36C24E18R0002-00001000.docx

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NIDA VA Medical Study Site Monitoring Services
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36C24E18R0002
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5. PROJECT NUMBER (if applicable)

CODE

7. ADMINISTERED BY

2. AMENDMENT/MODIFICATION NUMBER

CODE

6. ISSUED BY

8. NAME AND ADDRESS OF CONTRACTOR

4. REQUISITION/PURCHASE REQ. NUMBER

3. EFFECTIVE DATE

9A. AMENDMENT OF SOLICITATION NUMBER

9B. DATED

PAGE

OF PAGES

10A. MODIFICATION OF CONTRACT/ORDER NUMBER

10B. DATED

BPA NO.

1. CONTRACT ID CODE

FACILITY CODE

CODE

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 NUMBERED 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 amendment, and is received prior to the opening hour and date specified.

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

D. OTHER

BY

Contractor

16C. DATE SIGNED

14. DESCRIPTION OF AMENDMENT/MODIFICATION

16B. UNITED 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.

15A. NAME AND TITLE OF SIGNER

16A. NAME AND TITLE OF CONTRACTING OFFICER

15B. CONTRACTOR/OFFEROR

STANDARD FORM 30

PREVIOUS EDITION NOT USABLE

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.)

(If required)

(SEE ITEM 11)

(SEE ITEM 13)

(X)

CHECK

ONE

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) 00001 N/A 00240E US Department of Veterans Affairs Veterans Health Administration Service Area Office (SAO) East 323 North Shore Drive, Suite 500 Pittsburgh

PA

15212-5319 00240E US Department of Veterans Affairs Veterans Health Administration Service Area Office (SAO) East 323 North Shore Drive, Suite 500 Pittsburgh

PA

15212-5319 To all Offerors/Bidders

36C24E18R0002

X See CONTINUATION Page X The purpose of this amendment is to correct CLIN information to add Option period 3 line item and grid.

To correct information in Addendum to FAR 52.212-1.

All other terms and conditions remain unchanged.

CONTINUATION PAGE

A.1 PRICE/COST SCHEDULE

BASE PERIOD (4/1/2018 – 3/31/2019)

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
UNIT
UNIT

PRICE/RATE

AMOUNT

0001
MONITORING SERVICES Contractor/CRQA shall

conduct site visits at VA facilities and associated non-VA facilities in accordance with contract specifications.

Referenced enclosed Multi-site Price Schedule

Referenced enclosed

Schedule

0002
TRAVEL: SERVICES

Reimbursable Travel Costs (in accordance with Federal Travel Regulations)

NTE

Price Determined per Task Order based on travel location and in accordance with the Federal Travel Regulations)

0003
MONITORING SERVICES (GCP QA SUPPORT) Contractor/CRQA shall

provide hourly rate for GCP QA support to the VA Cooperative Studies Program in accordance with contract specifications

HR
__________________

PRICE SCHEDULE - NIDA MONITORING SERVICES - BASE PERIOD

Clinical Research Quality Assurance Visits (Price includes time on site, pre & post work, and travel time)
Clinical Research Quality Assurance Visits No pre & post work required (Price includes time on site and travel time)

Metro Area (within 75 miles)

1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
Birmingham
AL
Montgomery
AL
Little Rock
AR
Phoenix
AZ
Prescott
AZ
Tucson
AZ
Fresno
CA
San Diego
CA
Los Angeles
CA
San Francisco
CA
Denver
CO
New Haven
CT
Washington
DC
Wilmington
DE
Bay Pines
FL
Gainesville
FL
Lake City
FL
Miami
FL
Tampa
FL
Atlanta
GA
Augusta
GA
Decatur
GA
Honolulu
HI
Des Moines
IA
Iowa City
IA
Boise
ID
Chicago
IL
Indianapolis
IN
Topeka
KS
Wichita
KS
Lexington
KY
Louisville
KY
Alexandria
LA
New Orleans
LA
Boston
MA
Northhampton
MA
Baltimore
MD
Detroit
MI
Minneapolis
MN
St. Louis
MO
Kansas City
MO
Biloxi
MS
Jackson
MS
Ashville
NC
Durham
NC
Salisbury
NC
Fargo
ND
Omaha
NE
Manchester
NH
Newark
NJ
Albuquerque
NM
Reno
NV
Las Vegas
NV
Albany
NY
Buffalo
NY
New York
NY
Syracuse
NY
Cincinnati
OH
Cleveland
OH
Columbus
OH
Dayton
OH
Muskogee
OK
Oklahoma City
OK
Portland
OR
Philadelphia
PA
Pittsburgh
PA
San Juan
PR
Providence
RI
Charleston
SC
Columbia
SC
Hot Springs
SD
Sioux Falls
SD
Memphis
TN
Nashville
TN
Amarillo
TX
Big Springs
TX
Dallas
TX
Houston
TX
San Antonio
TX
Salt Lake City
UT
Hampton
VA
Richmond
VA
White River Junction
VT
Seattle
WA
Spokane
WA
Milwaukee
WI
Clarksburg
WV
Martinsburg
WV
Sheridan
WY

OPTION PERIOD 1 (4/1/2019 – 3/31/2020)

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
UNIT
UNIT

PRICE/RATE

AMOUNT

1001
MONITORING SERVICES Contractor/CRQA shall

conduct site visits at VA facilities and associated non-VA facilities in accordance with contract specifications.

Referenced enclosed

Referenced enclosed

Schedule

1002
TRAVEL: SERVICES

Reimbursable Travel Costs (in accordance

NTE

Price Determined per Task Order based on travel location and in accordance with the Federal Travel Regulations)

1003
MONITORING SERVICES (GCP QA SUPPORT) Contractor/CRQA shall

provide hourly rate for GCP QA support to the VA Cooperative Studies

HR
__________________

PRICE SCHEDULE - NIDA MONITORING SERVICES – OPTION PERIOD 1

Clinical Research Quality Assurance Visits (Price includes time on site, pre & post work, and travel time)
Clinical Research Quality Assurance Visits No pre & post work required (Price includes time on site and travel time)

Metro Area (within 75 miles)

1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
Birmingham
AL
Montgomery
AL
Little Rock
AR
Phoenix
AZ
Prescott
AZ
Tucson
AZ
Fresno
CA
San Diego
CA
Los Angeles
CA
San Francisco
CA
Denver
CO
New Haven
CT
Washington
DC
Wilmington
DE
Bay Pines
FL
Gainesville
FL
Lake City
FL
Miami
FL
Tampa
FL
Atlanta
GA
Augusta
GA
Decatur
GA
Honolulu
HI
Des Moines
IA
Iowa City
IA
Boise
ID
Chicago
IL
Indianapolis
IN
Topeka
KS
Wichita
KS
Lexington
KY
Louisville
KY
Alexandria
LA
New Orleans
LA
Boston
MA
Northhampton
MA
Baltimore
MD
Detroit
MI
Minneapolis
MN
St. Louis
MO
Kansas City
MO
Biloxi
MS
Jackson
MS
Ashville
NC
Durham
NC
Salisbury
NC
Fargo
ND
Omaha
NE
Manchester
NH
Newark
NJ
Albuquerque
NM
Reno
NV
Las Vegas
NV
Albany
NY
Buffalo
NY
New York
NY
Syracuse
NY
Cincinnati
OH
Cleveland
OH
Columbus
OH
Dayton
OH
Muskogee
OK
Oklahoma City
OK
Portland
OR
Philadelphia
PA
Pittsburgh
PA
San Juan
PR
Providence
RI
Charleston
SC
Columbia
SC
Hot Springs
SD
Sioux Falls
SD
Memphis
TN
Nashville
TN
Amarillo
TX
Big Springs
TX
Dallas
TX
Houston
TX
San Antonio
TX
Salt Lake City
UT
Hampton
VA
Richmond
VA
White River Junction
VT
Seattle
WA
Spokane
WA
Milwaukee
WI
Clarksburg
WV
Martinsburg
WV
Sheridan
WY

OPTION PERIOD 2 (4/1/2020 – 3/31/2021)

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
UNIT
UNIT

PRICE/RATE

AMOUNT

2001
MONITORING SERVICES Contractor/CRQA shall

conduct site visits at VA facilities and associated non-VA facilities in accordance with contract specifications.

Referenced enclosed

Referenced enclosed

Schedule

2002
TRAVEL: SERVICES

Reimbursable Travel Costs (in accordance

NTE

Price Determined per Task Order based on travel location and in accordance with the Federal Travel Regulations)

2003
MONITORING SERVICES (GCP QA SUPPORT) Contractor/CRQA shall

provide hourly rate for GCP QA support to the VA Cooperative Studies

HR
__________________

PRICE SCHEDULE - NIDA MONITORING SERVICES - OPTION PERIOD 2

Clinical Research Quality Assurance Visits (Price includes time on site, pre & post work, and travel time)
Clinical Research Quality Assurance Visits No pre & post work required (Price includes time on site and travel time)

Metro Area (within 75 miles)

1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
Birmingham
AL
Montgomery
AL
Little Rock
AR
Phoenix
AZ
Prescott
AZ
Tucson
AZ
Fresno
CA
San Diego
CA
Los Angeles
CA
San Francisco
CA
Denver
CO
New Haven
CT
Washington
DC
Wilmington
DE
Bay Pines
FL
Gainesville
FL
Lake City
FL
Miami
FL
Tampa
FL
Atlanta
GA
Augusta
GA
Decatur
GA
Honolulu
HI
Des Moines
IA
Iowa City
IA
Boise
ID
Chicago
IL
Indianapolis
IN
Topeka
KS
Wichita
KS
Lexington
KY
Louisville
KY
Alexandria
LA
New Orleans
LA
Boston
MA
Northhampton
MA
Baltimore
MD
Detroit
MI
Minneapolis
MN
St. Louis
MO
Kansas City
MO
Biloxi
MS
Jackson
MS
Ashville
NC
Durham
NC
Salisbury
NC
Fargo
ND
Omaha
NE
Manchester
NH
Newark
NJ
Albuquerque
NM
Reno
NV
Las Vegas
NV
Albany
NY
Buffalo
NY
New York
NY
Syracuse
NY
Cincinnati
OH
Cleveland
OH
Columbus
OH
Dayton
OH
Muskogee
OK
Oklahoma City
OK
Portland
OR
Philadelphia
PA
Pittsburgh
PA
San Juan
PR
Providence
RI
Charleston
SC
Columbia
SC
Hot Springs
SD
Sioux Falls
SD
Memphis
TN
Nashville
TN
Amarillo
TX
Big Springs
TX
Dallas
TX
Houston
TX
San Antonio
TX
Salt Lake City
UT
Hampton
VA
Richmond
VA
White River Junction
VT
Seattle
WA
Spokane
WA
Milwaukee
WI
Clarksburg
WV
Martinsburg
WV
Sheridan
WY

OPTION PERIOD 3 (4/1/2021– 3/31/2022)

ITEM NUMBER
DESCRIPTION OF SUPPLIES/SERVICES
UNIT
UNIT

PRICE/RATE

AMOUNT

3001
MONITORING SERVICES Contractor/CRQA shall

conduct site visits at VA facilities and associated non-VA facilities in accordance with contract specifications.

Referenced enclosed

Referenced enclosed

Schedule

3002
TRAVEL: SERVICES

Reimbursable Travel Costs (in accordance

NTE

Price Determined per Task Order based on travel location and in accordance with the Federal Travel Regulations)

3003
MONITORING SERVICES (GCP QA SUPPORT) Contractor/CRQA shall

provide hourly rate for GCP QA support to the VA Cooperative Studies

HR
__________________

PRICE SCHEDULE - NIDA MONITORING SERVICES - OPTION PERIOD 2

Clinical Research Quality Assurance Visits (Price includes time on site, pre & post work, and travel time)
Clinical Research Quality Assurance Visits No pre & post work required (Price includes time on site and travel time)

Metro Area (within 75 miles)

1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
1 Day Visit
2 Day Visit
3 Day Visit
4 Day Visit
Birmingham
AL
Montgomery
AL
Little Rock
AR
Phoenix
AZ
Prescott
AZ
Tucson
AZ
Fresno
CA
San Diego
CA
Los Angeles
CA
San Francisco
CA
Denver
CO
New Haven
CT
Washington
DC
Wilmington
DE
Bay Pines
FL
Gainesville
FL
Lake City
FL
Miami
FL
Tampa
FL
Atlanta
GA
Augusta
GA
Decatur
GA
Honolulu
HI
Des Moines
IA
Iowa City
IA
Boise
ID
Chicago
IL
Indianapolis
IN
Topeka
KS
Wichita
KS
Lexington
KY
Louisville
KY
Alexandria
LA
New Orleans
LA
Boston
MA
Northhampton
MA
Baltimore
MD
Detroit
MI
Minneapolis
MN
St. Louis
MO
Kansas City
MO
Biloxi
MS
Jackson
MS
Ashville
NC
Durham
NC
Salisbury
NC
Fargo
ND
Omaha
NE
Manchester
NH
Newark
NJ
Albuquerque
NM
Reno
NV
Las Vegas
NV
Albany
NY
Buffalo
NY
New York
NY
Syracuse
NY
Cincinnati
OH
Cleveland
OH
Columbus
OH
Dayton
OH
Muskogee
OK
Oklahoma City
OK
Portland
OR
Philadelphia
PA
Pittsburgh
PA
San Juan
PR
Providence
RI
Charleston
SC
Columbia
SC
Hot Springs
SD
Sioux Falls
SD
Memphis
TN
Nashville
TN
Amarillo
TX
Big Springs
TX
Dallas
TX
Houston
TX
San Antonio
TX
Salt Lake City
UT
Hampton
VA
Richmond
VA
White River Junction
VT
Seattle
WA
Spokane
WA
Milwaukee
WI
Clarksburg
WV
Martinsburg
WV
Sheridan
WY

A.2 DELIVERY SCHEDULE

ITEM NUMBER
QUANTITY
DELIVERY DATE

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS I. GENERAL INSTRUCTIONS: To assure timely and equitable evaluation of proposals, offerors shall follow the instructions contained herein. Proposal packages shall be complete, self-sufficient, and respond directly to the requirements of this solicitation. The response shall consist of three (3) separate volumes: Volume I – Technical Proposal; Volume II – Past Performance; and Volume III Price.

A. Proposals shall be submitted and in VA dominion and control no later than the time/date specified in the solicitation to be considered for award. The Government is not responsible for lost or mishandled packages or late deliveries.
B. The Government reserves the right to extend the notification deadline of the solicitation up to the date proposals are initially due.
C. The Contracting Officer has determined there is a high probability of adequate price competition in this acquisition. Upon examination of the initial offerors, the Contracting Officer will review this determination and if, in the Contracting Officer’s opinion, adequate price competition exists, no additional cost information will be requested and certification under FAR 15.406-2 will not be required. However, if at any time during this competition the Contracting Officer determines that adequate price competition no longer exists; offerors may be required to submit information to the extent necessary for the Contracting Officer to determine the reasonableness of the price.
D. Proposals shall be submitted in electronic format via email before the submission date and time listed in page 1 of the solicitation to be considered for award. Email proposals shall be complete and in VA control no later than the time/date specified. Proposal packages will be accepted via email at:
Contracting Officer
Michael Haydo
michael.haydo@va.gov
Phone: 412-822-3158
E. The Minimum Proposal Acceptance Period is 60 days. The offeror shall make a clear statement in their proposal that their prices are valid for a period of not less than 60 days from the solicitation close date.
F. Content Requirements. All information shall be confined to the appropriate Volume. The offeror shall confine submissions to essential matters, sufficient to define the proposal and provide adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each proposal. Each Volume of the proposal shall consist of a Table of Contents, Summary Section, and the Narrative discussion. The Summary Section shall contain a brief abstract of the file. Proprietary information shall be clearly marked. The price volume shall be in a separate file from all other information.
G. Proposal packages should be made up of separate technical and price proposals. Proposals shall be in electronic format only utilizing Microsoft Office and/or Adobe software, and not exceed 20 single sided pages, each (inclusive of cover pages, table of contents, glossary, and appendices). Statistical and other technical terminology shall not be used without providing a glossary of terms and acronyms.

NOTES:

ALL QUESTIONS ABOUT THE REQUEST FOR PROPOSAL OR THE POSTING OF THE REQUEST FOR PROPOSAL SHALL BE SUBMITTED TO THE CONTRACTING OFFICER BY FEBRUARY 21 AT 10:00 AM EST. ALL QUESTIONS SHALL BE SUBMITTED VIA EMAIL TO MICHAEL.HAYDO@VA.GOV. QUESTIONS AND ANSWERS WILL BE ADDRESSED VIA RFP AMENDMENTS AND POSTED WITH THE RFP.

II. SPECIFIC INSTRUCTIONS: PROPOSALS SHALL BE SUBMITTED IN THREE (3) VOLUMES:

A) VOLUME I - TECHNICAL PROPOSAL: 1) OFFEROR SHALL SUBMIT TWO COPIES OF THE TECHNICAL PROPOSAL: COPY ONE: A FULL, NON-REDACTED COPY OF THE TECHNICAL PROPOSAL - OFFEROR MAY INCLUDE COMPANY NAMES, LOGOS, PHOTOS, EMPLOYEE NAMES, ETC. B) COPY TWO: A REDACTED COPY OF THE TECHNICAL PROPOSAL-OFFEROR SHALL ONLY USE OFFEROR CODE (SEE ABOVE) IN THIS COPY. DOCUMENT SHALL BE OF A PLAIN TEXT FORM AND ALL MENTION OF COMPANY NAMES, LOGOS, PHOTOS, EMPLOYEE NAMES, ETC SHALL BE REMOVED AND/OR REPLACED WITH THE OFFEROR CODE (SEE NOTES ABOVE).

SUB-FACTOR 1. Understanding and Compliance with requirements – The offeror shall address each task and solicitation requirement in sufficient detail to demonstrate a clear understanding of the statement of work and specific tasks, including the contractor qualifications, and certifications. The offeror shall provide a Project Management Plan to address the tasks necessary to complete the monitoring services and shall include technical solutions to indicated requirements and how tasks will be met on schedule.

Simply acknowledging the VA’s requirements of the statement of work does not qualify for sufficiently demonstrating an understanding of the tasks.

SUB-FACTOR 2. Relevant Experience: Experience reflects whether contractors have performed similar work before, and is independent from the past performance factor below.

1. The offeror shall provide within its proposal the Relevant Experience which includes past, similar experience with performing monitoring services for projects of a similar scope. This relevant experience shall also include the experience of Key Personnel, and shall provide resumes. Project staff shall have the skills and experience in providing monitoring support for projects similar in scope as those specified in the solicitation.

2. The offeror shall provide data on the level of experience in specific contracts of this type. Provide information on performance in these contracts, particularly as it relates to the offeror’s overall abilities. Information shall include Contract numbers, contracting activity points of contact, contract type, total awarded price, and a brief explanation of the scope of work. The Government reserves the right to obtain information for use in the evaluation of past performance from any and all sources.

SUB-FACTOR 3. Delivery/Turnaround time – The offeror shall address the turnaround time from the time the samples are received to the time the VA receives the required data. The offeror shall indicate solutions to how tasks will be met on schedule.

C) VOLUME II – PAST PERFORMANCE: PAST PERFORMANCE IS AN ASSESSMENT OF HOW WELL A CONTRACTOR PERFORMED UNDER PREVIOUSLY AWARDED CONTRACTS, AND IS RATED SEPARATELY FROM EXPERIENCE.

1. Past performance – The Offeror shall request past performance surveys from at least three (3) current or previous contractors for contracts similar in size, scope, and complexity to this solicitation. Relevant contracts shall be within the past 3 years. Information shall include contract numbers, contracting activity points of contact, contract type, total awarded price, and a brief explanation of the scope of work. Surveys shall be sent directly from the agency to the contracting officer at: michael.haydo@va.gov and titled with this solicitation number. The Government reserves the right to obtain information for use in the evaluation of past performance from any and all sources.

2. Past performance questionnaires shall be submitted to Michael.haydo@va.gov no later than the close date/time listed on the solicitation.

3. The offeror shall provide past performance information or affirmatively state that it possesses no relevant information directly related to a similar past performance. An offeror failing to provide the past performance information or to assert that it has no relevant directly related or similar past performance may be considered in-eligible for award. Offerors lacking relevant past performance history will receive a neutral rating for past performance.

D) VOLUME III – PRICE: 1) PRICE SHALL BE ON THE CONTRACT LINE ITEM PAGE IN THE REQUEST FOR PROPOSAL-OFFEROR MAY SUBMIT ADDITIONAL DOCUMENTS IN ADDITION TO THE CONTRACT LINE ITEM PAGE IF THE OFFEROR FEELS IT TO BE NECESSARY, HOWEVER THE CLIN STRUCTURE MUST REMAIN AS IS.

File details come from the government source that posted it.