01. RFQ - HHSN-21-Q-000048.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO.

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. DUNS: DUNS+4:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. 2/2012)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS

5. SOLICITATION NUMBER

HHSN-21-Q-000048

6. SOLICITATION ISSUE DATE

03/08/2021

Anthony Q. Hawley anthony.hawley@nih.gov 301-496-0101 04-

12PM

09-2021

(EST)

Y

541380

$16.5 Million

X

N/A

RFQ IFB

National Institutes of Health (NIH) Clinical Center (CC) Office of Research Support and Compliance (ORSC) 10 Center Drive Bethesda, MD 20814

CC

National Institutes of Health (NIH) Clinical Center (CC) Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892

Please see Payment and Invoice Procedures

See CONTINUATION Page

The National Institutes of Health (NIH), Clinical Center (CC), Office of Research Support and Compliance (ORSC) requires an APF certification and testing program including cleanroom certification services with high efficiency particulate air (HEPA) filter testing and maintenance, air visualization studies (AVS), equipment calibration, and controlled temperature unit (CTU) qualification program at the NIH APF facilities located in Bethesda, Maryland.

Please see Statement of Work (SOW) and Price Schedule for all specifics pertaining to Project Deliverables.

Proposals Due: Friday, April 09, 2021 at 12:00 p.m. (EDT) nih.gov byQuestions shall be emailed to anthony.hawley@

5:00 p.m. (EDT) on Monday, March 22, 2021.

CONTRACTOR NAME/POC:

CONTRACTOR DUNS AND TIN NUMBER:

CONTRACTOR EMAIL ADDRESS:

CONTRACTOR PHONE NUMBER:

PLEASE SUBMIT ALL PROPOSALS AND SUBSEQUENT PROPOSAL MATERIALS

VIA EMAIL TO THE CONTRACTING OFFICER AT anthony.hawley@nih.gov.

See CONTINUATION Page

X X

National Institutes of Health (NIH) Clinical Center (CC) Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892

CC

CC

X

X mailto:anthony.hawley@va.gov

SOLICITATION #: HHSN-21-Q-000048

TABLE OF CONTENTS

B.1 CONTRACT ADMINISTRATION

B.2 STATEMENT OF WORK

B.3 QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

B.4 PRICE SCHEDULE

B.5 DELIVERY SCHEDULE

SECTION C – CONTRACT CLAUSES

C.1 52.219-14 LIMITATIONS ON SUBCONTRACTING (JAN 2017)

C.2 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (JAN

2017) ………………………………………………………………………………………………36

C.3 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.4 52.216-18 ORDERING (OCT 1995)

C.5 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.6 52.216-21 REQUIREMENTS (OCT 1995)

C.7 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ... 44

SECTION D – CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

D.1 ATTACHMENT 1 – WAGE DETERMINATIONS AND REQUESTS – SERVICE

CONTRACT ACT (SCA) – NIH CLINICAL CENTER (BETHESDA, MD (MONTGOMERY COUNTY) ... 45

D.2 ATTACHMENT 2 – PAST PERFORMANCE QUESTIONNAIRE

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017) 57

ADDENDUM TO 52.212-1 INSTRUCTIONS TO OFFERORS--COMMERCIAL ITEMS (FEB 2012)

E.2 52.209-5 CERTIFICATION REGARDING RESPONSIBILITY MATTERS (OCT

2015) ………………………………………………………………………………………………62

E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (JUL 2013)

………………………………………………………………………………………………63

E.4 52.216-1 TYPE OF CONTRACT (APR 1984)

E.5 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.6 52.212-2 EVALUATION—COMMERCIAL ITEMS (OCT 2014)

E.7 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL ITEMS (NOV 2017)

B.1 CONTRACT ADMINISTRATION

All contract administration matters shall be handled by the following:

CONTRACTOR:

GOVERNMENT:

National Institutes of Health (NIH) Clinical Center (CC) Office of Purchasing and Contracts (OPC) Two Democracy Plaza 6707 Democracy Boulevard, Suite 106 Bethesda, MD 20892

1. PAYMENT AND INVOICE PROCEDURES:

[X] FAR 52.232-34, Payment by Electronic Funds Transfer – Other Than System for Award Management

ELECTRONIC INVOICING INSTRUCTIONS FOR NIH CONTRACTORS/VENDORS

The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: Prompt Payment (Jan 2017) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow:

I. INVOICE REQUIREMENTS

A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within seven (7) days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under III. below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor.

1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact).

2. Remit-to address (Name and complete mailing address to send payment).

3. Remittance name must match exactly with name on original order/contract. If the

Remittance name differs from the Legal Business Name, then both names must appear on the invoice.

4. Invoice date.

5. Unique invoice #s for all invoices per vendor regardless of site.

6. NBS document number formats must be included for awards created in the NBS:

Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number.

7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR).

8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor’s name on the face page of the award document.

9. Identify that payment is to be made using a three-way match.

10. Description of supplies/services that match the description on the award, by line billed.*

11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately.

12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.*

∗ NOTE: If your invoice must differ from the line items on the award, please contact the Contracting

Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid.

B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt.

II. ELECTRONIC INVOICE SUBMISSION INSTRUCTIONS

A. Invoice Instructions for NIH Fixed-Price Type Contracts are listed below. Following the instructions provided below are paramount to ensure a “proper/correct/accurate” invoice is submitted pursuant to FAR 32.9 therefore ensuring timely payment for supplies delivered or services performed.

(1) Invoices shall be submitted in the following manner:

o The Contractor shall submit an Electronic Copy of the Invoice via email to the Contract Specialist and to the designated Contracting Officer’s Representative (COR). The Invoice shall be transmitted as an attachment via e-mail in a format compatible with the computer systems at NIH [e.g., MS Word, MS Excel, or Adobe Portable Document Format (PDF)]. The purpose of submitting an Electronic Copy of the Invoice to the aforementioned individuals is to ensure accuracy/completion. The COR will validate the contents of the invoice (i.e. Accurate Quantities of Services Received, Pricing, etc.) and will enter receiving for the Invoice provided. The Contract Specialist will validate that the contents of the invoice are accurate and correct. If changes are required, the Contract Specialist will provide notification of these revisions. Once the invoice is deemed accurate and complete by the Contract Specialist, a follow-up email will be provided to the Contractor by the Contract Specialist directing the Company to submit the invoice to the Office of Financial Management (OFM), Commercial Accounts.

(2) Upon receipt of the finalized invoice from the Contract Specialist, the Contractor/Vendor shall:

o Submit an Electronic Copy of the Invoice via email to the NIH Centralized Invoice in accordance with the instructions provided below:

4 Steps to Create the Invoice Submission Email

PLEASE READ THE BELOW INSTRUCTIONS THOROUGLY BEFORE SUBMITTING YOUR INVOICE

ELECTRONICALLY.

*Note: The key words (Vendor, PO, and Invoice), Colon (:) character following the keywords and the PIPE (|) character must be present to identify the information. The pipe (|) character is entered by pressing and holding the shift key and the backslash (\) key at the same time. The term “PO” is being used as a generic term to identify the award number [purchase order, contract, Blanket Purchase Agreement (BPA) call, task or delivery order] and must be used in the subject line, regardless of the specific type of your award.

Step 1:

Send invoices to the following email address:

invoicing@nih.gov

Step 2:

Subject line must follow this format for the invoice you are submitting (see note* below)

Step 3:

Attach the invoice to the email as either a PDF or Word document.

See Reminders below.

Step 4:

In the body of the email, type “Correspondence Email:” followed by your email address.

How to Properly Format the Subject Line of Your Email

EXAMPLE 1 – If Your Contract Includes a Contract Number AND an Order Number or Call Number:

Vendor: Name of the Contractor or Vendor|PO:Contract Number/Order Number or Call Number|Invoice:9999999

EXAMPLE 2 – If Your Contract ONLY Includes a Contract Number:

Vendor: Name of the Contractor or Vendor|PO:Contract Number|Invoice:9999999 EXAMPLE 3 – If Your Contract ONLY Includes an Order Number:

Vendor: Name of the Contract or Vendor|Order Number|Invoice:99999999

Screenshot of How to Locate the Contract Number and Order Number on Your SF 1449 (SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS Form)

The screenshot below shows where the Contract Number and Order Number are located on the SF 1449.

The SF 1449 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your SF 1449 to populate the correct Contract Number and Order Number in the subject line of your email invoice submission.

The Contract Number is required in order to process all invoices. The Contract Number is the same as the “PO” on the invoice email subject line. The Order Number is only applicable for certain contracts and can be found in field number 4, on the SF 1449 form. If your SF 1449 does not include an Order Number, then follow EXAMPLE 2 above to ensure the Subject line of your email is properly formatted.

Screenshot of How to Locate the Contract Number on Your SF 1447 (SOLICITATION/CONTRACT Form)

The screenshot below shows where the Contract Number is located on the SF 1447. The SF 1447 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your SF 1447 to populate the correct Contract Number in the subject line of your email invoice submission.

The Contract Number is required in order to process all invoices. The Contract Number is the same as the “PO” on the invoice email subject line.

Screenshot of How to Locate the Contract Number and Release Number on Your OF 347 (ORDER FOR SUPPLIES OR SERVICES Form)

The screenshot below shows where the Contract Number and Order Number are located on the OF 347.

The OF 347 is provided to you by the NIH Contracting Officer upon awarding the contract. Please use the information on your OF 347 to populate the correct Contract Number (if any) and Order Number in the subject line of your email invoice submission.

The Order Number is required in order to process all invoices. If there is no Contract Number, the Order number is the same as the “PO” on the invoice email subject line. The Contract Number is only applicable for certain contracts and can be found in field number 2, Contract Number, on the OF 347 form. If your OF 347 does not include a Contract Number, then follow EXAMPLE 3 on page 2 to ensure the Subject line of your email is properly formatted.

Subject Line Examples

For your reference, below is a chart listing examples of the correct and incorrect subject lines. Note:

These are just examples, you must enter the applicable information for the invoice you are submitting.

Subject Line Correct Incorrect Vendor: XYZ Corp|PO:HHSN299202000053J/75X98019S00848|Invoice:XYASAD

XYZ Corp|PO # HHSN299202000053J \75X98019S00848|Invoice # XYASAD

XYZ Corp| HHSN299202000053J \75X98019S00848|Invoice # XYASAD

XYZ Corp| HHSN299202000053J \75X98019S00848| XYASAD

Vendor: XYZ Corp,PO: HHSN299202000053J \75X98019S00848,Invoice:XYASAD

Reminders

• Effective December 1, 2020, OFM will no longer accept hard copy vendor invoices sent to the OFM billing office via any shipping services (i.e., USPS, FedEx, UPS, DHL, etc.) or those delivered by any in-person drop off. OFM will not accept any invoices postmarked and/or delivered in-person on/after December 1, 2020. Please follow the electronic submission instructions on page 1. Failure to follow the above electronic submission instructions will result in invoice processing delays.

• Only invoices should be sent to the following mailbox: invoicing@nih.gov. Please do not send emails to this mailbox requesting a status of your invoice(s) and do not include the invoicing@nih.gov email address in your correspondence with NIH Institutes/Centers.

• You must submit only one invoice per email.

• Follow the system size limits that apply to the email and each invoice: individual email attachments cannot exceed 5 megabytes each; and the email plus all attachments cannot exceed a total of 30 megabytes.

• Clearly identify a valid and complete contract number on each invoice.

• Clearly identify an accurate DUNS number on each invoice.

• DO NOT include confidential information such as Social Security Numbers (do not include TIN if it is a Social Security Number).

The invoice attached to the email must be in a PDF or Word format. The date/time that a valid invoice is submitted electronically to the email box (invoicing@nih.gov) will be the same date/time logged as the invoice is received by NIH.

Questions?

Please direct inquiries regarding the status of invoices such as receipt of invoices, due date, or payment of invoices to the OFM Commercial Accounts Branch, Customer Service Office. The OFM Customer Service contact information and of methods to contact are available at the following OFM website https://ofm.od.nih.gov/Pages/Customer-Service.aspx and below.

The Customer Service Office is open Monday – Friday from 8:30 am to 5:00 pm (Eastern Standard Time) and is closed daily between 12:00 pm to 1:00 pm (Eastern Standard Time). The Customer Service Office phone number is 301-496-6088.

Vendor: XYZ Corp|PO:HHSN299202000053J|Invoice:XYASAD

Vendor: XYZ Corp|PO:HHSN311201600011U|Invoice:XYASAD mailto:invoicing@nih.gov https://ofm.od.nih.gov/Pages/Customer-Service.aspx

Instructions for Contractor/Vendor Courtesy Copy Electronic Invoice Submission to the Contracting Officer (CO):

The Contractor/Vendor shall send a cc: copy to the NIH Contracting Officer and the NIH Contracting Officer’s Representative (COR) stated in the award and the NIH Program point of contact when submitting the invoice to NIH/OFM for payment.

III. INVOICE PAYMENT

A. A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events:

1. The 30th day after the designated billing office has received a proper invoice.

2. The 30th day after Government acceptance of supplies delivered or services performed.

B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended.

IV. INTEREST PENALTIES

A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable.

1. A proper invoice was received by the designated billing office.

2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition.

3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor.

B. Determination of interest and penalties due will be made in accordance with the provisions of the

Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget.

V. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR

52.232-40 (December 2013)

a. Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor.

b. The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act.

c. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items.

(End of Clause)

2. SOLICITATIONS: Proposals for furnishing the supplies or services in the Schedule will be received at the address specified in Block 9 of SF 1449, or if hand carried, to the address shown in block 9, until the date and time specified in Block 8. CAUTION - LATE Submissions, Modifications, and Withdrawals: See provision 52.212-1. All offers are subject to all terms and conditions of this solicitation.

3. ACKNOWLEDGEMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NUMBER DATE

4. MISSING PAGES: It is the responsibility of the offeror to examine this solicitation to verify that he or she has received all pages. In addition, in compiling this package, some pages may have been duplicated. If the offeror feels that pages are missing or duplicated, the offeror is encouraged to contact the Contracting Officer at the telephone number shown in Block 7B, Standard Form 1449, Solicitation/Contract/Order for Commercial Items.

5. ORDER PROCESSING SEQUENCE: The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) is the only activity authorized to issue orders under this contract.

6. NOTICE TO PROSPECTIVE AWARDEE(S): Prospective Awardee(s) MUST be registered in the

System for Award Management (SAM) at https://www.sam.gov/SAM/, PRIOR TO AWARD and through Final Payment, and must complete the Online Representations and Certifications Applications (ORCA) at https://www.sam.gov/SAM/ PRIOR TO AWARD and through Final Payment.

CONTRACT WILL NOT BE AWARDED UNTIL SAM REGISTRATION HAS BEEN COMPLETED

AND VERIFIED.

7. GOVERNMENT HOLIDAYS:

Holidays observed by the Federal Government:

New Year’s Day January 1st Martin Luther King, Jr.’s Birthday Third Monday in January

President’s Day Third Monday in February Memorial Day Last Monday in May https://www.sam.gov/SAM/ https://www.sam.gov/SAM/

Independence Day July 4th Labor Day First Monday in September

Columbus Day Second Monday in October Veterans Day November 11th

Thanksgiving Day Fourth Thursday in November Christmas Day December 25th

8. ADDITIONAL INFORMATION FOR OFFERORS:

∗ Contract Type: The Federal Government intends to award a Firm-Fixed Price (FFP) Indefinite- Delivery Indefinite-Quantity Contract Type in accordance with FAR 16.504. Attention should be directed to FAR Clauses 52.216-18 “Ordering” and 52.216- 19 “Order Limitations”, which are a part of this solicitation/contract.

∗ Non-Personal Services Contract: The services provided in the contract will involve non-personal services. The personnel rendering the services of the contract are not subject, either by contract terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

∗ PRE-BID SITE VISIT: Due to limited access to the NIH Clinical Center and subsequent sites as a result of the current COVID-19 Pandemic, a Pre-Bid Site Visit will not be facilitated. However, NIH Clinical Center site-specific information needed to successfully complete this project will be provided upon request.

B.2 STATEMENT OF WORK

PROJECT TITLE: Aseptic Processing Facility (APF) Certification and Testing Program

DEPARTMENT: National Institutes of Health (NIH), Clinical Center (CC) Office of Research Support and Compliance (ORSC)

A. INTRODUCTION:

To meet regulatory requirements in accordance with the Food and Drug Administration (FDA), International Organization for Standardization (ISO) and United States Pharmacopeia (USP) standards for sterile compounding preparations, the National Institutes of Health (NIH) requires an APF certification and testing program including cleanroom certification services with high efficiency particulate air (HEPA) filter testing and maintenance, air visualization studies (AVS), equipment calibration, and controlled temperature unit (CTU) qualification program at the NIH APF facilities located in Bethesda, Maryland.

The NIH Clinical Center Office of Research Support and Compliance (ORSC) is seeking a qualified and experienced contractor to provide project management and coordination of routine and emergent calibration(s) and certification(s) services for the APFs located at the NIH’s Bethesda campus.

A critical component to contamination control is the calibration(s) and certification(s) for the controlled and/or classified areas, which must be well-defined, contain detailed calibration(s)/certification(s) processes that must be stringently followed by highly trained and competent staff. In addition, the use of appropriate, National Institute of Standards and Technology (NIST) traceable equipment to perform calibration(s)/certification(s) of laboratory equipment(s) is required. Calibration(s)/certification(s) must be documented, and performed in a way which does not interfere with the daily aseptic work of the NIH staff.

Currently the APFs requiring routine and ad hoc services include the Clinical Center Pharmacy, Position Emission Tomography (PET), Department of Laboratory Medicine (DLM), Center for Cellular Engineering (CCE), Nuclear Medicine (NM), National Cancer Institute (NCI), and the National Institute of Allergy and Infectious Diseases (NIAID) Laboratory of Malaria Immunology and Vaccinology (LMIV). Department of Transfusion Medicine (DTM) Blood Bank may require services on an ad hoc basis. Additional facilities may be added to the APF certification and testing program during the contract period of performance.

The total need for these types of services at the NIH fluctuates as protocols are created and completed, and individual APF needs rise and fall. Timely and quality calibration and certification services are critical to patient safety and product integrity, purity, quality, identity, and strength. Failure to comply with these requirements by an APF will deem all aseptic processing in these facilities adulterated under the Federal Food, Drug, and Cosmetic Act.

B. BRIEF DESCRIPTION of SERVICES:

B.1.1. These services will be performed at the APFs at the NIH Bethesda campus. The scope of services for this contract includes but is not limited to the following services for both routine and ad hoc needs. Any future new services that may arise in addition to the list of services below will likely be a result of changes in regulatory requirements. The NIH may order the services below as individual tests or as a full package of tests.

1. Room Certifications (Routine and Ad Hoc):

a. Room Level

i. Terminal HEPA Leak Testing

ii. Room Air Change Rate calculations

iii. Static Room Differential Pressure measurements

iv. Room ISO Classification / Particulate Counts

v. Temperature and humidity testing

b. Primary Engineering Control (PEC) Level Field Testing

i. Biological Safety Cabinets (BSC) - NSF 49 testing

ii. Laminar Airflow Workstation (LAFW) – CETA CAG-003 testing

iii. Isolators – CETA CAG-002 testing

c. Pass-through Chambers testing

2. Replacement Parts Services (Routine and Ad Hoc):

a. PEC/Equipment Replacement parts

b. Replace/Repair HEPA parts

3. Room AVS/Smoke Study (Routine and Ad Hoc):

a. Room Level

b. PEC Level

4. Department Equipment and CTUs (Routine and Ad Hoc):

a. Equipment calibration

b. Equipment preventative maintenance (PM)

c. CTU qualification/requalification

B.1.2. Project Management: An important component of this contract is to provide project management to the NIH to coordinate the required services outlined in B.1.1. The contractor shall assign a Project Manager, capable of successful completion of all task orders satisfactory to the purchase order.

The Project Manager:

1. Shall be the single point of contact (POC) who will coordinate all activities with the Contracting Officer’s Representative (COR) and the applicable APF POC for each APF facility. The COR will maintain an accurate listing of APF POCs for the NIH including primary and alternate POCs for each facility. For any activities requiring coordination with the APF POC and the primary POC is unavailable, the contractor must attempt contact with the alternate APF POC. If neither the primary or alternate APF POC is available, the contractor shall attempt to make contact with the

COR.

2. Shall be approved by the NIH COR prior to appointment. The contractor shall not replace the Project Manager without prior approval from the COR.

3. Must have a minimum of five years proven cleanroom certification/validation experience and HEPA certification and maintenance/replacement experience.

4. Shall be permanently assigned to work full-time on-site at the NIH’s Bethesda campus for the duration of the contract. The ORSC will provide space and IT resources such as a computer/phone for the Project Manager.

5. Shall represent any sub-contractor(s).

6. Shall be readily available to provide information and assistance as the need may arise to the NIH.

B.2.1. The contractor required to complete testing shall adhere to practices which will ensure the highest industry standards of performance, safety, and most energy efficient operation of the equipment and systems, and as necessary to prevent compromise to the facility environment through system failure.

B.2.2. The contractor shall furnish all personnel, equipment, materials, supplies, supervision, and services and otherwise do all things necessary for, or incident to, performance of these requirements in accordance with the statement of work.

B.2.3. All services must comply with established and relevant regulatory requirements as required by written protocols from APFs. The applicable regulations include but are not limited to the following regulations outlined in Table 1:

TABLE 1

Clean Rooms HEPA Filters PECs Equipment

Calibrations and

CTU

Qualifications

ISO Standard 14644- 1:2015

IEST-RP-CC006.2 NSF/ANSI 49 Testing

ISO 9001:2015

ISO Standard 14644- 2:2015

IEST-RP-006.3 ISO 14644-1;

Cleanrooms & Associated Environments

ISO-17025:2017

ISO Standard 14644- 3:2005

IEST-RP-CC-034.2 CETA CAG-003

IEST-RP-CC006.2 CETA CAG-002

IEST-RP-006.3

USP 797

USP 800

USP 823

USP 825

C. DESCRIPTION/SPECIFICATIONS/STATEMENT OF WORK:

C.1 Cleanroom, PEC (LAFW/Biosafety Cabinet/Isolator), and Pass-through Chamber Testing and Certification:

C.1.1. Description: Clean room certifications are needed for both routine and ad hoc purposes. Clean room certifications are conducted on all ISO classified spaces. Additionally, the NIH conducts the testing on its Controlled Not Classified (CNC) spaces but they are not subject to the same strict acceptance criteria as the ISO classified spaces.

1. Room Level Testing

a. Terminal HEPA Leak Testing

b. Room Air Change Rate calculations

c. Static Room Differential Pressure measurements

d. Room ISO Classification / Particulate Counts (routine particulate count testing is not required for CNC spaces)

e. Temperature and humidity testing

2. PEC Level Field Testing (Biological Safety Cabinets/LAFW/Isolators)

a. Biological Safety Cabinets (BSC) - NSF 49 Testing including but not limited to:

i. HEPA Leak Testing

ii. Air Velocity / Air Change Rate

iii. ISO Classification / Particulate Count

iv. Airflow Visualization Studies

b. LAFW – CETA CAG-003 Testing including but not limited to:

i. HEPA Leak Testing

ii. Air Velocity / Air Change Rate

iii. ISO Classification / Particulate Count

iv. Airflow Visualization Studies

c. Isolators – CETA CAG-002 testing including but not limited to:

i. HEPA Leak Testing

ii. Air Velocity / Air Change Rate

iii. ISO Classification / Particulate Count

iv. Airflow Visualization Studies

3. Pass-through Chambers - Pass-through chamber testing will be conducted concurrent with Cleanroom certifications and will be tested to the requirements of the more stringent space the pass-through is serving. The testing will include but not limited to:

a. HEPA leak testing (for active pass-throughs)

b. Air change rate

c. Interlock functions

d. Differential pressure

e. Particulate Count

C.1.2. Testing/Deliverables:

1. The contractor shall provide evaluation/testing/certification of cleanrooms for all APFs at the NIH’s Bethesda Campus in accordance with industry standards. This will include but is not limited to particulate counts, airflow testing (ACH), BSC/LAFW, and HEPA filter integrity testing. The baseline counts of current and future cleanrooms and PECs are provided in Attachment A.

2. It is the expectation that the contractor will provide documentation for each clean room certification(s) completed as part of this contract:

a. Cleanroom and BSC Certification Report. Contractor will provide for each ISO Classified Room, LFW and BSC (per IEST-RP-CC006.3). The Certification report will contain but not be limited to:

i. Particulate count testing and documentation. Contractor will provide for each ISO classified zone (Rooms and BSCs).

ii. Air change per hour (ACH) calculations and documentation. Contractor will provide for each ISO classified zone.

iii. HEPA Filter Integrity testing and documentation including:

1. HEPA filter Aerosol Challenge (Leak) testing

2. Air volume or air velocity testing

3. Airflow uniformity testing

iv. Sample AVS testing

v. Test result documentation

vi. Equipment calibration report for all equipment(s) utilized in the completion of the certification BSCs, HEPAs, or rooms. Include NIST traceable standards for all reference instruments.

C.1.3. Work Process:

1. The contractor shall be prepared to perform testing(s) in an At-Rest-Facility condition or Operating-Facility condition as dictated by the APF Facility POC.

C.2. REPLACEMENT PARTS SERVICES:

C.2.1. Description: Replacement parts services are required for both routine and ad hoc purposes for PEC/Equipment replacement parts and HEPA replacement/repair. The contractor is responsible for installation and recertification of any replacement parts.

1. PEC/Equipment Replacement Parts:

a. Contractor will be provided a list of replacement parts needed by the NIH, including parts for critical equipment, CTUs, PECs, etc.

b. Contractor to procure replacement parts, maintain inventory and replenish inventory to be able to make repairs on these items immediately if needed.

c. Contractor to repair or replace parts on CTU and PECs per the required replacement parts list.

d. Contractor will maintain the storage space for the replacement parts which is readily accessible within one hour of the NIH campus.

e. At the end of contract, the contractor must turn-over excess spare parts to the NIH.

2. Room HEPA Replacement:

a. Upon task order issuance, the contractor will procure and provide the NIH Department of Facilities, Operations, and Maintenance (DFOM) with needed HEPA filters for all APF facilities. The list and quantity of needed HEPA filters to be provided to contractor by

DFOM

b. DFOM will maintain the inventory and need for HEPA replacements.

c. Contractor shall evaluate existing HEPA Filter and HEPA Filter inventory and recommend alternate HEPA Filter(s) if deemed in the government’s best interest.

d. Contractor to repair or replace room HEPA filters immediately if found to fail HEPA integrity testing.

e. Contractor to be able to replace full set of room level HEPAs, which shall be requested to schedule with 90 days advance notice.

f. Drawings of facilities with HEPA locations are provided in Attachment C.

C.2.2. Testing/Deliverables:

1. Provide replacement model information and serial number if applicable.

2. Refer to Certification section C.1.2 for recertification testing process and deliverables.

a. Room level and PEC HEPA filters replacement the following will have to be retested.

i. HEPA Filter Integrity testing and documentation including:

1. HEPA filter Aerosol Challenge (Leak) testing

2. Air volume or air velocity testing

3. Airflow uniformity testing

ii. Test result documentation

iii. Equipment calibration report for all equipment(s) utilized in the completion of the certification BSCs, HEPAs, or rooms. Include NIST traceable standards for all reference instruments.

b. Equipment parts replacement:

i. Document replacement on PM

C.2.3. Work Planning:

1. Remove and dispose of used HEPA Filters that are not in compliance with industry standards and able to satisfy/maintain specified environmental conditions/requirements.

2. Install new HEPA filters that are in compliance with industry standards and will satisfy/maintain specified environmental conditions/requirements.

3. Provide reports/documentation including make, model, and serial numbers of replaced filters for reference in the event of a recall.

4. Complete all required disassembly and re-assembly associated with HEPA replacement and/or repair.

C3. AVS:

C.3.1. Description: Room AVS Study/Smoke Study (Ad Hoc /Routine for PECs): New ISO Classified rooms coming on line will undergo an AVS for the rooms as part of the initial qualification activities and will be repeated biannually. Initial qualification activities are out of scope for this contract. Classified room AVS will be repeated under this contract only if major equipment has been moved, physical changes to HVAC supply and exhaust or major changes to the TAB (Testing, Adjusting and balancing) have occurred.

1. Pharmacy – will require biannual AVS services on PECs in addition to NSF49 certification testing

a. This AVS will be conducted on units and adjacent areas in both static and dynamic condition.

b. NIH will supply the pre-approved executable protocol for these units.

c. NIH will supply the necessary personnel and material to conduct dynamic operations.

d. The tests listed above are in addition to the standard AVS testing required during the LAFW or BSC certification process.

2. Other Room Level – will require Ad Hoc AVS services if:

a. Any PEC is relocated.

b. Room undergoes a major HVAC change (HVAC supply/exhaust relocation or significant differential pressure/airflow change).

c. Major equipment movement and installation that would potential impact airflow around any PEC occurs.

3. PEC Level: conducted during certification process.

Airflow visualization testing not included within the required PEC certification process will be conducted per established protocols, pre-approved by appropriate NIH personnel. Estimated time frames per NIH protocols will be 1.5 hours for each PEC and 0.5 hours for each classified room;

however these are only estimates and time frames will become established further per meetings with the contractor.

C.3.2. Testing/Deliverables:

1. An AVS will include the introduction of a visible vapor generated either from food grade propylene glycol, liquid nitrogen, water-for-injection grade water or comparable material approved by NIH.

Video recording of the study will be capture using a high definition camera (not a cell phone) and the edited and unedited video files made available to the APF POC with submission of the executed protocol and summary report.

2. For AVSs performed, an executed protocol, summary report and videos upon conclusion of the testing shall be included in the documents uploaded to the designated ORSC SharePoint as outlined in E.1.

3. Include AVS report cover sheet, including the following:

a. Facility Name

b. Date(s) of Test Performance

c. Company Performing Test

d. Name of Technician(s)

e. Name of Reviewer

4. In addition, the AVS report will also include (where applicable):

a. General Room air pattern testing

b. BSC containment tests

c. Open Door containment testing

d. Room to Room directional Airflow testing

e. Dynamic activities documentation including number of dynamic personnel utilized for each area

f. An edited version of the video generated to aid in review time for end users.

g. Include calibration certificates for all reference instruments as applicable. Provide make, model and serial number for smoke generating materials and equipment.

C.3.3. Work Planning:

1. A subject matter expert (SME) in airflow visualization testing will be provided by the contractor to conduct the execution of the study, an additional assistant will also be provided to control smoke generation or filming of the study.

2. The SME will have authority to direct the work and quality of the airflow visualization testing.

3. The contractor shall furnish all labor, aerosol generating materials, equipment including recording equipment, and supervision necessary to accomplish the work.

4. Additional personnel required for dynamic AVS testing will utilize existing NIH personnel.

5. Work may be conducted during normal working hours or afterhours depending on the needs of the APF and may involve multiple mobilizations.

6. The testing shall be performed in Operating-Facility conditions for AVS as coordinated with the

APF POC.

C4. Department Equipment Calibrations/CTU Qualifications

C.4.1. Description: Equipment Calibration (Routine and Ad Hoc)

The contractor shall provide calibration services for CTUs, environmental monitoring viable and non-viable air samplers, and common scientific equipment located in the NIH APFs and their supporting quality control (QC) laboratories, which operate under GMP regulations. CTUs include items such as refrigerators, freezers, incubators, and liquid nitrogen freezers. Common laboratory equipment is provided in a bulleted list below in Section C.4.8. A unit or piece of equipment is deemed critical and requiring calibration if its use has the potential to directly impact patient care or product quality. The list of equipment and CTUs is provided in Attachment B as an initial estimate of the equipment requiring service. The volume of equipment requiring service may change for reasons including but not limited to equipment being purchased, replaced, or removed from service.

C.4.2. Testing/Deliverables:

1. All executable calibration templates will be created by the contractor and pre-approved by the APF POCs. A spreadsheet which estimates the number of and type of calibration services required each year is provided in Attachment B.

2. NIH will provide the contractor with an initial list of equipment types requiring calibration, along with their calibration due date. The contractor is responsible for maintaining an up-to-date equipment qualification list to reflect any new equipment, equipment replacements, or equipment disposal.

3. The contractor is responsible for managing the calibration schedule and contacting the APF POC to coordinate service based on facility/equipment availability and production schedules. All calibrations will be 3-point (high, middle/use point, low) calibrations and these test points will be pre-approved by NIH to align with CTU/equipment capabilities and end-user operating ranges.

4. The contractor shall use Good Documentation Practice (GDP) requirements when completing all calibration templates at the time of service. All test results shall be documented in accordance with ISO standard 9001: 2015 and ISO-17025:2017 and shall include NIST traceable standards for all reference instruments. The Contractor shall provide all notifications and calibration reports at the timeframes specified in Section E.

C.4.3. Work Planning

1. NIH will provide operating manuals upon request and calibrations shall be performed per manufacturer recommendations.

2. The types of gauges and sensors that will require calibration may include temperature, humidity, flow, RPM, CO2, pressure, weight, and time.

3. The contractor is required to acquire, use and maintain NIST-traceable standards to perform all calibration services.

4. Following successful calibration (prior to leaving the site), the contractor is required to replace the existing calibration sticker with a new sticker on the unit/equipment which indicates the new calibration due date. Any time that “as found” calibration measurements are out-of-tolerance, the contractor is required to verbally notify the APF POC prior to leaving the site.

5. Where possible, the contractor is required to adjust any out-of-tolerance devices so that they are left within tolerance prior to leaving the site. Following any unsuccessful calibration (prior to leaving the site), the contractor is required to tag the unit or equipment “Out of Service” and verbally notify the COR and APF POC of the unsuccessful calibration. A follow-up email report is required within one business day of the visit to the COR and APF POC. The NIH will be responsible for scheduling repairs made to such equipment prior to next calibration attempt.

6. Unplanned service requests (in addition to those on the established calibration schedule) will be handled as specified in Section F.3.1.

C.4.4. Equipment PM:

The contractor is responsible for basic manufacturer recommended PM only; the NIH is responsible for any repairs to equipment. The contractor is responsible for providing the APF POC the full list of manufacturer recommended PM tasks for a given piece of equipment.

PM’s that would void an existing warranty or maintenance agreement are not in scope for this contract.

The APF POC is responsible for management of equipment warranties and maintenance agreements.

C.4.5. Description: CTU Qualifications (Routine and Ad Hoc) The contractor shall provide qualification/re-qualification services (IQ/OQ/PQ) for CTUs located in the NIH APFs and their supporting quality control (QC) laboratories, which operate under GMP regulations. This includes installation, operational and performance qualification (IOPQ) for existing equipment and for new equipment purchased in existing facilities and future facilities after commissioning, qualification and validation (CQV). Qualification is needed for new and replacement CTUs in existing facilities and for existing CTUs that have failed. CO2 incubators that have a HEPA filter will also require qualification if moved.

CTUs include units such as refrigerators, freezers, incubators, and liquid nitrogen freezers. A CTU is deemed critical and requiring initial qualification and ongoing requalification if its use has the potential to directly impact patient care or product quality. The list of equipment and CTUs provided in Attachment B is an initial estimate of the equipment requiring service. The volume of equipment requiring service may change for reasons including but not limited to equipment being purchased, replaced, or removed from service.

C.4.6. Testing/Deliverables:

1. All executable qualification protocol templates will be created by the contractor and pre-approved by NIH.

2. A spreadsheet which estimates the number CTU qualifications required each year is provided in Attachment B. NIH will provide the contractor with an initial list of CTUs and (where applicable) their qualification due dates. The contractor is responsible for maintaining an up-to-date CTU qualification list to reflect any new CTUs, CTU replacements, or CTU disposal.

3. The contractor is responsible for managing the qualification schedule and contacting the APF POC to coordinate service based on facility/CTU availability and production schedules.

4. The contractor shall use GDP requirements when completing all qualification protocols at the time of service. Documentation shall include NIST traceable standards for all reference instruments.

The Contractor shall provide all notifications and qualification reports at the timeframes specified in Section E.

C.4.7. Work Planning:

a. NIH will provide operating manuals and pre-existing CTU qualification reports upon request. At a minimum, CTU qualifications will include complete temperature mapping, open door recovery testing and may require additional testing (i.e. for cryogenic freezers).

b. The contractor is required to acquire, use and maintain NIST-traceable standards/sensors to perform all qualification services. Any time that annual qualification test results are found to be out-of-specification, the contractor is required to and verbally notify the COR and APF POC of the unsuccessful calibration. A follow-up email report is required within one business day of the visit to the COR and APF POC. NIH will be responsible for scheduling repairs made to such equipment prior to the next qualification attempt.

c. Unplanned service requests (in addition to those on the established calibration schedule) will be handled as specified in Section F.3.1.

C.4.8. List of In-Scope Equipment and CTUs:

Equipment and CTUs considered in-scope are not limited to but include the following:

1. Gas delivery system (CO2, liquid nitrogen, medical air) manifold/gauges

2. EM air samplers (viable and non-viable)

3. Peristaltic pumps

4. LN2 freezers (excludes controlled rate freezers)

5. Refrigerator, freezer

6. Incubator

7. BSC

8. Centrifuge (refrigerated and non-refrigerated)

9. Balances/scales

10. Water bath (if critical)

11. Vortex mixer

C.5. General Work Planning: All services described in Section C.1 through C.4 above must adhere to the work planning requirements outlined below. The items outlined below are required for all services in addition to any test-specific requirements that may have been described in Section C.1 through C.4.

1. Contractors shall perform all testing in accordance with applicable design specifications or ISO standards including those outlined in Section B.2.3 as determined by the equipment and facility requirements.

2. Contractors shall complete and submit all documentation in accordance with NIH-approved standardized protocol and report templates as outlined in Section E.

3. Executed protocols, reports and videos shall be stored on a designated SharePoint managed by ORSC. The executed protocols, reports and videos shall be uploaded by the contractor to the designated SharePoint within the time frames outlined in Section E.

4. The contractor shall submit schedule and gain approval from the Project Manager and COR in advance of work to be performed.

5. The contractor shall perform work during…