Solicitation Amendment 0001 W81K0022Q0109.pdf

W81K0022Q0109

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

POC: MEDINA L. WOODSON

3551 ROGER BROOK DR BLDG 3600

FORT SAM HOUSTON TX 78236-6200

0011774495

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print)

30-105-04EXCEPTION TO SF 30

APPROVED BY OIRM 11-84

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

FAR (48 CFR) 53.243

A. The purpose of this Solicitation Amendment 0001 is to:

1. Incorporate the revised Statement of Work dated 21 July 2022 resulting from the question & answ er segment.

2. Include the Government answ ers to questions received in response to this solicitation.

3. Attach the questionnaire for Exhibit 2-Medical Device Questionnaire Assessment.

4. Attach the HEM-A303 Lymphoma Leukemia Panel Selection (HEM)__uncontrolled_copy, and

5. Extend the solicitation closing date/time to 3 August 2022, 4:00 PM CST.

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

See SUMMARY OF CHANGES

1. CONTRACT ID CODE PAGE OF PAGES

1 43

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

16C. DATE SIGNED

BY 26-Jul-2022

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

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

8. NAME AND ADDRESS OF CONTRACTOR (No., Street, County, State and Zip Code) X W81K0022Q0109

X 9B. DATED (SEE ITEM 11)

14-Jul-2022

10B. DATED (SEE ITEM 13)

9A. AMENDMENT OF SOLICITATION NO.

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

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

Offer must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended by one of the following methods:

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

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN

REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

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

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

A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE

CONTRACT ORDER NO. IN ITEM 10A.

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

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

D. OTHER (Specify type of modification and authority)

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

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

10A. MOD. OF CONTRACT/ORDER NO.

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

6. ISSUED BY

3. EFFECTIVE DATE

26-Jul-2022

CODE

W40M USA HLTH CONTRACTING ACT

REGIONAL HEALTH CONTRACT OFF CENTRAL

2539 GARDEN AVENUE

FT SAM HOUSTON TX 78234-0000

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

4. REQUISITION/PURCHASE REQ. NO.

CODE W81K00

FACILITY CODECODE

EMAIL:TEL:

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION SF 1449 - CONTINUATION SHEET

The following have been added by full text:

QUESTIONS & ANSWERS

Vendor Questions and Government Response for Solicitation W81K00-22-Q-0109

1. Question about Item No 0001AD (Residuals) on page 4 of the solicitation. I believe this refers to the reflex panels performed on Leukemia/Lymphoma patients after the initial screening panel is run. I think the labs reflex testing consists of 6 additional panels. If my assumption is correct, does the quantity of 138 represent an aggregate of all reflex panels run, or is it 138 per each reflex panel?

Government Response: Residuals shouldn’t apply as there should be no “residuals” please see the current attached SOW.

2. We are not aware of any vendor that has all of these tests IVD cleared and available on a single piece of hardware. Would a Laboratory Developed Test (LDT) equivalent be sufficient for the testing menu? The FDA allows this for flow cytometry testing/reimbursement.

Government Response: Yes, we have to do LDTs for most of the panels we want because the vendors only supply a limited number of pre-validated panels.

3. Should this solicitation be for two (2) Flow Cytometer analyzers? The solicitation only says one (1) but the other peripheral items (monitors, printers etc...) suggest this is for two (2) cytometers.

Government Response – Yes, the solicitation should be for two analyzers to ensure ability to divide work and have backup platforms. See revised SOW.

4. Will the DoD accept responses that are unable to follow RMF Assessment requirements? For example: RMF requires automatic patching of computer operating system. However, Beckman Coulter Navios Flow Cytometer cannot permit automatic patching as several window updates are incompatible with CXP software.

Government Response: If the device is not RMF compliant it cannot go on the network and you won’t be able to get a waiver to circumvent RMF.

5. Does the Military Health System (MHS) Genesis FFP system support ASTM or HL7 communication?

Government Response: Genesis does support ASTM and HL7.

6. We had sent a quote and information for both the cytometers and the PS10 for automated sample prep.

When our Flow Team met with the lab earlier this year both the technicians and the new flow pathologist seemed interested about the PS10 especially the automated cocktailing and error elimination features. Should we calculate pricing for the full flow system (both the cytometers and the sample prep instrument)? Would the lab want to see a quote with these instruments separated? Our sample prep system can be used with other flow cytometers (vendors).

Government Response: Please submit a quote for the following:

1. Sample prep system and two instruments

2. Two instruments only

3. Sample prep system only

7. Questions have arisen around RMF requirements. Can you please let us know if a DIACAPP certification or waiver was granted in Contract # W81K00-18-D-0004? This is our previous generation Flow Cytometer equipment currently in use at BAMC. This will help us to determine how best to respond to the current solicitation with the newer units.

Government Response: If the device is not RMF compliant it cannot go on the network and you won’t be able to get a waiver to circumvent RMF.

8. I am looking for clarification on the below as to whether the request is for a traditional CPT with a set payment per month which covers the equipment, service, reagents, consumables/controls …. Or if it is a reagent rental where they are contractually obligated to hit $___ per year based on volume and we bill and invoice reagents as they are ordered.

Government Response: This requirement will be a Traditional Cost-Per-Test Agreement with a set payment per month which covers the equipment, service, reagents, consumables/controls, etc.

9. Could you please provide the questionnaire for Exhibit 2-Medical Device Questionnaire Assessment? The

SAM.gov posting only contains the requirements.

Government Response: The Government will provide the questionnaire for the Exhibit 2-Medical Device Questionnaire Assessment as an attachment with this Solicitation Amendment.

10. BD is reviewing your solicitation W81K00-22-Q-0109. Exhibits 2 & 3 appear to be the same document?

We are looking for risk assessment questionnaire. Can you please send all of the documents…In addition, we may need additional time to complete this solicitation since there are many issue relating to security that we are reviewing.

Government Response: The Government will provide the questionnaire for the Exhibit 2-Medical Device Questionnaire Assessment as an attachment with this Solicitation Amendment and the proposal due date will be extended until Wednesday, 3 August 2022.

11. Per Item NO 0001AA on page 3 of the solicitation (Leukemia/Lymphoma Panel), does the lab run 1074

Leukemia Panels per year and 1074 Lymphoma Panels per year?

Government Response: It is the total number of panels of those types. There is an algorithm you can share (attached) that determines how they set up/utilize the two panels.

REVISED STATEMENT OF WORK

1. SCOPE

The Contractor shall provide FLOW CYTOMETRY equipment and reagents used in support of the FLOW CYTOMETRY Laboratory mission at San Antonio Military Medical Center (SAMMC), Joint Base San Antonio, TX 78234.

The Contractor shall provide Flow Cytometry testing, to include equipment, tools, materials, training, and other items (water purification system, UPS) and services necessary to meet the Flow Cytometry mission of the San Antonio Military Medical Center, JBSA, Fort Sam Houston, TX. All supplies and equipment outlined in this Statement of Work (SOW) must be supplied and serviced through a single Contractor (to whom the contract is awarded) All costs integrated into this contract must be calculated as cost per reportable result. The Contractor shall be responsible for maintenance service, on-site repair and parts as required. The machines must be in operational status for testing samples 98% of the time during the department’s hours of operation Monday through Friday. All testing materials to include reagents, equipment, etc., must be FDA approved platforms.

2. DEFINITIONS/ACRONYMS

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

2.2. 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.

2.3. 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

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

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

2.6. QUALITY IMPROVEMENT (QI): Those actions taken by the Government, inaccordance with

BAMC DPALS Quality Plan, relevant CSLI standards for quality, AR 40-68, to assure services meet the requirements of the SOW.

2.7. ACRONYMS/ABBREVIATIONS.

AR - Army Regulation

AFI - Air Force Instruction AFMS - Air Force Medical Service

BUMED - U.S. Navy Bureau of Medicine and Surgery CAP - College of American Pathologists COR - Contracting Officer's Representative DA - Department of the Army

DAF - Department of the Air Force

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 SOW - Statement of Work

QA - Quality Assurance

QA&I - Quality Assessment & Improvement

QC - Quality Control SOW - Statement of Work

3. QUALITY CONTROL (QC) AND QUALITY ASSURANCE (QA)

3.1. The Contractor shall provide a Quality Control (QC) Plan that contains, as a minimum, the items listed in 3.2 (below) to the Contracting Officer (KO) and Contracting Officer Representative (COR)/DPALS POC for acceptance not later than 21 calendar days after the start of the contract. 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.

3.2. The QC Plan shall include:

3.2.1. A description of the inspection system to cover all incidental support and maintenance services listed on the Performance Requirements Summary (PRS). 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.

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

3.2.3. 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.

3.3. Quality Assurance (QA). For those tasks listed on the PRS, the Contracting Officer Representative (COR)/DPALS POC Ordering Officer will follow the methods of surveillance specified in this contract.

Government personnel will record surveillance observations, as needed, and provide to the Contractor.

The receipt of the observation does not necessarily constitute concurrence with the observation, only acknowledgment that the Contractor has been made aware of the defective performance. Government surveillance may include additional 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.

3.4. 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 12.4.5. and 12.5.6.(below).

3.5. Meetings:

3.5.1. The Contracting Officer may require the Contractor to meet with the Contracting Officer and/or Ordering Officer, as deemed necessary.

3.5.2. 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.

3.5.3. During the installation and validation of the equipment and tests to be performed, the Contractor will coordinate scheduled meetings with technical experts of the Laboratory to discuss milestones and to provide updates on completion date. Following the completion of the installation of the new equipment and validation of the tests to be performed, the Contractor will meet with technical experts from the Laboratory at times mutually agreeable to discuss areas of interest to the Laboratory or hospital staff. When the validation of the equipment and tests are to be performed, the Contractor shall provide all reagents, calibrators, controls and any other materials used at no additional cost to the

Government. The contractor will provide analyzed data to laboratory supervisor for approval. If the validations are not found to be adequate, the Contractor will be responsible for repeating studies in a timely manner in order for the laboratory to meet go live deadlines.

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

4.HOURS OF OPERATION

4.1. Normal Hours of Operation: Monday through Friday from 0700 – 1630 CST.

4.2. 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 12.5. of this SOW.

4.3. The Contractor shall provide equipment maintenance and IT service/direct customer service and support during normal hours of operation and 24 hours/7 days a week for hotline telephone service.

4.4. Federal Holidays. The following Federal holidays will be observed by the Government: New Year’s Day 1 January Martin Luther King’s Birthday Third Monday in January President’s Day Third Monday in February Memorial Day Last Monday in May

Juneteenth 19 June

Independence Day 4 July

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day 11 November

Thanksgiving Day Fourth Thursday in November

Christmas Day 25 December

NOTE: Any if the above Federal holidays fall on a Saturday, the holiday 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 addition to and in the same manner as the holidays listed above.

5. CONTRACTOR PERSONNEL

5.1. All Contractor personnel must adhere to all required reporting procedures for BAMC prior to reporting to the laboratory for work, etc. Current procedures will be available through the COR or

ACOR.

5.2. 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.

5.3. Contract employees must adhere to security standards set forth in section 14 Information Security.

5.4. Contractor and Contractor employees must adhere to DoD 6025.18-R “Department of Defense Health Information Privacy Regulation,” January 24, 2003 (Appendix A).

5.5. Contractor and Contractor employees must adhere to Information Assurance Standards- General Security, Personnel Security, Electronic Security and Information Systems (IS)/Networks Physical Security Requirements as stated in (Appendix B).

6. GOVERNMENT-FURNISHED FACILITIES, EQUIPMENT,

MATERIAL, AND SERVICES.

6.1. The Government will provide, without additional cost to the Contractor, the facilities, equipment, materials, and services listed below:

6.1.1 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.

6.1.2. EQUIPMENT. No equipment will be provided.

6.1.3. MATERIALS. No materials will be provided.

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

6.2. 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.

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

7. CONTRACTOR FURNISHED PROPERTY

7.1. General. Except for those Government-furnished items and services specified in section 5, the Contractor shall furnish all items, equipment, and incidental support and maintenance services required under this contract. All such items supplied by the Contractor shall conform to the applicable Safety and Health Standards as indicated in the current code of federal Regulations, Title 29, Chapter XVII, paragraph 1910, Occupational Safety Health Act of 1970.

7.2. 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.

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

8. DOCUMENTS/RECORDS.

8.1. 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.

8.2. The Contractor must provide paper and electronic copies of material safety data sheets (SDSs) for each reagent item delivered under this contract (as appropriate).

9.INSTRUMENTATION

9.1. Flow Cytometry 10 Color Analyzer for the SAMMC CORE FLOW Laboratory. Contractor shall provide the necessary equipment/analyzers, required reagents, calibrators, consumables, controls with catalog numbers and installation.

9.2. Four (4) Prep Workstations

9.3. Four (4) 20” LCD computer monitors

9.4. Must have sample carousel capable of holding 32 sample tubes or more.

9.5. Must have barcode reader capable of reading Code 39 barcodes.

9.6. Unaffected by ambient room temperature variations.

9.7. Instrument to instrument variation < 3% CV to insure comparable results (i.e., same sample run on multiple instruments during the same day will generate the same result).

9.8. Automated cell processing station required for standardized whole blood lysis and washing with a minimum 60 samples/hour processing capability.

9.9. Sample tube mixing on-board prior to sample acquisition – individual tube mixing preferred.

9.10. Sample carryover <0.1%.

9.11. Capable of resolving particles ≤ 1 µm in size from background noise.

9.12. Data acquisition rate ≥ 10,000 events/second.

9.13. Ability to perform leukemia/lymphoma panels on blood, bone marrow, tissue, and body fluids with broad range of surface and cytoplasmic B-cell, T-cell, and myeloid antibodies with premixed antibody panels.

9.14. Ability to perform single platform stem cell and CD3 enumeration on peripheral blood and apheresis products.

9.15. Ability to perform CDC basic panel (lymphocyte subtyping with

CD3/CD4/CD8/CD19/CD56).

9.16. Ability to print color scatterplots and store scatterplot data for at least 2 years.

9.17. Ability to perform Hairy Cell, Plasma Cell, Sezary Cell testing.

9.18. Must include LGL tubes and cytoplasmic testing.

9.19. Must include all other computer hardware/software required for the use of the analyzers

9.20. System redundancy required.

9.6. Operational hours for flow cytometry are identified in Paragraph 4. All maintenance is done during operational hours. Initial startup from the shutdown state shall not exceed 30 minutes

9.7. System must provide data management/editing software for test results. Manufacturer software with full editing tools, storage of previous patient data,

9.8. Peripherals, to include Uninterruptable Power Sources (UPSs) capable of providing all necessary electrical power to each analyzer system, to include the data management system for 20-30 minutes.

The Contractor is responsible to ensure the UPS remains operable throughout the length of the contract. Other items include electrical line conditioners as required, instrument-specific computer terminals/CPUs and printers.

9.9. The system must not require remote communication to outside sources to be functional.

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

9.11These analyzer systems shall be capable of producing measurable results throughout the manufacturer's stated linearity/analytic measurement range.

9.12. 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 Table 1. An operator level maintenance tool/spare parts kit will be provided by the contractor and replenishment of all expended items, 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.

9.13. All instrumentation required to complete testing for a particular laboratory must be located in one designated area without violating OSHA or local safety regulations regarding instrument clearance, egress width, etc. Configuration must be approved by the end user.

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

9.15. The analyzer systems shall be approved by the Food & Drug Administration (FDA) for performing all tests listed in Table 1. 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.

9.16. The analyzer shall (must) have the on-board ability to maintain required reagents at the proper storage temperatures. All assays must be FDA approved.

9.17. INFORMATION MANAGEMENT.

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

9.17.2. The analyzer system shall (must) include a data management system for control of the operation of the analyzer system, management of the quality control program, management of the on-instrument useful life of the reagents/reagent packs, and management of patient results; and a printer for the production of hard copy patient reports and other reports generated via the analyzer system’s data management system. The Data Management system shall have a comprehensive, fully-integrated Quality Control (QC) software module that stores and evaluates quality control results.

Results can be viewed in a variety of formats including Levy-Jennings charts, and statistical summaries. The application shall validate QC results by checking them against user selected rules and automatically alert the operator when a rule violation has occurred. 9.24.3. The QC software shall have a large capacity to store graphics and results, cumulative patient reports and quality control files with statistics - all available to user.

9.17.3. Data Management system shall (must) have a user friendly "Windows Based" interface that shall include a data management system for operational control of the analyzer system, management of the QC program, on-instrument useful life of the reagents/reagent packs, and management of patient results.

9.17.4. The software shall provide a single operator interface for workload management, data management, and instrument operational status monitoring. The software controls the operations of the analyzer, monitors the lot number expiration date of on-board reagents and control materials. This shall be accomplished via communication connections between the automation, analyzers, and hospital Laboratory Information System (LIS).

9.17.5. The results management application shall manage patient data, sample and QC results by offering archiving, status, calculation of results and long-term results storage.

9.17.6. The software shall provide proactive monitoring of key instrument parameters to allow for predictive diagnostics.

9.17.7. Store patient results for a minimum of 12-months.

9.17.8. The analyzers and its components to include the workstation should not exceed the following dimensions (7.5 ft wide, 2.5 feet deep and 2 ft high) and should be a tabletop analyzer. There is no floor space for anything larger than tabletop.

9.17.9. All computer systems connecting to the network and MHS Genesis must be RMF compliant, have an authority to operate (ATO) and be Health Insurance Portability and Accountability Act (HIPAA) compliant.

9.17.10. Government requires delivery of the analyzer/ instrumentation within 30 days and correlated, validated and connected to the DHA system before or on 1 October 2022.

Table 1. Mandatory Tests/Functions and Estimated Volumes

Test Base Option 1 Option 2 Option 3 Option 4

LEUKEMIA/LYMPHOMA

PANEL

CDC BASIC 2561 2561 2561 2561 2561

CD34

90 90 90 90 90

VIABILITY 59 59 59 59 59

10. REAGENTS AND SUPPLIES

10.1. 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 Table 1.

10.2. Shelf life greater than 3 months if in liquid form; greater than 6 months if lyophilized.

10.3. Monoclonal antibody-fluorochrome combinations preferred. Antibody clones must be available with multiple fluorochromes to increase testing/panel flexibility.

10.4. Lyophilized reagents with standard reconstitution volumes and diluent preferred.

10.5. Provided reagents must be FDA-classified IVD or ASR reagents – no RUO reagents can be used to meet testing requirements.

10.6. Capability of vendor to provide defined pre-mixed panels.

10.7. The Contractor shall provide quality control materials sufficient to run every 24 hours and to be used as needed for trouble shooting, etc. Reagents used for troubleshooting analytical systems must be reimbursed (or replaced) by the Contractor at no additional cost.

10.8. The Contractor shall pre-program and adjust program as necessary for all quality control, maintenance, calibrator material in vendor provided racks or testing containers.

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

10.5. 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 Table 1. An operator level maintenance tool/spare parts kit will be provided by the contractor and replenishment of all expended items, 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. Reagents shall (must) have a minimum shelf life of six (6) months upon receipt by the Government, or, if this shelf life requirement cannot be met, the Contractor shall (must) identify the guaranteed shelf life after receipt that can be accommodated in their response to the Request for Proposal.

10.6.. 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.. 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.

10.7. All reagents/calibrators/QC materials provided must be FDA approved for use in the systems stated in Section 9. All reagents/reagent packs shall be provided as follows:

10.8 Be provided by the manufacturer of the

equipment. 10.8.1. Be marked with the required storage temperature.

10.8.2. 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.

10.9. 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.

10.10. The Contractor shall provide linear materials for all testing that spans the vendor’s published analytical measuring range (AMR) every six-months and as needed to verify repairs per the College of American Pathologist (CAP) inspection criteria.

10.11. The Contractor must include access to peer-group quality control programs and all training at no additional cost.

11. SPECIFIC TASKS

11.1. 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. Additionally, the installation of equipment may need to be performed in a phase process at no additional cost to the government.

11.2. The Contractor must assign a Project Manager and IT Project Manager to oversee all operations up to go-live, to include transition and validations. The total transition period (up to the go-live date) must be no more than 90 days.

11.3. During the initial implementation, a primary, dedicated technical representative must be assigned and available on site throughout the entire implementation period and go-live.

Substitutions must be coordinated with and approved by the CORE/DPALS POC.

11.4. Method validation

11.4.1. Method Validation will be conducted entirely by the Contractor 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 C (below) are the minimum guidelines that will be referenced when conducting method validation. Additional guidelines may be required, depending on regulatory requirements.

11.4.2.. Method Validation will include but not be limited to, reference 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 (within day and between day) and accuracy (recovery study), plasma/serum correlation studies, carryover studies and establishment of initial control ranges using control materials, as designated by the DPALS POC.

11.4.3. All data collected for method validations will be provided to the government in a manner appropriate for review. Statistical analysis of all method validations will be reviewed and approved in accordance with CAP guidelines prior to reporting of patient results. Payment will not begin until the analyzer system has been approved for reporting of patient results.

11.4.4. The Contractor shall provide a team of qualified Technical Service Representatives (TSRs) that possess a thorough knowledge of method validation and is familiar with the use of the Lab’s current statistical evaluation software to provide technical assistance for the method validation studies.

The assigned Contractors will be responsible for the entire method validation. The team must complete method validation within 1 month of installation. In the event of instrument/facility failures, new deadlines will be agreed upon by the contractor and Contracting Officer.

11.4.5.. All reagents, calibrators and linearity materials used in the method validation will be provided by the Contractor at no additional cost to the Government. These materials will not be used in the analysis of specimens for patient care. When new tests or new Generations of reagents are available/added, the Contractor will perform all necessary validation studies and supply all necessary reagents, calibrators, linearity materials.

11.4.6. 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.

11.5. Work flow analysis

11.5.1. Specific instrument layout and selection of pre-analytic and post-analytic processes will be determined by a detailed, comprehensive workflow analysis.

11.5.2. The workflow analysis shall be conducted IAW commonly accepted industry standards for maximizing efficiency as outlined in the PMBOK® Guide 3rd Ed, and Lean/Six Sigma principles.

The workflow analysis shall focus on maximizing efficiency, throughput, and minimizing turn-around-times.

11.6. Both the Contractor and Contractor personnel shall abide by all Health Insurance Portability & Accountability Act of 1996 (HIPAA) regulations and Information Technology (IT)/Security requirements and as outlined in Appendices A and B.

11.7. The Contractor shall provide two (2) paper and two (2) electronic (CD) copies of the Operator’s and Maintenance manuals and a statement of the warranty terms in the English language. The level of detail required of appropriate instrument maintenance manuals extends only to routine maintenance procedures performed by the user. All instrumentation specified is non-Government owned equipment that is provided, serviced, and maintained by the Contractor.

11.8. The Contractor shall provide print and electronic copies of all safety data sheets (SDS) for each item delivered under this contract that is considered to be HAZARDOUS MATERIAL by the United States. The SDS shall contain information on the hazards associated with each specific chemical or material. The SDS shall 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.

11.9. The Contractor shall provide the reagents and shall coordinate exact quantities and shipment schedule with the COR prior to shipment IAW Section 12 Deliveries and Installation (below).

12. DELIVERY AND INSTALLATION

12.1. All systems must be delivered to the appropriate location indicated below within 30 calendar days after contract award. The Analyzers shall (must) be delivered to the location as indicated below and match renovation timeframes (if applicable) as indicated during post-award site-visit. Equipment setup, on-site training, method validation studies, and analytical measurement range/linearity verification, shall (must) be completed by Contractor personnel to ensure that equipment is fully operational. 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.

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

12.2. Exact installation locations at the primary locations shall be coordinated by the Contractor with the point of contacts listed below. A memorandum on Contractor’s letter head will also be provided to the individual below at the time of installation that includes all serial numbers, names, costs and any additional information identified for each piece of equipment.

The Point of Contact (POC) for all deliveries:

NCOIC, Core Laboratory Department of Pathology San Antonio Military Medical Center

Tel: (210) 916-9062/3386/3625

12.3. Deliveries of required items shall be quarterly standing order or as called in by the COR/DPALS POC. The Contractor will provide, upon shipment, an electronic tracking mechanism whereby the Government is able to identify the shipping status of any equipment, reagents, or materials. Large items (e.g., 20L and above), must be shipped in a split order to arrive 2 weeks apart.

12.4. The Contractor needs to specify the last date that a standing order can be modified for a single delivery and/or all subsequent orders.

12.5. Orders shall arrive on the date agreed upon and if the scheduled date is a Federal Holiday (listed above), the delivery will be scheduled for the day following the Federal Holiday.

12.6. Any supplies that are placed on back order shall be clearly identified on the shipping documents and shall be delivered in a timely manner, not to exceed ten (10) working days. In the instance a back-order exceeds 10 working days, the Contractor shall provide testing services through local sub-contract at no cost to the government.

12.7. 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. Contractor will notify the Government via email and telephonic message when an order is not available or capable to be shipped within these timelines.

12.8. For all orders, standing or emergency, the Contractor shall notify via email the designated points of contact that orders have shipped and provide a tracking number.

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

12.10 Removal/Replacement-The Contractor shall be responsible for the collection and transportation of equipment upon termination of the contract at no cost to the government.

13. Maintenance and Service

13.1. 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.

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

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

13.1.3. The Contractor shall provide a full unscheduled and preventive maintenance service for the lease period at no additional cost. Service shall include repair and replacement of defective parts, complete maintenance program (as required by the manufacturer’s maintenance manuals), and hotline telephone service, to assist operators in troubleshooting problems in accordance with paragraph 13.3.1. of this SOW.

13.2. REPAIR.

13.2.1 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 twelve (12) hours of establishing telephonic contact. The equipment shall be repaired and operational within 48 hours after initial response by the Contractor. 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.

13.2.2. 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.

13.2.3. 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.

13.2.4. 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.

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

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

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

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

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

MTF.

13.2.7. Within 2 business days after completion of a repair, the Contractor’s representative shall furnish via email 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

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

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

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

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

13.2.12. 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 government.

13.3. SERVICE:

13.3.1. 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 and IT problems.

13.3.2. 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.

13.3.3. The Contractor shall provide a full unscheduled and PMS throughout the contract.