36C25920Q0618 0004.docx

Amendment 0004 of RFQ 36C25920Q0618 Pharmacy Compounding Area Certifications, Sheridan VA Health Care System, WY

5. PROJECT NUMBER (if applicable)

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Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

E. IMPORTANT:

is extended,

(a) By completing Items 8 and 15, and returning __________ copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE

OF YOUR

ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY is not extended.

12. ACCOUNTING AND APPROPRIATION DATA

(REV. 11/2016)

is required to sign this document and return ___________ copies to the issuing office.

is not, A. THIS CHANGE ORDER IS ISSUED PURSUANT TO:

Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

15C. DATE SIGNED

B. THE ABOVE NUMBERE

D CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES

SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendmen t, and is received prior to the opening hour and date specified.

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

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Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

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STATES OF AMERICA

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

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Prescribed by GSA - FAR (48 CFR) 53.243 (Type or print) (Type or print) (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

(Number, street, county, State and ZIP Code) (If other than Item 6) (Specify type of modification and authority) (such as changes in paying office, appropriation date, etc.)

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13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF

SOLICITATIONS

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

(Signature of person authorized to sign) (Signature of Contracting Officer) 09-01-2020 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401 36C259 Department of Veterans Affairs Network Contracting Office

NCO 19

1011 Honor Heights Drive Muskogee OK 74401 To all Offerors/Bidders

36C25920Q0618 08-24-2020

X X X

See CONTINUATION Page X Amendment to RFQ for Pharmacy Compounding Area Certification for Sheridan VA Health Care System, WY.

Amendment instructs offerors to use the following Price Schedule and PWS to replace prev ious versions of the B.3 PRICE/COST SCHEDULE and B.4 PERFORMANCE WORK SCHEDULE (PWS).

All other items remain unchanged.

Monica Gary Contracting Officer

NCO1614L2-5620

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Certification, per the PWS.

Refer to FAR clause 52.232-18 (APR 1984) Contract Period: Base POP Begin: 10-01-2020 POP End: 09-30-2021

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Laminar Flow Hood Certification, per the PWS.

Contract Period: Base

Development of Pharmacy Compounding Area Certification Report, per the PWS.

Contract Period: Base

Bio-Safety Hood Certification in Sheridan VA Laboratory, per the PWS.

Contract Period: Base

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Certification, per the PWS.

Contract Period: Option 1 POP Begin: 10-01-2021 POP End: 09-30-2022

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Laminar Flow Hood Certification, per the PWS.

Development of Pharmacy Compounding Area Certification Report, per the PWS.

Bio-Safety Hood Certification in Sheridan VA Laboratory, per the PWS.

Contract Period: Option 1

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Certification, per the PWS.

Contract Period: Option 2 POP Begin: 10-01-2022 POP End: 09-30-2023

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Laminar Flow Hood Certification, per the PWS.

Development of Pharmacy Compounding Area Certification Report, per the PWS.

Bio-Safety Hood Certification in Sheridan VA Laboratory, per the PWS.

Contract Period: Option 2

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Certification, per the PWS.

Contract Period: Option 3 POP Begin: 10-01-2023 POP End: 09-30-2024

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Laminar Flow Hood Certification, per the PWS.

Development of Pharmacy Compounding Area Certification Report, per the PWS.

Bio-Safety Hood Certification in Sheridan VA Laboratory, per the PWS.

Contract Period: Option 3

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Certification, per the PWS.

Contract Period: Option 4 POP Begin: 10-01-2024 POP End: 09-30-2025

Measurement, testing, adjusting, sampling, and documentation required for Pharmacy Compounding Area Laminar Flow Hood Certification, per the PWS.

Development of Pharmacy Compounding Area Certification Report, per the PWS.

Bio-Safety Hood Certification in Sheridan VA Laboratory, per the PWS.

Contract Period: Option 4

GRAND TOTAL

Base period plus all Options:

ACCOUNTING AND APPROPRIATION DATA

[Updated upon award]

B.4 PERFORMANCE WORK SCHEDULE (PWS)

PURPOSE:

VA requires a qualified contractor to develop a pharmacy compounding area certification report, and subsequent certification of the pharmacy compounding area including the buffer and ante rooms, and provide a hood certification for the laminar flow hood - Baker EG-6320 S/N 114140, at the Sheridan VA Healthcare System, in accordance with this performance work statement (PWS). Additional services include hood certification of a NuAire Brand, model NU-430-400 hood in the Sheridan VA Laboratory. Services must be accomplished in a cost effective, safe, efficient and secure manner for the VA and in support of the VA Mission.

Qualified Contractor: Services must be performed in accordance with the most current versions of Controlled Environment Testing Association (CETA) Standards and technician performing testing must maintain current CETA certification.

Period of Performance: Refer to the Price Cost Schedule of this contract.

Service Frequency:

1. The Pharmacy Compounding area requires CETA certification every six months, as follows:

a. The first certification is required 01 October with completion no later than 02 October.

b. The second certification is required in March.

2. The VA Laboratory Bio-Safety hood requires CETA certification every year in October.

Location: Service are required at the VA Medical Center at the address listed in block 15 of SF1449, page 1 of this contract.

This is a non-personal services contract. The Contractor, it’s employees, agents and subcontractors shall not be considered government employees for any purpose. Contractor shall furnish all labor, materials, parts, equipment, tools, shipping, transportation, insurances, licenses, certifications and supervision necessary to provide services in accordance with this Performance Work Statement (PWS). The Contractor is responsible for all charges, fees, applications and procurement of all permits, licenses, registrations and certificates, pursuant to lawful application of the provision of services. For a contract of this size, scope and complexity, the successful Contractor must perform in a professional manner as recognized by commercial industry standards as good to excellent.

TASKS and REQUIREMENTS: The Contractor must provide the tasks and requirements for services, during the applicable period of performance, and within the constraints of this PWS and the terms and conditions of this contract. Services are required in each of the three pharmacy rooms.

Contractor must deliver the pharmacy compounding area report, perform pharmacy compounding area certification and perform the laminar flow hood certification. The timeframe for completion of services is critical and failure to perform in the required timeframe will place the VA at risk and will be considered as an unacceptable performance standard.

Contractor shall work with VA maintenance staff to ensure mechanical systems are adjusted to perform at required capacities.

Contractor must coordinate with VA local POC to work outside Standard Business Hours, where required to fully satisfy this PWS. This will assist with expediting the testing and certification, if necessary.

Tasks and requirements that must be provided by the contractor are:

Airflow testing, airflow measurements, airflow balancing, room airflow exchange rate calculations, room segregation smoke tests, room pressurization measurements, room differential pressure measurements, nonviable particle count in dynamic conditions measurements, leak testing of room termination HEPA filters, documentation and verification of room pressure gauge readings, DCA Smoke Studies with Video, Positive and negative plate, bacterial and fungal testing in LAFW Hood 114140, buffer room, and anteroom in dynamic conditions. Provide controls needed. Provide Positive and negative plate, bacterial and fungal testing in area Air Handler. Provide controls needed. Adjusted HVAC system to provide the code required Air Changes Per Hour (ACPH) in each space.

Provide Bio-Safety Cabinet (hood) certification tests for a NuAire Brand, model NU-430-400 hood. Testing shall include Inflow and Downflow air volume measurement tests, Particle Counts, Smoke pattern test, Lighting, Vibration, Noise, and Electrical inspections. Certification testing will also include leak testing of the HEPA filters in the hood. The tests performed shall be for the purpose of maintaining the accreditation of the cabinet/hood processes by CAP (College of American Pathologists) and TJC (the Joint Commission).

Deliverables: Contractor must provide a Pharmacy Compounding area Certification report.

1. Certification report must "Separately" document the ACPH from HVAC and the ACPH from the primary engineering control (PEC) and then the total ACPH combined for the room.

2. Contractor must ensure the HVAC system is adjusted to provide the code required Air Changes Per Hour (ACPH) in each space.

3. Certification report must "Separately" document the ACPH from HVAC and the ACPH from the primary engineering control (PEC) and then the total ACPH combined for the room.

4. Contractor must provide Hood Certification for the Laminar Flow Hood - Baker EG-6320 S/N 114140.

5. Contractor must provide a Hood Certification for the NuAire Bio-Safety Hood, model NU-430-400 in the Sheridan VA Laboratory.

Quality Control: The contractor shall develop and maintain an effective quality control program (QCP) to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor’s quality control program is the means by which the contractor assures the results of the service comply with the requirement of the contract. Within 15 days after contract award a comprehensive written QCP shall be submitted to the CO and local VA POC. Any proposed change to his QC system.

SERVICE REPORTS

Contractor shall provide the VA local POC field certification report. Field certification report must document associated findings and recommendations once the work has been completed and lab results finalized. Reports must be legible. Complete service reports must be received by the COR or CO before any invoice can be certified for payment. Contractor shall email copies of service reports to CO and VA local POC in Adobe PDF format.

Each Service Report must legibly document the following to be considered complete:

1. Name of Contractor and contract number

1. Contractor Service Report number/log number

1. Description of services performed during the applicable Service period or phase of requirement

1. Description of any problems during service (if applicable)

1. The final report, signed

CONTRACT OVERSIGHT BY THE CONTRACTOR

Contractor Representative and Point of Contact - The Contractor shall specify an individual who shall serve as a single point of contact for all Contract issues. Contractor must provide the COR and Contracting Office with the Contractor’s Representative contact details, to include cell phone and email. The Contractor’s Representative must be easily accessible by phone.

The contract number shall be referenced in all communications, to include written documents and emails, for all exchanges relating to the contract.

CONTRACT OVERSIGHT BY THE VA

Local VA Point of Contact or Contracting Officer’s Representative (COR) - Upon contract commencement, the Contracting Officer will notify the Contractor in writing as to the assigned COR for this contract, and upon reassignment of a new individual, as applicable. When a COR is not assigned, the CO will inform the Contractor of the locally assigned point of contact (POC) at the VA location. In this instance, the Contractor shall communicate and coordinate services through the VA POC and copy the CO on all written communications. Contractor shall only respond to requests for service from the COR/POC or the CO. If service is requested from any source, other than the COR/POC or the CO, the Contractor is to advise the individual of this requirement and refuse to respond. Any billing resulting from unauthorized service will not be paid by the government.

The COR/POC will periodically evaluate the Contractor’s performance to ensure services are received in accordance with this PWS. The COR/POC will evaluate the Contractor’s performance through review of the deliverables and Contractor’s performance.

Authority to Make Contract Changes - The Contracting Officer is the only person authorized to approve changes in any of the requirements of this contract. In the event the Contractor affects any changes at the direction of any person other than the Contracting Officer, the changes will be considered to have been made without authority and no adjustment will be made in the contract price or schedule to cover any increase in costs incurred as a result thereof. The

Contracting Officer shall be the only individual authorized to accept nonconforming work, waive any requirement of the contract, and/or modify any term or condition of the contract. The Contracting Officer is the only individual who can legally obligate Government funds. No costs chargeable to the proposed contract can be incurred before receipt of a fully executed contract or specific authorization from the Contracting Officer.

Penalties for Unauthorized Commitments: CORs, or VA POCs, who violate their delegation are subject to penalties if the violation results in an Unauthorized Commitment. An Unauthorized Commitment is an agreement that is not binding solely because the Government representative who made it lacked the authority to enter into that agreement on behalf of the Government. (FAR 1.602-3(a)) Penalties for violations are outlined in VA Acquisition Regulation 801.690-7 and VA Handbook 7401.7. Examples of Unauthorized Commitments include but are not limited to: COR or other Program Office official directs contractor to deviate from the contract. A contractor mistakes a request from a COR (or VA POC) seeking information as an order, ships the item, the COR (or POC) does not realize it is an improper order and accepts the item rather than reject and return the item. COR (or VA POC) exceeds authority and authorizes work, additional time, money or any other type of extension on contract.

SAFETY AND COMPLIANCE: The Contractor must perform services in accordance with:

1. All federal, state and local laws, whether or not related to the performance of contract services.

1. Local, state and federal Occupational Safety and Health guidelines and legislation, to include Occupational Safety and Health Administration (OSHA);

1. Local, state and federal guidelines and legislation, as well as MTVAHCS Directives and guidelines, relating to privacy protection laws

Medical Center Directives and Policies: Each VA Medical Center has directives and policies that are updated from time to time. The COR can provide more detailed information to the Contractor of these upon commencement of the contract and throughout the term of the contract, as needed. VA universal policies include parking, possession of weapons, cell phone use, and use of photography as well as smoking on VA property. Contractor’s must comply with posted rules and signs on federal property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court.

FEDERAL HOLIDAYS AND STANDARD BUSINESS HOURS - Standard Business Hours at the VA Medical Center are between 8:00am and 4:30pm Monday-Friday excluding Federal holidays, except by special alternate arrangement, coordinated and authorized by the COR.

The Federal Government observes the following days as holidays. Federal Holidays can be found at the OPM website. At time of writing, the information can be found at https://www.opm.gov/policy-data-oversight/snow-dismissal-procedures/federal-holidays/

The Federal Government observes the following days as holidays.

*Holidays that fall on Saturday are observed on the preceding Friday. Holidays that fall on Sunday are observed on the following Monday.

In addition to the days designated as holidays, the Government observes the following days:

· Any other day designated by Federal Statute

· Any other day designated by Executive Order Any other day designated by the President of the United States to be a Federal holiday

DEFINITIONS

Acceptance Signature - VA employee who is authorized to sign-off on the Service Report Authorization Signature - COR's signature; indicates COR accepts work status as stated in Service Report.

CO - Contracting Officer COR – Contracting Officer’s Representative OSHA – Occupational Safety and Health Administration Service Report - a documentation of the services rendered for each incidence of work performance under the terms and conditions of the contract.

Services – includes those identified in the Purpose of this PWS SOW – for the purpose of this contract SOW has the same meaning as PWS, and refers to the PWS in this contract.

VA - Department of Veterans Affairs VAHCS – VA Health Care System VAMC – Veterans Affairs Medical Center VA Mission Statement: “To fulfill President Lincoln's promise “To care for him who shall have borne the battle, and for his widow, and his orphan” by serving and honoring the men and women who are America’s Veterans.”

VHA - Veterans Health Administration

COVID-19 HEALTH REQUIREMENTS

Employee Physical Health: Contractor's employees are expected to be in good physical health and able to work in patient care areas without risk to the patients. No personnel shall be assigned to this contract who are not in good physical health or pose a risk to patients. Contractor's personnel who acquire a communicable illness shall not perform service under the contract and shall be free of illness before returning to work. All employees will be screened daily upon arriving on the VA Medical Center property, any contract worker complaining of or showing symptoms will be sent away and must quarantine for 14 days (unless they provide a Doctor’s note stating they are able to work and are not contagious).

If a contractor refuses screening, they can be denied access to the facility. 38 C.F.R. § 1.218(a)(1) vests the Secretary or his designee with authority to close facilities or portions of facilities that are under the charge and control of VA to the public. This includes the authority to prohibit contractors from entering VA facilities, if they refuse to undergo screening measures. Additionally, FAR 52.212-4(q) requires contractors to comply with all applicable Federal, State and local laws, executive orders, rules and regulations applicable to its performance under contracts for commercial services and supplies.

The CDC states that employees, including contractors, with symptoms of influenza-like illness at work during a pandemic should leave the workplace. The CDC provides guidance for the workplace which OMB references in their COVID-19 guidance. The CDC recommends that employees who appear to have acute respiratory illness symptoms (i.e. cough, shortness of breath) upon arrival to work, or become sick during the day, should be sent home immediately. Additionally, if the employee is asymptomatic but tests positive, the employee should be sent home immediately. The responsible Contracting Officer must be notified immediately.

It is incumbent upon the contractor to familiarize themselves with the quarantine rules and directions on COVID-19 by visiting the latest information on State and Federal government websites to ensure safety and precautions are followed during performance of services in this applicable state in which the VA Health Care System is located.