

|Standard/Guideline |

|14.00.11 Death Record Review. |

|Hospitals shall include death record review and monitoring of the donation programs in their hospital-wide Quality Assessment and Improvement Program. |

|Explanation/proof of compliance available? |Y |N |Document Title, Person Responsible |

|Review of death records is the key method used by an OPO to determine a hospital’s donor potential. This allows the hospital to develop | | | |

|strategies for improving donation and allocating resources to educate hospital staff. | | | |

|The review of death records also enables hospitals to recognize missed opportunities for organ donation and to identify hospital, OPO, and | | | |

|recovery staff who may need additional education. | | | |

|DOCUMENT REVIEW: | | | |

|Review QAPI committee minutes to determine whether death records and procurement programs are reviewed. | | | |

|Notes: |

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