A.09.03_W81K00Q0068-0001.pdf

W81K0018Q0068

0011172410

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

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 (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

STANDARD FORM 30 (Rev. 10-83) Prescribed by GSA

FAR (48 CFR) 53.243

The purpose of this amendment is to extend the due date until 12:00 pm, 5 September 2018 and revise the solicitation as indicated on the attached summary of changes.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 49

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

16C. DATE SIGNED

BY 28-Aug-2018

16B. UNITED STATES OF AMERICA15C. DATE SIGNED15B. CONTRACTOR/OFFEROR

(Signature of Contracting Officer)(Signature of person authorized to sign)

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K0018Q0068

X 9B. DATED (SEE ITEM 11)

10-May-2018

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

X The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offer X is extended, is not extended.

Offer 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:

(a) By completing Items 8 and 15, and returning 1 copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram 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 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 telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

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.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(B).

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

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return copies to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

10A. MOD. OF CONTRACT/ORDER NO.

2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO.(If applicable)

6. ISSUED BY

3. EFFECTIVE DATE

28-Aug-2018

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

JBSA FT SAM HOUSTON TX 78234-0000

W81K00 7. ADMINISTERED BY (If other than item 6)

4. REQUISITION/PURCHASE REQ. NO.

CODE

See Item 6

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

SOLICITATION/CONTRACT FORM

The required response date/time has changed from 11-Jun-2018 12:00 PM to 05-Sep-

2018 12:00 PM.

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

: ClinRep Complete Kit for VMA, HVA, 5-HIAA in Urine. for 100 assays. EC Detection. Part # 3000

To:

Vanillylmandelic Acid (VMA) ReagentPart No. 195-5004

CLIN 0002

: Standard Solution for VMA, HVA,5-HIAA, 5 x 1 ml. Part # 3011

VMA Cartidge Solution Part No. 195-5008

CLIN 0003

: Analytical column with test chromatrogram for kit 3000 (VMA, HVA, 5-HIAA). Part # 3030

VMA CartridgePart No. 195-5009

The pricing detail quantity has decreased by 15.00 from 31.00 to 16.00.

CLIN 0004

The CLIN description has changed from Mobile phase for Kit 3000 to VMA Mobile Phase.

: Mobile phase for Kit 3000 (VMA, HVA, 5-HIAA). 1000 ml Part # 3010

VMA Mobile PhasePart No. 195-5010

CLIN 0005

The CLIN description has changed from Internal Standard, lyophil. for VMA to VMA Cartridge Holder.

: Internal Standard, lyophil. for VMA, HVA, 5-HIAA, 100 ml. Part # 3012

VMA Cartridge HolderPart No. 195-5023

The pricing detail quantity has decreased by 9.00 from 10.00 to 1.00.

CLIN 0006

The CLIN description has changed from ClinCal Urine Calibrator, Lyophil to Homovanillic Acid or 5 hydroxyindoleacet.

: ClinCal Urine Calibrator, lyophil., for VMA, HVA, 5-HIAA, 5 x 8 ml. Part # 3013

Homovanillic Acid or 5 hydroxyindoleacetic Acid Reserve Phase Column (5HIAA) Part No.195-5028

The pricing detail quantity has increased by 5.00 from 10.00 to 15.00.

CLIN 0007

The CLIN description has changed from Standard SolutionStandard Solution, to 5 HIAA Internal Standard.

: Standard SolutionStandard Solution, 10 ml. Part # 4011

5 HIAA Internal Standard Part No.195-5215

The pricing detail quantity has increased by 6.00 from 4.00 to 10.00.

CLIN 0008

The CLIN description has changed from Analytical Column with test Part 2030 to 5 HIAA Urine Calibrator.

: Analytical Column with test chromatogram Part # 2030

5 HIAA Urine Calibrator Part No.195-5216

The pricing detail quantity has decreased by 5.00 from 15.00 to 10.00.

CLIN 0009

The CLIN description has changed from Analytical Column with test Part 4030 to UMET Test Mix.

: Analytical Column with test chromatogram Part # 4030

UMET Test Mix Part No.195-6024

The pricing detail quantity has decreased by 16.00 from 20.00 to 4.00.

CLIN 0010

The CLIN description has changed from Standard Solution, 10 ml to CAT/MET Column.

: Standard Solution, 10 ml. Part # 2011

CAT/MET ColumnPart No. 195-6033

The pricing detail quantity has increased by 26.00 from 4.00 to 30.00.

CLIN 0011

The CLIN description has changed from ClinRep Complete Kit for Metanephrines to UCAT Basic Reagent.

: ClinRep Complete Kit for Metanephrines in Urine. 100 assays Part # 4000

UCAT Basic ReagentPart No. 195-6038

The pricing detail quantity has decreased by 16.00 from 30.00 to 14.00.

CLIN 0012

The CLIN description has changed from ClinRep Complete Kit for Catecholamines to UCAT/Plasma Catecholamines (PCAT) Test.

: ClinRep Complete Kit for Catecholamines in Urine. for 100 assays Part # 2000

UCAT/Plasma Catecholamines (PCAT) Test Mix Part No. 195-6062

The pricing detail quantity has decreased by 26.00 from 30.00 to 4.00.

CLIN 0013

The CLIN description has changed from Mobile Phase for Kit 1000, 1000 ml to UMET Reagent.

: Mobile Phase for Kit 1000, 1000 ml assays Part # 1210

UMET Reagent Part No. 195-6068

The pricing detail quantity has increased by 12.00 from 18.00 to 30.00.

CLIN 0014

: Mobile Phase for Metanephrines Part # 4010

Mobile Phase for Metanephrines Part No. 4010

CLIN 0015

The pricing detail quantity has increased by 15.00 from 3.00 to 18.00.

CLIN 1001

CLIN 1002

CLIN 1003

CLIN 1004

CLIN 1005

CLIN 1006

hydroxyindoleacet.

CLIN 1007

Standard.

5 HIAA Internal Standard Part # 195-5215

CLIN 1008

Calibrator.

CLIN 1009

CLIN 1010

CLIN 1011

Reagent.

CLIN 1012

Catecholamines (PCAT) Test.

CLIN 1013

CLIN 1014

CLIN 1015

CLIN 2001

CLIN 2002

CLIN 2003

CLIN 2004

CLIN 2005

VMA Cartridge HolderPart No. 195-5023

CLIN 2006

hydroxyindoleacet.

CLIN 2007

Standard.

CLIN 2008

Calibrator.

CLIN 2009

CLIN 2010

CLIN 2011

Reagent.

CLIN 2012

Catecholamines (PCAT) Test.

CLIN 2013

CLIN 2014

CLIN 2015

CLIN 3001

CLIN 3002

CLIN 3003

CLIN 3004

CLIN 3005

CLIN 3006

hydroxyindoleacet.

CLIN 3007

Standard.

CLIN 3008

Calibrator.

CLIN 3009

CLIN 3010

CLIN 3011

Reagent.

CLIN 3012

Catecholamines (PCAT) Test.

CLIN 3013

UMET Reagent Part No. 195-6068

CLIN 3014

CLIN 3015

CLIN 4001

CLIN 4002

CLIN 4003

CLIN 4004

CLIN 4005

CLIN 4006

hydroxyindoleacet.

CLIN 4007

The CLIN description has changed from Standard SolutionStandard Solution, to 5 HIAA Internal Standard.

CLIN 4008

Calibrator.

CLIN 4009

CLIN 4010

CLIN 4011

Reagent.

CLIN 4012

Catecholamines (PCAT) Test.

CLIN 4013

CLIN 4014

CLIN 4015

CLIN 0016 is added as follows:

ITEM NO SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

0016 18 Each Urinary Metanephrines Mobile Phase

FFP

Urinary Metanephrines (UMET) Mobile Phas Part No.195-6073 FOB: Destination

PSC CD: 6550

NET AMT

CLIN 0017 is added as follows:

0017 15 Each HPLC Reverse Phase Columns

FFP

HPLC Reverse Phase Columns

CLIN 1016 is added as follows:

1016 18 Each OPTION Urinary Metanephrines Mobile Phase

FFP

Urinary Metanephrines (UMET) Mobile Phas Part No.195-6073

CLIN 1017 is added as follows:

1017 15 Each OPTION HPLC Reverse Phase Columns

FFP

HPLC Reverse Phase Columns

CLIN 2016 is added as follows:

2016 18 Each OPTION Urinary Metanephrines Mobile Phase

FFP

Urinary Metanephrines (UMET) Mobile Phas Part No.195-6073

CLIN 2017 is added as follows:

2017 15 Each OPTION HPLC Reverse Phase Columns

FFP

HPLC Reverse Phase Columns

CLIN 3016 is added as follows:

3016 18 Each OPTION Urinary Metanephrines Mobile Phase

FFP

Urinary Metanephrines (UMET) Mobile Phas Part No.195-6073

CLIN 3017 is added as follows:

3017 15 Each OPTION HPLC Reverse Phase Columns

FFP

HPLC Reverse Phase Columns

CLIN 4016 is added as follows:

4016 18 Each OPTION Urinary Metanephrines Mobile Phase

FFP

Urinary Metanephrines (UMET) Mobile Phas Part No.195-6073

CLIN 4017 is added as follows:

4017 15 Each OPTION HPLC Reverse Phase Columns

FFP

HPLC Reverse Phase Columns

DELIVERIES AND PERFORMANCE

The following Delivery Schedule item for CLIN 0003 has been changed from:

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

W81NWY

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0005 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0006 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

DELIVERY DATE QUANTITY SHIP TO ADDRESS DODAAC /

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0007 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0008 has been changed from:

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0009 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0010 has been changed from:

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0011 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0012 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0013 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0014 has been changed from:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule item for CLIN 0015 has been changed from:

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 0016 has been added:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 0017 has been added:

CAGE

POP 01-OCT-2018 TO

30-SEP-2019

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 1016 has been added:

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 1017 has been added:

CAGE

POP 01-OCT-2019 TO

30-SEP-2020

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 2016 has been added:

CAGE

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 2017 has been added:

POP 01-OCT-2020 TO

30-SEP-2021

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 3016 has been added:

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 3017 has been added:

CAGE

POP 01-OCT-2021 TO

30-SEP-2022

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 4016 has been added:

CAGE

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

The following Delivery Schedule for CLIN 4017 has been added:

POP 01-OCT-2022 TO

30-SEP-2023

N/A W2DN BROOKE ARMY MED CTR

W2DN BROOKE ARMY MED CTR

WAREHOUSE RECEIVING DOCK BLDG

3551 ROGER BROOKE DRIVE

JBSA FT SAM HOUSTON TX 78234-4504

210-808-2837

INSPECTION AND ACCEPTANCE

The following Acceptance/Inspection Schedule was added for CLIN 0016:

INSPECT AT INSPECT BY ACCEPT AT ACCEPT BY

Destination Government Destination Government

The following Acceptance/Inspection Schedule was added for CLIN 0017:

The following Acceptance/Inspection Schedule was added for CLIN 1016:

The following Acceptance/Inspection Schedule was added for CLIN 1017:

The following Acceptance/Inspection Schedule was added for CLIN 2016:

The following Acceptance/Inspection Schedule was added for CLIN 2017:

The following Acceptance/Inspection Schedule was added for CLIN 3016:

The following Acceptance/Inspection Schedule was added for CLIN 3017:

The following Acceptance/Inspection Schedule was added for CLIN 4016:

The following Acceptance/Inspection Schedule was added for CLIN 4017:

The following have been added by full text:

STATEMENT OF OBJECTIVES

STATEMENT OF OBJECTIVES BIOGENIC AMINES REAGENTS \

1. GENERAL REQUIREMENTS:1.1. SCOPE OF WORK: The Contractor shall provide Biogenic Amines used in support of the HPLC mission at Brooke Army Medical Center, Fort Sam Houston, Texas.

The Contractor shall be responsible for providing all reagents/reagents packs, calibrators/standards, and quality control materials. The Contractor shall perform to the standards of this Statement of Objectives (SOO). 1.1.1. The Contractor must provide all reagents/reagents packs, calibrators/standards, quality control materials. Reagents/consumables must meet the requirements of the 24/7 SAMMC mission, workload, and test menu

1.2. QUALITY CONTROL (QC) and QUALITY ASSURANCE (QA):

1.2.. The Contractor shall provide a Quality Control (QC) Plan that contains, as a minimum, the items listed in 1.2.2 (below) to the Contracting Officer and Ordering Officer for acceptance not later than 10 days AFTER the start of the contract (see Exhibit 1). The Contracting Officer will notify the Contractor of acceptance or required modifications to the plan. The Contractor shall make appropriate modifications and obtain acceptance of the plan by the Contracting Officer.

1.2.1.1. The QC Plan shall include:

1.2.1.1.1. A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS) listed in Exhibit 1. Description shall include specifics as to the areas to be inspected on both a scheduled and unscheduled basis, frequency of inspections, and the title and organizational placement of the inspectors. Additionally, control procedures for any Government provided keys or lock combinations shall be included.

1.2.1.1.2. A description of the methods to be used for identifying and preventing equipment failure and/or defects.

1.2.1.1.3. A description of the records to be kept to document inspections and corrective or preventive actions taken. NOTE: The records of inspections shall be kept and made available to the Government throughout the contract performance period and for the period after contract completion until final settlement of any claims, if any, under this contract.

1.2.2. Quality Assurance (QA). For those tasks listed on the PRS (Exhibit 1), the Ordering Officer will follow the methods of surveillance specified in this contract. Government personnel will record surveillance observations, as needed, and provide to the Contractor. The receipt of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that the Contractor has been made aware of the defective performance. Government surveillance may include observations/tasks not listed in the PRS. Such surveillance will be done according to standard inspection procedures or other contract provisions. Any action taken by the Contracting Officer as a result of surveillance will be according to the terms of this contract.

1.2.3. Equipment Troubleshooting. When the Government performs troubleshooting with the Contractor, the Contractor shall replace all reagents, calibrators, controls and any other materials used at no additional cost to the Government IAW Paragraphs 5.4.2.1 and 5.4.2.2. (below).

1.2.4. Performance Evaluation Meetings.

1.2.4.1. The Contracting Officer may require the Contractor to meet with the Contracting Officer and/or ORDERING OFFICER, as deemed necessary. Page 2 of 15

1.2.4.2. The Contractor may request a meeting with the Contracting Officer, when the Contractor believes such a meeting is necessary. If required, written minutes of any such meetings shall be recorded in the contract and signed by the Contractor and the Contracting Officer. If the Contractor does not concur with any portion of the minutes, such nonconcurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes. 1.3. HOURS OF OPERATION: 1.3.1. Normal Hours of Operation. Monday through Friday between the hours of 0730 - 1630. 1.3.1.1. Holidays. Routine equipment servicing and reagent delivery will not be required on standard Federal Holidays. If an emergency arises, equipment servicing and reagent delivery will be provided in accordance with Section 5.4.3 of this SOO. 1.3.2. The Contractor shall provide equipment maintenance service/direct customer service and support, 24 hours/7 days a week, to include hotline telephone service, and direct connect remote instrument diagnostic capability to assist operators in correcting equipment operation problems. 1.3.3. Legal Holidays. The following legal holidays will be observed by the Government:

New Year’s Day 1 January

Martin Luther King’s Birthday Third Monday in January

President’s Day Third Monday in February

Memorial Day Last Monday in May

Independence Day 4 July

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day 11 November

Thanksgiving Day Fourth Thursday in November

Christmas Day 25 December

NOTE: Any of the above holidays falling on a Saturday will be observed on the preceding Friday; holidays falling on a Sunday will be observed on the following Monday. Any holidays that are declared by Presidential Executive Order shall be observed in the same manner as the holidays listed above.

1.4. CONSERVATION OF UTILITIES. During maintenance, the Contractor shall make sure employees practice utilities conservation. The Contractor shall be responsible for operating under conditions that prevent the waste of utilities to include:

1.4.1. Lights shall be used only in areas where work is actually being performed.

1.4.2. Employees shall not adjust mechanical equipment controls for heating, ventilation, and air conditioning systems.

1.4.3. Water faucets or valves shall be turned off when not in use.

1.4.4. Environmental and Hazardous Materials Handling. If the disposal of any waste or byproduct of the analyzers cannot be safely dumped into each of the facility’s drain system, the Contractor must provide guidelines for safely disposing these wastes or byproducts in accordance with local and national guidelines.

1.5. RECORDS. The Contractor shall maintain all records necessary to comply with regulatory requirements and Food and Drug Administration (FDA) standards. The Contractor shall be responsible for creating, maintaining, and disposing of only those Government required records that are specifically cited in this SOO or required by the provisions of a mandatory directive listed in section 5.4, Applicable Publications and Forms. If requested by the Government, the Contractor shall provide the original record or a reproducible copy of any such record within 5 working days of receipt of the request.

1.6. REMOVAL OF EQUIPMENT. The Contractor shall not remove any equipment from the Government work site without prior approval of the ORDERING OFFICER or his/her designated representative.

1.7. UPGRADE OF EQUIPMENT. Subject to mutual agreement between the Government and the Contractor, instrumentation may be upgraded within the specifications of the contract as new technology may become available.

Additionally, the Government will add reagents through the life of this contract as a result of advances in technology or changes to clinical practice standards. Any such change to the reagents shall be mutually agreed upon by the contractor and the Government through a bilateral modification.

1.8. SPECIAL WORKING CONDITIONS. All equipment, parts, materials, and incidental services supplied by the Contractor shall conform to the applicable Safety and Health Standards as indicated in the current code of federal Regulations, Title 29, Chapter XVII, paragraph 1910, Occupational Safety Health Act of 1970.

1.9. CONTRACTOR PERSONNEL.

1.9.1. Contractor Employees. The Contractor shall not employ persons for work on this contract if such employee is identified to the Contractor by the Contracting Officer as a potential threat to the health, safety, security, general well-being or operational mission of the installations and their population.

1.9.1.1. Contractor employees shall present a neat appearance and be easily recognized as Contractor employees.

Contractor personnel shall either wear a distinguishable uniform or badge on the exterior of their clothing while performing any service at any Government facility.

1.9.1.2. The Contractor shall not employ any person who is an employee of the US Government. Additionally, the Contractor shall not employ any person who is an employee of the Department of Defense, either military or civilian, unless such person seeks and receives approval according to DOD 5500.7R, “Joint Ethics Regulation”. The Contractor shall not employ any person who is an employee of the Department of Defense, if such employment would be contrary to local policies.

2. DEFINITIONS/ACRONYMS.

2.1. DEFINITIONS. Following is a list of basic definitions. .

2.1.1. CONTRACTING OFFICER: The ONLY person with the authority to enter into, administer, change, and/or terminate contracts and make related determinations and findings.

2.1.2.: ORDERING OFFICER. A Government employee selected and designated in writing by the Contracting Officer to act as his/her designated representative in administering a contract. NOTE: The ORDERING OFFICER is not authorized to make any changes to the terms and conditions of the contract.

2.1.3. QUALITY ASSESSMENT AND IMPROVEMENT. Those actions taken by the Government to check services to determine if they meet the requirements of the CLIA/DoD CLIP ’88 & ’03, CAP, JCAHO, U.S. Army Medical Command and U.S. Navy Bureau of Medicine quality assurance and risk management programs, and ensure compliance with the terms and conditions of the contract

2.1.4. QUALITY CONTROL. Those actions taken by a Contractor to control the performance of services to ensure that they meet the requirements of the contract.

2.1.5. SERVICES: Includes incidental maintenance services and support performed and materials furnished or utilized to maintain the equipment.

2.1.6. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, in accordance with MAMC DPALS Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the SOO.

2.2. ACRONYMS/ABBREVIATIONS. Following is a list of basic acronyms/abbreviations used in the contract.

AR - Army Regulation

BUMED - U.S. Navy Bureau of Medicine and Surgery

CAP - College of American Pathologists

DA Department of the Army

Department of the Navy

Department of Defense Clinical Laboratory Improvement Program

Health Insurance Portability & Accountability Act of 1996 Minimum Acceptable Standards U.S. Army Medical Command

Joint Commission

Occupational Safety and Health Administration Preventive Maintenance Services Performance Requirements Summary

Quality Assurance

Quality Assessment & Improvement Quality Control Statement of Objectives

DN

DoD CLIP

HIPAA

MAS

MEDCOM

JC

OSHA

PMS

PRS

QA

QA&I

QC

SOO

3. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT, MATERIAL, AND SERVICES. The Government will provide, without additional cost to the Contractor, the facilities, equipment, materials, and services listed below.

3.1. FACILITIES. The Government will furnish the facilities for set-up and operation of the Contractor equipment analyzers required in support the SOW. The Contractor shall not alter the facilities without written approval of the Contracting Officer. The Contractor shall return the facilities to the Government in the same condition as received, fair wear and tear and approved modifications excepted. These facilities shall be used for performance of this contract only.

3.2. EQUIPMENT. No equipment will be provided.

3.3. MATERIALS. No materials will be provided.

3.4. SERVICES. The Government will provide the following services at no cost to the Contractor:

3.4.1. The Government will provide the normal range of facility utilities (e.g. electricity, water, heating, refuse collection, etc.) and other utilities necessary for the full functionality of the equipment/instrumentation.

3.4.2. Security: Police and Fire Protection, as is provided other personnel.

3.4.3. Emergency Healthcare for Contractor employees. The MTF will provide emergency health care for injuries or life threatening medical emergencies occurring while on duty. The Contractor shall reimburse the Government for such services as billed by the MTF, unless the Contractor employee is otherwise authorized to receive such services at no cost (e.g., is retired military or is a military dependent).

4. CONTRACTOR FURNISHED PROPERTY

4.1. General. Except for those Government-furnished items and services specified in section 3, the Contractor shall furnish all items, equipment, and incidental support and maintenance services required under this contract.

4.2. Transportation. Transportation in support of any equipment and incidental support and maintenance services is the responsibility of the Contractor. The Government will not provide transportation.

4.3. Nametags. The Contractor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee.

5. SPECIFIC TASKS

5.1. DESCRIPTION

5.1.1. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the specified assays, initial Method Validations per the Clinical Laboratory Standards Institute (CLSI) guidelines and the DPALS Quality Manual (QM). All costs will be calculated on a cost per patient reportable or patient billable basis based on the number of patients listed for each Mandatory Test or Desired Test listed on Appendix 1. Costs shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable or patient billable.

Table 1.

Table 1. Mandatory Tests

Catecholamine in plasma/Urine

Metanephrine in Urine

5-Hydroxy indoleacetic Acid in Urine

Homovanillic acid

Vanilmandelic Acid in Urine

Table 2. Expected Volumes (Annually)

Column Cap and Tip Remover (If needed)

VMA By HPLC Reagent Kit

VMA by HPLC Cartridge Test Solution

VMA by HPLC Cartridge

VMA by HPLC Mobile Phase Set

HPLC Reverse Phase Column

5-HIAA HPLC Internal Standard

5 HIAA Urine Calibrator

Metanephrine Cartridge Test Solution

HPLC CAT/MET Column (or 15 CAT Columns and 20 MET Columns)

Basic Reagent (if needed)

UCATS Cartridge Test Solution

UMET by HPLC Reagent Kit

UCATS by HPLC Reagent Kit

UCAT Mobile Phase Set of 2

UMET Mobile Phase, Set of 2

Polycolumn Rack (If needed)

5.1.1.1. The analyzer systems will be located at:

1) Brooke Army Medical Center – Core Chemistry Lab (4th floor) 3551 Roger Brooke Drive San Antonio, Texas 78234

5.1.2. Within 10 working days after contract award, Contractor shall coordinate and conduct a post award site visit for the purpose of coordinating schedule for equipment installation, if necessary.

5.1.3. Method Validation will be conducted in accordance with method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are in concordance with applicable standards as described by the Clinical Laboratory Standards Institute (CLSI) and/or required by the College of American Pathologists (CAP)). Relevant guidelines listed in Appendix 2 (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

5.1.3.1. Method Validation will include but not be limited to, normal range verification, demonstration of linearity, reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of precision (replication study) and accuracy (recovery study), and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

5.1.3.1.1. The Method Validation will be completed, reviewed, and approved by the Section Medical Director prior to reporting of patient results. Payment for services will not begin until the analyzer system has been approved for reporting of patient results.

5.1.3.2. The Contractor shall provide a qualified Technical Service Representative, who possesses a thorough knowledge of method validation and is familiar with the use of statistical evaluation software as determined by the Laboratory Director (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned Technical Service Representative will be responsible for the entire Method Validation and establish appropriate reporting parameters for each reportable result consistent with BAMC patient population and existing reporting criteria. In addition, periodically required to evaluate percent Microscopics required for goal of <=30% Microscopics required.

5.1.3.3. All reagents, calibrators and linearity materials used in the Method Validation Studies will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care.

5.1.3.4. The Government’s Technical Supervisor will obtain patient specimens for use in the Method Validation.

In the event that specimen requirements for correlation studies cannot be met (e.g., insufficient number of patients to challenge the extremes of a curve), the Contractor shall assist in procuring additional specimens. These specimens may be obtained from other laboratories or from Contractor sources.

5.1.3.5. Both the Contractor and Contractor personnel at each location shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) rules and regulations when conducting the Method Validation Study.

5.1.4. RESERVED

5.1.5. The Contractor shall provide safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States or the Contractor’s representative Government.

The SDS shall contain information on the hazards associated with each specific chemical or material and meet all regulatory agency (e.g., CAP, TJC, etc.) requirements. The MSDS shall be printed in the English language and shall contain, as a minimum, identification of:

- The hazardous material

- The specific hazard

- The required practices for the safe use of the product

- First aid procedures

- What to do in the event of a spill or other mishap or accident.

5.1.6. RESERVED

5.1.7. The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the ORDERING OFFICER prior to shipment IAW Paragraph 5.3.14, Deliveries (below).The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

5.2. ANALYZERS

5.2.1. None under this contract

5.3. REAGENTS

5.3.1. The analyzer shall (must) have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Appendix 1. All assays must be FDA approved.

5.3.1.1. The workload listed in Appendix 1 is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent patient reportable results, and do not include calibrators, controls, or re-runs due troubleshooting.

Reagents must have a shelf life not less than of 3 months upon receipt at the Receiving Activity (consignee), or as stated within the individual line item (i.e. Delivery Ticket, Invoice).

Controls will have shelf life of not less than 4 weeks.

An alternate quality control material must be provided by the contractor if the new lot of controls can not be delivered two weeks prior to the expiration date of the lot currently in use.

All test kits will be provided as follows:

Inclusive of an English language package inserts.

Be provided by the manufacturer of the equipment.

Delivered on time (see 5.11.3.3.1), at the appropriate storage temperature, and marked with any required temperature controls as necessary.

Routine or scheduled orders will arrive within one week before or after the scheduled date of delivery.

Emergency orders will be delivered within 24 hours after the order is placed.

Be compatible with all reagent packs used with the Analyzers.

Preservation and packing - preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination.

All reagents provided will be identical to those used in the FDA 510K approval application. If the bulk reagents are produced overseas, they will be manufactured in conformance with ISO or CE standards AND must be equal to or better than the U.S. products in quality/manufacturing. Documentation of item equivalency must be provided.

5.3.1.1.1. The actual workload may fluctuate in the first year of the contract due to changes in the distribution of patient care. In addition, workload may expand in subsequent option years due to fluctuations in patient volume, and with the inclusion of other locations within the Southern Regional Medical Command.

Appendix 1 provides the estimated workload for Contract Year 1 as well as an estimated workload for each option year. All workload numbers represent total estimated patient reportable/billable results for the indicated year.

5.3.1.1.2. To account for expected fluctuations in workload, the Contractor shall provide a “volume discount” based on exceeding the planned patient load each period of performance. As workload increases, the cost per reportable patient result should decrease. The workload shall be based on the total number of patient reportable results covered under the provisions of this SOW.

5.3.2. RESERVED

5.3.3. The Contractor shall provide an estimate of the yearly quantities of reagent/reagent packs, calibrators/standards, and quality control materials required to perform the volume of patient reportable tests for each assay as provided in Appendix 1.

5.3.3.1. The Contractor shall provide quality control materials IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director. This includes third-party controls where requested/required by the laboratory.

5.3.3.2. The Contractor shall ensure that requirements for routine quality control runs (as defined by the Laboratory Medical Director and outlined in the Laboratory QA program), routine calibration, periodic calibration/calibration verification (i.e., each assay must be calibrated or have calibration verification performed at intervals not to exceed a 6-month period of time), specimen dilutions, and for troubleshooting of out-of-control assays be considered when calculating the yearly requirements.

5.3.3.3. The Contractor shall estimate the volume of user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level periodic maintenance tasks, at the level of use specified in Appendix 1. An operator level maintenance tool/spare parts kit will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the Government. Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.3.4. Reagents shall (must) have a minimum shelf life not less than 3 months upon receipt by the Government, or, if this shelf life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal.

5.3.5. The Contractor shall sequester the required quality control materials and test reagents and ensure that no more than one (1) lot change for QC material and three (3) lot changes for reagents occurs per contract year. Assays shall (must) be stable enough to maintain a single control run per 24 hours of testing. Calibration frequency for all assays outlined in Table 5.1 shall not be less than once every twenty (20) days under routine operations. This calibration frequency does not include calibrations required following instrument repair or servicing (e.g., field service type maintenance or service, major changed in instrument components that affect readout, QC troubleshooting, etc.) or other instances as described in the Laboratory QA Program or approved by the Laboratory Director.

5.3.6. All reagents provided shall be identical to those used in the FDA 510K approval application. All reagents/reagent packs shall be provided as follows:

5.3.6.1. Be provided by the manufacturer of the equipment.

5.3.6.2. Be marked with the required storage temperature.

5.3.6.3. Be maintained at the proper storage temperature during transportation from the Contractor’s storage facility to the Government acceptance site and be delivered on time at the appropriate storage temperature.

5.3.7. The Contractor shall provide the reagents/reagents packs, calibrators/standards, quality control materials, user- replaceable maintenance items, and analyzer specific tools/supplies as outlined in the Schedule of Supplies/Services.

5.3.8. Deliveries. Deliveries of required items shall be per monthly periodic orders called in to the Contractor by the Ordering Officer as identified in the contract. Orders shall arrive within one week of requested date of delivery.

Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor shall provide testing services through local sub- contract at their cost.

5.3.8.1. Emergency orders shall be delivered within 24 hours after the order is placed and be of the same lot number of calibrators/standards, reagents/reagent packs, or quality control materials currently in use for the assay(s) for which supplies are being requested.

5.3.9. Preservation and packing - Preservation and packing shall be performed in accordance with the best commercial practice and in such a manner to afford adequate protection against any damage during shipment from source to destination. All packaging and shipping information shall be clearly marked as to contents on both the shipping documents and the shipping container/box. All deliveries will be made Tuesday through Thursday, to exclude Federal Holidays.

5.4. ANCILLARY MAINTENANCE AND SERVICE

5.4.1. ANCILLARY MAINTENANCE. The Contractor shall be responsible for furnishing maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

5.4.1.1. The Contractor shall maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the Government.

5.4.1.2. The Contractor shall provide all personnel, equipment, tools, materials, supervision, parts, transportation, and other items and services necessary to perform all required repairs and scheduled preventive maintenance/safety inspections and calibrations of equipment. The performance of scheduled periodic preventive maintenance, safety checks, and calibrations that are not normally performed at the operator level shall be performed by Contractor service personnel in accordance with requirements as specified in the Contractor’s instrument maintenance manual.

Completion of installation of the analyzers will establish time zero for determination of time frames for performance of the above periodic services.

5.4.1.3. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with paragraph 5.4.3.1. of this SOW.

5.4.2. REPAIR. Upon notification of equipment failure, the Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the Government notification to the Contractors Customer Service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within four (4) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. Should both instruments become inoperable, the Contractor’s technical specialist must be on-site within four (4) hours of initial notification. If the equipment cannot be repaired, a replacement instrument shall be provided within 72 hours. The Contractor shall provide replacement parts as necessary for operator level maintenance.

5.4.2.1. The Contractor shall provide all reagents, calibrators, controls and any other materials necessary to troubleshoot the reasons for the analyzer failure at no additional cost.

5.4.2.2. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the Government to trouble shoot the instrument failure prior to notification of the contractor.

5.4.2.3. All work shall be performed in a professional manner by an authorized service representative. If any deficiencies are found due to negligence of the service representative, the Contractor shall be required to correct the deficiency to a fully operational status in accordance with manufacturer specifications at no additional cost to the Government.

5.4.2.3. All correspondence, service reports, and invoicing shall be in English.

5.4.2.4. Preventive maintenance services shall be performed in accordance with the manufacturer’s standards/procedures. A preventive maintenance service shall include, but is not limited to, safety, calibration, complete operational testing, lubrication, adjustments, and cleaning of equipment to which the operator does not have access. This also includes the installation of all non-operator parts required to ensure proper operation.

5.4.2.4.1. The Contractor shall notify the Ordering Officer of the exact date and time for performance of a preventive maintenance service no less than 10 days prior to the scheduled preventive maintenance services.

5.4.2.5. The use of two-way radios, as well as smoking, is prohibited within Brooke Army Medical Center and its clinics.

5.4.2.6. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to and obtain from the Equipment Management Branch, at the MTF a Visitors Badge.

The badge must be returned to the Equipment Management Branch prior to departing the MTF.

5.4.2.7. Within one (1) working day after completion of a repair, the Contractor’s representative shall furnish the ORDERING OFFICER one (1) copy of a service report for all services performed with a copy to the Equipment Management Branch and the Laboratory Representative for the MTF. The report shall be in English and shall contain, as a minimum, the following information:

Nomenclature and serial number

Date

Description of services performed (i.e., preventive maintenance service, or unscheduled repair service)

Location of services performed

Duration of performance (hours)

List of parts replaced or other actions taken to restore operability of the instrument

Name of technician

5.4.2.8. The Government will and the Contractor shall exchange hazard communication information before the commencement of any repair.

5.4.2.9. When required, the Contractor shall comply with the Occupational Safety and Health Administration lockout and tagout procedures while performing maintenance on electrical equipment.

5.4.2.10. Safety Inspections shall be performed at least annually in accordance with NFPA 99, Chapter 7. This regulation can be reviewed in full text at the Equipment Management Branch.

5.4.2.11. Preventive maintenance inspections and calibrations shall (must) be performed in accordance with Contractor’s guidance as specified in the Contractor’s instrument…