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PubMed1990

Standardization and harmonization of the blood count: the role of International Committee for Standardization in Haematology (ICSH).

Scientific principles of standardization were first applied in haematology in 1963 when the International Committee for Standardization in Haematology was established with a primary objective to improve the measurement of haemoglobin. Subsequently, ICSH has established Expert Panels on a wide range of haematological topics, including especially a Panel on Cytometry. The purpose of haematological standardization is to obtain precision, accuracy, specificity and harmonization of results between different laboratories in all countries and also between different instruments or methods in the same laboratory. To achieve these objectives ICSH sponsors collaborative studies by scientists from academic centres and from industry and uses a consensus procedure for establishing standards on the basis of the scientific data, followed by an educational programme to ensure that the standards are adopted worldwide. ICSH defines material standards and standardized methods. Material standards are classified as primary international standards, certified reference materials, secondary standards and calibrators. These must be distinguished from control preparations which are intended exclusively for quality control. Standardization of methods must also be considered at four levels: definitive, reference, selected and routine. Each has a place in practice but their roles must be clearly defined. ICSH has an established protocol for evaluation of automated blood cell counters. This defines the levels of precision and accuracy of instrument performance. It is also necessary to assess "clinical utility". The main requirement of the practising haematologist is clinical reliability and harmonization of results for comparability. One of the major functions of ICSH is to provide an interface for collaboration between the manufacturers who develop the instruments and the users in order to achieve this goal.

Anticoagulants↗
PubMed1991

False resistance to imipenem with a microdilution susceptibility testing system.

Routine monitoring of antibiotic resistance at Children's Hospital, Boston, detected a dramatic increase in the prevalence of imipenem-resistant strains of Pseudomonas aeruginosa. Further studies documented that false resistance to imipenem was due, in part, to the loss of imipenem potency in customized MIC microdilution trays supplied by Sensititre Ltd. (West Sussex, United Kingdom). Recognition of the problem was delayed by use of the quality control standard recommended by the manufacturer, which were higher and broader than those suggested by the National Committee for Clinical Laboratory Standards.

Cystic Fibrosis↗
PubMed1992

Anatomy of a defective barrier: sequential glove leak detection in a surgical and dental environment.

OBJECTIVES: a) To determine the frequency of perforations in latex surgical gloves before, during, and after surgical and dental procedures; b) to evaluate the topographical distribution of perforations in latex surgical gloves after surgical and dental procedures; and c) to validate methods of testing for latex surgical glove patency. DESIGN: Multitrial tests under in vitro conditions and a prospective sequential patient study using consecutive testing. SETTING: An outpatient dental clinic at a university dental school, the operating suite in a medical school affiliated with the Veteran's Hospital, and a biomechanics laboratory. PERSONNEL: Surgeons, scrub nurses, and dental technicians participating in 50 surgical and 50 dental procedures. METHODS: We collected 679 latex surgical gloves after surgical procedures and tested them for patency by using a water pressure test. We also employed an electronic glove leak detector before donning, after sequential time intervals, and upon termination of 47 surgical (sequential surgical), 50 dental (sequential dental), and in three orthopedic cases where double gloving was used. The electronic glove leak detector was validated by using electronic point-by-point surface probing, fluorescein dye diffusion, as well as detecting glove punctures made with a 27-gauge needle. RESULTS: The random study indicated a leak rate of 33.0% (224 out of 679) in latex surgical gloves; the sequential surgical study demonstrated patency in 203 out of 347 gloves (58.5%); the sequential dental study showed 34 leaks in the 106 gloves used (32.1%); and with double gloving, the leak rate decreased to 25.0% (13 of 52 gloves tested). While the allowable FDA defect rate for unused latex surgical gloves is 1.5%, we noted defect rates in unused gloves of 5.5% in the sequential surgical, 1.9% in the sequential dental, and 4.0% in our electronic glove leak detector validating study. In the sequential surgical study, 52% of the leaks had occurred by 75 mins, and in the sequential dental study, 75% of the leaks developed by 30 mins. In terms of the anatomical localization, the thumb and forefinger accounted for more than 60% of the defects. There were no differences in the frequency of glove leaks between the left and right hand. Leak rates were highest for the surgeon (52%), followed by the first assistant (29%) and the scrub nurse (25%). No false negatives were noted using the electronic glove leak detector; one false positive was seen out of 225 gloves tested (0.44%), as noted in our validation studies. CONCLUSIONS: Significantly high glove leak rates were noted after surgical and dental procedures, indicating that the present day latex surgical gloves can become an incompetent barrier once they are used. Unused latex surgical gloves demonstrated a higher rate of defects than allowed by the Food and Drug Administration standards, indicating substantial noncompliance of quality control standards by manufacturers as well as inadequate governmental oversight. Double gloving, or the use of thicker latex surgical gloves, would probably reduce the frequency of glove leaks. Latex surgical gloves should be tested for patency before use and during surgical and dental procedures.

Dentistry↗
PubMedDate not supplied

Determination of nitrogen content in milk by the Kjeldahl method using copper sulfate: interlaboratory study.

Copper sulfate was substituted for mercury as the catalyst in the International Dairy Federation (IDF) Standard 20A:1986 method for the determination of nitrogen content in milk. The substitution was supported by results obtained in an interlaboratory study by 24 laboratories in 12 countries. Each laboratory analyzed 12 test samples of milk as blind duplicates in a double split level design with high, medium, and low nitrogen concentrations. The method protocol requires the concurrent analyses of an ammonium salt solution and a tryptophan solution as internal quality control standards with a minimum nitrogen recovery between 99 and 100% for the former and at least 98% for the latter. The repeatability and reproducibility relative standard deviations are 0.5 and 1%, respectively, for the range 0.35-0.70 g N/100 g. The performance of the laboratories that did not meet the required quality control specifications was clearly poorer than that of those that did meet the specifications.

Animals↗
PubMed1988

Control of diarrhoeal diseases.

During its early years, WHO was primarily concerned with epidemic control, standardization and quality control of vaccines, and administration of the International Sanitary Regulations. Among the acute enteric infections, cholera received the greatest attention because of its propensity for rapid epidemic spread. When the seventh pandemic of cholera began in 1961, WHO responded with a greatly expanded programme of activities which included cooperation with countries in training and control efforts, and research on treatment and prevention, especially vaccine development. At the same time, numerous training courses were held on enteric infections and a series of controlled field trials established the degree of protection conferred by existing typhoid and paratyphoid vaccines. In 1970, when the cholera pandemic spread to Africa, the emergency assistance programme was reactivated, with increasing attention to the provision of appropriate treatment, especially oral rehydration therapy, rather than the supply of ineffective vaccines. The requirement of cholera vaccination for international travel in the International Health Regulations was abolished in 1973 by the World Health Assembly. Another public health problem of importance during the 1970s was the increase in antibiotic resistance of enteric bacteria, especially Shigella dysenteriae 1 and Salmonella typhi, first in Central America and Mexico and later in Asia. There was a notable acceleration in research on diarrhoeal disease and especially on cholera during this period, with the discovery of several new viral and bacterial agents of diarrhoea, advances in knowledge of intestinal immunity indicating that better protection might be achieved with oral vaccines, and the demonstration of the effectiveness of a single formulation of oral rehydration salts (ORS) in the treatment of all diarrhoeas including cholera.(ABSTRACT TRUNCATED AT 250 WORDS)

Cholera↗
PubMed1977

What is quality care? A clinician's view.

The prospect of national health insurance means the establishment of government criteria for reimbursable psychiatric treatment. These cost-control standards are certain to be justified on the basis of quality maintenance as well. Such preestablished criteria would not only fail to insure quality, they would likely undermine it. Steps toward an urgently needed definition of "quality treatment" are considered.

Cost-Benefit Analysis↗
PubMed1992

[Quality control in hematology].

Qualified quality control is a necessary part of modern haematology: we cannot deem laboratory results reliable until effective quality checking is included. Quality assessment includes external (national, regional) and internal (intra-laboratory) control. We suggest to found a Czech national external quality control agency for haematology based on principles which were declared by the World Health Organization. Internal control includes correct identification of samples, analytical control (standardization of test, evaluation of accuracy and precision) and biological quality control (history of patient's characteristics, relation to other laboratory results in clinical context). The deviation index, which is expressed either as a number or verbally 'excellent', 'good', 'satisfactory', or 'unsatisfactory', can supply rapid information on the quality of results in the haematological laboratory.

Hematology↗
PubMed1980

Economic impact of quality control in diagnostic radiology.

With ever-increasing costs confronting health care facilities, much attention is being focused on various cost-containment projects. Although it is generally assumed that a radiology department quality control program will increase costs, institutional savings may also result. A comprehensive quality control program involving continuing education, simplification of technic, processor control, standardization of cassettes, and preventive maintenance resulted in substantial savings for a medical school radiology department.

Allied Health Personnel↗
PubMed1989

Infection as a complication of liver transplant.

The prognosis for recipients of a liver transplant has been vastly improved by the advent of cyclosporine therapy, and the future holds even more promise with improvements in drug therapy and surgical techniques. The transition from experimental procedure to accepted clinical practice requires nursing to develop standards of care to promote quality care in transplant nursing. With postoperative infection identified as a major cause of mortality for this patient group, nurses will be expected to be skillful in assessing and monitoring for signs and symptoms of infection. Nurses will also need to understand what is involved in the clinical diagnosis of infection, the role of immunosuppressive drug therapy, and the laboratory findings that predispose or herald infection. Infection control standards and methods to manage the risk of infection are appropriate areas of research for critical care nursing and hold the potential for improved patient outcomes for this vulnerable group of transplant patients.

Humans↗
PubMed1991

[Status quo and prospects of oral liquid prepared from Chinese drugs].

This paper reviews the rise of oral liquids and their preparations, control standards, pharmacological research and clinical pharmacy, etc. On the basis of investigation, an overall discussion is given in respect to product variety and sale, pharmaceutical research and development, and social benefit from new products, so as to highlight the merits of Chinese medicinal materials.

Administration, Oral↗
PubMed2026

Seed-derived mucilage polysaccharides as biomaterials for in vivo tissue regeneration: A systematic review.

Chronic wounds, bone defects, and cartilage injuries represent persistent clinical challenges requiring biomaterial platforms that actively regulate inflammation, oxidative stress, angiogenesis, and extracellular matrix remodeling. Conventional synthetic dressings often provide limited biological activity in these contexts. Seed-derived mucilages - polysaccharide-rich hydrocolloids obtained from chia (Salvia hispanica), flaxseed (Linum usitatissimum), fenugreek (Trigonella foenum-graecum), psyllium (Plantago ovata), guar (Cyamopsis tetragonoloba), quince (Cydonia oblonga) etc. - have emerged as biocompatible, biodegradable, and chemically versatile platforms for tissue engineering. This systematic review, conducted according to PRISMA 2020 guidelines, synthesized in vivo evidence on seed-derived mucilage-based biomaterials across wound healing, bone repair, cartilage regeneration, and related applications. PubMed, Scopus, and Web of Science Core Collection were searched for original in vivo experimental studies published in English between 2020 and 2026. Eligible studies reported at least one measurable regenerative outcome. Data were extracted independently by two reviewers, and methodological quality was assessed using the SYRCLE Risk of Bias tool. Forty-three studies were included. Hydrogels were the dominant biomaterial format, followed by films, scaffolds, sponges, nanoparticle systems, and bilayer or Janus composites. Included systems generally improved wound closure, re-epithelialization, collagen deposition, angiogenesis, antioxidant defense, and inflammatory regulation. However, most studies used small animals with short follow-up periods, and many incorporated nanoparticles or bioactive agents, limiting attribution of efficacy to the mucilage matrix alone. Risk of bias was predominantly unclear due to insufficient reporting of randomization and blinding. Blank mucilage controls, standardized characterization, long-term biosafety data, and clinically relevant models are essential prerequisites for translational progress.

Humans↗
PubMed1982

Formulae for maximum valid dilution.

The preparation of test specimens using the MVD calculation represents a reasonable approach to equating the sensitivity of the in vitro and in vivo tests for endotoxin. Labeling of LAL reagents and control standard endotoxins are a point of confusion for the parenterals industry. Government and reagent suppliers must work together expeditiously to provide test materials that are explicitly labeled as to reactivity in EU/ml and ng/ml. The relatively greater reactivity of LAL reagent to environmental endotoxin than the rabbit bioassay provides a greater margin of safety for the in vitro approach than previously anticipated, and suggests that rabbit retest of LAL failures may be appropriate for specific products.

Animals↗
PubMed1990

Cholesterol screening: comparative evaluation of on-site and laboratory-based measurements.

We measured cholesterol in capillary blood samples from 9683 volunteers over a four-day on-site community screening program, using the "Reflotron" desk-top analyzer (Boehringer-Mannheim Diagnostics, Indianapolis, IN). We also measured cholesterol in venous blood samples from 3% of those screened (a) with the Reflotron at the screening sites, (b) in a qualified hospital clinical laboratory, and (c) in a Centers for Disease Control standardized lipoprotein research laboratory. The sensitivity (and specificity) of the Reflotron measurements, with use of the lipoprotein laboratory measurements as the point of reference, was 0.95 (0.73) in capillary blood samples and 0.88 (0.93) in venous blood samples, compared with 0.99 (0.87) in the hospital clinical laboratory. The Reflotron measurements correlated less well with the lipoprotein laboratory values in both venous blood (r = 0.91) and capillary blood (r = 0.89) samples than did the clinical laboratory values (r greater than 0.99). Furthermore, the capillary blood measurements averaged 7% higher than venous measurements when both kinds of samples were analyzed in the Reflotron.

Adult↗
PubMed1988

Infection control in the Department of Nuclear Medicine.

Concern about the spread of infections in the hospital setting has prompted regulatory agencies to mandate infection control standards. Each hospital department is required to have written policies and procedures which describe measures to prevent and control the spread of nosocomial infections (hospital acquired infections), along with quality assurance programs to assure that procedures are followed. The Department of Nuclear Medicine, as other departments, should have procedures which address special precautions for the prevention of nosocomial infections. This article will focus on a new approach to prevent nosocomial infections, guidelines for handling patients and contaminated equipment, and the importance of quality assurance activities to monitor compliance to established standards. An opening discussion on the routes of transmission, and factors necessary for transmission of infection, will serve as a review to assist with understanding the concept for handling the hospitalized patient in a Nuclear Medicine setting.

Acquired Immunodeficiency Syndrome↗
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↗
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↗