Medicare and Medicaid programs; hospital conditions of participation: laboratory services. Final rule

This final rule finalizes the hospital conditions of participation requirements for hospitals that transfuse blood and blood components. It requires hospitals 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. 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.     

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.     

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.     

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.     

Revisions to the requirements applicable to blood, blood components, and source plasma. Department of Health and Human Services (HHS), Public Health Service (PHS), Food and Drug Administration (FDA). Direct final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is issuing these amendments directly as a final rule because they are noncontroversial and there is little likelihood that FDA will receive any significant comments opposing the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule under FDA's usual procedures for notice and comment in the event the agency receives any significant adverse comments. If FDA receives any significant adverse comment sufficient to terminate the direct final rule, FDA will consider such comments on the proposed rule in developing the final rule. FDA is issuing this rule as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood, blood components, and Source Plasma.     

Postmortem Detection of Hepatitis B,C, and Human Immunodeficiency Virus Genomes in Blood Samples from Drug‐Related Deaths in Denmark*

Abstract: Blood‐borne viral infections are widespread among injecting drug users; however, it is difficult to include these patients in serological surveys. Therefore, we developed a national surveillance program based on postmortem testing of persons whose deaths were drug related. Blood collected at autopsy was tested for anti‐HBc, anti‐HBs, anti‐hepatits C virus (HCV), or anti‐human immunodeficiency virus (HIV) antibodies using commercial kits. Subsets of seropositive samples were screened for viral genomes using sensitive in‐house and commercial polymerase chain reaction (PCR) assays. Hepatitis B virus (HBV) DNA was detected in 20% (3/15) of anti‐HBc‐positive/anti‐HBs‐negative samples, HCV RNA was found in 64% (16/25) of anti‐HCV‐positive samples, and HIV RNA was detected in 40% (6/15) of anti‐HIV‐positive samples. The postmortem and antemortem prevalences of HBV DNA and HCV RNA were similar. Postmortem HIV RNA testing was less sensitive than antemortem testing. Thus, postmortem PCR analysis for HBV and HBC infection is feasible and relevant for demonstrating ongoing infections at death or for transmission analysis during outbreaks.     

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.     

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.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human). Food and Drug Administration, HHS. Final rule

The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives.     

Assessing the Prevention of Juvenile Delinquency: An Evaluation of a Court‐Based Delinquency Prevention Program

In 2002, the State of Ohio mandated juvenile courts to provide prevention for at‐risk youth. This study examined official court records to evaluate the effectiveness of a prevention program administered by the Greene County Juvenile Court. A sample of 362 youth referred to the program for the years 2002 to 2009 by concerned caretakers, teachers, and police was analyzed. Consistent with intake goals, 81.7% of clients were referred for at‐risk but not actually delinquent behaviors. Completion of the prevention program did not predict future court referrals, but neither did seriousness of referral behavior. Children with two biological parents were significantly more likely to complete the program, whereas referrals to Strengthening Families Program and substance abuse screening significantly predicted program noncompletion. Implications for policy and research are discussed.

Key Points for the Family Court Community:
• This article highlights efforts by county juvenile court to implement a secondary prevention program for at‐risk but not officially court‐referred youth.
• Delinquency prevention research depends on good juvenile court data and adequate comparison groups.
• Evidence‐based predelinquent interventions with external process and outcome evaluations should be the standard.

     

Preliminary Study on the Effect of Heated Surfaces Upon Bloodstain Pattern Analysis

Bloodstain pattern analysis (BPA) involves the interpretation of distinct blood patterns found at crime scenes following a violent act. In this paper, we explored for the first time the effects of surface temperatures upon blood impacting a horizontal surface (steel) with its implications in BPA explored. Specific surface temperatures were explored over the range 24–250°C which relate to the four major boiling regimes of liquid media; natural convection, nucleate boiling, transition boiling, and film boiling, where a series of blood drops tests were performed at varying impact velocities. Blood was found to separate into its components at temperatures of 50°C+, displayed as temperature induced blood rings, where a single secondary and a series of further inner rings are exhibited. This consequently led to the development of a new constant expressing the decrease in spread factor (D_s/D_o) at the secondary ring.     

‘Catching’ and ‘Targeting’: Risk‐Based Policing,Local Culture and Gendered Practices

The aim of this article is to explore cultural and practical aspects of the growing use of information and communication technology (ICT) in policing. By using empirical research on policing in Norway, the focus will be on how ICT is used as a crime prevention instrument in everyday police work and culture. The transition, which the new technologies mediate, will be explored by focusing on concepts of risk and materialization of risk‐based policing at the practice level in two cases: 1) a special unit fighting serious and organized crime utilizing proactive policing methods, police informers, crime profiling and databases, and 2) a police station focusing on low‐level crime by using a problem‐oriented policing model, transmitting responsibility for personal security onto identified ‘problem‐owners’.1 ‘Problem‐owner’ is a notion used by the police in the two cases. It is referring to the POP‐model, and whom they identify as important to participate in the risk‐management. According to Wright (: 121): “Partnership refers to a purposeful relationship between the police and the public or between the police and other agencies in the field.” Based on an examination of risk phenomena as contextual, embedded in practice and cultural settings, various stories about risk management will be told. The stories reflect different control strategies in the crime control discourses, and point to how risk‐based technologies are shaped and adapted in occupational culture and practice. The article illuminates the importance of studying the empirical complexity ICT is used in, and looks towards, to paraphrase O'Malley and Palmer (), ‘firewalls of resistance’ in the local occupational culture, that are preventing full integration of risk tools.     

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."     

Blood Donor Locator Service--Social Security Administration. Final rules

We are issuing these final regulations to govern the Blood Donor Locator Service, which we will establish and conduct, as required by section 8008 of the Technical and Miscellaneous Revenue Act of 1988 (Pub. L. 100-647). Under these regulations, we will furnish to participating States at their request the last known personal mailing address (residence or post office box) of blood donors whose blood donation shows that they are or may be infected with the human immunodeficiency virus (HIV) which causes acquired immune deficiency syndrome, if the State or an authorized blood donation facility has been unable to locate the donors. If our records or those of the Internal Revenue Service (IRS) contain an adequate personal mailing address for the donor, we will provide it to the State so that the State or the blood donation facility can inform the donor that he or she may need medical care and treatment.     

Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); companion document to direct final rule. Food and Drug Administration, HHS. Proposed rule

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood products, including blood derivatives. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register. FDA is taking this action because the proposed changes are noncontroversial and FDA anticipates that it will receive no significant adverse comment.     

Not enough help for themselves--the risk of physicians to commit suicide

Physicians seem unwilling to deal with their own suicidal problems professionally. Suicide is a repressed topic. According to international studies, medical students and physicians are clearly over-represented among suicide victims. Committing suicide stands in sharp contrast to the positive image physicians enjoy as competent, strong helpers transmitting positive energy. Various studies and meta-analyses show that physicians use knowledge specific to their profession and are therefore "more successful" than the general population in committing suicide. Moreover, the data reveal a number of risk factors specifically correlating with medical practice. This is confirmed by an increased number of suicides during medical training and professional life in comparison with the general population. Gender-specific analyses show an even higher suicide risk for female physicians. In this context it cannot be excluded that out of "professional respect" cardiovascular causes of death are sometimes falsely documented in death certificates instead of suicide. Despite their special education, physicians are not very good at diagnosing their own emotional disorders and asking colleagues for adequate professional help. They rather tend to camouflage their own psychological problems also because they are afraid of occupational and personal discrimination.     

Guidance for industry: donor screening for antibodies to HTLV-II; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Donor Screening for Antibodies to HTLV-II." The guidance document provides information regarding human T-lymphotrophic virus type II (HTLV-II) screening tests for Whole Blood and blood components. This guidance document is a further effort of FDA to help ensure a safe blood supply for the United States of America (U.S.).     

Interim recommendations for deferral of donors at increased risk for HIV-1 Group O infection; guidance document; availability--FDA. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled "Interim Recommendations for Deferral of Donors at Increased Risk for HIV-1 Group O Infection," dated December 11, 1996. The guidance document, which discusses the appearance in 1996 of two cases of HIV-1 Group O infection in the United States, is intended to provide interim measures to reduce the risk of HIV-1 Group O transmission by blood and blood products pending the licensure of test kits specifically labeled for detection of antibodies to HIV-1 Group O viruses. The guidance document recommends adding three questions to screening questionnaires used to exclude donors at high risk of HIV-1 infection.