AMENDMENT ONE.pdf

State of South Carolina

Request for Proposal

AMENDMENT ONE

Solicitation:

Date Issued:

Procurement Officer:

Phone:

E-Mail Address:

5400021576 07/08/2021 Lisa Roland 803-898-0533 ROLANDLD@dhec.sc.gov

DESCRIPTION: Turnkey Asymptomatic COVID-19 Testing Services for all SC Schools 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): 07/22/2021 - 2:30PM ET(See "Deadline For Submission Of Offer" provision) QUESTIONS MUST BE RECEIVED BY: DATE HAS PASSED (See "Questions From Offerors" provision) NUMBER OF COPIES TO BE SUBMITTED: **See Pages 3 - 4**

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 07/29/2021. 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 thirty (30) 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 - PAPER ONLY (MAR. 2015)

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

SAP

SAP

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

Preferences do not apply per South Carolina Consolidated Procurement Code Section 11-35-1524, Part (E)(5).

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 do not apply per South Carolina Consolidated Procurement Code Section 11-35-1524, Part (E)(5).

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

AMENDMENT ONE

Solicitation No. 5400021576

DESCRIPTION: Turnkey Asymptomatic COVID-19 Testing Services for all SC Schools

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)

This 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 existing provision of the solicitation in an answer does not modify the original provision except as follows: underlined text is added to the original provision. Stricken text is deleted. [02-2A097-1]

The following prospective offeror questions and agency responses are hereby incorporated into the solicitation.

VENDOR QUESTION 1: Could you provide an estimated daily/weekly number of tests that you would expect to need for the bid?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent.

VENDOR QUESTION 2: Will testing be mandatory? If not, how many or what percentage of students/faculty/staff does DHEC anticipate testing on a daily, weekly, or monthly basis?

STATE’S RESPONSE: Testing is voluntary, and consent must be obtained before testing any individual. Anticipated testing will vary with each districts and/or school. DHEC provided guidance for testing based on CDC recommendations. (Note: CDC does not recommend routine testing for communities with low disease activity levels which currently applies to the majority of the state). We recommended testing for unvaccinated staff and athletes regardless of disease activity. Some districts and schools may choose to routinely test between 10%-20% of whole population but may choose to do testing of 100% of all populations or of targeted groups (like athletics and others). Participation will depend on staff and parental buy-in.

VENDOR QUESTION 3: What frequency of recurring testing is anticipated?

STATE’S RESPONSE: DHEC recommends at least once weekly testing according to CDC’s current school testing guidance, but some variability may occur from district to district.

VENDOR QUESTION 4: Will electronic registration data files be available for students, faculty, and staff prior to the testing event so it may be preloaded into the vendor testing system?

STATE’S RESPONSE: Some districts and schools will have capabilities to allow for electronic registration and consent, but vendors should be prepared to provide standard paper registration and consent forms as not all districts have consistent access to such tools and families within those districts may lack internet and technology access.

VENDOR QUESTION 5: Solicitation indicates that "DHEC shall be responsible for assigning contracted turnkey Contractor(s) to schools and school districts participating in the ELC Routine Asymptomatic School Testing program", what methodology will be used to equitably assign awarded vendors?

STATE’S RESPONSE: DHEC will assign vendors to geographic regions based on vendor capabilities and capacity while also taking into consideration district population sizes in order to distribute testing to vendor fairly without overextending vendor resources.

VENDOR QUESTION 6: Will awarded vendors be assigned the same sites on a recurring basis?

STATE’S RESPONSE: Yes. DHEC will assign vendors to geographic regions based on vendor capabilities and capacity while also taking into consideration district population sizes in order to distribute testing to vendor fairly without overextending vendor resources. These vendors will continue to test at schools in their assigned regions for the duration of the testing program or until “not-to-exceed” amounts are reached.

VENDOR QUESTION 7: Is it correct to assume that all events listed on the price proposal are one day events?

STATE’S RESPONSE: Most events will likely be one-day events, but it is possible that testing could occur at the same locations for multiple days.

VENDOR QUESTION 8: Is there a minimum or maximum number of hours for each event listed on the price proposal and will the hours of operation be set by the vendor? For example, if a vendor is capable of swabbing 75 people in two hours, will the vendor be required to staff a testing site for 8 hours or will 2 hours be acceptable?

STATE’S RESPONSE: Minimum and maximum number of hours will depend on district and school schedules. While vendors may be able to test all anticipated patients within a short timeframe, schools may be scheduling staff and students throughout the school day around class schedules, so there may be the need to staff testing sites for an entire school day.

VENDOR QUESTION 9: Will testing be open to the public at the school testing sites?

STATE’S RESPONSE: The ELC Reopening Schools funding is designated for student and staff testing only. If schools or districts wish to expand testing to the general public, another source of funding would be necessary.

VENDOR QUESTION 10: How many days per week will school testing occur? Will any single site be required to test over 40 hours per week?

STATE’S RESPONSE: This might vary depending on the size of the district and its schools, but we do not anticipate testing in excess of 40 hours per week per site.

VENDOR QUESTION 11: Will a single point of contact be provided to the vendors for each school or school district assigned?

STATE’S RESPONSE: Yes. DHEC will coordinate with the state department of education and schools to obtain points of contact for coordination for each district and charter school.

VENDOR QUESTION 12: Does DHEC anticipate testing will take place during the school day or outside of school hours? If this varies, what is the determining factor?

STATE’S RESPONSE: This might vary. Testing schedules will be coordinated with school districts and charter schools to align with their daily operations and in such a way that is least disruptive to the school day. Schools may wish to offer testing before and after school if they feel mid-day testing would be disruptive. Schools may also wish to test athletics and extracurriculars which will likely occur outside of the standard school day.

VENDOR QUESTION 13: Will space be allocated to vendors at the school or district level to store supplies and equipment?

STATE’S RESPONSE: It is possible that space at the district or school level may be provided, but this is not guaranteed, and vendors should have alternate plans for storing and transporting supplies and equipment for testing events.

VENDOR QUESTION 14: What parental consent is required by age in South Carolina for COVID testing?

STATE’S RESPONSE: Parental consent is required for all minors 15 years and younger.

South Carolina legal (S.C. Code Ann. § 65-5-340) allows for individuals 16 and older to consent to medical care procedures. However, this should be discussed with the district/ school to ensure this aligns with district policy.

VENDOR QUESTION 15: Will testing of any age groups require parents to be physically present?

STATE’S RESPONSE: Parents are not required to be physically present for student testing.

However, parental presence could be suggested for some students with disabilities or diagnoses.

VENDOR QUESTION 16: Does the language in the "Qualifications-special standards of responsibility" section negate any language in the "Qualifications" section preceding it? The qualifications section indicates the experience may be met through experience of key personnel, previous businesses, or partnerships, does the special qualifications section negate this? For example, if our company is not a lab, may we meet the qualifications through an existing partnership with a certified lab?

STATE’S RESPONSE: Yes. A contractual relationship with another third-party lab to provide test results is acceptable as long as it meets the timeline criteria and the lab has required CLIA and CAP certifications.

VENDOR QUESTION 17: Will the vendor be allotted sufficient locations to employ full time testing teams or is the vendor expected to have teams on standby for ad hoc deployment?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent.

VENDOR QUESTION 18: What lead time will the vendor be given to deploy a testing team to a new location?

STATE’S RESPONSE: Participating schools and districts have been advised to schedule testing 4 weeks in advance. Districts or schools may request additional testing outside of that schedule, preferably within two weeks of the additional testing date and location with the understanding that vendors will provide additional testing events to the extent possible.

VENDOR QUESTION 19: What do you expect out of an average month of testing in terms of quantity? How large is the student population we shall be testing?

https://www.scstatehouse.gov/code/t63c005.php

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent.

VENDOR QUESTION 20: I know that we are also responsible for the operation/assembly of testing sites at various locations across the state. Roughly how many of these sites are we expected to be running simultaneously at any given time?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent.

VENDOR QUESTION 21: Will vaccinated students, teachers, staff still participate in screening?

STATE’S RESPONSE: Vaccinated students, teachers, and staff have the option to participate in screening but are not required to participate. CDC does not currently recommend fully vaccinated people be required to participate in routine screening.

VENDOR QUESTION 22: In reference to page 19, Item 8.g. – Is the vendor required to provide mobile testing? For Mobile testing sites, will DHEC provide the vehicles or will this be the responsibility of the vendor? Is there any estimation for how many mobile sites may be required?

STATE’S RESPONSE: Mobile testing sites are defined as short-term testing sites. These may be set up in tents, in mobile vehicles, or in borrowed facilities, in this case district campus facilities. All site set-up will be the responsibility of the vendor. It is expected that most testing sites will be mobile.

VENDOR QUESTION 23: Throughout the RFP, 48-hour turnaround time is mentioned for tests, does this refer to the PCR texting only? What is the expected turnaround time for antigen testing?

STATE’S RESPONSE: All test results, PCR and antigen, should be delivered to patients (or guardians of patients) and designated school personnel within at least 48 hours.

VENDOR QUESTION 24: Pages 39 and 40, Price Proposal – there are several tables in the pricing. What price is expected in the Extended Price Column?

STATE’S RESPONSE: Unit Price will be the same as the extended price.

VENDOR QUESTION 25: Page 40, please clarify the NOTE at the end of the page.

STATE’S RESPONSE: In the past some DHEC vendors charged a site fee based on anticipated tests performed rather than actual tests performed. Moving forward, vendors will invoice for actual tests performed, not anticipated.

VENDOR QUESTION 26: In reference to page 19, Item 2.a.1. Will SC schools have a standing order for testing or is the vendor expected to obtain physician orders?

STATE’S RESPONSE: Vendors are expected to obtain standing physician’s order for all FDA EUA approved tests that require physician’s orders.

VENDOR QUESTION 27: Many schools conducting asymptomatic screening programs use an in-lab pooling approach (see: https://covidedtesting.com/getting-started-with-inlab-pooled-testing), which allows for home/self-collection of samples, reducing disruption and risk at the school. Will the State consider home collection approaches?

STATE’S RESPONSE: If a school or district requests pooled testing, vendors should be prepared to provide pooled testing. However, home/ self-collection of samples will not be considered.

VENDOR QUESTION 28: Will the Contractor be directly billing insurance for payment?

STATE’S RESPONSE: No. All payment is funded through the ELC Reopening Schools grant through the American Rescue Plan. Insurance should not be billed for any test administration. DHEC will issue payment for all routine asymptomatic testing performed under assigned contracts.

VENDOR QUESTION 29: Who is the payer of last resort?

STATE’S RESPONSE: The State does not understand the nature of this question.

VENDOR QUESTION 30: Will DHEC be providing the standing order through the Medical Director?

STATE’S RESPONSE: No. Vendors should supply their own standing physician’s order for testing.

VENDOR QUESTION 31: Will the Contractor be responsible for providing the Medical Director?

STATE’S RESPONSE: Yes. The Contractor is responsible for providing all required medical staff and standing physician’s orders for testing.

VENDOR QUESTION 32: For turn-key operations, are you asking for a mobile lab to be present on the site? If a mobile lab is not needed, do the schools have a room (Nurses room) that https://protect2.fireeye.com/v1/url?k=944d4356-cbd67a44-944d96a7-86b2e136ff17-b531f584987a763a&q=1&e=52b44714-4366-45d1-bd38-6e8bec6e3ded&u=https%3A%2F%2Fcovidedtesting.com%2Fgetting-started-with-inlab-pooled-testing https://protect2.fireeye.com/v1/url?k=944d4356-cbd67a44-944d96a7-86b2e136ff17-b531f584987a763a&q=1&e=52b44714-4366-45d1-bd38-6e8bec6e3ded&u=https%3A%2F%2Fcovidedtesting.com%2Fgetting-started-with-inlab-pooled-testing a lab staff personnel can use to collect samples? In other words, will the school provide locations?

STATE’S RESPONSE: DHEC is not requiring a mobile medical lab be present on site and cannot guarantee that participating schools will have adequate space for such labs. Schools will identify location for sample collection. While locations will be set up on campus, some schools may not be able to allot a room and may request tent or other setups on campus. So long as result delivery and reporting timelines are met, lab locations are of little significance.

VENDOR QUESTION 33: Will the school provide personnel such as nurses that can swab?

STATE’S RESPONSE: No. Vendors should supply all staff required for end-to-end testing services.

VENDOR QUESTION 34: Do we need a physician to sign for test? Can pharmacist, nurse or other provider order?

STATE’S RESPONSE: Vendors should provide standing physicians orders for test.

VENDOR QUESTION 35: Who is responsible for reporting to students, family, and school? In other words, are we able to email results to Parents/Guardians through our existing portal?

STATE’S RESPONSE: Vendors are responsible for reporting results to students, family, schools and DHEC. Vendors may be able to use existing portals for result delivery but should also be prepared to deliver results through other methods should families and schools lack appropriate technology and internet access to use such portals.

VENDOR QUESTION 36: Is an online portal for School and parents allowed to be used where they can access results themselves?

STATE’S RESPONSE: Vendors are responsible for reporting results to students, family, schools and DHEC. Vendors may be able to use existing portals for result delivery but should also be prepared to deliver results through other methods should families and schools lack appropriate technology and internet access to use such portals.

VENDOR QUESTION 37: Is direct ELR reporting to DHEC preferred? How do schools desire reporting?

STATE’S RESPONSE: DHEC must receive all lab results via Electronic Lab Report (ELR). Laboratories must be able to send HL7 v2.5.1 messages or CSV files. School or district preference for result delivery may vary, but the expected result delivery preference is Excel Spread Sheet or CSV file.

VENDOR QUESTION 38: Do we need to report Antigen testing results through DHEC? Both Positive and Negative?

STATE’S RESPONSE: Yes. All results, positive and negative, for any COVID-19 test performed for schools through ELC funding or otherwise, must be reported to DHEC, VENDOR QUESTION 39: Are schools wanting daily or weekly testing?

STATE’S RESPONSE: This may vary depending on the size of the district and school.

DHEC recommends at least once weekly testing based on CDC’s current testing guidance.

However, schools may wish to have testing performed more frequently for their student, staff, extracurricular, or athletic programs populations (etc.). This will be communicated and scheduled in advanced with the testing vendor.

VENDOR QUESTION 40: Are there different tier schools that will require multiple/daily testing services or will all schools be on a once weekly schedule?

STATE’S RESPONSE: This may vary depending on the size of the district and school.

DHEC recommends at least once weekly testing based on CDC’s current testing guidance.

However, schools may wish to have testing performed more frequently for their student, staff, extracurricular, or athletic programs populations (etc.). This will be communicated and scheduled in advanced with the testing vendor.

VENDOR QUESTION 41: Will we be at schools or at sites we set up near schools?

STATE’S RESPONSE: Testing will occur on school campuses or at other district facilities (i.e. school athletic complexes and auditoriums, etc.).

VENDOR QUESTION 42: Is the extended price the unit price as we do not know the absolute number of tests?

STATE’S RESPONSE: Unit Price will be the same as the extended price.

VENDOR QUESTION 43: Can we have multiple pricing tier for Antigen, pooled and standalone PCR tests?

STATE’S RESPONSE: Yes. Vendors may include line items for each testing type within the bidding schedule.

VENDOR QUESTION 44: The PCR program we would be putting forward is saliva self-collection, with an optional video witness and coaching service through Ichor, which we have been successfully using in Canada with one of the largest telecommunications company as well as air lines and major pharmacy chains.

My question with respect to this RFP is if having boots on the ground in SC to administer these tests is mandatory, or are you open to having a video support system in place to coach teachers and administrators on the program?

STATE’S RESPONSE: The purpose of this RFP is to have vendor staff administer or proctor all sample collection in order to reduce staffing and workload burdens on school staff.

VENDOR QUESTION 45: I did not see a specific spot in the document that stated the number of testing sites to expect. How many locations will be testing?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent.

VENDOR QUESTION 46: Can you define the frequency of testing desired?

STATE’S RESPONSE: This may vary depending on the size of the district and school.

DHEC recommends at least once weekly testing based on CDC’s current testing guidance.

However, schools may wish to have testing performed more frequently for their student, staff, extracurricular, or athletic programs populations (etc.). This will be communicated and scheduled in advanced with the testing vendor.

VENDOR QUESTION 47: In the section SCOPE OF WORK 1.f, the document states that the “contractor shall report test results electronically to DEHC.” What is the cost to connect to this service?

STATE’S RESPONSE: DHEC must receive all lab results via Electronic Lab Report (ELR). Laboratories must be able to send HL7 v2.5.1 messages or CSV files. There are no external costs associated with submitting other than having access to this software.

VENDOR QUESTION 48: Is the RFP limited to “observed” self-collections for PCR? Or would an “unobserved” PCR collection, with the option of being spectated by teachers/faculty, be considered?

STATE’S RESPONSE: The purpose of this RFP is to have vendor staff administer or proctor all sample collection in order to reduce staffing and workload burdens on school staff.

VENDOR QUESTION 49: What is the state’s anticipated volume for the 2021-2022 school year? Does SC DHEC have a preference for testing schedule or frequency at this point?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent. DHEC recommends at this time at least once-weekly testing, but testing frequency and scheduling will be coordinated directly with district or school points of contact. District or school POCs will directly coordinate testing schedules with the vendor, and schools may request testing more frequently than once per week.

VENDOR QUESTION 50: According to Scope of Work, 2-E, “Contractor shall report all test results, positive and negative, to DHEC within 24 hours after receipt of the specimen and completed sample processing by the contractor or contactors.” Is the 24 hr. period after the tests have been run? Or Are these resulting times different from the previously stated 48 hr.

turnaround time from specimen collection?

STATE’S RESPONSE: The 24-hour period reporting requirement is 24 hours after the tests have been run and resulted. However, result delivery to patients (and/or legal guardians) and schools will be prioritized. The 48 turn-around time refers to the total process of sample collection, delivery to the lab, sample processing, and result delivery.

VENDOR QUESTION 51: Can the Department provide a list of specific zip codes that the DHEC would like us to have testing locations in?

STATE’S RESPONSE: Not at this time. Once participation interest is assessed for the academic year and vendors are selected, DHEC will assign vendors to specific districts and counties.

VENDOR QUESTION 52: Page 4 indicates that proposals that include objections, deviations or qualifications will be deemed non-responsive and eliminated. Page 17 indicates they may be deemed non-responsive and eliminated. Can vendors submit proposed deviations to language without being eliminated or deemed non-responsive? In what situation would this be possible?

STATE’S RESPONSE: See Section VI. AWARD CRITERIA, DISCUSSIONS AND NEGOTIATIONS - OPTIONAL (FEB 2015) in the solicitation.

VENDOR QUESTION 53: Is the state agreeable to the selected vendor administering PCR only tests at school on site testing locations?

STATE’S RESPONSE: Yes. However, should the school or district request other forms of testing, (i.e. – rapid antigen or PCR or pooled PCR testing), with appropriate rationales, the vendor should be prepared to provide requested testing. It is anticipated that PCR will be the preferred testing type.

VENDOR QUESTION 54: Will the Department and/or SC schools mandate testing for all teachers, staff and students?

STATE’S RESPONSE: No. DHEC does not have authority to and does not wish to make routine asymptomatic COVID-19 testing mandatory for schools. It is not anticipated that schools will mandate testing for staff or students.

VENDOR QUESTION 55: What is the anticipated volume?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent.

VENDOR QUESTION 56: “Pricing: All-inclusive testing cost tiered by “event” size: Does all-inclusive mean staffing, PPE, logistics and testing/results in one price structure, or does this refer only to testing/kits/results and reporting?

STATE’S RESPONSE: All-inclusive pricing includes all items listed as vendor responsibilities in the “Scope of Work” section to include PPE, logistics, testing and resulting, test site materials, and reporting.

VENDOR QUESTION 57: Is it anticipated that antigen will be used as a screen primarily with PCR used as confirmation? Will this vary from district to district or remain a constant?

STATE’S RESPONSE: PCR is expected to be the primarily requested testing method for routine screening overall. However, schools or districts may request screening through antigen testing with confirmatory PCR.

VENDOR QUESTION 58: What is the anticipated number of regional testing sites around the state (understood mobile units may/will be required in addition to semi-permanent sites)?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent.

VENDOR QUESTION 59: Will the state accept an antigen test with a pending EUA but is acknowledged by the FDA as a Lab Developed Test (LDT) and is permissible for asymptomatic screening as an LDT?

STATE’S RESPONSE: All tests used under this contract should have an existing FDA provided EUA approval.

VENDOR QUESTION 60: Is there a preference or bias for/against saliva or nasal sample (anterior or nasoph)?

STATE’S RESPONSE: DHEC does not have a preference or bias for or against saliva or nasal sampling methods. If nasal is provided or requested by a district or school, the sample must be collected using the anterior nares method.

VENDOR QUESTION 61: Per the “Preferences” sections on page 2 of the RFP, please confirm that preferences do not apply to this RFP.

STATE’S RESPONSE: Preferences do not apply to this RFP.

VENDOR QUESTION 62: Regarding the Bidding Schedule/Price-Business Proposal on pages 38-39 of the RFP: If a bidder is pricing multiple options (antigen, PCR and pooled testing) should we include individual price tables for each type of test? Please indicate your preference on how pricing should be presented for the different types of tests.

STATE’S RESPONSE: Yes, pricing for multiple options should be included for each type of test. Vendors may include line items within each bidding schedule.

VENDOR QUESTION 63: Regarding the Bidding Schedule/Price-Business Proposal on pages 38-39 of the RFP: Should the all-inclusive testing price for each event go in the unit price or extended price cell? What number should go in the opposite cell?

STATE’S RESPONSE: Unit Price will be the same as the extended price.

VENDOR QUESTION 64: Does DHEC have an estimation of the number of schools and students that may be tested on a daily/weekly basis?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent. Testing through ELC Reopening Schools funding is offered to all more than 1,400 public K-12 schools in the state.

VENDOR QUESTION 65: Does DHEC have any a priori requirements regarding the frequency and screening strategy, or are they looking for proposals to include this? For example, one could follow CDC operational guidelines for school testing (sports, random sampling of 10- 20% of student body, etc). Alternatively, all students in districts that participate could be tested.

STATE’S RESPONSE: This may vary depending on the size of the district and school.

DHEC recommends at least once weekly testing based on CDC’s current testing guidance.

However, schools may wish to have testing performed more frequently for their student, staff, extracurricular, or athletic programs populations (etc.). Schools and districts may also determine if they wish to attempt testing full populations or percentages. This will be communicated and scheduled in advanced with the testing vendor.

VENDOR QUESTION 66: Will the state consider providing an ordering physician?

STATE’S RESPONSE: No. The vendor is responsible for providing standing physicians orders for testing and any medical staff required to provide the orders.

VENDOR QUESTION 67: May we submit pricing for both individual rt-PCR testing and pooled testing?

STATE’S RESPONSE: Yes. Pricing may be provided separately for individual rt-PCR testing and pooled testing as districts and schools might request either tests for routine screening.

VENDOR QUESTION 68: Can the pooled testing method be CLIA/CAP approved instead of

FDA EUA?

STATE’S RESPONSE: All testing methods used by vendors within this contract must have a FDA provided EUA.

VENDOR QUESTION 69: How many schools will be part of this program?

STATE’S RESPONSE: This is not yet determined. This program is expected to be scalable. Because testing will be voluntary, the number of testing sites will vary depending on buy-in from school districts and individual schools and from staff and parents or legal guardians who will provide and sign consent. Testing through ELC Reopening Schools funding is offered to all more than 1,400 public K-12 schools in the state.

VENDOR QUESTION 70: Will the award(s) be broken into regions?

STATE’S RESPONSE: Awards will not be broken into regions. However, DHEC plans to assign vendors to districts and individual schools based on relative geographic locations.

VENDOR QUESTION 71: Will the state be subdivided into regions where the “up to 4 offerors” will deliver services?

STATE’S RESPONSE: DHEC plans to assign vendors to districts and individual schools based on relative geographic locations.

VENDOR QUESTION 72: If so, should we be responding to specific areas or as an overall service to the State and post award, those areas will be identified?

STATE’S RESPONSE: DHEC plans to assign vendors to districts and individual schools based on relative geographic locations.

VENDOR QUESTION 73: Is there an expected daily or weekly through put we should be providing pricing for such as by volume?

STATE’S RESPONSE: Daily, weekly, and monthly testing volume will vary depending on several factors. Please refer to the bidding schedule which categorizes testing volume by event size.

VENDOR QUESTION 74: Will services be “on call” our scheduled in a routine manner?

STATE’S RESPONSE: Services will be scheduled in a routine manner up to 4 weeks in advance. Any unscheduled event requests within 4 weeks of prescheduled events may be considered and performed to the extent possible by the vendor.

VENDOR QUESTION 75: If so, by whom would the Offeror be receiving taskings/guidance/direction services?

STATE’S RESPONSE: Vendors will directly coordinate testing schedules and locations with district or school-assigned points of contact. Testing schedules do not require DHEC approval, but schools and vendors should communicate testing schedules and should reach out the DHEC with any questions and concerns regarding testing frequency.

VENDOR QUESTION 76: Will athletics, special events such as graduation be included in this SOW or will testing be delivered solely to schools/students during normal classroom periods?

STATE’S RESPONSE: Districts and schools may include special events like graduation, athletics and others, and this would be included in this SOW. However, the federal funding for this program and these contracts does not allow for and include testing of the general public, so any special event testing through these contracts and this funding should only be done for school staff and students.

VENDOR QUESTION 77: Are there any security requirements we need to be aware of such as restriction on movement with the schools, escorts etc that we should include in our delivery approach?

STATE’S RESPONSE: Each district or school in the case of charter or independent schools will have a safety and security policy and protocols, but these will vary by district or school. When coordinating testing locations and schedules, vendors should inquire about district/ school safety and security policies and protocols and should plan to respond accordingly.

VENDOR QUESTION 78: There are references throughout the Solicitation to PCR testing, antigen and/or pooled testing. However, there is no mention of SCDHEC's testing protocol (types/sequences/conditions of testing) and there is no distinction of the test type in the pricing proposal format. Looking at the subject differently, in Responsiveness/Improper Offers (b) we are told that offerors may submit more than one offer. Instead of following a testing protocol provided by SCDHEC, are offerors to propose various testing protocols that they believe will be most efficient and effective?

STATE’S RESPONSE: DHEC does not require vendors to adhere to a specific testing protocol as long as methods and processes have the appropriate EUAs and staffing have appropriate training.

VENDOR QUESTION 79: Section Ill. Scope of Work, 3. DHEC Responsibilities, Item a.

states that DHEC will assign contractor(s) to schools and school districts. For development of technical proposals, have certain decisions already been made:

a. Will the schools provide lists and contacts of individuals to be tested?

b. Will the schools or will the contractor contact the individuals and explain the program and the process?

c. Will the schools or will the contractor communicate time periods for "mass" specimen collection?

d Will the schools or will the contractor facilitate scheduling of individual specimen collection appointments?

e. Will the schools or will the contractor collect information from individuals prior to arrival to speed the collection process?

STATE’S RESPONSE:

a. Yes. This will be determined by the signed and returned consent forms.

b. This may be a combined effort depending on school capabilities. Schools may request or require assistance in program education.

c. This will be jointly coordinated between vendors and appointed points of contacts within districts or schools and might be jointly communicated through various available methods from schools and from vendors. Details will be determined in scheduling coordination between these parties.

d. This will be a coordinated effort between the schools or districts and the vendors.

Schools may have specific requests for scheduling around class schedules and extracurricular schedules in order to schedule in the least obtrusive manner possible.

e. This may be a joint effort. Most schools have capabilities to distribute consent forms in advance of testing; however, depending on capabilities and technologies available, schools may request vendor assistance or may defer to vendor capabilities.

VENDOR QUESTION 80: The Solicitation is clear that the contractor will staff and manage the specimen collection events. Has there been any consideration for teachers collecting their own and their students' saliva specimens using pre-prepared and labeled collection devices?

Same question for administration?

STATE’S RESPONSE: The purpose of this RFP is to have vendor staff administer or proctor all sample collection in order to reduce staffing and workload burdens on school staff. If staff and/or students are offered self-administered tests, it is preferred that samples be proctored to ensure test samples are properly collected.

VENDOR QUESTION 81: For volume planning:

a. Will teachers and administrators as well as students be tested?

b. Have SCDHEC or the schools established a percentage of the applicable student/teacher/administrator population to be tested each time?

c. There are several notations of "screening" and "regular" testing in the Solicitation.

Have SCDHEC or the schools established a frequency of testing?

STATE RESPONSE:

a. Yes. Testing is offered to but not required of all school staff.

b. DHEC provided guidance which follows that of CDC’s current 2021 School

Operations and Testing guidance that suggests at least once weekly testing of staff and of low, intermediate, and high- risk athletics regardless of disease activity.

DHEC also provided recommendations for options of population testing which include total staff and student populations not including fully vaccinated individuals, random sampling of 10% - 20% of populations which may include cohort or pooled testing. These decisions have not been finalized at this time.

c. Recommendations of at least once-weekly testing has been provided but decisions have not been finalized by schools.

VENDOR QUESTION 82: IV. Information for Offerors to Submit - Evaluation (modified), 1.

Technical Approach, Item a. states that offerors must "follow DHEC guidance requirements."

Please clarify what these guidance requirements are. Is it possible that this Item refers to a testing protocol to be provided by SCDHEC?

STATE’S RESPONSE: The referred-to DHEC guidance to be followed includes DHEC reporting requirements. Additionally, any information or fact sheets about testing and actions following testing that might be provided to patients when testing should align with DHEC guidance on the same topics.

VENDOR QUESTION 83: IV. Information for Offerors to Submit - Evaluation (modified), 1.

Technical Approach, Item e. requires offerors to secure any necessary agreements for any use of space, property, or facilities required for the testing services. Since there is no further mention of specimen collection or testing locations:

a. Are we correct in understanding that the testing locations will be on school property and that there will be no cost to the contractor for utilizing those locations?

b. In that case, should our understanding be that any agreements as mentioned are solely for the purpose of addressing general terms of access and use?

STATE’S RESPONSE:

a. Testing locations will be on school property. There should be no direct cost to the vendor such as a lease or rent, but should schools require tent or other set up rather than set up in school buildings, the vendor is responsible for any costs associated with tents, generators, etc. that are required.

b. The SC Department of Education and individual districts and schools may require agreements such as MOAs or MOUs for use of and access to facilities. Generally, these types of agreements focus on space, property, facilities rather than specific testing facility.

VENDOR QUESTION 84: In Ill. Scope of Work/Specifications, Scope of Work, 1. Contractor Responsibilities, Item h, we find requirements for contractors to produce provider's orders for tests. In Ill. Scope of Work/Specifications, Scope of Work, 2. Turn-Key Testing Services at School Testing Events, Item l, we find requirements for contractors to produce physicians' orders for tests. Is it accurate to understand that qualified providers' orders will be sufficient in all cases?

STATE’S RESPONSE: Vendors are responsible for providing medical physician’s standing orders necessary for conducting tests according to the test’s FDA EUA approval under this contract.

VENDOR QUESTION 85: During the COVID-19 National Health Emergency, and particularly for screening (as referred to in the Solicitation) of asymptomatic individuals, providers' orders are not required. Might this requirement be excluded while not required, thereby eliminating the time and cost, however large or small, associated with them?

STATE’S RESPONSE: Vendors are responsible for providing medical physician’s standing orders necessary for conducting tests according to the test’s FDA EUA approval under this contract.

VENDOR QUESTION 86: In Section VIII. Bidding Schedule / Price-Business Proposal, is it accurate to understand that the Item Descriptions included with the Line Numbers refer to tests per day? If not, how many days per event should offerors include in their proposals? This will have a significant impact on efficiency and cost.

STATE’S RESPONSE: The bidding schedule is representative of single day events. The line number within the bidding schedule refers to actual specimen collected and processed within a single day. Item descriptions are also reflective of single-day events, i.e. SMALL Event <, 75 tests per day, MID-SIZE Event, ,75-200 Tests per day, etc.

VENDOR QUESTION 87: We are including the Business Associate Agreement as required in Section IX. We have filled the business name and authorized signer information. At the same time, we are unable to enter the Contract Number, and date and sign the Agreement. Will this be sufficient to satisfy the Solicitation?

STATE’S RESPONSE: A signature and date is sufficient.

VENDOR QUESTION 88: The Section entitled IV. Information for Offerors to Submit - Evaluation (modified) states offerors are STRONGLY ENCOURAGED to submit a redacted copy of their proposals. Otherwise, all information provided may be shared in FOIA requests. As this is a proposal and not a bid, may redactions include pricing without penalty to the offeror's proposal?

STATE’S RESPONSE: Pricing may be redacted without penalty to the offeror’s proposal on the redacted copy only.

VENDOR QUESTION 89: The Solicitation states that we must use Internet Explorer 8, 9 or 10 that are compatible with SAP to submit proposals online. We are finding that only Internet Explorer 11 is available now, and it will be replaced entirely by Microsoft Edge within a year.

Can we reliably use Edge to submit proposals?

STATE’S RESPONSE: See page 3 of the solicitation with details on how to submit an offer. Vendors must be preregistered in the SCEIS vendor system. A hardcopy offer is also acceptable.

VENDOR QUESTION 90: As in a FOIA request and response, would you please share the names of the offerors having expressed interest in providing proposals under this Solicitation?

STATE’S RESPONSE: A FOIA request can be submitted after the award has been made.

END OF AMENDMENT ONE