STATE OF COLORADO - Request for proposalbids.findrfp.com/xDocs/8267701195984ba1962a4b92d074dc76_RFP_F… · STATE OF COLORADO Department of Public Health and Environment CDPHE LSD

STATE OF COLORADO

Department of Public Health and Environment

CDPHE LSD LABORATORY INFORMATION MANAGEMENT SYSTEM (LIMS)

RFP # FAAA 2017000105

Colorado Department of Public Health and Environment (CDPHE) Procurement Office 4300 Cherry Creek Drive South Denver, CO 80246


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CONTENTS1. Administrative Information ............................................................................................................................... 9

1.1 Issuing Office ............................................................................................................................................. 9

1.2 Bid Information and Distribution System (VSS) and VSS Registration .................................................... 10

1.3 Modification or Addendum to Request For Proposals ............................................................................ 10

1.4 Invitation To Submit Proposals ................................................................................................................ 10

1.5 Purpose .................................................................................................................................................... 10

1.6 Scope ....................................................................................................................................................... 10

1.7 Structure of this Request for Proposals ................................................................................................... 10

1.8 Official Means of Communication ........................................................................................................... 10

1.9 Inquiries ................................................................................................................................................... 10

1.10 Offeror Registration ................................................................................................................................. 11

1.10.1 VSS Registration ............................................................................................................................... 11

1.10.2 Registration to Conduct Business in Colorado ................................................................................ 11

1.11 Vendor Identification ............................................................................................................................... 11

1.12 Parent Company ...................................................................................................................................... 11

1.13 Modification Or Withdrawal of Proposals ............................................................................................... 11

1.14 News Releases ......................................................................................................................................... 11

1.15 Certification of Independent Price Determination .................................................................................. 12

1.16 Proprietary/Confidential Information ..................................................................................................... 13

1.17 RFP Response Material Ownership ......................................................................................................... 13

1.18 Acceptance of RFP Terms ........................................................................................................................ 13

1.19 Proposal Content Acceptance ................................................................................................................. 13

1.20 Contractual obligations of rfp documents ............................................................................................... 14

1.21 Contract ................................................................................................................................................... 14

1.22 Legislative Changes .................................................................................................................................. 14

1.23 Order of Precedence ............................................................................................................................... 14

1.24 Venue ....................................................................................................................................................... 14

1.25 Statewide Contract Management System (CMS) .................................................................................... 14

1.26 Offeror Proposed Terms and Conditions ................................................................................................. 15


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1.27 State Ownership of Contract Products .................................................................................................... 15

1.28 Proposal Pricing ....................................................................................................................................... 15

1.29 Contract Term .......................................................................................................................................... 15

1.30 Late Proposals.......................................................................................................................................... 15

1.31 Rejection of Proposals ............................................................................................................................. 15

1.32 Estimated Quantities ............................................................................................................................... 16

1.33 Number of Awards .................................................................................................................................. 16

1.34 Agreement Execution .............................................................................................................................. 16

1.35 Pre Performance Meeting ....................................................................................................................... 16

1.36 Incurring Costs ......................................................................................................................................... 16

1.37 Taxes ........................................................................................................................................................ 16

1.38 Insurance ................................................................................................................................................. 16

1.39 Cyber Security .......................................................................................................................................... 16

1.40 Telegraphic/Electronic Responses ........................................................................................................... 17

1.41 Administrative Review Factors – Pass/Fail .............................................................................................. 17

1.42 Cooperative Purchasing ........................................................................................................................... 17

1.43 RFP Cancellation ...................................................................................................................................... 17

1.44 Protested Solicitations and Awards ......................................................................................................... 17

1.45 Audit ........................................................................................................................................................ 17

1.46 Organizational Conflict of Interest .......................................................................................................... 18

1.47 Liquidated Damages ................................................................................................................................ 18

1.48 Intellectual Property Escrow ................................................................................................................... 18

2. Introduction ..................................................................................................................................................... 19

3. Overview .......................................................................................................................................................... 20

4. Glossary ........................................................................................................................................................... 21

5. Proposal Requirements and Scope of Work .................................................................................................... 23

5.1 General Requirements ............................................................................................................................. 23

5.2 Local System Administration ................................................................................................................... 24

5.3 Permissions and Security ......................................................................................................................... 24

5.4 Data Access for other divisions within CDPHE ........................................................................................ 25


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5.5 Web Interface General Requirements ..................................................................................................... 25

5.6 Web Customer Accounts ......................................................................................................................... 25

5.7 Web Customer Interface ......................................................................................................................... 26

5.8 Web Customer Supply Ordering .............................................................................................................. 26

5.9 Web Customer Sample Data Entry .......................................................................................................... 27

5.10 Web Customer Results ............................................................................................................................ 28

5.11 Electronic Messaging ............................................................................................................................... 28

5.12 Communication with other LIMS systems ............................................................................................... 29

5.13 General Inventory .................................................................................................................................... 29

5.14 Supply Inventory ...................................................................................................................................... 30

5.15 Sample Inventory ..................................................................................................................................... 30

Internal Communication ...................................................................................................................................... 31

5.16 Notifications ............................................................................................................................................ 31

5.17 Dashboards .............................................................................................................................................. 32

5.18 General Data Entry and Sample Reconciliation ....................................................................................... 32

5.19 Receipt of Electronically Ordered Samples ............................................................................................. 33

5.20 Data Entry Interface ................................................................................................................................ 34

5.21 Batch Entry of Data and Testing Codes ................................................................................................... 34

5.22 Label Printing and Bar Coding ................................................................................................................. 35

5.23 Sample ID Numbers ................................................................................................................................. 35

5.25 Submitter Information ............................................................................................................................. 35

5.25 Data Fields ............................................................................................................................................... 36

5.26 Status Fields ............................................................................................................................................. 36

5.27 Testing Codes ........................................................................................................................................... 37

5.28 Data Entry QC .......................................................................................................................................... 37

5.29 Assignment of samples to Laboratories and Staff ................................................................................... 37

5.30 Send Out Requests .................................................................................................................................. 38

5.31 Laboratory Data Entry ............................................................................................................................. 38

5.32 Sample Worksheets and Work lists ......................................................................................................... 39

5.33 Instrumentation Interface ....................................................................................................................... 39


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5.34 Electronic Laboratory Notebooks ............................................................................................................ 40

5.35 Manual Data Entry ................................................................................................................................... 40

5.36 Data Review, Interpretation and Sample Resulting ................................................................................ 41

5.37 Secondary Review of Laboratory Test Results ........................................................................................ 41

5.38 Test Results Review ................................................................................................................................. 41

5.40 Reporting ................................................................................................................................................. 42

5.41 Queries .................................................................................................................................................... 43

5.43 Quality Assurance and Quality Control Tracking ..................................................................................... 44

5.44 Records Management ............................................................................................................................. 45

5.45 Billing ....................................................................................................................................................... 45

5.46 Change Management and Implementation ............................................................................................ 47

5.47 Maintenance and Support ....................................................................................................................... 48

5.48 Technical Requirements .......................................................................................................................... 49

6. Proposal Requirements ................................................................................................................................... 50

6.1 Technical Requirements – Project Management and Deliverables ........................................................ 50

6.1.1 Kick‐off meeting,.................................................................................................................................. 50

6.1.2 Weekly Status Reporting, .................................................................................................................... 50

6.1.3 Project Plan, ......................................................................................................................................... 50

6.1.4 Project Schedule, ................................................................................................................................. 50

6.1.5 Implementation Plan, .......................................................................................................................... 50

6.1.6 Requirements Traceability Matrix, ...................................................................................................... 50

6.1.7 Functional Specifications Document, .................................................................................................. 50

6.1.8 Technical Specifications Document, .................................................................................................... 50

6.1.9 Change Management Plan, ................................................................................................................. 50

6.1.10 Business Continuity / Disaster Recovery Plan, .................................................................................... 50

6.1.11 Testing Plan and Scripts, ...................................................................................................................... 50

6.1.12 Training Plan, ....................................................................................................................................... 50

6.1.13 Contract Transition Plan, ..................................................................................................................... 51

6.1.14 System Security Plan, .......................................................................................................................... 51

6.1.15 System Operations and Interface Plan, ............................................................................................... 51


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6.1.16 Administrative Functions Manual (User Manual), .............................................................................. 51

6.1.17 Reports Manual, .................................................................................................................................. 51

6.1.18 Readiness for UAT Memorandum, ...................................................................................................... 51

6.1.19 Readiness for Pilot Memorandum, and ............................................................................................... 51

6.1.20 Readiness for Implementation Memorandum. ................................................................................... 51

6.3 RESPONSE EXAMPLE ‐ See Below ........................................................................................................... 51

8. Proposal Evaluation ..................................................................................................................................... 54

9. Appendices ...................................................................................................................................................... 58

Attachment A: Sample State Contract Template

Attachment B: CORE Interface Scema


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REQUEST FOR PROPOSALS SIGNATURE PAGE

RFP INFORMATION

RFP #:

FAAA 2017000105 TITLE: Laboratory Information Management System

SUBMIT INQUIRIES & SEALED PROPOSALS TO:

Colorado Department of Public Health and Environment (CDPHE) Procurement Office

4300 Cherry Creek Drive South Denver, CO 80246

Purchasing Agent: Sam Fuller

[email protected]

Submit one (1) Original, one (1) Electronic copy, one (1) Electronic (redacted) copy and Seven (7) Hard Copies.

OFFERORS CONTACT INFORMATION

COMPANY NAME: CONTACT:

STREET ADDRESS: PHONE:

CITY/STATE/ZIP: E-MAIL:

VC # (FROM CO VSS) FEIN:

DUNS # (IF APPLICABLE):

OFFEROR’S AUTHORIZED SIGNATURE

AUTHORIZED SIGNATURE:

PRINTED NAME: TITLE:


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IMPORTANT

The following information must be on the OUTSIDE of the sealed RFP response:

RFP Number and RFP Submission Deadline

RETURN COMPLETED SIGNATURE PAGE WITH YOUR RESPONSE


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SCHEDULEOFACTIVITIES

ACTIVITY DATE/TIME (MTN TIME)

RFP Notice Published on VSS

As posted on VSS

(www.gssa.state.co.us/vensols)

Prospective Offerors Written Inquiry Deadline

(No questions accepted after this date/time; e-mail preferred)

11/28/16 11:00 A.M.

Responses to Written Inquiries Published on VSS 1 12/1/16

Bid Submission Deadline As posted on VSS as applicable

(www.gssa.state.co.us/vensols)

Oral Presentations/Best and Final Offers 1,2 Optional and to be determined

Initial Contract Period 1,2 [Date of Contract Execution

thru[June 30, 2017]

The resulting contract may be renewed for Four (4) additional years, up to a five (5) year total contract term at the sole discretion of the State.

Footnotes

1 Estimated

2 Initial contract term and option years will be at the discretion of the State in any combination thereof.

1. ADMINISTRATIVEINFORMATION

1.1 ISSUINGOFFICEThis Request for Proposals (RFP) is issued by the State of Colorado, Department of Public Health and

Environment (CDPHE), Procurement Office, for the benefit of the State of Colorado (State). The CDPHE


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Procurement Office and Purchasing Agent listed on the Request for Proposals Signature Page is the sole point of

contact concerning this RFP. All communication must be done through the CDPHE Procurement Office.

1.2 BIDINFORMATIONANDDISTRIBUTIONSYSTEM(VSS)ANDVSSREGISTRATIONThis solicitation is published using the Colorado Bid Information and Distribution System (VSS). Offerors must be

registered on VSS in order to download solicitation documents and information and to be considered responsive

at the time of proposal submission. VSS and its registration information may be accessed through the State

Purchasing Office website at http://www.gssa.state.co.us/VenSols.

1.3 MODIFICATIONORADDENDUMTOREQUESTFORPROPOSALSIn the event it becomes necessary to revise any part of this RFP, a modification/addendum will be published on

the VSS web page at www.gssa.state.co.us/VenSols. It is incumbent upon Offerors to carefully and regularly

monitor VSS for any such postings.

1.4 INVITATIONTOSUBMITPROPOSALSCDPHE is posting this RFP on VSS so that Offerors who have an interest may submit a proposal in accordance

with terms of this RFP. Please read and be aware of the administrative information attached to this RFP.

1.5 PURPOSEThis RFP provides prospective Offerors with sufficient information to enable them to prepare and submit

proposals for consideration to satisfy the need for expert assistance in the completion of the scope of this RFP.

1.6 SCOPEThis RFP contains the instructions governing the proposal to be submitted and the material to be included

therein; mandatory requirements must be met to be eligible for consideration.

1.7 STRUCTUREOFTHISREQUESTFORPROPOSALSThe State of Colorado Solicitation Instructions and Terms and Conditions linked through the VSS Solicitation

Page govern, except as modified or supplemented in these instructions.

1.8 OFFICIALMEANSOFCOMMUNICATIONDuring the solicitation process, for this RFP, all official communication will be via notices on VSS. Notices may

include any modifications to administrative or performance requirements, answers to inquiries received,

clarifications to requirements, and the announcement of the awarded Offeror(s). It is incumbent upon Offeror to

carefully and regularly monitor VSS for any such notices.

1.9 INQUIRIESUnless otherwise noted, prospective Offerors may make written or electronic mail inquiries concerning this RFP

to obtain clarification of requirements. E‐mail is the only method for Offerors to submit inquiries. No inquiries

will be accepted after the date indicated in the Schedule of Activities section of this RFP.


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Inquiries shall be made to the sole point of contact as listed on the Request for Proposals Signature Page.

Clearly identify your inquiries by referencing the RFP number. Where appropriate include references to RFP

section, paragraph and or question numbers; using page numbers as references is problematic because not all

printers number the pages consistently.

Response(s) to Offerors' inquiries (if required) will be published as a modification(s) on the VSS system in a

timely manner. Offeror should not rely on any other statements, either written or oral, that alter any

specification or other term or condition of this RFP. Offerors are responsible for monitoring VSS for publication

of modifications to this solicitation.

1.10 OFFERORREGISTRATION

1.10.1 VSSREGISTRATIONOfferor registration (VSS Registration) MUST be current at the time and date of the Bid Submission Deadline,

specific to this RFP, and as noted on the VSS webpage. Offeror registration status is based on the Offerors’

Federal Employer Tax ID Number (FEIN), as provided by the Offeror, on the Request for Proposals Signature

Page. This FEIN shall be the number used to determine if or if not an Offeror is registered. Only registered

Offerors will be considered. Offerors shall be registered in accordance with the Vendor Identification section of

this RFP.

1.10.2 REGISTRATIONTOCONDUCTBUSINESSINCOLORADOAfter award and before Contract execution the successful Offeror must be registered to do business in the State

of Colorado. This registration is maintained through the Colorado Secretary of State Office.

(http://www.sos.state.co.us/ ) If Offeror is a foreign corporation (formed under a statute or common law in a

jurisdiction other than Colorado) or other foreign entity transacting business in the State of Colorado, shall

warrant that it currently has obtained and shall maintain any applicable certificate of authority to transact

business in the State of Colorado and has designated a registered agent in Colorado to accept service of process

1.11 VENDORIDENTIFICATIONThe tax identification number provided must be that of the Offeror responding to the RFP. Offeror must be a

legal entity with the legal right to contract in the State of Colorado and shall be the entity that is used to

determine Offeror registration status.

1.12 PARENTCOMPANYIf an Offeror is owned or controlled by a parent company, the name, main office address and parent company’s

tax identification number shall be provided in the proposal.

1.13 MODIFICATIONORWITHDRAWALOFPROPOSALSProposals may be modified or withdrawn by the Offeror prior to the established due date and time.

1.14 NEWSRELEASES


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News releases or contact with media representatives pertaining to this RFP or concerning any Offeror’s proposal

shall NOT be made prior to execution of the contract without prior written approval by the State.

1.15 CERTIFICATIONOFINDEPENDENTPRICEDETERMINATION1.15.1 BY SUBMISSION OF A PROPOSAL EACH OFFEROR CERTIFIES, AND IN THE CASE OF A JOINT

PROPOSAL EACH PARTY THERETO CERTIFIES, AS TO ITS OWN ORGANIZATION, THAT INCONNECTIONWITHTHISPROCUREMENT:

(a) The prices in the proposal have been arrived at independently, without

consultation, communication, or agreement, for the purpose of restricting

competition, as to any matter relating to such prices with any other Offeror or

with any competitor, other than a joint Offeror;

(b) Unless otherwise required by law, the prices which have been quoted in the

proposal have not been knowingly disclosed by the Offeror and will not

knowingly be disclosed by the Offeror prior to opening, directly or indirectly to

any other Offeror or to any competitor; and

(c) No attempt has been made or will be made by the Offeror to induce any other

person or firm to submit or not to submit a proposal for the purpose of

restricting competition.

1.15.2 EACH PERSON SIGNING THEREQUEST FOR PROPOSALS SIGNATURE PAGE OF THE PROPOSALCERTIFIESTHAT:

(a) She/he is the person in the Offeror's organization responsible within that

organization for the decision as to the prices being offered herein and that

she/he has not participated, and will not participate, in any action contrary to

(1.16.1)(a) through (1.16.1)(c) above; or

(b) She/he is not the person in the Offeror's organization responsible within that

organization for the decision as to the prices being offered herein but that

she/he has been authorized in writing to act as agent for the person(s)

responsible for such decision in certifying that such persons have not

participated, and will not participate, in any action contrary to (1.16.1)(a)

through (1)(c) above, and as their agent does hereby so certify; and she/he has

not participated, and will not participate, in any action contrary to (1.16.1)(a)

through (1.16.1)(c) above.

1.15.3 APROPOSALWILLNOTBECONSIDEREDFORAWARD:

Where (1.15.1)(a), (1.15.1)(c), or (1.15.2) above has been deleted or modified. Where

(1.15.1)(b) above has been deleted or modified, the proposal will not be considered for award

unless the Offeror furnishes with the proposal a signed statement which sets forth in detail the


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circumstances of the disclosure and the head of the agency, or her/his designee, determines

that such disclosure was not made for the purpose of restricting competition.

1.16 PROPRIETARY/CONFIDENTIALINFORMATIONAny restrictions on the use or inspection of material contained within the proposal shall be clearly stated in the

proposal itself; written requests for confidentiality shall be submitted by the Offeror with its proposal. The

Offeror must state specifically what elements of the proposal are to be considered confidential/proprietary.

Confidential/Proprietary information must be readily identified, marked and separated/packaged from the rest

of the proposal. Co‐mingling of confidential/proprietary and other information is not acceptable. Neither a

proposal, in its entirety, nor proposal price and/or rate information will be considered confidential and

proprietary. Any information that will be included in any resulting contract cannot be considered confidential.

The Colorado Department of Public Health and Environment, Procurement Director and or delegate will make a

written determination as to the apparent validity of any written request for confidentiality. In the event CDPHE

does not concur with the Offeror’s request for confidentiality, a written determination will be sent to the

Offeror. If the request is denied, the Offeror will have an opportunity to withdraw its entire proposal, or remove

the confidential and or proprietary restrictions. Ref. Section 24‐72‐200.1 et. seq., Colorado Revised Statutes

(C.R.S.) as amended, the Colorado Open Records Act (CORA).

1.17 RFPRESPONSEMATERIALOWNERSHIPAll material submitted regarding this RFP becomes the property of the State of Colorado. As such, the State of

Colorado may retain or dispose of all copies as is lawfully deemed appropriate. Proposals may be reviewed by

any person after the "Notice of Intent to Make an Award" letter has been issued, subject to the terms of C.R.S.

Title 24, Article 72, Part 2 as amended. The State of Colorado has the right to use any or all

information/material presented in reply to the RFP, subject to limitations outlined in Section 1.17 ‐

Proprietary/Confidential Information. Offeror expressly agrees that the State of Colorado may use the materials

for all lawful State purposes, including the right to reproduce copies of the material submitted for purposes of

evaluation, and to make the information available to the public in accordance with the provisions of CORA.

1.18 ACCEPTANCEOFRFPTERMSA proposal submitted in response to this RFP shall constitute a binding offer. Acknowledgment of this condition

shall be indicated by the autographic signature of the Offeror or an officer of the Offeror, legally authorized to

execute contractual obligations. It is assumed by the Offeror's response that it acknowledges all terms and

conditions of this invitation for an offer. An Offeror shall identify clearly and thoroughly any variations between

its proposal and the State's RFP. Failure to do so shall be deemed a waiver of any rights to subsequently modify

the terms of performance, except as outlined or specified in the RFP.

1.19 PROPOSALCONTENTACCEPTANCEThe contents of the proposal (including persons specified) of the successful Offeror will become contractual

obligations of the Offeror if a contract ensues. Failure of the successful Offeror to accept these obligations in a


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resulting contract may result in cancellation of the award and such Offeror may be removed from future

solicitations.

1.20 CONTRACTUALOBLIGATIONSOFRFPDOCUMENTSThe contents of the proposal and the terms of this RFP will become contractual obligations of the successful

Offeror(s). This RFP consists of all documents listed under the Table of Contents and are hereby referenced and

incorporated herein. “The State of Colorado Solicitation Instructions and Terms and Conditions” linked to the

VSS Notice on the website govern, except as modified or supplemented within the RFP. The final contract shall

provide the order of precedence of all related documents, in the following order: Colorado Special Provisions,

contract, exhibits, RFP and Offeror’s response.

In responding to this RFP, Offerors agreeing to abide by the requirements of this RFP are also agreeing to abide

by all terms and conditions contained herein, so Offerors should identify or seek to clarify any problems with

contract language or any other document contained within this RFP packet through their written inquiries about

the RFP or within their proposal. Any proposed changes or objections to the contract language or other

documents must be submitted as a part of the Offeror’s proposal. Each change or exception shall be presented

in the form of proposed alternative or substitute language. General objections, to be negotiated subsequent to

the award, will not be accepted. Exceptions to the State of Colorado Special Provisions, attached to the contract,

will not be accepted. Failure of the successful Offeror(s) to accept these obligations may result in cancellation of

the award.

1.21 CONTRACTExcept as modified herein, the Model Contract included in this RFP shall govern this procurement and is hereby

incorporated by reference.

1.22 LEGISLATIVECHANGESThe State of Colorado reserves the right to amend the contract in response to legislative changes.

1.23 ORDEROFPRECEDENCEIn the event of any conflict or inconsistency between terms of this RFP and the Offeror’s proposal, such conflict

or inconsistency shall be resolved, first, by giving effect to the Colorado Special Provisions, contract, exhibits,

RFP, Offeror’s response.

1.24 VENUEThe parties agree that venue for any action related to performance of the contract shall be in the City and

County of Denver, Colorado.

1.25 STATEWIDECONTRACTMANAGEMENTSYSTEM(CMS) For all contracts resulting from this solicitation, Contractor agrees to be governed, and to abide, by the

provisions of CRS §24‐102‐205, §24‐102‐206, §24‐103‐601, §24‐103.5‐101 and §24‐105‐102 concerning the


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monitoring of vendor performance on state contracts and inclusion of contract performance information in a

statewide contract management system.

CDPHE shall evaluate, review and rate Contractor’s performance for all contracts resulting from this solicitation

for any contracted amount.

1.26 OFFERORPROPOSEDTERMSANDCONDITIONSExcept as specified in the Offeror’s proposal, the submission of the Offeror’s proposal will indicate its

acceptance of the terms and conditions of this RFP. Offerors must disclose in their proposals terms and

conditions or required clarifications of terms and conditions consistent with these instructions. The State

reserves the right to clarify terms and conditions not having an appreciable effect on quality, price/cost risk or

delivery schedule during post‐award formalization of the contract.

1.27 STATEOWNERSHIPOFCONTRACTPRODUCTSAll products produced in response to the contract resulting from this RFP will be the sole property of the State of

Colorado. Any exceptions must be outlined in detail. Exceptions may serve as cause for rejection of the proposal.

1.28 PROPOSALPRICINGEstimated proposal prices are not acceptable. Offers submitted must include all related costs (e.g. surcharges,

travel, etc.). Any costs not included as part of the offer will be disallowed. Pricing must be in U.S. funds. Best

and final offers may be considered in determining the successful Offeror. Proposals shall be firm for a period of

not less than one hundred eighty (180) calendar days from date of award.

1.29 CONTRACTTERMThis RFP may result in a multiple year contract(s); estimated term stated in the Schedule of Activities. The initial

contract(s) will be effective upon approval by the State Controller or designee. The term of the awarded

contract shall be upon completion of the fully executed contract, with the option to cancel, at the sole discretion

of the State, contingent upon contractual requirements being satisfied and funds, being appropriated, budgeted,

and otherwise made available, or for any other reason for up to five years. The contract performance

contemplated herein shall commence as upon the effective date of the resulting contract(s) and shall be

undertaken and performed in the sequence and manner set forth therein.

1.30 LATEPROPOSALSLate proposals will not be accepted. It is the sole responsibility of the Offeror to ensure that their proposal

arrives in the designated office prior to the date and time as specified on VSS.

1.31 REJECTIONOFPROPOSALSCDPHE reserves the right to reject any or all proposals, to waive informalities and minor irregularities in

proposals received, and to accept any portion of a proposal or all items proposed if deemed in the best interest

of the State.


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1.32 ESTIMATEDQUANTITIESQuantities where provided are estimates only, no volumes can be guaranteed.

1.33 NUMBEROFAWARDSThe State intends to award one or more awards/contracts as a result of this RFP.

1.34 AGREEMENTEXECUTIONAn awarded Offeror shall have no longer than thirty (30) calendar days to enter into a contract after being

notified by the State. If this date is not met, the State may elect to cancel the award and award the selection to

the next most successful Offeror(s) if the delay is not the fault of the State.

1.35 PREPERFORMANCEMEETINGUpon execution of the contract(s), an CDPHE Contract Administrator shall conduct a review of the contract

requirements with key personnel of the State and Awarded Offeror(s). The purpose of the meeting is for all

working parties to gain a better knowledge of contract requirements, have questions answered, and conduct a

needs assessment so that transition to performance will commence timely and smoothly.

1.36 INCURRINGCOSTSThe State of Colorado is not liable for any costs incurred by Offerors prior to issuance of a legally executed

contract. No property interest of any nature shall accrue until a contract is awarded and signed by all concerned

parties and approved by the State Controller.

1.37 TAXESThe State of Colorado, as purchaser, is exempt from all federal excise taxes under Chapter 32 of the Internal

Revenue Code (Registration No. 84‐730123K) and from all state and local government use taxes C.R.S. 39‐26‐

114(a). The State’s Colorado State and Local Sales Tax Exemption Number is 98‐02565. Offerors are hereby

notified that when materials are purchased in certain political sub‐divisions (for example, City and County of

Denver) the seller of such materials may be required to pay sales tax even though the ultimate product or

service is provided to the State. This sales tax will not be reimbursed by the State.

1.38 INSURANCEThe Awarded Offeror(s) shall obtain, and maintain at all times during the term of the contract, insurance in the

kinds and amounts outlined in the linked VSS State of Colorado Solicitation Instructions/Terms and Conditions

and the attached Model Contract.

1.39 CYBERSECURITYThe awarded Offeror(s) are required by CDPHE to comply with the State of Colorado Cyber Security Policies:

www.colorado.gov/cs/Satellite/Cyber/CISO/1167928186414. All responses to this solicitation will be evaluated,

in part, according the Offerors agreement with the Cyber Security Policies.


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In addition, awarded Offeror(s) will be required to meet all the security requirements in the attached model

contract. Indicate your acceptance of these requirements.

1.40 TELEGRAPHIC/ELECTRONICRESPONSESTelegraphic or electronic bids (Fax, Western Union, Telex, e‐mail, etc.) cannot be accepted as a sealed proposal.

Offerors are urged to read the solicitation document thoroughly before submitting a proposal.

1.41 ADMINISTRATIVEREVIEWFACTORS–PASS/FAILOfferors must demonstrate in writing their ability and willingness to comply with the mandatory minimum

requirements found in Section 3 ‐ Proposal Requirements of this RFP, as applicable, to be considered responsive

to this RFP. These items are judged on a pass or fail basis and must be satisfied in their entirety in order for the

Offeror’s response to be considered for further review by the Evaluation Committee.

1.42 COOPERATIVEPURCHASINGIn order to address the requirements of and as part of the Department of public Health and Environment

(CDPHE) effort to address the requirements of 24‐37.5‐106(1)(h), this solicitation and the resulting contract(s)

shall be a cooperative purchasing agreement, pursuant to 24‐110‐101 et seq. All Executive Branch state

agencies are included in this solicitation and any resulting contract. Legislative and Judicial Branch agencies,

institutions of Higher Education, and local governments may participate. CDPHE will be the primary state party

to the contract, pursuant to 24‐37.5‐105(3)(i).

1.43 RFPCANCELLATIONThe State reserves the right to cancel this entire RFP or individual phases at any time, without penalty.

1.44 PROTESTEDSOLICITATIONSANDAWARDSAny actual or prospective Offeror who is aggrieved in connection with the solicitation or award of a contract

may protest to the Department of public Health and Environment (CDPHE), Procurement Director, 4300 Cherry

Creek Drive South, Denver, CO 80246. The protest must be submitted in writing within seven (7) working days

after such aggrieved person knows, or should have known, of the facts giving rise thereto. Reference C.R.S.,

Title 24, Article 109.

1.45 AUDITThe States reserves the right to require that the successful Offeror(s) has a process audit conducted of its

program at least once every three (3) years. If the successful Offeror(s) has not had such an audit prior to

awarding of this contract, and the State requires one, then an audit must begin within six months of the award

of this contract. The State reserves the right to approve the selected firm. A complete copy of the audit must

be provided to the Governor’s Office of Information Technology within five (5) working days of its completion.

The Governor’s Office of Information Technology will negotiate directly with the successful Offeror(s) regarding

any exceptions or findings from the audit.


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1.46 ORGANIZATIONALCONFLICTOFINTEREST—REQUIREMENTSOFTHISSOLICITATIONANDSUBSEQUENTCONTRACT

Any business entity or person is prohibited from being awarded a contract if the business entity or person has an

“Organizational Conflict of Interest” with regard to this solicitation and the resulting contract.

No person or business entity who was engaged by the State to prepare the original RFP or has access prior to the

solicitation to sensitive information related to this procurement process, (including, but not limited to

requirements, statements of work, or evaluation criteria), will be eligible to directly or indirectly submit or

participate, directly or indirectly in the submission of a proposal for this solicitation. The State considers such

engagement or access to be an Organizational Conflict of Interest, which would cause such business entity or

person to have an unfair competitive advantage.

If the State determines that an Organizational Conflict of Interest exists, the State, at its discretion, may cancel

the contract award. In the event the successful Offeror was aware of an Organizational Conflict of Interest prior

to the award of the contract and did not disclose the conflict to the procuring agency, the State may terminate

the contract for default. The provisions of this clause must be included in all subcontracts for work to be

performed by subcontractors in connection with the performance of the contract, with the terms “contract,”

“contractor,” and “contracting officer” modified appropriately to preserve the State’s rights.

ADDITIONAL CONTRACT REQUIREMENTS

1.47 LIQUIDATEDDAMAGESIn the event the Contractor is given notice of a delay or nonperformance and fails to cure in the time specified,

in addition to any other damages that are applicable, the Contractor shall be liable for $500 per calendar day

from the date set for cure until either the State reasonably obtains similar goods or services if the Contractor is

terminated for default, or until the Contractor provides the goods or services if the Contractor is not terminated

for default. The parties agree that damages from such delay or non‐performance are difficult to prove or

estimate, and the amount of liquidated damages specified herein represents a reasonable estimation of

damages that will be suffered by the State from such breach, including costs of additional inspection and

oversight, and lost opportunity for additional efficiencies that would have attended on‐time completion of

performance. The assessment of liquidated damages shall not be exclusive or in any way limit remedies

available to the State at law or equity for the Contractor’s breach.

1.48 INTELLECTUALPROPERTYESCROWWithin thirty days of the Effective Date, the Contractor agrees to deposit the software, documentation, and/or

other related material(s) with a third‐party software escrow agent for the term of this contract, including any

extensions. Software is the source code accompanied by a running object code version submitted on a virus‐

free magnetic or optical media, compiled and ready to be read by a computer. Documentation is all materials

sufficient for a trained computer programmer of general proficiency to maintain and support the software

without further assistance from the Contractor. The Contractor shall also have a continuing obligation to


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deposit any maintenance modifications, updates, upgrades, new releases, or documentation related to the

deposited materials for the term of this contract, including any extensions.

The Contractor agrees to enter into an agreement with the escrow agent which will instruct the escrow agent to

cause delivery of the software, documentation, and all other related materials in its possession to the State if

any one of the following events occurs:

1.48.1 Contractor agrees in writing to the delivery;

1.48.2 Contractor ceases to do business and no successor shall have agreed to assume the Contractor’s

obligations to the State;

1.48.3 Contractor has failed to support the software or has otherwise defaulted under this contract; or,

1.48.4 Contractor files for liquidation under the U.S. Bankruptcy Code, or files for reorganization under

the U.S. Bankruptcy Code and does not remain debtor in possession.

The Contractor shall grant the appropriate licensee rights to the escrow agent to allow the agent to exercise its

rights under this contract.

The Contractor agrees that if the escrow agent delivers the software to the State, the State shall have the same

license and rights to use the software, documentation, and other related materials as the State had under the

original contract, including the right to utilize the source code and create updates and derivative works

consistent with the purposes of this Contract.

All costs and fees associated with the escrow agreement and this clause shall be the responsibility of the

Contractor. Contractor shall forward a copy of the escrow agreement to the State within ten days of execution

of the escrow agreement.

2. INTRODUCTION

The Laboratory Services Division (LSD) within the Colorado Department of Public Health and Environment

(CDPHE) is seeking proposals from qualified Offerors to provide a Laboratory Information Management System

(LIMS). The Laboratory Services Division is seeking to replace a server‐based Laboratory Information Tracking

System by implementing a web‐based LIMS which would provide automated support to the laboratory and

business processes, and promote improvements to program efficiency, effectiveness, data quality and security.

The implementation of a new system builds on the department’s (CDPHE) objective to get quality data into the

CDPHE Data Repository and to the Centers for Disease Control (CDC). The Division will consider both on‐site and

hosted solutions. The core business processes any system should support include but are not limited to:

1. Data entry


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2. Data access

3. Billing

4. Communication and data support for responses to external customers

5. Analysis and reporting of program data

6. Electronic Laboratory Results (ELR)

After execution of a State Contract, CDPHE requires Offerors to provide a warranty period of at least 1 year after

acceptance of the application software and reporting system. After the initial warranty period, the State may, at

the its sole discretion, opt to extend the State Contract for maintenance and support of the application software

and reporting system in one‐year increments. The total Contract term, including any subsequent annual

maintenance periods, shall not exceed five years.

The Department’s budget for this project is $600,000 ‐ 800,000. This amount includes the cost of all necessary

hardware, software, services to fulfill the requirements of this contract and maintenance support and services

cost for 1 year after implementation. The Offeror shall propose annual maintenance, service and support costs

for the remaining 4 years of the contract.

Offerors should carefully review this RFP and all attachments for defects, incongruities, questionable or

objectionable material. If such items are identified, it is the responsibility of the Offeror to submit a question to

CDPHE Purchasing Office. All questions must be in writing, submitted to the email address of the Purchasing

Agent as noted in the Proposals Signature Page and cite the RFP number, section number and page number. The

Procurement Officer must receive these written questions or requests by the deadline specified in the RFP

Schedule of Activities to allow issuance of any necessary amendments. CDPHE will disallow any protests based

on the content of the solicitation if the Offeror does not bring these objections to the attention of the

Procurement Officer, in writing, before the “Prospective Offeror’s Written Inquiries Deadline” as indicated in the

Schedule of Activities.

The Offeror’s proposal will be evaluated on fulfillment of the requirements included in this RFP, the cost

of the system (both implementation and annual costs), the Offeror’s acceptance of the State of Colorado’s terms

and conditions for this contract, and the Offeror’s expertise in Laboratory Management Systems. CDPHE has

appointed a committee to evaluate the proposals received.

3. OVERVIEWThis project requires purchasing Laboratory Information Management System (LIMS) software, which includes

the maintenance support from an outside vendor. CDPHE will accept offers for both vendor‐hosted and state‐

hosted systems. Offerors shall provide up time documentation and line redundancy requirements. Those


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offering either system architectures should present data for both solutions. The system can be a commercial

off‐the‐shelf system (COTS) which shall include the following mandatory outcomes:

3.1 HIPAA compliant (including any supporting documentation)

3.2 Meets the ISO 17025 accreditation standard (include supporting documents)

3.3 Electronic billing capabilities and must interface with the Colorado Operations Resource Engine

(CORE) which is the State accounting system

3.4 Ability to have data flow electronically for test requisitions and/or requests

3.4.1 Create bi‐directional test ordering and reporting with external stakeholder LIMS systems

3.4.2 Supply a web‐based portal for data exchange

3.5 Ability to electronically interface with laboratory instrumentation as listed in Appendix 7.1

3.5.1 Direct uploading of laboratory result and quality control (QC) data from laboratory

instruments replacing manual entry, staff created excel macros, and paper records.

3.6 Provide sample workflow management

3.7 Data intelligence analysis functionality to include metric functionality

3.7.1 Expanded query capabilities and ability to create standardized reports, provide data

trending and tracking of specific metrics with statistical analysis of routine data

collection and control charts.

4. GLOSSARYAPHL: Association of Public Health Laboratories.

ARRA: The American Recovery and Reinvestment Act of 2009 (Public Law 111‐5, enacted February 17, 2009),

this is also known as is the federal stimulus package.

Awarded Offeror: The submitter whose proposal is the most closely aligned with the requirements that are set

forth in this Request for Proposals, and is the awarded the contract. Also known as the Selected Offeror.

VSS: The State of Colorado's Bid Information and Distribution System Web site, located at:

https://www.gssa.state.co.us/VenSols. All solicitations published by State agencies and institutions are

published on VSS. All bidders or Offerors wishing to respond to a solicitation (including this RFP) must be

registered with VSS.

CDC: U.S. Center for Disease Control and Prevention


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CDPHE: Colorado Department of Public Health and Environment.

CLIA: Clinical Laboratory Improvement Amendments

Contractor: The Offeror that is awarded a contract as a result of this RFP. This is also referred to as the "Selected

Offeror," and "Successful Offeror."

C.R.S.: Colorado Revised Statutes.

EPA: U.S. Environmental Protection Agency

External Customers: Entities submitting samples to LSD for testing, including the general public, hospitals, local

health departments, regulatory agencies, etc.

FDA: U.S. Food and Drug Administration

Governing Agencies: CLIA, CDC, FDA, ISO 17025, FDA, Homeland Security, EPA

Homeland Security: U.S. Department of Homeland Security

HIPAA: Health Insurance Portability and Accountability Act

ISO 17025: International Standards Organization laboratory standard

Internal System Administrator: An LSD employee who will serve as the point of contact and system

administrator. This LSD employee will grant user permissions, configure LIMS parameters, coordinate system

updates and repairs, and generally manage the system for LSD.

LIMS: Laboratory Information Management System

LSD: Laboratory Services Division, a division within CDPHE.

Offeror: Any organization or individual submitting a proposal in response to an RFP. Sometimes used

interchangeably with the term "Bidder vendor or contractor."

OIT: Colorado Governor’s Office of Information Technology.

Proposal: An offer in response to a Request for Proposals (RFP). Sometimes used interchangeably with the terms

"bid," "offer," or "response."

QA: Quality Assurance

QC: Quality Control

QA/QC: Quality Assurance and Quality Control


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RFP: Request for Proposals. A procurement solicitation that seeks offers from organizations or individuals to

perform the scope of work as defined in the RFP and in accordance with the terms listed in the RFP. An RFP is

issued with the intent of selecting the most advantageous proposal, making an award to that Offeror, and

entering into a contract.

Solicitation: A document issued by a prospective buyer that requests competitive offers from organizations or

individuals to sell the goods or services that are specified in the document. A solicitation typically results in an

award of a contract or purchase order for the goods or services, based on an award methodology defined in the

solicitation. Types of solicitations issued by State of Colorado agencies include: Requests for Proposals (RFPs),

Successful Offeror: Same as "Selected Offeror."

Timeline: A document that details dates and targets for achieving program goals or requirements.

Users: CDPHE employees with access to the LIMS system.

Vendor: Any organization or individual that seeks to provide, or is already providing, goods or services. Often

synonymous with “selected, successful, or awarded Offeror”.

5. PROPOSALREQUIREMENTSANDSCOPEOFWORK‐LIMSREQUIREMENTS

5.1 GENERALREQUIREMENTSMandatoryRequirements:

5.1.1 LIMS shall provide a vendor supported, web‐browser based solution.

5.1.2 LIMS shall be HIPAA compliant (provide documentation of how the system meets these

requirements).

5.1.3 LIMS shall meet the ISO 17025 laboratory standard (provide documentation of how the system

meets these standards).

PreferredRequirements

5.1.4 CDPHE prefers the system to implement a consistent look‐and‐feel, including cognitive

ergonomics, workflow progression and complexity in order to minimize training and maximize

intuitive user interaction. 5.1.5 CDPHE prefers a system which can integrate with Google Drive which functionalities such as

creating reports in Google Docs, exporting query information tables to Google Sheets, and


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associating data entry fields with fields in Google Forms for user‐created customizable data

entry forms.

5.2 LOCALSYSTEMADMINISTRATION

MandatoryRequirements

5.2.1 LIMS shall allow a local system administrator to make minor changes to the system variables.

5.2.2 LIMS shall allow the system administrator to have the ability to control user/group access to

data.

5.2.3 LIMS shall allow the system administrator to create, delete, modify, and group tests and data

fields to the system.

5.2.4 The LIMS shall allow the system administrator to add, delete and modify parameters of

configured data and testing fields.

5.2.5 LIMS shall allow the system administrator to configure all business rules for functionality

described.

5.2.6 LIMS shall allow the system administrator to configure business rules to facilitate sample

workflow.

5.2.7 LIMS shall allow the system administrator to access and administer the database supporting the

LIMS.

Preferred Requirements

5.2.8 CDPHE prefers the system to will provide access on the database level to administrative

users. This includes the ability to execute SQL queries on the data.

5.3 PERMISSIONSANDSECURITYMandatoryRequirements

5.3.1 LIMS shall have an organizational structure to include the standard CRUD (Create, Read, Update

and Delete) permissions available with exclusions available on an individual basis.

5.3.2 LIMS shall have role based permissions for both individuals and groups.

5.3.3 LIMS audit information shall include:

5.3.3.1 the name of the individual that made the change;

5.3.3.2 date/time changed,

5.3.3.3 original value/report,

5.3.3.4 new value/report,

5.3.3.5 reason the data was changed.

5.3.3.6 allow for supervisor approval if required either by the type of edit or by the

role of the user.

5.3.4 LIMS shall have a system for supervisory data review and approval of all analytical results.

5.3.5 LIMS shall have queried data captured in data access logs.


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5.3.6 LIMS shall have a role based security organizational structure with editable permissions in

compliance with all federal, local, and state regulations and standards.

5.3.7 LIMS data shall be encrypted at rest.


5.3.8 CDPHE prefers users to be able to be included within multiple configurable groups.

5.3.9 CDPHE prefers the system to be configured and maintained by the internal system administrator

for the purpose of assigning specific permissions to data.

5.3.10 CDPHE prefers the local administrator will have the ability to reset or access user accounts.

5.4 DATAACCESSFOROTHERDIVISIONSWITHINCDPHEPreferredRequirements

5.4.1 CDPHE prefers the system allows read only access to other divisions within CDPHE.

5.4.2 CDPHE prefers the system data viewing and export by read only users is captured in the record

log.

5.5 WEBINTERFACEGENERALREQUIREMENTSMandatoryRequirements

5.5.1 LIMS web interface shall allow for external customers to create accounts, order sample

collection supplies, order laboratory testing, enter sample data, and to view and print laboratory

results.

5.5.2 LIMS the web interface shall not to be limited by number of customers and be specific for use by

external customers.

5.5.3 LIMS customer web interface shall utilizes an https protocol.


5.5.4 CDPHE prefers the system to be configurable by LSD’s internal system administrator to allow for

additional testing, or sample types, to be added to the web interface.

5.5.5 CDPHE prefers the web interface to be a portable electronic device compatible format.

5.5.6 CDPHE prefers any links for laboratory customer support within the web interface to integrate

directly into CDPHE LSD’s web page.

5.6 WEBCUSTOMERACCOUNTSMandatoryRequirements

5.6.1 Customers shall be able to create a secure web interface customer account and password that

satisfies OIT security policies.



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5.6.2 CDPHE prefers the web interface customers have the ability to recover their username and to

reset their password through an automated feature.

5.6.3 CDPHE prefers web interface customers are able to manage and update their account

information.

5.6.4 CDPHE prefers web interface accounts include necessary information to bill the customer and

identify the type of institution they represent. Profile will include but not be limited to name,

address, city, state, zip, phone number, email address, fax number and contact name.

5.6.5 CDPHE prefers the web interface to directly interface with the State of Colorado’s CORE

customer payment portal.

5.6.6 CDPHE prefers the web interface to manage a customer’s permission to order specified lab

supplies or testing.

5.7 WEBCUSTOMERINTERFACEPreferredRequirements

5.7.1 CDPHE prefers web interface customers to browse laboratory testing information such as fees,

sample requirements and expected turnaround times.

5.7.2 CDPHE prefers the system’s web interface include a search function to locate appropriate

content within the site.

5.7.3 CDPHE prefers the web interface direct customers to appropriate testing information using

configurable business rules which will provide them with all the necessary information to

correctly order services.

5.7.4 CDPHE prefers the web interface contain detailed descriptions of laboratory tests, testing

criteria, sample types, collection criteria, testing cost, and sample supplies determined by the

internal system administrator.

5.7.5 CDPHE prefers the web interface direct customers to testing criteria from a directory of sample

types or laboratory tests located on centralized pages.

5.8 WEBCUSTOMERSUPPLYORDERINGPreferredRequirements

5.8.1 CDPHE prefers external customers are able to order approved sample collection supplies

through the web environment.

5.8.2 CDPHE prefers the system generate external identification numbers, distinct from internal

identification numbers, and associate these numbers with the customer account for the purpose

of providing identification numbers for sample submission.

5.8.3 CDPHE prefers the web interface to allow testing supply ordering using a “shopping cart” style

interface.

5.8.4 CDPHE prefers the internal LIMS administrator will have the ability to assign the cost of supplies

to individual customers, overriding the default supply costs.


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5.8.5 CDPHE prefers notification to be provided to specific internal users through the LIMS system

when supplies are ordered through the web interface.

5.8.6 CDPHE prefers the system‘s web interface to update the customer’s account with supply order

information.

5.8.7 CDPHE prefers the web interface to allow external ID numbers to be created and printed as bar

codes prior to shipment from the laboratory.

5.8.8 CDPHE prefers the web interface to maintain a record of sample collection supplies ordered by

customers and reconcile when appropriate samples associate with these supplies are received

back at LSD.

5.8.9 CDPHE prefers the web interface to maintain a list of outstanding supplies ordered by the

customer but not recovered by LSD.

5.8.10 CDPHE prefers the web interface to provide the customer with order updates such as shipping

date‐times, description of supplies shipped, external supply ID numbers and tracking numbers.

5.9 WEBCUSTOMERSAMPLEDATAENTRYMandatoryRequirements

5.9.1 LIMS shall allow the web environment provide an interface to allow the customer to order

laboratory testing and enter sample data.


5.9.2 CDPHE prefers the web interface to environment be logically arranged and facilitate the

customer to correctly enter sample data.

5.9.3 CDPHE prefers the web interface to link the customer data entry page with sample and testing

descriptions for customers to determine which test is appropriate.

5.9.4 CDPHE prefers the web interface to have configurable business rules that only allow selection of

testing methods that are appropriate for a given specimen type.

5.9.5 CDPHE prefers the web interface to allow the customer to see the cost of testing before

entering data based on the number of samples and testing methods selected.

5.9.6 CDPHE prefers the web interface to maintain a history of user account supply and test orders to

provide the ability to select these criteria for new orders.

5.9.7 CDPHE prefers the web interface to differentiate between samples that require the use of

supplies ordered through LSD and samples that do not.

5.9.8 CDPHE prefers the web interface to allow customers to print sample labels and barcodes.

5.9.9 CDPHE prefers the web interface to include configurable business rules to direct the customer to

enter appropriate and necessary sample data when ordering testing.

5.9.10 CDPHE prefers the web interface business rules to be configurable by the internal system

administrator.

5.9.11 CDPHE prefers the web interface give customers the opportunity to review data before

submission.


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5.9.12 CDPHE prefers the web interface upload completed sample data to the LIMS system in a

pending receipt status.

5.9.13 CDPHE prefers the web interface allow sample requisition forms to be printed directly from the

interface with the external ID and entered any pre‐populated data into the forms.

5.9.14 CDPHE prefers the web interface allow customers to upload a testing schedule to automatically

request supplies and testing when needed.

5.9.15 CDPHE prefers the web interface allow for export of non‐sensitive environmental results data in

.CSV format.

5.10 WEB CUSTOMERRESULTSMandatoryRequirements

5.10.1 LIMS shall allow lab customers to easily view and print laboratory testing results.


5.10.2 CDPHE prefers the web interface allow the customer to see the testing status of submitted

samples and filter by testing status.

5.10.3 CDPHE prefers the web interface present customers with a list of available results.

5.10.4 CDPHE prefers the web interface allow customers to view and print laboratory results in .PDF

format.

5.10.5 CDPHE prefers the results are available through the web interface for a limited time period to be

set by the internal system administrator.

5.10.6 CDPHE prefers the web interface provide a link from the web interface to the State of

Colorado’s CORE webpage for customer payment.

5.10.7 CDPHE prefers the web interface have the ability to associate their web interface Customer ID

with their CORE customer ID.

5.11 ELECTRONICMESSAGINGMandatoryRequirements

5.11.1 LIMS shall incorporate a configurable integration engine capable of interpreting and producing

HL7 messages in XML format for the purpose of creating and reporting test information.

5.11.2 LIMS integration engine shall meet HL7 2.5 messaging standards or above.

5.11.3 LIMS integration shall allow CDPHE staff with limited technical expertise to configure manage

and maintain message profiles.

5.11.4 LIMS shall allow electronic messages to be configurable to include sample metadata, test

interpretation, QA/QC data, and technician comments.


5.11.5 CDPHE prefers the integration engine be capable of configuring messages other than HL7 format

such as APHL’s environmental messaging or ASCII.


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5.11.6 CDPHE prefers assistance in configuring HL7 messaging for CDC’s LIMSi and PHLIP messaging

programs.

5.11.7 CDPHE prefers electronic messages are configurable to be sent to multiple recipients.

5.11.8 CDPHE prefers electronic messaging is configurable to automatically be sent when results are

approved.

5.12 COMMUNICATIONWITHOTHERLIMSSYSTEMSPreferredRequirements

5.12.1 CDPHE prefers the Vendor assist in configuring receipt of HL7 messaging from Perkin Elmer’s

“SpecimenGate” software for billing interface purposes.

5.13 GENERALINVENTORYPreferredRequirements

5.13.1 CDPHE prefers the system includes a reagent and equipment inventory to comply with LSD’s QA

and QC policies.

5.13.2 CDPHE prefers inventory interface captures reagent information such as, but not limited to;

5.13.2.1 receive date,

5.13.2.2 manufacturer's,

5.13.2.3 description,

5.13.2.4 manufacturer lot number,

5.13.2.5 expiration dates,

5.13.2.6 quantity received,

5.13.2.7 storage requirements

5.13.2.8 open date.

5.13.3 CDPHE prefers inventory interface create internal reagent tracking number.

5.13.4 CDPHE prefers inventory interface creates and manages barcodes for reagent tracking.

5.13.5 CDPHE prefers inventory interface captures users associated with opening, receiving and

creating reagents.

5.13.6 CDPHE prefers inventory interface provides access to the MSDS of chemicals and reagents.

5.13.7 CDPHE prefers inventory interface manages chemicals and reagent inventory including tracking

volumes, storage conditions, location and disposal.

5.13.8 CDPHE prefers inventory interface allows the creation of internal “kit” lot numbers for similar

reagents or when a reagent, such as microbial culture media, is made from a combination of

reagents.

5.13.8.1 CDPHE prefers internal lot numbers associate the information for the

individual components with new internal lot and also capture information

about the creation of the lot such as the user creating the lot, creation date,

expiration date, and any additional QA/QC information.

5.13.9 CDPHE prefers the inventory interface provides alerts when;


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5.13.9.1 reagents are scheduled to expire,

5.13.9.2 a configurable amount of items on hand is reached in the inventory

5.13.9.3 when instruments require scheduled service

5.13.10 CDPHE prefers the system prohibit the use of expired reagents except with user comment.

5.13.11 CDPHE prefers the inventory interface track the use of reagents for the purpose of determining

how many samples are tested per unit, how long a unit is in use, to determine cost metrics.

5.13.12 CDPHE prefers the inventory interface allow .PDF files of reagent and equipment information to

be attached to the inventory record.

5.13.13 CDPHE prefers the inventory interface assigns individual instruments internal asset control

numbers.

5.13.14 CDPHE prefers the inventory interface;

5.13.14.1 maintain a record of equipment locations

5.13.14.2 creates and prints barcodes for each piece of equipment inventoried

5.13.14.3 maintain equipment information such as, but not limited to,

5.13.14.3.1 manufacturer,

5.13.14.3.2 model number,

5.13.14.3.3 serial number,

5.13.14.3.4 State of CO capital inventory number,

5.13.14.3.5 laboratory ID number,

5.13.14.3.6 in service and retirement dates

5.13.14.4 manage equipment maintenance records including instrument service

schedules.

5.13.14.5 allow the exchange of information between users regarding reagents and

instrumentation.

5.14 SUPPLYINVENTORYPreferredRequirements

5.14.1 CDPHE prefers the inventory interface captures the receive date, lot number, and quantity of

supplies received.

5.14.2 CDPHE prefers the inventory interface maintain the quantity of supplies in inventory as

configured by the local administrator.

5.14.3 CDPHE prefers the inventory interface maintain a record of users removing supplies from

inventory into service.

5.14.4 CDPHE prefers the inventory interface allow users to order supplies from another user for the

purpose of creating supply orders and deliveries.

5.14.5 CDPHE prefers the functionality to track use of supplies by users.

5.15 SAMPLEINVENTORYPreferredRequirements


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5.15.1 CDPHE prefers the inventory interface;

5.15.1.1 create and prints barcodes for primary sample containers, secondary

sample containers, refrigerator/freezer and room for tracking

5.15.1.2 track the location of sample during storage

5.15.1.3 track the length of time a sample has been stored

5.15.1.4 track the temperature at which a sample is stored

5.15.1.5 manage sample destruction schedules based on its contents, testing

method and sample type

5.15.1.6 manages sample storage based on sample status including transfer of

samples from short term to long term storage

5.15.1.7 provide sample destruction lists based on storage dates and retention

schedules

5.15.1.8 maintain destruction dates of samples

5.15.1.9 be capable of tracking user detailed end‐to‐end chain of custody of secure

samples

5.15.1.10 tracks sample volumes

5.15.1.11 provide search features to find samples based on data and testing fields

from within the LIMS system

5.15.1.12 track the storage of testing controls and standards

5.15.1.13 flag samples and remove them from the sample retention schedule if

necessary.

5.15.1.14 directs the user to the location of a sample when moving it to storage based

on testing and sample type

INTERNALCOMMUNICATION

5.16 NOTIFICATIONSPreferredRequirements

5.16.1 CDPHE prefers the ability;

5.16.1.1 to configure groups and sub‐groups of users in order to distribute

notifications

5.16.1.2 to include within multiple groups for receiving notifications

5.16.1.3 to create notifications when sample data and testing field requirements are

met or changed.

5.16.1.4 to select samples, reagents or equipment and distribute notifications to

other users or user groups.

5.16.1.5 configurable notifications every time the status changes for a designated

sample.


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5.16.1.6 to notify users when sample data from designated samples or testing

methods are received electronically.

5.16.1.7 to create notifications with acknowledgement and response.

5.16.1.8 to retain notifications for a configurable length of time.

5.17 DASHBOARDSPreferredRequirements

5.17.1 CDPHE prefers the system provides dashboards;

5.17.1.1 displays summaries of samples currently in process and in configurable time

periods

5.17.1.2 are accessible within the LIMS

5.17.1.3 are accessible by both individual users and user groups, for example by

laboratory, section, supervisory level and any other appropriate personnel.

5.17.1.4 are configurable by the users with permissions and display data fields,

testing fields, sample status and results

5.17.1.5 are updated in real time

5.17.1.6 are configurable on a summary level to show data such as, number of

samples testing requested, data and test field criteria, and status

5.17.1.7 are interactive allowing access directly to dashboards on the sample level

5.17.1.8 are configurable to create and distribute to notification to users within the

LIMS system when samples are added

5.17.1.9 are configurable to be displayed on remote monitors

5.17.2 Examples of desired Dashboards include:

5.17.2.1 Pre‐receipt status: A dashboard for users to view samples which data has

been received electronically but the sample is in transit to the lab and

information such as the number of samples to be received, the submitter,

sample type and testing requested

5.17.2.2 Data entry Request status: A dashboard for data entry users to view

samples received at the lab requiring data entry, display parameters

captured at the time of receipt.

5.17.2.3 Samples Pending Testing: A dashboard for laboratory users to view samples

have been received and data entry complete and display the number of

samples pending configurable by data and testing fields

5.17.2.4 Review Pending: Dashboards that display samples which testing has been

completed by testing method.

5.17.2.5 Workload: A dashboard that displays all tests within a timeframe, the

number of samples for that test, and broken down by status.

5.18 GENERALDATAENTRYANDSAMPLERECONCILIATION


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5.18.1 LIMS shall provide an easily usable interface for LSD staff to reconcile samples as they are

received and enter necessary identifying sample information.

5.18.2 LIMS shall utilize bar coding for reconciling samples as they are received.

5.18.3 LIMS shall provide the capability for the user to manually enter sample data into the system

with minimal effort as well as populate incoming sample information with any information

received electronically.

5.19 RECEIPTOFELECTRONICALLYORDEREDSAMPLESMandatoryRequirements

5.19.1 LIMS shall provide an interface to rapidly reconcile samples as they are received with any data

electronically submitted and verify the information received with the sample.

5.19.2 LIMS shall allow the user to enter additional information regarding the sample at the time of

receipt including but not exclusive to condition of the sample, time of receipt and the delivering

agency.

5.19.3 LIMS shall allow configurable business rules to require notation any time specified information is

missing, out of date or out of specified ranges before internal COC is initiated.

5.19.4 LIMS shall generate a unique internal identification number once the user acknowledges the

validity and receipt of the sample.

5.19.5 LIMS shall allow configurable business rules to identify received samples that require further

data entry and limit sample workflow until required information is recorded.


5.19.6 CDPHE prefers the system provide an interface allowing samples to be directly identified with

external sample ID numbers generated and received from the submitting agency or the web

interface by scanning standardized bar codes or manually entering the ID number.

5.19.7 CDPHE prefers minimal data entry to create the internal ID number to create internal and begin

maintaining COC.

5.19.8 CDPHE prefers the system provide a screen displaying any pre‐populated sample information

when a sample is received and reconciled.

5.19.9 CDPHE prefers the system allows business rules to be configured to identify mandatory

information for sample receipt and data entry.

5.19.10 CDPHE prefers the system creates an electronic record of receipt by the user to begin the

internal chain of custody.

5.19.11 CDPHE prefers the system allows configurable business rules to require notation any time

specified information is missing, out of date or out of specified ranges before internal COC is

initiated.


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5.19.12 CDPHE prefers the system allow the user receiving the satisfactory samples to create an internal

ID number, capture required sample receipt information such as temperature, date‐time, and

delivery information, and print barcodes of the internal ID number to label the paperwork

received and the sample the minimal amount of mouse clicks necessary.

5.19.13 CDPHE prefers the system accept data from other electronic devices such as infrared

thermometers, submitter mobile devices and recognize standard information formats such as

date time, latitude and longitude, and addresses to populate their corresponding data fields.

5.19.14 CDPHE prefers the system assign received samples to the appropriate laboratory based on

sample type and testing method requested.

5.19.15 CDPHE prefers the system notifies designated users of samples flagged for incomplete data.

5.19.16 CDPHE prefers the system inform the submitter of unsatisfactory samples through electronic

messaging.

5.20 DATAENTRYINTERFACEMandatoryRequirements

5.20.1 LIMS data entry user interface shall be intuitive and designed to minimize data entry user error.


5.20.2 CDPHE prefers the system allow users to open samples in the data entry interface by choosing

an active link in a sample receipt queue, scanning a barcode, or entering the internal ID number.

5.20.3 CDPHE prefers the system provide configurable business rules to limit data to be entered into

proper fields based on a cascading format beginning with sample type or testing section. For

example, if a sample type is entered for an environmental sample or environmental sample

type, it shall exclude entering data exclusive for clinical samples as well as prohibit ordering tests

specific for clinical samples.

5.20.4 CDPHE prefers the system allow configured business rules to be overridden by permitted user

after acknowledgement and comment.

5.20.5 CDPHE prefers the internal system administrator is able to make changes to the general layout

and content of the data entry interface.

5.21 BATCHENTRYOFDATAANDTESTINGCODESMandatoryRequirements

5.21.1 LIMS shall provide a means to enter data for multiple samples of similar type and testing

method simultaneously.


5.21.2 CDPHE prefers the system allow permitted users to configure spreadsheet‐style tables of

specific data fields to be edited.

5.21.3 CDPHE prefers the system allow users to query samples by configurable rules to populate tables

for data entry.


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5.21.4 CDPHE prefers tables can be utilized to add testing codes to multiple samples simultaneously.

5.22 LABELPRINTINGANDBARCODINGMandatoryRequirements

5.22.1 LIMS shall have a barcode system to track samples (location and analyst’s custody) within the

building from arrival to disposal or storage.

5.22.2 LIMS shall accept all standard barcode fonts, including 2D barcodes, and generate barcode

labels representing laboratory and field sample identification numbers.


5.22.3 CDPHE prefers the system prints labels for samples and paperwork.

5.22.4 CDPHE prefers the system label printing formats are configurable by the internal system

administrator.

5.22.5 CDPHE prefers the system labels are printed using both standard printers as well as label specific

printer

5.22.6 CDPHE prefers Users can choose the quantity of labels to be printed.

5.22.7 CDPHE prefers labels can be printed from the sample receiving and data entry interfaces the

minimal amount of mouse clicks necessary.

5.23 SAMPLEIDNUMBERSPreferredRequirements

5.23.1 CDPHE prefers Internal ID numbers;

5.23.1.1 are configurable

5.23.1.2 are created in numerical order in a format that represent the year which the

number is assigned.

5.23.1.3 are retained for the life of the specimen and never duplicated.

5.23.1.4 link parent specimens with aliquots, split specimens and any other sub

sample.

5.23.1.5 CDPHE prefers the system generate unique, configurable field sample

identification numbers, separate from the internal identification number.

5.25 SUBMITTERINFORMATIONMandatoryRequirements

5.24.1 LIMS shall maintain a list of LSD’s customers and include functionalities to assure its accuracy.


5.24.2 CDPHE prefers the system identifies and updates customer information on file if discrepant with

information received electronically.


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5.24.3 CDPHE prefers changes to customer information are tracked and viewable by designated users

for verification purposes.

5.24.4 CDPHE prefers customer information can be quickly searched during data entry.

5.25 DATAFIELDSPreferredRequirements

5.25.1 CDPHE prefers the system utilizes flexible formats that are able to be controlled by designated

users.

5.25.2 CDPHE prefers the system data fields are configurable in numerous formats including, but not

limited to, date‐time, free text, and pick lists, and multiple choice check lists.

5.25.3 CDPHE prefers permitted users are able to;

5.25.3.1 add,

5.25.3.2 delete,

5.25.3.3 hide,

5.25.3.4 activate and inactivate data entry fields.

5.25.4 CDPHE prefers the system auto fills text fields with data previously associated with that field.

5.25.5 CDPHE prefers the system limits dates to only be entered for ranges set by the internal system

administrator.

5.25.6 CDPHE prefers the system compares data fields following configurable rules and auto‐populate

additional fields with their results.

5.25.7 CDPHE prefers the system utilizes configured data entry fields to link specimens together for the

purpose of creating patient test lists, patient sample lists, for linking sample in related outbreak

investigations, or for research studies.

5.25.8 CDPHE prefers the system includes a free text comments field traceable to the user for the

purpose of recording any information about the sample that is not easily described by the other

data fields such as sample quality and phone records.

5.25.9 CDPHE prefers the system allow attachments of files such as .PDF, .JPG, .PNG, .TIFF, .CSV,

Microsoft office files, to internal ID numbers of specimens

5.25.10 CDPHE prefers RUSH/ STAT samples can easily be designated and tracked.

5.25.11 CDPHE prefers data fields can be linked with list either created within the LIMS system or

imported from external sources.

5.25.12 CDPHE prefers data field can be configured to recognize and associate designated formats with

specific submitters, sample types, or testing methods.

5.26 STATUSFIELDSMandatoryRequirements

5.26.1 LIMS shall be time stamped with a user and date‐time in the audit log.



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5.26.2 CDPHE prefers status fields are required to track samples though laboratory processing for COC

or communication purposes.

5.26.3 CDPHE prefers the system automatically updates when the associated data or testing field

changes or is added.

5.26.4 CDPHE prefers changes to status fields are capable of being updated.

5.26.5 CDPHE prefers status fields are visible to users based on permissions.

5.26.6 CDPHE prefers status fields are independently associated with a data and testing fields or groups

of testing or data fields.

5.26.7 CDPHE prefers the system allows for configurable business rules that may trigger functions

within the LIMS system, such reporting, reflex testing, notifications or dashboard when updates

occur to sample status fields.

5.27 TESTINGCODESPreferredRequirements

5.29.1 CDPHE prefers the system allows testing codes to be configured for the purpose of

standardization and continuity to mimic the testing algorithms of LSD.

5.27.2 CDPHE prefers individual testing codes as well as testing code groups can be assigned to

samples, sub‐samples and sample aliquots.

5.27.2 CDPHE prefers testing codes groups are associated with a group status field that automatically

updates as tests within the group are updated.

5.27.3 CDPHE prefers testing codes are added to samples based on configurable rules to the possible

testing codes only to those applicable to the sample.

5.27.4 CDPHE prefers the system adds testing codes with one mouse click if the testing criteria limit the

potential tests on a sample to 1 possible selection.

5.27.5 CDPHE prefers the system allows addition of testing codes that do not meet configured business

rules only after acknowledgment and comment by the user.

5.27.6 CDPHE prefers designated users must have the ability to delete tests from a sample without

deleting the sample from the LIMS entirely.

5.27.7 CDPHE prefers testing codes have both a numeric code and descriptive element.

5.27.8 CDPHE prefers testing reflexive testing is configurable based on business rules.

5.28 DATAENTRYQCPreferredRequirements

5.28.1 CDPHE prefers the system provides the ability to, but not require, double data entry by separate

users for the purposes of quality control assessment.

5.28.2 CDPHE prefers the system provides a report assessing the double data entry process.

5.29 ASSIGNMENTOFSAMPLESTOLABORATORIESANDSTAFFMandatoryRequirements


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5.29.1 LIMS shall maintain records of sample workflow from receipt to reporting and storage by

associating users, date‐times and locations every time a sample is updated, transferred or

archived.

5.29.2 LIMS shall manage laboratory workflow by associating specified users with testing, tasks, and

date ranges with samples.

5.29.2.1 Automatic sample assignment shall be able to be overwritten.

5.29.3 LIMS shall calculate appropriate sample hold times using configurable sample criteria such as

sample collection date‐time, receive date‐time, test method and temperature and notify users if

the sample is out of compliance based on assigned, configurable time values.

5.29.4 LIMS shall follow the progress of samples, sub‐samples and aliquots throughout the analytical

process and capture data such as user and date‐time at information processing points such as

ETOR, sample receipt, work‐list generation. data input, direct notation, results review and

reporting.

5.29.5 LIMS shall allow sample workflow data to be permanently stored and associated with the

sample.


5.29.6 CDPHE prefers the system allows, but not requires, samples to be assigned to specific

laboratories and users.

5.29.7 CDPHE prefers users are notified when samples are assigned to a specific laboratory or users.

5.30 SENDOUTREQUESTSPreferredRequirements

5.30.1 CDPHE prefers the system to allow configurable business rules to distinguish between samples

analyzed in‐house versus those submitted to third party laboratories and track them separately.

5.30.2 CDPHE prefers the system to identify testing methods performed by third party laboratories and

automatically label samples as send‐outs when these methods are ordered.

5.31 LABORATORYDATAENTRYMandatoryRequirements

5.31.1 LIMS shall create the data entry interface to allow the user to enter individual samples basis as

well as batches of samples being processed together.


5.31.2 CDPHE prefers the system is able to integrate with the workflow of the laboratories it is

employed in.

5.31.3 CDPHE prefers the system to populate sample data from multiple sources including but not

limited to, data electronically uploaded from instruments, manually entered, or uploaded from

secondary analysis macros.


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5.31.4 LIMS prefers to allow configuration of reflex testing to secondary testing methods based on

sample test data.

5.31.5 CDPHE prefers the system provides a means of noting communications between users and

customers, such as phone conversations.

5.32 SAMPLEWORKSHEETSANDWORKLISTSPreferredRequirements

5.32.1 CDPHE prefers the system to group samples into work lists, preparation batches, and QC

batches by user definable selection criteria such as sample number, client, project, test, method,

department for the purpose of sample identification and capturing QA/QC data during the

testing process

5.32.2 CDPHE prefers sample worksheets (e.g., clinical, zoonotic, environmental) display the individual

sample data necessary to make appropriate decisions regarding testing, sample identification,

sample quality, and sample QA.

5.32.3 CDPHE prefers individual sample worksheet templates are configurable to capture test

information from elaborate testing schemes (e.g. microbial biochemical identification).

5.32.4 CDPHE prefers worksheets and work lists are;

5.32.4.1 available in both printable and electronic formats

5.32.4.2 capture sample QA/QC

5.32.4.3 testing information

5.32.4.4 capable of recording qualitative and quantitative testing results

5.32.4.5 capable of recording test interpretations

5.32.4.6 are sharable for use by users without configuration permissions

5.32.4.7 associated with tests or test groups to automatically generate when the

user chooses to begin testing the samples

5.32.4.8 include free text notation fields for technician comments as needed

5.32.4.9 include free text fields to capture user notation about sample condition and

testing.

5.32.5 CDPHE prefers QA fields captured in sample worksheets and work lists include but are not

limited to, lot numbers, expiration of reagents used, equipment used, location of lab

workstation used for sample processing.

5.32.6 CDPHE prefers QC information captured in sample worksheets and work lists include, but not

limited to, quantitative and qualitative values associated with testing results.

5.32.7 CDPHE prefers work lists and worksheets capture user information at multiple stages of the

testing process as configured by the internal system administrator.

5.32.8 CDPHE prefers QA/QC data fields captured within sample worksheets and work list are

configurable to limit data to only valid inventory lots numbers.

5.33 INSTRUMENTATIONINTERFACE


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5.33.1 LIMS shall allow sample testing results and QC information be directly uploaded from laboratory

instruments into associated data fields in the LIMS system (see Appendix A for Instrument List)

5.33.2 The vendor shall provide a list of instruments currently capable of being interfaced with the

system and a plan for addition of instruments to this list

5.33.3 The vendor shall provide the estimated cost of integrating future instruments into the system.


5.33.4 CDPHE prefers sample testing information can be directly downloaded into laboratory

instruments from the LIMS.

5.33.5 CDPHE prefers the system enables the creation of macros for analysis of instrument data.

5.33.6 CDPHE prefers testing parameters are configurable for individual instruments for data

interpretation.

5.33.7 CDPHE prefers instrument operation is not affected in the case of LIMS operations failure.

5.33.8 CDPHE prefers templates of sample information be downloadable from the LIMS directly into

the instrument interface.

5.33.9 CDPHE prefers LIMS provides remote access to instrument data.

5.34 ELECTRONICLABORATORYNOTEBOOKSPreferredRequirements

5.34.1 CDPHE prefers the system captures sample information on portable electronic devices, e.g. an

electronic laboratory notebook.

5.34.2 CDPHE prefers the system interface with portable electronic devices, such as tablets, through a

secure wireless network

5.34.3 CDPHE prefers portable electronic devices capture all testing data on worksheets and work lists

and update the LIMS in real time.

5.34.4 CDPHE prefers portable electronic devices create sample work lists by scanning barcode IDs of

samples.

5.34.5 CDPHE prefers portable electronic devices capture QA data by scanning barcodes of equipment

and reagents associated with the testing performed.

5.34.6 CDPHE prefers portable electronic devices can automatically calculate sample testing metrics.

5.35 MANUALDATAENTRYPreferredRequirements

5.35.1 CDPHE prefers the system to provide the ability to cut and paste data between fields.

5.35.2 CDPHE prefers the system upload data from secondary analysis program or macros.

5.35.3 CDPHE prefers the system allow sample data to be uploaded in the LIMS in standard formats

such as .CSV files.


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5.35.4 CDPHE prefers the system provide users an interface to easily select files and associate data

within the files with LIMS data fields for data upload.

5.35.5 CDPHE prefers the system allow permitted users to configure spreadsheet‐style data entry

tables for entering data from multiple samples of the same sample type and testing format

concurrently.

5.35.6 CDPHE prefers configured data entry tables to be sharable with other users

5.36 DATAREVIEW,INTERPRETATIONANDSAMPLERESULTINGMandatoryRequirements

5.36.1 LIMS shall have a configurable interface to compare sample test data (including data uploaded

from instrumentation) to test control data, sample testing batch statistics, or predetermined

values or ranges, and notify the user if the comparisons yield results outside of configured value,

range, or statistic specifications.


5.36.1 CDPHE prefers sample data review and result entry to be in the least number of steps, easily‐

accessed process that occurs in a format that is easily followed to the user.

5.36.2 CDPHE prefers the LIMS interface allows users to view sample data, verify data accuracy, update

sample status, enter comments and enter sample result conclusions on one screen.

5.36.3 CDPHE prefers the results entry interface to be configured for both individual and multiple

sample formats.

5.36.4 CDPHE prefers the system to automatically update sample status and result date fields as testing

results are entered.

5.36.5 CDPHE prefers the system to provide an easy, intuitive way for users to select standardized

interpretations for sample testing results.

5.36.6 CDPHE prefers the system to save and update sample information within 5 seconds of the user

saving the sample record. Provide any network requirements to meet this specification.

5.36.7 CDPHE prefers the system to automatically attach prepared messages based on testing methods

and results.

5.37 SECONDARYREVIEWOFLABORATORYTESTRESULTSPreferredRequirements

5.37.1 CDPHE prefers the system to allow attachment of reports received from secondary testing

laboratories to the sample information in .PDF format.

5.38 TESTRESULTSREVIEWMandatoryRequirements

5.38.1 LIMS shall automatically flag samples where QA or QC is out of user configured specifications.

5.38.2 LIMS shall provide easy access to all captured sample QC and primary data.


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5.38.3 LIMS shall allow those specimens requiring a multi‐test group algorithm to show the individual

testing methods completed and the testing algorithm interpretation.

5.38.4 LIMS shall require secondary review of sample data before reports can be released.

5.38.5 LIMS shall provide an interface to manage and streamline the results review process.


5.38.6 CDPHE prefers the test results review include;

5.38.6.1 approval of QA and QC for reagents and instrumentation,

5.38.6.2 Review of both raw data and interpretations of sample results, and

technician credentials,

5.38.6.3 the ability to prioritize review based on critical testing result values which

can be configured by the user,

5.38.6.4 the ability to track technicians performing each step in sample testing

process,

5.38.6.5 Worksheet style interface for viewing data and batch approval of test

results,

5.38.6.6 batch approval of testing results with a “select all” option,

5.38.6.7 automatically update status field and collect approval times,

5.38.6.8 notify configured reviewers when results are pending review.

5.40 REPORTINGMandatoryRequirements

5.40.1 LIMS shall provide a user friendly interface to manually generate, print and electronically send

reports.

5.40.2 LIMS shall report formats shall be configurable by permitted users.

5.40.3 LIMS reports shall be created in .PDF format and be exportable.


5.40.4 CDPHE prefers the system;

5.40.4.1 configurable to automatically report specimens once final review has been

completed,

5.40.4.2 have an auto‐reporting function which can be manually overridden at time

of approval,

5.40.4.3 configurable to report individual tests within a group or only when all tests

within a group are completed,

5.40.4.4 configurable to fax reports, including cover sheets,

5.40.4.5 to be configurable to email of reports though CDPHE encrypted email,

5.40.4.6 configurable to be exported in configurable .XLSX and .CSV files,

5.40.4.7 automatically release reports after approval to the web interface for

customers to access through their accounts,


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5.40.4.8 color code quantitative results based on configured data values for easy

interpretation by the customer,

5.40.4.9 configurable to attach cover sheets and documents to reports send by any

messaging method other than direct electronic data transfer.

5.40.4.10 CDPHE prefers the method of test reporting be configurable based on

submitter, testing method requested, and sample type.

5.40.4.11 CDPHE prefers all data fields, testing fields, and QA/QC information

captured for a specimen be configurable in the report.

5.40.4.11 CDPHE prefers results sent for test completed by secondary laboratories to

be configurable to attach the primary lab report to the LSD report.

5.40.4.13 CDPHE prefers reports to be configurable to automatically upload to

specified Google Drive folders.

5.41 QUERIESMandatoryRequirements

5.41.1 LIMS shall provide a query function to retrieve sample information by;

5.41.1.1 work order,

5.41.1.2 sample number,

5.41.1.3 client,

5.41.1.4 analysis,

5.41.1.5 project test,

5.41.1.6 department,

5.41.1.7 date range,

5.41.1.8 site.

5.41.2 LIMS shall allow query parameters to be;

5.41.2.1 savable and deletable by the user

5.41.2.2 sharable between users.


5.41.3 CDPHE prefers query parameters to;

5.41.3.1 follow data accessibility permissions

5.41.3.2 be configurable as read only or read‐write access based on permissions

5.41.3.3 be flexible and ad hoc configurable

5.41.3.4 incorporate search engine capabilities for free text fields

5.41.3.5 utilize logical expressions (>, <, =, contains, and, or,)

5.41.3.6 be exportable in .XLSX and .CSV table formats

5.41.3.7 capable of selecting samples to generate reports

5.42BUSINESSINTELLIGENCE


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Mandatory Requirements

5.42.1 LIMS shall allow for 3rd party software to query (create “hooks” into) data.


5.42.2 CDPHE prefers a system that provides functionalities to track and analyze laboratory workload,

workflow and customers.

5.42.3 CDPHE prefers the system;

5.42.3.1 create statistics on laboratory business metrics,

5.42.3.2 presents business metrics in graphical formats for interpretation and

presentation,

5.42.3.3 track analyst and workgroup workloads,

5.42.3.4 provide real time reports of workloads by multiple categories including

testing method, sample type and customer,

5.42.3.5 provide analysis of reagent and supply usage,

5.42.3.6 provide customer analysis including submissions, sample types, testing

requests and turnaround time,

5.42.3.7 provide turnaround time analysis including by analyst, method, and sample

type,

5.42.3.8 provides analysis in available in real time,

5.42.3.9 include extensive analysis capabilities to include;

5.42.3.9.1 Query,

5.42.3.9.2 calculating,

5.42.3.9.3 summarizing capabilities,

5.42.3.9.4 ability to scan large amount of data to review trends, patterns

and correlations,

5.42.3.9.5 ability to display data in a visual and pictorial manner, Tabular

and/or detail data prefixed by column definition.

5.42.4 CDPHE prefers analyses are configurable for any given time frame.

5.43 QUALITYASSURANCEANDQUALITYCONTROLTRACKINGMandatoryRequirements

5.43.1 LIMS shall include QA/QC tracking functionality to assure compliance with regulatory and

governing agency standards.

5.43.2 LIMS shall allow the user to be able retrieve all data associated with a testing method, both

manually entered and directly uploaded from analytical instruments.


5.43.3 CDPHE prefers the system provide a means to validate and verify any calculations for

interpreting sample data and generating analytical results.

5.43.4 CDPHE prefers the system track and chart quality control data, including sample replicates,

matrix spikes, quality control check standards, recoveries, and blanks via control charting.


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5.434.5 CDPHE prefers QA control charts to be presented in tabular and graphical formats.

5.43.6 CDPHE prefers the system perform statistical analysis of QA/QC data to identify trends in sample

data.

5.43.7 CDPHE prefers control charts to be available to all query capabilities and limited based on

selective queries (e.g. turn‐around times, report approval times, analyst testing output, results,

QC data).

5.43.8 CDPHE prefers the system link all quality control data recorded for a sample testing work list to

individual sample records.

5.43.9 CDPHE prefers the system identify QC parameters for test results and identify samples not

within configured QC specifications.

5.43.10 CDPHE prefers QC specifications be configurable by the permitted user with notation.

5.43.11 CDPHE prefers user configured QC specifications have an approval mechanism with notation of

any updates/changes to quality control limits.

5.43.12 CDPHE prefers QC data points to be plotted automatically as defined by user.

5.43.13 CDPHE prefers QA data captured electronically by scanning barcodes associated equipment,

reagents, work benches, etc.

5.43.14 CDPHE prefers QA fields include lot numbers and expiration of reagents used, equipment used,

analyst, location of lab bench used.

5.43.15 CDPHE prefers users be required to enter configured QA/QC data when manually entering

results for specified testing methods.

5.43.16 CDPHE prefers a system include configurable QA/QC "checkpoints" requiring user or supervisory

approval before further analysis can be performed.

5.43.17 CDPHE prefers a system track analyst competency by testing method.

5.43.18 CDPHE prefers the system email reminders to analyst and supervisors when a user’s

competency is close to expiring.

5.44 RECORDSMANAGEMENTMandatoryRequirements

5.44.1 LIMS shall provide the capability to meet required retention schedules as determined by the

State’s governing bodies.

5.44.2 LIMS shall allow records retention schedules to be configurable by the local administrator.


5.44.3 CDPHE prefers the system to include the capability to destroy all laboratory data and associated

records based on the specified testing method and sample type.

5.44.4 CDPHE prefers the system monitor physical and electronic records (paper requisitions, paper

reports, instrument electronic data) stored onsite to track and assure of compliance with

destruction of all relevant sample data.

5.45 BILLING


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Mandatory Requirements

5.45.1 LIMS shall interface with CORE (Colorado Operations Resource Engine), the State’s accounting

system.

5.45.1.1 Create and upload a .xls file to an FTP site when new customers are added

or customer information changes

5.45.1.2 Generate a space delimited ASCII file with billing invoice information.

5.45.1.3 Upload and read an .xls file to update payment status information for

invoices

5.45.2 LIMS shall include an interface for;

5.45.2.1 tracking internal/external billing,

5.45.2.2 creating invoices,

5.45.2.3 billing detail,

5.45.2.4 accounting reports,

5.45.2.5 interface with CORE for tracking invoice payments.

PreferredRequirement

5.45.3 CDPHE prefers the system provide a means for documenting payment status for each sample;

5.45.3.1 testing method,

5.45.3.2 child sample,

5.45.3.3 sample aliquot with configurable payment status types including;

5.45.3.3.1 Paid,

5.45.3.3.2 Partial Paid,

5.45.3.3.3 Bill,

5.45.3.3.4 Grant,

5.45.3.3.5 General Fund,

5.45.3.3.6 No Charge,

5.45.3.3.7 Invoiced,

5.45.3.3.8 Paid Invoice,

5.45.3.3.9 Partial Paid Invoice

5.45.4 CDPHE prefers sample aliquots and child samples have a separate payment status than the

parent sample.

5.45.5 CDPHE prefers parent samples, child samples and sample aliquots pull separately on billing

detail reports.

5.45.6 CDPHE prefers billing queries are configurable to easily reconcile sample payment status.

5.45.7 CDPHE prefers billing queries are configurable to generate automatically on a regular schedule

or on demand.

5.45.8 CDPHE prefers the system be limited to 60 characters for Company/Customer name and allow

only 2 characters in the state field for customer address.

5.45.9 CDPHE prefers the system outputs customer billing address information in standard United

States Postal Service format for the purpose of generating labels, addressing letters, etc.


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5.45.10 CDPHE prefers new billable customers or billing address update automatically exports into a

scheduled .XLSX report that shall interface with CORE.

5.45.11 CDPHE prefers the system house a fee schedule and associate fees with specific test methods

for billing purposes.

5.45.12 CDPHE prefers testing is user configurable and able to be exported/ imported directly into LIMS

via Excel spreadsheet.

5.45.13 CDPHE prefers billing rates to be configurable for fee changes and based on customer type

(internal/external/grant/oral health).

5.45.14 CDPHE prefers the system be configurable to bill samples identified as “Rush” a separate rate

than non‐rushed samples with the same testing method.

5.45.15 CDPHE prefers billing accounting data is a summary of data; per customer, in a specified date

range, lab module, payment type and other identified criteria. The summary data includes the

customer billing information and the sum of all samples pulled in that billing report. This must

be an .ASCI file to interface with CORE and must correspond exactly with CORE interface schema

(example Attachment B)

5.45.16 CDPHE prefers LIMS to parse a space delimited .txt file to update customer billing information

from CORE into the LIMS.

5.45.17 CDPHE prefers billing detail consists of detailed sample backup; per customer, in a specified date

range, lab module, by payment type and other identified criteria.

5.45.18 CDPHE prefers billing detail reports shall be exportable to Microsoft Office.

5.45.19 CDPHE prefers the system creates customer invoices consisting of;

5.45.19.1 one face page remit information,

5.45.19.2 customer information,

5.45.19.3 a description of the invoice,

5.45.19.4 a sum of the billing cycle amount,

5.45.19.5 detailed sample backup for that billing cycle,

5.45.19.6 assign a unique invoice number to each invoice.

5.45.20 CDPHE prefers invoices encompass all modules in the LIMS so one customer that has samples in

3 modules receives one invoice with all 3 modules on the detailed backup even when the

modules have different revenue coding.

5.45.21 CDPHE prefers invoice and detailed backup documents are System Administrator or specified

user configurable.

5.45.22 CDPHE prefers the system retrieves customer address information and billing summary data

only from another LIMS, PerkinElmer “Specimen Gate”, for the creation of customer ID’s and

invoices but not detailed backup, and for interfacing summary data to CORE.

5.46 CHANGEMANAGEMENTANDIMPLEMENTATIONMandatory Requirements

5.46.1 Fulfillment of all requirements shall be documented and captured using a common

requirements development tool.


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Preferred Requirement

5.46.2 CDPHE prefers the contract define the tolerance of changes made during implementation within

and outside the scope of the contract and costs associated with these changes.

5.46.3 CDPHE prefers the vendor work along with LSD staff to jointly perform a workflow assessment

of current LSD processes and recommend how these processes can be improved and

incorporate the functionalities of the new LIMS system.

5.46.4 CDPHE prefers suggested changes to be included in the cost of implementations if they are

accepted by a predetermined implementation milestone.

5.46.5 CDPHE prefers to have the ability to initiate changes within the scope of implementation

without cost for at least 6 months after full implementation.

5.46.6 CDPHE prefers the vendor work along with LSD staff to jointly suggest the structure of LSD LIMS

implementation team.

5.46.7 CDPHE prefers the vendor state any requirements of LSD they feel necessary for successful

implementation such as physical space provided by LSD, equipment provided by LSD, estimated

LSD staff time required of the members of the implementation team, estimated staff time

required of the LSD project manager, or travel time of LSD staff,

5.46.8 CDPHE prefers the vendor provide at least one on‐boarding and one off‐boarding presentation

to all users.

5.46.9 CDPHE prefers the vendor state the requirements of IT support staff for successful

implementation of the system including time and access to CDPHE servers, time necessary for

installation on local user PC’s, access privileges necessary for implementation, troubleshooting

time of OIT staff, and training time of IT support staff.

5.47 MAINTENANCEANDSUPPORTMandatory Requirements

5.47.1 The Offeror’s proposal shall include system upgrades to maintain compatibility with hardware

and software standards including operating systems, PC and server configurations in yearly

maintenance costs.

5.47.2 The Offeror’s proposal shall provide support for troubleshooting outside the scope and

capabilities of the internal system administrator.

5.47.3 The Offeror’s proposal shall identify, list and provide estimated costs for any routine

configurations or changes that will require vendor support such as business rules configuration,

user administration, electronic message configuration (uni‐and bi‐directional), instrument

integration, test administration, inventory configuration, web interface administration,

customer administration or billing configuration.

5.47.4 The Offeror’s proposal shall provide a Service Level Agreement identifying the response times,

and latency time frames along with the turnaround times and escalation standards.

5.47.5 The Offeror’s proposal shall provide cost estimates associated with on‐site customer service.


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5.47.6 The Offeror’s proposal shall provide CDPHE with a maintenance schedule. This maintenance

schedule must be approved by CDPHE.

5.47.7 The Offeror’s proposal shall notify CDPHE immediately of any necessary, unscheduled

maintenance.

5.48 TECHNICALREQUIREMENTSMandatory Requirements

5.48.1 LIMS shall have a reliability requirement of 99.9% on a 24×7 basis excluding CDPHE network

downtime.

5.48.2 LIMS shall provide specifications for all equipment, hardware and software required in the

system architecture, including end user devices.

5.48.3 LIMS shall comply with State of Colorado IT security standards. The system must comply with

the following security standards as well as future revisions to them:

5.48.3.1 NIST 800‐122 ‐ Guide to Protecting the Confidentiality of Personally

Identifiable Information (PII)

5.48.3.2 NIST 800‐95 ‐ Guide to Secure Web Services

5.48.3.3 NIST 800‐53 ‐ Recommended Security Controls for Federal Information

Systems and Organizations

5.48.3.4 The Open Web Application Security Project (OWASP) Development Guide

5.48.3.5 Microsoft Security Development Life‐cycle (SDL)

5.48.3.6 CIS Security Benchmarks

5.48.4 LIMS shall be scalable and expandable. Specifically, the system shall be able to support a

performance of 20 concurrent transactions with no greater than a 5 second response time

and/or 5 second transaction time, to create, query, update and delete customer record. These

performance constraints include only system processing time, not human‐computer interaction

time manipulating the user interface. A description of each system component configuration

and its ability to meet the availability and performance specifications shall be provided.

5.48.5 LIMS vendor shall provide a description of the backup, recovery, and disaster recovery (including

identifying diminished capacity under disaster) operational characteristics. At minimum, a

recommendation for backup and disaster recovery (DR) shall be provided, with more mature

planning including identification of diminished capacity under DR condition and instructions

detailing paths to full operation.

5.48.6 Offeror’s proposal shall identify the bandwidth needs identifying:

5.49.6.1 Average and service spikes

5.49.6.2 Latency issues

5.48.7 Offeror’s proposal shall provide an architectural overview detailing the necessary components

of the system, from critical to periphery; with third‐party components demarked and identified.

Any proposed architecture shall include a previous experience reference and performance

characteristics (target and present day, if available).

5.48.8 Offeror’s proposal shall provide Network Diagrams presenting the appropriate;


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5.48.8.1 Vendor hosted solution

5.48.8.2 State of Colorado hosted solution

5.48.9 LIMS shall present an adaptable solution utilizing extensible architecture for future expansion

and scalability without the need for architectural modifications.

5.48.10 LIMS shall provide a means for users to recall or reset their password using techniques including:

5.48.10.1 Forgot My Password techniques.

5.48.10.2 Challenge questions and answers established during user setup.

5.48.10.3 If the user successfully answers the challenge question, provide a temporary

complex password and require a new user password upon successful

session sign‐on.

5.48.10.4 Ability for the service desk or authorized designee to reset a password if

necessary.

5.48.11 LIMS shall provide a response plan for a security breach in either application code or hosted

environment, and shall integrate with applicable state‐operated facilities, datacenter or security

policies.

5.48.12 LIMS shall make the use of encryption for all transmissions between servers, and servers and

clients.

5.48.13 LIMS shall provide a test environment for changes testing modifications before they are

implanted into production.

6. PROPOSALREQUIREMENTSThe following sections provide the Offeror with a general overview of the requirements contained

within this RFP. Additional requirement information is contained in the attached appendices.

6.1 TechnicalRequirements–ProjectManagementandDeliverablesThe Offeror shall provide a PMP certified Project Manager, a project collaboration site, and at a minimum the following deliverables:

6.1.1 Kick‐off meeting,

6.1.2 Weekly Status Reporting,

6.1.3 Project Plan,

6.1.4 Project Schedule,

6.1.5 Implementation Plan,

6.1.6 Requirements Traceability Matrix,

6.1.7 Functional Specifications Document,

6.1.8 Technical Specifications Document,

6.1.9 Change Management Plan,

6.1.10 Business Continuity / Disaster Recovery Plan,

6.1.11 Testing Plan and Scripts,

6.1.12 Training Plan,


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6.1.13 Contract Transition Plan,

6.1.14 System Security Plan,

6.1.15 System Operations and Interface Plan,

6.1.16 Administrative Functions Manual (User Manual),

6.1.17 Reports Manual,

6.1.18 Readiness for UAT Memorandum,

6.1.19 Readiness for Pilot Memorandum, and

6.1.20 Readiness for Implementation Memorandum.

6.2 CostProposals

6.2.1 Prices shall remain firm through the initial term of the Contract. The Contractor may seek a

price increase, not to exceed 3% of the then current price, in any succeeding period, by

submitting detailed written justification to the State, pursuant to the “Notices and

Representatives” section of the Contract which is attached as Attachment A.

6.2.2 Only one increase shall be allowed in any twelve‐month period of the Contract. All requests for

increase must be submitted no less than sixty (60) days prior to the proposed effective date of

the increase and must be accompanied by the detailed justification.

6.2.3 If an increase is requested and justification is not deemed acceptable by the State, an increase

of less than 3% may be negotiated by the Contractor and the State. In the event the

negotiations do not result in any agreement between both parties, the Contract may be

canceled with no penalty to the State.

6.3 RESPONSEEXAMPLE‐SEEBELOW

6.3.1 5.xx.xx; Statement: LIMS shall utilize bar coding for reconciling samples as they are received. Offeror’s Response

Q1. Exampleresponse–Offeror’sResponse

System X is capable of utilizing bar code readers at any point in the laboratories sample workflow. Standard bar code formats can be configured by the user to capture data for any specified field. If applicable, bar coding can be used as a key to associate the captured ID with information previously entered in the system.

6.4 CompliancetoMandatoryRequirements

6.4.1 Offerors must comply with the following mandatory requirements in order to be considered responsive to this RFP and to be eligible to be awarded a contract. These items are reviewed as a pass or fail during evaluation of proposals.


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6.4.2. Offeror must submit a signed Request for Proposal Signature Page to be considered for this award. The State may accept an alternative signed document by a person legally authorize to bind the Offeror to the proposal; acceptance is at the States discretion. In any instance where this occurs, the State shall require the Offeror to submit a signed Request for Proposal Signature Page within 24 hours (1 business day) upon notice.

6.4.3 Security/ Cyber Security. Offeror agrees at all times to maintain network, system, and application security that, at a minimum, include: network firewall provisioning, intrusion detection, and State of Colorado Office of Cyber Security (OCS) security testing on an annual basis.

6.4.4 Offer shall clearly state, with no exception, agreement to comply the State of Colorado Cyber Security polices as found at http://www.colorado.gov/cybersecurity and the security requirements in the model contract.

6.4.5 Offeror agrees to maintain network, system and application security that conforms to the following:

6.4.5.1 State of Colorado Cyber Security Policies as found at http://www.colorado.gov/cybersecurity

6.4.5.2 Current cyber security Standards set forth and maintained by the Center for Internet Security, which can be found at: http://www.cisecurity.org

6.4.6 Proposals must be received on or before the Bid Submission Deadline as indicated on VSS. Late

proposals shall not be accepted. It is the responsibility of the Offeror to ensure that its proposal

is received by the CDPHE Procurement Office, on or before the Bid Submission Deadline.

Offerors mailing their proposals shall allow sufficient mail delivery time to ensure receipt of

their proposals by the Bid Submission Deadline. All proposals submitted must be "sealed"; i.e.

package, envelope, box, etc.

6.4.7 Proposals must be submitted in a sealed package with an appropriate label affixed. The label

must show the following information:

Offeror’s Name

RFP‐Number FAAA 2017000105

Proposal Due Date and Time

Offerors must segregate the portion of the proposal responding to the Cost.

6.4.8 The proposal must be signed in ink, preferably blue ink, by an officer of the Offeror who is

legally authorized to bind the Offeror to the proposal. Proposals that are determined to be at a

variance with this requirement may not be accepted. A Request for Proposals Signature Page

has been provided.

6.4.9 The State desires and encourages that proposals be submitted on recycled paper, printed on

both sides. While the appearance of proposals and professional presentation is important, the

use of non‐recyclable or non‐recycled glossy paper is discouraged.


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6.4.10 Proprietary/confidential information must be submitted in accordance with the

Proprietary/Confidential Information section of this RFP. In addition, an Offeror shall provide all

proprietary/confidential information in its electronic response on a separate CD/USB flash drive

clearly marked as such.

7. OFFEROR’SPRESENTATION

The original hard copy in all cases is the official record and shall be used to resolve any differences. All electronic copies shall be provided in Microsoft Word or Microsoft Excel, where appropriate. The information within this section outlines specific information required in your response, which shall assist in determining how well your presentation shall be able to meet the requirements set forth within the Proposal Requirements section of this RFP.

7.1 Offerorsarerequiredtosubmit:7.1.1 One (1) original hardcopy with segregation of all cost sections. 7.1.2 Required number of hardcopies as stated on the Request for Proposal Signature Page with

segregation of all cost sections. 7.1.3 One (1) electronic copy (CD or USB) with electronic segregation of all cost sections. 7.1.4 One (1) electronic redacted copy (CD or USB) ‐ copy must be clearly marked “Redacted Version”

with electronic segregation of all cost sections. Redaction is per Section 1.17 of this RFP, to include all confidential / proprietary information.

7.1.5 Offerors are required to submit an electronic version of all solicitations documents, including but not limited to; original proposal, clarifications, oral presentation documentation, best and finals.

7.1.6 Segregated cost proposal in original response, electronic response and required number of copies.

7.1.7 Signed Request for Proposals Signature Page. 7.1.8 All Offerors, regardless of which option is being proposed, must respond to ALL portions of

Sections 3: Overview, and 5: Proposal Requirements and Scope of Work. 7.1.9 Cost Breakdown to include the total cost of Ownership.

7.2 REFERENCESPlease provide at least three (3) and no more than five (5) references that match the scope of work

outlined in this solicitation. Provide the principal contact, telephone number and email address, as well

as a brief description of work performed. The State reserves the right to include the State of Colorado

and other states as additional references. The State also reserves the right to call references only on the

selected Offerors as a method of determining responsibility.

7.3 Security

7.3.1 ContentQuality


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Do not include extensive artwork, unusual printing or binding, or other materials, which do not enhance

the utility or clarity of the Offeror’s proposal. General statements without supporting documentation

are not encouraged. Documents shall be double sided on recycled paper, and easy to copy/scan (no

bound material, clips, etc). Paper shall be white or extremely light paper without dark backgrounds.

Enhance electronic images for pages with a poor image quality.

7.3.2 ProposalOrganization

Offeror’s proposal shall be submitted in a binder (3 ring binder(s) preferred) with all material clearly

labeled or, such other organization that shall facilitate the committee members’ evaluation. Offerors

must respond to every item listed within Section 5 – using the Offeror Response Format and label its

proposal with the corresponding number for each question or request for information.

7.3.3 ConflictswithTerms,Conditions,orRequirements

Offeror must review the attached Model Contract and list any exceptions or confirm that no exceptions

are taken to the Model Contract. Exceptions to the Model Contract must be accompanied by alternative

or substitute language, which would be acceptable to the Offeror. Conflicts with stated requirements

must be noted in the corresponding paragraphs within the Offeror’s response format. Additional terms

or conditions proposed by Offeror for consideration must be provided with a reference to the

corresponding paragraph of the Model Contract. References may direct reviewers to appendices within

Offeror’s response.

8. PROPOSALEVALUATIONAn Evaluation Committee shall judge the merit of proposals timely received in accordance with the criteria

outlined in the Offeror Response Format section of this RFP.

This section supplements paragraph 3.8, “Evaluation and Award,” in the Colorado Solicitation

Instructions/Terms and Conditions that are available through the link on VSS.

8.1 EvaluationProcess

CDPHE shall undertake an intensive, thorough, complete and fair evaluation process. All Offerors

shall be afforded fair and equal treatment throughout the evaluation process.

8.2 EvaluationCommittee

Each Evaluation Committee member shall independently evaluate the merits of proposals

received in accordance with the evaluation factors stated within this RFP, followed by discussion

of the entire Evaluation Committee. The sole objective of the Evaluation Committee shall be to

recommend for award the proposal(s) determined most advantageous to the State.

8.3 BasisforAward


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The purpose of this RFP is to solicit proposals for the goods/services specified herein. The

requirements stated within this RFP represent the minimum performance requirements necessary

for response as well as desired elements of performance. All proposals must meet the mandatory

minimum requirements established by this RFP to be eligible for award.

Evaluation and award shall be based on the following factors, in decreasing order of importance:

1. Fulfillment of the Business Requirements Stated for the LIMS

2. Vendor’s Experience with LIMS and References

3. Vendor’s Acceptance of the State of Colorado’s Terms and Conditions

4. LIMS Maintenance and Support Cost

5. LIMS Implementation Cost

8.4 EvaluationBasedonInitialProposals

CDPHE reserves the right to make an award(s) on receipt of initial proposals, so Offerors are

encouraged to submit their most favorable proposal at the time established for receipt of

proposals.

Proposals requiring major revision in order to be considered for any award, or otherwise not

meeting the mandatory or other requirements required for further consideration as specified in

this RFP, may be classified as unacceptable and ineligible for further consideration.

The technical aspects of proposals shall be assessed based on the soundness of the Offeror’s

approach and the Offeror’s understanding of the requirement. Past experience/qualifications

shall be assessed by considering the extent to which the qualifications, experience, and past

performance are likely to foster successful, on‐time performance. Technical and past experience

assessments may include a judgment concerning the potential risk of unsuccessful or untimely

performance, and the anticipated amount of State involvement necessary to insure timely,

successful performance.

8.5 CompetitiveRange

CDPHE may establish a competitive range of Offerors whose proposals have been initially

evaluated as most responsive to the requirements and reasonably susceptible of being selected

for award.

8.6 Clarifications/Discussions


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CDPHE may conduct discussions with Offerors for the purpose of promoting understanding of

CDPHE’s requirements and the Offeror’s proposal, clarifying requirements, and making

adjustments in services to be performed and in prices and or rates. Offerors engaged in such

discussions may be sent a list of questions and shall be given a specified number of days in which

to formulate and submit written responses to the questions and provide any related revisions to

their initial proposals. The nature of the questions shall be, generally, clarifying in nature and shall

permit related revisions to proposals. Such revisions shall be at the option of the Offeror, but shall

be limited to the guidelines set forth in CDPHE’s requested clarifications. No major changes shall

be permitted, nor shall CDPHE accept any additional written materials not relevant to the

questions/clarifications requested. Clarifications/discussions may be limited to Offerors within

the Competitive Range.

8.7 Presentations/Demonstrations

Offerors may be given an opportunity to provide an oral presentation or demonstration via

webinar. During the presentation, an Offeror shall provide specific responses to the questions

posed to it and may also make a summary presentation of its proposal. The presentation shall

include a description of how Offeror’s revisions, if any, may have affected the over‐all nature of its

offer as compared to the initial proposal. The presentation is typically limited to 60 minutes. If

the Evaluation Committee members believe it to be necessary, a question/answer period may

follow. Presentations/Demonstrations may be limited to Offerors within the Competitive Range.

8.8 BestandFinalOffers(BAFO)

Adjustments may also be allowed in conjunction with clarifications, discussions, presentations and

or demonstrations, but only to the extent such revisions are consistent within the proposal

requirements. These revisions shall be considered as best and final offers. Such adjustments

must be submitted in writing.

8.9 FinalEvaluations

After completion of clarifications, presentations, and BAFOs, as may be required, the Evaluation

Committee shall re‐consider the initial proposal ratings and may make any adjustments they

believe to be warranted as a result of the additional information obtained.

8.10 AwardRecommendation

Upon completion of the evaluation process, the Evaluation Committee shall formulate a

recommendation as to which proposal(s) is/are determined to be most advantageous to the State

within available resources. A formal recommendation of the Evaluation Committee shall be

forwarded to the CDPHE, Purchasing Director for review and approval.

8.11 NoticeofIntenttoAward


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Upon approval of the recommendation, a Notice of Intent to Award shall be published on VSS.

Upon issuance of the notice, all non‐proprietary/confidential documents submitted by all Offerors,

not just the awarded Offeror(s), shall become public records and shall be available for inspection.

The time period for consideration of any protest of the award decision shall commence at this

time. The Awarded Offeror(s) shall be contacted by CDPHE to complete post award requirements.

8.12 AdequacyandCompletenessofResponse

In general, all aspects of a proposal shall be evaluated based on its adequacy and completeness

with regard to the information specified in the RFP; i.e., compliance with terms, conditions and

other provisions contained in the RFP, as well as Offeror’s ability to read and follow instructions.

Failure of an Offeror to provide the information required in this RFP may result in disqualification

of the proposal. This responsibility belongs to the Offerors.

8.13 ContractReview

Offerors must review the attached Model Contract and list any exceptions or confirm that no

exceptions are taken to the State’s contract. Any exceptions to the Model Contract must be

accompanied by alternative or substitute language which would be acceptable to the Offeror.

CDPHE shall review the proposal to ensure the Offeror has not taken any exceptions to the State’s

contract provisions which may be deemed unacceptable or exceptions to stated requirements

which may be deemed unacceptable in meeting the needs of the State. Any exceptions taken

could result in elimination of the Offeror’s proposal from further consideration, or result in delay

or failure to execute a contract, whereby the State could terminate the award and commence

negotiations with another Offeror. Exceptions to the State of Colorado Special Provisions,

attached to the contract, will not be accepted.


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9. APPENDICES

9.1 APPENDIXA:INSTRUMENTLISTLSD Instrument List (Instrument, software version, (serial number)) 1. Applied Biosystems 7500 DX, SDS v 1.4 (275010718, 275030045, 275030183). 2. BioRad BioPlex 200, Luminex xPonent v 3.1 (LX10007033402). 3. Illumina MiSeq, MCS v2.5 (MS03503). 4. Cepheid Smartcycler II, v2.0d (901003, 901013. 400326). 5. Beckten Dickenson MGIT (MG2524). 6. Bio-Rad EVOLIS (9163700981). 7. Bio-Rad Geenius, 1.2.201.1.1 (DPSE004707). 8. Hologic (Gen-Probe) Panther 9. Biomerieux Vidas (IVD3002773, IVD3004241). 10. Biomerieux Vitex (VK2C5959). 11. Cepheid GeneXpert, v4.3 (707495). 12. Lachat QuickChem 8500, Omnion 3.0.224 (070600000459). 13. Lachat QuickChem 8500 Series II, Omnion 3.0.224 (100800001239 AND 110800001353). 14. Shimadzu UV-1800, UVProbe ver 2.43 (H54335232056CS). 15. Agilent ICP/MS 7500 Series, MassHunter B.01.01 (JP14101295). 16. Dionex ICS-2000, Chromeleon Ver 6.8 SR 11d Build 3302 (04060252). 17. Dionex ICS- 1500, Chromeleon Ver 6.8 SR 10 Build 2818 (06060550). 18. Perkin Elmer IC Optima 7300 DV, Winlab 32 for ICP Ver 5.3.0.0656 (077C9052202). 19. Agilent 1100 Series LC, Chemstation Ver. B.01.03 [204] (DE43607453). 20. Agilent 1260 Infinity, ChemStation Ver B.04.02SP1[256] (DE64259094). 21. Agilent 6890 GC/ECD, ChemStation ver. D.02.00.275 (US00032884/ U18480). 22. Agilent 6890 GC/ECD ChemStation ver E.02.00.493 (US10536061/ U8935). 23. Agilent 5973 GC/MS, MSD ChemStation D.02.00.275 (US00007985/ US71430699). 24. Agilent 5975C GC/MS, MSD ChemStation E.02.00.493 (US10840010 / US83130606). 25. Shimadzu TOC-L CPH, TOC- Control L ver 1.04 (H54335232056CS). 26. Phoenix 8000 TOC analyzer, TOC Talk ver. 3.2.105 (US04215006).


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9.2 APPENDIXB:LIMSSAMPLECOSTPROPOSALLIMSSampleCostProposal

Offeror: Project: ColoradoLaboratoryInformationManagementSystem(LIMS)

Deliverable Item SampleCost1 SystemSoftware(Listindividualmodulecostsifapplicable) $1.002 SystemHardware $1.003 LaboratoryWorkflowandNeedsAssessment $1.004 ProjectManagementandReporting $1.00

5Planning(Security,DisasterRecovery,Training,Operations,Transition) $1.00

6 SystemConfiguration $1.007 SystemImplementation $1.008 InstrumentIntegration $1.009 SystemTesting $1.0010 SystemTransitionandGoLive $1.0011 Training(Listanyspecifictrainingplans) $1.0012 PostGoLiveTransitionSupport $1.00

Total $12.00

Project: ColoradoLaboratoryInformationManagementSystem(LIMS)Year MaintenanceandEnhancementSupport Cost1 AnnualMaintenanceSupport $1.002 AnnualMaintenanceSupport $1.003 AnnualMaintenanceSupport $1.004 AnnualMaintenanceSupport $1.005 AnnualMaintenanceSupport $1.00

Project: ColoradoLaboratoryInformationManagementSystem(LIMS) HourlyRatesforSystemEnhancements Rate/Hr ProjectManager $1.00 BusinessAnalyst $1.00 TechnicalAnalyst $1.00 DatabaseAnalyst $1.00 QualityAssurance $1.00 DocumentationSpecialist $1.00 Trainer $1.00 Other $1.00