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We will at some places refer to androgen hormone vs neurotransmitter generic pilex 60caps fast delivery specific guidelines or legal documents as illustrations man health month generic pilex 60 caps without prescription, especially some of the more recognised regulatory guides prostate cancer message boards purchase 60 caps pilex. However prostate zone anatomy purchase pilex 60 caps fast delivery, the intention is not in any way to prostate cancer 2015 pilex 60caps cheap endorse specific documents as opposed to prostate natural remedies buy generic pilex canada others. It lists approximately 1, 100 laws, regulations, and guidelines that govern human participant research in 96 countries. Its purpose is to help these groups familiarise themselves with the laws, regulations and guidelines in effect wherever research is conducted, to ensure that those standards are followed appropriately. Some review protocols for animal studies, some for human studies in social sciences such as psychology and education, and others for clinical trials in patients or healthy volunteers. In this Guide, we address only the principles of ethics review of protocols involving interventional studies or clinical trials in humans. As stated in the Declaration of Helsinki: The research protocol must be submitted for consideration, comment, guidance and approval to a research ethics committee before the study begins. This arrangement is especially useful when the investigator works from a single physicians private practice or when multiple sites are involved in the same geographical or judicial region. Clinical Trials Pre-clinical biomedical research is important for expanding the knowledge of basic biological mechanisms. Studies are Non-interventional commonly conducted in pre-clinical Clinical Research departments or institutions in fields such as anatomy, biochemistry, cellular biology, immunology, microbiology, molecular biology, neuroscience, pharmacology and physiology. Pre-clinical research can Pre-clinical contribute to the discovery of new medical Research treatments. Clinical research ranges from clinical laboratory or investigational studies to testing of new clinical procedures, new clinical diagnostic tools and new medicinal Biomedical research and experimental medicine are terms used products in humans. Clinical research includes non-interventional research and Clinical Trials on Medicinal Products interventional research or clinical trials. There is a persistent demand, in addition to a great need, to develop new medical treatments that are as effective and safe as, or more effective or safer for specific types of patients than, treatments already on the market. Research also enables discovery of new therapeutic uses for currently available medications, as well as enabling development of innovative treatments for currently untreated conditions. New medicinal products are commonly discovered by means of laboratory research and animal studies before they can be tested in humans through clinical trials and eventually used in medical care. Clinical trials are the mandatory bridge between pre-clinical discovery of new medicinal products and their general uses. This means that clinical trials must take place before new research treatments can be made available to the public, whether for prescription, over-the-counter sale or for use in a clinic. Pre-clinical testing of new medicinal products can only forecast their treatment and side-effects in humans. On average, only one out of 14 new drugs that enter clinical testing programmes is eventually introduced for clinical use. The main reasons for the high drop-out rate are unforeseen side-effects or insufficient treatment effects. Pre clinical laboratory and animal studies thus only partially indicate effects in humans. A new drug application, for instance, will include all aspects of the test article, from pre-clinical information about the molecular structure and action, manufacturing information, formulation and animal studies to test results in humans depicting the pharmacological action, dosage, preventive or curative effects, and potential side-effects. Pre-clinical and clinical developments are carefully monitored under strict government regulations in most countries to ensure that all aspects of the compound have been studied and that research has used proper trial designs in a high-quality manner, in accordance with international and local human research ethical standards. Clinical testing of the product passes through different phases, from human pharmacology to exploratory research in participants with the target disorder, and eventually large-scale trials where the products safety and effects are compared to the best current treatment on the market (see illustration). On average, there are 25-30 the mandatory different trials conducted on bridge from pre clinical discovery the same compound, each to clinical usage adding some essential information to the existing body of knowledge. The Pre-clinical Clinical Usage Discovery & Trials trials are conducted in a Testing close to sequential manner, although the clinical development plan is altered Confirmatory and adjusted according to Exploratory results obtained at certain points in time. Human Most (about 85%) approved pharmacology medicinal products are developed and tested by the pharmaceutical and biotechnology industries, not academic institutions or non profit organisations. The link Modern drug development: Each arrow represents one clinical trial for one and the same test drug here a diabetes drug is an example. Low and High Risk Clinical Trials Three essential factors echo the risk of harm level of a clinical trial: cumulative clinical experiences of the test article, targeted participant population and biological characteristics of the test article. As clinical testing proceeds, more and more participants are exposed to the test article. The information gathered is used to evaluate the effects negative as well as positive of the product in humans. Accordingly, it follows that risk of harm in general is much higher during the initial clinical testing phase, i. Thus early phase clinical trials often need more oversight than later phase trials. The highest level of risk arises when the product is first tested in humans (first-into human trials), followed by trials with dose escalation and multiple dosing. Most of these trials are conducted in healthy volunteers, not participants with the Confirmatory target disease. Initial human pharmacology Exploratory clinical trials, High risk conducted mostly on healthy volunteers, are Human followed by exploratory pharmacology trials where the test article is administered on target participant groups for the first time. The reactions from these participants may differ from those in healthy volunteers, so first-into-human trials are also often regarded as having a higher risk Medium/low risk of harm and therefore need extra oversight Each arrow represents a clinical trial for one and the same test drug here a diabetes drug as an example. Clinical testing of medicinal products that are ineffective and/or have unreasonable side-effects is terminated early. This means that late exploratory and confirmatory clinical trials are performed on a subsample of products confidently expected to have a reasonably low risk of inducing side-effects in relation to the treatment effect, since the safety profile is acceptable. The targeted patient population may also influence the degree of risk of a medicinal product. For instance, life-threatening diseases such as cancer usually call for stronger and thus potentially more toxic drugs with a different risk of harm acceptance from, for instance, anti-flu drugs. Likewise, young children may have a higher risk of side-effects than adults, due to their ongoing organ growth and the bodys functional development in early life. Participants in need of multiple drug treatments, such as psychiatric patients or drug abusers, have a risk of harm from drug-to-drug interaction, which may be higher than for participants given the test drug who have no other significant medical conditions. Proper risk assessment of a trial can be made only with detailed access to the results of previous testing of the product, in animals and humans, as well as details of the target population and knowledge about the characteristics of the test article. For trials overseen by a regulatory authority, additional details are documented in a mandatory investigators brochure. The former comprises pharmaceutical and biotechnology companies, while the latter comprises medical schools, biomedical research institutes, government institutions or clinical trial networks. Depending on the body, non-industry trials are referred to as non-profit, non industry-sponsored, investigator-initiated, or institutional-initiated trials. Globally, there are many more investigator-initiated than industry-sponsored clinical trials. The overall objective of a commercial life-science company in conducting clinical trials on a medicinal product is to collect information about the safety and efficacy of the product in human participants, i. The data collected and analysed from the development of new medicinal products usually includes on average six trials eventually represent years of pre-clinical and six years of clinical research. The clinical testing phase may require 30 clinical trials for a single test compound. The testing commercial company is therefore concerned that the trial follows international and local regulations from scientific, ethical and quality assurance viewpoints so government market approval can be achieved in a timely and undisputed manner. In contrast, an investigator acting as sponsor of a clinical trial may primarily be involved for scholarly reasons, rather than to bring a new medicinal product to the market. Often, the investigators motive is scientific achievement, leading to published findings, advancing knowledge among peers, and many times also improvement of patient care, health care or population health. Such trials may compare new surgical procedures, health interventional programmes or clinical diagnostic tools. They may also test combination therapies or new indications of already approved commercial medicinal products. A smaller number of investigator-initiated trials test new medical products that an investigator or institution has invented, with the primary objective being commercial. Industry-sponsored trial protocols have commonly been subject to third-party review because the clinical development plan of products is continuously monitored by drug regulatory authorities. Investigator-initiated trials, on the other hand, may lack the review of an independent third party before they are submitted to Chapter 1. Regardless of who the sponsor may be, the clinical trial protocol should detail the same aspects: the scientific rationale behind the protocol, the rationale behind the trial design and sample size, treatment blinding, the risk-benefit balance, participant compensation, informed consent, insurance/indemnity, any conflicts of interest that may influence the collection of data or results, and essential quality assurance measures. With rare and follow the participants and to deliver the study data to the sponsor. The sponsor or its representative shall not have knowledge of participants identity and does not usually have direct contact with them; an exception is a Phase I unit owed by a sponsor. Drug Regulatory Authority Each country has its own drug regulatory authority with its own regulations for approving clinical trial protocols and also for conducting clinical trials when testing and approving new medicines and other medicinal products. A clinical trial of a new medicinal product can be overseen by one or several drug regulatory authorities. In addition, the drug regulatory authority has important quality assurance responsibilities in the development of new medicines, as well as the production, distribution, labeling and safety monitoring of medicines, including medicines already registered. There are a number of local and international regulations/guidelines that must be followed when new medicines are developed and tested. Responsibilities of the regulatory authority (examples): Reviewing and approving clinical trial protocols. Sponsor A clinical trial sponsor is an individual, company, institution or organisation that takes responsibility for the initiation, management, and financing of a clinical trial. A sponsor can be a pharmaceutical or biotech company, a non-profit organisation such as a research fund, a government organisation or an institution where the trial is to be conducted, or an individual investigator. The sponsor initiates a clinical trial and has a number of responsibilities such as protocol development, financing the trial and quality assurance. The sponsor will seek permission for trial initiation from the drug regulatory authority or authorities if more than one country is involved in conducting the trial. A clinical trial project manager acts as a coordinator among the activities of clinical trials. The monitor interacts regularly with the investigator and his/her team members, while monitoring the participant informed consent process, participant recruitment rate, test drug presence, protocol compliance and payment schedules. The monitor visits the trial site approximately every month and reports findings to the project manager coordinating the trial. Responsibilities of the sponsor (examples): Submitting a plan for the clinical trial to the regulatory authority for approval. The investigative team can belong to academic medical centres, public hospitals or outpatient clinics, private health care organisations, private practices or commercial research sites. The sponsor identifies a potential principal investigator for the trial and communicates with the investigative team throughout the course of it, usually by way of a project manager and a trial monitor. Introduction 25 investigator, government institution, or another funding body takes on the role and responsibilities of the sponsor. An investigator is a person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team. A more formal definition of an investigator is under whose immediate direction the test article is administered or dispensed to, or used involving, a participant, or, in the event of an investigation conducted by a team of individuals, is the responsible leader of that team. Synonyms are trial coordinator, study coordinator, research coordinator, clinical coordinator, research nurse and protocol nurse. Responsibilities of the investigator (examples): Protecting the rights and well-being of the participants. It may require giving a small self-interested minority group veto power over decisions; it may take an extremely long time and it may encourage groupthink, where members modify their opinions to reflect what they believe others want them to think. It can also lead to a few dominant individuals making all the decisions, and may even fail altogether in a situation where there is simply no agreement possible and where interests are irreconcilable. As for research that involves vulnerable participants, there should be one or more members who are knowledgeable about or experienced in working with such participants. Trial Participant Most clinical trials include participants with a specific disease that is the target for the test drug, device or diagnostic tool, such as cancer or allergy. Participants are usually recruited from an ordinary pool of patients at a trial site, but sometimes by referral from other clinics or through local advertisements. Trial participation is voluntary, and participants do not normally have to pay any hospital fees during the duration of a trial. However, some clinical trials are conducted on healthy participants or healthy volunteers. Examples are studies on preventive medicinal products such as vaccines, or when the product is tested for the first time in human participants, for drug safety and dosage to be determined. Healthy volunteers are commonly paid for participation because they receive no direct benefit, and may have to take leave from their ordinary work during the trial. Clinical Trial Services Provider Outsourcing of tasks related to clinical trials has increased substantially over the past two decades. Such outsourcing services can be related to the pre-clinical testing phase, such as animal studies. There are three major Institutional management organisation reasons for using a single central Both local and overseas regulatory authorities can oversee a clinical trial. Since results from all sites from the same trial are stored in a centralised computer, with a database updated several times a day, the data can be continually analysed to detect side-effects from all study sites. Site Supporting Organisation Another emerging clinical trial organisation a for-profit or non-profit institutional management organisation acts as an interface between the investigator and the sponsor. It can be located either at an academic institution or at a non-academic health care organisation (see illustration).

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A There is no need to prostate 0 4 purchase pilex overnight explain to prostate mri anatomy cheap pilex children C In palliation for pain in advanced the procedures for which consent has malignancy mens health 4 week six pack purchase pilex 60caps fast delivery, a potential lethal dose of already been given by their parent/ analgesia is appropriate prostate oncology center purchase pilex visa. The obtaining of consent should not be delegated to prostate cancer 46 cheap pilex 60caps without a prescription a junior member of the team who has not performed the procedure androgen hormone 2nd cheap pilex 60caps on-line. Patients must be given information and choices so that they can make subsequent plans and decisions in future. They must be given appropriate and accurate information to agree to undergo surgical treatment and in a language that they can understand. Information should consist of: the condition and the reason for the operation; the type of operation; the prognosis with anticipated side-effects; unexpected complications; any alternative but successful treatment; and the outcome of not having the procedure carried out. Written and verbal communication in the patients preferred language, by the use of an interpreter, should be given with adequate time for patients to mull over the advice given, so as to be able to make up their own mind. Prior to touching a patient for physical examination, consent must be obtained; otherwise it constitutes battery. However, this is unnecessary every time a patient is to be touched while under the care of the surgeon. Implied consent will have been given by the patient once an initial consent has been taken. It is not necessary to inform of every possible hazard, however remote the possibility. Surgeons should inform patients of hazards that any reasonable person in their position would like to know. A signed consent form is no proof that a valid consent has been properly obtained. Surgeons should therefore record in the notes details of information given, particularly about complications. C the surgeon must take care to explain to children in laypersons terms the proposed treatment, and where possible their views should be sought. In the presence of psychiatric illness or mental handicap, the legal guardian can give consent. In patients who are detained for compulsory psychiatric care, their competence to consent to surgical treatment should be assumed and hence consent sought. If they are incompetent to provide consent, then life-saving surgical treatment can proceed. If adult patients are permanently incompetent to give consent for surgery, treatment can proceed to save life or prevent disability. The exception to this rule is when the patient has already drawn up a legally valid document refusing specific intervention a living will. B, C the surgeon is not obliged to provide or continue life-sustaining treatment in the following cases: if doing so is futile; death is imminent and irreversible; there is permanent brain damage. A decision to withhold treatment should be taken in consultation with a senior colleague. There are circumstances when palliation for disseminated and inoperable cancer is becoming increasingly difficult. The management of pain under such circumstances may require analgesia in doses that may cause respiratory depression, thus hastening death. This is legally justifiable on the premise of double effect pain relief and death might follow. A surgeon must not discuss a patients clinical condition with anyone else without the patients explicit consent; to do so would incur the wrath of the General Medical Council. Surgeons may communicate with other members of the multidisciplinary team should this information help in the patients management. Confidentiality cannot be strictly adhered to if doing so poses a serious threat to the health and safety of others, if there is a court order, or in an attempt to prevent serious crime or protect individuals who may be at risk. In orthopaedic imaging, which of the are safer than their higher-osmolality following statements are false D X-ray is the first investigation in D the majority of ionising radiation destructive bone lesions. E Portable X-ray machines use much more F Plain film of a joint is best for suspected radiation to achieve the same result. E Plain X-ray is the first-line investigation for suspected perforation or obstruction. The majority of ionising radiation in the human comes from natural sources, medical exposure accounting for only 12 per cent. Along with fluoroscopy, these imaging equipments use much more radiation to obtain the same result. A Different soft tissues cannot be reliably distinguished as all soft tissues contain the same quantity of water. In certain circumstances, however, such as mammography, by manipulating the X-ray systems and X-ray energies, differentiation between the different types of soft tissues can be obtained. Special transducers have been developed for intracavitary imaging, such as transvaginal, transrectal and endoscopic (of oesophagus and stomach). B, C, E Ultrasound has its drawbacks: it is very operator-dependent; the information is mostly useful during the actual scanning process so that images cannot be reliably reviewed by looking at static pictures; it does not go through air and bone; resolution depends upon the machine used; and the process has a long learning curve. Computed tomography scan has a high contrast resolution, allowing the assessment of tissues with similar attenuation characteristics. The injection of contrast allows images at various phases of the blood supply, the early arterial phase, for example, in vascular liver lesions and the delayed pictures for solid renal lesions. Magnetic resonance imaging gives excellent contrast resolution without any radiation hazard. It lends itself to imaging particularly of tissues with relatively little natural contrast. Those patients with metallic implants cannot be examined because the investigation entails the use of high-strength magnetic fields. The chosen radionuclide technetium, gallium, thallium, iodine is coupled with other compounds and administered intravenously for it to be tracked by a gamma camera, thus forming a functional image. A plain X-ray is the first imaging technique when a destructive bone lesion is suspected. When malignancy is suspected, further investigations are mandatory to establish a firm diagnosis. Ultrasound is the most accurate method of assessing acute inflammation of a joint, as a plain film may be normal unless there is bone erosion. Although the areas to be X-rayed will depend upon the mechanism of injury and the condition of the patient (intubated or not), the initial radiographs are X-rays of the chest, an anteroposterior view of the pelvis and the cervical spine (C/S). Computed tomography is the ideal method of imaging intracranial and intra-abdominal injuries and vertebral fractures. Using a multidetector scanner a comprehensive examination of the entire body can be completed in 5 min in far less time than it takes to organise the investigation. C Ultrasound is a good initial imaging for most acute abdominal conditions biliary colic, acute cholecystitis, acute appendicitis, acute pancreatitis and pelvic diseases. Clinical suspicion of perforation of a hollow viscus is best confirmed by an erect chest X-ray or an abdominal X-ray to include the diaphragmatic domes or lateral decubitus film (if the patient is too ill). While the size of nodes (pararectal in rectal cancer or mediastinal in oesophageal cancer) gives an idea of nodal involvement, one cannot be absolutely certain as the enlargement can be due to metastasis or reactive hyperplasia. A Sedation has no significant dangers and E Perforation and haemorrhage are can be used without restrictions. A Young age B Difficult cannulation Antibiotic prophylaxis in C Increased bilirubin D Pancreatic sphincterotomy endoscopy E Balloon dilatation of biliary sphincter. In which of the following should antibiotic prophylaxis not be Recent trends in endoscopy considered Which of the following about recent A Prosthetic heart valves developments in endoscopy are false B Previous history of endocarditis A Chromoendoscopy involves the use of C Severe neutropenia stains or pigments to improve tissue D Chronic liver disease undergoing variceal localisation. Which of the following statements achieves near cellular definition of the regarding endoscopy are true E Balloon enteroscopy permits visualisation B the current state-of-the-art endoscope is of the small bowel but is unable to the fibreoptic endoscope. Endoscopic diagnosis A Barretts oesophagus B Cancer of the oesophagus C MalloryWeiss tear D Peptic stricture E Hiatus hernia F Reflux gastritis G Oesophageal varices H Linitis plastica I Gastrointestinal stromal tumour Choose and match the correct diagnosis with each of the scenarios below: 1 Abnormal veins are seen at the lower end of the oesophagus which are dilated and grape-like. A Medication-induced respiratory depression in elderly patients or those with co-morbidities is the greatest cause of endoscopy-related mortality and hence safe sedation practices are essential. The use of supplemental oxygen and pulse oximetry is essential in all sedated patients. The current guidelines suggest that the dose of sedation is halved in patients over 70 years of age. A trained assistant should be available for patient monitoring throughout the procedure. E the majority of endoscopy can be performed safely without the need for routine antibiotic prophylaxis. However, certain endoscopic procedures are associated with a significant bacteraemia. In fact, the incidence of bacteraemia can be between 34 and 54 per cent after an oesophageal dilatation. Patients with high-risk conditions such as severe neutropenia, prosthetic heart valves or a previous history of infective endocarditis should have prophylaxis for all endoscopic procedures. Patients with moderate-risk conditions such as mitral valve prolapse with leaflet pathology or regurgitation only require antibiotics for procedures which cause significant bacteraemia. The patient will need to stop clopidogrel prior to a colonoscopic polypectomy to minimise the risks of bleeding. Although endoscopy is safe, it is still associated with rare but potentially life-threatening complications such as bleeding, perforation and sedation-related problems. It is hence mandatory to explain the procedure and complications clearly to the patient and take a fully informed signed consent prior to the procedure. E Balloon enteroscopy allows the direct visualisation of, and therapeutic intervention for, the entire small bowel and may be attempted via the oral or the rectal route. Endoscopic diagnosis 1G this may be seen in patients with portal hypertension presenting with haematemesis. The clinical differential diagnoses include duodenal perforation, acute pancreatitis, myocardial infarction and oesophageal perforation. The incidence of adenocarcinoma at the lower end of the oesophagus is presently increasing. There is still some debate about its management but most agree that severe dysplastic changes would be a strong candidate for surgery. This can rarely present with complications such as incarceration, necrosis and perforation. Endoscopic complications 1C, 2A, 3B, 4E, 5D 106 12 Tissue diagnosis Multiple choice questions Specimens for histology Inflammation and cytology 1. Which of the following statements is regarding specimens for histology are untrue A Inflammatory conditions are characterised A They must always be sent fixed in by the predominant cell type. B Cytology has some advantages over B They can be obtained by fine-needle histology. C In an ulcerated tissue, ideally cytology C They are classified as biopsies and and biopsy should be taken from the resections. D Frozen section histology has many D Additional techniques may be necessary disadvantages. E Both macroscopic and microscopic E Special stains may sometimes be findings are reported. B In some instances, an invasive method B It relies on the use of a specific antibody. D There is risk to laboratory personnel D It has a role in the determination of associated with cytology and histology. With regard to microscopic diagnosis, A Electron microscopy is routinely used in which of the following statements are histology. C Study of chromosomes (cytogenetics) B Dysplasia indicates microscopic features can be done using fluorescence in-situ of cancer. Fresh tissue samples are sent for frozen section, when microbiological assessment is necessary as in suspected tuberculosis. In such a situation, a part of an excised lymph node is sent fresh and the remainder is fixed in formalin. Fine-needle aspiration cytology only gives cytology; compared with histology, it has a limited value. While biopsy means any tissue sample, histology specimens are classified as biopsies and resections. Types of biopsy include punch biopsy, as in skin lesions, and core biopsy as in Tru-Cut of breast lump or a prostatic nodule. Biopsy following a resection is usually also therapeutic as in small ulcerated skin lesions. The speed of a diagnosis after frozen section is outweighed by many disadvantages: the patient will not have a preoperative diagnosis and so cannot make an informed choice with regard to the definitive treatment; the tissue is not fixed and so there is a risk of infection to laboratory staff; the quality is inferior, thereby compromising diagnostic accuracy; the procedure is time-consuming. Any specimen sent for histology is first sliced up into parts depending upon the size, fixed in formalin, and after about 24 h a description of the macroscopic appearance is reported. Report from a malignant specimen will include resection margins, tumour, lymph nodal status and neighbouring non-neoplastic tissue. A Tru-Cut biopsy gives histological tissue which helps to grade the tumour, may show the presence of perivascular and lymphovascular invasion, and gives an idea of the oestrogen receptor status.

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Although this terminology predates the recommendations in this document and is at variance with the definition herein, it has been commonly used and understood to include induced termination of pregnancy. However, calculations based on the rates as defined allow a more accurate comparison of practice between health care providers and institutions. Current Reporting Requirements the general fetal death reporting requirements, as of 2005 (Table F-1), should be brought into conformity with the recommendations in this report. Reporting Requirements for Fetal Death According to State or Reporting Area, 2005 ^ Criteria State and Reporting Area Gestational age criteria only All periods Arkansas, Colorado, Georgia, Hawaii, New York, * Rhode Island, Virginia, Virgin Islands 16 weeks or greater Pennsylvania 20 weeks or greater Alabama, Alaska, California, Connecticut, Florida, Illinois, Indiana, Iowa, Maine, Maryland, Minnesota, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Texas, Utah, Vermont, Washington, West Virginia, Wyoming 5 months or greater Puerto Rico (continued) 512 Guidelines for Perinatal Care Table F-1. Reporting Requirements for Fetal Death According to State or Reporting Area, 2005 (continued) Criteria State and Reporting Area Both gestational age and birth weight criteria 20 weeks or greater or 350 g or more Arizona, Idaho, Kentucky, Louisiana, Massachusetts, Mississippi, Missouri, New Hampshire, South Carolina, Wisconsin, Guam 20 weeks or greater or 400 g or more Michigan 20 weeks or greater or 500 g or more District of Columbia Birth weight criteria only 350 g or more Delaware, Kansas, Montana 500 g or more New Mexico, South Dakota, Tennessee|| *Includes New York City, which has separate reporting. State definitions and reporting requirements for live births, fetal deaths, and induced termi nations of pregnancy. Appendix G Federal Requirements for Patient Screening and Transfer* ^77^171^172^175 In 1986, the United States Congress first enacted legal requirements specify ing how Medicare-participating hospitals with emergency services must handle individuals with emergency medical conditions or women who are in labor. Since then, the patient screening and transfer law has undergone numerous refinements and revisions. Physicians should expect that this law will continue to evolve and that there will be additional modifications to it in the future. Requirements for an Appropriate Medical Screening Examination Federal law requires that all Medicare-participating hospitals with a dedicated emergency department must provide an appropriate medical screening exami nation for any individual who comes to the emergency department for medical treatment or examination to determine whether the patient has an emergency medical condition. This examination must be made within the capability of the hospitals emergency department, including ancillary services routinely available to the emergency department. For example, [i]f a hospital has a department of obstetrics and gynecology, the hospital is responsible for adopting procedures under which the staff and resources of that department are available to treat a woman in labor who comes to its emergency department. Therefore, a hospital can determine *Data from Emergency Medical Treatment and Labor Act. Determining Whether a Patient Has an Emergency Medical Condition the legal definition of emergency medical condition is not the same as the medical one. Under the law, it is defined as: A medical condition manifesting itself by acute symptoms of sufficient severity (including severe pain, psychiatric disturbances and/or symptoms of substance abuse) such that the absence of immediate attention could reasonably be expected to result in (A) Placing the health of the individual (or, with respect to a pregnant woman, the health of the woman or her unborn child) in serious jeopardy; (B) Serious impairment to bodily functions; or (C) Serious dysfunction of any bodily organ or part. Special Determination of Emergency Medical Conditions for Pregnant Women the definition of an emergency medical condition also makes specific reference to a pregnant woman who is having contractions. It provides that an emergency medical condition exists if a pregnant woman is having contractions and there is inadequate time to effect a safe transfer to another hospital before deliv ery; or that transfer may pose a threat to the health or safety of the woman or the unborn child. Labor is defined as the process of childbirth beginning with the latent phase of labor or early phase of labor and continuing through delivery of the placenta. A woman experiencing contractions is in true labor unless a physician, certified nurse-midwife, or other qualified medical person acting within his or her scope of practice as defined in hospital medical Appendix G 515 staff bylaws and State law, certifies that, after a reasonable time of observation, the woman is in false labor. Under this definition, a qualified medical person must certify that a woman is in false labor before she can be released. Patients With Emergency Medical Conditions Once a patient comes to an emergency department, is appropriately screened, and is determined to have an emergency medical condition, the physician may do one of two things: 1. Transfer the patient to another medical facility in accordance with spe cific procedures outlined later. In situations in which a pregnant woman is in true labor, her condition will be considered stabilized once the newborn and the placenta have been delivered. Patients Can Refuse to Consent to Treatment If a patient refuses to consent to treatment, the hospital has fulfilled its obliga tions under the law. If a patient refuses to consent to treatment, however, the following three steps must be taken: 1. The patient must be informed of the risks and benefits of the examina tion or treatment or both. The medical record must contain a description of the examination and treatment that was refused by the patient. The hospital must take all reasonable steps to secure the patients written informed refusal. The written document must indicate that the indi vidual has been informed of the risks and benefits of the examination or treatment or both. Procedures for Transferring a Patient to Another Medical Facility In general, a patient who meets the criteria of an emergency medical condition may not be transferred until he or she is stabilized. The patient may request a transfer, in writing, after being informed of the hospitals obligations under the law and the risks of transfer. The unstabilized 516 Guidelines for Perinatal Care patients written request for transfer must indicate the reasons for the request and that the patient is aware of the risks and benefits of transfer. An unstabilized patient also may be transferred if a physician signs a written certification that based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. If a physician is not physically present in the emergency department at the time of the transfer of a patient, a qualified medical person can sign the certi fication described previously after consulting with a physician who authorizes the transfer. The physician must countersign the certification as contemporane ously as possible. Patients Can Refuse to Consent to Transfer If the hospital offers to transfer a patient, in accordance with the appropriate procedures, and the patient refuses to consent to transfer, the hospital also has fulfilled its obligations under the law. When a patient refuses to consent to the transfer, the hospital must take the following three steps: 1. The medical record must contain a description of the proposed transfer that was refused by the patient. The hospital must take all reasonable steps to secure the patients writ ten informed refusal. The written document must indicate that the individual has been informed of the risks and benefits of the transfer and the reasons for the patients refusal. Additional Requirements of the Transferring and Receiving Hospitals the transferring hospital must comply with the following three requirements to ensure that the transfer was appropriate: 1. The receiving hospital must have space and qualified personnel to treat the patient and must have agreed to accept the transfer. A hospital with specialized capabilities, such as a neonatal intensive care unit, may not refuse to accept patients if space is available. The transferring hospital must minimize the risks to the patients health, and the transfer must be executed through the use of qualified personnel and transportation equipment. The transferring hospital must send to the receiving hospital all medical records related to the emergency condition that are available at the time of transfer. These records include available history, records related to the emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and informed written consent or certification, and the name of any on-call physician who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Medical records related to transfers must be retained by both the trans ferring and receiving hospitals for 5 years from the date of the transfer. Hospitals are required to report to the Centers for Medicare and Medicaid Services or the state survey agency within 72 hours from the time of the transfer any time they have reason to believe they may have received a patient who was transferred in an unstable medical condi tion. Hospitals are required to post signs in areas, such as entrances, admit ting areas, waiting rooms, and emergency departments, with respect to their obligations under the patient screening and transfer law. Hospitals also are required to post signs stating whether the hospital participates in the Medicaid program under a state-approved plan. This requirement applies to all hospitals, not only those that participate in Medicare. Hospitals must keep a list of physicians who are on call after the initial examination to provide treatment to stabilize a patient with an emer gency medical condition. Hospitals must keep a central log of all individuals who come to the emergency department seeking assistance and the result of each indi viduals visit. A hospital may not delay providing appropriate medical screening to inquire about payment method or insurance status. Enforcement and Penalties Physicians and hospitals violating these federal requirements for patient screen ing and transfer are subject to civil monetary penalties of up to $50, 000 for each violation and to termination from the Medicare program. Hospitals are prohib ited from penalizing physicians who report violations of the law or who refuse to transfer an individual with an unstabilized emergency medical condition. Appendix H Occupational Safety and Health Administration Regulations on Occupational Exposure to Bloodborne Pathogens* In 1970, the U. Congress enacted the Occupational Safety and Health Act to protect workers from unsafe and unhealthy conditions in the workplace. The Occupational Safety and Health Administration has the responsibility for developing and implementing job safety and health standards and regulations. It also maintains a reporting and record keeping system to monitor job-related injuries and illnesses. The regulations cover all employees in physician offices, hospitals, medical laboratories, and other health care facilities where workers could be reasonably anticipated as a result of performing their job duties to come into contact with blood and other poten tially infectious materials. The regulations were revised, effective April 2001, to comply with the Needlestick Safety and Prevention Act of 2000. Complying With the Regulations Exposure Control Plan In order to comply with the regulations, health care employers are required to prepare a written Exposure Control Plan designed to eliminate or minimize employee exposure to bloodborne pathogens. This plan must list all job clas sifications in which employees are likely to be exposed to infectious materials and the relevant tasks and procedures performed by these employees. Appendix H 521 Under the plan, employers are required to adopt universal precautions, engin eering and work practice controls, and personal protective equipment require ments. Employers also must establish a schedule for implementing the following controls: Housekeeping requirements Employee training and record-keeping requirements Hepatitis B virus vaccination for employees and postexposure evaluation and follow-up procedures Communication of hazards A detailed discussion of each of these requirements follows. The Exposure Control Plan must be reviewed annually and updated to reflect changes in technology that eliminate or reduce exposure to bloodborne patho gens. The employer must document this annual consideration and use of appropriate effective safer medical procedures and devices that are commer cially available. In designing and reviewing the Exposure Compliance Plan, the employer must solicit input from nonmanagerial employees who are potentially exposed to injuries from contaminated sharps. Employers must document, in the Exposure Control Plan, how they received input from employees. Mandatory Universal Precautions the regulations require that universal precautions must be used to prevent contact with blood or other potentially infectious materials. As defined by the Centers for Disease Control and Prevention, the concept of universal precautions requires the employer and employee to assume that blood and other body fluids are infectious and must be handled accordingly. Engineering and Work Practice Controls Specific engineering and work practice controls for the workplace must be implemented and examined for effectiveness on a regular schedule. Employers are required to provide hand-washing facilities that are read ily accessible to employees; when this is not feasible, employees must be provided with an antiseptic hand cleanser with clean cloth/paper towels 522 Guidelines for Perinatal Care or antiseptic towelettes. It is the employers responsibility to ensure that employees wash their hands immediately after gloves and other protec tive garments are removed. Contaminated needles and other contaminated sharp objects shall not be bent, recapped, or removed unless the employer can demonstrate that no alternative is feasible or that a specific medical procedure requires such action. Recapping or needle removal must be accomplished by a mechanical device or a one-handed technique. Contaminated reusable sharp objects shall be placed in appropriate containers until properly reprocessed; these containers must be puncture resistant, leakproof, and labeled or color-coded in accordance with the regulations for easy identification. Eating, drinking, smoking, applying cosmetics or lip balm, and han dling contact lenses are prohibited in work areas where there is a reason able likelihood of exposure to potentially infectious materials. Food and drink must not be kept in refrigerators, freezers, shelves, cabinets, or on countertops where blood or other potentially infectious materials are present. All procedures involving blood or other infectious materials shall be performed in a manner to minimize splashing, spraying, spattering, and creating droplets; mouth pipetting and suctioning of blood or other potentially infectious materials is prohibited. Specimens of blood or other potentially infectious materials must be placed in closed containers that prevent leakage during collection, handling, processing, storage, transport, or shipping; containers must be labeled or color-coded in accordance with the regulations for easy identification. However, when a facility uses universal precautions in the handling of all specimens, the required labeling or color coding of specimens is not necessary as long as containers are recognizable as containing specimens; this exemption applies only while the specimens and containers remain in the facility. If outside contamination of the primary container occurs, it must be placed within a second container that is leakproof, puncture resistant, and labeled or color-coded accord ingly. Equipment that could be contaminated with blood or other infectious materials must be examined before servicing or shipping and shall be decontaminated as necessary, unless the employer can demonstrate that decontamination of the equipment or parts of the equipment is not Appendix H 523 feasible. A visible label must be attached to the equipment stating which parts remain contaminated. The employer must ensure that this infor mation is conveyed to all affected employees, the servicing representa tive or the manufacturer or both before handling, servicing, or shipping so that the necessary precautions will be taken. Personal Protective Equipment the regulations also stress the importance of appropriate personal protective equipment that employers are required to provide at no cost to employ ees whose job duties expose them to blood and other infectious materials. Appropriate personal protective equipment includes but is not limited to gloves, gowns, laboratory coats, face shields or masks, eye protection, mouthpieces, resuscitation bags, pocket masks, or other ventilation devices. Employers must ensure that the employee uses appropriate personal pro tective equipment unless the employer can demonstrate that the employee temporarily declined to use the equipment, when under rare and extraordinary circumstances, it was the employees professional judgment that use of personal protective equipment would have prevented the delivery of health care services or would have posed an increased hazard to the safety of the worker or co worker. When an employee makes this judgment, the circumstances shall be investigated and documented in order to determine whether changes can be made to prevent such situations in the future. Personal protective equipment in the appropriate sizes must be accessible at the worksite or issued to employees. Hypoallergenic gloves, glove liners, powder less gloves, or other similar alternatives, shall be accessible to those employees who are allergic to the gloves normally provided. The employer shall provide for laundering and disposal of personal protective equipment, as well as repair and replace this equipment when necessary to maintain its effectiveness, at no cost to the employee. If a garment(s) is penetrated by blood or other infectious materi als, it must be removed immediately or as soon as feasible. All personal protective equipment must be removed before leaving the work area, whereupon it shall be placed in a designated area or storage container for washing or disposal. Gloves must be worn when it reasonably can be anticipated that the employee may have hand contact with blood, other potentially infectious mate 524 Guidelines for Perinatal Care rials, mucous membranes, and nonintact skin; when performing vascular access procedures; and when handling or touching contaminated surfaces. Disposable gloves shall be replaced as soon as practical when contaminated or when torn or punctured; they shall not be washed or decontaminated for reuse. Utility gloves may be decontaminated for reuse but must be discarded if a glove is cracked, peeling, torn, punctured, or shows other signs of deterioration.

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Service description/care pathway All paediatric specialised services have a component of primary man health news disqus cheap 60 caps pilex with visa, secondary androgen hormone questions purchase 60 caps pilex otc, tertiary and even quaternary elements mens health 7 tests of true strength pilex 60caps with visa. The efficient and effective delivery of services requires children to prostate weight cheap 60caps pilex mastercard receive their care as close to prostate cancer questionnaire pilex 60 caps line home as possible dependent on the phase of their disease prostate oncology kingston purchase pilex overnight delivery. Specialist acute pain services for babies and children are organised within existing departments of paediatric anaesthesia and include the provision of agreed (hospital wide) guidance for acute pain, the safe administration of complex analgesia regimes including epidural analgesia, and the daily input of specialist anaesthetists and acute pain nurses with expertise in paediatrics. Accommodation, facilities and staffing must be appropriate to the needs of children and separate from those provided for adults. Each hospital who admits inpatients must have appropriate medical cover at all times taking account of guidance from relevant expert or professional bodies (National Minimum Standards for Providers of Independent Healthcare, Department of Health, London 2002). Staff must carry out sufficient levels of activity to maintain their competence in caring for children and young people, including in relation to specific anaesthetic and surgical procedures for children, taking account of guidance from relevant expert or professional bodies (Outcome 14g Essential Standards of Quality and Safety, Care Quality Commission, London 2010). Providers must have systems in place to gain and review consent from people who use services, and act on them (Outcome 2a Essential Standards of Quality and Safety, Care Quality Commission, London 2010). These must include specific arrangements for seeking valid consent from children while respecting their human rights and confidentiality and ensure that where the person using the service lacks capacity, best interest meetings are held with people who know and understand the person using the service. Staff should be able to show that they know how to take appropriate consent from children, young people and those with learning disabilities (Outcome 2b) (Seeking Consent: working with children Department of Health, London 2001). Children and young people must only receive a service from a provider who takes steps to prevent abuse and does not tolerate any abusive practice should it occur (Outcome 7 Essential Standards of Quality and Safety, Care Quality Commission, London 2010 defines the standards and evidence required from providers in this regard). Providers minimise the risk and likelihood of abuse occurring by: Ensuring that staff and people who use services understand the aspects of the safeguarding processes that are relevant to them Ensuring that staff understand the signs of abuse and raise this with the right person when those signs are noticed. Implementation is also expected to contribute to improvements in health inequalities and public health outcomes. When children and young people who use paediatric services are moving to access adult services (for example, during transition for those with long term conditions), these should be organised so that: All those involved in the care, treatment and support cooperate with the planning and provision to ensure that the services provided continue to be appropriate to the age and needs of the person who uses services. All hospital settings should meet the Standards for the Care of Critically Ill Children (Paediatric Intensive Care Society, London 2010). These require: A choice of suitable and nutritious food and hydration, in sufficient quantities to meet service users needs; Food and hydration that meet any reasonable requirements arising from a service users religious or cultural background Support, where necessary, for the purposes of enabling service users to eat and drink sufficient amounts for their needs. For children, these should include specific arrangements that: Ensures the medicines given are appropriate and person-centred by taking account of their age, weight and any learning disability Ensures that staff handling medicines have the competency and skills needed for children and young peoples medicines management Ensures that wherever possible, age specific information is available for people about the medicines they are taking, including the risks, including information about the use of unlicensed medicine in paediatrics. Providers should ensure that: They are supported to have a health action plan Facilities meet the appropriate requirements of the Disability Discrimination Act 1995 They meet the standards set out in Transition: getting it right for young people. These may be classified as below: Non-spinal Hospital: A local hospital that has an Emergency department, orthopaedic and trauma services which are capable of basic assessment of acute spinal conditions, but does not perform spinal surgery. Areas will develop robust pathways routing these patients to the appropriate hospital for their surgery relative to their varying presentations. Only when spinal hub hospitals have sufficient elective work to support the on-call service will additional work be commissioned with spinal spoke hospitals and other providers. It is necessary to understand the type of patients who are receiving treatment for spinal conditions and where and how they are accessing this treatment. It has also been considered helpful to cluster types of treatment into a number of broad categories, which indicate which area of specialist care can provide the service. The procedures carried out within each of these sub groups has been reviewed to identify whether they would meet the criteria for a specialised or non specialised service. The detailed procedure coding related to each of these has also been reviewed in order to ensure that the split of activity can be allocated to the responsible commissioner and the results are attached as an annex to this scope. Revision surgery: Revision cervical and lumbar decompressions are non-specialised i. Therefore revision surgery with instrumentation for lumbar fusion for 2 levels or under is classed as non specialised. Cervical, Thoracic and Anterior Lumbar surgery: All thoracic and anterior lumbar surgery is specialised. Some specific guidelines have been produced by recognised bodies, including specialist organisations. Spinal Deformity Surgery All spinal deformity surgery is considered specialised in adults and children. Otherwise, the surgical procedures should be considered specialised or non specialised as for their adult spinal surgery. However, before these non specialised procedures are performed discussion with one of the network specialised spinal centres should occur. The only procedures performed in these conditions which are considered non-specialised in degenerative spinal surgery but should be considered specialised in tumour, trauma and infection are anterior and posterior cervical decompression/discectomy and posterior instrumented lumbar fusion. Curative or potentially curative oncological surgery this is highly specialised work which shall be located in only a small number of centres in England. There needs to be further discussion as to whether these are considered in the Specialised Spinal Surgery Scope or considered in the Specialised Paediatric Neurosciences and Neurosciences Scopes. While every effort has been made to ensure the accuracy of the information contained within this publication, neither the authors nor the publishers can accept liability for errors or omissions. The final responsibility for delivery of the correct dose remains with the physician prescribing and administering the drug. In every individual case the respective user must check current indications and accuracy by consulting other pharmaceutical literature and following the guidelines laid down by the manufacturers of specific products and the relevant authorities in the country in which they are practising. Technological and other developments in the diagnosis of fetal abnormalities 17 6. Feticide 29 References 32 Glossary 35 vi Remit and Membership Remit of the Working Party 1. To review the Working Party Report, Termination of Pregnancy for Fetal Abnormality in England, Wales and Scotland (published in January 1996). To review all evidence submitted to the Science and Technology Committee relating to the Abortion Act 1967. To review all other relevant evidence relating to advances in antenatal screening and fetal and neonatal management, including corrective surgery. It is designed to be explanatory rather than prescriptive and does not purport to give ethical guidance. Improved imaging, with follow-up of specific abnormalities, has led to a better understanding of their natural history, a more accurate assessment of prognosis and better informed counselling. In addition, antenatal screening has expanded and improved and is now part of routine antenatal care. The law relating to termination of pregnancy has not changed since 1990 although it has been tested in a number of specific cases. The 1967 Abortion Act, as amended, sets out the grounds and time limits for termination of pregnancy, as well as stating who can perform an abortion and where it can be performed. Termination of pregnancy for fetal abnormality may only be considered if there is a substantial risk that the child, if born, would suffer physical or mental abnormalities that would result in serious handicap. Termination for fetal abnormality will only be lawful, except in an emergency, when the two practitioners, who testify by signing the certificate of opinion form, believe in good faith that the grounds for termination of pregnancy are met. Whether a risk will be regarded as substantial may vary with the seriousness and consequences of the likely disability. An assessment of the seriousness of a fetal abnormality should be considered on a case-by-case basis, taking into account all available clinical infor mation. More recently, three dimensional ultrasound technology has been introduced for diagnostic purposes, although its exact role remains unclear. Magnetic resonance imaging can be effective as an adjunct to ultra sound in diagnosing and evaluating structural abnormalities, particularly those involving the fetal central nervous system. Progress in fetal diagnosis is improving knowledge of the natural history of many fetal disorders. While amniocentesis, chorionic villus sampling and fetal blood sampling remain standard methods for the diagnosis of aneuploidy, noninvasive techniques are being developed which should reduce the need for invasive procedures in the future. All women should be provided with information about the purpose and potential outcomes of antenatal screening tests to detect fetal abnormalities and should have an opportunity to discuss their options, before the test is performed (section 6). A robust management pathway must be in place to ensure that appropriate information and support are available. For most major fetal abnormalities, referral to a doctor with expertise in fetal medicine is recommended (section 6). All practitioners performing fetal anomaly ultrasound screening should be trained to impart information about abnormal findings to women and a health professional should be available to provide immediate support to the woman and her partner (section 6). Optimal care for women after a diagnosis of fetal abnormality relies on a multidisci plinary approach. Those involved should be clear about their own roles and should ensure that the woman is carefully guided along a planned care pathway by fully briefed and supportive staff (section 6). All staff involved in the care of a woman or couple facing a possible termination of pregnancy must adopt a non-directive, non-judgemental and supportive approach (section 6). It should not be assumed that, even in the presence of an obviously fatal fetal condition such as anencephaly, a woman will choose to have a termination. A decision to decline the offer of termination must be fully supported (section 6). Live birth following termination of pregnancy before 21+6 weeks of gestation is very uncommon. Nevertheless, women and their partners should be counselled about this unlikely possibility and staff should be trained to deal with this eventuality (section 8). Live birth becomes increasingly common after 22 weeks of gestation and, when a decision has been reached to terminate the pregnancy for a fetal abnormality after 21+6 weeks, feticide should be routinely offered. Where the fetal abnormality is not compatible with survival, termination of pregnancy without prior feticide may be preferred by some women. In such cases, the delivery management should be discussed and planned with the parents and all health professionals involved and a written care plan agreed before the termination takes place (section 8). Where the fetal abnormality is not lethal and termination of pregnancy is being under taken after 21+6 weeks of gestation, failure to perform feticide could result in live birth and survival, an outcome that contradicts the intention of the abortion. In such situa tions, the child should receive the neonatal support and intensive care that is in the childs best interest and its condition managed within published guidance for neonatal practice. A fetus born alive with abnormalities incompatible with life should be managed to maintain comfort and dignity during terminal care (section 8). After a termination for fetal abnormality, well-organised follow-up care is essential (section 6). The Working Party recognises the need for the National Health Service Fetal Anomaly Screening Programmes to be linked to databases that enable detection rates of specific congenital abnormalities to be monitored and the impact of the programmes to be evaluated. An appropriately funded and centrally coordinated system of congenital anomaly x ascertainment that covers all parts of the country is essential (section 4). Outcome data on children born with specific abnormalities are required to provide better information on natural history and prognosis. The Working Party recommends that the envisaged 2-year data collection for preterm infants should be expanded to collect outcome data for infants with abnormalities (section 4). Abortion statistics for England and Wales for 2008 report that 124 terminations for fetal anomalies (Ground E) were performed of pregnancies over 24 weeks of gestation. As numbers in most categories of abnormality were fewer than ten, the nature of the abnor malities is not disclosed and trends or patterns in termination cannot be determined. We recommend that such information is published in the Department of Health Abortion Statistics on a 3 and 6-year cycle (section 4). Introduction the Working Party was set up by the Royal College of Obstetricians and Gynaecologists in 2008 to produce updated guidance on the termination of pregnancy for fetal abnormality, taking into account changes that have occurred since the College report of 1996. The report is also designed to help staff to provide appropriate care both for those women who elect to have an abortion as well as those who decide not to have the pregnancy terminated. Over the 13 years since the last guidance was issued, there has been a range of developments in the detection and treatment of congenital abnormalities that has resulted in earlier diagnosis and clearer indications for the offer of termination of pregnancy. Data from improved imaging with follow-up of specific abnormalities has allowed a better understanding of the natural history of many fetal abnormalities and has resulted in a more accurate assessment of prognosis and better informed counselling. In addition, screening is now an integral part of routine antenatal care and most women accept the offer of screening. This has resulted in the development of clear auditable standards for fetal anomaly screening and better access for women. The Department of Healths abortion statistics show that in 2008 there were 195 296 abortions to residents in England and Wales (18. Of the total number of terminations, around 1% (1988) were performed under Section 1(1)(d), known as Ground E, of the Abortion Act (see section 2 of this report), namely that there was a substantial risk that, if the child were born, it would suffer physical or mental abnormalities that would result in serious handicap. However, despite improved antenatal screening programmes to detect fetal anomalies, there has been little change in the number of abortions carried out under Ground E over the past 5 years. In 2008, for residents of England and Wales, 1308 of the 1988 (66%) terminations of pregnancy for fetal abnormality were performed before 20 weeks of gestation; 309 (16%) were carried out in the first 12 weeks. Terminations performed over 24 weeks for fetal anomaly have remained constant at 124137/year between 2002 and 2008 (Figure 1). About one-third (37%) of pregnancies terminated under Ground E were reported to be for chromosomal abnormalities. Trisomy 21 (Down syndrome) was the most common reported chromosomal abnormality and accounted for 22% of all Ground E cases. Structural abnor malities accounted for 48% of terminations in this group; most were for nervous system (24%) and musculoskeletal system abnormalities (7%). Structural abnormalities constitute a major cause of mortality, accounting for about 23% of neonatal deaths and 16% of stillbirths in 2006. Of these, 28 were for trisomy 21, 86 for other chromosomal anomalies and 38 for neural tube defects and other abnormalities. Legal status of termination of pregnancy the law governing termination of pregnancy by doctors is found in four different Acts of Parliament: G the Offences Against the Person Act 1861 G the Infant Life (Preservation) Act 1929 G the Abortion Act 1967 G the Human Fertilisation and Embryology Act 1990. The Offences Against the Person Act 1861, Section 58, prohibits the unlawful medical or surgical induction of a miscarriage. The Infant Life (Preservation) Act 1929 makes it an offence to destroy the life of a child capable of being born alive but, in defence, specifies that no person shall be found guilty of an offence under this section unless it is proved that the act which caused the death of the child was not done in good faith for the purpose only of preserving the life of the woman.

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