W81K0020R0002 Amendment 0002 Extend Offer Due Date.pdf

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: ROSALBA MARTINEZ

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78234-6200

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 solicitation due date to 4 May 2020, 3:00 pm CST and to correct paragraphs 3.2.3.1 and

5.1.2 of the PD.

1. CONTRACT ID CODE PAGE OF PAGES

1 35

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

16C. DATE SIGNED

BY 22-Apr-2020

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 W81K0020R0002

X 9B. DATED (SEE ITEM 11)

24-Mar-2020

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 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

22-Apr-2020

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:

W81K0020R0002

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 23-Apr-2020 03:00 PM to 04-May-2020 03:00 PM.

The following have been modified:

PROCUREMENT DESCRIPTION

PURCHASE DESCRIPTION

CHEMISTRY IMMUNOASSAYS AND TESTING REAGENT KITS

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Contractor shall provide chemistry immunoassays and testing reagents along with consumables, calibrators, maintenance support, along with the following incidental equipment: (1) one modular, continuous, customizable laboratory track line, at minimum (2) two chemistry analyzers, at minimum (2) immunoassay analyzers, and other equipment outlined in para 3.2 for William Beaumont Army Medical Center (WBAMC) (See Para 5.1 for location). The Contractor shall provide (2) two integrated chemistry/immunoassay analyzers for Mendoza Clinic, Ft Bliss and Soldier Family Medical Center, Ft Bliss. The Contractor shall provide all reagents for these three locations in Appendix 1, along with consumables, calibrators, and maintenance support at no additional, separately billed cost to the government. The cost for maintenance, reagents, consumables, and calibrators will be calculated into the cost of the kits. The Contractor shall perform to the standards of this contract.

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

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

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 in 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 deficiency. 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 KO 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 in accordance with (IAW) Paragraphs 5.4.2.1 and 5.4.2.2. (below). If kits are used out of WBAMC inventory they will be replaced at no cost to WBAMC.

1,2,4. Performance Evaluation Meetings.

1.2.4.1. The KO may require the Contractor to meet with the KO and/or COR as deemed necessary.

1.2.4.2. The Contractor may request a meeting with the KO 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 KO. If the Contractor does not concur with any portion of the minutes such non-concurrence shall be provided in writing to the KO within 10 calendar days following receipt of the minutes.

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation. WBAMC 24/7; 0700-1630 M-F Soldier Family and Mendoza

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 purchase description (PD).

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 PD. 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 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.

New equipment must meet the agreement for the original solicitation and does not obligate the government to any additional costs or testing menu items.

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 KO 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 (DoD), 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.

1.9.1.3. The Contractor employees will be registered with the Symplr© system for WBAMC. Contractors must check in with Symplr© and report to PMO to check in. At no time is the Contractor employee to walk about the WBAMC without an escort. PMO will contact the COR to escort the contractor to the laboratory area.

1.9.1.4 Contractor employees will not be admitted to the Department of Pathology without a prior scheduled appointment. No walk-ons will be accepted by the COR.

2. DEFINITIONS/ACRONYMS.

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

2.1.1. CONTRACTING OFFICER (KO): 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): 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 ’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 WBAMC DPALS Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the contract.

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 QA Quality Assurance QA&I Quality Assessment & Improvement QC Quality Control WBAMC William Beaumont Army Medical Center

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 this contract. The Contractor shall not alter the facilities without written approval of the KO. 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.

3.2.1 Contractor will supply (1) one modular, continuous, customizable laboratory track line, at minimum (2) two Chemistry analyzers, at minimum (2) Immunoassay analyzers for WBAMC, new hospital location. If the minimum required analyzers are not enough to meet the workload demands the Contractor, an additional chemistry or immunoassay analyzer shall be supplied by the Contractor.

3.2.1.1 The Contractor shall supply (2) two centrifuges, (1) one capper, (1) one decapper, (1) one resealer, (1) one recapper, (1) one refrigerated storage/retrieval unit, (1) input/output module with STAT priority capabilities, (1) one deionized water unit, and middleware.

3.2.1.1.1 The Contractor’s main line must fit within the dimensions listed in Appendix 4.

3.2.1.2 The Contractor shall provide (1) one integrated chemistry/immunoassay analyzer for the Mendoza Clinic, Ft Bliss.

3.2.1.3 The Contractor shall supply (1) one integrated chemistry/immunoassay analyzer for Soldier Family Medical Center, Ft Bliss.

3.2.1.4 For specific requirements of all equipment listed reference paragraph 5.

3.2.2. RESERVED

3.2.3. All equipment for the main line shall be operational for 24/7 support. Equipment shall be operational 100% of the time without exception. Redundancy is built into the main line so that if one chemistry analyzer goes down there is a second to support. At no time is it acceptable to have two analyzers for the line down at the same time.

3.2.3.1. All equipment for the outlying clinics shall have 98% uptime.

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 shall contain the name of the company and the employee and must be worn at all times when at the government’s facilities.

5. SPECIFIC TASKS

5.1. DESCRIPTION

5.1.1. The Contractor shall provide a fully automated, discrete random access chemistry/immunoassay track system capable of performing all of the required assays listed in Appendix 1 for WBAMC. 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 CLIA/NCCLS/DPALS QM guidelines and analyzer removal upon termination of the contract.

5.1.1.1. For the purposes of this PD the analyzer system includes at a minimum:

- Any and all analyzers identified under Equipment, paragraph 3.2

- Robotics Automation Systems

- Automated Preanalytical Processing Systems

5.1.1.2. The analyzer systems and main line will be located at:

William Beaumont Army Medical Center 18511 Charlie Medic Way El Paso, TX 799218

5.1.2. The Contractor shall provide chemistry/immunoassay capabilities to SFMC and SFCC. Each facility shall be given an integrated CC/IA analyzers. The analyzers shall be capable of performing all of the required assays listed in

Appendix 1 for each area. 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 CLIA/NCCLS/DPALS QM guidelines and analyzer removal upon termination of the contract.

5.1.2.1. The analyzers for the clinic areas will be located at:

Soldiers Family Medical Clinic (SFMC) 2496 Wicker Rd.

Ft. Bliss, TX 79916

Mendoza Clinic (SFCC) 11335 SSG Sims St.

East Ft. Bliss, TX 79916

5.1.3. 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.

5.1.4. Method validation will be at no cost to the government. All reagents, consumables, calibrators, and QC required to complete the validation will be covered by the Contractor. The Contractor will only be paid once validation is complete and patients are being run.

5.1.4.1. Method validation shall be conducted IAW method validation protocols established by the Department of Pathology’s Quality Management Program (these protocols are IAW 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 3 (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

5.1.4.2. Method validation shall include, but not be limited to, normal range verification, demonstration of linearity with limit of quantitation verification (LOQ), limit of detection verification (LOD), reportable range, correlation with current methods (comparison of methods study), validation of analytical measurement range (AMR), validation of clinical reportable range (CRR), validation of precision (replication study) and accuracy (recovery study), middleware rule validations, automation validation and establishment of initial control ranges using control materials, to include third party controls, as designated by the Laboratory Director.

5.1.4.3. The Contractor shall provide a qualified Technical Service Representative on site for the duration of the validation/verification time frame at no additional cost to the government. The technical service representative must possess 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.

5.1.4.4. 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, but will be at no cost to the government.

5.1.4.5. If an appropriate number of patient samples cannot be procured to meet the Medical Director’s approval validation of those identified tests may be discontinued until a later time. The Contractor will be contacted when the facility is ready to validate the test and the Technical Service Representative will return onsite to complete the validation at no cost to the government.

5.1.4.6. 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.

5.1.5. The Contractor shall provide 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.

5.1.6. The Contractor shall provide material safety data sheets (MSDS) 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 MSDS shall contain information on the hazards associated with each specific chemical or material.

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.

5.1.7. The Contractor shall provide a water system (e.g. filtered, deionized etc.), if required by the analyzer, that shall provide uninterrupted service for the duration of the contracting period.

5.1.8. The Contractor shall collect and transport equipment upon termination of this contract.

5.2. ANALYZERS.

5.2.1. For WBAMC:

5.2.1.1. Individual analyzers shall have fully automated, discrete random access capabilities for chemistry, immunometric, potentiometric, and colorometric assays.

5.2.1.2. There shall be a single point of specimen entry for the routine analysis of all required chemistry and immunoassay tests. There shall be a separate specimen point or method to prioritize STAT specimens in order to meet 60 minute turnaround time.

5.2.1.3. Each analyzer shall be a random access, discrete analyzer system with STAT interrupt capability and a primary tube sampling system capable of handling 100mm x 16mm, 100mm x 13mm, 75mm x 13mm, and 64mm x

10.25 test tubes with standard or Hemaguard caps. The analyzer shall accommodate both Becton-Dickinson and Greinier tubes.

5.2.1.4. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care.

These analyzer systems shall perform in low, medium, and high volume work periods to produce results that are accurate and precise throughout the manufacturer’s stated linearity/analytic measurement range.

5.2.1.5. Minimum actual through-put shall be 200 tests per hour for immunometric assays, 800 tests per hour for enzymatic/rate and colorimetric/photometric assays and 1200 tests per hour for ISE assays.

5.2.1.6. The 60-minute STAT panel includes the assays listed in Table 5.2.1. The entire Table 5.2.1. shall be resulted within 60 minutes as individual assays.

Table 5.2.1 – Assays that must be completed from the same specimen within 60 minutes as a STAT panel.

Table 5.2.1 – Assays that must be completed from the same specimen within 60 minutes as a STAT panel.

Alanine Amino Transferase (ALT) Creatinine Kinase, Total (CK) Aspartate Amino Transferase (AST) Creatinine Kinase, MB Fraction (CK-MB) Bilirubin (Direct) Glucose Bilirubin (Total) Chorionic Gonadotropin (hCG) Brain Natriuretic Peptide (BNP) or NT-pro BNP

Potassium

Calcium (Total) Protein, Total Carbon Dioxide (CO2) Sodium Chloride Troponin I or T Creatinine Urea Nitrogen

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

5.2.1.8. Initial startup from the shutdown state shall not exceed 20 minutes.

5.2.7. Each analyzer system must come equipped with an uninterruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for 15 to 20 minutes. All un-interruptible power supplies shall come with a minimum 11-foot cable. Power plugs will be in the ceiling at this location

5.2.8. The analyzer systems and all 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 for first installation or as replacement for faulty/broken equipment.

5.2.2. For Soldier Family/Mendoza:

5.2.2.1. The single analyzer shall have all chemistry/immunoassay testing capabilities for all tests in Appendix 1.

5.2.2.2. Shall handle 100mm x 16mm, 100mm x 13mm, 75mm x 13mm, and 64mm x 10.25 test tubes with standard or Hemaguard caps. The analyzer shall accommodate both Becton-Dickinson and Greinier tubes.

5.2.2.3. Minimum actual through-put shall be 200 tests per hour for immunometric assays, 800 tests per hour for enzymatic/rate and colorimetric/photometric assays and 1200 tests per hour for ISE assays.

5.2.2.4. STATs shall be completed within 60-minutes from receipt, loading, running, and reporting. The items in Table 5.2.2 shall be completed within this timeframe:

Table 5.2.2 – Assays that shall be completed from the same specimen within 60 minutes as a STAT panel.

Renal Panel (Glucose....)

Hepatic Panel (…) Bilirubin (Direct) Bilirubin (Total)

Direct Bilirubin hCG Calcium (Total) Glucose

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

5.2.2.6. Initial startup from the shutdown state shall not exceed 20 minutes.

5.2.2.7. Each analyzer system shall be equipped with an uninterruptible power supply capable of providing all necessary electrical power to each analyzer system, to include the data management system for 15 to 20 minutes.

The UPS cable must be at least 12 feet in length.

5.2.2.8. The analyzer systems and all 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.

5.3. REAGENTS.

5.3.1. For WBAMC:

5.3.1.1. The analyzer shall maintain reagents at the proper storage temperatures for the assays listed in Appendix 1.

All assays shall be FDA-approved.

5.3.1.2. The assays listed in Table 5.2.1. shall be present on the analyzer at all times.

5.3.1.3. All other reagents (See Appendix 1) need not be maintained on an analyzer at the same time, but the analyzers provided shall have the capability to add/change out reagents/reagent packs with only a minimal calibration/quality control requirement (i.e., shall allow the user to calibrate any assay, remove the assay reagents/reagent packs for a period of undetermined time, and then reload the reagents/reagent packs to run the assay without the need for recalibration in most instances, thereby allowing the user to meet work test scheduling requirements specific to the location).

5.3.1.4. The Contractor shall optimize the specific arrangement of the reagents/reagent packs for assays that are routinely maintained on the analyzer during the initial installation of the analyzer and when a new assay is added to the test menu. The Contractor shall ensure that all required reagents/reagents packs are accounted for in the loading plan for the assays that are routinely maintained on the analyzer (assays to be routinely maintained on each of the analyzers will be specified at the time of installation).

5.3.2 All Testing Sites:

5.3.2.1. The workload listed in Appendix 1 is an estimate based on projected patient workload. Actual workload may vary. The workload numbers represent the maximum reportable results that can be billed for each test.

5.3.2.2. The workload listed in Appendix 1 is an estimate. Based on the onboard stability timeframe, number of calibrations required, and frequency of QC the workload numbers quoted may not meet the requirement for patient testing as workload numbers do not account for onboard stability time of reagents, tests required for quality control, or tests required for calibrations. The Contractor shall discuss this and account for this additional workload not projected by WBAMC to add into the contract inventory allotments for each kit in Appendix 1, in the firm, fixed-priced agreement, and final contract.

5.3.2.2. The actual workload may fluctuate from 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 Central Regional Medical Command. Appendix 1 provides option year workload numbers.

5.3.2.3. The analyzers shall maintain calibration curves for all of the assays listed in Appendix 1 simultaneously.

5.3.2.4. The Contractor shall clearly demonstrate an acceptable correlation between plasma and serum values during the initial set up and correlation studies. Table 5.3. tests shall be cleared for plasma testing and will not be accepted as a lab-developed test.

Table 5.3.–Assays That Shall be Approved for Use With Plasma Samples Acetaminophen Cortisol; Total Lactate Dehydrogenase (LDH) Alanine Amino Transferase

(SGPT)

C-Reactive Protein (CRP) Myoglobin

Albumin C-Reactive Protein, High Sensitive (HS-CRP)

Phosphorus Inorganic (Phosphate)

Alcohol (Ethanol) Creatinine Potassium Alkaline Phosphatase Creatinine Kinase (CK) Total Protein, Total Creatinine Kinase Mb Fraction

(CK-MB)

Procalcitonin

Amylase Digoxin Salicylate Aspartate Amino Transferase

(SGOT)

Gentamicin Sodium

Bilirubin (Direct) Glucose Theophylline Bilirubin (Total) Glutamyl transferase, Gamma

(GGT)

Troponin

Calcium (Total) Gonadotropin, Chorionic (hCG)

Urea Nitrogen

Carbamazepine Homocystine Vancomycin Carbon Dioxide (CO2) Lactate (Lactic Acid) Chloride

5.3.2.5. The assays listed in Table 5.3.1 shall be approved by the FDA for urine samples.

Table 5.3.1. – Listing of Assays That Shall be Approved for Use With Urine Samples Calcium (Total) Potassium Creatinine Protein, Total Microalbumin (Quantitative)

Phosphorus Inorganic (Phosphate)

Urea Nitrogen Sodium

5.3.2.6. The assays listed in Table 5.3.2 shall be approved by the FDA for CSF samples.

Table 5.3.2. – Listing of Assays That Shall be Approved for Use With CSF Glucose Protein

5.3.2.7. 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 at the beginning of each contract period.

5.3.2.8. The Contractor shall provide quality control materials IAW requirements outlined in the Laboratory QA program and approved by the Laboratory Director at no additional cost to the government.

5.3.2.9. Reagents shall have a minimum shelf life of three (3) months upon receipt by the government.

5.3.2.10. Reagents packs/cartridges shared between WBAMC, SFMC, and Mendoza shall be interchangeable.

Reagents packs that are loaded onto the laboratory line shall be compatible with the desktop analyzers at the other sites for those tests identified in Table 5.3.3.

Table 5.3.3 – Listing of Reagents that SHALL be interchangeable for all analyzers (WBAMC and Clinics) Albumin Alkaline phosphatase Alanine Amino Transferase (ALT) Amylase Aspartate Amino Transferase (AST) Bilirubin (Direct) Bilirubin (Total) Calcium Chloride Cholesterol Carbon dioxide (CO2) Human Chorionic Gonadotropin, Quantitative Prostate specific antigen

Creatinine Glutamyl transferase, Gamma (GGT) Glucose HDL cholesterol Potassium Protein (Total) Sodium Triglycerides Urea nitrogen Uric acid LDL Cholesterol T4, Free Thyroid Stimulating Hormone (TSH)

5.3.2.11. 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 be stable enough to maintain a single control run per 24 hours of testing. Calibration frequency for all assays outlined in Table 5.2.1 shall not be less frequent 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.

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

5.3.2.12.1. Be provided by the manufacturer of the equipment.

5.3.2.12.2. Be marked with the required storage temperature.

5.3.2.12.3. 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. Any supplies received out of temperature will not be accepted. These will be sequestered and the Contractor will be contacted to replace before any payment is made on supplies. Payment will not be made for any supplies received outside of temperature requirements.

5.3.2.13. 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.

5.4. Deliveries.

5.4.1. No drop shipments will be accepted. Deliveries and orders will be on an as-needed basis by the COR or Alternate Contracting Officer Representative (ACOR) as identified in the contract.

5.4.2. Orders shall arrive within one week of requested date of delivery. Temperature sensitive items will be shipped as overnight at no additional cost to the government to ensure reagent stability. If overnight cannot be accommodated then temperature transit/storage requirements shall still be met per 5.3.2.12.3. for these reagents to be accepted.

5.4.3. 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 COR will document Contractor’s inability to meet demands of the contract in the monthly COR report.

5.4.4. 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.

5.4.5. Deliveries for the three individual sites identified in this contract, WBAMC, Mendoza, and Soldier Family, shall have their own orders delivered directly to their site. All orders will not go to a central address to be distributed.

5.4.6. Preservation and packing - Preservation and packing shall be performed IAW the best commercial practices 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 shall be made Tuesday through Thursday, to exclude federal holidays.

5.5. BILLING AND PAYMENTS.

5.5.1. The Contractor shall provide a reagent/test list with each fixed price for the appropriate test upon award of the contract to the COR. This will be the firm, fixed price for the entire term of the contract to include option years.

5.5.2. The Contractor shall bill in WAWF within 30 days of receiving the billing statement.

5.5.2.1. The Contractor shall attach an itemized invoicing, breaking down into each individual test type, in WAWF for proper review of fixed test pricing in order for invoices to be paid.

5.5.3. The Contractor shall have an inventory monitoring system in place for each individual test.

5.5.5. If the Contractor is aware that the workload is exceeded for an individual CLIN or item, the Contractor shall not ship and shall contact the COR about the rejected processing.

5.6. ANCILLARY MAINTENANCE AND SERVICE

5.6.1. ANCILLARY MAINTENANCE. The Contractor shall furnish maintenance, services, repairs, and parts as required in order to maintain the systems in optimal operating condition.

5.6.1.2. 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 shall be provided and replenishment of all expended items shall 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.

5.6.1.3. 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.

5.6.1.4. 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.

5.6.1.5. 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.

5.6.2. 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 24 hours of establishing telephonic contact. The equipment shall be repaired and operational within 24 hours after initial response by the Contractor onsite. Should both instruments become inoperable, the Contractor’s technical specialist must be on-site within 12 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.

5.6.2.1. 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.

5.6.2.2. The Contractor shall replace all reagents, calibrators, controls and any other materials used by the government to troubleshoot the instrument failure prior to notification of the Contractor.

5.6.2.3. 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 correct the deficiency to a fully operational status IAW manufacturer specifications at no additional cost to the government.

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

5.6.2.2. Preventive maintenance (PM) services shall be performed IAW the manufacturer’s standards/procedures.

PM 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.

5.6.2.4. The Contractor shall notify the COR or ACOR of the exact date and time for performance of PM service within ten (10) days prior to the scheduled PM services. All PM and repairs must have a work order logged with Medical Maintenance for tracking purposes prior to contractor arrival onsite

5.6.2.4.1. 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 visitor badge. The badge shall be returned to the Equipment Management Branch prior to departing the MTF.

5.6.2.5. Within one (1) working day after completion of a repair, the Contractor’s representative shall furnish the COR 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

5.6.2.6. The government and the Contractor shall exchange hazard communication information before the commencement of any repair.

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

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

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

5.6.2.10. PM inspections and calibrations shall conform with manufacturer as specified in the manufacturer’s instrument maintenance manual.

5.6.2.11 When appropriate, the Contractor’s representative shall attach and complete a DD Form 2163 (sticker), entitled “Medical Equipment Verification/Certification” to the equipment upon completion of calibration services.

The COR shall provide the DD Form 2163 to the Contractor’s representative. If the DD Form 2163 is already attached to the equipment, the Contractor’s representative shall update the existing DD Form 2163. Procedures for updating the 2163 will be provided by the COR.

5.6.3. SERVICE:

5.6.3.1. The Contractor shall provide direct customer service and support 24 hours/7 days a week to include hotline telephone service (provided in English) and on-call emergency repair service support, to assist operators in correcting equipment operation problems.

5.6.3.2. The Contractor shall perform PM services (PMS), safety tests, calibrations, and unscheduled repair services IAW procedures and practices prescribed by the equipment manufacturer. The Contractor shall provide routine calibration services for those calibration procedures that are outside the scope of user responsibility.

5.6.3.3. The Contractor shall provide a full unscheduled and PMS throughout the contract. PMS shall be at no additional cost to the government inclusive of all costs for the performance of scheduled periodic maintenance (as required by the Contractor’s instrument maintenance manuals), unscheduled maintenance and repair of the analyzers and any associated equipment provided by the Contractor as part of the analyzer system, including replacement parts, replacement part shipment costs, and service technician travel costs for performance of maintenance services.

5.6.3.4. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding federal holidays.

5.6.3.5. The Contractor’s qualified service technician shall be on site to provide routine services; service requiring immediate repair; and one (1), two (2) or four (4) scheduled services for PM (as specified in the manufacturer’s instrument maintenance manual), safety and calibration as required by this statement of work. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.6.3.6. Upon analyzer failure, the Contractor’s qualified service technician shall be on-site to provide unlimited emergency service (service requiring immediate repair; an unscheduled maintenance/service requirement). The Contractor’s qualified service technician shall establish telephonic contact within 60 minutes of the government’s notification to the Contractor’s Customer Service “Hotline” and shall be on-site to provide unlimited emergency service (service requiring immediate repair) within twenty four (24) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.6.3.6.1. 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.

5.6.3.6.2. 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.

5.6.3.6.3. The Contractor’s qualified service technician shall ensure all repairs are completed and the analyzer is fully operational prior to departing the lab. In addition the service technician or Customer Service “Hotline” will verify the repairs corrected the problem and the analyzer is operational in a follow-up call. This call will be made in a timely fashion (not to exceed 24 hours) after the service technician departs the lab.

5.6.3.7. Emergency Services and unscheduled services outside regular working hours, on weekends, and on federal holidays shall be listed as a separate line item. These services shall be conducted in the same manner as all other emergency services.

5.6.3.7.1. Should both analyzers become inoperable, the technical repair specialist shall be on-site as…