PRINCIPLES in performing laboratory analyses.
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The results of the 1976--1977 College of American Pathologists Survey of serum creatinine measurements performed by more than 5,000 laboratories are presented. The most widely used method employs the colorimetric measurement of the alkaline picrate-creatinine (Jaffe) reaction. In general, all manual and automated systems yielded comparable creatinine concentrations except the centrifugal analyzers, which manifested a consistently high bias. Interlaboratory variation was lowest for continuous-flow and the DuPont discrete systems. Lloyd's reagent resulted in a clinically insignificant reduction of creatinine concentration in lyophilized sera.
An analysis of the 1976 CAP Comprehensive Chemistry Survey of total serum proteins is presented. More than 2,000 laboratories contributed data in this survey. Estimation of total serum protein concentration by the biuret reaction remains the most widely used technic, followed by refractometry. Precision and accuracy data for a number of analytic systems and methods are presented. Precisions for the entire group are nearly comparable. A negative bias for total protein concentration was shown by the SMAC.
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Six paired specimens of lyophilized human serum were circulated to participants in the CAP Comprehensive Chemistry Program. The intervals between circulations ranged from 13 to 33 weeks. Each specimen was analyzed for 21 constituents, and the six pairs of specimens provided 126 paired sets of data for statistical comparison. The mean values for all constituents reported by the participants for each pair showed close agreement. The median difference between the two mean values for 126 pairs was 0.6% of the concentrations of the constituents. Twenty-six individual pairs showed differences that were sufficiently large to be significant (p = less than .0005). The majority of these stemmed from differences reported by participants using the SMA 12/60. Although significant, these differences were so small that they exerted no demonstrable effect on the dispersion of the results reported by the SMA 12/60 users. One vial pair showed a loss of glucose. All six pairs showed a loss of triglyceride. There was a suggestion of loss of cholesterol and uric acid in one pair. These differences were small. This study demonstrates that a comparison of mean values in a large Survey program can provide a very sensitive method of monitoring the stability of the specimens. The study also suggests the repeatability of mean values in a large Interlaboratory Survey program far exceeds clinical needs, and the agreement may be closer than can be obtained by any other system of measurement.
OBJECTIVE: Therapeutic interchange (TI) interventions are commonly used to manage pharmacy benefit costs. While several studies have considered the effect that TI interventions have on drug costs, most have not considered the effect they have on medical management costs. The purpose of the present study was to assess drug cost and drug therapy management costs of a TI intervention following a change in the drug formulary for 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitor (statin) drugs, including the conversion of atorvastatin from formulary to nonformulary status. METHODS: A retrospective, quasi-experimental within-subjects design was used in this study. Administrative claims data were obtained from a select northeastern segment of a multistate Medicaid managed care organization (MCO). To be included in the study, patients had to meet the following criteria: (1) they must have had a minimum of 3 atorvastatin prescriptions during a 6-month enrollment phase, (2) they must have been continuously enrolled throughout the 900-day study period, and (3) they must have switched from atorvastatin to another statin between April 1, 2003, and July 31, 2003. The day of the switch from atorvastatin marked for each patient the end of the 12-month pre-TI period and the beginning of the 12-month post-TI period. Two separate dependent variables were developed: (1) statin drug costs (statin cost + dispensing fee) and (2) the costs paid by the MCO for the medical management of statin therapy, including office visit costs and the medical laboratory costs of measuring lipids and creatine kinase, and of checking liver functions. To estimate expenditures over 24 months, a panel analytic technique was used that allows each patient to serve as his or her own control. Multivariate models were used to assess the effects of the TI policy while controlling for age, gender, adjunctive dyslipidemia therapy, comorbidity, presence of a prior coronary artery event, statin compliance, cardiologist management, and disease severity. RESULTS: Of the 3,636 patients who met the study inclusion criteria and were converted from atorvastatin to an alternate statin drug, 129 patients (3.5%) switched back to atorvastatin following the TI. The average statin cost per claim in the 12-month post-TI period was Dollars 70.93, 9.5% less than the average cost in the 12-month pre-TI period (Dollars 78.40). The average cost per patient per year (PPPY) for statin laboratory tests (lipid panels, creatine kinase tests, and liver function tests) increased by 31.5% to Dollars 16.15 in the post-TI period compared with Dollars 12.28 PPPY in the pre-TI period, and medical office visit costs increased by 44.9% to Dollars 20.70 PPPY in the post-TI period compared with Dollars 14.29 PPPY in the preperiod. These increased costs related to the medical management of statin therapy were overwhelmed by an 11.7% reduction in statin drug costs, from Dollars 793.69 PPPY in the pre-TI period to Dollars 701.01 PPPY in the post-TI period, resulting in a net 10.0% reduction for combined statin costs and related medical costs, from Dollars 820.27 PPPY in the pre-TI period to Dollars 737.87 in the post-TI period. After limiting the analysis to patients who did not convert from atorvastatin to pravastatin (which cost more than atorvastatin before the rebate) and controlling for the influence of potential confounders, statin expenditure decreased by 33% (P < 0.001). Multivariate models indicated no statistically significant differences in the costs related to the medical management of statin therapy after the TI compared with before the TI.
The laboratory determination of serum and urine amylase activity is commonly requested by the Emergency physician. While depressed levels are occasionally seen, they are almost always secondary to chronic pancreatitis and pancreatic destruction. The typical abnormality is an elevation that may represent a normal physiologic process, a benign inflammation, the concomitance of ongoing disease, or an emergent problem. The differential diagnosis of hyperamylasemia is difficult, but most high levels are caused by pancreatitis and biliary tract disease. Serial determinations of amylase levels, as well as simultaneous assessments of urine and serum amylase, may be useful in determining the source of the problem. The laboratory methods for measurement are many and varied, reflecting the lack of a perfect test. Because of the different procedures, confusion has ensued over the units of description and the normal or reference ranges. Any standard equipped medical laboratory should be able to determine amylase activity in both serum and urine in a timely fashion. The average cost per amylase determination is $17.75. The actual time to perform the test in the laboratory is approximately 7.5 minutes, though turnaround times usually exceed 1 hour. The fractionation of amylase into isoenzymes is a sophisticated procedure requiring equipment not routinely found in a typical hospital laboratory.
There are few formally documented proficiency testing programs for cytology laboratories, and those that have been documented are not entirely comparable in format. The first of three papers documenting a mandatory universal proficiency testing program for cytology laboratories in the Province of Ontario, Canada, presents data on the structure and function of the participating laboratories (including a comparison of the data for 1974 and 1980) and on the organization of the testing model (including selection of terminology, construction and use of the survey and assessment of responses). In 1980, of the 463 medical laboratories in Ontario, 91 of 222 hospital laboratories and 65 of 216 nonhospital laboratories were licensed in cytology. In that year, the 156 cytology laboratories processed 1.48 million cytology specimens, 92% of which were gynecologic. Hospital laboratories processed 87.5% of the nongynecologic cytology specimens and 30% of the gynecologic cytology specimens. These proportions have been virtually constant for several years. Between 1974 and 1980, there was a trend in Ontario to fewer laboratories processing less than 5,000 cytology specimens per annum. Subsequent papers in this series describe the results of the initial surveys in this program and a precision study to evaluate the consistency of reporting by individual laboratories.
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