RFQ.pdf

REQUEST FOR QUOTATIONS

(THIS IS NOT AN ORDER) THIS RFQ IS X IS NOT A SMALL BUSINESS SET-ASIDE.

PAGE OF PAGES

1 14

1. REQUEST NO.

75D301-19-Q-70330

2. DATE ISSUED

05/22/2019

3. REQUISITION/PURCHASE REQUEST NO.

000HCCGD-2019-35083

4. CERT. FOR NAT. DEF.

UNDER BDSA REG. 2

AND/OR DMS REG. 1

RATING

5a. ISSUED BY

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

626 Cochrans Mill Rd

Pittsburgh PA 152360070

6. DELIVERY BY (Date)

5b. FOR INFORMATION CALL (No collect calls) X

NAME TELEPHONE NUMBER

AREA CODE NUMBER

Abbie Jemmott (412) 386-6433 x

8. TO: 9. DESTINATION

a. NAME b. COMPANY a. NAME OF CONSIGNEE

DHHS PHS CDC NIOSH

c. STREET ADDRESS b. STREET ADDRESS

1090 Tusculum

c. CITY

Cincinnati

d. CITY e. STATE f. ZIP CODE d. STATE e. ZIP CODE

OH 45226-1938

10. PLEASE FURNISH QUOTATIONS TO

THE ISSUING OFFICE IN BLOCK 5a ON OR BEFORE CLOSE OF BUSINESS (Date)

June 5, 2019 @ 11:00 AM EST

IMPORTANT: This is a request for information, and quotations furnished are not offers. If you are unable to quote, please so indicate on this form and return it. This request does not commit the Government to pay any costs incurred in the preparation of the submission of this quotation or to contract for supplies or services.

Supplies are of domestic origin unless otherwise indicated by quoter. Any representations and/or certifications attached to this Request for Quotations must be completed by the quoter.

11. SCHEDULE (Include applicable Federal, State and local taxes)

ITEM NO.

(a)

SUPPLIES/SERVICES

(b)

QUANTITY

(c)

UNIT

(d)

UNIT PRICE

(e)

AMOUNT

(f)

001 See Section D, Statement of Work See Section D Firm Fixed Price

Firm Fixed Price

12. DISCOUNT FOR PROMPT PAYMENT

a. 10 CALENDAR DAYS

b. 20 CALENDAR DAYS

c. 30 CALENDAR DAYS

d. CALENDAR DAYS

NUMBER PERCENTAGE

NOTE: Additional provisions and representations are are not attached.

13. NAME AND ADDRESS OF QUOTER 14. SIGNATURE OF PERSON AUTHORIZED TO

SIGN QUOTATION

15. DATE OF

QUOTATION

a. NAME OF QUOTER

b. STREET ADDRESS 16. SIGNER

a. NAME (Type or print) b. TELEPHONE

c. COUNTY AREA CODE

d. CITY e. STATE f. ZIP CODE c. TITLE (Type or print) NUMBER

AUTHORIZED FOR LOCAL REPRODUCTION STANDARD FORM 18 (REV. 6-95)

Previous edition not usable Prescribed by GSA

FAR (48 CFR) 53.215-1(a)

7. DELIVERY

FOB

DESTINATION

OTHER

(See Schedule)

75D301-19-Q-70330

SECTION B: Line Items

ITEM SUPPLIES / SERVICES QTY / UNIT UNIT PRICE EXTENDED PRICE

0001 User Check- CSTD-SIFT Performance Testing of Closed System Transfer Devices using SIFT-MS in accordance with the attached statement of work.

Period of Performance - 7/1/19 - 9/30/19

1 Each

SECTION C: CLAUSES

FAR & HHSAR

SOURCE

TITLE AND DATE

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE (OCT 2016)

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE MAINTENANCE (JUL 2016)

52.212-4 CONTRACT TERMS AND CONDITIONS- COMMERCIAL ITEMS (JAN 2017)

52.232-18

52.232-39

52.232-40

352.222-70

AVAILABILITY OF FUNDS (APR 1984)

UNENFORCEABILITY OF UNAUTHORIZED OBLIGATIONS (JUN 2013)

PROVIDING ACCELERATED PAYMENTS TO SMALL BUSINESS CONTRACTORS (DEC 2013)

CONTRACTOR COOPERATION IN EQUAL EMPLOYMENT OPPORTUNITY INVESTIGATIONS

(DEC 2015)

FAR 52.252-2 -- CLAUSES INCORPORATED BY REFERENCE. (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://farsite.hill.af.mil/reghtml/regs/far2afmcfars/fardfars/far/far1toc.htm http://www.hhs.gov/policies/hhsar/subpart301-1.html

(End of Clause)

FAR 52.212-5 -- CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR

EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2018)

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017)

(section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L.

113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Nov 2015).

(3) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(4) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004)(Public Laws 108-77 and 108-78 (19

U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.203-6, Restrictions on Subcontractor Sales to the Government (Sept 2006), with Alternate I (Oct

1995) (41 U.S.C. 4704 and 10 U.S.C. 2402).

__ (2) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509)).

__ (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009

(June 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and

Reinvestment Act of 2009.)

_x_ (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2016)

(Pub. L. 109-282) (31 U.S.C. 6101 note).

__ (5) [Reserved].

__ (6) 52.204-14, Service Contract Reporting Requirements (Oct 2016) (Pub. L. 111-117, section 743 of Div.

C).

__ (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (Oct 2016)

(Pub. L. 111-117, section 743 of Div. C).

_x_ (8) 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors

Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).

__ (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41

U.S.C. 2313).

__ (10) [Reserved].

__ (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (Nov 2011) (15 U.S.C. 657a).

__ (ii) Alternate I (Nov 2011) of 52.219-3.

__ (12)(i) 52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT

2014) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a).

__ (ii) Alternate I (JAN 2011) of 52.219-4.

__ (13) [Reserved]

__ (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011) (15 U.S.C. 644).

__ (ii) Alternate I (Nov 2011).

__ (iii) Alternate II (Nov 2011).

__ (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644).

__ (ii) Alternate I (Oct 1995) of 52.219-7.

__ (iii) Alternate II (Mar 2004) of 52.219-7.

__ (16) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)).

__ (17)(i) 52.219-9, Small Business Subcontracting Plan (Jan 2017) (15 U.S.C. 637(d)(4)).

__ (ii) Alternate I (Nov 2016) of 52.219-9.

__ (iii) Alternate II (Nov 2016) of 52.219-9.

__ (iv) Alternate III (Nov 2016) of 52.219-9.

__ (v) Alternate IV (Nov 2016) of 52.219-9.

__ (18) 52.219-13, Notice of Set-Aside of Orders (Nov 2011) (15 U.S.C. 644(r)).

__ (19) 52.219-14, Limitations on Subcontracting (Jan 2017) (15 U.S.C. 637(a)(14)).

__ (20) 52.219-16, Liquidated Damages—Subcon-tracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)).

__ (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (Nov 2011) (15

U.S.C. 657 f).

__ (22) 52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013) (15 U.S.C. 632(a)(2)).

__ (23) 52.219-29, Notice of Set-Aside for, or Sole Source Award to, Economically Disadvantaged Women-

Owned Small Business Concerns (Dec 2015) (15 U.S.C. 637(m)).

__ (24) 52.219-30, Notice of Set-Aside for, or Sole Source Award to, Women-Owned Small Business

Concerns Eligible Under the Women-Owned Small Business Program (Dec 2015) (15 U.S.C. 637(m)).

_x_ (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755).

_x_ (26) 52.222-19, Child Labor—Cooperation with Authorities and Remedies (Jan 2018) (E.O. 13126).

_x_ (27) 52.222-21, Prohibition of Segregated Facilities (Apr 2015).

_x_ (28) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

__ (29) 52.222-35, Equal Opportunity for Veterans (Oct 2015)(38 U.S.C. 4212).

_x_ (30) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

__ (31) 52.222-37, Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212).

__ (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496).

_x_ (33)(i) 52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O.

13627).

__ (ii) Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

__ (34) 52.222-54, Employment Eligibility Verification (OCT 2015). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.)

__ (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA–Designated Items (May

2008) (42 U.S.C. 6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (ii) Alternate I (May 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.)

__ (36) 52.223-11, Ozone-Depleting Substances and High Global Warming Potential Hydrofluorocarbons

(JUN 2016) (E.O. 13693).

__ (37) 52.223-12, Maintenance, Service, Repair, or Disposal of Refrigeration Equipment and Air

Conditioners (JUN 2016) (E.O. 13693).

__ (38)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and

13514).

__ (ii) Alternate I (Oct 2015) of 52.223-13.

__ (39)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-14.

__ (40) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007) (42 U.S.C. 8259b).

__ (41)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (OCT 2015) (E.O.s

13423 and 13514).

__ (ii) Alternate I (Jun 2014) of 52.223-16.

_x_ (42) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)

(E.O. 13513).

__ (43) 52.223-20, Aerosols (JUN 2016) (E.O. 13693).

__ (44) 52.223-21, Foams (JUN 2016) (E.O. 13693).

__ (45)(i) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

__ (ii) Alternate I (JAN 2017) of 52.224-3.

__ (46) 52.225-1, Buy American—Supplies (May 2014) (41 U.S.C. chapter 83).

_x_ (47)(i) 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014) (41 U.S.C.

chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-

182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43.

__ (ii) Alternate I (May 2014) of 52.225-3.

__ (iii) Alternate II (May 2014) of 52.225-3.

__ (iv) Alternate III (May 2014) of 52.225-3.

__ (48) 52.225-5, Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note).

__ (49) 52.225-13, Restrictions on Certain Foreign Purchases (June 2008) (E.O.’s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury).

__ (50) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016)

(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

__ (51) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150).

__ (52) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C.

5150).

__ (53) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10

U.S.C. 2307(f)).

__ (54) 52.232-30, Installment Payments for Commercial Items (Jan 2017) (41 U.S.C. 4505, 10 U.S.C.

2307(f)).

_x_ (55) 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (Jul 2013)

(31 U.S.C. 3332).

__ (56) 52.232-34, Payment by Electronic Funds Transfer—Other than System for Award Management (Jul

2013) (31 U.S.C. 3332).

__ (57) 52.232-36, Payment by Third Party (May 2014) (31 U.S.C. 3332).

__ (58) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a).

__ (59) 52.242-5, Payments to Small Business Subcontractors (JAN 2017)(15 U.S.C. 637(d)(12)).

__ (60)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C.

Appx. 1241(b) and 10 U.S.C. 2631).

__ (ii) Alternate I (Apr 2003) of 52.247-64.

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

[Contracting Officer check as appropriate.]

__ (1) 52.222-17, Nondisplacement of Qualified Workers (May 2014)(E.O. 13495).

__ (2) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

__ (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (May 2014) (29 U.S.C. 206 and 41 U.S.C.

chapter 67).

__ (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards-Price Adjustment (Multiple

Year and Option Contracts) (May 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards—Price Adjustment (May

2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

__ (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for

Maintenance, Calibration, or Repair of Certain Equipment—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for

Certain Services—Requirements (May 2014) (41 U.S.C. chapter 67).

__ (8) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

__ (9) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

__ (10) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

__ (11) 52.237-11, Accepting and Dispensing of $1 Coin (Sept 2008) (31 U.S.C. 5112(p)(1)).

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records—Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor’s directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the

Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial items. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (Oct 2015) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (Jan

2017) (section 743 of Division E, Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015

(Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.219-8, Utilization of Small Business Concerns (Nov 2016) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds $700,000 ($1.5 million for construction of any public facility), the subcontractor must include

52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(iv) 52.222-17, Nondisplacement of Qualified Workers (May 2014) (E.O. 13495). Flow down required in accordance with paragraph (l) of FAR clause 52.222-17.

(v) 52.222-21, Prohibition of Segregated Facilities (Apr 2015)

(vi) 52.222-26, Equal Opportunity (Sept 2016) (E.O. 11246).

(vii) 52.222-35, Equal Opportunity for Veterans (Oct 2015) (38 U.S.C. 4212).

(viii) 52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014) (29 U.S.C. 793).

(ix) 52.222-37, Employment Reports on Veterans (Feb 2016) (38 U.S.C. 4212)

(x) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O.

13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xi) 52.222-41, Service Contract Labor Standards (May 2014) (41 U.S.C. chapter 67).

(xii)

52.222-50, Combating Trafficking in Persons (Mar 2015) (22 U.S.C. chapter 78 and E.O 13627). Alternate I (Mar 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O 13627).

(xiii) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for

Maintenance, Calibration, or Repair of Certain Equipment-Requirements (May 2014) (41 U.S.C. chapter 67).

(xiv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for

Certain Services-Requirements (May 2014) (41 U.S.C. chapter 67).

(xv) 52.222-54, Employment Eligibility Verification (OCT 2015) (E.O. 12989).

(xvi) 52.222-55, Minimum Wages Under Executive Order 13658 (Dec 2015).

(xvii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2017) (E.O. 13706).

(xviii)(A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xix) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Oct 2016)

(Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note).

(xx) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (May 2014) (42 U.S.C. 1792).

Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxi) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C.

Appx. 1241(b) and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-

64.

(2) While not required, the Contractor may include in its subcontracts for commercial items a minimal number of additional clauses necessary to satisfy its contractual obligations.

(End of clause)

CDCA_G001 – INVOICE SUBMISSION (JUL 2017)

(a) The Contractor shall submit the original contract invoice/voucher to the address shown below:

The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O. Box 15580 Atlanta, GA 3033

Or – The Contractor may submit the original invoice via facsimile or email:

Fax: 404-638-5324

Email: FMOAPINV@CDC.GOV

NOTE: Submit to only one (1) of the above locations.

(b) The contractor shall submit 2 copies of the invoice to the cognizant contracting office previously identified in this contract. These invoice copies shall be addressed to the attention of the Contracting Officer.

(c) The Contractor is , is not required to submit a copy of each invoice directly to the Contracting Officer’s Representative (COR) concurrently with submission to the Contracting Officer.

(d) In accordance with 5 CFR part 1315 (Prompt Payment), CDC's Office of Financial Resources is the designated billing office for the purpose of determining the payment due date under FAR 32.904.

(e) The Contractor shall include (as a minimum) the following information on each invoice:

(1) Contractor’s Name & Address

(2) Contractor’s Tax Identification Number (TIN)

(3) Purchase Order/Contract Number and Task Order Number, if Appropriate

(4) Invoice Number

(5) Invoice Date

(6) Contract Line Item Number and Description of Item

(7) Quantity

(8) Unit Price & Extended Amount for each line item

(9) Shipping and Payment Terms

(10) Total Amount of Invoice

(11) Name, title and telephone number of person to be notified in the event of a defective invoice

(12) Payment Address, if different from the information in (c)(1).

(13) DUNS + 4 Number

(14) Electronic funds transfer (EFT) banking information

(End of Clause)

CDC0_G008 CONTRACTING OFFICER’S REPRESENTATIVE (COR) (JUL 2017)

Performance of the work hereunder shall be subject to the technical directions of the designated COR for this contract.

As used herein, technical directions are directions to the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may not alter the scope of work or cause changes of such a nature as to justify an adjustment in the stated contract price/cost, or any stated limitation thereof.

In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator of the technical direction and the Contracting Officer, immediately or as soon as possible, in a letter or e-mail separate of any required report(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract.

The Government COR is not authorized to change any of the terms and conditions of this contract. Contract changes shall be made only by the Contracting Officer by properly written modification(s) to the contract.

The Government will provide the Contractor with a copy of the COR delegation memorandum upon request.

(End of Clause)

SECTION D: Statement of Work

Title: User Check of draft NIOSH Analytical Method for Performance Testing of Closed System Transfer Devices using SIFT-MS

Period of Performance: July 1, 2019 – Sep 30, 2019

SECTION 1 – BACKGROUND

Accurate, precise, validated analytical methods are the foundations upon which quality chemical exposure assessment studies are based. The publication of new and updated methods is critical to meeting the needs of health and safety professionals around the globe. Prior to publication, NIOSH is seeking the subject analytical method to undergo a User Check, or a secondary laboratory validation. This acquisition is being pursued for a proposed method that was developed here at NIOSH in the Chemical Exposure and Monitoring Branch. The method is Performance Testing of Closed System Transfer Devices using SIFT-MS.

SUBSECTION A – DEFINITIONS

N/A

SECTION 2 – PURPOSE

To fulfill the requirements of a User Check similar to that set forth by the NIOSH Manual of Analytical Methods team through an independent review and validation of the draft method Performance Testing of Closed System Transfer Devices using SIFT-MS.

SECTION 3 – SCOPE OF WORK

The vendor will provide all labor, materials, and equipment required to complete the tasks outlined below. The vendor will require communications with NIOSH to obtain materials needed to complete the User Check. The draft NIOSH method Performance Testing of Closed System Transfer Devices using SIFT-MS and its corresponding back up data report will be provided as Microsoft Word documents. The vendor will review the method and its back up data report. The contractor will set up the method as close to as written as is possible in their laboratory and perform experiments to ensure adequate levels of analytical precision and accuracy. The vendor will assess breakthrough for 5 each of 5 models of closed system transfer devices (CSTDs) subjected to vapor of a semi-volatile challenge agent for a total of 25 breakthrough tests. The vendor will also create calibration curves from both a solution and its headspace, assess linearity and limit of detection/limit of quantitation, and measure approximately 43 unknown samples of solution and headspace. The vendor will also evaluate 5 each of 5 models of closed-system transfer devices (CSTDs) for leaks during normal use for a total of 25 evaluation tests. The vendor will report the results of this sample set and all other observations about the method to NIOSH upon completion. A more detailed description of the tasks is in the next section.

SECTION 4 – TASKS TO BE PERFORMED

The vendor shall perform the following tasks to complete the User Check of draft NIOSH method Performance Testing of Closed System Transfer Devices using SIFT-MS :

A. Review the method and its backup data report and provide NIOSH with this review. Any technical difficulties or errors found will be discussed and corrected before the vendor sets up the method in their lab.

B. The vendor will set up the method as closely to as written as possible in their lab, consulting with NIOSH on any and all proposed changes to the method and obtaining permission for such changes from the Project End User.

C. The vendor will perform experiments to ensure that acceptable levels of analytical precision, accuracy and sensitivity are obtained. These experiments will include generating calibration curves and determination of limits of detection (LOD) and limits of quantitation (LOQ), The results of these experiments will be reported to NIOSH for evaluation, collaboration, and agreement to proceed. Below is a brief synopsis of these activities.

a. A sufficient volume of a calibration solution containing PG, acetone, and methyl t-butyl ether (MTBE) in water will be provided by NIOSH.

b. Using this solution, create a calibration curve of response as a function of volume for liquid leaks by delivering aliquots from approximately 0.5 µL to 50 µL into the chamber and recording SIFT- MS responses for acetone and MTBE.

c. Using the headspace of this same solution, create a calibration curve of response as a function of headspace volume for headspace leaks by delivering aliquots from approximately 0.1 mL to 100 mL of headspace into the chamber and recording responses for acetone and MTBE.

d. Use response factors (i.e. slope of the calibration curves) in the Excel spreadsheet provided by NIOSH that converts instrument response to volumes of liquid and headspace leaks.

e. Determine LOD and LOQ of the method in a similar manner as the calibration just described, but use aliquot levels from slightly below the estimated LOD to about 10 times the estimated LOD of the method.

f. Using the same solution as in the previous calibration, deliver aliquots of liquid over the range of approximately 0.1 µL to 1 µL, adjusting the range as necessary so that the low end appears to be slightly below the LOD of the method.

g. Using the acetone and MTBE data separately, follow the NIOSH protocol to determine the LOD and LOQ for the method in terms of liquid leak volume. In other words, there should be an LOD/LOQ based on acetone and an LOD/LOQ based on MTBE.

h. Using the headspace of the calibration solution, deliver aliquots of liquid over the range of approximately 0.01 mL to 1 mL, adjusting the range as necessary so that the low end appears to be slightly below the LOD of the method.

i. Using the acetone and MTBE data separately, follow the NIOSH protocol to determine the LOD and LOQ for the method in terms of headspace leak volume. Note that the LOD/LOQ based on MTBE may be substantially lower than that based on acetone for the headspace procedure.

D. NIOSH will submit a set of unknown samples (~40-45) to the vendor. The vendor will analyze these samples based on the more detailed directions below and in accordance with the draft method. The vendor will submit the results of this sample set to NIOSH upon completion.

a. Test unknown solutions supplied by NIOSH by introducing specified volumes of the liquid, headspace, or both into the chamber.

b. Record the SIFT-MS readings of the aliquots of unknowns in ppb after the response has stabilized.

Enter the acetone and MTBE readings into the spreadsheet to produce the equivalent volumes of calibration solution liquid leak (µL) and/or headspace leak (mL). NOTE – In actual use of the method, the calibration solution and the solution used in the test are identical.

E. The vendor will test 5 each of 5 models of CSTDs in a breakthrough test (analyzing for PG) as described below.

a. Using the small chamber supplied by NIOSH and a solution of 2 M propylene glycol (PG) in water, evaluate breakthrough of PG through closed system transfer devices (CSTDs).

b. Verify that volumes of headspace transferred by syringe into the empty chamber yield reproducible responses for PG in the SIFT-MS. An extensive calibration curve is not required for this exercise, but a proportional and reproducible PG response should be observed via administration of 20 mL, 50 mL, and 100 mL headspace into the small chamber in the absence of a CSTD. If a proportional and reproducible response is not observed, there may be adsorption problems in the system that must be dealt before proceeding to the breakthrough tests.

c. Test 5 each of 5 models of CSTD for breakthrough. After having demonstrated the expected PG response in an empty chamber, attach a CSTD to the interior of the chamber and pass 100 mL PG solution headspace into the CSTD. Monitor and record the PG response. Repeat this for all 25 CSTDs.

F. The vendor will test 5 each of 5 models of CSTDs in a test for liquid and headspace leaks during normal use of CSTDs as described below.

a. Using the large chamber and the calibration procedure previously done for the evaluation of unknown samples using the PG/acetone/MTBE solution, test 5 each of 5 models of CSTDs for liquid and headspace leaks.

b. Using directions supplied by NIOSH to conduct various tasks with the CSTDs that represent normal usage of the devices, conduct these tasks using the PG/acetone/MTBE solution and monitor for all three compounds with the SIFT-MS during the tasks. Demonstrate a steady background signal for 5 minutes before beginning the tasks for each device and continue to monitor with the SIFT-MS for 5 minutes after the tasks have been completed.

c. Record the complete time profile for each compound from 5 minutes before the tasks begin to 5 minutes after completion of the tasks.

d. Use the steady acetone and MTBE signals that exist after the tasks are completed to measure total acetone and MTBE releases over the course of the tasks for a device. These values are used in the Excel spreadsheet to determine total liquid and headspace leak volume.

e. The PG signal is not needed to calculate volumes of liquid and headspace leaks. However, it may provide additional qualitative information. The PG signal in the headspace is so much weaker than that of the acetone and MTBE that it may frequently be undetectable in this test even when strong signals of acetone and MTBE are observed. The PG signal for liquid leaks is delayed compared to acetone and MTBE because of the slow evaporation of the PG.

f. All SIFT-MS data is provided to NIOSH.

G. The vendor will provide a final report on the method consisting of a final review, ease of use, and any other observations that the contractor deems necessary or interesting.

SECTION 5 – GOVERNMENT FURNISHED MATERIALS

Government will furnish Word documents of the draft method and its back up data report to be reviewed and evaluated. The Government will supply the Excel spreadsheet needed to calculate leak volumes from SIFT-MS response data. The Government will provide a large chamber and a small chamber for testing. The Government will provide calibration solution and unknown samples.

SECTION 6 – PERIOD OF PERFORMANCE

July 1, 2019 - September 30, 2019

SECTION 7 – PLACE OF PERFORMANCE

Performance will be at the contractor’s facility.

SECTION 8 – DELIVERABLES/REPORTING SCHEDULE

The vendor shall provide the following deliverables to the End Project User by the dates reflected below

All electronic files should be delivered in Word format or Excel format (Office 2013) and provided via e-mail.

Items Description Quantity or No.

of Copies Delivery Date Deliver To

Initial Method Review

Review of draft method Performance Testing of Closed System Transfer Devices using SIFT-MS and its back up data report in Word format

1 electronic copy Deb Hirst

Preliminary Analytical Results

Analytical experimental results showing linearity, limits of detection and quantitation, precision and accuracy of the method after initial set up.

1 electronic copy, including representative SIFT-MS data files.

Deb Hirst

Submitted Sample Set Results

Experimental results of the unknown sample set submitted by NIOSH to the vendor.

1 electronic copy of results as well as SIFT-MS data files for all samples.

Deb Hirst

Submitted results of testing 5 each of 5 models of

CSTD

Experimental results of performance of 5 each of 5 models of CSTD for both PG breakthrough testing and liquid/headspace leak volume testing.

1 electronic copy of results as well as SIFT-MS data files for all 50 tests.

Deb Hirst

Final Review Final report and overall review of the use of the method.

1 electronic copy Deb Hirst

The Project End User (or designee) will review the delivered reviews and experimental results for accuracy and completeness. Once the document (or experimental results) are deemed acceptable, payment will be released.

Payments are expected to be made as each deliverable is completed and will be based upon percentage completed of the overall contract.

The contractor can present any problems encountered or expected delays to the Project End User via e-mail at any time. Status updates are expected on a weekly basis. These updates should include an expected timeline for completion for each deliverable. Any problems or delays and their resolutions should also be included in the status updates. The status updates should be emailed to the Project End User.

July 15, 2019

August 5, 2019

September 2, 2019

September 16, 2019

September 30, 2019

SECTION 9 – TRAVEL

No travel expected.

SECTION 10 – SPECIAL REQUIREMENTS

(1) All test results and observations shall be considered confidential and shared or discussed only with CDC-NIOSH or their governmental representative.

(2) The vendor should have a Selected Ion Flow Tube Mass Spectrometer (SIFT-MS) and experienced operator(s).

SECTION 10 – REFERENCE MATERIALS

References can be found in the method, if further reading or information is desired by the vendor. Please see the current NMAM at http://www.cdc.gov/niosh/docs/2003-154/

Preferred method of communication: E-mail

75D301-19-Q-70330 http://www.cdc.gov/niosh/docs/2003-154/