Salient_Characteristics.xlsx

XLSX spreadsheet 29 KB Posted Sep 11, 2018

Attached to: Quality Systems International (QSI) Laboratory Inventory (Brand Name or Equal)
Solicitation number: HC102818R0162
Issued by: Defense Information Systems Agency

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Salient_Characteristics_Updated.xlsx	XLSX spreadsheet	Sep 12, 2018
Attachment_1_Equipment_List.XLS	XLS spreadsheet	Sep 11, 2018
HC102818R0162.docx	DOCX document	Sep 11, 2018

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Final Salient Features

LIMS (Laboratory Inventory Management System) Salient Features

1	1	IT Requirements
2		Central hosting - shall allow central hosting of the application and the database with the capability to support targeted access for multiple sites with multiple laboratories within each site
3		Web interface via Microsoft (MS) Internet Explorer with version 11 or newer
4		Public Key Infrastructure (PKI)/Public Key Enabling (PKE) Common Access Card (CAC) authentication/enforcement - allow logon, audit tracking and digital signature using Smartcard (DoD CAC)
5		DISA Security Technical Implementation Guides (STIGs) Compliance must comply and be tested against the current applicable STIGs. LIMS will not be accepted with any open High (CAT I) or Medium (CAT II) findings; must be patchable and upgradeable
6		Must display the Unclassified - Navy Nuclear Propulsion Information (U-NNPI) Welcome Banner when logging into system
7		Database must be hosted on Oracle or Microsoft SQL Server
8		Vendor provided updates or upgrades will not adversely affect existing functionality
9	a	Sample Result Archival
10		Allow the archival of samples from within the application by defined users
11	2	Security Requirements
12		Must be capable of tagging sensitive data and displaying appropriate markings visually on the screen and on printed reports such as For Offcial Use Only (FOUO), Not Releasable to Foreign Nationals (NOFORN), TEST SAMPLE.
13	3	Base Functionality
14	a	Admin Management
15		Capability to assign "admin" or "super-user" privileges within the application to configure the LIMS. Admin users will have the ability within the application to change requirements of laboratory testing - users, user roles, passwords, and responsibilities; site-specific data; and master data definitions required to maintain samples, tests, and requirements. Master data definitions include specifications, limits, methods, quantitation values, instrument parameters, etc.
16		Supports the access and control of configuration data and sample data by physical or logical location
17	b	Configurable Roles
18		Ability to place users into defined groups. (The individual users or groups of users shall be able to be placed in one or more roles which provide access to role-specific LIMS functionality. With changing responsibilities, the LIMS shall allow for assigning new or restricting existing functionality from existing and newly created roles.)
19		Ability for users can belong to multiple sites and be able to interact with samples associated with those sites if so approved by the POC from each site.
20	c	Instrument Interfacing and Management
21		Data entry shall support automating the import of data from instruments and instrument data files. Instrument analysis output, usually in the form of a text file (.txt), a comma-separated values file (.csv), or an excel file (.xls)
22	d	Alarms and/or Alerts
23		Ability for automatic alerts when sample results are out of range, and site-defined alerts for scheduled equipment maintenance, reagent expiration date, etc.
24	e	Customer Interface
25		Ability for laboratory clients to monitor the progress of their samples and sample results through a limited web portal. After release by the laboratory, clients have the ability to download final report.
26		Customer ability to submit test requests or work orders via the application
27	f	Online or Integrated Help
28		The ability to add customized help screens within the application for Navy or site-specific functions.
29	g	Digital Signatures
30		For review and approval of samples and reports using DoD CAC
31	h	Audit Trail
32		Document & Record the sequence of activities that have affected an action or result. Information recorded shall include:
33		- Record date time and user for data entry and any modification while retaining the original information
34		- Option to require a text comment or a selection of text comments from a drop-down list for any modifications
35	i	Interoperability
36		Ability to share login configurations, test procedures, and specification limits between the sites while allowing site specific versions of each
37	j	Version Control
38		Ability to modify test methods, training methods, limits, specifications, procedures, etc., within the application, and to assign a version number to each modification for the purpose of identifying sample results to the version in use at the time of analysis.
39	4	Sample, Inventory and Data Management
40	a	Sample login and management
41		Laboratory site: A site can consist of a single administrative laboratory, a physical laboratory, a logical grouping of samples, defined by the laboratory, considered as being associated together
42		Samples ownership by site. The system has the ability to segregate samples for the purposes of display, result entry, review, validation. Only allowing defined users the ability to validate other sites.
43		A laboratory sample consists of similar nature of testing, as defined by facility in the implementation phase
44		Support logging in of multiple batches and/or multiple samples in one sample login session
45		Allow sample(s) additions to an existing batch without reentering information associated with the batch other than the batch identifier
46		Differentiate samples by sample type and sub-type or material code/product code
47		Samples will be grouped by major categories of samples (such as Gases or Metals) and further divided into sub-categories (such as Nitrogen or Argon). [For purposes of this document, the major categories will be referred to as "Sample Type" and the sub-categories referred to as "Product Code."] The level of validation required for each type of analysis (who can review and validate, whether peer review or two-level validation is required) can be customized within the application.
48		Collects information common to a batch of samples. This information may be mandatory or optional based on the Sample type and Product Code. Common information includes: Request Type, Customer, Submitter, Funding Source, Project/Program, Assigned Laboratory Branch, Designation, Trace Number, Requested Completion Date, Priority, Service Requested, Additional Distribution, and Remarks
49		Collect information solely dependent on the Sample type and Product Code. (This information may be mandatory or optional based upon Sample Type and Product Code.)
50		The person logging in the sample has the ability to modify default values to attributes during sample login based upon existing sample information (Sample Type, Product Code, Key Values)
51		Automatically schedules tests based on the information entered during sample login
52		Manually schedules tests during sample login which are not dependent on information entered during login
53		Allow the removal of automatically scheduled and manually scheduled tests during sample login
54		Uniquely identify each sample logged into LIMS based upon defined criteria (year, site designator, laboratory designator, sequential numbering). Example: Batch number to consist of 4-digit year (2019), followed by 2-character site designator (NS, PS, PT, BG, etc.), followed by a 5-digit sequential number (00099) = 2019NS00099. Each sample within a batch would have a number added to the end to create a unique ID = 2019NS00099-001, 2019NS00099-002, etc. Based on criteria defined. In addition, the designator at the sample level should include a letter or other designator to indicate which team that sample is assigned.
55		Print labels and receipts, as defined by the laboratory, for sample containers, and sample request/traveler.
56		Compliance with the Office of the Chief of Naval Operations Instruction (OPNAVINST) N9210 for U-NNPI marking and labeling
57		Labels will have the ability to include barcodes
58		Have the ability to print sample Hazard Communication (HAZCOM) compliant labeling
59		Ability to assign sample number(s) and schedule testing based on a pre-defined event schedule (e.g., certain samples taken every Tuesday could be logged in advance by the system).
60		Login samples from imported files (MS Word, Excel or Text files, etc.)
61		Allows addition of notes at the batch or sample level during login.
62		Allow admin users to modify login configuration, including login parameters and default tests, within the application.
63		Allow users to remove tests scheduled by default and add additional tests applicable to the type of material being tested.
64		Allow admin users to modify product specification limits from within the application.
65		Allow for creation of manual test procedures for analysis of samples not applicable to an existing specification (allowing the analyst to fill in the specification and the test limits as well as the results of analysis)
66		Change sample test requirements\specification\limits without re-logging and retesting the sample (Apply new limits to existing data)
67		Generate end user bench forms using standard format with customization based on scheduled tests
68	b	Sample Release
69		Allow samples to be logged in prior to receipt by the laboratory. Assignment of unique laboratory sample IDs prior to receipt by the laboratory is supported. Sample Release releases the sample(s) to the laboratory so that testing may be performed. The sample ‘clock’ for turn-around time starts following release
70		Ability to log in and assign sample number(s) prior to receipt of samples by the laboratory.
71		Ability to release samples for analysis after samples are inspected and accepted by the laboratory.
72		Start the sample 'clock' for turnaround time only after samples are released to the laboratory.
73		When predefined by the login configuration for a specific sample type, automatically release samples to laboratory for testing upon completion of login.
74		Manually release samples during sample login
75	c	Result Entry
76		Allow for the scheduling of single samples or sample groups. Sample group scheduling shall support the inclusion of multiple types of standards, such as blanks, calibration, spikes, etc., as well as cross-sample/standard calculations in a definable sequence.
77		Result entry by sample(s), samples associated with a batch, or samples on a worklist
78		Filtering to display sample attributes, pending results, calculated results, completed measurements
79		Modification/correction of result entries by analysts.
80		Allow addition or cancellation of a repeat test
81		Track date, time, and user for all results entry
82		Ability to view audit trail
83		Ability to add formatted text (including underlining, special characters, color text, highlighting, etc) or "memo" field to a sample for inclusion of narrative to sample reports.
84		Ability to add comments or notes to a batch or sample during result entry
85		Allow manual data entry for any data element
86		Ability to add pictures (Graphics Interchange Format (.gif), JAY-peg (.jpg), Bitmap (.bmp), etc) and charts to reports
87		Allows Unicode character set (string data) in result entry
88		Supports Electronic Laboratory Notebook (ELN) features allowing data entry incorporated into test workflow
89	d	Result Review
90		Review by sample(s), samples associated with a batch, or samples on a worklist
91		Filters to display sample attributes, calculated results, completed measurements
92		Indicate results which fail a limit check with conditional formatting
93		Restricts sample review based on defined sample review level and user’s defined role
94		Ability for site admin users to designate from within the application whether or not a particular type of sample requires second level review.
95	e	Sample Result Approval
96		Approved by sample(s), samples associated with a batch, or samples on a worklist
97		Sample approval only after reviewed/validated
98		Automatic Batch approval when associated samples are approved
99		Restrict sample approval based on defined sample approval level and user's defined role
100		"Locking" of samples after approval so that no further entry or modification can take place on them without the sample being reopened by an admin user.
101		Ability for site admin users to pre-designate specific types of samples to be automatically Approved and locked after last level of review and electronic signatures are complete.
102	f	Reopen Samples
103		Ability for site admin users to reopen Approved samples to allow for modification of attributes and test results.
104		Following modification of attributes and test results the sample will have to proceed through the review and approval phases of the sample lifecycle
105		Upon reopening, the system will add a consecutive amendment designator (A, B, C, etc.) to the Batch ID number (example: 2019NS00099A), and add a field requiring a reason for the amendment.
106		The amended Batch ID number and the reason for the amendment will be printed on the test report.
107	g	Task and Event Scheduling
108		Ability to schedule tasks and events based on laboratory defined criteria (Laboratory defined criteria = criteria defined at the site level.)
109	h	Data and Trend Analysis
110		Provides ability to analyze data sets and provide reporting and graphical analysis
111	i	Customizable Fields and/or Interface
112		Allow customization of system nomenclature
113		Within the application allow the customization of:
114		- equations used in calculations
115		- data and universal fields
116		- appearance of the interface and/or menus
117	j	Query Capability
118		Provide an ad hoc query capability to search specified fields
119	k	Inventory Management
120		Stockroom inventory management functions:
121		- records of manufacturer, lot number, expiration dates
122		- notification of expiring materials
123		- notification of low supplies
124		- electronic certificates of analysis records (PDF,DOC, Etc)
125		- Option to track use and in-use items based on expiration date
126		- Ability to create alerts for when items reach a minimum stock level defined by the site

Example: The site defines the minimum stock level for Reagent B as 6 bottles. The system would produce an alert when the 7th bottle was used.

127		- Automatic incrementing/decrementing of item quantities with a manual override feature
128		- Track usage of laboratory consumables
129		- Assign storage locations
130		- Track lab created standards/reagents including automatic expiration date assignment based on constituents
131		Assignment of unique identification of purchased reference materials and reagents based on stock inventories
132		Standard and reagent preparation records and tracking– electronically created from in-stock, in-date, uniquely identified vendor stock reagents and reference materials
133		Assignment of unique identification for in-house prepared reagents and standards
134		Barcode printing and reading of all uniquely identified purchased reference materials, reagents and prepared measurement standards
135		Site and location specified barcode labeling and label printing - Compatible with Microsoft Windows and Navy Marine Corps Intranet (NMCI) Compatible Device List (CDL)
136		Ability to print labels compliant with Occupational Safety and Health Administration (OSHA) Hazard Communication (HAZCOM) requirements.
137	l	Specification Management
138		Allow the user to enter product specifications, measurement uncertainty and bias and report conformance or nonconformance to the product specification based on the test bias and uncertainty
139		Supports testing to multi-level, complex specifications and include the ability to schedule tests and determine conformance with military specifications, vendor specifications, as well as, local/state and federal regulatory requirements for a large spectrum of samples including:
140		- Materials Conformance - material specification conformance to chemical, physical and mechanical testing requirements to include paint, fuels, oil, gas, rubber, metals, adhesives
141		- Environmental Testing - compliance of samples to local/state and federal testing requirements
142		- Occupational Safety and Health Act (OSH Act) Compliance of sample to OSHA testing requirements
143		- Shop processes and monitoring - electroplating, chemical receipt inspection which can defined at the site level
144	m	Customer Management
145		Customer with name, phone number, shop or code, e-mail address and mailing address
146	5	Test Procedure Attributes
147		Define test attributes such as test methods which are associated with the test but are not a measured or calculated result
148		Compliance/non-compliance with product specifications including reporting:
149		- measurement uncertainty
150		- bias
151		Define multiple measured results, formats, and units, associated with the test based on data elements both internal and external to the LIMS
152		Define formulas for multiple calculated results associated with the test based on data elements
153		Define calculated results formats, units, requirements and limits checks
154		Allow comparison of multiple results to multiple limit classes (reported limits and/or check limits) per result
155		Allow limits to be referenced external to the test procedure
156		Round results in accordance with American Society for Testing and Materials (ASTM) - E29
157	6	Login capability for materials associated with federal, military, and commercial material specifications, scheduling tests, and assigning appropriate test limits within the confines of the application interface
158		Log in samples to material specifications asking appropriate determinative questions based on the specification to appropriately schedule tests and assign test limits.

Example: The limits and tests performed to some ASTM specifications vary based on sample configuration, type of heat treatment or milling, etc.

159		Allow the login of samples to differing revisions of specifications maintained by the system
160		Utilize terminology defined in the revision of the specification used during sample login
161		Allow users to manually schedule and remove tests and their associated limits
162	7	Sample Worklists
163		Laboratory defined worklist templates: defined by users within the application at the site level.
164		Worklist templates are specialized login configurations which record attributes associated with a worklist and which define the sequence of known or standard samples with a pool of unknown samples for specific test procedures
165		Worklist templates define the sequence of known or standard samples with a pool of unknown samples in three phases of the worklist - the Initial Phase, the Main Phase, and the End Phase
166		Initial Phase - Defines Quality Control samples to be run before any unknown samples can be run
167		Main Phase – Defines the sequence of unknown samples to Quality Control samples during analysis according to rules of repeated sequences
168		End Phase – Defines Quality Control samples to be run after all unknown samples have been run to close out the sequence and ensure the quality of data during the run
169		After the worklist is generated the analyst is presented with the analysis sequence and allowed to move unknown samples within the sequence and add additional Quality Control Samples
170		Samples may be released from the worklist and re-pooled for future analysis provided that results associated with the worklist have not been entered
171		Following analysis, worklist records are retained by the system to indicate the unique worklist identifier, all samples processed on the worklist, and the sequence used for analysis
172	8	Specialized Result Entry and Data Review for Asbestos Samples
173		Allows the analyst to determine the number of layers in a sample and to record information associated with each layer analysis
174		Provides a customized data entry screen addressing the specific attributes of the sample layer and using picklists for layer homogeneity, color, and texture to ensure data consistency
175		Provides multi picklist to indicate presence of asbestos, non-asbestos fibers, and non-fibrous material. This shall allow for additional data entry for each type.
176		Totals the percent asbestos across the layers in a sample
177		The asbestos information is presented in a similar manner to facilitate data review
178		After every tenth asbestos sample added to the system, a duplicate sample of the tenth sample is created
179	9	Specialized Asbestos Daily Quality Control (QC) Checks as Defined by the Laboratory
180		The Asbestos Daily QC Module records the information under the user logged into the LIMS:
181		- The Microscope Station used for the QC check
182		- The date that the microscope was last aligned.
183		- The refractive index and whether contamination is present in a QC Blank Oil analysis
184		The module selects a random daily blind sample from a defined sample set to be analyzed by the analyst and records type of asbestos found, weight percent and the two refractive indexes
185		When the QC check is complete, the system generates a Quality Check Asbestos Analysis Report displaying the analyst's results and the stored true value for the blind sample for comparison
186		The module allows the reanalysis of a daily check and generates a new Quality Check Asbestos Analysis report when reanalysis is complete
187	10	Integrated Validation of Test Procedures, Test Schedule, and Limits Prior to Use
188		Each time a change is made to configuration settings (Test Procedure, Test Scheduling, or Limits) that change must be validated before a customer report can be issued
189		Supports a two level validation process, defined by the laboratory, for test procedures, test schedules, and limits
190		During report generation the system verifies that the test configuration settings have been validated and invalidates the report indicating which component requires validation
191		Provides a list report giving validation status (e.g., None, Level 1, Level 2) of procedures, default test scheduling, and limits.
192		Provides a report of invalidated procedures, test schedules, and limits with current validation status of each component (none, Level 1, Level 2)
193	11	Management of Laboratory documents
194		Version control - solution shall generate an identifier for each approved version of a document.
195		Review - the system shall record the user, date and review status of a document in process
196		Approval - the system shall allow a laboratory defined approval process recording the user, date and time for each approval
197		Maintain a running remarks log for each document under management
198		Distribution - the system will allow the user to track the documents
199	12	Management of Corrective Action Process
200		Manage corrective action process in accordance with International Organization for Standardization (ISO) 17025 - General requirements for the competence of testing and calibration laboratories
201	13	Management of Preventive Action Process
202		Manage preventive action process in accordance with ISO 17025 - General requirements for the competence of testing and calibration laboratories
203	14	Managing Provider Information of Services and Supplies
204		Manage providers of quality critical services and supplies: supplier name, Point of Contact (POC) info, mailing address, phone number, ability to record when approved/disapproved
205	15	Personnel Authorization Tracking/Management
206		Tracking individual analyst authorizations for specific tests
207		Tracking analyst authorization and reauthorization dates to support continuing demonstration of competence
208		Allows the query and reporting of future personnel authorization expirations using a user specified future date or time period (e.g. days in advance/next 60 days)
209		Optional ability to restrict result entry to only currently authorized analysts
210	16	Equipment Tracking/Management
211		Calibration records - Tracking of equipment calibration dates, including notification of expiring calibrations
212		Support equipment performance verification as defined for each piece of equipment at the site level.
213		Track instrument maintenance records as defined at the site level.
214		Provide an alert of the need for preventive maintenance based on criteria defined at the site level.
215	17	Test Contracts and Work Requests
216		Record the review and evaluation of new work requests
217		Record offers/contracts for testing services including other details as defined by the site such as:
218		- measurements to be reported
219		- test methods
220		- agreed upon reporting levels
221		- sample turn around times
222	18	Electronic Records of Sample Integrity Checks
223		Sample container, preservation, holding time, sample volume, sample temperature checks, sample condition, and acceptability upon receipt
224		Sample preservation by laboratory
225		Records of sample integrity issues
226		Resolution of sample integrity issues including (but not limited to):
227		- customer contact, decisions and approvals
228		- automatic report qualifications for sample integrity issues based on customer decisions and integrity issues
229		Electronic chain-of-custody
230		Sample holding time calculation based on sample data
231		Barcode printing and reading of sample containers with unique, automatically assigned, laboratory sample ID - Compatible with Microsoft Windows and Navy Marine Corps Intranet (NMCI) Compatible Device List (CDL)
232	19	Ability to Import and Export Data
233		Ability of the system to import data from instruments from .txt, .csv, .xml, etc.
234		Ability of the system to import data from .csv, delimited, .xml, and .xlm
235		Ad-hoc data queries and data export as .csv, delimited, .xml, Word Document (.docx), .xlm
236		Supports compatibility with Microsoft Word and Excel for import and export
237	20	Flexible Reporting
238		Electronic signature on reports
239		Inclusion of images in reports with .jpeg or other standard picture format
240		Generation, printing, and storage of Portable Document Format (PDF) reports
241		Report generation in .docx, .xlm, .pdf, Hypertext Markup Language (HTML)
242		Manual and automatic generation of reports
243		Limited customer access to view reports
244		Allows for tables, graphs and charts
245		Electronic distribution of reports
246		Ability to generate ad hoc reports based on user defined data fields
247		Ability to format barcode labels to contain different fields for different sample types and uses and to associate them with different events
248		Support the use of barcodes, preferably a number of symbologies such as Code 128 and Code 3 of 9, both in printing and through the use of supported barcode readers
249	21	Quality Assurance Functions
250		Integration of statistical process control limits
251		Manual and automatic generation of control measurement trend tables and charts
252		Single or batch quality control measurements
253		Allow the rules for the control charting to be specified controlled for each test and analyte. This shall also allow for standardized and additional options.
254		Flag result associated with unacceptable QC measurements and show when results are reviewed within the system, and would also be printed on the test report as defined by the site.
255	22	Specific Administrative and Customer Reporting Capabilities
256		Pre-formatted standard reports for turnaround time, hold time, work in progress, with the ability to filter by different parameters such as (but not limited to) sample type, branch, project, date range, etc.
257		Ability to change fields on standardized reports and worksheets to suit different types of reporting requirements
258	a	Regulatory Compliance
259		System must ensure laboratory compliance with:
260		- The NELAC Institute (TNI) Standard EV-V1-2009, Modules 2, 3 and 4
261		- International Standard ISO/IEC 17025, Sections applicable to testing laboratories
262	b	Reporting - Essential Reporting Functions
263		Compliance with ISO 17025 specified report line items including reports associated with:
264		- qualifying statements (aka "data qualifier flags") that are both customizable and "standardized"/built-in
265		- test deviations
266		- opinions and interpretations
267		- laboratory sampling
268		Report distribution
269		- ability to distribute reports electronically
270		- ability to store/distribute reports electronically as part of distribution (e.g., "one-button" distribution and store)

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