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District of Columbia's Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response for Bioterrorism Program Funds
"Our audit objectives were to determine whether the District of Columbia Department of Health (District) properly recorded, summarized and reported bioterrorism preparedness transactions by specific focus area designated in the cooperative agreements and whether the District has established controls and procedures to monitor sub-recipients' expenditures of Centers for Disease Control and Prevention (CDC) funds. We found that the District generally accounted for Program funds in accordance with the terms and conditions of the cooperative agreement and applicable departmental regulations and guidelines. Specifically, the District recorded, summarized and reported bioterrorism transactions by specific focus area. However, in Fiscal Year 2002, the supplemental funds were not segregated by focus area. The District did not have a system to track and monitor sub-recipients; such as, application and award processes, grant conditions, ongoing fiscal activities, and reporting."
United States. Department of Health and Human Services. Office of Inspector General
2004-01-30
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State of Maryland's Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response for Bioterrorism Program Funds
"The objectives of this audit were to determine whether the Maryland Department of Health and Mental Hygiene (State agency) properly recorded, summarized and reported bioterrorism preparedness transactions by specific focus area designated in the cooperative agreements and whether the State agency has established controls and procedures to monitor sub-recipients' expenditures of Centers for Disease Control and Prevention funds. We found that the State agency generally accounted for Program funds in accordance with the terms and conditions of the cooperative agreements and applicable departmental regulations and guidelines. Specifically, the State agency recorded, summarized and reported transactions by specific focus area. The State agency had a system to track and monitor sub-recipient activities; such as, application and award processes, grant conditions, ongoing fiscal activities, and reporting. In addition, the State agency was planning to add reviews of Program funds to current audits performed on sub-recipients."
United States. Department of Health and Human Services. Office of Inspector General
2003-10-16
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State of Florida's Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response for Bioterrorism Program Funds
"This final report points out that the Florida Department of Health (Florida) generally accounted for program funds ($44.8 million received for the 4-year period ending August 30, 2003) in accordance with the terms and conditions of the cooperative agreement with the Centers for Disease Control and Prevention (CDC) and applicable departmental regulations and guidelines. Specifically, Florida recorded, summarized and reported transactions by specific focus area. At the time of our review, Florida did not have any sub-recipients. When Florida contracts with sub-recipients, it has monitoring procedures in place. In addition, Florida is developing a site visit component. Further, Florida officials indicated that CDC funding had not been used to supplant programs previously funded by other organizational sources. We recommended Florida implement sub-recipient monitoring when contracts are awarded, and address problem areas, as they are identified. Florida concurred with our findings and recommendation and is taking corrective actions to improve its bioterrorism grant program."
United States. Department of Health and Human Services. Office of Inspector General
2003-10-21
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State of Georgia's Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response for Bioterrorism Program Funds
"This final report points out that the Georgia Department of Human Resources (Georgia) generally accounted for program funds ($27.1 million received as of April 30, 2003 for the 4-year period ending August 30, 2003) in accordance with the terms and conditions of the cooperative agreement with the Centers for Disease Control and Prevention (CDC) and applicable departmental regulations and guidelines. Specifically, Georgia recorded, summarized and reported transactions by specific focus area. When Georgia contracts with sub-recipients, it has monitoring procedures in place. In addition, Georgia is developing a site visit component. Further, Georgia officials indicated that CDC funding had not been used to supplant programs previously funded by other organizational sources. We recommended Georgia implement sub-recipient monitoring when contracts are awarded, and address problem areas, as they are identified. Georgia concurred with our findings and recommendation and is taking corrective actions to improve its bioterrorism grant program."
United States. Department of Health and Human Services. Office of Inspector General
2003-11-12
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Audit of Costs and Reporting of Funds Under the Public Health Preparedness and Response for Bioterrorism Program: Ohio Department of Health
"The objectives of our audit were to determine whether the State agency: recorded and reported Centers for Disease Control and Prevention (CDC) bioterrorism program funds in accordance with the cooperative agreement; ensured that the bioterrorism preparedness program funds were used for necessary, reasonable, allocable, and allowable costs under the terms of the cooperative agreement; and did not supplant current State or local funding with bioterrorism preparedness program funds. We determined that the State agency properly recorded and reported bioterrorism preparedness program funds awarded, expended, obligated, and unobligated by focus area in accordance with the cooperative agreement; generally ensured that bioterrorism preparedness program funds were used for necessary, reasonable, allocable, and allowable costs under the terms of the cooperative agreement; and did not supplant current State or local expenditures with bioterrorism preparedness program funds. We recommend that the State agency: ensure bioterrorism preparedness program activities are funded in a manner to minimize unobligated fund balances and to achieve bioterrorism preparedness program goals, and ensure the inadequately documented costs of $4,154 at the Jefferson County subrecipient are properly resolved. In response, the CDC officials agreed with the findings and recommendations."
United States. Department of Health and Human Services. Office of Inspector General
2005-02-04
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Los Angeles County's Efforts to Account for the Use of Public Health Preparedness and Response to Bioterrorism Program Funds and Monitoring of Subrecipients
"The objectives of this review were to determine whether the Los Angeles County Department of Health Services (LA County): (i) properly recorded, summarized and reported bioterrorism preparedness transactions by specific focus area designated in the cooperative agreements, (ii) established controls and procedures to monitor subrecipients' expenditures of Centers for Disease Control and Prevention (CDC) funds; and (iii) used bioterrorism program (Program) funds to supplant funds previously provided by other sources. We found that: (i) LA County did not properly report Program expenditures to CDC for the two reporting periods ended August 30, 2000 and 2001, (ii) had not conducted on site monitoring reviews because the subrecipients were generally in the planning stage; and (iii) had not used Program funding to supplant existing State or local funds. We recommended that LA County: (i) submit final Financial Status Reports that include actual expenditures with no outstanding obligations for reporting periods ended August 30, 2000 and 2001 and ensure that, in the future, final Financial Status Reports are submitted for reporting periods required by CDC; and (ii) implement the subrecipient monitoring procedures as planned. LA County officials concurred with our recommendations."
United States. Department of Health and Human Services. Office of Inspector General
2003-10-01
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State of California: Review of Public Health Preparedness and Response for Bioterrorism Program Funds
"This final report points out that the California Department of Health Services (DHS) did not account for bioterrorism program funds ($4.9 million received for the 2-year period ending August 30, 2001) by focus area as required by the cooperative agreement with the Centers for Disease Control and Prevention (CDC), nor could it adequately support program expenditures on financial reports submitted to CDC. Specifically, DHS; 1) did not organize its accounting system to record, summarize, and report expenditures by program focus area, 2) relied on summary spreadsheets maintained outside the accounting system to prepare financial reports, 3) did not have adequate controls over the preparation and review of financial reports, and 4) did not adequately monitor sub-recipients. In addition to recommendations to correct accounting and procedural weaknesses, we recommended that DHS determine, in coordination with the CDC, the amount of bioterrorism program funds that were expended in each focus area, identify unallowable costs, and make adjustments to current and future awards so that funds are rebalanced by focus area to provide appropriate levels of preparedness. The DHS concurred with our findings and recommendations."
United States. Department of Health and Human Services. Office of Inspector General
2003-08-13
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State of Texas' Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response for Bioterrorism Program Funds
"The objective of this review was to determine whether: (1) the Texas Department of Health properly recorded, summarized and reported Public Health Preparedness and Response for Bioterrorism Program costs by specific focus area designated in cooperative agreements; (2) program funding supplanted programs previously provided by other organizational sources; and (3) the Department of Health had established controls and procedures to monitor subrecipients' expenditures of program funds. We noted one problem. At the start of 2003, Department of Health officials identified a problem with the payroll allocation that, if not corrected, could affect the accuracy of the year 3 financial status report due November 30, 2003. Officials at the Department of Health stated they should have the problem corrected in the next 2 or 3 months."
United States. Department of Health and Human Services. Office of Inspector General
2003-08-06
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HHS Public Health and Medical Services Emergency Support Preparedness
"In 2010, the Council of the Inspectors General on Integrity and Efficiency (CIGIE), a group of Inspectors General (IG) from agencies across the Federal Government, created 'An IG's Guide for Assessing Federal Response Capabilities' (IG's Guide). The 'IG's Guide' recommends that IGs assess their Federal agency's emergency preparedness capabilities. It provides a framework for Offices of Inspectors General to conduct independent assessments of their department or agency's (agency) incident response capabilities. The 'IG's Guide' is based on the National Response Framework (NRF), Emergency Support Functions, and the National Planning Scenarios. Recent incidents such as Hurricane Sandy emphasize the need for Federal agencies to assess their emergency response capabilities."
United States. Department of Health and Human Services. Office of Inspector General
Levinson, Daniel R.
2012-11
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Department of Health and Human Services: Semiannual Report to Congress, October 1, 2007 - March 31, 2008
"This report, which is submitted to Congress pursuant to the Inspector General Act of 1978, as amended, summarizes the activities of the Office of Inspector General (OIG) for the 6-month period ending March 31, 2008. As detailed in these pages, OIG's work during this period encompasses a broad range of audits, evaluations, and compliance and enforcement activities designed to protect the integrity and promote the efficiency and effectiveness of the programs of the Department of Health and Human Services (HHS). Our efforts touch upon many of the 300 programs administered by HHS. In accordance with OIG's statutory funding allocations, we have directed the majority of our resources toward safeguarding the Medicare and Medicaid programs and the health and welfare of beneficiaries."
United States. Department of Health and Human Services. Office of Inspector General
2008
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Hospital Emergency Preparedness and Response During Superstorm Sandy
"Federal regulations require that hospitals prepare for emergencies including natural disasters. The strength of Superstorm Sandy and the population density of the affected areas placed high demands on hospitals and related services. Prior studies by the Office of Inspector General found substantial challenges in health care facility emergency preparedness and response. In a 2006 study, we found that many nursing homes had insufficient emergency plans or did not follow their plans. In a 2012 followup study, we found that gaps continued to exist in nursing home emergency preparedness and response. […] For this study, we surveyed 174 Medicare-certified hospitals located in declared disaster areas in Connecticut, New Jersey, and New York during Superstorm Sandy. We also conducted site visits to 10 purposively selected hospitals located in areas most affected by the storm. Additionally, we examined information from State survey agency and accreditation organization surveys of hospitals conducted prior to the storm and spoke to surveyors about their survey process related to emergency preparedness. We also interviewed State hospital associations and health care coalitions in the three States."
United States. Department of Health and Human Services. Office of Inspector General
2014-09
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Office of the Secretary of Health and Human Services Did Not Comply with Federal Regulations for Chartered Aircraft and Other Government Travel Related to Former Secretary Price
"Federal Travel Regulations limit the circumstances in which chartered aircraft can be used for official Government business. The Office of Inspector General (OIG) conducted an audit of the use of chartered aircraft and other types of transportation for Federal travel by the former Department of Health and Human Services (HHS) Secretary Thomas E. Price during his tenure from February 10 through September 29, 2017. HHS's Office of the Secretary had the primary responsibility for decisions that determined the need for chartered aircraft. Our objective was to determine whether former Secretary Price's use of chartered aircraft for Federal travel complied with applicable Federal regulations and HHS policies and procedures. We also reviewed his Federal travel using Military Aircraft (MilAir), commercial flights, and the Presidential fleet."
United States. Department of Health and Human Services. Office of Inspector General
2018-07
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Department of Health and Human Services Semiannual Report to Congress: April 1, 2006 - September 30, 2006
"This report, submitted pursuant to the Inspector General Act of 1978, as amended, summarizes the activities of the Office of Inspector General (OIG) for the 6-month reporting period that ended September 30, 2006. During this reporting period, OIG enforcement activities produced significant and noteworthy results. OIG obtained the largest-ever administrative recovery under its civil monetary penalty authority and its first settlement with a pharmacy benefits manager for soliciting and receiving kickbacks from pharmaceutical manufacturers and potential customers. In addition, OIG reviewed pricing of Medicare and Medicaid prescription drugs and testified before Congress regarding Medicare Part B drug pricing. OIG also completed a study of nursing home emergency preparedness and response to recent Gulf Coast hurricanes. OIG also issued final regulations that establish two new safe harbors under the Federal anti-kickback statute for arrangements involving the donation of certain prescribing and electronic health information technology and services. These regulations will help to further the President's and the Secretary's goal of widespread adoption of electronic health records technology by 2014."
United States. Department of Health and Human Services. Office of Inspector General
2006-12
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Audit of Unobligated Balances of Funds Awarded Under the Public Health Preparedness and Response for Bioterrorism Program
"This final report provides the results of our audit of unobligated balances of funds awarded under the Public Health Preparedness and Response for Bioterrorism Program (Bioterrorism Program). From August 31, 1999, to August 30, 2005, when the Bioterrorism Program ended, the Centers for Disease Control and Prevention (CDC) awarded almost $3 billion to States and major local health departments (awardees). To monitor the expenditure of these funds, CDC required awardees to submit financial status reports within 90 days after the end of each budget period. The reports showed such information as the amounts expended, obligated, and unobligated."
United States. Department of Health and Human Services. Office of Inspector General
2006-12-05
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Commissioned Corps' Response to Hurricanes Katrina and Rita
This report contains findings of an evaluation OIG conducted to assess the U.S. Public Health Service Commissioned Corps' (Corps) response to the hurricanes and whether improvements were needed. OIG determined that Corps officers provided critical support to affected communities and State health officials, but the Corps could improve its response to public health emergencies. OIG found that the Corps was not able to meet some State needs and that deficiencies in officer preparation, deployment logistics, field operations, and officer reimbursement impacted the efficiency and the effectiveness of the response. OIG recommended that the Corps incorporate a number of infrastructure changes into its comprehensive transformation process. The Assistant Secretary for Health concurred with OIG's findings and recommendations.
United States. Department of Health and Human Services. Office of Inspector General
2007-02
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Review of New York City's Efforts to Account for and Monitor Sub-Recipients' Use of Bioterrorism Hopstial Preparedness Program Funds
"This final report presents the results of the Office of Inspector General's self-initiated audit entitled, 'Review of New York City's Efforts to Account for and Monitor Sub-recipients' Use of Bio-terrorism Hospital Preparedness Program Funds.' The objectives were to determine whether Health Research, Incorporated (HRI) properly recorded, summarized and reported bio-terrorism preparedness transactions in accordance with the terms and conditions of the cooperative agreement with the Department of Health and Human Services (DHHS), Health Resources and Services Administration (HRSA). In addition, we inquired as to whether the Bio-terrorism Hospital Preparedness Program (the Program) funding supplanted programs previously funded by other organizational sources and whether HRI and the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) established controls and procedures to monitor sub-recipients' expenditures of HRSA funds. Our review found that HRI accounted for the Program funds in accordance with the terms and conditions of the cooperative agreement with HRSA. Specifically, HRI recorded, summarized and reported transactions in discrete accounts established to account for bio-terrorism funding. In response to our inquiry as to whether DOHMH reduced funding to existing public health programs, DOHMH officials stated that HRSA funding had not been used to supplant existing State or local programs. We also found that, while HRI and DOHMH implemented controls and procedures to monitor sub-recipient's expenditures of HRSA funds, they are not currently performing on-site audits of sub-recipients. However, HRI and DOHMH indicated that they plan to add an on-site audit component to their monitoring procedures with funding from the Program."
United States. Department of Health and Human Services. Office of Inspector General
2003-11
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Review of New York City's Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response of Bio-Terrorism Program Funds
"This final report presents the results of the Office of Inspector General's self-initiated audit entitled, "Review of New York City's Efforts to Account for and Monitor Sub-recipients' Use of Public Health Preparedness and Response to Bio-Terrorism Program Funds." The objectives were to determine whether the New York City Department of Health and Mental Hygiene (DOHMH) and the Medical and Health Research Association of New York City (MHRA) properly recorded, summarized and reported bio-terrorism preparedness transactions by specific focus areas designated in the cooperative agreements. In addition, we inquired as to whether bio-terrorism funding supplanted programs previously funded by other organizational sources and whether DOHMH and MHRA established controls and procedures to monitor sub-recipients' expenditures of Centers for Disease Control and Prevention (CDC) funds. Our review found that DOHMH and MHRA accounted for bio-terrorism program funds in accordance with the terms and conditions of the cooperative agreements with CDC. Specifically, DOHMH and MHRA recorded, summarized and reported transactions in discrete accounts established to account for bio-terrorism funding. In response to our inquiry as to whether
DOHMH reduced funding to existing public health programs, DOHMH officials stated that CDC funding had not been used to supplant existing State or local programs. In addition, based on the results of the questionnaires and interviews with MHRA officials, we found the MHRA had adequate controls and procedures to monitor sub-recipient expenditures of CDC funds."
United States. Department of Health and Human Services. Office of Inspector General
2003-10-15
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Balance Billing for Medical Equipment and Supplies
This paper is meant to determine the effects and level of Medicare beneficiary awareness of balance billing for durable medical equipment and supplies. Part B of the Medicare program covers outpatient services and items, including durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS). Under Medicare Part B, physicians and suppliers submit both assigned and non-assigned claims for these services and items. For assigned claims, physicians and suppliers agree to accept the amount allowed by Medicare as full payment. Medicare pays 80 percent of this amount directly to the physician or supplier and the beneficiary pays 20 percent (plus any outstanding deductible). In non-assigned claims, the physician or supplier bills the beneficiary for the total charge for the service or item provided, which can exceed the amount allowed by Medicare. Medicare pays the beneficiary 80 percent of the allowed amount; the beneficiary pays all remaining charges. This paper defines balance billing as the portion of the charge in excess of the Medicare allowed amount.
United States. Department of Health and Human Services. Office of Inspector General
2001-01
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Nationwide Audit of State and Local Government Efforts to Record and Monitor Subrecipients' Use of Bioterrorism Hospital Preparedness Program Funds
"Under the Bioterrorism Hospital Preparedness Program, State or territorial health departments and municipal governments or health departments receive funding from the Health Resources and Services Administration (HRSA) to upgrade the preparedness of the Nation's hospitals and collaborating entities to respond to bioterrorism. Since April 1, 2002, HRSA has awarded $623 million to 59 State, territorial, and selected municipal offices of public health. The funding instrument used for the program is a cooperative agreement because substantial HRSA programmatic collaboration with awardees was anticipated during the performance of the project. On August 15, 2003, the Office of Inspector General (OIG) issued a report on California's accounting for Centers for Disease Control and Prevention (CDC) bioterrorism program funds (A-09-02-01007). The report, entitled 'State of California: Review of Public Health Preparedness and Response for Bioterrorism Program Funds,' stated that California did not account for program funds by focus area and could not adequately support expenditures on Financial Status Reports submitted to CDC. The conditions we found in California led us to perform this nationwide audit to determine if HRSA awardees were properly recording hospital preparedness program funds. We have since reviewed programs in 14 States and 4 major metropolitan areas (Appendix A) selected primarily based on their dollar funding levels. This rollup report presents the results of the reviews."
United States. Department of Health and Human Services. Office of Inspector General
2004-08-26
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Review of New Jersey's Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response for Bio-terrorism Program Funds
"The objectives of this review were to determine whether the State of New Jersey Department of Health and Senior Services (DHSS) properly recorded, summarized and reported bio-terrorism preparedness transactions by specific focus areas designated in the cooperative agreements. In addition, we inquired as to whether bio-terrorism funding supplanted programs previously funded by other organizational sources and whether DHSS established controls and procedures to monitor sub-recipient's expenditures of Centers for Disease Control and Prevention (CDC) funds. Our review found that DHSS accounted for bio-terrorism program funds in accordance with the terms and conditions of the cooperative agreements with CDC. DHSS officials stated that CDC funding had not been used to supplant existing State and local programs. DHSS did not perform site visits to its sub-recipients. We recommended that DHSS consider implementing a site visit component to its procedures for monitoring sub-recipients and address problem areas, as they are identified. New Jersey Officials concurred with our recommendation."
United States. Department of Health and Human Services. Office of Inspector General
2003-10-15
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City of Chicago's Efforts to Account for and Monitor Sub-Recipients' Use of Public Health Preparedness and Response for Bioterrorism Program Funds
"The objectives of this review were to determine whether the Chicago Department of Public Health (Department): (i) properly recorded, summarized and reported bioterrorism preparedness transactions by specific focus areas designated in the cooperative agreements and (ii) whether the Department had controls and procedures to monitor sub-recipient expenditures of Centers for Disease Control and Prevention (CDC) funds. We found that the Department generally accounted for program funds in accordance with the terms and conditions of the cooperative agreement and applicable departmental regulations and guidelines, with two exceptions. During Year 1 of the Program, the Department did not record, summarize and report transactions by specific focus area. We verified that the Department took corrective action and segregated expenditures by focus area during the succeeding Program years. In addition, Year 3 original and supplemental funds were not segregated in the accounting system. Although the cooperative agreement does not require separate accounting for original and supplemental funds, separate reporting of the funds is required. We recommended the Department implement procedures to record, summarize, and report expenditures for original and supplemental grant funds separately. Department officials generally concurred with our findings and recommendation."
United States. Department of Health and Human Services. Office of Inspector General
2003-11-20
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Summary Report on Select Agent Security at Universities
"The final report consolidates results from our reviews of select agent security at 11 universities. In general, serious weaknesses that compromised the security of select agents existed at all 11 universities. Physical security weaknesses left select agents vulnerable to theft or loss, thus elevating the risk of public exposure. Inadequate inventory and recordkeeping procedures prevented us from concluding that the universities had complied with the select agent transfer requirements. At least half the universities had inadequate procedures for identifying persons barred from accessing select agents. Five universities that used information technology resources for select agent data exhibited control weaknesses that could compromise the security and integrity of the data. The OIG reports contained numerous recommendations for strengthening physical security, compliance with the select agent transfer requirements, controls over restricted person access, and information technology controls. In general, the universities agreed with the OIG recommendation and began implementing corrective actions."
United States. Department of Health and Human Services. Office of Inspector General
2004-03-25
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FDA Lacks Comprehensive Data to Determine Whether Risk Evaluation and Mitigation Strategies Improve Drug Safety
"The Food and Drug Administration (FDA) requires manufacturers to submit structured plans, known as Risk Evaluation and Mitigation Strategies (REMS), for drugs associated with known or potential risks that may outweigh the drugs' benefits. If FDA does not properly monitor REMS' performance, it cannot ensure that the public is provided maximum protection from a drug's known or potential risks. However, FDA does not have the authority to require, but may request, drug manufacturers (i.e., sponsors) to submit specific information regarding REMS' effectiveness. [...] We reviewed approved REMS since program inception in 2008 through 2011 and conducted structured interviews with FDA officials about FDA's efforts to evaluate REMS components. We also reviewed 49 sponsors' REMS assessments and FDA's reviews of these assessments to determine the extent to which sponsors' assessments were complete, were submitted to FDA within required timeframes, and indicated that REMS were meeting their goals. We also determined whether FDA evaluated the elements to assure safe use (ETASU) of one drug in each year of the program, as required by Federal law. [...] Our findings raise concerns about the overall effectiveness of the REMS program. To address these concerns, we made seven recommendations regarding FDA's evaluation and assessment of REMS and its review of sponsors' REMS assessments. FDA concurred with six of our recommendations. For the remaining recommendation, to seek legislative authority to make FDA assessment plans enforceable, FDA did not state whether it concurred or did not concur. However, FDA agreed that this recommendation should be considered if another opportunity arises to pursue legislative changes to the statutory provisions that describe the requirements for REMS assessments."
United States. Department of Health and Human Services. Office of Inspector General
2013-02
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Security Controls Over the Implementation of Personal Identity Verification Cards at the Department of Health and Human Services Were Inadequate Due to Lack of Some Essential Information Security Requirements
"This report provides an overview of the results of our audit of the Department of Health and Human Services (HHS) implementation of Homeland Security Presidential Directive 12 (HSPD-12). Due to the sensitive nature of the specific findings identified during our audit, only a summary of the findings are included in this report. We have provided more detailed information and recommendations to HHS so that it can address the issues we identified. […] The HSPD-12, 'Policy for a Common Identification Standard for Federal Employees and Contractors,' August 27, 2004, mandated the promulgation by 2006 of a Federal standard for secure and reliable forms of identification for Federal employees and contractors and mandates the use of government-wide identification credentials for employees and contractors. The HSPD-12 and other Federal guidance require executive departments and agencies to (1) implement the standard for identification issued to Federal employees and contractors in gaining physical access to controlled facilities and logical access (the authorized and authenticated access to computer applications and data files) to controlled information systems and (2) implement and maintain adequate security for all their support systems and applications. We evaluated HHS' progress in implementing a reliable and effective system of personal identity verification (PIV) in compliance with the HSPD-12. Our objective was to determine whether HHS complied with Federal guidance when implementing its HSPD-12 system."
United States. Department of Health and Human Services. Office of Inspector General
2014-07
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Vulnerabilities in FDA's over Sight of State Food Facility Inspections
"Each year, 128,000 Americans are hospitalized and 3,000 die after consuming contaminated foods and beverages. FDA [Food and Drug Administration] is responsible for safeguarding the Nation's food supply and for routinely inspecting food facilities. In addition to conducting its own inspections, FDA relies on State agencies to conduct inspections on its behalf; however, in recent years, concerns have been raised about the rigor of these State inspections. For example, the peanut processing plant responsible for a 2009 salmonella outbreak was inspected multiple times by a State agency working on behalf of FDA. This outbreak resulted in one of the largest food recalls in U.S. history and has led to serious questions about the effectiveness of State food facility inspections. Because of concerns about food facility inspections conducted by State agencies, this review was requested by the House Committee on Appropriations, Subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies."
United States. Department of Health and Human Services. Office of Inspector General
Levinson, Daniel R.
2011-12
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Local Public Health Preparedness for Radiological and Nuclear Incidents
"According to the 2010 National Security Strategy, the American people face no greater or more urgent danger than a terrorist attack with a nuclear weapon. If State and local public health officials do not plan for such incidents, local public health departments will not be adequately prepared to quickly respond and protect the public. Although the Nuclear Regulatory Commission requires nuclear powerplants to have emergency plans for their facilities and the immediate surrounding area, no Federal entity requires States or localities to have public health emergency plans for nonpowerplant radiological and/or nuclear (RN) incidents, such as a terrorist attack."
United States. Department of Health and Human Services. Office of Inspector General
2012-01
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Nursing Home Emergency Preparedness and Response During Recent Hurricanes
"Federal law requires that Medicare and Medicaid-certified facilities have written plans and procedures to meet all potential emergencies and provide training to employees in emergency procedures. State surveys assess whether facilities meet these requirements. Four of the five Gulf States also have additional emergency preparedness requirements which are typically expected to be included in facility emergency plans. For this study, we reviewed State survey data for emergency preparedness measures both nationally and for Gulf States (Alabama, Florida, Louisiana, Mississippi, and Texas) and visited selected communities to interview nursing home staff, local authorities, and other stakeholders. We also compared emergency plans for 20 selected nursing homes affected by hurricanes in the 5 Gulf States against a list of suggested provisions compiled from all Gulf State requirements and guidance, a variety of published works from authoritative sources such as the American Journal of Public Health, and other health care, elder care and emergency preparedness experts."
United States. Department of Health and Human Services. Office of Inspector General
2006-08
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Gaps Continue to Exist in Nursing Home Emergency Preparedness and Response During Disasters: 2007-2010
"Federal regulations require that Medicare- and Medicaid-certified nursing homes have written emergency plans and provide employees with emergency preparedness training. In a 2006 report about nursing homes that experienced hurricanes, we found that emergency plans lacked many provisions recommended by experts. In response, the Centers for Medicare & Medicaid Services (CMS) issued guidance checklists for emergency planning of health care facilities, long-term care (LTC) ombudsman programs, and State survey agencies (SA). We conducted this study to assess emergency preparedness and response of nursing homes that experienced more recent disasters."
United States. Department of Health and Human Services. Office of Inspector General
2012-04
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Adverse Events in Hospitals: Medicare's Responses to Alleged Serious Events
The objectives of this study were: "1. To assess the responses of State survey and certification agencies and the Centers for Medicare & Medicaid Services (CMS) to complaints that allege serious adverse events. 2. To describe hospital responses to complaints that allege serious adverse events. […] The term 'adverse event' describes harm to a patient as a result of medical care. In response to the Tax Relief and Health Care Act of 2006, the Office of Inspector General (OIG) released a series of reports regarding adverse events. In that work, OIG estimated that over one-quarter of hospitalized Medicare beneficiaries were harmed during their hospital stays in October 2008. This report examines Medicare's responses to alleged serious adverse events. These responses represent important patient safety opportunities, yet little attention has been paid to their role in improving patient safety. Hospitals must meet the Medicare Conditions of Participation (CoP) to participate in Medicare. On behalf of Medicare, State survey and certification agencies (State agencies) investigate complaints alleging hospital noncompliance with CoPs. Immediate jeopardy (IJ) complaints are the most serious and may allege adverse events. Also, hospitals often conduct their own investigations of adverse events independently of State agencies. Because no national database of adverse events exists, this report uses a random sample of IJ complaints to identify alleged serious adverse events to which Medicare responded. To review the complaints, we used data from CMS, State agencies, hospital accreditors, and the hospitals associated with the sample."
United States. Department of Health and Human Services. Office of Inspector General
2011-10
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Office of Refugee Resettlement Generally Ensured That Selected Care Provider Facilities for Its Unaccompanied Children Program Complied with Federal Emergency Preparedness Requirements
From the Document: "The Office of Refugee Resettlement (ORR), a program office of the Administration for Children and Families within HHS [U.S. Department of Health and Human Services], manages the Unaccompanied Children (UC) Program, which serves children who have no lawful immigration status in the United States. Because of emergency events in 2017, 2018, and 2019, such as hurricanes and wildfires, we conducted several audits of HHS agencies to identify risks in preparing for and responding to emergency events. This audit continues those efforts. This is the second of two reports addressing emergency preparedness at ORR-funded facilities that provide care to children in the UC Program. The first report addresses communicable disease preparedness, and this report addresses emergency events. This report does not address emergency intake sites that were opened in response to the surge of unaccompanied children that occurred in 2021. Our objective was to determine whether ORR ensured that selected facilities followed Federal requirements in preparing for and responding to emergency events."
United States. Department of Health and Human Services. Office of Inspector General
Grimm, Christi A.
2022-02
