36C25022Q0632.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office (NCO) 10 260 E. University Avenue Cincinnati OH 45219

POINT OF CONTACT*

Contract Specialist Michael Riordan michael.riordan@va.gov 513-559-3724

PLACE OF PERFORMANCE

420 N. James Road

Columbus OH

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

NAICS Code:

Wage Determination:

Revision Number:

Date of Revision:

541380 2015-4729 3/15/2022

Contracting Office Address

Department of Veterans Affairs Network Contracting Office 10 The Chalmers P. Wylie Ambulatory Care Center 420 N. James Road Columbus, OH 43219 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as a request for quotations. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-04.

The associated North American Industrial Classification System (NAICS) code for this procurement is 541380, with a small business size standard of $16.5 million.

The FSC/PSC is H968.

The Chalmers P. Wylie Ambulatory Care Center (VAACC) has a requirement for semi-annual recertification of sterile compounding facilities including testing of rooms and equipment.

Statement of Work:

SECTION 1: GENERAL INFORMATION

1.1 Scope of Work:

The contractor to provide labor and materials to perform semi-annual certification of the Sterile Compounding Suite including testing of rooms and equipment. This will include certification of pressure relationship between Satellite Pharmacy workplace 2A210 & Ante Room 2A212, Buffer Room Non-Hazardous 2A211 & Ante Room 2A212, and Buffer Room Hazardous 2A213 & Ante Room 2A212. Also, equipment to be certified are Laminar Air Flow Workbench (LAFW), Model #NU-240-430, SN 200699090220, Biosafety Cabinet (BSC) Class II Type B1, Model #NCB 605, SN 134334, and Biosafety Cabinet (BSC) Class II Type B1, Model #NCB 605, SN 134335.

The Chalmers P. Wylie Ambulatory Care Center (VAACC) has a requirement for semi-annual recertification of sterile compounding facilities including testing of rooms and equipment. All testing is to be performed by personnel trained and competent to the specific equipment and facilities to be certified. Certification personnel/company, hereby “certifier,” shall be registered with the CETA National Board of Testing as a Registered Certified Professional for Sterile Compounding Facilities. Certifier will follow VAACC protocols for use of personal protective equipment in the hazardous and sterile compounding areas and understand the risks associated with facilities and equipment designed for storage and preparation of hazardous drugs.

Timing of recertification procedures must be coordinated so as not to interfere with the patient care needs of VAACC. Certifier shall perform recertifications every six calendar months or sooner, at the request of VAACC, if equipment is relocated or altered or major service to equipment or facilities is performed. When change in conditions of the sterile compounding facilities require certification sooner than six months, the six-month interval will be re-established base on the most recent recertification.

The certifier should meet with the Facility Program Manager for Compounded Sterile Preparations & Hazardous Drugs (FPM) to perform a risk assessment and develop a robust written sampling plan and diagram for viable and non-viable sampling prior to first recertification. This plan will designate the sample locations; method of collection, minimum air volume and sample time; time of day as related to the activities in the area; number of samples per location; time intervals between each sample; and action levels. Such a plan will be more detailed than this document and alterations agreed to by both parties will supersede to following plan.

Recertification procedures shall be conducted in all nonhazardous areas prior to hazardous areas, and from cleanest to dirtiest area – LAFW, then buffer room 2A211, then anteroom 2A212, then BSCs, then hazardous buffer room 2A213. Certifier shall perform the designated testing and sampling in accordance with the most recent version of the identified standards and testing methods (or those referenced therein). Procedures described in this document are a general description; the designated methods shall be referenced for detailed guidance of testing and sampling procedures. Certifier will make available to VAACC all SOPs for processes performed during the recertification. All particle counts will measure particles of 0.5 microns and larger. Where instruments are used for testing, they shall be calibrated in accordance with current industry practice or as designated, no less frequently than every 12 months, and certificates of calibration included in the final report.

Inspection, testing, certification, and acceptance criteria shall be in accordance with the current (as of time of performance of work) official version of the following recognized standards, as applicable:

i. United States Pharmacopeia, Chapter 797

ii. United States Pharmacopeia, Chapter 800

iii. United States Pharmacopeia, Chapter 1116

iv. CAG-003

v. CAG-008

vi. CAG-009

vii. ISO 14644-1

viii. IEST RP CC-006

ix. IEST RP CC-034

x. Manufacturer Recommendations

xi. NSF/ANSI 49, Annex F

During recertification, viable sampling will occur prior to facility and equipment testing. Sampling will be conducted in all nonhazardous areas prior to hazardous areas, and from cleanest to dirtiest area – inside LAFW, then buffer room 2A211, then anteroom 2A212, then BSCs, then hazardous buffer room 2A213. Provided agar plates for viable samples will be double or triple wrapped and certificate of quality for each lot will be provided. Aseptic technique per CAG-009 will be followed and care will be taken by certifier to not contaminate agar plates. Agar plates will be stored and transported inverted and cool, but not frozen. All viable samples must be sent same day or overnight to an appropriately credentialed laboratory for analysis. Testing results of negative and positive controls for each lot of each media type used will be provided. Chain of custody must be maintained. Reported results will include all data designated in CAG-009, including colony counts and genus determination. Staphylococci will be designated as coagulase-positive or coagulase-negative.

A total of nine (9) surface sampling locations and eight (8) air sampling locations are included in the viable sampling plan. Separate agar plates will be used for each bacterial and fungal sample at each location.

Action levels for viable samples are based on USP <797> (2008) recommendations, as follows, and are subject to change upon official publication and enforcement of future USP <797> updates. Action levels for highly pathogenic organisms (gram-negative rods, coagulase-positive staphylococci, molds and yeasts) are defined as >0 CFU, regardless of collection method, location, or media type. Certifier to provide repeat viable sampling, following VAACC investigation and mitigations strategies, for any sample exceeding the defined action levels.

The results of each sampling and testing shall be recorded and submitted, as a comprehensive report, along with a statement of compliance or non-compliance with the specified tests. A written report of certification for all primary engineering controls, with statement of Pass/Fail, will be furnished on the day of certification. Full recertification report including identification of viable growth will be furnished upon completion of all analyses, not to exceed 10 calendar days from recertification date. Report shall be transmitted via electronic mail to the VAACC Facilities Manager, Chief of Pharmacy, and FPM.

The report shall be informative and comprehensive, including the following at minimum:

· Name, address, and contact information of the testing organization;

· Written and signed names of certification personnel, with appropriate accreditations;

· Date on which the certification was performed;

· Reference to appropriate standards (CAG or other, most recent version) and testing/sampling method(s);

· Explanation of test procedures, or referral to SOP, and justification for any deviations from established industry practices;

· Clear identification of the physical location of the areas tested (in relation to the physical layout of the compounding facilities, including equipment) and specific designations for coordinates and nomenclature of all sampling locations, via diagram;

· All reported values designated in CAG-008-2010 for the specified tests;

· All reported values designated in NSF/ANSI 49 Annex F.12 for the specified tests;

· Specified designation criteria for the areas, including the ISO classification and considered particle size(s), relevant occupancy state(s), airflow volume or velocity, and pressure differential;

· Instruments and equipment used for data collection, including make, model, serial number, documentation of most recent calibration with date performed and date calibration due;

· Test results, including particle concentration data for all sampling location coordinates and aggregates, as applicable, and laboratory reports;

· A clear indication of Pass or Fail for each test or sample conducted, as indicated by the included criteria;

· An overall indication of Pass or Fail for each sterile compounding area and primary engineering control.

Locations & Equipment Secondary Engineering Controls 2A210 – Satellite Pharmacy workspace, unclassified 2A211 – Buffer Room, Non-Hazardous 2A212 – Anteroom, shared between hazardous and non-hazardous buffer rooms 2A213 – Buffer Room, Hazardous Primary Engineering Controls

Sash Height

Airflow Requirements

Zone 1: 80-90 FPM Zone 2: 70-80 FPM Exhaust 583-642 CFM Zone 1: 72-82 FPM Zone 2: 60-70 FPM Exhaust 486-535 CFM

GLOSSARY

Anteroom: An ISO Class 8 or cleaner area where personnel hand hygiene and garbing procedures and other activities that generate high particulate levels are performed. When servicing a hazardous buffer room, the anteroom shall be ISO Class 7 or cleaner. The anteroom is the transition area between the unclassified area of the facility and the buffer area.

Biological safety cabinet (BSC), Class II: A ventilated cabinet with an open front and inward and downward unidirectional HEPA-filtered airflow and HEPA-filtered exhaust. A BSC used to prepare a CSP must be capable of providing an ISO Class 5 or better environment for preparation of the CSPs.

Buffer area: An ISO Class 7 or cleaner area where the PEC that generates and maintains an ISO Class 5 environment is physically located.

Classified space: A space that maintains an air cleanliness classification based on the International Organization for Standardization (see also definition for ISO Class).

Direct compounding area (DCA): A critical area within the ISO Class 5 PEC where critical sites are exposed to unidirectional HEPA-filtered air, also known as first air.

Hazardous drug: Any drug identified by at least one of the following six criteria: carcinogenicity, teratogenicity or developmental toxicity, reproductive toxicity in humans, organ toxicity at low dose in humans or animals, genotoxicity, or new drugs that mimic existing hazardous drugs in structure or toxicity.

ISO Class: An air quality classification from the International Organization for Standardization.

Laminar airflow workstation (LAFW): A device that is a type of laminar airflow system that provides an ISO Class 5 or better air quality environment for sterile compounding. The device provides a unidirectional HEPA-filtered airflow.

Primary engineering control (PEC): A device or zone that provides an ISO Class 5 environment for sterile compounding. Examples of PECs include LAFW and BSC Secondary engineering control (SEC): The area where the PEC is placed (e.g., a cleanroom suite or an SCA). It incorporates specific design and operational parameters required to minimize the risk of contamination within the compounding area.

Unclassified space: A space not required to meet any air cleanliness classification based on the International Organization for Standardization (ISO).

Designated Testing and Sampling Secondary Engineering Controls

1. Airflow Test

a. Citations: USP <797> (2008), CAG-003-2006, CAG-008-2010

b. Method: IEST-RP-CC006.3 Section 6.1.2.a

c. Locations: Rooms 2A211, 2A212, 2A213

d. Procedure: Air Changes per Hour (ACPH) will be calculated using a validated method which will be kept on file. Measurements are to be taken of HEPA-filtered supply air by an airflow capture hood with backpressure compensation. HEPA-filtered exhaust air from an LAFW may be considered in total ACPH.

e. Pass/Fail Criteria (2A211):

i. PASS – greater than or equal to 35 air changes per hour (minimum of 15 ACPH must be provided through room HEPA filter)

ii. FAIL – less than 35 air changes per hour or less than 15 ACPH from room HEPA

f. Pass/Fail Criteria (2A212, 2A213):

i. PASS – greater than or equal to 35 air changes per hour

ii. FAIL – less than 35 air changes per hour

2. Airflow Smoke Pattern Test

a. Citations: USP <797> (2008), CAG-003-2006, CAG-008-2010

b. Method: Guidance for Industry Sterile Drug Products Produced by Aseptic Processing – Current Good Manufacturing Practice, U.S. Department of Health and Human Services Food and Drug Administration, September 2004

c. Locations:

i. Doorways between 2A211/2A212, 2A213/2A212, 2A212/2A210

ii. Pass-throughs between 2A211/2A210, 2A213/2A210

iii. Other undesignated openings and penetrations

d. Procedure: Visual observation of airflow patterns to prove that air pressure and/or flow differential is in the correct direction and consistent across entire openings and penetrations. Methods and locations tested will be kept on file. Delivery velocity of smoke generator shall not overcome room airflow patterns. Results to be diagramed and/or documented by video.

e. Pass/Fail Criteria (each room):

i. PASS – Airflow is in the appropriate direction and consistent across openings and penetrations.

ii. FAIL – Airflow does not meet direction or consistency across openings or penetrations

3. Room Pressurization

a. Citations: USP <797> (2008), CAG-003-2006, CAG-008-2010

b. Method: IEST-RP-CC006.3 Section 6.4

c. Locations: Doorways between 2A211/2A212, 2A213/2A212, 2A212/2A210

d. Procedure: Room pressurization will be measured in inches water column (wc) by an electronic manometer with resolution to the thousandths of an inch wc. The pressure differential will be determined at the doorway between each room. A validated method will be used and kept on file to measure pressure differential.

e. Pass/Fail Criteria (2A211):

i. PASS – Minimum differential pressure of 0.020 inches wc positive to 2A212

ii. FAIL – Pressure differential less than 0.020 inches wc positive, or negative pressure differential to 2A212

f. Pass/Fail Criteria (2A212):

i. PASS – Pressure differential 0.010 to 0.030 inches wc positive to 2A213 and minimum differential pressure of 0.020 inches wc negative to 2A211, minimum differential pressure of 0.020 inches wc positive to all other adjacent areas

ii. FAIL – Pressure differential not meeting designated range or direction to any adjacent areas

g. Pass/Fail Criteria (2A213):

i. PASS – Differential pressure of 0.010 to 0.030 inches wc negative to 2A212

ii. FAIL – Pressure differential less than 0.010 inches wc negative, greater than 0.030 inches wc negative, or positive differential to 2A212

4. HEPA Filter Installation Leak Test

a. Citations: USP <797> (2008), CAG-003-2006, CAG-008-2010

b. Method: IEST-RP-CC034.2 Section 6.2.1 for filters that can be scan tested

c. Locations: Rooms 2A211, 2A212, 2A213

d. Procedure: HEPA filters will be leak tested using a validated method which will be kept on file. An aerosol challenge of 10 micrograms per liter of Poly Alpha Olefin or equivalent will be introduced upstream and filter efficacy verified by aerosol photometer scan. Certifier shall have capability to patch and repair HEPA filter up to 3% of the face area per side and not to exceed 1.5 inches in width or provide replacement HEPA filter with filter of like size and construction (Type C or K) on same day.

e. Pass/Fail Criteria (each room):

i. PASS – leakage of less than or equal to 0.01% of upstream concentration

ii. FAIL – leakage of greater than 0.01% or patch size exceeds IEST-RP-CC034 limit

5. Particle Count Survey

a. Citations: USP <797> (2008), CAG-003-2006, CAG-008-2010

b. Method: ISO 14644-1

c. Locations: CETA 9.7.4 recommendation of collecting the minimum number of samples no less than the square root of the clean space area in square meters will be followed.

i. Room 2A211 – 4 samples

ii. Room 2A212 – 6 samples

iii. Room 2A213 – 7 samples

d. Procedure: Air particle counts will be measured under dynamic operating conditions using a validated method which will be kept on file. A discrete particle counter capable of detecting particles of 0.5 micron and larger shall be used. Sampling probe is to be oriented upward and a minimum sample of two liters of air over one minute will be taken for each testing location. Individual readings will be reported. All particle counts will be averaged to determine the final room classification for each area.

e. Pass/Fail Criteria (each room):

i. PASS – ISO Class 7 or better: less than or equal to 352,000 particles (0.5 micron and larger) per cubic meter, equivalent to 10,000 particles per cubic foot

ii. FAIL – greater than 352,000 particles (0.5 micron and larger) per cubic meter, equivalent to 10,000 particles per cubic foot

6. Lighting Level and Uniformity Test

a. Citations: USP <797> (2008), CAG-003-2006

b. Method: IEST-RP-CC006.3 Section 6.6

c. Locations: Rooms 2A211, 2A212, 2A213

d. Procedure: Background and operating light intensity to be recorded using a validated method and reported in foot-candles (FC), for baseline assessment.

e. Pass/Fail Criteria (each room):

i. PASS – Greater than or equal to 80 FC

ii. FAIL – Less than 80 FC

7. Noise Level Test

a. Citations: USP <797> (2008), CAG-003-2006

b. Method: IEST-RP-CC006.3 Section 6.7

c. Locations: Rooms 2A211, 2A212, 2A213

d. Procedure: Background and operating noise levels to be recorded using a validated method and reported in decibels (dB), for baseline assessment.

e. Pass/Fail Criteria:

i. PASS – Less than 85 dB

ii. FAIL – Greater than or equal to 85dB

8. General Temperature and Moisture Uniformity Tests

a. Citations: USP <797> (2008), CAG-003-2006, CAG-008-2010

b. Method: IEST-RP-CC006.3 Section 6.9

c. Locations: Rooms 2A211, 2A212, 2A213

d. Procedure: Temperature will be recorded with a sensor capable of measuring to 0.1°C or equivalent. Humidity will be recorded with a sensor capable of indicating a 1% change in relative humidity.

e. Pass/Fail Criteria: Temperature and humidity recordings are to be included in the formal report. Criteria identified in USP <797> are recommendations, therefore there is not a specific pass/fail limit.

9. Viable Air Sampling

a. Citations: USP <797> (2008), USP <1116>, CAG-009-2011

b. Methods: USP <797> (2008), CAG-009-2011

c. Locations:

i. 2A211 – one (1) sample location above the worktable, placed near the geometric center of the room, (represents outside the LAFW, and near the doorway and pass-through to 2A212)

ii. 2A212 – one (1) sample location in the gowning area (in front of the sink and between the doorways to 2A212 and 2A213)

iii. 2A213 – three (3) sample locations total, one outside each BSC (2), one near pass-through to 2A210

d. Procedure: Separate samples for bacterial and fungal to be collected at each location. All samples shall be collected under dynamic operating conditions by volumetric impaction. Bacterial samples will be collected using 55mm plates containing Trypticase Soy Agar (TSA) with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing Malt Extract Agar (MEA) or Sabouraud Dextrose Agar (SDA) with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and counts will be adjusted per manufacturer MPN calculation or statistical correction factor and reported as CFU per cubic meter.

e. Pass/Fail Criteria:

i. PASS – ≤ 10CFU per plate and no highly pathogenic organisms

ii. FAIL – >10 CFU per plate or ≥ 1 CFU of highly pathogenic organisms

iii. Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts

10. Viable Surface Sampling

a. Citations: USP <797> (2008), USP <1116>, CAG-009-2011

b. Methods: USP <797> (2008), CAG-009-2011

c. Locations:

i. 2A211 – two (2) sample locations total, one on the top of the work table at the front-center, one inside the pass-through to 2A212 at the center of the bottom surface

ii. 2A212 – one (1) sample location on the front-center of the 3rd shelf of the supply cart (to the left of doorway to 2A213)

iii. 2A213 – three (3) sample locations total, one on the work table between the BSCs, near the end closest to the BSCs and centered, one (1) on the front-center of the 3rd shelf of the drug cart (next to refrigerator), one (1) inside the pass-through to 2A210

d. Procedure: Separate samples for bacterial and fungal to be collected at each location. All samples shall be collected under dynamic operating conditions using convex agar plates by gently rolling across the surface once in a single direction. Surface to be disinfected by wiping with non-shedding wipe soaked with sterile 70% isopropyl alcohol (provided by facility) immediately after each sample is collected. Bacterial samples will be collected using 55mm plates containing TSA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing MEA or SDA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and reported as CFU per plate.

e. Pass/Fail Criteria:

i. PASS – ≤ 5 CFU per plate and no highly pathogenic organisms

ii. FAIL – >5 CFU per plate or ≥ 1 CFU of highly pathogenic organisms

iii. Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts

Primary Engineering Controls

1. Airflow Velocity Test

a. Citations: USP <797> (2008), CAG-003-2006, NSF/ANSI 49-2020, Facility & Manufacturer Specifications

b. Methods: CAG-003-2006, IEST-RP-CC002.3 Section 6.1, NSF/ANSI 49 Annex F

c. Locations: Each LAFW and BSC

d. Procedure: Appropriate airflow parameters will be measured using a validated method which will be kept on file. Reported in feet per minute, with % uniformity where appliable.

i. LAFW: Air velocity will be measured by thermal anemometer using equally spaced readings across a vertical plane 6 inches in front of the diffuser (LAFW). The locations within the plane, and the level of the plane in relationship to the filter diffuser will be documented.

ii. BSCs: Non-uniformed (zoned) downflow velocity will be measured by thermal anemometer using equally spaced readings across a horizontal plane 4 inches above the bottom edge of the sash (BSC). The locations within the plane, and the level of the plane in relationship to the filter diffuser will be documented. Additionally, inflow velocity and exhaust volume (CFM) will be measured by accepted methods.

e. Pass/Fail Criteria:

i. PASS – Average velocity, uniformity, and exhaust volume within manufacturer and facility specifications

ii. FAIL – Average velocity, uniformity, and/or exhaust volume outside manufacturer and/or facility specifications

2. Site Installation Assessment Tests

a. Citations: USP <797> (2008), CAG-003-2006, NSF/ANSI 49, Manufacturer Specifications

b. Methods: CAG-003-2006, IEST-RP-CC002.3 Section 6.1.3, NSF/ANSI 49 Annex F

c. Locations: Each LAFW and BSC

d. Procedure: Validated methods will be used to identify any leaks in PEC construction and/or exhaust system, and to verify that placement of PEC in the cleanroom does not adversely impact PEC airflow. Additional testing and verification for BSCs include supply fan interlock, sash and exhaust alarm performance, and exhaust duct static pressure will be documented.

e. Pass/Fail Criteria:

i. PASS – No air leaks or adverse airflows identified, and additional performance parameters meet specifications

ii. FAIL – Air leaks of adverse airflows identified, and/or additional performance parameters not meeting specifications

3. HEPA Filter Integrity Test

a. Citations: USP <797> (2008), CAG-003-2006, NSF/ANSI 49-2020

b. Methods: CAG-003-2006, IEST-RP-CC034.2 Section 6.2.1, NSF/ANSI 49 Annex F

c. Locations: Each LAFW and BSC

d. Procedure: HEPA filters will be leak tested using a validated method which will be kept on file. An aerosol challenge of 10-90 micrograms per liter of polydispersed dioctylphthalate, polyalphaolefin, or equivalent will be introduced upstream and filter efficacy verified by aerosol photometer scan. Certifier shall have capability to patch and repair HEPA filter up to 3% of the face area per side and not to exceed 1.5 inches in width or provide replacement HEPA filter with filter of like size and construction (Type C or K) on same day.

e. Pass/Fail Criteria:

i. PASS – leakage of less than or equal to 0.01% of upstream concentration for filters that can be scanned

ii. FAIL – leakage of greater than 0.01% or patch size exceeds IEST-RP-CC034 (current version) limit

4. Airflow Smoke Pattern Test

a. Citations: USP <797> (2008), CAG-003-2006, NSF/ANSI 49-2020

b. Methods: CAG-003-2006, NSF/ANSI 49 Annex F

c. Locations: Each LAFW and BSC

d. Procedure: Visual observation of airflow patterns, under dynamic operating conditions, demonstrating first-air flow through critical sites within the DCA. Minimal dead spots or reflux away from critical sites is allowable. Additionally, airflow patterns across the face and around the perimeter of the work access opening are outward for LAFW and inward for BSC. Methods will be kept on file. Delivery velocity of smoke generator shall not overcome isolator airflow patterns. Results to be video recorded.

e. Pass/Fail Criteria:

i. PASS – Airflow demonstrates smooth, unidirectional airflow with no dead spots or refluxing across critical sites and follows the appropriate direction at the work access opening

ii. FAIL – Airflow does not meet direction or turbulence standards

5. Particle Count Survey

a. Citations: USP <797> (2008), CAG-003-2006

b. Methods: CAG-003-2006, ISO 14644-1

c. Locations: Each LAFW and BSC

d. Procedure: Air particle counts will be measured using a validated method which will be kept on file. A discrete particle counter capable of detecting particles of 0.5 micron and larger shall be used. Sampling probe is to be oriented into the clean air stream with test points in a grid pattern at the working level. A minimum sample of two liters of air over one minute will be taken for each testing location. A minimum of five particle counts each will be taken in each LAFW and BSCs – one near each corner, and one in the geometric center, including 6-12 inches upstream of the DCA. Particle counts will be reported individually for each sampling location and designated by location and testing condition.

e. Pass/Fail Criteria (each PEC):

i. PASS – ISO Class 5 or better for all samples: less than or equal to 3,520 particles (0.5 micron and larger) per cubic meter

ii. FAIL – greater than 3,520 particles (0.5 micron and larger) per cubic meter for any sample

6. Viable Air Sampling

a. Citations: USP <797> (2008), USP <1116>, CAG-009-2011

b. Methods: CAG-009-2011

c. Locations: Three (3) sample locations total, one (1) of each bacterial and fungal at each location, near the geometric center of the work surface in each PEC (one LAFW, two BSCs)

d. Procedure: All samples shall be collected under dynamic operating conditions by volumetric impaction. Bacterial samples will be collected using 55mm plates containing TSA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing MEA or SDA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and counts will be adjusted per manufacturer MPN calculation or statistical correction factor and reported as CFU per cubic meter.

e. Pass/Fail Criteria:

i. PASS – ≤ 1CFU per plate and no highly pathogenic organisms

ii. FAIL – >1 CFU per plate or ≥ 1 CFU of highly pathogenic organisms

iii. Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts

7. Viable Surface Sampling

a. Citations: USP <797> (2008), USP <1116>, CAG-009-2011

b. Methods: CAG-009-2011

c. Locations: Three (3) sample locations total, one (1) of each bacterial and fungal at each location, near the geometric center of the work surface in each PEC (one LAFW, two BSCs)

d. Procedure: All samples shall be collected under dynamic operating conditions using convex agar plates by gently rolling across the surface once in a single direction. Surface to be disinfected by wiping with non-shedding wipe soaked with sterile 70% isopropyl alcohol (provided by facility) immediately after each sample is collected. Bacterial samples will be collected using 55mm plates containing TSA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated inverted at 30-35° C for 48-72 hours. Fungal samples will be collected using 55mm plates containing MEA or SDA with neutralizing agents (lecithin and polysorbate 80). Samples will be incubated at 26-30° C for 5-7 days. Colony forming units will be assessed daily and reported as CFU per plate.

e. Pass/Fail Criteria:

i. PASS – ≤ 3 CFU per plate and no highly pathogenic organisms

ii. FAIL – >3 CFU per plate or ≥ 1 CFU of highly pathogenic organisms

iii. Highly pathogenic organisms defined as gram-negative rods, coagulase-positive staphylococci, molds and yeasts

References:

CETA Certification Guide for Sterile Compounding Facilities CAG-003-2006-13 Revised May 20th, 2015 CETA Certification Matrix for Sterile Compounding Facilities (Secondary Engineering Controls) CAG-008-2010 Effective January 31st, 2012 CETA Certification Application Guide USP <797> Viable Environmental Sampling and Gowning Evaluation CAG-009-00 Effective January 31st, 2012 General information chapter 797: Pharmaceutical Compounding—Sterile Preparations. In: The United States pharmacopeia, 40th revision and The National Formulary, 35th ed. Rockville, MD: United States Pharmacopeia Convention; 2017:39-83.

General information chapter 800: Hazardous Drugs–-Handling in Healthcare Settings. In: The United States pharmacopeia, 40th revision and The National Formulary,35th ed. Rockville, MD: United States Pharmacopeia Convention; 2017:83-102 NSF/ANSI 49: Biosafety Cabinetry: Design, Construction, Performance, and Field Certification (2020). NSF International, Ann Arbor, MI, US.

1.2 Hours of Operation:

The Contractor shall perform all work during hours 8:00am – 5:00pm, Monday - Friday. Monday through Friday excluding Federal Holidays. The Veterans Affairs (VA) recognizes the following holidays:

Christmas Day

Any other day specifically designated as a holiday by the President of the United States. If a holiday falls on a Saturday, the preceding Friday is recognized as the holiday; if the holiday falls on Sunday, the following Monday is recognized as the holiday.

SECTION 2: DEFINITION & ACRONYMS

2.1 Definitions:

Contractor. A supplier or vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime.

Contracting Officer (CO). A person with the authority to enter into, administers, and/or terminates contracts and makes related findings. The Contracting Officer is the only individual who has the authority to contractually bind the Government. The Contracting Officer may designate a Government employee to act as his authorized technical representative.

Contracting Officer Representative (COR). The person has been designated as the authorized representative of the Contracting Officer acting within the limits of his/her authority. This individual shall not be authorized to award, agree to, or sign any contract or modification thereto, or in any way to obligate the payment of money by the Government. The COR advises the Contracting Officer on matters relating to this contract, verifies completion of the work, certifies invoices related to completed work, and ensures compliance with all provisions of the contract.

2.2 Acronyms:

SECTION 3: COMPETENCY OF PERSONNEL SERVICING EQUIPMENT

The FST(s) shall be authorized by the Contractor to perform the testing and certification services. All work shall be performed by “Fully Qualified” and competent FSTs. “Fully Qualified” is based: upon training and on experience in the field.

All certification procedures shall be performed by a CETA National Board of Testing (CNBT) Registered Cleanroom Professional (individual/company) for Sterile Compounding Facilities (RCPSCF)

SECTION 4: INFORMATION SECURITY REQUIREMENTS

The Certification and Accreditation (C&A) requirements do not apply, and that a Security Accreditation Package is not required.

Place of Performance: Chalmers P. Wylie Ambulatory Care Center (VAACC) 420 N. James Road, Columbus, OH 43219.

All interested companies shall provide quotations for the following:

Supplies/Services

The Government’s intent is to establish the awarded Purchase Order Contract for a period of five years (Base + 4 Option Years). However, the option years will be reviewed annually to determine its ongoing need. The contractor shall start the work required under this Statement of Work each June and December during the period of this service contract.

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

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” (NOV 2021)

· FAR 52.204-13, “System for Award Management Maintenance” (OCT 2018)

· FAR 52.204-18, “Commercial and Government Entity Code Maintenance” (AUG 202)

· FAR 52.217-8, “Option to Extend Services” (NOV 1999)

· FAR 52.217-9, “Option to Extend the Term of the Contract” (MAR 2000)

· FAR 52.232-40, “Providing Accelerated Payments to Small Business Subcontractors” (NOV 2021)

· FAR 52.237-2, “Protection of Government Buildings, Equipment, and Vegetation” (APR 1984)

· VAAR 852.212-70, “Provisions and Clauses Applicable to VA Acquisition of Commercial Items” (APR 2020)

· VAAR 852.203-70, “Commercial Advertising” (MAY 2018)

· VAAR 852.219-10, “VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside” (NOV 2020) (DEVIATION)

· VAAR 852.232-72, “Electronic Submission of Payment Requests” (NOV 2018)

· VAAR 852.219-74, “Limitations on Subcontracting – Monitoring and Compliance” (JUN 2018) (DEVIATION)

· VAAR 852.219-75, “Subcontracting Commitments Monitoring and Compliance” (JUN 2018) (DEVIATION)

· VAAR 852.219-77, “VA Notice of Limitations on Subcontracting – Certificate for Services and Construction” (SEP 2021) (DEVIATION) (Attached with Fill-ins) The following subparagraphs of FAR 52.212-5 are applicable:

(a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

(1) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E. Title VII, of the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(2) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kapersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(3) 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance or Equipment (NOV 2021) (Section 1634 of Pub. L. 115-91).

(4) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (NOV 2015).

(5) 52.233-3, Protest After Award (AUG 1996) (31 U.S.C. 3553).

(6) 52.233-4, Applicable Law for Breach of Contract Claim (OCT 2004) (Public Laws 108-77 and 108-78) (19 U.S.C. 3805 note)).

(b) The Contractor shall comply with the FAR clauses in this paragraph (b) that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

· FAR 52.204-10, Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020)

· FAR 52.209-6, Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (NOV 2021)

· FAR 52.219-28, Post Award Small Business Program Representation (SEP 2021) (15 U.S.C. 632(a)(2))

· FAR 52.222-21, Prohibition of Segregated Facilities (APR 2015)

· FAR 52.222-26, Equal Opportunity (SEPT 2016)

· FAR 52.222-35, Equal Opportunity for Veterans (JUN 2020)

· FAR 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2020)

· FAR 52.222-37, Employment Reports on Veterans (JUN 2020)

· FAR 52.222-50, Combating Trafficking in Persons (NOV 2021)

· FAR 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513)

· FAR 52.225-13, Restrictions on Certain Foreign Purchases (FEB 2021)

· FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management (OCT 2018)

(c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, that the Contracting Officer has indicated as being incorporated in this contract by reference to implement provisions of law or Executive orders applicable to acquisitions of commercial items:

· FAR 52.222-41, Service Contract Labor Standards (Aug 2018)

· FAR 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67).

· FAR 52.222.55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022)

· FAR 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022)

(d) Comptroller General Examination of Record. The Contractor shall comply with the provisions of this paragraph (d) if this contract was awarded using other than sealed bid, is in excess of the simplified acquisition threshold, and does not contain the clause at 52.215-2, Audit and Records - Negotiation.

(1) The Comptroller General of the United States, or an authorized representative of the Comptroller General, shall have access to and right to examine any of the Contractor's directly pertinent records involving transactions related to this contract.

(2) The Contractor shall make available at its offices at all reasonable times the records, materials, and other evidence for examination, audit, or reproduction, until 3 years after final payment under this contract or for any shorter period specified in FAR Subpart 4.7, Contractor Records Retention, of the other clauses of this contract. If this contract is completely or partially terminated, the records relating to the work terminated shall be made available for 3 years after any resulting final termination settlement. Records relating to appeals under the disputes clause or to litigation or the settlement of claims arising under or relating to this contract shall be made available until such appeals, litigation, or claims are finally resolved.

(3) As used in this clause, records include books, documents, accounting procedures and practices, and other data, regardless of type and regardless of form. This does not require the Contractor to create or maintain any record that the Contractor does not maintain in the ordinary course of business or pursuant to a provision of law.

(e)(1) Notwithstanding the requirements of the clauses in paragraphs (a), (b), (c), and (d) of this clause, the Contractor is not required to flow down any FAR clause, other than those in this paragraph (e)(1) in a subcontract for commercial products and commercial services. Unless otherwise indicated below, the extent of the flow down shall be as required by the clause—

(i) 52.203-13, Contractor Code of Business Ethics and Conduct (NOV 2021) (41 U.S.C. 3509).

(ii) 52.203-19, Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (JAN 2017) (section 743 of Division E, Title VII, or the Consolidated and Further Continuing Appropriations Act, 2015 (Pub. L. 113-235) and its successor provisions in subsequent appropriations acts (and as extended in continuing resolutions)).

(iii) 52.204-23, Prohibition on Contracting for Hardware, Software, and Services Developed or Provided by Kaspersky Lab and Other Covered Entities (NOV 2021) (Section 1634 of Pub. L. 115-91).

(iv) 52.204-25, Prohibition on Contracting for Certain Telecommunication and Video Surveillance Services or Equipment. (NOV 2021) (Section 889(a)(1)(A) of Pub. L. 115-232).

(v) 52.219-8, Utilization of Small Business Concerns (OCT 2018) (15 U.S.C. 637(d)(2) and (3)), in all subcontracts that offer further subcontracting opportunities. If the subcontract (except subcontracts to small business concerns) exceeds the applicable threshold specified in FAR 19.702(a) on the date of subcontract award, the subcontractor must include 52.219-8 in lower tier subcontracts that offer subcontracting opportunities.

(vi) 52.222-21, Prohibition of Segregated Facilities (APR 2015)

(vii) 52.222-26, Equal Opportunity (SEP 2016) (E.O. 11246).

(viii) 52.222-35, Equal Opportunity for Veterans (JUN 2020) (38 U.S.C. 4212).

(ix) 52.222-36, Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793).

(x) 52.222-37, Employment Reports on Veterans (JUN 2020) (38 U.S.C. 4212)

(xi) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). Flow down required in accordance with paragraph (f) of FAR clause 52.222-40.

(xii) 52.222-41, Service Contract Labor Standards (AUG 2018), (41 U.S.C. chapter 67).

(xii) (A) 52.222-50, Combating Trafficking in Persons (NOV 2021) (22 U.S.C. chapter 78 and E.O. 13627).

(B) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627).

(xiv) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment – Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xv) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services – Requirements (MAY 2014) (41 U.S.C. chapter 67).

(xvi) 52.222-54, Employment Eligibility Verification (NOV 2021) (E.O. 12989).

(xvii) 52.222-55, Minimum Wages for Contractor Workers Under Executive Order 14026 (JAN 2022).

(xviii) 52.222-62, Paid Sick Leave Under Executive Order 13706 (JAN 2022) (E.O. 13706).

(xix) (A) 52.224-3, Privacy Training (JAN 2017) (5 U.S.C. 552a).

(B) Alternate I (JAN 2017) of 52.224-3.

(xx) 52.225-26, Contractors Performing Private Security Functions Outside the United States (OCT 2016) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note)

(xxi) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (JUN 2020) (42 U.S.C. 1792). Flow down required in accordance with paragraph (e) of FAR clause 52.226-6.

(xxii) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (NOV 2021) (46 U.S.C. 55305 and 10 U.S.C. 2631). Flow down required in accordance with paragraph (d) of FAR clause 52.247-64.

(2) While not required, the Contractor may include in its subcontracts for commercial products and commercial services a minimal number of additional clauses necessary to satisfy its contractual obligations.

The following solicitation provisions apply to this acquisition:

· FAR 52.212-1, “Instructions to Offerors–Commercial Items” (NOV 2021)

· FAR 52.204-7, “System for Award Management” (OCT 2018)

· FAR 52.204-16, “Commercial and Government Entity Code Reporting” (AUG 2020)

· FAR 52.237-1, “Site Visit” (APR 1984)

· FAR 52.212-2, “Evaluation – Commercial Items” (NOV 2021)

· FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” (NOV 2021) Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at SAM.gov | Home 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.

All quotes shall be sent to electronically to Michael Riordan at michael.riordan@va.gov.

Evaluation Award will be based upon a comparative evaluation of quotes in accordance with the Simplified Acquisition Procedures of FAR 13. Comparative evaluation is the side by side pairwise comparison of quotes based on factors resulting in a Contracting Officer decision for the quote most favorable to the Government.

The Government will evaluate quotations using the comparative evaluation process outlined in FAR 13.106-2 (b) (3), where quotations…