36C24819Q0987-0001007.pdf

Request for Quotes: 36C24819Q0987

General Information

Document Type: Request for Quotes

RFQ Number: 36C24819Q0987

Posted Date: June 28, 2019

Response Date: July 30, 2019 @ 3 PM EST

Classification Code: H366

Set Aside: Small Business

NAICS Code: 541380

Contracting Office Address

NCO 8

ATTN: John Hamilton

10000 Bay Pines Blvd, Bldg. 2 RM 329

Bay Pines, FL 33744

Description

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6 in conjunction with Part 13, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation for this action. Quotes are being requested, and a written solicitation will not be issued.

This solicitation is issued as a Request for Quote (RFQ). Submit written quotes on

36C24819Q0987. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-02 effective June 5, 2019. This request for quote is issued June 28, 2019 and will end on July 30, 2019 at 3:00 PM EST and is Set-Aside for 100% Small Business.

The Network Contracting Office 8-SAO East intends to award a firm fixed priced contract to the contractor providing a Base Year and 4 Option Years service to provide inspection, service, certification for biological safety cabinets, TB isolation rooms, general isolation rooms, separative enclosures, and glove boxes, all Pharmacy (PEC) devices and (SEC) classified air space rooms and segregated compounding areas. Testing will take place at the C. W. Bill

Young VA Medical Center, 10000 Bay Pines Blvd, Bay Pines, FL 33744 and at the Lee

County VA Healthcare Center, 2489 Diplomat Parkway East, Cape Coral, FL 33909.

All the work will be in accordance with the Statement of Work below.

This procurement is being conducted under Subpart 13.5 Simplified Procedures for Certain

Commercial items. The intent is to award a firm fixed price contract.

This procurement is a 100% Small Business set-aside and all eligible offerors are encouraged to submit quotes. To be considered for award prospective offerors must be a verified Small Business (if applicable) or if SDVOSB and VOSB concern in the VA Center for Verification and Evaluation (CVE)

Veteran Information Pages (VIP) pages https://www.vip.vetbiz.gov/ at the date and time set for receipt of offers. An Offeror who is not a verified SDVOB or VOSB concern at the date and time set for receipt of offers will be considered Small Business to be considered for award. All offerors must be registered in

System for Award Management (SAM) at http://www.sam.gov to be considered for an award of a federal contract registered in the record must be complete and not missing elements such as representations and certifications.

Contractors interested in providing these services should submit their quotes via email to john.hamilton2@va.gov.

A Two (2) Day: Multiple Location Site Visits: are scheduled on

Tuesday, July 9th, 2019 Starting: at 10:00 a.m. EST and on

Wednesday, July 10, 2019 Starting at 10:00 a.m. EST.

Site Visit Day 1: is scheduled on Tuesday, July 9, 2019 at 10:00 a.m.

EST at the Lee County VA Healthcare Center Main Campus. 2489

Diplomat Parkway East, Cape Coral, Florida 33909.

ALL VENDORS WILL REPORT AND SIGN IN FRONT OF NORTH

ENTRANCE MAIN BUILDING NO LATER THAN 10:00 A.M. EST, PRIOR

TO CHECKING IN AT THE POLICE DISPATCH WINDOW AND

PROCEEDING TO THE SITE VISIT.

NOTE: Site Visit Day 2: is scheduled on Wednesday, July 10, 2019 at

10 A.M. EST at Multipule Sites on the Bay Pines VA Main Campus.

10000 Bay Pines Blvd, Bay Pines, Florida 33744.

https://www.vip.vetbiz.gov/ http://www.sam.gov/ mailto:john.hamilton2@va.gov

Interested contractors shall meet at Building 2, BY THE

ELEVATORS, NO LATER THAN 10 A.M. EST, BEFORE

PROCEEDING TO THE SITE VISIT.

The site visit is very and highly encouraged and expected prior to submission of quote.

All questions regarding this RFQ must be in writing and may be sent by email to john.hamilton2@va.gov

Questions must be received no later than Monday, July 15, 2019 at 12:00 P.M. No further questions will be accepted after this date and time.

ANSWERS TO VENDOR QUESTIONS: Answers to vendor question will be posted on FBO no later than Tuesday, July 16, 2019 by 3:30 P.M. EST.

You are reminded that representatives from your company SHALL NOT contact any Bay Pines VA Healthcare System personnel to discuss this RFQ during the RFQ process. All questions and concerns regarding this RFQ shall be directed to the

Contracting Officer.

Quotes are due by 3:00 PM Eastern Standard Time on Tuesday, July 3, 2019. Quotes received after this date and time will be considered late in accordance with 52.212-1(f) and will not be evaluated. Quotes shall be submitted via email to john.hamilton2@va.gov.

B. Schedule of Services:

Contractors shall quote prices using Attachment A for all of the following Contract Line

Item Numbers listed in ELIN List Spreadsheet.

C. Statement of Work

Statement of Work

Service: CERTIFICATION, ROUTINE TESTING AND MAINTENANCE OF TB

ISOLATION ROOMS AND EQUIPMENT, BIOLOGICAL SAFETY CABINETS, ROOMS

AND EQUIPMENT USED BY PHARMACY TO PREPARE COMPOUNDED STERILE

PRODUCTS (CSP).

A. GENERAL SCOPE

Certification, maintenance and service of TB isolation rooms and equipment, biological safety cabinets, and/ or all primary engineering control (PEC) devices (laminar airflow workbenches (LAFW), compounding aseptic containment isolators and secondary engineering controls (SEC) (i.e. cleanroom, anterooms) used for compounded sterile product preparation, are installed and maintained to meet all regulatory requirements.

1. Scope of Work: The contractor shall provide inspection, service and certification for biological safety cabinets, TB isolation rooms, general isolation rooms, separative enclosures and glove boxes, all Pharmacy (PEC) devices and (SEC) classified air space rooms and segregated compounding areas All areas and equipment used in compounding sterile products must meet requirements as specified in USP Chapter 797 Pharmaceutical

Compounding -Sterile Preparations, USP Chapter 800 Hazardous Drugs- Handling in

Healthcare Settings. and VHA Directive 1108.12 Management and Monitoring of

Pharmaceutical Compounded Sterile Preparations. All vendors used to conduct primary and secondary engineering controls certifications/ assessments for rooms and devices used in preparation of CSP must be registered with Controlled Environment Testing

Association (CETA). Contractor must perform field verification of all hoods and rooms and submit in writing within 30 business days to CO/COR.

2. Background: The current vendor performs semi-annual certification of all biological safety cabinets and negative pressure isolation rooms on an as-needed basis, as well as periodic decontamination and maintenance/repair of biological safety cabinets. All PECs and SECs used in preparation of CSP are also certified on a semi-annual basis. In addition, nonviable airborne monitoring and microbiological (viable) air and surface monitoring are performed in accordance with current USP 797.

3. Performance Location and Hours Testing will take place at the C.W. Bill Young VAMC, 10000 Bay Pines Blvd, Bay Pines, FL 33744 and at LCHCC, 2489 Diplomat Parkway East, Cape Coral, FL 33909. Testing will take place during normal business hours 0800 – 1630 Monday through Friday, excluding Federal holidays. When necessary contractor will be provided access 0600- 2100 C.W. Bill Young VAMC to enable testing of staff working second and third shifts.

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this SOW until the CO has conducted a kick-off meeting or has advised the contractor that a kick-off meeting is waived.

C. GENERAL REQUIREMENTS

1. Inspection and testing of all HEPA exhaust units designated for tuberculosis (TB) control shall be conducted semi-annually. Each HEPA exhaust unit, Laminar Flow hood, or

Biological Safety Cabinet (BSC) shall be certified six (6) months following previous certification.

2. Pre-filter changes/inspections in the Pharmacy shall be conducted monthly.

Microbial testing for mold and yeast in Pharmacy will be done in according with USP 797 and CETA Certification Application Guides.

3. Certification and maintenance of PECs and SECs used in preparation of CSP to meet USP 797/800 and VHA Directive 1108.12 standards

4. Inspections and testing shall be scheduled with the COR a minimum of three (3) working days in advance. There is potential difficulty in accessing some HEPA units due to the nature of patient care activities; therefore, close coordination with the COR is necessary. Contractor will be responsible for ensuring all certifications are completed within the required time frame (semi-annually) for all hoods and HEPA units.

5. Inspections shall consist of a complete check of equipment, making all necessary adjustments, alignments, cleaning, lubrication, performance testing and calibration to ensure equipment meets or exceeds manufacturers' original specifications available in manuals on site.

6. Any work requiring decontamination of Equipment/Components shall be performed with Hydrogen Peroxide Vapor decontamination.

7. The vendor shall refer to the most current versions of standards including but not limited to USP, FDA and CETA when conducting the requested monitoring and reporting. The frequencies of testing and specific procedure should be determined by the most updated version of CETA, USP <797> and <800>, and per specific facility requirements and/or requests.

The vendor shall be responsible for complying with the most updated versions of this guidance and will conduct all sampling per the procedures outlined within the official chapters.

8. Gowning and Garbing Evaluation: The Vendor shall perform a gowning and garbing evaluation for each employee in conjunction with the gloved fingertip and thumb sampling and media-fill test. The vendor shall use the facility’s standard operating procedure as guidance for their evaluation.

9. Gloved fingertip and thumb sampling: The Vendor shall perform the gloved fingertip and thumb sampling for the expected number of employees from each facility as listed in appendix

A. This should be done in conjunction with media-fill testing. The results should be reported by number of colony-forming units (CFU) per hand (left hand, right hand). If any agar plates demonstrate growth, the preliminary results will be reported to the CO/COR, to the Chief, Pharmacy Service and to the Compounded Sterile Products Program Manager, Pharmacy

Service as soon as the initial results are known. Final results will be expeditiously reported after further antimicrobial testing is complete.

10. Media-Fill Testing: The Vendor shall perform media-fill testing for the expected number of employees from each facility as listed in appendix A. This should be done in conjunction with gloved fingertip and thumb sampling. The results should include the name of the employee evaluated, the evaluation date/time, media and components used to include the expiration date and lot number, the results, and the signatures of the person evaluated and the observer.

Failure of the test in indicated by visible turbidity or other visual manifestations of growth in the medium in one or more container-closer units on or before the end of the incubation period. If any container-closer units demonstrate growth, the preliminary results will be reported to the

CO/COR, to the Chief, Pharmacy Service, and to the Compounded Sterile Products Program

Manager, Pharmacy Service as soon as the initial result is known as soon as the initial result is known, and results will be expeditiously reported after further antimicrobial testing is complete.

11. Compounding area certification: The vendor shall provide certification of classified areas using procedures in the current Controlled Environment Testing Association (CETA) application guides. Certification must be performed at least every 6 months and as needed depending on facility requirements or requests. Certification must include the following:

12. Airflow testing: The air changes per hour (ACPH) from the HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

13. HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

14. Total particle count testing: Must be performed under dynamic operating conditions using current, state-of-the-art electronic equipment. Air sampling sites must be selected in all classified areas. Measurements must be taken in each PEC at locations where there is greatest risk to the exposed CSPs, containers, and closures. Measurements of nonviable airborne particles in other classified areas including the buffer room(s) and ante-room(s), should be taken at representative locations that reflect the quality of air in the room(s).

15. Smoke visualization studies: Must be performed for each PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation (s). Additional smoke tests will need to be performed in rooms without low air returns. A video of the smoke test must accompany the report. Any media files must be provided in DVD format to comply with VHA guidance for media. No .zip files, usb storage, flash drives, or downloadable files from vendor web sites.

16. Primary engineering control (PEC) certification (laminar flow hoods, biological safety cabinets, compounding aseptic isolators, compounding aseptic containment isolators, pass through chambers etc.). The PEC must be certified to meet ISO class 5 at 0.5 μm and larger particles during dynamic operating conditions. PEC certification must include all specifications as outlined per CETA application guides and pertinent USP chapters. This must be performed at least every 6 months and as needed depending on facility requirements.

17. Differential pressure certification: Must be performed at least every 6 months and as needed depending on facility requirements for ante rooms and buffer rooms. Cleanrooms used for non-hazardous compounding must be positive pressure relative to the adjacent spaces.

USP chapter <797> requires a minimum pressure differential of 0.020” w.c. relative to adjacent spaces. Cleanrooms used for hazardous applications should be a minimum 0.010” w.c.

negative relative to adjacent spaces.

18. Viable Air Sampling: Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions at least every 6 months and as needed depending on facility requirements. At least 1 cubic meter or 1000 liters of air should be sampled at each designated location. The media should be examined and the report should detail the total number of discrete colonies of microorganisms on each plate as

CFU per cubic meter of air based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 1 for ISO Class 5, greater than 10 for ISO class 7, and greater than 100 for ISO class 8. If any container demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact as soon as the initial result is known and final results will be expeditiously reported after further antimicrobial testing is complete.

19. Viable Surface Monitoring: Each classified area including the interior of the PEC

(including equipment contained in it), staging or work areas near the PEC, frequently touched surfaces and pass through chambers must be sampled at least monthly. Sampling should be performed at the end of the compounding activities, but before the area has been cleaned and disinfected. The media should be examined and the report should detail the total number of discrete colonies of microorganisms on each device as CFU per sample based on the sample type, sample location and sample date. The genus of any microorganism recovered must be identified with the assistance of a microbiologist if the CFU count exceeds the following: greater than 3 for ISO Class 5, greater than 5 for ISO class 7, and greater than 50 for ISO class 8. If any device demonstrates the presence of CFU that exceed the actionable levels, the preliminary results will be reported to the Chief, Pharmacy Service and corresponding

Pharmacy Service point of contact (COR, etc.) as soon as the initial result is known and final results will be expeditiously reported after further antimicrobial testing is complete.

20. Environmental wipe sampling for hazardous drug (HD) surface residue should be performed routinely as outlined by USP <800> for those facilities listed in appendix A. Results will be reported to the Chief, Pharmacy Service and corresponding Pharmacy Service point of contact (COR, etc.) as soon as results are available.

21. The contracting officer representative will schedule testing with the vendor. The vendor shall provide the corresponding Pharmacy Service with all service reports and certification of the job performed. After completion of work, the vendor shall notify the contracting officer representative for signature and verification of work performed.

22. All equipment shall be maintained in proper operating condition as specified by the

Manufacturer, USP, CETA and FDA standards. The vendor is to have required supplies, manuals, and schematics, which must be available on site to perform the services. All work is to be performed in accordance with the guidelines established by state and local ordinances with manufacturer’s manual and quality control manual, and with all terms, conditions, provisions, schedules and specifications provided herein.

23. In the event that the facility or personnel require recertification or testing due to actionable results, the vendor must be able to provide retesting within 7 calendar days of the request. If vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

24. In the event that the samples obtained during testing are damaged during transport or processing, the vendor shall annotate the damage in the report and provide retesting within 7 calendar days of the request at no additional cost to the facility. If the vendor is not able to provide services within the required timeframe, the vendor shall propose a reasonable alternative response time.

D. CALIBRATION/CERTIFICATION PROCEDURES

1. Certifiers Instrument Calibration: Certificates of Calibration substantiating NIST

(National Institute of Standards & Technology) traceability annual compliance with requirements, and minimum sensitivities of instruments used in conducting testing in accordance with national Sanitation Standard No. 49 for Class I and Class II Biological

Safety Cabinets (BSC); and ISO Standard 146447 for Laminar Flow Clean Work Stations.

Compliance with USP 797, USP 800, CETA CAG-002-2006, CETA CAG-003-2006v May 2015

Performance Meet or exceed ISO 14644-1 for Class 5 air quality.

2. Photometers and Particle Counters are to have a minimum sample flow rate 1.0

FM.

3. Scan rate for filter leak testing shall be no more than three (3) inches per second against filter surface.

4. Field calibration of Photometer used for filter leak testing shall be made by inserting an aerosol challenge upstream of the filter and sampling between the blower and filter to verify an upstream challenge concentration of at least 10 micrograms of DOP or similar challenge medium of air volume handled by the filter.

5. Particle Counter shall be challenged with a particle count greater than 100,000 particles at 0.3 microns prior to use.

6. Inspections and testing for BSCs in Microbiology Acid Fast Bacteria (AFB) Room shall require the use of a HEPA Respirator. Inspections and testing for any items, including

TB isolation rooms shall require the use of a HEPA Respirator while the rooms are occupied by known or rule-out TB patients, in accordance with CDC guidelines.

7. Service to include all necessary performance testing and minor repairs to ensure equipment meets or exceeds manufacturer's original specifications. Contractor must field verify all inventory of equipment prior to submitting bids.

8. The cost of this certification agreement will include all necessary equipment, labor, and travel. All work to be warrantied for a period of one year for parts and labor furnished by the contractor. The contractor shall provide emergency repair on an as-needed basis, with charges originating only when required. Contractor shall provide hourly rates equivalent to the Department of Labor rates for repair technician as prescribed in the current wage determination number 2005-2125 (Rev-17), dated 6/19/2013 posted on www.wdol.gov on 6/25/2013 for Hillsborough and Pinellas County.

E. ROUTINE AND EMERGENCY SERVICES BEYOND PREVENTATIVE

MAINTENANCE PROCEDURES:

Contractor shall furnish equipment, parts, material, labor and supplies necessary to repair equipment listed in the Statement of Work. Contractor shall return equipment to full operational condition in accordance with manufacturer specifications. Contractor shall provide a written estimate with a breakout cost of labor, travel, material and parts prior to performance of repairs not to exceed $2,400.00. The written estimate shall be provided to the COR for CO final approval and funding.

Certification of classified areas (rooms and devices) using procedures in the current

Controlled Environment Testing Association (CETA), USP Chapter 797, and VHA Directive

1108.12 Management & Monitoring of Pharmaceutical Compounded Sterile Preparations, USP Chapter 797, CETA CAG_003_2006 v2015: Sterile Compounding Facilities, CETA

CAG_002_2006 v2008: Compounding_Isolator Testing_Guide

Airflow testing is performed to determine acceptability of the air velocity and volume, the air exchange rate, and the room pressure differential in doorways between adjacent rooms to ensure consistent airflow and that the appropriate quality of air is maintained under dynamic operating conditions. The ACPH from HVAC, ACPH contributed from the PEC, and the total ACPH must be documented on the certification report.

• HEPA filter integrity testing: HEPA filters must be leak tested at the factory and then leak tested again after installation and as part of recertification.

• Total particle count testing (see 5.1 Total Airborne Particle Sampling): Total particle count testing must be performed under dynamic operating conditions using calibrated electronic equipment.

• Dynamic airflow smoke pattern test: Smoke pattern tests must be performed for each

PEC during dynamic operating conditions to demonstrate unidirectional airflow and sweeping action over and away from the preparation(s). Smoke visualization studies: must have actual video for records , with written report.

Viable testing – Microbiological Air per CETA CAG_009_2011 V 2012 (USP 797

Viable Environmental Sampling Gowning Evaluation), USP Chapter 797—every 6 months, for all rooms. Each classified area and pass through shall have volumetric active air sampling using an impaction device during dynamic operating conditions

Surface sampling per CETA CAG_009_2011 V 2012 (USP 797 Viable Environmental

Sampling Gowning Evaluation) - Monthly, USP Chapter 797 http://www.wdol.gov/

Staff-- CETA CAG_009_2011 V 2012 (USP 797 Viable Environmental Sampling

Gowning Evaluation), USP Chapter 797 every 6 months ( ~ 50 staff members): Gowning and Garbing Evaluation, Gloved fingertip and thumb sampling and Media-Fill Testing

F. EQUIPMENT LISTING AND LOCATION

Pharmacy Hoods - Bay Pines

Serial # ID# EE# Location Type of Unit Frequency Comments

462.062 EE87910 Bldg 100 IP Pharm 1C-126

LAFW EG-

62652

6 MOS

93628 462.063 EE87908 Bldg 100 IP Pharm 1C-126

LAFW EG-

62652

6 MOS

93626 462.064 EE87909 Bldg 100 IP Pharm 1C-126

LAFW EG-

62652

6 MOS

1360100

221510 EE124946 Bldg 100 IP Pharm 1C-126 CAI 6 MOS

HAZARDOUS DRUG

Serial # ID# EE# Location Type of Unit Frequency Comments

1154060

60607 EE124946 Bldg 100 5A Pharm 5A-104 CACI - 6 MOS

Hazardous

Drug

Bldg 100 5A Pharm 5A-104 CACI - NEW 6 MOS Hazardous

Drug

Bldg 100 5A Pharm 5A-104 LAFW - NEW 6 MOS

Mobile CSP Pharmacy

Trailer Neg Side - Chemo BSC-1 6 MOS New On station HD

Trailer Neg Side - Chemo BSC-2 6 MOS New On station HD

Trailer Pos Side LAFW BV-1 6 MOS New On station

Trailer Pos Side LAFW BV-2 6 MOS New On station

Pharmacy Rooms - Bay Pines

Serial # Location Type of Room Frequency Comments

462.091 Bldg 100 IP Pharm 1C-126 Non HD Ante-Room ISO 8 6 MOS

Bldg 100 IP Pharm 1C-126 Gowning Room (ante-room) ISO 8 6 MOS

Bldg 100 IP Pharm 1C-126 Non HD Clean Room 1 ISO 7 6 MOS

Bldg 100 IP Pharm 1C-126 Non HDClean Room 2 ISO 7 6 MOS

5A CSP Pharmacy Satellite

Bldg 100 5A Pharm 5A-104 Non HD Clean Room Pos ISO 7 6 MOS new area

Bldg 100 5A Pharm 5A-104 HD Clean Room Neg ISO 7 6 MOS new area

Bldg 100 5A Pharm 5A-104 Ante Room ISO 7 6 MOS new area

Trailer Non HD Ante Room Pos ISO 8 6 MOS new area

Trailer Non HD Clean Room Pos ISO 7 6 MOS new area

Trailer HD Ante Room Neg ISO 7 6 MOS new area

Trailer HD Clean Room Neg ISO 7 6 MOS new area

Pharmacy Hoods – Lee County

Serial # Type Unit Location Type of Room Frequency

6S-15-BH-18100 Germfree LCHC 1B-164 Horizontal LAFW Bz-6ss 6 mos.

170440933-E Labconco LCHC 1B-166 BSC TYPE C1 6 mos.

n/a n/a LCHC 1B-166 HD CLEANROOM 6 mos.

n/a n/a LCHC 1B-165 ANTEROOM 6 mos.

n/a n/a LCHC 1B-164 NON-HD CLEANROOM 6 mos.

Pharmacy Room – Lee County

Serial # Unit # Location Type of Room Frequency n/a n/a LCHC 1B-166 HD CLEANROOM 6 mos.

n/a n/a LCHC 1B-165 ANTEROOM 6 mos.

n/a n/a LCHC 1B-164 NON-HD CLEANROOM 6 mos.

Testing Breakdown

Every 6 Months

Air flow testing

HEPA filter integrity testing

Total particle count

Smoke visualization studies

Every 6 Months

Primary engineering controls

Differential pressure certification

Viable Air Sampling

Every Month

Surface Sampling

Laboratory – Bay Pines Serial # ID# EE# Location Type of Unit Frequency

260747 462.007 516-EE8766 Bldg. 100 Immunology 2B-

36213-08 Annual

114722050207 462.058 516-EE75531 Bldg. 100 Lab 2B-130 (BSL3) NU-425-600 Annual

462.059 Bldg. 100 Lab 2B-130 (BSL3) BSL3 Annual

125245081508 462.065 516-EE60403 Bldg. 100 Lab 2B-129 NU-425-600 Annual

125243081408 462.066 516-EE60404 Bldg. 100 Virology Lab 2B-

NU-425-600 Annual

462.068 “A” Bldg. 100, Rm 2B-109 Wall Slot Annual

462.069 “B” Bldg. 100, Rm 2B-109 Slot-Type Annual

462.070 Bldg. 100, Rm 2B-127 Fume Hood Annual

128109 462.071 516-EE69199 Bldg. 100, Rm 2B-138 ThermoFishe r Table An-

Annual

LR43145 462.072 516-EE5482 Bldg. 100, Rm 2B-131 Captair E54, Annual

462.073 Bldg. 100, Rm 2B-131 Slot-Type

Fume Hood

Annual

462.074 “2” Bldg. 100, Rm 2B-141 Slot-Type Annual

462.075 “4” Bldg. 100, Rm 2B-141 Slot-Type Annual

462.076 “A” Bldg. 100, Rm 2B-124 Fume Hood Annual

462.077 “C” Bldg. 100, Rm 2B-124 Fume Hood Annual

462.078 “B” Bldg. 100, Rm 2B-124 Fume Hood Annual

462.079 516-EE74039 Bldg. 100, Rm 2B-137 Shandon Gross-Star

Annual

462.080 516-EE74038 Bldg. 100, Rm 2B-137 Shandon Grosslab Sr.

Annual

041027524 G 462.081 Bldg. 100, Rm 2B-142 Labc.

Protector

Annual

041027476 G 462.088 Bldg. 100, Rm 2B-110 Labc.

Protector #4880100

Annual

462.089 516-EE69198 Bldg. 100, Rm 2B-138 Thermo Scientific

Annual

EE74040 Bldg. 100, Rm 2B-137 Grossing Station

Annual

EE 124946 Bldg. 106 NuAire NR 797-400

Annual

146009082211 2096.001 516-EE81939 LCHC 1B-107 NU-425-600 Annual

146009082211 2096.001 516-EE81939 LCHC 1B-107 Fume Hood Annual

Other Hoods / Bay Pines

Serial # ID# EE# Location Type of Unit Frequency

Sterilizer #31 113452 Sterile Processing 1C-109 Steam Sterilizer Annual

Sterilizer #32 113449 Sterile Processing 1C-109 Steam Sterilizer Annual

Sterilizer #33 113451 Sterile Processing 1C-109 Steam Sterilizer Annual

Washer #18 115504 Sterile Processing 1C-109 Washer-Disinfector Annual

Other Hoods / Lee County

Sterilizer #3 87564 Sterile Processing Steam Sterilizer Annual

Sterilizer #4 87563 Sterile Processing Steam Sterilizer Annual

Washer #5 87624 Sterile Processing Washer-Disinfector Annual

Washer #6 87623 Sterile Processing Washer-Disinfector Annual

Research & Dental – Bay Pines & Lee County

12895 462.014 516EE91317 Bldg. 23, Research 207C CCI 740 Annual

BBF3 462.015 516-EE64378 Bldg. 23, Research 229 Flow Chamber

Annual

4c-10-T-1328 462.017 6640-42230/

516-EE17946

Bldg. 23, Research 208 TE-4 Annual

10689 462.018 516-EE01145 Bldg. 23, Research 227 CCI 740 Annual

462.026 6440-5362 Bldg. 23, Research 206 Hamilton Fume Hood

Annual

462.050 516-EE17957 Bldg. 23, Research 226 Fume Hood Annual

10090 462.051 516-EE28936 Bldg. 23, Research 226 54L933 Annual

100275-2472 462.052 516-EE34068 Bldg. 23, Research 219 1284 Annual

5X-43604 V 462.053 516-EE40863 Bldg. 23, Research 206 Model 4-TX Annual

107068060806 462.057 516-EE64218 Bldg. 23, Research 234E NU-430-400 Annual

120821013008 462.060 516-EE55231 Bldg. 23, 224A NU-425-400 Annual

090915798 R 462.067 516-EE69718 Bldg. 23 Research H 228 Labconco 3840000

Annual

462.070 Bldg. 100, Rm 2B-127 Fume Hood Annual

Research & Dental – Bay Pines & Lee County Serial # ID# EE# Location Type of Unit Frequency

462.082 516-EE17954 Bldg. 23, Rm 219 Fume Hood Annual

E-7466 462.083 516-EE12216 Bldg. 23, Rm 224B EG-6252 Annual

H74844 462.084 516-EE17958 Bldg. 23, Rm 225A Fume Hood Annual

462.085 Bldg. 23, Rm 208A Fume Hood Annual

462.086 516-EE17953 Bldg. 23, Rm 207 Fume Hood Annual

13942 462.087 Bldg. 23, Rm 210 Labc. Fume Absorber

Annual

97311 462.090 516-EE17959 Bldg. 23, Rm 224B Lerner Labs Fumegard

Annual

130778469B 462.093 516-EE90305 Bldg. 100 Research 2B110 Labconco 100400000

Annual

12743 462.094 Bldg. 23 Rm 114 Dental Lab Fume Hood Annual

12744 462.095 Bldg. 23 Rm 114 Dental Lab Fume Hood Annual

123/4 462.096 Bldg. 23 Rm 114 Dental Lab Fume Hood Annual

130170339E EE82068 LCHC Dental Lab Labconco

4862010XPF

Annual

G. ENVIRONMENTAL WIPE SAMPLES

Environmental wipe sampling for HD surface residue should be performed routinely

(e.g., initially as a benchmark and at least every 6 months, or more often as needed, to verify containment). Surface wipe sampling should include:

• Interior of the C-PEC and equipment contained in it

• Pass-through chambers

• Surfaces in staging or work areas near the C-PEC

• Areas adjacent to C-PECs (e.g., floors directly under C-PEC, staging, and dispensing area)

• Areas immediately outside the HD buffer room or the C-SCA

There are currently no studies demonstrating the effectiveness of a specific number or size of wipe samples in determining levels of HD contamination. Wipe sampling kits should be verified before use to ensure the method and reagent used have been tested to recover a specific percentage of known marker drugs from various surface types found in the sampled area.

There are currently no certifying agencies for vendors of wipe sample kits. There is currently no standard for acceptable limits for HD surface contamination. Common marker

HDs that can be assayed include cyclophosphamide, ifosfamide, methotrexate, fluorouracil, and platinum-containing drugs. An example of measurable contamination would be cyclophosphamide levels >1.00 ng/cm2, which were shown in some studies to result in uptake of the drug in exposed workers. If any measurable contamination is found, the designated person must identify, document, and contain the cause of contamination. Such action may include reevaluating work practices, re-training personnel, performing thorough deactivation, decontamination, cleaning, and improving engineering controls. Repeat the wipe sampling to validate that the deactivation/decontamination and cleaning steps have been effective.

Personnel Testing Requirements

Gowning and Garbing Evaluations 50 Employees

Gloved fingertip and thumb sampling Every 6 months

Media Fill Testing CETA Certified

H. EVALUATED OPTIONAL FEATURES

Even though the Contractor, at the Government's option, provides the requirements specified in this section; they are nonetheless treated with the same level of control as the mandatory specifications. The CO shall only exercise these options when requested by the

COR, and when the necessary funding is available.

I. CHANGES TO THE STATEMENT OF WORK

1. Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project.

2. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

J. REPORTING REQUIREMENTS

1. Service personnel shall sign in and out at the Safety Office (Bldg. 2, Room 102).

Failure to adhere to the reporting procedures may be cause for delay of payment for services performed or void contract.

2. When service is completed, the servicemen must indicate on his/her service report the specific action taken and all parts replaced. The equipment serviced must be identified clearly by name, serial number, location, and PMI number.

3. At the end of each certification inspection, a report shall be submitted to Safety and

Engineering Services indicating the elements of the inspection performed, findings, and recommendation (if applicable). This report may be submitted in the form of a checklist or regular service slip, provided all requested information is supplied.

4. Additionally, an inspection certification sticker shall be placed on each piece of equipment receiving certification inspection. The sticker will have the technician's signature that performed the certification inspection and date of service, the date of the certification inspection, the next due date, and the name of the company performing the certification.

5. Upon completion of service, the COR, or a Safety Specialist located in Safety Office, Building 2, Room 102, will sign the service report. When work is performed off site, e-mail notification of completion shall be sufficient.

K. GOVERNMENT RESPONSIBILITIES

The government will make the equipment available in accordance with the established schedule for the work.

L. CONTRACTOR EXPERIENCE REQUIREMENTS

Qualifications of Key Personnel (Standard mandatory language for all task orders):

1. Certification under the NSF Biohazard Cabinet Field Certifier Accreditation Program or the International Air Filtration Certifiers Association (IAFCA).

2. Respirator trained and fit-tested for protection against TB in accordance with 29

CFR 1910.134.

3. CETA Registered Certified Professional for Sterile Compounding Facilities

FAR Clauses:

Addendum to FAR 52.212-4:

The following RFQ clauses apply to this acquisition:

52.252-2 Clauses Incorporated By Reference (Feb 1998)

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

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

FAR Clauses Incorporated By Reference:

52.204-13 System for Award Management Maintenance (OCT 2018)

52.204-18 Commercial and Government Entity Code Maintenance (JUL 2016)

52.212-4 Contract Terms and Conditions- Commercial Items (Oct 2018)

52.222-62 Paid Sick Leave Under Executive Order 13706 (JAN 2017)

52.232-39 Unenforceability of Unauthorized obligations (JUN 2013)

52.232-40 Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

52.233-1 Disputes (MAY 2014)

52.233-4 Applicable Law for Breach of Contract Claim (OCT 2014)

52.245-1 Government Property Alternate I (JAN 2017)

52.247-34 F.O.B Destination (NOV 1991)

Clauses Incorporated By Full Text

52.222-42 Statement of Equivalent Rates for Federal Hires (May 2014)

In compliance with the Service Contract Labor Standards statute and the regulations of the Secretary of

Labor (29 CFR part 4), this clause identifies the classes of service employees expected to be employed under the contract and states the wages and fringe benefits payable to each if they were employed by the contracting agency subject to the provisions of 5 U.S.C. 5341 or 5332.

This Statement is for Information Only:

It is not a Wage Determination

Employee Class Monetary Wage -- Fringe Benefits

30090 – Environmental Technician $25.07 – Lee County

$22.11 – Pinellas County

(End of Clause) http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

52.237-2 - Protection of Government Buildings, Equipment, and Vegetation (Apr 1984).

The Contractor shall use reasonable care to avoid damaging existing buildings, equipment, and vegetation on the Government installation. If the Contractor’s failure to use reasonable care causes damage to any of this property, the Contractor shall replace or repair the damage at no expense to the Government as the

Contracting Officer directs. If the Contractor fails or refuses to make such repair or replacement, the

Contractor shall be liable for the cost, which may be deducted from the contract price.

(End of Clause)

52.246-4 -- Inspection of Services -- Fixed-Price (Aug. 1996)

(a) Definition: “Services,” as used in this clause, includes services performed, workmanship, and material furnished or utilized in the performance of services.

(b) The Contractor shall provide and maintain an inspection system acceptable to the Government covering the services under this contract. Complete records of all inspection work performed by the

Contractor shall be maintained and made available to the Government during contract performance and for as long afterwards as the contract requires.

(c) The Government has the right to inspect and test all services called for by the contract, to the extent practicable at all times and places during the term of the contract. The Government shall perform inspections and tests in a manner that will not unduly delay the work.

(d) If the Government performs inspections or tests on the premises of the Contractor or a subcontractor, the Contractor shall furnish, and shall require subcontractors to furnish, at no increase in contract price, all reasonable facilities and assistance for the safe and convenient performance of these duties.

(e) If any of the services do not conform with contract requirements, the Government may require the

Contractor to perform the services again in conformity with contract requirements, at no increase in contract amount. When the defects in services cannot be corrected by reperformance, the Government may --

(1) Require the Contractor to take necessary action to ensure that future performance conforms to contract requirements; and

(2) Reduce the contract price to reflect the reduced value of the services performed.

(f) If the Contractor fails to promptly perform the services again or to take the necessary action to ensure future performance in conformity with contract requirements, the Government may --

(1) By contract or otherwise, perform the services and charge to the Contractor any cost incurred by the Government that is directly related to the performance of such service; or

(2) Terminate the contract for default.

(End of Clause)

852.203-70 COMMERCIAL ADVERTISING (JAN 2008)

The bidder or offeror agrees that if a contract is awarded to him/her, as a result of this solicitation, he/she will not advertise the award of the contract in his/her commercial advertising in such a manner as to state or imply that the Department of Veterans Affairs endorses a product, project or commercial line of endeavor.

(End of Clause)

852.219-10 VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

As prescribed in 819.7009, insert the following clause:

VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-

ASIDE (DEC 2009)

(a) Definition. For the Department of Veterans Affairs, “Service-disabled veteran-owned small business concern”:

(1) Means a small business concern:

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans (or eligible surviving spouses);

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans (or eligible surviving spouses) or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran;

(iii) The business meets Federal small business size standards for the applicable North American

Industry Classification System (NAICS) code identified in the solicitation document; and

(iv) The business has been verified for ownership and control and is so listed in the Vendor Information

Pages database, (http://www.VetBiz.gov).

(2) “Service-disabled veteran” means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

(b) General. (1) Offers are solicited only from service-disabled veteran-owned small business concerns. Offers received from concerns that are not service-disabled veteran-owned small business concerns shall not be considered.

https://www.va.gov/oal/library/vaar/vaar819.asp#8197009 http://www.vetbiz.gov/

(2) Any award resulting from this solicitation shall be made to a service-disabled veteran-owned small business concern.

(c) Agreement. A service-disabled veteran owned small business concern agrees that in the performance of the contract, in the case of a contract for:

(1) Services (except construction), at least 50 percent of the cost of personnel for contract performance will be spent for employees of the concern or employees of other eligible service-disabled veteran-owned small business concerns;

(2) Supplies (other than acquisition from a nonmanufacturer of the supplies), at least 50 percent of the cost of manufacturing, excluding the cost of materials, will be performed by the concern or other eligible service-disabled veteran-owned small business concerns;

(3) General construction, at least 15 percent of the cost of the contract performance incurred for personnel will be spent on the concern’s employees or the employees of other eligible service-disabled veteran-owned small business concerns; or

(4) Construction by special trade contractors, at least 25 percent of the cost of the contract performance incurred for personnel will be spent on the concern’s employees or the employees of other eligible service-disabled veteran-owned small business concerns.

(d) A joint venture may be considered a service-disabled veteran owned small business concern if—

(1) At least one member of the joint venture is a service-disabled veteran-owned small business concern, and makes the following representations: That it is a service-disabled veteran-owned small business concern, and that it is a small business concern under the North American Industry Classification

Systems (NAICS) code assigned to the procurement;

(2) Each other concern is small under the size standard corresponding to the NAICS code assigned to the procurement; and

(3) The joint venture meets the requirements of paragraph 7 of the explanation of Affiliates in 19.101 of the Federal Acquisition Regulation.

(4) The joint venture meets the requirements of 13 CFR 125.15(b).

(e) Any service-disabled veteran-owned small business concern (non-manufacturer) must meet the requirements in 19.102(f) of the Federal Acquisition Regulation to receive a benefit under this program.

(End of Clause)

852.232-72 Electronic submission of payment requests

(a) Definitions. As used in this clause-

(1) Contract financing payment has the meaning given in FAR 32.001.

(2) Designated agency office has the meaning given in 5 CFR 1315.2(m).

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, e-mail, and scanned documents are not acceptable electronic forms for submission of payment requests.

(4) Invoice payment has the meaning given in FAR 32.001.

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System. (See Web site at http://www.fsc.va.gov/einvoice.asp.)

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards

Institute (ANSI). The X12 EDI Web site (http://www.x12.org) includes additional information on

EDI 810 and 811 formats.

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances below, the contracting officer directs that payment requests be made by mail, the contractor shall submit payment requests by mail through the United States

Postal Service to the designated agency office. Submission of payment requests by mail may be required for:

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the

VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

http://www.fsc.va.gov/einvoice.asp http://www.x12.org/

(End of clause)

852.237-70 Contractor Responsibilities

The contractor shall obtain all necessary licenses and/or permits required to perform this work. He/she shall take all reasonable precautions necessary to protect persons and property from injury or damage during the performance of this contract. He/ she shall be responsible for any injury to himself/herself, his/her employees, as well as for any damage to personal or public property that occurs during the performance of this contract that is caused by his/her employees fault or negligence, and shall maintain personal liability and property damage insurance having coverage for a limit as required by the laws of the State of Florida. Further, it is agreed that any negligence of the Government, its officers, agents, servants and employees, shall not be the responsibility of the contractor hereunder with the regard to any claims, loss, damage, injury, and liability resulting there from.

(End of Clause)

52.212-3 -- Offeror Representations and Certifications -- Commercial Items. (Oct 2018)

The offeror shall complete only paragraphs (b) of this provision if the Offeror has completed the annual representations and certification electronically via the System for Award Management (SAM) Web site accessed through http://www.acquisition.gov . If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (p) of this provision.

(a) Definitions. As used in this provision--

“Economically disadvantaged women-owned small business (EDWOSB) concern” means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the

United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

“Forced or indentured child labor” means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

“Highest-level owner” means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

“Immediate owner” means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

http://www.acquisition.gov/

“Inverted domestic corporation,” means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

“Manufactured end product” means any end product in product and service codes (PSCs) 1000-9999, except—

(1) PSC 5510, Lumber and Related Basic Wood Materials;

(2) Product or Service Group (PSG) 87, Agricultural Supplies;

(3) PSG 88, Live Animals;

(4) PSG 89, Subsistence;

(5) PSC 9410, Crude Grades of Plant Materials;

(6) PSC 9430, Miscellaneous Crude Animal Products, Inedible;

(7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products;

(8) PSC 9610, Ores;

(9) PSC 9620, Minerals, Natural and Synthetic; and

(10) PSC 9630, Additive Metal Materials.

“Place of manufacture” means the place where an…