WO2001006429A1 - Method of sequencing chronic disease testing, reporting and evaluation - Google Patents

Abstract

A method of coordinating and sequencing clinical test sampling, testing and results reporting and billing (24) is provided which is initiated by selecting a results evaluation event to cause initialization of a testing sequence comprising providing testing materials to a patient (18), prompting patient sampling, testing of patient sampling (26) and reporting of test results (32) to a requestor as required by the evaluation event.

Description

METHOD OF SEQUENCING CHRONIC DISEASE TESTING, REPORTING AND EVALUATION

Background of the Invention The present invention relates to a method of disease management for chronic illnesses. In particular, the present invention provides for scheduled sequencing of test materials distribution, patient initiated sample collection, clinical laboratory sample testing, test results reporting to patient and physician and execution of billing clearance data.

During the course of disease management of chronic illnesses, it is frequently necessary that a continuous course of periodic testing of patient clinical parameters be conducted to allow the physician to monitor, during an ongoing basis, the patient's status with respect to the chronic disease and to permit determination of the need to make modifications in chronic illness treatment programs. One example of this type of chronic illness management is the case of diabetes. In any care management program of the diabetic, it is necessary that blood glucose levels be monitored to determine whether or not the patient treatment regimen is maintaining the blood glucose within proper parameters. While there are several types of diabetes which are attributable to difference causes, the majority of diabetes cases are classified as either Type I or Type II. Type I diabetes is the most severe form of diabetes and is typified by the afflicted individual producing little or no insulin naturally. Type I diabetes is, therefore, also known as "insulin- dependent diabetes mellitus." As a result of this lack of insulin production, the Type I diabetic must depend on daily injections of insulin to stay alive. It is also necessary that the Type I diabetic track blood-sugar levels so that the correct dose of insulin to be injected can be determined. The other major form of diabetes is classified as Type II diabetes. Type II diabetes is generally not presented in patients until after the age of 40 and when left untreated, can result in hyperglycemia and ketosis. While Type II diabetes does not require daily injections of the hormone insulin, it is necessary that Type 11 diabetics closely regulate their diet and other aspects of daily life in order to avoid complications of Type II diabetes. Such complications include formation of cataracts, heart disease, strokes, neuropathy, kidney disease, retinopathy and sexual dysfunction. To avoid these complications, the Type II diabetic must engage in close control of their diet and exercise regimen. In this manner, Type II diabetics are often able to control their blood sugar through their diet, combined with exercise, drugs and stress reduction. For both Type I and Type II diabetics, it is important that blood glucose levels be monitored, if not to track the insulin dosage for Type I diabetics, then it is necessary for Type II diabetics to receive feedback that their regimen of diet and exercise and drugs and stress reduction is successfully operating to maintain proper blood glucose levels. To this end, the American Diabetes Association has recommended that diabetics measure their blood glucose levels when they get up in the morning, before and after meals, and before going to bed in the evening.

Summary of the Invention

The method of the present invention provides coordination for the management of periodic clinical testing for chronic disease conditions. The method operates to coordinate the presentation of test materials to a patient; determination of successful specimen collection; verification of correct patient data; verification of correct billing data; performance of clinical laboratory testing on the specimen; reporting of clinical test results to the physician and/or patient and/or managed care organization; and reinitialization of the scheduling coordination sequence to again provide the coordination for the next iteration of a periodic clinical testing procedure for monitoring a chronic disease state in a patient.

The method can comprise some or all of the above steps, depending upon the needs of the patient and the physician. The inventive method is adaptable to a variety of chronic disease states such as diabetes, and heart disease, or the inventive method can be applied to collection and analysis of various specimen types such as saliva, urine, blood, feces, hair, nail clippings or other specimen. The method is most effective for situations in which the patient can self-collect the specimen and send to a clinical laboratory testing site. In this manner the method permits the coordination between the activities of a physician and a patient and a clinical laboratory and a managed care organization to insure that the required information and activities for monitoring the patients disease state occur, and occur in a proper sequence to provide useful information to all parties.

The sequencing method of the present invention is first initialized by entering data from the patient and the physician. This introduces particular patient parameters and the physician selected clinical test to be performed, the particular test content desired by the physician and the timing of the various tests to be conducted such as monthly, quarterly, semi-annually or annually.

The sequencing method of the present invention is re-initialized for the second and subsequent tests by one of several options. These options are usually selected according to the preference of the care management organization. Three of the common based upon the date of a future meeting between the patient and their physician. Back- calculating from this initializing event, patient specimen self-collection materials can be selected according to the particular test be conducted or specimen to collected and the materials then can be transmitted to the patient for the patient to collect the specimen. The method can then check upon the return of the specimen based upon the transmittal date of the collection materials to the patient or based upon the back-calculation from the future patient-physician meeting. The method permits determination of the receipt of the specimen and permits reminders to patients who are slow in returning specimens. The method, allows checking on patient billing information and permits reporting of test results to a variety of selected recipients and reports regarding patient compliance with the testing program.

The foregoing and other objects are not meant in a limiting sense, and will be readily evident upon a study of the following specification and accompanying drawings comprising a part thereof. Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings, wherein is set forth by way of illustration and example, an embodiment of this invention. Description of the Drawings

Preferred embodiments of the invention, illustrative of the best modes in which the applicant has contemplated applying the principles, are set forth in the following description and are shown in the drawings and are particularly and distinctly pointed out and set forth in the appended claims.

Fig. 1 shows a flow chart of the method of the present invention which automatically reinitializes and including various notice transmittals and results reporting options;

Fig. 2 shows a streamlined method of the present invention which avoids unnecessary notices and results reporting and which requires a semi-formal reinitialization of the method after each sequence; and

Fig. 3 shows a method of the present invention which includes a formal reinitialization comprising presenting a prescription form to the patient's physician to authorize transmittal of the specimen collection materials to the patient.

Description of the Preferred Embodiment

Referring now to Fig. 1 , the general sequence of events involved in the present

invention are presented in a flow chart. The present method is initialized for use by

obtaining required information from the patient and from the patient's physician as shown

in Box 10, Registration of Patient & Selection of Tests and Test Schedule. This

information then allows the monitoring of a chronic disease state under the inventive

method which comprises selecting clinical tests to be performed, determining the

frequency of performance for the clinical tests, establishing the sequencing of those tests,

the manufacture of the appropriate test materials, transmittal of the test materials to the

patient, specimen gathering by the patient, conducting the clinical test on the specimen,

reporting the results of the particular test, providing patient testing trend analysis to the

patient's care giver and billing of the testing service to the patient's care maintenance

organization.

Registration of Patient & Selection of Tests and Testing Schedule

In Figs. 1 ,2 and 3 the first step of the inventive method involves initial information gathering for registration of a patient in the monitoring and testing system. This is shown as the Box Registration of Patient & Selection of Tests and Test Schedule which is Box 10 in all Figures. Box 10 consists of acquiring patient information related to patient identity such as social security number, patient name and address, gender and marital status, and date of birth. Also obtained is information relating to the patient's insurance or method of payment to be used in billing the testing services. Information related to the patient's physician is determined at this time including the physician name and address and physician ID number. It is at this time that the physician selects the particular clinical tests which are to be performed and the frequency at which the selected tests are to be performed in order to monitor the particular disease afflicting the patient. For example, the American Diabetes Association (ADA) recommends that all diabetic patients have a micro albumin test and a lipid panel of tests conducted annually. The ADA also recommends that diabetics have their hemoglobin A1c tested quarterly. These frequency guidelines are presented to the physician as default option. However the physician may elect to have any of the various tests conducted with greater or lesser frequency, depending on the health status of the patient.

In diabetes maintenance testing, for example, the physician can select the hemoglobin A1 c to be tested quarterly or semi-annually or not tested at all. For the lipid panel of tests and cholesterol and micro albumin tests, the physician can select these tests to be performed either semi-annually, annually or not at all. During this stage of information gathering and test selection and test scheduling, it can be determined whether or not the patient is to receive a copy of the test results along with the physician. In addition the reporting format of the patient's copy of the tests can be selected as to the preferred language for the report. Depending on the patient's preference, the report can be offered in English, Spanish or French or any other predominate language of the area in which the monitoring and testing service is being provided.

It is also at this time of initial registration of the patient and selection of tests and testing schedule that the physician can select the type of specimen which is to be collected for testing. While in the case of diabetes, all testing is conducted on patient dry-blood spot samples, the inventive method also contemplates that it may be desired by the physician and necessary for particular tests that a venous blood sample be drawn. For example, in the case of examining blood platelet levels, it is commonly reported that a different level of blood platelets will be determined when the blood sample is collected by the finger-stick method versus drawing tubes of blood from the patient. Since the inventive method contemplates many different methods of gathering specimens for testing such as hair, saliva, urine, etc., it is important to give the physician an opportunity to select the specimen type upon which the clinical testing is to be conducted. The inventive method allows for such selection and thereby avoids requiring the physician to follow a particular previously selected methodology and permits a physician to apply their best medical advice in determining the method of analysis of the patient's health status.

Other disease states and tests may be selected at this time by the physician. In the case of monitoring cardiovascular disease risk, the physician may elect that tests for cholesterol and triglycerides be conducted on a periodic basis. Where the concern relates to the management of stroke, the physician can select from a series of tests to monitor the activity of blood thinners which are typically used in the management of stroke cases. Other suitable disease-state candidates and particular test selections will be apparent to those skilled in the art as being well suited to inclusion with the present inventive methodology. The particular disease states and care-management principles and specimen collection procedures identified herein are not intended by way of limitation on the inventive method, but rather are offered for illustrative purposes and to more particularly define the wide scope of application of the present inventive method.

Establishment of Clock Monitoring and Start Sequence

The information gathered at Box 10 registration is then utilized to develop a complete annual cycle of testing for the patient which encompasses a variety of physician selected tests, each of which is modified for the particular patient according to clinical information to be gathered and frequency of testing to be conducted. This is represented in Figs. 1 ,2 and 3 as the Box Establish Clock Monitor Start Sequence for Test Sets, Box 12. This information forms the basis for the Patent Maintenance Sequence which identifies the clinical tests that have been selected to be conducted on the particular patient, a complete year's schedule for conducting the selected tests, the degree of authorization required prior to conducting each of the scheduled test sets, and any physician selected modification in the clinical information to be gathered from the tests.

The Patient Maintenance Sequence is monitored at Box 12 by setting a clock, or calendar counter, which continuously causes review and monitoring of the Patient Maintenance Sequence testing cycle for that patient and determines if the current date is a time for starting an action need to initiate a sequence of events culminating in collecting a clinical specimen of the patient and testing the specimen and reporting and billing the results of that testing. If monitoring of the Patient Maintenance Sequence indicates that present clock or calendar counter date is a date for initiating the next test set of the Patient Maintenance Sequence, then a command is issued to initialize a test clock which is specific to the starting of the test sequence which has been indicated by the monitoring of the Patient Maintenance Sequence.

Initialize Test Clock and Start Test Sequence

Box 14, Initialize Clock and Start Sequence, represents the action which is commanded by Box 12 upon determining that action should be initiated to accomplish the starting of a test sequence which has been indicated by the monitoring of the Patient Maintenance Sequence. Box 14 contains the initialization of the test clock for the particular test sequence commanded by Box 12. The initialization can be based upon either a future appointment scheduled with the patient's physician (Fig.2), or the initialization can be based upon an arbitrary date which is proximate to the quarterly, semi- annually or annually test cycle selected by the physician.

For example, a care maintenance organization may wish that all lipid panels for a particular physician be conducted concurrently so that patient test results may be sorted into normal and abnormal groups. This would permit those patients presenting abnormal test results to be scheduled for a physician or care giver visit sooner and those patients presenting normal test parameters to be scheduled for a care giver visit later in the month or calendar quarter.

Alternatively, as shown in Fig. 2 at decision Box 210, the test sequence initialization can be based upon a future appointment with the patient's physician. Under this method, the physician and patient establish a future appointment, and the time of this appointment is reported by the physician's office to the monitoring system as indicated by decision Box 210. This future appointment date, is then transmitted to Box 12 where the Patient Maintenance Sequence operates to back-calculate to the appropriate intervals on which to conduct the various activities related to accomplishing the clinical tests which have previously been indicated as desired by the physician at Box 10 for evaluation during that future appointment. If decision Box 210 does not receive a request to reinitialize from the physician's office, a command is issued to contact the physician's office according to the information received at Box 10 and to prompt the physician's office for a response on the issue of reinitialization. Another alternative for the reinitialization of Box 12 is shown in Fig. 1. The flow chart of Fig. 1 generally represents the Automatic Reinitialization Model. Under the Automatic Reinitialization Model, a particular appointment date of the physician and patient is not utilized for conducting a particular test sequence commanded by Box 12. Rather, the timing of testing is preset. The beginning date in this situation may be completely arbitrary, or it may relate to the date of registration of the patient and physician accomplished in Box 10. Under the Automatic Reinitialization Model, the clock is operating in Box 12 to monitor the patient maintenance sequence, and upon a particular calendar date, Box 12 initiates action related to a particular patient test sequence whereupon Box 14 initializes the test clock for the particular patient test to be conducted, while at the same time, instructing Box 12 to continue monitoring the overall patient- maintenance sequence for the next particular test sequence to be commanded by Box 12. It will be appreciated by those skilled in the art that the events of Box 14, initializing a test clock for a particular test sequence, can be monitored as a sub-routine within Box 12 as part of the overall patient maintenance sequence, and that the distinction between operating Box 14 as a separate sub-routine versus including the operations of Box 14 within the overall patient -maintenance sequence of Box 12 is a matter of design choice, and the separate location of the events of Box 12 and Box 14 as shown in the flow charts herein are presented as matters of clarity rather than a requirement that these activities be maintained separate from one another.

Manufacture Patient Specimen Collection Materials

Once the clock has been initialized for the sequence of the particular clinical test to be conducted on the patient, Box 14 which is designated to monitor the sequence of operations for the particular clinical test which has been initiated by the patient- maintenance sequence of Box 12 then commands that the proper clinical-specimen collection kit be manufactured for the particular patient. The manufacture of the kit consists of assembly of materials needed to conduct the particular test selected by the physician in Box 10. For example, during the first quarter of the year, the physician may have requested that only a hemoglobin A1 c test be conducted on the patient. In this case, only materials for the hemoglobin A1c test would be assembled for transmittal to the patient. On the other hand, during the second quarter of the year, the physician may have instructed that the patient undergo both hemoglobin A1c testing and a lipid panel. In this instance, Box 14 would instruct that a test kit for this patient be assembled which contains specimen collection materials for both the hemoglobin A1 c test, as well as, the lipid panel of tests. It should also be appreciated that in addition to causing the actual specimen collection items to be assembled at Box 16, that the inventive method also transmits and includes with the individually manufactured patient-specimen collection kit, various identification forms and labels which are necessary for labeling the collected specimens. In addition, Box 16 operates to include unique bar coding labels which are generated in response to Box 14 which contain the various patient identification information and other relevant information such as a physician code, a care-maintenance organization code, a payor code for billing the testing, and an ICD-9 code for indicating the particular clinical test being conducted. In this manner, the inventive method allows for unique assembly of patient-specimen collection kits exactly at the time they are required and containing exactly the materials and instruction information and identification information which will be required by the patient to properly label the specimens and inform the clinical testing laboratory of the identity of the specimens once they are received at the testing laboratory.

Transmit Materials to Patient

Once the proper specimen-collection materials have been assembled and packaged at Box 16, the materials are then sent to the patient for specimen self collection by the patient. It will be appreciated that information related to this step is also dictated by the information gathered in Box 10 when the patient is initially registered. Since each test kit of the present invention is assembled according to the particular instructions issued for the particular clinical test to be conducted, and for the particular period in the patient annual cycle, the transmittal of materials to the patient shown in Box 18 can be adjusted depending on the wishes of the patient for the particular time of year at which the test is to be taken. For example, with geriatric populations, much of that population will spend a portion of the year in one area of the country, and another portion of the year in a secondary of the country. By utilizing the inventive method, the patient can conveniently collect test samples, have the results determined, and have the results forwarded to their particular physician without the need for locating an additional testing laboratory and receiving permission from a distant care-maintenance organization to have specimen collection or clinical testing conducted at a distant location. Under the present inventive method, this situation is handled by the proper address for the particular time of year being transmitted to Box 16 during the assembly of the patient specimen collection materials, and at this time, a change in the mailing address of the patient can be instituted, and the materials for specimen collection sent to an alternate address for the portion of the year indicated by the patient in Box 10.

Patient Collection & Return of Specimen

Once the test materials have been transmitted to the patient as indicated in Function Box 18, the patient then self-collects a specimen according to the instructions provided in the specimen test kit. As indicated in Function Box 20, the patient receives the transmitted test specimens and will apply the devices contained in the test kit to collect the sample indicated by the test kit materials. In the case of a Hemoglobin A1 c dried-blood spot specimen collection, the patient will use the materials in the test kit to prick their finger and to place drops of blood on an absorbent card contained in the test kit. This dried- blood spot (DBS) procedure is described in greater detail hereinafter. Should the test kit contain specimen-collection materials for saliva or urine or hair or other physiological sample, the patient would collect those materials as directed by the instruction sheets contained in the test kit. Once the patient has self-collected the needed specimens, the patient then applies the proper labels to the collected specimens. As previously discussed, the labels that the patient applies are preprinted and bar coded for rapid and accurate identification. These labels have been specifically prepared for the patient during the actions of Function Box 16 in which the specimen collection materials were manufactured and assembled for that particular patient. The collected specimens of Function Box 20 are then returned to a pre-specified address by the patient. The return of specimens by the patient is noted in the inventive method as indicated by Decision Box 22. If the patient has returned the specimens within a predesignated amount of time, the return of the specimens is noted, and the inventive method proceeds onto Decision Box 24 where the billing data corresponding to that patient is confirmed. Alternatively, in the case where a specimen has not been promptly returned by the patient, this status of no- return specimen is noted at Decision Box 22, and Decision Box 22 prompts a reminder to be sent as indicated by Function Box 22A to the patient to remind the patient to collect the specimen and return it for testing. The reminder of Function Box 22A can be in the form of a written reminder sent to the patient, or the reminder can be in the form of a telephone call made by a bank of telephone operators which can be incorporated into the inventive method. In yet another alternative method of sending a reminder to a patient, it may be the wish of the patient's physician to personally notify the patient regarding sample collection. In this case, the option can be presented to the physician in Function Box 10 to elect that the reminder notification be sent to the physician's office, either by mail or by telephone so that the physician's staff can remind the patient.

Confirmation of Billing Data and Patient Data

Once the specimen has been properly returned to the clinical laboratory for testing or other address location indicated on the test materials, the specimen labels and the accompanying identification material is then cross-checked with the database registration materials of Function Box 10 to determine whether or not the patient has updated any patient information such as address change or telephone change, and to determine whether the billing data initially indicated by the patient or physician in Function Box 10 continues to be valid. If the patient information and billing data are confirmed as being valid, then the sample is passed onto the laboratory for actual clinical testing. In the event that the patient data or billing data do not conform to the database data collected in Function Box 10, then Decision Box 24 prompts a recheck of data as indicated at Function Box 24A. The recheck of data can take the form of telephoning the patient to verify information, or telephoning the patient's physician or managed-care organization to confirm billing data. If the problem data is subsequently corrected, then the specimens can be passed onto the laboratory for testing as indicated in Function Box 26. In the event that the error in the patient data or billing data cannot be corrected, or if the patient has ceased to be a part of the particular care-maintenance organization, then this outcome can be recorded at this point, and the proper changes made in the related databases for the inventive method and the specimen destroyed. Clinical Testing of Specimen

Once it has been confirmed that the self-collected patient specimen received by the laboratory has correct identification and billing information, the specimen is then passed on for the proper clinical laboratory tests indicated by the accompanying specimen identification material. It is at this point that the clinical analysis is performed on the specimen as indicated by Function Box 26. As discussed in more detail hereinafter, the Hemoglobin A1 c testing may be performed in the case of diabetics, or depending on the time of the year of the diabetic care-maintenance cycle, a lipid panel of tests may be conducted, or a cholesterol test may be conducted. Alternatively, if the patient is being monitored for maintenance care after a stroke, the blood samples received in the laboratory would be tested for the concentration of blood thinners being utilized to maintain the patient and avoid subsequent strokes. Yet in an alternative situation, if the patient is being tested for conforming to a program of alcohol or drug abstinence, such as might be required by an employer or legal authorities, the appropriate test may then be applied to examine the existence of such substances in the test specimen.

Send Results Out

After the specimen has been tested, and the clinical results on the specimen determined, the clinical test results are then distributed to individuals who have been identified during the registration procedure of Function Box 10. Once again, as with all the steps of the inventive procedure, the test clock of Box 14 is continually checking the progress of the sequence of events for the particular patient's test cycle in order to determine that the events of the schedule have taken place in a timely manner. In the Function Box 28, Send Results Out, the test clock will be monitoring the transmittal of results to the selected parties in accordance with the due date established in the test clock of Function Box 14, which was initialized originally according to either an arbitrary date or a scheduled appointment between a physician and patient.

As is indicated in Fig. 1 and Fig. 3, the test results generated from testing of the clinical specimen in Function Box 26 can be transmitted to a number of different entities. For example, and depending upon the selection made in a registration procedure of Function Box 10, it may be desirable to send the results of Function Box 28 to the patient 28B, or the physician, 28A, or the managed-care organization, 28C, or the results of Function Box 28 can be posted to a web site or other computer site as shown in Function Box 28D. In the case of posting results to a web site or computer bulletin-board site, the individuals or organizations for whom the results are attended would be provided with a password and identity number to allow access to the site, and to allow access to only the results for which they have permission to examine.

Send Billing Out

Under the inventive method, when the specimen has been tested, and the results generated and sent out, it is also necessary to present billing information to the proper payor organization. This is accomplished in Function Box 30, Send Billing Out. The billing generated by the inventive procedure is then prepared and sent to the payor identified during registration step of Function Box 10. It will be appreciated by those skilled in the art that a wide variety of charge schedules, allowances and payment schedules operate in the clinical laboratory testing field. These are dependent upon the various relationships between the managed-care organizations and the clinical laboratory, or the government program paying for the clinical tests to be conducted, such as Medicare or a law- enforcement program, or even the conventional direct payment by the patient to the clinical laboratory. All these variations are taken into account under the present inventive system, and the transmittal of a billing to the proper payor is monitored by the test clock sequence of Function Box 14.

Report Profiling and Trending of Patient Data

An additional advantage to the present inventive method is that for each patient that is a part of the clinical testing program under the inventive method, the test results for that patient can be maintained in the clinical database over time. This permits the operator of the inventive method to present to the patient and physician and other entities designated in registration Function Box 10 a number of additional reports which show the patient's present test results with respect to past patient test results, and with respect to various trends and profiles which can assist the physician or maintenance organization in improving the patient's health status.

By way of example, it may be useful to present to the physician and patient, a profile of the patient's test results for the past year in order to demonstrate the long-term success of the patient in maintaining the dietary and exercise regimen required in maintenance of a disease such as diabetes. In addition, it is possible to break out each one of the clinical test categories and to separately present the patient's clinical test history for each one of the individual tests. This aspect of the inventive method provides a powerful tool for physicians and patients and health-maintenance organizations in monitoring the long-term success of various patient care programs, as well as the individual patient's ability to conform to a diet or exercise regimen or treatment program for maintaining optimum health in the face of a diseased state.

It will be appreciated by those skilled in the art that without the inventive method, these types of long-term profiling and trending of patient data cannot be achieved, as under present systems of clinical testing, each test result for a patient is a discreet entity and is generally not maintained in a single database for that patient. Alternatively, under the present methods of clinical testing, it is frequently the case that patient specimen testing will be conducted by different laboratories at different times of the year depending on the location of the patient, or the particular status of a health-maintenance organization contract. Referring now to figures, it will be appreciated that the report profiling and trending of patient data, Function Box 32, Report Compliance, is only shown in Fig. 3. However, it will be appreciated by those skilled in the art that the steps of the inventive method shown in Function Box 32, Report Compliance, can be included in either the embodiment shown in Fig. 1 or the embodiment shown in Fig. 2. The use of the Report Compliance function is a matter for election by the physician or patient or managed-care organization and is selected during registration procedures of Function Box 10.

Physician Prescription Loop

In the embodiment of Fig. 3, an additional authorization loop is included which is absent from Figs. 1 and 2. Fig. 1 is an embodiment having an automatic reinitialization of the inventive method and is used in situations in which no authorization for each test sequence is required. In the embodiment of Fig. 1 , the registration that occurs in Function Box 10 is authorized to operate for a period of time and will continue to operate until a cessation order is received. In the case of Fig. 2, a semi-formal reinitialization procedure is used after each patient test sequence. In the embodiment of Fig. 2, the particular semi- formal reinitialization method utilized is to have the physician transmit an informal reinitialization order. This can take the form of a telephone call to the operator of the inventive method, or a postcard, or if on-line procedures are used, an on-line authorization to continue the test sequence. Referring now to Fig. 3 the Physician Prescription Loop of the Formal

Reinitialization Model will be described. In situations in which the physician or managed- care organization or payor entity wishes to closely control the authorization of clinical testing procedures, the embodiment of Fig. 3 may be utilized to accomplish this end. The embodiment of Fig. 3 utilizing a Formal Reinitialization Procedure will commonly be used in the case of a Medicare payor or a legal entity which feels compelled to officially reauthorize the test sequence for each patient test sequence conducted.

In operation, the embodiment of Fig. 3 utilizing a Formal Reinitializing Loop will rely on a written physician authorization, or health-maintenance organization authorization, to conduct the test. Frequently this will be in the form of a physician prescription which is transmitted to the operator of the inventive method.

Referring now to Fig. 3, this Formal Reauthorization Loop is included in the embodiment of Fig. 3 and is shown to begin with Function Box 40. In Function Box 40, a prescription-authorization form is generated by the inventive method at Function Box 40. The prescription is pre-formatted with the information related to the particular patient, the test to be conducted at that time, and the additional orders set forth by the physician during initial enrollment of registration occurring at Function Box 10. The prescription form generated at Function Box 40 is then transmitted to the physician for examination and execution. The physician executes the prescription as shown at Function Box 42, and then returns the executed prescription form to the operator of the inventive method. Under the inventive method, the receipt of the prescription is monitored at Decision Box 44, prescription returned?. If Decision Box 44 determines that no prescription has been returned, then a reminder is transmitted to the physician as indicated by Function Box 46. If Decision Box 44 determines that the prescription form has been returned, then authorization is transmitted for manufacture of the patient-specimen collection materials as indicated by Function Box 16 of Fig. 3. It will be appreciated by those skilled in the art that if no prescription is returned to the operator of the inventive method, that at some point, the test sequence will come to an end. While this is not shown in the flow chart of Fig. 3, it will be appreciated that those skilled in the art will account for this eventuality, and that this aspect of the methodology is a design choice. Further, it will be appreciated that the frequency of operation of Decision Box 44 is governed by the clock and sequence function of Box 14.

Automatic Reinitialization Embodiment The general operation of such a sequencing of a schedule for monitoring the clinical testing of a patient will be discussed. Once the future appointment time for the physician and patient has been determined, the sequencing clock is initialized, and the schedule is started. At an appropriate time in advance of the physician/patient appointment, the sequence activates a command to transmit specimen collection materials to the patient. As will be further discussed hereinafter, this step involves evaluation of the tests to be performed during the particular testing phase scheduled, and then causing those materials to be transmitted to the patient for appropriate specimen collection as dictated by the selected tests. The specimen collection materials are transmitted to the patient according to the previously obtained registration materials, and the selection of tests and test schedule determined by the physician. The transmittal of the specimen collection materials also initiates a monitoring system to determine whether or not the patient has responded to receipt of the sample collection materials by taking a sample and forwarding the specimen to the appropriate specimen receiving station. The monitoring consists of determining whether or not the patient specimen has been returned. If the specimen has been returned, receipt of the specimen is noted within the sequencing and monitoring system, and the process proceeds to the next step. If the monitoring system indicates that the patient's specimen has not been received, then the system initializes a reminder sequence to prompt the patient to take the specimen and return it to the specimen reception address. The step of reminding the patient to collect the specimen and return it can take one of several forms. A simple postcard may be sent to the patient presenting a reminder that the specimen needs to be returned to the specimen reception location, or a more active telephone system may be utilized. Under the telephone reminder system, the monitoring system forwards the telephone number of the patient to an automatic calling system. The patient is then telephoned, and either a recorded reminder can be provided to the patient, or a case worker can question the patient as to whether the specimen collection materials were received and whether the specimen has been collected, and whether the patient still wishes to participate in the monitoring system. The case-worker based provider system can also be used to determine whether the patient has any questions regarding the use of the system, and to obtain quality control feedback directly from the patient as to the ease of use of the system and patient willingness to comply with the physician's orders.

Still referring to Fig. 1 , once the monitoring system has determined that the patient specimen has been returned to the specimen reception area, identification materials on the specimen are read and utilized to update the system as to the continued scheduling of the particular patient's monitoring program. The first such instance occurs as soon as the specimen is received in the specimen reception area which consists of immediately checking patient identification and billing data to determine whether any changes have occurred in patient information or patient billing data, and to determine whether or not the patient billing data is still valid. If the billing data is invalid, or if patient data has changed, the present invention can send relevant notices to the physician and to the patient's managed care organization. If the billing data and patient information do not present any errors or warnings, the specimen is then forwarded to the test laboratory for analysis. Once the specimen is received in the testing laboratory, this occurrence can initiate, if desired, the transmittal of a reminder notice to the patient regarding the upcoming appointment which has been previously scheduled for the patient with the physician. The laboratory then conducts the appropriate tests on the specimen which have been previously selected during the patient registration process. Once the test results have been determined, the results are then transmitted to the various parties electing to receive the test results. A number of options exist for the transmittal and receipt of test results. It may be desired that only the physician receive the test results. Alternatively, patients who are dealing with long-term maintenance of a chronic disease are often well educated with respect to their disease and will wish to receive the test results along with the physician. This option also is available under the inventive system. In view of the increasing management of health care operations by third parties, the inventive system provides a method of transmitting the results to a managed care organization (MCO). Depending on the particular managed-care operation or physician office, or patient sophistication, it may be desirable to simply transmit the results to a single computer location such as a web site or dial-in bulletin board. In this latter instance, the test results are posted to various mailboxes within the site such as the particular physician's mailbox, and/or the particular patient's mailbox, and/or the particular managed-care organization's mailbox. In this manner, the individual organization for whom the information is intended can simply connect via computer to the result posting site and download or examine the test results. When the test results have been sent out, the inventive system also sequences the transmitting of billing related to the testing services and forwards the appropriate billing statement to the patient or the appropriate payor entity. At this point, a single pass through the clinical testing monitoring sequence is complete, and it is only necessary to reinitialize the system to begin a second pass through the sequencing schedule. The second and additional sequence of method steps is initialized by the physician's office at the conclusion of the first patient/physician meeting. Typically, at this time, the next patient/physician meeting will be scheduled between the physician and patient. Once the new appointment time has been identified, this time is transmitted to the reinitializing unit of the inventive system, and the patient's clock is reinitialized, and the sequence starts again. In the event that reinitialization request is not received, the system generates a notice to check with the physician to determine whether or not a next appointment is to be conducted. This notice will typically be in the form of a postcard request to the physician's office or, alternatively, the previously described telephone calling system may also be utilized to contact the physician's office to determine whether or not a reinitializing request is to be received regarding that particular patient.

Operation of the Semi-Formal Reinitialization Embodiment

The general operation of a preferred embodiment of the inventive method for sequencing and for monitoring the clinical testing of a patient now will be discussed with reference to Fig. 2. Before any operation of the inventive method can occur, the registration of procedures of function Box 10 must be conducted. After this information is registered within the computer system which operates the inventive method, the overall Patient Monitoring Sequence can be established as identified in function Box 12 and the clock can operate to determine the timings for taking the actions indicated in the Patient Monitoring Sequence.

After the Patient Monitoring Sequence has been established, the date of a future appointment time for the physician and patient meeting is determined and the operator of the inventive method is notified so the sequencing clock can be initialized. Once this initialization has been established, the Patient Monitoring Sequence is started as shown in function Box 12. The Patient Monitoring Sequence then determines an appropriate time in advance of the scheduled physician/patient appointment, and the Patient Monitoring Sequence then activates a command to activate the test sequence for the particular patient test which is indicate as being now due under the Patient Monitoring Sequence. This command initializes the particular test clock of function Box 14 and starts a monitoring sequence for the particular patient test which is due to be conducted according to the Patient Monitoring Sequence determination based on the scheduled physician/patient appointment. It will be appreciated that the phrase "particular patient test" is used to indicate any available clinical laboratory test which has been authorized during the registration procedure of function Box 10.

Upon establishing the Clock and Schedule Sequence of function Box 14 for the particular patient test, the method operates to manufacture the proper specimen collection materials called for during registration procedure 10 and then to transmit the prepared specimen collection materials to the patient as indicated by function Box 18. This procedure of function Box 16 involves evaluation of the tests to be performed during the particular patient test currently scheduled, and then causing those materials to be assembled and transmitted to the patient for appropriate specimen collection as dictated by the selected tests. The specimen collection materials are transmitted to the patient according to the previously obtained registration materials, and the selection of tests and test schedule determined by the physician.

The transmittal of the specimen collection materials also initiates the monitoring system of decision Box 22 to determine whether or not the patient has responded to receipt of the sample collection materials by taking a sample and forwarding the specimen to the appropriate specimen receiving station. The monitoring consists of decision Box 22 determining whether or not the patient specimen has been returned. If the specimen has been returned, receipt of the specimen is noted within the sequencing and monitoring system through decision Box 22, and the inventive method proceeds to the next step. If decision Box 22 indicates that the patient's specimen has not been received, then the system initializes a reminder sequence of function Box 22a to prompt the patient to obtain the specimen and return it to the specimen reception address included in the transmitted specimen collection materials.

The function of Box 22a of reminding the patient to collect the specimen and return it can take one of several forms. A simple postcard may be sent to the patient presenting a reminder that the specimen needs to be returned to the specimen reception location, or a more active telephone system may be utilized. Under the telephone reminder system, the reminder function of Box 22a forwards the telephone number of the patient to an automatic calling system. The patient is then telephoned, and either a recorded reminder can be provided to the patient, or a case worker can question the patient as to whether the specimen collection materials were received and whether the specimen has been collected, and whether the patient still wishes to participate in the monitoring system. The case-worker based provider system can also be used to determine whether the patient has any questions regarding the use of the system, and to obtain quality control feedback directly from the patient as to the ease of use of the system and patient willingness to comply with the physician's orders.

Still referring to Fig. 2, once the system of decision Box 22 has determined that the patient specimen has been returned to the specimen reception area, identification materials on the specimen are read and utilized at function Box 24 to update the registration data of function Box 10 regarding the patient information and continued scheduling of the particular Patient Monitoring Sequence. The first update function occurs as the specimen is received in the specimen reception area. At function Box 24 the patient identification and billing data are confirmed to determine whether any changes have occurred in patient information or patient billing data. It is also determined whether or not the patient billing data is still valid. If the billing data is invalid, or if patient data has changed, the present method can cause the information to be re-checked at function Box 24a and cause the relevant notices to be sent by function Box 24a to the physician and to the patient's managed care organization.

If the billing data and patient information do not present any errors or warnings at function Box 24a, the specimen is then forwarded to the test laboratory for analysis as indicated at function Box 26. Once the specimen is received in the testing laboratory, this can initiate, if desired, the transmittal of a reminder notice to the patient regarding the upcoming appointment which has been previously scheduled for the patient with the physician(function Box 26a, Fig.1 ). At function Box 26, the laboratory conducts the indicated scheduled tests on the specimen which have been previously selected during the patient registration process of function Box 10.

When the test results have been determined, the results are then transmitted by function Box 28 to the various parties electing to receive the test results. A number of options exist for the transmittal and receipt of test results. It may be desired that only the physician, function Box 28a, receive the test results. Alternatively, patients who are dealing with long-term maintenance of a chronic disease are often well educated with respect to their disease and will wish to receive the test results, function Box 28b, Fig. 1 , along with the physician. This option also is available under the inventive system. In view of the increasing management of health care operations by third parties, the inventive system provides a method of transmitting, function Box 28c, Fig. 1 , the results to a managed care organization (MCO). Depending on the particular managed-care operation or physician office, or patient sophistication, it may be desirable to simply transmit the results to a single computer location, function Box 28d, Fig. 1 , such as a web site or dial-in bulletin board. In this latter instance, the test results are posted to various mailboxes within the site such as the particular physician's mailbox, and/or the particular patient's mailbox, and/or the particular managed-care organization's mailbox. In this manner, the individual organization for whom the information is intended can simply connect via computer to the result posting site and download or examine the test results.

When the test results have been sent out, the inventive system also sequences the transmitting of billing related to the testing services and forwards the appropriate billing statement to the patient or the appropriate payor entity as indicated at function Box 30. At this point, a single pass through the clinical testing monitoring sequence is complete, and it is only necessary to reinitialize the system to begin a second pass through the sequencing schedule. In the embodiment of Fig. 2, the second sequence and additional sequences of the method steps are initialized by the physician's office at the conclusion of the first patient/physician meeting. Typically, at this time, the next patient/physician meeting will be scheduled between the physician and patient. Once the new appointment time has been identified to function Box 210, this date is transmitted to the reinitializing unit of function Box 12 of the inventive system, and the Patient's Maintenance Sequence clock is reinitialized, and the sequence starts again. In the event that reinitialization request is not received at decision Box 210, the system generates a notice, function Box 212, to check with the physician to determine whether or not a next appointment is to be conducted. This notice will typically be in the form of a postcard request to the physician's office or, alternatively, the previously described telephone calling system may also be utilized to contact the physician's office to determine whether or not a reinitializing request is to be received regarding that particular patient.

Operation of the Formal Reinitialization Embodiment Fig. 3 shows, in flowchart form, the method steps comprising the Formal

Reinitialization embodiment of the present method. The aspect of the Formal Reinitialization Embodiment which distinguishes it from the alternative embodiments of the invention is the inclusion of the Prescription Receipt Decision Loop indicated by function Boxes 40, 42 and 46 and decision Box 44. As discussed previously, this Prescription Receipt Decision Loop allows very formal and legal authorization of each of the particular patient tests which is established in the Patient Monitoring Sequence of function Box 12. This formal authorization may be required by a particular payor entity of by law depending upon the location in which the inventive method is operating.

Dried Blood Spot (DBS) Method of Specimen Collection

The application and operation of the present invention will now be discussed in more particular detail. In the case of management of diabetes, it is useful to collect blood samples for testing from the patient. To reduce costs it is important that the patient be able to self-collect the blood sample. Therefore, the present invention, when used in a disease management situation which requires a blood sample, is intended to operate in combination with what is known as dry-blood spot (DBS) methodology of blood sample collection and transport. The DBS technology in its most general form consists of utilizing an absorbent layer or matrix to receive a blood sample from the subject then allowing the blood sample to dry on the absorbent. In general, utilizing the DBS methodology substantially reduces the sample volume of blood required to be transported and thereby avoids the dangers presented by shipment of the relatively large volumes of blood required by other methodologies.

Dried blood spot or DBS methods of collecting blood samples have long been used in this art, and the particular manner of accomplishing the dried blood spot technology is a matter of choice to those skilled in the art. In general, when it is desired to collect a blood sample under the DBS technology to test an individual, a finger of the subject is pricked with a lance or other suitable instrument and several droplets of blood are squeezed from the subject's finger onto the absorbent layer. The blood contacts the absorbent layer and is absorbed and spreads on the absorbent. In order to guide the subject as to how much blood is necessary to be applied to the absorbent, it is common to utilize a paper absorbent which is carefully controlled in its manufacture so as to provide consistent absorption of a particular volume of blood per area of paper. Examples of such an absorbent paper include that manufactured by S & S® 903™ manufactured by Schleicher & Schuell, Inc. or equivalent papers from other venders such as Whatman, Inc. of Clifton, N.J. Alternatively, porous plastic having known absorption characteristics may be used in place of cellulose or sponge absorbent materials.

With respect to the absorbent, it is principally necessary that the materials selected hold a known, reproducible quantity of blood when it is provided with sufficient sample to saturate the material. By use of such a material, gravimetric determinations of the blood sample are eliminated. As the amount of blood sample required for adequate testing is known, it is only necessary to indicate on the absorbent layer the amount of area which should be saturated with the blood sample so as to provide sufficient sample quantity.

Once the sample is received at the analysis laboratory, small circles are punched from the center of the dried blood spot on the absorbent layer. It is best if the circles are punched from the center of the sample area so as to avoid areas of incomplete saturation which may tend to exist toward the outer edges of the sample application area. In addition, it is useful that the punched circles have smooth edges which do not have paper fibers clinging raggedly on the edges. These two aspects of circle punching procedure can contribute to anomalous sampling results, and are to be avoided.

Hemoglobin A1c Testing

As previously stated, one clinical test which is particularly suitable to the present inventive method is the Hemoglobin A1 c test for determining the percentage of glucose which is bound to the hemoglobin of blood. Monitoring of blood glucose is very important in the management of diabetes. Glucose in the bloodstream becomes irreversibly attached to hemoglobin. The higher the blood levels of glucose, the greater will be the amount of glucose attached to hemoglobin. For diabetics, the goal is to maintain glucose levels in as near a normal range as possible to reduce the amount of glucose bound to hemoglobin. Regulation of blood glucose levels for diabetics is a daily effort which includes measurement of blood sugar levels several times each day. The self-monitoring of blood glucose is widely accomplished using a finger-stick test and a blood glucose meter to measure the actual level of sugar in the blood. This type of testing provides a measure of the blood glucose level only for the moment at which the blood was taken. The hemoglobin A1 c test is preferred for analysis of diabetic care management as it provides a longer term indication of the diabetic's success in regulating blood glucose levels.

The hemoglobin A1 c test presents a view of the control of blood glucose during the three months prior to the blood sample being collected. Since the cell life of a red blood cell is approximately 120 days, and as the binding of glucose to red blood cells is irreversible, the measurement of hemoglobin-bound glucose by the hemoglobin A1c test allows a comparative determination of the long term success of the diabetic in keeping blood glucose levels within normal parameters. If the patient has been successful in maintaining the continuous discipline needed to keep glucose levels low, this will be reflected in the longer term hemoglobin A1 c results. The physiological damage from diabetes is largely a result of continuous high blood glucose levels. The short term fluctuations in blood glucose levels as a result of meals and changes in diet and exercise can cause short term high and low readings in blood glucose levels. Such short term increases in blood glucose levels are not of grave concern. Rather, it is the long term levels of blood glucose which are important for avoiding damages to the kidneys and eyes and limbs of diabetics. Therefore, the hemoglobin A1c test which provides an approximately three month analysis of blood glucose levels is far more valuable in determining the success of a particular diet and exercise regimen for a patient.

Hemoglobin A1c values are presented as a percentage of the hemoglobin which is bound to glucose. There is no direct conversion between hemoglobin A1 c percentages and the average blood glucose level as commonly reported in milligrams per deciliter (mg/dL) or as millimoles per liter (mmol/L). However, the approximate relationship between the Hemoglobin A1 c (HbA1 c) percentage and average blood sugar values as reported in the Diabetes Control and Complications Trial (DCCT) is compared in the following chart.

Correlation of HbAlc percentage and Average Blood Glucose Level

Percent Average Blood Average Blood HbAlc Glucose Level Glucose mg/dL

12.0 to 14.0 Seriously Elevated Levels 300 and above 9.0 to 11.5 Elevated Levels 210 to 295 7.0 to 8.5 Slightly Elevated Levels 150 to 195 4.0 to 6.5 Non-diabetic Levels up to 135

The goal in maintenance of diabetes is to maintain a hemoglobin A1c level of less that 7 percent. This translates to keeping blood sugar below 150 mg/dL on any self-monitoring blood glucose test.

In the foregoing description, certain terms have been used for brevity, clearness and understanding; but no unnecessary limitations are to be implied therefrom beyond the requirements of the prior art, because such terms are used for descriptive purposes and are intended to be broadly construed. Moreover, the description and illustration of the inventions is by way of example, and the scope of the inventions is not limited to the exact details shown or described. Certain changes may be made in embodying the above invention, and in the construction thereof, without departing from the spirit and scope of the invention. It is intended that all matter contained in the above description and shown in the accompanying drawings shall be interpreted as illustrative and not meant in a limiting sense. Having now described the features, discoveries and principles of the invention, the manner in which the improved method is constructed and used, the characteristics of the construction, and advantageous, new and useful results obtained; the new and useful structures, devices, elements, arrangements, parts and combinations, are set forth in the appended claims.

It is also to be understood that the following claims are intended to cover all of the generic and specific features of the invention herein described, and all statements of the scope of the invention which, as a matter of language, might be said to fall therebetween.

Claims

5 CLAIMS

Having thus described the invention what is claimed as new and desired to be secured by Letters Patent is as follows:

0 1. A method of sequencing a schedule of monitoring of clinical testing for a patient having a chronic disease state comprising the steps of: determining a test parameters set for monitoring the patient, initializing a monitoring schedule sequence for said test set, selecting clinical testing materials appropriate to the patient disease s state, transmitting said clinical testing materials to the patient for collection of a specimen, monitoring for return of said specimen from the patient receiving said specimen from the patient confirming payor data for received specimen, o performing testing on said specimen according to said test parameters set to generate a test result, and reporting said test result to at least one designated recipient.

2. The method as claimed in claim 1 , further comprising the step of selecting 5 clinical testing materials appropriate to a test cycle segment of the patient monitoring.

3. The method as claimed in claim 1 , where in said schedule sequence includes the events of transmitting clinical testing materials to the patient, the return of a specimen from the patient, report of test results to a recipient.

4. The method as claimed in claim 3, where in said schedule sequence further includes the event of receipt of a physician prescription authorization as a precondition to transmitting clinical test materials to the patient.

5. The method as claimed in claim 1 , where in said step of initializing a monitoring schedule sequence for said test set comprises back-calculation of the schedule sequence from the date of a future meeting between the patient and a care giver.

6. A method for maintaining clinical laboratory tests for a patient having a chronic disease state comprising the steps of: initializing a sequence for obtaining a clinical laboratory test related to the chronic disease state of the patient, transmitting in response to said initialized sequence a clinical testing apparatus to the patient for collection of a specimen, monitoring for return of said specimen from the patient receiving said specimen from the patient performing testing on said specimen according to said test parameters set to generate a test result, and reporting said test result to at least one designated recipient.

7. The method as claimed in claim 6, wherein said step of monitoring is conducted in response to said initialized sequence.

8. The method as claimed in claim 6, wherein said step of monitoring is conducted in response to said transmitting of said apparatus.

9. The method as claimed in claim 6, further comprising the step of confirming payor data for received specimen.

10. The method as claimed in claim 6, further comprising the step of reinitializing said sequence for obtaining a clinical laboratory test related to the chronic disease state of the patient.

11. The method as claimed in claim 6, further comprising the step of determining a test parameters set for monitoring the patient

12. The method as claimed in claim 6, further comprising the step of selecting clinical testing materials appropriate to the patient disease state.

13. The method as claimed in claim 12, further comprising the step of selecting clinical testing materials appropriate to a test cycle segment of the patient monitoring.

13. The method as claimed in claim 6, wherein said step of reporting said test result to at least one designated recipient includes reporting said test result to a physician and to a patient.

14. The method as claimed in claim 6, wherein said step of reporting said test

result to at least one designated recipient includes reporting said test result to a physician and to a patient and a health maintenance organization.