CHANGES IN HEALTH CARE DELIVERY: INFLUENCE ON THE CLINICAL LABORATORY

Dr John Barclay
Paris, France

Summary

Health care reforms are profoundly changing the role and the organization of clinical laboratory testing. The diversity of healthcare systems in Europe does not prevent each country from looking at the reforms taking place in neighboring countries and in the USA to identify both organizational and technical solutions to the political and economic problems they experience in implementing their national reforms.

One major trend is towards the consolidation of laboratories, both public and private. Consolidation of public hospital laboratories, however, goes beyond the simple grouping of equipment and people under one roof to get higher productivity with lower overheads and unit costs. It involves a complete review of the nature of the tests that will be provided to answer clinical questions, the way in which the tests are ordered and interpreted, the sample collection process, the sites at which the tests are performed, the turnaround times, etc. Indeed, the pressure to consolidate and to centralize the bulk of testing is accompanied by the pressure to provide immediately available results at the point-of-care in emergency rooms, ambulatory care facilities, and critical care units. Some major challenges in consolidation projects arise from the financing of new buildings and equipment and the fate of the staff and buildings that are no longer needed, issues that have to be taken into account from the earliest stages of planning.

The changes in laboratory organization are the consequences of changes in the types of medical and surgical care being provided, to the choice of pharmaceuticals, and to ever-more specific forms of imaging and other diagnostic techniques. The increasing use of molecular makers and markers of genetic predisposition to cancers and degenerative diseases adds new responsibilities to the laboratory, but the full impact of these will only be realized when there are specific treatments targeted at the receptors and molecular mechanisms involved in the disease processes.

An additional feature of these hospital reforms is the role of evaluation of the efficacy and the outcomes of care, and the cost-benefit of therapeutic and diagnostic interventions. This will lead Laboratory Managers to play an active part in the process of reappraisal of testing patterns and to be constantly aware of new technical solutions to clinical and organizational problems. This process of interaction with clinicians and administrators requires both flexibility and firmness, particularly when laboratories are to merge, because the success of any project of laboratory consolidation requires leadership, long-term vision, and full commitment and participation of all of the partners.

Perspective in Europe

The factors, which are driving the evolution of the clinical laboratory today, are political, economic, technological and medical. The primary influence of the political and economic factors is in the way healthcare is delivered. The reforms underway in Europe today are similar in each country, market-driven changes are occurring alongside state-driven reforms intended to control the "quantity" of healthcare, to control its quality, and especially to control its costs. The reform processes were originally inspired by a report from WHO published in 1985, "Health for All for the Year 2000." This report contained a set of 38 specific healthcare resource and delivery objectives with deadlines for implementation by all countries adhering to WHO. It recognized that each country has intrinsic genetic, cultural and lifestyle factors that have resulted in historical differences in health status, and that each country has a different ability to finance the changes and national policies that will reduce these differences. Nearly all countries in Europe produced their national targets for reducing the causes of excess mortality and morbidity in their population through public health issues such as cancer screening, immunization, drug abuse, mental health, accident prevention, etc. The reforms have since been modified by the Maastrich criteria for monetary union which decreased public expenditure on health, and by the increased demands caused by the aging population, advances in therapeutics, in surgery and transplantation, implantable prostheses, intensive care, endoscopic surgery, interventional radiology, fertility treatment, the expenditures associated with AIDS, and other public health issues. Since the 1985 report, there has been an exponential growth in the complexity of care with the emergence of medical specialties and subspecialties. Somehow, these have to be integrated into the system of reforms and be accessible from everywhere, because the European Union has a principle of social equality for all its citizens, with equal access to health care, independent of the ability of the patient to pay.

Other influences on the reform processes include:

• The economic situation in the regions within each country and historical imbalances in the distribution of hospitals and services.
• The emergence of the idea that healthcare costs can be managed like a service industry in the private sector, and run within a fixed budget or envelope. This has led to the externalization and contractualization of services, not only for the "hotel" aspects of care - laundry and catering, cleaning, etc. - but even for laboratory testing, notably in the UK. In France and in Germany, this has led to setting targets for expenditure- the quantified national objective" for private and public healthcare, with penalties for industry and for physicians if the actual expenditure exceeds the objectives.
• Reduced state funding for Universities and National Research Institutions. Many Clinical laboratories, especially in University Hospitals, share staff and facilities with University and Research appointments, which creates practical problems for consolidation and for budgeting.
• The emergence of the concept of the patient as a consumer, with rights and expectations for the kind of treatment received. This consumer attitude will also give patients the power to ask for and get specific types of treatment, and to take legal action if the treatment is not available or not of an acceptable standard.

There are two major processes that are used to control the diffusion of new techniques - accreditation and evaluation. Rapid adoption of ineffective new technologies has been blamed for inflating healthcare expenditure. The accreditation process, for facilities and for people, will develop and will be more and more specific to each type of procedure. Evaluation of professional practices is now accepted, with guidelines on evaluation procedures, published consensus conferences for specific procedures, and practice guidelines that can be national or even international. Evaluation agencies include the National Institute of Clinical Excellence (NICE) in the UK, the Agence Nationale de L’Accréditation et L’Evaluation en Santé in France (formerly called the National Agency for the Development of Evaluation) , MEDTAP, the Rand Corporation, and others. There is everywhere a movement towards Evidence-Based Medicine (EBM), which is another form of standardization by consensus. Indeed, the purpose of the evaluation agencies and reimbursement controls in most countries in Europe is to contain costs by creating a series of national "managed care" health services.

When the French agency issued its first guidelines for prescribing physicians outside hospitals, the workload of private laboratories fell by around 30%, since failure to prescribe drugs and tests appropriately, could be accompanied by fines and penalties for the doctors concerned. There are now over 200 guidelines for patient management, some of which limit the nature and types of test that can be prescribed for monitoring a disease or its treatment, and how often this can be done. A computer database is needed to check if what is proposed for a given patient fits with the guidelines.

A similar approach has been used in the UK, where there are many guidelines, which have been developed at local level for each town or region coming under the same budgetary control. This decentralization in the UK has led to major differences in the standards of care available in different parts of the country. The NICE and the National Health Service Health Technology Assessment service have been developed in order to provide common guidelines throughout the country to reduce the differentials created by local types of budgetary control.

Similarly, managed-care in the USA has reached the point where financial restriction means lower quality of care. The focus is now on achieving better patient outcomes at equivalent costs. The approach in French Hospitals is similar. Hospitals do have fixed budget allocations, and each Clinical Service is supposed to evaluate its practice in order to eliminate waste and ineffective treatments. Nationwide, a hospital medical information system has been put in place in which each patient’s stay in hospital is coded into a category of pathology similar to the Diagnosis-Related Groups (DRGs) in the USA. The costs of the hospital stay are calculated. Individual hospital departments are encouraged to get their average cost per admission in line with the national average, taking into account differences in patient age, the severity of the illness, etc.

Very few guidelines for hospital patients deal specifically with laboratory testing. However, an increasing proportion of the laboratory workload is coming from standardized treatment protocols, intended to contain costs, to facilitate the evaluation of treatment outcomes in the hospital or in Sponsored clinical trial protocols. Thus the Laboratory Manager is obliged to organize his laboratory in a flexible way as a consequence of the changes in types and location of care, with increased outpatient and day-care treatments, and as a consequence of the ways in which treatments are monitored and controlled, locally, regionally, and nationally.

Until recently, the Clinical Laboratory was affected mainly by the economic constraints. Although laboratory costs are only a small part of the overall hospital budget, they are relatively easy to identify and therefore to be contained. In France, as in many countries, the laboratory costs are included in a fixed daily charge for hospital care. Reducing the number of tests does not have a big impact on total costs. These are mainly those of salaries, with only a small part, ~ 10- 15 % arising from reagents, consumables, and control materials. If budgets are reduced, the Laboratory Manager passes on the reduction to reagent and equipment suppliers who, until now, find ways of providing equipment and reagents in flexible renting and leasing programs, in order also to obtain a controlled amount of revenue from each laboratory. There are limits to the extent that this can be continued, however. As the newer tests in molecular biology are more expensive, many more conventional tests have to cut to keep within budget, or the laboratory will have to reduce its staff, if this is possible.

Between 65 and 80% of the laboratory budget is in personnel costs. In some countries, reduction in personnel through automation with improved productivity has been difficult to achieve, but the pressure to cut staff continues, with an increasing focus on automation of pre-analytical functions and robotic sample transport to workstations within the laboratory. Much of the laboratory equipment and many of the organizational solutions for the Clinical Laboratory have been conceived for use in the US context, and ideas inspired by US healthcare reforms are being used in most countries in Europe. Although there are several differences in the relationships between patient, health insurer and healthcare providers between the US and the various countries in Europe, some of the solutions are of great interest. The most important of these for hospital reforms in Europe is the Integrated Provider Network.

Integrated provider networks and laboratory consolidation

An integrated provider network is a healthcare delivery system with hospitals, clinics and consulting rooms for family doctors and specialists, providing combined hospital care and community-based services for patients in a particular town or region. Each hospital or clinic provides local services close to the population that gets treated and specialist care in referral centers. The overall driving force is economic, related to containing the total costs of episodes of patient care, not just the hospital component. It works because there are protocols and standardized care for each type of intervention. Doctors in the system are not free to choose any kind of treatment or investigation, and the hospital provides in-patient care, home care, and community follow-up in a combination that has the lowest overall costs. What is remarkable about this type of system is that the groups of hospitals are self-sufficient. They offer the patients in the region a local health insurance. It is a business, and as such can grow and expand, or sell off parts that it no longer wants to neighboring networks. The workload capacity of the peripheral laboratories therefore has to be optimized to maintain the value of the facility as an asset in the business, which can be expanded or sold off, as required.

Non-urgent testing can be concentrated in an existing laboratory, shared between existing laboratories, or a new highly automated core laboratory can be built. Regional laboratories can also provide local testing services, in the same way that private community labs do. Laboratories in regional hospitals or clinics can therefore have a more cost-effective workload than they would have had if they made only those tests needed for essential daily care and specialist care in that particular hospital. Stat labs and satellite labs can support ambulatory care and day-hospitals, etc. Laboratory management in an integrated provider network is a key element for its success.

In France, the allocation of healthcare budgets to regional administrations is leading to a similar approach, at least for the hospitals in the region. The health insurance funds for hospital care and for community care are managed by different organizations, although both are accountable to the Ministry of Health.

Within the regionalization process, partnerships between public and private sector are encouraged, including partnerships with private laboratories. There are examples in cities where independent private labs provide routine and urgent testing for nearby surgical clinics, but the most obvious type of relationship concerns specialist testing, mainly hormones such as free T3 and hormone receptors, tumor markers, or esoteric coagulation factor tests from smaller hospitals. Two large reference laboratories in the area of Paris have highly efficient logistical support for sample collection all over the country. University Hospitals which might be closer to the hospital with the patient are unable to provide the convenience for sample collection and result reporting.

Integration with community care is made more difficult by the separation of the budgets. There are experimental projects introduce home care, for chemotherapy, for minor nursing care after surgery, or oxygen therapy, where nursing at home is managed by the hospital. There are also community care networks for patients with HIV and Hepatitis C infections, etc., aimed at minimizing the spread of infection. More recently, community networks for antenatal care have been set up in high-density suburban populations which do not have easy access to obstetricians and clinics, but the traditional budget separation between hospital and community care will have to be completely revised before fully-integrated hospital and community care can become general.

It is clear that computer networks that link patient records in hospitals and consulting rooms are important to capturing all the information on the patient and avoiding unnecessary testing. What is less well accepted is that the same network linked to the patient’s health insurance can guide the prescription of tests that the insurer will reimburse. This is one of the aims of a very wide area network in Nebraska in the USA, where Dr Robin Felder, one of the pioneers of laboratory robotics, is working towards a laboratory in which the test prescription made on-line by the clinicians will be monitored and controlled in real time for conformity with the guidelines on investigation and treatment that have been established by the insurer. In the USA, the same type of patient can get treated differently when insured by different managed care organizations. A report by the US National Committee on Quality Assurance showed that over 25% of consumers had difficulty in choosing a doctor and getting referred to a specialist because of insurance restrictions. Doctors prescribing unusual tests or treatments may have to justify these to Medicare before the patient can obtain reimbursement.

Will this type of difference happen in Europe? Probably yes. In the next decade we will see much greater differences than today in the levels of service and types of treatment that are given in the same hospital to patients with the same illnesses. The differences will depend on whether their care is paid for entirely by the State Health Insurance or with a contribution from the patient’s private insurance or directly by the patient. There will be minimum standards of care that are approved by national authorities, hospital management will accept that these are included in the daily costs for that category of patient, but if the patient has additional private insurance that accepts to pay for a different kind of treatment for that category of patient, then the hospital will provide it.

Most of the population is dependent on state health insurance, and this insurance is usually related to being employed or retired after employment. Some patients also have additional private insurance that will reimburse some costs not included in the state insurance. Another part of the population, usually the poorest people, do not qualify for public health insurance, but obtain free care by attending hospital emergency departments. Thus the different types of patient get different levels of service from the healthcare providers. As an example, France is considering a kind of "basket of services" to which everyone is entitled, and those patients with additional insurance can get things that are not included.

How will this type of difference affect the Clinical Laboratory? It is difficult to generalize. But if we accept that the basic treatment and investigation will include those things that are of proven benefit in life-threatening situations, and that the complementary insurance may pay for less-well proven treatments in situations that are not immediately life-threatening, one can imagine, for example, that laboratory investigations in the monitoring of hormone replacement therapy or for screening asymptomatic men for prostate cancer will not be part of the basic service. Thus, the Laboratory Director will have to ensure that the guidance given to doctors for test prescription and the interfacing of the hospital information system with the on-line test prescription procedures take into account the tests that are acceptable for the patient and the health insurance. This will be part of the "Quality" of the service provided by the laboratory.

Clinical Laboratory Business Models

Business models for profitability apply in the private sector, but not to public hospital laboratories. Most hospital laboratory consolidation projects are intended to reduce costs or to fix future levels of expenditure. The major difficulty in fixing future levels of expenditure in laboratory services is to identify the clinical demand, both in the types of test as well as the numbers of tests.

For each clinical service requesting tests, the patterns of investigation and the required TAT for the results have to be identified. In this way, the laboratory support can be conceived to provide an optimum level of resource utilization and of costs. For critical care, post-surgery recovery rooms, operating rooms, the TAT is of great importance. In France, the Laboratory Director is legally responsible for all testing, even if it is done outside of the lab. The Laboratory Manager has therefore to work with the clinicians on a spectrum of tests and response times going from continuous monitoring with in-vivo and ex-vivo techniques, through point-of-care testing to satellite lab and stat-lab testing.

In practice, for most consolidation projects, decisions have to be made several years in advance when the clinical specialties and activities are still uncertain. However, since the proposed solution has itself to be able to adapt and evolve, with new tests and new technologies, new types of patient management, etc., modularity and flexibility can be built-in to the proposed organization.

Standardizing sample types and testing protocols throughout a regional service has distinct advantages:

• Sample collection is simplified
• Pre-analytical automation is facilitated
• More flexible allocation of workload to different laboratories is possible, if needed (equipment breakdown).

Several types of laboratory organization are possible, singly or in combination:

• Core laboratories and Regional Laboratory Networks
• Outsourcing
• Revenue Generation
• Cost-sharing Partnerships and Joint-Ventures

Core laboratories and regional networks

Core laboratories are central laboratories providing services to one or more groups of hospitals. The core laboratory is a place where the bulk of "routine" testing is performed, and is usually equipped with large-scale automation, often with robotic handling of specimens for centrifugation, aliquotting and preparation of secondary ("daughter") samples from the original blood tube, sample archiving, etc.

Core-laboratories can be located at an existing laboratory, but when space is not available to optimize the layout and workflow, a new laboratory may be built and commissioned. The capital cost of building a new laboratory is a major issue that can cause delay or even abandonment of the project.

In France, the funding is usually by Regional Government, not the Health Insurance. As a consequence, it is subject to delays and changes in political priority for the expenditure. In the UK, private finance may be used for the rebuilding, and a private company may have the contract for running the new hospital and the laboratory for a fixed period of time. Some projects involve a real-estate transaction in which the new hospital and laboratory are built in exchange for developing other parts of the land as offices or apartments. This also occurs in other countries. Sometimes these re-developments are delayed or modified as a result of public protest against the demolition of historic buildings or public pressure that the redevelopment is for social housing or other public benefit than for private or commercial use.

Testing in the core laboratory is usually considered to be non-urgent, the main component of turn-around-time being the time of transport of the specimens from the clinical areas to the laboratory. Core labs are usually multidisciplinary: chemistry, immunochemistry, hematology, coagulation, and sometimes urinalysis.

Two main types of organizational layout have evolved:

• The total laboratory automation approach
• The work-cell/work-island approach

In the total laboratory automation approach, samples arrive at a reception area, are logged in or identified automatically for further processing, and the sample preparation process begins. After centrifugation, in an organization designed around the use of multiple primary tubes, these can be dispatched directly to the workstation, usually with robotic transport. There are variations in the layout of workstations. These variations largely depend on available space and the positions of drains and services in an existing building, but also depend on the types of analytical systems, the combinations of test parameters they offer, and the way in which sampling is performed.

Also, the transport track for samples can be routed around the periphery, down the middle, or parallel tracks to specific areas with different levels of automation and interfacing to the transport mechanism according to the degree of automation of the analytical equipment for the types of test as well as the geometry and layout of the laboratory area.

The work-cell/work-island approach also can be used for non-core laboratories in the regional network which perform the same tests. One major question is whether or not to use equipment from the same supplier in every location.

The potential advantages are :

• Economy of scale in purchasing
• Greater flexibility in staffing, with reduced training
• Comparability of results between laboratories

However some Laboratory Managers consider that being dependent on one supplier is a risk. They prefer to have multiple suppliers, encouraging competition between them. They may also prefer to have several medium capacity analyzers than one high capacity system in order to have flexibility and protection against loss of output in the case of breakdown. To some extent, this choice depends on the proximity of the service support and the possibilities for back-up testing in close proximity, but cross calibration of the analyzers performing the same tests is important.

The drive to save money by reducing the length of hospital stay changes the pattern of testing and timing during the day. Some results are urgent, not for medical reasons, but for administrative ones. The laboratory results may be needed in order to make the decision to discharge the patient. The questions for the Laboratory Manager are whether to provide the testing as a Stat service from the central lab, a dedicated stat lab near the clinical service, or as a point of care service.

When an integrated provider network covers a large geographic area, it usually maintains some regional laboratories to allow blood to be drawn and some testing to be performed closer to the patient’s place of residence, without the need to travel to the main center. The specialist who is following the patient’s treatment gets the result or the family doctor gets the result and instructions on how to interpret and act on the result. This approach is often used for laboratory testing in all disciplines, including microbiology and coagulation, when patients are discharged early to have a period of home care. This also means that some outpatient testing has to be considered as more urgent, with fast turn-around time of the results.

The use of scenarios and of workload simulation is of great help in planning because it is possible to identify the critical weak points. Potential suppliers of equipment should be involved in the planning so as to include the future products which will be available at the time. Indeed, the planning and simulation process can be taken further, enabling performance criteria to be developed against which the future installed equipment can be evaluated. In most recent laboratory consolidation projects in France, the planning and simulation stage results in a short list of candidates and the final choice is made after sequential trials of each of the installations over several weeks.

Issues of service and support can be dealt with through contracts. An extreme version of this approach occurs in the UK, where the agreements with instrument manufacturers include guarantees for performing tests elsewhere if instruments are down, preventive maintenance, and even ensuring the loading of instruments with reagents and calibrators. This gives an economy of labor in the laboratory, but also allows the hospital to recover value added tax included in the charges for this service, which is not the case when the laboratory technicians order reagents and put them on the instruments themselves.

Outsourcing

For many hospitals, it is less costly to send out small volumes of non-urgent specialized tests, for example, to a private reference laboratory, than to have the necessary specialized staff and facilities in-house for small volumes of testing. It is usually a straightforward economic question but the indirect costs have to be taken into account.

Revenue Generation

Contract testing can also be important when analytical capacity is present. Potential types of contract include pharmaceutical clinical trial testing, drug screening for prisons or industrial health services, forensic testing, etc., as well as tests prescribed by local doctors. About 25% of the laboratory workload in many University Hospitals is linked to clinical trials, and the tests and procedures related to clinical trials are now charged to the trial Sponsor. In some of the smaller non-core labs in hospitals, contract testing may be the only way to get adequate volumes, providing that the laboratories meet the required standards or are accredited for any special types of testing.

One USA consultant has estimated that this type of testing (so-called "outreach" testing in the USA) has increased by two-thirds in 10 years, to be nearly half of the workload in 150-300 bed hospitals. In hospitals with >300 beds, the increase is less – perhaps 50%, becoming more than a third of the workload. Hospital-based outreach testing is gained in competition with private laboratories and laboratory chains, and depends on having both logistics for sample transport and excess analytical capacity at a convenient time.

Cost-sharing Partnerships and Joint-Ventures

One of the growing areas of research and evaluation affecting the laboratory concerns molecular diagnostics. There is an exponential growth in the applications involving genetics, oncology, rheumatology, clinical immunology and transplantation in attempts to find markers predictive of responses to specific treatments and to find specific molecules acting on specific receptors that can result in better patient outcomes through selective treatment.

With the high capital costs and installation costs of some equipment used, such as time-of-flight mass spectrometry, or gene sequencing and analysis equipment, there may be opportunities for Clinical Laboratories requiring the equipment and facilities to establish Partnerships and Joint-Ventures with research workers and research organizations to share underutilized equipment and facilities.

The Changing Role of the Laboratory Manager

Laboratory Managers play a key role in the integration of laboratory information within the healthcare system. Laboratory Managers can influence more effective utilization of the laboratory and improve patient care. For the liaison between clinicians and the laboratory, they can be more effective than purely administrative staff at creating clinical decision pathways that improve patient outcomes though better selection of tests, testing locations, and turnaround times to optimize test and resource utilization, while at the same time reducing overall costs.

The Laboratory Manager also has to take into account all laboratory disciplines, including anatomical pathology, virology, microbiology, as well as biochemistry, immuno-chemistry, hematology and coagulation. Molecular biology laboratories may also be important, particularly in teaching hospital networks to support advanced services such as immunology, oncology, organ transplantation, or where testing is used to support populations with a high prevalence of HIV/HCV.

No single "universal" approach exists for the organization of laboratory services. Patient demographics, geography, service needs, and medical expertise all contribute to the type of laboratory system required for a particular region. Some common points for successful consolidation projects, however, include:

• Leadership

Laboratory consolidation efforts must have strong leadership that lasts beyond the planning phase through to practical implementation. A typical network involves 4-6 different hospitals with different Laboratory Managers. In order for consolidated laboratories to act as one entity, a decision-making body directed by a strong leader is needed, with the appropriate authority to make and enforce the same policies and procedures in each hospital and laboratory. Strong leadership may also be needed when preparing the future of the staff who will not be needed in the new laboratory organization.

• Administration support

Strong support from hospital administration is necessary for long-term success. It takes time and money to achieve long-term efficiencies. Administrators who make only short-term decisions are likely to force the failure of the project of laboratory consolidation.

• Sense of "ownership"

If the key individual managers do not work together towards a common goal, there is an increased risk of disagreements and longer times are needed to get to the most effective solution. When several hospitals are owned by a single organization, the likelihood of building a successful core laboratory for these hospitals is increased. When all of the different laboratory specialties are run by a common management team, the probability of success is also increased. Laboratory managers may try to defend their old laboratory operation, especially if the laboratory recently made significant improvements in quality and efficiency. Many laboratory ventures become complicated by political and inter-personal factors. With a common sense of "ownership", the team acts as a team, focussing on service, cost reduction, growth and mutual benefits. Everyone must be willing to give up something "good" for something "better", forgetting the "old" way of working and keeping an open mind or neutral view of the changes. Typical items leading to disagreement include areas of responsibility, such as for phlebotomy, quality control, analytical technology, salaries and benefits, training and education of staff, transport and couriers, point-of-care testing at each hospital, etc. The team has to solve these problems and arrive at a unified offer of service, for example, with common test methods and sample collection procedures at each site.

• Data processing

Usually there is a need for investment in an information system that facilitates consolidation and communication with all of the participants in the network, including cross-charges and billing. This investment can be perceived as competing with the laboratory equipment for funding, rather than as an intrinsic part of the consolidated laboratory network. Sometimes existing laboratory information systems can be retained and interfaced, but many data-processing suppliers prefer to put a new turnkey service in place everywhere rather than attempt to integrate one or two different systems in different sites.

The new data processing platform can standardize patient or procedural databases, billing systems and provide a common means of access. It can inform clinicians of their utilization of the laboratory or their prescription habits, and this is a key element of the Clinical Laboratories service to clinicians.

The data system may also provide controlled access to the Internet for data transmission or interpretation. It can also provide records of test prescription and execution that can be used for legal purposes in the event of malpractice claims, or for compliance with clinical guidelines or reimbursement regulations.