Long-term alliance for pathology equipment and technology acquisition: a paradigm shift for improved quality and efficiency.

OBJECTIVE: Personnel costs are the largest single budget item in the clinical laboratory, other major expenses being equipment, analyzers, blood and blood components, and cost of day-to-day consumables. This report describes our experience with developing a long-term relationship with a single major vendor as a paradigm shift from the traditional multiple vendors, multiple contracts, and recurrent extended negotiations. Our objective was to develop a long-term approach for replacement of effete equipment and upgrades to operations in a pathology and laboratory medicine department in collaboration with vendors providing equipment and services. METHODS: Major vendors were invited to visit the department to analyze the workload and workflow and suggest integrated solutions to meet the goals of the department. Multiple iterations of the proposals were evaluated, and a recommendation made to the medical center leadership. The vendor, the medical center, and the department jointly developed a 15-year partnership plan to improve the operations of pathology services. The agreement encompasses a range of management and performance criteria for both sides. The salient items discussed were laboratory staffing, turnaround time, workload change, test insourcing, reference laboratory costs, and scholarly productivity and teaching. RESULTS: The agreement reduced laboratory staffing by 21%, eliminated stat tests by reducing the turnaround time for routine tests to less than 45 minutes for 90% of tests, with an increase of 9.1% in the number of tests, Cost avoidance in salary and reference laboratory costs was $3,424,136/year against an expected target of $2 million in total savings, despite not including cost avoidance from promoting appropriate use of laboratory testing for inpatients and increase in revenue from increase in ambulatory testing. Vizient score in laboratory utilization improved from the 94th to 76th percentile. Scholarly output increased by more than 100%. CONCLUSION: This model of a long-term alliance with a chosen vendor led to improvements in quality and efficiency.

Within- and between-subject variation in semen parameters in infertile men and normal semen donors.

OBJECTIVE: To determine within- and between-subject variation of semen parameters in infertile and normal men. DESIGN: Retrospective analysis of 74 infertile men and 65 normal men producing five or more ejaculates each. SETTING: Clinical andrology laboratory. SUBJECT(S): Men presenting to an infertility clinic for semen analysis and normal men providing donor semen for cryopreservation. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Within-subject coefficients of variation (CVw) and between-subject coefficients of variation (CVb), calculated for sperm count, motility, and velocity, semen volume, and motility and velocity after cryopreservation. RESULT(S): The number of ejaculates ranged 5-20 in patients (479 total) and 5-136 in donors (2,043 total). Sperm counts, motility, and velocity were statistically greater in donors, whereas semen volume was significantly greater in patients. The CVw in patients and donors was greatest in sperm counts (54.2% and 45.8%, respectively) and lowest in velocity (20.1% and 19.9%, respectively). The CVb in patients and donors was markedly higher than CVw for all parameters in both patients and donors. The CVw was lower, and the CVb was higher, in donors compared with patients. The CVw was not affected by age of the individual or abstinence period. Cryopreservation resulted in a marked increase in variability. Intraclass correlations indicated that a minimum of three semen samples were required to achieve reliability. CONCLUSION(S): These data indicate large within- and between-subject variation in sperm parameters, especially sperm count, in both patients and healthy donors, and further substantiate the need for measurement of multiple ejaculates before characterizing a man as normal or infertile.

[Is the semen analysis a reliable test?].

The semen analysis is one, if not the most, important and widely used clinical laboratory test to evaluate the fertility potential of the male. However, recent reports have suggested that the semen analysis is unreliable. Quality control in the andrology laboratory is often seen as problematic, and many laboratories do not routinely employ QC procedures in semen testing. Quality assurance is an often overlooked and unappreciated aspect of overall quality laboratory performance. External proficiency testing programs in andrology are not universally accepted, and the results from the few programs currently available demonstrate huge variations between laboratories. Numerous different standards and criteria are being used by andrology laboratories, making it difficult if not impossible to compare results from one laboratory to another. However, reliable semen analyses can be obtained by following several recommendations: (1) all laboratories performing the semen analysis should adopt universally accepted performance standards and criteria, (2) all laboratories performing this test should participate in external proficiency testing programs, (3) andrology laboratories should implement effective internal quality control and quality assurance programs to ensure that the results reported are accurate and reproducible, and (4) physicians should only refer their patients to, or accept semen analysis results from, laboratories that have stringently followed these recommendations.

How reliable are results from the semen analysis?

Based on the results of a number of studies that have evaluated the reliability of semen analysis testing, it would appear that there is a significant lack of standardization in the performance and reporting of semen analyses among laboratories. A large degree of variation and disagreement exists among different laboratories performing this test, and quality control procedures are not routinely performed in a majority of these laboratories. These observations significantly impact physicians who have to interpret and compare results among laboratories, who receive patients and test results referred from other clinics, or who have to rely on reference or other unknown laboratories for semen analysis testing.

Protecting America's secrets while maintaining academic freedom.

The terrorist attacks of September 11, 2001, and the subsequent anthrax mail attacks, have had a profound impact on Americans' personal and professional lives and have sparked an active debate regarding the delicate balance between the need for national security and the pursuit of academic freedom. Although academic freedom can be defined in many ways, there are four primary tenets of freedom in an academic environment: freedom to research, freedom to publish, freedom to teach, and freedom to speak. Each of these tenets has come under attack in the wake of September 11, 2001. In this report the author further defines academic freedom and reflects upon recent events that have had a real or perceived impact on this freedom, including (1) attempts to categorize and restrict some research as "sensitive," (2) implementation of export control laws and select agent regulations, (3) limitations on the publication of research findings, (4) prohibition of certain foreign nationals from collaborating with U.S. researchers and receiving education and training in U.S. colleges and universities, and (5) restraint of faculty free speech. The author offers some suggestions as to how academia might achieve a proper balance between protecting our national security while promoting and maintaining academic freedom.

Quality control, quality assurance, and proficiency testing in the andrology laboratory.

The primary goal of any andrology laboratory should be the performance of accurate, reproducible, high-quality, and clinically relevant laboratory testing. An underlining objective of such a goal is to better serve the ordering physician, and the patient, by continually improving laboratory performance. Quality control (QC) is the procedure that determines accurate and reproducible testing. Proficiency testing (PT) is the process allowing physicians to compare results from one laboratory to another. Quality assurance (QA) is the mechanism ensuring high-quality, clinically relevant testing. Together, QC, QA, and PT serve as the foundation responsible for a program that continually improves the overall quality of the testing, allowing the physician ordering the test to be more effective in treating the patient. Several examples are presented to assist the implementation of effective QC and QA programs aimed at continually improving performance in the andrology laboratory.

Lack of standardization in performance of the semen analysis among laboratories in the United States.

OBJECTIVE: To determine the level of standardization in performance of the semen analysis among clinical laboratories in the United States. DESIGN: A survey was mailed to laboratories requesting information about the laboratory and performance of the semen analysis. Responses were received from 536 laboratories. SETTING: Clinical laboratories enrolled in the American Association of Bioanalysts Andrology Proficiency Testing Program. PATIENT(S): None. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Agreement among laboratories. RESULT(S): Sixty-one percent of respondent laboratories were part of an assisted reproductive technology program. The laboratories perform less than 50 (53%), less than 10 (25%), or less than 5 (16%) andrology laboratory procedures per month. The laboratories routinely report sperm count (94% of laboratories), motility (95%), morphology (85%) and forward progression (69%), and semen volume (96%) as part of the semen analysis. Only 64% of laboratories routinely report abstinence, and 60% of laboratories indicate the criteria used for sperm morphology on the report form. The most common lower limits of normality for sperm count and motility were >20 x 10(6)/mL (77% of laboratories) and >50% (59% of laboratories), respectively. Few laboratories performed quality control for sperm counts (29%), motility (41%), and morphology (41%). CONCLUSION(S): These data indicate a significant lack of standardization in the performance and reporting of semen analyses among laboratories in the United States.