An audit questionnaire that examines specifically the management of technical activities clauses in ISO 15189.

The aim of this study was to design an audit questionnaire that focuses on the management of the technical activities in a Diagnostic Pathology Laboratory. The ISO 15189 Standard is written in such a way that it continually moves back and forth from topics where the auditor needs to question bench level staff, to topics where the auditor needs to question Technical Management Staff. This makes for a disjointed audit process - both Bench Staff and Technical Managers are repeatedly interrupted. The solution was to do a clause by clause analysis of the Standard and assign the major responsibility for the compliance to each clause to either Technical Managers or Bench Staff. The Clauses were then grouped under four topic headings regardless of whether they were a Section 4 or Section 5 Clause. Two questionnaires have emerged - the one described in this work and one directed primarily towards the activities of bench staff. There are 95 questions and it takes approximately two hours to complete.

New datum handling methods for the quality control of antibiotic solutions and plates used in the antimicrobial susceptibility test.

Quality control programs are described for monitoring both the antibiotic solutions and the plates used in the dilution antimicrobial susceptibility test. For the quality control of antibiotic solutions, a simple comparative disk diffusion assay is used in which the data are expressed as zone ratios calculated from the following formula: zone ratios = mean zones of inhibition for disks impregnated with antibiotic under test/mean zones of inhibition of previously prepared quality control disks impregnated with the same antibiotic. The rejection limits set for this method are twice as stringent as for MIC estimation, and its precision is four times greater. For quality control of the antibiotic agar plates, fluid was absorbed directly into filter paper disks placed on the surface of the medium. These disks were then transferred to a seeded plate to produce zones of inhibition. These zones of inhibition were then converted to zone ratios by dividing the zone of inhibition for the individual antibiotics by the mean of the total zones of inhibition for all the antibiotics tested on the same plate. We further normalized these data by expressing each entry as a standard normal deviate calculated from the mean and standard deviation of the cumulative data for each individual antibiotic. The use of zone ratios reduced batch-to-batch variation, and standard normal deviate values gave a uniform result for convenience. The method has a sensitivity equal to that of an MIC estimation if it were possible to estimate the MICs of antibiotics at these low levels.

Improved method for calculating calcium fractions in plasma: reference values and effect of menopause.

Multiple linear regression analysis showed that total calcium was significantly and positively related to albumin, globulin, anion gap, and bicarbonate in plasma from 556 normal postmenopausal women. The residual constant of 1.21 mmol/L approximated the normal mean for ionized calcium in plasma. The coefficients derived from the multiple regression analysis were used to calculate ionized calcium from total calcium and ligand concentrations in a series of 105 clinical cases in whom ionized calcium was measured with the calcium electrode. The regression equation was y = 1.00x -0.0039 mmol/L, where x is measured and y calculated Ca2+ (r = 0.78, P less than 0.001). The protein-bound, ultrafiltrable, and complexed fractions of the calcium were also calculated for plasma from 69 normal young men, 66 normal young women, and 305 normal postmenopausal women. The increased plasma calcium in the postmenopausal group was accounted for by an increase in the complexed fraction, due to increases in plasma bicarbonate and anion gap.

Effects of nandrolone decanoate on forearm mineral density and calcium metabolism in osteoporotic postmenopausal women.

Although anabolic steroids have been used for many years to treat osteoporosis there is little available evidence about their efficacy or mode of action. These agents have recently been shown to produce an increase in total body calcium and bone density and it has been suggested that they stimulate bone formation. In this study 27 osteoporotic postmenopausal women were given 50 mg of nandrolone decanoate intramuscularly, every 2 or 3 weeks for 3 months, and the changes in forearm mineral density, fasting plasma, and urinary calcium, urinary hydroxyproline, and radiocalcium absorption were measured. Associated with a rise in forearm mineral density was a significant fall in fasting urinary calcium, but no significant change in fasting urinary hydroxyproline. The plasma calcium and phosphate fell significantly and there was a significant rise in the renal tubular reabsorption of calcium and a fall in the renal tubular reabsorption of phosphate. In a subset of 22 patients there was a significant rise in radiocalcium absorption. The results are consistent with the concept that nandrolone exerts a significant positive effect on bone formation and that this results in a fall in the fasting plasma calcium level, and consequently calcium excretion.

The effect of an oral calcium load on plasma ionized calcium and parathyroid hormone concentrations in osteoporotic postmenopausal women.

Plasma ionized calcium (IC) and parathyroid hormone (PTH) concentrations were measured in 31 osteoporotic postmenopausal women at hourly intervals for 5 hours after a 1 g oral calcium load. Fifteen subjects had normal radiocalcium absorption and 16 subjects were malabsorbers of calcium. IC rose and PTH fell after the calcium load in both groups with a plateau at 3-4 hours, and the rise in IC was greater (P less than 0.01) in the normal absorbers. There was a nonsignificant trend for the fall in PTH to be greater in the normal absorbers. In the group as a whole the mean increase in IC (above baseline) at 4 hours was directly related to calcium absorption (P less than 0.025) and the mean change in PTH was inversely related to calcium absorption (P less than 0.05). These results demonstrate that in subjects with postmenopausal osteoporosis the responses of IC and PTH to an oral calcium load are a function of calcium absorptive status.

Computerized chromatographic peak detection using the trigg tracking signal. An application devised for use with an online analog to digital converter connected between an amino acid analyser and a personal computer.

Manual integration of the amino acid peaks from physiological samples produced by conventional anion exchange liquid chromatography is a time-consuming process. This paper describes a combined unit, consisting of an analog to digital converter and a personal computer, which was connected in parallel with the chart recorder and the analyser's 570 nm channel of the colorimeter. The computer was programmed to log the digitized data, detect the start, maximum and end of each chromatographic peak, calculate the area under the peak and its retention time and provide a printout of the results at the end of the elution program. The computer program successfully exploited the Trigg Tracking Signal as both a peak detection and as a moving baseline monitoring device. This approach proved to have an equivalent performance to the manual method for 17 out of the 19 amino acids normally quantitated in physiological samples. The automated detection and quantitation of arginine was unsatisfactory due to its characteristically low profile peak shape, and proline was not measured because the device was not connected to the 440 nm channel of the colorimeter. The automated system provided economic and analytically acceptable solutions to the problem of providing an online integrator versatile enough to be used with the 255 min long amino acid analysis of physiological fluids.

Calcium metabolism and osteoporosis in corticosteroid-treated postmenopausal women.

Osteoporosis is a common complication of corticosteroid therapy and it is associated with both decreased bone formation and increased bone resorption. We have measured radiocalcium absorption and the fasting urinary calcium/creatinine and hydroxyproline/creatinine ratios in 30 postmenopausal women receiving prednisolone therapy and compared the patients with normal spine radiographs (N = 14) with those whose spine radiographs showed osteoporosis (N = 16). The osteoporotic cases had lower radiocalcium absorption (p less than 0.001), higher fasting urinary calcium (p less than 0.05), and higher fasting urinary hydroxyproline excretion (p less than 0.001). As calcium absorption has a positive effect on calcium balance and urinary calcium a negative effect, the difference between these two variables was calculated in each case. This derived variable (radiocalcium absorption--fasting urinary calcium/creatinine) disclosed a greater difference between the osteoporotic and normal groups (p less than 0.0001) than either variable alone.

Evaluation of aerosolized triamcinolone acetonide as a replacement for aerosolized beclomethasone dipropionate.

Substitution of aerosolized triamcinolone acetonide for aerosolized beclomethasone dipropionate in treatment of 30 chronic asthmatics resulted in subjective improvement in all patients. There was reduction in requirement of systemic steroids and inhaled beta adrenergics. No adrenal suppression or oropharyngeal candidiasis occurred after replacing beclomethasone dipropionate with triamcinolone acetonide.

The tubular maximum for calcium reabsorption: normal range and correction for sodium excretion.

Increased tubular reabsorption of calcium is one of the three variables which can contribute to the pathogenesis of hypercalcaemia. It is therefore important to establish the normal range for this variable in a manner which allows for its variation with the plasma calcium concentration. Graphic methods depicting the relationship between urinary calcium excretion and plasma calcium concentration are valid but cumbersome and imprecise. The notional tubular maximum for calcium reabsorption (TmCa) has therefore been calculated in 130 healthy young subjects and a normal range of 1.75-2.61 mmol/l of glomerular filtrate established. Owing to the dependence of urinary calcium on urinary sodium, TmCa was negatively related to sodium excretion. Because the latter was higher in the males than the females, mean TmCa was slightly (but not significantly) lower in our male than our female subjects. The normal range of TmCa, corrected to zero sodium excretion, is 1.98-2.76 mmol/l of glomerular filtrate. The TmCa was also calculated using plasma calcium values corrected for albumin concentration. The range of TmCa using both corrections is 1.98-2.71 mmol/l of glomerular filtrate.

Two methods for monitoring the photodecomposition of sodium nitroprusside in aqueous and glucose solutions.

The photodecomposition of sodium nitroprusside (SNP) in aqueous and 5% glucose solutions results in the accumulation of cyanide and ferricyanide ions. Methods for the determination of these ions in such solutions have been devised. The continuous-flow method for cyanide involved the generation of cyanogen chloride, ClCN, by oxidation with chloramine T and subsequent reaction of the ClCN with barbituric acid and pyridine to produce a chromophore measurable by spectrophotometry at 580 nm. This cyanide method had a detection limit and sensitivity of 10-12 mumol/L and 1.40 X 10(-3) absorbance units (AU)/mumol/L, respectively, with a working concentration range of 0-800 mumol/L. This method employed mild reaction conditions, pH = 4.1, which rendered it suitable for use in time-course studies of cyanide production from SNP solutions exposed to 366 nm UV light. A simple method for the determination of ferricyanide in SNP solutions was developed which involved the addition of a 1% FeSO4 X 7 H2O in 1% H2SO4 reagent to the SNP solutions under test followed by spectrophotometry at 750 nm. The detection limit and sensitivity of the method were 2-3 mumol/L and 4.05 X 10(-3) AU/mumol/L, respectively, with a working concentration range of 0-100 mumol/L. This method was considered suitable for use as a quality control test of SNP solutions close to the site of their clinical use.

Efficacy and tolerance of fluocortin butyl administered twice daily in adult patients with perennial rhinitis.

Fluocortin butyl (FCB) is a newly developed corticosteroid drug with no detectable systemic corticosteroid activity when it is used topically. Previous studies have demonstrated the therapeutic efficacy of FCB applied topically to the nasal mucosa three to four times a day for perennial rhinitis. The therapeutic efficacy of FCB used only twice daily, with total daily dosages similar to those previously found to be effective when these were applied more frequently, was studied in a multicenter, double-blind, placebo-controlled trial. This was a 4-week study with a 1-week observation (baseline) period and a 3-week period during which the response to three dosage regimens (2 mg per day, 4 mg per day, and 8 mg per day) of FCB and placebo were compared to baseline observations of rhinitis. Two hundred thirty-five patients from six centers were studied. Patients had perennial rhinitis of allergic, nonallergic, or combined etiology. Patients who received FCB exhibited significant amelioration of signs and symptoms of rhinitis as assessed by patients and physicians and had a greater reduction in the use of concomitant antihistamine and/or decongestant therapy compared to placebo-treated patients. Relief tended to occur early and was progressive during the 3 wk of therapy. There were no significant differences in response between the various dosages of FCB used. Side effects were minimal and insignificant and did not differ between FCB-treated and placebo-treated patients. FCB appears to be an effective well-tolerated topical steroid useful in the treatment of perennial rhinitis.

Serum amino acid concentrations in patients receiving total parenteral nutrition with an amino acid plus dextrose mixture.

The results of monitoring the serum amino acid concentrations during three infusion regimens using a 5:4 mixture of 70% glucose and the synthetic L-amino acid solution, Synthamin 17 (Travasol) are reported. Twelve stabilized patients received continuous total parenteral nutrition (TPN), eight of whom were subsequently placed on a second regimen of cyclical feeding. A separate group of five patients was infused with amino acids, both with and without simultaneous glucose. The serum amino acid concentrations indicated that the supply of valine, leucine, isoleucine, lysine, and histidine, and the synthesis of taurine from the infused methionine was suboptimal, particularly if the period of TPN was prolonged. The synthesis of tyrosine from phenylalanine appeared to be inversely proportional to the infusion rate of the TPN mixture, in particular the glucose component, resulting in depressed tyrosine and increased phenylalanine concentrations in serum during continuous iv nutrition. Cyclical infusions, on the other hand, permitted the tyrosine and phenylalanine concentrations to return to normal during the noninfusion stage of the cycle. Amino acid measurements enabled us to design an amino acids additive mixture which normalized the serum concentrations in three long-term home parenteral nutrition patients. As a result of these investigations serum amino acid measurements are used routinely to monitor the efficacy of TPN and accommodate any specific amino acid requirements of individual patients.

Fasting and non-fasting serum amino acid values in three home parenteral nutrition patients: a comparison between Synthamin 17R and vamin N 7%R.

Serum amino acid concentrations were measured during the fasting and non-fasting stages of nutrition in three home parenteral nutrition patients who received their nitrogen requirement as Synthamin 17R for 12 months then Vamin N 7%R for 12 months. When the patients received Synthamin 17R, the fasting serum amino acid values revealed consistently elevated levels of glycine, phenylalanine, methionine and alanine and low levels of leucine, iso-leucine, valine, lysine, histidine, cystine and serine. When the patients received Vamin N 7%R, the fasting serum amino acid levels showed consistently elevated levels of proline, phenylalanine, glutamate, alanine, cystine and valine and low levels of arginine. Many of the serum amino acid abnormalities observed reflected the differences in the amino acid profiles of Vamin N 7%R and Synthamin 17R when compared with a normal diet.

Hypercalcemia associated with parenteral amino acid and dextrose infusion.

A patient receiving parenteral nutrition with an amino acid dextrose solution developed hypercalcemia which seemed related to the rate of nutrient infusion. In a retrospective study of patients receiving parenteral nutrition over a 3-month period six of 72 (8%) developed hypercalcemia. After changes in infusion rate there were corresponding changes in the serum calcium concentration. There was a significant correlation between the serum calcium concentration and the average infusion rate over the preceding four days (p = 0.012). This was even more significant (p less than 0.005) when ionized calcium was calculated to diminish the effects of calcium binding by proteins.

Investigations into the optimum nitrogen and caloric requirements and comparative nutritive value of three intravenous amino acid solutions in the post-operative period.

Complete nitrogen balance studies have been conducted in 17 patients undergoing vagotomy and pyloroplasty during the first 6 post-operative days. All patients received only intravenous nutrition during this period and there were no metabolic complications. These studies have shown that the optimum nitrogen and energy intake in the post-operative period in adults are 0.24g nitrogen and 46 kcal/kg body weight/day, respectively. These studies throw further doubt on the use of the E/T ratio as a predictor of nitrogen source solution efficiency in intravenous nutrient regimes. It is suggested that more attention should be directed to the non-essential nitrogen constituents in those solutions where the essential amino acid nitrogen contributes 30% of the total nitrogen. A new solution, Amodex, with an E/T ratio of 2.62 and an essential amino acid nitrogen content of 30% of the total nitrogen content has been found to compare favourably with two other well-established solutions in the post-operative period. These studies suggest that of the three solutions, Vamin 7% may be marginally more efficient.