Data processing: measuring – calibrating – or testing – Measurement system in a specific environment – Quality evaluation
Reexamination Certificate
2001-12-14
2004-06-08
Barlow, John (Department: 2863)
Data processing: measuring, calibrating, or testing
Measurement system in a specific environment
Quality evaluation
C702S081000, C435S006120
Reexamination Certificate
active
06748337
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Technical Field
The present invention relates to instruments for medical analysis in general, and to methods of and apparatus for quality control of medical analysis instruments in particular.
2. Background Invention
Current laboratory practice uses skilled technologists to run quality control specimens in an analytical instrument and compare the results with reference values generally supplied by the manufacturer of the quality control material. It is then left up to the operator's or supervisor's judgement whether or not the instrument is “in control” i.e., whether the instrument is capable of producing correct results with samples from patients. There are many different guidelines published for performing comparisons, but at all times the decision whether or not to release a patient's results is up to the operator or laboratory supervisor. This system functions well when personnel skilled in laboratory sciences are used, but it becomes problematic in situations when the operator is less skilled and may have no direct supervision.
Federal regulatory agencies within the United States (e.g., U.S. Food and Drug Administration) have recently adopted guidelines and standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results. According to those guidelines, certain tests considered to be simple enough so as to be usable by an untrained operator may be subject to reduced regulatory oversight. Tests that fall into this “simple” category are those that either: 1) employ methodologies that are so simple and accurate that there is a negligible chance an untrained operator will get inaccurate results; or 2) have negligible risk of harm should the test be performed incorrectly. Tests having increased complexity or potential risk remain subject to regulatory oversight, and must therefore be performed by a trained professional. The classification of a test as “simple” is based on numerous considerations. For example, if an analytical instrument includes quality control measures that minimize the possibility of erroneous result, tests performed by that instrument are more likely to be subject to less regulatory oversight. Likewise, if an analytical instrument is fully automated and does not require operator technique, tests performed on that instrument are also likely to be subject to less regulatory oversight. It is also important that any such quality control measures be secure and not susceptible to unauthorized operator manipulation or false reporting. Those skilled in the art will recognize the value of enabling more tests to be classified as requiring less regulatory oversight; e.g., the public is likely to have better access to the testing at a lower price.
What is needed, therefore, is a method and/or an apparatus for providing quality control measures for medical analysis instruments that enable an operator, trained or untrained, to perform tests within acceptable guidelines, and a method and/or an apparatus that can make certain tests eligible for less regulatory oversight than was previously required. It is also desirable that any instrument labeled as having “quality control” measures include tamper-proof quality control measures that cannot be easily overridden by an operator.
DISCLOSURE OF THE INVENTION
It is, therefore, an object of the present invention to provide a method and/or an apparatus for providing quality control for medical analysis instruments that enables people, trained or untrained, to perform tests within acceptable guidelines, and a method and/or apparatus that make tests eligible for less regulatory oversight than was previously required.
According to the present invention, a method for providing quality control in a medical analysis instrument is provided. The method includes the steps of: 1) sending one or more quality control specimens to an operator of the analytical instrument; 2) directly or indirectly communicating control data to the analytical instrument, wherein the control data directly or indirectly relates acceptable standards to the analytical instrument; 3) analyzing the quality control specimen using the analytical instrument and thereby creating instrument analysis data; 4) evaluating the instrument analysis data using the control data to determine a functional status of the analytical instrument; 5) providing notice to the operator regarding the functional status of the analytical instrument; and 6) optionally preventing the reporting of patient data from the instrument if the functional status is unacceptable.
The present invention also contemplates a quality control system for analytical instruments that includes: 1) one or more quality control specimens, each having one or more predetermined characteristic values and an identifier that can identify the quality control specimen; 2) an analytical instrument, having an analyzer for analyzing the one or more quality control specimens, and thereby create instrument analysis data that includes one or more sensed characteristic values; 3) means for evaluating the sensed characteristic values of the instrument analysis data using the predetermined characteristic values; and 4) means for notifying an operator regarding the functional status of the analytical instrument.
An advantage of the present method and apparatus is that quality control procedures can be performed on the instrument without the assistance of a laboratory-trained technician. In most instances, the operator need only insert the quality control specimen and the quality control procedures are performed automatically. In other instances, the quality control specimen is provided electronically or automatically and the operator does not have to insert a quality control specimen. As a result, tests performed on the instrument are likely to be eligible for less regulatory oversight.
Another advantage provided by the ability of the present method and apparatus to operate quality control procedures with limited or no operator input is that the instrument is less vulnerable to operator tampering, and requires less operator training and skill for safe operation.
Another advantage of the present method and apparatus is that quality control procedures can be performed often because they require little or no operator input. As a result, the accuracy and reliability of the instrument can be assured often. Verifying the accuracy and reliability of the instrument will enhance the eligibility of the tests performed on the instrument for less regulatory oversight.
Another advantage of the present method and apparatus is that it gives the analytical instrument manufacturer the opportunity to provide a valuable service to its customers, one that can help distinguish it from competitors.
These and other objects, features, and advantages of the present invention will become apparent in light of the detailed description of the present invention.
REFERENCES:
patent: 4858154 (1989-08-01), Anderson et al.
patent: 6192320 (2001-02-01), Margrey et al.
patent: 2002/0003210 (2002-01-01), Marcus
patent: 2003/0064393 (2003-04-01), Bass et al.
Information on CLIA Waivers (Clinical Laboratory Improvement Amendments) pp. 1-2.
CLIA Categorization Criteria, pp. 1-2.
CLIA Home Page—Clinical Laboratory Improvement Amendments, pp. 1-2.
Guidance for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Criteria for Waiver; Draft Guidance for Industry and FDA Applications pp. 1-22.
Levine Robert A.
Wardlaw Stephen C.
Barlow John
Bhat Aditya
McCormick Paulding & Huber LLP
Wardlaw Partners LP
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