Difference between revisions of "User:Shawndouglas/sandbox"
Shawndouglas (talk | contribs) (→1.5 Industry-specific: Added PH info.) |
Shawndouglas (talk | contribs) (→1.4 General system functions: Added safety item.) |
||
Line 753: | Line 753: | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''p.''' Does your system | | style="padding:5px; width:500px;" |'''p.''' Does your system notify analysts of applicable safety hazards associated with a sample, reagent, or test before testing begins? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''q.''' Does your system allow | | style="padding:5px; width:500px;" |'''q.''' Does your system allow authorized users to review all analytical results, including pricing, spec violations, history or trend analysis by analyte, and comments? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''r.''' Does your system | | style="padding:5px; width:500px;" |'''r.''' Does your system allow on-screen review of the stored test result, diluted result with corrected method detection limits (MDLs), and qualifiers after running samples for multiple dilutions as in [[gas chromatography–mass spectrometry]] (GC-MS)? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''s.''' Does your system | | style="padding:5px; width:500px;" |'''s.''' Does your system display the standard operating procedure (SOP) associated with each test result to ensure proper techniques were used? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''t.''' Does your system | | style="padding:5px; width:500px;" |'''t.''' Does your system store test-related analysis comments with the test? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''u.''' Does your system | | style="padding:5px; width:500px;" |'''u.''' Does your system provide for high-volume multi-component transfers of test results, with the ability to automatically match samples to data files in either a backlog mode or a designated file mode, to parse the data, and to review and commit the sample data? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''v.''' Does your system's results validation process | | style="padding:5px; width:500px;" |'''v.''' Does your system's results validation process access all information about a sample or group of samples, including comments or special information about the sample? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''w.''' Does your system | | style="padding:5px; width:500px;" |'''w.''' Does your system's results validation process check each result against its individual sample location specifications (both warning and specification limits)? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''x.''' Does your system | | style="padding:5px; width:500px;" |'''x.''' Does your system support validation at the analysis and sample level, while also prohibiting sample validation when analysis validation is incomplete? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''y.''' Does your system | | style="padding:5px; width:500px;" |'''y.''' Does your system use a menu-driven process for results validation? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''z.''' | | style="padding:5px; width:500px;" |'''z.''' Does your system provide secure electronic peer review of results? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''aa.''' | | style="padding:5px; width:500px;" |'''aa.''' Can your system clearly differentiate released preliminary data from fully validated results? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ab.''' Does your system | | style="padding:5px; width:500px;" |'''ab.''' Does your system validate/approve data prior to being moved to the main database? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ac.''' Does your system | | style="padding:5px; width:500px;" |'''ac.''' Does your system fully manage all aspects of laboratory quality control, including the reporting and charting of all quality control data captured in the lab? Please explain how. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ad.''' Does your system | | style="padding:5px; width:500px;" |'''ad.''' Does your system provide a base for a quality assurance program, including proficiency testing, scheduled maintenance of equipment, etc.? Please explain how. | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ae.''' Does your system | | style="padding:5px; width:500px;" |'''ae.''' Does your system distinguish QA/QC duplicates from normal samples? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''af.''' Does your system | | style="padding:5px; width:500px;" |'''af.''' Does your system allow QA/QC tests to be easily created and associated with the primary analytical test? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ag.''' Does your system | | style="padding:5px; width:500px;" |'''ag.''' Does your system calculate monthly QA/QC percentages for testing? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ah.''' Does your system | | style="padding:5px; width:500px;" |'''ah.''' Does your system automatically flag out-of-range quality control limits? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ai.''' Does your system | | style="padding:5px; width:500px;" |'''ai.''' Does your system check data files for specification and corrects them for specific reporting and analyte limits and qualifiers like dilution factor, automatically assigning qualifiers based on project analyte limiting? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''aj.''' Does your system | | style="padding:5px; width:500px;" |'''aj.''' Does your system allow file transfer of data from instrument or user-generated files, with full on-screen review prior to database commitment? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ak.''' Does your system | | style="padding:5px; width:500px;" |'''ak.''' Does your system permit manual data entry into an electronic worksheet of test measurements and results? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''al.''' Does your system | | style="padding:5px; width:500px;" |'''al.''' Does your system allow incorrectly inputted data to be manually corrected? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''am.''' Does your system | | style="padding:5px; width:500px;" |'''am.''' Does your system provide colored visual indication of previously entered data as well as new data associated with a single sample when a result is entered, with the indicator changing color if the value is out of specification? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''an.''' Does your system | | style="padding:5px; width:500px;" |'''an.''' Does your system permit result entry via intelligent instrument interfaces or multi-sample/multi-test ASCII files? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ao.''' Does your system | | style="padding:5px; width:500px;" |'''ao.''' Does your system allow automated or semi-automated data insertion? | ||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | | ||
|- | |- | ||
| style="padding:5px; width:500px;" |'''ap.''' Does your system store non-narrative textual results in searchable fields? | | style="padding:5px; width:500px;" |'''ap.''' Does your system provide auto-commenting for common laboratory result comments? | ||
| style="background-color:white; padding:5px;" | | |||
| style="background-color:white;" | | |||
|- | |||
| style="padding:5px; width:500px;" |'''aq.''' Does your system store non-narrative textual results in searchable fields? | |||
| style="background-color:white; padding:5px;" | | | style="background-color:white; padding:5px;" | | ||
| style="background-color:white;" | | | style="background-color:white;" | |
Revision as of 20:26, 19 September 2013
This is my sandbox, where I play with features and test MediaWiki code. If you wish to leave a comment for me, please see my discussion page instead. |
Sandbox begins below
System questionnaire
This questionnaire lists the extensive requirements of a laboratory informatics system, primarily of a LIMS, though these requirements could easily apply to other informatics systems. The intention of this document is 1. to assist labs with identifying their system needs and 2. to help labs better determine if a specific vendor/product meets their requirements in the form of a request for information (RFI).
This questionnaire is comprehensive and includes many items that do not apply to every lab. Additionally, some laboratories' requirements include a functionality item not common to other labs. Section 1.5 "Industry-specific questionnaire" contains a selection of those industry-specific requirements and will continue to be amended over time. The last section, 1.6 "Custom system functions questionnaire," is designed for the vendor to insert any additional functionality that doesn't fall under the categories provided.
When referencing a particular item for someone else, use the section number followed by the requirement letter, e.g. 1.4.2.f for "Does the system allow the system admin to create custom screens, apps, and reports?"
Requirement code and notes
In responding to each requirement, the vendor must select a requirement code from the following:
- Y: Meets requirement in commercial off-the-shelf solution as delivered/configured (or vendor provides service)
- YC: Meets requirement only with customization (additional code, using a third-party application, etc.)
- N: Does not meet requirement
- I: Informational response only, N/A
The vendor should ideally enter a requirement code and a response for each functionality question.
To add the requirement code and vendor notes to a functionality item, look for this kind of code in the appropriate section: | style="padding:5px; width:500px;" |'''a.''' Lorem ipsum dolor sit amet, consectetur adipisicing elit, sed do eiusmod tempor
|
1.0 Vendor information
|
1.1 Vendor services
|
1.2 Information technology
|
1.3 Regulatory compliance and security
|
1.4 General system functions
|
1.5 Industry-specific
|
1.6 Custom functions
|