ness in vivo by genetic immunization. Nat. IVied. 2:540-544. 29. Raz, E. et al. 1996. Preferential induction of a Thl immune response and inhibition of specific IgE antibody formation by plasmid DNA immunization. Proc. Natl. Acad. Sci. USA 93:5141-5145. 30. Rodriguez, E, J. Zhang, and J.L. Whitton. 1997. DNA immunization: ubiquitination of a viral protein enhances cytotoxic T-lymphocyte induction and antiviral protection but abrogates antibody induction. J. Virol. 71:8497-8503. 31. Tobery, T.W. and R.F. Siliciano. 1997. Targeting of HIV- 1 antigens for rapid intracellular degradation enhances cytotoxic T lymphocyte (CTL) recognition and the induction of de novo CTL responses in vivo after immunization. J. Exp. Med. 185:909-920. 32. Wu, Y. and T.J. Kipps. 1997. Deoxyribonucleic acid vaccines encoding antigens with rapid proteasome-dependent degradation are highly efficient inducers of cytolytic T lymphocytes. J. Immunol. 159:6037-6043. 33. Hanke, T. et al. 1998. DNA multi-CTL epitope vaccines for HIV and Plasmodium falciparum: immunogenicity in mice. Vaccine 16:426-435. 34. Maecke, H.T. et al. 1998. Cytotoxic T cell responses to DNA vaccination: dependence on antigen presentation via class II MHC [In Process Citation]. J. Immunol. 161:6532-6536.
35. Thomson, S.A. et al. 1998. Delivery of multiple CD8 cytotoxic T cell epitopes by DNA vaccination. J. Immunol. 160:1717-1723. 36. Chen, Y., R.G. Webster, and D.L. Woodland. 1998. Induction of CD8 ÷ T cell responses to dominant and subdominant epitopes and protective immunity to Sendai virus infection by DNA vaccination. J. Immunol. 160:2425-2432. 37. Berman, P.W. et al. 1996. Protection of MN-rgp 120-immunized chimpanzees from heterologous infection with a primary isolate of human immunodeficiency virus type 1. J. Infect. Dis. 173:52-59. 38. Mancini, M. et al. 1996. DNA-mediated immunization in a transgenic mouse model of the hepatitis B surface antigen chronic carrier state. Proc. Natl. Acad. Sci. USA 93:12496-12501. 39. Guidotti, L.G. et al. 1996. Intracellular inactivation of the hepatitis B virus by cytotoxic T lymphocytes. Immunity 4:25-36. 40. Doe, B. et al. 1996. Induction of cytotoxic T lymphocytes by intramuscular immunization with plasmid DNA is facilitated by bone marrow-derived cells. Proc. Natl. Acad. Sci. USA 93:85788583. 41. Boyle, J.S. et al. 1997. DNA immunization: induction of higher avidity antibody and effect of route on T cell cytotoxicity. Proc. Natl. Acad. Sci. USA 94:1462614631.
42. Boyle, C.M. et al. 1996. Role of different lymphoid tissues in the initiation and maintenance of DNA-raised antibody responses to the influenza vires H 1 glycoprotein. J. Virol. 70:9074-9078. 43. Slifka, M.K. et al. 1998. Humoral immunity due to long-lived plasma cells. Immunity 8:363-372. 44. Robinson, H.L. et al. 1997. DNA immunization for influenza virus: studies using hemagglutinin- and nucleoprotein-expressing DNAs. J. Infect. Dis. 176(Suppl 1):$50-$55. 45. Xiang, Z.Q. et al. 1994. Vaccination with a plasmid vector carrying the rabies virus glycoprotein gene induces protective immunity against rabies virus. Virology 199:132-140. 46. Michel, M.L. et al. 1995. DNA-mediated immunization to the hepatitis B surface antigen in mice: aspects of the humoral response mimic hepatitis B viral infection in humans. Proc. Natl. Acad. Sci. USA 92:5307-5311. 47. Deck, R.R. et al. 1997. Characterization of humoral immune responses induced by an influenza hemagglutinin DNA vaccine. Vaccine 15:71-78. 48. Wang, R. et al. 1998. Induction of antigen-specific cytotoxic T lymphocytes in humans by a malaria DNA vaccine. Science 282:476-480. 49. Robinson, H.L. et al. The Scientific Future of DNA for Immunization. Washington: American Academy of Microbiology; 1997 May 31-June 2-1996.
Editorial
Group Purchasing Organizations and the Clinical Microbiology Laboratory Karen Krisher, Ph.D., D ( A B M M )
Clinical Director, Microbiology/Virology Children's Medical Center of Dallas and Department of Pathology University of Texas Southwestern Medical Center Dallas, TX 75235 Over 75% of American workers are currently covered by an employersubsidized managed healthcare system. Although overall healthcare as a percentage o f the gross domestic product (GDP) remained between 13.4 to 13.6%
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during the 1990s, healthcare spending has increased to 13.9% as we move into the year 2000. If left unchecked, the costs are projected to rise to at least 16.6% of the G D P within the next decade. Managed care providers acknowledge that advancing technology in diagnostic instrumentation and pharmaceuticals impels physicians to order more procedures to arrive at the correct assessment of the patient's condition. When faced with the c o m p l e x i t i e s o f p r o v i d i n g acceptable standards of care in the current economic atmosphere, healthcare
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administrators are forced to explore alternative ways in which to control spending in their institutions including reductions in non-essential personnel and more efficient use of hospital resources. One such solution has been the development of large group purchasing organizations (GPOs) that act on behalf of their hospital/health maintenance organization (HMO) clients for the negotiation of reduced pricing of goods and services from manufacturers. Such materials range from b a n d a g e s and gauze to sophisticated imaging equip-
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ment. Laboratory supplies also fall into the realm of the GPO and the advantages and disadvantages of this arrangement exist in a precarious balance.
Current Status of GPOs Based on the 1998 survey conducted by the weekly journal, Modern Healthcare (1), ten of the top purchasing groups in the United States (in order of purchasing volume) are Novation, Premier, AmeriNet, Health Services Corporation of American, BuyPower, Consorta, Purchase Connection, AllHealth, Joint Purchasing Corporation, and HealthCare Purchasing Partners, International. Among the top ten GPOs, purchasing volumes ranged from $330 million to $8.6 billion. The attraction of such programs for hospital administrators is easy to understand because of the obvious advantages inherent in membership. The GPO assumes responsibility for negotiating contracts for the member institutions. By representing the combined purchasing power of its member institutions, the GPO can more easily establish relationships with top vendors to leverage for reduced pricing for supplies. The GPO also frees the institution from the responsibility of negotiating contracts for materials and services and centralizes such activities to one organization, the GPO.
Product Selection GPO expectations for acceptability of a certain product are based on data collected from performance evaluations conducted by the manufacturer and/or healthcare facilities that participate in clinical trials used to fulfill the product approval requirements of the FDA. In addition, the College of American Pathologists (CAP) requires in-house validation by each laboratory of any assay used by that facility for diagnostic purposes. During the bidding process, one or more individuals under the governance of the GPO compares the products included in each contract for issues such as performance, pricing, and percentage of the market share throughout the healthcare community. Committees are often comprised of materials management directors, laboratory managers, or physicians depending on the product under consideration; for example, laboratory directors would act as advisers for laboratory-related materials. Clinical MicrobiologyNewsletter 22:3,2000
Contractual Agreements Within the GPO, all members must conform to the same contractual agreements. Several tactics are employed in order to maximize the efficiency of the purchasing consortium: mandatory compliance with the negotiated contracts, association with limited vendors, and sole-source awards. Enforcement of such practices encourages product standardization and appropriate utilization among member institutions. The greatest impact occurs when institutions are confronted with sole source negotiations for products and services. Many GPOs require purchasing compliance with the majority of products offered by the chosen vendor. The percentage of products unavailable from the sole-source provider is approved for purchasing from an alternative manufacturer. Of the 28 GPOs responding to the Modern Healthcare poll (1), 74% are involved in limited "strategic" partnerships with vendors and 56% have awarded solesource contracts for various supplies.
Sole-source Contracts The economic benefit to a medical facility of GPO membership often outweighs any concerns an individual department might have with a particular GPO. Problems related to product selection are usually eliminated when contracts for laboratory supplies are awarded to dual or multiple vendors. A dilemma occurs when the contract is awarded to a sole source. Although advantageous to the GPO, such an arrangement limits the options of the laboratory when a particular product fails quality control, experiences backorders, and/or does not meet the performance standards of the laboratory. In addition, the laboratory is not only bound to a particular manufacturer through GPO contractual arrangements but also to the manufacturer's product distributor. Differences in the quality of services provided by a distributor to various clients serves to influence the quality expectations in particular locales. Long-term arrangements with limited vendors also have the potential to promote complacency in product improvement and development of new methodologies.
Impact on the Microbiology Laboratory Materials chosen for organism detec© 2000 Elsevier Science Inc.
tion, identification, and antimicrobial susceptibility testing reflect the diagnostic requirements of the patient population and medical services that are supported by each microbiology laboratory. The qualities of the products used for specimen collection and transport, as well as organism isolation and identification, influence the ability of the laboratory to successfully recover and/or detect a microorganism. The materials used by the laboratory must allow for the earliest retrieval and correct identification of the pathogen in the most cost-effective manner. In clinical microbiology, the most mundane of hospital supplies can influence the successful isolation of an organism. For example, when used to collect a specimen for culture, a swab constructed from certain materials can be toxic to different organisms. Repeated procedures due to unsuitable products equate to increased cost due to wasted reagents and technologist time. To the patient, the impact of incorrect results or delayed diagnosis of an infection includes the potential of prolonged hospital stays and increased morbidity and mortality.
The Clinical Microbiology Conundrum For clinical microbiology, two main questions arise when considering the contribution GPOs make to the laboratory: (i) are we sufficiently assured of the selection of a quality product by our representative GPO and (ii) will selection of materials based on market share provide for the needs of all institutions? The obvious answer is to assume that the products used by the greatest numbers of laboratories must be of sufficient quality to meet the needs of all. If not, why are the products being used? In order to respond to this assertion, all parties are required to take a critical look at the practices of clinical microbiology laboratories. Quite simply, different laboratories have different modes of operation. The approach to testing and quality assessment performed by each facility is contingent upon factors such as competency, level of leadership, and access to current testing recommendations. The CAP inspection mandate of in-house validation of diagnostic assays is derived from a recent CLIA '88 requirement and lacks standardization. In addition, there is a lack of coor0196-4399/00 (see frontmatter)
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dination in quality control and quality assurance practices among clinical microbiology laboratories. Therefore, a higher percentage of market-share for a particular product may reflect a choice based on pricing or familiarity with the products manufactured by a certain company rather than the actual quality of the product for diagnostic microbiology.
Development o f a Productive Partnership Mandatory cost-effective practices are the reality of managed care in the future. Areas involving purchasing and distribution practices, equipment maintenance, and waste management all
have the potential for rapid cost-savings through enrollment in GPOs. The laboratory has a responsibility to communicate pertinent information on the suitability of any product to those individuals who are interacting with the GPOs on behalf of the institution. Developing a working partnership between the laboratory, healthcare administrators, manufacturers, and the GPOs will not be easy. A cooperative relationship can only occur if clinical microbiologists come together in a concerted effort to insure that the quality of materials used by the laboratory are assessed in a standardized manner on
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an on-going basis. These data, along with problems and concerns must be made available to both GPOs and manufacturers. In turn, the GPO and manufacturers must agree to address concerns and work with facilities to improve the quality of the products covered in the contracts. To achieve a successful partnership, all parties involved must commit to their ultimate mission: a continued dedication to providing what is best for patient care.
Reference 1. Hensley, S. 1998. Matching consolidation with consolidation. Modem Healthcare 21:60-73.
to Authors
The editors o f Clinical Microbiology Newsletter extend an invitation to authors who may wish to contribute an article or d infectious to discuss the
Paul A. Granato, Ph.D. Dept. o f Microbiology & Immunology WH 2204 SUNY Health Science Center 750 E. Adams St.
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Editors:
General Information
Mary Jane Ferraro Paul A. Granato Josephine A. Morello R.J. Zabransky © 2000 Elsevier Science Inc. ISSN 0196-4399 CMNEEJ 22(3) 17-24, 2000 Elsevier
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Editorials and letters printed in this newsletter are published for the interest of the readers and do not necessarily reflect the opinions of the editors.
Clinical Microbiology Newsletter is abstracted in Tropical Diseases Bulletin, Abstracts on Hygiene and Communicable Diseases, EMBASE/Excerpta Medica, and Current AIDS Literature.
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0196-4399100 (see frontmatter)
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Clinical MicrobiologyNewsletter 22:3,2000