Joint venture versus outreach: a financial analysis of case studies.

Medical centers across the country are facing cost challenges, and national commercial laboratories are experiencing financial declines that necessitate their capturing market share in any way possible. Many laboratories are turning to joint ventures or partnerships for financial relief. However, it often is in the best interest of the patient and the medical center to integrate laboratory services across the continuum of care. This article analyzes two hypothetical joint ventures involving a laboratory management agreement and full laboratory outsourcing.

Why is the laboratory an afterthought for managed care organizations?

Market forces have dramatically influenced the environment in which healthcare is delivered, but these changes do not need to be interpreted negatively by community laboratorians. Only total vertical integration of laboratory medicine can control episode-of-care cost. Opportunities also exist for horizontal integration with community partners to provide geographical coverage and to compete favorably for managed care contracts. Lowering cost through "economies of scale" may apply to the procurement of supplies and equipment, but the delivery of services must be considered in the context of their overall effect on episode-of-care cost. Laboratory services may make up 5% of a hospital's budget but leverage 60-70% of all critical decision-making such as admittance, discharge, and medication. Laboratory outreach can help the medical center's financial stability by: (a) providing tests and service that can reduce or avoid a hospital stay; (b) using the additional volume of testing to distribute existing fixed costs and lower unit cost; and (c) adding revenue as a direct contribution to margin. To successfully compete for contracted managed care services, the laboratory must network with other providers to demonstrate comprehensive access and capacity. Community hospital laboratories perform 50% of all laboratory tests in this country and have adequate excess capacity to fulfill the remaining community needs.

Total cost reduction in the laboratory: a team effort.

The laboratory has been seen as a revenue source and its product a commodity. In fact, good laboratories have always provided more of a service. As health care strives to reduce the cost of an episode of care, the laboratory may, ironically, incur additional costs to provide testing that contributes to earlier diagnosis and decreased length of stay. Laboratorians working with physicians and the institution must design processes to reduce cost through decreased utilization and improved decision making. Although materiel managers will continue to perform their traditional functions, they will become more involved in helping to select clinically relevant, cost-effective technologies through the technology assessment process. In order to evaluate new methods and equipment, laboratory expenses must be refined to include workload recording of individual tests and cost accounting of supplies, equipment, facilities and reagents.

Quantifying bone and liver alkaline phosphatase by the resolution of two-component inactivation data obtained with a centrifugal analyzer.

In this method we use a linear equation to resolve two-component decay data from the urea inactivation of mixtures of alkaline phosphatase (EC 3.1.3.1) of liver and bone origin. The specificity for the bone/liver isoenzyme is enhanced by including L-phenylalanine in the urea reaction to inhibit the intestinal and placental forms. Bone and liver fractions are each quantified from results of a single run on the centrifugal analyzer. Total activity and the L-phenylalanine-inhibited fraction are measured on separate runs. A simplification of this method has been used in our laboratory for 14 years in performing greater than 80,000 analyses of clinical specimens. Speed, accuracy, and precision are improved over previous methods by this mathematical solution. Data reduction is automated through the use of a personal computer interfaced to the analyzer. With such systems generally available, this method can now be suggested as suitable for routine use to separate these and perhaps other isoenzyme mixtures.

Pediatric reference intervals for 19 biologic variables in healthy children.

We defined age- and sex-specific reference intervals for 19 biologic variables in serum samples from healthy children, 1 to 22 years of age, using common laboratory equipment. Upper and lower reference intervals were defined as the estimated 2.5 and 97.5 percentiles of the distribution. For variables (y) that varied with age, the relationship of y to age was modeled with polynomial regression. Parametric percentile estimates specific to each age were then calculated as the predicted y value +/- 1.96 . SD, in which SD = the standard deviation of the residuals. For variables not associated with age, the nonparametric 2.5 and 97.5 sample percentiles were used to define the reference intervals. No significant age or sex differences were found for serum sodium, total protein, glucose, direct bilirubin, or albumin. Potassium, chloride, and urea showed constant values in children that were higher than adult values in the case of potassium and chloride and lower than adult values in the case of urea. No sex-related differences were seen for these analytes. Creatinine, uric acid, and bicarbonate showed an upward trend in values with increasing age, whereas aspartate aminotransferase, phosphorus, and total and ionized calcium showed a downward trend with increasing age. Sex-related differences were noted for these analytes. The immunoglobulins (IgG, IgA, and IgM) showed an upward trend with increasing age, with no sex-related differences except for IgM in children.

Interaction of immobilized anti-salivary amylase antibody with human macroamylases: implications for use in a pancreatic amylase assay to distinguish macroamylasemia from acute pancreatitis.

We examined the ability of an immobilized antibody to salivary amylase (Clin Chem 1985;33:1283-8) to react with amylase in macroamylasemic sera. The antibody removed 50% (SD 23%) of the total amylase activity from 39 macroamylase sera, a percentage indistinguishable (P greater than 0.75) from the percentage removed from concurrently analyzed sera from healthy volunteers (49%, SD 11%). Electrophoretic analysis of 23 macroamylasemic sera revealed that the antibody removed only part of the macroamylase band(s) in 71% of the cases. We conclude that the mean isoenzyme composition of the macroamylase complexes is essentially identical to the mean isoenzyme distribution in normal sera (i.e., about half salivary and half pancreatic amylase). Further, the immobilized antibody can be used to distinguish most patients with macroamylasemia from those with acute pancreatitis, because sera from the latter contain an increased proportion (greater than 80%) of pancreatic amylase.

A user's classification of problems identified by proficiency testing surveys.

Laboratory results judged as unacceptable in external proficiency surveys do not always signal laboratory testing problems. This is a report of the results of a user's investigation of the proficiency testing flags encountered in our laboratory from three survey programs over a two-year period. The survey programs were administered by the College of American Pathologists, the Centers for Disease Control, and the State of New York. The explanations for the abnormal survey results were classified into six categories: possible analytic measurement problem (28%), clerical error in transcription or completion of forms (16%), inappropriate survey criteria (17%), specimen problem (11%), agency amended report (5%), and no identifiable cause (23%).

Macroenzyme as a cause of unexplained elevation of aspartate aminotransferase.

Aspartate aminotransferase (AST) can exist as a macroenzyme by forming a complex with an immunoglobulin. This immunoglobulin-complexed macromolecule can cause an elevation in serum AST activity, which may be detected on routine blood chemistry analysis and erroneously considered to indicate the presence of liver disease. Clinicians should be aware of this phenomenon so patients are not subjected to unnecessary procedures. In patients with unexplained AST elevation, liver and muscle disease can be biochemically excluded by the finding of normal serum levels of alanine aminotransferase and creatine kinase. The presence of macro-AST can be determined by exclusion chromatography, electrophoresis, and activation assays with pyridoxal 5-phosphate. The elevated AST values can persist for many years.

Macroamylase: prevalence, distribution of age, sex, amylase activity, and electrophoretic mobility.

The contribution made by macroamylase to the occurrence of hyperamylasemia of unknown origin has not been previously quantitated nor has the distribution of age and sex been identified in a large sample. Knowing the pattern of this enzyme complex when analyzed by an electrophoretic isoenzyme procedure would be of importance in recognizing its presence. During a three-year period we have studied a population of 2 900 patients with elevated serum amylase from whom specimens were sent to our laboratory with a request for amylase isoenzyme analysis. It was assumed that the primary reason for requesting these analyses was to clarify the presentation of hyperamylasemia. Macroamylase occurred in 9.6% of these patients. The total activity of the macroamylase specimens was typically 1 to 4 times normal but ranged to 20 times normal. Comparing these patients with a macroamylase-negative group, the distribution of age and sex was found to be no different. Macroamylase had a characteristically unusual electrophoretic pattern with bands faster than normal pancreatic amylase in 10% of cases, bands between pancreatic and salivary in 30% of cases, and the remaining 60% with atypical anodal bands.

Selenium status in patients receiving home parenteral nutrition.

Selenium (Se) status was evaluated in patients with intestinal failure requiring home parenteral nutrition (HPN). Ninety-two percent of patients (11 of 12) studied just prior to starting HPN had low serum Se values, and the mean value was 42 ng/ml, significantly less than mean values in disease controls with Crohn's disease not on HPN (76 ng/ml) and healthy controls (88 ng/ml). Eighty-five percent of patients (22 of 26) already on HPN for 2 to 109 months when studied had low serum Se levels (mean 38.4 ng/ml). The mean 24-hr urinary Se values were 3.7 micrograms in patients on HPN who did not have Crohn's disease, 10.9 micrograms in HPN patients with Crohn's, and 17.9 micrograms in healthy controls. In patients with Crohn's disease on HPN, a significant direct correlation existed between serum Se and the activity of whole blood glutathione peroxidase, a selenoprotein ; and a significant inverse correlation was found between serum Se and months of HPN. This study confirms that Se deficiency is very common in patients before starting and during HPN. These data and recent reports of cardiomyopathies associated with Se deficiencies in patients on HPN increase the importance of proper Se replacement and maintenance.

Evaluation of commercial enzyme reagent kits by use of a semiautomated chemistry analyzer.

The overall performances of several enzyme reagent kits for alkaline phosphatase, creatine kinase, lactic dehydrogenase, and aspartate aminotransferase were evaluated using an ABA-100 Bichromatic Analyzer. Interassay precision using this instrument with commercial reagents compared well with published data for similar analyses performed at university hospitals and referral laboratories. Significantly poorer precision with lower limits of linearity was observed when reagents recommended for use at 30 C were used at 37 C. Significant differences in measured levels of creatine kinase, lactic dehydrogenase, and aspartate aminotransferase due to different lots of expendable cuvettes were found for elevated levels of these enzymes. All kit reagents met manufacturers' claims for stability; however, different absolute levels of lactic dehydrogenase were observed with one kit reagent on successive days. Slight hemolysis affected creatine kinase levels measured with some reagent kits significantly more than others.