W814K00-21-Q-0003_0001.pdf

0011450888

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 post and respond to questions, revise paragraph 1.6 and delete Appendix 1. The due date is not extended.

1. CONTRACT ID CODE PAGE OF PAGES

J 1 34

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

16C. DATE SIGNED

BY 09-Nov-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 W81K0021Q0003

X 9B. DATED (SEE ITEM 11)

28-Oct-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 is extended, X 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

09-Nov-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

See Item 6

FACILITY CODECODE

EMAIL:TEL:

W81K0021Q0003

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

QUESTIONS AND ANSWERS

RFQ W81K00-21-Q-0003 Questions and Answers

Question 1. There are several tests which are currently being performed on the existing BioPlex that are not included on this RFP. Do you want these tests included in the proposal?

Anti-phospholipid Syndrome:

Anti-Cardiolipin IgA Antibody Anti-Beta-2-GPI IgA Antibody Anti-Cardiolipin IgG Antibody Anti-Beta-2-GPI IgG Antibody Anti-Cardiolipin IgM Antibody Anti-Beta-2-GPI IgM Antibody

Herpes Simplex Virus:

HSV 1 IgG HSV 2 IgG

Answer 1. We do not need any of the tests above. They do not need to be in the solicitation response.

Question 2. The current agreement is a Cost Per Reportable where the CPR charge covers instrument, service and reagent costs. Do you want the same type of proposal for this RFP? Page 15 has a line item for the cost of the BioPlex. In the current agreement it is noted that the instrument and service costs are included with CPR. Do you want a purchase proposal?

Answer 2. We want a Cost Per Reportable arrangement that covers the instrument, service and reagent costs. No, we do not want a purchase proposal for Line 15.

Question 3. Appendix 1 - Workload and Mandatory Reagent List (page 168). The tests listed look to be allergy reagents for another instrument. Can this be corrected?

Response 3. Appendix 1 was included by error and has been removed from the solicitation.

The following have been modified:

PROCURMENT DESCRIPTION

ALLERGEN TESTING REQUIREMENT

1. GENERAL REQUIREMENTS:

1.1. SCOPE OF WORK: The Government will continue to use existing instrument in place at WBAMC as long as the instrument is serviceable. The Contractor shall provide necessary consumables/reagents as outlined in Appendix 1 for William Beaumont Army Medical Center. Consumables, calibrators, and maintenance support will be at no cost to the government. The Contractor shall perform to the standards of this Statement of Work (SOW).

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

1.2.1. The Contractor shall provide a Quality Control (QC) Plan that contains, at 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 non-concurrence shall be provided in writing to the Contracting Officer within 10 calendar days following receipt of the minutes.

1.3. HOURS OF OPERATION:

1.3.1. Normal Hours of Operation. WBAMC Monday through Friday 0700-1700.

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 PWS.

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 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 or his/her designated representative.

1.6.1. Equipment installed at the current William Beaumont location will not be moved to the new hospital location. Equipment onsite at 5005 North Piedras Street will stay until COR notifies vendor to decommission and remove from current location. Brand new equipment will be provided from the vendor at no additional cost at the Charlie Medics Way location upon notification of the COR. See Para 5.9 regarding Delivery of Equipment.

1.6.1.1. Equipment installation will occur upon vendor notification of the move. Equipment must be onsite and validated within 30 days of notification from the COR to ensure no break in service with patient testing. The only exception to this is Para 1.1.1. Dates and deadlines are outlined as such for the new hospital and equipment.

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 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.

1.9.1.3. The contractor employees will be registered with the Symplr© system for WBAMC.

Vendors must check in with Symplr© and report to Provost Marshal Office (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 vendor to the laboratory area.

1.9.1.4 Contractor employees will not be admitted to the department of pathology with 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: 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 MAMC 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 QA - Quality Assurance QA&I - Quality Assessment & Improvement QC - Quality Control

SOW

WBAMC

Statement of Work 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 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.

3.2.1 This contractor will provide one (1) Immunodiagnostic analyzer to William Beaumont Army Medical Center and one (1) brand new Immunodiagnostic analyzer to the new hospital.

Once new hospital equipment is installed and verification/calibration is complete, old equipment will be removed on or after October 1, 2020. See Para 1.6, Removal of Equipment and 5.9, Installation of equipment.

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

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.

3.4.1.1. Electrical facilities at the new facility will be fixed. Electrical specifications for equipment should be provided to the contractor prior to award to ensure equipment will be compatible with the new hospital space.

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

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

4. CONTRACTOR FURNISHED PROPERTY

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

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

4.3. Nametags. The Contractor shall furnish a nametag for each contract employee. The nametag will contain the name of the company and the employee and must be worn at all times when at the Government facilities.

5. SPECIFIC TASKS

5.1. DESCRIPTION

5.1.1. The Contractor shall provide (1) immunodiagnostic analyzer and necessary consumables/reagents as outlined in Appendix 1 for William Beaumont Army Medical Center.

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 at the termination of the contract.

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

- Any and all analyzers identified under Equipment, paragraph 3.2

5.1.1.2. The analyzer will be located at the following address for the one-month base:

William Beaumont Army Medical Center 18511 Charlie Medics Way El Paso TX, 79918

5.1.1. 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 vendor. The vendor will only be paid once validation is complete and patients are being run. This includes the equipment at the current WBAMC and the equipment placed at the new WBAMC location.

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

5.1.4.2. 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.

5.1.4.3. 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 vendor 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.

5.1.4.4. 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 be responsible for the collection and transportation of equipment upon termination of the contract.

5.2. ANALYZERS.

5.2.1. Contractor will provide at minimum one (1) Immunodiagnostic analyzer. If workload requires upon agreement with the contractor a second instrument may be required and space restrictions allow.

5.2.1.1. Vendor must be able to support all tests listed in Appendix 1.

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

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

5.2.2. Each analyzer system must come equipped with an un-interruptible 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 must come with a minimum 11 foot cable. Power plugs will be in the ceiling at this location

5.2.3. The analyzer systems and all reagents shall be approved by the Food & Drug Administration (FDA). The analyzer 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.

5.3. REAGENTS.

5.3.1. For WBAMC:

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

5.3.2.1. 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 required. The vendor must 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 price agreement and final contract.

5.3.2.3. 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.

5.3.2.4. The analyzers must be capable of maintaining calibration curves for all of the assays listed in Appendix 1 simultaneously.

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

5.3.2.6. 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.

5.3.2.7. Reagents must have a minimum shelf life of six (6) months upon receipt by the Government.

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

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

5.3.2.9.1. Be provided by the manufacturer of the equipment.

5.3.2.9.2. Be marked with the required storage temperature.

5.3.2.9.3. 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 vendor will be contacted to replace before any payment is made on supplies. NO payment will be made for any supplies received outside of temperature requirements.

5.3.2.10 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 at need 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 cost to the government to ensure reagent stability. If overnight, cannot be accommodated then temperature transit/storage requirements must still be meet 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 vendor’s inability to meet demands of the contract in CORT.

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

5.5. BILLING AND PAYMENTS.

5.5.1. The vendor must 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 vendor must bill in WAWF within 30 days of receiving the billing statement.

5.5.2.1. The vendor must 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 vendor must have an inventory monitoring system in place for each individual test.

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

5.6. ANCILLARY MAINTENANCE AND SERVICE

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

5.6.1.2. 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 will be provided and replenishment of all expended items will be made by the contractor, at no additional cost to the Government.

Replenishment shall be made as needed or on a periodic basis not to exceed the normal preventive maintenance cycle.

5.6.1.3. 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.

5.6.1.1. 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. 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.

5.6.1.1.1. 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.

5.6.1.1.2. 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.

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

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

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

5.6.1.1.6. The Contractor shall notify the COR or ACOR of the exact date and time for performance of a preventive maintenance service within ten (10) days prior to the scheduled preventive maintenance services.

5.6.1.1.7. Prior to performing Scheduled Maintenance and Unscheduled Repair Services work, the Contractor's representative shall report to and obtain from the Equipment Management Branch, at the MTF a Visitors Badge. The badge must be returned to the Equipment Management Branch prior to departing the MTF.

5.6.1.1.8. 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

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

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

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

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

5.6.1.1.13. Preventive maintenance inspections and calibrations must be performed in accordance with Contractor’s guidance as specified in the Contractor’s instrument maintenance manual.

5.6.1.1.14. 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 Contractors’ representative. If the DD Form 2163 is already attached to the equipment, the Contractors' representative shall update the existing DD Form 2163. Procedures for updating the 2163 will be provided by the COR.

5.6.2. SERVICE:

5.6.2.1. 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.

5.6.2.2. The Contractor shall perform Preventive Maintenance Services (PMS), safety tests, calibrations, and unscheduled repair services in accordance with procedures and practices prescribed by the manufacturer of the equipment.

5.6.2.3. 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.

5.6.2.4. Scheduled routine services shall be performed between 0730-1630 Monday-Friday, excluding Federal Holidays.

5.6.2.5. 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 preventive maintenance (as specified in the Contractor’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.

5.6.2.6. 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 equipment shall be repaired and operational within 48 hours after initial response by the Contractor.

5.6.2.6.1. 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.

5.6.2.6.2. 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.

5.6.2.6.3. 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) 6after the service technician departs the lab.

5.6.2.7. 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.

5.6.2.7.1. Should both analyzers become inoperable, the technical repair specialist shall be on-site as described in 5.6.2.6.

5.6.2.7.2. The Contractor’s qualified service technician shall be on-site to provide unlimited emergency service as described in 5.6.2.6.

5.6.2.7.3. If the equipment is out of service for longer than 48 hours (from the time of service technician’s arrival on site), the Contractor shall notify the Chief, Clinical Engineering Branch and the COR in writing as to the reason(s) (i.e., non-availability of parts, etc.) for non-compliance.

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

5.6.2.9. The Government will make the equipment available to the Contractor for servicing at such time and duration necessary to perform needed repairs.

5.7. TRAINING:

5.7.1. The Contractor shall provide initial on-site operator training to all technicians assigned to the Government site (i.e., WBAMC Dept. of Pathology Laboratory staff) prior to initiation of use of the analyzers for patient testing. In addition, the Contractor shall provide training for two (2) primary operators prior to delivery and installation of the analyzer offiste. Outside training will be at no additional cost (including transportation airfare, lodging, etc.) to the Government. The Contractor may charge the Government only for training services exceeding the basic requirement for a given year.

5.7.1.1. The on-site operator training shall be provided by qualified Contractor trained personnel using Contractor-owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and troubleshooting.

5.7.2. The Contractor shall provide one additional training slots per contract year, at the Contractor’s training site, at no additional cost (including transportation airfare, rental car, per diem, etc.) to the Government. The Contractor may charge the Government only for training services exceeding the basic requirement for a given year.

5.7.3. The Contractor shall provide on-site training for 2 technicians annually, between all three sites, at no additional cost to the Government or individual trainee.

5.7.4. The on-site operator training shall be provided by qualified Contractor-trained personnel using Contractor-owned instrumentation in a mobile environment. The training shall encompass basic operation, maintenance and advanced troubleshooting.

5.7.5. All training manuals/guides, instructional literature, and any other related written/electronic material shall be in the English language. Training shall include basic operation of the analyzers, troubleshooting procedures, performance of operator-level periodic preventive maintenance procedures, and use of the data management/quality control software.

5.8. INFORMATION MANAGEMENT.

5.8.1. The analyzer system shall (must) be capable of interfacing with the military hospital computer system, i.e., the Composite Health Care System (CHCS) and MHS Genesis. The Contractor must have an established driver compatible for interfacing the analyzer with the CHCS. The interface between the LIS and the analyzer shall must be bi-directional. No Patient Identifying Information (PII) will be stored on the analyzers at any time.

5.9. DELIVERY OF EQUIPMENT:

5.9.1. The Analyzers must be delivered in accordance with this SOW.

Equipment will be installed by 1 August 2020 at the location listed in Para 5.1. This period will be considered validation/verification timeframe and are considered at no cost to WBAMC until 1st patient day on September 1 2020 POP Date.

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

5.9.2. This installation will be treated as a first install.

5.10. MATERIAL SAFETY DATA SHEETS (MSDS)

5.10.1. 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 COR. 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 the following information: identification of the specific hazard, the required practice for the safe use of the product, first aid procedures, and what to do in the event of a spill or other mishap or accident.

6. INFORMATION SECURITY

6.1. TELECOMMUNICATION

6.1.1. All Contractor systems that communicate with Department of Defense (DoD) systems shall interconnect through the established Military Healthcare System (MHS) Virtual Private Network (VPN) Business to Business (B2B) gateway. For all Web applications, Contractors shall connect to a Defense Information Systems Agency (DISA)-established Web Demilitarize Zone (DMZ). All software must be approved through the DHA Software and Application Certification Assessment. Submission of DHA Application Request Worksheet must be completed within the six (6) months of contract award.

6.1.2. The Contractor shall follow Army Regulation 25-1, “Army Knowledge Management and Information Technology, AR 25-2, “Cybersecurity,” and DoD 6025.18-R, DoD Health Information Privacy Regulation.

6.1.3. In accordance with contract requirements, Contractors shall connect to the B2B gateway via a Contractor procured Internet Service Provider (ISP) connection. The Contractor shall assume all responsibility for establishing and maintaining their connectivity to the B2B gateway.

This shall include acquiring and maintaining the circuit to the B2B gateway and acquiring a Virtual Private Network (VPN) device compatible with the MHS VPN device.

6.1.4. The Contractor shall comply with DoD guidance regarding allowable ports, protocols and risk mitigation strategies and will provide, maintain and configure VPN concentrator that complies with DoD security standards.

6.1.5. All costs for VPN hardware and software shall be incurred by the Contractor.

6.1.6. The Contractor shall initiate, maintain, and document personnel security investigations appropriate to the Business Associate Representative’s responsibilities and required access to MEDCOM Sensitive Information (SI) as determined by the site Chief Information Officer.

6.1.7. The Contractor shall validate that systems authenticate users through the use of the Common Access Card (CAC) or CAC alternative as a part of a two-factor authentication mechanism on the business partner side of the VPN. The Contractor shall also identify the exact location from which remote operational control will take place from, the encryption that will be used, and how the vendor's technical users will maintain secure logon.

6.2. DEPARTMENT OF RISK MANAGEMENT FRAMEWORK (RMF) IMPLEMENTATION

PLAN

6.2.1. The Vendor shall provide information for the Risk Assessment Analysis to the Government for all networking IT applicability.

6.2.2. Vendors shall only offer items, which already have an Authorization to Operate (ATO), or items for which the Vendor agrees to go through the DHA RMF process and obtain an RMF

ATO.

6.2.3. Any offered system must meet DoD Cybersecurity/Risk Management Framework (RMF) and the attached Service Information Assurance (IA) requirements. Vendors are required to provide a statement with their quote that they agree to the Service Cybersecurity/IA Requirements, HIPAA requirements and B2B requirements that are attached to this RFO.

6.2.4. Vendors are required to provide a completed Joint Medical Device Risk Assessment Questionnaire (v1.1) for the offered system along with their offer. These should be provided by DHA Cyber Logistics.

6.2.5. RMF shall be evaluated as part of the System Capability Factor. Vendors must meet all the below RMF minimum requirements along with any additional RMF requirements listed/attached to the RFO. Vendors may be assigned strengths if they exceed any RMF minimum requirement and/or meet any RMF objective. Additionally, weaknesses may be assigned based on the vendor’s responses in the Joint Medical Device Risk Assessment Questionnaire (v1.1). RMF weaknesses may include; but are not limited to; deficiencies in architecture or software versions, other services having cancelled RMF efforts due to vendor non-responses or inability to get an RMF ATO, system having received a DATO from any service, and deficiencies that cannot be mitigated/accepted.

6.2.6. Submitting a quote for any requirement under this initiative constitutes full agreement to all specific Service IA requirements and the attached IA document.

6.2.7. Failure to agree to the attached Service IA requirements and to provide a completed Joint Medical Device Risk Assessment Questionnaire shall result in rejection of the vendors quote.

Failing to disclose that a system cannot meet IA requirements, failure to meet certification timeframes or failure to receive ATO may result in termination for cause in accordance with FAR 52.212-4(m).

ESTABLISHING INTERFACE:

(a) The system shall…