Medical Radiation Advisory Committee; request for nominations for membership--FDA. Notice

The Food and Drug Administration (FDA) is requesting nominations for membership on the Medical Radiation Advisory Committee. There is currently one vacancy on the committee and there will be three additional vacancies on June 30, 1985.     

Health Care Financing Administration: adoption of the National Bureau of Standards fire safety evaluation system for health care facilities. Notice of comment period

The Department of Health, Education, and Welfare is proposing to extend use of the new Fire Safety Evaluation System (FSES) to all hospitals participating in the Medicare and Medicaid programs. We are seeking public comment on this proposal and on whether to apply the FSES to intermediate care and skilled nursing facilities. The Fire Safety Evaluation System (FSES) was designed by the National Bureau of Standards. It defines the combinations of widely accepted fire safety systems and structural arrangements which can be used by health care facilities to meet safety standards equal to or exceeding those in the Life Safety Code. The FSES provides a framework which guarantees that the high standards of fire safety necessary to protect patients will be met and which is flexible enough to allow for new advances in safety technology and practice. It is based on our experience, which clearly demonstrates that the Life Safety Code can be implemented more effectively and without waste if certain changes are made in the procedures for achieving these mandated levels of safety.     

论《核安全法》与《原子能法》的关系

国务院通过的《核安全与放射性污染防治"十二五"规划及2020年远景目标》提出,要抓紧研究制定原子能法和核安全法。国际法的要求和各国的立法实践表明,同时推进这两部法律的立法工作不存在法律障碍。在我国还没有一部专门规定核能产业发展与核安全方面内容的法律的情形下,同时推进两部法律的立法工作,解决"无法可依"的局面势在必行。但鉴于两部法律可能存在的内容重叠和交叉情况,正确处理这两部法律的关系对明确我国核安全立法的定位尤为重要。     

Regulating to ensure patient safety in hospitals: towards a comprehensive framework

This article critically examines the successes and failures of the current internal and external regulatory regimes for ensuring the delivery of patient safety in public hospitals. It argues that governments should develop a holistic approach to regulation through the enhancement of existing compliance mechanisms in conjunction with some formal regulation to ensure that public hospital systems-deliver high standards of service with minimal patient harm. It recommends that a Patient Safety Authority be established in order to assist with the monitoring of incidents and the enforcement of compliance with patient safety standards.     

Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Interim final rule with comment period

This interim final rule with comment period requires hospitals that transfuse blood and blood components to: Prepare and follow written procedures for appropriate action when it is determined that blood and blood components the hospitals received and transfused are at increased risk for transmitting hepatitis C virus (HCV); quarantine prior collections from a donor who is at increased risk for transmitting HCV infection; notify transfusion recipients, as appropriate, of the need for HCV testing and counseling; and extend the records retention period for transfusion-related data to 10 years. These changes are based on recommendations by the Secretary's Advisory Committee on Blood Safety and Availability and are being published in conjunction with the Food and Drug Administration's (FDA) Final Rule, "Current Good Manufacturing Practice for Blood and Blood Components; Notification of Consignees and Transfusion Recipients Receiving Blood and Blood Components at Increased Risk of Transmitting HCV Infection" ("lookback") found elsewhere in this issue of the Federal Register. The intent is to aid in the prevention of HCV infection and to create opportunities for disease prevention that, in most cases, can occur many years after recipient exposure to a donor.     

Patient safety and quality improvement. Notice of proposed rulemaking

This document proposes regulations to implement certain aspects of the Patient Safety and Quality Improvement Act of 2005 (Patient Safety Act). The proposed regulations establish a framework by which hospitals, doctors, and other health care providers may voluntarily report information to Patient Safety Organizations (PSOs), on a privileged and confidential basis, for analysis of patient safety events. The proposed regulations also outline the requirements that entities must meet to become PSOs and the processes for the Secretary to review and accept certifications and to list PSOs. In addition, the proposed regulation establishes the confidentiality protections for the information that is assembled and developed by providers and PSOs, termed "Patient safety work product" by the Patient Safety Act, and the procedures for the imposition of civil money penalties for the knowing or reckless impermissible disclosure of patient safety work product.     

Exempt distribution of a radioactive drug containing one microcurie of carbon-14 urea--NRC. Final rule

The Nuclear Regulatory Commission (NRC) is amending its regulations to permit NRC licensees to distribute a radioactive drug containing one microcurie of carbon-14 urea to any person for "in vivo" diagnostic use. The NRC has determined that the radioactive component of such a drug in capsule form presents an insignificant radiation risk and, therefore, regulatory control of the drug for radiation safety is not necessary. This amendment makes the drug more widely available and reduces costs to patients, insurers, and the health care industry. This action grants a petition for rulemaking (PRM-35-12) from Tri-Med Specialties, Inc. and completes action on the petition.     

中國食品安全法律制度的新推進

2013年10月9日,江蘇連雲港地溝油案一審判決。這起備受關注的特大地溝油案的主犯王成奎因犯生產、銷售有毒有害食品罪,被判處無期徒刑,剝奪政治權利終身,沒收個人全部財產。這也是地溝油案件中量刑最重的一次。事實上,早在這起食品安全罪案抓住人們眼球前,今年6月,《食品安全法》的修訂已被列入2013年國務院立法規劃。正如國家食品藥品監督管理總局法制司司長徐景和所言,「加快建立起理念更加現代、價值更加和諧、制度更加健全、機制更加完善的食品安全法律制度已是時代發展和社會進步的迫切需要」。「民以食為天」。五千年歷史縱橫,形成了中國獨有的飲食文化。然而,瘦肉精、三聚氰胺等的曝光,卻讓國人的美味餐桌埋下隱患。當運用「重典」成為社會共識,當治理食品安全問題的集結號被高調吹響,新近出臺的司法解釋、量刑從重的典型案例和重拳出擊的專項行動無不堅定了人們對食品安全治理的信心。2010年9月,最高人民法院等4部門發佈通知,要求依法嚴懲危害食品安全的犯罪分子,與危害食品安全相關的職務犯罪分子一般不得適用緩刑,為從重處罰食品安全犯罪奠定了基礎。今年5月,最高人民法院和最高人民檢察院發佈《關於辦理危害食品安全刑事案件適用法律若干問題的解釋》,首次明確界定了生產、銷售不符合安全標準的食品罪和生產銷售有毒、有害食品罪的定罪量刑標準,迎來一片歡呼聲。事後追究的「重典」正在日臻完善,源頭治理環節中也應當建立起嚴格的法律制度。本期特邀請徐景和司長,著眼全局,從企業責任、政府責任、監管機制、社會共治、懲罰舉措等多個方面切入,全面闡述中國食品安全法律制度的完善和發展。     

Standards for the accreditation of educational programs for and the credentialing of radiologic personnel--PHS. Notice of proposed rulemaking

These proposed regulations would establish standards for the accreditation of educational programs for radiologic personnel, and for the credentialing of such persons. These standards are proposed as part of the implementation of the Consumer-Patient Radiation Health and Safety Act of 1981 (Title IX of Pub. L. 97-35), which requires their promulgation by regulation. The standards are voluntary for States and are intended to encourage the adoption of uniform accreditation and credentialing procedures.     

Medicaid program; use of restraint and seclusion in psychiatric residential treatment facilities providing psychiatric services to individuals under age 21. Health Care Financing Administration (HCFA), HHS. Interim final rule with comment period

This interim final rule with comment period establishes a definition of a "psychiatric residential treatment facility" that is not a hospital and that may furnish covered Medicaid inpatient psychiatric services for individuals under age 21. This rule also sets forth a Condition of Participation (CoP) that psychiatric residential treatment facilities that are not hospitals must meet to provide, or to continue to provide, the Medicaid inpatient psychiatric services benefit to individuals under age 21. Specifically, this rule establishes standards for the use of restraint or seclusion that psychiatric residential treatment facilities must have in place to protect the health and safety of residents. This CoP acknowledges a resident's right to be free from restraint or seclusion except in emergency safety situations. We are requiring psychiatric residential treatment facilities to notify a resident (and, in the case of a minor, his or her parent(s) or legal guardian(s)) of the facility's policy regarding the use of restraint or seclusion during an emergency safety situation that occurs while the resident is in the program. We believe these added requirements will protect residents against the inappropriate use of restraint or seclusion.     

论食品安全规制中的企业主体责任——以日韩食品安全监督员为例

为了应对食品安全风险,进一步发挥企业主体责任,在企业内部设置食品安全监督员,是一种有效的措施。虽然我国2009年制定的《食品安全法》引入了食品安全员制度,但规定得过于原则。目前,我国《食品安全法》修订在即,最近的《食品安全法(修订草案送审稿)》规定了食品安全员资格,但是,我国在食品安全监督员的任职资格、责任等领域仍然需要进一步规定。日本、韩国的食品安全监督员制度比较成熟,可资借鉴;通过对比分析两种不同的制度背景和运作模式,有助于完善我国《食品安全法》中的食品安全员制度。     

Medicare and Medicaid programs; fire safety requirements for certain health care facilities. Final rule

This final rule amends the fire safety standards for hospitals, long-term care facilities, intermediate care facilities for the mentally retarded, ambulatory surgery centers, hospices that provide inpatient services, religious nonmedical health care institutions, critical access hospitals, and Programs of All-Inclusive Care for the Elderly facilities. Further, this final rule adopts the 2000 edition of the Life Safety Code and eliminates references in our regulations to all earlier editions.     

江苏省放射卫生监督管理现状调查与分析

根据国家放射卫生监督的相关法律、法规和放射防护有关的标准,分析江苏省放射诊疗防护管理的现状,掌握目前我省放射诊疗监督管理中存在的问题和困难,探讨加强放射卫生监督管理,提高卫生监督执法的专业化、科学化水平。强化技术服务机构的技术支撑作用。切实加大基层医疗机构宣传、培训、指导和执法力度,增强放射诊疗单位和放射工作人员法律意识和责任意识。     

Medicare program; coverage and administrative policies for clinical diagnostic laboratory tests; intent to form Negotiated Rulemaking Committee--HCFA. Notice of intent to form Negotiated Rulemaking Committee and notice of meetings

The Balanced Budget Act of 1997 requires the Secretary to establish a Negotiated Rulemaking Committee under the Negotiated Rulemaking Act and the Federal Advisory Committee Act. The Negotiated Rulemaking Committee's (the Committee) purpose will be to negotiate national coverage and administrative policies for clinical diagnostic laboratory tests under Part B of the Medicare program as required by the Balanced Budget Act of 1997 (BBA). The Committee will consist of representatives of interested parties that are likely to be significantly affected by the proposed rule. The Committee will be assisted by a neutral facilitator. The BBA outlines the scope of issues to be negotiated by the Committee. We specifically request public comment as to whether we have identified the interests that will be affected by key issues listed below.     

Quality management program and misadministrations--Nuclear Regulatory Commission. Final rule

The Nuclear Regulatory Commission (NRC) is amending regulations governing therapeutic administrations of byproduct material and certain uses of radioactive sodium iodide to require implementation of a quality management program to provide high confidence that the byproduct material or radiation from byproduct material will be administered as directed by an authorized user physician. The Commission believes this performance-based amendment will result in enhanced patient safety in a cost-effective manner while allowing the flexibility necessary to minimize intrusion into medical judgments. This amendment also modifies the notification, reporting, and recordkeeping requirements related to the quality management program and misadministrations.     

Medicare program; solvency standards for provider-sponsored organizations; intent to form negotiated rulemaking committee--HCFA. Intent to form negotiated rulemaking committee and notice of meetings

The Balanced Budget Act of 1997 requires the Secretary to establish a Negotiated Rulemaking Committee under the Federal Advisory Committee Act (FACA). The Committee's purpose will be to negotiate the solvency standards for provider-sponsored organizations under part C of the Medicare program. The Committee will consist of representatives of interests that are likely to be significantly affected by the solvency rule. The Committee will be assisted by a neutral facilitator. We request public comment on whether--We have identified the key solvency issues to be negotiated by the Committee; We have identified the interests that will be affected by key issues listed below; The party we are proposing to serve as the neutral facilitator is acceptable. Additionally, comments are sought on several key definitions related to the negotiated rulemaking and the forthcoming rulemaking for Medicare+Choice organizations.     

Police Officers in Schools: Effects on School Crime and the Processing of Offending Behaviors

The use of police in schools has increased dramatically in the past 12 years, largely due to increases in US Department of Justice funding. This study used data from the School Survey on Crime and Safety to assess the extent to which the addition of police in schools is associated with changes in levels of school crime and schools responses to crime. We found that as schools increase their use of police, they record more crimes involving weapon and drugs and report a higher percentage of their non-serious violent crimes to law enforcement. The possibility that placement of police officers in schools increases referrals to law enforcement for crimes of a less serious nature and increases recording of weapon and drug offenses requires that more rigorous research be carried out to assess more carefully the school climate and school safety outcomes related to this popular and costly practice.     

Federal support for hospital construction in overbedded areas

This memorandum established policies and procedures to limit Federal financial support for the construction of hospitals in overbedded areas. The policy for Federal hospitals is that no new or replacement hospitals will be built in an overbedded area unless suitable, existing, non-Federal facilities cannot reasonably be acquired through purchase or lease. The policy for non-Federal facilities is that no Federal grants, loans, loan subsidies, or loan guarantees will be provided for hospital construction or renovation in an overbedded area, unless the proposed project is consistent with an approved local hospital facility plan or the Secretary of Health and Human Services (HHS) determines that it is necessary. In addition, legislation and regulations will be proposed to revise the current Medicare and Medicaid reimbursement policies for costs related to hospital construction or renovation. Finally, legislation will be proposed to revise Federal tax exempt bond financing for hospital construction and renovation in overbedded areas. This memorandum also prescribes agency responsibilities and procedures for implementing these policies.     

Medicare and Medicaid programs; hospital standard for potentially HIV infectious blood and blood products--HCFA. Final rule

This final rule requires hospitals participating in the Medicare and Medicaid programs to take appropriate action when the hospitals learn that they have received whole blood, blood components (including recovered plasma), source plasma, and source leukocytes (hereafter referred to as blood or blood products) that are at increased risk of transmitting Human Immunodeficiency Virus (HIV) infection. If the hospital learns that it has received blood or blood products collected from a donor recently exposed to HIV, before the donor has a sufficient level of antibody to be detected by the screening test for antibody to HIV, the hospital must quarantine any blood or blood products remaining in inventory pending confirmation testing. If the presence of HIV is confirmed by more specific testing, the hospital must notify patients who received the blood or blood product. This final rule is intended to ensure that proper health and safety steps are taken to minimize further spread of HIV infection. A final rule published elsewhere in this Federal Register by the Food and Drug Administration applies the same requirements to entities furnishing transfusion services that do not participate in the Medicare and Medicaid programs and clarifies the responsibilities of blood establishments to identify and notify the transfusion service that received affected blood and blood products.     

Quality mammography standards--FDA. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend its regulations governing mammography that published in a document entitled "Quality Mammography Standards." The purpose of these amendments is to eliminate a conflict between the mammography regulations, which must be followed by all facilities performing mammography, and FDA's Electronic Product Radiation Control (EPRC) performance standards, which establish radiation safety performance requirements for x-ray units, including mammographic systems.