5400022138_Amend 1.pdf

SAP

State of South Carolina

Best Value Bid

Amendment No. One

Solicitation:

Date Issued:

Procurement Officer:

Phone:

E-Mail Address:

5400022138 11 / 04 / 2021 REBECCA NICHOLS bjn 803-898-1262 nicholrj@dhec.sc.gov

DESCRIPTION: Reagents/Instrument Testing HSV and STD USING GOVERNMENTAL UNIT: SC Dept of Health & Environmental Control

The Term "Offer" Means Your "Bid" or "Proposal". Your offer must be submitted in a sealed package. Solicitation Number & Opening Date must appear on package exterior. See "Submitting Your Paper Offer or Modification" provision.

SUBMIT YOUR OFFER ON-LINE AT THE FOLLOWING URL: http://www.procurement.sc.gov (See Pages 3 through 5 for Instructions)

SUBMIT OFFER BY (Opening Date/Time): 11 / 09 / 2021 11 / 23 / 2021 - 2:30 PM ET (See "Deadline For Submission Of Offer" provision) QUESTIONS MUST BE RECEIVED BY: 10 / 22 / 2021 – 5:00 PM ET (See "Questions From Offerors" provision) NUMBER OF COPIES TO BE SUBMITTED: **See Pages 3 & 4 for Instructions** CONFERENCE TYPE: Not Applicable

DATE & TIME:

(As appropriate, see "Conferences - Pre-Bid/Proposal" & "Site Visit" provisions)

LOCATION: Not Applicable

AWARD &

AMENDMENTS

Award will be posted on November 30 December 16, 2021. The award, this solicitation, any amendments, and any related notices will be posted at the following web address:

http://www.procurement.sc.gov

You must submit a signed copy of this form with Your Offer. By signing, You agree to be bound by the terms of the Solicitation. You agree to hold Your Offer open for a minimum of ninety (90) calendar days after the Opening Date. (See "Signing Your Offer" provision.)

NAME OF OFFEROR

(full legal name of business submitting the offer)

Any award issued will be issued to, and the contract will be formed with, the entity identified as the Offeror. The entity named as the offeror must be a single and distinct legal entity. Do not use the name of a branch office or a division of a larger entity if the branch or division is not a separate legal entity, i.e., a separate corporation, partnership, sole proprietorship, etc.

AUTHORIZED SIGNATURE

(Person must be authorized to submit binding offer to contract on behalf of Offeror.)

DATE SIGNED

TITLE

(business title of person signing above)

STATE VENDOR NO.

(Register to Obtain S.C. Vendor No. at www.procurement.sc.gov)

PRINTED NAME

(printed name of person signing above)

STATE OF INCORPORATION

(If you are a corporation, identify the state of incorporation.)

OFFEROR'S TYPE OF ENTITY: (Check one) (See "Signing Your Offer" provision.)

___ Sole Proprietorship ___ Partnership ___ Other_____________________________

___ Corporate entity (not tax-exempt) ___ Corporation (tax-exempt) ___ Government entity (federal, state, or local)

COVER PAGE - ON-LINE ONLY (MAR. 2015)

http://www.procurement.sc.gov/

PAGE TWO

(Return Page Two with Your Offer)

HOME OFFICE ADDRESS (Address for offeror's home office / principal place of business)

NOTICE ADDRESS (Address to which all procurement and contract related notices should be sent.) (See "Notice" clause)

Area Code - Number - Extension Facsimile

E-mail Address

PAYMENT ADDRESS (Address to which payments will be sent.)

(See "Payment" clause)

____Payment Address same as Home Office Address ____Payment Address same as Notice Address (check only one)

ORDER ADDRESS (Address to which purchase orders will be sent) (See "Purchase Orders and "Contract Documents" clauses)

____Order Address same as Home Office Address ____Order Address same as Notice Address (check only one)

ACKNOWLEDGMENT OF AMENDMENTS

Offerors acknowledges receipt of amendments by indicating amendment number and its date of issue. (See "Amendments to Solicitation" Provision) Amendment No. Amendment Issue

Date Amendment No. Amendment Issue

Date Amendment No. Amendment Issue

Date Amendment No. Amendment Issue

Date

DISCOUNT FOR

PROMPT PAYMENT

(See "Discount for Prompt

Payment" clause)

10 Calendar Days (%) 20 Calendar Days (%) 30 Calendar Days (%) _____Calendar Days (%)

PREFERENCES - A NOTICE TO VENDORS (SEP. 2009): On June 16, 2009, the South Carolina General Assembly rewrote the law governing preferences available to in-state vendors, vendors using in-state subcontractors, and vendors selling in-state or US end products. This law appears in Section 11-35-1524 of the South Carolina Code of Laws. A summary of the new preferences is available at www.procurement.sc.gov/preferences . ALL THE PREFERENCES MUST BE CLAIMED AND ARE APPLIED BY LINE ITEM, REGARDLESS OF WHETHER AWARD IS MADE BY

ITEM OR LOT. VENDORS ARE CAUTIONED TO CAREFULLY REVIEW THE STATUTE BEFORE

CLAIMING ANY PREFERENCES. THE REQUIREMENTS TO QUALIFY HAVE CHANGED. IF YOU

REQUEST A PREFERENCE, YOU ARE CERTIFYING THAT YOUR OFFER QUALIFIES FOR THE

PREFERENCE YOU'VE CLAIMED. IMPROPERLY REQUESTING A PREFERENCE CAN HAVE SERIOUS

CONSEQUENCES. [11-35-1524(E)(4)&(6)]

PREFERENCES - ADDRESS AND PHONE OF IN-STATE OFFICE: Please provide the address and phone number for your in-state office in the space provided below. An in-state office is necessary to claim either the Resident Vendor Preference (11-35-1524(C)(1)(i)&(ii)) or the Resident Contractor Preference (11-35-1524(C)(1)(iii)). Accordingly, you must provide this information to qualify for the preference. An in-state office is not required, but can be beneficial, if you are claiming the Resident Subcontractor Preference (11-35-1524(D)).

**PREFERENCES ARE NOT APPLICABLE**

[§11-35-1524(E)(2)]

____In-State Office Address same as Home Office Address ____In-State Office Address same as Notice Address (check only one) PAGE TWO (SEP 2009) End of PAGE TWO

INSTRUCTIONS FOR OFFERORS IF SUBMITTING BIDS ONLINE

All Offerors desiring to respond to this solicitation should register and submit your response online. To respond online, Offeror must follow the new South Carolina Enterprise Information System (SCEIS) vendor registration instructions found at the South Carolina Division of Procurement Services website address of:

https://procurement.sc.gov/doing-biz/registration. If Offeror is registered in the old procurement system, Offerors must register or update their information in the new SCEIS system. Once the registration process is complete, the system will generate a SCEIS vendor user ID and password. The Offeror must keep this information current or the Offeror will not be able to submit future bids.

Offerors will need to follow these instructions carefully when responding to the solicitation online.

1. The original solicitation response should be submitted online and it will be the official response.

2. All Offerors must attach all additional requested documents to their response in the online system.

These documents can be attached under the “Notes and Attachments” tab of the online solicitation either on the main page or under the necessary line item.

OFFERORS ENCOUNTERING REGISTRATION OR BIDDING PROBLEMS SHOULD CONTACT:

DSIT Help Desk (803) 896-0001 Select Option 1 then Option 2 Monday – Friday 8:00 AM – 4:30 PM Offeror instructions can be found at:

https://procurement.sc.gov/doing-biz/submitting-offers

NOTICE

• To submit bids vendors must use Internet Explorer 8, 9 or 10, which is compatible with SAP. Other browsers such as Internet Explorer 11, Google Chrome, or Mozilla Firefox will not function properly and may prohibit bid submissions.

• It will be the responsibility of each bidder to ensure that their response was submitted properly.

The Response Status must indicate 'Submitted'. If the response is in a 'HELD' or 'SAVED' status, you MUST go back in the system and submit the response before it can be 'ACCEPTED' by the State.

• Bidders are encouraged to review the 'Simulation for Bid Creation' before trying to submit their response.

• Electronic bid submission (SRM Login) – https://vendorportal.sc.gov/irj/portal

• Submitting Confidential Data - https://procurement.sc.gov/legal/general-info

ADDRESSES FOR SUBMITTING HARD COPY BIDS

Mailing Address: Physical Address:

SC DHEC – Division of Procurement Services SC DHEC – Division of Procurement Services Bureau of Business Management Bureau of Business Management Columbia Mills Building Columbia Mills Building – 4th Floor 2600 Bull Street 301 Gervais Street Columbia, S.C. 29201-1708 Columbia, S.C. 29201

See Section II.A. – Public Opening Information – DHEC Clause

NUMBER OF COPIES – ONLINE OR HARD COPY SUBMISSION

1. The original solicitation response should be submitted on-line and is the official response.

2. All Offerors should attach all additional requested documents to their response in the online system. These documents can be attached under the “Notes and Attachment” tab in the online system either on the main response page or under the necessary line item.

https://procurement.sc.gov/doing-biz/registration https://procurement.sc.gov/doing-biz/submitting-offers https://vendorportal.sc.gov/irj/portal https://procurement.sc.gov/legal/general-info

In addition to the offer you submit, the Offeror must submit the following:

1. One (1) original (hard copy) marked “ORIGINAL”

2. Individual copies of your Offer on One (1) USB drive, identical to the Original, to include all attachments (but

NOT including the “Price Proposal”)

3. One (1) each separate copy of the Price Proposal (marked “Price Proposal”) in a separate sealed envelope.

4. One (1) each separate individual copy of your Price Proposal on a USB drive identical to the paper copy, labeled “Price Proposal.”

5. One (1) Redacted Hard Copy (marked “Redacted”), if applicable. (See Section IV – “Submitting Redacted

Offers”.

All copies requested must be delivered no later than the date and time specified on the cover page of the solicitation to the following address:

South Carolina Department of Health and Environmental Control Division of Procurement Services – Rebecca Nichols Solicitation #: 540022138 301 Gervais Street – Columbia Mills Building – 4th Floor Columbia, S. C. 29201

PLEASE NOTE THAT IF TERMS AND CONDITIONS ARE OBJECTED OR QUALIFIED OR OFFEROR

INCLUDES ADDITIONAL TERMS AND CONDITIONS TO BE CONSIDERED, THE OFFER WILL BE

DEEMED NON-RESPONSIVE AND WILL BE ELIMINATED FROM FURTHER CONSIDERATION.

IF YOU QUALIFY YOUR OFFER WITH A STATEMENT SUCH AS, “THIS IS NOT AN OFFER”, THE OFFER

WILL BE DEEMED “NON-RESPONSIVE” AND REMOVED FROM FURTHER CONSIDERATION.

AMENDMENT NO. One Request for Proposal - 5400022138

Description: Reagents/Instrument Testing HSV and STD

AMENDMENTS TO SOLICITATION (JAN 2004)

(a) The Solicitation may be amended at any time prior to opening. All actual and prospective Offerors should monitor the following web site for the issuance of Amendments: www.procurement.sc.gov(b) Offerors shall acknowledge receipt of any amendment to this solicitation (1) by signing and returning the amendment, (2) by identifying the amendment number and date in the space provided for this purpose on Page Two, (3) by letter, or (4) by submitting a bid that indicates in some way that the bidder received the amendment. (c) If this solicitation is amended, then all terms and conditions which are not modified remain unchanged. [02-2A005-1]

QUESTIONS FROM OFFERORS – AMENDMENT (JUN 2017)

THE SOLICITATION IS AMENDED AS PROVIDED HEREIN. INFORMATION OR CHANGES RESULTING

FROM QUESTIONS WILL BE SHOWN IN A QUESTION-AND-ANSWER FORMAT. ALL QUESTIONS

RECEIVED HAVE BEEN REPRINTED BELOW. THE “STATE’S RESPONSE” SHOULD BE READ WITHOUT REFERENCE TO THE QUESTIONS. THE QUESTIONS ARE INCLUDED SOLELY TO PROVIDE A CROSS-

REFERENCE TO THE POTENTIAL OFFEROR THAT SUBMITTED THE QUESTION. QUESTIONS DO NOT

FORM A PART OF THE CONTRACT; THE “STATE’S RESPONSE” DOES. ANY RESTATEMENT OF PART OR ALL OF AN EXISTING PROVISION OF THE SOLICITATION IN AN ANSWER DOES NOT MODIFY THE

ORIGINAL PROVISION EXCEPT AS FOLLOWS: UNDERLINED TEXT IS ADDED TO THE ORIGINAL

PROVISON. STRICKEN TEXT IS DELETED. [02-2A097-1]A P

CHANGES TO THE ORIGINAL SOLICITATION

Opening Date Change From: 11 / 09 / 2021 Change To: 11 / 23 / 2021

Award Date Change From: November 30, 2021 Change To: December 16, 2021*

*Subject to change based on product evaluation.

The following prospective offeror question and agency response is hereby incorporated into the solicitation:

QUESTION 1: Will these items be delivered in bulk or ‘as needed’ over the year? What would be the estimated monthly quantity of each?

STATE’S RESPONSE: The items would be delivered as needed over the year. Due to the quantities fluctuating month to month, annual estimates were provided in the solicitation.

QUESTION 2: Product Specifications, Section 3.2.1 (Page 17): Can you confirm that all four reagents must be currently available, clinically tested within a high-volume laboratory, and FDA approved for clinical assays of HSV-1, HSV-2, Mycoplasma genitalia, Chlamydia trachomatis, Neisseria on the same platform in order to be considered a responsive offer?

STATE’S RESPONSE: HSV-1 & HSV-2 are acceptable on an alternate platform. Mycoplasma genitalia, Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis on the same platform.

QUESTION 3: V. Qualifications (Page 23) it states ‘Corporate subsidiaries are cautioned that the financial capability of an affiliated or parent company will not be considered in determining financial capability’- what if the subsidiary shares the same financials as the parent? Can we submit parent’s public financial statements in that case?

STATE’S RESPONSE: Yes, in the event the subsidiary shares the same financials as the parent, the parent’s public financial statements may be submitted.

QUESTION 4: If the State has already agreed to deviations/additional terms and conditions in previous bids, can the Offeror submit those for consideration?

STATE’S RESPONSE: No, deviations/additional terms and conditions will cause the offer to be non-responsive.

QUESTION 5: Bidding Schedule: If the Offeror has an assay that detects both CT & NG (Lines 001 and 002), how would you like the Offeror to list the price in the Bidding Schedule (in which line item so the price does not get counted twice)?

STATE’S RESPONSE: To avoid the price for an assay that detects both CT & NG, list prices separately and equally in the Bidding Schedule, as well as the Product Item Number, which is mandatory.

QUESTION 6: Bidding Schedule: The quantities in the Bidding Schedule are expressed in volume of tests but most Offerors do not sell individual tests (reagents are sold by the kit). Can you clarify what you want Offeror to enter as the unit price (cost per test inclusive of all items needed to run the test or cost per kit)? If former, the cost per test is comprised of several part numbers, do you want Offeror to list the different part numbers in a separate list? If latter, currently there are no spaces in the Bidding Schedule for the additional items needed to run the test (e.g. collection devices and tips).

STATE’S RESPONSE: Unit price will equal cost per test inclusive of all items needed to run the test.

QUESTION 7: [Vendor] would like to schedule a meeting with Lab (Lab Director, Serology Supervisor, Medical Director) during week of October 25. Points of discussion would include: evaluation of new technology, timing of award, evaluation of testing, and implementation. Would this be considered?

STATE’S RESPONSE: Meetings cannot be conducted during this solicitation process.

QUESTION 8: Under what circumstances would DHEC consider delaying submission date until March 1, 2022?

STATE’S RESPONSE: Due to the timing of the termination of the current contract a delay will not be considered.

QUESTION 9: Under what circumstances would DHEC consider delaying Decision Date/Issue of Award until April 1, 2022?

STATE’S RESPONSE: Due to the timing of the termination of the current contract a delay will not be considered.

QUESTION 10: Under what circumstances would DHEC consider splitting the testing, having the CT/NG/TV/MG under one contract (current solicitation) and HSV 1,2 tested using equipment on-site at DHEC?

STATE’S RESPONSE: The State would be willing to consider splitting the testing between CT/NG/TV/MG & HSV 1,2.

QUESTION 11: Under what circumstances would DHEC consider a non-FDA approved assay?

STATE’S RESPONSE: The selected platform must be FDA approved for consideration.

QUESTION 12: If new technology is commercially available after the submission deadline, but before the issue of the Award, would the State allow a modification of the submission to reflect the new technology as an offering to the State?

STATE’S RESPONSE: No additional offers will be accepted after the latest published bid opening date and time.

Substitutes for technology offered is not allowable after bid opening. Partial and/or incomplete offers will be deemed non-responsive.

QUESTION 13: If new technology is commercially available after the submission deadline, but before the implementation, would the State allow a modification of the submission to reflect the new technology as an offering to the State?

STATE’S RESPONSE: See response to Question 12.

QUESTION 14: 3.2.5 - Do all assays require to be run using the same patient sample tube? Or, is the expectation that duplicate sample collections will be conducted on the patient?

STATE’S RESPONSE: All assays from the same specimen source need to be able to be tested on the same media, i.e.

CT/NG/TV/MG & HSV 1,2 should be tested from the same media, blood tests should be tested from the same tube.

QUESTION 15: 3.2.12 - Is the intent to run QC on new reagent lot numbers? How will this be accomplished? What criteria will be used to grade compliance to stated parameters of the product?

STATE’S RESPONSE: QC is to be tested daily on all reagents with the manufacturer’s controls. The criteria will be based on manufacturer’s package insert.

QUESTION 16: 3.3.2 - To propose the most accurate price schedule, would you consider providing a more concise percentage range for estimated annual test volume?

STATE’S RESPONSE: See response to Question 1.

QUESTION 17: 3.4.1.3 - Is the instrument required to run different amplification technologies at same time? If the instrument meets testing criteria, can one amplification technology be used?

STATE’S RESPONSE: No, the instrument is not required to run different amplification technologies at the same time.

QUESTION 18: 3.4.3 - If replacement parts or loaner equipment is required, does delivery via next-day delivery translate to next workday and exclude Holidays and weekends?

STATE’S RESPONSE: Workdays are considered Monday thru Friday excluding SC state holidays.

QUESTION 19: 3.5.2 - With ongoing uncertainty of COVID as it pertains to visitation parameters and testing demands, the location(s) availability to coordinate Product evaluations are undetermined at current time. Would alternative means for Product evaluations be considered, such as phone references, shortened evaluation period, and/or evaluation at DHEC (vendor responsible for delivery/installation)?

STATE’S RESPONSE: Alternative means of evaluations would be considered under the current COVID circumstances.

QUESTION 20: 3.5.2 - For Product evaluation, will the State allow Vendor to deliver and install instrument at DHEC Laboratory to conduct Product evaluation performing a minimum of 200 tests?

STATE’S RESPONSE: No, product evaluation will take place prior to any equipment installation at DHEC.

QUESTION 21: 3.5.2 - For Product evaluation, will the State allow for multiple sites with different criteria (proximity to DHEC, size of lab, assays tested) to be offered and site determined by DHEC?

STATE’S RESPONSE: Yes, the State will allow for multiple sites with different criteria and site agreed upon by DHEC.

QUESTION 22: 3.5.3 - Under Product Evaluation, is the CLIA-88 verification tied to the DHEC validation required to conduct clinical testing? Please clarify how it is different from 3.5.1 & 3.5.2.

STATE’S RESPONSE: Product evaluation will be conducted prior to award of contract to determine its suitability. The validation process will be completed after award and the equipment is in place to verify its functionality and testing accuracy.

END AMENDMENT NO. ONE