EDITORIAL MILITARY MEDICINE, 178, 12:1151,2013
Improving Laboratory Test Ordering Practices in Military Medical Centers MAJ Kelly W. Wilhelms, MS USA*; LTC George T. Leotiard, MC USA*; LTC Jude M. Abadie, MS USAf
Increasing national health care costs have created additional pressures to reduce expenses related to medical testing and procedures while maintaining high quality of care in the screening, diagnosis, monitoring, and treatment of patients. The recent announcement of extensive governmental spending cuts necessitates the réévaluation of current medical practices and the identification of less expensive alternatives without compromising care. Of interest, laboratory-based diagnostics are reported to influence up to 70% of medical decisions; however, costs associated with these services account for only 2.3% of health care spending in the United States.''^ This disparity may present clinicians with considerable opportunity to use inexpensive clinical laboratory tests to support cost-effective strategies in the provision of health care. In the evaluation of potential laboratory-based alternatives, laboratory professionals and health care providers share the responsibility in determining best ordering practices to optimize appropriate and conservative test use while maintaining superior standard of care. Appropriate patient care has been deñned by numerous organizations, to include the Institute of Medicine, RAND Corporation, and the College of American Pathologists.^ Among these, as defined by the College of American Pathologists, approfM'iate care is understood as "the extent to which a procedure, treatment, test or service is effective, clearly indicated, not-excessive and adequate in quantity where best suited to a patient's need."^ In the context of laboratory tests, inappropriate use may include misuse such as ordering for purposes other than standard of care, overuse such as habitual ordering practices not directed by clinical guidelines or continued assessment of patient status, and/or underuse such as foregoing testing indicated by high pretest probability for standard of care. Although misuse, overuse, and underuse have varying severities of clinical consequence, publications •Department of Pathology, Madigan Army Medical Center, 9040 Fitzsimmons Drive, Tacoma, WA 98431. tTripler Army Medical Center, I Garrett White Road, Honolulu, HI 96859. doi: 10.7205/lVlILMED-D-13-00168
MILITARY MEDICINE, Vol. 178, November 2013
directed to control and guide appropriate laboratory testing are observed by the authors to focus on overuse and misuse scenarios (e.g., Refs.^ and "* among others). Inappropriate or excessive test ordering and use can be confounded by numerous factors, such as knowledge gaps, lack of available or effective consultation services, fear of malpractice or causing patient harm, or specific patient demand." A 2008 report prepared for the Centers for Disease Control and Prevention cited two major reasons for physician knowledge gaps associated with laboratory test utilization: (1) rapid proliferation of available tests and (2) lack of formal education in laboratory testing.^ These gaps are exacerbated by increasing daily demands with rapidly expanding practice expectations; many providers have little time to stay current with literature, new methods, and current clinical guidelines.'^'^'^ Successful programs guiding appropriate laboratory testing have implemented multifaceted approaches that include provider education, information technology solutions, general consultation, and review and approval criteria-based laboratory testing (e.g., Ref.^). Traditionally, and perhaps as expected, such programs gravitate to regulating access to the most expensive and/or esoteric diagnostic evaluations, including many molecular and genetic tests. While lack of regulation can lead to misuse, overuse, and significant unnecessary costs, directed changes in available test options and profile contents in conjunction with health care provider education and facility-wide coordination of ordering guidelines can lead to significant decreases in test usage without corripromising care.'' Recently, one facility demonstrated that a simple and direct strategy could be used to mitigate reference testing costs, implementing a policy requiring prior written justification for externally referenced tests. This policy resulted in a 50% reduction in reference testing, proportional cost savings, and minimal perceived impact on patient care.'* However, information regarding the direct effect of this program on quality of patient care was limited outside of the observation that little negative feedback was received from health care professionals. The establishment of laboratory testing control measures is particularly important in the rapidly growing realm
1151
Editorial
of molecular diagnostics, where per-test costs can be in the thousands of dollars and evidence-based efficacy is proven in only ~30% of available tests7 Further, although clinicians may use screening guidelines to assist in test selection, many genetically based screens lack sensitivity to provide useful clinical information when considering the corresponding guideline. For example, up to 30% of cases of Lynch syndrome may be missed under current eligibility criteria for genetic testing.* For those patients found eligible for testing, panel-based testing options enable ease of ordering for a provider who is trying to cover all contingencies. However, commercially available panels often cover common as well as uncommon mutations, potentially resulting in numerous unnecessary (and expensive) tests for one relevant finding (e.g., Ref. ). Further, panel testing can lead to a false sense of security on behalf of the provider and the potential for less than optimal patient outcomes. As an alternative, a carefully devised screening algorithm, using stepwise analysis, could minimize extraneous testing and associated costs while encouraging the use of a meaningful series of tests that support diagnosis. Conversely, microarray analysis is a less expensive broad screen that may be used to guide test use and reduce expenses associated with targeted gene testing, maximizing specificity of diagnosis without a broad approach using multiple genetic tests. However, with microarray analysis, concems arise with the identification of additional diagnostic information unrelated to the condition of interest; disposition of this information requires ethical medical management. To address ordering practices and cost-effectiveness in military medical treatment facilities (MTFs), many locations have independently established rudimentary procedures for review and approval of expensive diagnostics performed by commercial reference laboratories. To effectively administer such a program, a multidisciplinary approach is required for appropriate ordering and result interpretation. For example, at Madigan and Tripler Army Medical Centers, the ordering process for expensive, esoteric, and genetic tests is a collaborative effort between clinical providers, medical geneticists, genetic counselors, clinical scientists, and pathologists where appropriate. Before approval, the clinical validity of a request is discussed alongside costs and identification of laboratories that can provide the test. Unfortunately, variable success is observed in implementing such programs. For example, consultative or review services may be offered, but essential expertise may be limited to the strengths of a local staff pathologist or clinical scientist. Further, daily responsibilities of professional staff may restrict time for sufficient review and/or research to provide appropriate consultation. Regrettably, in some cases, it may appear easier to allow a relatively inexpensive esoteric laboratory test to be performed than to provide a potentially time-consuming consultation. An example may include a request for low-density lipoprotein particle fractionation, a procedure that has only very recendy had clinical use guidelines available and where methods are not standardized
1152
between laboratories.'" However, in the context of overall daily operations, allowing this test (with a relatively low cost under $50) to be sent to a reference laboratory may be easier than contacting the requesting provider to discuss the order. In smaller facilities, the limitations may be more pronounced with even lower numbers of qualified staff to execute a program. Using automated computer systems to regulate and guide ordering practices is also limited throughout the MTFs. With one current hospital information system (the Composite Health Care System [CHCS]), duplicate orders may be detected and perhaps controlled, but test options cannot be easily removed from routine use without "hiding" them or requiring paper order requisitions. Further, a lack of complete connectivity between the CHCS and other information systems often requires use of paper requisitions with subsequent potential for misinterpretation of the test being ordered. This can lead to laboratory orders that bypass the review process, are ordered incorrectly, or are inappropriately submitted for testing. In addition, the laboratory component for the CHCS often lacks standardization between MTFs, making provider interactions with the system a learning experience at each location. Attempts to improve standardization (e.g., through the use of specific test nomenclature, standardized interpretations, etc.) have been partially effective, but diverse requirements at each MTF coupled with limited encompassing guidance often result in dissolution of standardized practices. In light of current fiscal constraints, it is recommended that clinical laboratory use guidelines be established at global or regional levels of medical care to support efficient laboratory test use, with perhaps molecular and genetic tests being priority. If developed and implemented effectively, these guidelines would provide direction at regional and local levels that could be leveraged into standardizing operations between facilities, translating into efficient, quality laboratory services that support the rapidly changing environment of military medicine. Further, standardization of general protocols and procedures (e.g., test nomenclature, maximizing electronic ordering procedures, etc.) would facilitate the regional and local implementation and transferability of these guidelines. In addition, global development of additional Centers of Excellence (COE) would support the reduction in overall costs by performing testing at centralized locations at cost as opposed to contracted prices with commercial facilities. Unfortunately, the start-up costs for many of these new tests are extensive; however, the potential retum-on-investment, if properly assessed, will more than makeup for these costs over time. MTFs should leverage the use of current and future COEs as much as possible, using consolidated test volumes to drive cost-effective operations that can evolve to recapture more and more commerciallyreferenced tests over time. Where COE testing is not available, not efficient, or not practical, or where procedures are under patent, continued use of commercial reference laboratories will be required. Each location should review
MILITARY MEDICINE, Vol. 178, November 2013
Editorial
utilization patterns/volume as well as contract services provided. Where warranted, volume and/or service renegotiations or development of regional agreements could be used to realize the most potential from these contracts. On a local level, it is recommended that each MTF establish a collaborative reference testing review service to meet local clinical needs. These programs would ideally be developed in concert with the pathology department, health care providers, and clinical specialists/scientists. If a program is already in place, a review should be performed to update procedures to meet ever-changing provider and patient needs consistent with standard of care testing. Further, it is recommended that all MTFs develop (or maintain) an active Clinical Laboratory Utilization Ccxnmittee (CLUC) composed of members from the pathology department as well as ancillary service representatives who have similar pursuits in cost-effective medicine. This committee, as well as chnical and professional staff, should develop local practice standards that are consistent with global and published clinical guidelines where appropriate. Where possible, local standards should be data driven by historical performance and supplemented by expertise of local staff and/or through consultation with specialists at higher level facilities. If implemented effectively, global guidelines in concert with regional and/or local interventions will assist each MTF, and military medicine as a whole, in reducing inappropriate laboratory testing and, with persistence and active monitoring, improve overall fiscal efficiency without compromising patient care.
MILITARY MEDICINE, Vol. 178, November 2013
REFERENCES 1. Wians FH: Clinical laboratory tests: which, why, and what do the results mean? Lab Medicine 2009; 40: 105-13. 2. Wolcott J, Schwartz A, Goodman C: Laboratory Medicine: A National Status Report, May 2008. Available at https://www.futurelabmedicine .org/our_findings/; accessed March 3, 2013. 3. Kim JY, Dzik WH, Dighe AS, Lewandrowski KB: Utilization management in a large urban academic medical center. Am J Clin Pathol 2011; 135: 108-18. 4. Lui Z, Abdullah A, Baskin L, Lewis G, Kelter G, Naugler C: An intervention to reduce laboratory utilization of referred-out tests. Lab Medicine 2012; 43: 164-7. 5. Lundberg GD: How clinicians should use the diagnostic laboratory in a changing medical world. Clin Chim Acta 1999; 280: 3-11. 6. Taylor MR, Edwards JG, Ku L: Lost in transition: challenges in the expanding field of adult genetics. Am ] Med Genet C Semin Med Genet 2006; 142C: 294-303. 7. United Health Center for Health Reform and Modernization: Personalized Medicine: Trends and Prospects for the New Science of Genetic Testing and Molecular Diagnostics. Working paper 7, March 2012. Available at http://www.knome.com/wp-content/uploads/2012/08/UNH_ WorkingPaper71.pdf; accessed April 23, 2013. 8. Recommendations from the EGAPP Working Group: Genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives. Genet Med 2009; II: 35-41. 9. Peltomaki P: Role of DNA mismatch repair defects in the pathogenesis of human cancer. J Clin Oncol 2003; 21: 1174-9. 10. Cole TG, Contois JH, Csako G, et al: Association of apolipoprotein B and nuclear magnetic resonance spectroscopy-derived LDL particle number with outcomes in 25 clinical studies: assessment by the AACC lipoprotein and vascular diseases division working group on best practices. Clin Chem 2013; 59: 752-70.
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Copyright of Military Medicine is the property of Association of Military Surgeons of the United States and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Improving Laboratory Test Ordering Practices in Military Medical Centers MAJ Kelly W. Wilhelms, MS USA*; LTC George T. Leotiard, MC USA*; LTC Jude M. Abadie, MS USAf
Increasing national health care costs have created additional pressures to reduce expenses related to medical testing and procedures while maintaining high quality of care in the screening, diagnosis, monitoring, and treatment of patients. The recent announcement of extensive governmental spending cuts necessitates the réévaluation of current medical practices and the identification of less expensive alternatives without compromising care. Of interest, laboratory-based diagnostics are reported to influence up to 70% of medical decisions; however, costs associated with these services account for only 2.3% of health care spending in the United States.''^ This disparity may present clinicians with considerable opportunity to use inexpensive clinical laboratory tests to support cost-effective strategies in the provision of health care. In the evaluation of potential laboratory-based alternatives, laboratory professionals and health care providers share the responsibility in determining best ordering practices to optimize appropriate and conservative test use while maintaining superior standard of care. Appropriate patient care has been deñned by numerous organizations, to include the Institute of Medicine, RAND Corporation, and the College of American Pathologists.^ Among these, as defined by the College of American Pathologists, approfM'iate care is understood as "the extent to which a procedure, treatment, test or service is effective, clearly indicated, not-excessive and adequate in quantity where best suited to a patient's need."^ In the context of laboratory tests, inappropriate use may include misuse such as ordering for purposes other than standard of care, overuse such as habitual ordering practices not directed by clinical guidelines or continued assessment of patient status, and/or underuse such as foregoing testing indicated by high pretest probability for standard of care. Although misuse, overuse, and underuse have varying severities of clinical consequence, publications •Department of Pathology, Madigan Army Medical Center, 9040 Fitzsimmons Drive, Tacoma, WA 98431. tTripler Army Medical Center, I Garrett White Road, Honolulu, HI 96859. doi: 10.7205/lVlILMED-D-13-00168
MILITARY MEDICINE, Vol. 178, November 2013
directed to control and guide appropriate laboratory testing are observed by the authors to focus on overuse and misuse scenarios (e.g., Refs.^ and "* among others). Inappropriate or excessive test ordering and use can be confounded by numerous factors, such as knowledge gaps, lack of available or effective consultation services, fear of malpractice or causing patient harm, or specific patient demand." A 2008 report prepared for the Centers for Disease Control and Prevention cited two major reasons for physician knowledge gaps associated with laboratory test utilization: (1) rapid proliferation of available tests and (2) lack of formal education in laboratory testing.^ These gaps are exacerbated by increasing daily demands with rapidly expanding practice expectations; many providers have little time to stay current with literature, new methods, and current clinical guidelines.'^'^'^ Successful programs guiding appropriate laboratory testing have implemented multifaceted approaches that include provider education, information technology solutions, general consultation, and review and approval criteria-based laboratory testing (e.g., Ref.^). Traditionally, and perhaps as expected, such programs gravitate to regulating access to the most expensive and/or esoteric diagnostic evaluations, including many molecular and genetic tests. While lack of regulation can lead to misuse, overuse, and significant unnecessary costs, directed changes in available test options and profile contents in conjunction with health care provider education and facility-wide coordination of ordering guidelines can lead to significant decreases in test usage without corripromising care.'' Recently, one facility demonstrated that a simple and direct strategy could be used to mitigate reference testing costs, implementing a policy requiring prior written justification for externally referenced tests. This policy resulted in a 50% reduction in reference testing, proportional cost savings, and minimal perceived impact on patient care.'* However, information regarding the direct effect of this program on quality of patient care was limited outside of the observation that little negative feedback was received from health care professionals. The establishment of laboratory testing control measures is particularly important in the rapidly growing realm
1151
Editorial
of molecular diagnostics, where per-test costs can be in the thousands of dollars and evidence-based efficacy is proven in only ~30% of available tests7 Further, although clinicians may use screening guidelines to assist in test selection, many genetically based screens lack sensitivity to provide useful clinical information when considering the corresponding guideline. For example, up to 30% of cases of Lynch syndrome may be missed under current eligibility criteria for genetic testing.* For those patients found eligible for testing, panel-based testing options enable ease of ordering for a provider who is trying to cover all contingencies. However, commercially available panels often cover common as well as uncommon mutations, potentially resulting in numerous unnecessary (and expensive) tests for one relevant finding (e.g., Ref. ). Further, panel testing can lead to a false sense of security on behalf of the provider and the potential for less than optimal patient outcomes. As an alternative, a carefully devised screening algorithm, using stepwise analysis, could minimize extraneous testing and associated costs while encouraging the use of a meaningful series of tests that support diagnosis. Conversely, microarray analysis is a less expensive broad screen that may be used to guide test use and reduce expenses associated with targeted gene testing, maximizing specificity of diagnosis without a broad approach using multiple genetic tests. However, with microarray analysis, concems arise with the identification of additional diagnostic information unrelated to the condition of interest; disposition of this information requires ethical medical management. To address ordering practices and cost-effectiveness in military medical treatment facilities (MTFs), many locations have independently established rudimentary procedures for review and approval of expensive diagnostics performed by commercial reference laboratories. To effectively administer such a program, a multidisciplinary approach is required for appropriate ordering and result interpretation. For example, at Madigan and Tripler Army Medical Centers, the ordering process for expensive, esoteric, and genetic tests is a collaborative effort between clinical providers, medical geneticists, genetic counselors, clinical scientists, and pathologists where appropriate. Before approval, the clinical validity of a request is discussed alongside costs and identification of laboratories that can provide the test. Unfortunately, variable success is observed in implementing such programs. For example, consultative or review services may be offered, but essential expertise may be limited to the strengths of a local staff pathologist or clinical scientist. Further, daily responsibilities of professional staff may restrict time for sufficient review and/or research to provide appropriate consultation. Regrettably, in some cases, it may appear easier to allow a relatively inexpensive esoteric laboratory test to be performed than to provide a potentially time-consuming consultation. An example may include a request for low-density lipoprotein particle fractionation, a procedure that has only very recendy had clinical use guidelines available and where methods are not standardized
1152
between laboratories.'" However, in the context of overall daily operations, allowing this test (with a relatively low cost under $50) to be sent to a reference laboratory may be easier than contacting the requesting provider to discuss the order. In smaller facilities, the limitations may be more pronounced with even lower numbers of qualified staff to execute a program. Using automated computer systems to regulate and guide ordering practices is also limited throughout the MTFs. With one current hospital information system (the Composite Health Care System [CHCS]), duplicate orders may be detected and perhaps controlled, but test options cannot be easily removed from routine use without "hiding" them or requiring paper order requisitions. Further, a lack of complete connectivity between the CHCS and other information systems often requires use of paper requisitions with subsequent potential for misinterpretation of the test being ordered. This can lead to laboratory orders that bypass the review process, are ordered incorrectly, or are inappropriately submitted for testing. In addition, the laboratory component for the CHCS often lacks standardization between MTFs, making provider interactions with the system a learning experience at each location. Attempts to improve standardization (e.g., through the use of specific test nomenclature, standardized interpretations, etc.) have been partially effective, but diverse requirements at each MTF coupled with limited encompassing guidance often result in dissolution of standardized practices. In light of current fiscal constraints, it is recommended that clinical laboratory use guidelines be established at global or regional levels of medical care to support efficient laboratory test use, with perhaps molecular and genetic tests being priority. If developed and implemented effectively, these guidelines would provide direction at regional and local levels that could be leveraged into standardizing operations between facilities, translating into efficient, quality laboratory services that support the rapidly changing environment of military medicine. Further, standardization of general protocols and procedures (e.g., test nomenclature, maximizing electronic ordering procedures, etc.) would facilitate the regional and local implementation and transferability of these guidelines. In addition, global development of additional Centers of Excellence (COE) would support the reduction in overall costs by performing testing at centralized locations at cost as opposed to contracted prices with commercial facilities. Unfortunately, the start-up costs for many of these new tests are extensive; however, the potential retum-on-investment, if properly assessed, will more than makeup for these costs over time. MTFs should leverage the use of current and future COEs as much as possible, using consolidated test volumes to drive cost-effective operations that can evolve to recapture more and more commerciallyreferenced tests over time. Where COE testing is not available, not efficient, or not practical, or where procedures are under patent, continued use of commercial reference laboratories will be required. Each location should review
MILITARY MEDICINE, Vol. 178, November 2013
Editorial
utilization patterns/volume as well as contract services provided. Where warranted, volume and/or service renegotiations or development of regional agreements could be used to realize the most potential from these contracts. On a local level, it is recommended that each MTF establish a collaborative reference testing review service to meet local clinical needs. These programs would ideally be developed in concert with the pathology department, health care providers, and clinical specialists/scientists. If a program is already in place, a review should be performed to update procedures to meet ever-changing provider and patient needs consistent with standard of care testing. Further, it is recommended that all MTFs develop (or maintain) an active Clinical Laboratory Utilization Ccxnmittee (CLUC) composed of members from the pathology department as well as ancillary service representatives who have similar pursuits in cost-effective medicine. This committee, as well as chnical and professional staff, should develop local practice standards that are consistent with global and published clinical guidelines where appropriate. Where possible, local standards should be data driven by historical performance and supplemented by expertise of local staff and/or through consultation with specialists at higher level facilities. If implemented effectively, global guidelines in concert with regional and/or local interventions will assist each MTF, and military medicine as a whole, in reducing inappropriate laboratory testing and, with persistence and active monitoring, improve overall fiscal efficiency without compromising patient care.
MILITARY MEDICINE, Vol. 178, November 2013
REFERENCES 1. Wians FH: Clinical laboratory tests: which, why, and what do the results mean? Lab Medicine 2009; 40: 105-13. 2. Wolcott J, Schwartz A, Goodman C: Laboratory Medicine: A National Status Report, May 2008. Available at https://www.futurelabmedicine .org/our_findings/; accessed March 3, 2013. 3. Kim JY, Dzik WH, Dighe AS, Lewandrowski KB: Utilization management in a large urban academic medical center. Am J Clin Pathol 2011; 135: 108-18. 4. Lui Z, Abdullah A, Baskin L, Lewis G, Kelter G, Naugler C: An intervention to reduce laboratory utilization of referred-out tests. Lab Medicine 2012; 43: 164-7. 5. Lundberg GD: How clinicians should use the diagnostic laboratory in a changing medical world. Clin Chim Acta 1999; 280: 3-11. 6. Taylor MR, Edwards JG, Ku L: Lost in transition: challenges in the expanding field of adult genetics. Am ] Med Genet C Semin Med Genet 2006; 142C: 294-303. 7. United Health Center for Health Reform and Modernization: Personalized Medicine: Trends and Prospects for the New Science of Genetic Testing and Molecular Diagnostics. Working paper 7, March 2012. Available at http://www.knome.com/wp-content/uploads/2012/08/UNH_ WorkingPaper71.pdf; accessed April 23, 2013. 8. Recommendations from the EGAPP Working Group: Genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives. Genet Med 2009; II: 35-41. 9. Peltomaki P: Role of DNA mismatch repair defects in the pathogenesis of human cancer. J Clin Oncol 2003; 21: 1174-9. 10. Cole TG, Contois JH, Csako G, et al: Association of apolipoprotein B and nuclear magnetic resonance spectroscopy-derived LDL particle number with outcomes in 25 clinical studies: assessment by the AACC lipoprotein and vascular diseases division working group on best practices. Clin Chem 2013; 59: 752-70.
1153
Copyright of Military Medicine is the property of Association of Military Surgeons of the United States and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
