36C25923Q0110.docx

DOCX document 165 KB Posted Nov 29, 2022

Attached to: J065--Biological Safety Cabinets Inspect/Certification Laboratory Hoods & Pharmacy Clean/Ante Room
Solicitation number: 36C25923Q0110
Issued by: Department of Veterans Affairs Veterans Health Administration Veterans Integrated Service Network 19

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36C25923Q0110

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

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

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a.

PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

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. SIGNAT

URE 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. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

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

36C25923Q0110 11-29-2022 Mitchael Purdom 918-577-4435 12-06-2022 10:00

CST

36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401 X X 811210 $8 Million N/A X Department of Veterans Affairs Oklahoma City VA Health Care System 921 N.E. 13th St.

Oklahoma City OK 73104 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

6162 South Willow Drive, Suite 300 Greenwood Village CO 80111

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971 See CONTINUATION Page Inspection & Certification of Biological Safety Cabinets, Laboratory Hoods & Pharmacy Clean/Ante Rooms, and Specialized Room Ventilation Systems.

Respond to Solicitation: Email Jeffery.Eller@va.gov by date and time in block 8.

Evaluation of Solicitation:

1. Price.

2. Certification/License (See Special Standards of Responsibility, 52.212-2, page 73).

3. As per VAAR 852.219-77 return "Certificate of Compliance for Services" (page 45).

See CONTINUATION Page X X Mitchael Purdom

VA-VHA-RPOW-2022-249455

Table of Contents

SECTION A	1
A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES	1
SECTION B - CONTINUATION OF SF 1449 BLOCKS	4
B.1 CONTRACT ADMINISTRATION DATA	4
B.2 PERFORMANCE WORK STATEMENT	5
B.3 PRICE/COST SCHEDULE	10
ITEM INFORMATION	10
B.4 CONTRACTOR PAYMENT REQUESTS	31
B.5 COVID-19 HEALTH REQUIREMENTS	32
B.6 VHA SUPPLEMENTAL CONTRCT REQUIREMENTS FOR COMBATTING COVID-19	32
SECTION C - CONTRACT CLAUSES	35
C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)	35
C.2 52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)	41
C.3 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)	41
C.4 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA ACQUISITION OF COMMERCIAL ITEMS (APR 2020)	41
C.5 VAAR 852.219-74 LIMITATIONS ON SUBCONTRACTING—MONITORING AND COMPLIANCE (JUL 2018)	43
C.6 VAAR 852.219-77 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—CERTIFICATE OF COMPLIANCE FOR SERVICES AND CONSTRUCTION (SEP 2021) (DEVIATION)	44
C.7 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)	45
C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)	45
C.9 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)	46
SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS	54
D.1 WAGE DETERMINATION (WD)	54
SECTION E - SOLICITATION PROVISIONS	65
E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (NOV 2021)	65
E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)	69
E.3 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)	72
E.4 52.212-2 EVALUATION – COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES	72
E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL 2020) (DEVIATION)	74

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[]

52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[]

52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly	[]
b. Semi-Annually	[]
c. Other	[X] following satisfactory services.

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

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

AMENDMENT NO

DATE

B.2 PERFORMANCE WORK STATEMENT

Performance Work Statement

Inspection & Certification of Biological Safety Cabinets, Laboratory Hoods & Pharmacy Clean/Ante Rooms and Specialized Room Ventilation Systems Oklahoma City VA Medical Center Oklahoma City, Oklahoma

1. PURPOSE

1.1 This requirement is for procuring services for testing and certification of specialized room ventilation systems, chemical hoods, Laminar Flow Workstations (LFWs) and Biological Safety Cabinets (BSCs) to provide a safe environment for laboratory personnel at multiple locations. Contractor shall test and certify laboratory equipment, sterile processing areas, and pharmacy clean/ante rooms.

2. SCOPE

2.1 Contractor shall furnish service as specified below to ensure that the equipment functions in accordance with:

NCI Specification “General Purpose, Clean Air, Biological Safety Cabinet, revised August 19, 1975”, NIH specification NIH-03-11ZC dated Sept 17, 1974;

National Sanitation Foundation-Class II, (Laminar Flow) Biohazard Cabinetry-Standard Number 49 [NSF 49];

Federal Standard No. 209E-April 24, 1973, “Clean Room and Work Station Requirements, Controlled Environment”;

SAMA Standard LF10-1980 Laboratory Fume Hoods and USP 797/USP 795 USP General Chapter <800> Hazardous Drugs-Handling in Healthcare Settings 2017

CAG-002-2006

CAG-003-2006

CAG-007-2010

CAG-008-2010

IEST RP-CC-034

CETA Compounding Testing Guide 2006 FDA Insanitary conditions for Compounding CETA Viable Sampling SOP CETA Certification Guide May 2015

2.2 Furnish all labor, equipment, tools, materials, and travel necessary to test, certify and measure Government – owned Biological Safety Cabinets (BSCs), Laminar Flow Work Stations (LFWs), and Pharmacy clean rooms

2.3 Equipment and locations are identified on the Schedule of Items.

2.4 The annual/semi-annual certifications shall be performed in sufficient time to ensure that none shall lapse (contractor will schedule testing that builds in time for repairs should that be necessary to insure certifications never lapse). With two lab hoods in Chemo and two hoods in IV mixing areas. Lab hoods are to be staggered for certification with two hoods certified in the months of December/June and the other two hoods certified during the months of March and September each year. Research provides backup bariatric hoods for mixing chemo and IV’s and these hoods are certified during the months of March/September.

2.5 The Contractor shall provide certification reports upon completion of semi-annual and annual testing/certification. Report will include training/certifications of technicians performing the work and calibration certificates of the equipment used during the testing/certification.

2.6 Contractor will immediately notify COR in writing (letter) or by email, in the event any/all regulatory guidance governing the certifications of any subject equipment changes. Written advisement will include any issues which will impact testing/certification. Contractor will also advise Oklahoma City VA Medical Center of recommendations to resolve any issues related to the regulatory changes.

2.7 When testing/servicing/certifying equipment, the Contractor will provide on-site consultation to Oklahoma City VA staff (answer questions, make recommendations to maintain at optimum level) that use the Pharmacy cleanroom, the biosafety cabinets, and the laminar flow workstations. Technicians knowledgeable about certification requirements will converse with staff/COR to inform them of recommended adjustments to behaviors used in daily use, cleaning of area, maintenance of equipment, and any structural/HVAC/electrical/engineering issues related to the equipment or rooms encompassing equipment. Technicians will brief COR of any issues/questions raised by staff upon checking out post-certification.

2.8 Contractor shall have the capability to respond within 24 hours of contact for emergency repair. Contractor shall furnish the Contracting Officer Representative (COR) with written estimate of cost to make necessary repairs and receive COR approval prior to initiating repairs.

2.9 All of the following information should be included in the report for clean room certification. Room number and/or location, Room type (e.g. oncology prep room), Date of testing, Date of next required certification, Standards used to test room, Room sketch, Total room area and volume, Room humidity and temperature, Air changes per hour, Pressure differential, Non-viable particle counts, and viable particle count analysis.

Pass/Fail notifications should be included on a per test basis where applicable.

3. CERTIFICATION AND TESTING REQUIREMENTS

3.1. Biological Safety Cabinets (BSC): The Pharmacy biosafety cabinet shall be certified semi-annually. All other Biosafety cabinets will be certified annually. Certification shall consist of the following:

Down flow velocity test Inflow velocity test Airflow smoke pattern test (videotaping must be included for Pharmacy hoods only) HEPA filter leak test Alarm function test Blower interlock test (Class II, type B cabinets) Electrical leakage on the main cabinet (those that aren’t UL listed) Ground Fault Circuit Interrupter (GFCI) outlet trip test.

A visual inspection to identify defects, damage, misuse or missing parts Documentation of the certification and inspection results A decal or label affixed to the cabinet in a visible location that indicates the results and date of the certification Posting an “Out of Service” sign on cabinets that fail certification;

Notifying the cabinet user and the COR of cabinets that fail certification.

3.2 Laminar Airflow Workstations (LAFW):

All LAFWs will be certified annually.

Certification shall consist of the following:

Measurement of sash face velocity according to the current version of ASHRAE 110.

Comparison of the sash face velocity to the current ACGIH recommendation.

Airflow smoke pattern test.

GFCI outlet trip test.

A visual inspection to identify defects, damage, misuse or missing parts;

Documentation of the certification and inspection results (e.g., a decal or label affixed in a visible location that indicates the sash certification height, the face velocity and the date of certification).

Posting an “Out of Service” sign on lab fume hoods that fail certification.

Notifying the lab fume hood user and the COR of lab fume hoods that fail certification.

3.3 Pharmacy Cleanroom(s) Testing and Certification:

Testing and certification (under CAG-003-2006-11 and to USP797 Standards and 800 Hazardous Drugs—Handling in Healthcare Settings.) of the Pharmacy: Ante Room, Hazardous Buffer (IV) Room and Non-Hazardous Buffer (Chemo) Room as well as viable air and surface sampling for mold and bacteria will be semi-annually. Certification and testing shall consist of the following:

Test and validate the number of air changes per hour (ACH) through the rooms Heating Ventilation and Air Conditioning (HVAC) equipment and exhaust hood.

Pressure Requirements: The contractor shall include in their report differential pressure reading from each buffer/ante room to all surrounding areas

Non-viable Particle Testing: The contractor shall perform environmental nonviable particle testing semiannually Test and validate that the hood and room exhaust provide a unidirectional/laminar flow of air.

Inspect HVAC filter assembly for air bypass issues.

Test and calibrate the existing air balancing monitors (Chemo and Ante Rooms).

Take viable air samples for mold and bacteria (1 location in each PEC: LFWs, BSC, Pass Thru, and 1 location in the room Ante, and 2 locations Chemo and IV Room. Colony forming units (CFU) results from the cultures shall be calculated in cfu per cubic meter (m3) of air.

Take viable surface samples for bacteria (1 each in LFWs, BSC, Pass Thru, Ante, Chemo and IV Room.

4. PERSONNEL ACCREDITATION REQUIREMENTS

4.1 Contractor services personnel must be NSF accredited and submit their NSF accreditation certificates with their bid proposal.

4.2 Technician performing on-site testing for Pharmacy must be CETA certified.

5. PERIOD OF PERFORMANCE AND WORK HOURS

5.1 The period of performance shall be for one base year with four possible one-year option periods (as outlined with the schedule / line items).

5.2 The Contractor (or Representative) shall contact the COR, Contracting Officer’s Representative, to schedule work and prior to the beginning of work.

5.3 Services are to be performed during our business hours between 7:30 a.m. and 4:00 p.m.

central time, excluding federal holidays. Because of the workload of the pharmacy during business hours, the contractor may need to work after 4:00 p.m. in order to accommodate the compounding schedule at the pharmacy. Contractors that are willing to perform after-hours work should include this information in their bid documentation. If a contractor is willing to perform services after 4:00 p.m. this service must be included within the bid pricing as no extra charge will be allowed. The ability to perform work after hours is not required;

however, preference will be given to contractors that offer flexible work hours.

6. INSPECTION AND ACCEPTANCE:

6.1 The Contractor shall conduct a joint inspection with the COR upon certification and testing of equipment.

7. DELIVERABLES

7.1 After work is completed, the contractor is to submit in writing, a complete report of services performed for each item of equipment and must include a listing of replacement parts, when applicable. Within one week of obtaining sampling results, the vendor will electronically report ventilation and sampling data semiannually to Oklahoma City VA Medical Center Safety Management has a means of evaluating the overall control of the compounding environment. The report should have guidance on interpreting results, possible contamination pathways and proper corrective actions to remediate contamination.

7.2 The contractor shall supply every unit that passes required certification specifications with a certification sticker.

8. TRAINING

8.1 No training is required from the contractor.

9. Transportation Visits = 6 visits a year (4 required and 2 additional trips for troubleshooting/retesting etc.)

10. Facility Information Security Officer (FISO) SECURITY LANGUAGE:

10.1 GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

Pharmacy Testing BioSafety/Laminair hood/cabinet testing/inspection/certification

BSC Cabinets		5 BSC cabinets	4 rooms	Semi-annual testing
Laminar hoods	4 hoods		2 rooms	Semi-annual testing
Research GR-102	1 hood			1 room	Semi-annual testing

Path lab Testing

4F115		Microbiology		Nuaire		1 hood	annual testing
4F115C1	Microbiology		Nuaire		1 hood	annual testing
4F115 B	Microbiology		Nuaire		1 hood	annual testing
4F133		Cytology		Nuaire		1 hood	annual testing
4F137		Molecular		Nuaire		1 hood	annual testing
4F105		Hematology		Nuaire		2 hoods annual testing

Sputum Booth 1A105J Aero med 1 booth annual testing

Isolation Rooms (Ceiling HEPA filter)

5F116 annual inspection/testing 5F144 annual inspection/testing BF132 annual inspection/testing BF133 annual inspection/testing

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

1.00

__________________

Hood, Biosafety Cabinet (Microbiology Lab), MFG/Model NUAIRE Lab Guard ES, SN# 159780102513, Located in Room 4F115, Annual Certification (to be completed in December), in accordance with the PWS.

Contract Period: Base POP Begin: 12-15-2022 POP End: 11-30-2023 PRINCIPAL NAICS CODE: 811210 - Electronic and Precision Equipment Repair and Maintenance PRODUCT/SERVICE CODE: J065 - Maintenance, Repair, and Rebuilding of Equipment - Medical, Dental, and Veterinary Equipment and Supplies

1.00

__________________

Hood, Biosafety Cabinet (BSL3 Lab), MFG/Model NUAIRE Lab Guard ES, Located in Room 4F115-C1 Annual Certification (to be completed in December), in accordance with the PWS

POP Begin: 12-15-2022 POP End: 11-30-2023