A.09.03_Solicitation_Modification_Amendment__0003.pdf

W81K00-17-T-0403

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

POC: ALEX J. HOUSTON

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

0011070833

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

1. The purpose of Amendment 0003 is to re-open the solicitation and extend the due date. Quotes are now due 15 November 2017 at 12:00

Noon CST. Late offers w ill not be accepted.

2. Some of the Technical Requirements in the Statement of Objectives have been revised or deleted.

3. Offerors that previously submitted a quote on or before September 25, 2017, please choose one of the follow ing options to proceed: A)

Submit a new quote, B) Inform the Contracting Officer that the quote already submitted w ill stand, C) Withdraw their quote completely.

How ever, offerors are cautioned that if electing option B (i.e., using existing offer), they w ill still be evaluated against the revised Statement of Objectives, and Addendums to FAR 52.212-1 & FAR 52.212-2.

4. Offerors that missed the initial opportunity to submit a quote are encouraged to submit their offeror NLT 15 NOV 2017, 12:00 noon CST to be considered.

5. Offerors are reminded to read the revised solicitation in it's entirety and submit accordingly.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 16

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

16C. DATE SIGNED

BY 06-Nov-2017

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 W81K00-17-T-0403

X 9B. DATED (SEE ITEM 11)

03-Nov-2017

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

06-Nov-2017

CODE

W40M USA HLTH CONTRACTING ACT

SOUTHERN REG CONTR OFC

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

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

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 30 - BLOCK 14 CONTINUATION PAGE

The following have been added by full text:

STATEMENT OF OBJECTIVES

Statement of Objectives

The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to the Department of Pathology at General Leonard Wood Army Community

Hospital, Fort Leonard Wood, Missouri for the purpose of immunoassay testing under a Cost-Per-Reportable (CPR)

Agreement. All equipment and reagents/consumables shall be supplied and serviced through the Contractor to include all parts, equipment, supplies, and other services required to ensure GLWACH is able to meet its objectives as listed herein.

The contractor shall provide one (1) fully automated discrete random access multiplex immunoassay analyzer and two (2) fully automated enzyme immunoassay (EIA) analyzers, training, supplies, reagents, unscheduled maintenance, preventive maintenance for the equipment and telephonic assistance. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the initial method validation per CLIA/NCCLS QM guidelines and analyzer removal at the termination of the contract.

The analyzers will be located at the following location:

General Leonard Wood Army Community Hospital

Department of Pathology

4430 Missouri Ave.

Fort Leonard Wood, Missouri 65473

Period of Performance:

Base: 1 April 2018 – 30 September 2018

Option 1: 1 October 2018 – 30 September 2019

Option 2: 1 October 2019 – 30 September 2020

Option 3: 1 October 2020 – 30 September 2021

Option 4: 1 October 2021 – 30 September 2022

MULTIPLEX IMMUNOASSAY ANALYZER AND REAGENT

1.0 INSTRUMENTS / EQUIPMENT

1.1 ANALYZER REQUIRED FEATURES: The contractor must provide the following at a minimum for ASIP operations at the GLWACH laboratory.

1.1.1 The immunoassay analyzer system must be capable of interfacing with the laboratory’s Laboratory

Information System (LIS) Composite Health Care System (CHCS). The contractor must have an established driver compatible for interfacing with CHCS. The interface between CHCS and the analyzer must be bi-directional.

1.1.2 The immunoassay analyzer system must include a data management system for control of the operation of the analyzer, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer’s data management system.

1.1.3 The analyzer must be random access, discrete analyzer with STAT interrupt capability and a primary tube sampling system.

1.1.4 Immunoassay analyzer with multiplex methodology is required to permit simultaneous detection and identification of antibodies outlined in Table 1.

1.1.5 Initial startup from the shutdown state must not exceed 20 minutes.

1.1.6 The analyzer must come equipped with an un-interrupted power supply capable of providing all necessary electrical power to all components of the blood bank system, for a minimum of thirty (30) minutes.

1.1.7 The analyzer must allow for growth (i.e., increased numbers of patient testing or addition of additional assays to include vitamin D).

1.1.8 The analyzer and all reagents shall be FDA approved. Analyzers and associated parts and accessories shall be new. No used, refurbished or like-new equipment will be provided in support of the contract at any time.

1.1.9 The analyzer shall have a minimum capacity of 50 specimen samples and a minimum capacity of 5 onboard reagents.

1.1.10 The analyzer must process a minimum of 90 samples per hour.

1.1.11 The analyzer must perform a minimum of 1800 tests per hour.

1.1.12 The analyzer shall have the ability to test multiple analytes from a single tube.

1.1.13 Lab Layout: The offeror shall provide a diagram or other graphical representation demonstrating how its proposed equipment fits within the dimensions below with its quote.

1.2 REAGENT REQUIRED FEATURE: The contractor must provide the following at a minimum for ASIP operations at the GLWACH laboratory.

1.2.1 The analyzer must have the ability to maintain reagents on-board at the proper storage temperature.

1.2.2 The mandatory tests outlined in Table 1 must be approved by the FDA for serum and plasma samples.

1.2.3 Reagents/consumables must meet the requirements of the GLWACH mission, workload and test menu outlined in Table 2.

1.2.4 Reagents must have minimum shelf life upon receipt by the Government of at least four (4) weeks.

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

1.2.5.1 Be provided by the manufacturer of the equipment.

1.2.5.2 Be marked with the required storage temperature.

1.2.5.3 Be marked with the lot number and date of expiration.

1.2.6 Reagents must be shipped in a manner that will preserve the proper storage temperature during transportation and be delivered on time at the appropriate storage temperature.

1.2.7 The contractor shall provide the reagents/reagent packs, calibrators/standards, user-replaceable maintenance items and analyzer specific tools/supplies.

1.2.8 Emergency orders will be delivered within 24 hours after the order is placed by 1400

Monday through Thursday.

1.2.9 The Government retains the right to modify the quantity of each reagent/reagent pack based on changing patient population and test requests.

1.2.10 All reagents shall be FDA-approved and should exhibit at least 90% sensitivity and 90% specificity.

1.2.11 Reagents used for troubleshooting analytical systems shall be reimbursed (or replaced) by the

Contractor at no additional cost.

1.2.12 Delivery of the reagents will be on an “As Needed” basis by the individual delivery orders issued by the contracting officer. The Contracting Office or their representative shall be the only entity authorized to issue orders against the resulting contract.

1.2.13 Delivery of reagents will not exceed 7 days from the date of request.

1.2.14 The contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

1.2.15 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. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall contain, as a minimum, the following information: identification of the hazardous material and the specific hazard, the required practices for the safe use of the product, first aid precautions and what to do in the event of a spill or other mishap or accident.

Table 1

Mandatory Tests for Analyzer A FDA Approved for Serum Samples

Measles IgG Rubella IgG Varicella IgG

Anti-Nuclear Antibody

Screen (ANA) to include:

Ribosomal P SS-A SS-B

Centromere B dsDNA Chromatin DNP

Sm Sm/RNP Scl-70

Jo-1

Table 2

Annual Volume-Core Laboratory

TEST BASE OPTI OPTI OPTI OPTI

O N O N O N O N

Measle 40,00 42,000 44,100 46,305 48,620

IgG 0

Rubella 40,0 42,000 44,10 46,30 48,62

IgG 0 0 5 0

Varicel 40,0 42,000 44,10 46,30 48,62 l a IgG 0 0 5 0

ANA 600 630 662 695 730

Screen

2.0 ENZYME IMMUNOASSAY (EIA) ANALYZERS AND REAGENT REQUIRED FEATURE

2.1 ANALYZER REQUIRED FEATURE: The contractor must provide the following at a minimum for ASIP operations at the GLWACH laboratory.

2.1.1 The immunoassay analyzes must be capable of interfacing with the laboratory’s Laboratory

Information System (LIS) Composite Health Care System (CHCS). The contractor must have an established driver compatible for interfacing with CHCS. The interface between CHCS and the analyzers must be bi-directional.

2.1.2 The analyzers must include a data management system for control of the operation of the analyzers, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer’s data management system.

2.1.3 Two analyzers with microplate enzyme immunoassay (EIA) methodology are required to perform tests outlined in Table 3.

**2.1.4 Initial startup from the shutdown state must not exceed 40 minutes.

2.1.5 The analyzers must come equipped with an un-interrupted power supply capable of providing all necessary electrical power to all components of the analyzers, for a minimum of thirty (30) minutes.

2.1.6 The analyzers must allow for growth (i.e., increased numbers of patient testing or addition of additional assays to include QuantiFERON TB Gold).

2.1.7 The analyzers and all reagents shall be FDA approved. Analyzers and associated parts and accessories shall be new. No used, refurbished or like-new equipment will be provided in support of the contract at any time.

2.1.8 The analyzers shall have a minimum capacity of 120 specimen samples.

2.1.9 N/A

2.1.10 The analyzers shall have the ability to test multiple analytes from a single tube.

2.2 REAGENT REQUIRED FEATURES

2.2.1 N/A

2.2.2 The mandatory tests outlined in Table 3 must be approved by the FDA for serum samples.

2.2.3 Reagents/consumables must meet the requirements of the GLWACH mission, workload and test menu outlined in Table 4.

2.2.4 Reagents must have minimum shelf life upon receipt by the Government of at least four (4) weeks, or if this shelf life cannot be met, the Contractor must identify the guaranteed shelf life after receipt that can be accommodated.

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

2.2.5.1 Be provided by the manufacturer of the equipment.

2.2.5.2 Be marked with the required storage temperature.

2.2.5.3 Be marked with lot number and expiration date.

2.2.6 Reagents must be shipped in a manner that will preserve the proper storage temperature during transportation and be delivered on time at the appropriate storage temperature.

2.2.7 The contractor shall provide the reagents/reagent packs, calibrators/standards, user-replaceable maintenance items and analyzer specific tools/supplies.

2.2.8 Emergency orders will be delivered within 24 hours after the order is placed by 1400

Monday through Thursday.

2.2.9 The Government retains the right to modify the quantity of each reagent/reagent pack based on changing patient population and test requests.

2.2.10 All reagents shall be FDA-approved and should exhibit at least 90% sensitivity and 90% specificity.

2.2.11 Reagents used for troubleshooting analytical systems shall be reimbursed (or replaced) by the

Contractor at no additional cost.

2.2.12 Delivery of the reagents will be on an “As Needed” basis by the individual delivery orders issued by the contracting officer. The Contracting Office or their representative shall be the only entity authorized to issue orders against the resulting contract.

2.2.13 Delivery of reagents will not exceed 7 days from the date of request.

2.2.14 The contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

2.2.15 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. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall contain, as a minimum, the following information: identification of the hazardous material and the specific hazard, the required practices for the safe use of the product, first aid precautions and what to do in the event of a spill or other mishap or accident.

Table 3

Mandatory Tests for Analyzers B Approved by the FDA for Serum Samples

QuantiFERON TB Gold HBc IgM Anti-HBc

HBsAg HBsAb HCV

HAV IgM HAVT

Table 4

Annual Volume-Core Laboratory

TEST BASE OPTION 1 OPTION 2 OPTION 3 OPTION 4

Anti-HBc 700 735 772 811 852

HBc IgM 1,200 1,260 1,323 1,389 1,458

HBsAg 1,800 1,890 1,985 2,084 2,188

HBsAb 23,000 24,150 25,358 26,626 27,957

HCV 2,600 2,730 2,867 3,010 3,161

HAV IgM 1,300 1,365 1,433 1,505 1,580

HAVT 23,000 24,150 25,358 26,626 27,957

QuantiFERON TB 7,200 7,560 7,938 8,335 8,752

Gold

3.0 MAINTENANCE AND SERVICE:

3.1 MAINTENANCE:

3.1.1 At the start of the contract, the Contractor shall have a contract representative and alternate responsible for scheduling and coordination of service calls. The name and phone number of the designated individual and alternate shall be provided to the Chief, Medical Maintenance Branch at (573) 596-0482.

3.1.2 Contractor shall deliver all new equipment to the Property Management

Section at the beginning of the contract. Clinical Engineering Section will perform acceptance inspection and establish maintenance records for equipment. These records will be maintained for the duration of the contract period. Clinical Engineering will maintain historical data that shows the acceptance inspection and services performed on the equipment by Medical

Maintenance and/or the MFG as long as the equipment is in the Government

Facility.

3.1.3 Any and all equipment contracts to include, lease, cost per test, loan, etc., must be reviewed and approved by the Chief, Clinical Engineering and reviewed by the PBO for purposes of maintenance and accountability, whether accomplished by in-house maintenance or contract personnel.

3.1.4 The GLWACH Medical Maintenance Branch will first evaluate any equipment malfunction and facilitate repairs (screening process). If a service call is necessary, the Contractor shall provide unlimited service calls. Only the Medical

Maintenance Branch will determine if the required repair service is emergency or routine.

3.1.5 The contractor shall be responsible for furnishing maintenance, services, repairs and parts as required in order to maintain the system is operating in the proper working condition in accordance with the Original Equipment Manufacture’s (OEM) specifications.

3.1.6 The contractor is required to maintain all equipment installed under this contract except for repairs necessitated by willful damage or negligence on the part of the U.S. Government.

3.1.7 The contractor shall provide a full unscheduled and preventive maintenance service for the performance period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer's manuals), and hotline telephone service to assist operators in troubleshooting problems in accordance with paragraph 3.4.2 of this Statement of Work.

3.2 REPAIR:

**3.2.1 Upon notification of equipment failure, the Contractor’s technical specialist must be on-site within one (1) working day of initial telephonic notification.

3.2.2 All work shall be performed in a professional manner by an authorized service representative or have two (2) years of maintenance experience on the contracted equipment. 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 U.S.

Government.

3.2.3 Services are to be performed during the month(s) of October through September. Contractor shall respond within 48-hours, during normal duty hours of 8:00 AM and 4:00 PM excluding Federal

Public Holidays.

3.2.4 LEGAL PUBLIC HOLIDAYS:

New Year’s Day, January 1

Martin Luther King's Birthday, 3rd Monday in January

Washington's Birthday, 3rd Monday in February

Memorial Day, last Monday in May

Independence Day, July 4

Labor Day, 1st Monday in September

Columbus Day, 2nd Monday in October

Veteran's Day, November 11

Thanksgiving Day, 4th Thursday in November

Christmas Day, December 25

3.2.5 Contractor's representative shall report to Medical Maintenance, 4430 Missouri Avenue, Room No.

034, General Leonard Wood Army Community Hospital, Telephone No. 573-596-0482, prior to commencing services during normal operating hours. The contractor will get a security badge from

Logistics Division, Room No. 034. During other than normal operating hours, contractor's representative shall report to Staff Duty, Front Desk, 4430 Missouri Avenue, General Leonard Wood Army Community

Hospital. The service representative will obtain a badge before reporting to service area.

3.2.6 Contractor's service representative shall report in person or telephonically notify the maintenance manager, Building No. 310, 4430 Missouri Avenue, Medical Maintenance Department, Telephone No.

573-596-0482 prior to commencing services during normal duty operating hours of 8:00 AM and 4:00 PM.

3.2.7 The government and the contractor’s service representative shall exchange any hazard communication information before the commencement of any repair.

3.2.8 When required, the contractor’s service representative will comply with the Office of Safety and Health Administration lockout/tag out standards while performing maintenance on equipment.

3.2.9 Upon completion of services by the contractor’s service representative, a written service report shall be provided to the maintenance manager or the AOD. The service report shall provide detailed information regarding the cause of the equipment malfunction and corrective action taken. Include, at a minimum, 1) the time required to complete the work 2) price of labor (hourly rate) 3) list of parts replaced with part numbers and prices for each part 4) Nomenclature and Serial Number 5) Date 6) Name of the Technician.

3.2.10 In the event all information is not available to the contractor's service representative when services are performed, the initial service report shall include all available information. The contractor shall provide the balance of the required information to the maintenance manager no later than 10 days after services are completed.

3.2.11 In the event of calibration, after performing Calibration/Verification/Certification services, the contractor’s service representative will affix and/or update DD Form 2163 (Medical Equipment

Verification/Certification). The contractor shall complete DD Form 2163 in accordance with the instructions provided in Technical Bulletin (TB) 38-750-2, or by the maintenance activity’s internal

SOP.

3.2.12 If the contractor's calibration equipment produces a printed summary of the calibration procedure used, attach the printed summary to the DD Form 2164. Ensure that the heading of the DD Form 2164 is filled out and that the form is properly signed.

3.2.13 Contractor’s service representative will be factory trained and have a minimum of two years of experience working on the contracted equipment.

3.3 Not used.

3.4 SERVICE:

3.4.1 The GLWACH Medical Maintenance Branch will first evaluate any equipment malfunction and facilitate repairs (screening process). If a service call is necessary, the Contractor shall provide unlimited service calls. Only the Medical Maintenance Branch will determine if the required repair service is emergency or routine.

3.4.2 The Contractor shall provide direct customer service and support, 24 hours/7 days a week, to include hotline telephone service and on-call emergency repair service support, to assist operators i n correcting equipment operation problems.

3.4.3 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.

3.4.4 The contractor shall notify the Point of Contact of the exact date and time for performance of a preventive maintenance service at least two (2) days prior to the scheduled preventive maintenance services.

**3.4.5 The contractor's qualified service technician shall be onsite to provide routine services, service requiring immediate repair and one (1), two (2) or four (4) scheduled services for preventive maintenance (as specified in the Contractor's instrument maintenance manual), safety and calibration as required by this performance based work statement. The contractor will take every reasonable action to have the equipment repaired and operational within 48 hours after initial response by the contractor.

**3.4.6 The Contractor shall perform routine repair service between 8:00 AM and 4:15 PM Monday through Friday, excluding Legal Public Holidays. Contractor response time shall be within 48 clock hours after telephonic notification excluding weekends and Legal Public Holidays.

3.4.7 Repair completion time for a routine repair service shall not be more than 48 clock hours after telephonic notification excluding weekends and Legal Public Holidays.

3.4.8 Upon analyzer failure between 0730-1 630 Monday-Fridays, the Contractor's qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement) within 24 hours.

**3.4.9 Should the analyzers at GLWACH become inoperable, the Contractor's technical repair specialist should be on-site within one (1) day of initial notification and the repair of the analzyer completed within one 48 hours of initial notification. If deemed necessary after consultation with the contractor, if analyzer cannot be repaired within 48 hours of the initial notification, contractor will work with

GLWACH for determining the identification of alternative sources of testing. The Contractor will pay all costs associated with the provision of this service, for as long as the analyzer remains inoperable.

3.4.10 If the equipment is determined to be out of service for longer than 48 hours (from the time of service technician's arrival on the site), the contractor shall notify the Lab Manager as to the reason(s)

(i.e. non-availability of parts, etc.) for non-operability.

3.4.11 The Contractor shall provide all necessary user-replaceable maintenance items that will be required to support the analyzer, and any analyzer specific tools/supplies necessary to perform operator-level maintenance tasks, at no additional cost to the Government.

3.4.12 Contractor's representative shall report to Medical Maintenance, 4430 Missouri Avenue, Room

No. 034, General Leonard Wood Army Community Hospital, Telephone No. 573-596-0482, prior to commencing services during normal operating hours. The contractor will get a security badge from

Logistics Division, Room No. 034. During other than normal operating hours, contractor's representative shall report to Staff Duty, Front Desk, 4430 Missouri Avenue, General Leonard Wood

Army Community Hospital. The service representative will obtain a badge before reporting to service area.

3.4.13 Service reports. Upon completion of services, a written service report shall be provided to the medical equipment maintenance manager, or the government medical equipment repairer assigned to the service call.

3.4.14 The service report shall indicate the Contract Number, service performed (e.g., PM and/or repair), provide detailed information regarding the cause of equipment malfunction, corrective action taken, to include the time required to complete the work. The service report shall also include the estimated price of labor (hourly labor rate); a list of parts replaced with price for each part, the unit Site ID and ECN number, and the name of the technician performing the service.

3.4.15 After normal duty hours, service tickets shall be given to the Government AOD/SDNCO, at the

Information/ reception desk. Faxed reports are acceptable with the concurrence of the Government.

3.4.16 In the event that all information is not available to contractor's representative when services are performed, the initial service report shall include all information available. Contractor shall provide the balance of the required information in writing to the Chief, Medical Equipment Branch, not later than 10 days after services are completed. The remaining information should be mailed to: Commander, USA

Medical Department Activity, ATTN: MCXP- LO-MM, Service Reports, 126 Missouri Avenue, Ft.

Leonard Wood, MO 65473-8952 or Faxed to 573-596-1786, ATTN: Medical Maintenance Branch. This address is not to be used for any purpose other than as stated in the paragraph and C.5.8.2.

3.4.17 Contractor shall provide a copy of the invoice to the Chief, Medical Maintenance Branch, for verification of services performed. This is in addition to the requirements of block 13 of the DD Form

1155, Order for Supplies or Services. The copy of the invoice can be mailed to Commander, USA Medical

Department Activity, and ATTN:

MCXP-LO-MM, 126 Missouri Avenue, Ft. Leonard Wood, MO 65473-8952 or Faxed to 573-596-1786, ATTN:

Service Report.

3.4.18 The Contractor shall be responsible for all items of Government equipment throughout the period they are under his control. The Contractor shall be responsible for any contractor-caused damage to Government-owned property and shall replace or repair at the contractor’s expense. The

Contracting Officer will approve replacements or repairs.

3.4.19 The Contractor shall ensure all areas where equipment is serviced on-site are left in a clean, neat, safe, and orderly condition. To prevent safety hazards, no equipment shall be left pulled out or apart at the end of the workday. All equipment under repair shall be secured at all times.

3.4.20 If the Contractor determines that the item being serviced is uneconomically repairable, the

Chief, Medical Maintenance Branch shall be notified. The Chief, Medical Maintenance Branch, GLWACH will determine economic reparability in accordance with US Army Directives.

4.0 TRAINING:

**4.1.1 The Contractor will provide initial on-site operator training to all technicians assigned to the

Pathology Laboratory prior to initiation of use of the analyzer for patient testing.

**4.1.2 In addition, the Contractor will provide at least two (2) training slots per analyzer at the

Contractor's training site at no additional cost to the U.S. Government. The Contractor may charge the

Government only for training services exceeding the basic requirement for a given year. Such training will be provided during designated implementation weeks and at mutually times, between the hours of 7 am - 7 pm local time.

4.1.3 Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator- level periodic preventive maintenance procedures and use of the data management/quality control software.

5.0 Delivery and Installation:

**5.1.1 The Analyzers will be delivered to the location as indicated below within 30-45 calendar days after contract award. Equipment setup, method validation studies, and analytical measurement range/linearity verification, shall (must) be completed by Contractor personnel within a period of time to ensure that equipment is fully operational on or before 31 March 2018.

During the initial implementation, a dedicated technical representative must be available on site throughout the entire implementation period. Substitutions must be coordinated with the COR.

**5.1.2 Contractor shall provide a milestone chart with their quote that depicts significant events from the time of award through the "Go-Live" date.

5.1.3 PRIMARY LOCATIONS OF COMPLETE SYSTEMS:

General Leonard Wood Army Community

Hospital Department of Pathology

4430 Missouri Avenue

Building 310

Fort Leonard Wood, Missouri 65473

5.1.4 Exact installation locations at the primary location shall be coordinated by the Contractor with the point of contacts listed below:

Laboratory Manager

General Leonard Wood Army Community

Hospital Tel: 573-596-1509

SECTION SF 1449 - CONTINUATION SHEET

The following have been modified: Addendum to 52.212-1

Quotes are due NLT 15 November 2017, 12:00 PM (Noontime), Central Standard Time. They shall be submitted electronically through email sent directly to alex.j.houston.civ@mail.mil and

Robyn.a.villafranco.civ@mail.mil .

mailto:alex.j.houston.civ@mail.mil mailto:Robyn.a.villafranco.civ@mail.mil mailto:alex.j.houston.civ@mail.mil mailto:Robyn.a.villafranco.civ@mail.mil

Volume I. Administrative.

Provide the following items:

o Completed SF 1449: Blocks 12, 17 (to include CAGE code and DUNS number), 30A ‐ C o Completed SF30, if applicable. Blocks 15A - 15C for all amendments o Point of Contact Information (Name, Telephone Number, Fax Number, and Email) o Statement that the offeror will hold its quote firm for at least 90 days from the due date for receipt of quotes, subject to any changes that may occur as a result of discussions if applicable.

Potential contractors must be registered in the System for Award Management (SAM) to be eligible for award.

The SAM website is http://www.sam.gov. Please provide completed provisions, as listed in the solicitation.

Alternately, complete all provisions in SAM and provide confirmation of completion with offer. Please provide completed provisions, as listed in the solicitation. Alternately, complete all provisions in SAM and provide confirmation of completion with offer.

Volume II. Technical Capability

Factor 1. Technical Capability. Offerors shall demonstrate how their proposed items comply with the Government's

Statement of Objectives via the submission of a written capability statement, product literature, or other materials, to include proof where applicable (e.g., Food and Drug Administration approval of equipment and assays). Offerors shall separately address each paragraph AND subparagraph within the Statement of Objectives. Failure to separately address each paragraph will be construed to mean the offeror is unable to meet the requirements of that particular paragraph and would thus not be eligible for award.

This is an "all or none" solicitation, in that the offerer must provide a quote for all CLINs listed. Failure to provide a quote for any CLIN, unless it is specifically identified as "not separately priced" within the quote, will be construed to mean the offeror is not quoting that CLIN and thus, not eligible for award.

Subfactor 1A. Instruments/Equipment and Reagents/Consumables

Subfactor 1B. Maintenance/Service

Subfactor 1C. Delivery/Installation

Subfactor 1D. Training

Volume III. Price.

Factor 2. Price. A unit price shall be submitted for each line item (i.e., per test), as well as the extended price (i.e., unit price multiplied by quantity). ** If sold in packages, vendors may so state and provide a unit price for package in addition to a price per test. For example, if the Government requires 3,200 tests and tests are sold in packages of

100, the vendor may give a unit price for 3,200 tests AND 32 packages. This is an "all or none" solicitation. Failure to provide a quote for any CLIN, unless it is specifically identified as "not separately priced" within the quote, will be construed to mean the offeror is not quoting that CLIN and thus, not eligible for award.

Volume IV. Subcontracting Plan.

The offeror shall submit a current Subcontracting Plan with their quote. If the offeror already has a Commercial

Subcontracting Plan approved by a Government Contracting Officer, that plan (along with corresponding approval) is sufficient for submission. The Approver's signature must be visible.

(m) The non-FAR Part 12 discretionary FAR and DFARS provisions included herein are incorporated into this solicitation either by reference or in full text. If incorporated by reference, see provision 52.252-1 herein for locations where full text can be found.

End changes.