Solicitation Amendment 0001 W81K00-23-Q-0001 Coagulation Analyzers and Reagents.pdf

W81K0023Q0001

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: MEDINA L. WOODSON

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78236-6200

0011774957

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

A. The purpose of this Amendment 0001 is three-fold:

1) Include the Government Answ ers to the questions received in response to this solicitation on 04 November 2022, and

2) Incorporate the revised Statement of Work dated 15 November 2022.

3) Extend the solicitation closing date/time to 28 November 2022, 4:00 PM CST.

B. All other solicitation terms and conditions remain the same.

See SUMMARY OF CHANGES

1. CONTRACT ID CODE PAGE OF PAGES

1 30

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

16C. DATE SIGNED

BY 16-Nov-2022

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 W81K0023Q0001

X 9B. DATED (SEE ITEM 11)

25-Oct-2022

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

16-Nov-2022

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

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 1449 - CONTINUATION SHEET

SUPPLIES OR SERVICES AND PRICES

CLIN 0001

The CLIN extended description has changed from:

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01 April 2023 - 30 September 2023 The Government will order reagents on as-needed basis, and shall only pay for the actual reagents ordered, received, and accepted by the Government.

To:

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01 April 2023 - 30 September 2023

CLIN 1001

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01 October 2023 - 30 September 2024 The Government will order reagents on as-needed basis, and shall only pay for the actual reagents ordered, received, and accepted by the Government.

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01

CLIN 2001

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01 October 2024 - 30 September 2025 The Government will order reagents on as-needed basis, and shall only pay for

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01

CLIN 3001

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01

October 2025 - 30 September 2026 The Government will order reagents on as-needed basis, and shall only pay for

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01

CLIN 4001

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01 October 2026 - 30 September 2027 The Government will order reagents on as-needed basis, and shall only pay for

Hematology Coagulation Analyzers - Cost-Per-Reportable Result (CPRR) Agreement. The successful offeror shall furnish all equipment, reagents, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) as per the Statement of Work to support the Brook Army Medical Center (BAMC), Joint Base San Antonio, TX 78234. a. The analyzers and their components (to include the workstation) cannot exceed the following dimensions: for the two floor-size analyzers that will be in the main laboratory (6’ wide, 4.5’ deep, and 4’3’’ high).

For the single table-top analyzer going in the Emergency Department Laboratory the size of the analyzer and all its components including the workstation should not exceed the following dimensions (5’ long, 2.5’ deep, and 2’3’’ high). b. All other computer hardware/software required for the use of the analyzers. Period of Performance: 01

The following have been added by full text:

OFFEROR QUESTIONS & ANSWERS

Offeror’s Questions & Government Response

1. Is it feasible to begin a contract on 1 April for a 12 month period? If not, please advise, and the numbers for the 6 month base year would simply be half of full option year.

Government Response: Since it is a supply contract, it cannot cross fiscal years like our service contracts. The base year will have to end 30 September and a new performance period beginning 01 October.

2. Clarify the test volumes as they appear the same for Base year plus 4 option years. The Base year states it is only for a 6 month period. Please clarify Base year test volumes and/or Option year volumes.

Government Response: Please see the attached revised Statement of Work (SOW) dated 15 November 2022 with the updated test volume estimates included in Table 1 of the Mandatory Tests & Estimated Patients/Year Section SOW.

3. 5.1.9 The Contractor will provide, over the course of this contract and all option years, relocation of instruments up to two (2) times after initial installation between testing locations where needed to meet evolving mission requirements at no additional cost to the Government.

All materials to revalidate the system after move will be provided by the Contractor at no additional cost to the Government. – Please clarify is this per instrument? In other words move each analyzer 2 times (6 moves)? Are there plans to relocate the instruments and if so time frame?

Government Response: Yes, the relocation of the instruments is per analyzer. In other words please include two times for each analyzer. At this time there is no plans to move the analyzer.

The only plans are to connect it to the automation line. Nevertheless, laboratory science is constantly evolving and including moves in the contract is beneficial due to unforeseen circumstances.

4. 5.5.1 The Contractor must provide initial on‐site operator training to all technicians assigned to the Government site (i.e., SAMMC and surrounding clinic laboratory staff) prior to implementation of the analyzer for patient testing. Please clarify if the on‐site operator training is to occur prior to the Key Operators initial training at the Contractor’s training site or after Method Validation and prior to going live with the systems for patient testing.

Government Response: The on‐ site operator training is to occur after method validation and prior to going live with the systems for patient testing to all BAMC technicians performing testing with the instrument.

5. 5.5.3 The Contractor must provide on‐site training for 8 technicians annually at no additional cost to the Government or individual trainee. Please clarify if the 8 onsite training slots are in addition to the 2 training slots per analyzer on an annual basis at the Contractors training site.

Government Response: Yes, the 8 onsite training slots are in addition to the 2 training slots per analyzer on an annual basis at the Contractors training site. We have constant turnover, thus the 8 training slots will prove beneficial.

6. Please remove the following paragraph from Items No. 0001, 1001, 2001, 3001, 4001, The Government will order reagents on as‐needed basis, and shall only pay for the actual reagents ordered, received, and accepted by the Government.

Government Response: The paragraph above has been removed for CLINs 0001, 1001, 2001, 3001 and 4001.

REVISED STATEMENT OF WORK

COAGULATION

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide Coagulation Reagents used in support of the coagulation/special coagulation mission at San Antonio Military Medical Center (SAMMC), Fort Sam Houston, TX 78234. The Contractor shall be responsible for furnishing fully automated coagulation analyzer systems (inclusive of instruments, ancillary equipment, maintenance, services, repairs, support, parts as required in order to maintain the systems in optimal operating condition, and any installation and removal, at no extra cost to the Government). The Contractor shall perform to the standards of this Statement of Work (SOW).

NOTE: Everything outlined in this SOW will be serviced and supplied through a single Contractor (to whom the contract is awarded), including any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor.

All testing materials to include reagents, equipment, etc., must be FDA approved platforms.

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 Contract Officers Representative (COR) 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 COR 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 COR, as deemed necessary.

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.

1.2.4.3. During the installation and validation of the equipment and tests to be performed, the Contractor will coordinate scheduled meetings with technical experts of the Laboratory to discuss milestones and to provide updates on completion date. Following the completion of the installation of the new equipment and validation of the tests to be performed, the Contractor will meet with technical experts from the Laboratory at times mutually agreeable to discuss areas of interest to the Laboratory or hospital staff. When the validation of the equipment and tests are to be performed, the Contractor shall provide all reagents, calibrators, controls and any other materials used at no additional cost to the Government IAW Paragraphs 12.4.5. and 12.4.6.(below). The contractor will provide analyzed data to laboratory supervisor for approval. If the validations are not found to be adequate, the Contractor will be responsible for repeating studies in a timely manner in order for the laboratory to meet go live deadlines.

1.2.4.4. The Contractor shall provide at no additional cost to the Government the ability to request visits that are educational in nature from medical and/or scientific advisors/specialists to discuss with the Laboratory and/or hospital staff areas of interest, to include but not limited to, new tests of interest, application of current tests in specific specialty areas (e.g., Cardiology, Endocrinology, Nephrology, etc.), etc.

1.3. HOURS OF OPERATION:

1.3.1. The Core Laboratory is open 24 hours per day, 7 days a week. Routine operations are held 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 SOW.

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, 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

Juneteenth 19 June

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 SOW 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 COR and hand receipt holder 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. CONTRACTING OFFICER'S REPRESENTATIVE (COR): This may also include a designated Point of Contact (POC). 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 COR 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, 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 BAMC DPALS Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the

SOW.

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

COR - Contracting Officer's Representative

DA - Department of the Army

DN - Department of the Navy

DoD CLIP - Department of Defense Clinical Laboratory Improvement Program

HIPAA - Health Insurance Portability & Accountability Act of 1996

MAS Minimum Acceptable Standards

MEDCOM - U.S. Army Medical Command

JC - Joint Commission

OSHA - Occupational Safety and Health Administration

PMS Preventive Maintenance Services

PRS Performance Requirements Summary

POC Point of Contact (See Contracting Officer’s Representative defined above)

QA&I - Quality Assessment & Improvement

QC - Quality Control

SOW Statement of Work

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. All such items 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.

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. The Contractor shall provide, as outlined below, fully automated, discrete, random access coagulation analyzers capable of performing all of the required assays as listed in Table 1. All components outlined in this SOW, to include analyzers, associated peripherals, and data management systems will be serviced and supplied through a single Contractor (to whom the contract is awarded), including any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor. These components, as defined in 5.1.1.1, shall provide redundancy to ensure continuous operations. Each analyzer, and all associated analytical reagents must be approved by the Food & Drug Administration (FDA). The Contractor shall provide the system, training, supplies, reagents, unscheduled maintenance, and preventive maintenance for these systems. All equipment displays and supporting literature must be in the English language. 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/or Department of Pathology policy. The Contractor will also provide removal of all components at the termination of the contract. All costs for Prothrombin Time (PT), Activated Partial Prothrombin Time (aPTT), D-Dimer, Fibrinogen (FIB) and Anti-Xa assays will be calculated on a cost per patient reportable or patient billable basis based on the number of patients listed for each mandatory test listed in Table 1. For these tests, costs for reagents, analyzers, consumables, peripherals and any data management systems (among other requirements) shall be amortized over the total number of tests described in this SOW and factored into the cost per reportable or patient billable. All other assays (special coagulation) will be provided on a cost per kit basis based on the estimated total number of patient results as outlined in Table 1.

5.1.1.1. For the purposes of this SOW the, systems required include at a minimum:

- Any and all coagulation analyzers required to meet the workload (while providing redundancy) at SAMMC.

- Peripherals, to include Uninterruptable Power Sources (UPSs), electrical line conditioners where required, instrument-specific computer terminals/CPUs, printers, other peripherals where required.

- A data management system, to include middleware (e.g., Data Innovations), unless similar capability can be supported within the analyzer system(s).

- Pedestal (floor stand) capable of supporting each coagulation analyzer system (as appropriate), computer terminal or other automated instrument/peripheral as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance).

5.1.1.2. The analyzers/equipment will be located at:

San Antonio Military Medical Center Department of Pathology, Core Laboratory 3551 Roger Brooke Drive Fort Sam Houston, TX 78234

And

San Antonio Military Medical Center Department of Pathology, Emergency Department Laboratory 3551 Roger Brooke Drive Fort Sam Houston, TX 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 the schedule for equipment installation.

5.1.3. Method validation will be conducted in accordance with procedures outlined in the SAMMC Department of Pathology policies and standard operating procedures and as required by the CLIA and/or the College of American Pathologists (CAP)). Relevant Clinical Laboratory Standards Institute (CLSI) guidelines will be referenced as appropriate to verify validity of any procedures. Additional guidelines may be required, depending on regulatory requirements.

5.1.3.1. Method validation will include, but not be limited to: normal range (reference interval) verification, demonstration of linearity, reportable range (analytical measurement range, AMR), correlation to current methods, verification of precision and accuracy (recovery study), carryover studies (if required) and establishment of initial ranges using control materials, to include third party controls, where designated by the Laboratory Director.

5.1.3.1.1. The method validation will be completed and approved by the Laboratory 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 (TSR), who possesses a thorough knowledge of method validation and is familiar with the use of clinical laboratory statistical evaluation software (e.g. EP Evaluator®), to provide technical assistance for the method validation studies. The assigned TSR will be responsible for the entire method validation. Additional TSRs may be brought in to assist in method validations, but only the primary TSR will be responsible for the entire operation.

5.1.3.3. All instrument reagents, calibrators, linearity materials and other required reagents/materials used in the Method Validation Study 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. The Contractor shall provide, for each analytical platform, two (2) paper and two (2) CD copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned leased equipment that is serviced and maintained by the Contractor.

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. The SDS 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

- Description of actions in the event of a spill or other mishap or accident.

5.1.6. The Contractor must provide a water system to supply reagent grade water if required by an analyzer or other system. The water system must provide uninterrupted service for a period of time to be determined by the Laboratory Director. Further, a backup-procedure or system must be available in the instance the water system becomes inoperable. The Contractor must provide or purchase and manage a service contract for each of these items for the duration of the contract.

5.1.7. Each analyzer and associated peripheral (e.g., computers) must be supplied with an Uninterruptable Power Source (UPS), electrical line conditioners where required, instrument-specific computer terminals/CPUs and other required peripherals (e.g., air compressors) as required. The Contractor must provide or purchase and manage a service contract for each of these items for the duration of the contract.

5.1.7. The primary computer for each coagulation analyzer must be supplied with a printer. Damaged or worn printers must be maintained and/or replaced by the Contractor at no additional cost to the Government with the exception where damage was caused by willful acts or negligence on the part of the Government. Toner or ink cartridges (as appropriate) must be provided for each printer to maintain operations thorough the contract at no additional cost to the Government.

5.1.8. The Contractor shall perform local inventories at least monthly and coordinate exact quantities and shipment schedule with the COR prior to shipment IAW Paragraph 5.3.14, Deliveries (below). The Contractor must use Lean principles of inventory management to facilitate implementation of a pull inventory system at SAMMC, minimizing on-hand inventory without jeopardizing availability of service.

5.1.9 The Contractor will provide, over the course of this contract and all option years, relocation of instruments up to two (2) times after initial installation between testing locations where needed to meet evolving mission requirements at no additional cost to the Government. All materials to revalidate the system after move will be provided by the Contractor at no additional cost to the Government.

5.1.10. The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract.

5.2. REQUIRED EQUIPMENT

5.2.1. COAGULATION ANALYZERS/REAGENTS

5.2.1.1. Individual analyzers must have fully automated, discrete random access capabilities. There must be a procedure to allow priority analysis of STAT specimens.

5.2.1.2. The instruments provided will be capable of the following:

5.2.1.2.1. Each analyzer will come equipped to perform continuous, random statistical analysis; capable of internal, real-time statistical Quality Control (QC). Each analyzer must include comprehensive, full integrated QC program that uses common statistical control rules (e.g., Westgard Rules). In addition, the QC program must be able to present data in a graphical format useful to detect shifts and/or trends in the QC system (e.g., Levy-Jennings charts).

The system must be able to participate in additional QC assessments using peer-group comparisons available on at least a monthly basis, with statistical comparisons including the mean, standard deviation and % coefficient of variation by QC lot number at a minimum.

5.2.1.2.2. The analyzer must provide results for PT, aPTT, Fibrinogen, D-Dimer and Anti-Xa within 15 minutes of sample introduction to the system.

5.2.1.2.3. The system must provide a minimum test throughput of at least 150 tests per hour for PT and aPTT respectively.

5.2.1.2.4. Each system must have a maximum sample size less than 200 µL in all modes with a maximum dead volume of 250 µL.

5.2.1.2.5. The analyzers will have an interface that is compatible to the government system MHS Genesis and will be able to recognize MHS Genesis generated bar-code labels (code 39 or 128) on primary sample tubes.

5.2.1.2.6. The systems must provide the capability to perform reflex testing without the need to retrieve/replace specimens on the analyzer.

5.2.1.2.7. The system must provide basic clot-detection capability.

5.2.1.2.8. Analyzer routine manual maintenance will be minimized; no manual maintenance is preferred.

5.2.1.2.9. The analyzer must have the on-board ability to maintain reagents at the proper storage temperatures for the assays listed in Table 1.

5.2.1.2.10. The PTT reagent must be appropriately sensitive and responsive to Heparin.

5.2.1.3. The system must continually monitor volumes and expiration for all on-board reagents, providing a warning and testing lockout for reagents that are expired.

5.2.1.4. Each analyzer must be capable of performing in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytical measurement range.

5.2.1.5. All analyzer/data management system displays and supporting literature shall be in the English language.

5.2.1.6. Analyzer initial startup from the shutdown state must not exceed 30 minutes.

5.2.1.7. Each analyzer must come equipped with an un-interruptible power supply (UPS) capable of providing all necessary electrical power to each analyzer system, to include the data management system, for 15 to 20 minutes after loss of power. Further, electrical line conditioners must be provided to support each analyzer if determined necessary upon evaluation of the local facilities.

5.2.1.8. Each analyzer and all associated reagents shall be approved by the Food & Drug Administration (FDA). All analyzers and associated parts and accessories shall be new. No used, refurbished, or like-new equipment shall be provided in support of this contract at any time.

5.2.1.9. Each analyzer must be capable of handling multiple tube sizes. Specifically, 1.8 mL, 2.7 mL and 4.5 mL Becton Dickinson tubes, as well as 2 mL Greiner tubes, are mandatory.

5.2.1.10. Must have Cap piercing option.

5.2.1.11. The systems must have the ability to interface with third party pre-analytical automation systems, to include automated track systems/centrifuges.

5.2.1.12. The D-Dimer assay must be FDA approved for the exclusion Deep Vein Thrombosis (DVT) and Pulmonary Embolism (PE).

5.2.1.13. All assays/reagents outlined in Table 1 must be available directly through the Contractor or through use of open-channel systems with 3rd party vendor reagents. Reagents that are not manufactured by the Contractor must be provided through alternative means by the Contractor, to include any reagents, calibrators, controls or other required reagents.

5.2.1.14. The primary computer for each coagulation analyzer must be supplied with a printer. Damaged or worn printers must be maintained and/or replaced by the Contractor at no additional cost to the Government with the exception where damage was caused by willful acts or negligence on the part of the Government. Toner or ink cartridges (as appropriate) must be provided for each printer to maintain operations thorough the contract at no additional cost to the Government.

TABLE 1

Mandatory Tests and Estimated Patients/Year

MANDATORY TESTS Estimated Base Option Year 1 Option Year 2 Option Year 3 Option Year 4

Antithrombin III 142 284 300 315 331

Antithrombin III Antigen 53 106 112 118 124

Fibrinogen 1947 3894 4089 4294 4509

D-Dimer 2508 5016 5267 5531 5808

DRVV SCR 142 284 300 315 331

DRVV CONFM 142 284 300 315 331

Factor Inhibitor 7 14 15 16 17

Factor II 36 72 76 80 84

Factor V 99 198 208 209 220

Factor VII 54 108 114 120 126

Factor X 15 30 32 34 36

Factor VIII 316 632 664 693 728

Factor IX 88 176 185 195 205

Factor XI 4 8 9 10 11

Factor XII 46 92 97 102 108

Factor XIII 6 12 13 14 15

Heparin (Anti-Xa) 1281 2561 2691 2826 2967

Prkl/Plsmgn 10 20 21 23 25

Protein ST 26 52 55 58 55

Protein SF 30 60 63 67 71

Protein S 101 201 211 222 234

Protein C 103 206 217 228 240

PT 34439 68878 72322 75938 79735

aPTT 31058 62116 65222 68483 71907

Reptilase 2 4 5 6 7

Lupus Anticoagulant 186 372 391 392 412

Thrombin Time 1733 3466 3640 3957 4155 vWFAg 134 268 282 296 311

Emergency Department Lab Base Year

Option Year 1

Option Year 2

Option Year 3

Option Year 4

PT 4647 9293 9758 10245 10758

aPTT 4139 8277 8691 9126 9583

Fibrinogen 60 119 125 131 138

D-Dimer 1056 2112 2218 2329 2445

5.2.2. DATA MANAGEMENT SYSTEMS

5.2.2.1. The analyzer system shall (must) be capable of interfacing with the military hospital computer system, i.e., the Military Health System Genesis. The Contractor shall (must) have a driver compatible for interfacing the analyzer with the MHS Genesis. The interface between MHS Genesis and the analyzer shall (must) be bi-directional.

5.2.2.2. The analyzer system shall (must) include a data management system for control of the operation of the analyzer system, 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 system’s data management system. The Data Management system shall have a comprehensive, fully-integrated Quality Control (QC) software module that stores and evaluates quality control results. Results can be viewed in a variety of formats including Levy-Jennings charts, moving patient averages, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred.

5.2.2.3. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

5.2.2.4. The QC software shall provide the capability to write user defined Westgard QC Rules. In addition it shall integrate with the result manager for auto-verification of results, allow viewing and maintaining of QC data across multiple levels and lots for connected analyzers, provide a mechanism to maintain an action log of comments from QC review, provide real-time access to QC charts, graphs (Levy-Jennings) and provide the ability to add comments, and eliminate data point(s) from statistics. The QC software shall (must) include the ability to apply Westgard quality control result decision rules in real-time, with the ability of the user to individually select the rules to be applied.

5.2.2.5. Data Management system shall (must) have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument…