Quality control of DP systems |
62 |
|
01.001 |
Do you have laboratory guidelines for DP covering overall DP workflow and is it easily accessible? |
4 |
|
01.002 |
Does the DP director regularly review and check all guidelines for DP system? |
2 |
|
01.003 |
If the guidelines are changed, or added, or revised, or partly discarded, does the person in charge of the DP system review and confirm the content? |
2 |
|
01.004 |
When the DP system director changes, does the new director review and confirm all guidelines? |
4 |
|
01.005 |
Is there a system to ensure that all employees using the DP system are all aware of the guidelines? |
2 |
|
01.006 |
Do you have an internal quality control system for the DP system in place and implemented? |
32 |
|
01.007 |
Do you regularly conduct internal quality control of DP systems? |
8 |
|
01.008 |
Does the person in charge of the DP systems review and resolve the internal QC results in documentation? |
8 |
Personnel in DP systems |
16 |
|
02.001 |
Are the personnel managing the DP system adequate in numbers? |
4 |
|
02.002 |
Is the education/training for personnel using/managing DP systems being documented? |
4 |
|
02.003 |
Are there personnel primarily assigned to whole slide scanning? |
8 |
The hardware and software used in DP systems |
28 |
|
03.001 |
Is the WSS in the DP systems approved by the Ministry of Food and Drug Safety? |
4 |
|
03.002 |
Is the performance of the WSS regularly checked and maintained by the manufacturer? |
4 |
|
03.003 |
Is the performance of the WSS and the quality of scanned WSIs regularly evaluated by DP personnel? |
4 |
|
03.004 |
Does the image database system guarantee that the identification information of the glass slide matches that of the digital image? |
2 |
|
03.005 |
Even though the version of the image archiving software changes, is it still available to view and use the archived data with a new software without any technical difficulty? |
2 |
|
03.006 |
Does the image storage method take a form of backup or mirroring? |
4 |
|
03.007 |
Do the image display devices (e.g., monitor) have the appropriate image quality for primary diagnosis? |
2 |
|
03.008 |
Does the image viewing software properly implement overview image functions, annotation functions, and image comparison functions to suit the pathological workflow? |
2 |
|
03.009 |
Are DP systems properly linked to the LIS, EMR, or HIS in an appropriate manner? |
4 |
Operation, management, and validation of DP systems |
82 |
|
04.001 |
Is the laboratory SOP well prepared stating the following? |
10 |
|
04.002 |
Is an in-house validation on newly introduced devices of DP system being conducted and documented? |
12 |
|
04.003 |
Is the validation study conducted under conditions that are consistent with the clinical use intended by the DP system manufacturer? |
4 |
|
04.004 |
Is the validation study designed to be as similar as possible to the actual clinical settings in which the technology will be used? |
4 |
|
04.005 |
Does the validation study cover the entire DP system? |
4 |
|
04.006 |
When there are significant changes in the composition of the DP system, is the revalidation on the whole DP system being conducted? Or do you have any guidelines for this? |
8 |
|
04.007 |
Is the validation intended to be conducted by at least one pathologist who has been acclimated to the DP system? |
4 |
|
04.008 |
Is the validation carried out using a comparative analysis of concordance between microscopic and WSI-based diagnoses made by a single observer (intra-observer variability assessment)? |
4 |
|
04.009 |
Did you have a washout period of at least 2 weeks to minimize the influence of recall bias during the validation? |
4 |
|
04.010 |
During validation, do you assess data integrity of image acquisition by verifying whether all tissues on the glass slide have been properly scanned to form the digital image? |
8 |
|
04.011 |
Is the additional validation being conducted on the samples for the detection of microorganisms (e.g., Helicobacter pylori), the cytology slides (cell smears, liquid-based cytology, or blood smears), and the cases suspicious for lymphoreticular neoplasms? |
4 |
|
04.012 |
Are all the errors, its statistics and cause analysis being recorded during the whole slide scanning? |
4 |
|
04.013 |
Are WSIs being scanned at a minimum magnification of 20x (In case of H&E slides)? |
4 |
|
04.014 |
Do you manage regular inspection results for the image display device (e.g., monitor)? |
4 |
|
04.015 |
Is the data being stored according to the data preservation period determined by the individual laboratory? |
4 |
Personal information protection and information security of DP images |
|
|
05.001 |
Do the guidelines include the instruction and regulation on the collection and management of personal information and information safety? |
16 |
|
05.002 |
Does the DP guideline specify external personnel or institutions that can access medical information and access data using DP systems? |
4 |
|
05.003 |
Is there a person in charge of information security for DP system? |
4 |
|
05.004 |
Is there a suitable system to prevent the loss of personal medical information in case of hardware or software failure in DP system and other emergencies or disasters (e.g., power outages due to natural disasters)? |
4 |