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PubMed2002

Deferred standards, an on-line qualification, validation and system stability probe for chromatographic assay.

Specific programming of automated HPLC systems allows total on-line qualification, validation and stability monitoring using the concept of deferred standards. Setting up such a process for routine analyses in an automated HPLC system requires specific autosampler programming as well as specific monitoring software. With an autosampler, a double injection procedure is programmed, the first introducing the sample, and the second, a few minutes deferred, the deferred control standard. Two additional compounds are therefore added to the sample before and during the chromatographic process: the intemal standard for sample quantification and the deferred standard for system control. Specific methodologies are described of how to obtain classical quantitative analysis information as well as system qualification validation stability information. Experiments were performed to develop specified methodologies to monitor the quality of quantitative analysis during the life of the column by using the deferred standard concept to probe the effects of column ageing on separation characteristics.

Automation↗
PubMed1990

The advent of clinical standards for professional liability.

The development of clinically based written standards to reduce the frequency and severity of medical malpractice loss appears to be gaining in popularity among provider specialty groups and professional liability underwriters. To date, such standards have addressed problems in specialties such as obstetrics and anesthesia where dollar losses associated with malpractice claims have been high. Guidelines can be developed and used by providers on a purely voluntary basis or mandated on an involuntary basis by third parties such as malpractice insurance companies or legislators. Because the advent of risk-control standards is a relatively new phenomenon, formal scientific studies on the long-term benefits of such guidelines have not yet been published. However, it appears that sharp reductions of malpractice losses in specialties such as anesthesia have coincided with the implementation of formal written standards specifically designed for liability control. This has led some liability insurance carriers to decrease premiums associated with specialists following such standards. Many providers are understandably concerned about the potential use of written standards by plaintiff attorneys in medical malpractice suits. Although it is possible that such policies and guidelines could be admitted into evidence to show that a provider breached the legal duty or standard of care owed to a patient, it is uncertain whether these risk-control standards could ultimately pass the evidentiary rules of relevancy or materiality in a given lawsuit. It is clear, however, that the consensus-based process of creating clinical standards and guidelines specifically for controlling professional liability losses is itself a powerful and emerging standard for health care risk management programs.

Clinical Competence↗
PubMed2006

Analysis of primary fine particle national ambient air quality standard metrics.

In accordance with the Clean Air Act, the U.S. Environmental Protection Agency (EPA) is currently reviewing its National Ambient Air Quality Standards for particulate matter, which are required to provide an adequate margin of safety to populations, including susceptible subgroups. Based on the latest scientific, health, and technical information about particle pollution, EPA staff recommends establishing more protective health-based fine particle standards. Since the last standards review, epidemiologic studies have continued to find associations between short-term and long-term exposure to particulate matter and cardiopulmonary morbidity and mortality at current pollution levels. This study analyzed the spatial and temporal variability of fine particulate (PM2.5) monitoring data for the Northeast and the continental United States to assess the protectiveness of various levels, forms, and combinations of 24-hr and annual health-based standards currently recommended by EPA staff and the Clean Air Scientific Advisory Committee. Recommended standards have the potential for modest or substantial increases in protection in the Northeast, ranging from an additional 13-83% of the population of the region who are living in areas not likely to meet new standards and thereby benefiting from compliance with more protective air pollution controls. Within recommended standard ranges, an optimal 24-hr (98th percentile)/annual standard suite occurs at 30/12 microg/m3, providing short- and long-term health protection for a substantial percentage of both Northeast (84%) and U.S. (78%) populations. In addition, the Northeast region will not benefit as widely as the nation as a whole if less stringent standards are selected. Should the 24-hr (98th percentile) standard be set at 35 microg/m3, Northeast and U.S. populations will receive 16-48% and 7-17% less protection than a 30 microg/m3 standard, respectively, depending on the level of the annual standard. A 30/12 microg/m3 standard suite also provides nearly equivalent 24-hr and annual control of PM2.5 distributions across the United States, thereby ensuring a more uniform and consistent level of protection than unmatched or "controlling" and "backstop" standards. This could occur even within EPA staff's recommended range of standard suites, where 22-43% of the monitors in the country could meet a controlling standard but fail to meet the combined backstop standard, resulting in inconsistent short- and long-term protection across the country. An equivalent standards combination of 30/12 microg/m3 would minimize the wide variation of protectiveness of 24-hr and annual PM2.5 concentrations. Furthermore, given recent associations of subdaily exposures and acute adverse health effects, in the absence of a subdaily averaging metric, a stringent 24-hr standard will more effectively control maximum hourly and multihourly peak concentrations than a weaker standard.

Air Pollutants↗
PubMed1995

Joint Commission on Accreditation of Healthcare Organizations.

The Joint Commission on Accreditation of Healthcare Organizations was founded in 1951 as a private, not-for-profit organization that evaluates and accredits hospitals and other healthcare organizations. In 1987, the JCAHO launched its Agenda for Change to create a more modern and sophisticated accreditation process to place primary emphasis on actual performance. Coincident with this new emphasis, a number of task forces were established, including two for infection control standards.

Accreditation↗
PubMed2006

Biomodulative effects of polarized light on the healing of cutaneous wounds on nourished and undernourished Wistar rats.

OBJECTIVE: This study aimed to evaluate, by light microcopy, the differences in healing process of cutaneous wounds on nourished or undernourished rats following illumination by polarized light (lambda400-2000 nm) with 20 or 40 J/cm(2). BACKGROUND DATA: There are some reports in the literature on different effects of polarized light on wound healing. Amongst the factors that interfere with wound healing one is the nutritional status of the subject. METHODS: Thirty nourished or undernourished Wistar rats had one standardized surgical wound created on the dorsum and were divided into six groups: group 1, control (standard diet); group 2, control (Northeastern Brazilian Basic Diet [DBR]); group 3, standard diet + polarized light (20 J/cm(2)); group 4, standard diet + polarized light (40 J/cm(2)); group 5, DBR + polarized light (20 J/cm(2)); group 6, DBR + polarized light (40 J/cm(2)). The first application of treatment was carried out immediately after wounding and repeated every 24 h during 7 days. The animals were sacrificed, and specimens were taken and routinely processed to wax, cut, and stain with hematoxylin and eosin (H&E) and Sirius Red. These were then analyzed under light microscopy. The analysis included re-epitheliialization, inflammatory infiltrate, and fibroblastic proliferation. Sirius Red-stained slides were used to perform descriptive analysis of collagen. RESULTS: The analysis of the results showed better results in these groups illuminated with 20 J/cm(2). CONCLUSION: It is concluded that nutritional status influenced the progression of the healing process as well as the quality of the healed tissue, and that the use of polarized light resulted in a positive biomodulatory effect.

Animals↗
PubMed2004

Does the use of electroencephalographic bispectral index or auditory evoked potential index monitoring facilitate recovery after desflurane anesthesia in the ambulatory setting?

BACKGROUND: Analogous to the Bispectral Index (BIS) monitor, the auditory evoked potential monitor provides an electroencephalographic-derived index (AAI), which is alleged to correlate with the central nervous system depressant effects of anesthetic drugs. This clinical study was designed to test the hypothesis that intraoperative cerebral monitoring guided by either the BIS or the AAI value would facilitate recovery from general anesthesia compared with standard clinical monitoring practices alone in the ambulatory setting. METHODS: Sixty consenting outpatients undergoing gynecologic laparoscopic surgery were randomly assigned to one of three study groups: (1) control (standard practice), (2) BIS guided, or (3) AAI guided. Anesthesia was induced with 1.5-2.5 mg/kg propofol and 1-1.5 microg/kg fentanyl given intravenously. Desflurane, 3%, in combination with 60% nitrous oxide in oxygen was administered for maintenance of general anesthesia. In the control group, the inspired desflurane concentration was varied based on standard clinical signs. In the BIS- and AAI-guided groups, the inspired desflurane concentrations were titrated to maintain BIS and AAI values in targeted ranges of 50-60 and 15-25, respectively. BIS and AAI values, hemodynamic variables, and the end-tidal desflurane concentration were recorded at 5-min intervals during the maintenance period. The emergence times and recovery times to achieve specific clinical endpoints were recorded at 1- to 10-min intervals. The White fast-track and modified Aldrete recovery scores were assessed on arrival in the PACU, and the quality of recovery score was evaluated at the time of discharge home. RESULTS: A positive correlation was found between the AAI and BIS values during the maintenance period. The average BIS and AAI values (mean +/- SD) during the maintenance period were significantly lower in the control group (BIS, 41 +/- 10; AAI, 11 +/- 6) compared with the BIS-guided (BIS, 57 +/- 14; AAI, +/- 11) and AAI-guided (BIS, 55 +/- 12; AAI, 20 +/- 10) groups. The end-tidal desflurane concentration was significantly reduced in the BIS-guided (2.7 +/- 0.9%) and AAI-guided (2.6 +/- 0.9%) groups compared with the control group (3.6 +/- 1.5%). The awakening (eye-opening) and discharge times were significantly shorter in the BIS-guided (7 +/- 3 and 132 +/- 39 min, respectively) and AAI-guided (6 +/- 2 and 128 +/- 39 min, respectively) groups compared with the control group (9 +/- 4 and 195 +/- 57 min, respectively). More importantly, the median [range] quality of recovery scores was significantly higher in the BIS-guided (18 [17-18]) and AAI-guided (18 [17-18]) groups when compared with the control group (16 [10-18]). CONCLUSION: Compared with standard anesthesia monitoring practice, adjunctive use of auditory evoked potential and BIS monitoring can improve titration of desflurane during general anesthesia, leading to an improved recovery profile after ambulatory surgery.

Adult↗
PubMedDate not supplied

Joint Commission perspective: using standards and indicators to monitor performance.

Two activities are concurrently underway at the Joint Commission on Accreditation of Healthcare Organizations: revision of standards for "Infection Control" which will continue to be used for the survey of hospitals development of the "Agenda for Change", a progress report on an extensive research and development project which is expected to use several infection control-related topics in the development of hospital-wide clinical indicators. This article outlines the Joint Commission's scope of services, and discusses the proposed new infection control standards and the topics to be pilot-tested for potential use as hospital-wide clinical indicators. The initiatives defined in the Agenda for Change, which involve several programmatic changes and modifications in the standards and survey procedures for the 1990s, are also addressed.

Accreditation↗
PubMed2004

Phototherapy improves healing of cutaneous wounds in nourished and undernourished Wistar rats.

A wound represents the interruption of the continuity of tissue that is followed by damage or cellular death. Wound healing occurs due to a competitive mechanism between the synthesis and lysis of collagen. Any factor that increases collagen lysis or reduces its synthesis may result in changes in the healing process, i.e., nutritional deficiencies. Phototherapies have been suggested as an effective method to improve wound healing. This study evaluated, histologically, the differences in the healing of cutaneous wounds in nourished and undernourished rats following laser therapy or illumination by polarized light. Fifty nourished or undernourished Wistar rats had a standardized wound created on the dorsum and were divided into 6 subgroups: Group 1--Control (Standard diet; n=5); Group 2--Control (DBR; n=5); Group 3--Standard diet + laser therapy (lambda635nm; 20J/cm2, n=5; or 40J/cm2, n=5); Group 4--Standard diet + Bioptron (lambda400-2000nm; 20J/cm2, n=5; or 40 J/cm2, n=5); Group 5--DBR + laser therapy (lambda635nm; 20J/cm2, n=5; or 40J/cm2, n=5); Group 6--DBR + Bioptron (lambda400-2000nm; 20J/cm2, n=5; or 40 J/cm2, n=5). The first application of the treatment was carried out immediately after surgery and repeated every 24 h during 7 days. Specimens were routinely processed (wax, cut and stained with H&E and Picrosirius stain) and analyzed under light microscopy. Analysis included re-epithelization, inflammatory infiltrate, and fibroblastic proliferation. Picrosirius stained slides were used to perform descriptive analysis of the collagen fibers. The results showed the best results for nourished and undernourished groups treated with polarized light at a dose of 20J/cm2 and the undernourished groups irradiated with the laser light. It is concluded that the nutritional status influenced the progression of the healing process as well as the quality of the healed tissue and that the use of both modalities of phototherapy resulted in a positive biomodulatory effect in both nourished and undernourished subjects. The effect of the polarized light was more evident in nourished subjects and laser therapy more effective in the treatment of undernourished subjects, in both cases with a dose of 20J/cm2.

Animals↗
PubMed1978

[Problems in production, control and utilization of veterinary vaccines in the developing countries].

For a whole series of reasons, most of which are political, the developing countries are following a policy of national self-sufficiency in veterinary vaccines. They are faced with problems at various levels: (1) at the level of logistic distribution, the developing countries suffer from a shortage of trained personnel, frequently lacking in enthusiasm, an often chronic shortage of funds; poorly equipped premises; poor maintenance of sophisticated but indispensable equipment (e.g. freeze-driers); a lack of facilities for cold storage and of distribution channels; field personnel with limited experience; (2) at the level of production, they must contend with difficulties in obtaining supplies of flasks and glassware; irregular supplies of water and electricity; difficulties in obtaining susceptible animals for quality control. The developing countries have found basically pragmatic solutions to these problems, such as the strict separation of the sites, materials and personnel involved in routine diagnosis and those involved in production; temporary foreign technical assistance, with or without financial aid; the use of simple, unsophisticated techniques, which are known to be reliable, even if somewhat outdated; manufacturing in bulk in multiple-dose bottles; research into the thermostabilisation of vaccine strains and the development of thermoprotective diluents for freeze-drying and reconstitution; the extensive use of combined vaccines; the establishment of production and control standards under the auspices of the WHO/FAO/OIE. In spite of these obstacles, the cost price is particularly low (from 0.20 to 0.35 francs per dose), which compares favourably with that of foreign private industry.

Africa↗
PubMedDate not supplied

The importance of the quality of water in Limulus Amebocyte Lysate tests.

Commercial pharmaceutical waters were evaluated regarding their interference in the chromogenic Limulus Amebocyte Lysate (LAL) test. Two of the four tested waters strongly inhibited the U.S. Reference Standard Endotoxin, while a Control Standard Endotoxin was less affected. The inhibitory effect could be mimiced by adding trace amounts of certain metal ions to a non-interfering water. In conclusion, the water used in the LAL test must be chosen with great care.

Endotoxins↗
PubMed1976

Veterinary public health implications of U H T processing of milk.

The introduction of U H T treatment of milk into South Africa raises problems for local public health authorities controlling milk hygiene in their respective areas because of the legislation concerning milk produced and sold for various purposes. It is essential that the raw milk supply be derived from healthy cows with healthy udders, and be produced under sanitary conditions. Uniform control standards are necessary for U.H.T. milk and other forms of milk supplying throughout the Republic. Uniformity is also desirable for efficient local authority veterinary health services. The progress of veterinary control and supervision of Johannesburg's milk supply is discussed to indicate what has been achieved. There is need for a national scheme for controlling mastitis. Tests for the purchase of milk on quality must include tests for udder health by regular electronic cell counting of raw milk sources. Appropriate mastitis control incentive or penalty schemes for milk producers should be instituted.

Animals↗