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Other sources include brussels sprouts, cauliflower, broccoli, strawberries, cabbage, and spinach. The vitamin C content of foods can vary depending on growing conditions and location, the season of the year, the stage of maturity, cooking practices, and the storage time prior to consumption. Bioavailability There does not appear to be much variability in the bioavailability of vitamin C between different foods and dietary supplements. However, absorption falls to 50 percent or less as intake increases to doses of 1,000 mg/day or more. However, studies in which the vitamin was added to meals over long periods have not shown significant improvement of body iron status, indicating that ascorbic acid has a lesser effect on iron bioavailability than has been predicted from tests involving single meals. Copper Vitamin C may reduce Excess vitamin C may reduce copper absorption, but copper absorption. Vitamin B12 Large doses of vitamin C Low serum B12 values reported in people receiving may reduce vitamin B12 megadoses of vitamin C are likely to be artifacts of the levels. Dietary Interactions There is evidence that vitamin C may interact with certain nutrients and dietary substances (see Table 2). In the United States, low blood levels of vitamin C are more common in men, particularly elderly men, than in women, and in populations of lower socioeconomic status. The classic disease of severe vitamin C deficiency is scurvy, which is characterized by the symptoms related to connective tissue defects. In experimental subjects who were made vitamin C deficient but not frankly scorbutic, gingival inflammation and fatigue were among the most sensitive markers of deficiency. Vitamin C deficiency in infants, known as infantile scurvy, may result in bone abnormalities, hemorrhagic symptoms, and anemia. Infantile scurvy is rarely seen because human milk provides an adequate supply of vitamin C and infant formulas are fortified with the vitamin. There is no evidence suggesting that vitamin C is carcinogenic or teratogenic or that it causes adverse reproductive effects. Special Considerations Blood and urine tests: Vitamin C intakes of 250 mg/day or higher have been associated with false-negative results for detecting stool and gastric occult blood.

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Suppliers with pre-existing service agreements preceding the implementation of this standard can be qualified as meeting expectations by a retrospective review of the quality of service provided. Equipment qualification is performed to establish that equipment and ancillary systems are capable of consistently operating within established limits and tolerances. Verification is the confirmation of the accuracy of something or that specified requirements have been fulfilled. Validation should confirm acceptable endpoints can be achieved while maintaining purity, potency and safety of the cellular therapy product. Examples of acceptable endpoints may include nucleated cell recovery, viability, sterility, and red cell reduction. The introduction of a piece of equipment such as a controlled rate freezer of the same model as already present in the facility would generally require a verification study, whereas the introduction of a different model or a model from a different manufacture would require a more extensive validation study. Validation of the labeling process should demonstrate completeness and correctness of each data point, as well as the accuracy of data as shown by traceability and trackability of the product from donor to recipient or final disposition. When this is not possible, a validation study must be performed using mock products with known values to document that the reagent or supply meets acceptable endpoints and does not cause harm to the product (purity, potency and safety) or the recipient of the product. Examples of acceptable endpoints may include but are not limited to nucleated cell recovery, viability, sterility, and red cell reduction. The inspector should note that studies are properly designed, objectively collect the required data, that outcome and intended actions are summarized, and that both the finalized plan and report are reviewed and approved by the Processing Facility Director and Quality Manager. Example(s): A change of reagents used for processing, such as cryopreservation, would need to be validated to verify cellular therapy product nucleated cell recovery, viability, sterility and potency are maintained at acceptable limits. The potential for adverse reactions and comparison of times to engraftment should also be examined. Another example of a change that would need to be validated is a change to a different method of red cell reduction. Documentation of red cell content remaining in the products tested as well as confirmation of acceptable endpoints such as nucleated cell recovery and viability should also be included in evaluation of the new method. Example(s): Identification of a risk can be made by providing a description of a potential or known risk. A general description of the issue and identity of the specific risk(s) should be included. After the risk(s) has been identified, it must be assessed on the potential of criticality or on their likelihood of occurrence and the potential impact including quantitative and qualitative evaluation. An example might be a change in using another reagent or supply item of suitable grade. Explanation: Feedback (including complaints) from donors, recipients, and legally authorized representatives may be obtained directly by the Processing Facility; however, it is also acceptable to use a hospital-wide system, such as patient satisfaction surveys, as long as the cellular therapy program is included and relevant issues can be readily identified.

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The major food vehicles of transmission to humans include food of animal origin, such as poultry, beef, eggs, and dairy products. Other food vehicles (eg, fruits, vegetables, peanut butter, frozen pot pies, powdered infant formula, cereal, and bakery products) have been implicated in outbreaks, presumably when the food was contaminated by contact with an infected animal product or a human carrier. Other modes of transmission include ingestion of contaminated water; contact with infected reptiles or amphibians (eg, pet turtles, iguanas, lizards, snakes, frogs, toads, newts, salamanders) and rodents or other mammals. Unlike nontyphoidal Salmonella serotypes, the enteric fever serotypes (Salmonella serotypes Typhi, Paratyphi A, Paratyphi B) are restricted to human hosts, in whom they cause clinical and subclinical infections. Chronic human carriers (mostly involving chronic infection of the gall bladder but occasionally involving infection of the urinary tract) constitute the reservoir in areas with endemic infection. Infection with enteric fever serovars implies ingestion of a food or water vehicle contaminated by a chronic carrier or person with acute infection. Nomenclature for Salmonella Organisms Complete Namea Serotypeb Antigenic Formula S enterica a subspecies enterica serotype Typhi Typhi 9,12,[Vi]:d:S enterica subspecies enterica serotype Typhimurium Typhimurium [1],4,[5],12:i:1,2 S enterica subspecies enterica serotype Newport Newport 6,8,[20]:e,h:1,2 S enterica subspecies enterica serotype Paratyphi A Paratyphi A [1],2,12:a:[1,5] S enterica subspecies enterica serotype Enteritidis Enteritidis [1],9,12:g,m:aSpecies and subspecies are determined by biochemical reactions. In the current taxonomy, only 2 species are recognized, Salmonella enterica and Salmonella bongori. S enterica has 6 subspecies, of which subspecies I (enterica) contains the overwhelming majority of all Salmonella pathogens that affect humans, other mammals, and birds. Serotypes are now written nonitalicized with a capital frst letter (eg, Typhi, Typhimurium, Enteritidis). The serotype of Salmonella is determined by its O (somatic) and H (fagellar) antigens and whether Vi is expressed. Consequently, typhoid fever and paratyphoid fever infections in residents of the United States usually are acquired during international travel. Age-specifc incidences for nontyphoidal Salmonella infection are highest in children younger than 4 years of age. Most reported cases are sporadic, but widespread outbreaks, including health care-associated and institutional outbreaks, have been reported. The incidence of nontyphoidal Salmonella gastroenteritis has diminished little in recent years, in contrast to other enteric infections of bacterial etiologies. Every year, nontyphoidal Salmonella organisms are one of the most common causes of laboratory-confrmed cases of enteric disease reported by the Foodborne Diseases Active Surveillance Network (FoodNet [ A potential risk of transmission of infection to others persists for as long as an infected person excretes nontyphoidal Salmonella organisms. Twelve weeks after infection with the most common nontyphoidal Salmonella serotypes, approximately 45% of children younger than 5 years of age excrete organisms, compared with 5% of older children and adults; antimicrobial therapy can prolong excretion. Approximately 1% of adults continue to excrete Salmonella organisms for more than 1 year.

Diseases

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Serum concentrations of itraconazole should be determined to ensure that effective, nontoxic levels are attained. Immunocompetent children with uncomplicated acute pulmonary histoplasmosis rarely require antifungal therapy, because infection usually is self-limited. If the patient is symptomatic for more than 4 weeks, itraconazole should be given for 6 to 12 weeks, although the effectiveness of this treatment is not well documented. For severe acute pulmonary infections, treatment with amphotericin B is recommended for 1 to 2 weeks. After clinical improvement occurs, itraconazole is recommended for an additional 12 weeks. Methylprednisolone during the frst 1 to 2 weeks of therapy can be used if respiratory complications develop. Clinical practice guidelines for the management of patients with histoplasmosis: 2007 update by the Infectious Diseases Society of America. Severe cases initially should be treated with amphotericin B followed by itraconazole for the same duration. Mediastinal and infammatory manifestations of infection generally do not need to be treated with antifungal agents. However, mediastinal adenitis that causes obstruction of a bronchus, the esophagus, or another mediastinal structure may improve with a brief course of corticosteroids. In these instances, itraconazole should be used concurrently and continued for 6 to 12 weeks. Dense fbrosis of mediastinal structures without an associated granulomatous infammatory component does not respond to antifungal therapy, and surgical intervention may be necessary. Pericarditis and rheumatologic syndromes may respond to treatment with nonsteroidal anti-infammatory agents (indomethacin). For treatment of progressive disseminated histoplasmosis in a nonimmunocompromised infant or child, amphotericin B is the drug of choice and is given for 4 to 6 weeks. An alternative regimen uses induction with amphotericin B therapy for 2 to 4 weeks and, when there has been substantial clinical improvement and a decline in the serum concentration of histoplasmosis antigen, oral itraconazole is administered for 12 weeks. Longer periods of therapy can be required for patients with severe disease, primary immunodefciency syndromes, acquired immunodefciency that cannot be reversed, or patients who experience relapse despite appropriate therapy. Stable, low concentrations of urine antigen that are not accompanied by signs of active infection may not necessarily require prolongation or resumption of treatment. Exposure to soil and dust from areas with signifcant accumulations of bird and bat droppings should be avoided, especially by immunocompromised people.

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