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Pharmacy-managed patient-controlled analgesia service.

The implementation and functioning of a patient-controlled analgesia (PCA) service operated by staff pharmacists are described. The pharmacy-managed PCA service was introduced into the hospital in 1988. Pharmacists initiate PCA therapy upon physician request. Standard narcotic-dosing guidelines were developed for patients receiving PCA; criteria were also developed to allow the pharmacist to adjust the narcotic dose based upon the patient's response. The dosing guidelines were approved by the pharmacy and therapeutics committee. A hospitalwide education program introduced nurses and physicians to the pharmacy-managed PCA service. Of 299 patients who received PCA therapy in 1989, more than 90% were managed by staff pharmacists. Pharmacists calculate and program initial narcotic doses and are responsible for daily patient monitoring to determine the success of therapy. Using the established guidelines, pharmacists adjust the narcotic dose based upon patient response. A quality assurance review of the PCA service has documented its safety and success. A pharmacy-managed PCA service has increased the clinical involvement of pharmacists and provided safe and effective pain management for postsurgical patients.

Analgesia, Patient-Controlled↗

Cost containment in microbiology.

Prospective reimbursement will impose an additional challenge on clinical microbiologists. In order to avoid an inevitable decrease in quality and increasing delay in providing results of examination of specimens, efforts must be undertaken to restrict the submission of specimens and the extent of work that is performed to that which is cost effective for patient care. This will require education and the introduction by the laboratory of controls on ordering and specimen submission. Laboratory personnel must also establish criteria to limit the extent of specimen processing to the production of information that can be expected to be clinically useful. This will involve a close interaction with infectious disease services and clinical departments. Introduction of new screening tests, rapid antigen detection procedures, computers, and automation may provide some increase in productivity but cannot be expected to solve the entire problem. Currently, most attention to controlling hospital cost is being given to the length of patient stay, and little progress has been made in establishing more effective communication between laboratory staffs, house staffs, medical staffs, and hospital administration in monitoring and controlling misuse of laboratory resources.

Clinical Laboratory Techniques↗

Perspectives on the U.S. FDA Bioresearch Monitoring Program.

An overview is presented of the U.S. FDA Bioresearch Monitoring Program from the field perspective. The presentation includes current insight as to how FDA conducts field audits in various program areas and observations regarding shared responsibilities for ensuring both quality data and patient safety during the preclinical and clinical investigation processes.

Clinical Trials as Topic↗

The use of total quality principles to achieve regulatory compliance in research laboratories.

Since the late 1980s, the U.S. Food and Drug Administration (FDA) has increased its focus on regulatory compliance. This is evidenced by an increase in warning letters, product seizures, injunctions, prosecutions, and recalls. This increased level of FDA enforcement activity is evidenced across all of the compliance regulations. Thus, the ability to comply with the Good Laboratory Practices (GLPs). Good Clinical Practices (GCPs) and Good Manufacturing Practices regulations could result in FDA enforcement activities and delays in the approval process for new products. Therefore, the ability to achieve compliance with the GLPs, GCPs, and GMPs in research laboratories is a key to business success in the 1990s. Applying the principles of total quality is one way to address these important business issues. The principles of total quality (customer focus, improvement, involvement, leadership, and measurement) provide a methodology for ensuring success in a rapidly changing regulatory environment. The FDA needs to be treated as a customer by research organizations. Valid regulatory requirements need to be negotiated with the agency. Once these customer requirements have been identified, the quality unit needs to play a leadership role in translating these requirements into action plans. Quality units, no matter how skillful or good, cannot achieve success without involvement of the scientific staff and management group of their organizations. Without their involvement there will be no organizational commitment to compliance programs undertaken to meet the valid requirements of the FDA. Meeting these valid customer requirements will require improvement efforts. The many tools of quality improvement in achieving the desired improvements.(ABSTRACT TRUNCATED AT 250 WORDS)

Clinical Trials as Topic↗

Preparing for and handling the results of regulatory inspections of biomedical facilities.

Although there have been numerous presentations on how to conduct and survive a government inspection, it appears that these sessions do not always adequately include suggestions from those who have been the subjects of regulatory inspections. This paper will include comments from the experience of one of the regulated. Remarks apply to experience with U.S. regulatory authorities, principally the U.S. Food and Drug Administration (FDA) and the U.S. Environmental Protection Agency (EPA). This paper attempts to give guidance on how to prepare for an inspection and what to do at the debriefing and after the inspector(s) leave your facility.

Communication↗

Reporting and scheduling in-study inspections with the study director using microsoft Excel.

Our Environmental and Metabolic Fate division conducts a variety of different studies that can require between 1 month and 3 years to complete. Our master schedule for this division can contain as many as 50-75 of these studies. Since the Good Laboratory Practices (GLP) regulations require in-study inspections at intervals adequate to assure study integrity and our quality assurance unit (QAU) standard operating procedure (SOP) requires us to monitor studies that last longer than 3 months at least once a quarter, in-study inspection scheduling can be challenging. In order to keep up with the work load described we have developed a method using a spreadsheet program, Excel, to facilitate in-study inspection scheduling through periodic reporting of all QAU inspection activity to the study director. This report makes the scheduling of critical phase and quarterly inspections a cooperative effort between the study director and QAU auditor. The details of the development and utilization of Excel for these "in-study inspection tracking reports" are presented.

Facility Regulation and Control↗

Excerpts from Maintaining Radiation Protection Records. National Council on Radiation Protection and Measurements.

This is the first of a three-part series of articles from a report by the NCRP, to be reprinted in successive issues of Radiology Management. The report offers practical recommendations for establishing a radiation safety program. Different aspects of record-keeping, an essential part of all radiation safety programs, will be highlighted in each article. The introduction and a chapter on the systematic generation of records are included in this issue.

Facility Regulation and Control↗

Analysis of sharps injury occurrences at a hospital in Singapore.

Relatively little attention has been directed to investigating the risks of sharps injuries in Singapore. This study examines the epidemiology and causes of sharps injuries at a university teaching hospital. The type of instruments, site of injuries and personnel involved in each sharps injury were determined retrospectively by reviewing the Incident Reports forms and Infection Control records between 1997 and 2000. Descriptive information on the forms and records were extracted and collected on standard charts. The data were then analysed using SPSS Windows software. The rates of sharps injuries were 11.0 per 100 medical staff and 6.9 per 100 nursing staff. Medical staff yielded highest proportion of sharps injuries rendering 33 cases (40.2%), followed by 24 cases involving nursing staff (29.3%) and 12 cases of nursing students (14.6%). In total, 62.2% of injuries were caused by hollow bore needles (51 cases). Non-hollow bore needle injuries only accounted for 17.1% of total injuries (14 cases). Hollow bore needles accounted for the highest proportion of sharps injuries in this study, corresponding to findings in other studies. Rates of injuries were similar to the rates found at another local hospital. At the hospital studied, sharps with safety features had effectively produced no reported cases of sharps injuries.

Catchment Area, Health↗

Privacy Act of 1974; new system of records--Department of Health and Human Services; Public Health Service. Notification of a new system of records: 09-25-0143.

In accordance with the requirements of the Privacy Act, the Public Health Service (PHS) is publishing notice of a proposal to establish a new system of records, 09-25-0143, Biomedical Research: Records of Subjects in Clinical, Epidemiologic and Biometric Studies of the National Institute of Allergy and Infectious Diseases, HHS/NIH/NIAID. We are also proposing routine uses for this system. This system will be used to support (1) epidemiologic, clinical and biometric investigations into the causes, nature (morbidity and mortality), outcome, therapy and cost of infectious, immunologic and related diseases; (2) review and evaluation of the progress of these research projects, and identification and planning for improvements or for additional research. The population and statistical studies supported by this system may be conducted or managed by Institute staff as well as others outside the Institute. This system comprises records maintained in a number of distinct research projects. The number and specific nature of projects will change over time as new ones are started and as work on existing projects is completed.

Communicable Disease Control↗

AIDS and confidentiality.

As the AIDS epidemic within Australia grows, a concerted effort should be made to preserve confidentiality of medical records for patients who are HIV positive. A significant number of the AIDS patients in Victoria are treated at Fairfield Hospital. Infected individuals need to retain control over disclosure of their HIV infection status to ensure that any adverse consequences such as discrimination are minimised. Stringent confidentiality procedures should be established and enforced by every Australian Health Care Institution.

AIDS Serodiagnosis↗