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REVIEW ARTICLES

Received: November 2^nd 2015

Judged: May 2^nd 2015

Excessive spending by misuse of clinical laboratory

Gamaliel Benítez-Arvizu,^a Bárbara Novelo-Garza,^b Antonia Lorena Mendoza-Valdez,^b Jorge Galván-Cervantes^b Alejandro Morales-Rojas^b

^aUnidad Complementaria del Banco Central de Sangre, Hospital de Especialidades, Centro Médico Nacional Siglo XXI

^bCoordinación de Planeación de Infraestructura Médica

Instituto Mexicano del Seguro Social, Ciudad de México, México

Communication with: Gamaliel Benítez Arvizu

Telephone: (55) 5627 6900, extensions 21801 and 21800

Email: gamaliel.benitez@imss.gob.mx

Seventy five percent or more of a diagnosis comes from a proper medical history along with an excellent physical examination. This leaves to the clinical laboratory the function of supporting the findings, determining prognosis, classifying the diseases, monitoring the diseases and, in the minimum of cases, establishing the diagnosis. In recent years there has been a global phenomenon in which the allocation of resources to health care has grown in an excessive way; the Instituto Mexicano del Seguro Social is not an exception with an increase of 29 % from 2009 to 2011; therefore, it is necessary to set containment and reduction without compromising the quality of patient care.

Keywords: Clinical laboratory services; Diagnosis

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The aim of this paper is to show growth in clinical laboratory tests at the Instituto Mexicano del Seguro Social (IMSS), as a result of a multifactorial global phenomenon, and proposed measures to contain it.

75% or more of diagnosis of a disease entity comes from a proper medical history with a thorough physical examination that uncovers abnormalities in a patient; this lets the clinical laboratory function to support the presumptive diagnosis (and in some rare occasions to rule it out), through the analysis of biological samples. Other laboratory functions are to establish prognosis, to classify a disease, to monitor conditions and the therapeutic effects of treatment, and, in a minimum of cases, to diagnose entities that are difficult to study. For various reasons, an escalation in laboratory spending has been seen, which has had no impact on the quality of care, so it is urgent to implement strategies for the suitable use of the clinical laboratory to contain excessive spending without compromising the quality of patient care.^1,2

World stage

In recent years there has been a global phenomenon (including Mexico) in which the allocation of health care resources has increased radically, to the extent that the growth of this spending is higher than the growth of the gross domestic product (GDP). For example in the US, the growth of this expense was 5.1% of GDP in the sixties, 8.9% in the eighties, and 13% in the nineties, and the laboratory has been one of the main factors in this increase. In European countries such as Sweden the estimated annual laboratory expense is 728 million euros, and in the United Kingdom spending amounted to 2.96 billion euros, while Spain has an annual growth in laboratory spending of 6.1%; in Ontario, Canada, spending on laboratory services increased 130% over a period of 16 years. Of all health care services, laboratory services has the greatest cost increase of any service; it is estimated that the budget allocated by health services for the laboratory is between 3 and 15% in different countries; unfortunately, the increase in laboratory spending does not correlate with better quality in patient care, nor is it reflected in the health of the population.^3-7

The laboratory service contributes significantly and measurably to the inflation of health care costs, so the governments of different countries are concerned with establishing strategies to contain and reduce this expense, reducing unnecessary expenses through adequate control of laboratories.^3,6,7

Magnitude of inappropriate use and the Ulysses phenomenon

Studies in the United Kingdom and the United States show that 25 to 30% of laboratory tests were inadequate, unnecessary, or did not contribute to patient care. Also, there is no association between the number of tests and the health of a patient; for example, up to 27% of the tests done on a patient with ketoacidosis have no direct impact on them; on the other hand, requesting tests for a clinically asymptomatic individual exposes them to the Ulysses phenomenon, which is to be subjected to unwarranted testing situations with the consequent stress and cost implied; it is well established that if an asymptomatic individual has 10 tests done, up to 40% of the tests can be found to have abnormalities without greater clinical significance.^5-7

Causes of inappropriate laboratory use

The various causes identified in inappropriate laboratory use can be grouped into three classes:

 

• Attributable to patients: the expectations of the patient regarding the attention received, paired with the pressure on the doctor to do tests that are commensurate with what they have "investigated" on their own, in addition to increased life expectancy of the population; these are all factors that put pressure on the number of tests in older age groups, as well as increased survival with diseases like cancer, or the appearance of "new" diseases such as HIV, or graft versus host disease, which is the result of a transplant. Also, administrative pressure, which is a result of increasing population, causing less consultation time for a proper doctor-patient relationship.
• Attributable to the laboratory: automation, accessibility of testing, practice dichotomy causing an excess of unnecessary laboratories in health systems, and the development of new tests give rise to two phenomena: one is access to new ways of supplementing a diagnosis, and the other is, when a new test is introduced, in most cases it goes through a period of overestimation, causing it to be used excessively.
• Attributable to the doctor: doctors are the major players in the improper use of the laboratory, and the main target of policies to correct this anomaly. Among the identified situations, doctors request tests due to factors that are irrelevant, such as a) curiosity (thanks to the availability of tests); b) the lack of clinical assessment of the patient, placing trust in technology and not in their clinical judgment, causing them to request tests in search of unusual diseases in populations where the prevalence these diseases is very low; c) lack of review of previous results, causing unjustified repetition (for example, repeating the diagnostic protocol in a patient already diagnosed in the referral hospital), and the fragmentation of care (subspecialties). If we follow this vein, we have unevaluated or not continuously monitored protocols, in which tests are done that give information that is not reviewed or that does not cause any changes in patient care, although alterations are found. The lack of knowledge about testing causes unnecessary repetition, as in schools, where laboratory requests are "inherited" among residents without any reasonable clinical evaluation, and without awareness of the cost of testing (as there is the false perception that they are cheap), due largely to their accessibility, the idiosyncrasies of the doctor (who believes that comprehensive laboratory testing will give a "better diagnosis" than adequate clinical evaluation), the doctor wanting to impress their colleagues or the patient, or, in the case of doctors in training, seeking to avoid humiliation by their teachers; it should be added that some doctors use laboratory studies as a delaying strategy. The use of portable point of care devices is another factor that causes inappropriate use of the laboratory. In addition, an extremely important situation is the development of defensive medicine, in which tests are preemptively requested due to possible demand; paradoxically, this attitude is based more on fear and ignorance than on a scientific basis, because it sometimes backfires. From the point of view of proper medical practice, timeliness and relevance is what determines a proper request for a test, and not the quantity; that is, the right test before the right diagnosis in the right patient. It is interesting to see that there is an inverse relationship between age of doctor and the number of laboratory tests (expertise); this fact is relevant because the laboratory is a tool to support diagnosis based on an appropriate clinical trial, and it is always oriented towards patient welfare, so it is expected that physicians requesting fewer studies are those that have considerable clinical experience, appropriate clinical judgment, commitment to their work, and honesty in the face of diagnostic uncertainty.^1,5-8

Containment and control strategies

The implementation of individual strategies gives little result, so different researchers in the world have shown that the way to address this problem involves different coordinated actions, including administrative, technological, educational, and supervisory action.

The UK has achieved a savings of 500 million pounds through the implementation of strategies at different levels, which reengineered laboratories on a large scale.⁴

Among the proposed actions is the regionalization of laboratories. This offers the advantage that, with increasing testing, operating costs and direct and indirect costs decrease (economy of scale); also causes a decreased variation coefficient and the possibility of finding false positives or false negatives; it also facilitates internal and external quality control, thus increasing the precision and accuracy of the tests, increasing the reliability of the result.

If we use computer systems, results can be sent the same day to different centers; in addition, most of the studies can be processed within 24-48 hours (except for life support testing -emergency-) without compromising results, and with proper management in the conservation of samples.

Outpatient sampling centers have been established through regionalization, with an improvement in the quality of care. Another strategy used is the introduction and technological improvement through automation, which reduces costs and time. For example, in New York the cost per test was $2.65 in 1965 and $0.51 in 1975. Also the implementation of portable point of care devices, which we mentioned, facilitates patient care at the bedside. However, the strategy that has had the greatest impact has been the direct reduction of testing. It has been established conclusively that this strategy does not affect the clinical outcome of the patient. This reduction of testing clearly must obey a logical sense, i.e., the most sensitive and specific tests must replace and eliminate those with lower performance. For example, prostate-specific antigen is a better test than acid phosphatase. Continuing education and reviewing the requested tests, along with clinical feedback for improving laboratory requests, is a crucial point in laboratory re-engineering. The orientation of tests according to a diagnosis and not an organ or system reduces the tests requested. Laboratory administration on demand has been implemented as a management strategy. The approach of this strategy is based on ensuring the appropriate request, and not on reducing requests. An inappropriate request can be defined as a request for a laboratory test that can reasonably be avoided without detriment to patient care.^4,8-11 

The reasons for inappropriate requests are diverse; the laboratory, the patient, the physician, and factors of the system itself are involved. Therefore, the goal of administration on demand is to establish the necessary guidelines to reduce laboratory spending; for this, its impact is measured based on 1) savings in health spending, 2) improvement in patient care, 3) improved quality of life, and 4) social benefits, such as fewer days of missed work. Appropriate request is subject to the needs of each center, but should ensure testing in a relevant and timely manner; this must be distinguished from unnecessary requests (one in which the applicant requests a study that has no impact on the patient), late inappropriate requests (in which the laboratory study requested is correct, but not in time), and inappropriate requests (a laboratory error in which a different study was requested). Thus, inappropriate requests include one or more of the following conditions: wrong patient (e.g., pregnancy tests for men), erroneous test (factor V in patients with normal C protein), wrong time (weekly test for glycated hemoglobin) or inadequate process (sample tube without anticoagulant), all cases in which the request should be rejected. To implement the administration on demand strategy, each institution should articulate their strategies based on their operating characteristics, always with the participation of stakeholders in patient care, for a coordinated and effective action. The recommendations made by Fryer⁴ to implement administration on demand by taking into account that the authorities must define when a request is inappropriate and when it is appropriate. It should also be clear that the request that meets inadequate criteria will not be processed and should be rejected. The prevalences of conditions should be identified to determine the relevance of the requests; continuously review inappropriate requests to try to identify the root of these causes; establish a menu of tests according to the service; define which tests provide more information to avoid duplication of testing; identify the most expensive studies and assess their relevance and timeliness; implement a control of tests with a minimum frequency (e.g., lipid profile should not be less than 30 days) using administrative and technological tools to avoid duplicating studies; establish a close relationship between the applicant and the laboratory to prevent these inappropriate requests (between doctors); maintain a continuous education program; design diagnosis-oriented requests, not by organ or system; assess the cost-volume; establish penalty strategies for those who generate inappropriate requests; restrict special tests to specialists; and validate by the laboratory based on diagnosis; establish guidelines according to the site; implement a system of continuous assessment of implemented measures in the education and performance of the applicant, and interventions for reducing costs always focused on patient care (by the way, this is the best indicator of laboratory performance and not only savings). Also, patients should be advised not to exert pressure regarding their testing.^4,7-14

Indicators for laboratory evaluation

There are several indicators that can be used for laboratory evaluation, but these are focused on performance "within" the laboratory and not as a service, so the creation of indicators has been proposed to measure its impact in terms of decrease in allocated spending, improvement in patient care, and improved quality of life and social gain.⁴

The review of pathology services in the UK focused on three points: 1) improving patient quality and safety, 2) improving efficiency, and 3) identifying mechanisms to promote the changes. In this report, strategies were evaluated by means of a pilot study, which resulted in a series of recommendations for pathology services in the UK that would allow it to save up to 20%, approximately 250 to 500 million pounds.⁷ The conclusion of most authors is that the best indicator of action is the results in patient care by the relevance of the test, and not the number of tests required, which shows that reducing testing does not compromise attention and does improve performance.^4,7,9,12-14

The situation of IMSS

In Mexico the situation is no different from that in the rest of the world. Under pressure to streamline their health care spending, our country has been forced to implement savings policies at a national level, in adherence to the Plan Nacional de Desarrollo 2013-2019.

Because of this, IMSS introduced the Comprehensive Medical Service (Servicio Médico Integral, SMI) through the Dirección de Prestaciones Médicas through the Coordinación de Planeación de Infraestructura Médica (CPIM), which gives certainty to the spending policies of the Institute regarding the laboratory. This service consists of the delivery, installation, and commissioning of equipment and information system with associated computing programs, which includes equipment, technological upgrading, preventive and corrective maintenance, training and counseling of staff designated by the Institute (before the implementation of comprehensive medical services, the different units had difficulty ensuring 100% of laboratory tests for enrollees; sometimes these were not carried out, resulting in in laboratory requests reported "Unreactive"). With the implementation of SMI, 100% coverage of enrollees in the demand for clinical laboratory studies is achieved.

Behavior of IMSS clinical laboratories  

We consulted the pages of the Coordinación de Planeación de Infraestructura Médica (restricted access for people at IMSS only), the statistics of the Instituto Mexicano del Seguro Social, and the "Report to the President and to Congress on the Financial Position and Risks of the Instituto Mexicano del Seguro Social 2011-2012"^15,16 to document the behavior of the clinical laboratories of the Institute. After implementing the SMI, the behavior of laboratory testing was demonstrated nationwide and cited in accordance with international literature, showing a growth in the number of tests of 29% from 2009 to 2011. This growth trend has continued to date due to the improper use of the laboratory by the different levels of care. This growth cannot be explained based on population growth, as this has remained stable;^15,16 nor has it meant an improvement in health care, as a decline in conditions such as diabetes mellitus and renal failure has not been reflected, as both are among the ten leading causes of consultation.¹⁶ Furthermore, in reviewing the ten most used analyses at the national level, a disproportionate expense was seen that shows a lack of attachment to observed clinical practice guidelines and a lack of congruence between the reasons for care and requested analyses. For example, coagulation tests, according to the international literature, are indicated in patients with suspected coagulation disorders; the excess of these tests (10,913,780 tests in total (Table I) were done between prothrombin time and partial thromboplastin time),¹⁵ often ordered in daily practice as presurgical routine, is not justified compared to the number of surgeries performed (1,514,904 surgeries performed in 2012),¹⁵ and clotting disorders and liver disease are not listed in the ten most frequent diseases.

To cope with this situation it is necessary to implement coordinated strategies to contain spending.^17-20 Proposals from the Coordinación de Planeación de Infraestructura Médica are summarized in Table II, and correspond to globally accepted strategies that have shown results in cost containment. If implemented, they must be monitored continuously to verify their effectiveness.

Discussion

It is noted that the growth in the number of laboratory tests has no relation with the population behavior, since in recent years the number of IMSS enrollees has remained relatively constant. It is very likely that this increase is due to the same causes that are reported in the world, and, because the physician is primarily responsible for this increase, they should be the target of strategies to reduce laboratory misuse and abuse. More studies are needed in this regard to test this assumption and evaluate the proposed strategies to control and reduce laboratory spending.

The increase in spending from increased clinical laboratory testing is a global phenomenon. Growth in spending has not been associated with better health care. Of primary importance is the establishment of control strategies and reduction in spending on clinical laboratory tests at IMSS to optimize the Institute's resources without detriment to care.

References

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