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GAO Issues Report on Organ Transplants
WASHINGTON, Nov. 5 -- The Government Accountability Office has issued a report (GAO-21-70) entitled "Organ Transplants: Changes in Allocation Policies for Donated Livers and Lungs".The report was sent to Sen. Roy Blunt, R-Missouri, chairman of the Senate subcommittee on Labor, Health and Human Services, Education and Related Agencies, and Sen. Jerry Moran, R-Kansas, chairman of the Senate Appropriations subcommittee on Commerce, Justice, Science and Related Agencies, on Nov. 4, 2020. Here are excerpts of summaries associated with the report.
What GAO Found: "The Organ Procurement and Transplantation ... Show Full Article WASHINGTON, Nov. 5 -- The Government Accountability Office has issued a report (GAO-21-70) entitled "Organ Transplants: Changes in Allocation Policies for Donated Livers and Lungs". The report was sent to Sen. Roy Blunt, R-Missouri, chairman of the Senate subcommittee on Labor, Health and Human Services, Education and Related Agencies, and Sen. Jerry Moran, R-Kansas, chairman of the Senate Appropriations subcommittee on Commerce, Justice, Science and Related Agencies, on Nov. 4, 2020. Here are excerpts of summaries associated with the report. What GAO Found: "The Organ Procurement and TransplantationNetwork (OPTN) develops allocation policies in the United States to determine which transplant candidates receive offers for organs, such as livers or lungs, that are donated from deceased donors. In July 2018, the Department of Health and Human Services (HHS), which oversees OPTN, directed it to change the liver allocation policy to be more consistent with federal regulations. The liver allocation policy changed in February 2020 from a system that, in general, offered donated livers first to the sickest candidates within the fixed boundaries of a donation service area or region to a system based on a candidate's level of illness and distance from the donor hospital. The current liver allocation policy offers livers first to the sickest candidates within 500 nautical miles of the donor hospital using a series of distance-based concentric circles, called acuity circles.
The processes used to develop the liver and lung allocation policies had various similarities and differences. For example, while the current liver allocation policy, the 2017 liver allocation policy, and the current lung allocation policy each had public comment periods, the length of these comment periods varied--25 days for the current liver allocation policy; two separate 62-day and 64-day periods for the 2017 liver allocation policy; and 61 days (retroactive) for the current lung allocation policy. In addition, the current lung allocation policy resulted in part from a federal district court order directing HHS to initiate emergency review of the policy. However, the 2017 liver allocation policy--that was approved but never implemented--resulted from a 2012 OPTN Board directive to reduce geographic disparities in organ allocation. HHS oversight of OPTN's processes were similar for all three allocation policies and included reviewing the proposed changes to the policies to ensure compliance with federal regulations, according to HHS officials."
Why GAO Did This Study: "Organ transplantation is the leading form of treatment for patients with severe organ failure. OPTN, a nonprofit entity that was established in 1984 under the National Organ Transplant Act, manages the nation's organ allocation system. In 2019, 32,322 organs were transplanted from deceased donors in the United States. Nevertheless, as of July 2020, close to 110,000 individuals remained on waiting lists for donor organs. Previously, donated livers and lungs were generally offered first to the sickest candidates in donation service areas. However, livers and lungs are now generally offered first to the sickest candidates based on distance.
GAO was asked to review the changes to the liver and lung allocation policies. This report describes (1) changes to the liver allocation policy, and (2) similarities and differences in the processes OPTN used to change the liver and lung allocation policies, and federal oversight of these processes, among other things.
GAO reviewed documents, including those related to the current liver and lung allocation policies, and the 2017 liver allocation policy; interviewed HHS officials and OPTN members; reviewed the National Organ Transplant Act and its implementing regulations; and conducted a literature review of studies published from January 2017 through April 2020 in peer-reviewed and other publications.
HHS and the United Network for Organ Sharing (the contractor serving as OPTN) provided technical comments on a draft of this report, which GAO incorporated as appropriate."
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October 16, 2020
To: The Honorable Roy Blunt, Chairman, Subcommittee on Labor, Health and Human Services, Education, and Related Agencies, Committee on Appropriations, United States Senate
To: The Honorable Jerry Moran, Chairman, Subcommittee on Commerce, Justice, Science, and Related Agencies, Committee on Appropriations, United States Senate
Organ transplantation is the leading form of treatment for patients with severe organ failure. In 2019, individuals received 32,322 organ transplants from deceased donors across the United States. However, as of July 2020, close to 110,000 individuals remained on a waiting list to receive an organ. On average, more than 20 people die each day waiting for an organ transplant.
Within the Department of Health and Human Services (HHS), the Health Resources and Services Administration (HRSA) oversees the Organ Procurement and Transplantation Network (OPTN), a nonprofit entity that was established in 1984 under the National Organ Transplant Act to manage the nation's organ allocation system./1 OPTN develops national allocation policies that determine which patients receive organs from deceased donors, maintains the waiting lists of individuals seeking organ transplants, and tracks data on individuals awaiting and receiving donated organs in the United States, among other things.
OPTN implemented the current liver allocation policy in February 2020 and the current lung allocation policy in November 2017. Livers and lungs that are donated for transplants are now generally offered first to the sickest candidates based on distance from the donor hospital. Previously, donated livers were generally offered first to the sickest candidates within the fixed boundaries of donation service areas (DSA) and then within the boundaries of OPTN regions before being offered nationally. Donated lungs were generally offered first to the sickest candidates within the DSA and then in increasing increments of 500 nautical mile circles outside the donor hospital's DSA. You asked us to report on these changes, as well as federal oversight of OPTN's processes to change allocation policies and the effects of the changes to the lung allocation policy. Specifically, this report describes
1. how the liver allocation policy changed and the rationale for the changes;
2. similarities and differences in the processes OPTN used to change the liver and lung allocation policies, and HRSA's oversight of these processes; and
3. what is known about changes to outcomes and spending following the lung allocation policy changes made in 2017.
To examine how the liver allocation policy changed and the rationale for the changes, we reviewed OPTN and United Network for Organ Sharing documents, such as a December 2018 briefing paper from the OPTN Liver and Intestine Transplantation Committee (OPTN Liver Committee) that included proposals to revise the liver allocation policy./2 We also reviewed federal agency documents, including a July 2018 letter from HRSA directing OPTN to review the liver allocation policy; and reports and analyses from the Scientific Registry of Transplant Recipients, including the modeling conducted to assess the potential effects of the proposals to revise the liver allocation policy./3 In addition, we reviewed the National Organ Transplant Act, which established the framework for the U.S organ transplant system, and the OPTN Final Rule, which established the regulatory framework for the structure and operations of OPTN./4 We also interviewed HRSA and United Network for Organ Sharing officials and OPTN members, including OPTN Liver Committee members, to obtain information on the changes to the liver allocation policy.
To examine the similarities and differences in the processes OPTN used to change the liver and lung allocation policies, and HRSA's oversight of these processes, we reviewed information related to the current liver allocation policy and two other policies: a 2017 liver allocation policy approved by the OPTN board but never implemented (2017 liver allocation policy), and the current lung allocation policy, which was implemented in November 2017. Specifically, we reviewed Scientific Registry of Transplant Recipients reports and analyses, including the modeling conducted for the proposals to revise the liver allocation policy.
We also reviewed the National Organ Transplant Act and the OPTN Final Rule. We examined federal agency documents pertaining to organ allocation, to the liver and lung allocation policies, and to HRSA's oversight of these policies, including a November 2017 letter from HRSA directing OPTN to comply with a court order to initiate an emergency review of the lung allocation policy. We also reviewed OPTN bylaws, policies, and other documents, including documents on the processes used to make changes to organ allocation policies and on HRSA's oversight processes, such as OPTN meeting notes and briefing papers.
We also interviewed HRSA and United Network for Organ Sharing officials and OPTN members to obtain information on changes to the liver and lung allocation policies and HRSA's oversight of these changes.
To examine what is known about changes to outcomes and spending following the lung allocation policy changes made in 2017, we conducted a literature review of peer-reviewed and trade publications since January 2017, examined OPTN monitoring reports, and interviewed federal officials and other stakeholders:
* Literature review. We identified peer-reviewed studies, and government, legislative, and trade articles published from January 2017 through April 2020 through a search of bibliographic databases, including ProQuest, Scopus, DIALOG, and EBSCO, using terms such as "organ," "transplant," "allocation," "liver," and "lung." Of the 242 citations we identified, we obtained 89 full studies and articles for further review. Of those, we determined that one study included relevant information. We examined this study for information related to the effects of changes in the lung allocation policy on outcomes, such as the level of illness of lung transplant recipients, and spending. We also reviewed the methodology of the relevant study to confirm our understanding of the data and analyses.
* OPTN monitoring reports. We reviewed data from OPTN's monitoring reports on changes to the lung allocation policy, including outcomes, such as the number of lung transplants, the distance to recover donor lungs for transplants, and 6-month post-transplant patient survival for lung transplant recipients before and after the lung allocation policy change in 2017.5 We focused on the 2-year monitoring report that contains data from the 2-year period before the current lung allocation policy was implemented and the 2-year period after the policy was implemented.6 We analyzed these data and obtained additional data from the United Network for Organ Sharing that was not included in the 2-year monitoring report, including data on lung transplant recipients by OPTN region.7
* Federal agency and stakeholder interviews. We interviewed federal agency officials from HRSA and the Centers for Medicare & Medicaid Services, and relevant stakeholders, including OPTN members, officials from the United Network for Organ Sharing, and officials from the Association of Organ Procurement Organizations, to identify available information related to the effect of the lung allocation policy changes on outcomes and spending.8
We conducted this performance audit from October 2019 to October 2020 in accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.
See footnotes here: https://www.gao.gov/assets/720/710178.pdf
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Agency and Third Party Comments
We provided a draft of this report to HHS for review and comment. HHS provided technical comments, which we incorporated as appropriate. In addition, we provided a draft report to the United Network for Organ Sharing for review and comment, and incorporated its technical comments, as appropriate.
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The text of the GAO report is available at https://www.gao.gov/products/GAO-21-70
GAO Issues Report on Nuclear Safety
WASHINGTON, Nov. 2 -- The Government Accountability Office has issued a report (GAO-21-141) entitled "Nuclear Safety: DOE and the Safety Board Should Collaborate to Develop a Written Agreement to Enhance Oversight".The report was sent to Sen. James M. Inhofe, R-Oklahoma, chairman, Sen. Jack Reed, D-Rhode Island, ranking member of the Senate Armed Services Committee, Sen. Lamar Alexander, R-Tennessee, chairman, Sen. Dianne Feinstein, D-California, ranking member of the Senate Appropriations subcommittee on Energy and Water Development, Rep. Adam Smith, D-Washington, chairman, Rep. Mac Thornberry, ... Show Full Article WASHINGTON, Nov. 2 -- The Government Accountability Office has issued a report (GAO-21-141) entitled "Nuclear Safety: DOE and the Safety Board Should Collaborate to Develop a Written Agreement to Enhance Oversight". The report was sent to Sen. James M. Inhofe, R-Oklahoma, chairman, Sen. Jack Reed, D-Rhode Island, ranking member of the Senate Armed Services Committee, Sen. Lamar Alexander, R-Tennessee, chairman, Sen. Dianne Feinstein, D-California, ranking member of the Senate Appropriations subcommittee on Energy and Water Development, Rep. Adam Smith, D-Washington, chairman, Rep. Mac Thornberry,R-Texas, ranking member of the House Armed Services Committee, Rep. Marcy Kaptur, D-Ohio, chairwoman, and Rep. Mike Simpson, R-Idaho, ranking member of the House Appropriations subcommittee on Energy and Water Development, and Related Agencies, on Oct. 29, 2020. Here are excerpts of summaries associated with the report.
What GAO Found: "The Department of Energy's (DOE) Order 140.1 included provisions inconsistent with the Defense Nuclear Facilities Safety Board's (DNFSB) original enabling statute--the statute in place when the order was issued--and with long-standing practices. For example, GAO found that Order 140.1 contained provisions restricting DNFSB's access to information that were not included in the statute. GAO also found Order 140.1 to be inconsistent with long-standing DNFSB practices regarding staff's access to certain National Nuclear Security Administration (NNSA) meetings at the Pantex Plant in Texas, where nuclear weapons are assembled and disassembled (see fig. https://www.gao.gov/products/GAO-21-141). In December 2019, the National Defense Authorization Act for Fiscal Year 2020 (FY20 NDAA) amended DNFSB's statute to clarify and confirm DNFSB's authority and long-standing practices between the agencies. DOE replaced Order 140.1 with Order 140.1A in June 2020.
DNFSB, DOE, and NNSA officials that GAO interviewed identified concerns with Order 140.1 that GAO found are not addressed under DOE's Order 140.1A. In particular, DOE's Order 140.1A was not part of a collaborative effort to address DNFSB's remaining concerns related to access to information and other regular interagency interactions. For example, DNFSB officials cited concerns that DOE could interpret a provision of DNFSB's statute authorizing the Secretary of Energy to deny access to information in a way that could limit DNFSB access to information to which it has had access in the past. GAO has previously recommended that agencies develop formal written agreements to enhance collaboration. By collaborating to develop an agreement that, among other things, incorporates a common understanding of this provision, DOE and DNFSB could lessen the risks of DNFSB being denied access to information important for conducting oversight. DOE and NNSA officials, as well as contractor representatives involved in operating the facilities, also raised concerns that insufficient training on Order 140.1 contributed to uncertainties about how to engage with DNFSB staff when implementing the order, a problem that GAO found could persist under Order 140.1A. Providing more robust training on Order 140.1A would help ensure consistent implementation of the revised order at relevant facilities."
Why GAO Did This Study: "Established by statute in 1988, DNFSB has broad oversight responsibilities regarding the adequacy of public health and safety protections at DOE defense nuclear facilities. In May 2018, DOE issued Order 140.1, a new order governing DOE's interactions with DNFSB. DNFSB raised concerns that the order could affect its ability to perform its statutory mandate.
Congressional committee reports included provisions for GAO to review DOE Order 140.1. This report examines (1) the extent to which the order was consistent with DNFSB's original enabling statute and with long-standing practices, as well as actions DOE has taken in light of changes to the statute outlined in the FY20 NDAA; and (2) outstanding areas of concern that DNFSB and DOE identified, and the potential effects of these concerns on how the two agencies cooperate. GAO reviewed legislation and agency documents; visited DOE sites; and interviewed DNFSB, DOE, and NNSA officials and contractor representatives."
What GAO Recommends: "GAO is making a recommendation to DOE and DNFSB that they collaborate to develop a written agreement, and an additional two recommendations to DOE, including that it develop more robust training on Order 140.1A. DOE and DNFSB agreed to develop a written agreement. DOE agreed with one of the other two recommendations, but did not agree to provide more robust training. GAO maintains that the recommended action is valid."
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October 29, 2020
To: Congressional Committees:
Since its establishment by statute in 1988,/1 the Defense Nuclear Facilities Safety Board (DNFSB, or the Board) has provided independent analysis, advice, and recommendations to the Secretary of Energy regarding the adequacy of public health and safety protections at the Department of Energy's (DOE) defense nuclear facilities./2 DNFSB is an independent establishment in the executive branch that has broad oversight responsibilities regarding these facilities, which are located at 10 active DOE sites across the United States./3 The activities that DNFSB typically oversees at DOE defense nuclear facilities are primarily conducted by DOE and National Nuclear Security Administration (NNSA)/4 contractors that manage and operate DOE's sites and often entail high-consequence (although low-probability) risks to public health and safety./5 For example, some of the work conducted at these facilities involves the handling of radioactive and hazardous materials, such as plutonium and radioactive wastes that, if not handled safely, could cause nuclear accidents or expose workers, the public, and the environment to heavy doses of radiation. Other work that DNFSB monitors at these sites is also inherently dangerous, such as the production, handling, and testing of certain explosive materials that are essential to the operation of U.S. nuclear weapons.
DNFSB also reviews and evaluates the content and implementation of standards relating to the design, construction, operation, and decommissioning of defense nuclear facilities and investigates any event or practice at defense nuclear facilities that the Board determines has adversely affected, or may adversely affect, public health and safety.
DNFSB seeks to use informal interactions with DOE to resolve safety issues that are of concern to the Board. DNFSB also uses formal communications, such as written recommendations, to address more substantial safety issues it identifies at a facility or site, as well as broader safety issues across DOE defense nuclear sites.
In the years following the establishment of DNFSB, DOE created the Office of the Departmental Representative to DNFSB, hereafter the Office of the Departmental Representative, for the purposes of coordinating departmental interactions with the Board. DOE also issued a set of guidelines to departmental staff and contractors that provided direction for engaging with the Board and its staff. Prior to May 2018, interactions between DOE and the Board were guided by DOE Manual 140.1-1B, the first version of which was developed in collaboration with DNFSB in 1996./6 DOE Manual 140.1-1B included requirements and guidance on how to interact and cooperate with the Board and its staff; address requests for information; establish departmental commitments in order to resolve Board-identified safety issues; and respond to Board recommendations, among other things.
In May 2018, after taking steps to reassess its relationship with DNFSB, DOE replaced Manual 140.1-1B with Order 140.1./7 According to the DOE Deputy Secretary of Energy's testimony at an August 2018 DNFSB public hearing about Order 140.1, DOE stated that the manual was outdated and had contributed to a blurring of the distinction between DOE's responsibilities to own and operate defense nuclear facilities and to self-regulate them, and those of the department's external advisors, such as DNFSB./8 The Deputy Secretary further indicated that DOE had determined it was necessary to reform the department's engagement with DNFSB so as to clarify each agency's role, with DOE serving as the owner and regulator responsible for ensuring the safety of its workers, the public, and the environment, and DNFSB serving as the independent agency providing advice, analysis, and recommendations to assist DOE in overseeing its defense nuclear facilities. Consequently, DOE took steps to develop an order that would more clearly distinguish DOE's roles and responsibilities from those of DNFSB and further clarify how DOE would cooperate with the Board. According to DOE officials, while DOE incorporated some comments it received from DNFSB in its new order, DOE did not collaborate with DNFSB when developing this order, in part because DOE considered its order to be an internal departmental document.
Soon after DOE issued Order 140.1, DNFSB expressed concerns about the order. In a September 2018 letter from the DNFSB Chairman to the Secretary of Energy, the Chairman stated that Order 140.1 "wrongly attempts to diminish the Board's ability to perform its statutory mandate under the Atomic Energy Act of 1954, as amended."/9 According to the Chairman's letter, DOE Order 140.1 claims to exempt on-site individuals and workers from the Board's oversight and included provisions that improperly limit timely access to information, personnel, and facilities that DNFSB considers necessary to carry out its responsibilities. Senior DOE leadership subsequently responded to DNFSB's concerns. For example, during a November 2018 DNFSB public hearing held with senior DOE officials that focused on Order 140.1, DOE's Assistant Secretary for the Office of Environmental Management (EM) stated that the order provides direction to DOE, and not DNFSB, personnel./10 Moreover, in a December 2018 letter to the DNFSB Chairman, the Secretary of Energy stated that Order 140.1 did not hinder DOE's cooperation with DNFSB or prevent DNFSB from conducting its independent safety oversight mission.
Subsequent to the disagreements between DNFSB and DOE regarding Order 140.1, in December 2019, the National Defense Authorization Act for Fiscal Year 2020 (FY20 NDAA) amended DNFSB's original enabling statute./11 Among other things, the amendments modified DNFSB's mission to include providing independent analysis, advice, and recommendations to provide for adequate protection of the health and safety of employees and contractors at defense nuclear facilities as well as clarified when the Secretary of Energy may deny DNFSB access to facilities, personnel, or information. In addition, the explanatory statement accompanying the Further Consolidated Appropriations Act, 2020, directed DOE to "collaborate with the DNFSB to address the Board's specific concerns with Order 140.1" in order to ensure that DNFSB can continue to meet its statutory oversight responsibilities./12 In light of the changes to DNFSB's enabling statute, DOE revised and replaced Order 140.1 with Order 140.1A in June 2020./13
The June 2019 committee report accompanying a bill for the FY20 NDAA included a provision that GAO review DOE Order 140.1./14 In addition, the committee report accompanying DOE's fiscal year 2020 appropriation act included a provision that GAO evaluate the impact to public and worker safety of Order 140.1 and whether the order prevents DNFSB access to information required to carry out its congressionally mandated responsibilities./15 In response to these provisions, we examined (1) the extent to which DOE Order 140.1 was consistent with DNFSB's original enabling statute and long-standing practices, as well as the actions DOE has taken in light of the changes to the Board's enabling statute outlined in the FY20 NDAA; and (2) outstanding areas of concern that DNFSB and DOE have identified, and the potential effects of these concerns on the ways in which the two agencies cooperate.
To determine the extent to which DOE Order 140.1 was consistent with DNFSB's original enabling statute and long-standing practices,/16 we reviewed and compared DOE Order 140.1 to DNFSB's enabling statute in order to identify any inconsistencies. As part of our efforts to identify longstanding practices between DOE and DNFSB regarding the activities the Board and its staff conduct to provide independent safety oversight of DOE defense nuclear facilities, we reviewed DOE Manual 140.1-1B; DNFSB and DOE annual reports to Congress; DNFSB recommendations to DOE and DOE's responses; DNFSB weekly site reports; and legal interpretations by DNFSB's and DOE's Offices of the General Counsel. In addition, we reviewed documents related to the DOE integrated project team's effort to convert DOE Manual 140.1-1B into Order 140.1, including a crosswalk that compared the manual with legislation and current DOE practices. We interviewed the DNFSB Chairman and Board members, as well as officials from DNFSB's Office of the General Counsel and Office of the Technical Director. We also interviewed DOE and NNSA officials, including officials from the Office of the Departmental Representative and DOE's and NNSA's Offices of the General Counsel, as well as members from the integrated project team that developed Order 140.1.
To determine the actions being taken by DOE in light of the changes made to DNFSB's enabling statute by the FY20 NDAA, we compared DOE Order 140.1 to DNFSB's amended statute to identify any inconsistencies between the order and the changes made to DNFSB's statute. We reviewed DOE's February 2020 draft revisions to Order 140.1 and compared the revisions to both the order, as issued, and DNFSB's amended enabling statute. We also reviewed correspondence from DNFSB to DOE in response to the amendments made to DNFSB's enabling statute. Moreover, we reviewed Order 140.1A after it was issued on June 15, 2020, and compared it to both the previous version of the order and DNFSB's amended enabling statute. In addition, we interviewed DOE and NNSA officials in response to the changes made to DNFSB's enabling statute, including staff from the Office of the Departmental Representative and DOE's and NNSA's Offices of the General Counsel.
To determine any outstanding areas of concern that DNFSB and DOE have and the potential effects these concerns may have on the ways in which in the two agencies cooperate, we reviewed DOE Order 140.1A, DOE Order 140.1 and its accompanying guidance document,/17 and DNFSB and DOE documents that identified concerns related to how the two agencies interact. For example, we reviewed correspondence between DNFSB, DOE, and NNSA about DNFSB staff being denied
access to certain nuclear explosive safety (NES) evaluation meetings at the Pantex Plant (Pantex) in Texas./18 In addition, we analyzed data from the Savannah River Site (SRS) to determine when document requests from DNFSB staff were received and fulfilled.
We also reviewed the FY20 NDAA to understand how the amendments made to DNFSB's enabling statute may affect the two agencies' cooperation. We also interviewed relevant DNFSB, DOE, and NNSA officials, and contractor representatives about DOE Order 140.1; its implementation; and the impacts it had on the agencies' interactions regarding their responsibilities for ensuring the safety of workers, the public, and the environment. In particular, we interviewed DNFSB resident inspectors, DOE and NNSA officials, and contractor representatives at the five DOE sites where DNFSB resident inspectors are present./19 These included in-person interviews with DNFSB resident inspectors, DOE and NNSA officials, and contractor representatives at three sites: Los Alamos National Laboratory (LANL), Pantex, and SRS.
We visited these sites to better understand the working relationship between DNFSB resident inspectors and local DOE, NNSA, and contractor staff following DOE's issuance of Order 140.1. We selected these sites because either DOE or NNSA is located at each site; the DNFSB resident inspectors had experience working at the sites under Manual 140.1-1B and Order 140.1; and there were existing examples where DNFSB indicated that DOE, NNSA, or contractor staff had denied or used Order 140.1 as a means to delay providing DNFSB resident inspectors with requested information. From our interviews across multiple sites, we identified examples of the impacts Order 140.1 had on the agencies' interactions and compared them to previous practices between DOE and DNFSB, such as those outlined in DOE Manual 140.11B, as well as federal standards for internal control/20 and key considerations for implementing interagency collaborative mechanisms./21 See appendix I for additional information on our objectives, scope, and methodology.
We conducted this performance audit from August 2019 to October 2020, in accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.
See footnotes here: https://www.gao.gov/assets/720/710410.pdf
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Conclusions
DNFSB plays an important role in providing oversight and offering advice to DOE to help ensure the protection of public health and safety at DOE's defense nuclear facilities. For DNFSB to continue to conduct effective oversight of DOE's defense nuclear facilities, it is important that the Board and DOE have a shared understanding of DNFSB's role and access to facilities and certain information. When DOE replaced the manual governing its relationship with DNFSB with Order 140.1, it included a number of provisions that were inconsistent with DNFSB's enabling statute and long-standing practices of DNFSB and DOE. These inconsistencies raised concerns about the order's effect on DNFSB's ability to carry out its statutory responsibilities. DOE's replacement of Order 140.1 with Order 140.1A in June 2020 aligns the order with the changes to DNFSB's enabling statute made by the National Defense Authorization Act for Fiscal Year 2020.
However, DOE and DNFSB have not developed a common understanding of one of the changes made by the FY20 NDAA.
Specifically, the agencies do not have a common understanding of section 2286c(b) of DNFSB's enabling statute, the provision that authorizes the Secretary of Energy to deny access to information to people in certain situations. According to DNFSB officials, a broad interpretation of this provision could potentially limit DNFSB from accessing information necessary to conduct its oversight responsibilities.
Other concerns related to Order 140.1 may continue to affect how the agencies cooperate and DNFSB's ability to conduct oversight, even after the issuance of Order 140.1A. According to some DNFSB and DOE officials and contractor representatives, Order 140.1 did not address many of the regular interactions between DOE and DNFSB. Specifically, there were no jointly agreed-upon norms for many interagency interactions to create consistency for engagement between the agencies.
This created uncertainties for some DOE, NNSA, and contractor staff about how and when to interact with DNFSB resident inspectors and other DNFSB staff. Based on our review, these concerns were not addressed when DOE replaced Order 140.1 with Order 140.1A.
Developing an MOU between DOE and DNFSB that incorporates a common understanding of section 2286c(b) would reduce the risk of DNFSB being denied access to information important for conducting oversight. It could also help DOE and DNFSB to improve their communication and standardize their interactions, which may help to ensure more consistent engagements among DOE, NNSA, and contractor staff at facilities under DNFSB's oversight.
In addition, concerns about the adequacy of training could persist following the issuance of DOE Order 140.1A. Clearer and more robust training on Order 140.1A from DOE headquarters could help mitigate any remaining misunderstandings and ensure that DOE, NNSA, and contractor staff more consistently implement the revised order at DOE's defense nuclear sites.
Finally, there are outstanding concerns related to the inconsistent implementation of Order 140.1 that contributed to some increased delays in receiving requested documents at DOE sites. These concerns could persist, if not addressed, following the issuance of DOE Order 140.1A.
Clearer guidance on how to respond to DNFSB document requests would help ensure that DOE and NNSA staff have a more consistent and efficient document request process when responding to DNFSB requests.
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Recommendations for Executive Action
We are making a total of four recommendations, including three to DOE and one to DNFSB.
* The Secretary of Energy, in collaboration with the Chairman of DNFSB, should develop a formal written agreement, such as a memorandum of understanding, that could be used to, among other things, establish a common understanding of how DOE will implement section 2286c(b) of DNFSB's enabling statute regarding denial of DNFSB staff access to information, and clarify procedures for regular interactions between DOE and DNFSB related to each agency's responsibilities for ensuring the adequacy of public health and safety protections at DOE's defense nuclear facilities. (Recommendation 1)
* The Chairman of DNFSB, in collaboration with the Secretary of Energy, should develop a formal written agreement, such as a memorandum of understanding, that could be used to, among other things, establish a common understanding of how DOE will implement section 2286c(b) of DNFSB's enabling statute regarding denial of DNFSB staff access to information, and clarify procedures for regular interactions between DOE and DNFSB related to each agency's responsibilities for ensuring the adequacy of public health and safety protections at DOE's defense nuclear facilities. (Recommendation 2)
* The Secretary of Energy, in coordination with the Office of the Departmental Representative to DNFSB, should develop clearer and more robust training on Order 140.1A for DOE sites to ensure that DOE, NNSA, and contractor staff have a uniform understanding of the order and that those staff interacting with DNFSB implement the order more consistently. (Recommendation 3)
* The Secretary of Energy, in coordination with the Office of the Departmental Representative to DNFSB, should develop clearer and more standardized guidance on how to respond to DNFSB document requests under Order 140.1A to ensure a more uniform and efficient document request process at DOE sites with defense nuclear facilities. (Recommendation 4)
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Agency Comments and Our Evaluation
We provided a draft of this report to DOE, NNSA, and DNFSB for review and comment. DOE and NNSA provided us with consolidated written comments, reproduced in appendix VI, as well as technical comments, which we incorporated in the report as appropriate. DNFSB provided us with written comments, reproduced in appendix VII, but did not provide any additional technical comments.
In its written comments, DOE concurred with two recommendations and did not concur with one recommendation. DOE concurred with our report's first recommendation that the department collaborate with DNFSB to develop a formal written agreement to, among other things, clarify procedures for regular interactions between DOE and DNFSB.
DOE noted that in an August 26, 2020, letter to DNFSB, the Deputy Secretary of Energy agreed with DNFSB that a foundation for mutual communication, transparency, and information sharing would be beneficial to both agencies and that DOE would coordinate with DNFSB to develop a memorandum of agreement or understanding.
DOE also concurred with our report's fourth recommendation that the department develop clearer and more standardized guidance on how to respond to DNFSB document requests under Order 140.1A. DOE indicated that following the development of a memorandum of agreement or understanding with DNFSB, the department would update its guidance to reflect the agreement with DNFSB as pertains to responding to document requests.
DOE did not concur with our report's third recommendation that the department develop clearer and more robust training on Order 140.1A for DOE sites to ensure that DOE, NNSA, and contractor staff have a uniform understanding of the order and that those staff interacting with DNFSB implement the order more consistently. According to its comments, DOE concluded that the department maintains adequate communication and training for DOE and NNSA staff regarding interactions with DNFSB.
Moreover, DOE stated that the previous training for Order 140.1 generally targeted individuals responsible for interactions with DNFSB and noted that these individuals represent a small fraction of the employees who work at DOE's defense nuclear facilities. DOE further noted that DOE and NNSA sites developed site-specific procedures pertaining to interactions with DNFSB and Order 140.1 and shared them with DNFSB staff.
In our report, we describe examples where DOE and NNSA officials and contractor representatives we interviewed expressed concerns about the level of training they received for Order 140.1 and how this affected their implementation of the order and their engagement with DNFSB staff. In particular, we note that the absence of in-depth training contributed to confusion about how to implement Order 140.1 at DOE sites with defense nuclear facilities, as well as to some contractor staff uncertainties about how to engage with DNFSB staff. For example, a contractor representative at the Y-12 National Security Complex told us that they encountered difficulties when drafting changes to their site-specific procedures to match Order 140.1 because the order implied greater changes to their cooperation with the Board and its staff than implied by senior leadership during public hearings.
Moreover, during our review, DNFSB's enabling statute was amended, which led DOE to issue an updated Order 140.1A in June 2020 and a revised guidance document to accompany the updated order in July 2020. In light of the confusion experienced by DOE, NNSA, and contractor staff--issues some of these staff experienced after receiving DOE training on Order 140.1--as well as the changes to DNFSB's enabling statute and DOE's order and accompanying guidance document, we continue to believe that developing and providing clearer and more robust training on Order 140.1A is warranted.
In its written comments, DNFSB concurred with the report's second recommendation to collaborate with DOE to develop a formal written agreement and reiterated the Board's commitment to collaborating with DOE to develop a written agreement. DNFSB also described actions that it continues, or intends, to take in response to our recommendation.
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The text of the GAO report is available at https://www.gao.gov/products/GAO-21-141
GAO Issues Report on Navy Maintenance
WASHINGTON, Nov. 2 -- The Government Accountability Office has issued a report (GAO-21-66) entitled "Navy Maintenance: Navy Report Did Not Fully Address Causes of Delays or Results-Oriented Elements".The report was sent to Sen. James M. Inhofe, R-Oklahoma, chairman, Sen. Jack Reed, D-Rhode Island, ranking member of the Senate Armed Services Committee, Sen. Richard C. Shelby, R-Alabama, chairman, Sen. Richard J. Durbin, D-Illinois, ranking member of the Senate Appropriations subcommittee on Defense, Rep. Adam Smith, D-Washington, chairman, Rep. Mac Thornberry, R-Texas, ranking member of the House ... Show Full Article WASHINGTON, Nov. 2 -- The Government Accountability Office has issued a report (GAO-21-66) entitled "Navy Maintenance: Navy Report Did Not Fully Address Causes of Delays or Results-Oriented Elements". The report was sent to Sen. James M. Inhofe, R-Oklahoma, chairman, Sen. Jack Reed, D-Rhode Island, ranking member of the Senate Armed Services Committee, Sen. Richard C. Shelby, R-Alabama, chairman, Sen. Richard J. Durbin, D-Illinois, ranking member of the Senate Appropriations subcommittee on Defense, Rep. Adam Smith, D-Washington, chairman, Rep. Mac Thornberry, R-Texas, ranking member of the HouseArmed Services Committee, Rep. Peter Visclosky, D-Indiana, chairman, and Rep. Ken Calvert, R-California, ranking member of the House Appropriations subcommittee on Defense, on Oct. 29, 2020. Here are excerpts of summaries associated with the report.
What GAO Found: "The Navy's July 2020 report identified two key causes and several contributing factors regarding maintenance delays for aircraft carriers, surface ships, and submarines, but did not identify other causes. For public shipyards, the Navy's report identified the key cause of maintenance delays as insufficient capacity relative to growing maintenance requirements. For private shipyards, the Navy's report identified the key cause as the addition of work requirements after a contract is awarded. These causes and other identified factors generally align with factors that GAO has previously identified as originating during the maintenance process. However, the Navy's report did not consider causes and factors originating in the acquisition process or as a result of operational decisions, as shown below.
The report identified stakeholders needed to implement action plans, but did not fully incorporate other elements of results-oriented management, including achievable goals, metrics to measure progress, and resources and risks. Some examples from the report:
* Stakeholders: Identified Naval Sea Systems Command as the primary implementer of most initiatives related to maintenance at shipyards.
* Goals: Included a goal of reducing days of maintenance delay by 80 percent during fiscal year 2020.The Navy did not achieve this goal based on GAO's analysis of Navy data.
* Metrics: Included some metrics. The Navy is still identifying and developing other key metrics.
* Resources: Did not identify costs of the actions in the report.
* Risks: Identified as risks the coronavirus pandemic, unstable funding, and limited material availability. However, the report did not assess additional risks that GAO previously identified. "
Why GAO Did This Study: "The Navy generally has been unable to complete ship and submarine maintenance on time, resulting in reduced time for training and operations, and additional costs. The Navy's ability to successfully maintain its ships is affected by numerous factors throughout a ship's life cycle, such as decisions made during acquisition, which occurs years before a ship arrives at a shipyard for maintenance. Others manifest during operational use of the ship or during the maintenance process.
The conference report accompanying a bill for the Fiscal Year 2020 Consolidated Appropriations Act directed the Secretary of the Navy to submit a report identifying the underlying causes of maintenance delays for aircraft carriers, surface ships, and submarines and to include elements of results-oriented management. The conference report also included a provision for GAO to review the Navy's report that was released in July 2020. This report evaluates the extent to which the Navy's report (1) identifies the underlying causes of maintenance delays and (2) incorporates elements of results-oriented management. GAO reviewed the Navy's report and interviewed Navy officials."
What GAO Recommends: "Since 2015, GAO has made 39 unclassified recommendations related to Navy maintenance delays. The Navy or the Department of Defense concurred or partially concurred with 37 recommendations, and had implemented six of them as of September 2020."
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October 29, 2020
To: Congressional Committees
The 2018 National Defense Strategy states that restoring and retaining readiness is critical in the emerging security environment./1 The Navy is working to rebuild its readiness while also growing and modernizing its aging fleet of aircraft carriers, surface ships, and submarines. Completing maintenance on time is integral to supporting fleet readiness, meeting strategic and operational requirements, and ensuring the Navy's ships reach their expected service lives. Since delays in maintenance result in fewer available ships for training or operations, a critical component for the Navy to rebuild and maintain readiness is completing maintenance on time./2 However, the Navy has continued to face persistent maintenance delays that affect the majority of its maintenance efforts and threaten its attempt to restore readiness.
Since 2015, we have issued more than 20 reports and testimonies examining Navy maintenance challenges, shipyard workforce and capital investment, ship crewing, scheduling, force structure, and acquisition decisions (see Related GAO Products at the end of this report). We testified in December 2019 about significant, ongoing maintenance delays for aircraft carriers, surface ships, and submarines during fiscal years 2014 through 2019./3 Since 2015, we have made 39 unclassified recommendations to the Navy or to Department of Defense (DOD) components in coordination with the Navy related to Navy maintenance delays. The Navy or DOD concurred or partially concurred with 37 recommendations, and had implemented six of them as of September 2020.
The conference committee report accompanying a bill for the Fiscal Year 2020 Consolidated Appropriations Act directed the Secretary of the Navy to assign responsibility to conduct a comprehensive and systematic analysis to identify the underlying causes of aircraft carrier, surface ship, and submarine maintenance delays and to submit a report on its findings to congressional defense committees and GAO./4 The conference report also directed the Navy to include results-oriented elements in the report, including analytically based goals related to maintenance delays; results-oriented metrics to measure progress; and required resources, risks, and stakeholders to achieve those goals./5 Further, Congress included a provision for us to submit a review of the report to the congressional defense committees not later than 90 days after receiving the report from the Navy. That report was released in July 2020 (hereafter referred to as the July 2020 report). This report evaluates the extent to which the Navy's July 2020 report (1) identified the underlying causes of aircraft carrier, surface ship, and submarine maintenance delays, and (2) identified actions to address maintenance delays and incorporates elements of results-oriented management.
For our first objective, we reviewed the July 2020 report to identify the causes of maintenance delays described in the report. In particular, we compiled a list of factors contributing to maintenance delays based on our recent prior work on Navy maintenance./6 We categorized each factor by the phase of a ship's life cycle in which it occurs, namely: acquisition, operations, and maintenance. We then developed an analysis tool to compare the causes and contributing factors of maintenance delays identified in the July 2020 report with those identified in our list. Two analysts independently used this analysis tool to determine whether the Navy had identified each factor from our list in their report. A third analyst adjudicated any differences in their determinations. We determined that the information and communication component of internal control was relevant to this objective, along with the underlying principle that management should use quality information to achieve the agency's objectives./7 We evaluated this standard by comparing the information on causes of maintenance delays in the Navy's July 2020 report with the causes previously identified by GAO, as described previously. Finally, we met with officials in the Office of the Deputy Assistant Secretary of the Navy (Ships) and Naval Sea Systems Command (NAVSEA) to discuss the report's contents and methodology.
For our second objective, we reviewed the July 2020 report to determine what actions the report identifies to address maintenance delays. We also developed a second analysis tool to assess the extent to which the July 2020 report included elements of results-oriented management: analytically based goals; results-oriented metrics to measure progress; and required resources, risks, and stakeholders to achieve those goals.
Two analysts used the analysis tool to independently assess the extent to which each element was included in the July 2020 report. A third analyst adjudicated any differences based on the report. We determined that the control environment and risk assessment components of internal control were relevant to this objective, along with the underlying principles that management should establish an organizational structure, assign responsibility, and delegate authority to achieve the entity's objectives, and define objectives clearly to enable the identification of risks./8 As part of our assessment of the Navy's July 2020 report, we compared the Navy's report to these principles. Further, we met with officials in the Office of the Deputy Assistant Secretary of the Navy (Ships) and NAVSEA to discuss the July 2020 report's contents and the extent to which it included elements of results-oriented management. We used this information to add additional context to our report, but did not specifically consider the additional information when determining the extent to which the report itself included results-oriented elements.
We conducted this performance audit from June 2020 to October 2020 in accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives.
See footnotes here: https://www.gao.gov/assets/720/710414.pdf
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Agency Comments
We provided a draft of this report to DOD for review and comment. In response, the Navy provided technical comments, which we incorporated as appropriate.
Among other comments, the Navy noted that we calculated days of maintenance delay differently than the Navy did. The Navy stated that it was able to reduce such delays by nearly 80 percent in fiscal year 2020 from the prior year. However, the Navy also acknowledged that its method included adjusting the baselines--the expected durations of the maintenance periods--for fiscal year 2020 maintenance periods. The Navy stated that it made these adjustments to align work with available shipyard capacity and improvements in planning and directed maintenance. Our calculations did not include such adjustments to baselines, and instead measured the days that a maintenance period extended past its original planned end date. We believe this is a more appropriate method for measuring days of delay during any given maintenance period, rather than adjusting the baseline.
The Navy also disputed the accuracy of our characterization of the goal outlined in its July 2020 report. The Navy characterized the goal as a "stretch" goal designed to drive urgency in addressing maintenance delays. It also stated that the goal was informed by efforts such as the Performance to Plan initiative. None of the Navy's comments demonstrated that our characterization was inaccurate. Our analysis found that while the Navy did reduce days of maintenance delay during 2020, it did not achieve its goal for fiscal year 2020 and is no longer able to achieve its fiscal year 2021 goal. Therefore, the plans to address maintenance delays outlined in the July 2020 report lack an achievable goal.
The Navy's comments are reproduced in full in appendix I.
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The text of the GAO report is available at https://www.gao.gov/products/GAO-21-66