36C25619Q0403-001.pdf

36C25619Q0403

SECTION A – COMBINED SYNOPSI/SOLICITATION FOR COMMERCIAL ITEMS

General Information

Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C25619Q0403 Posted Date: April 26, 2019 Questions Due Date/Time: May 3, 2019 / 10:00am (CST) Response Due Date/Time: May 14, 2019 / 10:00am (CST) Product or Service Code: R420 – Certifications & Accreditation Services Set Aside: Small Business NAICS Code: 561990 – All Other Support Services Size Standard: $11.0M Point of Contact: John L. Walker, Jr.- Email: John.Walker15@va.gov

Contracting Office Address

Department of Veterans Affairs Network Contracting Office 16 ATTN: John L. Walker, Jr., Contract Specialist Michael E. DeBakey VA Medical Center (MEDVAMC) 2002 Holcombe Blvd, Bldg. 100 Houston, TX 77030

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; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-01 (effective 01/22/2019).

The associated North American Industrial Classification System (NAICS) code for this procurement is 561990, with a small business size standard of $11.0 million.

Contractor is required to be actively registered in the System for Award Management (SAM) and Small Business Administration (SBA). Quotes may be considered non-compliant and rejected if the Contracting Officer is unable to verify active registration status.

The MEDVAMC is seeking a contractor to provide USP 797 Sterile Compounding Compliance Testing, Sampling and Certification services in accordance with the below. Performance Work Statement (PWS).

All interested vendors shall provide quotations for the following:

mailto:John.Walker15@va.gov

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

Company Name: __________________________ POC Name: ______________________________ Address: ________________________________ Phone: __________________________________ Email: __________________________________

DUNS#: ________________________________

Tax ID#: ________________________________ GSA/FSS, NAC, SEWP Contract # (if applicable): _____________________________

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs Network Contracting Office 16 ATTN: John L. Walker, Contract Specialist Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030 4298

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or [] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly [X]

b. Semi-Annually []

c. Other []

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

Department of Veterans Affairs Financial Service Center PO Box 149971 Austin TX 78714-9971

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

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

4.00

QTR

The contractor shall perform facility-related testing and sampling according to the most current version of CAG-003-2006 and CAG-009-2011v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use under USP 797.

Includes, but not limited to:

1. LAFW Certification: 5 certifications semi-annually (10 total) $ __________________ per certification

2. BSC Certification: 2 certifications semi-annually (4 total) $ __________________ per certification

3. Cleanroom Certification: 9 certifications semi-annually (18 total) $ __________________ per certification

4. Viable Air Sampling: 22 samples semi-annually (44 total) $ __________________ per Sample

5. Viable Surface Sampling: 90 samples semi-annually (180 total) $ __________________ per Sample

6. Environmental Wipe Sampling: 5 samples semi-annually (10 total) $ __________________ per Sample

Contract Period: Base POP Begin: 06-01-2019 POP End: 05-31-2020

4.00 QTR ___________ ___________

The contractor shall perform personnel-related assessments and testing according to the most current version of CAG-009-2011v3 to ensure that sterile compounding personnel are properly trained to aseptically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility under USP 797.

1. Gloved Fingertip Testing: 130 tests annually $ __________________ per test

2. Media-Fill Testing: 130 tests annually $ __________________ per test

3. Gloving and Garbing Assessment: 170 assessments annually

$ __________________ per assessment Contract Period: Base POP Begin: 06-01-2019 POP End: 05-31-2020

4.00 QTR ___________ ___________

testing and sampling according to the most current version of CAG-003-2006 and CAG-009-2011v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use under USP 797.

1. LAFW Certification: 5 certifications semi-annually (10 total) $ __________________ per certification

2. BSC Certification: 2 certifications semi-annually (4 total) $ __________________ per certification

3. Cleanroom Certification: 9 certifications semi-annually (18 total) $ __________________ per certification

4. Viable Air Sampling: 22 samples semi-annually (44 total) $ __________________ per Sample

5. Viable Surface Sampling: 90 samples semi-annually (180 total) $ __________________ per Sample

6. Environmental Wipe Sampling: 5 samples semi-annually (10 total) $ __________________ per Sample

Contract Period: Option 1 POP Begin: 06-01-2020 POP End: 05-31-2021

4.00 QTR ___________ ____________

assessments and testing according to the most current version of CAG-009-2011v3 to ensure that sterile compounding personnel are properly trained to aseptically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility under USP 797.

1. Gloved Fingertip Testing: 130 tests annually $ __________________ per test

2. Media-Fill Testing: 130 tests annually $ __________________ per test

3. Gloving and Garbing Assessment: 170 assessments annually $ __________________ per assessment Contract Period: Option 1 POP Begin: 06-01-2020 POP End: 05-31-2021

4.00 QTR ____________ ____________

testing and sampling according to the most current version of CAG-003-2006 and CAG-009-2011v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use under USP 797.

1. LAFW Certification: 5 certifications semi-annually (10 total) $ __________________ per certification

2. BSC Certification: 2 certifications semi-annually (4 total) $ __________________ per certification

3. Cleanroom Certification: 9 certifications semi-annually (18 total) $ __________________ per certification

4. Viable Air Sampling: 22 samples semi-annually (44 total) $ __________________ per Sample

5. Viable Surface Sampling: 90 samples semi-annually (180 total) $ __________________ per Sample

6. Environmental Wipe Sampling: 5 samples semi-annually (10 total) $ __________________ per Sample

Contract Period: Option 2 POP Begin: 06-01-2021 POP End: 05-31-2022

4.00 QTR ___________ _____________

assessments and testing according to the most current version of CAG-009-2011v3 to ensure that sterile compounding personnel are properly trained to aseptically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility under USP 797.

1. Gloved Fingertip Testing: 130 tests annually $ __________________ per test

2. Media-Fill Testing: 130 tests annually $ __________________ per test

3. Gloving and Garbing Assessment: 170 assessments annually $ __________________ per assessment Contract Period: Option 2 POP Begin: 06-01-2021 POP End: 05-31-2022

4.00 QTR __________ ____________

testing and sampling according to the most current version of CAG-003-2006 and CAG-009-2011v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use under USP 797.

1. LAFW Certification: 5 certifications semi-annually (10 total) $ __________________ per certification

2. BSC Certification: 2 certifications semi-annually (4 total)

3. Cleanroom Certification: 9 certifications semi-annually (18 total) $ __________________ per certification

4. Viable Air Sampling: 22 samples semi-annually (44 total) $ __________________ per Sample

5. Viable Surface Sampling: 90 samples semi-annually (180 total) $ __________________ per Sample

6. Environmental Wipe Sampling: 5 samples semi-annually (10 total) $ __________________ per Sample Contract Period: Option 3 POP Begin: 06-01-2022 POP End: 05-31-2023

4.00 QTR ____________ _____________

assessments and testing according to the most current version of CAG-009-2011v3 to ensure that sterile compounding personnel are properly trained to aseptically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility under USP 797.

1. Gloved Fingertip Testing: 130 tests annually $ __________________ per test

2. Media-Fill Testing: 130 tests annually $ __________________ per test

3. Gloving and Garbing Assessment: 170 assessments annually $ __________________ per assessment

Contract Period: Option 3 POP Begin: 06-01-2022 POP End: 05-31-2023

4.00 QTR ____________ _____________

testing and sampling according to the most current version of CAG-003-2006 and CAG-009-2011v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use under USP 797.

1. LAFW Certification: 5 certifications semi-annually (10 total) $ __________________ per certification

2. BSC Certification: 2 certifications semi-annually (4 total) $ __________________ per certification

3. Cleanroom Certification: 9 certifications semi-annually (18 total)

4. Viable Air Sampling: 22 samples semi-annually (44 total) $ __________________ per Sample

5. Viable Surface Sampling: 90 samples semi-annually (180 total) $ __________________ per Sample

6. Environmental Wipe Sampling: 5 samples semi-annually (10 total) $ __________________ per Sample

Contract Period: Option 4 POP Begin: 06-01-2023 POP End: 05-31-2024

4.00 QTR _____________ _____________

assessments and testing according to the most current version of CAG-009-2011v3 to ensure that sterile compounding personnel are properly trained to aseptically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility under USP 797.

1. Gloved Fingertip Testing: 130 tests annually $ __________________ per test

2. Media-Fill Testing: 130 tests annually $ __________________ per test

3. Gloving and Garbing Assessment: 170 assessments annually $ __________________ per assessment

Contract Period: Option 4 POP Begin: 06-01-2023 POP End: 05-31-2024

GRAND TOTAL

i. Prior to exercising any option, the Contracting Officer shall ensure it is still in the governments best interest to do so, price and other factors considered.

ii. Any extension, in accordance with FAR 52.217-8, shall utilize Option 4 pricing. Thus, the offeror’s total price for the purpose of evaluation shall include the base period, 1st option, 2nd option, 3rd option, 4th option, and ½ of the 4th option. As indicated in FAR 52.217-8, the government will have the option provision to extend the performance of the contract up to an additional 6 months when the contractor is provided written notice. Thus, providing separate price for the option six-month extension period is not required.

B.3 REGISTRATION WITH CONTRACTOR PERFORMANCE ASSESSMENT SYSTEM

(CPARS)

a. As prescribed in Federal Acquisition Regulation (FAR) Part 42.1502 and 42.1503, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $250,000. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, Contractor Performance Assessment System (CPARS), which is maintained by the Naval Sea Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the Federal Awardee Performance and Integrity Information System (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

b. The Contractor will have an opportunity to review their ratings/comments, under the step “Contractor Comments” in CPARS. You will be notified via email by the CPARS system to review the report and provide comments. Each contractor whose contract award is estimated to exceed $250,000 may register with CPARS database at the following web address: www.cpars.gov in order to review the past performance evaluations. Help in registering can be obtained by contacting Customer Support Desk @ DSN: 684-1690 or COMM: 207- 438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the Contractor's registered representative.

B.4 PERFORMANCE WORK STATEMENT (PWS)

Title: Sterile Compounding Compliance Supplemental Quality Management Plan

1. SCOPE:

The contractor shall provide all labor, equipment, materials (including replacement parts upon request), supplies, tools, certified personnel, transportation, and travel necessary to perform all facility and personnel related assessments, monitoring, sampling, and testing necessary to supplement the Central Arkansas Veterans Healthcare System (CAVHS) United States Pharmacopeia (USP) 797 Sterile Compounding Compliance Committee Quality Management Program.

The contractor shall perform routine work detailed in this PWS on a regular schedule, mutually agreed upon by the Contractor and Contracting Officer Representavie (COR). The contractor shall perform unscheduled work or emergency request within seven (7) days of a request from the COR. No additional funding will be provided to pay for travel to the CAVHS for service.

CAVHS uses a variety of engineering ventilation controls to maintain employee exposures to hazardous air contaminants below applicable regulatory limits. The CAVHS Pharmacy Service has both Secondary Engineering Controls (SEC) and Containment Secondary Engineering Controls (C-SEC) which make up the USP 797 compliant cleanrooms which contain a variety of Primary Engineering Controls (PEC) and Contaiment Primary Engineering Controls (C-PEC).

The PEC includes Laminar Airflow Workbenches (LAFW) for all other non-hazardous sterile drug compounding and the C-PEC includes Class II Biological Safety Cabinets (Class II BSCs) for hazardous sterile drug compounding.

The number of cleanrooms, LAFW, and BSC in service may change throughout the contract period. Table A is the Government's best estimate of the number and type expected to be tested, sampled, serviced, and certified by the contractor. The Government reserves the right to add and/or delete units as required.

CAVHS requires 170 personnel validations for all personnel responsible for the receipt, storage, compounding, dispense or administration of non-hazardous and hazardous sterile compounded products. All of these validations are done annually.

If the numbers of listed items will be exceeded, no work is authorized without the prior written approval of the Contracting Officer (CO) to account for it.

2. Places of Performance:

a. John L. McClellan (JLM) Memorial Veterans Hospital 4300 West 7th Street Little Rock, AR 72205

b. Eugene J. Towbin (EJT) Healthcare Center 2200 Fort Roots Drive North Little Rock, AR 72114

3. CONTRACTOR QUALIFICATIONS: The contractor and requisite technicians shall meet the following qualifications, of which, shall be received at time of quote submittal:

a. Controlled Environment Testing Association (CETA) National Board of Testing (CNBT) accredited Registered Cleanroom Certification Professional for Sterile Compounding Facilities

b. National Safety Foundation (NSF) accredited Biosafety Cabinet Field Certifier

c. Contractor shall have at least 2 projects within the past 5 years of the same or similar size, scope and complexity as Pharmacy Cleanroom Certification within a state, federal or government medical facility setting as the requirement being solicited.

4. GENERAL REQUIREMENTS:

4.1 The contractor shall perform facility-related testing and sampling according to the most current version of CAG-003-2006 and CAG-009-2011v3 to determine whether the cleanroom, LAFW, and BSC within the sterile compounding facility can be certified for use under USP 797.

a. Facility-related testing for LAFW and BSC certification includes the following:

Air Velocity Test HEPA Filter Integrity Test Induction Leak/Backstreaming Test

Non-Viable Particle Counting Particle Count Tests Lighting Test (upon request) Noise Test (upon request) Airflow Visualization Test

(at rest) Exhaust Alarm Test (BSC Cert only) Airflow Visualization Test (dynamic operating conditions)

b. Facility-related testing for cleanroom certification includes the following:

Airflow Testing Room Segregation Airflow Visualization Test (when applicable)

Room Non-Viable Particle Counting Airflow Displacement (when applicable)

Pressurization Noise Level Test

(upon request) Lighting Level and Uniformity

Test (upon request) HEPA Filter Installation Leak Test

General Temperature and Moisture Uniformity Test (upon request)

c. Facility-related environmental sampling for the cleanrooms, LAFW, and BSC includes the following:

Viable Surface Sampling Viable Air Sampling Environmental Wipe Sampling

4.2 The contractor shall perform personnel-related assessments and testing according to the most current version of CAG-009-2011v3 to ensure that sterile compounding personnel are properly trained to aseptically compound hazardous and non-hazardous sterile compounded products within the sterile compounding facility under USP 797.

a. Personnel-related assessments and tests include the following:

Media-Fill Testing Gloved Fingertip Sampling Garbing and Gloving Assessment

5. PERFORMANCE REQUIREMENT SUMMARY:

Facility-related LAFW and BSC certification, test, and samplings

Performance Objective

Standard Performance Threshold

Method of Surveillance

Air Velocity Test IEST-RP-CC002.3

IEST-RP-CC034.3

IEST-RP-CC001.5

ISO Standard 14644-1

IEST-RP-CC002.2

CAG-003-2006v13

FDA

NSF/ANSI 49 Annex F CAG-009-v3

USP <797>

Facility-related performance requirements are to be performed for each LAFW and BSC every 6 month.

Contractor provided reports

Video surveillance

HEPA Filter Integrity Test Induction Leak/Backstreaming Test Non-Viable Particle Counting Particle Count Tests Lighting Tests Noise Test Airflow Visualization Test Exhaust Alarm Test Viable Surface Sampling Viable Air Sampling Environmental Wipe Sampling

Facility-related cleanroom certification, tests, and samplings

Performance Objective

Standard Performance Threshold

Method of Surveillance

Airflow Testing IEST-RP-CC006.3

IEST-RP-CC013.2

IEST-RP-CC014.1

IEST-RP-CC006.3

IEST-RP-CC034.3

ISO 14644:4

Facility-related performance requirements are to be performed for each cleanroom every 6 month.

Contractor provided reports

Video surveillance

Room Segregation Room Pressurization Airflow Displacement Airflow Visualization

Test CAG-003-2006v13

IEST-RP-CC013.2

IEST-RP-CC001.5

ISO Standard 14644-1

IEST-RP-CC006.3

IEST-RP-CC006.3

IEST-RP-CC006.3

NSF/ANSI 49-2016

CAG-010-2011

CAG-009-v3

USP<797>

OSHA 1910 Subpart Z

HEPA Filter Installation Leak Test Non-Viable Particle Counting Lighting Level and Uniformity Test Noise Level Test General Temperature and Moisture Uniformity Test Viable Surface Sampling Viable Air Sampling Environmental Wipe Sampling Testing Equipment Calibration Report

Personnel-related Tests Performance Objective

Standard Performance Threshold

Method of Surveillance

Garbing and Gloving Assessment

OSHA 1910 Subpart I CAG-009-v3

USP <797>

Validation of 100% of designated personnel yearly.

Contractor provided reports Gloved Fingertip

Sampling Media-Fill Testing

6. ADDITIONAL REQUIREMENTS:

a. Scheduling of work: The contractor shall coordinate a schedule with the COR to provide the services at the required intervals at both JLM and EJT; with the exception of Environmental Wipe Sampling, which applies to JLM only.

i. 5 (five) LAFW certifications are required semi-annually, or whenever the device is relocated, or whenever major service to the equipment is performed. LAFW to be certified are shown on Table A.

ii. 2 (two) BSC certifications are required semi-annually, or whenever the device is relocated, or whenever major service to the equipment is performed. BSC to be certified are shown on Table A.

iii. 9 (nine) rooms required for cleanroom certifications are required semi-annually, or whenever the room is altered, or whenever major service to the facility is performed. Cleanroom areas to be test for cleanroom certification are shown on Table A.

iv. 22 viable air and 90 viable surface samplings are required semiannually.

Suggested sampling locations are the LAFW, BSC, and rooms shown in Table A (passthroughs should also be included). Additional sampling may be done after any of the following:

a) Initial certification but prior to recertification

b) Any situation which may impact the normal operation of the cleanroom, LAFW, or BSC

c) Movement of the LAFW or BSC

d) Servicing of facilities and/or equipment

e) Any patient incident in which the compounded material is suspect

f) Changes to the process that affect the cleanroom environment

g) Observation of incorrect work practices such as gowning, technique, material flow, cleaning etc.

h) Identified problems with end-product

i) Significant changes in work flow or addition of new procedures or equipment

v. 5 (five) environmental wipe samplings are requested semi-annually using a single panel hazardous drug wipe kit. Additional samplings may be done upon request.

Suggested sampling locations are shown in Table B.

vi. 170 garbing and gloving assessments are required annually to validate personnel according to the following criteria:

a) Initial assessment shall be completed three times successfully before compounding

b) All assessments after the initial assessment shall be completed one time successfully to resume compounding

c) 24 of those assessments are to validate personnel who receive, compound, and dispense hazardous compounded sterile products and therefore should demonstrate gloving and garbing appropriate for hazardous drug receiving, compounding, dispense and/or administration.

d) 40 of those assessments are to validate personnel who administer hazardous compounded sterile products and therefore should demonstrate gloving and garbing appropriate for hazardous drug administration.

vii. 130 gloved fingertip samplings are required annually to validate personnel according to the following criteria:

a) Initial sampling shall be completed three times with no growth before compounding

b) All tests after the initial sampling shall be completed one time with no growth to resume compounding

viii. 130 media-fill test are required annually to validate personnel. 24 of those media fill test will be for those personnel who compound hazardous compounded sterile products and therefore should demonstrate validity using a chemotherapy media fill test

b. Certification Reports- The contractor shall provide to the COR a certificate for each cleanroom, LAFW, and BSC that is certified before leaving the facility. Any cleanroom, LAFW, or BSC that is not certifiable shall be brought to the attention of the COR by the contractor before leaving the facility. In addition, the cleanroom, LAFW, or BSC in question will be marked as such with clear signage that the unit is out of service until further notice. Each certification report from the contractor shall contain, at a minimum, the following information:

i. Contractor name, address and contact information also listing contract personnel with appropriate accreditations.

ii. Confirming remark that the most current version of this CAG was referenced for this certification and the actual date the certification was completed.

iii. Simple and clear method of identification of the approximate location of the collected data in relation to the physical layout of the equipment or facility tested, including specific and clear nomenclature for the data locations.

iv. Explanation of test procedure used for data collection and justification for any deviations from established industry practices encountered during the certification process.

v. Comparison of data recorded against expected values or specific equipment performance criteria established in the CAVHS Pharmacy Service Standard Operating Procedures (SOP). In the absence of a current CAVHS Pharmacy Service SOP; the contractor’s SOP, USP 797, recommended practices, and manufacturer’s specifications will be used.

vi. Safety data sheets (SDS) for all chemical products that will be used during certification procedures.

vii. A list of equipment utilized in data collection to include make, model, serial number, and calibration date

viii. A copy of the current calibration documentation for each piece of equipment utilized in data collection, when applicable.

ix. A written report detailing the airflow patterns from the airflow visualization test must be provided. The report shall contain a definitive statement of acceptabiity for the intended purpose. The documentation shall clearly identify the area or equipment being assessed along with the appropriate aseptic technique performed by the compounding personnel. A vidoe recording shall be used to support this written statement. The plan for recording and transmitting this video to CAVHS shall be established and mutually agreed upon prior to scheduled testing.

x. Pass/Fail notifications, where applicable

xi. Listing of replacement parts provided, when applicable

c. Assessment Reports: The contractor shall ensure the COR signs the personnel assessment prior to departing the facility. Pass/Fail notifications shall be included where applicable. Failure to follow these procedures may result in delay of payment.

d. Sampling Reports: The contractor shall contact the COR upon completion of work to verbally report any sampling issues before the contractor leaves the facility. Larger formal reports as required for the pharmacy clean rooms that include viable sampling and environmental sampling kits for hazardous drug detection shall be submitted to the COR within fifteen (15) business days following the collection of the viable sampling and /or surface sampling kit. Results of viable samples and/or surface sampling kit shall be submitted to the COR within one (1) business day of the receipt of the results from a properly accredited laboratory. All microbiological samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Environmental Microbiology Lab Accreditation Program (EMLAP). All environmental wipe samples shall be analyzed by an ISO/IEC 17025 accredited laboratory accredited under the Industrial Hygiene Laboratory Accreditation Program (IHLAP). Pass/Fail notifications should be included where applicable. Each sampling reports from the contractor shall contain, at a minimum, the following information:

i. An SOP or protocol that describes the procedures used for sampling along with the volume, ISO classification, method of collection, frequency, activity level, action levels, response to exceeded concerns levels, media types, risk level, laboratory analysis, incubation time and temperature.

ii. A sampling map of the cleanroom, LAFW, and BSC noting the locations and types of samples to be taken where applicable.

iii. Growth and Sterility Control Reports (where applicable)

e. Excluded services: The contractor shall not be obligated to provide services under this contract for damage to or destruction of instrument(s) covered where such damage or destruction is a result of or caused by:

i. Fire or explosion of any origin, riot, civil commotion, aircraft, war

ii. Act of God or other force majure including but not limited to lightning, windstorm, hail, flood, earthquake

iii. VAMC misuse or abuse of such instrument (as determined by COR and contractor)

iv. Decontamination due to spillage by VA personnel due to their own negligence

v. Installation of unauthorized field modifications.

f. Schedule of Insurance: The contractor shall procure and maintain for the entire contract period, Workmen's Compensation and employer's general liability Insurance. The contractor shall provide proof of annual insurance coverage with their technical proposal. The contractor shall ensure that a valid insurance certificate is submitted to the Contracting Officer on an annual basis. The parties agree that such personnel shall not be considered a VA employee for any purpose and shall be considered employees of the contractor.

g. Operational Coverage: The contractor shall perform certification services during normal work hours of 8:00am to 4:30pm, Monday-Friday (excluding weekends and federal holidays). The ten holidays observed by the Federal Government are: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day and Christmas Day, along with any other day specifically declared by the President of the United States to be a national holiday.

Exception: work may be performed outside of regular administrative working hours when deemed necessary. The contractor shall receive prior approval from the COR for irregular testing hours.

h. Price Schedule: The contract rate is an all-inclusive rate. No separate fees will be allowed.

i. Environment of Care: The contractor shall maintain a clean/safe environment.

j. Contracting with Parties Listed on the OIG List of Excluded Individuals/Entities:

In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Office of Inspector General has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal payments due to fraud and/or abuse of the Medicare and Medicaid programs. The list of excluded individuals/entities can be found on the OIG web site at www.hhs.gov/oig.

With submittal of proposal, the contractor shall provide evidence than none of the contractor’s employees are on the Excluded Parties list.

k. Invoices/Payments: This provision shall survive the termination or ending of the contract. Payment for services rendered by the Contractor under the terms of this contract will be made upon receipt of a properly executed invoice. Invoice to be submitted within fourteen (14) workdays following completion of the Contractors rendered services. VA will verify services performed and certify invoice for payment within thirty (30) days following date of receipt of sampling reports. Any identified discrepancy(s) in billings shall be cause for extending provisions of this paragraph until the discrepancy or other identified problem with the billing invoice has been resolved. Invoices shall:

i. Be electronically prepared and submitted in accordance with FAR 52.212-4(g)

ii. Clearly state the terms of any discounts offered

iii. Include the current fiscal year and purchase order number

iv. Include the period of performance covered by the invoice

v. Accept payment for services rendered under this contract as payment in full.

This provision shall survive the termination or ending of the contract.

l. Information Security Officer, Information Protection: The contractor will not have access to VA Desktop computers nor online resources belonging to the government while conducting services. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody.

m. Privacy Officer: The contractor will not have access to Patient Health Information (PHI) nor have the capability of accessing patient information during the services provided to the VA. If removal of equipment from the VA is required, any memory storage devices, such as hard drives, solid state drives and non-volatile memory units will remain in VA control and will not be removed from VA custody. All research data available for Contractor analyses is de-identified.

n. Records Manager: The contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chapters 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

o. Security: The contractor shall be liable for security of all areas accessed by the technician(s). All doors, passageways, windows and accesses to equipment and service areas, shall be locked and/or secured after passage. In no instance will any door, window or access be rendered unlocked, propped open, mechanism taped open or rendered to prevent securing. Contractor shall be responsible to physically ensure such accesses are secured to prevent unauthorized entry.

p. Contractor Personnel Badges and Parking: The contractor technician shall acquire an access badge upon entrance into the CAVHS buildings. Contractor shall safeguard the access badge and report any lost, stolen, or destroyed badges to the COR. Contractor shall ensure technicians properly display their access badges. Access badges shall be worn at or above the waist (facing forward). Access badges shall be returned to the COR at the end of each site visit. Contractor shall ensure technician parks in the appropriate designated parking areas. Parking information shall be coordinated with the COR for both JLM and EJT sites. Contractor shall be aware that CAVHS does not validate or make reimbursement for parking violations of the contractor technician under any circumstance.

q. Interference to Normal Function: Contractor may be required to adjust their work at any time so as not to interfere with the normal functioning of the facility, including utility services, fire protection (detection and suppression) systems, passage of facility patients, personnel, equipment and carts and patient care activities (e.g. preparing sterile compounds). In the event of an emergency, contractor services may be stopped by the CAVHS and rescheduled at no additional cost to the government. Contractor personnel shall inform the COR of the need to gain access to secured areas. If access is required to secure areas, prearranged scheduling will be made with the COR.

r. Changes to Contract or PWS: Changes to this PWS or the impending contract shall only be authorized and approved through written correspondence form the CO. A copy of each change shall be kept in a project folder along with all other documents or items pertaining to the project. Costs incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor.

7. APPENDIX:

Table A

Facility Location Room Type*

LAFW / BSC Rooms

JLM

Mobile Pharmacy Trailer Non-hazardous cleanroom

LAFW - Mfg: Germfree Model: BVBI-3SSRX / Serial#3S-15-BVBI-18300 buffer room ante room LAFW - Mfg: Germfree

Model: BVBI-4SSRX / Serial# 4S-15-BVBI-18301

JLM

Mobile Pharmacy Trailer Hazardous cleanroom

Class II Type A1 BSC Mfg: Germfree Model: BBF-3SSRX / Serial# 3S-15-BR2-16796 buffer room ante room

Class II Type A1 BSC Mfg: Germfree Model: BBF-3SSRX / Serial# 3S-15-BR2-18284

JLM

Room GC-189

Cleanroom

LAFW - Mfg: Baker Model: EG-4252 / Serial#: 89982 buffer room ante room

LAFW - Mfg: Baker Model: EG-4252 / Serial#: 89978

EJT - Bldg 170 Room 2F-111

Cleanroom

LAFW - Mfg: Baker Model: EG-4252 / Serial#: 90005 buffer room ante room

JLM

Room 6C-149

Hazardous drug storage area n/a storage room

*Room details shown below in Diagrams A-E

Table B

Facility Location Room Sampling location JLM - Mobile Pharmacy Trailer hazardous buffer room Staging area JLM - Mobile Pharmacy Trailer hazardous buffer room Chemo Cart JLM - Mobile Pharmacy Trailer Office area Passthrough area JLM - Room 6C-149: Hazardous drug storage area Break down area JLM - Room 6C-146: Chemotherapy Administration Room Counter

Diagram A:

Diagram

B:

Diagram C:

Diagram

D:

Diagram E:

JLM

6C-149

(hazardous storage area)

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

ITEMS (OCT 2018)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price. If repair/replacement or reperformance will not correct the defects or is not possible, the Government may seek an equitable price reduction or adequate consideration for acceptance of nonconforming supplies or services. The Government must exercise its post-acceptance rights—

(1) Within a reasonable time after the defect was discovered or should have been discovered; and

(2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

(b) Assignment. The Contractor or its assignee may assign its rights to receive payment due as a result of performance of this contract to a bank, trust company, or other financing institution, including any Federal lending agency in accordance with the Assignment of Claims Act (31 U.S.C. 3727). However, when a third party makes payment (e.g., use of the Governmentwide commercial purchase card), the Contractor may not assign its rights to receive payment under this contract.

(c) Changes. Changes in the terms and conditions of this contract may be made only by written agreement of the parties.

(d) Disputes. This contract is subject to 41 U.S.C. chapter 71, Contract Disputes. Failure of the parties to this contract to reach agreement on any request for equitable adjustment, claim, appeal or action arising under or relating to this contract shall be a dispute to be resolved in accordance with the clause at FAR 52.233-1, Disputes, which is incorporated herein by reference. The Contractor shall proceed diligently with performance of this contract, pending final resolution of any dispute arising under the contract.

(e) Definitions. The clause at FAR 52.202-1, Definitions, is incorporated herein by reference.

(f) Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence such as, acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

(g) Invoice.

(1) The Contractor shall submit an original invoice and three copies (or electronic invoice, if authorized) to the address designated in the contract to receive invoices. An invoice must include—

(i) Name and address of the Contractor;

(ii) Invoice date and number;

(iii) Contract number, line item number and, if applicable, the order number;

(iv) Description, quantity, unit of measure, unit price and extended price of the items delivered;

(v) Shipping number and date of shipment, including the bill of lading number and weight of shipment if shipped on Government bill of lading;

(vi) Terms of any discount for prompt payment offered;

(vii) Name and address of official to whom payment is to be sent;

(viii) Name, title, and phone number of person to notify in event of defective invoice; and

(ix) Taxpayer Identification Number (TIN). The Contractor shall include its TIN on the invoice only if required elsewhere in this contract.

(x) Electronic funds transfer (EFT) banking information.

(A) The Contractor shall include EFT banking information on the invoice only if required elsewhere in this contract.

(B) If EFT banking information is not required to be on the invoice, in order for the invoice to be a proper invoice, the Contractor shall have submitted correct EFT banking information in accordance with the applicable solicitation provision, contract clause (e.g., 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or 52.232-34, Payment by Electronic Funds Transfer—Other Than System for Award Management), or applicable agency procedures.

(C) EFT banking information is not required if the Government waived the requirement to pay by

EFT.

(2) Invoices will be handled in accordance with the Prompt Payment Act (31 U.S.C. 3903) and Office of Management and Budget (OMB) prompt payment regulations at 5 CFR part 1315.

(h) Patent indemnity. The Contractor shall indemnify the Government and its officers, employees and agents against liability, including costs, for actual or alleged direct or contributory infringement of, or inducement to infringe, any United States or foreign patent, trademark or copyright, arising out of the performance of this contract, provided the Contractor is reasonably notified of such claims and proceedings.

(i) Payment.—

(1) Items accepted. Payment shall be made for items accepted by the Government that have been delivered to the delivery destinations set forth in this contract.

(2) Prompt payment. The Government will make payment in accordance with the Prompt Payment Act (31 U.S.C. 3903) and prompt payment regulations at 5 CFR part 1315.

(3) Electronic Funds Transfer (EFT). If the Government makes payment by EFT, see 52.212-5(b) for the appropriate EFT clause.

(4) Discount. In connection with any discount offered for early payment, time shall be computed from the date of the invoice. For the purpose of computing the discount earned, payment shall be considered to have been made on the date which appears on the payment check or the specified payment date if an electronic funds transfer payment is made.

(5) Overpayments. If the Contractor becomes aware of a duplicate contract financing or invoice payment or that the Government has otherwise overpaid on a contract financing or invoice payment, the Contractor shall—

(i) Remit the overpayment amount to the payment office cited in the contract along with a description of the overpayment including the—

(A) Circumstances of the overpayment (e.g., duplicate payment, erroneous payment, liquidation errors, date(s) of overpayment);

(B) Affected contract number and delivery order number, if applicable;

(C) Affected line item or subline item, if applicable; and

(D) Contractor point of contact.

(ii) Provide a copy of the remittance and supporting documentation to the Contracting Officer.

(6) Interest.

(i) All amounts that become payable by the Contractor to the Government under this contract shall bear simple interest from the date due until paid unless paid within 30 days of becoming due. The interest rate shall be the interest rate established by the Secretary of the Treasury as provided in 41 U.S.C. 7109, which is applicable to the period in which the amount becomes due, as provided in (i)(6)(v) of this clause, and then at the rate applicable for each six-month period as fixed by the Secretary until the amount is paid.

(ii) The Government may issue a demand for payment to the Contractor upon finding a debt is due under the contract.

(iii) Final decisions. The Contracting Officer will issue a final decision as required by 33.211 if—

(A) The Contracting Officer and the Contractor are unable to reach agreement on the existence or amount of a debt within 30 days;

(B) The Contractor fails to liquidate a debt previously demanded by the Contracting Officer within the timeline specified in the demand for payment unless the amounts were not repaid because the Contractor has requested an installment payment agreement; or

(C) The Contractor requests a deferment of collection on a debt previously demanded by the Contracting Officer (see 32.607-2).

(iv) If a demand for payment was previously issued for the debt, the demand for payment included in the final decision shall identify the same due date as the original demand for payment.

(v) Amounts shall be due at the earliest of the following dates:

(A) The date fixed under this contract.

(B) The date of the first written demand for payment, including any demand for payment resulting from a default termination.

(vi) The interest charge shall be computed for the actual number of calendar days involved beginning on the due date and ending on—

(A) The date on which the designated office receives payment from the Contractor;

(B) The date of issuance of a Government check to the Contractor from which an amount otherwise payable has been withheld as a credit against the contract debt; or

(C) The date on which an amount withheld and applied to the contract debt would otherwise have become payable to the Contractor.

(vii) The interest charge made under this clause may be reduced under the procedures prescribed in 32.608-2 of the Federal Acquisition Regulation in effect on the date of this contract.

(j) Risk of loss. Unless the contract specifically provides otherwise, risk of loss or damage to the supplies provided under this contract shall remain with the Contractor until, and shall pass to the Government upon:

(1) Delivery of the supplies to a carrier, if transportation is f.o.b. origin; or

(2) Delivery of the supplies to the Government at the destination specified in the contract, if transportation is f.o.b. destination.

(k) Taxes. The contract price includes all applicable Federal, State, and local taxes and duties.

(l) Termination for the Government's convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges the Contractor can demonstrate to the satisfaction of the Government using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor's records. The Contractor shall not be paid for any work performed or costs incurred which reasonably could have been avoided.

(m) Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

(n) Title. Unless specified elsewhere in this contract, title to items furnished under this contract shall pass to the Government upon acceptance, regardless of when or where the Government takes physical possession.

(o) Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

(p) Limitation of liability. Except as otherwise provided by an express warranty, the Contractor will not be liable to the Government for consequential damages resulting from any defect or deficiencies in accepted items.

(q) Other compliances. The Contractor shall comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under this contract.

(r) Compliance with laws unique to Government contracts. The Contractor agrees to comply with 31 U.S.C. 1352 relating to limitations on the use of appropriated funds to influence certain Federal contracts;

18 U.S.C. 431 relating to officials not to benefit; 40…