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.     

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 hepatitis C virus infection ("lookback"). Final rule

The Food and Drug Administration (FDA) is requiring establishments collecting Whole Blood or blood components, including Source Plasma and Source Leukocytes, to establish, maintain, and follow an appropriate system for identifying blood and blood components previously donated by a donor who tests reactive for evidence of hepatitis C virus (HCV) infection on a subsequent donation identified either by current testing or after a review of historical testing records, or when the collecting establishment is made aware of other reliable test results or information indicating evidence of HCV infection. Such collections may be at increased risk of transmitting HCV infection. FDA is requiring collecting establishments to quarantine prior in-date blood and blood components from such a donor, to notify consignees of prior in-date blood and blood components from such a donor for quarantine purposes, and to perform further testing on the donor. FDA is also requiring consignees to notify transfusion recipients of blood and blood components from such a donor, as appropriate. In addition, FDA is revising the human immunodeficiency virus (HIV) "lookback" requirements for greater consistency with the HCV "lookback" requirements, and extending the record retention period to 10 years. FDA is taking this action to help ensure the continued safety of the blood supply and to help ensure that information is provided to recipients of blood and blood components that may have been at increased risk of transmitting HIV or HCV infection. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled "Guidance for Industry: 'Lookback' for Hepatitis C Virus (HCV): Product Quarantine, Consignee Notification, Further Testing, Product Disposition, and Notification of Transfusion Recipients Based on Donor Test Results Indicating Infection with HCV' (the "lookback" guidance). We are also issuing this final rule in conjunction with a companion interim final rule published by the Centers for Medicare and Medicaid Services (CMS) elsewhere in this issue of the Federal Register.     

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.     

Current good manufacturing practices for blood and blood components: notification of consignees receiving blood and blood components at increased risk for transmitting HIV infection--FDA. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations to require that blood establishments (including plasma establishments) prepare and follow written procedures for appropriate action when it is determined that Whole Blood, blood components (including recovered plasma), Source Plasma and Source Leukocytes at increased risk for transmitting human immunodeficiency virus (HIV) infection have been collected. This final rule requires that when a donor who previously donated blood is tested on a later donation in accordance with the regulations and tests repeatedly reactive for antibody to HIV, the blood establishment shall perform more specific testing using a licensed test, if available, and notify consignees who received Whole Blood, blood components, Source Plasma or Source Leukocytes from prior collections so that appropriate action is taken. Blood establishments and consignees are required to quarantine previously collected Whole Blood, blood components, Source Plasma and Source Leukocytes from such donors, and if appropriate, notify transfusion recipients. The Health Care Financing Administration (HCFA) is also issuing a final rule, published elsewhere in this Federal Register, which requires all transfusion services subject to HCFA's conditions of Medicare participation for hospitals to notify transfusion recipients who have received Whole Blood or blood components from a donor whose subsequent donation test results are positive for antibody to HIV (hereinafter referred to as HCFA's final rule). FDA is requiring transfusion services that do not participate in Medicare and are, therefore, not subject to HCFA's final rule, to take steps to notify transfusion recipients. FDA is taking this action to help ensure the continued safety of the blood supply, and to help ensure that information is provided to consignees of Whole Blood, blood components, Source Plasma and Source Leukocytes and to recipients of Whole Blood and blood components from a donor whose subsequent donation tests positive for antibody to HIV.     

Occupational exposure to tuberculosis--OSHA. Proposed rule and notice of public hearing

The Occupational Safety and Health Administration is proposing a health standard, to be promulgated under section 6(b) of the Occupational Safety and Health Act of 1970, 29 U.S.C. 655, to control occupational exposure to tuberculosis (TB). TB is a communicable, potentially lethal disease that afflicts the most vulnerable members of our society: the poor, the sick, the aged, and the homeless. As many as 13 million U.S. adults are presently believed to be infected with TB; over time, more than 1 million of these individuals may develop active TB disease and transmit the infection to others. TB remains a major health problem with 22,813 active cases reported in the U.S. in 1995. A number of outbreaks of this disease have occurred among workers in health care settings, as well as other work settings, in recent years. To add to the seriousness of the problem, some of these outbreaks have involved the transmission of multidrug-resistant strains of Mycobacterium tuberculosis, which are often fatal. Although it is the responsibility of the U.S. Public Health Service to address the problem of tuberculosis in the general U.S. population, OSHA is solely responsible for protecting the health of workers exposed to TB as a result of their job. OSHA estimates that more than 5 million U.S. workers are exposed to TB in the course of their work: in hospitals, homeless shelters, nursing homes, and other work settings. Because active TB is endemic in many U.S. populations, including groups in both urban and rural areas, workers who come into contact with diseased individuals are at risk of contracting the disease themselves. The risk confronting these workers as a result of their contact with TB-infected individuals may be as high as 10 times the risk to the general population. Although the number of reported cases of active TB has slowly begun to decline after a resurgence between 1985-1992, 16 states reported an increase in the number of TB cases in 1995, compared with 1994. Based on a review of the data, OSHA has preliminarily concluded that workers in hospitals, nursing homes, hospices, correctional facilities, homeless shelters, and certain other work settings are at significant risk of incurring TB infection while caring for their patients and clients or performing certain procedures. To reduce this occupational risk, OSHA is proposing a standard that would require employers to protect TB-exposed employees by means of infection prevention and control measures that have been demonstrated to be highly effective in reducing or eliminating job-related TB infections. These measures include the use of respirators when performing certain high hazard procedures on infectious individuals, procedures for the early identification and treatment of TB infection, isolation of individuals with infectious TB in rooms designed to protect those in the vicinity of the room from contact with the microorganisms causing TB, and medical follow-up for occupationally exposed workers who become infected. OSHA has preliminarily determined that the engineering, work practice, and administrative controls, respiratory protection, training, medical surveillance, and other provisions of the proposed standard are technologically and economically feasible for facilities in all affected industries.     

Raman spectroscopy of blood samples for forensic applications

We investigated Raman scattering from human blood as a function of parameters that are relevant for forensic field analysis, such as substrate, sample dilution, individual from which the sample originates, and age of the sample. Peaks characteristic of blood components and in particular the hemoglobin peaks were routinely detected when blood was deposited on substrates that are not strongly luminescent, such as plastic, metal utensils and dry wall. Raman scattering from blood proved quite sensitive and blood samples with a dilution up to 1:250 could be measured for an excitation power of ～2 mW measured at the sample plane. The sensitivity of Raman scattering to diluted blood allowed measurement using blood reconstituted from fabric substrates, thereby alleviating issues related to luminescence and scattering from the substrate. The dependence of Raman scattering on sample age and individual was also investigated. We found that the relative intensities of scattering peaks depended on sample age and history. For example, the relative intensity of oxyhemoglobin peaks decreases after blood has dried. Fresh blood drawn directly from a donor without intermediate storage exhibits also scattering peaks at 1155 and 1511 cm(-1) which disappear after drying. The origin of these peaks is under investigation. We noticed, however, that they were not found in blood that had been stored for longer than one week in EDTA containers before analysis, thus requiring the use of fresh blood for future studies and validation purposes. The relative intensity of scattering peaks was also found to be somewhat dependent on the donor and, for a same donor, on the day on which blood was drawn.     

AIDS prevention: legislative options

This article reviews legislative options to prevent the transmission of HIV infection. It distinguishes between pre-exposure measures designed to prevent initial exposure, and post-exposure measures aimed at preventing infected individuals from exposing others. Part I identifies education as the key component of a comprehensive prevention program, and reviews options for pre-exposure education programs designed to avoid or minimize exposure. Part II reviews post-exposure prevention measures, focusing on reporting and contact tracing provisions. Mandatory reporting by name of individuals testing HIV positive and mandatory contact tracing are opposed as counterproductive prevention measures; voluntary partner notification is supported. Part III examines various prevention efforts for settings where there may be either a real or perceived risk of transmission of HIV infection. Part IV sets out conclusions.     

AIDS-related risks in the health care setting: HIV testing of health care workers and patients

Do patients and health care workers have the legal right to know each other's HIV status? Professor Flanagan argues that they do not. Given that with appropriate precautions the risk of transmitting HIV in the health care setting is extremely small and that the discriminatory consequences of HIV disclosure can be extremely high, it is suggested that the right of a patient or a health care worker not to disclose their HIV status must outweigh the other's "right to know."     

The contribution of statistics in the forensic appraisal of post-transfusion contamination by hepatitis C virus

Many patients were contaminated by blood products in the 1980s and early 1990s, a period during which there was no means of detecting hepatitis C virus (HCV) and measures of vigilance in French blood transfusion centers were lacking in rigor, and it has become a real public health issue by now. The blood transfusion centers which produce and distribute the products are liable for such contamination, as long as the expert appraisal has established a link of causality between the transfusion and the contamination. When the viral serologic status (i.e. the contaminating potential) of the donors is not known, experts often resort to indirect evidence, including use of probability estimates calculated according to the following method. The probability (P) that there was at least one contaminating donor among those having provided the blood given to a patient, is calculated using the following formula:P=1.(1.pHCV)(N)where pHCV is the prevalence of subjects who have tested positive for anti-C virus antibodies in a population of blood donors, and N is the number of donors having contributed to the transfusion in question. Although the polymerase chain reaction (PCR) is very sensitive, its threshold, below which weak replication is undetectable, varies depending on the technique used. One study has demonstrated that below a dilution of 10(-4), RNA is no longer detected by the majority of laboratories. The specificity of PCR is not flawless either, since false-positive results are found, probably resulting from contamination of the samples. Considering that 0.10% is a reasonable approximation of the prevalence of subjects who had anti-HCV antibodies that were detectable by recombinant immunoblot assay during that period, one can calculate the probability that there is a contaminating donor among the blood donors who contributed to the product that was administered and determine a curve.     

Preventing Suicide in Jails and Prisons: Suggestions from Experience with Psychiatric Inpatients

Abstract:  Both among psychiatric inpatients and inmates of prisons and jails, suicide is highly prevalent with alarming rates. In many countries, there has been a call for action to prevent such deaths and to educate staff in the early recognition of suicide risk. A careful MedLine search was used to identify relevant papers dealing with suicide prevention in psychiatric inpatients. This paper reviews this research and the policy recommendations that have been developed for psychiatric hospitals in order to reduce the incidence of suicide in their patients. Results derived from this search indicated that these policy recommendations can be applied to suicide prevention in correctional settings, and it is argued that suicide prevention programs in correctional settings can benefit from the research conducted and the policy recommendations for suicide prevention in psychiatric facilities. In conclusion, the best practices for preventing suicides in jail and prison settings should include the following elements: training programs, screening procedures, communication between staff, documentation, internal resources, and debriefing after a suicide.     

Identification and phylogenetic analysis of hepatitis C virus in forensic blood samples obtained from injecting drug users

Injecting drug users (IDUs) are a high-risk group for contracting hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV) infections. In Japan, data on the prevalence of those blood-borne viruses among IDUs are very limited. Blood samples were obtained from 12 cadavers of IDUs sent to Nagoya City University for the purpose of judicious autopsy and two alive IDUs with hepatitis C referred to a local hospital at the same period. The viruses were detected by polymerase chain reaction and phylogenetic analysis was performed. Two (16.6%) of the 12 autopsy cases were positive for HCV, but no case was positive for either HBV or HIV. Phylogenetic analysis of the two HCV isolates revealed that one was classified into genotype 1b and another was genotype 2b. Furthermore, nucleotide sequences of two isolates recovered from IDUs with hepatitis C were identical, that indicated the transmission of HCV between them, and those HCV were phylogenetically classified into genotype 2a. The prevalence of HCV infection among IDUs in Japan, despite the case of judicious autopsy, seems to be high, but HIV infection seems to be rare. The transmission of HCV between IDUs was demonstrated, and this indicates that phylogenetic analysis would applicable to also forensic analysis. HCV isolates identified in this study did not phylogenetically segregate, thus multiple transmission route of HCV among IDUs seems be exist in Japan.     

Blood and blood components; error and accident reports--Food and Drug Administration. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations concerning blood and blood components to require the submission of certain error and accident reports to the agency by licensed and unlicensed blood etablishments. These reports of error and accidents are being limited to those related to the issue of hepatitis-reactive blood and blood components and the accidental infusion of the wrong red blood cells to a donor during plasmapheresis. Certain other reports of error and accidents would no longer be required to be submitted to the Director, Bureau of Biologics, by these blood establishments. The agency is also proposing to amend the current good manufacturing practice (GMP) regulations for blood and blood components to provide a uniform procedure for reporting and maintaining these records.     

US: hospital negligent for failing to warn prior patient of risk of HIV infection by transfusion

The Supreme Court of Tennessee has ruled that a university hospital was negligent for not contacting patients who had received blood transfusions in the early 1980s to advise them of the risk of HIV infection. In Amos v Vanderbilt University, it awarded US$4.3 million in damages to the estate and family of a woman who died eight years after receiving HIV-tainted blood during surgery.     

Human tissue intended for transplantation--FDA. Interim rule; opportunity for public comment

The Food and Drug Administration (FDA) is issuing an interim rule to require certain infectious disease testing, donor screening, and recordkeeping to help prevent the transmission of AIDS and hepatitis through human tissue used in transplantation. The regulations are effective upon publication. FDA is taking this action in response to growing concerns that some human tissue products are being offered for transplantation use without even the minimum donor testing and screening needed to protect recipients against human immunodeficiency virus (HIV) infection and hepatitis infection. The new regulations require all facilities engaged in procurement, processing, storage, or distribution of human tissues intended for transplant to ensure that minimum required infectious disease testing has been performed and that records documenting such testing for each tissue are available for inspection by FDA. The regulations also provide authority for the agency to conduct inspections of such facilities and to detain, recall, or destroy tissue for which appropriate documentation is not available.     

WINNING THE BATTLES AND THE WARS. An evaluation of comprehensive,community-based delinquency prevention programming

This three-year program evaluation investigated the primary prevention aspects of Youth Assistance (YA), a community-based program of the Oakland County Probate Court providing casework and prevention services. The activities studied included parent education sessions, supervised teen recreation, summer camp scholarships, skill building activities, and a one-to-one mentorship program. The goals of the study were to determine how effectively the program succeeded in mobilizing community volunteers, and to examine whether the incidence of neglect and delinquency had been reduced as a result of children and parents participating in one or more of these primary prevention activities. Ethnographical as well as quasi-experimental approaches were used. The following results are highlighted: YA primary prevention services do serve “at risk” populations in the community; overall, participation in the YA activities had positive effects on the participants, such as improved communication skills, increased respect for authority, and more use of positive discipline techniques; 92% of the primary prevention program participants had no subsequent contact with YA or the Court; the program is cost-effective. The study also confirmed that volunteers are an essential part of the success of a community-based prevention program. The study resulted in a number of specific recommendations which will be implemented over the next few years in order to continuously improve the program.     

Molecular genetics of sudden cardiac death

Sudden cardiac death (SCD) is one of the most common causes of death. An important number of sudden deaths, especially in the young, are due to genetic heart disorders, both with structural and arrhythmogenic abnormalities. In recent years, significant advances have been made in understanding the genetic basis of SCD. Identification of the genetic causes of sudden death is important because close relatives are also at potential risk of having a fatal cardiac condition. A comprehensive post-mortem investigation is vital to determine the cause and manner of death and provides the opportunity to assess the potential risk to the family after appropriate genetic counselling. In this paper, we present an update of the different genetic causes of sudden death, emphasizing their importance for the forensic pathologist due to his relevant role in the diagnosis and prevention of SCD.     

Bar code label requirement for human drug products and biological products. Final rule

The Food and Drug Administration (FDA) is issuing a new rule to require certain human drug and biological product labels to have bar codes. The bar code for human drug products and biological products (other than blood, blood components, and devices regulated by the Center for Biologics Evaluation and Research) must contain the National Drug Code (NDC) number in a linear bar code. The rule will help reduce the number of medication errors in hospitals and other health care settings by allowing health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time. The rule also requires the use of machine-readable information on blood and blood component container labels to help reduce medication errors.     

论输血及血液制品感染的侵权责任——基于日本法上的经验

在医学界,血液被称为"生命的源泉"。然而,近年来,随着临床用血和血液制品使用的大量增加,患者感染梅毒、肝炎、甚至艾滋病的案例已屡见不鲜。而上世纪末,我们的邻国日本也曾遭遇过同样的"血液之殇",日本司法实践在处理诸如"东大梅毒事件"、"药害肝炎事件"、"药害艾滋事件"上的成功经验会带给我国怎样的启示,以下将对日本法上血液的法律属性、医疗过失的判断标准、因果关系的证明以及医药产品责任主体的责任分配等进行分析,并结合我国《侵权责任法》相关规定,从法解释学的角度出发,针对我国司法现状,探讨日本法对我国在法律解释适用方面的借鉴意义。