LIMS_Appendix_1._Abbreviations_and_Definitions.docx

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E00B5600024 FEB Laboratory Information Management System RFP
Solicitation number
BPM050703
Issued by
Maryland

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The file is an Appendix of Abbreviations and Definitions for a Request for Proposals (RFP) issued by the Comptroller of Maryland (COM) related to a Laboratory Information Management System (LIMS). The document provides comprehensive definitions for technical terms, acronyms, and key concepts relevant to a state procurement process, with an effective date of July 2024. The appendix covers definitions for critical terms such as data breaches, security measures, sensitive data, enterprise license agreements, and various technical standards including FedRAMP, FISMA, and ISO specifications.

The document outlines specific requirements for a digital laboratory management system, emphasizing quality control, data management, and security protocols. Key elements include provisions for minority and veteran-owned business enterprises (MBE and VSBE), requirements for security audits (such as SOC 2 Type 2), and detailed definitions of sensitive data protection. The definitions suggest the procurement is for a comprehensive, secure, and technologically advanced laboratory information management system with robust data tracking, reporting, and security capabilities, targeting precise laboratory workflow enhancement and data management across state government operations.

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Appendix 1. Abbreviations and Definitions For purposes of this RFP, the following abbreviations or terms have the meanings indicated below:

A. AD – Active Directory.

B. API - Application Programming Interfaces.

C. ASTM D6299-23a Standard Practices for Applying Statistical Quality Assurance and Control - This practice covers information for the design and operation of a program to monitor and control ongoing stability and precision and bias performance of selected analytical measurement systems using a collection of generally accepted statistical quality control (SQC) procedures and tools.

NOTE 1-A complete list of criteria for selecting measurement systems to which this practice should be applied and for determining the frequency at which it should be applied is beyond the scope of this practice. However, some factors to be considered include (1) frequency of use of the analytical measurement system, (2) criticality of the parameter being measured, (3) system stability and precision performance based on historical data, (4) business economics, and (5) regulatory, contractual, or test method requirements.

This practice is applicable to stable analytical measurement systems that produce results on a continuous numerical scale.

This practice is applicable to laboratory test methods.

This practice is applicable to validated process stream analyzers.

This practice is applicable to monitoring the differences between two analytical measurement systems that purport to measure the same property provided that both systems have been assessed in accordance with the statistical methodology in Practice D6708 and the appropriate bias applied D. AUP - Acceptable Use Policy.

E. Bid/Proposal – The Bidder’s Bid or, as appropriate, either or both of the Offeror’s Technical or Financial Proposal.

F. Bid Package - The Bidder’s Bid or the Offeror’s Proposal and all required Attachments as identified in IFB/RFP Table A (Attachments and Documents Required with the Bid/Attachments and Documents Required with Proposal). Any attachments not required will be labeled “Not Applicable” or “N/A” in Table A.

G. Bid/Proposal Price Form or Price Form - The Attachment B The Price Form that contains the prices bid by the Bidder or proposed by the Offeror.

H. Bidder/Offeror – An entity that submits a Bid or Proposal in response to this IFB/RFP.

I. Business Day(s) – The official working days of the week to include Monday through Friday. Official working days excluding State Holidays (see definition of “Normal State Business Hours” below).

J. Certificates of Analysis - A formal laboratory-prepared document that details the results of (and sometimes the specifications and analytical methods for) one or more laboratory analyses, signed—manually or electronically—by an authorized representative of the entity conducting the analyses.

K. COMAR – Code of Maryland Regulations available on-line at https://dsd.maryland.gov/Pages/COMARSearch.aspx L. COM - Comptroller of Maryland.

M. CSV - a plain text file that stores data in a tabular format, where each line represents a data record. Each record consists of fields separated by commas. CSV files are commonly used for data exchange between different applications, such as databases and spreadsheets.

N. Content Strategy - Defining what data is desired to be stored in the system and how it is accessed and protected.

O. Contract – The Contract, in the form of Exhibit 2 hereto, to be awarded to the successful Bidder pursuant to this RFP.

P. Contract Monitor – The State representative, or their documented designee, for this Contract who is primarily responsible for Contract administration functions, including, but not limited to, issuing written direction, invoice approval, monitoring this Contract to ensure compliance with the terms and conditions of the Contract, monitoring MBE and VSBE compliance, and achieving completion of the Contract on budget, on time, and within scope. The Contract Monitor may authorize in writing one or more State representatives to act on behalf of the Contract Monitor in the performance of the Contract Monitor’s responsibilities. The Contract Monitor may be changed at any time by written notice to the Contractor.

Q. Contractor – The selected Bidder/Offeror awarded a Contract by the State.

R. Contractor Personnel – Employees, agents and subcontractor’s employees and agents performing work for or at the direction of the Contractor under the terms of the Contract.

S. Data Breach – The unauthorized acquisition, use, modification or disclosure of State data, or other Sensitive Data.

T. ELA - Enterprise License Agreement.

U. Elements of quality control/assurance - In the field of Laboratory analysis and laboratory information management systems (LIMS), implementing effective quality control processes is crucial for ensuring the accuracy and reliability of test results. Quality control is of utmost importance in LIMS to ensure the validity and precision of laboratory test results. By implementing robust quality control processes, laboratories can minimize errors, increase confidence in their data, and meet regulatory requirements.

V. eMMA – eMaryland Marketplace Advantage; the State’s eProcurement system.

W. FedRAMP - Federal Risk and Authorization Management Program.

X. FISMA - Federal Information Security Management Act.

Y. Information architecture - the design of the system that manages how data is entered, stored, managed, accessed, and retired.

Z. International Standards Organization ISO 4259 - Specifies the methodology for the design of an Interlaboratory Study (ILS) and calculation of precision estimates of a test method specified by the study. In particular, it defines the relevant statistical terms (Clause 3), the procedures to be adopted in the planning of ILS to determine the precision of a test method (Clause 4), and the method of calculating the precision from the results of such a study (Clauses 5 and 6). The procedures in ISO 4259-1:2017 have been designed specifically for petroleum and petroleum related products, which are normally considered as homogeneous. However, the procedures described in ISO 4259-1:2017 can also be applied to other types of homogeneous products. Careful investigations are necessary before applying ISO 4259-1:2017 to products for which the assumption of homogeneity can be questioned.

AA. Key Personnel – All Contractor Personnel identified in the solicitation as such that are essential to the work being performed under the Contract.

AB. Laboratory dashboard – A user-friendly interface that displays key performance indicators, metrics, and other critical information in real-time. Dashboards are customizable, allowing lab managers to focus on the specific data points that matter most to their operations. Whether it’s the status of samples, pending tests, or compliance thresholds, the dashboard provides a centralized location to monitor lab activities. Dashboards present this data visually. Graphs, charts, heat maps, and other visual elements make it easy to identify trends, spot bottlenecks, and monitor performance without having to sift through endless spreadsheets or raw data tables.

AC. Laboratory Information Management System (LIMS): A digital framework that allows laboratories to collect, store, manage, and analyze data linked to laboratory processes. When motor fuel samples arrive at the lab, the LIMS tracks them through every step of the process—from initial collection specification analysis, and reporting. The primary function of a LIMS is to enhance laboratory workflow, efficiency, reduce errors, and manage laboratory data effectively over time. It ensures that lab technicians can focus on actual testing rather than getting bogged down by manual documentation and spreadsheets.

AD. Local Time – Time in the Eastern Time Zone as observed by the State of Maryland. Unless otherwise specified, all stated times shall be Local Time, even if not expressly designated as such.

AE. Minority Business Enterprise (MBE) – Any legal entity certified as defined at COMAR 21.01.02.01B (54) which is certified by the Maryland Department of Transportation under COMAR 21.11.03.

AF. NIST - National Institute of Standards and Technology.

AG. Normal State Business Hours - Normal State business hours are 8:00 a.m. – 5:00 p.m. Monday through Friday except State Holidays, which can be found at: www.dbm.maryland.gov – keyword: State Holidays.

AH. Notice to Proceed (NTP) – A written notice from the Procurement Officer that work under the Contract, project, Task Order or Work Order (as applicable) is to begin as of a specified date. The NTP Date is the start date of work under the Contract, project, Task Order or Work Order. Additional NTPs may be issued by either the Procurement Officer or the Contract Monitor regarding the start date for any service included within this solicitation with a delayed or non-specified implementation date.

AI. NTP Date – The date specified in a NTP for work on Contract, project, Task Order or Work Order to begin.

AJ. Personal Information (PI) or Personally Identifiable Information (PII) – As defined by statute under the State Government Article, Annotated Code of Maryland, Section 10-1301(c):

1) “Personal information” means an individual's first name or first initial and last name, personal mark, or unique biometric or genetic print or image, in combination with one or more of the following data elements:

i) a Social Security number;

ii) a driver's license number, state identification card number, or other individual identification number issued by a unit;

iii) a passport number or other identification number issued by the United States government;

iv) an Individual Taxpayer Identification Number; or

v) a financial or other account number, a credit card number, or a debit card number that, in combination with any required security code, access code, or password, would permit access to an individual's account.

2) “Personal information” does not include a voter registration number.

AK. POC – Point of contact.

AL. Procurement Officer – As defined in COMAR21.01.02.01B.(67) and prior to the award of any Contract, the sole point of contact in the State for purposes of this solicitation. After a Contract award, the Procurement Officer has responsibilities as detailed in the Contract and is the only State representative who can authorize changes to the Contract. The Procurement Officer may be changed at any time by written notice to the Contractor.

AM. Protected Health Information (PHI) – Information that relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual; or the past, present, or future payment for the provision of health care to an individual; and (i) that identifies the individual; or (ii) with respect to which there is a reasonable basis to believe the information can be used to identify the individual.

AN. Request for Proposals (RFP) – This Request for Proposals issued by COM with the Solicitation Number and date of issuance indicated in the Key Information Summary Sheet, including any amendments and attachments thereto.

AO. Root cause analysis - A common technology phrase for performing an exhaustive investigation into the technical problem, determining the cause of the problem, the timeline of the problem event, and the steps that should be taken to prevent the issue from reoccurring.

AP. SAML - Security Assertion Markup Language.

AQ. Security Incident – A violation or imminent threat of violation of computer security policies, Security Measures, acceptable use policies, or standard security practices. “Imminent threat of violation” is a situation in which the organization has a factual basis for believing that a specific incident is about to occur.

AR. Security or Security Measures – The technology, policy, and procedures that a) protects and b) controls access to networks, systems, and data.

AS. Sensitive Data - Means PII; PHI; other proprietary or confidential data as defined by the State, including but not limited to “personal information” under Md. Code Ann., Commercial Law § 14-3501(e) and Md. Code Ann., St. Govt. § 10-1301(c) and information not subject to disclosure under the Public Information Act, Title 4 of the General Provisions Article; and information about an individual that (1) can be used to distinguish or trace an individual‘s identity, such as name, social security number, date and place of birth, mother‘s maiden name, or biometric records; or (2) is linked or linkable to an individual, such as medical, educational, financial, and employment information.

AT. SOC 2 Type 2 Audit Report - A document produced by a third-party auditor that assesses a service organization's security controls related to customer data, evaluating how well they protect the confidentiality, integrity, availability, processing integrity, and privacy of that data.

AU. State – The State of Maryland, including the agency that is issuing this solicitation and executing the awarded contract.

AV. Thin Client - The end user interface for accessing the system. Normally this is a desktop application or a web page/web app.

AW. TO – Task Order.

AX. Total Bid/Proposal Price - The Bidder’s bid price or evaluated bid price for goods and services in response to this solicitation or the Offeror’s financial proposal price or evaluated financial proposal price, included in Attachment B – Price Form Instructions.

AY. Turnkey implementation - A turnkey solution is a ready-made product that meets certain requirements and can be used straight away. Turnkey solutions are developed with the customer in mind, ensuring that they meet specific needs and requirements. Turnkey solutions can often be customized to a certain extent. However, the level of customization may vary depending on the specific vendor and solution.

AZ. Veteran-owned Small Business Enterprise (VSBE) – A business that is verified by the Center for Verification and Evaluation (CVE) of the United States Department of Veterans Affairs as a veteran-owned small business. See Code of Maryland Regulations (COMAR) 21.11.13.

BA. W3C - World Wide Web Consortium.

Appendix 1. Abbreviations and Definitions Effective Date: July 2024

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