LII:LIMS and laboratory informatics questionnaire/1.6 Industry-specific

This addendum to the primary system questionnaire cover industry-specific laboratory requirements not common to other labs.

1.6 Industry-specific

1.6a Agriculture industry 1.6a.1 Compliance and support Request for information Requirement code Vendor response a. The system supports the Food and Drug Administration's (FDA) and the United States Department of Agriculture's (USDA) mandatory hazard analysis and critical control points (HACCP) programs for seafood, juice, and meat. b. The system supports the USDA organic regulations of 7 CFR Section 205. c. The system manages the activities necessary to support the USDA's Pesticide Data Program. 1.6a.2 Pre-analysis and testing Request for information Requirement code Vendor response a. The system efficiently receives and processes data captured by remote inspectors. b. The system provides a transport and routing management module. c. The system permits input and query of information such as (but not limited to) client ID numbers, animal species, animal breed, animal sex, animal diagnostic test performed, animal diagnostic test result, client or bill to zip code, program or funding codes, date ranges, lab department, case coordinator, and lab technician. d. The system allows users to group soil and water samples, including test results, by location and depth. e. The system provides the standard tests associated with agricultural analysis. f. The system permits manual override of allowable test/species combinations for circumstances outside the norm. 1.6a.3 Post-analysis Request for information Requirement code Vendor response a. The system offers a way to separately manage non-compliance records. b. The system makes report output available online for external and internal web viewing. 1.6a.4 Custom requirements Request for information Requirement code Vendor response a. b. c. d. 1.6b Chemical and petrochemical industry 1.6b.1 Compliance and support Request for information Requirement code Vendor response a. The system supports the European Union's REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) requirements. 1.6b.2 Pre-analysis and testing Request for information Requirement code Vendor response a. The system includes multi-level product specification management. b. The system provides product and batch traceability. c. The system supports statistical process control (SPC) quality control methodology and provide SPC charting tools. d. The system permits on-demand customization of instrument calibration and maintenance protocols. e. The system interfaces with digital control systems (DCSs). f. The system interfaces with laboratory execution systems (LESs). g. The system provides the standard tests associated with chemical analysis, including density, limit, melting point, and acid neutralization testing. h. The system integrates chemical drawing and computational tools. If it can't, it can still interface with third-party chemical drawing tools like ChemDraw, MarvinSketch, and Ketcher. i. The system allows the import of chemical structure and spectroscopic files. j. The system permits users to query by functional group or designed structure. 1.6b.3 Custom requirements Request for information Requirement code Vendor response a. b. c. d. 1.6c Environmental, water, and wastewater industry 1.6c.1 Compliance and support Request for information Requirement code Vendor response a. The system supports the baseline requirements of the Department of Defense's (DoD) Quality Systems Manual (QSM) for Environmental Laboratories. b. The system supports the electronic delivery of analytical data for environmental programs via the EPA's Staged Electronic Data Deliverable (SEDD) format. c. The system supports the Cross Media Electronic Reporting Rule (CROMERR) of Title 40 CFR Part 3. 1.6c.2 Pre-analysis and testing Request for information Requirement code Vendor response a. The system generates permits, permit applications, directions for the application, and semi-annual report templates with fields like "name of industry," "mailing address," "SIC code," "permit number," and "contact name". b. The system generates correspondence letters for permit renewals and new permits. c. The system stores permits for each industry. d. The system indexes all industries/companies by Standard Industrial Classification (SIC) code. e. The system indexes all industries/companies by: categorical and non-categorical, exempt and non-exempt, alphabetical order, permit number, bar code, permit due dates, as well as daily, weekly, biweekly, monthly, quarterly, bi-annual, and annual. f. The system contains an address book for all industries and programs in environmental compliance that indexes alphabetically, by industry, by address, etc. g. The system provides a flexible procedure for assigning location codes or sample types for each default sample point, including tests required, report types, invoice information, maximum holding time, project accounts, and location description; each location code has an upper and lower warning limit, target specification for every analyte assigned, and stored defaults for all user-defined universal fields, special project fields, and sample comments. h. The system stores standard operating procedures (SOPs) for all pretreatment procedures. i. The system permits entering matrix duplicates for oil and grease samples. j. The system includes tools to track and monitor nuclear-related sample and analysis data. k. The system includes tools to track and monitor hazardous waste sample and analysis data. 1.6c.3 Post-analysis Request for information Requirement code Vendor response a. The system allows for the electronic exportation of raw quality control data. b. The system includes tools to measure data against different quality objectives. c. The system links all lab results with the correct reporting test method. d. The system generates and prints industrial reports, sampling reports, inspection reports, fact sheets, citations, formal charges, correspondence letters, and industrial permits. e. The system generates and prints corresponding letters/templates for special and routine cases (e.g. industrial waste, permit renewals, semi-annual reports). f. The system generates and prints sampling cost reports for each industry, including the number of visits, types of analyses, calculated administrative cost, tubing cost, and duplicate sample cost, etc. g. The system generates and prints a biochemical oxygen demand (BOD) and total suspended solids (TSS) result report for industries. h. The system generates and prints a special report for HAZMAT incidents, storm water violations, spills/slugs, and local limit violators. i. The system generates and prints a report that determines if an industry is in significant non-compliance (SNC). j. The system indexes and compiles lists of businesses and industries that are in non-compliance/violation. k. The system generates notices of violation according to permit criteria and local limits. l. The system determines violation by either combined waste stream formula or local limits. m. The system generates documentation for filing charges. n. The system generates reminder notices for citation dates. o. The system links permit criteria with significantly non-compliant criteria. p. The system calculates surcharge fees for each industry. q. The system calculates surcharge from chain of custodies and data results. r. The system compiles cost data for each industry. 1.6c.4 Custom requirements Request for information Requirement code Vendor response a. b. c. d. 1.6d Forensics industry 1.6d.1 Compliance and support Request for information Requirement code Vendor response a. The system meets ASCLD standards for certified lab evidence transfers. b. The system supports ASTM standards, including evidence handling and numbering. c. The system permits analysis of evidence in support of intelligence activities, including dissemination of document intelligence, document analysis, and other technical information to the law enforcement community. d. The system facilitates sharing of information with federal, state, and local law enforcement agencies. 1.6d.2 Pre-analysis and testing Request for information Requirement code Vendor response a. The system provides functionality for each discipline, including latent prints, crime scene unit, multi-media lab, evidence control, ballistics, polygraph, forensic chemistry, and DNA. b. The system manages inventory of chemicals, ammo, supplies, etc. c. The system maintains evidence inventory and include the ability to make a report from it. d. The system supports open field numbering to create evidence packets. e. The system supports additional segmentation of evidence. f. The system provides complete, accurate, and timely processing and tracking of evidence, reports, and statistical information. g. The system uses barcode or radio frequency (RFID) technology to identify and track property/evidence. h. The systems makes evidence associated with a case or submission searchable by defendant, victim, case number, etc. i. The system records transaction date/time/persons associated with the movement of lab evidence. j. The system provides a complete reconciliation history for each evidence item stored in the system. k. The system implements security functions such as password, PIN, etc. for evidence transfers. l. The system lists evidence currently or recently checked out by an analyst. m. The system initiates automatic flags and processing for evidence return. n. The system provides automated chain of custody for all items of evidence. o. The system permits a supervisor or assignee to review all pending cases before assignment to staff. p. The system internally manages case workflow, including case assignment, case forwarding, and notification. q. The system allows authorized users to configure case reports for location. r. The system supports a statewide single case number. s. The system links system and lab case numbers or Z (database) numbers. t. The system makes objects associated with a case or submission accessible only from within the application. u. The system captures data from external property management systems. v. The system supports the documentation of expert witness and other court testimony in courts of law and other judicial proceedings. w. The system supports submission of forensic analysis requests electronically via e-mail, the FDL intranet, or FTP server. x. The system permits authorized users to define analytical test parameters based on case and standard operation procedure (SOP). y. The system supports the analysis of document and fingerprint evidence. 1.6d.3 Post-analysis Request for information Requirement code Vendor response a. The system requires case notes, data, and reports to be previewed before approval. b. The system provides report templates with variable fields for things such as case, item results, and conclusion. c. The system collects data on and report on meeting forensic case requester and case return deadlines. d. The system provides to external customers and staff automated, limited remote access to the database for case status inquiries and to view case reports. e. The system provides a record locate function by name, agency, ORI, etc. 1.6d.4 Custom requirements Request for information Requirement code Vendor response a. b. c. d. 1.6e Medical, public health, and veterinary industry 1.6e.1 Compliance and support Request for information Requirement code Vendor response a. The system creates reports for and routes samples to the Centers for Disease Control and Prevention (CDC), Food and Drug Administrations (FDA), Environmental Protection Agency (EPA). and other contract laboratories. b. The system records test results or map them to the Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) and/or Logical Observation Identifiers Names and Codes (LOINC) standards. c. The system records veterinary tests with results and map them to VeNom (Veterinary Nomenclature) Codes. 1.6e.2 Pre-analysis and testing Request for information Requirement code Vendor response a. The system differentiates among clinical, environmental, and other types of samples and their associated test requests. b. The system handles biobanking and blood banking activities and the data associated with them. c. The system geographically organizes clinical, environmental, and other types of samples and their associated tests for special analysis. d. The system captures and stores patient demographics, risk factors, and exposure data included with third-party test requests. e. The system accepts and processes third-party epidemiology data associated with test requests. f. The system provides the tools for creating and maintaining licensing, proficiency testing, inspection, and regulatory records for other public health laboratories within jurisdiction. g. The system includes an incident tracking system for recording, investigating, and managing safety and accident violations in the laboratory and other industries. h. The system includes or integrates with an electronic medical or health record system. i. The system includes an electronic medical record specifically for animal care. 1.6e.3 Post-analysis Request for information Requirement code Vendor response a. The system automatically reports any diagnostic test results deemed "suspect" or "positive" for reportable diseases. 1.6e.4 Custom requirements Request for information Requirement code Vendor response a. b. c. d.