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The national health system: future possibilities for the clinical laboratory
Clinica Chimica Acta 319 (2002) 101 – 105 www.elsevier.com/locate/clinchim
The national health system: future possibilities for the clinical laboratory Nicola Pansini* Patologia Clinica 1, Via Salvatore Matarrese 2/G, Azienda Policlinico, 70124 Bari, Italy Received 7 January 2002; accepted 21 January 2002
Abstract Background: The heavy burden of the costs of medical care has brought changes in the public health policy. The changes are partly related to the health management factors, but several cultural, social and environmental factors have also had a significant impact on healthcare. The role of the laboratory is now considered amidst changes that have occurred in the American health model (free-trader) and in the European – Canadian model (universalistic). Moreover, costs and clinical decision-making in laboratories in Italy have also changed in response to the new focus on the pre- and post-analytical phases of the testing process. Methods: In the present study, we used the Laboratory Information System (LIS) to evaluate whether the time involved in stages in the turnaround time (TAT) (admission, performance of tests, validation and decision-making for treatment) were reduced following improvements made to the laboratory organization and management of the pre-analytical and post-analytical phases. In particular, an analysis was made of laboratory testing for myocardial markers in patients with acute coronary syndrome. Results: TAT for myocardial markers in an emergency setting was reduced by 30% following changes made in the laboratory organization and in the management of the pre-analytical and post-analytical phases of the testing process. Conclusions: Thanks to changes in healthcare service/system in Italy, laboratory services will now play a crucial role in cultural and socioeconomic changes, particularly where testing processes and techniques are concerned. D 2002 Elsevier Science B.V. All rights reserved. Keywords: Health systems; Turnaround time; Screening; Laboratory organization
1. Introduction In recent years, significant changes have been made to health system/care policy, largely because governments have had to address extremely complex economic issues. The difference between the need(s) of healthcare and the demand for treatment largely depends on changes in the health service itself, but this in turn
*
Tel.: +39-80-5592124; fax: +39-80-5592629. E-mail address: [email protected] (N. Pansini).
is linked to cultural, socioeconomic (e.g. behaviour, lifestyles, attitudes) and environmental factors (i.e. the ecosystem) [1]. The above factors have had an impact on life expectancy ( > 75 years). In this aspect, the health sector has had a somewhat limited impact (10 –15%), while the contribution of our improved understanding of genetics has accounted for 20 – 30%, and the changes in the ecosystem, 20%. Finally, socioeconomic factors have had a great impact, estimated at 40 –50%. Efforts made in improving the healthcare service/ system, mainly linked to the fields of prevention, diagnosis, therapy and rehabilitation, usually follow
0009-8981/02/$ - see front matter D 2002 Elsevier Science B.V. All rights reserved. PII: S 0 0 0 9 - 8 9 8 1 ( 0 2 ) 0 0 0 2 9 - 3
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N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
Table 1 Peculiarity of healthcare systems ‘‘Free-trader’’ (United States) . Services financed by insurance . Healthy people pay in favour of damaged people (patients) . Medical treatment is insured, not prevention . A qualified specialized medicine is well developed . The primary care is strongly deprived ‘‘Universalist’’ (Europe, Canada) . Solidaristic . People pay according to their own economic conditions in favour of the community in need . In spite of the main purposes, the investments in medical treatment and rehabilitation are still predominant as opposed to health prevention
free-trade social status (American) or universalistic (European –Canadian) models. For different reasons, both models have always paid great attention to therapeutic goals and rehabilitation without focusing on prevention (Table 1). In the liberalist system of the United States, due in particular to a lack of primary care, errors in medicine are the third cause of death (225,000 deaths/year) [2] (Fig. 1). This has forced the healthcare system to address the following issues: (a) rampant costs of healthcare; (b) a need for changes in the assistance models; (c) search for measures that take sociocultural factors into account.
Fig. 2. The ‘‘paradox’’ of modifications in healthcare services/ systems.
More importantly, however, the differences of healthcare policies pertain to the above social models, although the defined goals are similar. Cultural changes in the European healthcare service/system (decisive health factors, real efficacy of medicine, health self-management, awareness) are also present in the changing trends in the United States. The latter strictly pertain to the following: (a) the adoption of scientifically developed ‘‘best practice’’ guidelines; (b) making information on performance available to customers, professionals and institutions; (c) a longer term of planning for the healthcare system.
Fig. 1. Mortality (patients who died) due to ‘‘errors’’ in medical care in United States.
N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
The European structural aspects (organization, management, financial systems), on the other hand, are to be addressed with a privatised approach (DRG, Managed Care), while the American trend has the slightly different aims (Fig. 2): (a) basic coverage for all Americans; (b) private sector health management (financial incentives for performance); (c) more individual financial responsibility for unhealthy lifestyle choices and demands for service beyond the medical protocol.
2. The clinical laboratory and healthcare systems The main strategies used to address increasing costs are common to both the above healthcare system models [3]. Although the burden of the clinical laboratory accounts for only 7% of the total public healthcare costs, clinical laboratories play a crucial role (70%) in
103
clinical decisions (admittance, discharge, diagnosis and therapy), and measures taken to counteract economic problems are directed toward consolidating laboratories, developing a network between hospitals and territories and increasing the Point of Care (POC) testing (25% greater than laboratory diagnostic testing), which will double within the next 10 years. In the Italian healthcare system, the cutback in staff and the greater influence of administrators in decisionmaking regarding instrumental choices have been achieved in a ‘‘physiological’’ way. These economic measures may soon result in a reduction of the number of tests made in hospital laboratories, with a consequent increase in commercial laboratories (outreacher) [4]. Because of these changes, clinical laboratories will have a new opportunity to participate in patient care and take on a leading role in utilization, cost control and management of outcomes in the medical community. Laboratories have already focused on the preanalytical and post-analytical phases in diagnosis
Fig. 3. The laboratory workflow (Clinical Pathology, Bari, Italy).
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N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
Table 2 TAT: evaluation of different fractions
Chemistry panel (urea, NA, K, glucose) Hematologic tests Mycocardial markers (cTnl, Myo, CK-MB) Coagulation tests (P.T.-A.P.T.T.)
Years
Admittance time
Execution time
Validation time
Evaluation time
TAT
2000 2001 2000 2001 2000 2001 2000 2001
0.33 0.27 0.04 0.04 0.33 0.23 0.12 0.15
0.15 0.15 0.05 0.05 0.18 0.17 0.07 0.09
0.07 0.05 0.07 0.06 0.08 0.04 0.18 0.19
0.36 0.18 0.29 0.28 0.38 0.14 0.16 0.20
1.31 1.05 0.44 0.45 1.39 0.58 0.53 1.03
(0.04 – 2.31) (0.22 – 2.33) (0.04 – 2.50) (0.06 – 3.51) (0.56 – 3.02) (0.34 – 3.09) (0.13 – 2.50)
Values expressed as median of hours.
and therapy. The influence of biological variables has also been evaluated, particularly in the pre-analytical phase, and greater attention has been paid to the interpretation of and comments on results, with a tendency to relating them to clinical aspects in order to improve patients’ outcomes [5]. In our experience, data supplied by the Laboratory Information System (LIS) on turnaround time (TAT) in different steps (time of admittance, execution, validation, therapeutic approach) have revealed weak points in the workflow of the emergency care, and this issue must be addressed (Fig. 3). Corrective measures taken in the pre-analytical (changes in organisation) and in the post-analytical phase (changes and integration of telematics) have effected a 30% reduction in TAT (Table 2). However, the delivery time of samples to the laboratory has a significant influence (35%) on the ‘‘real’’ TAT conducive to improving patients’ outcomes and testify to the great importance of programming a POC network.
Recent studies revealed that 60% of the population in the United States is willing to participate in screening (e.g. CA 19.9 serum marker) for the useless early identification of cancer of the pancreas, which is rare and invariably fatal [6]. However, this ‘‘willingness’’ decreases to 13.5% when subjects are given the following further information: (a) poor test sensitivity (70% false positive rate); (b) low incidence of the disease (11/100,000); (c) lack of ‘‘curative’’ treatment. The above illustrates that laboratory data could be determinants in an integrated socio-sanitary policy, giving useful information for the identification of target populations at risk and indicators for the outcomes [7]. In conclusion, while the cutting of costs may be destructive, the ‘‘setting up’’ of new healthcare systems could become a rewarding challenge for clinical laboratories.
3. The future role of the laboratory Future changes in health models will call for a greater attention to the preventive and informative aspects (‘‘empowerment’’) of healthcare. This means that the laboratory will play an increasingly important role in the scene. Complete and rational information on the validity of screening tests should lead to a sense of responsibility on the part of the citizen, who is often attracted by results claimed to be achieved by ‘‘mythical’’ or ‘‘alternative’’ medicine (Table 3).
Table 3 What the patient should ask before the screening test . What disease can you diagnose with the test you are suggesting to me? . What is the precision of the test? . What is the probability to have ‘‘false positives’’ and ‘‘false negatives’’? . What is the incidence of the disease in the population (number of persons/every 100,000 inhabitants/year)? . Are there any possibilities to treat the disease you are going to diagnose? And what about the probabilities of success? . Are there any side effects?
N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
References [1] Kunst AE, Groenhof F, Mackenbach JP the EU Working Group on Socio-Economic Inequalities in Health. Occupational class and cause specific mortality in middle aged men in 11 European countries: comparison of population based studies. Br Med J 1998;316:1636 – 42. [2] Starfield B. Is US health really the best in the world? JAMA, J Am Med Assoc 2000;284(4):483 – 5, July 26. [3] Elevitch FR. Impact of managed care on laboratory economics. Lab Med 1998;29(12):747 – 52.
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[4] Takemura Y, Beck JR. Laboratory testing under managed care dominance in the USA. J Clin Pathol 2001;54(2):89 – 95. [5] Plebani M. The clinical importance of laboratory reasoning. Clin Chim Acta 1999;280(1 – 2):35 – 45, February. [6] Austoker J. Gaining informed consent for screening. Br Med J 1999;139:722 – 3. [7] Emons MF. Integrated patient data for optimal patient management: the value of laboratory data in quality improvement. Clin Chem 2001;47(8):1516 – 20, August.
The national health system: future possibilities for the clinical laboratory Nicola Pansini* Patologia Clinica 1, Via Salvatore Matarrese 2/G, Azienda Policlinico, 70124 Bari, Italy Received 7 January 2002; accepted 21 January 2002
Abstract Background: The heavy burden of the costs of medical care has brought changes in the public health policy. The changes are partly related to the health management factors, but several cultural, social and environmental factors have also had a significant impact on healthcare. The role of the laboratory is now considered amidst changes that have occurred in the American health model (free-trader) and in the European – Canadian model (universalistic). Moreover, costs and clinical decision-making in laboratories in Italy have also changed in response to the new focus on the pre- and post-analytical phases of the testing process. Methods: In the present study, we used the Laboratory Information System (LIS) to evaluate whether the time involved in stages in the turnaround time (TAT) (admission, performance of tests, validation and decision-making for treatment) were reduced following improvements made to the laboratory organization and management of the pre-analytical and post-analytical phases. In particular, an analysis was made of laboratory testing for myocardial markers in patients with acute coronary syndrome. Results: TAT for myocardial markers in an emergency setting was reduced by 30% following changes made in the laboratory organization and in the management of the pre-analytical and post-analytical phases of the testing process. Conclusions: Thanks to changes in healthcare service/system in Italy, laboratory services will now play a crucial role in cultural and socioeconomic changes, particularly where testing processes and techniques are concerned. D 2002 Elsevier Science B.V. All rights reserved. Keywords: Health systems; Turnaround time; Screening; Laboratory organization
1. Introduction In recent years, significant changes have been made to health system/care policy, largely because governments have had to address extremely complex economic issues. The difference between the need(s) of healthcare and the demand for treatment largely depends on changes in the health service itself, but this in turn
*
Tel.: +39-80-5592124; fax: +39-80-5592629. E-mail address: [email protected] (N. Pansini).
is linked to cultural, socioeconomic (e.g. behaviour, lifestyles, attitudes) and environmental factors (i.e. the ecosystem) [1]. The above factors have had an impact on life expectancy ( > 75 years). In this aspect, the health sector has had a somewhat limited impact (10 –15%), while the contribution of our improved understanding of genetics has accounted for 20 – 30%, and the changes in the ecosystem, 20%. Finally, socioeconomic factors have had a great impact, estimated at 40 –50%. Efforts made in improving the healthcare service/ system, mainly linked to the fields of prevention, diagnosis, therapy and rehabilitation, usually follow
0009-8981/02/$ - see front matter D 2002 Elsevier Science B.V. All rights reserved. PII: S 0 0 0 9 - 8 9 8 1 ( 0 2 ) 0 0 0 2 9 - 3
102
N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
Table 1 Peculiarity of healthcare systems ‘‘Free-trader’’ (United States) . Services financed by insurance . Healthy people pay in favour of damaged people (patients) . Medical treatment is insured, not prevention . A qualified specialized medicine is well developed . The primary care is strongly deprived ‘‘Universalist’’ (Europe, Canada) . Solidaristic . People pay according to their own economic conditions in favour of the community in need . In spite of the main purposes, the investments in medical treatment and rehabilitation are still predominant as opposed to health prevention
free-trade social status (American) or universalistic (European –Canadian) models. For different reasons, both models have always paid great attention to therapeutic goals and rehabilitation without focusing on prevention (Table 1). In the liberalist system of the United States, due in particular to a lack of primary care, errors in medicine are the third cause of death (225,000 deaths/year) [2] (Fig. 1). This has forced the healthcare system to address the following issues: (a) rampant costs of healthcare; (b) a need for changes in the assistance models; (c) search for measures that take sociocultural factors into account.
Fig. 2. The ‘‘paradox’’ of modifications in healthcare services/ systems.
More importantly, however, the differences of healthcare policies pertain to the above social models, although the defined goals are similar. Cultural changes in the European healthcare service/system (decisive health factors, real efficacy of medicine, health self-management, awareness) are also present in the changing trends in the United States. The latter strictly pertain to the following: (a) the adoption of scientifically developed ‘‘best practice’’ guidelines; (b) making information on performance available to customers, professionals and institutions; (c) a longer term of planning for the healthcare system.
Fig. 1. Mortality (patients who died) due to ‘‘errors’’ in medical care in United States.
N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
The European structural aspects (organization, management, financial systems), on the other hand, are to be addressed with a privatised approach (DRG, Managed Care), while the American trend has the slightly different aims (Fig. 2): (a) basic coverage for all Americans; (b) private sector health management (financial incentives for performance); (c) more individual financial responsibility for unhealthy lifestyle choices and demands for service beyond the medical protocol.
2. The clinical laboratory and healthcare systems The main strategies used to address increasing costs are common to both the above healthcare system models [3]. Although the burden of the clinical laboratory accounts for only 7% of the total public healthcare costs, clinical laboratories play a crucial role (70%) in
103
clinical decisions (admittance, discharge, diagnosis and therapy), and measures taken to counteract economic problems are directed toward consolidating laboratories, developing a network between hospitals and territories and increasing the Point of Care (POC) testing (25% greater than laboratory diagnostic testing), which will double within the next 10 years. In the Italian healthcare system, the cutback in staff and the greater influence of administrators in decisionmaking regarding instrumental choices have been achieved in a ‘‘physiological’’ way. These economic measures may soon result in a reduction of the number of tests made in hospital laboratories, with a consequent increase in commercial laboratories (outreacher) [4]. Because of these changes, clinical laboratories will have a new opportunity to participate in patient care and take on a leading role in utilization, cost control and management of outcomes in the medical community. Laboratories have already focused on the preanalytical and post-analytical phases in diagnosis
Fig. 3. The laboratory workflow (Clinical Pathology, Bari, Italy).
104
N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
Table 2 TAT: evaluation of different fractions
Chemistry panel (urea, NA, K, glucose) Hematologic tests Mycocardial markers (cTnl, Myo, CK-MB) Coagulation tests (P.T.-A.P.T.T.)
Years
Admittance time
Execution time
Validation time
Evaluation time
TAT
2000 2001 2000 2001 2000 2001 2000 2001
0.33 0.27 0.04 0.04 0.33 0.23 0.12 0.15
0.15 0.15 0.05 0.05 0.18 0.17 0.07 0.09
0.07 0.05 0.07 0.06 0.08 0.04 0.18 0.19
0.36 0.18 0.29 0.28 0.38 0.14 0.16 0.20
1.31 1.05 0.44 0.45 1.39 0.58 0.53 1.03
(0.04 – 2.31) (0.22 – 2.33) (0.04 – 2.50) (0.06 – 3.51) (0.56 – 3.02) (0.34 – 3.09) (0.13 – 2.50)
Values expressed as median of hours.
and therapy. The influence of biological variables has also been evaluated, particularly in the pre-analytical phase, and greater attention has been paid to the interpretation of and comments on results, with a tendency to relating them to clinical aspects in order to improve patients’ outcomes [5]. In our experience, data supplied by the Laboratory Information System (LIS) on turnaround time (TAT) in different steps (time of admittance, execution, validation, therapeutic approach) have revealed weak points in the workflow of the emergency care, and this issue must be addressed (Fig. 3). Corrective measures taken in the pre-analytical (changes in organisation) and in the post-analytical phase (changes and integration of telematics) have effected a 30% reduction in TAT (Table 2). However, the delivery time of samples to the laboratory has a significant influence (35%) on the ‘‘real’’ TAT conducive to improving patients’ outcomes and testify to the great importance of programming a POC network.
Recent studies revealed that 60% of the population in the United States is willing to participate in screening (e.g. CA 19.9 serum marker) for the useless early identification of cancer of the pancreas, which is rare and invariably fatal [6]. However, this ‘‘willingness’’ decreases to 13.5% when subjects are given the following further information: (a) poor test sensitivity (70% false positive rate); (b) low incidence of the disease (11/100,000); (c) lack of ‘‘curative’’ treatment. The above illustrates that laboratory data could be determinants in an integrated socio-sanitary policy, giving useful information for the identification of target populations at risk and indicators for the outcomes [7]. In conclusion, while the cutting of costs may be destructive, the ‘‘setting up’’ of new healthcare systems could become a rewarding challenge for clinical laboratories.
3. The future role of the laboratory Future changes in health models will call for a greater attention to the preventive and informative aspects (‘‘empowerment’’) of healthcare. This means that the laboratory will play an increasingly important role in the scene. Complete and rational information on the validity of screening tests should lead to a sense of responsibility on the part of the citizen, who is often attracted by results claimed to be achieved by ‘‘mythical’’ or ‘‘alternative’’ medicine (Table 3).
Table 3 What the patient should ask before the screening test . What disease can you diagnose with the test you are suggesting to me? . What is the precision of the test? . What is the probability to have ‘‘false positives’’ and ‘‘false negatives’’? . What is the incidence of the disease in the population (number of persons/every 100,000 inhabitants/year)? . Are there any possibilities to treat the disease you are going to diagnose? And what about the probabilities of success? . Are there any side effects?
N. Pansini / Clinica Chimica Acta 319 (2002) 101–105
References [1] Kunst AE, Groenhof F, Mackenbach JP the EU Working Group on Socio-Economic Inequalities in Health. Occupational class and cause specific mortality in middle aged men in 11 European countries: comparison of population based studies. Br Med J 1998;316:1636 – 42. [2] Starfield B. Is US health really the best in the world? JAMA, J Am Med Assoc 2000;284(4):483 – 5, July 26. [3] Elevitch FR. Impact of managed care on laboratory economics. Lab Med 1998;29(12):747 – 52.
105
[4] Takemura Y, Beck JR. Laboratory testing under managed care dominance in the USA. J Clin Pathol 2001;54(2):89 – 95. [5] Plebani M. The clinical importance of laboratory reasoning. Clin Chim Acta 1999;280(1 – 2):35 – 45, February. [6] Austoker J. Gaining informed consent for screening. Br Med J 1999;139:722 – 3. [7] Emons MF. Integrated patient data for optimal patient management: the value of laboratory data in quality improvement. Clin Chem 2001;47(8):1516 – 20, August.