Method and apparatus for continously monitoring and forecasting slide and specimen preparation for a biological specimen population

Claim 2

A laboratory process monitoring method for a laboratory that prepares slides said method comprising the steps of: (a) acquiring an initial set of laboratory slides so as to select an initial batch of slides for initialization; (b) extracting an initial monitor parameter with an automated cytology system from said initial batch of slides so as to determine a control limit; (c) monitoring field data by extracting said monitor parameter from said field data with said automated cytology system; and (d) comparing said monitor parameter from said field data to said control limit to monitor a slide preparation.

Claim 3

The laboratory process monitoring method of claim 1 further comprising the step of controlling coverslip application wherein protocols for coverslip application processes are responsive to said monitor parameter.

Claim 4

The laboratory process monitoring method of claim 2 further comprising the steps of: (a) acquiring field monitoring data; and (b) applying control rule results for at least one slide preparation monitor parameter to automatically regulate coverslip application.

Claim 5

The laboratory process monitoring method of claim 1 further comprising the step of controlling staining processes wherein protocols for staining application processes are responsive to said monitor parameter.

Claim 6

The laboratory process monitoring method of claim 4 further comprising the steps of: (a) acquiring field monitoring data; and (b) applying control rule results for at least one slide preparation monitor parameter to automatically regulate staining of slides.

Claim 7

The laboratory process monitoring method of claim 1 wherein the step of monitoring field data further comprises the steps of: (a) dynamically updating a set of slide batches; (b) dynamically updating said monitor parameter using the updated slide batches to produce an updated monitor parameter; and (c) comparing said updated monitor parameter with said control limit to determine integrity of a laboratory slide population and at least one preparation process.

Claim 8

The laboratory process monitoring method of claim 6 further comprising the step of ruling a laboratory process out of range if said monitor parameter falls outside of said control limit.

Claim 9

The laboratory process monitoring method of claim 6 wherein the step of dynamically updating a set of slide batches further comprises the step of continuously forming and updating two batches including a short-term batch and a mid-term batch.

Claim 10

The laboratory process monitoring method of claim 8 wherein the short-term batch includes up to a first predetermined number of most recently processed laboratory slides.

Claim 11

The laboratory process monitoring method of claim 8 wherein the mid-term batch comprises a superset of the short-term batch and comprises up to a second predetermined number of most recently processed slides and wherein a laboratory process is considered "out of range" if values of monitoring parameters for the mid-term batch are outside control limits.

Claim 12

The laboratory process monitoring method of claim 8 wherein the step of continuously forming and updating two batches, including a short-term batch and a mid-term batch, further includes the step of reporting recent variations in laboratory process based on the short-term batch that can be adjusted before adverse screening conditions occur, thereby allowing tracking of variation patterns, and providing the means to forecast adverse conditions.

Claim 13

The laboratory process monitoring method of claim 1 wherein the step of acquiring an initial set of laboratory slides further comprises the steps of: (a) determining slide qualification criteria using the initial set of laboratory slides; and (b) selecting an initial batch of slides using said initial set; (c) forming a characterization batch using said initial batch of slides using said slide qualification criteria and (d) determining said control limit by extracting said initial monitor parameter from the initial batch of slides or characterization batch.

Claim 14

The laboratory process monitoring method of claim 12 wherein the step of determining slide qualification criteria further comprises the steps of: (a) applying reduced process suitability limits; and (b) applying a global analysis score upper bound.

Claim 15

The laboratory process monitoring method of claim 13 wherein the step of applying reduced process suitability limits further comprises the steps of generating reduced process suitability limits by adjusting limits of features used in suitability tests that determine a reliability of other slide scores, wherein adjustment is applied only to feature limits that are not exceeded by feature values of slide data, and wherein adjusted limits comprise an average of an original limit and a closest feature value of slide data.

Claim 16

The laboratory process monitoring method of claim 13 wherein the step of applying a global analysis score upper bound further comprises the step of determining a global analysis score upper bound using successfully processed normal slides that are ranked by their analysis scores.

Claim 17

The laboratory process monitoring method of claim 1 wherein the step of extracting an initial monitor parameter further comprises the step of extracting at least one slide physical characteristics parameter for monitoring physical characteristics of slides.

Claim 18

The laboratory process monitoring method of claim 16 wherein the at least one slide physical characteristics parameter is selected from the group consisting of a slide characteristics category, coverslip dimensional characteristics category, and combined coverslip and specimen characteristics category.

Claim 19

The laboratory process monitoring method of claim 16 wherein the step of extracting an initial monitor parameter further comprises the step of testing slides in a given batch by scanning failure conditions for each slide physical characteristics category.

Claim 20

The laboratory process monitoring method of claim 18 wherein the step of testing slides in a given batch by scanning failure conditions further comprises the steps of: (a) measuring the proportions of slides that fail any scanning failure conditions; and (b) outputting at least one proportion as a slide physical characteristics parameter, wherein the at least one proportion is selected from the group consisting of slide characteristics failure proportion, coverslip dimensional characteristics failure proportion, coverslip/specimen characteristics failure proportion, and overall slide physical characteristics failure proportion.

Claim 21

The laboratory process monitoring method of claim 1 wherein the step of extracting an initial monitor parameter further comprises the step of extracting at least one specimen collection monitoring parameter for monitoring quality or sufficiency of a collected specimen.

Claim 22

The laboratory process monitoring method of claim 20 wherein the at least one specimen collection monitoring parameter is selected from the group consisting of a material monitoring parameters category and reference cell characteristics category.

Claim 23

The laboratory process monitoring method of claim 21 wherein said material monitoring parameters category is selected from the group consisting of a scanty material distribution parameter and a variable material distribution parameter.

Claim 24

The laboratory process monitoring method of claim 21 wherein the reference cell characteristics category further comprises a predetermined percentage of the number of reference cells divided by all detected objects.

Claim 25

The laboratory process monitoring method of claim 20 wherein the step of extracting at least one specimen collection monitoring parameter further comprises the steps of: (a) testing at least one slide specimen collection monitoring category by measuring the proportions of slides in a given batch that fail any scanning failure conditions or process suitability conditions; and (b) outputting at least one proportion as a specimen collection characteristic parameter wherein the at least one proportion is selected from the group consisting of scanty material proportion, distribution failure proportion, variable material distribution failure proportion, and overall material quality failure proportion.

Claim 26

The laboratory process monitoring method of claim 1 wherein the step of extracting an initial monitor parameter further comprises the step of extracting at least one slide handling monitoring parameter for monitoring quality of a laboratory's slide handling practices.

Claim 27

The laboratory process monitoring method of claim 25 wherein the at least one slide handling monitoring parameter is selected from the group consisting of a barcode error category, a positioning error parameter category, and a cleaning error parameter category.

Claim 28

The laboratory process monitoring method of claim 26 wherein the step of extracting at least one slide handling monitoring parameter further comprises the steps of: (a) testing at least one slide handling quality category by measuring the proportions of slides in a given batch that fail any scanning failure conditions or process suitability conditions; and (b) outputting at least one proportion as a slide handling monitor parameter wherein the at least one proportion is selected from the group consisting of barcode error failure proportion, positioning error failure proportion, cleaning error failure proportion, and overall slide handling quality failure proportion.

Claim 29

The laboratory process monitoring method of claim 1 wherein the step of extracting an initial monitor parameter further comprises the step of extracting at least one preparation monitoring parameter for monitoring the quality of a laboratory fixation, staining, or coverslip application processes.

Claim 30

The laboratory process monitoring method of claim 28 wherein the at least one preparation monitoring parameter is selected from the group consisting of a bubble adequacy category, a mounting medium adequacy category, a staining adequacy category, and an additional adequacy category.

Claim 31

The laboratory process monitoring method of claim 29 wherein the staining adequacy further comprises a light stain adequacy category, nuclear stain adequacy category, cytoplasm stain adequacy category, chromatin adequacy category, and N/C contrast adequacy category.

Claim 32

The laboratory process monitoring method of claim 29 wherein the additional adequacy category further comprises staining score adequacy category, stage3 alarm category, QC score category, and chromatin details category.

Claim 33

The laboratory process monitoring method of claim 29 wherein the step of extracting at least one preparation monitoring parameter further comprises the steps of: (a) testing at least one preparation monitoring category by measuring the proportions of slides in a given batch that fail any scanning failure conditions or process suitability conditions; and (b) outputting at least one proportion as a preparation monitoring parameter wherein the at least one proportion is selected from the group consisting of bubble adequacy failure proportion, mounting medium failure proportion, light stain failure proportion, nuclear stain failure proportion, cytoplasm stain failure proportion, chromatin adequacy failure proportion, N/C contrast adequacy failure proportion, overall staining adequacy failure proportion, and combined bubble mounting, medium and staining adequacy failure proportion.

Claim 34

The laboratory process monitoring method of claim 29 wherein the step of extracting at least one preparation monitoring parameter further comprises the step of outputting at least one preparation monitoring parameter from the group consisting of a staining score parameter, a stage3 alarm parameter, a QC score parameter, a population beyond global QC score upper bound parameter and a chromatin details parameter.