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PubMed1998

Physician qualifications for stereotactic breast biopsy: a revised statement. American College of Surgeons and American College of Radiology.

Following review and approval by both the Board of Regents of the American College of Surgeons (ACS) and the Board of Chancellors of the American College of Radiology (ACR), the guidelines document Physician Qualifications for Stereotactic Breast Biopsy was published in the September 1997 issue of the Bulletin of the American College of Surgeons. Several ACS Fellows subsequently contacted the College to suggest revisions to the document that significantly clarify the requirements and delineate the additional clinical skills that should be required for radiologists practicing independently. The College agreed to incorporate the proposed changes in the guidelines document and to submit the revised statement to the ACS Board of Regents and the ACR Board of Chancellors for their consideration and review. The revised document was approved by both of those bodies in February of this year and is presented here in its entirety. Changes to the text are printed in italics.

Biopsy↗

PubMed1998

Medicare program; peer review organization contracts: solicitation of statements of interest from in-state organizations--Alaska, Delaware, the District of Columbia, Hawaii, Idaho, Illinois, Kentucky, Maine, Nebraska, Nevada, South Carolina, Vermont, and Wyoming--HCFA. Notice.

This notice, in accordance with section 1153(i) of the Social Security Act, gives at least 6 months' advance notice of the expiration dates of contracts with out-of-State Utilization and Quality Control Peer Review Organizations. It also specifies the period of time in which in-State organizations may submit a statement of interest so that they may be eligible to compete for these contracts.

Centers for Medicare and Medicaid Services, U.S.↗

PubMed1979

The necessity for a collection development policy statement.

The heart of the library lies in its collections, and collections have to be built continuously. Budgetary constraints perforce stress the need for better defined collection development policy, although the ultimate goal should be an improvement of library service rather than any reduction of library cost. A written collection development policy facilitates a consistent and balanced growth of library resources, and a dynamic policy is one that evolves as the institution grows. Such a policy is based on the understanding of the needs of the community it serves and seeks to define and delimit the goals and objectives of the institution. A collection development statement is not a substitute for book selection; it charts the forest but does not plant the trees. It should be used as a guidepost, not a crutch. Book selection requires judgment and the courage to choose. A sound collection development policy, on the other hand, provides the necessary rational without which a collection may grow amoebalike, by means of pseudopodia.

Book Selection↗

PubMed1980

Drug Enforcement Administration--controlled substances in emergency kits for long term care facilities. Statement of policy.

The Drug Enforcement Administration has received numerous requests from State licensing and regulatory boards, pharmaceutical associations, and professional organizations concerning this agency's policy for the use and handling of controlled substances in emergency kits for patients in Long Term Care Facilities (LTCF). The Drug Enforcement Administration has determined that an amendment to current regulations is not necessary or desirable, in that LTCF's are not controlled premises under Federal law. However, issuance of a Statement of Policy will provide the individual State licensing and regulatory boards with general guidelines under which they may, in turn, promulgate specific rules for the use and handling of controlled substances in emergency kits in Long Term Care Facilities. Additionally, this course of action should improve health care services to such patients and decrease the quantities of controlled substances which might otherwise accumulate at Long Term Care Facilities which federally are non-registered locations.

Drug and Narcotic Control↗

PubMed1982

Civilian Health and Medical Program of the Uniformed Services (CHAMPUS); amendment on elimination of nonavailability statement where primary insurance covers 75 percent of the cost--Office of the Secretary of Defense. Final rule.

This amends the CHAMPUS Regulation to implement section 741 of Pub. L. 97-114. This public law eliminates the requirement for a nonavailability statement where the beneficiary has other insurance which will pay for at least 75 percent of the services. The intent of these changes is to encourage the use of other insurance to pay for necessary medical care, thus reducing the Government's expense through the direct care system. It also gives beneficiaries with other insurance greater freedom of choice as to where they obtain medical services.

Health Benefit Plans, Employee↗

PubMed1984

Privacy Act of 1974; system of records--PHS. Notification of a proposal to add a routine use and to add a special disclosure statement to the existing system of records 09-37-0015.

In accordance with the requirements of the Privacy Act and the Debt Collection Act of 1982 (Pub. L 97-365), the Public Health Service (PHS) is publishing notice of a proposal to add a new routine use and the (b)(12) special disclosure statement to consumer reporting agencies to system of records 09-37-0015, National Center for Health Services Research Grant Records System. The new routine use is for the purpose of determining credit worthiness of individual grant applicants of the National Center for Health Services Research (NCHSR).

Civil Rights↗

PubMed1986

Reimbursement rates for health care services authorized under the Indian Health Service contract health service regulations--HRSA. Issuance of statement of policy.

The Indian Health Service (IHS) is issuing this Statement of Policy to inform the public that the IHS will contract to purchase health services for Indian beneficiaries only with those hospitals, physicians and other health care providers which agree to accept, as payment in full, reimbursement at rates no higher than the prevailing Medicare allowable rates (including deductibles and co-payments). This encompasses those rates established for hospitals designated by the Health Care Financing Administration as "sole community providers" or "regional referral centers." Reimbursement rates for services not covered by Medicare allowable rates will be negotiated. In addition, the IHS will refer patients and/or arrange for the transfer of patients to IHS facilities or contract providers, so that non-contract providers will be used only in two situations: In emergency situations for services necessary to stabilize a patient prior to transfer to an IHS facility or to a contract provider, and in situations when the patient's health requires that the services be rendered by a particular provider which may not have a contract with the IHS. The IHS will phase this policy into administration of its contract health services programs. We may, upon further consideration and after consultation with tribal contractors, extend this policy to tribally administered contract health services programs. While tribal contractors are encouraged to adopt cost containment measures, this policy will apply only to contract health services programs administered by the IHS.

Health Services, Indigenous↗

PubMed1988

Medicare program; Peer Review Organization contracts; solicitation of statements of interest from in-state organizations--HCFA. General notice.

This notice, in accordance with section 4092 of the Omnibus Budget Reconciliation Act (OBRA) of 1987, gives six months advance notice of the dates when contracts with out-of-State Utilization and Quality Control Peer Review Organizations (PROs) end. It also specifies the period of time in which in-State organizations may submit statements of interest so that they may receive Requests for Proposals (RFPs) and compete for those contracts. The areas currently affected are Alaska, Idaho, Maine, Vermont and the District of Columbia.

Alaska↗

PubMed1999

Revocation of Office of Generic Drug's interim policy statement on inactive ingredients. Food and Drug Administration, HHS. Notice.

The Food and Drug Administration (FDA) is revoking an interim policy statement on inactive ingredients in parenteral, ophthalmic, otic, and topical generic drug products (Interim Inactive Ingredient Policy). These generic drug products are the subjects of abbreviated new drug applications (ANDA's). The Interim Inactive Ingredient Policy was issued as a memorandum from the Acting Director of the Center for Drug Evaluation and Research's (CDER's) Office of Generic Drugs, FDA, to CDER's Associate Director for Science and Medical Affairs, FDA. FDA is taking this action because the Interim Inactive Ingredient Policy no longer represents current agency policy.

Drugs, Generic↗

PubMed1999

Structures required, roles and responsibilities in maintaining laboratories for quality assurance of anti-tuberculosis fixed-dose combinations in accordance with the IUATLD/WHO statement.

Combining rifampicin in the same tablet with isoniazid, with or without pyrazinamide, is known to affect the bioavailability of the drug. It is also known that many fixed-dose combination (FDC) preparations exist in the market which are of inferior quality, but are unknowingly used extensively in tuberculosis treatment programmes in low-income countries with high tuberculosis caseloads. This has led to joint statements by the International Union Against Tuberculosis and Lung Disease and the World Health Organization (WHO) pointing out that anti-tuberculosis FDCs should only be used in National Tuberculosis Programmes if the bioavailability of at least the rifampicin component has been demonstrated. Through the FDC Quality Assurance Project launched by the WHO in 1997, a strategy was proposed which aimed to provide specific guidance to ensure the improved quality of such preparations, and in particular the bioavailability of the rifampicin component. A crucial component of drug quality assurance is to ensure that the infrastructure and logistics required to carry out the operational aspects of quality assurance are adequate and sustainable. This paper describes the structures and management responsibilities required to meet this objective, based on general WHO guidelines for the quality assurance of pharmaceuticals.

Antibiotics, Antitubercular↗

PubMedDate not supplied

Possible health hazards from exposure to power-frequency electric and magnetic fields--a COMAR Technical Information Statement.

In recent years concerns have been raised about the biological effects of exposure to electric and magnetic fields at extremely low frequencies (ELF), particularly those associated with the distribution and utilization of electric power. In 1989, the Institute of Electrical and Electronics Engineers (IEEE) issued an "Entity Position Statement" which stated that "there is not enough relevant scientific data to establish whether common exposure to power-frequency fields should be considered a health hazard" and that "there is general agreement that more research is needed to define safe limits of human exposure to power-frequency fields." After examination of relevant research reports published during the last ten years, COMAR concludes that it is highly unlikely that health problems can be associated with average 24-hour field exposure to power frequency magnetic fields of less than 1 microT (10 mG). Good laboratory evidence shows that magnetic fields 100 to 10,000 times higher than this level, either ELF sinusoidal or pulsed, can induce a variety of biological effects, including beneficial health effects such as bone or tissue healing. Many of the reports of effects of weaker fields should be considered preliminary, as some observations have not been reproduced in different laboratories, while others, observed in cells, have not been clearly connected to effects in intact animals. Also, the means of interaction of low-level ELF fields with cells, tissues or laboratory animals is not fully understood; therefore the health impacts of such weak fields on intact animals and humans, if any, cannot be predicted or explained. Further research is needed to confirm or negate reports of effects of weak fields, and to determine mechanisms and relevance of these effects to actual health hazards. Continued study in this complicated area will enhance our understanding of biological systems, as well as help identify levels and types of ELF exposure that may be deleterious to human health.

Animals↗

PubMed1999

Notified body consensus statements.

The ability of governments, official bodies, industry and others to uniformly interpret the European Directives for medical devices will have a profound effect on the success of the European system regulating these products. This is particularly important for Notified Bodies. This article will discuss Notified Body consensus statements. An article in the near future will discuss Notified Body recommendations.

Certification↗

PubMed1999

How can we improve informatics education for German nurses? Statements derived from the first German nursing informatics summer school.

For German nurses it is difficult to join training in health informatics besides their professional activity. The authors have successfully established a German nursing informatics summer school in shape of a 5 day intensive curriculum which they offer to German nurses during the summer holidays. The summer school introduces nurses into health informatics and nursing informatics. It targets interested nursing staff, nurse executives, and nurse teachers. It promotes self learning abilities for continued self education of the participants. One of its goals is to enable participants to formulate their own requirements in health information processing and to influence system design and system introduction. The paper presents the curriculum, talks about first experiences, and demonstrates the results of an evaluation among the participants. Conclusions are drawn in a set of statements on informatics education of nurses.

Curriculum↗

PubMed2000

[Dialogue with schizophrenics statements not derived from inner experiences].

When we examine the psychopathological issues of schizophrenia, we usually try to find clues in patients' statements spoken in dialogic situations. However, if we take into account that schizophrenic changes are supposed to contain various degrees of difficulties in inter-subjectivity, we must discuss first how and to what extent such patients are expressing themselves and communicating to us. The purpose of the present study was to determine the characteristics of dialogues between psychiatrists and schizophrenic patients and to consider the relationship of the communication to the patients' inner experiences. In order to discuss these problems, the authors made a study of 3 schizophrenic patients who had been in highly deteriorated mental states but managed to express themselves. The clinical characteristics of these patients were as follows: 1) First, the patients had been quite at a loss for words and remained silent. However, if the therapist carefully attended them and helped them express their feelings, they began to speak slowly. 2) However, shortly after they had finished expressing something, they often complained that they could not look backward or they did not know anything about what had been expressed even when there were no defects of memory. 3) The patients did not know what their inner experiences were until they had been asked back again and again about their experiences by the therapist. In other words, they could encounter their inner worlds only through the intervention of the therapist. These clinical observations maintain the following interpretations: 1) The patients' expressions did not pass into their own possession and had derivation from their inner experiences. 2) From a phenomenological point of view, this was apparently related to the disunion between 'expressing selves' and 'experienced selves.' 3) Through the therapeutic dialogues, their experiences came up to the inter-subjective dimension, which led them to create their inner experiences.

Adult↗

PubMed2000

Regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body; partial stay of compliance. Food and Drug Administration, HHS. Final rule; partial stay of compliance.

The Food and Drug Administration (FDA) is announcing a partial stay of compliance for the final rule defining the types of statements that can be made concerning the effect of a dietary supplement on the structure or function of the body for certain dietary supplement products. Dietary supplement products that were labeled, or for which labeling had been printed, on or before January 6, 2000, the publication date of the final rule, are eligible for the stay. This action is in response to two petitions for stay and reconsideration.

Body Composition↗

PubMed2001

Statement of organization and functions. Final rule.

The Consumer Product Safety Commission is amending its statement of organization and functions to reflect the transfer of the National Injury Information Clearinghouse from the Office of Information Services to the Directorate for Epidemiology.

Consumer Product Safety↗

PubMed2001

An advisory statement from the Pediatric Working Group of the International Liaison Committee on Resuscitation.

The International Liaison Committee on Resuscitation (ILCOR), with representation from North America, Europe, Australia, New Zealand, Africa, and South America, was formed in 1992 to provide a forum for liaison between resuscitation organizations in the developed world. This consensus document on resuscitation extends previously published ILCOR advisory statements on resuscitation to address the unique and changing physiology of the newly born infant within the first few hours after birth and the techniques for providing advanced life support. After careful review of the international resuscitation literature and after discussion of key and controversial issues, consensus was reached on almost all aspects of neonatal resuscitation, and areas of controversy and high priority for additional research were delineated. Consensus on resuscitation for the newly born infant included the following principles: Personnel trained in the basic skills of resuscitation should be in attendance at every delivery. A minority (fewer than 10%) of newly born infants require active resuscitative interventions to establish a vigorous cry and regular respirations, maintain a heart rate > 100 beats per minute (bpm), and maintain good color and tone. When meconium is present in the amniotic fluid, it should be suctioned from the hypopharynx on delivery of the head. If the meconium-stained newly born infant has absent or depressed respirations, heart rate, or muscle tone, residual meconium should be suctioned from the trachea. Attention to ventilation should be of primary concern. Assisted ventilation with attention to oxygen delivery, inspiratory time, and effectiveness judged by chest rise should be provided if stimulation does not achieve prompt onset of spontaneous respirations and/or the heart rate is < 100 bpm. Chest compressions should be provided if the heart rate is absent or remains < 60 bpm despite adequate assisted ventilation for 30 seconds. Chest compressions should be coordinated with ventilations at a ratio of 3:1 and a rate of 120 "events" per minute to achieve approximately 90 compressions and 30 rescue breaths per minute. Epinephrine should be administered intravenously or intratracheally if the heart rate remains < 60 bpm despite 30 seconds of effective assisted ventilation and chest compression circulation. Common or controversial medications (epineprine, volume expansion, naloxone, bicarbonate), special resuscitation circumstances affecting care of the newly born, continuing care of the newly born after resuscitation, and ethical considerations for initiation and discontinuation of resuscitation are discussed. There was agreement that insufficient data exist to recommend changes to current guidelines regarding the use of 21% versus 100% oxygen, neuroprotective interventions such as cerebral hypothermia, use of a laryngeal mask versus endotracheal tube, and use of high-dose epinephrine. Areas of controversy are identified, as is the need for additional research to improve the scientific justification of each component of current and future resuscitation guidelines.

Environment↗

PubMed2002

Amendment of regulations regarding certain label statements on prescription drugs. Final rule.

The Food and Drug Administration (FDA) is amending its regulations concerning certain statements that have been required on the labels of prescription drugs generally and on certain narcotic or hypnotic (habit-forming) drugs. The agency is taking this action in accordance with provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act).

Drug Prescriptions↗