01. HHSN-20-Q-198547 - Cleaning Services Project.pdf

PDF 1 MB Posted May 26, 2020

Attached to: Contamination Control and Cleaning Services Project for the NIH Clinical Center
Solicitation number: HHSN-20-Q-198547
Issued by: Department of Health and Human Services National Institutes of Health Clinical Center

View the file

Other files

File	Type	Posted
RFQ - HHSN-20-Q-198547 - Solicitation Amendment 0001.pdf	PDF	Jun 15, 2020
01. ATT 3. Master Facility Cleaning Schedule.xlsx	XLSX spreadsheet	May 26, 2020
01. Price Schedule.xlsx	XLSX spreadsheet	May 26, 2020
01. ATT 6. 2C500 Cleaning Solution Preparation Log.pdf	PDF	May 26, 2020
01. ATT 4. Trailer 10B Cleaning Workflow Diagram.pdf	PDF	May 26, 2020
01. ATT 5. SOP for Contractor Cleaning.pdf	PDF	May 26, 2020

On GovTribe

Work with this file

Download the original file
Contacts named in this file
Similar government files
Ask GovTribe AI about this file

Try for free Login

Text version

The file's text, extracted by GovTribe without its formatting.

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-20-Q-198547

6. SOLICITATION ISSUE DATE

05-26-2020

Anthony Q. Hawley anthony.hawley@nih.gov 06-

12PM

16-2020

(EST)

561720

$19.5 Million

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

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 NIH Clinical Center, Office of Research Support and Compliance (ORSC)is seeking a qualified and experienced vendor to provide contamination control cleaning services for aseptic processing facilities at the NIH Clinical Center on the Bethesda, MD campus. The vendor must be able to demonstrate that it has a significant presence and experience in the pharmaceutical industry or equivalent regulated by cGMP through past and current client lists.

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

Proposals Due: Tuesday, June 16, 2020 at 12:00 p.m. (EST) nih.gov byQuestions shall be emailed to anthony.hawley@

5:00 p.m. (EST) on Monday June 08, 2020.

CONTRACTOR NAME/POC:

CONTRACTOR DUNS AND TIN NUMBER:

CONTRACTOR EMAIL ADDRESS:

CONTRACTOR PHONE NUMBER:

PLEASE SUBMIT ALL QUOTES AND SUBSEQUENT QUOTE MATERIALS VIA EMAIL TO

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

See CONTINUATION Page

X X

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

100X mailto:anthony.hawley@va.gov

SOLICITATION #: HHSN-20-Q-198547

TABLE OF CONTENTS

B.1 CONTRACT ADMINISTRATION

B.2 STATEMENT OF WORK

B.3 PRICE SCHEDULE

B.4 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) ………………………………………………………………………………………………17

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) ... 25

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) ... 26

D.2 ATTACHMENT 2 – PAST PERFORMANCE QUESTIONNAIRE

D.3 ATTACHMENT 3 – MASTER FACILITY CLEANING SCHEDULE (EXCEL

SPREADSHEET) ………………………………………………………………………………………………38

D.4 ATTACHMENT 4 – TRAILER 10B CLEANING WORKFLOW DIAGRAM (PDF) .. 38

D.5 ATTACHMENT 5 – SOP FOR CONTRACTOR CLEANING (PDF)

D.6 ATTACHMENT 6 – 2C500 CLEANING SOLUTION PREPARATION LOG (PDF) 38

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (JAN 2017) 39

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

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

2015) ………………………………………………………………………………………………44

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

………………………………………………………………………………………………45

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)

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:

STEP 4:

In the body of the email, type

“Correspondence

Email:” followed by your email address.

STEP 3:

Attach the invoice to the email as either a

PDF or Word document.

STEP 2:

Subject line must follow this format for the invoice you are submitting

(See note below)

STEP 1:

Send invoices to the following email address:

invoicing@nih.gov

4 STEPS TO CREATE THE INVOICE SUBMISSION EMAIL

STEP 2 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.

EXAMPLE: Vendor: name of the contractor or vendor|PO: Contract Number/Release Number|Invoice:9999999 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: Contract Number/Release Number|Invoice:XYASAD

XYZ Corp|PO # Contract Number\Release Number|Invoice # XYASAD

XYZ Corp|Purchase Order # Contract Number\Release Number|Invoice # XYASAD

XYZ Corp| Contract Number\Release Number| XYASAD

Vendor: XYZ Corp,PO: Contract Number\Release Number,Invoice:XYASAD mailto:invoicing@nih.gov

NOTE(S):

o Must submit only ONE invoice per email.

o 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.

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

o Clearly identify a valid and complete order number on each invoice.

o Clearly identify an accurate DUNS number on each invoice.

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

Please do not hand-deliver invoices to any NIH office. Please follow the above electronic submission instructions until further notice. In addition, please note that your contract or order will not be modified to reflect the above changes to the invoicing instructions. Failure to follow the above electronic submission instructions may result in invoice processing delays.

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 methods to contact are available at OFM website:

https://ofm.od.nih.gov/Pages/Customer-Service.aspx The Customer Service Office is open Monday – Friday from 8:30 a.m. to 4:30 p.m. (EST) and is closed daily between 12:00 p.m. to 1:00 p.m. (EST).

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.

mailto:invoicing@nih.gov https://ofm.od.nih.gov/Pages/Customer-Service.aspx

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), 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

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.

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 Maps, pictures, etc. of the sites requiring services will be provided upon request.

These resources will be made available at the conclusion of the question and answering period and will be posted via an Amendment to the Solicitation.

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.

https://www.sam.gov/SAM/ https://www.sam.gov/SAM/

B.2 STATEMENT OF WORK

PROJECT TITLE: National Institutes of Health (NIH), Clinical Center (CC), Contamination Control and Cleaning Services Project

DEPARTMENT: NIH Clinical Center Office of Research Support and Compliance (ORSC)

1. INTRODUCTION

The mission of the NIH Clinical Center is to provide clinical research servicing the needs of the NIH Intramural Research Program by providing a safe and effective environment for the care and treatment of patients participating in structured biomedical research protocols.

2. BACKGROUND

The NIH Clinical Center is a 200-bed research hospital located on the main campus of the National Institutes of Health in Bethesda, MD. The NIH’s CC provides state-of-the-art clinical care for patients that are enrolled in NIH research study protocols. The CRC serves as a center of excellence in medical research, training, and the clinical care for patients with unique and rare conditions. The CRC plays a critical role in the discovery and application of novel therapeutic agents to assist in the treatment or cure of acute and chronic diseases. To achieve this, the CRC carries out specialized research and is involved in the discovery and development of pharmaceutical grade reagents, cell therapy products, Positron Emission Tomography (PET)/radioactive drugs, and vaccine products. Optimal aseptic processing of these human administered medical products produced by NIH facilities is of upmost importance to ensure best clinical care and patient safety outcomes.

The Food and Drug Administration (FDA) ensures the quality of drug products by carefully monitoring drug manufacturers' compliance with its Current Good Manufacturing Practice (cGMP) regulations especially those on sterile drug product produced by aseptic processing, require stringent cleaning and hygiene programs in pharmaceutical/biologics manufacturing areas. Regulations require that aseptically produced biologics be produced in a cleanroom environment. A critical component to contamination control is the cleaning program for the classified areas which must be well-defined, contain detailed cleaning processes that must be stringently followed by highly trained and competent cleaning staff, and use appropriate, in some cases sterile, and dedicated cleaning supplies and equipment. To effectively clean for aseptic processing and other controlled areas, personnel need to be both qualified and motivated.

3. SCOPE OF WORK

The NIH is seeking a qualified and experienced vendor to provide contamination control cleaning services per the attached Standard Operating Procedure (ORSC-APF-001) and Cleaning Schedule (ORSC-APF- 001A) for the below list of aseptic processing facilities at the NIH Clinical Center on the Bethesda, MD campus. The vendor must be able to demonstrate that it has a significant presence and experience in the pharmaceutical industry or equivalent regulated by cGMP through past and current client lists.

Facility Owner Detailed Description Square Footage

Classified Space CNC

Pharmacy

Interim Intravenous Admixture Unit

(I-IVAU)

1661 1589

Expansion Intravenous Admixture Unit

(E-IVAU)

2173 N/A

Center for Cellular Engineer

2J Facility 3022 N/A

3T 2252 N/A

East Terrace Modular Facility (T10B) 2357 541

Facility Owner Detailed Description Square Footage

Classified Space CNC

Department of Laboratory Medicine (DLM)

2C500 BSL3 area 483 N/A

Building 50 Room N/A 300

PET Department cGMP 191 1507

Segregated Compounding Area N/A 200

NCI Surgery Branch

3W 948 N/A

1B42 247 N/A

TR10B 354 115

NCI TIL Modular Facility 285 2395

NCI Hyperpolarization Facility 128 N/A

4. ADMINISTRATIVE

4.1 The Contracting Officer’s Representative (COR) will be the Contracting Officer’s (CO) authorized representative in administering the contract. A contractor representative shall be available to discuss any problems that the contractor personnel may be experiencing during the performance of this contract. Problems experienced by the Government with the contractor performance will be discussed and resolved. Unresolved problems will be referred to the CO for resolution. The COR is not authorized to make changes to the contract’s terms and conditions.

4.2 All contractor personnel shall receive passing background check results before they can be sponsored ORSC to work at NIH. All facilities within the scope of the contract shall be accessed via NIH-Issued Personal Identity Verification (PIV) ID badges. Contractor personnel shall satisfy all of the federally mandated requirements for obtaining ID badge and/or background investigation required by the U.S. Government. These requirements will need to be fulfilled by each contractor personnel within the allowed timeframe in order to continue work at the NIH. Adequate time and planning must be built in to ensure the badging process is completed in a timely manner. The contractor is responsible for obtaining full cooperation from the contractor staff to prevent delays in the badging process.

4.3 Government Furnished Property (Supplies and Equipment): The contractor shall be responsible for safeguarding all Government property provided or obtained in connection with this contract. NIH facilities, cleaning and disinfection tools, cleaning and disinfection consumables, forms, and other properties required for contract performance shall be maintained in good condition by the contractor.

Contractor shall notify the Government whenever maintenance of equipment is required or whether equipment or items necessary for performance are missing or outdated and should be replaced.

Contractor shall abide by all NIH requirements for physical security of government property and equipment. NIH shall be supplying the following consumables:

Item Description Usage

Aluminum Extendable Universal Handle Moping

Duo Plus Frame Moping

CE Bucket Trolley - Vileda Professional-

FHP

Moping

Hand wiping Bucket Hand-wiping

Transport Bins Transport of consumable outside Building 10

Transport Carts Transport of consumable up to and never beyond facility entry point

Item Description Usage

Vacuum Cleaners For vacuuming floors

Computer Checking emails, responding to request, working with facilities.

HEPA Vacuum Filters A component of HEPA Vacuum

One Solution st LpH Cleaning and Disinfecting agent

PeridoxRTU Sporicidal Cleaning and Disinfecting agent

One Solution st Vesphene Cleaning and Disinfecting agent.

DECON-CLEAN

Removal of cleaning agents from ceiling, walls and floors

Wiper Prosat Sterile Hand wiping activities requiring sIPA

Wipes.

DECON-AHOL Sterile Hand wiping activities requiring sIPA

Wipes.

Sterile Suite Mophead Ceiling, Walls, Doors and Floor Moping.

Bucket liner B-7 Irradiated 31x19 Lining mop buckets

Wipe HSII Sterile12 X 12 Used for hand wiping function.

4.4 The contractor under this contract shall have access to and/or process information requiring protection under the Privacy Act of 1974. These positions are considered “Automated Data Processing (ADP) Sensitive” positions. Contractor shall comply with Executive Order (EO) 10450 and OMB Memorandum M-05-24.

4.5 The contractor shall abide by federal and local NIH regulations and requirements concerning the nature of privileged communication between patients and the contractor as may be necessary for security and personnel reliability programs. They shall also abide by federal and local regulations concerning the confidentiality of patient records, to include but not limited to the Privacy Act of 1974.

All regulations referenced are available for review from the COR, or the CO.

5. REQUIREMENTS

5.1 Contractor Qualifications:

The contractor will be subjected to NIH Supplier Qualification which shall include Paper Audit or in person audits.

At minimum, the contractor must be ISO 9001:2008 certified.

The contractor must have the proven track record of success and expertise, meeting stringent sanitation requirements including equipment-appropriate cleaning agents, methods and products, as well as suitable frequencies of cleaning for various surfaces under strict gowning requirement, necessary to assist the Clinical Center with designing an effective cleaning program.

The contractor must provide experience in the pharmaceutical industry or equivalent regulated by cGMP through past and current client lists.

The contractor should possess knowledge in the effect and impact of cleaning on the Microbiology and Environmental Monitoring of the types of spaces they are cleaning.

The contractor shall demonstrate how they provide a strong presence in management of the cleaning staff and quality assurance of the work done.

5.2 Contract Core Basis:

The fixed price contract coverage will be based on four factors: number of facilities, cleaning levels, square footage and frequency that are set as baseline and outlined in SOP ORSC-APF- 001 and Master Cleaning Schedule (Form ORSC-APF-001A). When any of the four factors change, the work will be considered out of scope, then the contractor shall refer to Section 5.3 for guidance.

At the commencement of the contract, the contractor must provide the stated number of staff for the core basis of this contract.

The contractor is expected to increase staff by 1 FTE per increase of 2500 sq. ft. for 5 days of work; 2 FTEs per increase of 2500 sq. ft. for 7 days of work.

The contractor shall provide a day porter stock cleanroom apparels (gown, smock, lab coat, boot covers, and googles) within each APF and perform cleaning and disinfection when needed during the day.

The contractor shall purchase and replace HEPA Filters in the NIH-owned HEPA Vacuum Cleaners on quarterly basis. The invoice of this purchase shall be submitted to NIH for payments.

The filters must be replaced before they are due, otherwise the contractor shall be responsible for initiating an impact investigation.

The contractor is to specify at the start of each month the number of staff provided based on the four factors stated in the Master Cleaning Schedule.

The contractor is to provide full coverage of staff for 365 days a year including major holidays and holiday eves and during the closure of NIH due to inclement weather.

Contractor will not negotiate the reduction of cleaning or skipping of cleaning for staffing convenience.

The contractor shall be accept any ad hoc or out of scope work requests, via NIH-approved Cleaning Change Request form, 12 hours in advance of work.

The contractor shall be accept and execute emergency cleaning request where lead times are less than 12 hours at a rate of $100.00 per request.

A cancellation charge of $100.00 and 8 hours labor time per person scheduled will be charged in addition to this contract for less than 12 hours’ notice of cancellation for scheduled out of scope and emergency cleanings. Cancelation of routine cleanings will not incur additional cost to NIH.

The contractor is financially responsible for damages incurred in facilities upon a thorough investigation determining the damage is due to negligence and/or not following the procedures as outlined in the Standard Operating Procedures. The restitution may include paying for the cost of repair service and replacement of equipment or parts.

5.3 Ad Hoc or Out of Scope Work:

The fixed price contract consists of core work that is set by the Master Cleaning Schedule. There is additional cleaning work that cannot be set on a regular schedule due to its unexpected, infrequent or temporary nature, thus a section for ad hoc or out of scope work is created. The ad hoc or out of scope work are specified below. Similarly, there are work that NIH does not assessed to be ad hoc or out of scope. Both lists are set in the SOW and cannot be altered without a discussion and approval from the COR.

Ad hoc or out of scope work:

o Lower level cleaning to higher level cleaning (L2 to L3) o One Time Cleaning of an out-of-scope facility o Emergency Cleaning (flood, HVAC issue) o Production Change Over Clean o Delay in cleaning due to Facilities/Production o Performance of cleaning validation that is not part of regular cleaning schedule on behalf of NIH o Special training not derived from contractor performance issues correction actions.

Example, retraining as part of changes to NIH procedures or part of process improvement.

o NIH required annual training of cleaning staff (besides cleaning time) o Temporary increase in cleaning levels (overall) o Temporary increase in facilities o Temporary increase in cleaning frequency o Temporary increase in square footage to an area o Additional step to the cleaning process after repairs o NOTE: Contractor will not execute any cleaning or activity NIH considers ad hoc or out of scope listed above before receiving prior approval from the NIH COR.

Not considered ad hoc or out of scope work:

o Higher level cleaning to lower level cleaning (L3 to L2).

o One for one (L3 cleaning moving from one day to another day or week to week) substitution of cleaning.

o Inadequate number of staff leading to overtime.

Ad hoc cleaning or out of scope cleaning with 12 hour advance notification.

Cover one-for-one cleaning substitution from moving L3 cleaning one day to another day or week to week.

During major holidays when many staff are on holidays.

Cover time frame of daily cleaning.

Cover ad hoc or out of scope cleaning.

Contract Modification o Increase in occurrence for ad hoc or out of scope to a point of regular work should be discussed with the COR to consider for a contract modification.

o A permanent increase of work (immediate or observation of trend) should be discussed with the COR to consider for a contract modification.

5.4 Deliverables:

Weekly Call with COR and/or POC to provide update and discuss any quality issues.

Monthly report for ad hoc / out of scope work.

Creation of Monthly Cleaning Schedule based on NIH template

Complete deviations or investigations.

Continuous improvement.

Evaluate scope of work or adjustments.

5.5 Personnel and Management:

The contractor must have management that has a background consisting of education, training, and experience in microbiological contamination control and be fluent in terminology and understanding of the cleanroom environment.

The contractor must provide adequate staffing to cover the needs the facilities within the scope of this contract.

At minimum, the contractor shall maintain a site manager and one supervisor or lead to oversee the cleaning and disinfection program.

The contractor manage and supervisor must provide clear supervision and low worker turnover maximize for cleaning consistency and regulatory compliance.

Staffing levels of the contractor must be periodically adjusted as more facilities gets added to the scope.

The contractor must provide a sufficient number of employees to meet the requirements of the contract. It is the responsibility of the contractor to appropriately coordinate employees to show up facilities on a timely basis and provide sufficient coverage for sick or absent employees. The contractor is then responsible to inform the Clinical Center of any unexpected gaps or changes.

For personnel safety, the contractor must ensure adequate staffing to ensure that there will be no less than 2 employees present in each facility at all times. In addition, the contractor must provide sufficient supervisors to ensure adequate quality control and review of documentation.

Employees must be prompt and the service provided by the contractor must be continuously meeting Clinical Center operational needs.

Employees should be designated and identified for each of the Clinical Center facilities in order to limit the number of different personnel who will be authorized entry to the facility.

Employees must strictly adhere to approved methods and cleaning procedures and will be periodically observed by Clinical Center personnel for adherence to the procedure.

If discrepancies are observed, the contractor must have mechanisms in place to take corrective and preventive action, including investigating the cause of the deviation from procedure, and provide staff retraining where appropriate.

The contractor must also provide replacement-cleaning staff when requested by the Clinical Center if there are 3 consecutive incidents of non-compliance with any of the cleaning staff.

It is the responsibility of the contractor to ensure that adequate staff is available at all times to meet contractual needs.

Regardless of the nature of night shift work, weapons are not permitted at the NIH, a Federal facility.

5.6 Adherence to ORSC Standard Operating Procedure (SOP):

The contractor shall execute the cleaning and disinfection program per NIH approved procedure

SOP ORSC-APF-001.

The contractor shall execute all routine cleanings specified on the Master Cleaning Schedule (Form ORSC-APF-001A) and at the times specified. The contractor shall not change, replace, or modify the cleaning schedule at any time during this contract. All changes to cleaning scope be authorized by NIH. The contractor shall accommodate any changes to the specified cleaning times upon minimum of a 12 hour notification.

The facility will be under an environmental monitoring program for particulates as well as viable organisms. If any objectionable organism or an unacceptably high enumeration of organisms is detected, the contractor must be able to provide the Clinical Center with a corrective sanitization and decontamination of the facility to restore to operating condition and cooperate with a Clinical Center root cause investigation as it may pertain to cleaning supplies, methods or contractor personnel as a potential root cause. The contractor will work with the Clinical Center to provide corrective and preventive actions if an investigation definitively determines contractor supplied materials or personnel as the root cause to a contamination in the controlled facility.

5.7 Creation of Monthly Cleaning Schedule:

The contractor shall create and disseminate Monthly Cleaning Schedules using NIH approved templates a week before the next month

5.8 Training Requirements:

The contractor must provide cleaning technicians that are highly qualified in education, experience, and training of cleaning.

The contractor shall train all personnel on the Cleaning and Disinfection program employed by NIH before sending them over for NIH gowning and cleaning qualification.

The contractor must provide periodic refresher training to keep staff up-to-date on new methods and makes sure everyone is working to meet the highest standards of Quality Assurance and Environmental Health and Safety.

All contractor personnel shall undergo facility specific gowning training and qualification before performing any cleaning and disinfection activities for the facility.

All personnel shall be subjected to Cleaning and Disinfection Qualification by NIH on random basis.

Contractor site managers and supervisors shall be trained in cGMP investigations in order to follow proper techniques when resolving cleaning related events.

Maintain GMP trainings annually and have current GMP knowledge.

Possess relevant experience cleaning in GMP controlled environments such as ISO 7 and 8.

Possess a basic understanding of microbiological principles as they relate to contamination control including an understanding of the pathways for contamination and the principles of sanitization.

Be able to read, comprehend, and perform cleaning in accordance to detailed instructions provided in Standard Operating Procedures (SOPs).

Provide proper documentation including any observations upon the completion of the cleaning in accordance to the requirements stated in SOPs.

Pass knowledge and performance assessments relating to cleaning tasks.

Successfully pass a gowning certification program.

Adhere to standard, accepted cleanroom practices, such as absence of jewelry, perfumes, or makeup.

Complete additional training and requirements required by each facility for authorization to enter the facility.

Quality Assurance (QA) oversight shall be provided by NIH as part of this contract. The cleaning technicians are to comply with any advice, observations, and corrective actions provided by the QA oversight.

B.3 PRICE SCHEDULE

CONTRACT

LINE ITEM

NUMBER

(CLIN)

DESCRIPTION OF

SUPPLIES/SERVICES

PERIOD OF

PERFORMANCE

QTY. UNIT UNIT PRICE TOTAL

AMOUNT

0001 Contamination Control and Cleaning