H966--Pharmacy Equipment Service Contract

Solicitation is extended to 9/30/2020 at 3:00PM eastern standard time.

USP Equipment Certification Service Contract RFIs

1. F1204 (Line items 01-03) Location has 3 hoods to be tested. Are there any sterile or non-sterile rooms tested that need to be tested?

RESPONSE: There are only 2x PECs to be tested in that space (LFGI 6S-15-VF-17957 & LFH 4Q8B6300E1). Note, the BSC in HD-buffer no longer in use and doesn t need testing). 2x sterile rooms needing air changes per hour measured are non-HD buffer and its ante room.

2. SICU (Line item 04) Location has 1 hood to be tested. Are there any sterile or non-sterile rooms tested that need to be tested?

RESPONSE: No, SICU is considered as an SCA and will not be treated as a SEC.

3. N1004 (Line items 05) Location has 1 hood to be tested. Are there any sterile or non-sterile rooms tested that need to be tested? Per page 12 of 27 this area has two rooms that need ACPH? If they are sterile rooms it would require full USP testing (HEPA leak, non-viable, viable, pressures, etc.). If non-sterile only USP 800 applies (pressure and RAER).

RESPONSE: No, N1004 is considered as an SCA and will not be tested as a SEC, however we need ACPH readings performed in both the compounding room and the ante room.

4. Annex (Line item 06-11) Location has 4 hoods, how many rooms need to be tested? Can we get clarification on how many individual rooms this location has (i.e., 3 sterile rooms Ante, HD Buffer, Non-HD Buffer) or (i.e., 2 nonsterile rooms C-SCA HD non-sterile room, SCA non-HD non- sterile room). Per page 11 of 27 this area has sterile rooms but not a number of rooms.

RESPONSE: 4 discrete rooms HD Buffer with dedicated ante room, and Non-HD Buffer with dedicated ante room. There is a non-sterile common area between the two spaces.

5. Greenville HCC (Line item 12-14) Location 1 BSC and 2 sterile rooms. Page 12 of 27 shows this area has a Laminar flow clean bench in room 1A135, is this not part of the contract? Can we get clarification on how many individual rooms this location has (i.e., 3 sterile rooms Ante, HD Buffer, Non-HD Buffer) or (i.e., 1 non-sterile rooms C-SCA HD non-sterile)?

RESPONSE: Greenville HCC has a total of 2x PECs and 4x sterile SEC rooms. There are four individual rooms (HD Buffer with dedicated ante room, and Non-HD Buffer with dedicated ante room) to be certified. HD buffer 2C418 has one primary, a BSC hood (Baker SG403A-HE). The LAFW Hood, Baker EG-3252, is in the non-HD buffer room (1A135) and is a part of this contract.

6. Please provide the physical number of individual rooms (individual room count not a suite, a suite can be any number of rooms) that need to be and the type of each room tested (Ante, HD Buffer, Non-HD Buffer, HD non-sterile, etc.).

RESPONSE: See excel attachment. (Durham Greenville USP Certification Equipment Area List.xlsx) for complete list of rooms.

7. The Equipment list, shows 14 pieces of equipment. The Equipment schedule charts indicated 17 inspections/certifications. The Line Item cost sheet has 14 line items. Since the smoke survey video would be considered a test that cost out be included in the Line item cost sheet as part of the semi-annual inspection. Also, equipment and Line Item cost sheet numbers 0010 and 0011, show and annex C- Secondary Engineering control (non-hazardous) and (Hazardous) is this the Pharmacy Annex Trailer location?

RESPONSE: See excel attachment. (Durham Greenville USP Certification Equipment Area List.xlsx) for complete list of equipment and rooms. There should only be 10 pieces of equipment. Each PEC requires a smoke survey video and should be part of the certification cost. Please provide cost breakdown of certification costs to assess values.

Solicitation 36C24620Q0887 has been extended from 9/28/2020 to 9/30/2020 at 10AM Eastern Standard Time.

NAICS HAS BEEN UPDATED FROM 541690 TO 541380

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This is a combined synopsis/solicitation for commercial services prepared in accordance with FAR Subpart 12.603 and guidance of FAR Part 12 as included in this notice. The Department of Veterans Affairs anticipates a single award, fixed price, base plus four option years contract. Quotes are being requested, and a written solicitation document will not be issued.

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2020-07 (eff. 07/20/2020). VAAR Update 2008-23 (eff. 07/16/20)

This solicitation is set-aside for Service-Disabled Veteran Owned Small Business (SDVOSB).

The associated North American Industrial Classification System (NAICS) code for this procurement is 541690- Other Scientific and Technical Consulting Services

$16.5 Millions of Dollars.

The FSC/PSC is H966- Other QC/Test/Inspect- Instruments and Laboratory Equipment

The Durham VA Medical Center currently has a need for a service contract for semi-annual testing and certification of U.S. Pharmaceutical Convention (USP) equipment and rooms located at 508 Fulton St, Durham, NC 27705 in accordance with the statement of work and terms and conditions herein.

Period of Performance: The expected period of performance is 10/1/2020-9/30/2025

Base Year-10/1/2020-9/30/2021

Option Year 1 10/1/2021-9/30/2022

Option Year 2 10/1/2022-9/30/2023

Option Year 3 10/1/2023-9/30/2024

Option Year 4 10/1/2024-9/30/2025

DESCRIPTION OF WORK:

Hours of Operation: Services shall be performed Monday through Friday starting at 7:30am until 4:00pm, excluding Federal holidays, and any other day specifically declared by the President of the United States. Federal holidays are available at the Federal Holiday OPM Site. For working outside the hours as defined in this contract, the vendor shall give 3-day notice to the Contracting Officer Representative so that arrangements can be provided for the employees. This notice is separate from any notices required for utility shutdown described later in this section. All work to be coordinated around an operational medical center as to minimize impact to patient care.

The contractor shall furnish all labor, material, equipment, parts, supervision, etc., necessary to test and certify USP equipment and rooms at the Durham VA Health Care System.

STATEMENT OF WORK:

Certification of Primary Engineering Controls (PEC)/Hoods

Contractor shall provide testing and certification of all the Durham VA Health Care System pharmacy hoods either once a year (every 12 months +/- 30 days) or twice per year (every 6 months +/- 20 days) as described in the price/cost schedule. The term Hoods refers to all of the following: Biosafety cabinets, chemical fume hoods and HEPA units.

The contractor shall also provide testing and certification of all primary engineering controls (PECs) and pharmacy compounding rooms/suites used for preparation of Compounded Sterile Preparations (CSPs). PECs include biological safety cabinets (BSCs), laminar airflow workstation (LAFW) hoods, compounding aseptic containment isolators (CACI), and compounding aseptic isolators (CAI). Testing and certification of all PECs and compounding rooms/suites will be completed in accordance with the latest version of United States Pharmacopeia (USP) Chapter , and USP Chapter or current guidelines.

PECs will need to be certified biannually (2x a year) and they are not all performed on the same day, they shall be staggered for contingencies.

b) The Durham VAHCS is required to maintain all primary engineering controls (PECs) used for staff and product protection. This requirement will describe all testing and certification activities required for all PECs and Pharmacy Compounding areas. PECs are used for personnel protection and/or product protection and must be certified to industry standards to ensure they are providing the required protection. All contractors and technicians shall be required to wear and maintain personal protective equipment (PPE) as provided and directed by the local facility policies described and mandated, in VHA policy 1108.12.

c) The Durham VAHCS requires standardizing testing criteria appropriate for all PECs used pursuant to current USP Chapter and Chapter standards using Controlled Environment Testing Association (CETA) Certified National Board of Testing (CNBT) certified individuals to establish consistent PEC certification procedures using the Certification Guide for Sterile Compounding Facilities CAG-003-2006 or current guidelines. Although USP states that certification procedures such as those outlined CAG-003-2006 shall be performed, Veterans Affairs (VA) will be requiring that CAG-003-2006 be used in lieu of any other such as procedures that may exist. Testing procedures shall be maintained in compliance with all current applicable standards. CAG 001-2005 CETA Guide for the use of Compounding Aseptic Isolators in Healthcare Facilities, Revised December 8, 2008 and CAG-002-2006 CETA Compounding Isolator Testing Guide Revised December 8, 2008, or current guidelines, will also be used as the applicable standard for their respective PEC.

d) The United States Pharmacopeia (USP) establishes standards for cleanroom design, environmental monitoring, and competencies for the preparation, handling, and storage of CSPs. The Joint Commission (TJC) Accreditation Manual for Home Care, effective January 13, 2018, established new Medication Compounding (MC) standards for non-sterile and sterile compounded preparations which are based on USP standards. The Food and Drug Administration (FDA) has the authority to inspect VA medical facilities under the Draft Guidance on Insanitary Conditions at Compounding Facilities which was published in August 2016.

e) Certification procedures defined in CETA CAG-003-2006 shall be performed by a CETA National Board of Testing (CNBT) certified testing individual no less than every 6 months (+ or - 20 days) or whenever the PEC or room is relocated or altered or when major service to the sterile compounding facility is performed.

3) Primary Engineering Control Testing and Certification Biological Safety Cabinets (BSCs), CACI, CAI

All certification of BSC, CAI, CACI shall comply with the latest version of NSF/ANSI Standard 49 Appendix

a) The contractor will immediately notify the Contracting Officer Representative with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the Contracting Officer Representative. Under no circumstance will repairs be accomplished by the contractor unless specifically covered under the contract. For each BSC passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name, address and phone number

Unit make, model and serial number

Report number reflecting the room certification

Location (room number)

Certification date

Recertification date

Technician signature

b) Chemical Fume Hoods

All certification of Laboratory Chemical Fume hoods will comply with the latest version of ANSI/ASHRAE Standard 110. Face velocity testing and smoke visualization testing will be required; however, the tracer gas containment test using sulfur hexafluoride will not be required. The sash height achieving the required 100 fpm will be marked with a sticker designed for this purpose. A test report will be generated, and any comments or problems noted. Additionally, any fume hoods with face velocity monitors or controllers will be recalibrated to the correct velocity. The contractor will immediately notify the Contracting Officer Representative with any results indicating failure. The unit will be marked with signage to let the user know that the unit shall not be used and contain the contact information of the Contracting Officer Representative.

For each unit passing the required certification tests, the contractor will supply each unit with a certification sticker with the following information:

Company name, address and phone number

Unit make, model and serial number

Report number reflecting the room certification

Location (room number)

Certification date

Recertification date

Sash height (only for fume hoods)

The average recorded face velocity

Technician signature

CSP PEC TESTING AND CERTIFICATION:

a) The contractor shall test and certify each PEC according to USP and using certification procedures from the Controlled Environment Testing Association (CETA) Certification Guides for Sterile Compounding Facilities (CAG-003-2006), ANSI/NSF-49 and/or the CETA Applications Guide for the Use of Compounding Aseptic Isolators in Compounding Sterile Preparations in Healthcare Facilities (CAG-001-2005 Revised Dec. 8, 2008) and/or CETA Compounding Isolator Testing Guide (CAG-002-2006 Revised Dec. 8, 2008) or the equivalent. All PECs shall:

be certified to meet ISO Class 5 or better

maintain unidirectional airflow

be supplied by HEPA filtered air

b) The list of tests, depending on CETA and manufacturer guidance for the type of PEC, includes, but is not limited to:

Viable and non-viable particle counts

Airflow velocity testing

HEPA filter leak test

Induction leak/back-streaming test

Cabinet leak test

In-flow velocity test to include exhaust airflow volume rate

Surface microbial and fungal sampling

Air microbial and fungal sampling

Airflow Smoke pattern test under dynamic operating conditions (contractor will provide video documentation of each test to facility POCs).

i) Airflow smoke pattern testing will be completed in accordance with CAG-003-2006 for each pharmacy PEC initially and when changes are made to the PEC or room configuration. The testing will be video-recorded, and the contractor must have experience in collecting these videos. The facility will provide a minimum of one pharmacy technician to conduct simulated drug compounding in each PEC during the smoke visualization testing. The testing must show that first air conditions are achieved at the critical site during all compounding tasks within the respective PEC. This may mean that the contractor provides movement of the smoke source and/or multiple camera angles to ensure that each compounding task is effectively shown to be completed within an area receiving first air. It is important that the contractor recognize that this testing is beyond the typical scope of an equipment certification. These videos are to capture both the effective operation of the PEC and also the effective compounding techniques of the pharmacy staff. The contractor should understand that coordination with the pharmacy staff and management is imperative in collecting useful PEC smoke visualization videos as intended by CAG-003-2006.

c) Laminar Flow Hoods (Laminar Airflow Workbench (LAWF), Integrated Vertical Laminar Flow Zone (IVLFW), and Biological Safety Cabinet (BSC)) must be tested and certified according to CETA CAG-003-2006 guidelines and to manufacturer s specifications. Horizontal laminar flow cabinets shall be certified according to The Institute of Environmental Sciences (IEST) RP-CC-002 Testing Laminar Air Flow Devices (to include Induction Leak/Back-streaming Test) and IEST-RP-CC034 HEPA Filter Leak Test.

Certifications for Class II Biological Safety Cabinets (BSCs) must be accomplished in accordance with the most current National Sanitation Foundation/American National Standards Institute (NSF/ANSI) Standard 49 Class II (laminar flow). The contractor shall use a National Institute of Standards and Technology (NIST) traceable or comparable calibrated piece of equipment (calibrated within past 12 months) to perform all testing and provide copies of the calibration tests to the Government Technical Representative upon request. Confirmation of this calibration shall be listed in the final certification report.

i) The contractor shall report each individual face velocity reading and the average of those readings, the downstream concentration reading of the HEPA filter leak test and the results of the induction leak test and back-streaming test. Any failures shall be reported directly to the identified site point of contact(s) as soon as practicable. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice.

ii) Restricted access barrier system (Compounding Aseptic Isolator (CAI), Compounding Aseptic Containment Isolator (CACI), and Isolators (i.e. PECs with a controlled workspace, transfer devices, access devices, and a decontamination system) must be certified according to CETA CAG-002-2006 and CAG-003-2006 guidelines and to manufacturer s specifications. Any unit that fails to meet required specifications shall be clearly marked with a sign that will notify technicians that the unit is out of order until further notice. In addition, any failures shall be reported directly to the site identified point(s) of contact (POC) as soon as practicable.

TESTING STANDARDS

a) All CSP Facilities must be tested and certified in accordance to ISO 14644-1 Classifications of Air Cleanliness, CETA CAG-03-2006 and CETA CAG-009-00 specifications. The contractor will provide comprehensive cleanroom testing and certification services with frequency required by most current USP standards and USP . Test equipment used for certification will be clean, in good working order and calibrated on a calibration frequency not to exceed 12 months or more frequently if recommended by the manufacturer. Calibration certificates should be provided upon request by the facility POC for all calibrated test equipment. USP Compliance Testing for Cleanrooms and Controlled Environment certification will include but is not limited to the following:

Non-Viable Particle Counting under dynamic operating conditions

Viable / Microbial and Fungal Air Testing

Viable / Microbial and Fungal Surface Testing

Airflow Volume Measurements

Air Velocity Profile

Room Air Exchange Rates

Room Pressure Measurement (in water columns)

In-Place Leak Testing of HEPA Filters

Temperature, Relative Humidity Measurements

Smoke test under dynamic conditions

b) Viable and Non-viable Particle Counts

For the PECs, viable and non-viable particle counts samples will be collected. Viable samples will be collected for each device (both bacterial and fungal) for the air and surface in accordance with USP and . Viable microbial and fungal air and surface sampling will also be required for each room where CSPs are made.

c) Air Changes per Hour

The contractor shall calculate the total room volume for each buffer, ante room, and hazardous drug storage room. A sketch of the room with dimensions, exhaust/supply diffuser locations and equipment locations shall be included in the report. The report provided will specify flow rates detailing returns and supply that were obtained during the testing. The contractor shall calculate air changes per hour (ACPH) for each buffer, ante room, segregated compounding area (SCA) and HD storage room and include their findings in the report. In the event, that a room does not meet USP or USP requirements for ACPH the identified site POC(s) shall be informed immediately.

d) Pressure Requirements

The contractor shall include in their report differential pressure readings from each buffer/ante room to all surrounding areas as well as the static pressure of the hazardous drug SCA. The report shall indicate whether the room is required to be a negative or positive pressure room per USP (or USP when applicable). The contractor shall report all pressures to an accuracy of 0.0001 water column (4 decimal places). Pressure differentials will be reflected on a report showing the sketch of the room(s).

e) Viable Environmental Sampling

i) The contractor shall perform viable environmental (air) sampling every 6 months for fungi and bacteria using high volume impaction samplers to conduct the sampling.

ii) In addition, semi-annual viable environmental surface sampling of classified areas will be performed. This includes the hazardous and non-hazardous buffer rooms, the ante room and each segregated compounding area. When conducted, surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

The interior of the PEC and the equipment contained in it

Staging or work area(s) near the PEC

Frequently touched surfaces

Pass-through chamber(s)

f) Air sampling

A sufficient volume of air (1000 liters) shall be tested at each location in order to maximize sensitivity. Samples of less than 1000 liters will not be acceptable.

g) Surface Sampling

The contractor shall perform surface samples for bacteria using Tryptic Soy Agar (TSA) contact plates and Malt Extract Agar (MEA) or Sab DEX contact plates for sampling of fungi. Surface sampling must be performed at the end of the compounding activities or shift, but before the area has been cleaned and disinfected.

i) The lab chosen to analyze the samples must be verified prior to testing and be certified.

g) Nonviable Particle Testing

The contractor shall perform environmental nonviable particle testing semiannually (e.g. every 6 months). The contractor shall derive the minimum number of sampling locations using Annex A in the ISO 14644-1.2 standard. Testing shall be performed by qualified operators using current, state-of-the-art electronic equipment with results per USP797, Section 4.1.

REPORTS

The following information shall be included in the report for clean room certification. Pass/Fail notifications should be included on a per-test basis where applicable.

Reports to include at a minimum:

Environmental sampling reports will contain both the quantitative number of bacterial/fungal isolates as well as the species grown.

The identification of highly pathogenic microorganisms will be highlighted in the report.

Action level for ISO area tested

Executive summary or summary of findings.

Room number and/or location

Room type (e.g. oncology prep room)

Type of PEC certified

Serial number of the equipment certified

Building Asset number of the equipment certified

Date and time samples are collected, and particle counts tested

Name of Technician collecting the samples

Date of next required certification

Standards used to test room or equipment

Comments indicating when dynamic operating conditions were used

Notes

Room sketch (location of supply/exhaust diffusers, equipment, room dimensions)

Sketch identifying location of each sample obtained

Total room area and volume

Room humidity and temp

Room air changes per hour

Pressure differentials in water columns

Nonviable particle counts (CFU s), action level for target ISO level

Viable particle count analysis

Sketch of viable particle test location in room

Viable sample results (CFU s), action level

Certificates of analysis of media used

Comments indicating when dynamic operating conditions were used

Report Distribution

a) The contractor will immediately notify the Contracting Officers Representative with any results indicating failure. A formalized written report including all required aspects specified in this Statement of Work will be provided in a timely manner with receipt by identified points of contact no more than 21 days from certification evaluation.

b) All completed reports will be provided via email to Contracting Officers Representative. Contractor will be notified by the facility of any updates to identified points of contact list on an as needed basis.

TEST EQUIPMENT AND CONTRACTOR STANDARDS

a) All test equipment will be supplied by the contractor and must be calibrated within the last 12 months to an industry standard and manufacturer specifications. Calibration certification letters for equipment must be kept with the contractor technician for review by the Government Technical Representative at the time of inspection, if needed. All technicians performing the work must be qualified by education and experience. At least one technician performing the work in areas where CSP are prepared must be Controlled Environment Testing Association (CETA) certified and registered as required by VHA Directive1108.12

(https://vaww.va.gov/vhapublications/ViewPublication.asp?pub_ID=8151). A copy of this publication can be requested from the Contracting Officers Representative.

b) Contractor Furnished Materials

i) All materials and tools to complete the work identified.

ii) Contractor to ensure all staff that perform on-site testing arrive wearing non-shedding clothing.

iii) All equipment will be stored and transported by the contractor in a manner that maintains cleanliness of equipment and introduces minimal micro-organisms into the clean environments being tested. All equipment will be wiped/cleaned prior to taking into clean testing environments.

c) Contractor Qualifications/References

i) All contractor performed certifications must be signed by an NSF 49 certified technician.

ii) All cleanroom performance testing must be supervised by a technician with a CETA National Board of Testing (CNBT) certification. The CETA-certified technician must be onsite and working within the clean room areas while testing is being conducted. Supervision or oversight from a different location is not allowed.

III) Laboratory shall be American Industrial Hygiene Association (AIHA) accredited for all USP viable sampling analysis.

ADDITIONAL TRIP CHARGES

If additional testing, troubleshooting, adjustment or repair is required, the contractor shall provide 4 additional service visits each contract year. These additional site visits will only be utilized at the request of the Contracting Officers Representative. The additional site visit line item shall include all costs associated with travel, per diem, lodging, mileage, movement/shipping of equipment, overnight pay or any other costs the contractor may incur in visiting the facility outside of the normal semiannual visits. The cost must cover a site visit which may exceed a single workday (depending on the additional work required).

EQUIPMENT SCHEDULE:

1. Compounding Aseptic Isolator in F1204 (s/n 6S-15-VF-17957)

2. Laminar Airflow Workbench in F1204 (s/n 4Q8B6300E1)

3. Biological Safety Cabinet in F1204 (s/n 3S-15-BT-13786)

4. Compounding Aseptic Isolator in (SICU) (s/n 3S-15-LGU-18533)

5. Biological Safety Cabinet in N1004 (s/n 3S-15-BT-13785)

6. Laminar Airflow Workbench in ANNEX (s/n 3S-15-BVBI-19001)

7. Laminar Airflow Workbench in ANNEX (s/n 3S-15-BVBI-19002)

8. Biological Safety Cabinet in ANNEX (s/n 3S-15-BT-18914)

9. Biological Safety Cabinet in ANNEX (s/n 3S-15-BT-18915)

10. ANNEX C-Secondary Engineering Control (non hazardous)

11. ANNEX C-Secondary Engineering Control (Hazardous Cleanroom)

12. Greenville HCC Ante-Room 2C416

13. Greenville HCC Hazardous Buffer Room 2C418

14. Greenville HCC Biological Safety Cabinet (s/n 110109)

EQUIPMENT SCHEDULE CONTINUED

Location

Testing Required

Months Due

508 Fulton Street, Durham NC 27705

F1204

Certification - Laminar Flow Clean Bench with Viable and Non-Viable Counts

Certification Isolator (glove box) with viable and non-viable counts

Smoke Study Videos

February 2021/August 2021

508 Fulton Street, Durham NC 27705

Pharmacy USP Annex (Trailer)

Biological Safety Cabinet Certification with Viable and Non-Viable Particle Counts (2x)

Certification - Laminar Flow Clean Bench with Viable and Non-Viable Counts (2x)

Cleanroom Certification - Testing and certification of HEPA filters, non-viable particle counts, cfms and/or velocities, pressures and air changes

Smoke Study videos

March 2021/September 2021

508 Fulton Street, Durham NC 27705

N1004

Biological Safety Cabinet Certification with Non-Viables and viables

Smoke Study videos

ACPH anteroom/buffer room

October 2020/April 2021

508 Fulton Street, Durham NC 27705

SICU A4038

Certification Isolator (glove box) with viable and non-viable counts

Smoke Study videos

October 2020/April 2021

401 Moye Blvd. Greenville, NC 27834

GHCC Non-Haz 1A135

Certification - Laminar Flow Clean Bench with Viable and Non-Viable Counts

Smoke Study videos

November 2020/May 2021

401 Moye Blvd. Greenville, NC 27834

GHCC Haz 2C418

Biological Safety Cabinet Certification with Viable and Non-Viable Particle Counts

ACPH anteroom/buffer room

Smoke Study videos

November 2020/May 2021

GENERAL:

All contract field personnel engaged in work on this project shall be trained in accordance with current regulations and enrolled in a medical monitoring program. Training shall include 30-hour and annual update training in compliance with OSHA and EPA regulations.

Key personnel shall be identified in the proposal and shall be considered key personnel essential for the successful completion of the work performed under the contract. The contractor agrees that such personnel shall not be removed, diverted or replaced from the work without prior written approval of the Contracting Officer. The contractor shall submit written notice of proposed personnel changes to the Contracting Officer for approval at least thirty (30) business days in advance.

The contractor shall provide a safety plan, that must be approved by VA safety office, for roof work prior to the performance of work.

The contractor s employees shall not enter the work site without appropriate identification. They may also be subject to inspection of their personal effects when entering or leaving the project site.

Execute work to interfere as little as possible with normal functioning of the hospital including operations of utility services, fire protection systems and any existing equipment, and with work being performed by others. Use of equipment and tools that transmit vibrations and noises through the building structure, are not permitted in buildings that are occupied jointly by patients or medical personnel, and Contractor s personnel, except as permitted by COR where required by limited working space.

No utility service such as water, gas, steam sewers or electricity, or fire protection systems and communications systems may be interrupted without prior approval of COR. Electrical work shall be accomplished with all affected circuits or equipment de energized. When an electrical outage cannot be accomplished, work on any energized circuits or equipment shall not commence without the Medical Center Director s prior knowledge and written approval. The vendor shall submit a request to interrupt any such services to COR, in writing, 48-hours in advance of proposed interruption. Request shall state reason, date, exact time of, and approximate duration of such interruption.

VA reserves the right to close down or shut down the project site and order the vendor s employees off the premises in the event of a national emergency. The vendor may return to the site only with the written approval of the Contracting Officer.

Site and Building Access: Maintain free and unobstructed access to facility emergency services and for fire, police and other emergency response forces in accordance with NFPA 241.

Means of Egress: Do not block exiting for occupied buildings, including paths from exits to roads. Minimize disruptions and coordinate with COR.

Buildings will be occupied during performance of work. Contractor shall take all measures and provide all material necessary for protecting existing equipment and property in affected areas against dust and debris, so that equipment and affected areas to be used in the Durham VAHCS operations will not be hindered. Coordinate alteration work in areas occupied by Department of Veterans Affairs so that Durham VAHCS operations will continue during the installation period.

The contractor shall maintain neat and orderly work areas and shall clean area of debris and rubbish daily and dispose of waste materials offsite per hospital policies. The contractor shall provide a dumpster if it is determined to be necessary and shall work with the COR in advance for a spot-on site to establish the dumpster.

All work shall be performed in full accordance with applicable local and Federal regulations. All materials and installation shall conform to the recommendations of National Fire Protection Association (NFPA), plumbing and mechanical codes. No departures from specification requirements will be permitted without written approval. The Supplier shall use good safety practices while working. All hardware should be installed in such a manner to minimize damage and maximize patient and employee safety.

New work shall be installed and connected to existing work safely and professionally. Disturbed or damaged work shall be replaced or repaired to its prior conditions.

All items furnished shall be free from defects that would adversely affect the performance, maintainability and appearance of individual components and overall assembly.

Where the Government determines that the vendor has installed equipment not conveniently accessible for operation and maintenance, equipment shall be removed, and reinstalled or remedial action performed as directed at no additional cost to the Government.

Hot Work: Perform and safeguard hot work operations in accordance with NFPA 241 and NFPA 51B. Obtain daily permits from facility Safety Manager at least 24-hours in advance.

Contractor personnel and sub-contractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA personnel regarding information and information system security.

If required by Infection Control, all contractor and sub-contractor personnel shall have completed tuberculosis skin test within the past year and provide documentation to the COR prior to performing any work at the VA facility. The contractor shall be issued temporary construction badges each day work is performed and must be returned at the end of each workday. All contractors shall wear badges so that the badges are easily viewed always while on-site. Contractor shall notify the COR immediately of any lost badges. Contractor and all their employees shall report to the safety office to receive safety training prior to working on site. Contractors will be issued a short-term parking pass. Contractor shall provide a valid driver s license, license plate number and signed copy of their contract. OSHA 10-hour training is required for all workers on site and the OSHA 30-hour training is required for Trade Competent Persons (CPs) and shall provide documentation to the COR prior to performing any work at the VA facility.

End of Statement of Work

PRICE/COST SCHEDULE

Base Year-10/1/2020-9/30/2021 $____________

Option Year 1 10/1/2021-9/30/2022 $____________

Option Year 2 10/1/2022-9/30/2023 $____________

Option Year 3 10/1/2023-9/30/2024 $____________

Option Year 4 10/1/2024-9/30/2025 $____________

ITEM INFORMATION

ITEM NUMBER

DESCRIPTION OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

0001

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Compounding Aseptic Isolator (CAI) in Room F1204 (sn: 6S-15-VF-17957)

0002

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Laminar Airflow Workbench (LAFW) in Room FI 204 (sn:4Q8B6300E1)

0003

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Biological Safety Cabinet (BSC) in Room F1204 (sn:3S-15-BT- 13786)

0004

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Compounding Aseptic Isolator (CAI) in SICU (sn:3S-15- LGU-18533)

0005

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Biological Safety Cabinet (BSC) in Room N1004 (sn:3S-15-BT- 13785)

0006

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Laminar Airflow Workbench (LAFW) in Annex (sn:3S-15-BVBI- 19001)

0007

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Laminar Airflow Workbench (LAFW) in Annex (sn:3S-15-BVBI- 19002)

0008

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Biological Safety Cabinet (BSC) in "Annex" (sn:3S-15-BR2-18914)

0009

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification of Biological Safety Cabinet (BSC) in Annex BSC (sn:3S-15-BR2- 18915)

0010

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification Annex SEC (non haz)

0011

2.00

EA

__________________

__________________

Semi-Annual Inspection and Certification Annex C-SEC (haz cleanroom)

0012

2.00

EA

__________________

__________________

Greenville HCC Ante-room 2C416

0013

2.00

EA

__________________

__________________

Greenville HCC Hazardous Buffer Room 2C418

0014

2.00

EA

__________________

__________________

Greenville HCC Biological Safety Cabinet (s/n 110109)

GRAND TOTAL

__________________

CONTRACT CLAUSES

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, Instructions to Offerors Commercial Items

(a) North American Industry Classification System (NAICS) code and small business size standard are stated in the combined synopsis/solicitation.

(b) Submission of quotations. Submit quotations to the office specified in this solicitation at or before the exact time specified in this solicitation. Quotations may be submitted on letterhead stationery, or as otherwise specified in the solicitation. As a minimum, quotations must show-

(1) The solicitation number;

(2) The name, address, and telephone number of the quoter;

(3) Technical description of services to be performed in accordance with the Statement of Work. This Technical description should address the requirement specifically. Capability statements that are merely an overview of what the contractor offers will be determined incomplete. Please address all the technical evaluation sub-factors. Failure to address all the sub-factors will result in your package being determined incomplete.

(4) Price should be for all services detailed in price and cost schedule of this document. The pricing must be broken down in a manner that allows for price reasonableness to be determined. Failure to provide complete pricing will result in contractors package being determined to be incomplete.

(5) Acknowledgement of any solicitation amendments

(6) Past performance information (optional)

(7) A statement specifying the extent of agreement with all terms, conditions, and provisions included in the solicitation.

2. FAR 52.212-3, Offerors Representations and Certifications Commercial Items

Offers that fail to furnish required representation or information or reject the terms and conditions of the solicitation will be excluded from consideration.

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018) applies to this acquisition.

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are included as addenda to FAR 52.212-4:

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

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

852.203-70 Commercial Advertising (JAN 2008)

852.212-70 Provisions and Clauses Applicable to VA Acquisition of Commercial Items (APR 2020

852.219-10 VA Notice of Total Service-Disabled Veteran Owned Small Business Set Aside (JUL 2019)

852.219-74 Limitations on Subcontracting-Monitoring and Compliance (JUL 2018)

852.232-72 Electronic Submission of Payment Requests (NOV 2012)

852.270-1 Representatives of Contracting Officers (JAN 2008)

FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders Commercial Items (OCT 2019)

The following subparagraphs of FAR 52.212-5 are applicable:

52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2016)

52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015)

52.219-6 Notice of Total Small Business Set-Aside (NOV 2011)

52.219-28 Post Award Small Business Program Representation (Jul 2013)

52.222-3 Convict Labor (June 2003)

52.222-21 Prohibition of Segregated Facilities (APR 2015)

52.222-26 Equal Opportunity (SEPT 2016) (E.O. 11246)

52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014)

52.222-41 Service Contract Labor Standards (AUG 2018)

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

52.222-43 Fair Labor Standards Act and Service Contract Labor Standards--Price Adjustment (Multiple Year and Option Contracts) (AUG 2018)

52.222-55 Minimum Wages Under Executive Order 13658 (DEC 2015).

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

Offers that fail to furnish required representation or information or reject the terms and conditions of the solicitation will be excluded from consideration.

The following provisions are included as addenda to FAR 52.212-1:

52.204-7 System for Award Management (OCT 2018)

52.204-16 Commercial and Government Entity Code Reporting (JUL 2016)

852.215-70 Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors (JUL 2016)

852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008)

The provision at FAR 52.212-2, Evaluation Commercial Items (OCTOBER 2014), applied to this acquisition.

Award shall be made to the contractor whose quotation offers the best value to the government, considering technical capability and price. The government shall evaluate information based on the following evaluation criteria below.

52.217-8 OPTION TO EXTEND SERVICES (NOV 1999)

The Government may require continued performance of any services within the limits and at the rates specified in the contract. These rates may be adjusted only as a result of revisions to prevailing labor rates provided by the Secretary of Labor. The option provision may be exercised more than once, but the total extension of performance hereunder shall not exceed 6 months. The Contracting Officer may exercise the option by written notice to the Contractor within 30 days.

(End of Clause)

52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 30 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 60 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

(End of Clause)

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/

(End of Clause)

INSTRUCTIONS TO OFFERORS

INSTRUCTIONS FOR QUOTE SUBMISSION

All quotes shall be submitted via email to Desiree Mills at desiree.mills-hicks@va.gov by 1 PM, EST, September 28, 2020. Quotes shall be assembled by the following Sections; each section shall be easily identified.

FAR SUBPART 13.5 SIMPLIFIED ACQUISITION PROCEDURES

Note that FAR part 13.5 Simplified Acquisitions Procedures for Certain Commercial items procedures will be used. A contractor may be eliminated from consideration without further exchanges if technical and/or pricing quotes are not among those Offerors considered most advantageous to the Government based on a best value determination.

Submission of Offers:

Offers shall be based on requirements contained in the Statement of Work (SOW). Offers shall include:

Offer Form -Complete the price cost schedule above, include Original Signature and Date,; DUNS Number; Acknowledgement of Solicitation Amendments (if applicable)

A completed price/cost schedule and attachments addressing all Contract Line

Items Numbers (CLINSs).

System for Award Management (SAM): Federal Acquisition Regulations require that federal contractors register in the SAM database at http://www.sam.gov and enter all mandatory information into the system. Award cannot be made until the contractor has registered. Offerors are encouraged to ensure that they are registered in SAM prior to submitting their quotation.

Amendments: Amendments to this solicitation will be posted on www.beta.sam.gov. Paper

copies of the amendments will NOT be individually mailed. By registering to receive

notifications on www.beta.sam.gov, offerors will be notified by email of any new amendments that have been issued. No other notification of amendments will be provided. Potential Offerors are advised that they are responsible for obtaining and acknowledging any amendments to the solicitation. FAILURE to acknowledge an amendment may result in your offer being considered unacceptable.

QUOTE PREPARATION INSTRUCTIONS

Quote Preparation Costs: The Contracting Officer is the only individual legally

authorized to commit the Government to the expenditure of public funds in connection

with this procurement. The solicitation does not commit the Government to pay any costs for the preparation and submission of an offer in response to this solicitation.

Price Submission: Submit Original Quote

Price submission shall be submitted and labeled

(1). Alternate price schedules will not be considered.

Total Price will be evaluated including all options.

The quote should be submitted in a format which clearly addresses the evaluation factors.

All technical elements applicable to the utilization of subcontractors must be addressed in the quote and detail provided. The technical quote should be as detailed as necessary to fully explain the proposed methods and rationale; it should reflect a clear understanding of the nature of the work being undertaken. and shall not exceed twenty-five (25) pages in length (minimum 12-point font and no less than ½ inch margins). Page limitation includes any drawings, charts, images, etc., and excludes section dividers, table of contents, glossary of terms, cross-referencing indices, and resumes. If more than 25 pages (not counting excluded pages) are submitted, only the first 25 pages will be considered.

Past Performance Information: A survey of CPARS will be conducted.

Quality and Satisfaction Ratings for Contracts Completed in the Past Three Years:

Provide any information currently available (letters, metrics, customer surveys, independent surveys, etc.) which demonstrates customer

satisfaction with overall job performance and quality of completed product for the same or similar type of contract. In addition, explain corrective actions taken in the past, if any, for substandard performance and any current performance problems.

Performance Surveys:

The government will evaluate the quality and extent of offeror s performance deemed relevant to the requirements of this solicitation. Identify all federal, state, and local government contracts as well as any private/commercial contracts of similar scope, size, complexity that are ongoing or have been completed within the last three (3) years. List the following information for each contract:

Company Name and Address

Description of Services Performed

Name, Telephone Number and Email Address of Responsible individuals who have first-hand knowledge of performance relative to similar type of services-

Contract Number

Dates of Contract Performance

Contract Type (e.g. fixed price, cost reimbursable) and total contract value

Provide all past performance information requested in the Past Performance award factor (See award Basis).

Subcontractor Consent:

Past performance information pertaining to a subcontractor cannot be disclosed to the prime offeror without the subcontractor s consent.

Provide with the technical quote, a letter from all subcontractors that will perform major or critical aspects of the requirement, consenting to the release of their past performance information to the prime contractor.

Documents submitted in response to this solicitation must be fully responsive to and consistent with the following:

Requirements of the solicitation (CLINSs & SOW and government standards and regulations pertaining to the SOW)

Evaluation Factors for Award (See Award Basis)

Content Requirements: All information shall be confined to the appropriate section. The titles and file type requirements for each file are shown below:

*Note page limitations: A Cover Page, Table of Contents, resumes and/or a glossary of abbreviations or acronyms will not be included in the page count of the Technical Section. However, be advised that all information contained within any Table of Contents and/or glossary of abbreviations or acronyms submitted with an Offeror s Quote will not be evaluated by the Government.

AWARD BASIS AND EVALUATION METHOD

Award shall be made to the responsible offeror whose offer, conforming to the requirements in this request for quote, will be most advantageous to the Government and presents the best value. Technical and Past Performance when combined are equal and not significantly more important than Price. By submission of its quote, the offeror accedes to all solicitation requirements, including terms and conditions, representations and certifications, and technical requirements, in addition to those identified as evaluation factors. Failure to meet a requirement may result in an offer being ineligible for award. Offerors must clearly identify any exception to the solicitation terms and conditions and provide complete accompanying rationale. The government reserves the right to award a contract to other than the lowest priced offeror.

Evaluation Factors - The following factors apply to this procurement:

SECTION I TECHNICAL APPROACH

Technical/Management Approach

Capability to Perform - Offeror must demonstrate that it currently possesses and employs the personnel with appropriate skill mix/qualification, equipment, standards, work processes, and general resources to accomplish the requirements of the SOW. Key Personnel shall be clearly identified.

Certifications Offer must provide proof of the following certifications:

Offeror must include a copy certification or licenses required by the local, State, and Federal Government to perform these services.

Offers shall provide proof of trained, certified and licensure for all Key Personnel employed.

The Technical Rating shall be rated based on the information below:

Technical Ratings

Rating

Definition

Met

Offeror demonstrates understanding of the requirements and an approach that significantly meets performance or capability standards and will significantly benefit the Government.

Not met

Offeror fails to meet performance or capability standards. Requirements can only be met with major changes to the entire proposal.

SECTION II - PAST PERFORMANCE

The CO shall seek recent and relevant past performance information on each offeror based on: (1) the references provided by the offeror and (2) data independently obtained from other government and commercial sources. Relevant past performance includes performance of efforts involving pharmacy equipment inspections and certifications of U.S. Pharmaceutical Convention (USP) equipment, Primary Engineering Controls (PEC)/Hoods and all other relevant systems as identified in the SOW that are similar or greater in scope, magnitude and complexity to the effort described in this solicitation. The government reserves the right to seek information on higher priced offerors if none of the lower priced offerors receive a Substantial Confidence performance assessment rating. The purpose of the past performance evaluation is to allow the government to assess the offeror s ability to perform the effort described in the solicitation, based on the offeror s demonstrated present and past performance. Past performance evaluated will be the past performance of the prime contractor (Company submitting the quote). The assessment process will result in an overall performance confidence assessment rating of MET OR NOT MET. Past performance regarding predecessor companies, key personnel who have relevant experience, or sub-contractors that will perform major or critical aspects of the requirement will not be considered as highly as past performance information for the principal offeror. Offerors with no relevant past or present performance history or the offeror s performance record is so limited that no confidence assessment rating can be reasonably assigned shall receive the rating Unknown Confidence , meaning the rating is treated neither favorably nor unfavorably.

The offer shall provide evidence demonstrating a minimum of 3 years of experience performing the required services that are similar or greater in scope, magnitude and complexity to the effort described in this solicitation.

In evaluating past performance, the government reserves the right to give greater consideration to information on those contracts deemed most relevant to the effort described in this solicitation.

Offerors are cautioned to submit sufficient information and, in the format, specified in the technical quote preparation instructions to permit a meaningful assessment of past performance. Offerors may be asked to clarify certain aspects of their technical quote or respond to adverse past performance information to which the offeror has not previously had an opportunity to respond. Adverse past performance is defined as past performance information that supports a less than satisfactory rating on any evaluation element or any unfavorable comments received from sources without a formal rating system. The following will be used to rate the past performance of each offeror:

Past Performance

Rating

Definition

Met

Based on the offeror s performance record, the government has a

HIGH EXPECTATION that the offeror will successfully perform the required effort.

Not Met

No performance record is identifiable, or the offeror s performance record is so limited that NO CONFIDENCE ASSESSMENT rating can be reasonably assigned

SECTION III - PRICE

Offerors prices shall be submitted in accordance with the Price/Cost Schedule comprised within this combined synopsis document. Total price will be evaluated by the Government. In evaluating the offeror s price for this service, the government concern includes determining price reasonableness.

Options The Government will evaluate offers for evaluation purposes by adding total price for all options to the base year of the performance period. Evaluation of options shall not obligate the Government to exercise the option(s).

The government will evaluate prices for the option under FAR 52.217-8 by using the last year s option prices to calculate the price for six months of effort and adding that amount to the base and other option years to arrive at the total.

Amendments to this solicitation will be posted on https://beta.sam.gov/. Paper copies of the amendments will NOT be individually mailed. By registering to receive notifications on https://beta.sam.gov/, offerors will be notified by email of any new amendments that have been issued. No other notification of amendments will be provided. Potential Offerors are advised that they are responsible for obtaining and acknowledging any amendments to the solicitation. Failure to acknowledge an amendment may result in your quote being considered unacceptable.

DUE DATES

All quotes shall be submitted by 1PM EST September 28, 2020 via email to Desiree Mills desiree.mills-hicks@va.gov. Address Subject Line: USP EQUIPMENT SERVICE CONTRACT DURHAM VAMC 36C24620Q0887.

Facsimile are not authorized under this announcement.

(End of Provision)

52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions 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. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html

http://www.va.gov/oal/library/vaar/

(End of Provision)