Special issuance of third-class airman medical certificates to insulin-treated diabetic airman applicants--FAA. Policy statement

This document announces the new policy of the Federal Aviation Administration (FAA) regarding individuals with insulin-treated diabetes mellitus (ITDM) who apply for airman medical certification. It also addresses comments received concerning this policy as requested in a December 1994 Federal Register notice. The new policy will permit special issuance of third-class airman medical certificates to certain ITDM individuals who meet selection criteria and who successfully comply with an FAA-approved monitoring protocol.     

Criteria for use of blue "Star of Life" for emergency medical services. National Highway Traffic Safety Administration. Notice

This notice amends NHTSA's guidelines for the authorized use of the blue "Star of Life" symbols for emergency medical services. Comments received in response to an earlier notice suggested uses for this symbol that were not considered when these guidelines were first developed. These amendments are intended to provide additional flexibility to the States within the purposes for which the blue Star of Life was originally registered as a certification mark.     

Public Health Service--health systems agencies and state health planning and development agencies; certificate of need reviews. Notice regarding certificate of need programs

This Notice sets forth advance information regarding amendments to the regulations governing certificate of need reviews by health systems agencies and State health planning and development agencies. This Notice is intended to provide early guidance to States prior to publication of interim final regulations implementing the amendments to certificate of need provisions of the Public Health Service Act made by the Health Planning and Resources Development Amendments of 1979 (Pub. L 96-79). This early guidance will assist the States in beginning to revise their certificate of need laws. Under the amended provisions of the Public Health Service Act, the planning agencies are required to review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. The Secretary intends to publish these interim final regulations within a few weeks. Following consideration of comments which will be solicited with regard to the interim regulations, the Secretary will publish an analysis of the comments and will revise those regulations as appropriate.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, amends the regulations governing certificate of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The amendments accomplish two tasks: (1) To implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35), and (2) to reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Department's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations change the requirements for satisfactory certificate of need programs.     

Health systems agency and state health planning and development agency reviews; certificate of need programs--PHS. Notice of proposed rulemaking

The Assistant Secretary for Health, with the approval of the Secretary of Health and Human Services, proposes to amend the regulations governing certificates of need reviews by State health planning and development agencies (State Agencies) and health systems agencies (HSAs). The proposed amendments would accomplish two tasks: (1) Implement amendments to the Public Health Service Act made by the Health Programs Extension Act of 1980 (Pub. L. 96-538) and the Omnibus Budget Reconciliation Act of 1981 (Pub. L. 97-35) and (2) reduce Federal regulatory burdens. Under the provisions of Title XV of the Public Health Service Act, the planning agencies are required to administer certificate of need programs consistent with the Secretary's regulations, under which they review and determine the need for proposed capital expenditures, institutional health services and major medical equipment. These regulations set forth proposed changes to the requirements for satisfactory certificate of need programs. Interested persons are invited to submit written comments and recommendations concerning these proposed rules as well as suggestions for alternative methods of implementing any of the provisions of the amendments that affect the requirements for certificate of need programs.     

Mind your manners: quality of manner of death certification among medical examiners and coroners in Taiwan

To assess the quality of manner of death (MOD) certification among medical examiners/coroners (ME/Cs) in Taiwan, death certificates issued in 2002 for which the final MOD was suicide or undetermined were extracted for analysis. Indicators of the quality of MOD certification included (1) MOD not given by the ME/Cs; (2) MOD assigned by the ME/Cs was changed by the coder; (3) ratio between undetermined and suicide deaths (U/S ratio). There were 450 death certificates for which the ME/Cs did not assign the MOD in the original certificate. Three fifths (285/450) of them were issued by 4 ME/Cs. The same 4 ME/Cs also had extremely high U/S ratios (1.25-1.84) compared with the average (0.31). The overall quality of MOD certification among ME/Cs in Taiwan was fair; only a small number of ME/Cs had poor quality in MOD certification. The high U/S ratio among the 4 ME/Cs would certainly affect the suicide mortality rates of the counties the 4 ME/Cs were in charge of. Actions should be taken to improve the certification quality of these 4 ME/Cs.     

海淀区托儿所幼儿园医疗资质现状及对策研究

海淀区大部分托儿所、幼儿园(以下简称托幼园所)按照卫生部,国家教委联合发布的《托儿所、幼儿园卫生保健管理办法》(以下简称《卫生保健管理办法》)和北京市人民政府文教办公室,北京市卫生局、北京市教育局制定的《北京市托儿所、幼儿园卫生保健管理实施细则》(以下简称《卫生保健管理实施细则》)成立了保健室并配备了儿童保健人员。同时,国家对于医疗机构开展诊疗活动和医疗卫生人员从事执业活动作出了严格的规定。通过对海淀区托幼园所保健机构和人员现状分析及对策的研究,为政府有关部门解决存在的问题提供依据。     

Diagnosis and the dole: the function of illness in American distributive politics

This article argues that the concept of illness has certain properties that make it a convenient administrative device for managing a need-based redistributive system in a society whose primary distributive system is based on work. These properties--cultural acceptance of illness as a legitimate excuse for not working, objective standards for identifying illness, and restrictiveness--have led to the widespread use of illness as an eligibility criterion for many social benefits, including cash transfers, services, privileges and exemptions. Paradoxically, the traditional rationales for using illness as one of the keystones of categorical welfare policy are eroding, yet welfare programs based on illness certification are growing rapidly. To explain this anomaly, the author suggests that medical certification as a distributive mechanisms serves certain latent political functions, such as allowing welfare programs to be responsive to political unrest, siphoning off opposition to controversial policies by the granting of medical exemptions to intense opponents, are reducing political conflict by using physicians as arbiters.     

Errors on death certificates requiring amendments: the Broward County experience

The medical examiner's office in Broward County is responsible for determining the cause and manner of death in cases falling under its jurisdiction and issuing death certificates on these decedents. Amendments are occasionally required to correct misinformation on death certificates or within the autopsy reports. The purpose of this study was to investigate the major causes for the amendments and to develop strategies to avoid future errors. We found 128 cases from 2006 to 2007 that required amendments; 103 contained sufficient data in the file for further analysis. Over this time period, 3790 death certificates were issued over that same period, resulting in a 3.37% amendment rate. In this study, the cohort included both males and females with a ratio of 2:1. Their ages ranged from newborn to 103 years, with a mean age of 49 years. Of the 103 amended cases, amendments were made to the cause (n = 30) and often the manner (n = 21) of death listed on the death certificate; the remaining changes were limited to the autopsy report. The most common reasons for amendments included reception of delayed laboratory findings (35%), acquisition of additional medical history (22.5%), and typographic errors (15.5%). Typographic errors mainly occurred because of inaccuracies in the names originally provided to our office, the use of aliases by decedents, incorrect personal/demographic history, or various misspellings by funeral homes or medical examiner staff. The most significant reclassifications involved changing certified natural deaths to accidental overdoses and vice versa, based on toxicological analysis. Because of delays in specimen turnaround, these amendments often were made months after the original death certificate was issued. STAT urine drug screening has been helpful in reducing the number of amendments made, but certain drugs of significance are missed by rapid screens. Given that our office performed complete toxicological analysis on all cases over this period, it seems likely that we detected several overdoses that would have been missed if natural deaths were not routinely screened for potential toxins.     

Origin and development of forensic medicine in India

CONTEXT:: The medical profession is one of great antiquity in India. However, the history of medicine and, in particular, the role of medicine in the administration of justice in India has not been discussed very much. The present paper attempts to fill in this lacuna and traces the medicolegal practice from ancient times to British India. SOURCE:: This paper is based on archival materials collected from the Tamilnadu State Archives, Chennai, and Madras Medical College Library, Chennai, and University of Madras Library, Chennai. MAIN OBSERVATIONS:: The medical men in ancient India were considered as men of wisdom, and one of the ancient Tamil hymns equates the doctor-patient relationship to that of the dedicated love of a devotee to God. Kautilya's Arthashastra gives a list forensic evidence for establishing the cause of death and describes the necessity of autopsy in establishing the cause of death.In British India, the early incidence of custodial death and its certification by medical practitioners, issuance of medical certificate and wound certificate, and medicolegal autopsy are documented. The most outstanding contribution of India to legal medicine during this period is modern dactylography. It is recorded that there was a high ratio of homicidal poisonings in India.     

Current trends in the dynamics of violent and nonviolent deaths and the problems in recording them

The number of forensic autopsies in cases with violent and spontaneous deaths increases from 1984 to 1996 by 11.1 and 25.8%, respectively. The rate of increase in the incidence of violent deaths outstripped 1.6 times the total mortality values. This resulted in an essential increase in the work loading of experts, with an increase in the number of complex expert evaluations. The system of registration of violent deaths is imperfect: it does not provide accurate data on the number of murders and suicides, which are overrated at regional statistical departments in comparison with the records of legal organs, while the values recorded at statistical departments are notably underrated in comparison with forensic medical records. The authors offer amendments and revisions for the current form of medical certificate of death and the order of its filling, granting, and storage.     

Medical devices; classification for medical washer and medical washer-disinfector. Final rule

The Food and Drug Administration (FDA) is classifying the medical washer and medical washer-disinfector intended for general medical purposes to clean and dry surgical instruments, decontaminate or disinfect anesthesia equipment, hollowware, and other medical devices into class II (special controls). FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors" (the guidance) as the special control that, in addition to general controls, the agency believes will reasonably ensure the safety and effectiveness of the device. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (the FDAMA).     

Payment of reimbursement for emergency treatment furnished by non-VA providers in non-VA facilities to certain veterans with service-connected or nonservice-connected disabilities. Final rule

This document amends the Department of Veterans Affairs (VA) medical regulations concerning emergency hospital care and medical services provided to eligible veterans at non-VA facilities. The amendments are required by section 402 of the Veterans' Mental Health and Other Care Improvements Act of 2008. Among other things, the amendments authorize VA to pay for emergency treatment provided to a veteran at a non-VA facility up to the time the veteran can be safely transferred to a VA or other Federal facility and such facility is capable of accepting the transfer, or until such transfer was actually accepted, so long as the non-VA facility made and documented reasonable attempts to transfer the veteran to a VA or other Federal facility.     

Removal of regulations regarding certification of drugs composed wholly or partly of insulin--FDA. Direct final rule

The Food and Drug Administration (FDA) is repealing its regulations governing certification of drugs containing insulin and making conforming amendments to other sections of its regulations. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDAMA repealed the statutory provision in the Federal Food, Drug, and Cosmetic Act (the act) under which the agency certified drugs containing insulin. FDAMA also made conforming amendments to the act. FDA is using direct final rulemaking for this action because the agency expects that there will be no significant adverse comment on the rule. Most of the amendments in this rule are a direct result of the repeal of the statutory certification provision. The remainder of the amendments repeal or update out-of-date, noncontroversial regulations dealing with insulin. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule under FDA's usual procedure for notice-and-comment rulemaking to provide a procedural framework to finalize the rule in the event the agency receives significant adverse comments and withdraws this direct final rule.     

准行政行为研究

准行政行为是行政主体运用职权以观念表示的方式作出的间接产生行政法律效果的行政行为 ,具有行政行为的预备性、中间性及阶段性等特征 ;具体形态包括受理、登记、证明、确认、鉴定、通知、答复及咨询等 ;准行政行为原则上不可诉 ,具有可诉性的例外取决于其具体形态是否对相对人产生实际影响且没有其它救济方式可以利用。     

Operational criteria for the determination of suicide

Suicide is an important public health problem for which we have an inadequate public health database. In the United States, decisions about whether deaths are listed as suicides on death certificates are usually made by a coroner or medical examiner. These certification decisions are frequently marked by a lack of consistency and clarity, and laws and procedures for guiding these decisions vary from state to state and even from county to county. Without explicit criteria to aid in this decision making, coroners or medical examiners may be more susceptible to pressures from families or communities not to certify specific deaths as suicide. In addition, coroners or medical examiners may certify similar deaths differently at different times. The degree to which suicides may be underreported or misclassified is unknown. This makes it impossible to estimate accurately the number of deaths by suicide, to identify risk factors, or to plan and evaluate preventive interventions. To remedy these problems, a working group representing coroners, medical examiners, statisticians, and public health agencies developed operational criteria to assist in the determination of suicide. These criteria are based on a definition of suicide as "death arising from an act inflicted upon oneself with the intent to kill oneself." The purpose of these criteria is to improve the validity and reliability of suicide statistics by: (1) promoting consistent and uniform classifications; (2) making the criteria for decision making in death certification explicit; (3) increasing the amount of information used in decision making; (4) aiding certifiers in exercising their professional judgment; and (5) establishing common standards of practice for the determination of suicide.     

Federal Old-Age, Survivors, and Disability Insurance; revised medical criteria for the determination of disability--Social Security Administration. Proposed rules

These proposed amendments revise the medical evaluation criteria for both the title II and title XVI disability programs. These criteria were last revised in 1979. The proposed revisions reflect advances in the medical treatment of some conditions and in the methods of evaluating certain impairments. These proposals will provide up-to-date medical criteria for use in the evaluation of disability claims.     

A functional approach to sudden unexplained infant deaths

There is a great deal of variation in the methods and wording used by medical examiners in the medicolegal investigation and certification of infant deaths. This paper was created by the NAME Ad Hoc Committee on Sudden Unexplained Infant Death to address several specific issues, namely: * To establish a functional approach to the investigation of sudden unexplained infant deaths; * To outline a "bare minimum" set of recommendations to define the scope of investigation required; * To recommend methods and wording to be used when certifying infant deaths; * To develop a list of potential stressors or possible external causes of death that should be identified and reported on the death certificate and/or within a medical examiner/coroner office database. This paper was electronically posted for NAME member review and comment for a period of 30 days. The paper was further revised based on member comments and then submitted to the NAME board of directors in the fall of 2005 prior to the annual meeting. This text of this paper was officially approved and endorsed by the NAME board of directors on October 14, 2005, at the annual meeting in Los Angeles, CA.     

State certification of mammography facilities. Final rule

The Food and Drug Administration (FDA) is amending its regulations governing mammography. The amendments implement the "States as Certifiers" (SAC) provisions of the Mammography Quality Standards Act of 1992 (MQSA). These amendments permit FDA to authorize individual States to certify mammography facilities, conduct facility inspections, enforce the MQSA quality standards, and administer other related functions. The amendments establish the standards to be met by States receiving this authority. They also establish procedures for application, approval, evaluation, and withdrawal of approval of States as certification agencies. FDA retains oversight responsibility for the activities of the States to which this authority is given. Mammography facilities certified by those States must continue to meet the quality standards established by FDA for mammography facilities nationwide.     

Medical benefits for newborn children of certain woman veterans. Final rule

The Department of Veterans Affairs (VA) is amending its regulation concerning the medical benefits package offered to veterans enrolled in the VA health care system. This rulemaking updates the regulation to conform to amendments made by the enactment of the Caregivers and Veteran Omnibus Health Services Act of 2010, which authorized VA to provide certain health care services to a newborn child of a woman veteran who is receiving maternity care furnished by VA. Health services for newborn care will be authorized for no more than seven days after the birth of the child if the veteran delivered the child in a VA facility or in another facility pursuant to a VA contract for maternity services.